1 NO. 90-CI-6033            JEFFERSON CIRCUIT COURT
                                    DIVISION ONE (1)
 2 
   
 3 JOYCE FENTRESS, ET AL.                 PLAINTIFFS
   
 4 
   VS.
 5 
   
 6 SHEA COMMUNICATIONS, ET AL.            DEFENDANTS
   
 7 
                   * * * * * * * * * *
 8 
   
 9              DEPOSITION FOR PLAINTIFFS
   
10 
                   * * * * * * * * * *
11 
   
12 
   DEPONENT:    JAN POTVIN, PH.D.
13 
   
14 DATE:        JUNE 16, 1993
   
15 
   
16                 * * * * * * * * * *
   
17 
   
18 
   REPORTER:     KATHY NOLD
19 
   
20 
                       KENTUCKIANA REPORTERS
21                           SUITE 260
                       730 WEST MAIN STREET
22                  LOUISVILLE, KENTUCKY  40202
                          (502) 589-2273

                                                 Page 1

 1 
   
 2            UNITED STATES DISTRICT COURT
              SOUTHERN DISTRICT OF INDIANA
 3                INDIANAPOLIS DIVISION
   
 4 IN RE ELI LILLY AND COMPANY  )
     Prozac Products Liability  )  MDL Docket No. 907
 5   Litigation                 )
   
 6                 * * * * * * * * * *
   
 7                   NO. 91-02496-A
   
 8 JACKIE LYNN BIFFLE, ET AL  )  IN THE DISTRICT
                              )  COURT OF
 9 V.                         )  DALLAS COUNTY, TEXAS
                              )
10 ELI LILLY & COMPANY AND    )  14TH JUDICIAL
   DISTA PRODUCTS COMPANY     )  DISTRICT
11 
                   * * * * * * * * * *
12 
                     NO. 92-14775-E
13 
   RICHARD HAROLD CROSSETT, JR.,       ) IN THE
14 CHAD H. CROSSETT, AMY MICHELLE      ) DISTRICT
   CROSSETT AND KRISTEN ANN CROSSETT,  ) COURT OF
15 INDIVIDUALLY AND AS SURVIVORS OF    )
   AND ON BEHALF OF THE ESTATE OF      )
16 JOCQUETTA ANN CROSSETT, DECEASED    )
                                       )
17 V.                                  ) DALLAS COUNTY,
                                       ) TEXAS
18 ELI LILLY & COMPANY, DISTA          )
   PRODUCTS COMPANY, TEXAS             )
19 PSYCHIATRIC COMPANY, INC.           )
   D/B/A/ HCA WILLOW PARK              ) 101ST JUDICIAL
20 HOSPITAL, JAMES K. WITSCHY, M.D.,   ) DISTRICT
   AND DOUG BELLAMY, ED.D.             )
21 
                   * * * * * * * * * *
22 
                     NO. A-921,405-C
23 
   MARIA GUADALUPE REVES               ) IN THE
24 INDIVIDUALLY AND AS NEXT            ) DISTRICT COURT
   FRIEND OF GRANT JULIAN REVES        ) OF

                                                 Page 2

 1 A MINOR CHILD, AND ON BEHALF        )
   OF THE ESTATE OF CHRISTIAN          )
 2 MARIE REVES, DECEASED               )
                                       ) ORANGE COUNTY,
 3 V.                                  ) TEXAS
                                       )
 4 ELI LILLY & COMPANY, DISTA          )
   PRODUCTS COMPANY, RAVIKUMAR         )
 5 KANNEGANTI, M.D., HOSPITAL          )
   CORPORATION OF AMERICA, A           )
 6 TENNESSEE CORPORATION, HEALTH       )
   SERVICES ACQUISITION CORP.,         )
 7 A DELAWARE CORPORATION,             )
   HCA PSYCHIATRIC COMPANY, A          )
 8 DELAWARE CORPORATION, TEXAS         )
   PSYCHIATRIC CO., INC.. A/K/A        )
 9 AND/OR D/B/A HCA BEAUMONT           )
   NEUROLOGICAL HOSPITAL, AND HCA      )
10 HEALTH SERVICES OF TEXAS, INC.      ) 128TH JUDICIAL
   A/K/A AND/OR BEAUMONT               ) DISTRICT
11 NEUROLOGICAL HOSPITAL               )
   
12                 * * * * * * * * * *

                                                 Page 3

 1 
           IN THE UNITED STATES DISTRICT COURT
 2          FOR THE WESTERN DISTRICT OF TEXAS
                  SAN ANTONIO DIVISION
 3 
   ELIZABETH T. SANCHEZ,          )
 4 INDIVIDUALLY AND AS THE        )
   SURVIVING SPOUSE, MARGARET R.  )
 5 SANCHEZ, INDIVIDUALLY AND NEXT )
   OF FRIEND OF DEBRA JEAN        )
 6 SANCHEZ, VERONICA MARIE        )
   SANCHEZ, EDWARDO ESTEBAN       )
 7 SANCHEZ, AND MICHAEL ANTHONY   )
   SANCHEZ, CHILDREN; AND ALL ON  )
 8 BEHALF OF THE ESTATE OF        )
   EDWARDO SANCHEZ                )
 9                                )
   V.                             ) CIVIL ACTION NO.
10                                ) SA93CA367
   ELI LILLY AND COMPANY AND      )
11 DISTA PRODUCTS COMPANY         )
   
12                 * * * * * * * * * *
   
13         IN THE UNITED STATES DISTRICT COURT
           FOR THE SOUTHERN DISTRICT OF TEXAS
14                  HOUSTON DIVISION
   
15 MARIA SANCHEZ, INDIVIDUALLY    )
   AND AS NEXT FRIEND OF DEBORAH  )
16 SANCHEZ, VERONICA SANCHEZ,     )
   EDDIE SANCHEZ, AND MICHAEL     )
17 SANCHEZ, AND ON BEHALF OF THE  )
   ESTATE OF EDUARDO SANCHEZ      )
18                                )
   V.                             ) CIVIL ACTION NO.
19                                ) H-93-1469
   ELI LILLY AND COMPANY AND      )
20 DISTA PRODUCTS COMPANY, A      )
   DIVISION OF ELI LILLY AND      )
21 COMPANY                        )
   
22                 * * * * * * * * * *

                                                 Page 4

 1 
   STATE OF NEW YORK
 2 
   SUPREME COURT        COUNTY OF JEFFERSON
 3 _____________________________________________
   
 4 STEPHANIE CAPONE, AS EXECUTOR OF THE
   ESTATE OF JOSEPH J. CAPONE, JR., AND
 5 STEPHANIE CAPONE, INDIVIDUALL,
                                     NOTICE TO TAKE
 6                   PLAINTIFF,      DEPOSITION UPON
                                     ORAL EXAMINATION
 7 
           VS.                       INDEX NO. 93-251
 8 
   ELI LILLY AND COMPANY, DISTA PRODUCTS
 9 COMPANY, A DIVISION OF ELI LILLY AND
   COMPANY, FLOYD BAJJALY, M.D,
10 
                    DEFENDANTS.
11 _____________________________________________
   
12                 * * * * * * * * * *
   
13 SUPREME COURT OF TEH STATE OF NEW YORK
   COUNTY OF ORANGE
14 --------------------------------------X
   BRUCE R. MALEN AS EXECUTOR OF THE     : INDEX NO.
15 ESTATE OF BARBARA E. MALEN, AND OF    : 4119/92
   BRUCE R. MALEN, INDIVIDUALLY,         :
16                                       : HON. PETER
       PLAINTIFF                         : PATSALOS,
17                                       : J.S.C.
               -against-                 :
18                                       :
   ELI LILLY & COMPANY, DISTA PRODUCTS   :
19 COMPANY, A DIVISION OF ELI LILLY &    :
   COMPANY, BARRY SINGER AND UNITED      :
20 HOSPITAL,                             :
                                         :
21     DEFENDANTS.                       :
   --------------------------------------X
22 
                   * * * * * * * * * *

                                                 Page 5

 1 ---------------------------------X
   VALARIE J. FRIEDMAN AND DAVID    : SUPERIOR COURT
 2 FRIEDMAN, HER HUSBAND,           : OF NEW JERSEY
                                    : LAW DIVISION:
 3         PLAINTIFF,               : MIDDLESEX COUNTY
                                    : DOCKET NO.
 4                                  : L-3191-91
   VS.                              :
 5                                  :
   ELI LILLY & COMPANY; DISTA       :
 6 PRODUCTS INC, A DIVISION OF      :
   ELI LILLY & COMPANY; LISS        :
 7 PHARMACY; MADISON PHARMACY AND   :
   JOHN DOES NOS. 1-25 (UNKNOWN     :
 8 ENTITIES),                       :
                                    :
 9         DEFENDANTS.              :
   ---------------------------------X

                                                 Page 6

 1 
                             I N D E X
 2 
   JAN POTVIN, PH.D.
 3 
   
 4 
 5      DIRECT EXAMINATION BY MS. ZETTLER         10
 6 
 7 
 8 CERTIFICATE                                   216
 9 
10 ERRATA                                        217
11 
12                      EXHIBITS
13 
14       EXHIBITS NO. 1 THROUGH 4                140
15       EXHIBITS 5 AND 6                        171

                                                 Page 7

 1       THE DEPOSITION OF JAN POTVIN, PH.D., TAKEN
 2  AT THE OFFICE OF BAKER & DANIELS, 300 NORTH
 3  MERIDIAN STREET, SUITE 2700, INDIANAPOLIS,
 4  INDIANA 46204, ON JUNE 16, 1992; SAID DEPOSITION
 5  TAKEN PURSUANT TO NOTICE IN ACCORDANCE WITH THE
 6  RULES OF CIVIL PROCEDURE.
 7                 * * * * * * * * * *
 8                A P P E A R A N C E S
 9 
   
10      NANCY ZETTLER
        COUNSEL FOR GROUP A PLAINTIFFS
11      LEONARD M. RING AND ASSOCIATES, P.C.
        111 WEST WASHINGTON AVENUE, SUITE 1333
12      CHICAGO, ILLINOIS  60602
   
13      GREGORY GREEN
        COUNSEL FOR GROUP B PLAINTIFFS
14      LAW OFFICES OF LEONARD L. FINZ, P.C.
        222 BROADWAY
15      NEW YORK, NEW YORK  10038
   
16      LISA M. GOLDMAN
        COUNSEL FOR ELI LILLY AND COMPANY
17      MCCARTER & ENGLISH
        FOUR GATEWAY CENTER
18      100 MULBERRY STREET
        NEWARK, NEW JERSEY  07101-0652
19 
        EDWARD H. STOPHER
20      COUNSEL FOR ELI LILLY AND COMPANY
        BOEHL STOPHER & GRAVES
21      SUITE 2300, CAPITAL HOLDING CENTER
        400 WEST MARKET STREET
22      LOUISVILLE, KENTUCKY  40202
   
23      CURTIS G. OLTMANS
        ELI LILLY AND COMPANY
24      LILLY CORPORATE CENTER
        INDIANAPOLIS, INDIANA  46285

                                                 Page 8

 1      DENISE BRODSKY
        COUNSEL FOR GOOD SHEPHERD HOSPITAL
 2      415 WASHINGTON STREET, SUITE 214
        WAUKEGAN, ILLINOIS
 3 
        MIGUEL A. RUIZ
 4      COUNSEL FOR DEFENDANT BRUINSMA
        CLAUSEN MILLER GORMAN CAFFREY & WITOUS
 5      10 SOUTH LASALLE
        CHICAGO, ILLINOIS  60603
 6 
        ROBERT J. MCCULLY
 7      COUNSEL FOR THE UPJOHN COMPANY
        SHOOK, HARDY & BACON
 8      ONE KANSAS CITY PLACE
        1200 MAIN STREET
 9      KANSAS CITY, MISSOURI  64105
   
10      PAUL J. CLEMENTI
        COUNSEL FOR DR. DICKIE KAY
11      HINSHAW & CULBERTSON
        222 NORTH LA SALLE STREET, SUITE 300
12      CHICAGO, ILLINOIS  60601-1081
        KATHERINE L. LAWS
13      COUNSEL FOR DRS. WITSCHY AND KANNEGANTI
        BAILEY AND WILLIAMS
14      3500 NCNB PLAZA
        901 MAIN STREET
15      DALLAS, TEXAS  75202-3714
   
16      JEANNE R. CLEMENS
        COUNSEL FOR DR. LEE COLEMAN
17      OGDEN NEWELL & WELCH
        1200 ONE RIVERFRONT PLAZA
18      LOUISVILLE, KENTUCKY  40202

                                                 Page 9

 1            COMES JAN POTVIN, PH.D., CALLED BY THE
 2  PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, WAS
 3  DEPOSED AND TESTIFIED AS FOLLOWS:
 4 
 5                 DIRECT EXAMINATION
 6 BY MS. ZETTLER:
 7            Q.      Doctor, could you state your
 8  full name for the record and spell your last name
 9  for the court reporter, please.
10            A.      Yes.  My name is Janet Potvin.
11  My last name is spelled P, as in Paul, O-T, V as
12  in Victor, I-N, as in Nancy.
13            Q.      You're a Ph.D; is that correct?
14            A.      Yes.
15            Q.      Let the record reflect that
16  this is a discovery deposition of Dr. Janet
17  Potvin taken pursuant to notice in Fentress
18  versus Shea Communications, et al, action under
19  the discovery evidence of the Rules of Civil
20  Procedure in the State of Kentucky and any
21  applicable circuits or county rules.
22            MR. STOPHER:  Nancy, let me also state
23  that the deposition has also been noticed in the
24  various other cases that we discussed last week

                                                 Page 10

 1  and the same notice requirements pertain here.
 2            MS. ZETTLER:  And the same objections
 3  that we made last week, is that okay?
 4            MR. STOPHER:  Sure.  I just don't want
 5  to be construed as having waived the notices that
 6  were proprly sent out.  I understand your
 7  position and you understand mine, but now we have
 8  a record that protects both of us.
 9            MS. ZETTLER:  Sure, we don't have to
10  argue, I agree with you.
11            MS. LAWS:  Nancy, for those people that
12  weren't here last time, we did agree that the
13  objections of one defendant is good as to all.
14            MS. ZETTLER:  That's fine with me as
15  long as everybody understands that as far as I'm
16  concerned, if you're going to make objections
17  it's going to be under the Kentucky rules, so any
18  objections as to any rule under any other state
19  court that's involved here, my position is make
20  the objection if it's necessary.
21            MS. LAWS:  Right, like make the
22  objection under your own state rules if you need
23  to.
24            Q.      (BY MS. ZETTLER)  Let me

                                                 Page 11

 1  explain -- first of all, my name is Nancy Zettler
 2  and I represent some of the plaintiffs in the
 3  Fentress case down in Kentucky.  I will be doing
 4  the questioning today and then everybody else
 5  will have an opportunity to ask you questions if
 6  they wish to.  Let me explain the ground rules.
 7  First of all, for the court reporter, we both
 8  have to answer or ask questions or speak
 9  verbally, we can't communicate by nodding our
10  heads or saying uh-huh, things of that nature,
11  because it's very difficult for her to take down
12  a nod of the head.  Is that okay?
13            A.      Yes.
14            Q.      If you have -- if you need to
15  take a break at anytime, just let us know and
16  we'll let you know and we'll take a break, for
17  any reason whatsoever, you take as many as you
18  want.
19            A.      Okay.
20            Q.      And if you don't, for some
21  reason, understand my question or don't hear it,
22  especially since we're sitting at opposite sides
23  of a long table, or I misspeak or you don't
24  understand my question in any way, let me know.

                                                 Page 12

 1  If you answer the question, we're going to assume
 2  you understood the question as asked.  Is that
 3  okay?
 4            A.      Yes.
 5            Q.      And finally, it's human nature
 6  when you're having a conversation to basically
 7  talk over each other.  We can't do that here.  We
 8  have to try, as best as possible, and I'm sure
 9  I'm going to make mistakes and stuff on some of
10  your answers, and I'm not going to mean to, but
11  to the best of your ability, please let me finish
12  my question and I'll let you finish your answer
13  so that the court reporter can take everything
14  down.  Is that okay?
15            A.      That's okay.
16            Q.      Can you tell me what your date
17  of birth is?
18            A.      February 5th, 1943.
19            Q.      And where were you born?
20            A.      Grass Valley, California.
21            Q.      And what's your Social Security
22  number?
23            A.      XXXXXXXXXXX.
24            Q.      Can you tell us what your

                                                 Page 13

 1  current address is, please?
 2            A.      XXXXXXXXXXXXXXXXXXXXXXXXXXXX
 3  XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
 4            Q.      And how long have you lived at
 5  that address?
 6            A.      About nine and a half years.
 7            Q.      Do you have a family, Doctor,
 8  are you married?
 9            A.      I'm married.
10            Q.      Do you have any kids?
11            A.      No.
12            Q.      Would you give us a little bit
13  of your educational background, starting from
14  high school on?
15            A.      I have a diploma from La Sierra
16  High School in California, I have degrees from
17  Stanford University and Texas Christian
18  University.
19            Q.      Where did you do your
20  undergraduate work?
21            A.      Stanford.
22            Q.      And what kind of degree did you
23  receive there?
24            A.      A Bachelor's degree in English.

                                                 Page 14

 1            Q.      In English?
 2            A.      Uh-huh.
 3            Q.      I take it you got your Ph.D
 4  from Texas Christian?
 5            A.      That's correct.
 6            Q.      What year did you graduate from
 7  Stanford?
 8            A.      1965.
 9            Q.      Did you go to Standord right
10  out of high school?
11            A.      No, I went to American River
12  College for two years and then I transferred to
13  Stanford.
14            Q.      Where's American River located?
15            A.      Sacramento, California.
16            Q.      Is that a two-year college?
17            A.      Yes.
18            Q.      Did you a receive an
19  Associates?
20            A.      Yes.
21            Q.      What was your Associate in?
22            A.      English.
23            Q.      Did you happen -- I'm sorry,
24  where is Texas Christian located?

                                                 Page 15

 1            A.      Fort Worth, Texas.
 2            Q.      She's from Texas.
 3            MS. LAWS:  I'm near Angelos.
 4            Q.      When did you start at Texas
 5  Christian?
 6            A.      1966.
 7            Q.      Would that be the Fall?
 8            A.      Yes.
 9            Q.      And when did you receive your
10  Ph.D?
11            A.      I received my Ph.D in 1974.
12            Q.      What was your Ph.D in?
13            A.      English.
14            Q.      Was there a period of time
15  between the Fall of '66 and 1974 where you
16  weren't working towards your Ph.D?
17            A.      I received a Master's degree in
18  '68 and then I worked, and then I went back to
19  school to work on my Ph.D.
20            Q.      So did you receive your
21  Master's from Texas Christian as well?
22            A.      Yes.
23            Q.      From the Fall of 1966 to the
24  Fall of 1968 did you work continuously on your

                                                 Page 16

 1  Master's?
 2            A.      Yes.
 3            Q.      I'm sorry, when did you say you
 4  went back to get your Ph.D?
 5            A.      1972.
 6            Q.      And from 1972 until 1974 did
 7  you work continuously towards your Ph.D?
 8            A.      I did.
 9            Q.      Did you do a thesis for your
10  Master's?
11            A.      I did.
12            Q.      Was that in English, also, was
13  your Master's in English?
14            A.      Yes.
15            Q.      What was your thesis on?
16            A.      James Joyce's Ulysses.
17            Q.      And how about your Ph.D, did
18  you have to publish to obtain your Ph.D?
19            A.      I had to write a dissertation
20  for my Ph.D.
21            Q.      And what was that on?
22            A.      I worked with James Joyce's
23  Finnigan's Wake.
24            Q.      Either your thesis or your

                                                 Page 17

 1  dissertation published?
 2            A.      No.
 3            Q.      Did any of your -- I take it
 4  that your major in undergrad was English?
 5            A.      Right.
 6            Q.      Did you have any other majors
 7  or minors?
 8            A.      I minored in speech problems
 9  for my Bachelor's degree.
10            Q.      How about your Master's, did
11  you pursue any other course of study besides
12  English while you were working towards your
13  Master's?
14            A.      No.
15            Q.      How about your Ph.D, was there
16  any other course of study besides English?
17            A.      No.
18            Q.      When you were working towards
19  your Bachelor's, did you take any courses related
20  to medicine or psychology or psychiatry?
21            A.      General science courses and an
22  introduction to psychology course.
23            Q.      So basically your university
24  studies-type courses, Biology 101?

                                                 Page 18

 1            A.      Right.
 2            Q.      Since your Ph.D, have you taken
 3  any continuing education courses or courses in
 4  study?
 5            A.      I've been involved in various
 6  seminars and various training programs and short
 7  courses.
 8            Q.      Could you give us an idea of
 9  what types of seminars you've been involved in?
10            A.      I went to a clinical research
11  administrative seminar series, I've taken courses
12  in various computer software programs, I've taken
13  a course in electronic publishing, I've taken a
14  course in page design.
15            Q.      I'm sorry, was the third one
16  electronic publishing?
17            A.      Electronic publishing and page
18  design.
19            Q.      That was one course or two
20  courses?
21            A.      They were two, two separate.
22            Q.      Anything else that you can
23  think of, any other seminars or courses that you
24  took?

                                                 Page 19

 1            A.      Manual development, as in
 2  manuals for computer software documentation.
 3  There may be other courses, but it's hard to
 4  recollect back over that period of time, so I'm
 5  sure there are probably more but those are the
 6  main ones.
 7            Q.      Were these -- did you take
 8  these courses all related to your employment with
 9  Eli Lilly?
10            A.      No.
11            Q.      How about the clinical research
12  administrator, did you take that series within
13  your employment at Eli Lilly?
14            A.      Yes, I did.
15            Q.      How about computer software
16  courses?
17            A.      Those have been taken in
18  conjunction with my employment at Lilly.
19            Q.      Electronic publishing, how
20  about those?
21            A.      Some were associated with
22  employment at Lilly, and others were independent.
23            Q.      How about manual development
24  for computer software?

                                                 Page 20

 1            A.      Not in conjunction with
 2  employment at Lilly.
 3            Q.      And page -- what was that?
 4            A.      Page design.  That was in
 5  conjunction with employment at Lilly.
 6            Q.      If you think of any other
 7  courses that you've taken, feel free to let me
 8  know anytime during the deposition, okay?
 9            A.      (Witness moves head up and
10  down.).
11            Q.      That goes for everything.  If I
12  ask you a question and at the time you don't
13  remember and if it comes back to you later,
14  please let me know.
15            A.      Fine, I'll do that.
16            Q.      Let's talk about your
17  employment.  When did you start working with Eli
18  Lilly?
19            A.      In January of 1984.
20            Q.      Okay.  Prior to that time, had
21  you been associated in any way with Eli Lilly?
22            A.      No.
23            Q.      When you were working towards
24  your Bachelor's, were you employed during that

                                                 Page 21

 1  period of time?
 2            A.      Just part-time work.
 3            Q.      Anything related to research,
 4  writing, medical or psychiatric types of
 5  positions?
 6            A.      No.
 7            Q.      Can you give us a general idea
 8  of what types of things, you don't have to be
 9  specific at this point, types of things you did
10  when you were working towards your undergraduate?
11            A.      I had a Summer position with
12  the State of California working for the personnel
13  board where we did various types of clerical
14  tasks.
15            Q.      Okay.  Anything else?
16            A.      Just clerical, primarily.
17            Q.      How about while you were
18  working towards your Master's, what types of
19  employment did you have?
20            A.      I didn't have employment while
21  I was working for my Master's.
22            Q.      Okay.  I think you said that
23  there was a period of time between 1968 and 1974
24  or 1972, I'm sorry, where you were working and

                                                 Page 22

 1  you were not working towards a degree, right?
 2            A.      That's correct.
 3            Q.      Could you tell us what you did
 4  in this time period between 1968 and 1972 as far
 5  as employment?
 6            A.      Yes.  I was a production editor
 7  for the Institute of Continuing Legal Education
 8  at the University of Michigan for one year, and
 9  then I was a technical writer and editor for Comp
10  Sharing, Incorporated in Ann Arbor, Michigan.
11            Q.      You worked with Continuing
12  Legal Education for one year?
13            A.      Yes, approximately one year.
14            Q.      And the rest of time you worked
15  for Comp Sharing?
16            A.      Approximately, yes.
17            Q.      What kind of work or what kind
18  of business is Comp Sharing?
19            A.      Computer time sharing firm.
20            Q.      What did you do for them?
21            A.      I was a writer, editor.
22            Q.      What types of things would you
23  write at Comp Sharing?
24            A.      Computer software

                                                 Page 23

 1  documentation, for the most part.  We also did a
 2  newsletter.
 3            Q.      Was that pretty much the same
 4  type of things you were involved in as an editor
 5  also, computer software documentation and
 6  letters?
 7            A.      Right.  Our job title was
 8  writer, editor, and we did a combination of
 9  writing and editing.
10            Q.      When you say computer software
11  documentation, you wouldn't actually write the
12  computer software, would you?
13            A.      No.
14            Q.      Would it be something along the
15  lines more of a manual describing the use of the
16  software, things of that nature?
17            A.      That's correct.
18            Q.      Would you be involved in
19  anything technical from a creation standpoint
20  regarding the software itself?
21            A.      I worked with a team of people
22  that consisted of systems programers and
23  applications programers, and they were
24  responsible for technical aspects of the manuals.

