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1 IN THE UNITED STATES DISTRICT COURT

2 NORTHERN DISTRICT OF ALABAMA

3 SOUTHERN DIVISION

4

5 IN RE: ) Master File No.

6 ) CV92 10000 S

7 SILICONE GEL BREAST ) April 20, 1999

8 IMPLANT PRODUCTS ) April 21, 1999

9 LIABILITY LITIGATION ) April 22, 1999

10 ) Birmingham, AL

11 * * * * *

12

13 VIDEO DEPOSITION OF DR. BARBARA S. HULKA

14 BEFORE THE HONORABLE SAM C. POINTER, JR.

15 UNITED STATES DISTRICT JUDGE

16

17

18 Lindy M. Fuller, CSR, RMR, CRR

19 Federal Official Court Reporter

20

21 Mickey Turner

22 Foshee & Turner Court Reporters

23

24

25

2


1 A P P E A R A N C E S

2 FOR THE NATIONAL

3 SCIENCE PANEL:

4 Ina B. Leonard, Esq.

5

6 FOR THE PLAINTIFFS:

7 Leslie J. Bryan, Esq.

8 Ralph Knowles, Esq.

9 Fredric L. Ellis, Esq.

10 Ernest H. Hornsby, Esq.

11 Dianna L. Pendleton, Esq.

12 Edward D. Rapacki, Esq.

13

14 FOR THE DEFENDANT,

15 BAXTER HEALTHCARE COMPANY:

16 Debra E. Pole, Esq.

17 Mary A. Wells, Esq.

18

19 FOR THE DEFENDANTS, BRISTOL MYERS

20 SQUIBB COMPANY and MEDICAL ENGINEERING

21 CORPORATION:

22 Nathan A. Schachtman, Esq.

23 Richard M. Eittreim, Esq.

24

25

3


1 FOR THE DEFENDANT,

2 MINNESOTA MINING AND

3 MANUFACTURING COMPANY:

4 Jane Thorpe, Esq.

5 Joseph M. Price

6 David P. Herrick

7 Arvin Maskin, Esq.

8

9 FOR THE DEFENDANT,

10 DOW CORNING CORPORATION:

11 John Donley, Esq.

12

13 COUNSEL ALSO PRESENT:

14 Cynthia Brennan, Esq.

15 Robert Nieman, Esq.

16 Alan Levine, Esq.

17 Elizabeth Gardner, Esq.

18 Doug Shoettinger, Esq.

19 Karen E. Read, Esq.

20 Steven Skikos, Esq.

21 Joe Cecil, Esq.

22

23 ALSO PRESENT:

24 Dr. Judith Steinman

25 Ms. Lana Alcorn

4


1 Ms. Mary Kamplain

2 Ms. Beth Wilson

3 Mr. Richard Rawls

4 Ms. Kathryn LeTourneau

5 Ms. Kelly Stepno

6 Mr. Chad Hopper

7 Ms. Annette Vandenberg

8 Ms. Cheryl Bradley

9

10 VIDEOGRAPHERS:

11 Mr. Tom Aims

12 Mr. Steve Shipley

13 Mr. Curtis Cox

14 Mr. Rick Longenecker

15

16

17

18

19

20

21

22

23

24

25

5


1 INDEX OF EXHIBITS

2 PAGE NUMBER:

3 1   11 29 98 Letter 82

4 2   Order No. 31C 97

5 3   Lecture   Epidemiological

6 Studies Using Biological

7 Markers 139

8 4   Burns Study 193

9 5   Dugowson Study 197

10 6   Englert Study 199

11 7   Goldman Study 201

12 8   Henekens Study 202

13 9   Hochberg Study 204

14 10   Lacey Study Letter 206

15 11   Study of Lupus 209

16 12   Strom Study 212

17 13   Teel Study 216

18 14   Wolfe Study 219

19 15   Edworthy Study 298

20 16   Friis Study 298

21 17   Gabriel Study 273

22 18   Giltay Study 298

23 19   Nyren Study 262

24 20   Park Study 299

25

6


1 21   Sanchez Guerrero

2 Study 247

3 22   Schusterman Study 298

4 23   Wells Study 298

5 49   Slide   Hulka F21 302

6 52   Slide   Hulka F25 306

7 66   Slide   Hulka F57 322

8 67   Slide   Hulka F58 322

9 68   Slide   Hulka F59 322

10 69   Slide   Hulka F60 322

11 70   Slide   Hulka F61 308

12 71   Slide   Hulka F62 322

13 72   Slide   Hulka F63 322

14 73   Slide   Hulka F64 322

15 75   Curriculum Vitae 94

16 76   Report of Science Panel 99

17 82   Report of Science Panel 260

18 100   Outline with 9 4 97

19 Handwritten Note 384

20 101   Silverman Report 431

21 102   Notes from 1 14 98

22 Meeting 467

23 103   Minutes for "SBI"

24 2 11 98 Meeting 519

25 104   Notes of 12 24 97

7


1 Meeting 523

2 105   Lancet Article 531

3 105 A   Lancet Article 538

4 106   Abstract   Absence of

