Toxicologist Dennis Pastenbach who serves as a defense expert in hundreds of asbestos cases took the stand in the ongoing Dupuy Hip implant trial in California. Rather than Charaterize his credibility you can read for yourself below and draw your own conclusions. 🙂
4470
1 IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
2 COUNTY OF LOS ANGELES, CENTRAL DISTRICT
3
4 COORDINATION PROCEEDING SPECIAL )
TITLE [RULE 3.550(c)] )
5 )
DePUY ASR HIP SYSTEM CASES )
6 _______________________________ ) JCCP Case No. 4649
)
7 THIS DOCUMENT RELATES TO: )
)
8 Loren Kransky and Sheryl )
Kransky (originally filed under )
9 Sandra Ellis, et al. v. DePuy, )
Inc., et al.) )
10 )
Los Angeles Superior Court )
11 Case No. BC456086 )
_______________________________ )
12
13
14 Transcript of
15 TRIAL PROCEEDINGS
16
17
18 Los Angeles, California,
Thursday, February 21, 2013
19
20
21 REPORTED BY: Lisa Moskowitz, CSR 10816, RPR, CLR
22
23 GOLKOW TECHNOLOGIES, INC.
877.370.DEPS
24 Deps@golkow.com
25
4471
1 APPEARANCES:
2
3 BEFORE: The Honorable J. Stephen Czuleger
4
PANISH, SHEA & BOYLE, LLP
5 BY: BRIAN PANISH
11111 Santa Monica Boulevard, Suite 700
6 Los Angeles, California 90025
(310) 477-1700
7
Counsel for Plaintiffs
8
9
WALKUP MELODIA KELLY & SCHOENBERGER
10 BY: MICHAEL A. KELLY
BY: KHALDOUN A. BAGHDADI
11 650 California Street, 26th Floor
San Francisco, California 94108
12 (415) 981-7210
13 Counsel for Plaintiffs
14
15 THE GOMEZ LAW FIRM
BY: JOHN H. GOMEZ
16 625 Broadway, Suite 1200
San Diego, California 92101
17 (619) 237-3490
18 Counsel for Plaintiffs
19
20 TUCKER ELLIS, LLP
BY: MICHAEL C. ZELLERS
21 BY: PETE KAUFMAN
515 South Flower Street, 42nd Floor
22 Los Angeles, California 90071-2223
(213) 430-3400
23
Counsel for Defendants
24
25
4472
1 APPEARANCES:
2
3 YUKEVICH CALFO & CAVANAUGH
BY: ALEXANDER G. CALFO
4 BY: KELLEY SPENCER OLAH
355 South Grand Avenue, 15th Floor
5 Los Angeles, California 90071-1560
(213) 362-7777
6
Counsel for Defendants
7
8
DRINKER BIDDLE & REATH, LLP
9 BY: RODNEY M. HUDSON
50 Fremont Street, 20th Floor
10 San Francisco, California 94105-2235
(415) 591-7500
11
Counsel for Defendants
12
13 – – –
14
15
16
17
18
19
20
21
22
23
24
25
4473
1 I N D E X
2
3 Testimony of:
4
5 CYRUS RANGAN, M.D.
6 By Mr. Calfo 4483
7 By Mr. Kelly 4489
8
9 DENNISH PAUSTENBACH, Ph.D.
10 By Mr. Calfo 4507, 4729
11 By Mr. Panish 4607, 4732
12
13 THOMAS VAIL, M.D. (Videotaped) 4736
14
PAMELA PLOUHAR (Videotaped) 4777
15
16
17
18
19
20
21
22
23
24
25
4474
1 EXHIBITS
2
3 Exhibit 2971 – Paustenbach Slide Show 4480
4 Exhibit 2972 – Paustenbach CV 4515
5 Exhibit 2973 – Witness Drawing 4518
6 Exhibit 2974 – Witness Drawing 4536
7 Exhibit 2981 – Witness Drawing 4542
8 Exhibit 2982 – Witness Drawing 4572
9 Exhibit 2983 – Witness Drawing 4586
10 Exhibit 2984 – Witness Drawing 4607
11 Exhibit 2985 – Bottle of Cobalt 4640
12 Exhibit 2986 – Zhang Article 4652
13 Exhibit 2987 – Memo 4658
14 Exhibit 2988 – Memo, dated 6/6/96 4664
15 Exhibit 2989 – Journal Article 4671
16 Exhibit 2990 – Journal Article 4706
17 Exhibit 2991 – Journal Article 4712
18
19
20
21
22
23
24
25
4475
1 Los Angeles, California, Thursday, February 21, 2013
2 8:30 a.m.
3 – – –
4 COURT ATTENDANT: Please come to order.
5 Department 3 is, again, in session. The Honorable
6 Stephen Czuleger, judge presiding.
7 THE COURT: In the case of Kransky vs. DePuy,
8 the record will reflect all counsel are present. All
9 jurors and alternates are out of the court.
10 Someone wanted to see me?
11 MR. PANISH: Yes, I did, Your Honor, regarding
12 this witness, Dr. Paustenbach. Last night Mr. Calfo
13 delivered to us about 11:00 some of the slides he
14 intends to use. Numerous of them contain medical
15 articles and substance of medical articles written by
16 the witness which would be hearsay and should not be
17 shown during direct examination of a medical witness
18 pursuant to the evidence code. That would be my first
19 issue with all these slides he has.
20 THE COURT: Second issue?
21 MR. PANISH: My second issue is in the end
22 after all the medical articles that he’s — there’s an
23 exhibit called “Mr. Kransky Hematocrit Levels 2001 to
24 2012.” This witness is, first of all, I assume he’s
25 giving some opinions about this. I couldn’t really get
4476
1 that out of Mr. Calfo, but I assume he will. If he
2 intends to give any opinions about it, number one, it’s
3 a medical opinion. He’s not a medical doctor.
4 Number two, it’s not covered in the overview of
5 all his opinions or anywhere in his deposition. The
6 first time I saw this was last night at 11 o’clock, and
7 I would object, number one, it would be beyond the scope
8 of any opinions he’s previously offered, and number two,
9 that it’s a medical opinion that he’s not having a
10 foundation upon which to opine.
11 MR. CALFO: First, Your Honor, I contacted
12 Mr. Panish at 7:00. I told him that we were — I was
13 going to get the slides over to him. We had a problem
14 with Ms. Olah and our printer. At 8:50, I e-mailed it
15 to them. And by the way, I received his slides at 9:35
16 for Dr. Harrison and never complained to the Court.
17 Mr. Baghdadi told me he had problems opening up certain
18 slides; so I actually walked down to their hotel to meet
19 Mr. Baghdadi halfway and handed him a copy. I do
20 apologize. It does happen.
21 What we are talking about are peer-reviewed
22 articles that were actually written by this witness.
23 They’re not hearsay, number one.
24 THE COURT: What are they being used for?
25 MR. CALFO: To support his opinion. I’m not
4477
1 going to go through word by word of the article.
2 THE COURT: Are you seeking to introduce the
3 articles themselves?
4 MR. CALFO: No, Your Honor. I do want to show
5 them on the screen to show that they are peer-reviewed.
6 I’m not — and I can do it. I don’t plan to, but I can
7 go through —
8 THE COURT: If I say yes, you can.
9 MR. CALFO: I know, but I don’t plan to do
10 that. That’s number one.
11 Number two, this graph —
12 THE COURT: To support his expert opinion.
13 MR. CALFO: Correct. Those were produced
14 during the deposition.
15 THE COURT: Okay.
16 MR. CALFO: Number two, when it comes to his
17 opinion, there is a way, and we will lay the foundation,
18 there’s a way to determine — there’s something called
19 polycythemia. Polycythemia talks about red blood cell
20 production. It’s in his papers, and he produced it in
21 his deposition, and it’s just a graph to assist the jury
22 for Mr. Kransky’s red blood cell levels; so the jury can
23 see how those relate to parts per billion and whether or
24 not they are in the normal range.
25 THE COURT: I’m sorry. I guess I’m beginning
4478
1 to lose it with all the experts in the case. He’s a
2 Ph.D. in toxicology.
3 MR. CALFO: That’s what toxicologists do. They
4 write papers on this and they deal with these issues.
5 MR. PANISH: He can address that, but I just
6 wanted the medical articles. It doesn’t matter whether
7 he wrote it or the president wrote it, it’s hearsay.
8 It’s an out-of-court statement being offered for the
9 truth of the matter asserted whether he wrote it or not.
10 It’s not appropriate —
11 THE COURT: Experts can rely on learned
12 treatises.
13 MR. PANISH: They can rely on it, but they’re
14 not able to publish it in front of the jury.
15 THE COURT: I understand.
16 What you’re going to do is put it up and say,
17 “Is this the article you wrote?” What was this article
18 about? Is this something he wrote —
19 MR. CALFO: He’s written on cobalt chromium,
20 and they’ve been published in peer-reviewed
21 toxicological journals. He’s going to get up there and
22 he’s going to — this was a paper that was peer-reviewed
23 that you published. What’s the name of it? Share with
24 us, generally, what work you did to do that, and how
25 does that help you with your opinions in this case.
4479
1 It’s that simple.
2 MR. PANISH: He can ask him about if he wrote
3 it. I’m not complaining about that. But he can’t put
4 up specific statements out of articles that are hearsay
5 written by the individual. This is what I’ve been
6 complaining about. He can’t go up there and read to the
7 jury these articles, the substance of an article.
8 That’s hearsay under the evidence code. That’s
9 inappropriate. He can say, “I relied on this article.
10 This is what I did.” I’m not complaining about that.
11 THE COURT: The article itself is not
12 admissible. It is something that can be relied on by
13 the expert. The line is between establishing the
14 article and what’s in the article and the value of the
15 article and why the expert relied on it versus
16 publishing the article.
17 To begin with, does someone have a copy for me?
18 MR. PANISH: I don’t. That’s evidence code
19 Section 721. It’s pretty specific on that.
20 THE COURT: I understand.
21 Let’s put it this way. It needs to be marked.
22 Do we have a number yet?
23 MR. CALFO: What is the next in order?
24 THE COURT: 2971. This is the Paustenbach
25 slide show.
4480
1 (Exhibit No. 2971 was marked for
2 identification.)
3 THE COURT: I’ll allow it to be used. It can
4 be shown to the jury. If we get into too much detail,
5 I’ll say no.
6 MR. CALFO: I understand.
7 MR. PANISH: Now the second point.
8 MR. BAGHDADI: The last slide, Your Honor, I
9 just wanted to speak briefly on it.
10 THE COURT: The blood slide?
11 MR. BAGHDADI: Correct. This is a plot of the
12 hematocrit levels. Hematocrit is the percentage of red
13 blood cells in your body. The witness is going to say,
14 “I looked at his hematocrit levels, and on the basis of
15 those levels, I don’t believe this person, Mr. Kransky,
16 suffered an ill effect to his blood count or blood
17 volume on the basis of cobalt and chromium.” That’s how
18 they plotted these cells to show that. To show that
19 there’s been no damage, that there’s been no
20 polycythemia because if you look at how the blood count
21 evolves over time. That’s an argument they can make,
22 but the person to make that argument is a medical
23 doctor. This witness cannot diagnose illness. This
24 witness cannot treat, prescribe, or otherwise deal with
25 a patient such as this, and this is a concern we raised
4481
1 before.
2 THE COURT: But that’s a foundation question.
3 If Mr. Calfo is unable to lay a foundation, then I would
4 agree with you. I don’t know yet. So subject to an
5 objection if they’re unable to lay a foundation.
6 MR. ZELLERS: Your Honor, at some point,
7 Ms. Olah is going to be taking my place at the counsel
8 table. Would you prefer she does it now?
9 THE COURT: You just need to let the jury know.
10 Just identify her.
11 MR. ZELLERS: Thank you.
12 (Jurors enter the courtroom.)
13 THE COURT: In the case of Kransky vs. DePuy,
14 the record will reflect all counsel are present. All
15 jurors and alternate are present.
16 Good morning, ladies and gentlemen. Sorry for
17 the delay. As you may notice, the beginning of the day
18 and the end of the day we do housekeeping things; so we
19 don’t take up your time. More of that happens as you
20 get towards the end of the trial because we’re trying to
21 get it in a final format before closing arguments.
22 We are ready to proceed.
23 Mr. Calfo, you may call your next witness.
24 MR. CALFO: We call Dr. Cyrus Rangan, and if I
25 may go out and grab him.
4482
1 THE COURT: Yes.
2 MR. CALFO: Your Honor, may we have a brief
3 second?
4 (Sidebar proceedings.)
5 THE COURT: Sorry for the delay, ladies and
6 gentlemen.
7 You may call your next witness.
8 MR. CALFO: Thank you, Your Honor. We call to
9 the witness stand Dr. Cyrus Rangan.
10 THE CLERK: Do you solemnly state that the
11 testimony you’re about to give in the cause now pending
12 before this Court shall be the truth, the whole truth,
13 and nothing but the truth so help you God?
14 THE WITNESS: Yes, I do.
15 THE CLERK: You may be seated. Please state
16 and spell your first and last name.
17 THE WITNESS: Cyrus, C-y-r-u-s, Rangan,
18 R-a-n-g-a-n.
19 THE COURT: You may inquire.
20 MR. CALFO: Thank you, Your Honor.
21 CYRUS RANGAN, M.D.,
22 having been duly sworn, was examined and testified as
23 follows:
24 – – –
25 ///
4483
1 DIRECT EXAMINATION
2 BY MR. CALFO:
3 Q. Doctor, thank you for coming today. Let’s
4 start by telling the jury a little bit about yourself.
5 A. Okay.
6 Q. Are you a medical doctor?
7 A. Yes.
8 Q. Share with us where you received your medical
9 degree and your college degrees.
10 A. College degree is from Tufts University in
11 Boston, and medical degree is from the Medical College
12 of Pennsylvania in Philadelphia.
13 Q. Do you have any board certifications, Doctor?
14 A. Yes.
15 Q. Do you currently treat patients?
16 A. Yes.
17 Q. And can you tell us generally about your work
18 treating patients?
19 A. I am a pediatrician and a medical toxicologist.
20 So in that capacity, I see patients who have been
21 affected by toxic agents, whether it’s a drug or some
22 kind of environmental exposure, snake bites, mushrooms,
23 et cetera, and I render diagnosis and treatment.
24 Q. Aside from treating patients, Doctor, what
25 other professional positions do you hold?
4484
1 A. I am the director of — it’s called the Bureau
2 of Toxicology and Environmental Assessment, which is
3 part of the Los Angeles County Department of Public
4 Health just down the road. There, I direct a bureau
5 that is involved with responding to public inquiries
6 about toxic exposures, whether it be a neighborhood or a
7 school or some other entity or other agencies that are
8 concerned about toxic exposures in the environment, and
9 we perform investigations, sometimes jointly, with the
10 fire department, hazardous materials, et cetera, and we
11 work together to solve environmental toxicology
12 problems.
13 Q. You’re the assistant medical director and
14 director of the Los Angeles medical toxicology education
15 program?
16 A. In that capacity — that’s my work with the
17 California Poison Control System. In that capacity, I’m
18 the assistant medical director and what I direct is, as
19 you mentioned, the Los Angeles and also Orange County
20 Medical Toxicology Education Program where I instruct
21 doctors, nurses, EMTs, first responders, about the
22 evaluation assessment and treatment of toxicology
23 agents.
24 Q. Those are your duties with respect to your
25 position with the California Poison Control System?
4485
1 A. Yes. In addition to that, I also do media
2 issues with them; so if there are toxicology stories in
3 the news, for example, newspapers or television, I
4 participate in those as well.
5 Q. Okay. Now, the jury has heard the term
6 California Poison Control from a plaintiff expert,
7 Dr. Harrison. Can you tell us what is the California
8 Poison Control System?
9 A. Sure. Our system is a statewide system that is
10 responsible for providing advice and guidance about the
11 treatment of patients who have been exposed to something
12 toxic. So if a parent calls from home or if a doctor or
13 nurse calls from the medical care setting and says, “We
14 have a person here or a patient here who may have been
15 exposed to a toxic agent, here are the symptoms or here
16 is the poison they were exposed to,” we work with them
17 on the phone in a consultative fashion to help them take
18 care of that patient. We take approximately 300,000
19 calls every year in that capacity.
20 Q. Now, Doctor, does the California Poison Control
21 System have a set amount or level at which it considers
22 cobalt to be toxic?
23 A. No.
24 Q. Let me show you evidence that’s been presented
25 in this case through plaintiff’s expert, Dr. Harrison.
4486
1 MR. CALFO: I’d like to put it on the screen,
2 Your Honor. Page 1195 of the trial testimony.
3 THE COURT: All right.
4 BY MR. CALFO:
5 Q. QUESTION: Does the California?
6 Poison Control Center consider cobalt to
7 be toxic?
8 ANSWER: It does.
9 QUESTION: Do they have a set
10 standard or amount or level in which
11 the California Poison Control Center
12 considers cobalt levels to be toxic?
13 ANSWER: The poison center does
14 have a recommendation on what they
15 consider toxic.
16 QUESTION: And what is that?
17 ANSWER: Seven.
18 QUESTION: Seven what?
19 ANSWER: I’m sorry. Seven
20 micrograms per liter. That same that
21 we talked about earlier.
22 You see that testimony, Dr. Rangan?
23 A. Yes.
24 Q. Is Dr. Harrison’s testimony that we just read
25 that the California Poison Control has a set level at
4487
1 which it considers cobalt to be toxic, is that accurate?
2 A. No.
3 Q. And why is that inaccurate, Doctor?
4 A. At poison control, we don’t have any
5 established criteria or standard or recommendation for
6 cobalt.
7 Q. Now, let me present to you one more piece of
8 evidence that’s been in this case from Dr. Harrison.
9 MR. CALFO: I’m going to refer, Your Honor, to
10 page 1328, line 18 through 1329, line 7 of the trial
11 transcript.
12 QUESTION: Oh, by the way, all
13 these opinions that you formed about
14 was the level and what was — what
15 articles you read, you knew that the
16 State of California had set as a level
17 of cobalt to be concerned about;
18 right?
19 ANSWER: Poison Control Center.
20 That’s correct.
21 QUESTION: Everybody, anybody that
22 wanted to look would know that; right?
23 ANSWER: Yeah, that’s right.
24 QUESTION: If DePuy wanted to
25 look, they would have known; right?
4488
1 ANSWER: Correct.
2 Now, Doctor, does the California Poison
3 Control System have any policies, guidelines, or
4 recommendations, written or otherwise, that says
5 7 parts per billion of cobalt is toxic?
6 A. No.
7 Q. Has the California Poison Control System ever
8 published anything that sets forth a specific level of
9 cobalt that it considers to be toxic?
10 A. No.
11 Q. Now, as assistant medical director of the
12 California Poison Control System, would you know if such
13 a document existed?
14 A. Sure, yes.
15 Q. If there is any such document that says the
16 California Poison Control considers cobalt to be toxic
17 at 7 parts per billion, you would know that?
18 A. Yes, I would.
19 Q. So there’s no document from the California
20 Poison Control System that DePuy or anyone else could
21 have looked up that says cobalt is toxic at 7 parts per
22 billion; true?
23 A. That’s correct.
24 Q. Finally, Dr. Rangan, are you being paid by
25 DePuy or counsel for DePuy for your testimony here
4489
1 today?
2 A. No. I’m simply here as a representative of
3 California Poison Control.
4 Q. You’re here in your capacity as assistant
5 medical director of the California Poison Control
6 System?
7 A. Yes.
8 Q. The California Poison Control System, have they
9 given you permission to come here and talk to our 13
10 jurors here and testify today on behalf of the system?
11 A. Yes.
12 Q. Just to be clear, contrary to what Dr. Harrison
13 told this jury, the California Poison Control System
14 does not have a set level at which it considers cobalt
15 to be toxic; is that correct?
16 A. That’s correct.
17 MR. CALFO: Thank you, Doctor.
18 THE COURT: Cross-examination?
19 MR. KELLY: Yes, thank you.
20 CROSS-EXAMINATION
21 BY MR. KELLY:
22 Q. Good morning, Dr. Rangan. My name is Mike
23 Kelly. I had called you. Did you get my message?
24 A. I did.
25 Q. We have not met before; right?
4490
1 A. Correct.
2 Q. Have you met with Ms. Curry, who called you
3 about a week ago and met with you on Monday?
4 A. Yes.
5 Q. Did you meet with her again since Monday?
6 A. No.
7 Q. Did you have a chance to meet Mr. Calfo and
8 talk to him?
9 A. On Monday, yes.
10 Q. That was the day we had the holiday here;
11 right?
12 A. Right.
13 Q. So I wondered if I could ask you a few
14 questions about the poison control system.
15 First of all, there are four poison control
16 offices in the state; correct?
17 A. Yes.
18 Q. And actually, the central administrative office
19 is in San Francisco, isn’t it?
20 A. Yes.
21 Q. That’s where the headquarters are. That’s
22 actually where Dr. Harrison is?
23 A. He is in San Francisco. He’s not at poison
24 control headquarters.
25 Q. I understand that, but the administrative
4491
1 center for poison control is in San Francisco?
2 A. Yes.
3 Q. It’s at the UCSF facility; isn’t it?
4 A. That’s right.
5 Q. And there are three other poison control
6 centers; right?
7 A. Right.
8 Q. One is not in Los Angeles; is it?
9 A. Correct.
10 Q. And you’re not working at a Poison Control
11 Center?
12 A. I work for the poison control system.
13 Q. The system?
14 A. Yes.
15 Q. So we want to make clear you were talking about
16 community education; correct?
17 A. The system is the four centers and all their
18 other activities.
19 Q. But your job is not getting on the phone and
20 responding to poison control inquires for the PCC
21 currently; is it?
22 A. I do on occasion, yes.
23 Q. The administrative center — that’s actually
24 directed by Dr. Kenneth Olson in San Francisco; isn’t
25 it?
4492
1 A. He’s the medical director of the San Francisco
2 division.
3 Q. He knows what he’s doing?
4 A. Sure.
5 Q. Smart guy?
6 A. Yes.
7 Q. They have a good program there?
8 A. Very good.
9 Q. Would it be within his area of responsibility
10 to determine who would respond to calls when they came
11 to the San Francisco center?
12 A. No. The calls just go right to an operator.
13 He’s not making a determination on any other basis.
14 Q. So there’s an 800 number, and this is what I
15 wanted to chat about. Depending on where you call, it
16 can ring in San Francisco; is that right?
17 A. It could.
18 Q. It could ring at UC Davis; is that right?
19 A. Yeah.
20 Q. It could ring at Valley Children’s in Madera
21 because that’s a UCSF facility; correct?
22 A. Correct.
23 Q. And it could ring at UCSD in San Diego; right?
24 A. That’s right.
25 Q. It’s not ringing directly in L.A. where you
4493
1 are; true?
2 A. No. Correct. Yes.
3 Q. There are people who are answering the phone,
4 some of them are nurses; correct?
5 A. Yes.
6 Q. Okay. And some of them are clerks who are
7 trained or third year residents; correct?
8 A. Yes, under the supervision of those nurses,
9 yes.
10 Q. And as you were saying, you get a lot of calls
11 about snake bites; is that right?
12 A. That’s one thing we get called about, yes.
13 Q. Poisoned mushrooms?
14 A. That’s another thing we get called about.
15 Q. Overwhelmingly, though, most of the calls are
16 from really concerned moms whose child may have eaten
17 something; right?
18 A. About half the calls, yes.
19 Q. That’s why — actually you’re a pediatrician?
20 A. I am.
21 Q. So there’s kind of a natural connection between
22 pediatric work and pediatric toxicology; right?
23 A. Sure, there is.
24 Q. If we look in the various literature, we see
25 that much of the work you do is responding to moms and
4494
1 dads who are concerned about a child having eaten
2 something out of the medicine cabinet; correct?
3 A. That’s some of it, yes.
4 Q. Or nail polish remover?
5 A. That may be one, yes.
6 Q. Or something that’s really scary to the
7 parents?
8 A. Sure.
9 Q. And so they’re kind of routine calls that come
10 in that you hear often; right?
11 A. Yes.
12 Q. And if there’s a call that’s novel about
13 something like, “I’m afraid of my cobalt level,” there’s
14 actually a system in place for the call screener to get
15 the call to somebody who knows what they’re saying;
16 correct?
17 A. I’m not aware of a systematic process such as
18 that.
19 Q. In San Francisco, don’t you know that when a
20 call comes through and the screener doesn’t know what to
21 do, it gets triaged to a doctor?
22 A. No. There’s no system in place for that
23 process. It does happen, but there’s not a system in
24 place for that.
25 Q. Actually, I was given some materials from
4495
1 counsel that indicated apparently you had an e-mail that
2 I saw that said Dr. Harrison had been getting calls as
3 long as a year ago or more when he was asked questions
4 through the PCC about cobalt levels; right?
5 A. He may have, yes.
6 Q. Not that he may have. This is what I was given
7 that apparently you gave to defense counsel that said he
8 and someone named Timur Durrani. I don’t know that
9 person. Do you know that person?
10 A. Yes.
11 Q. How do you know Timur Durrani?
12 A. Timur. It’s pronounced Timur. He is a
13 toxicology fellow in training in San Francisco.
14 Q. Is he, to your experience, an honest and
15 straightforward guy?
16 A. I know him casually; so I suppose he is.
17 Q. Okay. He’s smart?
18 A. I suppose he is. I don’t really have the
19 ability to make that assessment.
20 Q. Was it your sense in however you got this
21 e-mail that Dr. Harrison was smart and straightforward?
22 A. He was straightforward. I don’t know if he’s
23 smart or not.
24 Q. Okay. You know that he has an appointment on
25 some National Institute of Occupational Health Boards,
4496
1 NIOSH boards, in Washington, D.C.?
2 A. I’m not aware of that.
3 Q. Did you know that he has the position of chief
4 of one of the divisions of the California Department of
5 Environmental and Occupational Safety?
6 A. He may.
7 Q. Okay. In the e-mail, didn’t you — again, I
8 got this from defense counsel. Didn’t you learn that
9 Dr. Harrison said he had been getting calls over a year
10 ago and working with Timur Durrani to get a guideline
11 for the PCC?
12 A. No, that’s not what was going on. They weren’t
13 developing a guideline for the PCC. They were working
14 together to investigate the literature, but it was not
15 in conjunction with any kind of process we had going on
16 at the PCC, at the Poison Control Center.
17 Q. He’s in a PCC office; isn’t he?
18 A. Dr. Harrison is not part of the California
19 Poison Control Center.
20 Q. But Dr. Harrison fields calls for the
21 San Francisco Poison Control Center, doesn’t he?
22 A. No.
23 Q. Are you certain about that?
24 A. He is not an employee that takes calls from
25 California Poison Control. When you call that 1-800
4497
1 number, it does not go to Dr. Harrison.
2 Q. I didn’t say it did, but don’t you understand
3 that in San Francisco when the call screener doesn’t
4 know anything, they find a doctor to respond to the
5 question?
6 A. There’s no procedure for that. Occasionally,
7 we will use colleagues when we know that someone may
8 have some expertise, and we will refer someone outside,
9 but that’s not a procedure within the California Poison
10 Control System.
11 Q. Have you worked in the San Francisco office of
12 the PCC?
13 A. No.
14 Q. Do you know how they work on a daily basis?
15 A. I know how the system works on a daily basis.
16 Q. I’m asking about San Francisco. Do you know
17 how they work in San Francisco?
18 A. The system has systemwide policies. It’s a
19 statewide organization. There’s no policy on that.
20 People may do what you mentioned, but it’s not a policy
21 within our system.
22 Q. Didn’t you learn from the e-mail that
23 Dr. Harrison and Dr. Durrani were attempting to answer
24 questions from people calling the Poison Control Center?
25 A. After they had called the Poison Control
4498
1 Center, that may have been the case, but if you call the
2 Poison Control Center —
3 Q. Hold on.
4 THE COURT: Hold on.
5 BY MR. KELLY:
6 Q. And it would be part of the Poison Control
7 Center’s job to try and find someone smart to answer
8 questions that the call screener didn’t know the answer
9 to; isn’t that right?
10 A. No, it doesn’t work that way.
11 Q. Oh.
12 A. It’s not their responsibility to try to find
13 out —
14 THE COURT: Hold on. You’ve answered the
15 question.
16 The answer “no” will stand.
17 BY MR. KELLY:
18 Q. Have you called Dr. Olson and say, “You should
19 stop Dr. Harrison from talking to people who call?
20 A. Of course, not.
21 MR. CALFO: Objection. No foundation.
22 THE COURT: The answer “no” will stand.
23 BY MR. KELLY:
24 Q. You have not called Dr. Olson and told him to
25 stop Dr. Harrison from talking to people?
4499
1 A. Of course, not.
2 Q. Is that because it might actually be helpful to
3 have the input of someone like Dr. Harrison talking to
4 people with questions?
5 A. Sure, it could be helpful.
6 Q. Okay. So you don’t object to Dr. Harrison
7 answering people’s questions at the referral of
8 Dr. Olson or the San Francisco PCC?
9 A. If you’re talking about referral, if that’s the
10 case, yes, but you weren’t talking about referrals
11 before.
12 Q. In fact, at least based on what I saw here,
13 what you learned was that Dr. Harrison and Dr. Durrani
14 worked in developing guidelines that could assist
15 patients who called the PCC with questions about their
16 cobalt and chromium levels; true?
17 A. That’s what it says in the e-mail.
18 Q. Do you think this is a lie?
19 A. I think it is misleading to say that they were
20 developing guidelines for the California Poison Control
21 System. That was not the case.
22 Q. Hold on.
23 Well, that’s what he believes he was doing in
24 San Francisco; right?
25 A. That may be what he believed. We don’t have
4500
1 guidelines.
2 Q. He indicated in this e-mail that he had also
3 seen patients and they were trying to find a level and
4 the level they came up with was 7 parts per billion;
5 correct?
6 A. That’s what he states.
7 Q. And he was telling you the truth when he told
8 you that, wasn’t he?
9 MR. CALFO: Objection. No foundation, calls
10 for speculation.
11 THE COURT: Sustained.
12 MR. KELLY: Your Honor, he’s testified —
13 THE COURT: Sustained.
14 MR. KELLY: I’m sorry —
15 THE COURT: Sustained. Speculation.
16 BY MR. KELLY:
17 Q. You have this e-mail. He told you they had
18 selected 7 parts per billion; correct?
19 MR. CALFO: Objection. Vague and ambiguous.
20 THE COURT: Overruled.
21 Is that your understanding?
22 THE WITNESS: For what purpose? I don’t
23 understand what you mean “selected 7.” For what
24 purpose?
25 BY MR. KELLY:
4501
1 Q. Did you read the e-mail?
2 A. Of course, I did.
3 Q. Did you give to Ms. Curry?
4 A. Of course, I did.
5 Q. Presumably, you gave it to her because you
6 believed what was in it was accurate; right?
7 A. No, I gave it to her because I had it.
8 Q. Okay. It said that they selected 7 parts per
9 billion, and he cited some literature to you, didn’t he?
10 A. When you say “he selected 7 parts per billion,”
11 what do you mean by that?
12 Q. I actually mean what he told you in the e-mail.
13 He told you —
14 A. As far as I can tell from that e-mail —
15 THE COURT: Hold on. No question pending.
16 Put a question.
17 BY MR. KELLY:
18 Q. Excuse me.
19 He told you, based upon the references he
20 looked at, those references suggested the 7 parts per
21 billion as a level that indicated the potential for soft
22 tissue reaction. He told you that; correct?
23 A. That’s what he says in this his e-mail, sure.
24 Q. Okay. You had never met him before?
25 A. No.
4502
1 Q. Okay. Now, he sent you, or you got apparently
2 with this, medical articles that he and Dr. Durrani had
3 located; right?
4 A. Yes.
5 Q. Okay. And did the medical articles — did you
6 read them?
7 A. I looked through them.
8 Q. Do they stand for the proposition for which he
9 cited them?
10 MR. CALFO: Objection, Your Honor. Calls for
11 expert opinion from this lay witness.
12 MR. KELLY: He just established he’s an expert.
13 Excuse me.
14 THE COURT: Lay a better foundation.
15 BY MR. KELLY:
16 Q. Are you an expert in toxicology?
17 A. Yes.
18 Q. Do you understand the peer-reviewed literature?
19 A. I do.
20 Q. Do you believe you are incompetent to answer a
21 question about whether the literature stands for the
22 proposition that Dr. Harrison cited?
23 MR. CALFO: Objection. Beyond the scope.
24 THE COURT: Reframe the question. It’s
25 argumentative.
4503
1 BY MR. KELLY:
2 Q. You were cc’d. This was a communication to
3 Dr. Olson, wasn’t it?
4 A. Yes.
5 Q. And in there, were four medical articles that
6 dealt with he and Dr. Durrani’s analysis of the 7-parts
7 per billion level. Isn’t that true?
8 THE COURT: Hold on. “He.” Olson or Harrison?
9 MR. KELLY: Harrison and Dr. Durrani’s
10 selection of that level. Is that true?
11 THE WITNESS: Can you rephrase that question?
12 BY MR. KELLY:
13 Q. Yes.
14 In connection with the transmission of this
15 e-mail, there were medical articles Dr. Harrison sent
16 along, which he refers to in his e-mail that he says he
17 utilized in selecting a 7-part per billion level. Is
18 that true?
19 A. Yes, but I still don’t know what you mean by
20 “selecting.”
21 Q. Well, he talks here in a number of places about
22 7 parts per billion as a level at which he believed
23 there was evidence local soft tissue reaction could
24 occur; right?
25 A. Okay. He says that, sure.
4504
1 Q. That’s what I’m talking about.
2 A. Okay.
3 Q. Did you recognize that in this exhibit he was
4 talking about — and I don’t know what exhibit number
5 this is. The first one that was marked?
6 MR. CALFO: Counsel, I referred to the page.
7 THE COURT: You’re talking about the
8 transcript?
9 MR. KELLY: I am. 1195, lines 14 through 18.
10 Do you see that? There was a question of 7.
11 THE WITNESS: Yes, I see it.
12 BY MR. KELLY:
13 Q. That was the testimony here in court.
14 Did you understand that?
15 A. I understand.
16 Q. And when he was writing to you, he was talking
17 about 7 parts per billion; correct?
18 A. Yes.
19 Q. Okay. So then he actually said here are an
20 interesting selection of articles from everyone from the
21 MHRA to some other people; correct?
22 A. Correct.
23 Q. Did you open them and read them?
24 A. I took a look at them. I didn’t really look in
25 detail.
4505
1 Q. When you didn’t look at them in detail, did you
2 notice not looking at them in detail that they stood for
3 the proposition he said relative 7 parts per billion in
4 local tissue reaction?
5 MR. CALFO: Objection. Beyond the scope and
6 beyond this impeachment witness.
7 THE COURT: Overruled.
8 THE WITNESS: The number 7 was mentioned
9 several times in those articles, but there was really
10 no —
11 THE COURT: Hold on. You’ve answered the
12 question.
13 BY MR. KELLY:
14 Q. At any time in your meeting with Mr. Calfo or
15 Ms. Curry, did they show you the DePuy recommendation
16 that physicians should be concerned with a 7-part per
17 billion level?
18 A. No.
19 Q. At any time in your meeting with Mr. Calfo or
20 Ms. Curry, did they show you literature indicating that
21 one of their design surgeons, Dr. Schmalzried
22 recommends —
23 MR. CALFO: Your Honor, objection. We’re way
24 beyond.
25 THE COURT: I’ve got to hear the question.
4506
1 BY MR. KELLY:
2 Q. — a safe level of 2 parts per billion?
3 THE COURT: Sustained.
4 Anything in redirect?
5 MR. CALFO: I’d like to thank and request he be
6 excused.
7 THE COURT: Any objection?
8 MR. KELLY: No, Your Honor.
9 THE COURT: Thank you, Doctor. You may be
10 excused.
11 Call your next witness.
12 MR. CALFO: Your Honor, the defense calls next
13 Dr. Dennis Paustenbach.
14 THE CLERK: Raise your right hand.
15 Do you solemnly state that the testimony you’re
16 about to give in the cause now pending before this Court
17 shall be the truth, the whole truth, and nothing but the
18 truth so help you God?
19 THE WITNESS: Yes.
20 THE CLERK: Thank you. You may be seated.
21 Please state and spell your first and last name.
22 THE WITNESS: Dennis James Paustenbach,
23 P-a-u-s-t-e-n-b-a-c-h.
24 THE CLERK: Thank you.
25 THE COURT: Mr. Zellers, you’re stepping back?
4507
1 MR. CALFO: Your Honor, I’d like to introduce
2 to the jury Ms. Kelley Spencer, a lawyer in my office.
3 THE COURT: All right. Mr. Calfo, you may
4 examine.
5 MR. CALFO: Thank you, Your Honor.
6 DENNIS PAUSTENBACH, Ph.D.,
7 having been duly sworn, was examined and testified as
8 follows:
9 – – –
10 DIRECT EXAMINATION
11 BY MR. CALFO:
12 Q. Good morning, Doctor.
13 A. Good morning, Mr. Calfo. How are you?
14 Q. Good.
15 Are you here to tell the jury the truth about
16 cobalt and chromium?
17 MR. PANISH: Objection. Argumentative.
18 THE COURT: Sustained.
19 BY MR. CALFO:
20 Q. Are you hear to tell the jury about cobalt and
21 chromium?
22 A. Yes.
23 Q. What I’d like to do is just take a few minutes,
24 be patient with me, I’d like to go through your
25 qualifications; so the jury knows a little bit about
4508
1 you. Okay?
2 A. Sure.
3 Q. Doctor, what is toxicology?
4 A. It’s the study of the beneficial, as well as
5 adverse effects, of chemicals on living things. That
6 could include humans or wildlife.
7 Q. How many board — are you board certified?
8 A. I am.
9 Q. How many board certifications do you have in
10 toxicology?
11 A. I have two.
12 Q. And share with the jury, if you could, what
13 does it mean to be board certified?
14 A. It means that you have passed certain criteria
15 by your peers, which could be degrees, accomplishments,
16 written examinations. But they’ve set a standard that
17 you have to achieve to be considered credible.
18 THE COURT: I’m sorry. To be considered?
19 THE WITNESS: Credible.
20 BY MR. CALFO:
21 Q. Now, you told us that you were board certified
22 twice; is that right?
23 A. That’s right.
24 Q. Share with us, how do you get certified by the
25 American Board of Toxicology?
4509
1 A. You get certified by the American Board of
2 Toxicology, in my case, by getting a Ph.D. in
3 toxicology, getting two sponsors who will vouch for your
4 ethical conduct. I had to take a written exam and also
5 make some contributions to the field.