                                                 Page 24

 1            Q.      You were responsible for making
 2  it readable?
 3            A.      That's correct, for writing the
 4  information so it was understandable by a
 5  nontechnical user.
 6            Q.      Somebody like me.  And how
 7  about the newsletter, was that like an
 8  intra-company newsletter?
 9            A.      The newsletter went to the
10  company's clients.  It was a technical newsletter
11  with information about new releases of the
12  software and similar kinds of information.
13            Q.      Before your job as writer,
14  editor with Comp Share, were you required to gain
15  a certain level of knowledge as to how computer
16  data bases work, various computer data bases?
17            A.      I don't understand your
18  question, what you mean by required.
19            Q.      Okay.  Well, for you to be able
20  to put the technical data in layman's terms or
21  communicate it so that a layman could understand
22  it, were you required or was it necessary for you
23  to be able to perform your job to require a
24  certain level of understanding on how computers

                                                 Page 25

 1  worked, computer data software, things of that
 2  nature?
 3            A.      Yes.
 4            Q.      And earlier you talked about
 5  courses in computer software, were those courses
 6  something that you took in conjunction with
 7  acquiring your knowledge of your job at Comp
 8  Share?
 9            A.      No, the courses that I referred
10  to were -- in computer software were not
11  associated with Comp Share.
12            Q.      Did they give you some sort of
13  training at Comp Share to familiarize you with
14  the technical aspects of computer software, data
15  bases, things of that nature?
16            A.      Yes.
17            Q.      What kind of courses did they
18  give you?
19            A.      A lot of training was hands-on
20  learning experience working with programers.
21  Also there were a lot of source materials to
22  read, but it was more of a tutorial nature rather
23  than formal courses.
24            Q.      Have you ever written any

                                                 Page 26

 1  computer software programs?
 2            A.      No, I have not.
 3            Q.      Do you feel like you would be
 4  qualified to do so if you wanted to?
 5            MS. GOLDMAN:  Object to that question,
 6  but I'll allow her to answer it.
 7            Q.      Let me ask it this way:  If
 8  somebody came to you and said, Dr. Potvin, we
 9  would like you to write or assist in writing a
10  computer software for a specific purpose, would
11  you feel comfortable in assisting that person or
12  writing that software?
13            MS. GOLDMAN:  Object to that question
14  as vague and ambiguous, but I'll permit her to
15  answer it if she's able.
16            A.      I'm sorry, but I don't
17  understand what you mean by computer software, in
18  this regard.
19            Q.      Do you feel that you have the
20  technical knowledge and ability to assist in
21  writing a computer program of any kind?
22            A.      I guess -- I'm sorry, again you
23  say to assist in writing a program?
24            Q.      Let me ask it this way:  If

                                                 Page 27

 1  somebody came to you and said Dr. Potvin, we
 2  would like to develop a program that we could use
 3  with our computers, to be able to develop a
 4  dictionary terminology for use with medical
 5  reporting or anything of that nature, would you
 6  be able to be comfortable in either working with
 7  that person or developing a program on your own?
 8            MS. GOLDMAN:  Object to the form of the
 9  question on the grounds that it's vague and
10  ambiguous, it's an incomplete hypothetical and
11  we'll leave issues of relevance aside for the
12  moment.  But given those deficiencies in the form
13  of the question, if the Doctor nonetheless feels
14  herself able to answer it, I'll allow her to
15  respond to the question.
16            Q.      Can you answer that?
17            A.      It seems to be a compound
18  question, I don't really believe I can.
19            Q.      Part of it is my lack of
20  knowledge of computers myself, and I apologize,
21  Doctor, but -- okay, are you familiar with
22  WordPerfect?
23            A.      No, I'm not familiar with
24  WordPerfect.

                                                 Page 28

 1            Q.      Are you familiar with COSTART,
 2  have you ever heard that name before, COSTART?
 3            A.      I've heard the name COSTART.
 4            Q.      Do you know what COSTART is?
 5            A.      COSTART is the name of a drug
 6  dictionary.
 7            Q.      And is that drug dictionary --
 8  like can I go out and buy that, buy COSTART as a
 9  software package for use on my PC, or in my
10  computer system, can anybody do that or is that
11  something that's limited?
12            A.      I'm sorry, I don't know the
13  answer to your question.
14            Q.      Okay.  Do you know who produces
15  COSTART or who developed COSTART?
16            A.      Yes.
17            Q.      Who?
18            A.      The Food and Drug
19  Administration.
20            Q.      From a technical computer point
21  of view, could you describe for me what COSTART
22  is?  In other words, is it a software program, is
23  it something that is built into a system when you
24  buy an entire computer system or what is COSTART?

                                                 Page 29

 1            MS. GOLDMAN:  I object to the form of
 2  that question, especially to the extent that it
 3  includes the predicate from the computer word,
 4  technical point of view.  You seem to be --
 5            MS. ZETTLER:  Really, all I'm trying to
 6  do here is find out what Dr. Potvin's experience
 7  is and what her technical abilities are.
 8            MS. GOLDMAN:  I understand the goal of
 9  questioning, Counsel, my only interest is in
10  making sure the forms of the question are
11  appropriate and the witness is capable of
12  answering on the grounds that they're
13  intelligible and don't contain hidden assumptions
14  that might come back and haunt her later.
15            Q.      Let me ask it this way:  Tell
16  me about the training you've had in computer
17  software, if any.
18            MS. GOLDMAN:  Do you understand that
19  question?
20            THE WITNESS:  I'm sorry, the use of the
21  term software is confusing to me.
22            Q.      Earlier you told us that you
23  had taken courses in computer software, right?
24            A.      Right.

                                                 Page 30

 1            Q.      What kind of courses have you
 2  taken?
 3            A.      I have taken courses in Word
 4  for Windows, Microsoft -- I'm sorry, Microsoft
 5  Word for Windows, Excel and Power Point, and I've
 6  taken those courses on the PC and the MacIntosh.
 7  I've also taken a course in MacDraw Pro.  And
 8  I've taken training in Interleaf Technical
 9  Publishing software.
10            Q.      Have these courses basically
11  been in the uses of the various software?
12            A.      Yes, they have.
13            Q.      Have you taken any courses in
14  developing software?
15            A.      No, I have not.
16            Q.      Do you have any experience in
17  developing software?
18            A.      No, I do not.
19            Q.      Have you taken any other
20  courses related to computers in any way?
21            MS. GOLDMAN:  Do you understand the
22  form of that question?
23            Q.      When I say that, I don't mean
24  where you had to use a computer during the course

                                                 Page 31

 1  for writing or things of that nature, I mean
 2  anything in the use of computers, computer
 3  software, data bases, things of that nature.
 4            A.      I'm sure that I'm probably
 5  missing some training courses that I may have
 6  taken, but I've recently taken a course in land
 7  management which is a course to help people
 8  understand the file manager's system, and the way
 9  the local area network is configured, I don't
10  know if that's the kind of course that you're
11  referring to.
12            Q.      Earlier you said that you took
13  a course in -- I think it's MacDraw program?
14            A.      MacDraw Pro.
15            Q.      MacDraw Pro, okay.  What's
16  MacDraw Pro?
17            A.      It's a software program on the
18  MacIntosh for drawing graphics.
19            Q.      Can you tell us a little bit
20  about the page design courses that you've taken?
21            A.      In electronic publishing of
22  documents, there are certain standards for
23  design, and I took a seminar, I've taken several
24  seminars, as I mentioned, to learn how to

                                                 Page 32

 1  properly design information in manuals.
 2            Q.      Okay.
 3            A.      Other documents.
 4            Q.      Is this a substance or
 5  substance-type thing or is this a visual-type
 6  thing?  In other words, these courses don't teach
 7  you how to put substance, for instance, in a
 8  clinical investigator's manual on protocols and
 9  things of that nature?
10            MS. GOLDMAN:  Object to the form of
11  that question as being ambiguous.  Could you
12  retry that, Counsel?
13            Q.      The courses you've taken are a
14  graphic-type thing, I mean from a visual
15  standpoint as opposed to a substantive textual
16  standpoint?
17            A.      I don't understand what you
18  mean by substantive textual standpoint.
19            Q.      In other words, the page design
20  classes that you've taken do not deal with -- for
21  instance, in a clinical investigator manual you
22  have to have a section on protocols, it would be
23  more of a course to say in a manual, you know,
24  the title page should look like this or the

                                                 Page 33

 1  categories should be set up in a certain way or
 2  charting, things of that nature?
 3            MS. GOLDMAN:  I appreciate your effort.
 4  I must continue to object to the form of the
 5  question because it seems to have elements
 6  unrelated to the question of page layouts slipped
 7  into it to which the witness may unwittingly
 8  respond, which may or may not be correct, in an
 9  effort to answer what I think is the real thrust
10  of your question, which I don't mind having her
11  answer at all.
12            MS. ZETTLER:  I have to object to your
13  continuously prompting the witness how to respond
14  or not respond to my question by your editorial
15  comments.  If you have an objection, I prefer
16  that you keep it to your objection, such as to
17  form, things of that nature.
18            MS. GOLDMAN:  Ms. Zettler, no one wants
19  to get through this more than I.  I object to
20  your characterization of my objections as leading
21  the witness.  To this point it has been my effort
22  not merely to object to form, but to try to imply
23  advice and guidance as to deficiencies of
24  questions so that we don't have to go through

                                                 Page 34

 1  interminable rephrasings.  You and I both know
 2  what our respective obligations are when we
 3  represent witnesses at a deposition.  I'm doing
 4  my job, I understand you are doing yours, let's
 5  continue.
 6            Q.      Do you understand the question,
 7  do you remember the question that I asked you
 8  earlier?
 9            A.      Could you rephrase the
10  question?
11            Q.      All I'm trying to find out is
12  whether or not courses that you have taken in
13  page design have anything to do with the
14  substance of any given manual or any given
15  document that you're creating, from the
16  standpoint of what types of information have to
17  go in there, what has to be communicated, as
18  opposed to whether the courses deal with how
19  somebody should look at a given page, regardless
20  of what it says.
21            A.      I'm sorry, but it's just a
22  compound question, I can't really respond to it.
23  Perhaps you could break it down into two parts.
24            Q.      Sure.  The page design classes

                                                 Page 35

 1  that you've taken, have they involved what needs
 2  to be communicated in a given document?  In other
 3  words, in a clinical -- in a newsletter, do you
 4  have to tell everybody what meetings are going to
 5  be included or do you have to say, you know,
 6  we're going to have a picnic on such and such a
 7  date or this is our new product, as opposed to
 8  how that newsletter should look from a visual
 9  standpoint?
10            A.      It seems like the question is
11  still compound.
12            Q.      Okay.  Why don't you tell me --
13  give me an example of one of the page design
14  classes that you've taken?
15            A.      One of the page design classes
16  that I took was a workshop in which principles of
17  page design, visual arrangement of information to
18  convey meaning was discussed.
19            Q.      To convey what?
20            A.      Visual arrangement of
21  information to communicate, to convey meaning was
22  discussed.
23            Q.      Would that -- did that workshop
24  deal with the substance of the information that

                                                 Page 36

 1  was being conveyed?
 2            A.      I don't know how to answer your
 3  question about the substance.
 4            Q.      Let me ask you, I think I'm
 5  starting to understand what the problem is here.
 6  Were any of these page design courses specific to
 7  any types of documents?
 8            A.      Yes.
 9            Q.      Okay.  Would you give me some
10  examples of what those courses were?
11            A.      One of the workshops used
12  computer software documentation, user manuals, as
13  the subject matter for the examples.
14            Q.      Okay.  But that class was not
15  in developing computer manuals, per se, was it?
16            A.      No.
17            Q.      They used that as examples?
18            A.      That's correct.
19            Q.      So let's take an example of a
20  user manual.
21            A.      Okay .
22            Q.      Did you take any class that
23  said in a user manual you have to say anything in
24  particular, you know, I mean specifically like --

                                                 Page 37

 1  and I'm not talking about categories of
 2  information, I'm talking about anything specific
 3  to any type of document.  In other words, in a
 4  user manual, you always have to put in here
 5  trademark information.
 6            A.      No, those page design workshops
 7  did not give the specific detail of the content
 8  for developing a computer software document or
 9  manual.
10            Q.      Did you take any course
11  whatsoever regarding page design that suggested
12  to you or instructed you that you had to include
13  specific information or specific types of
14  information in a particular document?
15            A.      Could you repeat the question?
16            Q.      Sure.  Let me tell you what my
17  understanding of what you're trying to
18  communicate.  If I'm wrong, please let me know.
19  My understanding from what we're talking about or
20  at least your inability to respond to my
21  questions, is that these courses basically dealt
22  with things such as in a user manual you should
23  organize information in this way to better
24  communicate information.  In other words, there's

                                                 Page 38

 1  an introduction section, there's a section on --
 2  like a history section of a product or things of
 3  that nature, as opposed to saying in the
 4  introduction section you have to say A, B, C, D,
 5  E, F and G, specifically.
 6            MS. GOLDMAN:  If that's a question, I
 7  object to the form.  I'll allow her to answer it.
 8            A.      A page design workshop teaches
 9  visual arrangement of information, placement of
10  elements, headings, subheadings, figures.  It
11  doesn't deal with the organization of content,
12  nor does it indicate what specific components of
13  information needs to be done.  In general -- I'm
14  certain that there are some classes that do this,
15  but the ones that I took focused more on simply
16  the arrangement of information and what made for
17  a good visual design as opposed to a poor one.
18            Q.      Okay.
19            A.      There are other -- I'm sure
20  there are other classes that do the kinds of
21  combinations that you're talking about, but the
22  specific ones I was referring to did not, as far
23  as I recall.
24            Q.      Tell us about the electronic

                                                 Page 39

 1  publishing classes.
 2            A.      I took a series of workshops in
 3  Interleaf Technical Publishing software, and
 4  these were courses to learn to use this
 5  particular software product.
 6            Q.      That's Interleaf Technical?
 7            A.      Interleaf Technical Publishing
 8  software.
 9            Q.      And I think you testified
10  earlier that you used this or you took some of
11  these classes while you were working at Lilly?
12            A.      Yes, that's correct.
13            Q.      Did you use any of this
14  information that you gained from the classes in
15  your employment with Lilly?
16            A.      Yes.
17            Q.      Did they have an Interleaf
18  Technical Publishing, did they have that software
19  at Lilly?
20            A.      We have that software at Lilly.
21            Q.      How is it used, for what
22  purposes?
23            A.      It's used for electronic
24  publishing of documents.

                                                 Page 40

 1            Q.      What types of documents?
 2            A.      Clinical study reports,
 3  summaries.
 4            Q.      Any others?
 5            A.      Clinical investigation
 6  brochures.  The list of applications is still in
 7  development and we are going to be adding
 8  additional types of documents, but we have not
 9  done a large number of different types so far.
10            Q.      How long have you been using
11  that software at Lilly, to the best of your
12  knowledge?
13            A.      Oh, I'm going to have to guess,
14  it seems like we've had it for approximately
15  three years.  We don't have a production system
16  yet, we had it as a prototype system and we've
17  been doing some piloting with it, and the work
18  has been ongoing for a while.  But I can't tell
19  you the exact date when we started, I don't know
20  it.
21            Q.      Is this software used to create
22  any of these documents that you talked about
23  earlier?
24            A.      To create?

                                                 Page 41

 1            Q.      In other words, are they
 2  written with this software or is this something
 3  that's strictly used to convey the information
 4  once it's written?
 5            A.      It can be used in either way,
 6  we have used it for both applications.
 7            Q.      Okay.
 8            A.      But again, as an experimental
 9  tool, something in development.
10            Q.      When you say electronic
11  publishing, what do you mean by publishing?
12            A.      The electronic integration of
13  texts, tables and graphics into a single
14  document.
15            Q.      Okay.
16            A.      For submission.
17            Q.      For submission to who?
18            A.      To a regulatory authority or to
19  a journal or for internal distribution.
20            Q.      And then could this be used
21  something like an electronic mail system, could
22  that document then be conveyed to somebody else
23  without having to print it out in hard form and
24  submit a hard form?

                                                 Page 42

 1            A.      As our software is presently
 2  configured, we do not have that option.
 3            Q.      Do you plan on doing that in
 4  the future?
 5            A.      I don't know what the final
 6  plans are, we're just developing a pilot.
 7            Q.      Who developed the Interleaf
 8  Technical Publishing software?
 9            A.      I'm sorry, by who --
10            Q.      Was that something that was
11  developed within Lilly or was that something that
12  was created by an outside source?
13            A.      It was created by the Interleaf
14  Corporation.
15            Q.      In your position at Comp Share,
16  did you have any responsibility for writing any
17  programs or for writing any computer software
18  programs related to medicine?
19            A.      I'm sorry, it seems as if you
20  have a compound question, one is whether I wrote
21  any computer software programs, and the second
22  was any related to medicine.  I did not write any
23  programs at all, as I mentioned to you earlier.
24            Q.      Did you have any responsibility

                                                 Page 43

 1  for writing and editing or editing any documents
 2  related to any software created for medicine,
 3  using medicine?
 4            A.      I'm trying to remember.  We had
 5  some various application programs that were
 6  developed, and I don't know of any that were
 7  specifically medical related, but they could have
 8  been used in medicine, but I'm not aware of that
 9  usage.
10            Q.      Okay.  Were you involved in
11  writing and editing any documents related to
12  software that may be used in a clinical drug
13  trial?
14            A.      I'm not aware of having worked
15  on any applications that would have been used in
16  that way.  Again, some of these were very general
17  and I don't know what all of our customers'
18  applications were.
19            Q.      Okay.  Why did you leave Comp
20  Share?
21            A.      To return to Texas and graduate
22  school.
23            Q.      To work towards your Ph.D?
24            A.      Uh-huh.

                                                 Page 44

 1            Q.      You have to say yes or no.
 2            A.      Excuse me, yes, I returned to
 3  Texas to work on my Ph.D.
 4            Q.      And did you work during the
 5  period of time when you were working towards your
 6  Ph.D?
 7            A.      I was a graduate assistant --
 8  or graduate fellow.
 9            Q.      In the English department?
10            A.      Yes.
11            Q.      What types of things did you do
12  as a graduate fellow?
13            A.      I taught English.
14            Q.      What did you do after receiving
15  your Ph.D, employment-wise?
16            A.      I accepted a position with the
17  University of Texas at Arlington.
18            Q.      What was that position?
19            A.      Initially I was a lecturer, and
20  then I was an assistant professor of technical
21  writing and director of a technical writing
22  program.
23            Q.      When you say technical writer,
24  what do you mean?

                                                 Page 45

 1            A.      The university offered a course
 2  in technical writing which is writing for
 3  science, engineering.
 4            Q.      An industry-based type of
 5  writing as opposed to a layman-type of writing?
 6  In other words, the information you would try to
 7  convey would be something that would be conveyed
 8  to someone within the industry?
 9            A.      The information would be
10  conveyed to someone in a scientific discipline, a
11  technical discipline such as an engineering
12  discipline, or might be conveyed to someone in
13  business or industry or in government.  I mean
14  the categories overlap somewhat, but the basic
15  content of material is scientific or technical in
16  nature.
17            Q.      How long were you at the
18  University of Texas in Arlington?
19            A.      For approximately ten years.
20            Q.      Other than being a lecturer and
21  an assistant professor, did you hold any other
22  positions at the university?
23            A.      I spent one year on an exchange
24  program at NASA.

                                                 Page 46

 1            Q.      What did you do within that
 2  exchange program?
 3            A.      I worked as a computer software
 4  documentation specialist.
 5            Q.      What were your responsibilities
 6  as computer software documentation specialist?
 7            A.      To prepare documentation for
 8  some of the computer applications for writing and
 9  editing that NASA used.
10            MS. ZETTLER:  Could you read that back?
11             (THE COURT REPORTER READ BACK THE
12              REQUESTED TESTIMONY.)
13            Q.      When you say writing and
14  editing that NASA used, what do you mean by that?
15            A.      There were computer application
16  programs that could be used for writing and
17  editing much like Microsoft Word for Windows is
18  used today, and I worked to update manuals and
19  put manuals on line for that application.
20            Q.      Okay.  So the manuals you
21  worked on were in use of computer software?
22            A.      That's correct.
23            Q.      Any other documents that you
24  worked on?

                                                 Page 47

 1            A.      A newsletter.  And there may
 2  have been other documents, memos and summaries
 3  and that sort of thing, but the main document was
 4  the documentation.
 5            Q.      When was this exchange program
 6  at NASA?
 7            A.      1974 to '75.
 8            Q.      After that exchange program,
 9  you then went back to the University of Texas?
10            A.      I did.
11            Q.      What did you do there then?
12            A.      I was a lecturer in technical
13  writing.
14            Q.      The same position you held
15  before you went into the exchange program?
16            A.      I went to NASA my first year
17  with the university, and then I came back and was
18  a lecturer.
19            Q.      Did you do anything else while
20  employed at the University of Texas besides what
21  you've already told us?
22            A.      I spent some Summers working as
23  a research associate at V.A. Wadsworth Hospital
24  in the neurology research lab.  It was a joint

                                                 Page 48

 1  appointment through the University of California
 2  at Los Angeles.
 3            Q.      You were a research associate?
 4            A.      A research associate, this was
 5  a Summer position.
 6            Q.      And that was in neurology?
 7            A.      Uh-huh.
 8            Q.      You have to say yes or no.
 9            A.      Yes.
10            Q.      Tell us what you did as a
11  research associate in the neurology department at
12  V.A. Wadsworth?
13            A.      I assisted with work on
14  clinical trials, I did writing and editing.
15            Q.      What Summers did you work as a
16  research associate at V.A. Wadsworth?
17            A.      Let me think, it's been a long
18  time ago.  As best as I can recall, it was the
19  years that we were in Texas and -- between the
20  years of '68 and '72, I've lost the exact dates.
21  I could look it up and double check for you.
22            Q.      I guess I'm getting confused
23  again, Doctor.  Did you say earlier that you
24  received your Ph.D in 1974?

                                                 Page 49

 1            A.      Yes, I did.
 2            Q.      And was it after you received
 3  your Ph.D that you began working at the
 4  University of Texas?
 5            A.      Right.
 6            Q.      And when you worked as an
 7  assistant, research assistant, at V.A. Wadsworth,
 8  was that during the Summers when you were
 9  employed at the University of Texas?
10            A.      That's correct.
11            Q.      So those Summers would be after
12  1974?
13            A.      That's correct.
14            Q.      Okay.  Would those Summers have
15  been after you did your exchange program work
16  with NASA?
17            A.      Yes.
18            Q.      How many Summers, if you can
19  remember, offhand, did you do this at V.A.
20  Wadsworth?
21            A.      I believe it was four and part
22  of a fifth Summer.
23            Q.      Were those consecutive Summers?
24            A.      Yes.

                                                 Page 50

 1            MS. ZETTLER:  Can we take a quick
 2  break?
 3             (A SHORT RECESS WAS TAKEN.)
 4            MS. ZETTLER:  We left off, I think,
 5  before the break talking about your Summer
 6  experiences as a clinical -- or as a research
 7  associate at V.A. Wadsworth in neurology.
 8            A.      (Witness moves head up and
 9  down.).
10            Q.      How did you acquire that
11  position, how did you come to be hired by V.A.
12  Wadsworth as a research associate?
13            A.      Through associations at the
14  University of Michigan.
15            Q.      Let me ask you this:  Did these
16  clinical trials that you worked on for four and a
17  half Summers in the '70s -- is that the period of
18  time?
19            A.      Yes.
20            Q.      Were any of these clinical
21  trials on Prozac or Fluoxetine Hydrochloride?
22            A.      No, they were not.
23            Q.      Were they on drugs?
24            A.      They were.

