pinnaclehipdocuments.compinnaclehipdocuments.com/Lessons Learned/16-03-02PetersonVol3… · IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF TEXAS

DALLAS DIVISION

IN RE: DEPUY ORTHOPAEDICS, ( MDL Docket No. INC. PINNACLE HIP IMPLANT ( PRODUCTS LIABILITY LITIGATION (

( 3:11-MD-2244-K ( This Document Relates to (

AOKI - 3:13-CV-1071 ( CHRISTOPHER - 3:14-CV-1994 (

GREER - 3:12-CV-1672 (KLUSMANN - 3:11-CV-2800 (PETERSON - 3:11-CV-1941 ( MARCH 2, 2016

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TRANSCRIPT OF TRIAL - VOLUME 33

BEFORE THE HONORABLE ED KINKEADE,

UNITED STATES DISTRICT JUDGE, and a jury

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A P P E A R A N C E S:

FOR THE PLAINTIFFS: MARK LANIER ALEX BROWN The Lanier Law Firm 6810 FM 1960 West Houston, TX 77069 713/659-5200 [email protected]

ERNEST H. CANNON ERNEST CANNON & ASSOCIATES PO Box 1193 Stephenville, TX 76401 254-918-1006

PAMELA J. WILSON, CSR/RMR/CRRU.S. DISTRICT COURT - 214.662.1557

mailto:[email protected]

RICHARD ARSENAULT JENNIFER M. HOEKSTRA Neblett, Beard & Arsenault 2220 Bonaventure Court Alexandria, Louisiana 71309 800/256-1050 [email protected]

WAYNE FISHER Fisher, Boyd, Johnson & Huguenard, LLP 2777 Allen Parkway, 14th Floor Houston, Texas 77019-2129 713.400.4001 [email protected]

JAYNE CONROY Simmons Hanly Conroy, LLC 112 Madison Ave 7th Floor New York, NY 10016 212-784-6410 [email protected]

ALSO PRESENT: ROBERT HIRSCHHORN LEE CIRCSH ROBERT LEONE

FOR THE DEFENDANTS: MICHAEL V. POWELL Locke Lord Bissell & Liddell LLP 2200 Ross Ave Suite 2200 Dallas, TX 75201-6776 214/740-8520 [email protected]

STEVEN W. QUATTLEBAUM Quattlebaum, Grooms, Tull & Burrow, PLLC 111 Center St #1900, Little Rock, AR 72201 501.379.1707






RICHARD E. SARVER Barrasso Usdin Kupperman Freeman & Sarver 909 Poydras Street, Suite 2400 New Orleans, Louisiana 70112 504.589.9733 [email protected] SETH MICHAEL ROBERTS Locke Lord Bissell & Liddell LLP 2200 Ross Ave. Suite 2200 Dallas, TX 75204 214/740-8453 Email: [email protected]

KENNETH H. INSKEEP Barnes & Thornburg LLP 11 South Meridian Street Indianapolis, IN 46204-3535 317.236.1313 [email protected]

ALSO PRESENT: ANDREW WHITE JOHN TULL DENNIS STOLLE

SPECIAL MASTER: JAMES M. STANTON Stanton Law Firm PC 4350 Beltway Drive Addison, TX 75001 972/233-2300 Email: [email protected]

COURT REPORTER: PAMELA J. WILSON, RMR, CRR 1100 Commerce Street, Room 1525 Dallas, Texas 75242 214.662.1557 [email protected]

Proceedings reported by mechanical stenography, transcript produced by computer.







VOLUME 33 - TRIAL TRANSCRIPT - MARCH 2, 2016

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

THE SECURITY OFFICER: All rise and come to order,

please.

The United States District Court in and for the Northern

District of Texas at Dallas is now in session, the Honorable

United States District Judge Ed Kinkeade presiding.

Let us pray.

God bless these United States and this Honorable Court.

(Outside the presence of the jury.)

THE COURT: He told me you wanted to address me?

MR. POWELL: Yes.

Your Honor, what I requested a little bit of the Court's

time to do is to advise the Court --

THE COURT: Outside the presence of the jury.

MR. POWELL: -- advise the Court of a scheduling

situation and move the Court for certain relief with respect

to scheduling.

THE COURT: Okay.

MR. POWELL: Here's the situation, we've been

advised that the Court has placed a deadline on completion of

the evidence for 5:00 p.m. this coming Wednesday March 9th.

We are not scheduled to have court the next two days, March

3rd and 4th.

THE COURT: Right.

PAMELA J. WILSON, CSR/RMR/CRRFEDERAL COURT REPORTER - 214.662.1557

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MR. POWELL: Mr. Lanier has advised that he plans to

take most of the day for the cross of Ms. Turner but that he

would allow time for us to do a redirect so we will finish

Ms. Turner today.