6 MR. PANISH: Excuse me, Your Honor. If we’re
7 going to have exhibits popping up, maybe we should
8 identify them for the record.
9 THE COURT: You read my mind.
10 We have this 2971. The first three pages. We
11 need to paginate this exhibit.
12 MR. CALFO: Yes, Your Honor. The second one,
13 and I apologize, is 2971-2.
14 THE COURT: We’re on page 3 now.
15 MR. CALFO: Yes, Your Honor.
16 BY MR. CALFO:
17 Q. So Dr. Paustenbach, share with us, if you
18 could, what is 2971-3?
19 A. Is that the one on the screen?
20 Q. Yes.
21 A. Okay. That’s the certificate that’s awarded
22 for having successfully accomplished the certification
23 in the American Board of Toxicology.
24 Q. And are you a diplomat of the American Board of
25 Toxicology?
4510
1 A. I am.
2 Q. I’d like to show you what is now marked as
3 2971-4.
4 Doctor, what is 2971-4?
5 A. That’s a certificate for the other accrediting
6 body. It’s called the Academy of Toxicological
7 Sciences.
8 Q. Does this relate to the second board
9 certification you have in toxicology?
10 A. It does.
11 Q. Are you a fellow of the Academy of
12 Toxicological Sciences?
13 A. I am.
14 Q. In the whole country, what is your knowledge as
15 to how many toxicologists are in the Academy of
16 Toxicological Sciences?
17 A. About 300.
18 Q. How many toxicologists are you aware of,
19 Doctor, who are board certified in not just one but both
20 toxicological organizations?
21 A. About 50.
22 Q. Are you aware that plaintiffs brought into this
23 courtroom Dr. Harrison to talk about cobalt and chromium
24 as poisons?
25 MR. PANISH: Objection. Leading and
4511
1 suggestive.
2 THE COURT: I’ll allow that question. It’s
3 redirecting to a different area.
4 THE WITNESS: Yes.
5 MR. PANISH: Your Honor, there’s another
6 exhibit that’s flashed up here.
7 MR. CALFO: Let me identify for the record
8 Exhibit 2971-5.
9 BY MR. CALFO:
10 Q. It’s a picture of Dr. Harrison?
11 A. Yes, sir.
12 Q. Are you aware that Dr. Harrison was brought in
13 here to talk about cobalt and chromium?
14 A. Yes, sir.
15 Q. And as a result of his testimony in this case,
16 Doctor, did you seek to determine whether Dr. Harrison
17 is certified by the American Board of Toxicology?
18 A. I did.
19 Q. Did you review his resume or curriculum vitae?
20 A. Yes, sir.
21 Q. Is Dr. Harrison certified by the American Board
22 of Toxicology?
23 A. No, sir.
24 Q. Is Dr. Harrison certified by the Academy of
25 Toxicological Sciences?
4512
1 A. No, sir.
2 Q. What I’d like to show you now is Exhibit 2971
3 and ask you to identify that.
4 THE COURT: Page 6?
5 MR. CALFO: Page 6.
6 THE WITNESS: It’s a certificate given when you
7 receive full membership to the Society of Toxicology.
8 BY MR. CALFO:
9 Q. Are you a member of that society too, Doctor?
10 A. Yes.
11 Q. Share with us, what does it take to be a member
12 of the Society of Toxicology?
13 A. You have to have a prescribed number of years
14 of experience. There are different levels of membership
15 I should mention, but you need sponsorship, work in the
16 field, some experience; in your early years, a sponsor,
17 and then you should pay your dues.
18 Q. Based on your experience and your review of
19 Dr. Harrison’s curriculum vitae, is Dr. Harrison a
20 member of the professional society of toxicologists?
21 A. No.
22 Q. Did you read the testimony of Dr. Harrison?
23 A. I did.
24 Q. Did you note in Dr. Harrison’s testimony
25 presented to this jury that he acknowledged he was not
4513
1 board certified in toxicology?
2 MR. PANISH: Your Honor, excuse me. Objection.
3 Leading and suggestive of the answers.
4 THE COURT: Sustained.
5 MR. PANISH: It’s also irrelevant to the
6 testimony.
7 THE COURT: You can ask the question whether
8 he’s certified or not. I think you’ve already done
9 that.
10 BY MR. CALFO:
11 Q. Why is it important, Dr. Paustenbach, before
12 you testify in court before a judge and jury that you be
13 board certified in toxicology?
14 A. Those of us that are certified in the
15 profession believe everyone that shares information with
16 the public, teaches generally, and gives testimony in
17 the courtroom should meet certain standards of
18 education, qualification, experience and contributions
19 before they share that information.
20 We want to protect the integrity of the
21 profession much like the medical profession, the law
22 profession, and engineers wish to protect the integrity
23 of their professions.
24 MR. PANISH: I’m going to move to strike the
25 last portion about lawyers and engineers as no
4514
1 foundation on this witness.
2 THE COURT: I’ll allow that to stay.
3 BY MR. CALFO:
4 Q. Doctor, in your review of Dr. Harrison’s
5 résumé, did you note whether or not he had written even
6 one published paper on cobalt or chromium? Did you note
7 that?
8 A. I noticed that he had not.
9 Q. Now, what I’d like to do is refer to
10 Exhibit 2971-7.
11 Doctor, I have a document in my hand. What is
12 this document?
13 A. That’s my curriculum vitae or what most jurors
14 probably call a résumé.
15 Q. How many pages is your résumé, Doctor?
16 A. I think it’s about 160 pages.
17 Q. It’s late in the trial. We’ve been here a
18 while. I’m not going to go through your résumé. But
19 will you share with us, how about five professional
20 accomplishments that you have had and you can share with
21 the jury, and please don’t be humble.
22 A. Probably the two I’m most proud of is I
23 received two honorary Ph.D.s, one from Purdue and one
24 from the Rose Hulman Institute. These are awarded to
25 people with lifetime contributions, which doesn’t speak
4515
1 well to my age, by the way, but lifetime contributions
2 to the field, and these are usually awarded at
3 graduation annually at the various colleges.
4 MR. CALFO: Your Honor, I’d like to identify
5 the curriculum vitae as Exhibit 2972 next in order. And
6 it’s 158 pages; so it’s Exhibit 2972-1 through -158.
7 THE COURT: I’ll mark it as 2972.
8 (Exhibit No. 2972 was marked for
9 identification.)
10 BY MR. CALFO:
11 Q. Now, Doctor, can you share with us something
12 else you’re proud of without going through your résumé,
13 about your professional accomplishments?
14 A. When I first entered the field it was in
15 industrial hygiene, which is the science of the
16 recognition, evaluation and control of occupational
17 health hazards. When I first started, occupational
18 disease was something of concern in this country.
19 So I was asked to start the undergraduate and
20 graduate programs at Purdue, which is a small midwestern
21 school a long way from here, and I did that. I taught
22 virtually all the courses at the beginning of that
23 program, and then over the last 30 years, it became, I
24 think, the largest, certainly undergraduate program in
25 the country, and has been a significant industrial
4516
1 hygiene program for 30 years. That’s actually why I got
2 my honorary Ph.D. at Purdue.
3 Q. How old were you, Doctor, when you set up that
4 industrial hygiene department at Purdue University?
5 A. I was 28 or 29.
6 Q. How about teaching at universities, are you
7 proud of that?
8 A. Very proud of that. I really enjoy teaching.
9 Q. Will you share with the jury the universities
10 that you’ve taught at?
11 A. I’ve taught at the University of Michigan, the
12 University of Massachusetts, the University of
13 California at Irvine in the medical school, and I’ve
14 given guest lectures at University of California, Davis,
15 University of North Carolina. I think that’s enough.
16 MR. CALFO: Your Honor, may I approach the
17 witness and provide this résumé for him?
18 THE COURT: Sure.
19 BY MR. CALFO:
20 Q. Doctor, I’m going to hand you Exhibit 2972-1
21 through 158. Is that your résumé or curriculum vitae?
22 A. Yes.
23 MR. PANISH: Your Honor, I would object to the
24 admissibility of a CV.
25 THE COURT: Another issue.
4517
1 MR. PANISH: Okay. Just so I have a way back.
2 THE COURT: We’ll have a long discussion about
3 exhibits without the jury.
4 MR. PANISH: Thank you.
5 BY MR. CALFO:
6 Q. Doctor, in that 158-page résumé, have you
7 written hundreds and hundreds of papers?
8 A. Oh, I don’t know if I’d go quite that far but
9 there’s 250 published peer-reviewed papers in here.
10 Q. How many book chapters have you written,
11 Doctor?
12 A. About 50.
13 Q. In addition to industrial hygiene and
14 toxicology where you’re board certified twice, did you
15 also take an interest in a field of what’s called risk
16 assessment?
17 A. I have.
18 Q. Will you share with the jury, what is the field
19 of risk assessment?
20 A. Can I use the blackboard?
21 Q. Sure.
22 MR. CALFO: Is that okay, Your Honor?
23 THE COURT: Depends what he’s going to do. Do
24 you wish to make another exhibit?
25 MR. CALFO: Sure. 2973, Your Honor, we’ll mark
4518
1 it as.
2 THE COURT: All right. Go ahead.
3 MR. CALFO: Do we have pens?
4 THE COURT: There should be a marking pen.
5 MR. CALFO: May I mark the exhibit, Your Honor?
6 THE COURT: Yes. It will be marked as 2973.
7 Make a 2973 in the bottom right corner and put a circle
8 around it.
9 (Exhibit No. 2973 was marked for
10 identification.)
11 THE WITNESS: This will only take a moment, but
12 risk assessment —
13 MR. PANISH: Excuse me. Is there a question
14 pending?
15 THE COURT: Put a question.
16 BY MR. CALFO:
17 Q. Doctor, I think I asked you why don’t you share
18 with us what the field of risk assessment is?
19 A. So risk assessment was codified around 1983 in
20 the United States by the National Academy of Science.
21 And really, all it did was combine the idea that
22 toxicology, which is the study of the effects of
23 chemicals, basically adverse effects at certain doses,
24 with exposure data. Because you can’t have one without
25 the other.
4519
1 So exposure’s dose and with the combination of
2 information of tox, which is the potency of the
3 chemicals that cause adverse effects. You have to
4 combine that, of course, with dose to come up with risk.
5 What this profession did was codify the fact you
6 can’t — when you talk about the risk to people or
7 populations, you have to consider both. There became
8 mathematical approaches for doing that, especially with
9 the advent of computers in the ’80s.
10 So that’s what the field is about. It’s
11 different than exposure science. It’s different than
12 toxicology. It’s different than industrial hygiene.
13 That’s what I specialized in for a long time.
14 Q. Did you write on the field of risk assessment?
15 A. I have written quite a lot about the field of
16 risk assessment.
17 Q. In fact, I’ll mark as Exhibit 2974, for
18 demonstrative, purposes a book.
19 THE COURT: You know, if it’s marked, we’ll
20 keep it.
21 MR. CALFO: Okay. I just thought I’d identify
22 it for the record, Your Honor.
23 THE COURT: Why don’t you just show it.
24 BY MR. CALFO:
25 Q. Doctor, do you see this book?
4520
1 A. Yes.
2 Q. Did you author it?
3 A. Yes.
4 Q. And is it entitled, Human and Ecological Risk
5 Assessment: Theory and Practice?
6 A. Yes.
7 Q. Then we’ve got other books here on risk
8 assessment; is that true?
9 A. True.
10 Q. And share with us what these generate.
11 A. The one on your right and my left is the first
12 edition in 2002, I think, and then the one on the right
13 is the 2002 edition. The black one is — commemorates
14 having sold, I think, 10,000 copies. It’s a best
15 seller, in other words. They put it in a different
16 book.
17 Q. Doctor, can you give the jury some samples of
18 universities around the country and elsewhere that you
19 know have used your book to teach toxicology and risk
20 assessment to their students?
21 A. Yes. It’s been out a while so a lot of schools
22 have had a chance to use it. Johns Hopkins, Harvard,
23 University of Michigan, Purdue, UC Riverside, UC
24 California at Davis. Now recently, King’s College in
25 England probably is the premiere buyer of the book.
4521
1 They have a big risk assessment program, and it’s used
2 in China quite a bit.
3 Q. Doctor, have you written papers on chromium?
4 A. Yes, I have, quite a few.
5 Q. Have you written papers on cobalt?
6 A. Yes, I have. Not as many as chromium. I have
7 30 in chromium, roughly.
8 MR. CALFO: Finally, I’d like to mark as
9 Exhibit 2974, the next in order, 2974-9.
10 THE COURT: Oh, page 9. I’m sorry.
11 MR. PANISH: Are we skipping 8?
12 MR. CALFO: Yes.
13 THE COURT: Yes. It’s up.
14 BY MR. CALFO:
15 Q. Doctor, have you been honored for your
16 contributions to the field?
17 A. Yes, I have.
18 Q. As we see on the screen, there are a lot of
19 awards up there. Can you roughly summarize a few of
20 them for us?
21 A. I’ll make this fast. I don’t think you’ll find
22 it all that interesting. There’s four different awards
23 here by four different professional societies. They all
24 deal with either toxicology, industrial hygiene, or risk
25 assessment. So these different professional societies
4522
1 annually meet and then they identify people who have
2 specialties and recognize them with a plaque or a glass
3 trophy. These all specialize in, like I say,
4 toxicology, risk assessment, or industrial hygiene.
5 Q. If we look up at this exhibit on the screen,
6 there’s AIHA. Do you see that?
7 A. Yes.
8 Q. How many awards are given out each year by the
9 organization AIHA?
10 A. Their particular award for contributions to the
11 field of hygiene, which is called the Ed Baier Award, is
12 given to one person annually.
13 Q. And how many members are there in the AIHA?
14 A. I think there are a little over 10,000 these
15 days.
16 Q. Doctor, have you received awards for your
17 research in relation to protecting worker health?
18 A. Yes.
19 MR. CALFO: Now, I’d like to mark next in order
20 2971-10.
21 THE COURT: The entire exhibit is marked
22 already. Just identify it as Exhibit 2971, page 10.
23 BY MR. CALFO:
24 Q. Yes. Your Honor, do you — I’m sorry.
25 Dr. Paustenbach, do you work at a company called
4523
1 ChemRisk?
2 A. I do.
3 Q. Share with the jury what is ChemRisk?
4 A. ChemRisk is a consulting firm that focuses on
5 understanding scientific issues regarding chemicals and
6 radionuclides in the environment. To do that, we have
7 to have specialists as shown here in the areas of
8 toxicology, epidemiology, health physics, industrial
9 hygiene, occupational med, occupational safety, risk
10 assessment, and public safety.
11 Q. What is your mission at ChemRisk?
12 A. We try to use the best scientific methods
13 possible and draw from the world’s literature and do our
14 own research to properly advise companies and the
15 governments, lawyers, and others about how to deal with
16 challenges involving chemicals.
17 Q. Doctor, can you share for us what percentage of
18 your time is devoted to government and companies?
19 A. It varies from 20 to 80 percent a month. It
20 depends on the contract that’s here. I try to get about
21 50 percent of my work for government or private
22 sector-related work or research-related work. The other
23 half would be litigation.
24 Q. And can you give the jury an example of some of
25 the work you’ve done recently for companies?
4524
1 A. You’d be surprised. I mean, I often say I
2 wouldn’t trade my job for anything because every day is
3 different. One example would be a major restaurant
4 chain asked us if it posed a health hazard to have a toy
5 put in their meal or beside their meal, from either a
6 health chewing hazard, that is, did the chemicals that
7 came out of the thing they chewed, would it pose a
8 hazard to the child or a choking hazard. So that would
9 be an interesting kind of assignment.
10 The other assignment we had recently that you’d
11 probably relate to is there’s something called Brazilian
12 Blowout, which was in the news for probably three or
13 four years. That was a hair treatment at salons where
14 people would want their hair straighter. They had this
15 treatment applied that was alleged to have formaldehyde
16 in it. Some companies said it did, some didn’t, but all
17 the hairdressers and all the people that had it applied
18 to them said their eyes burned, and it was an
19 intolerable treatment.
20 And there was a big controversy about whether
21 it was or wasn’t. We did the research to evaluate that,
22 published that work, and then ultimately the federal
23 government and state governments weighed in, and I don’t
24 think it’s used nearly as much as it used to be.
25 Q. Doctor, can you give the jury an example of the
4525
1 work you do or have done for the government?
2 A. Sure. We —
3 MR. CALFO: Your Honor, may I show
4 Exhibit 2971, page 11?
5 THE COURT: Yes.
6 BY MR. CALFO:
7 Q. Go ahead.
8 A. He were very lucky a little over 20 years ago
9 to win a contract to evaluate the nuclear arsenals. If
10 you’re not over 50 or 60, that may not mean anything,
11 but there were five or six places in the United States
12 that were identified to make the atomic bomb. These
13 were the so-called hidden cities, in large measure.
14 We were asked — the Congress, when Reagan
15 declassified millions upon millions of documents, the
16 senators for many of the states that had those arsenals,
17 which is basically a workplace, wanted to know if their
18 towns were affected by the work of that facility. So we
19 won the first contract at Rocky Flats to evaluate
20 whether the townspeople had been affected by that almost
21 secret town who worked making parts of the atomic bomb.
22 So for, I think, almost eight or nine years, we
23 went through millions of documents in order to see if
24 there was information there which we could glean to
25 decide if any of the townspeople had been affected by
4526
1 emissions, both radioactive and chemical. So it was a
2 very novel project. It was the largest risk assessment
3 in the country at the time.
4 We were lucky, after that we won two more. We
5 got to look at Los Alamos and Oak Ridge laboratories,
6 which were the other two probably prominent ones.
7 Q. Doctor, what do we see on the screen here?
8 A. This is Los Alamos in New Mexico. As you can
9 see, imagine trying to hide a town like this. Even when
10 it was much smaller, it was quite a feat, but it was a
11 secret town.
12 Q. Now, in addition to the governments, Doctor,
13 you told the jury that a lot of the work you do is for
14 companies and law firms as well; is that right?
15 A. True.
16 Q. Let me ask you, Doctor, do you tell whoever
17 hires you what the science shows, whether or not it’s
18 good or it’s bad?
19 A. Sure.
20 Q. And why do you do that, Doctor?
21 A. Well, in our business, all you have is your
22 integrity. So you have to preserve that, not only for
23 your mental health, I think, but for your professional
24 livelihood. So we put a high priority on that. One way
25 we’ve done that — because I know consultants have a bad
4527
1 name and have had a bad name for a long time — when I
2 set up the company 25 years ago, I said we were going to
3 be different and we were going to publish in the
4 peer-reviewed literature as much as we could so that our
5 colleagues could decide if our science was worthwhile.
6 That’s probably the thing I’m most proud of.
7 Q. And did you do that with the government when
8 they hired you to take a look at what happened in Los
9 Alamos, New Mexico, for example?
10 A. Yes.
11 Q. What did you tell the government that the
12 science showed at Los Alamos?
13 A. We told them a lot of things. I think there’s
14 a huge report on it, but one of the things that we had
15 to tell them, that was awkward, was that they had had
16 some accidents which overexposed the people in Los
17 Alamos, and they never told them. Now, whether they
18 knew, I don’t know, but the data did show that they had
19 overexposed quite a few people, and to radiation, in
20 particular.
21 Q. Doctor, did you publish those results that were
22 not favorable to the government that hired you in that
23 instance?
24 A. We did publish those results in the journal
25 that’s appropriate for that, which is Health Physics.
4528
1 Q. In addition to the government, do you also tell
2 companies the science you find, whether it’s good or
3 bad?
4 A. Sure.
5 Q. In fact, have you consulted for, let’s take an
6 example, the R.J. Reynolds Tobacco Company?
7 A. I have.
8 Q. What were you asked to do for them?
9 A. I was asked about 20 years ago to look at a
10 model that the EPA had applied to sidestream or to — I
11 don’t know what you call it. It’s called environmental
12 tobacco smoke, basically. The person is not smoking,
13 it’s the people near them. So environmental tobacco
14 smoke. The surgeon general estimated what he thought
15 was the cancer risk to those people, and I did a
16 peer-review on it and concluded that I thought the
17 numbers were too high.
18 I also was asked to look at the risks regarding
19 respiratory disease to children of living in homes of
20 people that smoked, and I concluded that there was an
21 increased risk for those children.
22 Q. After you told R.J. Reynolds what could happen
23 to children from secondhand smoke, what happened then,
24 Doctor?
25 A. We haven’t been retained by them since then.
4529
1 Q. The other half of your work is working on cases
2 like this one; is that right?
3 A. That’s true.
4 Q. And, Doctor, what is your hourly rate for
5 working on cases?
6 A. $575 an hour.
7 Q. Just in full disclosure, Doctor, you’ve served
8 as an expert witness in a case that I was involved with
9 before; is that right?
10 A. True.
11 Q. In fact, we had a trial together in a
12 courthouse just like this; is that right?
13 A. I think it was this courthouse.
14 Q. And can you share with us generally what was
15 that case about?
16 A. I’d been asked by you and Ford to provide some
17 scientific advice on an incident in which they were
18 involved.
19 Q. After working with you on that Ford case, did
20 there come a time when I called you and asked you or
21 told you that I was helping DePuy in the defense of hip
22 litigation?
23 A. Yes.
24 Q. And did I tell you that I, as a nonscientist,
25 had a lot of questions about cobalt and chromium?
4530
1 A. You had a lot of questions about cobalt and
2 chromium.
3 Q. And at that time, by that time, Doctor, had you
4 published a lot on chromium?
5 A. I had probably published nearly the 30 papers
6 that I eventually published.
7 Q. And at that time, did I say to you, Doctor —
8 A. Basically, those were 30 on chromium, none on
9 cobalt yet.
10 Q. And at that time, did I tell you, Doctor, I
11 need some help in understanding these hip cases?
12 MR. PANISH: Every question is leading and
13 suggestive.
14 THE COURT: Sustained. Don’t lead.
15 BY MR. CALFO:
16 Q. Were you initially retained to analyze cobalt
17 and chromium relating to the Pinnacle hips as opposed to
18 ASR hips?
19 A. Yes.
20 Q. What were you asked to do by me with respect to
21 Pinnacle hips?
22 A. You asked me to look at all the information
23 that I could find independently to assess whether there
24 was a possible chromium and cobalt systemic health
25 hazard associated with the Pinnacle.
4531
1 Q. Share with the jury, what is a systemic health
2 effect?
3 A. A systemic health effect — you’ll know right
4 away what this is. If you were to use cayenne pepper
5 when you cook and you use too much, you sometimes breath
6 it and it burns your nose or your throat. That’s a
7 local effect. If a minute later your big toe started
8 swelling up or itched, which it doesn’t, but if it did,
9 that would be a systemic effect. That means the cayenne
10 pepper would have moved through the blood to another
11 organ, and the toe in that case would have been the
12 target organ. So that’s called a systemic effect.
13 Q. Now, what metal alloys are Pinnacle hips made
14 of, based on all the work you’ve done so far?
15 A. Cobalt and chromium, and they have trace
16 elements of alluminum and other metals.
17 Q. Is it just like the ASR?
18 A. They’re very similar.
19 Q. After we retained you on behalf of DePuy, did
20 you conduct research in the toxicology of cobalt and
21 chromium in artificial hips like the ASR and Pinnacle?
22 A. Yes.
23 Q. And did you and the scientists at ChemRisk
24 conduct a lot of research on these topics?
25 A. Conducted a lot of research, thousands of hours
4532
1 of research the last 18 months.
2 Q. Doctor, at any time since you’ve been retained,
3 have I or anyone at DePuy suggested or told you what the
4 science should show?
5 A. Never.
6 Q. When were you first retained in an ASR case?
7 A. About four or five months ago.
8 Q. Was that this case?
9 A. It was.
10 Q. And when you were — after you were retained in
11 this case four or five months ago, did you review
12 Mr. Kransky’s medical records?
13 A. I had an occupational physician in my office
14 review them all, and I reviewed the selected portions
15 that were relevant to my testimony.
16 Q. Doctor, given your background, research, review
17 of the medical records, do you have an opinion to a
18 reasonable degree of scientific certainty whether cobalt
19 and chromium for Mr. Kransky’s ASR hip caused in any way
20 Mr. Kransky’s systemic health problems?
21 A. I do.
22 Q. What’s your opinion?
23 MR. CALFO: And, Your Honor, I’d like to show
24 Exhibit 2971, page 13.
25 THE WITNESS: I believe that the cobalt — is
4533
1 it all right, Your Honor?
2 THE COURT: Page 13?
3 MR. CALFO: Yes, Your Honor.
4 THE COURT: Maybe I’ve mismarked. I have that
5 as page 12.
6 MR. PANISH: It’s page 12.
7 MR. CALFO: Page 12.
8 THE COURT: On the hard copies we’ll make sure
9 that we have got the right page. All right. Page 12.
10 BY MR. CALFO:
11 Q. What’s your opinion?
12 A. My opinion is that the cobalt and chromium from
13 the ASR implant did not cause or worsen Mr. Kransky’s
14 systemic health problems.
15 Q. Now, Doctor, I’m going to show you a slide that
16 the plaintiffs presented to the jury during
17 Dr. Harrison’s testimony. I’d like to show that as
18 page 13. Maybe I can just put it on the screen.
19 MR. CALFO: We’ll mark it as next in order,
20 2970 —
21 THE COURT: Hold on. Have we used 2974 yet?
22 The next number is 2974.
23 MR. PANISH: This is not a slide. This is
24 Mr. Calfo’s opening statement.
25 MR. CALFO: Your Honor, it’s an exhibit —
4534
1 actually, it’s page 57 — it’s Exhibit 57.2.
2 THE COURT: So we don’t need to give you a new
3 number.
4 MR. CALFO: You’re right.
5 BY MR. CALFO:
6 Q. Doctor, do you see Exhibit 57.2, where I told
7 the jury that the evidence will show that cobalt and
8 chromium from the ASR hip are not poison? Do you see
9 that?
10 A. I do.
11 Q. Given your background, training, experience,
12 and scholarly work, let me ask you a simple question,
13 Doctor. Is cobalt poisonous?
14 A. The short answer is that it is not a poison
15 because of the doses which we get in our diet and which
16 you see in your blood. Everybody in the courtroom has
17 cobalt in its diet and its blood.
18 Q. So is the short answer no?
19 A. The short answer is no.
20 Q. What’s the longer answer?
21 A. The longer answer is, in toxicology, we have a
22 phrase that says all chemicals are poisonous at some
23 dose. The corollary is also true. All chemicals are
24 safe at some dose.
25 Q. In your toxicological opinion, Doctor, did
4535
1 Mr. Kransky in any way reach a high enough dose of
2 cobalt and chromium to be poisonous and cause adverse
3 systemic health problems?
4 A. No.
5 Q. Doctor, can one substance do all three things,
6 for example, have no effect, have a beneficial effect,
7 or a potentially hazardous effect, depending on the
8 dose?
9 A. Yes.
10 Q. And is it what toxicologists do? In other
11 words, do they talk about a dose response?
12 A. That’s exactly what we talk about.
13 Q. Now, the dose response — I tried to explain it
14 in my opening statement, and it was little difficult for
15 me, and I told the jury that you’d do it better than I
16 would.
17 Can you explain the dose response relationship?
18 A. Sure. May I use the blackboard?
19 Q. Sure.
20 MR. CALFO: We’ll mark it as 2975.
21 THE COURT: No, we did not use 2974 yet.
22 MR. CALFO: Dr. Paustenbach, will you mark it
23 as 2974.
24 THE COURT: Bottom right corner, put a circle
25 around it.
4536
1 (Exhibit No. 2974 was marked for
2 identification.)
3 BY MR. CALFO:
4 Q. So, Doctor, can you explain the dose response
5 relationship for us?
6 A. Sure. The dose response relationship is the
7 hallmark to toxicology. It’s what we spend all of our
8 time, especially in the old days, trying to determine
9 for any new chemical. You know there’s 8,000 to 80,000
10 chemicals for which we’d like to have toxicology
11 information so we can identify safe doses of exposure.
12 There’s a percent response on this ordinate, it’s not a
13 very complicated plot, where dose is zero to high on
14 this side and the response is zero to a hundred.
15 To make that easy, imagine a hundred animals on
16 this side. So a hundred animals get dosed at different
17 doses. What we see when you dose an animal — let’s
18 start with a famous study like cyclamates for diet soda.
19 If you were to plot that, for a few doses, low
20 doses, there would be no response. None of the animals
21 would have any adverse effect. As the dose goes up,
22 more animals have an adverse effect. It could be
23 serious. It could be minor. The curve goes like this.
24 Inevitably, by definition, it ends there, equal to a
25 hundred. This area is the one we care about because, of
4537
1 course, nothing is happening. We know we’re not worried
2 about chemical in those doses, after we take correction
3 factors for it being an animal study or a smaller study.
4 Then up here, we know that in this case, if
5 you’re looking at fatality, all of the animals would
6 have passed away at a very high dose. I’ll give you
7 some examples about that. That’s a classic dose
8 response curve.
9 Q. Are you telling us that every substance we know
10 of can both have a no effect level or an effect level
11 that can kill you?
12 A. Every chemical that I can think of. And this
13 is that no — no effect level.
14 THE COURT: Why don’t up put the pens
15 someplace. All right.
16 MR. CALFO: Your Honor, I’d like to show
17 page 13.
18 THE COURT: Of Exhibit 2971, yes.
19 BY MR. CALFO:
20 Q. Doctor, do we have an example on the screen of
21 a dose response?
22 A. I came up with two dose response curves that I
23 thought would be illustrative. Since it’s important in
24 every toxic case, I thought you should fully understand
25 this.
4538
1 So here’s a dose response curve just here like
2 I showed here, a response on the Y axis and a dose on
3 the X axis. If you see — eat an aspirin, if you take a
4 little tiny bite out of an aspirin, it doesn’t do
5 anything beneficial for the body.
6 If you are getting up in years a little bit, we
7 take half a baby aspirin or a baby aspirin a day, and it
8 helps with preventing the risk of stroke. If you take
9 two aspirins or three, you hope that your headache will
10 go way. If you take 10 or 20 aspirins, I don’t know why
11 you would, but if you did, you’d probably get nauseous
12 and you may have some other side effects.
13 And then lastly, at the high end, the one I
14 showed here where it tapers out, if you take a hundred
15 aspirin, which is what you worry about at poison control
16 centers, and when I was a child it was a very big deal
17 because that was one of the most common ways that
18 household poisonings occurred, and many of the reports
19 to the Poison Control Center were because a child would
20 eat a whole bottle of aspirin and that would cause quite
21 a panic in the household.
22 And sadly, children and even adults died,
23 especially those trying to commit suicide who would take
24 a whole bottle of aspirin. That’s a classic dose
25 response curve.
4539
1 Q. So, Doctor, if I were to ask you, which I am,
2 if aspirin is poisonous, would there be the same short
3 and long answer like there was for cobalt?
4 A. It’s exactly the same short and long answer.
5 The short answer is at some doses, it’s nontoxic; at
6 other doses, it can be fatal.
7 MR. CALFO: Your Honor, I’d like to show the
8 next in line 2971 — I believe we’re on page 14.
9 THE COURT: 14, yeah.
10 BY MR. CALFO:
11 Q. Doctor, is alcohol poisonous?
12 A. For sure. We all — not everybody, but some
13 people know something about alcohol. You know at a low
14 dose, a thimbleful, even a lightweight isn’t going to be
15 affected. If you go up to two beers or three beers in a
16 young lady who doesn’t weigh very much, you might find
17 that she gets a little giddy after — within one hour on
18 three beers. Those people that watch football, some of
19 my friends can take a six-pack or two in two hours, but
20 they still — they get a little drowsy, quite often, by
21 halftime.
22 At the end — at the high end of the dose, we
23 also know annually, at least one college student dies
24 due to an acute overdose of alcohol. That’s normally
25 involving drinking a fifth of hard alcohol in less than
4540
1 an hour. If they haven’t regurgitated the alcohol for
2 various reasons, they quite frequently will die.
3 Q. Would the same be true of coffee? If you drink
4 one or two cups of coffee, that’s fine, but if you drink
5 a large number, it could kill you?
6 A. It’s not actually the coffee that kills you,
7 probably, although the caffeine may contribute to it.
8 What you worry about is, as you knew — a couple of
9 years ago here in L.A., there was a contest who could
10 drink the most water in a short period of time, and they
11 died. It’s the same as if you were to drink 75 cups of
12 coffee in an hour, you create an electrolyte imbalance
13 and the heart fails.
14 Q. So, Doctor, any time you say poison, do you
15 have to consider dose response?
16 A. You absolutely have to consider dose and
17 response in potency.
18 Q. Did you read Dr. Harrison’s examination in this
19 case?
20 A. I did.
21 Q. And how many times would you estimate the word
22 “poison” came up?
23 A. I counted between 20 and 30 times.
24 Q. How many times would you estimate the word
25 “dose” came up?
4541
1 A. It came up very few times.
2 Q. As a toxicologist, Doctor, is it possible to
3 give accurate testimony about a substance without
4 referring to a dose?
5 MR. PANISH: I’m going to object. Foundation,
6 speculation for this witness.
7 THE COURT: Overruled.
8 THE WITNESS: I don’t know how you can give
9 testimony about cause and effect without considering
10 dose and response.
11 BY MR. CALFO:
12 Q. Can you even begin to form a scientific opinion
13 unless you understand what the dose is of cobalt?
14 A. I don’t believe so.
15 Q. Now, Doctor, when I first contacted you, had
16 you already studied cobalt in your career in order to
17 become a board certified toxicologist?
18 A. Yes.
19 MR. CALFO: Your Honor, I’d like to now show
20 slide page 15 of Exhibit 2971.
21 BY MR. CALFO:
22 Q. Doctor, I’d like to talk now about the
23 toxicology of cobalt and chromium. Okay?
24 A. Okay.
25 Q. In your profession, is there a rule of thumb
4542
1 about what is and is not — let me ask it again.
2 Is there a rule of thumb in your profession
3 about what is and what is not labeled a poison?
4 A. There’s a historical rule of thumb. It’s
5 changed over the years, but when I went to school there
6 was a definition, yes.
7 Q. What is that rule of thumb?
8 A. That rule of thumb was having an LD50 of
9 50 milligrams per kg or less. Now, you’ll see in a
10 moment, less is more dangerous. You probably already
11 know that.
12 Q. What does LD50 mean?
13 A. That’s a lethal dose for 50 percent of the
14 animals tested.
15 Q. And when we’re talking about LD, we’re not
16 talking about PPBs or parts per billion, are we?
17 A. This is a lethal dose for 50 percent of the
18 animals. So if you dosed a hundred animals with half a
19 bottle of aspirin, if within 24, 36 hours, half died,
20 that would be the LD50.
21 Q. Doctor, can you go to the easel and explain to
22 us the relative toxicity of cobalt in comparison to some
23 other substances that we might all be familiar with,
24 using the LD50 model?
25 A. Sure.
4543
1 MR. CALFO: Your Honor, may we mark that
2 as 2975?
3 THE COURT: No, because we already have one.
4 2981 is the next. In the bottom right corner, 2981,
5 draw a circle around it.
6 (Exhibit No. 2981 was marked for
7 identification.)
8 MR. CALFO: Thank you, Your Honor.
9 THE WITNESS: In this case, LD50 milligrams per
10 kg on this axis. And down here will be the name of the
11 substance. So if we go up here, we use 250, and this
12 would be aspirin. We’ve already established aspirin is
13 poisonous at some doses.
14 The next column is going to be cobalt plus 2,
15 which is the active component in cobalt, and it varies
16 between 100 and 150, depending on what you took. Our
17 best estimate is in that vicinity, depending on the
18 complex.
19 Over here, down here around 10, you see things
20 like arsenic and cyanide, mostly cyanide. And you can
21 see it’s significantly more toxic than either aspirin or
22 cobalt.
23 And then down here you have the more really
24 toxic chemicals, botulinum toxin is one. Another one
25 is — you’ve heard of dioxin,
4544
1 tetrachlorodibenzo-p-dioxin. It has an extremely low
2 LD50 in animals, not so for humans but for animals. So
3 one always thinks about animals and humans and if
4 there’s a possible difference in response. Sometimes
5 there’s dramatic differences.
6 I just wanted to make it clear that in the
7 number of textbooks and historically when I went to
8 school, we would label — we would tend to label poison
9 in the vicinity of 50 milligrams per kg. That makes
10 sense. I mean, you can see if you labelled everything a
11 poison because everything is poisonous at a particular
12 dose, that would be problematic. You may remember — it
13 may be still true. Drano, for instance, used to have a
14 skull and crossbones because you know that was really
15 hazardous. The one thing we as parents wanted to not
16 have happen was that a child drink some Drano, because
17 that was quite frequently fatal.
18 BY MR. CALFO:
19 Q. So, Doctor, from your drawing, is cobalt in the
20 world of everyday chemicals, does that qualify as a
21 classic poison?
22 A. It’s not a classic poison, but it may — it
23 doesn’t require — it typically does not require
24 labeling requirements as a poison. As I’ll discuss
25 later, you can buy cobalt liquid and it’s not labeled as
4545
1 a poison.
2 Q. If we looked at your LD50 chart of 2981, does
3 cobalt fall at a level under LD50 which is not a poison?
4 A. True.
5 Q. Now, before you conducted your research, share
6 with us what work you’ve done since I retained you.
7 A. We’ve done a lot of work. We started out by,
8 step 1, evaluating the world’s literature on cobalt and
9 chromium. Even though they’re not the most exciting
10 chemicals in our world of toxicology, there’s still been
11 a lot written about the two chemicals. It’s well over a
12 thousand papers. We then also looked at the history of
13 metal-on-metal and metal-on-poly implants
14 toxicologically to see how the evolution occurred there.
15 We then looked at, as part of the literature,
16 the medical literature, where we found that cobalt was
17 used as a medicine for many years, and then we came up
18 with a model to allow us to convert the medical
19 literature into hip implant literature, and I’ll discuss
20 how that was done.
21 And then we went forward to do some volunteer
22 studies to be able to confirm our model and to try and
23 learn more about cobalt.
24 Q. Doctor, before you conducted your research, did
25 you ever see the work DePuy did on cobalt and chromium
4546
1 and toxicology?
2 A. Not before we did our research, no.
3 Q. Why not?
4 A. We had asked to do an independent research on
5 this topic, and that’s what we did.
6 Q. So let me go back a little bit. I know we’re
7 talking about toxicology, which might be a little dry,
8 but what I want to do is go back and talk about cobalt
9 and chromium for a little bit generally. Okay, Doctor?
10 MR. CALFO: What’s — the next page is 2971,
11 page 16, Your Honor, we’d like to show.
12 THE COURT: Yes.
13 BY MR. CALFO:
14 Q. Doctor, what do we see on the screen?
15 A. You see chromium and cobalt as part of the
16 periodic table, which you all had in high school
17 chemistry. And these are called transition metals.