                                                 Page 51

 1            Q.      What types of drugs were they?
 2            A.      On drugs for Parkinson disease
 3  and multiplesclerosis.
 4            Q.      Earlier you said you assisted
 5  in clinical trials at V.A. Wadsworth; is that
 6  correct?
 7            A.      Assisted in the work of
 8  clinical trials.
 9            Q.      What type of things did you do
10  while you were assisting with the clinical
11  trials?
12            A.      Assisted with recruiting normal
13  subjects for a study, helping to put together
14  protocols for a study and helping to write up the
15  results of the studies.  And then there were some
16  various other tasks involved.  But those were, in
17  general, the main tasks.
18            Q.      Okay.  Now when you said -- you
19  also said earlier you assisted in clinical trials
20  and writing and editing.  Was your writing and
21  editing responsibilities different than the ones
22  you just described to us or are they kind of
23  included in that?
24            MS. GOLDMAN:  Object to the form, I

                                                 Page 52

 1  don't understand.
 2            Q.      When you -- I asked you earlier
 3  what your responsibilities were at V.A. Wadsworth
 4  over those Summers we talked about, and you said
 5  clinical trials and writing and editing,
 6  assisting with clinical trials and writing and
 7  editing.  Was the writing and editing you did
 8  separate and apart from what you just described
 9  to us as far as your responsibilities with
10  assisting clinical trials?  You just listed three
11  for us, recruiting normal subjects, putting
12  together protocols and writing up summaries.  In
13  other words, when you said writing and editing
14  earlier, you're talking about putting together
15  the protocols and helping write up summaries, or
16  was there something else you worked on as a
17  writer-editor?
18            A.      We also prepared some articles
19  for publication in the scientific literature.
20            Q.      During your employment with or
21  association with the University of Texas, did you
22  have any other responsibilities other than what
23  you've already told us?
24            A.      I'm sorry, I don't understand

                                                 Page 53

 1  what you mean by other responsibilities.
 2            Q.      Within your employment at the
 3  University of Texas you told us that you worked
 4  as a lecturer in technical writing, you did that
 5  exchange program with NASA, and that you were
 6  involved with V.A. Wadsworth, and you were an
 7  assistant professor --
 8            A.      Right.
 9            Q.      Was there anything else you did
10  in your employment with the University of Texas
11  that you haven't already told us about?
12            A.      No, I don't think so.  It
13  depends on how you define responsibilities.
14            Q.      Did you hold any other
15  positions at the university or in connection with
16  the university during that period of time?
17            A.      I was director of the technical
18  writing program, but that was in conjunction with
19  being a lecturer and assistant professor.
20            Q.      Any other positions?
21            A.      No.
22            Q.      When did you become director of
23  technical writing?
24            A.      After I returned from NASA.

                                                 Page 54

 1            Q.      1975?
 2            A.      '75-76.
 3            Q.      Just to the best of your
 4  recollection.
 5            A.      To the best of my recollection,
 6  in approximately '75-76.
 7            Q.      If you don't know an exact
 8  date, that's fine.  We're just trying to probe
 9  your memory basically with these answers, so if
10  you could give me to the best of your
11  recollection.  And you left the University of
12  Texas in, I believe you said, 1984; is that
13  correct?
14            A.      That's correct.
15            Q.      And where did you go after you
16  left the University of Texas?
17            A.      Eli Lilly and Company.
18            Q.      Why did you leave the
19  University of Texas?
20            A.      There was an opportunity to go
21  to Lilly.
22            Q.      And how did you hear of this
23  opportunity to go to Lilly?
24            A.      Through a head hunter.

                                                 Page 55

 1            Q.      Was that a head hunter that you
 2  were working with or somebody that contacted you?
 3            A.      It was neither of those.
 4            Q.      Okay.  How did you hook up with
 5  this head hunter?
 6            A.      My husband was contacted by the
 7  head hunter to go to Eli Lilly and Company.  And
 8  they had a position open for a writer, as well.
 9            Q.      What is your husband's name?
10            A.      Alfred Potvin.
11            Q.      Was your husband also working
12  at the University of Texas while you were there?
13            A.      Yes, he was.
14            Q.      What did he do with the
15  University of Texas?
16            A.      He was professor and chairman
17  of biomedical engineering and professor of
18  electrical engineering.
19            Q.      When did you guys get married?
20            A.      In 1965.
21            Q.      Do you remember the name of the
22  head hunter or the group the head hunter was
23  with?
24            A.      I'm sorry, I don't know, I

                                                 Page 56

 1  don't recall.
 2            Q.      Did your husband contact the
 3  head hunter or did the head hunter contact your
 4  husband?
 5            A.      The head hunter contacted my
 6  husband.
 7            Q.      What position at Lilly did the
 8  head hunter contact your husband about?
 9            A.      Director of research.  I'm not
10  sure that I have the correct title anymore
11  because there have been some changes in the
12  titles, but it was director of research for the
13  medical devices division.
14            Q.      Did he accept that position?
15            A.      He did.
16            Q.      That was sometime in 1984, I
17  believe you said earlier?
18            A.      We started to work at Lilly in
19  1984.
20            Q.      Was it kind of a package deal,
21  he would go work for Lilly if you would work for
22  them too, or is that something -- was your job
23  acquired separately from his position?
24            A.      We went to work for Lilly at

                                                 Page 57

 1  the same time.
 2            Q.      What position was open that you
 3  were interested in at Lilly at the time your
 4  husband was contacted?
 5            A.      A position in medical writing.
 6            Q.      When did you find out the
 7  position in medical writing was open?
 8            A.      I don't recall the exact date,
 9  but it was sometime in 1983.
10            Q.      So around the same time your
11  husband was contacted about the position as
12  director of research in the medical devices
13  division?
14            A.      Afterwards.
15            Q.      Do you remember if you found
16  out about the position in medical writing before
17  or after your husband accepted that position with
18  Lilly?
19            A.      I found out about the position
20  before my husband had accepted his position with
21  Lilly.
22            Q.      Was your husband's acceptance
23  of the position at Lilly contingent upon your
24  being offered a position in the medical writing

                                                 Page 58

 1  department?
 2            A.      Not to my knowledge, I'm not
 3  aware of that being a condition.
 4            Q.      Did you interview for that
 5  position in medical writing?
 6            A.      I did.
 7            Q.      Who did you interview with?
 8            A.      It's been a really long time.
 9  I'm sorry, I don't think that I can recall all
10  the names of the people that I interviewed with,
11  but I did have a full day's schedule of
12  interviews set up.
13            Q.      Do you remember the names of
14  any of the people that you interviewed with?
15            A.      One of the people that I
16  interviewed with was the manager of the group who
17  at that time was Alice Oliver.
18            Q.      I'm sorry?
19            A.      Alice Oliver.
20            Q.      When you say she was the
21  manager of the group, what group are you talking
22  about?
23            A.      The medical -- the group in
24  which the medical writers were included.

                                                 Page 59

 1            Q.      Did you say that Ms. Oliver was
 2  the director of the group?
 3            A.      At that time she was manager of
 4  the group.
 5            Q.      What group were the medical
 6  writers in?
 7            A.      At that time the group was
 8  called, I think, medical writing literature
 9  services.  There have been many organizations and
10  reorganizations and name changes since that time.
11            Q.      Okay.  You have to forgive me,
12  I'm not as familiar with the corporate structure
13  as you are.
14            A.      That's fine, it's just hard to
15  keep track of all the changes and making sure I
16  have the right names for things.  Medical writing
17  was a small group amongst other components.
18            Q.      Are you still with Lilly today?
19            A.      I am.
20            Q.      Have you worked with them
21  continuously since 1984?
22            A.      I have.
23            Q.      What position were you hired
24  for when you originally became employed by Lilly?

                                                 Page 60

 1            A.      My job title was medical
 2  writing associate.
 3            Q.      And are you still a medical
 4  writing associate today?
 5            A.      I am.
 6            Q.      When you first started as a
 7  medical writing associate at Lilly, what were
 8  your responsibilities?
 9            A.      To write, to edit, to do
10  project planning, to keep track of projects
11  amongst, I guess, the larger general scope of
12  responsibilities in such a group.
13            MS. ZETTLER:  Can you read that back?
14             (THE COURT REPORTER READ BACK THE
15              REQUESTED TESTIMONY.)
16            A.      As part of the larger
17  responsibilities of such a group.
18            Q.      I'm a little confused by the
19  last part of your answer.  What do you mean by as
20  part of the responsibilities of a larger group?
21            A.      The group's responsibility was
22  to provide writing and editing support for the
23  various types of documents that needed to be
24  done.

                                                 Page 61

 1            Q.      Okay.  So within that group,
 2  your responsibility was to write, edit and be
 3  involved in project planning and keep track of
 4  projects?
 5            A.      Right.
 6            Q.      Any other responsibilities?
 7            A.      We conducted some training
 8  classes.  Ultimately -- I guess part of this is a
 9  time frame question because the role has evolved
10  somewhat over time.
11            Q.      From the time that you began as
12  medical writing associate to the present, have
13  you always had responsibility in writing and
14  editing?
15            A.      Yes.
16            Q.      Have you always had
17  responsibility in project planning?
18            A.      Yes.
19            Q.      And keeping track of projects?
20            A.      Yes.
21            Q.      And conducting training
22  classes?
23            A.      Right.
24            Q.      When did that start, when did

                                                 Page 62

 1  your responsibility with that start?
 2            A.      That's a group responsibility
 3  rather than an individual responsibility, and
 4  that started after the first year we started
 5  talking about the training classes that we wanted
 6  to offer during the first year.
 7            Q.      First year being 1984?
 8            A.      That's correct.
 9            Q.      Have you had any individual
10  responsibility in conducting any particular
11  training classes?
12            A.      I have done some sessions on
13  the role of medical writing and some helpful
14  hints workshops to people doing clinical study
15  reports.
16            Q.      People who -- I'm sorry?
17            A.      Who are doing clinical study
18  reports.
19            Q.      When you say clinical study
20  reports, are you talking about the clinical
21  report forms themselves or the summaries of the
22  final product or something in between?
23            A.      I'm sorry, I don't know what
24  you mean by summary of the final product.

                                                 Page 63

 1            Q.      Okay.  Are you -- well, let me
 2  ask you this:  When you say the helpful hints for
 3  people who were --
 4            A.      Preparing clinical study
 5  reports.
 6            Q.      Okay.  Preparing clinical study
 7  reports.  What do you mean by clinical study
 8  reports?
 9            A.      The report of the results of a
10  clinical trial.
11            Q.      As opposed to -- they wouldn't
12  be the people who are preparing the clinical
13  report forms for patients?
14            A.      That's correct, they would be
15  different -- well, the types of documents are
16  different.
17            Q.      Okay.  Did you have any
18  responsibility for preparing clinical
19  investigation manuals?
20            A.      I have had some responsibility
21  for preparing clinical investigation manuals.
22            Q.      Have you ever heard the word
23  Prozac?
24            A.      Yes.

                                                 Page 64

 1            Q.      Okay.  I know that was kind of
 2  an obvious question.  Have you ever heard the
 3  term or the names Fluoxetine Hydrochloride?
 4            A.      Yes.
 5            Q.      When did you first hear the
 6  word Fluoxetine?
 7            A.      I don't know the exact date
 8  when I first heard the word Fluoxetine.
 9            Q.      When you were hired originally
10  in 1984 or started working at Lilly in 1984, were
11  part of your responsibilities related in any way
12  to Fluoxetine?
13            A.      Not initially, as I recall.
14            Q.      Do you remember when you first
15  got involved with Fluoxetine in your employment
16  at Lilly?
17            A.      Probably around 1985.  It could
18  have been toward the end of 1984, but I don't
19  recall the exact date.
20            Q.      Do you remember what months in
21  1984 you started working at Lilly?
22            A.      In January.
23            Q.      You told us a little bit about
24  your responsibility earlier as a medical writing

                                                 Page 65

 1  associate.  Was there ever a time when those
 2  responsibilities were exclusively related to
 3  Fluoxetine as opposed to another drug or product?
 4            A.      No, not really.  A great deal
 5  of my time for dedicated periods of time was
 6  devoted to Fluoxetine, but I did have other
 7  product responsibility.
 8            Q.      Is the department you worked in
 9  essentially the same as the one you worked in
10  when you first started at Lilly?
11            A.      I'm sorry, I don't know what
12  you mean by that question, essentially the same.
13            Q.      You said earlier that things
14  evolved over the years as far as responsibilities
15  of the department, things of that nature.  Has
16  the structure of your department evolved over the
17  years?
18            A.      Again, I'm not sure what you
19  mean by has the structure evolved.
20            Q.      Okay.  Let's do it this way:
21  Tell me, is there anybody that you have
22  supervisory position over in your department?  In
23  other words, are there people that work
24  underneath you?

                                                 Page 66

 1            A.      We have support personnel who
 2  work with a group of us.
 3            Q.      Okay.  What do you mean by
 4  support personnel?
 5            A.      Secretaries, publication
 6  assistants, editorial departments or information
 7  assistants.
 8            Q.      What does a publication
 9  assistant do?
10            A.      They do the electronic
11  integration of documents, the integration of text
12  graphics and tables for data.
13            Q.      They take the various portions
14  of the document and put it all together, so to
15  speak?
16            A.      Yes.
17            Q.      How about the information
18  assistants, what do they do?
19            A.      Copy editing and proofreading
20  for the most part.
21            Q.      Anybody else in the support
22  staff group besides secretaries?
23            A.      No, just information
24  assistants, publication assistants and then staff

                                                 Page 67

 1  secretaries.
 2            Q.      How about on the same level
 3  that you are in your position as, is it, medical
 4  research assistant -- medical writing associate,
 5  sorry.  Is there anybody else in a different
 6  position than a medical writing associate that's
 7  considered on the same level in the hierarchy of
 8  the group?
 9            A.      We also have the job title
10  medical science writer in our group.
11            Q.      So it's medical writing
12  associate and medical --
13            A.      Medical science writer.
14            Q.      You hold both those titles?
15            A.      No, I do not, I have just the
16  title medical writing associate.
17            Q.      So on your level there's
18  medical writing associates and medical science
19  writers.  Is that two separate positions or is
20  that one person with two separate titles?
21            A.      Right now there are two job
22  titles in the group.
23            Q.      How does a medical science
24  writer differ from your position as a medical

                                                 Page 68

 1  writing associate?
 2            A.      I'm not sure that I can answer
 3  the question for you.  I don't really know all of
 4  the distinctions between those.
 5            Q.      Okay.  Do you know of any ways
 6  in which your responsibilities as a medical
 7  writing associate differ from the
 8  responsibilities of a medical science writer?
 9            A.      I have responsibility for
10  coordinating some of our outside writers who help
11  us on projects.
12            Q.      What do you mean by the outside
13  writers?
14            A.      Occasionally we bring in
15  contractors to help us with projects.
16            Q.      Would the clinical
17  investigators be considered outside writers?
18            A.      Not as I have used the term in
19  this context.
20            Q.      Would this be somebody who
21  would be brought in from more of an editorial
22  point of view as opposed to a scientific,
23  medical, technical point of view?
24            A.      I don't understand your

                                                 Page 69

 1  distinction between a scientific technical point
 2  of view and an editorial point of view.
 3            Q.      Why don't you explain to me
 4  what types of responsibilities these outside
 5  writers would have?
 6            A.      They would have scientific
 7  writing responsibility.
 8            Q.      Is there anybody else or any
 9  other job title on your level of the hierarchy
10  besides the medical science writers within your
11  department?
12            A.      Within our department.  I'm
13  sorry, I do not know what, when you refer to
14  hierarchy, I don't know if you're referring to a
15  salary class level or what because the only other
16  job title that we have is department head.
17  However, I do not know what the salary class
18  levels are that are associated with this, so I
19  have trouble with your question about hierarchy.
20            Q.      Okay.  I'm not concerned about
21  how much everybody makes, I'm just concerned
22  about the corporate structure, so to speak,
23  within your department.  So I want to know if
24  there's anybody -- obviously there's somebody

                                                 Page 70

 1  above you at some level that you report to;
 2  correct?
 3            A.      Right.
 4            Q.      Okay.  Is there anybody else on
 5  your level that would report to that same person
 6  or group of people on the level that you would
 7  report to?
 8            A.      Not within our small unit.
 9            Q.      You said earlier, I think, that
10  there was a director?
11            A.      We report to a department head.
12            Q.      Department head.  And what's
13  the name of the department that you work in now?
14            A.      Medical writing services.
15            Q.      Who is the head of that
16  department at this time?
17            A.      Vickie Thompson.
18            Q.      Has she been the head of that
19  department since you've been working there in
20  1984?
21            A.      No.
22            Q.      Who preceded her as department
23  head?
24            A.      John Saunders.

                                                 Page 71

 1            Q.      S-A-U-N-D-E-R-S?
 2            A.      Yes.
 3            Q.      When did Vickie become
 4  department head?
 5            A.      Let me think.  As far as I
 6  remember, it was in the Fall of last year,
 7  perhaps around October.
 8            Q.      1992?
 9            A.      Of 1992.  I'm not sure, that's
10  to the best of my recollection.
11            Q.      That's fine.  And how long was
12  John Saunders department head?
13            A.      He was there a relatively short
14  time.
15            Q.      Okay.  Can you give me an idea
16  of how long, was it less than a year?
17            A.      Yes, I believe it was less than
18  a year.
19            Q.      Do you know why he left?
20            A.      He accepted another position
21  within Lilly, a promotion.
22            Q.      Do you know where he is, what
23  department?
24            A.      No, I'm sorry, I don't know the

                                                 Page 72

 1  name of his department now.
 2            Q.      Do you know what he's doing?
 3            A.      No, I'm sorry, I really don't.
 4            Q.      How about -- who was department
 5  head before John?
 6            A.      Oh, dear, I believe that John
 7  was our first department head.  We have had many
 8  organizational changes, as I've mentioned, and I
 9  believe -- that was the reorganization where we
10  first had a department head.
11            Q.      So prior to the existence of a
12  department head, who would you report to?
13            A.      A manager.
14            Q.      How does a manager differ from
15  a department head?
16            A.      A department head reports to a
17  manager, typically.
18            Q.      So before the position of
19  department head was established, you would report
20  directly to the manager?
21            A.      That's correct.
22            Q.      Who was the manager prior to
23  the department head position being created?
24            A.      Mike Noon.

                                                 Page 73

 1            Q.      Is there still a manager
 2  position in the department?
 3            A.      There is.
 4            Q.      Is Mike still the manager?
 5            A.      No.
 6            Q.      When did Mike stop being the
 7  manager?
 8            A.      I'm sorry, I don't know the
 9  exact date, but it was sometime after Vickie
10  became our department head.
11            Q.      Sometime after the Fall of
12  1992?
13            A.      Right.
14            Q.      Who is manager now?
15            A.      The manager is Ann Nobles.
16            Q.      Do you know if Ann is married?
17            A.      I believe she is.
18            Q.      Do you know what her husband
19  does?
20            A.      No, I'm sorry, I do not.
21            Q.      Prior to Mike Noon, who was the
22  manager of the department?
23            A.      Earleen Ashbrook.
24            Q.      When did Mike Noon become

                                                 Page 74

 1  manager?
 2            A.      I'm sorry, I don't know the
 3  exact date.  There are so many organization
 4  changes, I don't have a good estimate of that.
 5            Q.      Did Mike Noon become manager
 6  after Earleen left that position?
 7            A.      Yes.
 8            Q.      Who was manager when you first
 9  started with the department in 1984?
10            A.      Alice Oliver.
11            Q.      Do you remember how long Alice
12  was manager after you became an employee?
13            A.      No, I'm sorry, I don't know the
14  exact amount of time that she was there.
15            Q.      Was there anybody who was
16  manager between Alice Oliver and Earleen
17  Ashbrook?
18            A.      Yes, there was a manager in the
19  interim.
20            Q.      Do you remember that person's
21  name?
22            A.      One of our managers was Lisa
23  Hyde, and we also had one other manager whose
24  name was Tom Schroeder.  Those are the people

                                                 Page 75

 1  that I remember.
 2            Q.      Can you spell Tom's last name?
 3            A.      Yes, it's S-C-H-R-O-E-D-E-R.
 4            Q.      Other than the change of
 5  creating the director position, were there any
 6  other corporate changes as far as the hierarchy
 7  was concerned within your department?
 8            A.      I'm sorry, you said director
 9  position?
10            Q.      Department head, I'm sorry.
11  What was the one that you said earlier?  You said
12  at some point in time a department head position
13  was created that was between the manager and your
14  level?
15            A.      Right.
16            Q.      Other than that change, were
17  there any other positions created between your
18  level and any other managers' position?
19            A.      No.
20            Q.      Who would the manager report to
21  within your department, do you know?
22            A.      The reporting structure is all
23  in the process of change right now.
24            Q.      How about when you first

                                                 Page 76

 1  started there, who would the manager report to,
 2  what position?
 3            A.      I do not know now what the
 4  reporting structure was when I first started
 5  there.
 6            Q.      Is your department a part of a
 7  larger department?
 8            A.      We were part of a larger group.
 9            Q.      What group was that part of?
10            A.      In the original?
11            Q.      Right, when you first started,
12  I'm sorry.
13            A.      It was part of the medical
14  services group.
15            Q.      What was the purpose of the
16  medical services group?
17            A.      To provide support services to
18  the medical division.
19            Q.      Was the medical services group
20  a part of the medical division?
21            A.      I said to the medical division.
22  I don't recall where that was placed structurally
23  at that time because it has moved several
24  different times in the interim.

                                                 Page 77

 1            Q.      Have you ever acted within
 2  Lilly as a clinical research administrator?
 3            A.      No, I have not.
 4            Q.      Okay.  When you interviewed for
 5  the job as a medical writing associate back in
 6  1983, I believe you said, did anybody say
 7  anything to you about Fluoxetine or Prozac during
 8  those interviews?
 9            A.      I'm sorry, I don't recall.
10            MS. ZETTLER:  This might be a good time
11  to break if you want to break for lunch.
12            MR. STOPHER:  That sounds good.
13            MS. ZETTLER:  And return?
14            MR. STOPHER:  A little bit before 1:00
15  maybe.
16            MS. ZETTLER:  Sure.
17                 * * * * * * * * * *
18            (A lunch recess was taken and the
19  deposition resumed as follows:)
20                 * * * * * * * * * *
21            Q.      (BY MS. ZETTLER)  Welcome back,
22  Doctor Potvin.  So earlier you testified that you
23  had never been a CRA, correct?
24            A.      That's correct.

                                                 Page 78

 1            Q.      But you took a CRA course, I
 2  believe you said earlier?
 3            A.      That is correct.
 4            Q.      And that was in connection with
 5  your employment at Lilly?
 6            A.      Right.
 7            Q.      Why is it that you took a CRA
 8  course?
 9            A.      As part of my overall
10  orientation program and training.
11            Q.      Where was that course
12  conducted?
13            A.      At Eli Lilly and Company.
14            Q.      How long was that class, was it
15  just one class?
16            A.      It was a one week course, I
17  believe it was half days, but it was a number of
18  sessions.
19            Q.      Just on being a CRA or your
20  entire orientation?
21            A.      The CRA training class.
22            Q.      Was that conducted on-site at
23  Lilly or was that conducted somewhere else?
24            A.      On-site at Lilly.