5 an association between

6 silicone breast implants

7 and risk for development

8 of rheumatoid arthritis 560

9 107   Letter of Dr. Vasey

10 Re: Sanchez Guerrero 647

11 108   Abstract   Treatment of

12 Silicone Implant Associated

13 Symptoms 654

14 109   Young Abstract 656

15 110   Data Abstract Form 669

16 111   Handwritten Notes of

17 Conversation with

18 Dr. Daling 678

19 112   Article   Meta Analysis

20 in Epidemiology, etc. 688

21 113   Lacey Thesis 701

22 114   1996 Greenland Article 705

23 115   1998 Greenland Article 705

24 116   Rockhill Article 769

25

8


1 P R O C E E D I N G S:

2 April 20, 1999 10:00 a.m.

3

4 THE COURT: This deposition

5 is being conducted pursuant to Rule 30 of

6 the Federal Rules of Civil Procedure. By

7 agreement of the parties, the requirement

8 of Rule 30 that ordinarily requires the

9 court reporter to list and identify all

10 persons present is being waived so that

11 we do not have to keep up with everyone

12 present. Parties have also agreed that I

13 will administer the oath or affirmation

14 to the witness.

15 The deposition is being

16 conducted by Lindy Fuller as court

17 reporter, Federal Courthouse, Birmingham,

18 Alabama. She will be assisted by court

19 reporters from the firm of Foshee &

20 Turner. The videotaping will be done by

21 Desktop Video Productions, Incorporated.

22 Under Rule 30 and Rule 32, it

23 is not necessary that objections to

24 questions or to most questions be stated

25 during the deposition. Most objections

9


1 can be raised for the first time when a

2 deposition is being used or offered at

3 trial.

4 The primary exceptions to

5 that principle would be matters dealing

6 with a claimed privilege or with some

7 question and objection relating to the

8 form of a question, such as being a

9 leading question, which could be

10 corrected, if raised at the time the

11 examination is being conducted.

12 It is not necessary for the

13 parties to offer a document into

14 evidence, simply there can be examination

15 about a document. The parties would

16 reserve the right to offer one or more of

17 the identified documents at trial,

18 subject, however, to the potential for an

19 objection to such a document at the time

20 of trial as well.

21 The conduct of the deposition

22 will be pursuant to these rules, but with

23 the preservation of objections as

24 indicated. There may be some objections

25 made and the parties are not waiving

10


1 objections by not making them during the

2 conduct of the examination, except as it

3 may relate to something like the form of

4 a question.

5 With that background, we'll

6 start with the videotaping as well, and I

7 will ask the deponent to please stand and

8 raise your right hand.

9 THE WITNESS: Sir, may I ask

10 you a question.

11 THE COURT: Surely.

12 THE WITNESS: Somewhere my

13 purse has disappeared in the scheme of

14 things and just in case I need to blow my

15 nose or have some other    there is

16 nothing confidential in it, you

17 understand. Thank you very much, I

18 appreciate that. Thank you very much,

19 sir.

20 THE COURT: All right.

21 Thank you. If you would please stand?

22 THE WITNESS: I will stand.

23 THE COURT: And raise your

24 right hand. Do you swear or affirm under

25 penalties of perjury that the testimony

11


1 you give will be the truth, the whole

2 truth and nothing but the truth. Do you?