18 Q. Are these found in nature and all over the
19 planet?
20 A. They’re found in nature and all over the planet
21 in most earth, for example.
22 MR. CALFO: I’d like to show 2971, page 17,
23 Your Honor.
24 THE COURT: Yes.
25 ///
4547
1 BY MR. CALFO:
2 Q. Let’s talk about chromium, Doctor. Is chromium
3 in the environment and in our diet?
4 A. Yes.
5 Q. And share with us what we see on this slide.
6 A. Well, chromium is found in the air, water, and
7 soil. In some areas it’s measured routinely by the EPA.
8 We know it’s measured in our foods routinely. The FDA
9 looks at that, as has the military for various reasons.
10 Household products, and you can see the pan on the
11 right, we keep track of chromium and its transfer from
12 cooking utensils into the diet. And, of course, it’s
13 also used in the industrial setting. There’s many
14 industrial uses of chromium.
15 Q. And if we see on the screen, it says “Essential
16 trace elements in humans,” do you see that?
17 A. Right.
18 Q. As well as animals?
19 Why do we need chromium, Doctor?
20 A. We need it because it’s useful for glucose
21 tolerance for people that have difficulty controlling
22 blood sugar, but most important, it’s essential for fat
23 carbohydrate metabolism.
24 MR. CALFO: Your Honor, I’d like to show
25 page 18 of Exhibit 2971.
4548
1 THE COURT: Yes.
2 BY MR. CALFO:
3 Q. Doctor, what do we see on the screen?
4 THE COURT: I’m sorry.
5 BY MR. CALFO:
6 Q. Doctor, have you written on chromium?
7 A. As I said, I think around 30 papers we’ve
8 published on chromium. We —
9 Q. And we can see some examples on the screen?
10 A. These are a large fraction of them.
11 Q. And what kinds of things did you write about
12 with respect to chromium as we see on the screen some
13 examples?
14 A. We’ve examined chromium from about every way
15 you could. Chromium was found in the environment as a
16 result of industrial production, frequently. It was
17 found in the workplace. And because of the industrial
18 and naturally occurring chromium, it’s in the water and
19 in the air, as well as due to factory emissions.
20 So we’ve examined all that. We’ve set up
21 biological monitoring programs for people that want to
22 measure exposure to chromium. We’ve set occupational
23 limits for the workplace for safe levels of exposure.
24 We’ve looked at how much safety or lack of safety was in
25 the EPA water guidelines for chromium. We’ve looked at
4549
1 exposure assessments from people taking showers to
2 sitting in hot tubs to evaluate dermal absorption. And
3 we, in fact, conducted an epidemiology study that turned
4 out to be the primary basis for the occupational health
5 standard for chromium.
6 Q. And, Doctor, has the federal government relied
7 on these papers by you and ChemRisk in setting limits
8 for chromium?
9 A. These papers are frequently cited for both —
10 by EPA and FDA for regulating chromium, and OSHA.
11 MR. CALFO: Your Honor, I’d next like to show
12 2971, page 21 — or page 19. I’m sorry.
13 THE COURT: It’s 19, yes.
14 BY MR. CALFO:
15 Q. Doctor, are there different forms of chromium?
16 A. There are. In fact, almost all the metals have
17 different forms.
18 Q. What are the two primary chemical forms?
19 A. Chrome III and chrome VI.
20 Q. What form of chromium are we dealing with when
21 it comes to metal-on-metal hips?
22 A. Chrome III.
23 Q. Does chrome III occur naturally?
24 A. It does.
25 Q. Is chrome III very toxic?
4550
1 A. Not very toxic at all.
2 Q. Is it considered virtually nontoxic?
3 A. When I was in school, it was considered
4 virtually nontoxic. I think today they call it slightly
5 toxic.
6 Q. Is there another form of chromium that is more
7 toxic?
8 A. Chrome VI tends to be more toxic for sure,
9 especially chronically.
10 Q. Did you read Dr. Harrison’s testimony where he
11 too agrees that chromium III is the likely form of
12 chromium that’s released from the metal-on-metal
13 implants?
14 A. I read that?
15 Q. And do you agree with Dr. Harrison on that?
16 A. I can and there are several published reviewed
17 papers that agree with that.
18 MR. CALFO: I’d like to show next in order
19 2971, page 20.
20 THE COURT: Yes.
21 BY MR. CALFO:
22 Q. So, Doctor, are there, in fact, chromium III
23 supplements that people can buy at the store?
24 A. For sure. Fairly popular right now.
25 Q. Do they look like what we see on the screen?
4551
1 A. Yes.
2 Q. In fact, I brought one here. Is this one of
3 them?
4 A. That’s one of them.
5 THE COURT: Indicating a bottle.
6 MR. CALFO: Indicating a bottle.
7 BY MR. CALFO:
8 Q. Why do people take chromium III supplements?
9 A. The two main reasons that they tend to take
10 them is for weight loss and to help stabilize
11 prediabetic or diabetic conditions.
12 Q. Doctor, have you studied the issue of blood
13 concentrations in persons exposed to chromium?
14 A. Many times.
15 MR. CALFO: Your Honor, I’d like to show next
16 in order page 21 of Exhibit 2971.
17 THE COURT: Yes.
18 BY MR. CALFO:
19 Q. Doctor, share with us what do we see on the
20 screen?
21 A. This is an example of a paper that we
22 published, one that was pretty popular about 15 years
23 ago where we exposed volunteers to drinking water that
24 contained both tri- and hex-chromium, and then we
25 measured the blood and urine levels.
4552
1 Q. Doctor, there’s been evidence in this case that
2 Mr. Kransky’s levels were measured at 27 parts per
3 billion, and that’s in terms of chromium. Can you put
4 that number in parts per billion in perspective for the
5 jury?
6 A. I can try. In our study, which encompassed a
7 number of concentrations, some of our volunteers got up
8 to 60 parts per billion in their blood as a result of
9 drinking the contaminated water. The water was bright
10 yellow, so it was clearly contaminated. We were
11 attempting to figure out the reductive capacity of
12 chrome VI. In other words, when you drink chrome VI,
13 it’s virtually all converted to chrome III, the nontoxic
14 form, and that’s been a tenet in toxicology for probably
15 40 to 50 years. So we kind of wanted to prove that
16 tenet quantitatively, and we did that.
17 Q. Did you compare Mr. Kransky’s chromium blood
18 level to the estimated blood levels associated with the
19 EPA’s no adverse effect level?
20 A. We did.
21 MR. CALFO: Your Honor, I’d like to show
22 page 22 of Exhibit 2971.
23 THE COURT: Okay.
24 BY MR. CALFO:
25 Q. What do we see on the screen, Doctor?
4553
1 A. We have Mr. Kransky’s at 27.5 ppb on the left,
2 which was collected September 1, 2011. And on the
3 right, we tried to calculate or we did calculate, and
4 based on what EPA thinks was an appropriate no observed
5 effect level, from that diagram that I showed you, we
6 estimated that if you embrace that EPA no observed
7 effect level, your blood concentrations could be as high
8 as 2,000 parts per billion. This is simply to
9 illustrate in my mind that Mr. Kransky’s chromium blood
10 levels were of insignificant health or basically no
11 health risk.
12 Q. So let’s move on to cobalt. Okay, Doctor?
13 A. Yes.
14 MR. CALFO: Your Honor, I’d like to show
15 page 23 of Exhibit 2971.
16 THE COURT: Okay.
17 BY MR. CALFO:
18 Q. Doctor, is cobalt something that human beings
19 need for any reason?
20 A. Yes.
21 Q. Why?
22 A. Well, cobalt is a building block. It’s one of
23 those essential elements. There are roughly 15
24 essential elements. If you don’t have them, your body
25 doesn’t function well. It wasn’t hard generally over
4554
1 the millennium for people to get those essential
2 elements and to operate well. One, of course, is
3 iodine. We decided decades ago to add iodine to salt.
4 If you buy sea salt in L.A., it will always say
5 at the bottom, please be aware we have not added iodine.
6 They’re alerting you to make sure you get enough iodine
7 in your diet. If you switch entirely to sea salt, you
8 can get an iodine deficiency. So for cobalt, it’s also
9 important that you not become deficient in cobalt.
10 Fortunately, cobalt is not hard to get in your diet.
11 But if you were to be without it, you would have not
12 only some metabolism problems but you’d probably have
13 red blood cell production problems.
14 Q. Did you read Dr. Harrison’s testimony before
15 the jury that he does not know what happens if you don’t
16 have any cobalt in your system?
17 A. I did.
18 Q. Dr. Paustenbach, do you know what happens if we
19 don’t have cobalt in our systems or are cobalt
20 deficient?
21 A. Sure.
22 Q. Explain to us.
23 A. Cobalt deficiency, just like deficiency of the
24 other essential elements, is not good. In the
25 particular case of cobalt, even though it’s very rare,
4555
1 you can get some fairly significant adverse effects,
2 mostly neurological. They involve tingling of the
3 extremities, sometimes dizziness, sometimes memory loss,
4 depression.
5 Again, it’s unusual, but those are the symptoms
6 and we’re plenty aware of it. We get most of our cobalt
7 through vitamin B-12.
8 Q. So, Doctor, would a deficiency of an essential
9 part of vitamin B-12 lead possibly to those health
10 problems?
11 A. Oh, sure. If you look on the Internet, you’ll
12 see warnings to vegetarians to be aware that they don’t
13 go too far in denying themselves sources of cobalt.
14 That’s probably one of the handfuls of things that
15 vegetarians worry about.
16 Q. Doctor, do all of us in this courtroom have
17 cobalt in our blood?
18 A. We all have cobalt in our blood. I mean, I
19 hope they do, but they should.
20 MR. CALFO: Your Honor, may I show page 24 of
21 Exhibit 2971?
22 THE COURT: Yes.
23 BY MR. CALFO:
24 Q. This is a slide that was shown to the jury
25 earlier. Doctor, is cobalt found in the everyday foods
4556
1 that we eat?
2 A. Yes.
3 Q. Do some athletes also take cobalt?
4 A. Yes.
5 Q. Is cobalt on the market at general health food
6 stores or over the Internet?
7 A. Yes.
8 MR. CALFO: Your Honor, I’d like to show next
9 in order 2971, page 25.
10 THE COURT: Yes.
11 BY MR. CALFO:
12 Q. Doctor, what do we see on the screen?
13 A. You see two commercially available forms of
14 pure cobalt. This is not vitamin B-12. This is pure
15 cobalt.
16 Q. Doctor, I have in my hand a bottle. Do you see
17 it?
18 A. Yes.
19 Q. What is this bottle?
20 A. That’s cobalt. By pure, I mean, of course, not
21 the metal. It’s in a solution.
22 Q. Why do people take cobalt?
23 A. They take it under the belief — and I’ll
24 stress “the belief,” that it helps them either feel
25 better in general or because they know it increases the
4557
1 red blood cell count if they take enough of it. And
2 athletes — some athletes have tried to use that as an
3 enhancement drug because it produces more red blood
4 cells. And those people that live in high altitudes
5 will sometimes believe that if they take it, it will
6 help with the high altitude adjustment.
7 MR. CALFO: Your Honor, I’d like to show
8 page 26 of Exhibit 2971.
9 THE WITNESS: By the way, it’s kind of
10 obvious — although it should be said, most of the
11 metals are solid at room temperature. That’s why they
12 have to be in solution.
13 BY MR. CALFO:
14 Q. All right, Doctor. What is your understanding
15 as to why cobalt and chromium are used in implants?
16 A. They’re used in implants because there’s a
17 history of strength and a lack of corrosion, the
18 tendency to corrode.
19 Q. And you’ve told us you’ve done a lot of work.
20 Did you review the world literature on cobalt I think
21 you told us?
22 A. Yes.
23 Q. How long, to your knowledge, have
24 metal-on-metal hip implants been used?
25 A. Nearly 50 years.
4558
1 Q. And generally, Doctor, what did you find in the
2 literature regarding metal-on-metal hips and systemic
3 health effects?
4 A. I saw virtually nothing before the voluntary
5 recall of the ASR.
6 Q. Did you find that even thousands and thousands
7 of people received metal-on-metal hips and had them for
8 decades where there were no documented reports of
9 systemic health effects?
10 MR. PANISH: Objection. Leading and
11 suggestive.
12 THE COURT: Sustained.
13 BY MR. CALFO:
14 Q. What did you find in the world literature with
15 respect to systemic health effects?
16 A. I saw none.
17 Q. Are you saying, Doctor, that systemic health
18 effects of cobalt and chromium had been studied before?
19 A. Sure.
20 Q. Can you share with us what you know about that?
21 A. Yeah. For example, the — one of the systemic
22 effects we worry about, if it’s not obviously apparent,
23 especially beginning around 1978 during the so-called —
24 I believe it was Nixon’s war on cancer, everyone was
25 interested in the carcinogenic hazard, and that’s when
4559
1 mutagenicity and genotoxicity tests with Petrie dishes
2 and bacteria and Drosophila began to become very
3 popular.
4 At that point there was a question raised about
5 I wonder if implants increase the cancer risk. And some
6 epidemiologists in Europe have studied that issue a
7 number of times over the years and they have not seen an
8 increase in the cancer risk in patients that have
9 implants.
10 Q. Was there literature regarding
11 metal-on-polyethylene hip implants as well?
12 A. Yes. As you probably heard,
13 metal-on-polyethylene, given that it still has cobalt
14 and chromium in it, produces increased blood levels of
15 both in implant patients, not as much as metal-on-metal
16 but still clearly much statistically increased
17 concentrations. And that literature helps inform us as
18 well about the lack of systemic effects.
19 Q. In that literature on metal-on-polyethylene
20 implants, were there any reports of systemic health
21 illnesses?
22 A. I didn’t see any. Not before the recall.
23 MR. CALFO: Your Honor, I’m going to be moving
24 on. Would this be an appropriate time?
25 THE COURT: Sure. Take our morning recess.
4560
1 Ladies and gentlemen, we’ll take our morning
2 recess. Keep in mind the admonition. See you-all back
3 in 15 minutes.
4 (Recess taken from 10:13 a.m. to 10:32 a.m.)
5 COURT ATTENDANT: Please be seated and come to
6 order. Court is, again, in session.
7 THE COURT: In the case of Kransky vs. DePuy,
8 the record will reflect all counsel are present. All
9 jurors and the alternate are present.
10 Mr. Calfo.
11 MR. CALFO: Thank you, Your Honor.
12 BY MR. CALFO:
13 Q. Doctor, before the break, we were talking about
14 the literature and cobalt in hips. Putting the
15 literature regarding hip patients aside, was there other
16 literature that you reviewed discussing the effects of
17 cobalt in certain populations?
18 A. Yes.
19 Q. What populations, Doctor?
20 A. Persons with anemia, which included children,
21 those on dialysis and pregnant women. This was mostly
22 in the 1950s and ’60s.
23 MR. CALFO: Your Honor, I’d like to publish
24 page 27 of Exhibit 2971.
25 THE COURT: Yes.
4561
1 BY MR. CALFO:
2 Q. Now, Doctor, our jury heard during the
3 plaintiffs’ case that cobalt is a poison.
4 Was cobalt used to treat anemia patients?
5 A. Yes.
6 Q. Share with us, what is anemia?
7 A. Anemia is a shortage of red blood cells.
8 Typically the symptoms are weakness; so your doctor will
9 normally check for red blood cells.
10 Q. How does cobalt treat anemia?
11 A. Cobalt sends a message through the blood to the
12 kidney. The kidney produces erythropoietin which is a
13 hormone. That hormone then goes to the bone marrow.
14 The bone marrow is the source of all the blood
15 components called the progenitor cells. That’s where
16 the white cells and red cells come from.
17 It produces an increased red blood cell count.
18 It’s just a way to stimulate those red blood cells to
19 get you out of that anemia state.
20 Q. And as a toxicologist, Doctor, is the effect,
21 an increase in production of red blood cells, good for
22 anemic patients?
23 A. It’s very good. It was prescribed to hundreds
24 of people.
25 Q. How much cobalt did these anemic patients have?
4562
1 A. They got a lot. Quite a bit.
2 Q. Doctor, what I’d like to do —
3 MR. CALFO: Your Honor, may I show
4 Exhibit 2971, page 28?
5 THE COURT: Yes.
6 BY MR. CALFO:
7 Q. Doctor, are you aware that Dr. Harrison
8 presented this exhibit which was marked as Exhibit 57-5
9 to the jury?
10 A. I am aware of the exhibit.
11 Q. Are you aware that Dr. Harrison claimed that
12 the California Poison Control Center had set a toxic
13 cobalt level at 7 parts per billion?
14 MR. PANISH: Objection. Number one, misstates
15 testimony. Number two, it’s leading and suggestive.
16 Number three, it’s beyond.
17 THE COURT: Sustained on leading grounds.
18 BY MR. CALFO:
19 Q. Doctor, what do we see on the screen of page 28
20 of Exhibit 2971?
21 A. On the screen, we see a dose versus a component
22 chart, much like I drew. On the left, you see the
23 amount of cobalt typically taken up in the diet of
24 Americans, which is a little less than 0.4 milligrams
25 per kg. The next column is if you believe that 7 parts
4563
1 per billion in blood was a toxic concentration, that’s
2 what that shows. And then the third column is
3 Mr. Kransky’s cobalt concentrations, at least part of
4 them. They have a cutoff of 10. This is a portrayal to
5 compare what’s taken up in the diet as to what was
6 alleged to be a toxic level and in Mr. Kransky’s blood
7 levels.
8 MR. CALFO: Now, Your Honor, I’d like to show
9 page 29 of Exhibit 2971.
10 THE COURT: Yes.
11 BY MR. CALFO:
12 Q. Now, Doctor, you told us that some blood
13 concentrations for treatment of anemia —
14 THE COURT: Hold on. Maybe my numbers are off.
15 This is page 28 according to the way I have it numbered.
16 MR. CALFO: I have it as 29. We’ll mark that
17 as 28.
18 THE COURT: I just went through it by hand and
19 that’s what I came up with. Maybe I got my numbers
20 wrong.
21 BY MR. CALFO:
22 Q. Doctor, you told us that cobalt of up to
23 400 parts per billion was used for some anemic patients;
24 is that true?
25 A. I hadn’t quite said that yet. They take pills
4564
1 that brought the blood levels in the vicinity up to 400
2 and sometimes higher, 400 parts per billion. The idea
3 was you had children, you had pregnant women and you had
4 people on dialysis. So the doctors had to guess. They
5 gave them pills or liquid. They had to guess what the
6 response would be. There are controlled studies
7 published in the literature where physicians are trying
8 to figure out what the right dose is for different
9 populations. It was not uncommon for them to be at
10 about 400 parts per billion.
11 Q. Doctor, in your work in this case, did you have
12 an understanding that Mr. Kransky’s cobalt levels were
13 measured at 47 to 53 parts per billion?
14 A. Yes.
15 Q. Is that what’s depicted on the screen?
16 A. Yes.
17 Q. So share with us. What do we see on the
18 screen?
19 A. The normal amount of cobalt taken up due to the
20 foods and then the mathematically predicted blood
21 levels — let me be clear. The doctors in the ’50s and
22 ’60s did not know for sure what the blood concentrations
23 were. They knew what the pill size was. They knew how
24 many pills they were giving, and then they looked to see
25 what their response was.
4565
1 THE COURT: You said “the blood concentrations
2 were.” Blood concentrations of what?
3 THE WITNESS: Oh, cobalt. So they didn’t know,
4 generally, what the cobalt concentrations were. All
5 they knew was they were giving these pills. They got
6 this good response. They were happy, or they weren’t
7 happy if they overdosed. Then we figured out roughly
8 what those blood concentrations were. They were doing
9 it on a milligram per kilogram basis, just like you’d
10 take a drug two or three or four times a day.
11 This shows basically that these anemia patients
12 got a positive response without adverse effects,
13 generally, under 300 ppb, but sometimes people were not
14 getting an adverse effect but the positive effect up to
15 400 ppb.
16 BY MR. CALFO:
17 Q. Doctor, I’d like —
18 MR. CALFO: Actually, Your Honor, may I show
19 page 29 of Exhibit 2971?
20 THE COURT: Yes.
21 BY MR. CALFO:
22 Q. Doctor, how did your research, including the
23 data on the anemia patients you told us about, help you
24 to identify doses of cobalt in blood concentrations?
25 A. Well, in the last three or four years, as
4566
1 you’ve heard, the orthopedic surgeons are taking a lot
2 of blood samples of people to see what the cobalt levels
3 are. And the only way to interpret that data from a
4 systemic health effect standpoint is to compare apples
5 and apples. We were really blessed to be able to find
6 the anemia patients and find that rich history of
7 medicine from almost 50 years ago. Which allowed us to
8 compare the two.
9 Q. Is the form of cobalt given to anemia patients
10 the same as cobalt that we measure in the blood of hip
11 implant patients?
12 A. The active ingredient is the same as cobalt 2,
13 and Dr. Harrison agrees with me on that.
14 MR. CALFO: What I’d like to do is now show,
15 Your Honor, page 30 of Exhibit 2971.
16 THE COURT: Other sources?
17 MR. CALFO: Yes.
18 THE COURT: Yes.
19 BY MR. CALFO:
20 Q. Doctor, let’s talk about the other sources of
21 information that you reviewed in arriving at your
22 opinions. Okay?
23 Did you review Dr. Trotsky’s medical records?
24 A. I did.
25 MR. CALFO: Your Honor, I’d like to publish
4567
1 Exhibit 2971, page 31.
2 THE COURT: Yes.
3 BY MR. CALFO:
4 Q. Doctor, what do we see on the screen?
5 A. We see some notes from Dr. Trotsky’s
6 examination or discussion of Mr. Kransky’s health.
7 Q. And do you see where Dr. Trotsky noted that,
8 “There is no objective evidence that cobalt of chromium
9 toxicity will be any issue to be concerned about”?
10 Do you see where that’s written?
11 A. Yes.
12 Q. Do you understand that was pursuant to a
13 conversation Dr. Trotsky had with the Mayo Clinic?
14 MR. PANISH: Objection. Leading and
15 suggestive.
16 THE COURT: I’ll allow that question.
17 THE WITNESS: Yes.
18 BY MR. CALFO:
19 Q. Are you familiar with the Mayo Clinic, Doctor?
20 A. Yes, I am. And I’m familiar with Dr. Martin.
21 Q. Share with us, generally, what is the Mayo
22 Clinic?
23 A. Mayo Clinic is considered one of the premiere
24 medical and teaching institutions in the world.
25 Q. Now, do you agree with this statement in the
4568
1 medical record attributed to the Mayo Clinic, as
2 reflected in Dr. Trotsky’s record, that “There’s no
3 objective evidence that cobalt and chromium systemic
4 toxicity is an issue to be concerned about”?
5 A. It’s not an issue to be concerned about at
6 typical concentrations observed in implant patients.
7 MR. CALFO: Now, I’d like to show Exhibit 2971,
8 page 32.
9 THE COURT: Yeah.
10 BY MR. CALFO:
11 Q. Did you review page — did you review the Mayo
12 Clinic’s written policy on toxicity?
13 A. Yes.
14 MR. PANISH: Excuse me, Your Honor. 721
15 objection, again.
16 THE COURT: I’ll allow it. He won’t go into
17 the details but can rely on the language he relied on.
18 BY MR. CALFO:
19 Q. Doctor, share with us the language you relied
20 on.
21 MR. PANISH: It’s the same thing, Your Honor.
22 THE COURT: I understand.
23 Lay a foundation.
24 BY MR. CALFO:
25 Q. In doing your work in this case to render
4569
1 toxicological opinions, did you review the Mayo Clinic
2 communique?
3 A. Yes, I’ve been watching it for 18 months.
4 Q. Did you rely upon it in order to form your
5 opinions in this case?
6 A. I did.
7 Q. Share with us what the Mayo Clinic communique
8 is.
9 A. They stated just recently that the elevated
10 cobalt and chromium concentrations may indicate implant
11 wear, but they are not indications of toxicity.
12 Q. From your toxicological perspective, Doctor, do
13 you agree with that communique?
14 A. Definitely.
15 MR. CALFO: I’d like to show Exhibit 2971,
16 page 33.
17 THE COURT: Yes.
18 BY MR. CALFO:
19 Q. Doctor, you read Dr. Harrison’s testimony about
20 the California Poison Control and 7 parts per billion?
21 A. True.
22 Q. Did you read where Dr. Harrison testified that
23 anyone could have looked up the California Poison
24 Control Center to see the toxic levels set for cobalt?
25 A. I did.
4570
1 Q. Have you looked personally at what the State of
2 California Poison Center has said about cobalt toxicity
3 levels?
4 A. Yes.
5 Q. What did you — so you did a search of the
6 California Poison Control Center.
7 Did you find anything on cobalt?
8 A. No.
9 Q. Did you call the 1-800 number?
10 A. Yes.
11 Q. What did you learn?
12 MR. PANISH: Objection. Hearsay.
13 THE COURT: Sustained.
14 THE WITNESS: They said —
15 MR. PANISH: Your Honor, excuse me.
16 THE COURT: Hold on.
17 Next question.
18 BY MR. CALFO:
19 Q. After you looked at the data and literature
20 regarding cobalt, what did you do next as part of your
21 work?
22 A. I continued to look, to do research on what was
23 available in the literature.
24 MR. CALFO: Your Honor, I’d like to show page
25 34 of Exhibit 2971.
4571
1 THE COURT: Yes.
2 BY MR. CALFO:
3 Q. And, Doctor, you told us, I think, a little bit
4 about this earlier, but did you convert liquid ingestion
5 into blood concentrations?
6 A. As I said, we had to develop a model to be able
7 to convert the medical data from the ’50s and ’60s into
8 blood concentrations.
9 THE COURT: I’m sorry. I have this as page 33.
10 BY MR. CALFO:
11 Q. I’m sorry?
12 A. I think I answered the question.
13 THE COURT: He answered it.
14 BY MR. CALFO:
15 Q. So did you convert the doses from the published
16 literature into blood levels? Is that what you said?
17 A. True.
18 Q. How did you do that conversion, Doctor?
19 A. You basically take the human body and convert
20 that which is done, the amount that’s taken in orally
21 and convert into what the blood concentration would be
22 by considering the physiology of the body. I can draw
23 that in a very simple way, or they can accept it.
24 Q. Doctor, why wasn’t cobalt measured in the blood
25 in the 1950s with the anemia studies?
4572
1 A. The analytical chemistry wouldn’t have allowed
2 them to do that at the parts per billion level.
3 Q. When you did the conversion converting liquid
4 ingestion into blood concentration, can you share or
5 explain to us how that model works to convert a dose,
6 for example, I think you told us pills for anemia into
7 cobalt blood concentrations? How did you do that?
8 A. I can use the board. It might be easier.
9 Q. Will you do that, please?
10 THE COURT: I believe next in order is 2982.
11 Could you write 2982 in the bottom right corner and put
12 a circle around it.
13 (Exhibit No. 2982 was marked for
14 identification.)
15 THE WITNESS: By and large, all of us in the
16 courtroom are anatomically similar and physiologically
17 similar with certain obvious changes in body weight and
18 a few other things. What we’ve been able to do with a
19 computer the last 20 years is been able to take a person
20 and describe them mathematically based on the amount of
21 blood in the body. So we account for blood volume, it’s
22 called. And then elimination rate in the urine. If
23 it’s volatile, how much you exhale. How much goes out
24 in your feces. Sometimes how much goes out in your skin
25 and, of course, how much you eat.
4573
1 This may surprise you, but we can do this for
2 most any chemical or food that you eat. If you say you
3 eat a certain amount — if we understand the chemical
4 very well, we can tell you how much is inhaled within a
5 few hours based on the blood volume, the urinary
6 excretion rate, the fecal excretion rate, any skin
7 elimination. Obviously, it’s just a black box that
8 things go in and out of. So what we did was we
9 converted the ingestion, the pills that children and
10 pregnant women took to help their anemia, and by
11 considering — we don’t have to worry about exhalation.
12 It’s not volatile. It doesn’t come out of the skin,
13 that I’m aware of, in any appreciable amount.
14 By considering blood volume, urine and feces,
15 you can see quite quickly whatever you eat is going to
16 show up in the blood subtracting over time how much
17 appears in the feces and urine. It’s not that hard at
18 all. It sounds complicated. I was actually surprised
19 nobody had done it before, and that’s how we calculated
20 the blood concentrations because now you know the
21 milligrams per milliliter of blood of cobalt. It’s not
22 complicated. Well, it is and isn’t.
23 MR. CALFO: Okay. Your Honor, I’d like to show
24 page 34 of Exhibit 2971.
25 THE COURT: Yes.
4574
1 BY MR. CALFO:
2 Q. So, Doctor, you told us you did the conversion.
3 Did you create a model to do that conversion?
4 A. Luckily, we didn’t have to create a model.
5 Like so many things, there was so much money put in to
6 the war effort, World War II, that the military was able
7 to do an enormous amount of medical research during
8 World War II. As a result of their work with the
9 radionuclides, it transferred into medicine. World War
10 II just didn’t give us benefits of radiation due to the
11 bomb —
12 MR. PANISH: I’m going to object. The question
13 was did you create a model.
14 THE COURT: Put another question. I’ll allow
15 the answer to stand.
16 BY MR. CALFO:
17 Q. Doctor, what do we see on the screen?
18 A. It’s a published paper.
19 Q. Who published it?
20 A. My team and I.
21 Q. Can you share, generally, with the jury what
22 this published paper is about?
23 A. It’s an extension of government model that we
24 modified in order to accommodate what had been learned
25 since World War II when they developed a model and the
4575
1 government.
2 Q. Tell us how you did that model. How did you
3 create it? Did you have to go back and look at all the
4 literature? How did that happen?
5 A. Luckily, Dr. Leggett at Oak Ridge National Labs
6 published his government-funded model, and we were able
7 to modify it.
8 Q. And you published it?
9 A. Yes, sir.
10 Q. In a peer-reviewed literature?
11 A. Yes, sir.
12 MR. CALFO: Your Honor, I’d like to now show
13 2971, page 35.
14 THE COURT: Yes.
15 BY MR. CALFO:
16 Q. So applying the biokinetic model referenced in
17 your peer-reviewed piece to the anemia papers, what did
18 you find?
19 A. We found that the anemia patients received
20 substantial quantities of cobalt and that we could
21 convert to the range of blood concentrations that likely
22 appeared in the children and the adults. You’ll note
23 that at the low doses, they tended to be in the vicinity
24 of 62 to 150. At the high doses, they could go as high
25 as 390 to 890. They probably are actually even a lot
4576
1 higher than that, but we assumed conservative absorption
2 in the intestinal tract.
3 Q. Were there adverse effects seen in patients
4 that had such high blood levels as referenced on the
5 screen?
6 A. Some of them did, yes.
7 Q. Did you then provide this information that you
8 had to the scientific world?
9 A. Yes, we did.
10 Q. How did you do that?
11 A. In that paper where we did the modelling, we
12 went in and used the model on, I think, ten different
13 groups of famous or well-known studied cobalt
14 populations and said, “By the way, you’ll be interested
15 to know that these were the blood concentrations that
16 happened 50 years, 40 years ago.
17 MR. CALFO: Your Honor, I’d like to now show
18 Exhibit 2971, page 36.
19 THE COURT: Yep.
20 BY MR. CALFO:
21 Q. Doctor, was this article that you co-authored
22 peer-reviewed and published in a respected scientific
23 journal?
24 A. Yes.
25 Q. Share with us, generally, what this paper is
4577
1 about.
2 A. So what we did after we had the model
3 developed, we went in and looked at every high-quality
4 published paper we could find that met the criteria by
5 quality and then converted those doses to blood levels
6 and then looked at the effects that were observed, the
7 adverse effects and the beneficial effects of those
8 treatments that occurred between roughly 1950 and 1970.
9 Q. And share with us, if you could, in applying
10 the model to the literature and as referenced in the
11 paper, what did you find in terms of any effects and
12 parts per billion?
13 A. In the blood, we found there were virtually no
14 adverse effects in the people that had blood levels up
15 to about 300 parts per billion. The effect that you saw
16 was polycythemia. In other words, it goes too high
17 because they were trying to get the red blood cell count
18 up, but they didn’t get the dose calculation right.
19 That’s because each person has a big difference in its
20 cobalt absorption, and that’s beyond the scope of this
21 testimony, but that’s what we learned.
22 At the next higher blood levels, we saw other
23 toxic effects occur, like, effects on thyroid and other
24 organs as well. We reported on all four or five adverse
25 effects in this paper.
4578
1 MR. CALFO: May we show page 37, Your Honor, of
2 Exhibit 2971.
3 THE COURT: Yes.
4 BY MR. CALFO:
5 Q. So, Doctor, after developing the biokinetic
6 model and publishing your two papers in peer-reviewed
7 journals, did you then want to test the biokinetic model
8 that you shared with us that you created?
9 A. Yes. We were curious about what had been
10 learned since — or after World War II on the
11 distribution of cobalt as well as the absorption. The
12 only way to prove this model really could project what
13 was happening in these anemia patients, we decided to do
14 our own study of volunteers.
15 Q. Share with us how it was that you tested with
16 those volunteers.
17 A. Well, we found out that they sold cobalt in
18 solution on the Internet and in some health food stores.
19 So we bought the liquid cobalt, vitamin supplement, and
20 asked for volunteers to take the prescribed dose, and
21 then we measured their blood to see what would happen.
22 Q. Did you do a study?
23 A. We actually did three studies. A pre-study on
24 one person, and then a 14-day and a 30-day study.
25 MR. CALFO: Your Honor, I’d like to show
4579
1 page 38 of Exhibit 2971.
2 THE COURT: Okay.
3 We’re getting feedback from something down
4 here.
5 MR. KELLY: It’s over here, Your Honor. We’ll
6 get it turned off for you.
7 THE COURT: Good. Now it’s off.
8 Go ahead.
9 BY MR. CALFO:
10 Q. Who participated in your 14-day study, Doctor?
11 A. Well, we dosed these volunteers in the 14 days.
12 They’re all employees, and there were four of them.
13 Four males.
14 Q. Were they toxicologists?
15 A. I think they were all toxicologists.
16 Q. Is it strange for toxicologists to dose
17 themselves in studies, Doctor?
18 A. I know it sounds strange, but the field of
19 toxicology, as you’ve already figured out, isn’t just
20 another typical field in public health or medicine.
21 It’s not unusual, especially years ago, for
22 toxicologists who had a gut feel they had a good idea to
23 dose themselves and see if they were right and that’s
24 what happened.
25 Q. Can you give us an example that you’re aware of
4580
1 of a toxicologist, a famous one, who’s dosed himself?
2 A. When I was in school 30 years, of course, we
3 talked about this and the history of it.
4 MR. PANISH: Excuse me, Your Honor,
5 nonresponsive to the question.
6 THE COURT: Who is it that you talk about?
7 THE WITNESS: Herman Prager, who’s an M.D.
8 toxicologist in Switzerland. One of my very first
9 scientific meetings got up and said, “Ladies and
10 gentlemen, I’m going to present a paper where I ingested
11 the most toxic chemical known to man, dioxin, and then I
12 took my own blood levels for the last few years, and I’m
13 here to tell you how long it takes for that blood or for
14 that dioxin to leave the body, and I’m here to tell you
15 I’m alive and it’s not as toxic in humans as people
16 think.”
17 That’s really one of the more recent
18 interesting studies of a physician toxicologist dosing
19 themselves.
20 BY MR. CALFO:
21 Q. Are there formal procedures that are required
22 before you can just do studies involving human beings?
23 A. Yes. In the United States, if you’re going to
24 do a study, there are procedures you should follow.
25 Q. And what procedure?
4581
1 A. Well, they vary. If they’re toxicology
2 procedures not intended to result in a clinical drug,
3 the expectations are much different. There are
4 different levels of expectation. We recently have
5 chosen to use a more rigorous institutional review board
6 criteria for doing these studies.
7 Q. What does an institutional review board do?
8 A. An institutional review board looks at your
9 protocol, how you plan to do the study. You describe to
10 them the safeguards you’re going to take to protect the
11 person’s anonymity. They’re going to make sure that you
12 give them full and adequate warning of any potential
13 hazards. Some of them will tell you whether they think
14 the study should be done because of its health hazards,
15 and they establish the paperwork and criteria for how
16 they’d like to see the study conducted.
17 Q. Doctor, share with us what you learned,
18 generally, from the 14-day study.
19 A. We learned from the 14-day study that our model
20 was a very good predictor of blood concentrations based
21 on oral dosing. That was the primary thing that we
22 learned. We also learned that the four of us didn’t
23 have any adverse effects, and we also learned the
24 analytical chemistry lab had to focus on this aspect to
25 get it right.
4582
1 Q. Did you publish the results of the 14-day
2 study?
3 A. We did. It appeared in a journal a couple
4 months ago.
5 Q. A peer-reviewed journal?
6 A. Yes, sir.
7 Q. Do we see the cover of your paper on the
8 screen?
9 A. That’s it.
10 Q. After the 14-day study, did you do additional
11 research to further confirm your biokinetic model and
12 evaluate possible systemic adverse effects of cobalt?
13 A. We did.
14 MR. CALFO: And, Your Honor, I’d like to show
15 page 39 of Exhibit 2971.
16 THE COURT: Yep.
17 BY MR. CALFO:
18 Q. Doctor, share with us what you did.
19 A. We conducted a 30-day study which is typical in
20 toxicology. It usually goes one day, 14 days, 30 days
21 and 90. We conducted a 30-day study to look at more
22 parameters and a diversity of people. In this case, we
23 used five males and five females. We increased the dose
24 from .4 to 1, 1 is the prescribed recommended amount by
25 the company. It’s also an amount that in Great Britain,
4583
1 they consider tolerable.
2 We used the label dose, just as if we were
3 taking a shelf vitamin, and then measured the blood in
4 these people as well as some clinical parameters.
5 Q. I’m sorry. Did you use ChemRisk employees for
6 the 30-day study?
7 A. We didn’t use any ChemRisk employees for this
8 study.
9 Q. Did all the people who participated in the
10 30-day study, Doctor, sign what are called informed
11 consent forms?
12 A. Yes, they did.
13 Q. Did you tell the participants — what did you
14 tell the participants about various potential risks
15 regarding cobalt?
16 A. We told them about what we thought nearly every
17 plausible potential risk associated with cobalt exposure
18 at much, much higher doses than they would be taking.
19 Q. Why did you tell them about that?
20 A. When there’s a volunteer study for which
21 there’s no clear benefit and you’re simply doing it for
22 scientific advancement but no clear medical benefit,
23 there’s an expectation you should over warn. Tell them
24 of every plausible adverse effect, and that’s what we
25 did, and there’s a guideline for that that reinforces
4584
1 that recommendation.