                                                 Page 79

 1            Q.      Who conducted the course?
 2            A.      Lilly personnel.
 3            Q.      Do you remember any of the
 4  names of people that conducted the course?
 5            A.      No, I'm sorry, I don't.
 6            Q.      What types of things did they
 7  discuss during the course?
 8            A.      We talked -- the course covered
 9  the clinical trial process, the documents that
10  were done for various phases of clinical trials,
11  protocols, clinical investigation brochures and
12  the like.
13            Q.      Anything else?
14            A.      It's been a very long time ago,
15  it's hard to think of all the details.  As I
16  recall there was also a section, an overview on
17  the grants payment system.  There were other
18  topics but, I'm sorry, I don't remember all the
19  specific details of the outline and the contents
20  at this point.
21            Q.      Did they tell you anything
22  about what was done with the data from the
23  various trials once it was collected?  For
24  instance, once a study was completed, did they

                                                 Page 80

 1  ever tell you what was done with the data once
 2  the study was completed?
 3            A.      I don't know if you're talking
 4  in specific detail or in general.  We had a
 5  general overview of the clinical trial process
 6  including the completion of the study report.
 7            Q.      Okay.  Was this course on
 8  clinical trials in general or was it specific to
 9  any products?
10            A.      It was general.
11            Q.      What did they tell you about
12  the clinical trial process?
13            A.      It seems like a very broad
14  question, I wonder if you can break it down into
15  some smaller pieces for me.
16            Q.      Part of the problem is, I don't
17  know what the smaller pieces may be, but let me
18  try it this way:  Did they tell you how to set up
19  a study, a clinical study?
20            A.      No, this course was more a
21  broad overview, a general overview, not the
22  specific details of how to set up a particular
23  study.
24            Q.      Okay.  What did they tell you

                                                 Page 81

 1  about protocols?
 2            A.      We had -- again, I'm not sure
 3  how much detail you're looking for, but it was a
 4  general overview of the protocol and the
 5  components of a protocol, but not a protocol for
 6  a specific study.
 7            Q.      What is your understanding of
 8  what a protocol is?
 9            A.      A protocol is -- I would define
10  a protocol as an outline of the procedures to be
11  followed in conducting a clinical trial.  That's
12  a very general definition.  There again, I'm not
13  sure what kind of detail you're looking for in
14  that question.
15            Q.      How about a clinical
16  investigation report, what's your understanding
17  of what a clinical investigation report is?
18            A.      Let me -- can you clarify your
19  terminology, you say a clinical investigation
20  report.
21            Q.      Right, when I asked you what
22  they told you basically about clinical trials in
23  the course, you said that it dealt with the
24  clinical trial process, documents, regarding

                                                 Page 82

 1  protocols and clinical investigation reports?
 2            MS. CLEMENS:  I think she said
 3  brochures.
 4            Q.      Brochures, I'm sorry.
 5            A.      So you're asking?
 6            Q.      Clinical investigation
 7  brochure, what is that?
 8            A.      What is it or what is my
 9  understanding?
10            Q.      What is your understanding of
11  what it is?
12            A.      My understanding of a clinical
13  investigation brochure is that it's a document
14  provided to investigators at the start of a
15  clinical trial, that summarizes all the known
16  information about the drug at that time.
17            Q.      Would that be the same thing as
18  a clinical investigation manual?
19            A.      Yes, I think that the
20  terminology is sometimes used interchangably.  I
21  think the terminology that we use at Lilly has
22  changed from time to time.  We currently are
23  calling them clinical investigator brochures, I
24  believe.

                                                 Page 83

 1            Q.      Did you ever have any
 2  involvement in writing a protocol for Prozac?
 3  Let's stick to Prozac.
 4            A.      I have had the opportunity to
 5  review protocols that have been drafted by
 6  others.
 7            Q.      What was the purpose of your
 8  review of the protocol?
 9            A.      To provide commentary about the
10  clarity and consistency of the information
11  provided.
12            Q.      How about, let's see, let's
13  decide on the terminology for the clinical
14  investigation brochures.  Are you more
15  comfortable with that phrase than with clinical
16  investigation manual?
17            A.      Either term is okay.
18            Q.      Okay.  Did you ever have any
19  involvement in writing a clinical investigation
20  manual?
21            A.      I did.
22            Q.      For Prozac?
23            A.      Yes.
24            Q.      Which ones, do you remember?

                                                 Page 84

 1  Well, let me ask you this, were there different
 2  manuals for different indicated uses, like
 3  depression or obesity?
 4            A.      At one time there were two
 5  manuals as I recall, and then a decision was made
 6  to incorporate all the information into a single
 7  brochure.  But at one time there was more than
 8  one.
 9            Q.      Two that you know of?
10            A.      Yes, I believe it was just two.
11            Q.      What were -- was one of those
12  clinical investigation manuals for depression?
13            A.      Yes.
14            Q.      And the other one was for
15  obesity, correct?
16            A.      Right.  I think it was labeled
17  eating disorders at that time.
18            Q.      At some point those two were
19  combined into one manual, correct?
20            A.      A decision was made to have a
21  single brochure, yes.
22            Q.      Do you remember when that
23  decision was made to combine the two into a
24  single brochure?

                                                 Page 85

 1            A.      I don't know the exact date
 2  that the decision was made, it would have been
 3  with the previous edition of the brochure.
 4            Q.      I don't understand what you
 5  mean by the previous edition, would you explain
 6  that to me?
 7            A.      The current edition of the
 8  brochure has multiple indications in a single
 9  brochure, but the decision was made prior to the
10  issuance of the current brochure.
11            Q.      Do you know when the current
12  brochure was issued?
13            A.      I'm sorry, I don't know what
14  the date is on that document.
15            Q.      Can you give me a year?
16            A.      No, I'm sorry, I don't know
17  when the last edition was published or what its
18  date is.
19            Q.      Is your husband still involved
20  with the medical devices department at Lilly?
21            A.      He is.
22            Q.      Has he ever been involved with
23  the psychotropic drugs at Lilly?
24            A.      I am not aware of any

                                                 Page 86

 1  association or involvement with research in that
 2  area.
 3            Q.      Do you know if he was ever
 4  involved with Fluoxetine?
 5            A.      I don't know.  I don't believe
 6  that his area of research involved Fluoxetine.
 7            Q.      Now I am going to start asking
 8  you questions more specific to Prozac, okay.
 9  When I say Prozac or Fluoxetine, I mean Prozac or
10  Fluoxetine for any indicated use, depression,
11  obesity, obsessive-compulsive disorders, smoking
12  cessation, you know, not just depression.  So to
13  the extent that you know of anything, you know,
14  depression or otherwise, I'd like you to answer
15  the question to the best of your ability with
16  that assumption that I'm talking about all the
17  different indicated uses, okay?
18            MS. GOLDMAN:  We're going to pose an
19  objection to that general comment or general
20  preferatory instruction.  The subject matter of
21  the deposition is Prozac which is indicated for
22  use in the treatment of major depression pursuant
23  to its approval by the FDA.  We will of course
24  listen to each question and make determinations

                                                 Page 87

 1  with respect to each individual question, but I'm
 2  not going to permit this witness to answer in a
 3  wide ranging way questions about this compound
 4  for indications for which it is not approved.
 5            MS. ZETTLER:  The approval by the FDA
 6  doesn't determine relevance or admissibility of
 7  evidence in these cases and there is no order to
 8  that effect in the Kentucky cases in which we're
 9  taking the deposition.
10            Q.      So Doctor, I would like you to
11  assume that when I ask you about Fluoxetine or
12  Prozac -- first of all, when I ask you about
13  Prozac, I mean the compound Fluoxetine
14  Hydrochloride.  And when I ask you about either
15  Prozac or Fluoxetine, I'd like you to assume that
16  I'm asking about any use that Fluoxetine has been
17  tested for, not just depression, anything that's
18  being developed and tested for.
19            MS. GOLDMAN:  Counsel, it's understood
20  that that's what you intend for the scope of your
21  question to be, the responses will be as they may
22  be.
23            MS. ZETTLER:  Well, from the few
24  documents that you have produced to me, she has

                                                 Page 88

 1  been involved in reports on studies that have
 2  dealt with more than just depression.
 3            Q.      Were you involved in writing
 4  any user manuals for software at Eli Lilly, for
 5  any given software?
 6            A.      No.  I'm not aware of any
 7  materials I have written that would be considered
 8  software manuals.
 9            Q.      Were you involved in using --
10  in writing any manuals or documents regarding the
11  use of any certain data bases utilized by Lilly?
12            A.      Can you clarify your use of the
13  term data base, please?
14            Q.      Sure.  For instance, let's talk
15  about the COSTART software.  My understanding is
16  it's a software program, if I'm wrong, let me
17  know, but anything of that nature.  Have you been
18  involved in writing any manuals or any documents
19  instructing Lilly employees or anybody else how
20  to utilize COSTART in any of their job
21  capacities?
22            A.      I have had no writing
23  assignments related to the use of COSTART.
24            Q.      Any other computer related

                                                 Page 89

 1  texts or manuals or documents that you've
 2  authored with regards to your employment at
 3  Lilly?
 4            A.      As far as I'm aware, I don't
 5  believe that any of the writing that I have done
 6  would fit into the category that you described, I
 7  did prepare an electronic publishing style guide
 8  which summarizes information about the use of
 9  Interleaf and provides information about page
10  design and actual style standards.
11            Q.      What's Interleaf?
12            A.      Interleaf Technical Publishing
13  Software, which is a language we use for
14  electronic publishing, and I don't know whether
15  that type of writing fits in the category that
16  you described.
17            Q.      Okay.  Do you know if Earleen
18  Ashbrook still works at Lilly?
19            A.      Yes.
20            Q.      Do you know what department
21  she's in?
22            A.      I believe that -- I'm sorry, I
23  don't know the exact name of the department that
24  she has now, or the departments that she has now.

                                                 Page 90

 1            Q.      Do you know what her job is
 2  basically?
 3            A.      She's a manager.
 4            Q.      She's a manager of the
 5  department or departments?
 6            A.      I believe that she has three
 7  departments.
 8            Q.      Do you know if she's still
 9  involved in working with Fluoxetine?
10            A.      I don't know what involvement
11  she has, per se, with respect to Fluoxetine.
12            Q.      Do you know if she's involved
13  in some capacity but you just don't know what, or
14  is it that you don't know whether or not she's
15  involved at all?
16            A.      I don't know whether she's
17  involved in some capacity with Fluoxetine.  Her
18  primary role is a manager.
19            Q.      Okay.  Did you do anything in
20  preparation for your deposition today, such as
21  for instance reviewing any documents?
22            A.      I did not review any documents.
23            Q.      Did you meet with any of the
24  lawyers for Lilly?

                                                 Page 91

 1            A.      I met with lawyers for Lilly.
 2            Q.      On how many occasions?
 3            A.      I met with them today and on
 4  one other occasion.
 5            Q.      When was the first time that
 6  you met with them?
 7            A.      Earlier this year.
 8            Q.      Where was that meeting, the
 9  first meeting held?
10            A.      At Eli Lilly and Company.
11            Q.      How many lawyers were there?
12            A.      I believe that there were
13  three.
14            Q.      Three?
15            A.      I believe there were three, as
16  I recall.
17            Q.      Do you remember the names of
18  any of those lawyers?
19            A.      I do.
20            Q.      Can you tell me those names,
21  please?
22            A.      Lisa Goldman was one of the
23  lawyers.  I'm sorry, I don't have the correct
24  name for the other lawyer, I do not recall the

                                                 Page 92

 1  other lawyer's name.
 2            Q.      Does the name Jim Burns ring a
 3  bell?
 4            A.      No.
 5            Q.      How about Robert Stanley?
 6            A.      I'm sorry, I don't recall the
 7  name.
 8            Q.      How long did that first meeting
 9  last?
10            A.      Approximately, oh -- I'm not
11  sure of the exact amount of time that we actually
12  spent, I believe the meeting was scheduled for
13  between one and two hours.
14            Q.      Did it go longer than one or
15  two hours?
16            A.      No.
17            Q.      And you said you met with
18  lawyers from Lilly this morning?
19            A.      Yes.
20            Q.      And where did you meet?
21            A.      Here in this building.
22            Q.      Who did you meet with?
23            A.      Lisa Goldman, Curt Oltmans and
24  Ed Stopher.

                                                 Page 93

 1            Q.      How long did the meeting this
 2  morning last?
 3            A.      Approximately an hour and a
 4  half.
 5            Q.      Were you ever asked to turn any
 6  documents kept in your file at Lilly over to the
 7  lawyers for Lilly?
 8            A.      Yes.
 9            Q.      When were you asked to do that?
10            A.      Periodically we're asked to do
11  that.
12            Q.      Starting when?
13            A.      I don't recall the date of the
14  first request.
15            Q.      Was it something that was done
16  as a matter of course with any of the drugs that
17  you worked on at Lilly, or was that something
18  that was done only in relationship to Prozac?
19            A.      As part of our review process,
20  we submitted documents to legal for review.
21            Q.      What do you mean by review
22  process?
23            A.      When we prepare manuscripts for
24  publication, we have an internal review process

                                                 Page 94

 1  that includes legal and in that case information
 2  is supplied for them and that's routine for all
 3  compounds.
 4            Q.      Other than routine production
 5  of documents to Lilly lawyers, were you asked to
 6  produce any other documents from your files to
 7  Lilly's lawyers in regards to Prozac?
 8            A.      I'm sorry, can you restate the
 9  question or repeat the question for me?
10            Q.      Sure.  You just testified that
11  as part of the review process, you turned over
12  documents to Lilly lawyers for their review,
13  correct?
14            A.      Lilly lawyers are included in
15  the review process for documents.
16            Q.      What types of documents would
17  you turn over in that review process?
18            A.      As part of the standard review
19  process?
20            Q.      Right.
21            A.      Primarily manuscripts,
22  abstracts, poster presentations -- presentations
23  at a scientific meeting.
24            Q.      And outside of that, were you

                                                 Page 95

 1  ever asked to produce any documents from your
 2  files to lawyers from Lilly related to Prozac?
 3            A.      Yes.
 4            Q.      Tell me about that, when was
 5  the first time you were asked to do that?
 6            A.      I'm sorry, that's what I'm
 7  saying, I don't recall the date of the first
 8  request to provide information to the lawyers on
 9  Prozac.
10            Q.      Okay.  What types of
11  information were you asked to provide outside of
12  the review process?
13            A.      All types of documents relating
14  to Prozac.
15            Q.      And was that done on more than
16  one occasion?
17            A.      Yes.
18            Q.      Do you remember how long you
19  had been working for Lilly when the first request
20  was made for those documents?
21            A.      No, I'm sorry, it seems to be
22  somewhat the same question.  I just don't have a
23  good feeling for when that first request was
24  made.

                                                 Page 96

 1            Q.      When was the last time they
 2  asked you to produce documents like that?
 3            A.      The end of the last quarter.
 4            Q.      When was that?
 5            A.      At the end of March.
 6            Q.      Now these are documents outside
 7  the normal review process, right?
 8            A.      Right, and --
 9            Q.      I'm sorry, were you done?
10            A.      Yes.
11            Q.      Is there some sort of procedure
12  that they have enacted at this time where you
13  were to produce documents of that nature at the
14  end of each quarter or something along those
15  lines?
16            A.      Different groups have a
17  different reporting, or different frequency of
18  requests, but ours are being requested on an
19  approximately quarterly basis to the best of my
20  recollection.
21            Q.      Again, these are documents
22  outside the normal --
23            A.      Right.
24            Q.      -- review procedure?

                                                 Page 97

 1            A.      Right.
 2            Q.      Has this request been made in
 3  regards to any other drug products that you're
 4  working on other than Prozac?
 5            A.      I'm not aware of any such
 6  request with respect to any of the other products
 7  that I am currently working on.
 8            Q.      Are you currently working on
 9  Fluoxetine in any capacity at Lilly?
10            A.      Yes, I am.
11            Q.      Are your responsibilities with
12  regards to Fluoxetine essentially the same as to
13  what you testified earlier as your general
14  responsibilities in your position as medical
15  writing associate?
16            A.      With respect to the writing and
17  editing?
18            Q.      With respect to your
19  responsibilities with regards to Prozac right
20  now.  In other words, have your responsibilities
21  changed with regards to Prozac since you started
22  working as a medical writing associate?
23            A.      No, they're basically the same.
24            Q.      You're still involved in

                                                 Page 98

 1  writing and editing, project planning, keeping
 2  track of projects, things of that nature?
 3            A.      That's correct.
 4            Q.      Are you aware of any other
 5  studies being conducted right now regarding
 6  suicidality and the use of Fluoxetine?
 7            MS. GOLDMAN:  Is she aware of any
 8  studies presently ongoing?
 9            MS. ZETTLER:  Right.
10            MS. GOLDMAN:  Involving?
11            MS. ZETTLER:  Suicidality and the use
12  of Fluoxetine.
13            MS. GOLDMAN:  You can respond to that
14  question.
15            A.      Can you clarify for me whether
16  you're asking for specific studies of
17  suicidality?
18            Q.      Yes, I am.
19            A.      I am not aware of any studies
20  being specifically designed and conducted to
21  address suicidality as a primary measure right at
22  the present time.
23            Q.      Are you familiar with the word
24  akathisia, have you ever heard that word before?

                                                 Page 99

 1            A.      Yes, I have heard the word
 2  before.
 3            Q.      What is your understanding of
 4  what that word means?
 5            A.      I think that the definition of
 6  the term akathisia in the literature are somewhat
 7  controversial and I believe that an answer to
 8  your question really requires a scientific or
 9  medical interpretation.
10            Q.      When you say that the
11  definition of akathisia is controversial in the
12  medical literature, what medical literature are
13  you talking about?
14            A.      Published articles dealing with
15  the subject.
16            Q.      When you say the definition is
17  controversial, do you mean the condition of
18  akathisia itself or its cause?
19            A.      I think that the concept of
20  akathisia -- or let me start over.  I don't
21  believe that there is agreement about what
22  constitutes akathisia among physicians and
23  scientists.
24            Q.      Have you been involved in the

                                                 Page 100

 1  writing or publishing of any papers regarding
 2  what constitutes akathisia?
 3            A.      I have not been directly
 4  involved in any work that would be categorized
 5  that way to the best of my knowledge.
 6            Q.      Have you been indirectly
 7  involved?
 8            A.      I'm not sure what you mean now
 9  by indirect involvement.  I have not written any
10  papers specifically on akathisia, if that is what
11  you're asking.
12            Q.      Have you been involved in any
13  way with any papers that have been -- let me ask
14  you this:  To your knowledge has Eli Lilly or
15  anybody associated with Eli Lilly published a
16  paper regarding what constitutes akathisia?
17            A.      To the best of my knowledge, I
18  don't believe anyone has published an article on
19  what constitutes akathisia.  I believe that one
20  physician wrote a response to an article in which
21  he reviewed some of the literature relating to
22  akathisia.
23            Q.      What physician was that, who
24  was that?

                                                 Page 101

 1            A.      Doctor Beasley.
 2            Q.      When did Doctor Beasley write
 3  the letter, the response?
 4            A.      Within the past year.
 5            Q.      Has that been published?
 6            A.      I don't know whether that's
 7  been published or not.
 8            Q.      Are you familiar with the
 9  phrase, Dear Doctor letter?
10            A.      No, I'm sorry, I'm not.
11            Q.      Have you been involved in any
12  way with writing or drafting letters to medical
13  professionals, customers, things of that nature,
14  with regards to Prozac?
15            A.      No.  On one occasion that I
16  recall I was asked to review a letter that had
17  been written to help with punctuation, primarily,
18  and grammatical style, but I have not generally
19  been involved in the writing of letters.
20            Q.      When were you asked to review
21  the letter?
22            A.      Oh, let's see, probably around
23  two years ago.
24            Q.      Do you remember what the

                                                 Page 102

 1  subject of that letter was?
 2            A.      No, I'm sorry, I don't.  I just
 3  remember a person asking for some help with the
 4  letter.
 5            Q.      Do you remember if it was
 6  regarding Prozac?
 7            A.      It was regarding depression.
 8            Q.      Was Prozac mentioned, to the
 9  best of your memory?
10            A.      I don't remember.
11            Q.      Who was the person that asked
12  you to review the letter?
13            A.      It was an individual in medical
14  correspondence area, but I don't recall his name.
15            Q.      Did he have a lot of
16  grammatical errors in that letter?
17            A.      No, just a couple of
18  punctuation errors as I recall.
19            Q.      To your knowledge are there any
20  studies going on related to Prozac, the use of
21  Prozac and homicidal ideation or tendencies?
22            A.      I'm not aware of any studies
23  ongoing on that topic.
24            Q.      Have you ever been involved

                                                 Page 103

 1  with preparing reports or any other documents
 2  related to the use of Prozac and homicidal
 3  tendencies?
 4            A.      I have.
 5            Q.      What reports are those?
 6            A.      We have prepared a report for
 7  the Food and Drug Administration on that topic
 8  and we prepared a manuscript for publication.
 9            Q.      When did you prepare the report
10  for the FDA?
11            A.      I believe that it was in 1990.
12            Q.      Who else was involved in the
13  preparation of that report?
14            A.      A research physician and a
15  statistician.
16            Q.      Who was the research physician?
17            A.      Doctor John Heiligenstein.
18            Q.      Who was the statistician?
19            A.      Doctor Bruce Dornseif.
20            Q.      To your knowledge, were there
21  any -- was it only this one report that you were
22  involved in regarding Prozac, the use of Prozac
23  in homicidal behavior?
24            A.      And the publication.

                                                 Page 104

 1            Q.      The manuscript?
 2            A.      The manuscript.
 3            Q.      Let's deal with this report
 4  right now.
 5            A.      Okay.
 6            Q.      To your knowledge with regards
 7  to preparing this report, were there any clinical
 8  studies done specifically to investigate the use
 9  of Prozac in any homicidal behavior, or was this
10  a retrospective type study on data that was
11  already collected?
12            A.      The report that we're
13  discussing was a retrospective analysis of
14  clinical trial data that had already been
15  collected.
16            Q.      Where was that data collected
17  from, if you know?
18            A.      From a series of multicentered
19  trials conducted in the U.S. and Canada is my
20  belief.
21            Q.      You said the U.S. and Canada?
22            A.      Yes.
23            Q.      And were these various
24  multicenter studies specifically on the use of

                                                 Page 105

 1  Prozac and homicidal behavior or were these
 2  studies done for other purposes such as like
 3  fixed doses or efficacy studies, things of that
 4  nature?
 5            A.      The studies were done for other
 6  purposes.
 7            Q.      Do you know if this report was
 8  ever sent to the FDA?
 9            A.      To the best of my knowledge, it
10  was furnished to the FDA.
11            Q.      What was your involvement in
12  writing this report?
13            A.      I was a member of a team that
14  prepared the report.
15            Q.      What were your responsibilities
16  with regards to this report?
17            A.      To write and to edit.
18            Q.      Were you assigned any specific
19  sections of the report to write?
20            A.      In this particular case, a
21  draft had been prepared and so I was working with
22  the entire text.
23            Q.      Who prepared the original draft
24  or the draft that you were working on?

                                                 Page 106

 1            A.      I believe it was prepared by
 2  Doctor Heiligenstein and Doctor Dornseif.
 3            Q.      I guess I'm a little confused
 4  as to what you mean by you wrote or helped write
 5  the report.  Could you explain to me what you
 6  mean when you say you helped write it?
 7            A.      We had a preliminary draft and
 8  my task was to make sure that that report was
 9  consistent in format with other reports that we
10  prepare, to include information about the
11  methodology and to do a general editing of it as
12  well.
13            Q.      Methodology of what?
14            A.      The methodology used for the
15  analysis.
16            Q.      The methodology used for the
17  analysis of the data that was presented in the
18  report?
19            A.      Right.
20            Q.      When you say to make sure that
21  the report was consistent with other reports,
22  what did you mean by that?
23            A.      We have developed a standard
24  outline that we use for reports and a standard

                                                 Page 107

 1  format for headings and subheadings and that sort
 2  of thing, and it's part of the task of the
 3  medical writer to make sure that each report
 4  conforms to the standard style.
 5            Q.      Would that be an B-form?
 6            A.      No.
 7            Q.      Did you ever have any
 8  responsibility to determine how any certain
 9  information was presented, for instance any
10  statistical information?
11            A.      The statistical information was
12  provided by the statistician.
13            Q.      How about any other
14  information, did you have any responsibilities to
15  determine how any other information was
16  presented?
17            A.      I guess I'm not quite sure what
18  you mean by that.
19            MS. ZETTLER:  Strike it for now.
20            Q.      What happened to the draft
21  after you completed your work on it?
22            A.      It was reviewed, it was revised
23  and then it was submitted for approval.
24            Q.      Who reviewed it?