Mr. Lanier has advised that he expects a corporate

compliance witness on events overseas to come in Monday and

that he expects that to take all day Monday for the direct and

cross.

Mr. Lanier has said he will split the times with us on

Tuesday and Wednesday next week for two additional live

witnesses who would be Mr. Ulatowski and Dr. Emerson.

So the net/net of all of that is we have one more day to

present the defense case, that would be Tuesday morning --

THE COURT: That's your interpretation of that?

MR. POWELL: Tuesday morning of next week and -- and

Wednesday morning of next week.

THE COURT: You've had all these other days. Yeah.

Okay.

MR. POWELL: What other days, Your Honor?

THE COURT: All the other days you've been putting

your case on.

MR. POWELL: Well, two more days, two additional

days, that's our interpretation.

So that situation we think is untenable, and we certainly

object to being put into that situation.


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And here's -- and we have a proposal for the Court, and I

would like to propose a set of situations, and then we would

ask the Court to order this -- this schedule to go forward.

Number one, that the Court limit Mr. Lanier's cross of

Mrs. Turner to two more hours and limit our redirect to one

hour, and then we would finish her by noon today.

And then we would put on Mr. Ulatowski. He is here and

available this afternoon and probably get most if not all of

his direct done this afternoon.

Then on Monday we finish Mr. Ulatowski and the Court

would not order us to produce in the court a witness on

matters over in Europe or in Asia where everything has

happened over there.

And then what we would do then Monday afternoon and

Tuesday morning, we do want to play the depositions of Dr.

Griffin and Dr. Fehring, and we will eliminate the others. So

we would restrict our playing of the design surgeon

depositions to two.

And what we would propose is that the -- our designations

of their depositions, which have been provided to both

opposing counsel and the special master would in effect serve

as their reports. I mean, they are the verbatim transcript of

what they're going to say.

The counsel for plaintiffs have deposed 'em twice. They

have been produced all their documents. They were produced


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our designations of what we wanted to talk to them about. And

they have had two opportunities to take the depositions. So

it seems to me a report at this stage of the game would be

largely just a futile exercise because they know exactly what

it is that the witnesses are going to say.

So we would -- we would do that.

And another problem with the Griffin and Fehring

depositions is, for example, Dr. Fehring we've designated

about an hour and a half, and the plaintiffs have designated

three hours. Those are long depositions. Dr. Griffin is not

nearly that bad. We have one hour, and they have about 30

minutes.

What we would propose is the Court would put some total

time limits on both sides as to how much deposition testimony

they can play from those two depositions so we could fit one

in Tuesday afternoon -- I mean Monday afternoon and one in

Tuesday morning.

And then we would call Dr. Griffin. Dr. Emerson is

available starting Tuesday afternoon. So we would call him at

1:00 o'clock Tuesday afternoon, and we would split the time

with Mr. Lanier Tuesday afternoon and Wednesday to finish

Dr. Emerson.

And if the Court adheres to its 5:00 p.m. Wednesday

deadline, then that's what the schedule would look like, and

we think that would be a fair schedule for the rest of the


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time that the Court has allotted to us to present our defense.

So we would move the Court to order that schedule to be

carried out between now and 5:00 o'clock next Wednesday

afternoon.

THE COURT: Okay. I heard you.

MR. LANIER: Thank you, Your Honor, for the chance

to be heard.

We have had considerable conversations with defense

counsel through the night and wee hours of the morning, and I

think it important for the Court to understand that we tried

in good faith to reach some agreements, that they're not far

off from what Mr. Powell is suggesting, but they are a little

off.

And here is what we had suggested and what we would move

the Court to do.

I agreed to cut short the cross of Ms. Turner today and

not to take the full day with the understanding that the

defendants would play their depositions today instead of start

Mr. Ulatowski, put on their case through Mr. Ulatowski, then

taking a four-day break before we get to cross-examine him on

the merits of FDA opinions that are brand new to the jury when

they haven't heard any of that kind of stuff. We didn't want

the cement to get poured this afternoon and then we try to

shape it four days later when it's hardened.

Then I suggested if they want to play the depositions of


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Dr. Griffin and Dr. Fehring that they do that this afternoon.

We were willing to stay up all night in touch with them. The

special master gave us his understanding of where he thought

those depositions had playable units. We could have done that

easily --

THE COURT: Are both of y'all talking about the

order I've already entered with regard to those witnesses?

MR. LANIER: Yes, Your Honor. The problem is the

order you've entered is one that's consistent with the rules

and the briefing that's been filed by the defendants, which

helped force --

THE COURT: And that's what you're proposing still,

Mr. Powell, is within that order, correct, sir?