2 Q. Did you tell the participants that information,
3 Doctor, that the study might be published in the
4 scientific peer-reviewed literature, might be considered
5 by government bodies or might be used in litigation?
6 A. Yes, we did. We disclosed that to everyone.
7 Q. Did you disclose that in the consent form?
8 A. Yes.
9 Q. Is that consent form — was that approved by
10 the independent institutional review board you told us
11 about?
12 A. Yes, they did.
13 Q. What did you measure — and, Your Honor — I’m
14 sorry.
15 Doctor, what did you measure in the 30-day
16 study?
17 A. We measured the blood levels on several
18 occasions. We also measured the red blood cell count,
19 not surprisingly, because that’s the first most
20 sensitive effect. We looked at thyroid, which is the
21 second most sensitive effect, changes on thyroid
22 function. Then we looked at ferritin, which is to tell
23 you whether you’re taking too much blood from your
24 volunteers, more or less. And then, I believe, it’s not
25 listed here, but I believe we also looked for liver
4585
1 function.
2 Q. Share with us, generally, what were your
3 findings in the cobalt supplement 30-day study?
4 A. We saw when they took the label recommended
5 amount, 1 milligram per day, there was no increased
6 health risk to these people, but their blood levels went
7 up significantly.
8 Q. Did any of the participants reach what is known
9 in the toxicological world as steady state?
10 A. Some of them did reach steady state.
11 Q. Can you go back to the easel to a prior drawing
12 you had and explain to us all, what is steady state?
13 Can you do that?
14 A. Sure.
15 Q. If we’re going to create a new exhibit —
16 THE COURT: Before you start drawing, let us
17 mark it as an exhibit.
18 MR. PANISH: Do we have a new question now?
19 THE COURT: Hold on.
20 Are you asking him to make a new chart?
21 BY MR. CALFO:
22 Q. Will you make a new chart to explain to the
23 ladies and gentlemen of the jury the concept of steady
24 state?
25 THE COURT: The bottom right corner, put 2983
4586
1 as the next number.
2 (Exhibit No. 2983 was marked for
3 identification.)
4 THE COURT: Now you may.
5 THE WITNESS: This is probably the easiest
6 concept of the day, I think, although Mr. Calfo didn’t
7 find it that way. Concentration in blood versus dose.
8 So, for instance, when you start on a new blood pressure
9 medicine, you know that the blood concentration of that
10 medicine is zero. And let’s say the physician is
11 desiring to get to 10, I’ll pick a unit, part per
12 billion of that blood pressure medicine. He’ll
13 prescribe a particular dose per day and your blood
14 levels will start to go up for that drug. Based on that
15 other picture I showed with respect to the elimination
16 in urine and feces and air, that’s accommodated for by
17 the pharmaceutical companies and by the physician when
18 they prescribe the dose.
19 They know at what blood concentration they get
20 the beneficial effect. So they prescribe the dose, and
21 they know roughly when there’s equilibrium between, I’ll
22 say, in and out of the body, and that’s a steady state
23 where the blood concentration remains steady. When you
24 go see your physician when you take a drug for a long
25 time like a blood pressure medicine, they frequently
4587
1 measure your blood concentration to make sure that it’s
2 at the steady state level that it should be for a given
3 dose. It’s the same for cobalt.
4 So we wanted to find out if you took this
5 cobalt every day which we did, does steady state happen,
6 you know, after — this is actually time. I’m sorry.
7 This is time and the dose is prescribed here at a unit
8 of measure, like, one pill or, in this case, milligrams
9 per kg. So this is fixed and so at that dose, what’s
10 the time or days it takes to get to steady state. And
11 that’s what it’s about. In most people, you get to
12 steady state with cobalt in around 14 days. That’s, as
13 you know, not that uncommon in drug therapy as well.
14 14 days is not uncommon.
15 Anyway, that’s what we learned about most
16 people got to steady state between 14 and 30 days. We
17 went to the 30-day study to get more people; so we could
18 understand where steady state occurred.
19 BY MR. CALFO:
20 Q. Okay. Doctor, you may resume the stand.
21 In your 30-day study, can you share with us
22 after people took the cobalt, what were some parts per
23 billion that you measured and were noted with the
24 participants?
25 A. Well, for the males, they were 16 parts per
4588
1 billion with a range of 9 to 32. So that reflected both
2 body weight and stomach absorption. What we found that
3 was interesting is the women were twice as high. This
4 has been seen before but not as precisely as we were
5 able to identify it. The women were virtually twice as
6 high with a range of 7 to 91. This study that we
7 originally started to understand the pharmacokinetics,
8 this is called, the in and out, the time course of
9 drugs, we started to become aware of the mechanisms by
10 which cobalt is absorbed.
11 Q. So did one of the participants from taking the
12 cobalt supplement at that dose reach a part per billion
13 of 91?
14 A. 91 parts per billion in 30 days.
15 Q. People take cobalt because they think it will
16 enhance their athletic performance?
17 A. That’s what some people do it for.
18 Q. And they think it might improve their health?
19 A. Some do. I think most take it for enhanced
20 athletic performance.
21 Q. Is the 30-day study complete, Doctor?
22 A. It is complete.
23 Q. Have you shared with us — well, let me ask
24 you: Have you shared this information on the 30-day
25 study with the scientific community for them to read?
4589
1 A. We’ve submitted it for publication.
2 Q. Has it been published yet?
3 A. No.
4 Q. Does it take time to publish?
5 A. It takes time to get through the peer-review
6 process.
7 Q. Because of that, did you consider another way
8 to share this information with the scientific community?
9 A. We did.
10 Q. How?
11 A. We thought that — we had a feeling this might
12 take a while to get published because it’s a more
13 complicated study. We then — what you do if you want
14 to get the information out is you present it at the next
15 scientific conference because it can take a year or two
16 to publish sometimes a paper. So we submitted it to be
17 published or presented at the next Society of Toxicology
18 meeting.
19 Q. Did you submit the abstract?
20 A. Yes, we did.
21 Q. Was the abstract published and peer reviewed by
22 that society?
23 A. It was accepted. After peer review, it’s not
24 come out yet. The meeting is in about three weeks.
25 MR. CALFO: Your Honor, I’d like to now move on
4590
1 to 2971, page 40.
2 THE COURT: Okay.
3 BY MR. CALFO:
4 Q. So, Doctor, you told us you published on cobalt
5 in the peer-reviewed journals?
6 A. Right.
7 Q. Has anyone, Doctor, that you’re aware of in the
8 field of toxicology assembled and analyzed the amount of
9 information on cobalt like you and your team of how many
10 scientists?
11 A. We have nearly a hundred all together now.
12 Q. Are you aware of anyone that’s assembled and
13 analyzed that amount of information on cobalt?
14 A. No.
15 Q. Would you agree that not even a university
16 anywhere in the world has put together what you’ve
17 assembled on cobalt?
18 A. Not that I’m aware of.
19 Q. Does it take a lot of time to assemble this
20 information and analyze it?
21 A. It takes a considerable amount of time but more
22 money than time probably.
23 Q. Did DePuy pay for all the time that you and all
24 your scientists did to analyze this information and
25 actually share it in the peer-reviewed journals?
4591
1 A. They did pay us.
2 Q. Do you have an amount — can you give us an
3 estimate of how much time you and your staff spent
4 investigating all this work that we talked about?
5 A. I would say a couple thousand hours.
6 Q. And since the time you were first retained on
7 the other product, the Pinnacle, up until the present
8 for all the work you’ve conducted to date, reviewing and
9 publishing and analyzing all the literature and doing
10 the work to prepare it, how much money have you billed
11 the client?
12 A. I think that we’ve had about 40 people at
13 various times work on this job. The total bill will
14 probably be in the vicinity of 4 or $5 million.
15 Q. Does that include all the time you worked on
16 the Pinnacle product as well?
17 A. It does. And it includes work that’s not been
18 published yet that is in review.
19 Q. And that work — all that work and all that
20 time was not just for work in this case; right?
21 A. No.
22 Q. Is it expensive to conduct the studies that you
23 did?
24 A. Oh, yes, especially an ongoing study that we
25 have is incredibly complicated and expensive.
4592
1 Q. I don’t want to know anything about it, but
2 share with us why it’s so incredibly complicated and
3 expensive to do this type of work.
4 A. Well, when you do the literature search work,
5 of course, it takes time to identify the papers, read
6 them and understand them. But more importantly, it’s to
7 integrate them. It’s like reading 20 books or 30 books
8 and trying to figure out what the common thread is.
9 You’re tying to solve a puzzle by reading books and
10 articles over the course of 50 years and saying, okay,
11 what is the scientific interpretation of that.
12 Next stage, of course, is writing that up in a
13 cohesive way so that people can understand it. For us
14 scientists, unlike nonfiction and fiction writers, it’s
15 hard. It’s very hard to write a scientific paper that’s
16 cohesive, understandable, logical, that six professors
17 or four professors are going to say, this is worthy of
18 scientific publication.
19 On the model, the model itself took computer
20 programmers and biologists to come up with. We were
21 able to do that efficiently because of the government
22 model. I’d say the most expensive aspect of this has
23 been the volunteer studies, because the volunteer
24 studies involve sending people to a laboratory every few
25 days to get their blood drawn, and then it has to be
4593
1 drawn properly, it’s sent to an analytical lab by
2 Federal Express, it’s expedited analysis, that analysis
3 has to be done right and then it has to be tabulated and
4 statistically interpreted.
5 And it — and then in other cases, you need
6 permission, of course, and all these — to fill out the
7 forms from the IRB, make sure they’re happy, do several
8 iterations, and then prepare for trial. And all that is
9 a substantial amount of money.
10 Q. Did we tell you, Doctor, to do the research, do
11 the studies and publish the results good, bad or
12 indifferent?
13 A. That’s what you told me.
14 Q. Did you disclose in the studies that you
15 published that DePuy funded the research?
16 A. We did say that DePuy funded the research.
17 Q. Did you tell the participants of the study
18 that?
19 A. Told the participants of the study that and we
20 told both it might very well appear in litigation.
21 Q. Now, let’s move on to page 41 of Exhibit 2971.
22 MR. PANISH: Your Honor, the next slide is the
23 one we discussed, and I’m going to — before he puts it
24 up.
25 THE COURT: No, that sentence can go up.
4594
1 MR. PANISH: No, not that. The next because
2 they just keep —
3 THE COURT: Understand.
4 MR. CALFO: May I proceed, Your Honor?
5 THE COURT: Yes. Because I know you want to
6 jump right into accommodations.
7 BY MR. CALFO:
8 Q. Based on all the work you told us about,
9 Doctor, do you have an opinion as to a reasonable degree
10 of scientific certainty whether cobalt and chromium
11 caused any of Mr. Kransky’s systemic health effects?
12 A. I do.
13 Q. Is the opinion expressed on the board? Or what
14 is your opinion? I’m sorry.
15 A. My opinion is the cobalt and chromium that was
16 released from his ASR implant did not in any way
17 increase his risk of systemic disease or worsen his
18 diseases.
19 Q. Can you share with us the factual bases that
20 you can point to to support that opinion?
21 A. The easiest basis is he had all the diseases
22 before the implant was implanted, so to me, that was the
23 most logical strong scientific evidence as to why the
24 cobalt wasn’t a factor. The secondary support for that
25 is our studies of cobalt indicate that the blood
4595
1 concentrations did not reach those that would ever
2 remotely increase systemic disease.
3 Q. Now, Doctor, you talked about the anemia
4 studies earlier?
5 A. Yes.
6 Q. And you told the jury about polycythemia; is
7 that right?
8 A. Yes.
9 Q. Share with us again what the parts per billion
10 you noted in your biokinetic model were to the point
11 where you might get polycythemia.
12 A. We thought for most people it would take up to
13 300 parts per billion.
14 Q. And you did that pursuant to your expertise in
15 toxicology; is that right?
16 A. Sure.
17 Q. And did you analyze what would happen to the
18 body if exposed to very large amounts of cobalt in terms
19 of red blood cells in your opinions in this case?
20 A. Sure.
21 Q. Was that in relation to your published
22 literature with respect to polycythemia?
23 A. Sure.
24 Q. So, Doctor, if your body is exposed to very
25 large amounts of cobalt, would the first thing that
4596
1 would happen be an increase to production of red blood
2 cells or polycythemia?
3 MR. PANISH: Objection. Leading, suggestive,
4 and also medical foundation for this witness.
5 THE COURT: Overruled, on both grounds. I’ll
6 allow him to answer the question.
7 THE WITNESS: Yes, you would expect an increase
8 in polycythemia if the person were responding to cobalt.
9 BY MR. CALFO:
10 Q. When you reviewed Mr. Kransky’s medical
11 records, did you determine if Mr. Kransky ever had
12 polycythemia?
13 A. Yes.
14 Q. And what did you find?
15 A. I found that —
16 MR. PANISH: Objection. It’s a medical opinion
17 without foundation.
18 THE COURT: Sustained.
19 BY MR. CALFO:
20 Q. In order to determine polycythemia, did you
21 have — let me ask you this: How do hematocrit levels
22 relate to polycythemia?
23 MR. PANISH: Still foundation.
24 THE COURT: Overruled. You may answer.
25 THE WITNESS: Hematocrit is basically a measure
4597
1 of the red blood cells in the blood.
2 BY MR. CALFO:
3 Q. And in your work in this case, in determining
4 the toxicological issues that relate to this case, the
5 Kransky case, did you analyze the medical records to
6 determine Mr. Kransky’s hematocrit levels in order to
7 assess parts per billion and the possibility of
8 polycythemia?
9 A. Yes.
10 Q. And did you do that in order to render your
11 toxicological opinions in this case?
12 A. Yes.
13 Q. Is it common for you as a toxicologist, Doctor,
14 to do such an analysis where you analyze someone’s
15 medical records, including polycythemia and hematocrit
16 levels?
17 A. Absolutely. All through grad school, we
18 collect these same blood parameters on animals, whereas
19 physicians collect on humans.
20 Q. And when you reviewed Mr. Kransky’s medical
21 records, did you note his hematocrit levels?
22 A. Yes, sir.
23 Q. And why did you do that?
24 A. Because I was curious as to whether or not he
25 was having a biologic response to cobalt. If he was,
4598
1 you’d see a change in his RBC or hematocrit levels.
2 Q. Is that something you, as a professor and
3 expert in toxicology, do?
4 A. Of course. We look for the most sensitive and
5 appropriate toxicologic end points or biologic end
6 points.
7 MR. CALFO: Your Honor, I’d like to publish
8 Exhibit 2971, page 42.
9 MR. PANISH: Same — it’s the medical opinions.
10 THE COURT: There’s been sufficient foundation
11 laid. He can testify.
12 BY MR. CALFO:
13 Q. Doctor, what do we see on the screen?
14 A. We see an over time depiction of hematocrit
15 levels that were found in his medical — various medical
16 records starting from June 20, 2001, all the way through
17 June 20, 2012. We can make note of the fact of when the
18 first right hip replacement occurred, when the left hip
19 replacement occurred, when the right kidney was removed,
20 and when the left hip was revised.
21 You’ll note on the top — I don’t have a
22 pointer, but at the top of the blue dotted line, that’s
23 the normal range for — thank you, Your Honor. So you
24 see the normal range is 50 up here for hematocrit, and
25 you’ll see the normal range is about 38.5 on the low
4599
1 end. And, in fact, he’s chronically deficient in red
2 blood cells, not apparently clinically significant, but
3 deficient from the normal range.
4 If you thought that he was responding to
5 cobalt, which causes an increase in red blood cells,
6 you’d see something going on up here.
7 Q. So, Doctor, from a toxicological standpoint, do
8 you have an understanding as to whether or not
9 Mr. Kransky’s body ever recognized and responded to
10 cobalt in the blood?
11 MR. PANISH: Same objections.
12 THE WITNESS: All you can say —
13 THE COURT: Hold on. Read back the last
14 question.
15 (Record read.)
16 THE COURT: Overruled. You may answer.
17 THE WITNESS: All you can say is for this
18 particular toxicological response, there’s no apparent
19 response to cobalt.
20 BY MR. CALFO:
21 Q. Now, you can take that down.
22 Now, Doctor, are you aware that Dr. Harrison,
23 in his testimony before this jury, mentioned
24 cytotoxicity?
25 A. Yes.
4600
1 Q. Share with us again — the jury’s heard it, —
2 what does cytotoxic mean?
3 A. It means it can bring about cell death.
4 Q. And can you give the jury some examples of
5 things that are cytotoxic?
6 A. Well, when I mention these things, it’s like
7 every other chemical, it’s based on dose, and dose at
8 the target tissue. So you can have a range of things.
9 It could be caffeine. It can be a dry cleaning fluid,
10 it can be a cancer drug — you know, cancer treatment
11 drugs. It can be nonsteroidal antibiotics or
12 nonsteroidal antiinflammatories. A lot of chemicals
13 cause cytotoxicity in a high enough dose. In fact,
14 virtually all chemicals at a high enough dose.
15 Q. As a toxicologist, is it common for you to
16 measure the levels of a substance in terms of
17 cytotoxicity?
18 A. You measure the levels of a substance
19 intermedia and identify the concentrations that cause
20 cytotoxicity.
21 Q. And what level of cobalt is cytotoxic?
22 A. It depends on the cell culture that you’re
23 looking at. Depends very, very much on the media.
24 THE REPORTER: Can you say that again?
25 THE WITNESS: Yes. It depends very, very much
4601
1 on the media, m-e-d-i-a, that you’re testing. In my
2 review, it’s not uncommon to require 5,000 parts per
3 billion of cobalt to bring about the cytotoxic effects
4 in some media.
5 BY MR. CALFO:
6 Q. Did you also read where Dr. Harrison discussed
7 genotoxicity?
8 A. Yes.
9 Q. Doctor, what does genotoxic mean?
10 A. Genotoxic is when the chemical at some dose in
11 some media has the ability to influence the DNA. It can
12 break it. It can cause sister chromatid exchanges, it
13 can do one of many different things in different cell
14 lines. These are usually done in vitro, which means
15 outside the body, although there are in vivo animal
16 tests where you can measure this, and there’s a few
17 human tests. But it’s very much dose dependent, and
18 they each have their own level of biological
19 significance and severity.
20 Q. Have you analyzed genotoxicity with respect to
21 cobalt and chromium?
22 A. Yes.
23 Q. Can you share with the jury what you’ve opined
24 with respect to cobalt and chromium and genotoxicity?
25 A. Well, chromium III in vivo is thought not to
4602
1 have much genotoxicity at all. The way we test for
2 ultimate genotoxicity, because it’s meant to predict the
3 cancer response — that’s not a secret about this —
4 it’s meant to tell you is this a chemical I should be
5 worried about from a cancer standpoint? That’s the
6 objective.
7 And so for chrome III, it doesn’t have much
8 genotoxicity at all. For cobalt, it also doesn’t have
9 much genotoxicity at all, and fortunately, if you look
10 at the epidemiology studies, which are the ultimate
11 tests for cancer, they were been favorable thus far.
12 Q. With respect to metal-on-metal —
13 A. And I’m talking about oral intake.
14 Q. With respect to metal-on-metal hips generally,
15 have studies been conducted to determine if there is any
16 increased risk of cancer?
17 A. I’m sorry?
18 Q. With respect to metal-on-metal hips, are you
19 aware of studies that were conducted to determine if
20 there is any increased risk in cancer?
21 A. Yes. There’s been, I think, upwards of half a
22 dozen epidemiology studies on metal-on-metal and
23 metal-on-poly implants. An epidemiology study simply
24 means you’re looking at large groups of people that have
25 that device and compare it to those that don’t.
4603
1 Q. Can you share with us generally what those
2 cancer studies have shown?
3 A. They’ve not shown an increase of cancer, except
4 for one aberration that they concluded was biologic or
5 not relevant.
6 Q. Are you aware that the parties all agree that
7 Mr. Kransky’s cancer was in no way caused by his ASR or
8 metal-on-poly hip?
9 A. I mean, it’s a legal thing, but I’ve been told
10 that the lawyers have agreed to that.
11 Q. Is there any evidence, Doctor, that you can
12 point to whatsoever that cobalt and chromium had any
13 harmful genotoxic effect on Mr. Kransky’s DNA?
14 A. I have no evidence of that.
15 Q. Did you read Dr. Harrison’s testimony where he
16 has no opinion on cobalt having affected Mr. Kransky’s
17 kidney function?
18 A. I did read that.
19 Q. Now, in your review of understanding the
20 toxicological issues in this case, were you aware that
21 Mr. Kransky had preexisting chronic kidney disease?
22 MR. PANISH: Excuse me, Your Honor. Number
23 one, it’s leading and suggestive. Number two, there’s
24 no medical foundation for this doctor as a medical
25 doctor.
4604
1 THE COURT: Sustained.
2 BY MR. CALFO:
3 Q. As a toxicologist and in analyzing this case,
4 is it common for you to analyze medical records of a
5 patient?
6 A. Yes.
7 Q. And when you analyzed the issue of
8 metal-on-metal hips and cobalt chromium ion levels, did
9 you look to Mr. Kransky’s medical records to determine
10 his kidney function?
11 A. Yes.
12 Q. From a toxicological standpoint, Doctor, why,
13 if at all, would someone’s kidney function be important
14 in terms of metal ions and parts per billion?
15 MR. PANISH: I’m going to object on this
16 witness. Medical foundation.
17 THE COURT: Sustained. Beyond the scope of his
18 expertise.
19 BY MR. CALFO:
20 Q. Let me just ask you generally, Doctor. As a
21 toxicologist who analyzes parts per billion, does kidney
22 function determine in some way toxicologically whether
23 or not there is an increase in metal ion levels?
24 MR. PANISH: Same objection. Medical opinion.
25 THE COURT: Read back the last question,
4605
1 please.
2 (Record read.)
3 THE COURT: I don’t understand the question.
4 It sounds like it’s beyond the scope of his expertise.
5 MR. CALFO: Can I just ask one more?
6 THE COURT: You can ask.
7 BY MR. CALFO:
8 Q. Doctor, as a toxicologist you talked about
9 the — you remember the board where you had the drawing
10 about blood and all the other organs? Do you remember
11 that?
12 A. Yes, sir.
13 Q. In your analysis of this case and metal ions,
14 cobalt and chromium, can you share with us from a
15 toxicological perspective how metal ions are excreted
16 from the body?
17 MR. PANISH: I’m going to object on medical and
18 nephrology opinions.
19 THE COURT: Overruled. You can answer that
20 question.
21 THE WITNESS: The primary route of elimination
22 of cobalt is through the kidney into the urine.
23 BY MR. CALFO:
24 Q. And in this case, did you analyze the medical
25 records with respect to Mr. Kransky’s kidney function?
4606
1 A. Yes.
2 Q. What did you understand Mr. Kransky’s kidney
3 function was with respect to chronic kidney disease?
4 MR. PANISH: Same. Medical.
5 THE COURT: Sustained.
6 BY MR. CALFO:
7 Q. Doctor, is it your opinion that cobalt and
8 chromium from the ASR did not cause or worsen
9 Mr. Kransky’s systemic health effects?
10 A. Yes.
11 Q. Finally, Doctor, was Mr. Kransky poisoned by
12 the ASR?
13 A. Absolutely not.
14 Q. Thank you.
15 THE COURT: Cross-examination?
16 MR. PANISH: Yes, Your Honor. There’s just one
17 thing that I need to approach before I begin based on
18 your —
19 THE COURT: On or off?
20 MR. PANISH: It doesn’t matter. I’m happy to
21 do it without the reporter.
22 THE COURT: Okay.
23 (Sidebar proceedings.)
24 MR. PANISH: Could I approach for a second?
25 THE COURT: Yeah. You need to look at the
4607
1 exhibit?
2 MR. PANISH: No.
3 THE COURT: Are you attempting to mark
4 something?
5 MR. PANISH: I am, Your Honor, next in order,
6 2984.
7 THE COURT: The chart, whatever it is, will be
8 2984.
9 (Exhibit No. 2984 was marked for
10 identification.)
11 CROSS-EXAMINATION
12 BY MR. PANISH:
13 Q. Good afternoon almost, Mr. — or Dr. — is it
14 Dr.?
15 A. Yes, sir.
16 Q. You’re not a medical doctor, are you, sir?
17 A. No.
18 Q. Never been to medical school, have you?
19 A. No, sir.
20 Q. Never treated a patient, have you?
21 A. No, sir.
22 Q. Never performed a surgery, have you?
23 A. Only on rats.
24 Q. You’re not here as an independent witness, are
25 you, sir?
4608
1 A. I hope so.
2 Q. Sir, you’ve been paid nearly $5 million in this
3 case, have you not, sir?
4 A. My firm’s been paid nearly $5 million.
5 Q. Could you go up there for me, and I’d like to
6 make it Exhibit 2984 — could you help me and stand up
7 there —
8 A. Sure.
9 Q. And I left a pen for you. And if you could put
10 on the top of that dollar signs three across the page?
11 THE COURT: I’m sorry. What across the page?
12 MR. PANISH: Dollar signs.
13 BY MR. PANISH:
14 Q. You know what those are; right?
15 Now, sir, did you bring the bills with you of
16 how much your firm and you have been charging DePuy in
17 the last 18 months to get involved in this hip
18 litigation?
19 A. No, I wasn’t asked to do that.
20 Q. Mr. Calfo didn’t tell you that I made repeated
21 requests —
22 MR. ZELLERS: Your Honor, I object.
23 MR. PANISH: Excuse me. Can I ask the
24 question?
25 THE COURT: Put — ask the question. But if
4609
1 it’s going to be about discovery —
2 MR. PANISH: No.
3 BY MR. PANISH:
4 Q. It’s about, when you came to your expert
5 deposition, sir, you received a notice to bring all your
6 bills; correct?
7 A. Up until that time, I think I did.
8 Q. You didn’t bring them to your deposition, did
9 you, sir?
10 A. I believe some were produced at that
11 deposition.
12 Q. How much did those add up to?
13 A. I don’t know.
14 Q. Do you have an accounting system at this large
15 international company you run?
16 A. Yes, sir.
17 Q. It’s easy to get the amount of money that
18 DePuy’s paid or you’ve billed them so far; is that
19 right?
20 A. It could be done.
21 Q. Could you call over the noon hour and get the
22 bills sent down here for us, sir?
23 MR. CALFO: Your Honor, I object.
24 THE COURT: Talk to opposing counsel about
25 discovery matters.
4610
1 BY MR. PANISH:
2 Q. Well, if I give you a subpoena, will you honor
3 it and bring the documents?
4 THE COURT: Counsel, cross-examine this witness
5 on what we did this morning.
6 BY MR. PANISH:
7 Q. Well, can you write up for us how much you’ve
8 billed DePuy so far, sir?
9 A. I’ve estimated between 4 and $5 million.
10 Q. A billion — excuse me —
11 THE COURT: Are you asking him to write the
12 numbers?
13 MR. PANISH: Yeah.
14 THE COURT: Please write the numbers.
15 BY MR. PANISH:
16 Q. Which you say it is 4 to 5 million in
17 18 months; right?
18 A. Yes, sir.
19 Q. Write it up.
20 A. Where would you like it written?
21 Q. Wherever you’d like.
22 Now, sir, that’s within a million so it could
23 be 6 million?
24 A. Today?
25 Q. As of today, how much have you and your firm
4611
1 have billed —
2 A. I —
3 THE COURT: Hold on.
4 MR. PANISH: Let me ask the question.
5 THE COURT: Wait for the question and then you
6 can answer.
7 BY MR. PANISH:
8 Q. How much is it your testimony under oath here
9 today that you and your company have billed DePuy since
10 Mr. Calfo called you and retained you regarding the hip
11 litigation for DePuy?
12 A. I can’t under oath tell you if it’s much
13 greater than 5 million. I’ve given you my best
14 estimate.
15 Q. So your best estimate is now 5 million?
16 A. Yes, sir, as of today.
17 Q. Okay. So at your deposition it was only 4
18 million, and that was, what, a month ago?
19 A. Yes.
20 Q. So in a month you’ve billed a million?
21 A. We’ve done work that I haven’t talked about
22 here that could have amounted to a million dollars.
23 Q. But you could easily obtain that information
24 over the noon hour; is that right, sir?
25 A. I could. That doesn’t mean you’d be entitled
4612
1 to it, but I could get it.
2 Q. Well, if I serve a subpoena on you, would you
3 give it to me?
4 THE COURT: Counsel, take it out in the hallway
5 later on. We’re not going to deal with discovery
6 matters during trial.
7 BY MR. PANISH:
8 Q. Were you asked to bring your bills to the
9 deposition, sir?
10 A. Mr. Panish, you know there’s —
11 THE COURT: Hold on. The question is were you
12 asked to bring your bills.
13 THE WITNESS: I don’t know if I was asked to
14 bring all of the bills. I don’t know if all the bills
15 were asked for.
16 BY MR. PANISH:
17 Q. So is the answer no, you don’t know?
18 A. That’s fair.
19 Q. Okay. Now, sir, you charge 575 an hour; is
20 that right?
21 A. Yes, sir.
22 Q. Has your company changed names?
23 A. In the last 30 days it has — well, not
24 officially. It will change names in the next two
25 months.
4613
1 Q. Okay. And did you now merge and take on
2 another company?
3 A. Yes.
4 Q. You can sit down now, if you’d like.
5 A. Thank you.
6 Q. Now, sir, it’s important, as you’ve told us,
7 you used the word “integrity” four time; right?
8 A. At least twice.
9 Q. “Honesty,” you used those words; right?
10 A. Yes.
11 Q. You used “truthfulness,” didn’t you, sir?
12 A. I don’t know, but I’d support the word
13 “truthfulness.”
14 Q. So do you think it’s important that a witness
15 that’s paid $5 million when they come to court to
16 testify to the jury is truthful?
17 A. Absolutely.
18 Q. Has high integrity?
19 A. Yes, sir.
20 Q. Is honest?
21 A. Yes, sir.
22 Q. And independent?
23 A. Yes, sir.
24 Q. And, sir, you’ve been found to not be
25 independent; isn’t that true?
4614
1 A. That’s absolutely not true.
2 Q. Sir, have you — by the way, how many times
3 have you met with DePuy representatives and their
4 lawyers since you’ve been hired?
5 A. Are you counting by days or events or how would
6 you like that answered?
7 Q. Let’s start with days.
8 A. No less than 30.
9 Q. So you’ve spent at least 30 days meeting with
10 DePuy and their lawyers to prepare for this case;
11 correct?
12 A. No, that’s not what you asked me. Over the
13 last 20 months, it’s possible I prepared or discussed
14 issues with them between 20 and 30 days, I would say.
15 Q. Where have those meetings taken place?
16 A. They’ve taken place in Chicago, once in Boston,
17 and here in L.A.
18 Q. Have you been to the headquarters in Indiana,
19 Warsaw, Indiana?
20 A. No, sir.
21 Q. Have you gone there and checked out anything
22 there at — you haven’t? Okay.
23 Now, have you met this gentleman sitting over
24 here, Mr. O’Shaughnessy, from the company in Indiana?
25 A. Yes, sir.
4615
1 Q. What is Mr. O’Shaughnessy? What does he do?
2 A. I think he’s a senior lawyer at the firm, if
3 not assistant general counsel.
4 Q. For the company DePuy?
5 A. That’s my understanding.
6 Q. And you’ve met with Mr. O’Shaughnessy and told
7 him about the work you’ve done in this case; right?
8 A. I have at times.
9 Q. And Mr. Calfo, he’s the one that got you
10 involved in this; right?
11 A. Yes, sir.
12 Q. And you and Mr. Calfo have worked on other
13 cases together, haven’t you, sir?
14 A. I think he’s already said we had one trial
15 together and one case where it did not try.
16 Q. Okay. When he hired you in the other case,
17 that was on behalf of the Ford Motor Company that was
18 being sued for causing asbestos to somebody that was
19 working; correct, sir?
20 MR. CALFO: Objection, Your Honor. Vague and
21 ambiguous as to time.
22 THE COURT: Overruled. You may answer. That
23 was your understanding of the case?
24 THE WITNESS: The allegation was that Ford had
25 contributed to this man’s mesothelioma.
4616
1 BY MR. PANISH:
2 Q. And mesothelioma, is that a disease that
3 somebody gets when they’re exposed to asbestos?
4 A. Generally.
5 Q. Was that person dying when you were hired by
6 Mr. Calfo?
7 A. I believe he was.
8 Q. And you came to court in this building and you
9 testified just like you are here today; right?
10 A. Yes, sir.
11 Q. And you were cross-examined by the lawyers
12 representing the man that was dying from mesothelioma;
13 correct?
14 A. Yes, sir.
15 Q. And they went into a lot of things in your
16 background about your honesty and integrity, didn’t
17 they, sir?
18 A. Yes, sir.
19 Q. And Mr. Calfo was well aware of all those
20 things in your background before he hired you on behalf
21 of DePuy; isn’t that right, sir?
22 MR. CALFO: Objection, Your Honor. Calls for
23 speculation.
24 THE COURT: Sustained.
25 ///
4617
1 BY MR. PANISH:
2 Q. Was Mr. Calfo sitting there in the trial when
3 you were cross-examined?
4 A. Yes, sir.
5 Q. Did he hear all of the things that came out
6 about your background — do you have to go somewhere?
7 You’re looking at the clock.
8 THE COURT: Just put —
9 THE WITNESS: No, I’m looking at the jury, sir.
10 BY MR. PANISH:
11 Q. By the way, you’re not unfamiliar with coming
12 to courtrooms and turning to — when you testify,
13 looking at the jury, are you, sir?
14 A. Yeah. I testify once or twice a year,
15 Mr. Panish.
16 Q. Okay. Mr. Calfo, is he aware of the things in
17 your background about your integrity and honesty?
18 MR. CALFO: Objection, Your Honor. Calls for
19 speculation.
20 THE WITNESS: He’s aware.
21 THE COURT: Sustained.
22 BY MR. PANISH:
23 Q. When you testified in the Ford Motor Company
24 case on behalf of the Ford Motor — by the way, how much
25 has your firm over the years billed the Ford Motor
4618
1 Company?
2 MR. CALFO: Objection, Your Honor. Irrelevant.
3 THE COURT: Sustained. We’re not going to try
4 that case.
5 MR. PANISH: It’s just on the —
6 THE COURT: Counsel, sustained. No speaking
7 objections.
8 BY MR. PANISH:
9 Q. So in that case you were cross-examined on your
10 integrity and honesty, weren’t you, sir?
11 A. Allegations of integrity or honesty.
12 Q. Is that a “yes”? Were you questioned — was
13 your integrity and honesty questioned in that case?
14 MR. CALFO: Objection. No relevance as to
15 questions, Your Honor, in another case.
16 THE COURT: Overruled. See where it’s going.
17 THE WITNESS: Yes, counsel did question it,
18 yes, sir.
19 BY MR. PANISH:
20 Q. And did you share with Mr. O’Shaughnessy, the
21 lawyer from the company, some things in your background
22 that you might be concerned about when you were going to
23 testify on behalf of DePuy after billing them
24 $5 million?
25 MR. CALFO: Objection, Your Honor. There’s no
4619
1 foundation.
2 THE COURT: Overruled.
3 THE WITNESS: Can I hear that back, please?
4 THE COURT: You may ask me to have it back.
5 You may read — yes. Read back the last question.
6 (Record read.)
7 THE WITNESS: I don’t recall if I shared with
8 him concerns I had, but I shared with him or Mr. Calfo
9 that you would likely attempt to bring these to the
10 jury’s attention.
11 BY MR. PANISH:
12 Q. So they knew, you told either Mr. Calfo or the
13 lawyer back there, Mr. O’Shaughnessy, about the things
14 in your background that you somehow knew I was going to
15 bring up; right?
16 A. Somehow knew?
17 Q. You just said you knew that I was going to
18 bring them up. You weren’t asked about them in your
19 deposition, were you, sir?
20 A. No.
21 Q. You’ve never met me before, have you, sir?
22 A. No.
23 Q. So you didn’t have any idea what I was going to
24 ask you before you came to this courtroom, did you, sir?
25 A. Oh, I certainly had some ideas.
4620
1 Q. Because your integrity and honesty has been
2 questioned as a witness on behalf of companies, and you
3 shared that with Mr. Calfo and/or Mr. O’Shaughnessy
4 before taking the stand in this case; isn’t that true,
5 sir?
6 A. That’s not how I learned.
7 Q. Did you, sir, share with Mr. Calfo or
8 Mr. O’Shaughnessy from the company, about your
9 background and things that might come up as a witness
10 for the company? “Yes” or “no”?
11 A. I’ve already answered your question.
12 Q. You haven’t, sir. Could you answer it, please?
13 THE COURT: Is the answer “yes,” that you
14 talked about these things with them?
15 THE WITNESS: Yes.
16 BY MR. PANISH:
17 Q. When did you first raise them with
18 Mr. O’Shaughnessy before you came here?
19 A. I don’t know when it was raised with him. I
20 raised it the first hour that I met with the DePuy
21 lawyers.
22 Q. Who were those lawyers that you met with that
23 first hour?
24 A. Dawn Curry.
25 Q. Is that the person sitting back in the back
4621
1 from Boston?
2 A. Yes, sir.
3 Q. And she came out from Boston, she’s been
4 working with you; right?
5 A. Yes.
6 Q. Who else did you share that with other than
7 Ms. Curry?
8 A. Mr. Schmamman?
9 Q. Mr. Schmamman, where is he from?
10 A. He’s also from Boston.
11 Q. From Boston. Okay. Who else did you share
12 that with?
13 A. Kelley Olah.
14 Q. That’s Mr. Calfo’s associate who’s sitting
15 right here; is that right?
16 A. That’s right.
17 Q. And who else did you share that with?
18 A. I think that was adequate.
19 Q. Is this before or after you were retained by
20 Mr. Calfo?
21 A. In this engagement?
22 Q. For DePuy 18 months.
23 A. You’ve already established that he and I worked
24 together 18 months ago. He listened to a cross. I
25 don’t understand your question.
4622
1 THE COURT: Just say you don’t understand the
2 question. Reframe it.
3 BY MR. PANISH:
4 Q. Let’s go back now. We know the two lawyers
5 from Boston you’ve met with, Mr. Calfo and Ms. Olah.
6 MR. PANISH: I’m sorry if I mispronounced your
7 name.
8 BY MR. PANISH:
9 Q. Who else have you met with in the course of
10 these 30 meetings that you’ve had to defend DePuy in
11 this case?
12 A. As I testified in my deposition —
13 Q. Excuse me. Could you please answer the
14 question?