                                                 Page 108

 1            A.      It was reviewed by the
 2  physician, the statistician, the regulatory
 3  advisor and medical management, as well as the
 4  legal staff.
 5            Q.      I'm sorry, you said medical
 6  management?
 7            A.      Medical management.
 8            Q.      When you say the physician and
 9  statistician, are you talking about Doctor
10  Dornseif and Doctor Heiligenstein?
11            A.      Yes.
12            Q.      Who is the regulatory advisors
13  who reviewed that report?
14            A.      I believe that the regulatory
15  advisor was Doctor Al Weber.
16            Q.      Would that be Allen Weber?
17            A.      Yes.
18            Q.      Is his first name Allen?
19            A.      Yes, but that's not his first
20  name.
21            Q.      I'm sorry.
22            A.      The name that he goes by is
23  Allen, I believe he has another first initial.
24            Q.      Okay.  And what is medical

                                                 Page 109

 1  management?
 2            A.      Medical management consists of
 3  in this case a director or executive director and
 4  vice-president of the medical division review,
 5  the material, in addition to the preparing
 6  physician.
 7            Q.      I'm sorry, list those three
 8  titles again.  Vice-president?
 9            A.      Uh-huh.
10            Q.      Vice-president of medical
11  management?
12            A.      No, just vice-president of the
13  medical division.
14            Q.      And then what were the other
15  ones, I'm sorry?
16            A.      A director or executive
17  director.
18            Q.      Of the medical division?
19            A.      Yes.
20            Q.      Do you know who the
21  vice-president that reviewed this report was?
22            A.      I'm sorry, I don't know who was
23  the vice-president that reviewed it.
24            Q.      Okay.

                                                 Page 110

 1            A.      I don't know what the job
 2  titles actually were at that time.
 3            Q.      Okay.  Do you know -- do you
 4  remember the names of anybody else who reviewed
 5  this report after you were finished with working
 6  on it?  The first time, if there was more than
 7  one time.
 8            A.      I believe that Doctor Zerbe was
 9  one of the people who reviewed this document,
10  there may have been other people but I don't know
11  who everyone was that reviewed it.
12            Q.      Okay.  What types of changes
13  did you make on the report when you reviewed it?
14  Is there anything that sticks out in your mind?
15            A.      No, I'm sorry, I don't recall
16  the details of that project specifically or
17  changes that resulted from the review process.
18            Q.      Would you have any criticisms
19  or critiques of the report other than within your
20  normal duties to review, perform that, et cetera?
21            A.      I'm sorry, I don't understand.
22  Do I have any criticisms or critiques of it?
23            Q.      Do you have any criticism of
24  the way the report was presented to you in draft

                                                 Page 111

 1  form?
 2            A.      Again, I don't remember the
 3  specific details of that project.
 4            Q.      Did you disagree with any of
 5  the content of the report?
 6            A.      I don't recall having
 7  disagreement with the content.
 8            Q.      Did you disagree in any way
 9  with the process in which the report was created?
10            A.      No.
11            Q.      Did you ever see a final copy
12  of the report when it was submitted to the FDA?
13            A.      I do not -- let's see, I saw a
14  copy of the final report that we prepared for
15  submission to the FDA.
16            Q.      Did you read it?
17            A.      Yes.
18            Q.      Were you satisfied that the
19  changes you had made were incorporated?
20            A.      That's part of my
21  responsibility as a writer, before a document is
22  submitted to make sure that all the changes that
23  everyone has requested are incorporated.
24            Q.      Were you satisfied that all of

                                                 Page 112

 1  those changes were incorporated?
 2            A.      To the best of my knowledge, I
 3  believe they were.
 4            Q.      Were you aware of any
 5  disagreements between someone, such as Doctor
 6  Zerbe and Doctor Dornseif, with regards to
 7  anything that was presented in the paper?
 8            MS. GOLDMAN:  Object to the form of the
 9  question.
10            Q.      You can answer it, if you can.
11            A.      Can you restate your question
12  for me?
13            Q.      Sure.  Are you aware of any
14  disagreements between somebody, such as Doctor
15  Zerbe or anybody else who worked on the report,
16  with anybody else who had worked on the report?
17  For instance, did Doctor Zerbe have a
18  disagreement with the statistician or, you know,
19  Doctor Heiligenstein, as to what's contained in
20  the report or how any of the information is
21  presented?
22            A.      I'm not aware of any
23  disagreement about the contents of the report
24  from my perspective as a writer.

                                                 Page 113

 1            Q.      Okay.  I guess you said, was it
 2  manuscript, the other paper that -- report you
 3  worked on with regards to Prozac, the use of
 4  Prozac and homicidal ideation, was it a
 5  manuscript, correct?
 6            A.      There is a manuscript that was
 7  published, yes.
 8            Q.      What do you mean by manuscript?
 9            A.      An article published in the
10  scientific literature.
11            Q.      When was that published, if you
12  know?
13            A.      I believe it was published in
14  December of 1992.
15            Q.      Do you remember where it was
16  published?
17            A.      Annals of Clinical Psychiatry,
18  I believe.
19            Q.      Who authored that paper?
20            A.      Doctor Heiligenstein is the
21  senior author of that paper.
22            Q.      Anybody else?
23            A.      There are co-authors of the
24  paper.

                                                 Page 114

 1            Q.      Do you remember who any of the
 2  names of those co-authors are?
 3            A.      Doctor Dornseif is one of them,
 4  I am a co-author of the paper, there are other
 5  co-authors, as well, I believe.  Doctor Coccaro
 6  is one of the co-authors, C-O-C-C-A-R-O, I
 7  believe.
 8            Q.      What was your responsibility
 9  with regards to preparation of the manuscript?
10            A.      I was involved as a member of
11  the team who prepared the manuscript along with
12  the physicians and statistician.
13            Q.      As a member of the team, what
14  were your responsibilities?
15            A.      To work with the physician and
16  statistician to write a manuscript that was
17  suitable for publication in the Annals of
18  Clinical Psychiatry.
19            Q.      Doctor Heiligenstein, is he on
20  staff at Lilly or does he work outside of Lilly?
21            A.      He works at Lilly.
22            Q.      How about Doctor Dornseif?
23            A.      He was an employee of Lilly at
24  the time.

                                                 Page 115

 1            Q.      He's no longer employed there?
 2            A.      That's correct.
 3            Q.      Do you know where he's
 4  employed?
 5            A.      I'm sorry, I don't know the
 6  name of the company that he's now working with.
 7            Q.      Do you know where the company
 8  is located?
 9            A.      I believe that he's working in
10  New Jersey now.
11            Q.      Do you know why he left Lilly?
12            A.      He accepted another position,
13  at another company.
14            Q.      To your knowledge did he leave
15  Lilly on good terms?
16            A.      Oh, I'm certain he did.
17            Q.      Why is that?
18            A.      He was a member of the team and
19  a highly regarded statistician.
20            Q.      What do you mean when you say a
21  member of of the team?
22            A.      A member of the team that
23  worked to put together this particular report and
24  manuscript.

                                                 Page 116

 1            Q.      Okay.  Both documents?
 2            A.      Right.
 3            Q.      Who asked that this manuscript
 4  be prepared?
 5            A.      I'm not sure what you're asking
 6  by that.
 7            Q.      Was the idea to publish a
 8  report in a scientific publication regarding
 9  Prozac and homicidal ideation, was that Doctor
10  Heiligenstein's idea, to your knowledge?
11            A.      I can't say with certainty.
12            Q.      Are you aware of what the
13  process is within Lilly, if any, for determining
14  or deciding when to publish any given article,
15  was there a procedure within Lilly to determine
16  whether or not to prepare and publish or attempt
17  to publish a manuscript?
18            A.      I'm not aware of any standard
19  procedure that is followed.
20            Q.      Is there any nonstandard
21  procedure that's followed?
22            A.      I'm not aware of -- I guess I'm
23  not aware of a standard procedure that is
24  followed.

                                                 Page 117

 1            Q.      Were you ever involved in any
 2  meetings where the subject such as a need for an
 3  article such as this manuscript came up?
 4            A.      I don't recall any specific
 5  meetings that addressed publication in the terms
 6  in which you phrased that question.
 7            Q.      Have you been in any meetings
 8  whatsoever that discussed publication?
 9            A.      Yes.
10            Q.      Tell me about some of those
11  meetings.  What types of topics would come up
12  with regards to publication?
13            MR. STOPHER:  I'm kind of lost here,
14  are we talking about something other than Prozac
15  or something other than this publication or are
16  we talking about just this particular manuscript?
17            MS. ZETTLER:  She's already excluded
18  this publication and I've limited, unless I state
19  otherwise, I'm limiting all my questions to
20  Prozac at this point.
21            Q.      So do you remember the
22  question, Doctor?
23            A.      Could you restate the question
24  for me, please?

                                                 Page 118

 1            MS. ZETTLER:  Well, actually would you
 2  read it back?
 3                  (QUESTION READ.)
 4            A.      It's a very broad question.  We
 5  discussed publications and our prioritization of
 6  efforts to complete manuscripts, so as to share
 7  information in the scientific literature.  And
 8  the manuscript in question was discussed from a
 9  point of view of prioritizing it, so that it
10  could have the resources to be prepared for
11  publication.
12            Q.      Okay.  So when you say the
13  article in question, the manuscript regarding
14  Prozac and homicidal ideation?
15            A.      Right.
16            Q.      When you say prioritized, you
17  mean prioritized in relation to other pending
18  reports or articles?
19            A.      Yes.
20            Q.      Was there a time when this
21  article or manuscript was prioritized over other
22  pending reports and articles?
23            A.      Each of the articles received a
24  priorty, a relative priorty.

                                                 Page 119

 1            Q.      Okay.  Was there ever a time
 2  when either an individual or the group discussed
 3  taking this article from say the middle of the
 4  pack and sticking it at the top of the pack so it
 5  would have more resources for completion or for
 6  any other reason?
 7            A.      I don't recall the specific
 8  discussions of this particular manuscript.
 9            Q.      Okay.  Was there a particular
10  date you wanted the manuscript completed by?
11            A.      All of our projects have target
12  dates for completion.
13            Q.      What was the target date for
14  completion of this, if you remember?
15            A.      I don't recall a target date
16  for completion of the manuscript, I do recall the
17  desire to complete the report.
18            Q.      You recall a target date for
19  completion of the report?
20            A.      Yes.
21            Q.      What was the target date for
22  completion of the report?
23            A.      It was for submission in 1990,
24  as I mentioned before.

                                                 Page 120

 1            Q.      I thought you said it was
 2  published in 1992?
 3            A.      The journal article was but the
 4  report was submitted earlier.
 5            Q.      I'm sorry, I was talking about
 6  the manuscript.
 7            A.      Oh, okay.
 8            Q.      I'm sorry, my mistake.  How
 9  about the manuscript, do you remember any
10  meetings where the manuscript was being
11  prioritized so that it would have more resources
12  or completed quicker?
13            A.      Are you asking me was there a
14  time that I remember it being put on the top of
15  the list?
16            Q.      Right.
17            A.      I don't recall such a meeting.
18            Q.      Do you remember a target date
19  being set for publication of the manuscript or
20  attempted publication of the manuscript?
21            A.      No, I do not.  I don't recall a
22  specific date being targeted for that.
23            Q.      I'm trying to get an
24  understanding of how an article is developed from

                                                 Page 121

 1  inception to publication.  How is it that an idea
 2  of an article is presented, do you know, is it
 3  presented to the group or is it something that
 4  somebody undertakes on their own and when they
 5  have a draft it's presented to the group, or how
 6  does that work?
 7            A.      It works in many different
 8  ways, depending upon the individuals involved.
 9            Q.      Okay.  How about for somebody
10  like Doctor Heiligenstein, how would it work for
11  him?
12            A.      I'm sorry, I don't really
13  believe I can say.  I don't know if the process
14  is always the same when he writes an article.
15            Q.      Okay.  Is there a general
16  procedure within Lilly for reviewing, first of
17  all, ideas for articles or reports?
18            A.      You've asked if there's a
19  general procedure in Lilly.  Are you talking for
20  all articles or simply for Fluoxetine?
21            Q.      Fluoxetine.
22            A.      I don't believe that there is a
23  general procedure for reviewing ideas.  There was
24  an attempt to put together a list and to

                                                 Page 122

 1  prioritize ideas, but it's as I said before,
 2  there isn't any one standard procedure that
 3  people followed, that I am aware of.
 4            Q.      Would you agree that
 5  considerable resources, financial and timewise,
 6  are invested in putting together say a report for
 7  submission to the FDA?  In general, not just
 8  Prozac, in general.
 9            A.      I'm sorry, you've asked --
10  would you repeat the question, please?
11                  (QUESTION READ.)
12            A.      What kind of report are you
13  referring to there in that instance?
14            Q.      Generally, when you put
15  together a report for submission to the FDA,
16  there are going to be a number of people who are
17  working on that report one way or another,
18  correct?
19            A.      I guess, we do many kinds of
20  reports.
21            Q.      Then let's pick one like the
22  one report that Doctor Heiligenstein worked on
23  and you worked on with regards to homicidal
24  ideation, okay.  We'll use that as an example.

                                                 Page 123

 1  Generally when you're working on a report such as
 2  that, a retrospective analysis or reanalysis of
 3  data that's already been accumulated?
 4            A.      Right.
 5            Q.      There are a certain number of
 6  people who are going to work on reanalyzing that
 7  data, reaccumulating that data, things of that
 8  nature?
 9            A.      Correct.
10            Q.      And there are also people that
11  are going to work, such as Doctor Heiligenstein,
12  who are going to work on reporting on that
13  information, correct?
14            A.      Correct.
15            Q.      And there are going to be
16  people such as yourself and others in that group
17  that may review a draft or two of the report that
18  are submitted for various reasons, correct?
19            A.      Correct.
20            Q.      Not to mention the Doctor
21  Zerbes and everybody else on the upper level and
22  people from legal who are going to have to review
23  it from their different perspectives, correct?
24            A.      Right.

                                                 Page 124

 1            Q.      So again, I'm trying to get an
 2  understanding of how it is that somebody decides
 3  they're going to do something like this within
 4  the company.  Is it somebody that comes in and
 5  says gee, Mister Smith, I've got an idea for this
 6  report, and I wonder what you think, and then
 7  after that it's sent to a committee of sorts or a
 8  person who says, well, this looks like a viable
 9  idea, maybe it's something we should invest some
10  time or money into, or does somebody, Doctor
11  Heiligenstein, have a responsibility on his own
12  to collect data and put it together and bring it
13  to you in the form of a draft?
14            MS. GOLDMAN:  Object to the form of
15  that question, object in part as well on the
16  grounds that it is asked and answered and the
17  witness's testimony is on the record in a number
18  of different respects.  I will allow her to
19  attempt a responsive answer to that question one
20  more time, and God bless her if she can.
21            MS. ZETTLER:  I object to the editorial
22  comments and I also disagree that it's been
23  answered in a number of different ways, because
24  if I had gotten an answer, I wouldn't be trying

                                                 Page 125

 1  to get an answer at this point.  I'm not saying
 2  it's the witness's fault, it might be my fault,
 3  but I'm trying to work my way through this
 4  procedure and figure out how this is done and I
 5  think I have a right to know that.
 6            MS. GOLDMAN:  Counsel, respectfully, I
 7  think you got a response.  I think it's not a
 8  response that you want and I understand what
 9  you're trying to do and you understand my job as
10  well.  My objection stands, I will allow the
11  witness to make another attempt.
12            Q.      Do you understand where I'm
13  trying to go with this, Doctor?  I'm really not
14  trying to trick you or anything, I'm just trying
15  to find out if, number one, there is any sort of
16  procedure that's involved in presenting and
17  approving tentative ideas for articles, reports,
18  things of that nature, or, number two, how it is
19  that something like this is born and goes through
20  fruition?
21            MS. GOLDMAN:  Object to the form of the
22  question on the grounds that it's compound.
23            A.      I am not aware of a standard
24  procedure that is used throughout Lilly to

                                                 Page 126

 1  develop ideas for clinical trials or their
 2  publications.  I believe that different processes
 3  are used in different groups.
 4            Q.      Okay.  Was there a common
 5  practice that was used within the Prozac group,
 6  the group working on Prozac, to decide and/or
 7  develop an idea reporting on any aspect of
 8  Fluoxetine?
 9            A.      I don't believe that there is a
10  standard process amongst all physicians who work
11  in that area.
12            Q.      Okay.  Was there somebody who
13  would, one or two, somebody, not meaning
14  necessarily a single individual, but is there
15  somebody who decides on the need for a certain
16  type of article or certain type of report and
17  then in effect assigns it to somebody else within
18  the division to develop?
19            A.      It seems like you're asking me
20  two questions there, combined.  Can you read it
21  back, please.
22                  (QUESTION READ.)
23            MS. GOLDMAN:  Object to the form of the
24  question.  You can attempt to answer.

                                                 Page 127

 1            A.      I don't think I have any
 2  additional information to supply in that regard.
 3            Q.      Okay.  Does that mean you don't
 4  know or --
 5            A.      Well, I'm not aware of a
 6  standard procedure that was used.  I know that
 7  different individuals may have different ways of
 8  working to develop an idea.  There was, as I
 9  mentioned before, a group that met to prioritize
10  publication efforts, but as far as determining
11  which papers to pursue, I am not certain how that
12  process works.
13            Q.      Okay.  Who was in the group
14  that met to prioritize articles and reports?
15            A.      There was a publications
16  committee.
17            Q.      Okay.
18            A.      That met to do that.
19            Q.      Who was on that committee, say
20  at the time that Doctor Heiligenstein's article
21  or manuscript was in the process of being
22  developed?
23            A.      Are you interested in the
24  specific names of the people or simply the nature

                                                 Page 128

 1  of the people in it?  It was a research
 2  physician, a clinical research administrator, a
 3  medical plans department head, a physician.
 4            Q.      Okay.  Do you recall who any of
 5  those people were specifically?
 6            A.      Doctor Tolivson was a member of
 7  that group.
 8            Q.      What was his position?
 9            A.      He's --
10            Q.      Research physician?
11            A.      He's executive director.
12            Q.      Anybody else involved in that
13  group?
14            A.      The group membership has
15  changed and you're asking for the specific group
16  at the time that Doctor Heiligenstein's
17  manuscript was developed and I'm not certain that
18  I know specifically all the people who were
19  involved at that time.
20            Q.      You were involved in that
21  group?
22            A.      I was involved in that group.
23            Q.      Do you know who the CRA that
24  was involved in it?

                                                 Page 129

 1            A.      No, I'm sorry.  I think I may
 2  have spoken in error.  I don't believe that it
 3  was a CRA but it was a medical plans department
 4  head who was involved in that.
 5            Q.      Were you involved in any
 6  reports where the subject was a retrospective
 7  study of suicidality and the use of Prozac, using
 8  your definition of reports, I think like
 9  submissions to governmental agencies?
10            A.      The answer is yes.
11            Q.      How many such reports were you
12  involved with?
13            A.      I'm sorry, I don't think I have
14  a good estimate of the total number of reports, I
15  believe there were two, perhaps two.
16            Q.      Could there have been more than
17  two?
18            A.      Are we speaking of depression?
19            Q.      I'm speaking of any indicated
20  use whatsoever.
21            MR. STOPHER:  Let me note an objection
22  on the ground that I'm going to instruct her not
23  to answer except for the approved indicated use,
24  which is depression.

                                                 Page 130

 1            Q.      Let's start with depression.
 2  How many such studies were you involved in
 3  regarding suicidality, depression and the use of
 4  Fluoxetine.
 5            MR. OLTMANS:  Did you misspeak,
 6  Counsel, I think you said studies.  Did you mean
 7  to say studies?
 8            MS. ZETTLER:  Report, I'm sorry.
 9            A.      I believe that there were three
10  reports that we prepared on suicidality and
11  depression.
12            Q.      And these were reports for
13  submission to the FDA?
14            A.      Yes, that's correct.
15            Q.      These were retrospective
16  studies?
17            A.      Yes, they were.
18            Q.      Do you remember when these
19  reports were submitted to the FDA?
20            A.      I believe that one of them was
21  submitted in 1990, and I think that the others
22  were submitted in 1991.  I'm not certain, I'm not
23  absolutely certain of the dates.
24            Q.      Let's start with the report

                                                 Page 131

 1  that was submitted in 1990, who wrote that report
 2  besides yourself?
 3            A.      I worked with a team of people
 4  to do that project.
 5            Q.      Can you tell me who was on the
 6  team?
 7            A.      I am not sure that I can tell
 8  you all the people who were on the team, but to
 9  the best of my recollection, there was a CRA on
10  the team for that project, and there was at least
11  one research physician and a statistician.
12            Q.      Who was the statistician on
13  that project?
14            A.      I don't know who did the actual
15  statistical work on that project.  The people
16  have changed and I don't remember who did the
17  statistics on the first one.
18            Q.      How about who was the CRA on
19  the first one, do you know?
20            A.      Laura Fludzinski was the person
21  with whom I worked, she was in the medical plans
22  area as a department head at that time.
23            Q.      How about the clinical research
24  physician?

                                                 Page 132

 1            A.      I believe that the primary
 2  physician was Doctor Beasley.
 3            Q.      How about the '91 reports, can
 4  you tell us who were involved in those?
 5            A.      I believe that Doctor Beasley
 6  was also involved in that report, again I am not
 7  certain of who the actual statisticians were that
 8  worked on that project.
 9            Q.      Do you know if Doctor Dornseif
10  worked on any of those projects?
11            A.      I don't recall.  I don't know
12  whether Doctor Dornseif was one of the people who
13  worked on that project.
14            Q.      Do you know a G. Enas, E-N-A-S?
15            A.      Yes, I do.
16            Q.      What is his or her first name?
17            A.      Gregory.
18            Q.      Is he a statistician?
19            A.      Yes, he is.
20            Q.      Did he work on either of these
21  projects?
22            A.      As I was telling you, I don't
23  recall which of the statisticians actually worked
24  on those projects.  There was a team of

                                                 Page 133

 1  statisticians who worked on that, but I don't
 2  know who specifically did that particular part.
 3            Q.      Did that team of statisticians
 4  have a department head or head of the group or
 5  anything of that nature?
 6            A.      Yes.  At that time they had a
 7  director and a manager.
 8            Q.      Do you know who the director
 9  and manager was?
10            A.      The director at that time was
11  Charlie Sampson, and I don't know whether Greg
12  Enas was a manager at that time.
13             (A SHORT RECESS WAS TAKEN.)
14            Q.      Let's go back to Doctor
15  Heiligenstein's homicide manuscript.  After
16  everybody in your department does their job on
17  the manuscript, and everybody, the executives,
18  the vice-president, et cetera, review it, what
19  happens to the manuscript?
20            MS. GOLDMAN:  Objection to the form of
21  question.  You can answer.
22            A.      Would you repeat the question
23  for me, please?
24            MS. ZETTLER:  Let me restate it.

                                                 Page 134

 1            Q.      After the manuscript is
 2  finished and ready for publication, where does it
 3  go next within the Lilly organization?
 4            A.      What do you mean by ready for
 5  publication?
 6            Q.      Who would submit it to, I guess
 7  in this case it would be Annals of --
 8            A.      I believe it was Annals of
 9  Clinical Psychology.
10            Q.      Who would actually submit it to
11  the Annals for publication?
12            A.      The first author, Doctor
13  Heiligenstein submitted it for publication.
14            Q.      Would the marketing department
15  at Lilly have any involvement in either the
16  preparation or submission of the manuscript for
17  publication?
18            A.      I believe that they would
19  receive a copy for review at the time that it was
20  sent through the review process.
21            Q.      What kind of input would they
22  have into either the writing or publication of
23  the manuscript?
24            A.      Of this particular manuscript?