3 THE WITNESS: Yes, sir I do.

4 THE COURT: Thank you, if

5 you would be seated. And we will

6 commence with the examination.

7

8 EXAMINATION BY MS. LEONARD:

9 Q. Will you state your name?

10 A. My name is Barbara Sorenson

11 Hulka.

12 Q. Do you have a title that you

13 usually use?

14 A. I am Kenan professor in the

15 Department of Epidemiology at the

16 University of North Carolina in Chapel

17 Hill.

18 Q. Tell us about your

19 educational background.

20 A. I received my bachelor's

21 degree from Radcliffe College. I got a

22 masters degree from the Julliard School

23 of Music. My medical degree was from

24 Columbia College of Physicians and

25 Surgeons. I did an internship in the

12


1 Public Health Service. I did additional

2 work to get a masters of Public Health at

3 Columbia University, and I continued on

4 to do the work that's required to get

5 board certified in preventive medicine.

6 MS. THORPE: Your Honor,

7 excuse me. There is a roll of tape that

8 is making a fuzzy spot on the camera.

9 May I move it?

10 THE COURT: Surely.

11 MS. THORPE: Excuse me, Dr.

12 Hulka.

13 THE WITNESS: Sure.

14

15 (Discussion off the record.)

16

17 Q. Dr. Hulka, do you have a

18 license to practice medicine?

19 A. I do in the state of North

20 Carolina.

21 Q. Briefly summarize your

22 employment history.

23 A. It isn't that I hesitate to

24 do so, it's just I'm trying to remember.

25 Q. Well, you may hit the high

13


1 points.

2 A. High points. Well, I started

3 at the University of Pittsburgh. When I

4 finished my preventive medicine

5 residency, I started at the University of

6 Pittsburgh and actually was in the

7 department of obstetrics and gynecology

8 where I ran a cervical cancer screening

9 program. That was in the early years of

10 screening for cervical cancer.

11 I was there from 1961 to

12 1967, and then I moved to the University

13 of North Carolina where I joined the

14 Department of Epidemiology. And since

15 1967 I have been in the Department of

16 Epidemiology. I spent ten years as chair

17 of that department, one year as acting

18 chair.

19 I also have appointments in

20 the Department of Family Medicine at the

21 University of North Carolina and in the

22 Department of Community and Family

23 Medicine at Duke University.

24 Q. In addition to your duties as

25 a professor, Dr. Hulka, have you been

14


1 active professionally?

2 A. Well, I think I have done

3 quite a bit professionally in terms of

4 research, a major thrust of my work, and

5 as a epidemiologist is in research. I've

6 certainly done teaching, both in

7 classroom teaching and with doctoral

8 students. Our whole program is for

9 graduate students, so I have done those

10 things.

11 I have done quite a bit of

12 what I would call community service from

13 the standpoint of local in the state of

14 North Carolina, in national, in the

15 country nationwide, and worldwide.

16 I have been a member of and

17 chair of the committees for the Institute

18 of Medicine, the National Academy of

19 Sciences. I am a member of that

20 institution. Therefore, I've worked on

21 many of their committees. I've worked on

22 many committees and chaired committees

23 and been on the National Science Boards

24 for the National Cancer Institute and for

25 other of the National Institutes of

15


1 Health, a number of the other National

2 Institutes of Health.

3 I am trying to hit the high

4 points. In my national activity, the

5 main thing I've done is work with the

6 World Health Organization, and there I

7 spent seven years chairing what was the

8 Committee on the Epidemiology in Human

9 Reproduction. I now am on their

10 Scientific Technical Advisory Group of

11 the World Health Organization for Human

12 Reproduction.

13 Q. You've told us that you been

14 an active    you have been active in

15 research. Is your research published,

16 Dr. Hulka?

17 A. Yes, my research is

18 published.

19 Q. I am going to show you an

20 exhibit that's been marked as Hulka

21 Exhibit Number 75 and would you say if

22 you recognize that, please?

23 A. Yes, ma'am, I believe that's

24 my curriculum vitae. That is my

25 curriculum vitae.

16


1 Q. Would that be a current and
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