15 A. Sure. Bob Hastings.
16 Q. Okay. Mr. Hastings, where is he from?
17 A. Warsaw, Indiana, I believe.
18 Q. Okay. Is he with the company, like
19 Mr. O’Shaughnessy?
20 A. I believe so.
21 Q. Is Mr. O’Shaughnessy his boss?
22 A. Oh, I have no idea.
23 Q. Okay. Who else did you meet with in these
24 30 — did you say 30 or 20 meetings?
25 A. I said between 20 and 30, with the vast number
4623
1 of people you mentioned.
2 Q. With the attorneys. Yes, keep going.
3 A. That wasn’t your question.
4 THE COURT: Hold on. What’s the question? How
5 many lawyers?
6 BY MR. PANISH:
7 Q. All the lawyers that you’ve met with — have
8 you met Mr. Zellers, do you know who he is?
9 A. Yes — no — actually — yes, I have met
10 Mr. Zellers.
11 Q. How about Mr. Hudson over here, this gentleman
12 over here?
13 A. Yes.
14 Q. Okay. Who else have you met with, sir?
15 A. At least once, you mean like met or met, shake
16 their hand and had a meeting? That’s a different thing.
17 Q. Okay. Let’s talk about those 20 or 30
18 meetings. Tell us the lawyers that were present.
19 THE COURT: In every meeting?
20 BY MR. PANISH:
21 Q. Not every — just the vast — have you met with
22 over 30 attorneys on behalf of DePuy, sir?
23 A. No, I never said that.
24 Q. That was the question. Have you met with over
25 30? “Yes” or “no”?
4624
1 A. Oh, I didn’t hear it that way. No, I have not
2 met with over 30.
3 Q. Who else in this courtroom? How about the two
4 people that are sitting back in the first row, have you
5 met with them?
6 A. I don’t recall. I will give you my best
7 estimate of the number of lawyers I’ve met with, if you
8 like.
9 Q. First, let’s start with the people in the
10 courtroom. Mr. Josh over here, have you met with him,
11 the gentleman with the red tie?
12 MR. CALFO: Your Honor, I have to object, 352.
13 THE COURT: Let’s go through this quickly.
14 I’ll allow it, but very quickly.
15 THE WITNESS: I don’t recall that I have.
16 BY MR. PANISH:
17 Q. How about the person sitting next to him?
18 A. No.
19 Q. Anyone else in this courtroom that you
20 recognize, sir? Do you recognize Mr. Gary Paul sitting
21 back there?
22 A. No.
23 Q. You never met him?
24 A. I don’t know but I don’t recognize him.
25 Q. Okay. Now, isn’t it true, sir, that you’re
4625
1 referred to as the go-to guy for chemical companies?
2 A. I’m well aware of where the statement
3 originated.
4 Q. Sir, could you please —
5 A. That’s ridiculous. What do you mean?
6 THE COURT: Doctor, simply answer his
7 questions. Do not argue with him.
8 THE WITNESS: I have seen that quote.
9 BY MR. PANISH:
10 Q. You have been referred to — let me make sure I
11 said it accurately — the go-to guy for industry
12 defendants; isn’t that true, sir?
13 MR. CALFO: Your Honor, I’m going to object to
14 the extent this is hearsay. 352.
15 THE COURT: I’ll see where it’s going. I don’t
16 know what he’s referring to —
17 THE WITNESS: You’re referring to a quote by a
18 gentleman —
19 BY MR. PANISH:
20 Q. Excuse me —
21 THE COURT: Hold on.
22 MR. PANISH: Could you please —
23 THE COURT: Hold on. When I’m talking, both of
24 you be quiet. Put a question. Do not argue with
25 Mr. Panish. Put a question.
4626
1 BY MR. PANISH:
2 Q. Sir, have you been referred to as, quote, “the
3 go-to guy for industry defendants”; isn’t that true?
4 MR. CALFO: Objection. No foundation, hearsay.
5 THE COURT: Overruled.
6 Have you heard that reference?
7 THE WITNESS: Yes.
8 BY MR. PANISH:
9 Q. Sir, I want to read you a definition and ask
10 you if you’ve ever heard of this. Okay?
11 A substance that through its chemical action
12 usually kills, injures, or impairs an organism.
13 Do you know what that’s referring to, sir?
14 A. Usually a poison.
15 Q. Poison. Exactly. How about something that’s
16 destructive or harmful to cells. Is that a poison, sir?
17 A. Not necessarily. That would be cytotoxic.
18 Q. Cytotoxic. Okay.
19 Now, sir, you told us about these anemia
20 studies extensively during your testimony; correct?
21 A. True.
22 Q. Isn’t it true that those anemia studies that
23 you referred to were discontinued in the 1950s?
24 A. No.
25 Q. Okay. I’d like to play the deposition,
4627
1 page 86, line 16, page 87, line 17.
2 Do you remember giving your deposition, sir?
3 A. Absolutely.
4 Q. Under oath?
5 A. Sure.
6 Q. Mr. Calfo was there representing you?
7 A. Yes, sir.
8 Q. And you read that deposition, you signed it
9 under penalty of perjury?
10 A. Sure.
11 Q. Okay. Let’s play it, please.
12 THE COURT: Hold on. Deposition taken? Date?
13 MR. PANISH: Good point. December 20, 2012,
14 about — couple of months ago.
15 MR. CALFO: Your Honor, may I just have a
16 moment.
17 THE COURT: I’m sorry. Hold on.
18 BY MR. PANISH:
19 Q. You met that lawyer over that that brought that
20 deposition —
21 MR. CALFO: Your Honor, please. 352, some
22 decorum, please.
23 THE COURT: I think we have enough lawyers.
24 I’ll take judicial notice. We have enough lawyers.
25 MR. PANISH: No, I’m just talking about with
4628
1 this witness.
2 THE COURT: Let’s move on. I understand. Give
3 Mr. Calfo an opportunity to look at the transcript.
4 MR. PANISH: Sure.
5 BY MR. PANISH:
6 Q. Was Mr. Calfo present at the deposition with
7 you?
8 A. Yes, sir.
9 MR. CALFO: I’m sorry. What page, Counsel?
10 MR. PANISH: 86, page 16, page 78, line 17.
11 MR. CALFO: Okay.
12 (Videotaped testimony of DENNIS PAUSTENBACH was
13 played as follows:)
14 QUESTION: Has cobalt itself, not
15 vitamin B-12, but cobalt specifically
16 been used in modern medicine in the
17 last 30 years to treat any ailment
18 that you’re aware of?
19 ANSWER: It’s still used as a
20 radiotracer for determining either red
21 blood cell half-life or one other
22 diagnostic tool. It’s not — it’s no
23 longer used to deal with anemia, but
24 it’s used for some diagnostic tools.
25 QUESTION: Why is it no longer
4629
1 used to deal with anemia, sir?
2 ANSWER: There’s better drugs
3 today.
4 QUESTION: Was it also causing
5 harm to people that it was being used
6 to treat anemia?
7 ANSWER: At the doses that some
8 people were using it, that’s true.
9 QUESTION: So it was discontinued
10 when, in the ’50s?
11 ANSWER: We have tried to look at
12 that. I think some people used it up
13 until the middle ’60s, but generally,
14 it’s most popularly used in the middle
15 ’50s.
16 QUESTION: And it stopped because
17 it hurt people; right?
18 ANSWER: No. It stopped because
19 the margin of safety was too small
20 between its helpful effects and its
21 detrimental effects.
22 (Videotaped testimony of DENNIS PAUSTENBACH
23 concluded.)
24 BY MR. PANISH:
25 Q. Sir, in one of these textbooks, have you
4630
1 bragged about saving companies millions of dollars in
2 clean-up costs?
3 A. In one of my textbooks?
4 Q. Yes, sir.
5 A. It’s plausible, but I don’t remember the
6 statement.
7 Q. Well, sir, you’ve never heard that statement
8 where you’ve spoken or written about saving millions of
9 dollars for chemical companies when there was pollutants
10 that needed to be cleaned up? “Yes” or “no”?
11 A. That’s a different question.
12 Q. You can answer that one then.
13 THE WITNESS: Your Honor —
14 THE COURT: Yes.
15 BY MR. PANISH:
16 Q. Answer the question.
17 MR. CALFO: Your Honor, I object again. It’s
18 hearsay.
19 THE COURT: I’ll see where it’s going. You may
20 answer the question.
21 THE WITNESS: May I hear it from the reporter?
22 THE COURT: Read back the last question again.
23 (Record read.)
24 THE WITNESS: I wouldn’t have said it that way.
25 ///
4631
1 BY MR. PANISH:
2 Q. Okay. Have you ever consulted with companies
3 in litigation involving exposure to toxins?
4 A. Of course.
5 Q. And have you helped save hundreds of millions
6 of dollars in clean-up costs for chromium pollution in
7 New Jersey?
8 A. I believe I did.
9 Q. And you’ve written about that, haven’t you,
10 sir?
11 A. I wouldn’t be surprised.
12 Q. Is that — okay.
13 And, sir, isn’t it true that you consulted with
14 Honeywell, PPG, and Maxus Energy about chromium
15 pollution in New Jersey?
16 A. Absolutely.
17 Q. And you were paid to lobby the government of
18 the state of New Jersey to change their standards for
19 chromium in the soil; isn’t that true, sir?
20 A. I was asked to — by the government to meet
21 with them in a series of meetings to come up with soil
22 clean-up levels.
23 Q. You were paid by Honeywell, PPG, and other
24 chemicals to do that — companies, weren’t you, sir?
25 A. Yes, sir.
4632
1 Q. And, sir, isn’t is it true that you have worked
2 on behalf of almost every chemical company in the United
3 States of America, any large chemical company?
4 A. Over my 30-year career, that’s fundamentally
5 true.
6 Q. You’ve worked in litigation now, we’re just
7 talking about lawsuits where people are claiming that
8 these companies have either injured people; right?
9 A. Perhaps.
10 Q. Or damaged the environment by their chemicals
11 polluting the environment?
12 A. Usually one or the other.
13 Q. Right. And those companies include DuPont;
14 correct?
15 A. True.
16 Q. Union Carbide?
17 A. True.
18 Q. Dow Chemical?
19 A. True.
20 Q. 3M?
21 A. Yes.
22 Q. PPG?
23 A. Yes.
24 Q. Allied Chemical?
25 A. Yes.
4633
1 Q. Merck Pharmaceutical?
2 A. Yes.
3 Q. R.J. Reynolds you told us.
4 PG&E?
5 A. You’ve already said that I think but maybe not.
6 Yes, the answer is yes.
7 Q. Alcoa?
8 A. Yes.
9 Q. American Petroleum Institute?
10 A. True.
11 Q. Amoco?
12 A. True.
13 Q. Chevron Chemical Company?
14 A. True.
15 Q. General Electric?
16 A. True.
17 Q. General Dynamics?
18 A. True.
19 Q. Monsanto?
20 A. True.
21 Q. Mobil Oil?
22 A. True.
23 Q. Shell?
24 A. True.
25 THE COURT: How long is this list?
4634
1 MR. PANISH: Well, I’m not going to do the
2 whole — just two more.
3 THE COURT: Okay. Just two more, then.
4 BY MR. PANISH:
5 Q. U.S. Steel?
6 A. True.
7 Q. Exxon?
8 A. True.
9 Q. And there are many, many more that I didn’t
10 cover; isn’t that true, sir?
11 A. Sure.
12 Q. And you’ve been in litigation as an expert for
13 industry in cases involving formaldehyde; correct, sir?
14 A. I don’t think I’ve had a formaldehyde case yet.
15 Q. Okay. How about benzene?
16 A. For sure.
17 Q. What is benzene, sir?
18 A. Benzene is an aromatic hydrocarbon that’s in
19 gasoline.
20 Q. Has that caused — has it been alleged to cause
21 problems in individuals?
22 A. Oh, sure. If it’s a high enough dose and it’s
23 over enough years, it causes acute myelogenous leukemia.
24 Q. And you’ve testified on behalf of the industry
25 in cases that are brought against them for benzene
4635
1 exposure; isn’t that true?
2 A. True.
3 Q. And you’ve testified and been involved in much
4 litigation involving asbestos and the cause of
5 mesothelioma that results in dealt; correct?
6 A. True.
7 Q. And you’ve been in PCB litigation; correct?
8 A. Probably.
9 Q. And pesticide litigation where someone is
10 alleging injury from pesticide, you’ve defended industry
11 in those cases, haven’t you, sir?
12 A. Once or twice.
13 Q. How about silica?
14 A. The only silica case I had was —
15 Q. Is that a “yes” or “no,” sir, silica?
16 A. Well, it’s —
17 THE COURT: Allow him to explain. Go ahead.
18 THE WITNESS: It’s not a silica case. It’s a
19 respirator case.
20 BY MR. PANISH:
21 Q. What’s hexavalent chromium? Does that have
22 another name?
23 A. Chrome VI.
24 Q. Chromium VI, which you talked about extensively
25 this morning; right?
4636
1 A. Yes, sir.
2 Q. And in that — one of those matters, you were
3 hired by PG&E in the Hinkley matter, also referred to as
4 the Erin Brockovich case; correct?
5 MR. CALFO: Objection. It’s a violation of the
6 motion in limine.
7 THE COURT: Sustained.
8 MR. CALFO: Move to strike, Your Honor.
9 THE COURT: There hasn’t been an answer.
10 BY MR. PANISH:
11 Q. Were you hired —
12 THE COURT: We’re not going to get into any
13 more other cases. Okay?
14 BY MR. PANISH:
15 Q. Well, did you talk this morning about 30 papers
16 that you published about chromium VI?
17 A. VI and III, yes, sir.
18 Q. And did those follow the same methodology that
19 you used in this case?
20 A. I did research on hexavalent chromium and
21 chrome III in a similar manner as I have cobalt.
22 Q. And were you hired for litigation and paid by
23 PG&E to write papers about chromium VI?
24 A. I did some papers that were paid for and some
25 that were not.
4637
1 Q. Is that a “yes,” sir?
2 THE COURT: He answered “yes.” Some he was
3 paid for and some he wasn’t.
4 BY MR. PANISH:
5 Q. How much did PG&E pay you to write articles
6 about the effects of chromium VI in groundwater, sir?
7 MR. CALFO: Objection, Your Honor. 352.
8 THE COURT: I’ll allow that question, but we’re
9 right at the edge.
10 You may answer. How much did PG&E pay you?
11 THE WITNESS: For the papers, I’m not sure of
12 the total bill. I think I’ve said in the past it was in
13 the low millions.
14 BY MR. PANISH:
15 Q. Millions?
16 A. Yes, sir.
17 Q. Were you the sole owner of ChemRisk?
18 A. I was for a long time yes, sir.
19 Q. When did you stop being the sole owner?
20 A. I think about two years ago.
21 THE COURT: If you’re moving to a different
22 area, we can take a break, but if you want to finish
23 this thought.
24 MR. PANISH: No, that’s fine, Your Honor. No
25 problem.
4638
1 THE COURT: Is it okay with you?
2 MR. PANISH: You asked me if it was okay, and
3 I’m saying it’s okay.
4 THE COURT: We’re going to take our noontime
5 recess, and I’m not going to ask any more questions.
6 Keep in mind the admonition. See you back at 1:30.
7 (Lunch recess taken from 12:01 p.m. to
8 1:29 p.m.)
9 COURT ATTENDANT: Please be seated and come to
10 order. Department 3 is, again, in session.
11 THE COURT: In the case of Kransky vs. DePuy,
12 the record will reflect all counsel are present, all
13 jurors and the alternates are present.
14 Mr. Panish.
15 MR. PANISH: Thank you, Your Honor.
16 BY MR. PANISH:
17 Q. Good afternoon, Doctor.
18 A. Good afternoon, Mr. Panish.
19 Q. Did you have a nice lunch?
20 A. It was fine.
21 Q. Did you meet with the attorneys and review any
22 documents before you came back here?
23 A. No, sir.
24 Q. Did you go meet with the attorneys during
25 lunch, sir?
4639
1 A. Yes, sir.
2 Q. I’m not going to go through them all.
3 THE COURT: Good.
4 BY MR. PANISH:
5 Q. But were there some new ones that you didn’t
6 identify this morning?
7 A. Yes. Stacey was there this afternoon — or at
8 lunch today. She works with Mr. Calfo.
9 Q. How about Ms. Sharko from New Jersey who’s here
10 with us now?
11 A. I’ve not met Ms. Sharko.
12 Q. Okay. Doctor, this morning when you were
13 testifying, you talked extensively about — actually,
14 the first question was that you were here to tell the
15 jury about cobalt and chromium; right?
16 A. Yes, sir.
17 Q. And that you’d written — that Dr. Harrison
18 hadn’t written a single paper on cobalt and chromium;
19 right?
20 A. That was my understanding.
21 Q. But you’d written quite a few papers. Counsel
22 asked you that; right?
23 A. No. I differentiated that there were quite a
24 few on chromium and not very many on cobalt.
25 Q. Exactly. In fact, you said that you published
4640
1 nearly 30 papers on chromium in peer-reviewed
2 publications; right?
3 A. True.
4 Q. And then you showed us your big, huge CV with
5 all the articles in peer-reviewed publications; right?
6 A. True.
7 Q. And then you told us all about chromium being
8 in the environment and in our diet; right?
9 A. True.
10 Q. By the way, did you get your daily dosage of
11 cobalt at lunch?
12 A. I don’t know, but I ate a lot of vegetables.
13 Q. This cobalt here —
14 A. Yes, sir.
15 THE COURT: Indicating a bottle.
16 MR. PANISH: They didn’t mark it. I’ll be
17 happy to mark it. 2985, cobalt.
18 THE COURT: Hold on. The bottle will be marked
19 as 2985.
20 (Exhibit No. 2985 was marked for
21 identification.)
22 BY MR. PANISH:
23 Q. Have you looked at this before you came here to
24 testify about it, Doctor?
25 A. I didn’t look at that one but I’ve seen others
4641
1 like it.
2 Q. Does the United States government put
3 information on the back of this?
4 A. I don’t know who puts information on the back
5 of it.
6 Q. You’re not familiar with the labeling of
7 supplements?
8 A. I’m familiar with it, but I don’t know if
9 there’s a standard practice on labeling of supplements.
10 I think they enjoy a separate piece of the law.
11 Q. Is cobalt a supplement, sir?
12 A. I don’t know if they call it a supplement. I
13 think — I don’t know that it would enjoy that label.
14 Q. Let’s see what’s on this bottle that you
15 testified about. If I could use the ELMO, please.
16 First let’s look, it says, “Cobalt,
17 professional grade.” Right?
18 A. I can’t read it but I’ll trust you.
19 Q. You, I assume, reviewed it before you came and
20 testify about it this morning.
21 A. I didn’t memorize the label. I trust that what
22 you’re saying is accurate.
23 Q. No, no. Let’s check it out. It says,
24 “professional grade, ionic mineral concentrate”; right?
25 A. Yes, sir.
4642
1 Q. And then it says on the bottom, “dietary
2 supplement”; right?
3 A. Yes, sir.
4 Q. And on the back, that’s where they tell you how
5 much you should have each day. You’re familiar with
6 that, aren’t you, in supplement labeling, sir?
7 A. Yes.
8 Q. Okay. And on the back it tells us “Supplement
9 facts.” Do you see that? Are you not able to see that,
10 “Supplement Facts”?
11 A. Point it out for me for a second.
12 Q. Sure.
13 A. Yes, sir, I got it.
14 Q. Okay. Now, tell us, what is the daily amount
15 that you’re supposed to have as listed there on the back
16 of that cobalt, sir?
17 A. I think it says two droppers —
18 Q. No, no. It says that’s the dosage that you
19 should take; right?
20 MR. CALFO: Your Honor, I don’t think he was
21 finished with his answer.
22 THE WITNESS: I guess I didn’t understand.
23 BY MR. PANISH:
24 Q. If you didn’t understand, I’ll repeat it.
25 THE COURT: Good.
4643
1 BY MR. PANISH:
2 Q. Okay. Doesn’t it usually say — do you see
3 where it says, “Cobalt 1 milligram,” and then it says,
4 “Percent of daily value,” do you see that?
5 A. Yes.
6 Q. Like when you take vitamins and it will say,
7 this is X percent of the daily amount you’re supposed to
8 have; right?
9 A. Yes.
10 Q. What does it say the daily amount of cobalt is
11 you’re supposed to have?
12 A. Amount per serving — I don’t know that it
13 says.
14 Q. There’s nothing listed, is there, sir?
15 A. Right.
16 Q. Now, today I wrote down some of the things you
17 said, and I want to make sure that I wrote it down
18 accurately. The first thing you said, when Mr. Calfo
19 kept asking you about Dr. Harrison was, about your board
20 certification, that you want to protect the integrity of
21 the profession. That’s what you want to do; right,
22 Doctor?
23 A. Along with other certified toxicologists.
24 Q. Did you testify under oath here this morning
25 when Mr. Calfo was questioning you that you were here
4644
1 and your society protects the integrity of the
2 profession?
3 A. No. I said that being board certified helps
4 protect the integrity of the profession.
5 Q. Did you say you want to protect the integrity
6 of the profession, under oath, on the witness stand —
7 A. If you stipulate that’s what I said, that’s
8 fine.
9 Q. I’m not going to stipulate to anything.
10 THE COURT: He’s just asking, do you recall
11 saying that?
12 THE WITNESS: I said that the reason that
13 there’s certification is that it’s important that we
14 protect the integrity of the profession. I may have
15 even said I would like to continue to protect the
16 integrity of the profession.
17 BY MR. PANISH:
18 Q. Did you also say, sir, in our business, all we
19 have is our integrity and we put a high priority on
20 that?
21 A. Absolutely.
22 Q. Sir, you told us about all these articles that
23 you published in peer review; right?
24 A. True.
25 Q. You also told us about peer review, how
4645
1 important that is and how important it is that a
2 scientist publishing something is independent, didn’t
3 you, sir?
4 A. Yes.
5 Q. And you told us that researchers need to be
6 independent, didn’t you?
7 A. They should be, yes.
8 Q. You said it’s critical that they are, didn’t
9 you, sir?
10 A. I don’t know what I said about that, but it’s
11 important that they be independent. I think more
12 important than independent —
13 THE COURT: Hold on. You answered the
14 question. Put a question.
15 BY MR. PANISH:
16 Q. For example, if a scientist was conducting a
17 study to see if something was toxic or hazardous, it’s
18 important that the scientist be independent from the
19 company that may be causing the toxin to cause a
20 problem. Fair statement, sir?
21 A. No, I didn’t say that.
22 Q. I asked you, is that a fair statement?
23 A. No. It depends on how you define independent.
24 Q. So let me ask — would you agree, for
25 example — you told us about all these studies you did
4646
1 on chromium this morning; right?
2 A. Right.
3 Q. Would you agree if a scientist was conducting a
4 study to see if something was toxic or hazardous, like
5 chromium in groundwater or cobalt in a metal hip, it’s
6 important that the scientist be independent from the
7 company that might be causing chromium to go into the
8 groundwater or that may make a metal-on-metal hip
9 implant?
10 A. I absolutely did not say that.
11 Q. I just asked you, did —
12 MR. PANISH: Your Honor, could we —
13 THE WITNESS: I thought that was your question.
14 MR. PANISH: No, it wasn’t.
15 THE COURT: He didn’t understand.
16 MR. PANISH: Could I ask, could it please be
17 read back?
18 THE COURT: Yes. Read back the last question.
19 (Record read.)
20 MR. CALFO: Objection. Vague and ambiguous,
21 compound.
22 THE COURT: Overruled.
23 Do you agree with that?
24 THE WITNESS: No. I stand by what I said.
25 THE COURT: So you don’t agree with that?
4647
1 THE WITNESS: True.
2 BY MR. PANISH:
3 Q. Okay. Would you agree that a company shouldn’t
4 be able to influence the finding of a paper or study
5 because they paid a lot of money to the person doing it?
6 A. No.
7 Q. So you believe, then, that a company that pays
8 money should be able to influence the individual writing
9 the paper; correct?
10 A. Absolutely not.
11 Q. Which one is it? Is it the company should be
12 able to influence them with the money or the company
13 should not be able to influence them with the money?
14 A. Your questions are non-sequitur. They’re meant
15 to be confusing. You can be independent and do work —
16 MR. PANISH: Your Honor, if I can ask him to
17 please —
18 THE COURT: If you don’t understand the
19 question, say you don’t understand the question.
20 Put a question.
21 BY MR. PANISH:
22 Q. Do you think a company, let’s say DePuy, should
23 be able to influence somebody that they pay money that’s
24 doing a study and the findings that they have because
25 they paid them a lot of money?
4648
1 A. No.
2 Q. Do you think PG&E that pays someone a lot of
3 money to study chromium, like you did, should be able to
4 influence the results of the study?
5 A. No.
6 Q. Okay. Thank you.
7 A. Thank you.
8 Q. And a scientist that’s getting paid by a
9 company to study — strike that.
10 Any study or paper that is being paid for by a
11 company, that should be disclosed, shouldn’t it, sir?
12 A. It depends on the era you’re talking about.
13 The last 10 to 15 years, that’s been true. It’s been
14 acceptable.
15 Q. So 15 years ago, it’s your testimony that
16 scientists publishing allegedly independent papers
17 didn’t have to disclose that somebody paid them to do
18 that. Is that your testimony?
19 A. My testimony, to be specific, is this —
20 THE COURT: Hold on. He’s asking prior to
21 15 years ago, did writers have to disclose they were
22 being paid by companies?
23 THE WITNESS: No.
24 BY MR. PANISH:
25 Q. So you don’t believe it was — strike that.
4649
1 Do you believe that somebody that wrote a paper
2 that helped a company and didn’t disclose that it was
3 being paid to help a company, was showing the, as you
4 called it, putting integrity at the highest priority?
5 MR. CALFO: Objection, Your Honor. Vague,
6 ambiguous and overbroad as to time.
7 THE COURT: Try it again because I got lost.
8 BY MR. PANISH:
9 Q. Let’s do this, Doctor. Do you know who
10 Dr. Zhang Dong is?
11 A. Of course. Dr. Zhang is how I know him.
12 Q. Dr. Zhang was a scientist in China, wasn’t he,
13 sir?
14 A. Indeed.
15 Q. He was someone that studied chromium before you
16 did and its effects on people in a village — several
17 villages in China and its effect of chromium on their
18 contracting forms of cancer; right, sir?
19 A. True.
20 Q. That was from chromium in groundwater like you
21 talked about earlier today; right?
22 A. True.
23 Q. Sir, this was done in the 1960s and ’70s by
24 Dr. Zhang, in I think it was northeast China; right?
25 A. Yes, sir.
4650
1 Q. And, sir, you know —
2 A. I think the dates might be a little later than
3 that, but you’re close.
4 Q. Well, I’ll clear it up for you, sir. Don’t
5 worry. Okay?
6 THE COURT: Put a question.
7 BY MR. PANISH:
8 Q. You understand, sir, that he was trying to
9 determine then whether chromium in the groundwater was
10 causing cancer in high rates in the villages where these
11 people lived in China versus people in other villages in
12 China; right?
13 A. Yes, sir.
14 Q. And Dr. Zhang, he was a well-known scientist in
15 China; in fact, he won a big award in China, didn’t he?
16 A. There’s some controversy about that.
17 Q. Is it your understanding that Dr. Zhang won a
18 big award in China?
19 A. I don’t know that for certain.
20 Q. Okay. But you certainly know that he published
21 an article in 1987 about the effects of chromium on the
22 individuals in China getting cancer; right?
23 A. True.
24 Q. That was related to chromium; correct?
25 A. True.
4651
1 Q. And you also understand that ten years later,
2 there was updated version of that article published;
3 isn’t that true, sir?
4 A. True.
5 Q. And you also understand that the updated
6 article changed Dr. Zhang’s original conclusions and
7 opinions about the effect of the chromium causing
8 cancer; correct?
9 A. That’s not true.
10 Q. So you say “no”?
11 A. I’m saying no.
12 Q. Okay. Let’s look at it then. First of all, in
13 1997 — let me show you Exhibit No. 3, sir. 2985.
14 THE COURT: What is the exhibit number?
15 MR. PANISH: 2985. New article, “Cancer
16 Mortality in a Chinese Population,” Dr. Zhang, 1987.
17 Do you want to see a hard copy or is it okay if
18 I put it up?
19 MR. CALFO: Objection —
20 THE COURT: We already used 2985.
21 MR. PANISH: I’ll take number 86, then.
22 THE COURT: You’ll take 2986.
23 MR. PANISH: Thank you.
24 THE COURT: It will be marked for
25 identification now.
4652
1 (Exhibit No. 2986 was marked for
2 identification.)
3 MR. CALFO: Your Honor, objection under 721 of
4 the evidence code. No foundation.
5 THE COURT: I’ll see where it’s going.
6 BY MR. PANISH:
7 Q. You’ve read the article, haven’t you, sir?
8 A. Yes.
9 Q. Very familiar with it, aren’t you?
10 A. Yes.
11 Q. Would you like — would you like to see a copy
12 or is it okay if I just put it up for you? What would
13 be best for you?
14 A. Depends what the question is. If I can read
15 it, I’ll be happy do it.
16 Q. Okay. But I want to make sure —
17 THE COURT: Let’s put a copy in front of him.
18 BY MR. PANISH:
19 Q. Let me ask you this, sir. How many times have
20 you read this article?
21 A. Quite a few times.
22 Q. More than 50?
23 A. More than 20.
24 Q. Have you ever been asked in a deposition under
25 oath how many times you read this article, sir?
4653
1 A. I don’t know.
2 Q. You don’t know?
3 A. I don’t know the answer to that question, if I
4 said 20 or 50.
5 Q. Would you say it’s close to 50 times you read
6 this?
7 A. I don’t know.
8 Q. Okay. You’re very familiar with it. Is that
9 fair?
10 A. I’ve said that twice, yes.
11 Q. Thank you.
12 THE COURT: Put a question.
13 MR. PANISH: I haven’t said anything yet. He
14 said it.
15 THE COURT: You wanted to.
16 MR. PANISH: But I didn’t. I restrained
17 myself.
18 THE COURT: You said “thank you.” Put a
19 question.
20 BY MR. PANISH:
21 Q. Okay, sir. Let’s look at first page. It says,
22 “This report is a” —
23 MR. CALFO: Your Honor, I object to publishing
24 this. There’s no foundation for it with this witness.
25 THE COURT: I’ll allow it in the same way —
4654
1 MR. CALFO: In relation to this case, Your
2 Honor.
3 THE COURT: If you lay a foundation that he
4 relied on it in connection with his opinions here.
5 MR. PANISH: No. It’s a different reason and
6 I’ll get to that.
7 THE COURT: Well, we’ll see. Put it up, just
8 the front page.
9 BY MR. PANISH:
10 Q. Right, just the first part. And when I asked
11 you whether this report is a clarification and further
12 analysis of our previously published mortality study
13 regarding groundwater contamination. Remember I asked
14 that, sir?
15 A. Yes.
16 MR. CALFO: Objection, Your Honor. No
17 foundation to publish this to the jury.
18 THE COURT: I’ll will see where it’s going.
19 BY MR. PANISH:
20 Q. Do you see that, sir?
21 A. Yes.
22 Q. And that publication, sir, dealt with this
23 cancer relationship that we talked about; right?
24 MR. CALFO: Objection, Your Honor, relevance to
25 this case.
4655
1 THE COURT: I’m waiting for it to be tied up.
2 MR. PANISH: I’m getting there.
3 THE COURT: Get there fast.
4 BY MR. PANISH:
5 Q. Sir, you got involved in writing this article,
6 didn’t you, sir? Your company, ChemRisk, got involved
7 and paid money to write this article and change the
8 conclusions; isn’t that true?
9 A. It’s a total mischaracterization. I’m happy to
10 answer any question you want about it.
11 THE COURT: You’ve said no.
12 Go.
13 BY MR. PANISH:
14 Q. Okay. Sir, let’s start out with — so it’s
15 your testimony — and you can take that down — that
16 your company did not get involved with a company that’s
17 in litigation, PG&E, to rewrite Dr. Zhang’s article and
18 to change the conclusions that he had? Is that your
19 testimony under oath here today?
20 A. Definitely.
21 Q. Okay. And you’re as sure of that as everything
22 you’ve said in this trial so far; right?
23 A. I am positive of that.
24 Q. Okay. Now, is it fair to say that the first
25 article was written in 1987 by Dr. Zhang; correct?
4656
1 A. True.
2 Q. Then another article was written in 1997;
3 correct?
4 A. True.
5 Q. And Dr. Zhang was already retired by that time,
6 wasn’t he?
7 A. In a manner of speaking, but he was still
8 active.
9 Q. And in this article in 1995, before it was
10 published, your firm was working with the lawyers from
11 PG&E in a litigation related to chromium; correct?
12 A. That’s true.
13 Q. And your firm, ChemRisk, was asked by the
14 lawyers from PG&E to contact Dr. Zhang in China;
15 correct?
16 A. I think it was our idea to contact Dr. Zhang.
17 Q. Fair enough. And the lawyers that you worked
18 with wanted you to get information from Dr. Zhang;
19 correct?
20 A. No. As I said, we chose —
21 THE COURT: You’ve answered no.
22 BY MR. PANISH:
23 Q. Did your company, ChemRisk, pay money to
24 Dr. Zhang to have another article written regarding the
25 PG&E issue?
4657
1 A. No.
2 Q. Okay. I’m going to show you now Exhibit No. —
3 I need another number.
4 By the way, do you know an individual by the
5 name of Bill Butler?
6 A. Very well.
7 Q. Does he work in your company or has he worked
8 in your company?
9 A. He did. He committed suicide earlier this
10 year.
11 MR. PANISH: Your Honor —
12 THE COURT: Just answer the question.
13 MR. PANISH: I’m not going to respond.
14 THE COURT: Good.
15 BY MR. PANISH:
16 Q. Okay. Let me show you this, sir. Did your
17 company —
18 THE COURT: Hold on. You wish to mark —
19 MR. PANISH: Yes, I do, Your Honor.
20 THE COURT: — this memo?
21 MR. PANISH: I absolutely do.
22 MR. CALFO: Your Honor, I object until there’s
23 a foundation laid that’s appropriate, before it’s
24 published.
25 MR. PANISH: What’s the number on that,
4658
1 Your Honor?
2 THE COURT: I’m going to give you one in just
3 one second. It will be marked as 2987.
4 MR. PANISH: Thank you.
5 (Exhibit No. 2987 was marked for
6 identification.)
7 BY MR. PANISH:
8 Q. Sir, would you like to see a copy or are you
9 familiar with it?
10 A. What is it?
11 THE COURT: Let me show him a copy of 2987.
12 Why don’t you give me back the other exhibit, if you
13 would.
14 BY MR. PANISH:
15 Q. You’ve seen that before, haven’t you, sir?
16 A. I’ll assume I have.
17 Q. You’ve been asked about it under oath in cases
18 just like this, haven’t you, sir?
19 MR. CALFO: Objection. Vague and ambiguous as
20 to “just like this,” Your Honor.
21 THE COURT: Do you think you’ve seen that?
22 THE WITNESS: It’s a good chance I have. It
23 was 17 years ago, sir.
24 MR. PANISH: I didn’t get the answer. I
25 couldn’t hear.
4659
1 THE COURT: He said it’s a good chance he has.
2 BY MR. PANISH:
3 Q. Sir, you’ve seen it since 17 years ago. You
4 saw it recently when you were testifying under oath in a
5 courtroom just like this; isn’t that true, sir?
6 A. You’re telling me that Lainier showed me this
7 or Trey Jones; is that right?
8 Q. Sir, no, no.
9 A. I don’t remember seeing this in that case.
10 Q. Mr. Lainier, is that Mark Lainier?
11 A. Yes, sir.
12 Q. Is that a lawyer in Texas?
13 A. Yes.
14 Q. Is that a lawyer that you’ve testified against
15 in asbestosis cases or asbestos cases?
16 A. I haven’t had the pleasure of meeting
17 Mr. Lainier. I’ve only met someone in his firm.
18 Q. Trey Jones?
19 A. Yes, sir.
20 Q. You know that person?
21 A. Yes, sir.
22 Q. That person cross-examined you in a court just
23 like this and asked you about this situation with
24 Dr. Zhang in China?
25 A. I don’t think it was to this depth, but he did
4660
1 ask me.
2 Q. Sir, Mr. Butler, at this time of this memo, was
3 working for your company, wasn’t he, sir? ChemRisk?
4 A. No.
5 Q. Okay. Did ChemRisk pay $25,000 to have the
6 Dr. Zhang article rewritten? You can turn to page 2 if
7 you want.
8 MR. CALFO: Your Honor, I object. There’s no
9 foundation for this.
10 THE COURT: So far. Let’s see where it’s
11 going.
12 THE WITNESS: This is a budget request for
13 $25,000 for people in our firm to assist Dr. Zhang in
14 doing the statistics on this paper.
15 BY MR. PANISH:
16 Q. That’s your firm that did that; right, sir?
17 MR. CALFO: Objection. Vague and ambiguous as
18 to “that.”
19 THE WITNESS: No. Butler is in here for
20 13,000. In fact, you know what?
21 THE COURT: Hold on. There’s no question.
22 Let’s wrap this up, though.
23 MR. PANISH: Your Honor, I promise you.
24 THE COURT: I’m giving you a chance. Get
25 there.
4661
1 MR. PANISH: I can’t get an answer.
2 BY MR. PANISH:
3 Q. Mr. Butler was paid money for this; right? He
4 put in a budget request to your law firm; right? Or to
5 your company.
6 A. He was not a member, and he did submit a
7 request.
8 Q. On behalf of your company?
9 A. No. On behalf of his company.
10 Q. Did he submit it to your company?
11 A. True.
12 Q. And your company was involved in republishing
13 or rewriting an article, weren’t you?
14 A. No.
15 Q. Okay. Was Mr. Butler — strike that.
16 You’re saying that Mr. Butler, at this time,
17 was not employed by ChemRisk; is that right?
18 A. To the best of my memory, I’m almost certain he
19 was not employed by ChemRisk. I’m virtually certain he
20 wasn’t.
21 Q. Who’s Brent Kerger?
22 A. Brent Kerger is a — I don’t even know if he
23 was an employee of our company at that point. I don’t
24 know if he was or not but he was a former employee.
25 Q. Sir, it says on page 2, does it not, that you,
4662
1 Dr. Paustenbach, were going to be involved in writing
2 the first draft of this report, doesn’t it, sir?
3 MR. CALFO: Objection, Your Honor, 352. Undue
4 waste of time.
5 THE COURT: Come to sidebar with the reporter.
6 (Sidebar proceedings begin.)
7 THE COURT: Where are you going?
8 MR. PANISH: He did an article in a peer-review
9 that was retracted.