                                                 Page 135

 1            Q.      Right.
 2            A.      I'm sorry, I don't know what
 3  involvement, if any, that they have.
 4            Q.      When a manuscript is being
 5  prepared, is the marketing department usually
 6  involved in the review process?
 7            A.      I don't know what involvement
 8  the marketing group has in the review process for
 9  manuscripts in general.
10            Q.      But are they generally included
11  in the review process, in other words are they
12  given a copy of the manuscript to review?
13            A.      I don't know if that always
14  happens or not.
15            Q.      Do you know if that always
16  happened with the Prozac articles or manuscript?
17            A.      I don't know.
18            Q.      How about reports for
19  submission to the FDA?
20            A.      I don't know whether they
21  always received a copy or not.
22            Q.      Were there occasions where they
23  did receive copies?
24            A.      I believe that they did receive

                                                 Page 136

 1  a copy of the manuscript that we had been
 2  discussing, the violence-aggression manuscript,
 3  but I do not know at what point they received
 4  that manuscript, the manuscript that has been
 5  referred to as the homicide manuscript.
 6            Q.      How about the report that
 7  Doctor Heiligenstein worked on for submission to
 8  the FDA regarding -- I take it that was violence-
 9  aggression also?
10            A.      That was the title we used for
11  it.
12            Q.      The report that was submitted
13  to the FDA?
14            A.      Right, that was the topic that
15  we used.
16            Q.      How about the report on
17  violence-aggression submitted to the FDA, do you
18  know if that was submitted to marketing prior to
19  being sent to the FDA?
20            A.      I'm sorry, I don't know what
21  the review process was for that.
22            Q.      Are you aware of any other
23  Prozac manuscripts that were submitted to the
24  marketing department prior to publication?

                                                 Page 137

 1            MS. GOLDMAN:  Objection to the form.
 2            A.      I'm sorry, I don't know what
 3  review process was used in general.
 4            Q.      Okay.  But are you aware of
 5  any, other than the violence-aggression
 6  manuscript that Doctor Heiligenstein and you were
 7  involved in, were you aware of any other
 8  manuscripts that were sent at any point during
 9  the process to the marketing department regarding
10  Prozac?
11            MS. GOLDMAN:  Objection to the form.
12            A.      I believe that the manuscript
13  that was published in the British Medical Journal
14  was sent to the marketing department for review
15  at some time.
16            Q.      Which manuscript was that?
17            A.      It was an article by Doctor
18  Beasley and co-authors on suicidalities.
19            Q.      Suicidality and the use of
20  Fluoxetine?
21            A.      It was a retrospective analysis
22  of suicidality in depression trials.
23            Q.      Of Fluoxetine?
24            A.      Right.

                                                 Page 138

 1            Q.      Okay.
 2            A.      There may have been other
 3  manuscripts that were submitted, I'm just not
 4  familiar with specific details of the review
 5  processes.
 6            Q.      Okay.  My questions are only
 7  limited to your knowledge and what you can
 8  remember.  Is this British manuscript one of the
 9  three you were talking about right before we took
10  a break?
11            A.      We were talking about reports
12  prior to the break.
13            Q.      Reports -- that's right,
14  reports for submission to the FDA, correct?
15            A.      Right.
16            Q.      Were you involved in reports
17  for submission to any other governmental or
18  regulatory agency other than the FDA regarding
19  Prozac?
20            A.      I'm sorry, state your question
21  again.
22            Q.      Sure.  Other than the FDA,
23  reports for submission to the FDA, were you
24  involved in the preparation of any other reports

                                                 Page 139

 1  regarding Prozac for submission to any other
 2  governmental agency other than the FDA?
 3            A.      I do not know whether the
 4  reports that we prepared were submitted to other
 5  regulatory agencies than the FDA.
 6            Q.      How about any other public
 7  entities other than say magazines or other
 8  publishing types of entities, for instance the
 9  National Institute of Mental Health?
10            MS. GOLDMAN:  Objection to the form of
11  the question.
12            A.      I don't know the answer.
13            MS. ZETTLER:  I've asked the reporter
14  to mark four exhibits.
15             (PLAINTIFFS' EXHIBITS NO. 1 THROUGH
16              4 WERE MARKED FOR IDENTIFICATION
17              AND RECEIVED IN EVIDENCE.)
18            MS. ZETTLER:  You can show her Number
19  1.
20            Q.      Doctor, counsel has shown you
21  what has been marked as Exhibit Number 1 for
22  identification.  Can you take a look at that,
23  please?
24            A.      (Witness complies.)

                                                 Page 140

 1            Q.      Have you had a chance to look
 2  at that?
 3            A.      Yes.
 4            Q.      It appears to be a memorandum
 5  dated April 6, 1984, is that correct?
 6            A.      Yes, it is a memorandum dated
 7  April 6, 1984.
 8            Q.      Okay.  Now in the lower
 9  right-hand corner, do you see numbers starting
10  with the letters Pz?  I want to make sure we're
11  looking at the same document.
12            A.      Yes, I see numbers beginning
13  with Pz.
14            Q.      And then after that is 1302?
15            A.      Right .
16            Q.      1051?
17            A.      Right.
18            Q.      What is a B-Form?
19            A.      A B-Form stands for the term
20  product monograph.
21            Q.      How do you get B hyphen Form
22  out of product monograph?
23            A.      I wish I knew the answer to
24  your question, I do not.

                                                 Page 141

 1            Q.      What is a product monograph?
 2            A.      A product monograph is a
 3  summary of information about a drug product.
 4            Q.      Do you see after the listing
 5  carbon copy, there's in bold letters, it says
 6  Fluoxetine International B-Form?
 7            A.      Yes.
 8            Q.      Would that be referring to a
 9  summary of information for use in international
10  markets?
11            A.      I believe that it could be
12  defined as a summary of information for use in
13  international markets.
14            Q.      Is there any other way
15  Fluoxetine International B-Form could be used
16  under your definition of B-Form?
17            MS. GOLDMAN:  Objection to the form of
18  the question.
19            A.      An international product
20  monograph can also be used to register the drug
21  product in the international arena.
22            Q.      Would a product monograph be
23  known to a lay person as a package insert?
24            A.      No.

                                                 Page 142

 1            Q.      What's the difference?
 2            A.      A package -- a product
 3  monograph contains additional information not
 4  contained in the package insert.  The package
 5  insert is developed by U.S. regulatory
 6  authorities and the drug company together.
 7            Q.      What kind of information are
 8  included in the monograph that would not be
 9  included in the package insert?
10            A.      Usually more detail about
11  individual studies.
12            Q.      Such as, what types of detail?
13            A.      More information -- an example
14  would be more information about individual
15  clinical trials, their design, their inclusion
16  criteria, their efficacy results, their safety
17  results, as opposed to a package insert where you
18  might have a summary only of the safety data from
19  a study.
20                    That doesn't mean that you
21  couldn't have individual study results in a
22  package insert, it's just that the product
23  monograph usually has more detail about
24  individual studies.

                                                 Page 143

 1            Q.      Who is ultimately intended to
 2  see this monograph?  Earlier you said that you
 3  could use a monograph to register a product in a
 4  foreign country.  Is there any other way that the
 5  monograph could be used?
 6            A.      It could be used as the basis
 7  for a product monograph for the U.S. or it could
 8  be used as a basis for information for anyone
 9  internal to the company who was seeking a summary
10  of data.
11            Q.      Is there a difference between a
12  clinical investigation manual or a monograph or
13  are those the same things?
14            A.      They're similar but have some
15  differences.
16            Q.      What are the differences?
17            A.      A clinical investigation
18  brochure may have more information about safety,
19  and a product monograph might have -- the
20  sections or the topics covered are similar.  The
21  amount of detail provided differs.
22            Q.      I think you just mentioned that
23  the investigator manual would have more detail on
24  safety than the monograph?

                                                 Page 144

 1            A.      It could, yes.
 2            Q.      Is that generally true?
 3            MS. GOLDMAN:  Objection to form.
 4            Q.      You can answer it.
 5            A.      The clinical investigation
 6  brochure -- the safety section of the clinical
 7  investigation brochure is updated quarterly.  A
 8  product monograph doesn't usually have the same
 9  frequency of updates, a product monograph would
10  probably be reviewed annually.
11            Q.      Earlier you stated that the
12  monograph could be used in the United States.
13  How would you use a monograph in the United
14  States?
15            A.      To provide information about
16  the drug product.
17            Q.      To whom?
18            A.      Could be to physicians, it
19  could be to marketing associates, it could be
20  internal to the company or external.
21            Q.      Would you look at the first
22  sentence starting with, "attached for your
23  review."
24            A.      Yes.

                                                 Page 145

 1            Q.      It reads, "Attached for your
 2  review is the preliminary draft of the Fluoxetin
 3  International B-form prepared by Dr. Martha
 4  Tacker."
 5            A.      Yes.
 6            Q.      Who is Doctor Tacker?
 7            A.      Doctor Tacker is a consultant
 8  to Lilly.
 9            Q.      Is she an M.D.?
10            A.      No.
11            Q.      A Ph.D?
12            A.      Ph.D.
13            Q.      Do you know what she has her
14  Ph.D in?
15            A.      I don't know what -- no, I'm
16  sorry, I don't know.
17            Q.      What areas does she consult for
18  Lilly with?
19            A.      She is a biomedical
20  communication consultant.
21            Q.      Does she still work with Lilly?
22            A.      Yes, she does.
23            Q.      Is she located here in
24  Indianapolis?

                                                 Page 146

 1            A.      No.
 2            Q.      Where is she located?
 3            A.      West Lafayette.
 4            Q.      Could you take a look at that
 5  next sentence where it talks about the monograph
 6  serving as an international marketing brochure?
 7            A.      Yes.
 8            Q.      And I think the rest of it, it
 9  goes on to say in that sentence that, "it may
10  also be used in the future to register the drug
11  in countries that do not require the full NDA or
12  a formal registration document."
13            A.      Yes.
14            Q.      Do you know what countries
15  those would be?
16            A.      No, I'm sorry, I do not.
17            Q.      The last sentence in that
18  paragraph says, "This monograph will also serve
19  as the basis for the domestic B-Form, assuming
20  NDA approval within the next two years."  Were
21  you shooting for approval, NDA approval by 1986?
22            MS. GOLDMAN:  Objection to form.
23            A.      I'm sorry, I don't know what
24  the projected date for approval was, simply that

                                                 Page 147

 1  were approval to come within that time, the
 2  document that we were preparing would be the
 3  source document with current information.
 4            Q.      You authored this memo, didn't
 5  you?
 6            A.      I did.
 7            Q.      Who is Rosemary Abendroth,
 8  A-B-E-N-D-R-O-T-H?
 9            A.      Rosemary Abendroth was a
10  medical writer in our group at that time.
11            Q.      Were there more than one B-Form
12  for Fluoxetine?
13            A.      No.
14            Q.      Just one?
15            A.      Well, excuse me.  There was an
16  international B-Form and ultimately a domestic
17  product monograph.
18            Q.      What was the difference between
19  the international B-Form and the domestic product
20  monograph?
21            A.      The domestic product monograph
22  was shorter than the international document.
23            Q.      What was left out of the
24  domestic?

                                                 Page 148

 1            A.      I do not know what specific
 2  information was omitted.  The forms of the
 3  documents differed.  One was a typewritten
 4  document and the other was a typeset document and
 5  part of the shortening could simply have been the
 6  different media used to produce the document.
 7            Q.      How much shorter was the
 8  domestic document than the international
 9  document?
10            A.      I'm sorry, I don't know the
11  specific details of that.
12            Q.      Do you know what type face was
13  used in the international document?
14            A.      No, I'm sorry, I don't.  It's
15  several word processing systems ago.
16            Q.      How about the domestic
17  document, do you know what type face was used on
18  that?
19            A.      Offhand, no, not without
20  looking at it.
21            Q.      Do you know what point size
22  type was used on any of the documents?
23            A.      I do not know any of the
24  details of the domestic product monograph as to

                                                 Page 149

 1  its format.
 2            Q.      Did you work on the format of
 3  either one of those?
 4            A.      I worked on the format of the
 5  international B-Form but not the domestic one and
 6  I do not know the specific point size that were
 7  used.
 8            Q.      Let's go back to the
 9  suicidality Prozac reports that we were talking
10  about right before the break for a second.  You
11  said earlier that those were retrospective
12  studies of Prozac used in depression, correct?
13            A.      Retrospective analyses of data
14  from trials in depression.
15            Q.      Would those trials include all
16  trials in depression?
17            A.      Double blind placebo controlled
18  trials.
19            Q.      Do you know if any comparator
20  studies were used in that analysis?
21            A.      There were some trials in which
22  Fluoxetine was compared with a tricyclic
23  antidepressant and there were some trials in
24  which Fluoxetine was compared with both a placebo

                                                 Page 150

 1  and a tricyclic antidepressant, so there were
 2  three analysis groups.
 3            Q.      Were there ever any studies
 4  done on the use of Prozac as it related to
 5  suicidality in a general sense, not just with
 6  depression?
 7            MS. GOLDMAN:  Objection to the form.
 8            A.      When you use the term study, do
 9  you mean retrospective analysis or do you mean a
10  prospective study to look at that question?
11            Q.      Let's start with retrospective
12  analysis, were there ever any reports written
13  based on a retrospective analysis of all people
14  administered Fluoxetine for any reason whatsoever
15  and suicidality?
16            A.      I am not aware of any
17  retrospective analyses looking at the total pool
18  of all people treated with Fluoxetine in one
19  large group.
20            Q.      How about a prospective study,
21  were you aware of any prospective studies that
22  were done related to Fluoxetine for use in any
23  manner whatsoever and for any indication
24  whatsoever and suicidality?

                                                 Page 151

 1            MS. GOLDMAN:  Objection to the form.
 2            THE WITNESS:  I'm sorry, will you read
 3  the question back to me.
 4                  (QUESTION READ.)
 5            A.      I'm not aware of any.
 6            Q.      What types of information from
 7  the prospective studies on suicide and depression
 8  and Fluoxetine, what types of information would
 9  be analyzed, are you talking efficacy
10  information, safety data?
11            A.      I'm sorry, you said prospective
12  studies of suicidality?
13            Q.      Retrospective, I'm sorry.
14            A.      In retrospective -- can you
15  repeat the question?
16            Q.      Let me ask it again.  On
17  retrospective studies that you talked about,
18  including Prozac given for depression as it
19  relates to suicidality, what types of information
20  was reanalyzed in that study?
21            MS. GOLDMAN:  Objection to the form.
22            A.      What types of information was
23  analyzed from those studies with respect to
24  suicidality, is that what you're asking?

                                                 Page 152

 1            Q.      Right.
 2            A.      We looked at the incidence of
 3  suicidal acts, the emergence of substantial
 4  suicidal ideation.  Those were our primary
 5  measures.
 6            Q.      How did they define substantial
 7  suicidal ideation?
 8            A.      A change in item three of the
 9  Hamilton depression rating scale from zero or one
10  at baseline to three or four during double blind
11  therapy.
12            Q.      Anything else?
13            MS. GOLDMAN:  Objection to the form.
14            A.      I don't know of what other --
15  all of the other analyses that may have been
16  done.  Those were our primary measures.
17            Q.      Anything else that was used to
18  determine what was a substantial suicidal
19  ideation besides the change in item three on the
20  Ham-D?
21            A.      In the U.S. depression studies,
22  I don't recall that we used other measures.
23            Q.      How about in the international?
24            A.      I believe that in the

                                                 Page 153

 1  international trials, there was an evaluation of
 2  change in the MADRS score, but I'm not certain.
 3            Q.      What's the MADRS score?
 4            A.      Montgomery Asburg Depression
 5  Rating Scale.
 6            Q.      Was the Ham-D used in the
 7  international studies as well?
 8            A.      I believe it was used in some
 9  of the studies.
10            Q.      Was the MADRS used in the U.S.
11  studies?
12            A.      I don't believe it was.
13            Q.      Why not?
14            A.      I don't know.
15            Q.      Who would know that?
16            A.      I don't know of any one person
17  who could speak for the doing of all of the U.S.
18  studies, but a psychiatrist could speak to the
19  use of these scales in the U.S. and in the
20  international arena.
21            Q.      Is the MADRS scale an
22  international scale as far as you know?
23            A.      I believe it was developed by a
24  British psychiatrist.

                                                 Page 154

 1            Q.      Was the use of the MADRS scale
 2  limited to any certain countries?
 3            A.      I'm sorry, I don't know which
 4  studies used the MADRS or in which countries
 5  those studies were done.
 6            Q.      In the retrospective studies on
 7  suicide, depression and Prozac, was all available
 8  information from all studies taken into
 9  consideration as far as the depression studies
10  were concerned?
11            MS. GOLDMAN:  Objection to the form.
12            A.      Data were analyzed from double
13  blind placebo controlled trials.
14            Q.      How about Fluoxetine compared
15  to --
16            A.      Excuse me, I need to add to
17  that, or active comparator controlled trials.
18            Q.      That was my next question.  Was
19  a comparison ever done between the suicidality
20  scales and the depression studies in Prozac as
21  opposed to the suicidality scales, if they were
22  done, in any of the other indicated tests --
23  indicated use tests, such as obesity test or a
24  bulimia test, things of that nature?

                                                 Page 155

 1            MS. GOLDMAN:  Objection to the form of
 2  that question.
 3            A.      I'm sorry, I don't understand
 4  what you mean by a comparison of the scales.  Can
 5  you clarify?
 6            Q.      Sure.  At any time are you
 7  aware of the study where a retrospective study, a
 8  prospective, any kind of study -- well, let's
 9  take retrospective, a retrospective study where
10  the suicidality information like we just talked
11  about, the Ham-D 3 and the MADRS type of
12  information done in depression studies, was
13  compared to any similar information or any
14  similar testing that was done in any of the other
15  studies such as studies on obesity, studies on
16  obsessive-compulsive disorders, things of that
17  nature?
18            MS. GOLDMAN:  Objection to the form.
19            A.      Are you asking for a comparison
20  of the data and the different indications or
21  simply a correlation of scales?
22            Q.      A comparison of the data from
23  different studies, that was ever done.
24            A.      There were analyses of

                                                 Page 156

 1  suicidality in other indications, if that's what
 2  you're asking.
 3            Q.      Were those analyses ever
 4  reported to the FDA?
 5            A.      They were.
 6            Q.      Was it reported as an analysis
 7  of suicidality as it related to a specific use,
 8  such as use for using Prozac for obesity or was
 9  it reported in a general suicidality in Prozac
10  analysis?
11            MS. GOLDMAN:  Objection to the form.
12            A.      I think I need to ask you to
13  rephrase the question, maybe break it down into
14  some smaller pieces for me.
15            Q.      Was the suicidality in other
16  indications reported to the FDA as that,
17  suicidality -- for instance, suicidality in the
18  use of Prozac for treatment of obesity?
19            MS. GOLDMAN:  Objection to the form.
20            A.      The information was reported as
21  an analysis of suicidality in patients treated
22  with Fluoxetine for OCD or for obesity.
23            Q.      Were those separate reports?
24  In other words was there a separate report for

                                                 Page 157

 1  obesity, and a separate report for OCD?
 2            A.      Yes, there was.
 3            Q.      Any other indications that you
 4  can think of where that information was reported
 5  to the FDA?
 6            A.      Bulimia nervosa.
 7            Q.      How about smoking cessation?
 8            A.      I don't believe so.
 9            Q.      How about anxiety attacks,
10  panic attacks?
11            A.      I'm not aware of the
12  information in those indications.
13            Q.      Were the results of the
14  analysis of the studies on obesity, the
15  retrospective analysis on obesity and bulimia and
16  OCD ever compared with the analysis of the
17  retrospective studies done on depression?
18            A.      Yes.
19            Q.      Was it a -- was a report of
20  that comparison ever submitted to the FDA?
21            A.      I'm not sure how you're using
22  the term comparison, however a summary of the
23  data were submitted to the FDA.
24            Q.      In one form?

                                                 Page 158

 1            A.      Right.
 2            Q.      At one time?
 3            A.      Right.
 4            Q.      How was it presented to the
 5  FDA?
 6            A.      I'm sorry, I don't understand
 7  your question.
 8            Q.      Okay.  What I'm interested in
 9  is whether all of this data was reported to the
10  FDA in support of a single document or as part of
11  a single document and I think you answered that
12  yes, right?
13            A.      There were individual separate
14  reports of suicidality in the individual
15  indications and subsequently a summary of that
16  information in a single document.
17            Q.      Was submitted to the FDA?
18            A.      Right.
19            Q.      When was that -- what was the
20  title of that document, if you remember, that
21  report?
22            A.      Oh, I'm sorry, I don't know
23  what the title actually was.
24            Q.      Okay.  Do you remember when it

                                                 Page 159

 1  was submitted to the FDA?
 2            A.      I believe it was -- I believe
 3  it was submitted in 1991.
 4            Q.      Do you know what the purpose
 5  for submitting that document to the FDA was?
 6            A.      To provide a summary of safety
 7  information to the FDA.
 8            Q.      Is that in response to some
 9  sort of request from the FDA or some other
10  governmental entity?
11            A.      I am not familiar with the
12  total request and response process for that
13  analyses.
14            Q.      Do you know if this document
15  was submitted to the FDA in response to a request
16  by the FDA for reanalysis of the safety of Prozac
17  with regards to suicidality?
18            A.      I don't know whether it was.
19            Q.      Let's take the obesity studies,
20  for example.  Can you tell me what types of tests
21  were run or what types of information was relied
22  upon during the retrospective analysis to
23  determine suicidality?
24            A.      There was an analysis of

                                                 Page 160

 1  suicidal acts and there was a review of reports
 2  of suicidal ideation, and in one trial, there was
 3  an analysis of data from the SCL Hopkins Symptoms
 4  Checklist item fifteen question which relates to
 5  suicide.
 6            Q.      Other than the SCL Hopkins, and
 7  the study that included that, were there any
 8  other studies that included any other type of
 9  psychological testing geared towards suicide
10  ideation, suicidal ideation?
11            A.      No, I don't believe so.
12            Q.      So unless a suicidal act or
13  suicidal ideation was reported by the
14  investigator, that would not be taken into
15  consideration in certain of those studies?
16            MS. GOLDMAN:  Objection to the form.
17            A.      The Hamilton wasn't routinely
18  collected in obesity trials, nor was the Hopkins
19  Symptoms Checklist.
20            Q.      How about the bulimia studies,
21  was the Hamilton routinely used in the bulimia
22  studies?
23            A.      I believe it was in one but not
24  in the other.  It wasn't collected at every visit

                                                 Page 161

 1  as it was in depression studies.
 2            Q.      Okay.  How about the Hopkins,
 3  the SCL Hopkins, was that used in the bulimia
 4  studies?
 5            A.      Not to my knowledge.
 6            Q.      How about the OCD studies, when
 7  I say OCD, I mean obsessive-compulsive disorder,
 8  is that how you understand it?
 9            A.      Yes.
10            Q.      How about the OCD studies, were
11  there tests specifically given to measure
12  suicidality?
13            A.      I'm sorry, I do not recall what
14  measures were used in OCD.
15            Q.      Do you know if the Hamilton
16  Depression Scale was used with the OCD tests or
17  studies?
18            A.      I believe it may have been.
19            Q.      Again, if that were the case,
20  then item three on the Ham-D would be relied upon
21  for information regarding suicidal ideation?
22            A.      That's correct.
23            Q.      How about the SCL Hopkins, was
24  that used on the OCD studies?