MR. POWELL: Yes, Your Honor, we are.

THE COURT: Okay. Okay.

MR. POWELL: Except we're agreeing to pull down

Dr. Kindsfater and Dr. Barrett. We're not going to try to

push those two.

MR. LANIER: Okay. That's new to me.

THE COURT: That's not what I understood.

You want to play all of the depositions of the other

two -- You want me to back off on my order?

MR. POWELL: Yes. In effect, yes.

Now, the order, the order -- I want a slight modification

of your order.


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THE COURT: Okay.

MR. POWELL: And that is, you know, we've gotten

reports from the two Drs. Morrey, and they're just pages from

their transcript, you know, given to us in the form of a

report. That's not that helpful to us.

MR. LANIER: That's not --

MR. POWELL: Well, I mean, you summarized what their

testimony was with citations to the transcript of the -- from

this Court.

MR. LANIER: That's more accurate.

MR. POWELL: Okay. That's more accurate.

They summarized the testimony that the witness gave in

the courthouse with citations to the record in the Court.

MR. LANIER: Like you did for Haas.

MR. POWELL: We did the same thing with Dr. Haas.

No question about that. That's sort of a futile exercise, and

it's certainly a futile exercise where what we're proposing to

do is play a deposition that's already been taken because they

know exactly what it is the witness is going to say.

And so we would tender to the Court our designations from

the depositions of Drs. Fehring and Dr. Griffin as their

reports. That's what they are going to say. They have sworn

to those depositions so they have, in effect, done everything

that you would have to do.

And on top of that, counsel for the other side has


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deposed them twice, at least twice, and once -- once after an

order from the Court that said I'm concerned -- or they said

I'm concerned that they're not going to bring him to trial so

I'll let you depose them again. So that happened.

And before that happened, they were given their CVs, they

were given their documents. I mean, where do you think that

they got the pointer from Dr. Fehring --

THE COURT: Mr. Powell, you're the one that started

this fight with regard to Dr. Morrey and handing me the new

law at the very last minute, very last minute with regard to

that. So I don't feel sorry for you about this. You created

that problem. I mean, I'm sorry. I don't -- I don't have

any -- you've got to make those reports, period. I'm not

going to -- I'm not changing -- after you bring that up and

they're almost finished with their -- their case or in the

middle of their case and, oh, no, got to get a report, got to

get a report. And you do, too. They have got to put it and

put the points that have to be in there. You got to cut it.

You got to stay up tonight and do it, stay up tonight and do

it. That's y'all's job. Okay? I'm not changing that.

MR. POWELL: I don't think we have an order --

THE COURT: I just ordered it. I've been ordering

it. That's it, right there.

MR. POWELL: So the part we can't play is anything

other than what they did as a design surgeon?


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THE COURT: Yes. That's what I've told you. I've

been telling you that. I've told you for a week.

What else?

No, you got to bring the guy on Monday whenever the --

the fellow that's the compliance guy, unless you want me to go

back and sanction y'all. That was the -- that was the

solution that y'all offered to bring that guy over here.

That's your solution that you offered for y'all's violating my

prior order. Come on. My goodness.

I mean, Judge, back off all your orders, make everything

we did good. No. It's not. It wasn't right. You -- you

violated it, period. No. I'm not backing off that.

Y'all need to work this out with them and get the same

number of days they had, that's just the way it is. Do the

best you can by next Wednesday at five.

Unless y'all can work some agreement out and I'll try to

work with that.

But, no, I'm not going to back off my orders to make

y'all -- You know, you're the ones that created this. No.

Absolutely not.

MR. POWELL: Thank you, Your Honor for your time.

THE COURT: Okay. Okay.

I suggest, Mr. Powell, that y'all work more on what

you're -- the lines you were suggesting yesterday off the

record and try to come up with and maybe don't have to do some


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of these things, and y'all were pretty close on all those.

That's my suggestion. I'm happy to say that on the record.

I'd send somebody out right now and work on that. That's

what I would do. I'm not the defense. Y'all do whatever you

want. Just next Friday by five we're going to be done.

MR. POWELL: Next Friday.

THE COURT: Next Wednesday. Excuse me. That would

have made it nice, wouldn't it?

MR. POWELL: I was going to ask --

THE COURT: There we go. Please put that in your

order.

MR. POWELL: So, Your Honor is going to deny the

motion for more time that we filed?

THE COURT: Yes.

MR. POWELL: Thank you.

THE COURT: I'm happy to give you an order on all

this. If you don't think I've given you an order, let me

know. I will -- I will do that.

And let me say, yes, I think the -- that these cross are

taking longer, but that's because of the nature of the direct.