10 THE COURT: Who did an article?
11 MR. PANISH: Dr. Paustenbach and his company.
12 He’s had extensive testimony about peer review and not
13 integrity. He was sanctioned. The article was
14 retracted — what happened is they — Mr. Calfo just
15 says to me he knows all about this when we were proving
16 what happened was this individual — they went and got
17 this Dr. Zhang. They wrote — changed the opinions to
18 help PG&E in the groundwater litigation.
19 MR. CALFO: It’s too loud.
20 MR. PANISH: Can I finish, please?
21 THE COURT: Just keep your voice down.
22 MR. PANISH: He’s been interrupting me the
23 whole time. This individual and his company got money
24 from PG&E to change the conclusions in this
25 peer-reviewed article. The article was then retracted
4663
1 and sanctioned against them for —
2 THE COURT: Sanctioned by who?
3 MR. PANISH: By the publication for which it
4 was — the peer-reviewed publication for which it was
5 published. He testified extensively about all
6 peer-reviewed papers and this stuff.
7 THE COURT: I understand. I’ve allowed this on
8 direct examination. This was a start out about how
9 important it is to have independence and things done a
10 certain way. You’ve got to get to the punch line.
11 MR. PANISH: I’m trying to. He knows the
12 answers; so he’s trying to dance around. So I have to
13 do the setup. So I would ask he answer.
14 THE COURT: I understand. Why don’t you just
15 jump to the chase scene and ask the questions.
16 MR. PANISH: Because he’s going to deny it, and
17 I’ll have to go back and do it.
18 MR. CALFO: Your Honor, I’ve heard this cross.
19 It doesn’t go anywhere. It’s a waste of time. We’ve
20 heard it. There’s no foundation for these questions.
21 THE COURT: I’ve not heard it. I’m giving you
22 a chance. Do it quickly.
23 (Sidebar proceedings concluded.)
24 THE COURT: I’m not going to warn counsel
25 again. Stop the sniping, both sides. Knock it off. I
4664
1 have no sense of humor.
2 Inquire.
3 MR. PANISH: Thank you, Your Honor.
4 BY MR. PANISH:
5 Q. Sir, do you know the law firm Haight, Brown &
6 Bonesteel?
7 A. Yes, sir.
8 Q. Were they involved in retaining your firm in
9 the PG&E groundwater litigation?
10 A. Yes, sir.
11 Q. And, sir, did you write a letter to the office
12 of the environmental health hazard assessment in
13 July 17th, the year 2000?
14 A. I’d like to see it, but I might very well have.
15 Q. So you don’t remember?
16 A. I might very well have. I’ll trust that it’s
17 true, but I’d like to see it.
18 Q. Well, let me show you then, sir. I’d like to
19 mark another exhibit, Your Honor. It’s a memorandum to
20 Dr. Paustenbach dated June 6, 1996.
21 THE COURT: 2988.
22 (Exhibit No. 2988 was marked for
23 identification.)
24 BY MR. PANISH:
25 Q. Would you like to see a copy, sir?
4665
1 A. Yes.
2 THE COURT: 2988 is marked and before the
3 witness.
4 BY MR. PANISH:
5 Q. Do you know who Gwen Corbett is, sir?
6 A. Yes, sir.
7 Q. Who’s that?
8 A. Someone that used to work with me in the
9 company.
10 Q. In 1996 they were working for your company with
11 you on the PG&E groundwater litigation; correct?
12 A. Looks that way, yes, sir.
13 Q. And Gwen Corbett was writing an e-mail to you;
14 correct? Or a memorandum. I don’t know if they had
15 e-mail then. A memorandum; right?
16 A. I was a recipient, yes.
17 Q. This was regarding Dr. Zhang’s paper to —
18 excuse me. This was informing you, among others, that
19 this paper that initially had been written was going to
20 be rewritten; correct?
21 A. No, that’s not what it says. It says — this
22 is an announcement that the paper by Zhang had been
23 accepted for publication.
24 Q. I think it says, “We’re pleased to inform you
25 that the short communication regarding clarification of
4666
1 Dr. Zhang’s previous work on cancer mortality in the
2 Chinese population in water was accepted with no
3 revisions to the Journal of Occupational Environmental
4 Medicine; correct?
5 A. Absolutely.
6 Q. That’s a reliable scientific journal; correct?
7 A. True.
8 Q. That’s something that you had published in
9 before; correct?
10 A. It’s not my publication. It’s Zhang’s
11 publication.
12 Q. This is the memo that was also sent to the
13 lawyers from that case; correct? Do you see in the top,
14 Haight, Brown & Bonesteel?
15 A. Yes. It says Zhang’s paper was accepted.
16 Q. Okay. Well, sir, that paper that was published
17 was retracted by the journal, wasn’t it?
18 A. It was.
19 Q. And retracted means it’s taken out; correct?
20 A. True.
21 Q. And they do that when there are issues about
22 the reliability and the issues relating to the paper;
23 right?
24 A. Can be.
25 Q. And, sir, they published an editorial
4667
1 retraction of that paper that your firm was involved in
2 working on; isn’t that true, sir?
3 MR. CALFO: Objection, Your Honor. No
4 foundation, waste of time under 352.
5 THE COURT: I’ll allow — waste of time is not
6 an objection. 352 is an objection. I’ll allow it, but
7 then we’re going to wrap this up.
8 BY MR. PANISH:
9 Q. Well, the editor of the journal —
10 THE COURT: Were you involved in that second
11 report, the second Zhang report, or was your company?
12 THE WITNESS: Yes.
13 THE COURT: Okay.
14 BY MR. PANISH:
15 Q. Sir, wasn’t it true that the editor of that
16 journal that your company was involved with for the
17 article, determined that the financial and intellectual
18 input to the paper by outside parties, your company, had
19 not been properly disclosed; correct?
20 A. That’s what he concluded. That’s right.
21 Q. And therefore, retraction was necessary; right?
22 A. That’s what he decided.
23 Q. Now, sir, you’re familiar with the
24 environmental working group, are you not?
25 A. Very well.
4668
1 Q. And you know that’s a nonprofit public health
2 watchdog organization for health; right?
3 A. That’s your characterization, not mine.
4 Q. Okay. You’re familiar with them, aren’t you,
5 sir?
6 A. Very familiar with them.
7 Q. You’ve reviewed things that they’ve written
8 about you, sir?
9 A. They’ve written a lot of things about me.
10 Q. And, in fact, sir, are you — you’re a member
11 of the Society of Toxicology. You told us all about
12 that; right?
13 A. True.
14 Q. And there was an investigation by the working
15 group actually strongly urging the society to censure
16 you after this article was retracted, didn’t they?
17 A. True.
18 Q. And they wanted an expression of harsh
19 criticism against you; right?
20 A. True.
21 Q. They wrote that you’d engaged in highly
22 unethical conduct; correct?
23 A. That’s what they said.
24 Q. And that you’d committed a serious violation of
25 the code; right?
4669
1 A. That’s what they claimed.
2 Q. And then you made a contribution to the
3 society, didn’t you?
4 A. What do you mean by “contribution”?
5 Q. Financial. Do you know what it means to make a
6 financial contribution?
7 A. I funded a scholarship, that’s true.
8 Q. Did you make —
9 A. After they concluded that there was no
10 wrongdoing —
11 THE COURT: Hold on. Just wait for the
12 question.
13 BY MR. PANISH:
14 Q. As part of the society — that’s a 300-member
15 society?
16 A. Oh, no. There must be 5,000 members.
17 Q. In the 5,000-member society, when you were not
18 censured, you made a contribution to the society, didn’t
19 you, sir?
20 A. I did.
21 Q. Substantial financial contribution, didn’t you?
22 A. I funded a $25,000 scholarship.
23 Q. But you made other contributions financially,
24 didn’t you, sir?
25 A. To other professional societies and
4670
1 universities, but I don’t recall paying them to fund any
2 more scholarships.
3 Q. Sir, what’s the EPA?
4 A. The Environmental Protection Agency.
5 Q. And do you — you remember the environmental
6 working group writing about you to the EPA?
7 A. No. They may have, but I don’t recall that.
8 Q. Do you remember them making comments to the EPA
9 regarding your paid expert work with companies that had
10 caused pollution, their statement?
11 MR. CALFO: Your Honor, I again object, 352,
12 and there’s no foundation for the environmental work
13 group.
14 THE COURT: Sustained. Sustained on 352
15 grounds.
16 BY MR. PANISH:
17 Q. Sir, you’re familiar with the American Journal
18 of Industrial Medicine?
19 A. Oh, yes.
20 Q. It’s a reliable publication?
21 A. Some of the time.
22 Q. You’ve published in it, haven’t you, sir?
23 A. I have indeed.
24 Q. It’s a published journal; right?
25 A. Yes.
4671
1 Q. Sir, you published an article in 1990 in the
2 American Journal entitled “Organic Acids and Bases:
3 Review of Toxicological Studies”; right?
4 A. Indeed.
5 Q. That publication that you submitted for peer
6 review, was your article that you submitted in that
7 publication reliable?
8 A. Sure.
9 Q. Was that a peer-reviewed, reliable scientific
10 journal?
11 A. At times.
12 Q. Sir, was the Journal — was an article
13 published in there about you?
14 A. That, I don’t remember.
15 Q. Okay. Let’s see if we can refresh your
16 recollection.
17 MR. PANISH: I’d like to mark the next exhibit,
18 Your Honor, American Journal of Industrial Medicine.
19 THE COURT: It will be marked as 2989.
20 (Exhibit No. 2989 was marked for
21 identification.)
22 BY MR. PANISH:
23 Q. Now, sir, what’s Exponent?
24 A. Exponent is a consulting firm headquartered in
25 Menlo Park and generally considered probably the world’s
4672
1 authority on engineering, reconstruction of accidents
2 and disasters.
3 Q. They get paid millions and millions of dollars
4 working in litigation; correct?
5 A. That’s probably fair.
6 Q. That’s where you worked before you joined
7 ChemRisk, isn’t it, sir?
8 A. I started ChemRisk first and joined Exponent
9 and started ChemRisk again.
10 Q. Okay. How many years did you work for
11 Exponent, sir?
12 A. About five years.
13 Q. Were you a vice president with Exponent?
14 A. I was.
15 Q. And this article deals with interests —
16 conflicting interests and research; correct?
17 MR. CALFO: Your Honor, I object. I thought he
18 was refreshing the witness’s recollection.
19 THE COURT: Are you familiar with the article?
20 THE WITNESS: Not yet, sir.
21 THE COURT: I’ll put the exhibit in front of
22 witness.
23 BY MR. PANISH:
24 Q. You smile. You’ve seen that before?
25 A. Yes, sir.
4673
1 Q. Familiar with it?
2 A. Yeah, sort of. Sure.
3 Q. Now, are you familiar with the circumstances
4 described regarding the dioxin cancer and Adame? You
5 talked about dioxin during your direct exam, didn’t you,
6 sir?
7 A. I did.
8 Q. Are you familiar with Adame?
9 A. I am.
10 Q. And you’re familiar with the circumstances
11 described in this article, aren’t you, sir?
12 A. I am. I’m not on the article, of course.
13 Q. No, but it was your company at the time and
14 this is a journal that you published in; correct?
15 MR. CALFO: Objection, Your Honor, 352.
16 THE COURT: Was it your company or was this a
17 company that you were employed at?
18 THE WITNESS: I was an employee of a publicly
19 held company.
20 THE COURT: Did you have anything to do with
21 the subject matter of this article?
22 THE WITNESS: No.
23 THE COURT: Sustained.
24 BY MR. PANISH:
25 Q. Sir, your name is in the article, isn’t it,
4674
1 sir?
2 MR. CALFO: Objection, Your Honor. 721B.
3 THE COURT: I’ll allow that question. Is your
4 name in the article?
5 THE WITNESS: It’s not in the Adame article.
6 BY MR. PANISH:
7 Q. I’m sorry?
8 A. My name is not in the Adame article.
9 Q. Could you just look at page 2, sir?
10 A. No. No, I’m not an author of the Adame
11 article.
12 Q. You’re in the article, aren’t you, sir?
13 Page 2, second paragraph right there.
14 A. No. The comment is about Exponent’s article by
15 Adame. I happen to be in a separate paragraph that has
16 nothing to do with Adame.
17 THE COURT: Let me see the article.
18 THE WITNESS: Sure.
19 THE COURT: I’ll allow brief inquiry.
20 BY MR. PANISH:
21 Q. Sir —
22 THE COURT: Jump to the chase scene, though.
23 BY MR. PANISH:
24 Q. You were on the scientific advisory committee
25 for the FDA; right? I’m sorry, for the EPA?
4675
1 A. Yes. On dioxin.
2 Q. On dioxin?
3 A. Yes, sir.
4 Q. And you also at the same time were working for
5 Dow Chemical regarding dioxin in soil in Michigan;
6 correct?
7 A. True.
8 Q. And you, as a member of Exponent, did not
9 disclose that to the scientific advisory board for the
10 Environmental Protection Agency; isn’t that true, sir?
11 A. No, that’s a false statement.
12 Q. Well, could you go to paragraph 2?
13 MR. CALFO: Your Honor, I object. This is a
14 commentary.
15 THE COURT: He’s denied it. Move on.
16 MR. PANISH: I want to impeach him.
17 THE COURT: He’s denied it. Move on. This is
18 collateral.
19 BY MR. PANISH:
20 Q. Did you get involved with the EPA and dioxin?
21 A. Absolutely.
22 Q. Did the EPA disagree with the positions that
23 you were taking regarding the clean-up in Michigan?
24 MR. CALFO: Objection, your Honor. Relevance.
25 THE COURT: You can answer that question.
4676
1 THE WITNESS: They ultimately did.
2 BY MR. PANISH:
3 Q. Now, sir, in this case you had never published
4 any articles about cobalt before you were paid and hired
5 in this case by Mr. Calfo; correct?
6 A. I had not published any articles.
7 Q. Is that a “yes”?
8 THE COURT: Had you published any articles on
9 cobalt prior to being retained in this case?
10 THE WITNESS: No, sir.
11 BY MR. PANISH:
12 Q. And, sir, isn’t it true, as you told me
13 earlier, that the definition of a poison — do you
14 remember what it was when I read it to you? I’ve got to
15 find it again.
16 A. The one that you read me is an historical
17 definition.
18 Q. A substance that through its chemical action
19 usually kills, injures or impairs an organism; right?
20 A. That’s a good definition.
21 Q. Is tissue an organism?
22 A. No. They’re talking about an organism as a
23 full entity.
24 Q. Okay. How about something —
25 A. An organ is a tissue, not an organism.
4677
1 Q. Okay. Do organs make up organisms?
2 A. You can make up any vocabulary you want but
3 you’d be wrong. It’s an organ and a tissue and then
4 there’s organisms.
5 Q. Does poison cause damage to organs?
6 A. Sure. It can, in a high enough dose.
7 Q. Okay. Sir, by the way, before you were paid
8 the 5 million to do this research and everything, was
9 there any reason that you know of that DePuy couldn’t
10 have done that on their own before putting out the
11 ASR XL?
12 MR. CALFO: Objection. No foundation.
13 THE COURT: Sustained.
14 BY MR. PANISH:
15 Q. Did DePuy ever contact you before they put out
16 the ASR XL and ask you to perform research about cobalt
17 and chromium effects on someone with a metal-on-metal
18 hip?
19 A. No.
20 Q. Do you know if they contacted anyone and paid
21 them money to do that research before they released the
22 ASR XL in Europe?
23 A. They contacted someone in 2005. I don’t know
24 when they released it in Europe.
25 Q. You have no idea when they released it in
4678
1 Europe?
2 A. I just don’t remember right now.
3 Q. Do you know what a clinical study is?
4 A. Yes, sir.
5 MR. CALFO: Your Honor, beyond the scope. No
6 relevance.
7 THE COURT: It’s close.
8 BY MR. PANISH:
9 Q. Didn’t you talk about clinical trials and
10 clinical studies during your direct examination when
11 Mr. Calfo was questioning you, sir?
12 A. No, I didn’t. I talked about institutional
13 review board trials.
14 Q. Do institutional review boards review clinical
15 trials?
16 A. They’re usually different boards.
17 Q. Sir, in this case, you reviewed Dr. Hansen’s
18 medical records, didn’t you?
19 A. True.
20 Q. And you reviewed what he said about when he had
21 to remove Mr. Kransky’s hip, didn’t you?
22 A. Yes.
23 Q. And you saw and you were questioned about that
24 in this case in your deposition under oath, weren’t you,
25 sir?
4679
1 A. Yes.
2 Q. Sir, when you were hired, you told us that
3 Mr. Calfo, and I assume DePuy, was confused about
4 chromium and cobalt; is that right?
5 A. I said that Mr. Calfo was confused about cobalt
6 and chromium, which didn’t surprise me.
7 Q. Did you know whether he discussed it with any
8 scientist at DePuy before hiring you and paying you?
9 MR. CALFO: Objection, Your Honor. Calls for
10 speculation.
11 THE COURT: Sustained.
12 THE WITNESS: I don’t have any idea —
13 THE COURT: Sustained.
14 THE WITNESS: I’m sorry.
15 BY MR. PANISH:
16 Q. Do they have scientists at DePuy that know
17 about chromium and cobalt, to your knowledge, sir?
18 MR. CALFO: Objection. No foundation, calls
19 for speculation.
20 THE COURT: Sustained.
21 BY MR. PANISH:
22 Q. Do you know anything about the foundation of
23 the company, DePuy, who works there, what they do? Do
24 you know anything about that?
25 MR. CALFO: Objection. Vague and ambiguous and
4680
1 overbroad.
2 THE COURT: I’ll allow that question.
3 THE WITNESS: Sure. They’re in the implant
4 business.
5 BY MR. PANISH:
6 Q. Okay. Do they have a clinical department?
7 MR. CALFO: Objection. No foundation.
8 THE COURT: Sustained.
9 MR. PANISH: I’m trying to lay the foundation.
10 THE COURT: Sustained. This is not the witness
11 to go through the corporate structure of DePuy.
12 BY MR. PANISH:
13 Q. Okay. Let’s look, sir, in this case, you would
14 agree, would you not, that the chromium and cobalt
15 caused damage to the tissue in Mr. Kransky’s hip?
16 MR. CALFO: Objection. Beyond the scope of
17 direct, beyond his opinions.
18 THE COURT: I’ll allow that question. Did you
19 reach any opinion? You did express an opinion as to the
20 health effects, so you may ask him about that.
21 THE WITNESS: I did not express an opinion
22 regarding local effects.
23 BY MR. PANISH:
24 Q. You told us that Mr. Kransky was not poisoned
25 in any way, didn’t you, sir?
4681
1 A. That part is true.
2 Q. And poison would be killing tissue or
3 organisms, wouldn’t it, sir?
4 A. No. That’s where you defined it properly a few
5 minutes ago.
6 Q. Sir, isn’t it true that for a chemical that
7 would cause damage to a tissue, that is a poison?
8 A. No. That’s a cytotoxic agent.
9 Q. You told us that cobalt and chromium wasn’t
10 cytotoxic, didn’t you, sir?
11 A. No, I said they were both cytotoxic in
12 sufficient doses.
13 Q. Well, sir, did you investigate — or do you
14 have any basis to disagree with Dr. Hansen that chromium
15 and cobalt caused the tissue around Mr. Kransky’s
16 implant to die and be necrotic?
17 MR. CALFO: Objection, Your Honor, that’s not
18 part of his opinions in this case.
19 THE COURT: Overruled.
20 You may answer.
21 THE WITNESS: I’ve stated repeatedly I’m not
22 here to give an opinion about local effects and
23 cytotoxicities.
24 BY MR. PANISH:
25 Q. So then you don’t have an opinion and you can’t
4682
1 disagree with Dr. Hansen that chromium and cobalt
2 chromium caused injury to Mr. Kransky; is that true,
3 sir?
4 MR. CALFO: Objection. No foundation,
5 misstates.
6 THE COURT: Overruled.
7 THE WITNESS: I can answer?
8 THE COURT: You can answer.
9 THE WITNESS: As I said, I’m not here to give
10 an opinion about that.
11 BY MR. PANISH:
12 Q. So you can’t dispute Dr. Hansen; correct?
13 MR. CALFO: Objection. Asked and answered.
14 MR. PANISH: He hasn’t answered yet.
15 THE COURT: State objections. If I want a
16 response, I’ll ask for a response.
17 The objection is overruled.
18 Answer his question.
19 THE WITNESS: I don’t have the capacity to
20 question his opinion.
21 THE COURT: Do you disagree with Dr. Hansen’s
22 observations about damage to the tissue surrounding the
23 implant?
24 THE WITNESS: I haven’t rendered an opinion on
25 that.
4683
1 THE COURT: Do you disagree with it?
2 THE WITNESS: Can I hear it again?
3 THE COURT: Do you disagree with Dr. Hansen’s
4 opinion that the implant caused localized damage to the
5 tissue around the implant?
6 MR. CALFO: Your Honor, respectfully, he has
7 not —
8 MR. PANISH: Is there —
9 THE COURT: I’m going to overrule the
10 objection. I want an answer to my question.
11 Do you disagree with that opinion?
12 THE WITNESS: I don’t have any evidence to
13 suggest that he would be correct.
14 MR. PANISH: I’d like to play the deposition,
15 then, page 61. Let’s start with line 23 to 63, line 10.
16 MR. CALFO: Objection, Your Honor. If you read
17 it, it says it’s outside the scope of his opinions.
18 THE COURT: I just need the transcript.
19 The objection is overruled. Take out the
20 commentary and objections.
21 MR. PANISH: I hate to do this to you,
22 Your Honor. They told me I’ve already done this; so I’m
23 going to move on. I’m sorry.
24 BY MR. PANISH:
25 Q. Have you looked at the photographs of the
4684
1 injury site of Mr. Kransky?
2 A. Yes.
3 Q. And those were provided to you by Mr. Calfo on
4 behalf of DePuy?
5 A. I don’t remember how I got them.
6 Q. Who provided you information in this case other
7 than Mr. Calfo?
8 A. It was probably Mr. Calfo. I just don’t
9 remember if it was Mr. Calfo or some other lawyer.
10 Q. How many people were providing you information
11 in this case, sir?
12 A. Primarily Mr. Calfo or Ms. Olah.
13 Q. Would you agree with me, then, all the
14 information you had was from Mr. Calfo or Ms. Olah?
15 A. I believe that’s true.
16 Q. And they would have provided you the photograph
17 or the photographs of the injuries to Mr. Kransky’s hip;
18 correct?
19 A. I may not have seen the original. It may have
20 been copies, but I’ve seen the photos.
21 Q. Is that a “yes,” sir?
22 A. Sure.
23 Q. Let’s take a look at Exhibit 16.
24 THE COURT: I’m sorry. Exhibit?
25 MR. PANISH: 16.
4685
1 BY MR. PANISH:
2 Q. Is this what you reviewed, sir?
3 MR. CALFO: Again, Your Honor, it’s beyond the
4 scope.
5 THE COURT: Overruled.
6 THE WITNESS: I’ve seen that photo.
7 BY MR. PANISH:
8 Q. You reviewed that in this case, didn’t you,
9 sir?
10 A. Reviewed being an exaggeration. I saw it.
11 Q. Okay. Is that your understanding of what the
12 hip looked like inside Mr. Kransky when he was opened up
13 and the hip was removed?
14 A. That’s my understanding.
15 Q. One of the jobs you had in this case was to
16 find out why these hips were failing at such a high
17 rate. Isn’t that true?
18 A. No, that was not my primary objective.
19 Q. Was that one of the benefits or outcomes that
20 you were looking into, sir?
21 A. I said it would be a fortunate outcome if that
22 occurred.
23 Q. Let’s look at page 49, lines 25 to page 50,
24 lines 10 regarding your testimony on that issue, sir.
25 This deposition was December 22? What date was it?
4686
1 THE COURT: We have the date earlier, I
2 believe.
3 BY MR. PANISH:
4 Q. 20th.
5 THE COURT: Did you have a chance to look at
6 it?
7 MR. CALFO: Yes, I have.
8 THE COURT: Go ahead.
9 BY MR. PANISH:
10 Q. See if this refreshes your recollection of one
11 of the outcomes of your work was hoped to be.
12 (Videotaped testimony of DENNIS PAUSTENBACH was
13 played as follows:)
14 QUESTION: Was an additional
15 question why is the ASR requiring
16 revision as often as it is?
17 ANSWER: That was a secondary
18 hopeful outcome of our work.
19 QUESTION: Did you ever find an
20 answer as to why the ASR was requiring
21 revision as often as it did?
22 ANSWER: You mean as of today?
23 QUESTION: As you sit here now.
24 ANSWER: I don’t know why.
25 (Videotaped testimony of DENNIS PAUSTENBACH
4687
1 concluded.)
2 BY MR. PANISH:
3 Q. So, sir, after being paid 5 million, you
4 couldn’t come up with the answer to that question;
5 right?
6 A. I have not been able to do that.
7 Q. Nor any of the 70 scientists in your company,
8 or did you say it’s more than 70? I don’t want to limit
9 you.
10 A. We’re up to a hundred, but that was not our
11 charge.
12 Q. None of the hundred scientists — do you think
13 the hundred scientists in your company could figure that
14 out?
15 A. Oh, I couldn’t answer that. There have been a
16 lot of very, very good minds looking at this. I don’t
17 know that we will.
18 Q. Who’s been looking at it, sir? Which very good
19 minds have been looking at it?
20 A. You’ve got physicians all over Europe, the
21 United States, and Australia.
22 Q. Who has been looking into this issue that you
23 referred to as a “very good mind”? Can you start naming
24 the names for us, please?
25 MR. CALFO: Objection, Your Honor, 352.
4688
1 THE COURT: Sustained.
2 BY MR. PANISH:
3 Q. Were you provided the brochure for the hip that
4 shows the metallosis injury that was submitted or sent
5 out by DePuy?
6 A. I don’t know what you’re talking about.
7 Q. Okay. I’ll show you 1178 previously
8 identified.
9 Do you see this where it says, “Excessive wear
10 and ion release, metal”?
11 Do you see that, sir, it’s Exhibit 1178?
12 A. Yes.
13 Q. Did Mr. Calfo or Ms. Olah when they were
14 providing all this information to you provide you with
15 that?
16 A. I don’t mean to be difficult. Can I just see
17 the document for a moment?
18 Q. Sure.
19 A. The whole thing.
20 Q. You want to see all the pages?
21 A. Just a couple.
22 Q. Give him some more pages.
23 A. One more. I’ve seen it.
24 Q. Mr. Calfo, then, provided that to you?
25 A. Yes, he did.
4689
1 Q. You’ve seen that picture, then, of excessive
2 wear and ion release?
3 A. Yes, I have.
4 Q. Okay. Fair enough.
5 Now, sir, in coming up with your opinions in
6 this case, I think you’ve told us that you and other
7 ChemRisk employees were involved in some studies; right?
8 A. True.
9 Q. And that you did them on cobalt; is that right?
10 A. True.
11 Q. And the only reason for these studies was
12 because you were hired by the lawyers for DePuy to do
13 that; correct?
14 A. They never asked me to do that study. This is
15 something I thought would be informative.
16 Q. They told you to do whatever you needed to do;
17 right?
18 A. That’s what they said.
19 Q. They said unlimited budget, do whatever you
20 want; right?
21 A. No, sir. I’ve never said that. There was
22 always a limitation on the budget.
23 Q. What was the budget when you first were hired?
24 A. No. I was asked permission per project. I had
25 no unlimited budget.
4690
1 Q. What was the budget? You said there was a
2 budget. What was the budget?
3 A. Per task, I would ask for authorization to
4 proceed.
5 Q. What was the budget when you were first hired?
6 A. There was no budget initially.
7 Q. When did there ever become a budget?
8 A. As soon as they ask you to perform a scope of
9 work.
10 MR. PANISH: Your Honor, could I ask him,
11 please, to answer.
12 THE COURT: Overruled. He’s answered.
13 BY MR. PANISH:
14 Q. When was the first budget enacted in the case
15 when you were hired over 18 months ago?
16 A. To review the literature. To begin assembling
17 and reviewing the literature.
18 Q. What was their budget for that?
19 A. I’m going to — my best recollection is around
20 $25,000.
21 Q. Okay. What was the next budget? Did you
22 exceed that $25,000 budget?
23 A. Yes, sir.
24 Q. What did you charge for reviewing the
25 literature?
4691
1 A. Totally?
2 Q. Yes.
3 A. Reading and analyzing all the literature?
4 Q. Yes.
5 A. I can’t be certain. I can estimate if you’d
6 like.
7 Q. Sure. That would be great.
8 A. I think it would be over 250,000.
9 Q. So initially it was 25,000. You think you came
10 in around 250,000?
11 A. At the end of the 20-month journey, that
12 wouldn’t surprise me.
13 Q. Sir, what was the next budget that was
14 implemented?
15 A. I don’t recall.
16 Q. Can you recall any other budgets that were
17 implemented?
18 A. Sure.
19 Q. Tell us.
20 A. Well, there’s meeting budgets. There were
21 budgets to — of course, ultimately, there were budgets
22 on the volunteer study and other matters.
23 Q. Were these written budgets?
24 A. I don’t recall.
25 Q. Were they written in e-mails, “This is the
4692
1 budget”?
2 A. No, I doubt it.
3 Q. Who gave you the budget?
4 A. I have a staff, like you said, of a hundred
5 people. I don’t get involved in writing individual task
6 budgets.
7 Q. Who from your staff was involved in the budget
8 discussions?
9 A. It would be one of four or five different
10 people.
11 Q. Who did they deal with?
12 A. Primarily, they would have dealt with, I think,
13 Mr. Calfo.
14 Q. Okay. So Mr. Calfo and four or five potential
15 employees of yours would set the budgets for each task
16 in this case; right?
17 A. They’d make a proposal, and then I assume
18 Mr. Calfo would converse with the client.
19 Q. Mr. O’Shaughnessy to get approval to do that?
20 A. I don’t know the chain of command there.
21 Q. These would have been in writing when the
22 proposal was submitted?
23 A. Not necessarily. They could have been done
24 verbally.
25 Q. So all these budgets were set verbally?
4693
1 A. No, I didn’t say that. I said some could have
2 been and some may not have been, and there’s consulting
3 assignments and expert assignments related to trials.
4 Separate worlds.
5 Q. Sir, have you ever seen any written budget for
6 any work that your company has done for DePuy?
7 A. I believe I have.
8 Q. How many?
9 A. I don’t know.
10 Q. More than ten?
11 A. Perhaps.
12 Q. Okay. So that means your company would have a
13 copy of that; right?
14 A. If they exist, sure.
15 Q. Well, you’ve seen ten of them; right?
16 A. Yeah, I mean that means I’ve seen them. It
17 doesn’t mean they were issued in writing. They could
18 have been done verbally.
19 Q. So you saw something that was verbally given?
20 A. No. You can imagine how a staff would say to
21 me, “Dr. Paustenbach, this is the scope of work and this
22 is what we think it will cost.” What happens after
23 that, it’s uncertain to me.
24 Q. All I asked you whether you’ve seen any in
25 writing. You said you had; right?
4694
1 A. Yes.
2 Q. Yes?
3 A. Yes.
4 Q. And then I asked you whether your company would
5 still have them and you said, what?
6 A. I said I’m not sure.
7 Q. Are you in the practice, when you’re in a
8 litigated matter like this, of destroying documents
9 relating to the consulting that you’re doing?
10 MR. CALFO: Objection, Your Honor, 352.
11 THE WITNESS: Absolutely not.
12 THE COURT: He answered “no.”
13 BY MR. PANISH:
14 Q. Sir, you told us when Mr. Calfo was questioning
15 you that the most expensive thing that you did was the
16 studies. Right?
17 A. I think all in, that’s probably going to be the
18 most expensive task.
19 Q. Is that a “yes,” sir?
20 THE COURT: He agreed. Put a question.
21 BY MR. PANISH:
22 Q. Sir, let’s take the first — was that a 12-day
23 study?
24 A. 14-day study.
25 Q. 14-day study.
4695
1 In that study, did you pay the people to get
2 involved in the study?
3 A. Not in the 14-day study.
4 Q. So they did it for free?
5 A. Right.
6 Q. And they gave the blood tests for free?
7 A. You mean — I don’t understand. You mean,
8 like —
9 Q. Like, you didn’t pay someone to give a blood
10 test. That means for free.
11 A. They weren’t paid to give blood, that’s right.
12 Q. So you didn’t have to pay anything to the
13 people that were in the study. Is that what you’re
14 telling me?
15 A. No. The junior people were allowed to pay or
16 to charge for the time it took to go down and get the
17 blood taken, but the senior people were not.
18 Q. Sir, isn’t it true that you were never asked to
19 do these studies by any cobalt supplement manufacturer?
20 A. Absolutely true.
21 Q. The only reason you did these is because you
22 were hired by the lawyers for DePuy; right?
23 A. The only reason I did them is because I wanted
24 to figure out —
25 THE COURT: You can answer his question. Is
4696
1 that the reason you did these studies because you were
2 hired by DePuy?
3 THE WITNESS: I guess so.
4 BY MR. PANISH:
5 Q. Thank you.
6 Sir, you weren’t doing these studies because
7 you were concerned with how much cobalt people should be
8 getting; right?
9 A. That’s fair.
10 Q. And you never published any study on cobalt
11 before you were hired in this case; right?
12 A. That’s true.
13 Q. And these studies were done solely for the
14 purpose of the litigation; correct?
15 A. I would imagine they’re going to be involved in
16 other regulatory issues done the road.
17 MR. PANISH: Excuse me.
18 THE COURT: Can you answer his question?
19 Read back the last question.
20 (Record read.)
21 THE WITNESS: I think my answer is appropriate.
22 THE COURT: Answer that question. Were they
23 done —
24 THE WITNESS: No.
25 ///
4697
1 BY MR. PANISH:
2 Q. Sir, isn’t it true that as a general matter the
3 medical community considers a level below 1 to be a
4 normal level of cobalt in an individual?
5 A. 1?
6 Q. Yes. Below 1.
7 A. Oh, yes, definitely.
8 Q. Is that a “yes”?
9 A. I agree with you.
10 Q. And no one has ever been diagnosed, to your
11 knowledge, of being deficient in cobalt, have they?
12 A. From what I can tell, people have been — well,
13 they’re deficient in vitamin B-12 of which cobalt is
14 part of it.
15 Q. Let me ask it again, sir. Are you aware of
16 anyone ever being diagnosed by a doctor as having
17 insufficient cobalt? “Yes” or “no”?
18 A. I’m not aware of one.
19 Q. And you would agree it’s a good idea for
20 patients that have an ASR XL hip to have their cobalt
21 and chromium levels checked, wouldn’t you?
22 A. I’d follow either the Mayo or the MHRA
23 guidelines on that.
24 Q. Page 135, line 8, 135, 18 of your deposition.
25 MR. CALFO: No objection, Your Honor.
4698
1 (Videotaped testimony of DENNIS PAUSTENBACH was
2 played as follows:)
3 QUESTION: First of all, would you
4 agree that it’s a good idea for
5 physicians to check cobalt and
6 chromium levels in ASR patients?
7 ANSWER: Based on my reading of
8 the literature, the physician seems to
9 have agreed that that’s a wise thing
10 to do.
11 QUESTION: Do you agree with that?
12 ANSWER: Based on what I’ve read,
13 that’s a reasonable inference.
14 (Videotaped testimony of DENNIS PAUSTENBACH
15 concluded.)
16 BY MR. PANISH:
17 Q. Sir, are you aware when DePuy recalled this
18 device they put out a recall notice?
19 MR. CALFO: Objection. Beyond the scope of
20 direct.
21 THE COURT: Overruled.
22 THE WITNESS: Yes.
23 BY MR. PANISH:
24 Q. Did they list the level of which they felt
25 there could be a problem with cobalt?
4699
1 A. I don’t recall.
2 Q. Did Mr. Calfo provide that to you, sir —
3 A. No, I mean I don’t remember the number. I can
4 imagine what it’s between, but I don’t remember the
5 number.
6 Q. Tell us what it’s between.
7 A. Probably between 3 and 10.
8 Q. And in your papers, you note that cobalt is
9 used as hormone replacement therapy for older women;
10 right?
11 A. I’m sorry. I didn’t —
12 Q. I’ll say it again.
13 In your papers, you note that cobalt is used as
14 hormone replacement therapy for older women.
15 A. It’s been reported to be used that way, yes,
16 sir.
17 Q. Well, sir, you can’t name any organization that
18 recommends taking cobalt supplements other than
19 companies that sell cobalt supplements; right?
20 A. After doing research after my deposition —
21 THE COURT: Hold on —
22 THE WITNESS: The answer is right. True.
23 BY MR. PANISH:
24 Q. That wasn’t the answer you gave under oath
25 previously, was it, sir?
4700
1 A. I said that Dr. Wright —
2 THE COURT: Hold on. Is that the answer you
3 gave previously? You can answer “yes” or “no.”
4 THE WITNESS: I don’t believe so, Your Honor.
5 BY MR. PANISH:
6 Q. So you changed your answer in that regard?
7 A. No.
8 Q. Let’s see Dr. Wright is from the Tahoma Clinic;
9 is that right?
10 A. I believe so.
11 Q. And you’ve cited him in your paper to say that
12 cobalt is used to treat elderly women as a hormone
13 replacement therapy, didn’t you, sir?
14 A. That’s what he said.
15 THE COURT: Is that what you said in your
16 paper?
17 THE WITNESS: That’s also what I said in my
18 paper.
19 BY MR. PANISH:
20 Q. And he’s a homeopathic doctor; isn’t he?
21 A. He is.
22 Q. He sells everything but cobalt, doesn’t he,
23 sir?
24 A. I didn’t do that investigation.
25 Q. So you talked about people taking these cobalt
4701
1 supplements, athletes, is that what you said?
2 A. Yes, sir.
3 Q. Which athletes are you aware of taking this?
4 Does Barry Bonds take it?
5 A. I don’t have his medical information.
6 Q. You’re in the Bay area. How about anyone on
7 the 49ers? You told us all these athletes are taking
8 it. Can you name some athletes for us that are taking
9 it, sir?
10 THE COURT: Are you aware of any particular
11 athletes that take it?
12 THE WITNESS: I don’t know a specific athlete.
13 I only know papers that talk about it.
14 BY MR. PANISH:
15 Q. What athletes do they mention? Lance
16 Armstrong? Is he mentioned?
17 THE COURT: Are you aware of any particular
18 athlete?
19 THE WITNESS: No, sir.
20 BY MR. PANISH:
21 Q. Now, you and your firm authored and published
22 studies on cobalt consumption; is that right?
23 A. Yes.
24 Q. And there are four papers as a result of that
25 work; right?
4702
1 A. True.
2 Q. And these studies initially involved you and
3 other employees of your company actually drinking the
4 cobalt; right?