                                                 Page 162

 1            A.      No, not to my knowledge.
 2            Q.      Were there bulimia and obesity
 3  and OCD studies done internationally?
 4            A.      I am not familiar with the
 5  specific studies done in these indications
 6  outside of the U.S.
 7            Q.      The international depression
 8  studies, were those conducted by Lilly or
 9  somebody on Lilly's behalf?
10            A.      Yes, I believe they were.
11            Q.      On these retrospective analyses
12  of suicidal ideation and the use of Fluoxetine
13  for depression, was any data outside of the Eli
14  Lilly taken into consideration?
15            MS. GOLDMAN:  Objection to the form.
16            Q.      In other words, for instance,
17  were any of the suicidal ideations reported in
18  the medical literature taken into consideration?
19            A.      The analyses were based on data
20  from double blind controlled trials.  Information
21  about suicidality from the literature would be
22  captured in a different way.
23            Q.      Going back to Doctor
24  Heiligenstein's -- I'm saying that one right,

                                                 Page 163

 1  aren't I?
 2            A.      (Witness moves head up and
 3  down.).
 4            Q.      Doctor Heiligenstein's report
 5  and monograph on homicidal ideation, or I believe
 6  you called it violence-aggression studies or
 7  reports?
 8            A.      (Witness moves head up and
 9  down.).
10            Q.      What testing was used to
11  determine homicidal ideation or violence and
12  aggression?
13            A.      In that case, a data base was
14  reviewed to determine the terms that best
15  captured those attributes and the clinical trial
16  data base was searched to determine the incidence
17  of reports of those events.
18            Q.      Who made the decision on what
19  terms best describe those attributes?
20            A.      It was a clinical decision
21  through Doctor Heiligenstein.
22            Q.      Do you know what any of those
23  terms would have been?
24            A.      They analyzed what they called

                                                 Page 164

 1  the aggression cluster of events and there were
 2  specific terms within that, but offhand I don't
 3  recall all the specific terms.
 4            Q.      Do you recall any of them?
 5            A.      I'm sorry, I don't recall the
 6  way -- the specific terms that related to that.
 7            Q.      So would these be events that
 8  were reported again by the patient as opposed to
 9  something that was determined from a
10  psychological test?
11            A.      That's correct.
12            Q.      Do you know if any
13  psychological testing was administered to
14  patients in any of the clinical trials that were
15  geared towards determining aggression and violent
16  behavior?
17            A.      The Hamilton was administered
18  in the depression trials.
19            Q.      And what item on the Hamilton
20  scale, or items on the Hamilton depression rating
21  scale would be indicative of aggression or
22  violent behavior?
23            A.      I don't believe any specific
24  analysis of Hamilton items were done for that

                                                 Page 165

 1  particular report.  It was based on a search for
 2  the specific adverse event terms.
 3            Q.      With regards to the
 4  violence-aggression retrospective report and
 5  monograph, were any international studies taken
 6  into consideration?
 7            A.      I'm sorry, please repeat it.
 8            Q.      With regards to the
 9  Heiligenstein's aggression-violence report and
10  monograph, were any of the international studies
11  on depression taken into consideration?
12            A.      You say and monograph.
13            Q.      He did two things, right?  He
14  worked on a report that was submitted to the FDA.
15            A.      Right.
16            Q.      And he also worked on an
17  article that was published in the Journal Of --
18            A.      Okay.  So you said monograph
19  and I was thinking product monograph.
20            Q.      I'm sorry, I'll ask it again.
21  Manuscript, right?  We'll take them -- separate
22  them.
23            A.      All right.
24            Q.      With regards to the report that

                                                 Page 166

 1  Doctor Heiligenstein authored that was submitted
 2  to the FDA on violence-aggression, were the
 3  results or the data from any of the international
 4  depression studies taken into consideration in
 5  that analysis?
 6            A.      I believe the analysis was
 7  based on the U.S. IND trials which are conducted
 8  in the U.S. and Canada.
 9            Q.      Would that be the same for the
10  manuscript that Doctor Heiligenstein wrote on
11  violence and aggressive behavior?
12            A.      Yes.
13            Q.      Oh, by the way, if you could
14  look again at Exhibit Number 1.  Does that
15  refresh your recollection as to when you started
16  working with Fluoxetine while at Lilly?  I think
17  earlier you testified that you weren't sure when
18  in 1984 you started working on it.
19            A.      In this case I was coordinating
20  a project done by an outsider.
21            Q.      That outsider being Doctor
22  Tacker?
23            A.      Yes.
24            Q.      Do you remember -- do you know

                                                 Page 167

 1  anybody with the name Dorothy Dobbs?
 2            A.      Yes.
 3            Q.      Could you tell me who Ms. Dobbs
 4  is?
 5            A.      I believe Ms. Dobbs was our
 6  regulatory advisor at that time.
 7            Q.      Okay.  Do you know if she's
 8  still with Eli Lilly?
 9            A.      I believe she is not.
10            Q.      Would you look at Exhibit
11  Number 4, please.
12            A.      (Witness complies.)
13            Q.      Have you had a chance to take a
14  look at that, Doctor?
15            A.      Yes.
16            Q.      It appears to be a memorandum
17  dated July 6, 1984 entitled review of Fluoxetine
18  International B-Form clinical efficacy section?
19            A.      Yes.
20            Q.      In the bottom right-hand corner
21  is the number Pz 1302 838, correct?
22            A.      That's correct.
23            Q.      Okay.  Can you read that second
24  paragraph, you don't have to read it out loud,

                                                 Page 168

 1  but if you would read it again.
 2            A.      Okay.
 3            Q.      Did you author this memorandum,
 4  if you know?
 5            A.      Either I or Rosemary Abendroth
 6  did, but I believe that I authored this.
 7            Q.      What did you mean by, the
 8  contents should be read carefully to verify that
 9  accuracy and perspective have been retained in
10  regards to the clinical efficacy section in the
11  B-Form?
12            A.      Whenever we edit or revise
13  material in the medical writing services group,
14  we always send it back to our reviewers to make
15  sure that we haven't inadvertently changed
16  meaning during the editing and revision process.
17            Q.      Is that what you mean by
18  perspective also?
19            A.      Yes.
20            Q.      Who is R. C Casavant,
21  C-A-S-A-V-A-N-T?
22            A.      At the time, I believe Mister
23  Casavant was an international marketing associate
24  who was working on this project.

                                                 Page 169

 1            Q.      Would you look at that list of
 2  people at the top and tell me if anybody else in
 3  that group is from marketing, either domestic or
 4  international?
 5            A.      I believe that Mr. Argay may
 6  have been in the international marketing area at
 7  that time.
 8            Q.      Why would Mister Argay and
 9  Mister Casavant be interested in the B-Form
10  clinical efficacy section?
11            A.      Because this document was being
12  prepared for use in international markets as well
13  as for possible registration purposes.
14            Q.      So you mean it was being
15  prepared to be used as a marketing tool?
16            A.      As a possible marketing tool.
17            Q.      To be distributed to physicians
18  and hospitals?
19            A.      To Lilly's affiliates outside
20  of the U.S.
21            Q.      Would this be somebody -- would
22  the B-Form be something that might ultimately be
23  obtained by a prescribing physician?
24            MS. GOLDMAN:  Objection.

                                                 Page 170

 1            A.      I don't know whether that is
 2  true in the international arena or not.
 3            Q.      How about the domestic arena,
 4  would that be true?
 5            A.      A product monograph would be
 6  given to a physician in the U.S. -- would
 7  possibly be given to a physician in the U.S.
 8            Q.      Could a physician write to
 9  Lilly and say I'd like a copy of the product
10  monograph on Prozac?
11            A.      I don't know.
12            Q.      Is there some reason why a
13  physician in Europe say, couldn't write and ask
14  for a copy of an international B-Form?
15            MS. GOLDMAN:  Objection to the form.
16            A.      I don't know how the
17  information is distributed outside of the U.S.
18             (PLAINTIFFS' EXHIBITS NOS. 5 AND
19              6 WERE MARKED FOR IDENTIFICATION
20              AND RECEIVED IN EVIDENCE.)
21            Q.      Doctor, can you estimate for me
22  how many reports regarding Prozac you have been
23  involved with preparing for submission to the
24  FDA?

                                                 Page 171

 1            A.      I'm sorry, I don't really
 2  believe I can estimate the number.
 3            Q.      Would it be more than fifteen?
 4            A.      I'm sorry, it's hard for me to
 5  give you an accurate estimate.
 6            Q.      Well, give me an estimate.
 7            MS. GOLDMAN:  If all you can do is a
 8  guess, no one wants you to guess.  If you have a
 9  best estimate, she can ask you for your best
10  estimate.
11            A.      I'm sorry, I would just have to
12  guess.
13            Q.      Would it be more than five?
14            A.      Yes.
15            Q.      More than ten?
16            A.      I'm sorry, I don't really have
17  a good feeling for the total number of reports.
18            Q.      Would it have been more than a
19  hundred?
20            A.      No, I don't believe so.
21            Q.      How about more than fifty?
22            A.      Probably not more than fifty.
23            Q.      How about more than
24  twenty-five?

                                                 Page 172

 1            A.      I'm sorry, you're asking me to
 2  guess.
 3            Q.      So somewhere between five and
 4  fifty?
 5            A.      Well, it may be more and it may
 6  be less but I would say that somewhere between
 7  five and thirty reports, but it is a very rough
 8  estimate, an approximation.
 9            Q.      How about manuscripts, how many
10  manuscripts have you worked on with regards to
11  Prozac?
12            A.      Again, I guess I would say a
13  very rough estimate, a guess, it may be more, it
14  may be less, but somewhere between maybe ten and
15  thirty.
16            Q.      Have all of those manuscripts
17  that you worked on been published, to your
18  knowledge?
19            A.      Not all of them have been
20  published as of this date.
21            Q.      Okay.  What manuscripts are
22  pending for publication or are being prepared for
23  publication?
24            MS. GOLDMAN:  Wait a second.  Doctor

                                                 Page 173

 1  Potvin has testified that her responsibilities
 2  are greater than and transcend the area of Prozac
 3  for depression which is the subject of this
 4  deposition, and I'm going to object to any
 5  questions about any manuscripts or work that is
 6  in press that's not part of the general
 7  literature that doesn't relate to the subject on
 8  the table.
 9            MS. ZETTLER:  Well, the subject on the
10  table is Fluoxetine and suicidality and
11  aggressive behavior, it is not depression.  If
12  you're trying to limit it to that, that's not the
13  case here.  There is no way, in any shape or
14  form, any kind of order that limits discovery in
15  the Fentress case to depression and depression
16  only.  Also to a certain extent in other cases,
17  if we want to get nitpicky about it, such as the
18  MDL, you have agreed to produce information and
19  allow us to inquire into the areas of safety with
20  regards to other indicated usage.
21            So to that extent I'm going to certify
22  the question because in the Fentress case there
23  was absolutely no limitation to us questioning
24  her on anything other than depression, absolutely

                                                 Page 174

 1  none, and you know it.
 2            MS. GOLDMAN:  Well, counsel, leaving
 3  the ad hominem aspects of your remarks aside,
 4  your question is improper.  Our objection is
 5  proper and well stated.  None of your remarks
 6  address the question of other medications, other
 7  substances, other compounds, other things in
 8  development which have absolutely nothing to do
 9  with Prozac or Fluoxetine.  You are, of course,
10  welcome to certify any question that you choose
11  to certify.  However, the question as posed is
12  improper.  The witness is going to be instructed
13  to confine her response to a proper response.
14            MS. ZETTLER:  First of all, all of my
15  questions on Fluoxetine today have been as
16  understood by the witnesses and counsel is in
17  regards to Fluoxetine for any indicated use
18  whatsoever, not just for depression.  If in fact
19  it turns out that you are now saying that you're
20  limiting and she has limited her answers only to
21  depression, then I am going to bring her back
22  again and ask her all these questions all over
23  again regarding other indicated uses and we'll be
24  here for another entire day.

                                                 Page 175

 1            Q.      To the extent that you're
 2  instructing her not to answer, are you, Doctor
 3  Potvin, going to listen to your counsel's
 4  instructions and refuse to answer my question?
 5            MS. GOLDMAN:  Don't respond to that at
 6  this point, I have something further to say.
 7            Leaving aside again the inappropriate
 8  aspects of your remarks, the deposition has been
 9  conducted, the witness has answered questions,
10  the questions as answered, a wide variety of
11  questions that no court in the land would
12  consider to be relevant to anything of pertinence
13  in this case, and I don't think that counsel,
14  with all due respects, you have any grounds or
15  basis for a complaint about the nature and the
16  extent of your responses to the questions that
17  you have put.  You have now asked one question to
18  which I have objected on grounds previously
19  stated and already on the record, and the witness
20  will be instructed accordingly with respect to
21  the response to that question.
22            MS. ZETTLER:  Are you done?
23            MS. GOLDMAN:  Now I am.
24            Q.      Are you going to listen to your

                                                 Page 176

 1  counsel's instruction and refuse to answer my
 2  last question, Doctor?  If you can remember what
 3  it is at this point.
 4            MR. STOPHER:  Let us talk to her for
 5  just a minute and see if we can resolve this
 6  matter.
 7             (A SHORT BREAK WAS TAKEN.)
 8            MR. STOPHER:  Let the record show that
 9  we have discussed the issue of the objection with
10  the witness and we still stand by the objection.
11  It turns out that any instruction is moot in this
12  case and accordingly the witness will go ahead
13  and answer the question.  Our objection is noted
14  but she'll give you the answer.
15            MS. ZETTLER:  Can I hear the question
16  again now?
17                  (QUESTION READ.)
18            A.      Two suicidality manuscripts are
19  currently in process, one is on suicidality and
20  obesity which has been accepted for publication,
21  the other is a comparison of suicidality in the
22  various indications and it is in review.
23            Q.      Okay.  So when I asked you
24  earlier if there was ever a comparison done, and

                                                 Page 177

 1  maybe it was my bad question but let's make sure
 2  that we understand each other, when I asked you
 3  earlier if there was a comparison of suicidality
 4  and the use of Prozac between the various
 5  indications, the answer is yes?
 6            A.      That is correct.  There is a
 7  summary of the data for suicidality in each
 8  indication presented in a single publication.
 9            Q.      And that is the one that is
10  pending now?
11            A.      That is correct.
12            Q.      So there were two studies,
13  right -- or I'm sorry, two pending reports?
14            A.      Two manuscripts.
15            Q.      We'll write manuscripts down so
16  I don't forget.  Who are the authors of the
17  suicidality manuscript?  I believe you said it
18  was in depression, right -- obesity, I'm sorry.
19            A.      Doctor David Goldstein is the
20  senior author of that paper.
21            Q.      Any other doctors involved on
22  that paper?
23            A.      Yes, there are other
24  co-authors.  I believe Doctor Beasley is a

                                                 Page 178

 1  co-author on that paper and I'm not certain who
 2  all of the other authors are.  I am a co-author
 3  of that paper.
 4            Q.      Is this a retrospective
 5  analysis of safety data?
 6            A.      Yes, it is.
 7            Q.      On purely obesity trials,
 8  correct?
 9            A.      Uh-huh.
10            Q.      Do you have any idea where
11  that's going to be published?
12            A.      It would be published in the
13  Journal of Clinical Psychiatry.
14            Q.      Is Doctor Goldstein employed by
15  Eli Lilly?
16            A.      Yes, he is.
17            Q.      Does he work on-site or
18  off-site?
19            A.      He works on-site in
20  Indianapolis.
21            Q.      Do you have any idea when
22  that's going to be published?
23            A.      No, I'm sorry, I do not.
24            Q.      How about the comparison study,

                                                 Page 179

 1  who worked on that or is working on that?
 2            A.      Doctor Tolivson is the senior
 3  author of that paper.
 4            Q.      And all the information we
 5  talked about earlier, you were referring to this
 6  study, weren't you, or was that a separate
 7  report?
 8            A.      It was a separate report.
 9            Q.      Okay.  Is this a retrospective
10  analysis of safety data from all indications?
11            A.      Yes, it is.
12            Q.      Is Doctor Tolivson employed by
13  Eli Lilly?
14            A.      Yes, he is.
15            Q.      Has that been approved for
16  publication, I forgot?
17            A.      No, it's in review -- wait a
18  minute, I'm sorry, it has been accepted for
19  publication.
20            Q.      It has, so it's been through
21  the review process?
22            A.      Yes, it has.
23            Q.      Do you know where that's going
24  to be published?

                                                 Page 180

 1            A.      Annals of Clinical Psychiatry.
 2            Q.      Do you know who publishes the
 3  Annals of Clinical Psychology by any chance?
 4            A.      It's Annals of Clinical
 5  Psychiatry.
 6            Q.      I'm sorry, do you know who
 7  publishes that journal?
 8            A.      No, I'm sorry, I do not know
 9  offhand.
10            Q.      Are you familiar with the name
11  Jan Fossett, Doctor Jan Fossett?
12            A.      I have heard the name.
13            Q.      Have you ever worked with
14  Doctor Fossett?
15            A.      I have not worked directly with
16  Doctor Fossett.
17            Q.      Do you know is Doctor Fossett
18  affiliated with Eli Lilly in any way?
19            A.      Doctor Fossett has served as a
20  consultant to Eli Lilly and Company, and I
21  believe that he has done clinical trials for Eli
22  Lilly and Company.
23            Q.      Doctor Fossett has served as a
24  consultant with Lilly in what capacity?

                                                 Page 181

 1            A.      He reviewed our suicidality
 2  data.
 3            Q.      Have you ever heard of a
 4  manuscript or report being done on teen-age
 5  suicide or adolescent suicide and the use of
 6  Prozac?
 7            A.      No, I'm sorry, I'm not familiar
 8  with that paper.
 9            Q.      Do you know any other areas
10  that Doctor Fossett has consulted with Lilly on
11  other than reviewing the suicidality data?
12            A.      I am not aware of any other
13  consulting he may have done for us.
14            Q.      If you know, when did he review
15  that suicidality data?
16            A.      I believe it was in 1990.  My
17  recollection of the dates may be incorrect.
18            Q.      Okay, just to the best of your
19  recollection.
20                    Did he review suicidality data
21  in relation to any report or manuscript that has
22  been submitted to the FDA or published?
23            A.      Data were subsequently
24  published.

                                                 Page 182

 1            Q.      Where were they published?
 2            A.      In the British Medical Journal.
 3            Q.      Is that the one we talked about
 4  earlier?
 5            A.      That's the one we talked about
 6  earlier.
 7            Q.      Doctor Beasley was involved
 8  with that?
 9            A.      Yes.
10            Q.      Is Doctor Fossett a named
11  doctor on that article?
12            A.      I don't recall, I don't know.
13            Q.      You mentioned that also to your
14  knowledge Doctor Fossett was in charge of a
15  couple of the clinical investigations, the
16  studies on Prozac?
17            A.      I said that I believe that he
18  had done clinical -- that he was one of Lilly's
19  clinical investigators, I don't know which
20  specific studies he did.
21            Q.      But it's your belief that he
22  was a clinical investigator on Prozac studies?
23            A.      I don't know that.
24            Q.      He could have been an

                                                 Page 183

 1  investigator on some other drug study other than
 2  Prozac?
 3            A.      I'm sorry, I simply don't know
 4  what studies he was involved with.
 5            Q.      But to your knowledge or it is
 6  your belief that he was a clinical investigator
 7  for Lilly at some point?
 8            A.      I believe so.
 9            Q.      Do you know if he works on-site
10  at Lilly?
11            A.      He does not work on-site at
12  Lilly.
13            Q.      Do you know where he works?
14            A.      I don't know what his current
15  affiliation is.
16            Q.      Were you ever aware of what his
17  affiliation was at any time?
18            A.      I knew that he was an outsider
19  to Lilly, he was a consultant, but I don't know
20  which hospital he was affiliated with.
21            Q.      Do you know what city he lives
22  in?
23            A.      No, I'm sorry, I don't.
24            Q.      How about a Doctor James

                                                 Page 184

 1  Cavanaugh, have you ever heard of that name?
 2            A.      No, I'm not familiar with that
 3  name.
 4            Q.      Did you ever have -- in your
 5  position at Lilly, have you ever had any contact
 6  with any physicians who were customers of Lilly
 7  regarding Prozac?
 8            MS. GOLDMAN:  Objection to the form.
 9            Q.      Have you ever had any contact
10  with a doctor not related to the studies, you
11  know, not somebody who was a clinical
12  investigator or working for Lilly or working on
13  the study of Prozac in any way, in other words
14  somebody who has been prescribing Prozac, have
15  you ever had any contact with that sort of
16  customer?
17            A.      No.
18            Q.      Can you take a look at what has
19  been marked Potvin, I guess, Exhibit Number 5?
20            A.      Okay.
21            Q.      Have you had a chance to review
22  the document, Doctor?
23            A.      Yes.
24            Q.      It appears to be a memorandum,

                                                 Page 185

 1  a four page memorandum dated December 6, 1984
 2  entitled Fluoxetine International B-Form meeting,
 3  December 4, 1984; is that correct?
 4            A.      That's correct.
 5            Q.      And it is numbered Pz 1302 833
 6  through Pz 1302 836, correct?
 7            A.      That is correct.
 8            Q.      If you could look at under the
 9  heading Summary Of Discussion, it's the third
10  line down towards the end.  It says pre hyphen
11  A-C-N-P.  Can you tell me what Pre-ACNP means?
12            A.      Yes, a meeting was going to be
13  held at Lilly to present this data prior to the
14  ACNP meeting.
15            Q.      What's ACNP stand for?
16            A.      I'm sorry, it is a meeting of
17  psychiatrists, I do not know what the specific
18  letters refer to.
19            Q.      Is this a domestic -- does it
20  look like a meeting held in the U.S. or a meeting
21  held somewhere else outside of the U.S.?
22            A.      ACNP, I don't know that either,
23  I'm not familiar with the ACNP meeting.  I
24  believe for this particular year it was held in

                                                 Page 186

 1  the U.S. I don't know whether it was always held
 2  in the U.S. It's an annual meeting that is
 3  attended by psychiatrists.
 4            Q.      Do you know if this is an
 5  international group or a United States group?
 6            A.      I don't know that.
 7            Q.      Does the American Counsel of
 8  Neurologists and Psychiatrists sound familiar,
 9  does that ring a bell?
10            A.      I don't know if that is what it
11  stands for.
12            Q.      So the B-Form was going to be
13  presented to this ACNP group and you guys were
14  meeting prior to that to decide what was going to
15  be included in the presentation?
16            MS. GOLDMAN:  Objection to the form.
17            A.      The safety data on the compound
18  were going to be presented, not the entire
19  B-Form.
20            Q.      To your knowledge, do you know
21  what phase the studies were in at the time that
22  this memo was written, in other words were there
23  Phase 3 or Phase 4 studies being conducted to
24  your knowledge at that time?

                                                 Page 187

 1            A.      I don't know whether the
 2  studies were Phase 3 or Phase 4 that were being
 3  conducted at that time.
 4            Q.      But the safety data that you
 5  were presenting at this ACNP meeting wasn't
 6  limited to toxicology studies, was it?
 7            A.      This would have been the
 8  clinical safety data, not toxicology data.
 9            Q.      So things such as adverse
10  events, things of that nature?
11            A.      That's right, the adverse
12  events profile.
13            Q.      Right below that there is a
14  heading, Updated Package Insert.  Was that
15  package insert for international purposes or was
16  that the package insert for the the U.S.
17  packaging?
18            A.      It would have been the U.S.
19  package insert that would provide the model for
20  the individual inserts for the various countries
21  outside of the U.S.
22            Q.      Why is it that you didn't use
23  one insert for every single country?
24            A.      Individual countries have some

                                                 Page 188

 1  different requirements with respect to the
 2  content of a package insert.
 3            Q.      Can you name a country for me
 4  where their requirements are more stringent than
 5  the United States?
 6            MS. GOLDMAN:  Objection to the form.
 7            MR. STOPHER:  I think also that is
 8  probably going to call for a legal conclusion.
 9  If you can answer it without giving legal
10  opinions as to what laws are more stringent or
11  what requirements are more stringent.
12            MS. ZETTLER:  Let me ask it this way --
13  I'll withdraw it, let me ask it this way.
14            Q.      Are you aware of any country
15  that requires information additional to what the
16  United States requires in their package inserts?
17            A.      I am not familiar with
18  individual country's regulations and requirements
19  for packaged inserts.
20            Q.      You worked on packaged inserts
21  that were used in the United States, correct?
22            A.      I did not actually work on
23  package inserts.
24            Q.      Okay.  Did you work on package

                                                 Page 189

 1  inserts that were used internationally?
 2            A.      No.
 3            Q.      You worked on package --
 4  updated package inserts according to this memo,
 5  didn't you?
 6            A.      We were discussing the need for
 7  an updated package insert.  The package insert is
 8  typically put together by the research physician
 9  working with the statistician, regulatory people
10  and legal people, as well as international folks
11  to make sure that all of the requirements are
12  met.
13            Q.      You were familiar enough to
14  write in this memo that the package insert
15  provides the skeletal structure for the
16  international B-Form, correct?
17            MS. GOLDMAN:  Objection to the form.
18            Q.      Correct?  You can answer it.
19            A.      It is a correct statement that
20  the package insert forms the structure for a
21  product monograph.
22            Q.      If you weren't familiar with
23  the package insert, where did you get the
24  knowledge to write it in this memo?

                                                 Page 190

 1            MS. GOLDMAN:  Objection to form, it's
 2  argumentative.
 3            A.      There is a difference in
 4  knowing about the outline or a structure of a
 5  package insert and how it relates to a product
 6  monograph and actually being the one to write the
 7  insert.
 8            Q.      How about the present draft of
 9  the B-Form is based on the package inserts
10  submitted with the NDA, you wrote that, didn't
11  you?
12            A.      I wrote the statement that the
13  product monograph was designed to correspond to
14  the package insert.  I did not write the package
15  insert that was submitted with the NDA.
16            Q.      Who would be the person who
17  would know differences between the United States
18  package insert and the various international
19  package inserts?
20            MS. GOLDMAN:  Objection to the form of
21  the question.
22            A.      People in regulatory and legal
23  are the source of information about the
24  requirements for package inserts in the U.S. and

                                                 Page 191

 1  outside the U.S.
 2            Q.      Again in this memo, Exhibit 5,
 3  you're talking about the international package
 4  insert or are you talking about the United States
 5  package insert?
 6            A.      I believe that both are
 7  mentioned at difference places in here.
 8            Q.      Okay.  What is
 9  Phospholipidosis,
10  P-H-O-S-P-H-O-L-I-P-I-D-O-S-I-S?
11            A.      I cannot give you a definition
12  of Phospholipidosis, but it was a condition
13  observed in some of the animal studies.
14            Q.      Do you know if it's a
15  neurological condition or an ocular condition or
16  a digestive condition?
17            A.      No, I'm sorry, I do not.
18            Q.      When you say on page two under
19  discussion, some sections that occur in package
20  inserts will ultimately require changes, what
21  type of change are you talking about?
22            A.      The information would need to
23  be changed to reflect the additional data from
24  studies completed since the draft package insert

                                                 Page 192

 1  was submitted with the NDA.
 2            Q.      Right above the conclusion
 3  section, it says, "The data analyses prepared for
 4  the BGA response and Montecatini papers."  What's
 5  the BGA response?
 6            A.      The BGA is the German
 7  regulatory authority and they had asked a series
 8  of questions about Fluoxetine and we had prepared
 9  a response to those questions.
10            Q.      Were you involved in preparing
11  that response?
12            A.      I was a reviewer of that
13  response.  I was not involved in writing the
14  answers to the questions.
15            Q.      Okay.  To your recollection did
16  those questions on the BGA refer to suicidality?
17            A.      I don't recall.
18            Q.      How about homicidality?
19            A.      I don't recall.
20            Q.      What's the Montecatini papers?
21            A.      A symposium on Fluoxetine was
22  held in Montecatini, Italy, and there were a
23  series of papers presented reporting the results
24  of some of the studies that had been completed on

                                                 Page 193

 1  Fluoxetine as of that date.
 2            Q.      Do you know if any of those
 3  papers included suicidality or homicidality?
 4            A.      I don't know whether they did
 5  or not.
 6            Q.      How were these BGA responses
 7  and the Montecatini papers included in the
 8  package insert?
 9            A.      I believe that some additional
10  analyses of data were done for the BGA in
11  response to the questions that were supplemental
12  to information that we had originally submitted
13  and so the question was whether we needed to
14  include those analyses in the package insert.
15            Q.      So the BGA, you had to fill out
16  the BGA questionnaire and in fact for
17  registration in Germany of Prozac?
18            A.      For consideration for
19  registration.
20            Q.      Do you know if that was
21  successful, was that drug registered in Italy?
22            A.      I don't know what the outcome
23  of that was.
24            Q.      What's a 3-celled study?

                                                 Page 194

 1            A.      It's another term for a three
 2  armed study or a study with three treatment
 3  groups.
 4            Q.      So when you talked earlier
 5  about the placebo, Fluoxetine and Imiprimine
 6  study, would that be a 3-celled study?
 7            A.      That would be a 3-celled study.
 8            Q.      Are those all necessarily
 9  blind, placebo controlled or -- 3-celled studies
10  I mean.
11            A.      In this case, they were double
12  blind controlled.
13            Q.      Okay.  Have you ever heard the
14  word pivotal, or phrase pivotal studies?
15            A.      I've heard that term.
16            Q.      What's your understanding of
17  what that term means, pivotal study?
18            A.      I have heard different
19  definitions of the term pivotal study and I
20  believe that the definition may have changed over
21  time.  My understanding of a pivotal study is
22  that it is an important or major study for
23  registration of the drug with respect to efficacy
24  and safety.  But that's simply my understanding,

                                                 Page 195

 1  it may be incorrect.
 2            Q.      Did you have a previous
 3  understanding of what a pivotal study was?  You
 4  said earlier you think the meaning has changed
 5  over time or the definition has changed over
 6  time?
 7            MS. GOLDMAN:  Objection to the form.
 8            A.      Not a fundamentally different
 9  understanding, no.
10            Q.      Do you know if it has anything --
11  a pivotal study has anything to do with a double
12  blinded study, things of that nature?  In other
13  words does a pivotal study, to be pivotal does it
14  necessarily have to be a double blind study?
15            A.      I don't know what the official
16  or formal definition of a pivotal study is at the
17  present time.
18            Q.      You said you believe that a
19  pivotal study was an important study to efficacy
20  and safety.  What did you mean by important?
21            A.      A major study, a key study.
22            Q.      Key?
23            A.      Meaning large double blind
24  placebo controlled, generally.

                                                 Page 196

 1            Q.      How did you come by this
 2  understanding of the meaning of pivotal study?
 3            A.      Through reading of literature
 4  concerning clinical trials and registrations.
 5            Q.      Okay.  What literature, can you
 6  list some of it for me?
 7            A.      I'm sorry, I don't know that I
 8  have specific titles but I have read the
 9  regulations and -- well, regulations and
10  guidelines in part for the development of NDAs.
11            Q.      When you say the regulations
12  and guidelines, are those the FDA regulations and
13  guidelines?
14            A.      Yes.
15            Q.      And they define pivotal study
16  in those regulations and guidelines?
17            A.      I do not know whether there is
18  a formal definition of pivotal study in those
19  guidelines.
20            Q.      Under organization of clinical
21  efficacy section, second number there, it says
22  the Fluoxetine-placebo comparison will not be
23  referred to as pivotal.  Why is that, do you
24  know?

                                                 Page 197

 1            A.      It's been too long, I don't
 2  recall what the significance was.
 3            Q.      If you could look under
 4  organization of clinical efficacy section, number
 5  three, it says Martha Tacker will inventory the
 6  Montecatini papers to assess the availability of
 7  data on completers.  What's a completer?
 8            A.      A completer is a patient who
 9  completed the clinical trial.
10            Q.      Would that be something that
11  would be for efficacy as opposed to safety,
12  correct?
13            A.      I guess you could have a
14  completer analysis for safety but it is primarily
15  looking at efficacy in those who completed the
16  trial.
17            Q.      Under number five on page
18  three, the following efficacy ratings will be
19  presented, and then it lists -- well, it says
20  over time, and underneath that it has Ham-D
21  total, Ham-D factors, et cetera.  What does over
22  time mean?
23            A.      I believe that this refers to
24  showing the weekly analysis of data as well as

                                                 Page 198

 1  the end point analysis.
 2            Q.      It says under that, "all
 3  factors will be evaluated and written up; however
 4  the B-Form discussion will be limited to a
 5  presentation of Anxiety, Sleep Disturbance,
 6  Psychomotor Function, and Cognitive Function if
 7  it is possible to do so without it appearing that
 8  less favorable factors were selected out."  What
 9  does that paragraph mean?
10            A.      It means that we analyze data
11  for a number of factors, but for the the purpose
12  of presentation we wanted to select four factors.
13  It was a matter of size and amount of detail, we
14  wanted to show representative data rather than
15  all of the data, if it were possible to do that.
16            Q.      But the sentence above it says,
17  the B-Form discussion will be limited to
18  presentation of anxiety, et cetera.  Isn't the
19  B-Form either going to be used as a marketing
20  tool or for regulatory compliance purposes
21  internationally?
22            MS. GOLDMAN:  Objection to the form.
23            A.      I'm sorry.
24            Q.      Why is it that in the B-Form,

                                                 Page 199

 1  you would list three or four or five topics to
 2  discuss as opposed to including every factor that
 3  was available to you?
 4            A.      There was a concern with the
 5  length of the document being excessive and too
 6  much repetition of similar data.
 7            Q.      Aren't things like anxiety,
 8  sleep disturbance, psychomotor function and
 9  cognitive function something that could be
10  considered adverse reactions or events or related
11  to adverse events?
12            A.      I'm sorry, I think you're
13  asking a question that is outside my area of
14  expertise.  As the discussion here is posed,
15  we're looking at specific items from the Hamilton
16  and their presentation.
17            Q.      So this anxiety, sleep
18  disturbance, psychomotor function and cognitive
19  function are all elements of the Hamilton
20  depression reading scale?
21            A.      Right, they're a combination of
22  certain items on the Hamilton.
23            Q.      So included in this group is
24  not suicidality, is there?

                                                 Page 200

 1            A.      No, that would have been a
 2  safety measure, not an efficacy measure.
 3            Q.      Do you know if the safety
 4  measure of Hamilton-D rating suicidality was
 5  included elsewhere in this B-Form?
 6            A.      I do not recall.
 7            Q.      Were you able to discuss only
 8  those five elements without it appearing that the
 9  less favorable factors were selected out?
10            A.      We were, as I recall.
11            Q.      How did you do that?
12            A.      We looked at all of the data
13  and our statistician provided the final results
14  to us, based on the results of his analyses.
15            Q.      So he was able to reanalyze the
16  data to justify including only these five factors
17  as opposed to other factors?
18            MS. GOLDMAN:  Objection to the form of
19  that question.
20            A.      I'm sorry, I don't think that's
21  a correct statement.  You say he was able to
22  reanalyze the data, there wasn't a reanalysis of
23  the data that I'm aware of.  It was simply an
24  analysis of the data.

                                                 Page 201

 1            Q.      He was able to present the data
 2  using these five factors as opposed to these
 3  other factors and make it -- without making it
 4  appear that less favorable factors were selected
 5  out?
 6            A.      I'm sorry, you seem to be
 7  making an assumption that he is making the data
 8  look a particular way.  The statistician provided
 9  results of statistical analyses and I don't have
10  the expertise to answer the questions that you're
11  asking.
12            Q.      You say here all factors will
13  be evaluated and written up, however the B-Form
14  discussion will be limited to a presentation of,
15  and you list these five factors, if it is
16  possible to do so without it appearing that less
17  favorable factors were selected out.
18            A.      Right.
19            Q.      How was he able to do that?
20            MS. GOLDMAN:  Objection to the form of
21  the question.  And I believe it's been asked and
22  answered as well.  I'll allow her to make one
23  more response to your question.
24            A.      The statistician did analyses

                                                 Page 202

 1  of the Hamilton data and the Hamilton factors.
 2  Based on his review of the results of the
 3  analyses, he provided data on all of them.  When
 4  the review was complete, I believe it was the
 5  assessment that there were no differences and
 6  that it was possible therefore to show only those
 7  measures.  But that's a statistical question, as
 8  far as the details of the analysis and the
 9  processes that were used to make that
10  determination, that would have to be addressed to
11  a statistician.
12            Q.      Under that it says, Categorical
13  Analysis, and in parentheses it says, using finer
14  categories as in the Bremner paper.  What do you
15  mean by when you say using finer categories as in
16  the Bremner paper?
17            A.      I'm sorry, I do not recall what
18  categories were used to look at these measures in
19  the Bremner patients.  A categorical response is
20  a particular kind of analysis and the limits are
21  set, or definitions are set.  For example, you
22  might have Ham-D total response, but I do not
23  know what the categories were, I do not recall.
24            Q.      Do you remember what you mean

                                                 Page 203

 1  by saying finer categories?
 2            A.      No, I'm sorry, I do not know.
 3            Q.      How about under Endpoint
 4  Analysis, you have listed PGI, what is PGI?
 5            A.      It's a measure, patient global
 6  impression.
 7            Q.      Okay.  To your knowledge was
 8  the results of the patient global impression ever
 9  compared with the results of the Hamilton
10  depression scale results?
11            A.      I'm sorry, but in -- what do
12  you mean by the comparison?
13            Q.      Let me ask you this:  As far as
14  the PGI is concerned, do you know if that tests
15  the suicidality or suicide ideation?
16            A.      Patient global impression is
17  the patient's assessment of improvement since the
18  start of this study, it's generally considered an
19  efficacy measure.
20            Q.      Okay.  The Hamilton Depression
21  Scale was generally used in these studies as an
22  efficacy measure too, wasn't it?
23            A.      That's correct, but one item
24  relates to suicidality.

                                                 Page 204

 1            Q.      Any items on the PGI that
 2  relates to suicidality?
 3            A.      No, it's a single question.
 4            Q.      You're feeling better this time
 5  than you did the last time, something like that?
 6            A.      I don't know how that question
 7  is actually phrased, but it relates to the
 8  patient's condition at the present time relative
 9  to the beginning of therapy, I believe.
10            Q.      As far as efficacy is
11  concerned, do you know if the results of the PGI
12  were ever compared to the results of the Ham-D?
13            MS. GOLDMAN:  Objection to the form of
14  that question.
15            Q.      You can answer it.
16            A.      I believe that in the
17  monograph, we presented the results of the PGI
18  analysis and also the results of analyses of the
19  other measures listed there.
20            Q.      When you say the monograph
21  presented --
22            A.      Excuse me, the international
23  B-Form, in this document.
24            Q.      Okay.  Before the ACNP, the

                                                 Page 205

 1  monograph that we're talking about, or is that
 2  something different?
 3            A.      I think there was a
 4  presentation of safety data prior to the ACNP
 5  meeting, there was also the monograph, the two
 6  were separate.
 7            Q.      Okay.  What were the results of
 8  the comparison between the PGI and the Ham-D on
 9  the monograph, if you remember?
10            A.      I'm sorry, I'm not familiar
11  with all of that data.
12            Q.      Okay.
13            A.      At the present time.
14            Q.      Under PGI it says mean endpoint
15  data will not be shown.  What does that mean?
16            A.      I can tell you what I think the
17  sentence means, but I don't recall what question
18  or what queery it answered on the original
19  review.
20            Q.      Okay.  What do you think it
21  means?
22            A.      That we are not showing the
23  mean data at the end of the study, in the
24  monograph.

                                                 Page 206

 1            Q.      Why wouldn't you do that?
 2            A.      I don't recall what the basis
 3  was for those decisions.
 4            Q.      Okay.  Under number eight it
 5  says a decision must be made regarding the data
 6  base to be used and the cut off date for the
 7  B-Form.  What do you mean when you say a decision
 8  must be made regarding the data base to be used?
 9            A.      When we do analyses of safety
10  data, we normally pick a particular cut off point
11  for the data and then we lock that for the
12  analyses and it's generally stated in this
13  fashion.
14            Q.      So when you say a decision must
15  be made regarding the data base, you're making a
16  determination on when -- how to look at the data
17  base or the cut off date?  I'm confused, I'm
18  sorry.
19            A.      When we do an analysis of
20  safety, we establish a cut off point for the
21  analysis, so that it is a fixed point in time,
22  and we note in the monograph that the information
23  that is provided is current as of a certain date.
24            Q.      Okay.

                                                 Page 207

 1            A.      And then when we do an update,
 2  we either do an accumulative update or an update
 3  of information from the last cut off point to the
 4  next version.
 5            MS. ZETTLER:  I have, like I mentioned
 6  earlier, at least a few more hours worth of
 7  questions at least.  I'm frankly getting tired.
 8            MS. GOLDMAN:  I think we probably share
 9  your sentiments on the tired part, not having to
10  do the labor of asking the questions, nonetheless
11  the jobs we do are tiring also.  I am surprised
12  and dismayed to hear that you have a few more
13  hours of interrogation to do.  I would have
14  thought that within the time period alloted for
15  the conduct of this deposition today, and given
16  the manner in which counsel chose to spend some
17  of her time during the earlier portion of the
18  deposition, I would have thought that there would
19  have been no question about finishing this
20  deposition by a reasonable breaking time, which I
21  will agree with counsel 4:30 is certainly that, a
22  reasonable breaking time.  We do not feel that we
23  should have to go to the trouble and expense, not
24  to mention the great inconvenience to the witness

                                                 Page 208

 1  of producing her again for a further round of
 2  deposition.  I would like to invite you, if I
 3  could, Ms. Zettler, if it would be helpful, I'm
 4  happy to take a short break at this time for you
 5  to take a look at your notes to see whether you
 6  can come up with an estimate of an estimated time
 7  for completion that's something shy of a few
 8  hours and to try to accomodate your schedule by
 9  going further today in the hope that we could
10  finish.
11            MS. ZETTLER:  All the documents that
12  you produced to us, which are probably about a
13  tenth of what was out there, I've got to go over
14  all of these, all of these.  Not to mention the
15  fact that I'm here on four or five different
16  cases, okay.  I've got different facts on
17  different cases that I have to cover if you're
18  going to try to hold us all to this cross
19  noticing routine that you guys have set up.  Not
20  to mention the fact that there are other
21  plaintiffs and defendants in this case who
22  probably are going to have their one shot at
23  Doctor Potvin at this point and also including
24  the fact that there is no agreement that we are

                                                 Page 209

 1  going to limit these depositions.  If I want to
 2  take a week and a half complete with Doctor
 3  Potvin, I can, unless you can show that this in
 4  some way harassing.  Also, it should be included
 5  is the fact that these documents that have been
 6  produced are not responsive to our request for
 7  production and I intend to go before Judge
 8  Potter, as I'm sure you know, Monday morning and
 9  make the appropriate motion to compel.  So I am
10  reserving my right to bring Doctor Potvin back to
11  complete this deposition and I'm also reserving
12  my right to bring her back to interrogate her on
13  documents when they are properly produced.
14            MR. GREEN:  I have to reserve my right
15  to ask questions in the first place on behalf of
16  the plaintiffs I represent, both the plaintiffs
17  in Kentucky as well as the New York plaintiffs
18  where the defendants have cross noticed this
19  deposition.  If I don't have an opportunity to
20  ask the questions today, I think I have to bring
21  her back for me to have an opportunity on behalf
22  of those plaintiffs that I represent.
23            MR. CLEMENTI:  I'd like to make a
24  general statement that at least as to the

                                                 Page 210

 1  defendants that I represent, their questions are
 2  not even done from the first deposition.  It
 3  would be very difficult for us to obviously ask
 4  any questions at all if we had any, seeing as the
 5  first part of these depositions aren't finished.
 6  So we want to reserve our right to bring her
 7  back, if necessary.
 8            MS. LAWS:  It's about 4:30, isn't it,
 9  and I don't know why we're knocking off so early.
10  We haven't worked five and a half hours today and
11  if we can get done I'd like to get done instead
12  of having yet again another half completed
13  deposition.  I understand you have outstanding
14  documents, but if we can get to a point where you
15  can say I've done all the work that I can do
16  given the information that I have, that would be
17  closer to a conclusion, and I'd like to try and
18  get there if we could.
19            MS. ZETTLER:  I have another three
20  hours worth of questions and I'm frankly very
21  tired and we've worked since ten o'clock with an
22  hour break and it's almost 4:30 so I think we've
23  put in a decent amount of time today.  I don't
24  think it's fair to Doctor Potvin at this point to

                                                 Page 211

 1  put her through another at least three hours of
 2  grilling after she's been sitting here answering
 3  questions on a continuous basis for the past
 4  seven hours or so.  I don't know how much anybody
 5  else has got but I know there's going to be a
 6  question on documents as it is.  I'm confident
 7  that I'm going to receive more documents in this
 8  case and I want to reserve the right to bring her
 9  back.
10            MS. GOLDMAN:  Many things have been
11  said by many folk in this colloquy and my
12  apologies to anyone whose comments may not get
13  specifically addressed in what will be a brief
14  response.  Ms. Zettler, with respect to your
15  complaints about the documents which were
16  produced to you, I will say and say again that
17  the documents which were produced to you are
18  documents which were responsive to the notice
19  which was served, and rather than belabor
20  everyone's ears and time with more, the
21  correspondence which you have received from
22  counsel with respect to the terms and conditions
23  and nature and extent of documents which have
24  been produced in connection with this deposition,

                                                 Page 212

 1  should be incorporated by reference rather than
 2  taking everybody's time to repeat them verbatim.
 3            MS. ZETTLER:  Except that I've never
 4  have a chance to respond to them before the first
 5  deposition and my response is that under no
 6  discovery rules that I am aware of in any court
 7  in this country is it appropriate for the
 8  defendant to make a unilateral decision as to
 9  what is relevant and what is not in a case.  I'm
10  requesting in my motion before Judge Potter on
11  Monday morning that you produce to us all
12  documents responsive to our request, and in the
13  alternative, a listing of the documents you are
14  not going to produce and have not produced, and
15  list why, including date, the person who wrote
16  it, subject matter, type of document and why
17  you're claiming that it's either privileged or
18  otherwise confidential under Judge Eckert's March
19  of 1991 order.
20            MS. GOLDMAN:  Ms. Zettler, with
21  greatest courtesy, I reject your characterization
22  of my client's compliance with the deposition
23  notices and the request for production previously
24  produced.  I have no doubt you will do that which

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 1  you see fit before Judge Potter at such time as
 2  you see him and I certainly and you certainly
 3  understand that Lilly will do that which it sees
 4  fit before Judge Potter on Monday or at such time
 5  as we find ourselves before him in this or any of
 6  the other cases with respect to document issues.
 7  With respect to the continuation of the
 8  deposition at this time, I agree with you that
 9  the hour is late, I agree with you that it
10  certainly would be a shame to continue to grill
11  Doctor Potvin, but by saying that, I do not want
12  anyone for a minute to misunderstand me as
13  stating that I believe that it is right, fair,
14  reasonable or appropriate or necessary for this
15  deposition to have to consume yet another day of
16  witness and attorney time.  And that is Lilly's
17  position for the record.
18            MS. ZETTLER:  Well, regardless of
19  Lilly's position, we will be inviting Doctor
20  Potvin back to complete this deposition.
21            MS. GOLDMAN:  That's as it may be and
22  Lilly reserves its right to consider what, if
23  any, remedies it may have in the event that that
24  is done.

                                                 Page 214

 1 
 2             (THE WITNESS WAS EXCUSED.)

                                                 Page 215

 1 
   COMMONWEALTH OF KENTUCKY        )
 2                                 :  ss
   COUNTY OF JEFFERSON             )
 3 
 4       I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN
 5  AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY
 6  CERTIFY THAT THE FOREGOING TESTIMONY OF
 7                  JAN POTVIN, PH.D.
 8  WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS
 9  STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST
10  DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH,
11  AND NOTHING BUT THE TRUTH; THAT THE SAID
12  PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC
13  NOTES AND AFTERWARDS TRANSCRIBED UNDER MY
14  DIRECTION; THAT IT IS A TRUE, COMPLETE AND
15  CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO
16  HAD; THAT THE APPEARANCES WERE AS STATED IN THE
17  CAPTION.
18       WITNESS MY SIGNATURE THIS THE 17TH DAY OF
19  JUNE, 1993,
20       MY COMMISSION EXPIRES MARCH 10, 1994.
21 
   
22 
   
23                _________________________
                  MARY KATHLEEN NOLD
24                COURT REPORTER AND NOTARY PUBLIC
                  STATE OF KENTUCKY AT LARGE

                                                 Page 216

 1               E R R A T A   S H E E T
 2 
   
 3 STATE OF                      )
                                 : SS
 4 COUNTY OF                     )
   
 5 
   
 6 
 7            I, JAN POTVIN, PH.D., THE UNDERSIGNED
 8  DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES
 9  OF MY DEPOSITION AND WITH THE CHANGES NOTED
10  BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND
11  ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON
12  THE 16TH DAY OF JUNE, 1993 AT THE TIME AND PLACE
13  STATED THEREIN.
14 PAGE NO.     LINE NO.     CHANGE          REASON

                                                 Page 217

 1 PAGE NO.     LINE NO.     CHANGE          REASON
   
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 5 
   
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 7 
   
 8 
                    _____________________________
 9                  JAN POTVIN, PH.D.
   
10            SWORN TO AND SUBSCRIBED BEFORE ME THIS
11  _____ DAY OF __________, 1993.
12            _____________________________
              NOTARY PUBLIC, STATE OF
13            AT LARGE
   
14 
   
15 
   
16 
   
17 
   
18 
   
19 
   
20 
   
21 
   
22 
   
23 
   
24 
   

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                                                 Page 222

 1     DIRECT EXAMINATIONBY MS. ZETTLER:.................10
 2     (PLAINTIFFS' EXHIBITS NO. 1 THROUGH             4...140
 3     (PLAINTIFFS' EXHIBITS NOS. 5 AND             6...171
 4     E R R A T A......................................217
 5     COMMONWEALTH.....................................216
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