5 A. True.
6 Q. And were these people who ingested the cobalt,
7 they were all employed by your company; right?
8 A. In the first five persons or six persons, yes.
9 Q. The first 14-day study, these were all people
10 from your company, weren’t they, sir?
11 A. True.
12 Q. And this, again, was done because DePuy paid
13 for it; right?
14 A. No.
15 Q. Okay. Now, sir, did you tell the people in the
16 study that they were really interested — excuse me.
17 Did you tell the people in the study that what
18 you were really interested in was whether a defective
19 hip was causing hazardous levels of cobalt?
20 A. Can I hear that — Your Honor, can I hear that?
21 THE COURT: Yeah. Read it back.
22 (Record read.)
23 THE WITNESS: Absolutely not.
24 BY MR. PANISH:
25 Q. Sir, the best way to determine whether somebody
4703
1 with a hip was having a problem would be to put the hips
2 in actual patients and see what happened. Wouldn’t you
3 agree with me on that?
4 A. Depends on what the objective of the study was.
5 Q. To get the truth about the metal ions being
6 generated by the metal-on-metal hip and what levels, if
7 any, were caused by the wear in the hip.
8 A. You could do prospective design, yes.
9 Q. Did DePuy, to your knowledge, ever do that?
10 A. I don’t know.
11 Q. Sir, you talked about this communique, I think
12 you called it, from the Mayo Clinic that you relied on;
13 right?
14 A. Sure.
15 Q. And, sir, you refer to page — first of all —
16 let me withdraw that.
17 First of all, this article talked about
18 pseudotumors caused by metal ions, didn’t it, sir?
19 A. Yes.
20 Q. It talked about how people that had cobalt had
21 developed pseudotumors in the hip area, didn’t it, sir?
22 A. I don’t think you said that correctly.
23 Q. Maybe I didn’t. Let me try it again.
24 People that had metal-on-metal hips, ASR XL,
25 developed pseudotumors from the metal that was going in
4704
1 the hip area; correct?
2 A. No. They were using it as a surrogate, and
3 they believed some of the debris may have been the
4 cause.
5 Q. Didn’t they say that patients experienced edge
6 loading, a situation where the ball of the implant binds
7 against the edge of the cup flaking off metal debris?
8 A. True.
9 Q. You’re aware of that; right?
10 A. True.
11 Q. Didn’t they also say it’s clinically important
12 to know what the serum chromium levels are and what the
13 cobalt levels are because this is evidence of excessive
14 wear of the hip joint, the implant joint?
15 A. It can be, yes, sir.
16 Q. Did they say it can be or did they say it’s
17 likely to show if you have chromium or cobalt levels,
18 they would have significant implant deterioration?
19 A. I’d say I agree with what it says.
20 Q. Sir, do you agree that this article that you
21 relied on from the Mayo Clinic that you told us all
22 about this morning determined that people that were
23 having cobalt and chromium levels elevated was cause and
24 evidence of excessive wear of the implant device?
25 A. I don’t think that’s a quote from the article.
4705
1 Q. Do you agree with that or not, sir?
2 A. I would say this — if I’m allowed.
3 THE COURT: Go ahead.
4 THE WITNESS: The relationship between failures
5 and blood concentrations has not been established. In
6 fact, the most scholarly articles prove otherwise.
7 BY MR. PANISH:
8 Q. Sir, what was Mr. Kransky’s cobalt and chromium
9 serum levels in nanograms per milliliter?
10 A. About 26 for chromium and 57 for cobalt.
11 Q. Let’s take a look, sir, at this article you
12 relied on and let’s take a look at page 2, which wasn’t
13 discussed earlier.
14 THE COURT: Are you talking about Exhibit 2971,
15 page 32?
16 MR. PANISH: Yes, sir. Thank you.
17 THE COURT: We don’t have that. All we have is
18 the one-page.
19 MR. PANISH: Should I mark the page? The
20 article? What would you like me to do?
21 THE COURT: Do we have the article?
22 MR. PANISH: I have it right here.
23 THE COURT: It will be marked as 2990, I
24 believe. Yes.
25 ///
4706
1 (Exhibit No. 2990 was marked for
2 identification.)
3 BY MR. PANISH:
4 Q. If we go to where it says, “Clinically
5 important implant wear.”
6 Do you see that?
7 A. I’ve got it. Which paragraph is it?
8 Q. Second page under “The Role of Chromium and
9 Cobalt.”
10 Do you see that? You have it yellowed out on
11 your sheet.
12 A. I do.
13 Q. Exactly the paragraph I’m talking about; right?
14 A. Yes, sir.
15 Q. You didn’t talk about that when Mr. Calfo was
16 questioning you about this, did you?
17 MR. CALFO: Your Honor, I object. You wouldn’t
18 let me go into this. You only let me go into the first
19 page.
20 THE COURT: I understand the objection. You
21 only used a portion of it. I’ll allow him to use a
22 portion of it.
23 BY MR. PANISH:
24 Q. You relied on this article, you told us that;
25 right?
4707
1 A. Yes.
2 Q. It says in this article from the Mayo Clinic
3 that you talked all about that, “It’s clinically
4 important implant wear is indicated — clinically
5 important implant wear is indicated when serum chromium
6 exceeds 15,” and is that nanograms per milliliter?
7 A. Yes.
8 Q. What was Mr. Kransky? I think you told us 26.
9 A. Roughly.
10 Q. That exceeds 15? Yes?
11 A. True.
12 Q. “And cobalt exceeds 10-nanograms per
13 milliliter.”
14 Mr. Kransky you told us was 57; right?
15 A. Yes.
16 Q. “These symptomatic patients are likely to have
17 significant implant deterioration.”
18 Is that what it says, sir?
19 A. Yes.
20 Q. And the implant deterioration is caused by the
21 wear of the device, the edge wear, isn’t it, sir?
22 A. Not necessarily.
23 Q. Do you know what causes that?
24 A. It’s a combination of factors, of course.
25 Q. Okay. Is that an area that you’re ready to
4708
1 discuss with me, sir, in this case?
2 A. I can make a — I can talk about three of those
3 areas. I believe I did that in my deposition.
4 Q. Is that an area you were designated and intend
5 to talk about in this case?
6 MR. CALFO: Your Honor, it’s beyond the scope.
7 THE COURT: Sustained.
8 MR. PANISH: That’s why I’m asking.
9 THE COURT: Sustained.
10 BY MR. PANISH:
11 Q. Sir, did Mr. Calfo provide you any internal
12 documents from DePuy regarding massive excessive wear
13 and chromium and cobalt level in people that had ASR XL
14 implants?
15 MR. CALFO: Objection, Your Honor. No
16 foundation.
17 THE COURT: Overruled.
18 Did you get any material like that?
19 THE WITNESS: No, sir.
20 BY MR. PANISH:
21 Q. Sir, you came in here and you told us about
22 your findings of your studies; right?
23 A. True.
24 Q. And I want to make this clear. Did you ever
25 disclose to the people in the study that what you were
4709
1 really interested in is whether a defective hip was
2 causing hazardous levels of cobalt?
3 MR. CALFO: Objection. No foundation.
4 THE COURT: Overruled.
5 THE WITNESS: I don’t know if I put it that
6 way. I just said that this information would be
7 involved in litigation.
8 BY MR. PANISH:
9 Q. Sir —
10 MR. PANISH: Could I ask it be read back, Your
11 Honor?
12 THE COURT: Yes. Read back the last question.
13 (Record read.)
14 THE WITNESS: Actually, that wasn’t the purpose
15 of the study.
16 THE COURT: The question is: Did you disclose
17 that to the people?
18 THE WITNESS: No.
19 THE COURT: Okay.
20 MR. PANISH: Thank you.
21 BY MR. PANISH:
22 Q. Let’s take a look, sir, at your consent forms
23 that you talked about earlier. Right?
24 A. Right.
25 Q. Let’s take a look at the first one. So the
4710
1 reason — the reason you didn’t have to pay the subjects
2 in the first study is because they were already on your
3 payroll; right?
4 A. I guess so. I mean I didn’t think about paying
5 them.
6 Q. Because they were already being paid by your
7 company, weren’t they, sir?
8 A. I guess. I’d say — sure, they were getting
9 paid by us. They did it for free.
10 Q. Sir, they were being paid. They had to come to
11 work to get a paycheck from your company; right?
12 A. But I wasn’t charging DePuy for it. I was
13 paying for it out of my own money.
14 THE COURT: They were employees of yours?
15 THE WITNESS: Sure.
16 THE COURT: Do you pay your employees?
17 THE WITNESS: Yes, sir.
18 THE COURT: Good.
19 Go.
20 MR. PANISH: Thank you.
21 BY MR. PANISH:
22 Q. Now, sir, did you tell them that the purpose of
23 the research was to hope to learn the stable level of
24 cobalt after at least 30 days of ingestion?
25 A. Yes.
4711
1 Q. Was DePuy in the supplement business, to your
2 knowledge?
3 A. No.
4 Q. When you disclosed what the purpose of your
5 research was, you didn’t say anything about whether
6 metal ions or cobalt ions can cause local injury to a
7 hip, did you?
8 A. No, because none of them had hip implants.
9 THE COURT: Hold on. The answer is “no”?
10 THE WITNESS: No.
11 BY MR. PANISH:
12 Q. And you were one of the people that was
13 actually in the study you told us; right?
14 A. True.
15 Q. When you have to fill out these — I think, you
16 called them informed consent documents —
17 A. I don’t have to call them that. That’s a
18 standard term.
19 Q. I didn’t say —
20 THE COURT: Hold on. He’s answered it. Go.
21 BY MR. PANISH:
22 Q. Is there a conflict of interest portion to
23 that?
24 A. I don’t recall.
25 Q. Well, did you write an article about the 14-day
4712
1 study that you put up on the board earlier?
2 A. Yes, sir.
3 Q. Did you discuss in that article conflicts of
4 interest?
5 A. Absolutely.
6 Q. Okay. Let’s take a look at that. I don’t
7 think it’s been marked so let’s mark it.
8 MR. PANISH: That would be, Your Honor — do
9 you have this?
10 MR. CALFO: What is it, counsel?
11 MR. PANISH: This study you put up on the
12 board.
13 MR. CALFO: I have it. Thank you.
14 THE COURT: What’s the name of the study?
15 MR. PANISH: It’s called “Cobalt Whole Blood
16 Concentrations in Healthy Adult Male Volunteers,” on and
17 on.
18 THE COURT: It will be marked as 2991.
19 (Exhibit No. 2991 was marked for
20 identification.)
21 BY MR. PANISH:
22 Q. That was put up — is that funny, sir? You’re
23 laughing.
24 THE COURT: Hold on, Counsel. Put a question.
25 ///
4713
1 BY MR. PANISH:
2 Q. Doctor —
3 THE COURT: Mr. Panish, put a question.
4 BY MR. PANISH:
5 Q. Is your name on this article?
6 A. Yes, sir.
7 Q. And there’s one, two, three, four, five, six
8 people listed?
9 A. I believe so.
10 Q. And in the abstract, you kind of tell what the
11 article is about; right?
12 A. True.
13 Q. And you wrote in the abstract or your author —
14 did you review the abstract before it was published?
15 A. Absolutely.
16 Q. Did you write in the abstract, “Recently
17 there’s been an increase in the marketing sales of
18 dietary supplement, energy drinks and other consumer
19 products that may contain relatively high concentrations
20 of essential elements cobalt contained in
21 supplements” — did you write that, sir?
22 A. True.
23 Q. When the whole abstract of the article, which
24 is supposed to be a summary about the article; right?
25 A. True.
4714
1 Q. Did you write anything about the hip implants
2 and the DePuy litigation?
3 A. Not in the abstract. I don’t think so. I’d
4 like to check, but I don’t recall.
5 Q. You can check. That’s fine.
6 THE COURT: I’ll put 2991 before the witness.
7 BY MR. PANISH:
8 Q. Let’s just put that up, if we don’t mind.
9 That’s the abstract right there; right, sir?
10 A. It’s not in the abstract.
11 THE COURT: You’re talking about two different
12 things. He’s answering your question from one ago.
13 There’s nothing in the abstract about being involved
14 with DePuy?
15 THE WITNESS: True.
16 BY MR. PANISH:
17 Q. And you say, “There’s an increase of marketing
18 sales of dietary supplements”; right?
19 A. True.
20 Q. How much was the increase in the sales of
21 cobalt at this time, sir?
22 A. I would have no idea.
23 Q. You say there’s an increase. How much did it
24 increase? What was it before, and what was it after you
25 wrote this article?
4715
1 A. The word “cobalt” doesn’t appear in that
2 sentence.
3 Q. Dietary supplements. What was the increase of
4 dietary supplements, sir?
5 A. I have no idea.
6 Q. But you wrote here, “There’s been an increase
7 in marketing and sales of dietary supplements.”
8 A. That’s well known in the literature.
9 Q. How much did it increase if it’s well known?
10 A. I don’t know. It’s discussing a couple years
11 of time. It has nothing to do with cobalt.
12 Q. You go right down there and talk about cobalt.
13 “Little information regarding cobalt.” Right, sir?
14 “And cobalt dietary supplements.” Isn’t that what you
15 say there?
16 A. Yeah, it speaks for itself.
17 Q. So what was the increase of the sales of cobalt
18 that you needed to publish this article about?
19 MR. CALFO: Objection, Your Honor. Asked and
20 answered, vague.
21 THE COURT: Overruled.
22 You may answer.
23 THE WITNESS: It’s a non-sequitur. There’s two
24 separate issues.
25 ///
4716
1 BY MR. PANISH:
2 Q. Sir, how much of increased sales or marketing
3 was there of cobalt?
4 A. I have no idea.
5 Q. Do you know if there even was an increase of
6 marketing and sales of dietary supplements including
7 cobalt?
8 A. That’s not what it says.
9 Q. Could you answer the question?
10 A. It can’t be answered the way you asked.
11 Q. Do you know whether there was an increase in
12 the sales and marketing of cobalt?
13 A. I have — a third time, I don’t know.
14 Q. Did you refer to cobalt as a supplement?
15 THE COURT: In the article or here?
16 BY MR. PANISH:
17 Q. In this case.
18 A. I did not refer to it as a supplement. Cobalt
19 containing supplements which is vitamin B-12.
20 Q. Now, sir, let’s turn to page 7, the conflict of
21 interest section. That’s important in a paper isn’t it,
22 sir?
23 A. It’s becoming more important every day.
24 Q. Especially if you want to keep your integrity
25 and all that; right?
4717
1 A. You bet.
2 Q. You say here at the last sentence, “Funding for
3 the paper was primarily provided by DePuy.”
4 Did I read that right, sir?
5 A. Yes, sir.
6 Q. Can you tell us anyone that paid money to have
7 this article published, paid money, other than DePuy?
8 A. Yes, sir.
9 Q. Who paid money?
10 A. Me.
11 Q. How much did you pay?
12 A. I paid whatever it took to pay the employees to
13 finish it.
14 Q. Sir, how much money did you pay to fund this
15 paper?
16 A. I don’t know. I never calculated it.
17 Q. Did you reimburse yourself? Do you have a
18 document of how much money you paid?
19 A. Of course. I keep track of exactly what people
20 overrun on budgets.
21 Q. You paid the employees the same exact salary
22 that they got whether or not this study ever took place;
23 right?
24 A. True.
25 Q. You didn’t give them a bonus for participating
4718
1 in this, did you?
2 A. I didn’t penalize them —
3 THE COURT: Hold on. Did you give them a
4 bonus?
5 THE WITNESS: No, sir.
6 BY MR. PANISH:
7 Q. You said in the conflict of interest section,
8 “Funding for this paper was primarily provided by
9 DePuy”; right?
10 A. True.
11 Q. Now, sir, you didn’t say anywhere in that
12 article that this study was going to be used for
13 litigation, did you?
14 A. Yes, I did. If you’ll look in the conflict —
15 THE COURT: Hold on. The answer is “yes.”
16 THE WITNESS: Yes.
17 BY MR. PANISH:
18 Q. Did you say it was going to be used for medical
19 research?
20 A. I said it might be.
21 Q. What medical research has it been used for?
22 A. I likely consider it will be used in
23 understanding the hip implant issue.
24 Q. Sir, what medical research was this written —
25 A. I have not looked at how many times it’s been
4719
1 cited in the last 30 days. That’s the only way I would
2 know.
3 Q. Well, you say that it was — let me just read
4 it and make sure I’m careful. “This is going to be used
5 for nutrition research”; right? “Paper is prepared and
6 written. It is likely that this work will be relied
7 upon in medical research and nutrition research.”
8 A. I think that’s true.
9 Q. Who is the cobalt seller that’s doing nutrition
10 research, to your knowledge?
11 A. I don’t know.
12 Q. This is the same —
13 A. I’m sorry. I don’t know on cobalt. I know
14 nutrition researchers.
15 Q. I asked you about cobalt, sir. Just like you
16 brought in here to court and showed us.
17 A. Actually, you didn’t ask about cobalt. That’s
18 why I changed the answer.
19 Q. Isn’t it true that you and the other employees
20 drank the chromium?
21 A. True.
22 Q. And that’s the same thing that you did with
23 your employees in the PG&E case; isn’t it?
24 A. True, except it was chromium.
25 Q. In the PG&E case, you sat in a hot tub —
4720
1 THE COURT: Hold on. In this last study, did
2 you drink cobalt or chromium?
3 THE WITNESS: This study, sir?
4 THE COURT: Yes.
5 THE WITNESS: Cobalt.
6 THE COURT: In the PG&E, it was chromium;
7 right?
8 THE WITNESS: Yes, sir.
9 THE COURT: I think you got it switched.
10 MR. PANISH: You’re right.
11 BY MR. PANISH:
12 Q. Same thing, though. Your employees did it
13 again; right?
14 A. By “did it again,” I think you mean we drank a
15 xenobiotic, we did.
16 Q. And PG&E paid; right?
17 A. They paid for the research.
18 Q. And you used it in the lawsuit, testified just
19 like here; right?
20 A. True.
21 Q. In that case, though, you sat in a Jacuzzi;
22 right?
23 A. For dermal update, that’s what we did, yes,
24 sir.
25 Q. Have you ever — strike that.
4721
1 When you set up the study, you didn’t try to
2 find any patients to drink the cobalt that had an ASR
3 hip, did you?
4 A. The study wouldn’t make any sense if you did
5 that.
6 THE COURT: So the answer is “no,” you did not
7 do that?
8 THE WITNESS: Yes, Your Honor.
9 BY MR. PANISH:
10 Q. And you didn’t try to find anyone that had a
11 metal-on-metal hip, did you?
12 A. No.
13 Q. Now, sir, your company could and is capable of
14 performing a study to see how cobalt and chromium being
15 shed from an ASR hip damages tissue and bones in
16 patients that have hips, couldn’t you?
17 MR. CALFO: Objection. Vague and ambiguous.
18 THE COURT: I didn’t understand the question.
19 BY MR. PANISH:
20 Q. I’ll rephrase.
21 Your company, ChemRisk — a hundred scientists
22 you said?
23 A. Yes, sir.
24 Q. You’re capable to have performed a study to see
25 how cobalt and chromium that’s being shed from ASR hip
4722
1 patients was damaging tissues and bones in patients;
2 right?
3 MR. CALFO: Objection, Your Honor. Undue
4 consumption of time.
5 THE COURT: Overruled.
6 Could your company do that kind of study?
7 THE WITNESS: No, sir.
8 BY MR. PANISH:
9 Q. You’re not capable?
10 A. It would take surgeons. It would require
11 surgeons. We don’t have them.
12 Q. Couldn’t hire them?
13 A. We could be a general contractor, but we
14 couldn’t do the study ourselves.
15 Q. Could you be involved in that type of study?
16 A. Yes, sir.
17 Q. Did someone from DePuy ever say to you that you
18 could — we would like you to use all the resources you
19 have at ChemRisk to conduct an exhaustive analysis to
20 what harms happen to tissue, muscle and bone around the
21 ASR hip implants?
22 A. No.
23 Q. If they did ask you, would you know that you
24 couldn’t do that?
25 A. It’s a non-sequitur.
4723
1 Q. Sir, you testified you could do that. You’d
2 just have to draw on other resources to understand that
3 issue; correct?
4 A. That’s true.
5 Q. That could have been done years ago, couldn’t
6 it?
7 A. I don’t know that it wasn’t.
8 Q. Sir, you have the capability —
9 A. Not by us anyway.
10 Q. Your company had the capability to do that ten
11 years ago, didn’t you?
12 A. If we were asked to be general contractors for
13 such research, we could have done it.
14 Q. Is that a “yes”?
15 THE COURT: Yes. He said it.
16 BY MR. PANISH:
17 Q. Thank you.
18 In your opinion, so I can understand here, you
19 talked about that you think it needs to be 300 parts per
20 billion before it’s harmful to the patient; right?
21 A. I said, in general, that appeared to be what
22 the evidence is from the literature.
23 Q. Is that a “yes”?
24 A. No, that’s not a “yes” or “no” question.
25 Q. Well, can you give us a range of what it would
4724
1 be, what it would require to cause tissue damage and
2 black stuff on a hip implant? Do you have a level for
3 that?
4 A. No, we did not derive one.
5 Q. We already talked about what DePuy recommended
6 to look at; so I’m going to skip that.
7 Do you know Dr. Schmalzried, who he is?
8 A. I haven’t met him yet.
9 Q. You read his deposition in this case, didn’t
10 you?
11 A. Yes, sir.
12 Q. Do you know what level he considered metal ions
13 to be elevated in, in a person with a hip?
14 A. I’m not precise in my recollection.
15 Q. Do you have a general recollection?
16 A. Between 2 and 6, as I recall.
17 Q. Much lower than you; right?
18 A. I don’t embrace a particular value. I just
19 adhere to the MHRA and their suggestions.
20 Q. Would you agree with me, sir — well, have you
21 reviewed Dr. Graham Isaac’s testimony?
22 A. I have reviewed part of it.
23 Q. Who gave it to you?
24 A. Probably Mr. Calfo.
25 Q. When did he give it to you?
4725
1 A. I guess it’s been — it hasn’t been that long
2 since he was in this courtroom. I don’t remember when
3 he gave it to me.
4 Q. Would you agree with him that during the
5 development of the ASR hip, it was important to
6 understand how cobalt and chromium and ions could affect
7 the health of people who received the ASR?
8 A. I don’t know if he said that.
9 Q. Would you like to see it? Page 1026 — 1076,
10 lines 19 to 25.
11 A. I would like to see the precise wording, yes.
12 Q. Let’s take a look at it.
13 While he’s pulling that up, do you have an
14 understanding whether there was a toxicologist involved
15 in this ASR development team?
16 MR. CALFO: Objection. Asked and answered.
17 352.
18 THE COURT: Well, it’s cross-examination; so
19 asked and answered doesn’t apply.
20 MR. PANISH: I didn’t ask him that. I’ve never
21 asked him that.
22 THE COURT: Asked and answered doesn’t apply is
23 the point I’m trying to make.
24 MR. PANISH: Oh, I’m sorry.
25 THE COURT: We’re far afield here.
4726
1 MR. PANISH: I want to show you Dr. Isaac’s
2 testimony.
3 QUESTION: For that reason, it
4 would be important, wouldn’t it, since
5 you’re an engineer and don’t
6 understand it, to have available to
7 you whenever you needed one, a
8 toxicologist?
9 ANSWER: It’s important to have
10 people who do understand it such as
11 people who are on this paper, yes.
12 Did you read that?
13 A. Yes.
14 Q. Do you agree with that?
15 MR. CALFO: Objection, Your Honor. We don’t
16 know — it’s incomplete.
17 THE COURT: Overruled.
18 Do you agree with that statement?
19 THE WITNESS: I agree that he said it.
20 THE COURT: Do you agree a toxicologist should
21 be involved?
22 THE WITNESS: I’d have to see the whole context
23 to know what he’s talking about.
24 BY MR. PANISH:
25 Q. When you read the whole thing, did you agree —
4727
1 let me ask you this. You read Dr. Isaac’s testimony
2 because Mr. Calfo gave it to you; right?
3 A. True.
4 Q. Did he give you the whole thing or just parts
5 of it?
6 A. I think he gave me the whole thing.
7 Q. Did you read the whole thing?
8 A. I believe I did.
9 Q. Did you see things that Dr. Isaac said that you
10 didn’t agree with?
11 A. Oh, I couldn’t answer that question.
12 Q. Can you think of a single thing that you saw in
13 his testimony that you didn’t agree with, sir? “Yes” or
14 “no”?
15 MR. CALFO: Objection, Your Honor.
16 THE WITNESS: I —
17 THE COURT: Hold on. As it relates to
18 toxicology, is there anything you disagreed with?
19 THE WITNESS: No.
20 BY MR. PANISH:
21 Q. Thank you.
22 THE COURT: How much more do you have?
23 MR. PANISH: I’m trying to finish right now,
24 Your Honor.
25 THE COURT: Good.
4728
1 MR. PANISH: I’m just looking.
2 BY MR. PANISH:
3 Q. We talked about Mr. Kransky’s kidney; right?
4 A. True.
5 Q. Remember all those exhibits?
6 You’re not a nephrologist; right?
7 A. True.
8 Q. What is a nephrologist?
9 A. Kidney specialist.
10 Q. Is that somebody that’s a medical doctor?
11 A. Yes, sir.
12 Q. That treats patients?
13 A. Yes, sir.
14 Q. You don’t do that, do you?
15 A. Correct.
16 Q. And, sir, wouldn’t you agree that as soon as
17 Mr. Kransky’s hip was taken out, his cobalt and chromium
18 levels dropped?
19 A. True.
20 Q. Wouldn’t you agree that that drop was due to
21 the removal of the ASR implant?
22 A. True. Or the tissue around it.
23 MR. PANISH: I think that’s all I have for
24 right now. Thank you, sir.
25 THE WITNESS: Thank you, Mr. Panish.
4729
1 THE COURT: How long do you have on redirect?
2 MR. CALFO: Just a little bit.
3 THE COURT: Should we try to do it now?
4 MR. CALFO: Yes.
5 THE COURT: Great.
6 REDIRECT EXAMINATION
7 BY MR. CALFO:
8 Q. Doctor, you’ve been asked a lot of questions
9 about you personally; right?
10 A. Yes, sir.
11 Q. Share with the jury some of the appointments
12 you’ve had with the government. The main ones.
13 A. In recent time, I’m on the board of scientific
14 counselors for EPA. I’m on the senior board that gives
15 advice to the administrator on how they should spend
16 their research dollars. That, as I understand, is an
17 executive appointment from senior staff at the White
18 House. Or the administrator and I have done that for, I
19 think, coming up eight years. Prior to that, I was on
20 the advisory board for the Center of Disease Control in
21 Atlanta for their division of toxic substances.
22 In the past, I’ve served on other governmental
23 panels to examine research programs.
24 Q. Have you ever had any presidential
25 appointments?
4730
1 A. The two that I just mentioned for the board of
2 scientific counselors. You end up getting vetted by
3 White House staff.
4 Q. Were those presidential appointments in
5 relation to both the Bush and the Obama administration?
6 A. In this case, they were.
7 Q. Mr. Panish discussed the anemia studies being
8 discontinued.
9 Do you remember that?
10 A. Yes.
11 Q. Doctor, did the negative effects in those
12 patients only occur at 200 to 400 parts per billion?
13 MR. PANISH: Objection. Leading and
14 suggestive.
15 THE COURT: It is leading. Sustained.
16 BY MR. CALFO:
17 Q. What levels, in terms of parts per billion,
18 were the negative effects in those patients?
19 A. It appeared that it was in the high 200 parts
20 per million, and it could extend up into the 400s. It
21 depended on whether it was a child, a pregnant woman or
22 someone else.
23 Q. Now, let me ask you, you were talked — you
24 talked about cobalt not being used for anemia patients
25 since the ’60s, I believe?
4731
1 A. The last report I saw was ’67.
2 Q. Why is cobalt no longer used?
3 A. There’s a better drug that has — it’s just a
4 better drug. It’s more effective.
5 Q. You were asked if you were the go-to guy.
6 Do you remember that?
7 A. I do.
8 Q. By the way, you’ve heard all these questions or
9 attacks on your integrity before, haven’t you?
10 A. Yes, I have.
11 Q. By plaintiff lawyers; right?
12 A. All by plaintiff lawyers.
13 Q. Now, are you the go-to guy because of your
14 education and training, Doctor?
15 MR. PANISH: Objection. Leading and
16 suggestive.
17 THE COURT: Sustained.
18 MR. PANISH: No foundation.
19 BY MR. CALFO:
20 Q. Doctor, why are you the go-to guy? Share with
21 the jury, is it about your background, training and
22 experience?
23 THE COURT: Hold on. The first part was not
24 leading, and then you made it leading.
25 Why are you the go-to person, briefly, and then
4732
1 we’re going to wrap up.
2 THE WITNESS: I’m going to assume it’s because
3 I’ve published a lot in a number of fields, and I think
4 the only person in the country practicing today that has
5 an undergraduate degree in engineering and a MS in
6 occupational health and a Ph.D. in tox and a post-doc in
7 tox, and that is an unusual combination; so it allows me
8 to bring together the four basic sciences, other than
9 medicine, to work on complex problems. I think that’s
10 probably why.
11 MR. CALFO: Thank you, Doctor.
12 THE COURT: Anything further, Mr. Panish?
13 MR. PANISH: Just one about the go-to guy, sir.
14 RECROSS EXAMINATION
15 BY MR. PANISH:
16 Q. Isn’t it true that industry loves you?
17 MR. CALFO: Objection. Calls for speculation.
18 THE COURT: Sustained. We’re not going to get
19 into love here.
20 BY MR. PANISH:
21 Q. Peter Infante. You know Peter Infante, don’t
22 you, sir?
23 THE WITNESS: What am I allowed to say?
24 THE COURT: Do you know Peter Infante?
25 THE WITNESS: Yes, sir.
4733
1 BY MR. PANISH:
2 Q. Peter Infante is a former senior administrator
3 for the U.S. Occupational Safety and Health
4 Administration. That’s otherwise known as OSHA; right?
5 A. His career ended badly by a plaintiff’s
6 lawyer —
7 THE COURT: Do you know that he used to be the
8 head of OSHA?
9 THE WITNESS: He was never the head.
10 MR. PANISH: Senior administrator.
11 THE WITNESS: He was, indeed.
12 BY MR. PANISH:
13 Q. And he said and you’re aware of it —
14 MR. CALFO: Objection. Hearsay.
15 THE COURT: Sounds like it’s going to be.
16 BY MR. PANISH:
17 Q. Isn’t it true that one of the reasons why
18 you’re the go-to guy is because the industry knows what
19 answer they’re going to get, nothing is ever harmful?
20 THE COURT: Is that true?
21 THE WITNESS: It’s ridiculous.
22 THE COURT: Okay. It’s not true.
23 BY MR. PANISH:
24 Q. Have you ever come into a courtroom like this,
25 sir, and testified by a person who was injured by a
4734
1 chemical or toxin against a chemical company or a
2 manufacturer?
3 A. I’ve never been asked to do so.
4 Q. Have you ever come into a courtroom like this,
5 sir, and testified on behalf of an injured victim suing
6 a manufacturer or chemical company? “Yes” or “no”?
7 A. No.
8 MR. CALFO: Objection, Your Honor —
9 THE COURT: The answer stands. “No.”
10 BY MR. PANISH:
11 Q. And you know the reason why you’ve never been
12 asked to, don’t you, sir?
13 THE COURT: It sounding like it’s
14 argumentative. I’m going to sustain my own objection.
15 Anything further? He’s right.
16 MR. PANISH: What?
17 THE COURT: You’re done.
18 MR. PANISH: Who said that?
19 THE COURT: Your colleague was thinking that.
20 MR. PANISH: Thank you, Dr. Paustenbach. Laugh
21 all the way home.
22 THE COURT: Anything further, Mr. Calfo?
23 MR. CALFO: No, Your Honor.
24 THE COURT: May the witness be excused.
25 MR. CALFO: Yes.
4735
1 MR. PANISH: Yes.
2 THE COURT: Thank you. You may be excused.
3 Who’s the next witness?
4 MR. ZELLERS: Your Honor, we have a couple more
5 videos.
6 THE COURT: Ladies and gentlemen, we’ll take
7 our afternoon recess. Keep in mind the admonition. See
8 you all back in 15 minutes.
9 (Recess taken from 3:10 p.m. to 3:27 p.m.)
10 COURT ATTENDANT: Please be seated and come to
11 order. Department 3 is, again, in session.
12 THE COURT: In the case of Kransky vs. DePuy
13 the record will reflect all counsel are present, all
14 jurors and alternates are present.
15 Mr. Zellers.
16 MR. ZELLERS: Your Honor, defendants call
17 Dr. Thomas Vail, chair of orthopedic surgery at UCSF and
18 member of the ASR surgeon design team. His deposition
19 was taken on May 30, May 31, and June 1, 2012, in San
20 Francisco, California. It’s 43 minutes.
21 (Videotaped testimony of THOMAS VAIL, M.D., was
22 played as follows:)
23 THOMAS VAIL, M.D.,
24 having been duly sworn, was examined and testified as
25 follows:
4736
1 – – –
2 EXAMINATION
3 QUESTION: You started as UCSF in
4 January of 2007?
5 ANSWER: That’s correct.
6 QUESTION: Before that, you were
7 at Duke?
8 ANSWER: That’s correct.
9 QUESTION: How long were you at
10 Duke?
11 ANSWER: I joined the faculty at
12 Duke in 1992.
13 QUESTION: And I know this is
14 another easy one. You are one of the
15 designing surgeons of the ASR
16 resurfacing and the ASR XL; correct?
17 ANSWER: Yes. I was part of the
18 design surgeon team of the ASR
19 resurfacing and the ASR XL.
20 QUESTION: Of that team, you were
21 one of the two Americans on the team?
22 ANSWER: There were five surgeons,
23 two of which were American.
24 QUESTION: How long were you at
25 Duke before you came to UC, at Duke as
4737
1 a full-time faculty member?
2 ANSWER: I started on the faculty
3 at Duke in 1992 and stayed there until
4 I was recruited to UCSF in January of
5 2007.
6 QUESTION: How many doctors had
7 you taught how to do ASR XL surgeries
8 before you came to San Francisco?
9 ANSWER: How many had I taught?
10 QUESTION: Yes.
11 ANSWER: I hadn’t specifically
12 taught doctors to do ASR XL surgery.
13 I train orthopedic residents. I teach
14 them how to do hip surgery. I don’t
15 tell them what prosthesis to use.
16 QUESTION: You have the
17 opportunity to publish in lots of
18 different places, don’t you?
19 ANSWER: I’ve published abstracts.
20 I’ve published article, I’ve published
21 book chapters, yes.
22 QUESTION: Should of those are
23 peer reviewed, some aren’t; isn’t that
24 right?
25 ANSWER: Some of peer reviewed and
4738
1 some are not.
2 QUESTION: And for Thomas P. Vail,
3 whether or not they are peer reviewed,
4 they’re still equally accurate;
5 correct?
6 ANSWER: Anything I write, I try
7 to provide accurate information,
8 that’s correct.
9 QUESTION: And for every device
10 sold, you would receive a royalty,
11 wouldn’t you?
12 ANSWER: The agreement that I had
13 with DePuy as far as reimbursement was
14 that I would receive a royalty for
15 devices that were sold, not devices
16 that I implanted or devices that were
17 implanted in the hospital where I
18 worked.
19 QUESTION: Did you keep track of
20 how much money you received quarterly
21 for the number of devices which were
22 implanted by others?
23 ANSWER: I did receive notice from
24 DePuy about royalty payments,
25 generally on a quarterly basis, as I
4739
1 recall. I didn’t tabulate or
2 calculate that, but I did receive
3 notice.
4 QUESTION: And did you make sure
5 that you received the fair amount each
6 quarter?
7 ANSWER: I assumed that the
8 information that DePuy provided to me
9 in that regard was correct. I didn’t
10 take any other action.
11 QUESTION: Are you currently under
12 any royalty agreement with DePuy?
13 ANSWER: I am not currently
14 receiving royalties from DePuy.
15 QUESTION: All right. Are you
16 currently receiving any compensation
17 from DePuy for activities on its
18 behalf in your capacity as a surgeon?
19 ANSWER: In my capacity as a
20 surgeon, no.
21 QUESTION: And do you keep,
22 independent of the patient’s chart,
23 any type of list or registry or record
24 of how those patients have done as a
25 group?
4740
1 ANSWER: I keep track of all of
2 the patients through the patients’
3 confidential information. We track
4 how they’re doing and keep that in the
5 patient’s medical record.
6 QUESTION: What has been the
7 failure rate, if we define “failure”
8 as revision, for your ASR resurfacings
9 done at UCSF?
10 ANSWER: My ASR resurfacings done
11 at UCSF, I am aware of one revision
12 for fracture. I am aware of two
13 revisions for pain. I’m trying to get
14 the numbers right. I believe there’s
15 a total of four to six revisions that
16 I am aware of. There may be others
17 that I’m not aware of. But those are
18 the ones that I know about.
19 QUESTION: What do you mean by you
20 “track all of the patients”?
21 ANSWER: I ask them to come in for
22 regular follow-up so that I can
23 examine them and obtain X-rays, speak
24 to them about how they’re doing, and I
25 give them medical advice.
4741
1 QUESTION: And are you telling us
2 that you have ongoing regular contact
3 with all 105 to 110 patients that you
4 did at UCSF?
5 ANSWER: What do you mean by
6 “ongoing regular contact”?
7 QUESTION: Do you have current
8 regular contact — excuse me. Do you
9 have current accurate contact
10 information for all 105 to 110
11 patients?
12 ANSWER: The contact information
13 varies greatly in terms of how much
14 information is available. Certainly I
15 make every effort to bring patients in
16 on a yearly basis. But I don’t think
17 I have yearly follow-up on every
18 patient. Some are not able to come in
19 for various reasons; so there’s
20 variability in what’s in the database.
21 It’s, you know, a collection of
22 information that’s based upon the
23 individual patient’s ability to come
24 to the clinic and see me.
25 QUESTION: In that window of time,
4742
1 what other total hip prostheses did
2 you use besides the ASR XL on your
3 patients?
4 ANSWER: During — excuse me.
5 During the period of time from January
6 of 2007 until the present, I’ve used a
7 variety of total hip implants that
8 would be based upon the indications
9 and the needs of the patient that
10 would include devices from companies
11 such as Zimmer, DePuy, Smith & Nephew,
12 Wright Medical, and there may be
13 others that I’m not thinking of at the
14 moment.
15 QUESTION: Why did you use
16 products other than the DePuy ASR XL
17 for total hips in 2007, ‘8, ‘9, and
18 ’10?
19 ANSWER: Well, any time I was
20 considering an operation for a
21 patient, I would consider the
22 patient’s diagnosis, physical exam,
23 their needs, their anatomy, and then
24 make a determination of what would be
25 the best implant choice for that
4743
1 patient.
2 QUESTION: Which non-ASR DePuy hip
3 prostheses were you using in that time
4 frame?
5 ANSWER: There would have been a
6 variety of devices that I would have
7 implanted during that period of time.
8 You’re asking me specifically about
9 DePuy devices; so it would include a
10 variety of hip stems, a variety of
11 femoral heads, acetabular components,
12 acetabular liners of different shapes,
13 sizes, and materials, based upon my
14 assessment of what an individual
15 patient might need.
16 QUESTION: And which were those,
17 the stems, the cups, liners, femoral
18 heads?
19 ANSWER: Yes. The devices that I
20 used — I’ll give you my best
21 recollection. There may be things
22 that I leave out, but I’ll try to give
23 you the list of devices that I might
24 have used. This would include a
25 Summit hip stem. It would include a
4744
1 Solution hip stem. It would include a
2 long-bowed Solution hip stem. I would
3 include an S-ROM hip stem. It would
4 include various S-ROM sleeves. It
5 would include femoral heads of various
6 sizes, from 28 to 32 to 36 and larger.
7 It would include cross-linked
8 polyethylene liners. It would include
9 metal liners. It would include
10 Pinnacle acetabular shells. Perhaps
11 on occasion, although not frequently
12 in my practice, I would use a ceramic
13 femoral head.
14 I believe that that’s a fairly
15 complete listing of the various
16 devices from DePuy that were not ASR
17 that I might have used during that
18 period of time.
19 QUESTION: And in those years,
20 2007, 2008, 2009, 2010, did the total
21 number of those exceed five to ten?
22 ANSWER: Total number of what?
23 QUESTION: These non-ASR DePuy hip
24 components.
25 ANSWER: All of those together?
4745
1 QUESTION: No. Were there more
2 than five to ten cases altogether for
3 all of those combinations in those
4 four years?
5 ANSWER: I’m not sure what you
6 mean “for all of those combinations.”
7 Can you be more specific about your
8 question so I can answer you
9 accurately?
10 QUESTION: Sure. You’ve told us
11 that in the time frame that you were
12 doing the resurfacings, there’s five
13 to ten ASR total hips which you did.
14 My question is: For the non-ASR
15 components, was it more than five to
16 ten cases in those four-year period?
17 ANSWER: Yes.
18 QUESTION: And your best estimate
19 as to how many?
20 ANSWER: I don’t know the answer
21 to that. I don’t keep track of — or
22 I don’t know off the top of my head
23 the exact number of non-ASR DePuy
24 devices that I would have used during
25 that period of time. It’s just not
4746
1 information I can produce for you as I
2 sit here.
3 QUESTION: Do you believe it was
4 at least 100?
5 ANSWER: I would say probably is
6 at least 100, but I don’t know exactly
7 the number is.
8 QUESTION: And is it as high as
9 possibly 250?
10 ANSWER: It might be more than
11 that. It likely is more than that but
12 I don’t know the exact number.
13 QUESTION: Can you give us the
14 upper range of what it probably is in
15 that four-year period?
16 ANSWER: I really can’t. You’re
17 asking me to guess. I just don’t know
18 that. It’s not information that I
19 keep in my head. If I’m looking at
20 total numbers of cases, I ask for
21 assistance from medical records. I
22 just don’t have that in my head.
23 QUESTION: Do you think it’s as
24 high as 500 case?
25 ANSWER: I don’t know.
4747
1 QUESTION: How about the Zimmer?
2 In this same window of time, you’ve
3 told us that you did total hip cases
4 in which for some patients you used
5 the Zimmer product?
6 ANSWER: That’s right.
7 QUESTION: Which Zimmer product or
8 products?
9 ANSWER: The Zimmer product would
10 have been predominantly VerSys stems,
11 the Trabecular Metal sockets, and
12 various head sizes, an array of Zimmer
13 products, some of which is dictated by
14 devices that are already in place and
15 so forth. So that would be the extent
16 of it.
17 QUESTION: What is your best
18 estimate in that four-year period how
19 many surgeries you did using Zimmer
20 products?
21 ANSWER: I don’t know exactly how
22 many Zimmer products I would have used
23 over that period of time. I would be
24 guessing, as I don’t keep in my head
25 the exact numbers of devices that I
4748
1 used from a specific company in a
2 given year.
3 QUESTION: Would it be your
4 expectation that it was in excess of
5 100 over a four-year period of
6 patients in whom you used Zimmer
7 prostheses, 2007, ‘8, ‘9, and ’10?
8 ANSWER: I don’t know the answer
9 to that question. I don’t keep track
10 of the exact number of devices from a
11 specific company over a certain time
12 frame in my head. I would need to
13 look that up. I just don’t know the
14 answer to your question as I sit here.
15 QUESTION: Did you use Zimmer more
16 or less frequently than DePuy
17 products, non-ASR DePuy products?
18 MR. HEALY: Between ’07 and ’10?
19 MR. KELLY: Yes.
20 ANSWER: Generally speaking, my
21 usage of Zimmer hip products would be
22 less than my use of DePuy hip
23 products.
24 QUESTION: In those four years,
25 did you do more total dips with Zimmer
4749
1 than you did with ASR XL?
2 ANSWER: I don’t know the exact
3 number of Zimmer total hips that I did
4 during that period of time from 2007
5 to 2010.
6 QUESTION: Yes.
7 ANSWER: So I really can’t answer
8 your question with certainty. I don’t
9 keep that information in my head.
10 QUESTION: So you’re unable to
11 tell us whether, based upon your
12 memory, you think in four years you
13 did more than ten cases with Zimmer
14 prostheses; right?
15 ANSWER: Based upon my memory, I
16 don’t know the exact number of Zimmer
17 prostheses that I did. It was
18 probably more than ten, but I just
19 don’t know the exact number to be able
20 to relate that to you today.
21 QUESTION: Was it probably more
22 than 100?
23 ANSWER: I don’t know what the
24 upper limit is. 100 may be too high,
25 it may not be. I just don’t keep that
4750
1 number in my head.
2 QUESTION: Was it probably more
3 than 50?
4 ANSWER: I don’t know the exact
5 number of Zimmer implants that I used.
6 I would be guessing to tell you that
7 it was more or less than 50. I just
8 don’t know the answer to that.
9 QUESTION: Can you give us
10 examples of circumstances where the
11 other devices you’re talking about or
12 we’ve talked about, non-ASR DePuy
13 devices or Zimmer or Smith & Nephew,
14 would offer the patient more in terms
15 of benefits than the ASR XL for a
16 primary total hip?
17 ANSWER: For any patient that
18 presents to me, I would consider their
19 specific circumstances, their history,
20 their activity levels, their age,
21 their bone, their X-rays, their needs,
22 and make a decision for a decision for
23 a specific patient. So I didn’t
24 strictly use one device for that
25 reason.
4751
1 QUESTION: In 2005, did you give
2 your patients any information as to
3 what you thought a safe and acceptable
4 blood level of cobalt or chromium was?
5 ANSWER: In 2005, as today, we
6 don’t have a definition of a safe
7 level of chromium and cobalt. We
8 would routinely discuss with any
9 patient receiving a metal device that
10 the device would potentially generate
11 chromium and cobalt, just as we would
12 discuss with a patient getting
13 polyethylene that that device might
14 generate polyethylene.
15 QUESTION: Am I correct that the
16 surgeon design team had the potential
17 for metal ion production — let me
18 back up.
19 The surgeon design team was aware
20 of these various ways that metal could
21 be produced in the body with the use
22 of a metal-on-metal prosthesis; right?
23 ANSWER: Yes. Mechanisms of wear
24 in joint replacement were described in
25 the literature, and the use of
4752
1 metal-on-metal devices has a history
2 that goes back to the 1950s. So there
3 is experience, prior experience with
4 metal-on-metal devices.
5 QUESTION: Did you say yes, that
6 the surgeon design team was aware of
7 these various mechanisms by which
8 metal ions could be produced?
9 ANSWER: I don’t specifically
10 recall conversations among the surgeon
11 design team about this. I was
12 answering your question regarding
13 production of metal ions from a total
14 hip in a hypothetical sense, trying to
15 provide you with that information.
16 But I don’t remember specific
17 conversations at a surgeon design team
18 meeting about this issue. It may be
19 included in some of the minutes that I
20 provided to you.
21 QUESTION: The surgeon design team
22 decided among themselves what would be
23 an acceptable level of metal ion
24 production for the DePuy ASR, didn’t
25 they?
4753
1 ANSWER: The surgeon design team
2 considered many facets of design. One
3 of the — one of the aspects of
4 designing a metal resurfacing device
5 was the fact that prior experience
6 with metal-on-polyethylene and high
7 levels of wear debris created problems
8 for patients, and there was an
9 opportunity with metal to create a
10 bearing that had much lower rates of
11 wear than polyethylene.
12 QUESTION: The surgeon designers
13 didn’t want to create new and
14 different complications by using metal
15 that previously had not existed with
16 plastic, did they?
17 ANSWER: There were problems with
18 plastic that existed. There was
19 experience with metal that existed.
20 The effort of the surgeon design team
21 was to create the best possible
22 bearing with the lowest possible wear,
23 something that might be appropriate in
24 well-selected patients.
25 QUESTION: Was it any part of the
4754
1 goal to have less wear than the
2 Conserve Plus?
3 ANSWER: Our focus was on
4 designing the ASR device to meet the
5 specifications and needs of our
6 patients, not to impact any choices
7 Wright Medical might make about the
8 Conserve Plus.
9 QUESTION: So is the answer it
10 wasn’t part of our goal to do better
11 than the Conserve Plus?
12 ANSWER: In what way?
13 QUESTION: In terms of metal ion
14 production.
15 ANSWER: There was no available
16 literature on metal ion production in
17 Conserve Plus during, you know, the
18 early period of designing the ASR
19 device.
20 QUESTION: How about less wear
21 than the Conserve Plus? Was that part
22 of the design goal?
23 ANSWER: A design goal would be to
24 create the lowest possible wear of the
25 device, not specifically matching it
4755
1 against any particular implant. There
2 are some — even if you look at one
3 implant like Conserve Plus, there’s
4 quite a bit of variability of the
5 debris generation from case to case.
6 So hard to make a direct comparison
7 from one implant to another.
8 QUESTION: Does patient activity
9 influence metal ion generation?
10 ANSWER: There is literature on
11 both sides of that point, some
12 suggesting that high activity patients
13 generate higher levels and some
14 suggesting that that’s not the case.
15 QUESTION: So going back for a
16 moment, if we can, to — or forward to
17 the present day, do you use any
18 particular metal ion levels to guide
19 you in deciding whether a given
20 patient should undergo revision
21 currently?
22 ANSWER: No. I use metal ions as
23 one bit of information in the whole
24 constellation of data that I would use
25 to evaluate a patient. There is not a
4756
1 specific metal level that has a given
2 meaning universally.
3 QUESTION: And in your patients
4 who have double digit cobalt and
5 chromium levels, that is, 10 or
6 higher, do you tell them that those
7 levels are fine and acceptable?
8 ANSWER: Yeah. I think to answer
9 your question would be very difficult,
10 for 10 or higher is a pretty broad
11 range.
12 QUESTION: What we do know is that
13 some kinds of debris, at some levels,
14 will be harmful to all patients; isn’t
15 that right?
16 ANSWER: There is wide variability
17 in how patients react to debris. This
18 is one thing that we’ve noticed with
19 polyethylene, with metal, with
20 ceramic. Some patients seem to react
21 clinically to lower levels of debris.
22 Some patients don’t seem to react.
23 There’s not a consistent patient
24 response to debris, be it metal,
25 plastic or ceramic.
4757
1 QUESTION: And with the ASR, was
2 it possible to tell before you put it
3 in a given patient how that patient
4 would react clinically to the debris
5 from the ASR?
6 ANSWER: There’s no way to predict
7 on an individual basis how a patient
8 will react to metal.
9 QUESTION: And for that reason,
10 isn’t it critically important that you
11 make sure that you expose the patient
12 to as little metal debris as possible?
13 ANSWER: What we knew was that any
14 debris could cause negative effects in
15 a patient; so we wanted to choose a
16 bearing material that would expose the
17 patient to the lowest possible volume
18 of wear debris.
19 QUESTION: And that was out of a
20 concern for the patient’s health and
21 safety; correct?
22 ANSWER: Patient’s health and
23 safety was a concern and part of the
24 consideration in designing this
25 device.
4758
1 QUESTION: Did you use any
2 guidelines for what would be an
3 acceptable annual revision rate in
4 designing the device?
5 ANSWER: I don’t know what an
6 acceptable annual revision rate might
7 be. I think it’s quite variable from
8 place to place, person to person,
9 patient to patient. So there’s not a
10 definition of acceptable annual
11 revision rate that I’m aware of.
12 QUESTION: And in the time that
13 you were working as a member of the
14 surgeon design team, you have no
15 memory of an announced acceptable
16 annual revision rate that the ASR
17 would have to conform to; is that
18 correct?
19 ANSWER: Our goal among the design
20 team would be to create a device that
21 had the lowest possible revision rate
22 in the hands of the surgeons using it.
23 QUESTION: Did any of your
24 colleagues at UCSF tell you that they
25 thought that the ASR XL device
4759
1 incorporated any flaws or defects?
2 ANSWER: None of my colleagues at
3 UCSF or anywhere else have ever told
4 me that they thought the ASR XL
5 incorporated flaws or defects.
6 QUESTION: We learned from the
7 earlier testimony that you did
8 significantly more ASR XL hip
9 replacements at Duke than at UCSF;
10 correct?
11 ANSWER: That’s right.
12 QUESTION: Why? Why did the
13 number drop so substantially when you
14 came to San Francisco during the
15 period 2007 to 2010?
16 ANSWER: I don’t know all of the
17 reasons. I think that part of it was
18 that when I came to San Francisco,
19 people were seeking me for resurfacing
20 in particular. So those patients that
21 might be a candidate for a large
22 diameter metal-on-metal were
23 specifically interested in
24 resurfacing, and that’s why the number
25 of resurfacing devices exceeded the
4760
1 number of XLs.
2 QUESTION: It wasn’t because you
3 were concerned at all about the safety
4 of the XLs?
5 ANSWER: No, I didn’t have safety
6 concerns. The patient selection was
7 based upon specific patient needs; so
8 I was fairly specific about devices
9 and who I would use, what device I
10 would choose for a particular patient.
11 But I didn’t feel there was a safety
12 issue that would be part of the choice
13 at that point.
14 QUESTION: Would it be correct to
15 say that different physicians would
16 have different techniques or tools
17 that they would use to try and assist
18 them in achieving appropriate cup
19 placement?
20 ANSWER: Yes, that’s correct.
21 QUESTION: And this would be an
22 area where the issue of surgeon or
23 physician judgment would play into how
24 a given surgeon would use whatever
25 tools are at her or his disposal to
4761
1 get the best result for them?
2 ANSWER: Yes.
3 QUESTION: Who determined that
4 this device incorporated optimal
5 clearance?
6 ANSWER: The idea of achieving a
7 clearance for a given head size that
8 would provide the best possibility for
9 fluid film lubrication is what we were
10 seeking, and that was a function of
11 the design trade-offs that related to
12 head size, cup size, implantation
13 devices, all of which led to the
14 choices that were made that ultimately
15 describe the design features of the
16 ASR device.
17 QUESTION: How “what might be
18 optimal for a given size might lead to
19 a trade-off in some other design
20 feature”? That was what you said.
21 Can you give me an example?
22 ANSWER: Right. So if you go back
23 to the idea of achieving a fluid film
24 lubrication, the optimal circumstance,
25 the optimal situation for fluid film
4762
1 is a function of clearance, of head
2 size, of surface roughness. All of
3 these are factors that relate to and
4 have a bearing on the ability to
5 achieve a fluid film.
6 So as one increases head size,
7 the clearance changes, the surface
8 roughness changes, other parameters
9 might change. So this is how — this
10 is what I mean by trade-offs in
11 engineering principles.
12 QUESTION: Those features of
13 achieving a fluid film lubrication and
14 what would be optimal, things such as
15 clearance, head size, surface
16 roughness, are those the only features
17 that would be considered in
18 determining whether you have optimal
19 fluid film lubrication?
20 ANSWER: No, I don’t think there
21 is a definition of optimal that I’m
22 aware of.
23 QUESTION: The aim with fluid film
24 lubrication is to have as little wear
25 as possible; right? That’s the
4763
1 concept?
2 ANSWER: Fluid film lubrication
3 refers to having a barrier of fluid
4 between the two metal surfaces, and
5 that allows the surfaces to run more
6 smoothly against each other and
7 decreases the wear production, yes.
8 QUESTION: With optimal clearance
9 and lowest possible wear, the aim of
10 the designers was to have a hip
11 prosthesis or a resurfacing prosthesis
12 that would produce less metal debris
13 than any other metal-on-metal implant
14 ever put on the market; isn’t that
15 right?
16 ANSWER: The idea was to produce a
17 device that would function well in
18 patients. That would include all
19 aspects of implantation, and one of
20 the desired features would be low
21 wear.
22 QUESTION: Well, in any event, the
23 surgeon design team was initially
24 convened in February of 2001 at the
25 Fairmont Hotel in San Francisco. Do
4764
1 you remember that?
2 ANSWER: I don’t remember that
3 first meeting, no.
4 QUESTION: Were you at the first
5 meeting?
6 ANSWER: I don’t remember the
7 first meeting; so I can’t say.
8 QUESTION: Is it fair to say that
9 from the very first meeting that you
10 were at, the issue of trying to make
11 certain that patients were not exposed
12 to more metal debris than necessary
13 was something the doctors on the team
14 kept in mind?
15 ANSWER: That was one of many
16 issues that we considered, yes.
17 QUESTION: And from the time of
18 the very first meeting, is it correct
19 to say that the group of surgeons
20 involved in this product development
21 had in mind that they wanted to avoid
22 exposing patients to any risks that
23 they could reasonably avoid exposing
24 them to?
25 ANSWER: I think that our goal as
4765
1 designing surgeons was to produce a
2 device that would function well in
3 patients, and that included many
4 aspects of the design and —
5 QUESTION: Would it be correct to
6 amend that answer and say —
7 MR. HEALY: Are you finished?
8 ANSWER: — metal ion exposure
9 included.
10 QUESTION: Is it true that the
11 goal as designing surgeons was to
12 produce a device that would function
13 well and safely in patients?
14 ANSWER: We had many goals with
15 this design team, and that included
16 all aspects of designing this device,
17 from patient selection to
18 implantation, instrumentation, design
19 features. We wanted a device that
20 would function optimally in patients.
21 QUESTION: But you wanted a device
22 that would function as safely as
23 possible in patients, didn’t you?
24 ANSWER: Safety is certainly an
25 important part of the equation, yes.
4766
1 QUESTION: And no surgeon in that
2 group would have approved a device
3 that they thought would expose
4 patients to excessive levels of metal
5 ions, would they?
6 ANSWER: Our goal was not to — or
7 one of our design goals was not to
8 expose patients to excessive levels of
9 metal ions.
10 QUESTION: And at that time,
11 during the design phase, was there
12 among the group a definition of what
13 would be an excessive level of metal
14 ions?
15 ANSWER: There isn’t a definition
16 of excessive levels of metal ions that
17 I’m aware of even today.
18 QUESTION: In the absence of a
19 definition of what is an excessive
20 level of metal ions, how could you
21 determine whether or not the patients
22 would be exposed to an excessive level
23 of metal ions?
24 ANSWER: At the outset of this
25 project, we were trying to address a
4767
1 problem with hip replacement and
2 resurfacing in young patients with
3 polyethylene where debris would create
4 local tissue problems, loosening,
5 osteolysis. And it was felt that a
6 metal bearing offered an opportunity
7 to provide a device that had a lower
8 volume of wear.
9 So one of our goals was to create
10 a device that would have a low volume
11 of wear debris.
12 QUESTION: But in terms of
13 determining whether or not the device
14 would produce an excessive level of
15 metal ions, how could you determine
16 what was an excessive level if you
17 hadn’t determined a definition for
18 what is an excessive level?
19 ANSWER: The idea was to create a
20 device that had low levels of wear, as
21 low as possible levels of wear, and we
22 felt that using a metal bearing, we
23 could produce a lower volume of wear
24 than what was historically available
25 with polyethylene.
4768
1 QUESTION: Is it true that the
2 goal as design surgeons was to produce
3 a device that would function well and
4 safely in patients?
5 ANSWER: We had many goals with
6 this design team, and that included
7 all aspects of designing this device,
8 from patient selection to
9 implantation, instrumentation, design
10 features. We wanted a device that
11 would function optimally in patients.
12 QUESTION: But you wanted a device
13 that would function as safely as
14 possible in patients, didn’t you?
15 (Videotaped testimony paused.)
16 THE COURT: You played that twice.
17 (Videotaped testimony resumed.)
18 QUESTION: I wasn’t going ask you
19 this for a while, but I’ll ask now
20 since we’re talking about it, which
21 is, what do you typically tell your
22 patients about the life expectancy of
23 either — of a hip implant, whether
24 it’s a resurfacing or a total hip
25 replacement?
4769
1 ANSWER: I don’t use the term
2 “life expectancy” when I’m counseling
3 patients about —
4 QUESTION: That’s a good idea, I
5 think. Yeah.
6 ANSWER: — a hip implant device.
7 What I try to talk to patients about
8 is their unique circumstance, the
9 decisions, the factors that go into
10 any decisions that I would make about
11 their circumstance in terms of an
12 operation or not an operation, a
13 partial versus a total hip, what type
14 of total hip.
15 And then we would typically talk
16 about reasonable expectation for
17 returning to activity. Many times
18 patients have questions about can they
19 walk, can they hike, can they play
20 golf, and things like that. And I
21 talk to them about what are the
22 potential complications, what
23 circumstances might lead to
24 reoperation or revision of the
25 components.
4770
1 And the risk of these
2 reoperations or revision varies widely
3 from patient to patient depending upon
4 health factors, their anatomy, their
5 activity levels. And so I try to help
6 patients understand those factors as
7 they think about what might lead to
8 the need for another operation or a
9 revision.
10 So how do I counsel a patient
11 today?
12 QUESTION: Exactly. Thank you.
13 ANSWER: About differing bearings?
14 Is that your question?
15 QUESTION: Yes.
16 ANSWER: So I think the answer is
17 going to be very similar to what I
18 just described to you, trying to
19 understand the patient’s goals, trying
20 to understand their complaints, why
21 are they in the office, what — often
22 it’s pain, if we’re talking about
23 arthritis of a hip joint, for example,
24 stiffness. Are there other
25 alternatives to treating other than
4771
1 surgery?
2 If we determine that a patient
3 needs a hip replacement and we’re
4 talking about bearing surfaces, I’ll
5 review with the patient the pros, the
6 cons, the risks, the potential
7 benefits of different types of bearing
8 materials, to be specific to your
9 question, or approaches to the hip,
10 all of the variables that might be of
11 interest or relevant to the patient.
12 QUESTION: Well, wouldn’t the idea
13 that it was an internal inserter
14 versus the external one that you
15 mentioned, the Conserve Plus, wouldn’t
16 that be a trade-off that you, in the
17 acetabular shell, would be required to
18 have a notched ridge inside the shell
19 in order to have an internal inserter;
20 is that correct?
21 ANSWER: I would view it to the
22 contrary. Having an external
23 attachment, I would view as a
24 downside.
25 QUESTION: You saw no negatives
4772
1 attached to having an internal notched
2 ridge?
3 ANSWER: The way the — this cup
4 inserter works, the advantages of
5 having a low profile, seeing the cup
6 edge, I think are all advantages. And
7 the way it attaches to the cup I don’t
8 think is a disadvantage.
9 QUESTION: So as you sit here
10 today, you were never an advocate for
11 increasing the arc of coverage on the
12 ASR shell?
13 ANSWER: I was willing to consider
14 any design of the cup, pros and cons.
15 If we were going to change the cup
16 design, I would want to see the data
17 in favor of that. What I’ve told you
18 today is that I liked that cup
19 inserter. It worked well in my hands.
20 I liked the way it fit on the cup.
21 And if we were going to make changes
22 or improvements in the cup going
23 forward, my preference would have been
24 to try to figure out how to maintain
25 the benefits of that cup inserter if
4773
1 changes would be made in the next
2 iteration of the implant design.
3 QUESTION: Well, you have actually
4 requested from Duke information about
5 your experience with ASR total hips
6 and resurfacings, haven’t you?
7 ANSWER: I have reviewed with
8 investigators from Duke the total
9 ASR XL experience at Duke, which would
10 include my own experience and that of
11 other people at Duke using the device.
12 QUESTION: How many did you do at
13 Duke?
14 ANSWER: I don’t recall
15 specifically how many ASR XL
16 resurfacing devices I did at Duke, and
17 I don’t have access to those numbers
18 at this point in time.
19 QUESTION: And what prevents you
20 from obtaining access to those numbers
21 at this point in time?
22 ANSWER: Well, because I no longer
23 work at that university, I don’t have
24 access to those charts and the
25 information about those patients.
4774
1 QUESTION: You have access to the
2 information by asking your colleagues
3 at Duke, don’t you?
4 ANSWER: I speak to my colleagues
5 at Duke frequently about a variety of
6 issues, sometimes related to specific
7 patients, if they have a question.
8 But I don’t have access to the
9 aggregate of data or the patients that
10 I operated on there.
11 QUESTION: So would it be true
12 that at no time in 2012 have you asked
13 anyone from Duke what the total number
14 of ASR total hips you did were at
15 Duke?
16 ANSWER: I don’t recall asking
17 specifically the number of total hips
18 that I did at Duke. I have had
19 conversations with colleagues at Duke
20 regarding the ASR XL total hips done
21 by the practice, not my specific
22 numbers that I can recall.
23 QUESTION: Have you not been
24 interested in what the outcome of your
25 own specific surgeries have been at
4775
1 Duke?
2 ANSWER: I’m always very
3 interested in outcomes, how my
4 patients are doing, and that remains
5 an interest as I sit here today.
6 QUESTION: And because you’re
7 interested in how your patients do,
8 have you therefore attempted to follow
9 up to see how the XL total hip
10 implants you did at Duke, how those
11 patients have done?
12 ANSWER: Well, because I’ve
13 changed practices, was recruited to
14 San Francisco, I’m no longer part of
15 the faculty at Duke, which means I
16 don’t have access to patient records
17 from that practice.
18 QUESTION: It is correct that
19 polyethylene and cobalt and chromium
20 present different risks to the person;
21 right?
22 ANSWER: Any orthopedic implant,
23 any surgery, presents risks to
24 patients.
25 (Videotaped testimony of DR. THOMAS VAIL
4776
1 concluded.)
2 MR. HUDSON: Your Honor, that concludes the
3 deposition testimony of Dr. Thomas Vail.
4 THE COURT: All right. Do you have one more
5 depo?
6 MR. ZELLERS: We do, Your Honor. Yes, we do.
7 THE COURT: How long is that one?
8 MR. ZELLERS: Well, I can play one that’s
9 16 minutes, if you’d like.
10 THE COURT: Let’s do one that’s 16 minutes.
11 MR. ZELLERS: All right. The defendants will
12 call Dr. Pamela Plouhar, worldwide vice president for
13 clinical research, was vice president for worldwide
14 clinical affairs at DePuy Orthopaedics. There are
15 actually two separate depositions, Your Honor. One was
16 taken on March 1 and 2 of 2012; the second was taken on
17 January 4 of 2013. Total, they’re 16-minute.
18 THE COURT: Roll ’em.
19 (Videotaped testimony of PAMELA PLOUHAR was
20 played as follows:)
21 PAMELA PLOUHAR,
22 having been duly sworn, was examined and testified as
23 follows:
24 – – –
25 ///
4777
1 EXAMINATION
2 QUESTION: I’d like to ask you
3 just briefly to tell the ladies and
4 gentlemen of the jury about your job
5 duties at DePuy, and specifically from
6 2004 to the present. So from 2004 to
7 2007, what was your title at DePuy?
8 ANSWER: From 2004 to 2007 I was
9 the director for U.S. clinical
10 research.
11 QUESTION: What were your duties
12 and responsibilities as director of
13 U.S. clinical research?
14 ANSWER: So for director of U.S.
15 clinical research, I had oversight for
16 the U.S. clinical team related to the
17 development and conduct of clinical
18 studies in the U.S., as well as
19 managing investigator — the review
20 and approval and reporting of
21 investigator-initiated studies.
22 QUESTION: From 2007 to 2008, what
23 was your title at DePuy?
24 ANSWER: My title from 2007 to
25 2008 was vice president of U.S.
4778
1 clinical and regulatory affairs.
2 QUESTION: And what were your
3 duties and responsibilities in that
4 role?
5 ANSWER: So basically it was
6 similar to the duties as director of
7 U.S. clinical research. However, I
8 think at that time I picked up
9 responsibility for biostats and data
10 management and also regulatory
11 affairs.
12 QUESTION: Then from 2009 to the
13 present, what is your title at DePuy?
14 ANSWER: My title at DePuy is vice
15 president — DePuy Orthopaedics is
16 vice president of worldwide clinical
17 affairs from 2009 to the present.
18 QUESTION: And what duties and
19 responsibilities do you have today in
20 that role?
21 ANSWER: I have oversight for
22 clinical — all clinical activities
23 globally.
24 QUESTION: Earlier in the
25 deposition you were asked some
4779
1 questions about the doctors receiving
2 knowledge or information.
3 Do you recall those questions?
4 ANSWER: Yes.
5 QUESTION: Dr. Plouhar, where do
6 surgeons get their information?
7 ANSWER: So are you talking about
8 information that would influence their
9 medical practice?
10 QUESTION: That and information
11 about surgical products and anything
12 having to do with hip revision
13 surgery. My question is: Where do
14 surgeons get their information, or
15 where can surgeons get their
16 information?
17 ANSWER: So surgeons can obtain
18 information from a variety of
19 different places. They can obtain
20 information from medical or orthopedic
21 meetings such as the annual meeting of
22 the orthopedic association. There is
23 also Current Concepts in Joint
24 Replacement; so there’s a variety of
25 different industry meetings where
4780
1 patient treatment and implant
2 selection are discussed. There’s also
3 training courses that are provided by
4 AAOS. There’s training courses that
5 are provided by manufacturers, and
6 there’s information that’s provided by
7 manufacturers related to the
8 performance of their product.
9 There’s — excuse me — annual
10 reports of National Joint Registries,
11 primarily from the U.K. and Australia,
12 although there are a few other
13 registries that report results. Those
14 are all outside of the U.S., and
15 there’s also literature, you know,
16 there’s multiple orthopedic journals
17 that report information related to
18 patient care, implants available,
19 those types of things.
20 QUESTION: Would all of those
21 potential sources of information to
22 surgeons be in addition to their
23 education and their professional
24 experience?
25 ANSWER: Yes, although some of the
4781
1 courses may actually fulfill the
2 requirement for continuing education
3 that medical professionals have to
4 complete.
5 QUESTION: Dr. Plouhar, how does
6 DePuy determine what data to give
7 surgeons?
8 ANSWER: So we want to provide
9 current and up-to-date information
10 related to our products, but we want
11 to provide a comprehensive picture of
12 the performance of our products; so
13 when we choose to communicate to the
14 surgeons, we try to evaluate all of
15 the possible information available,
16 including literature, data sats that
17 are available to clinical or to the
18 company and put the — all of the
19 information together to create a
20 complete picture.
21 QUESTION: Why is it important to
22 analyze and put data in context before
23 providing it to surgeons?
24 ANSWER: Again, we want to
25 complete — provide them with as
4782
1 complete a picture as possible related
2 to all of the information available.
3 QUESTION: I want to ask you about
4 specific binders. There are 12
5 binders here, and I want to go through
6 these binders and sort of get a good
7 idea, just a general concept of what’s
8 actually contained in each of these
9 binders.
10 Binder 3. What does binder 3
11 contain?
12 ANSWER: So DePuy initiated a
13 study comparing the ASR XL device to
14 the Pinnacle metal-on-metal device,
15 and that study is numbered 04062. So
16 that binder contains the protocol for
17 that study, as well as periodic
18 reports on that study across the time
19 frame of the study.
20 QUESTION: So I’ll ask you a
21 similar question. If I wanted to go
22 back and look at what reports were
23 available to DePuy over time in 2007,
24 2008, and 2009 and later, that would
25 be contained in binder 3 with respect
4783
1 to the 04062 study; is that right?
2 ANSWER: That’s correct. The
3 first item is typically the protocol,
4 and then after that, there are annual
5 tabs and within those annual tabs,
6 there are reports of the study data to
7 date.
8 QUESTION: I want to move on to —
9 well, I guess, yes; so binder 4 is
10 entitled CT0329.
11 Can you describe a little bit
12 about what is contained in binder 4?
13 ANSWER: CT0329 is a single-center
14 clinical study that was conducted in
15 South Africa. That binder contains,
16 first, the protocol and then the data
17 reports on an annual basis through to
18 the end of 2011.
19 QUESTION: So, again, sort of the
20 same question. If I wanted to go back
21 and look at what reports DePuy is
22 receiving over time related to data in
23 the CT0329 study, I could find that,
24 those periodic reports in binder 4; is
25 that right?
4784
1 ANSWER: Yeah. This — the
2 reports in all of these binders are
3 actually data reports. The data is
4 maintained at DePuy, and then our data
5 management team generates tables and
6 summaries from that data that’s
7 in-house.
8 QUESTION: Okay. Let’s move on to
9 binder 5. That says CT0121 study, and
10 could you describe, again, what would
11 be in binder 5?
12 ANSWER: CT0121 was a study of the
13 ASR resurfacing device. It’s the
14 designer initial series. So it
15 involved three designing surgeons, and
16 it captured their first cases with the
17 implant. It was conducted in the
18 United Kingdom and Germany and
19 Australia. Again, it starts out with
20 the protocol for the — for the study,
21 and then the reports on an annual
22 basis throughout the binder.
23 QUESTION: Again, if I wanted to
24 see what information was available to
25 DePuy over time related to the data in
4785
1 the CT0121 study, I could find that
2 periodic information in binder 5; is
3 that right?
4 ANSWER: Yes.
5 QUESTION: Binder 6. That says
6 CT0518 study.
7 What’s generally in that binder?
8 ANSWER: That’s an international
9 study. It’s a multi-center study. I
10 believe that there were 14 to 16 sites
11 involved in that study across Europe.
12 It’s an outcome study of both ASR
13 resurfacing and ASR XL. The binder is
14 set up so that the protocol is at the
15 beginning, and then the — there are
16 data reports, again, on an annual
17 basis, and the reports are for ASR XL
18 patients and ASR resurfacing patients.
19 QUESTION: Okay. So if I wanted
20 to go and see what information was
21 available to DePuy over time with
22 respect to the CT0518 study, I could
23 go and look at binder 6; is that
24 right?
25 ANSWER: Yes.
4786
1 QUESTION: Binder 7, you weren’t
2 asked about before. It’s entitled
3 “HHEs.”
4 Can you describe what’s in that
5 binder?
6 ANSWER: So the HHE summaries, the
7 HHE is a health hazard evaluation.
8 It’s basically a risk assessment
9 that’s done on a product when we
10 receive new data to the — and we
11 assess that data to determine whether
12 the risk associated with the product
13 has changed. And there were several
14 HHEs that were conducted across the
15 time frame of the ASR product, and
16 those are included in that binder.
17 QUESTION: All right. Binder 9 is
18 titled “Registry Reports.”
19 What’s contained in that binder?
20 ANSWER: So I believe what’s
21 contained in that binder are reports
22 from the Australian and the United
23 Kingdom joint registries as a function
24 of time. So they publish annual
25 reports in the fall of every year, and
4787
1 it’s the data from those annual
2 reports across time.
3 QUESTION: Okay. So if I wanted
4 to understand what was available to
5 DePuy over time from the registry
6 reports of the United Kingdom and
7 Australia and maybe other registry
8 reports that would be in that binder,
9 I could go and look at binder 9 and
10 find that information; is that right?
11 ANSWER: Yes.
12 QUESTION: Binder 11 is entitled
13 “Presentations and Publications.”
14 What is generally, again, in that
15 binder?
16 ANSWER: It’s a compiled list of
17 presentations and publications related
18 to the ASR and ASR XL implants across
19 time.
20 QUESTION: And do you know who
21 pulled that information and how it was
22 pulled?
23 ANSWER: Jack Mantel kept track of
24 it all.
25 QUESTION: And so if I wanted to
4788
1 see what was available over time to
2 DePuy by way of publications or
3 presentations about ASR or ASR XL, I
4 could go and look at binder 11; is
5 that right?
6 ANSWER: Yes.
7 QUESTION: But contained just
8 within these binders here and maybe
9 even with the exhibit that encompasses
10 investigator-initiated studies, how
11 many surgeons’ implantation or how
12 many surgeons do you think are
13 represented in the studies that are —
14 that you brought information here
15 today?
16 ANSWER: So I would say that there
17 are probably 40 to 50 surgeons that
18 have been involved in studies where
19 DePuy has been involved in some way.
20 QUESTION: So it would be a little
21 misleading of me if I were to focus
22 just on the specific results of one or
23 two surgeons to try to say that that’s
24 the — that’s the clinical study data
25 that the company had available to it
4789
1 over time? That would be a little
2 misleading, wouldn’t it?
3 ANSWER: Yes.
4 QUESTION: In any event,
5 Dr. Plouhar, I want to move on to
6 another topic. You were asked some
7 questions about exclusion,
8 exclusionary criteria for clinical
9 studies, and can you kind of explain
10 what the purpose of having
11 exclusionary criteria for clinical
12 studies is?
13 ANSWER: So in developing a
14 protocol for a clinical study, we try
15 to — we try to design the study so
16 that the interpretation of the results
17 will be as clear and straightforward
18 as possible. So we typically exclude
19 patients that are not going to return
20 for follow-up or typically don’t
21 return for follow-up because if you
22 enroll those patients and then they
23 never return for follow-up, you have
24 missing data. We also exclude
25 patients that may have — that may
4790
1 have other factors which may affect
2 the outcome of the total hip
3 replacement.
4 So in this case, you know, for
5 example, we talked about rheumatoid
6 arthritis, and patients with
7 rheumatoid arthritis typically have a
8 different outcome than patients with
9 osteoarthritis; so we try to get as
10 clean a population as possible so that
11 we have results that are clear and
12 straightforward and not confounded by
13 other comorbidities.
14 QUESTION: Now, is exclusion a
15 criteria for a clinical trial protocol
16 the same thing as contraindications
17 for an IFU?
18 ANSWER: No. I think that the —