Y'all opened up these folks know everything, they're either

experts in four or five, six, seven areas. Well, you got to

expect them to be crossed in four, five, six areas. You

created this. That's y'all's choice. Whatever.

I mean, it is what it is.


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So I'd use my time differently, but that's y'all's

choice. I'm the one has to make the decision of how y'all --

whether you used your time, and you didn't. You're getting

the same amount of time they did. It's your choice.

Okay. Here we go, bring the jury in.

THE SECURITY OFFICER: All rise.

THE COURT: Wait a minute. I've got to do something

I forgot about outside -- y'all go back in there. Go back in

there.

All right. Let me see y'all.

Let me see y'all back in the real room, back there.

We can put it on the record later.

You can step down.

(Recess taken at 10:24.)

(Jury enters the courtroom.)

MR. LANIER: Thank you, Your Honor. May it please

the court.

THE COURT: Yes.

MR. LANIER: Good morning, ladies and gentleman.

CROSS EXAMINATION (Cont'd)

BY MR. LANIER:

Q. Ms. Turner, I'm going to try to finish you in the next

hour and a half of my questions so I can save 30 minutes back

to talk to you after Mr. Quattlebaum has another go at you.

In that regard I'll try to keep my answers short, but


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I'll probably need to get your answers directed to my

questions.

Does that seem okay to you? Seem fair?

A. Do my best.

Q. All right. Thank you, ma'am.

We stopped yesterday, we were on the issue of where did

y'all give these great warnings to the doctors, and we looked

at the design rationale -- or I'm not sure, I think that's

what I put up here as we quit, Defendant's Exhibit 931.

Can we just agree that there's no warnings in here at

all?

A. In the design rationale, no.

Q. So the surgical technique, Defendant's Exhibit 56, can we

just agree that even though this runs 40-some-odd pages the

only warnings in here are the same ones that we looked at that

really didn't seem to say that much on the insertion

technique?

Can we agree?

A. I'm sorry, which document are you looking at?

You said insertion technique, and then mine is much -- is

not 30 pages.

Q. Okay. No, the surgical technique --

A. Oh, sorry.

Q. -- Defendant's 56, the only warning in this is just a

reproduction of that same sheet we went through very carefully


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in the insertion technique where I read them -- maybe you'll

recognize it if I put it up here. I read them to the jury and

we talked about that it's talking about match the 28 to the

28, the 36 to the 36, don't scratch it before you put it in

there, you know, high levels of activity and falls and bone

stock and things can affect the order, fractions,

dislocations, infection. There's that one reference to tissue

reactions.

It's the same thing, isn't it?

A. I'm sorry, I'm not very good without the side-by-side

comparison.

Q. Okay. In the interest of time we'll do it this way.

Warnings and precautions. The warnings --

A. This is which document? Surgical technique?

Q. This is Exhibit 56, the new one that y'all had said gave

warnings to everybody.

The warnings that are given in this are warnings for any

hip replacement about patient weight, high levels of activity,

falls, poor bone stock, metabolic disorders, or other joint

disabilities, right?

A. Yes.

Q. Talks about cemented use, has to be used with cement,

right?

THE COURT: I'm not sure she's found the page up

here yet.


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MR. LANIER: I'm sorry.

THE WITNESS: Yeah. If it -- if it says labeled for

cemented use only, then, yes, you have bone cement.

BY MR. LANIER:

Q. Yes. It talks about the inner diameter must correspond

to the head size. This is where it fits 28, use it with a 28,

36, use it with a 36. Right?

A. Yes.

Q. And then it talks about the highly polished bore

shouldn't be scratched before you put it in there.

A. Yes.

Q. Make sure it's clean before you put it in there.

A. Yes.

Q. Make sure it seats properly.

And then under -- so those are the warnings. Those are

the precautions.

And then the adverse events is just for general hip

replacements, that it can change the position of the

components, they can get loose or break or dislocate, you can

have an infection or a tissue reaction.

That's all you get, isn't it?

A. Would you mind moving the page down?

Q. Yes, ma'am.

A. Okay. So, yes, I agree you're read that correctly. We

talked about the statement at the top as well under


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"important."

Q. Yes. That says this doesn't include all the info you

need to select and use a device, see the full labeling for all

necessary information. Right?

A. Yes.

Q. All right. In other words, the same as what we had

already looked at. Fair?

A. Similar.

I am -- again, without the side-by-side comparison, the

engineer in me is reluctant to say the same.

Q. Let me ask you more precisely as a lawyer. You don't see

any difference, do you?

A. Again, without --

Q. As you're sitting here today, just looking at it, not

side by side, there's no difference you're ready to testify

to; is that right?

A. I'm not -- I cannot testify to the similarity or the

difference without the side by side.

Q. Now, ma'am, new subject.

I want to talk to you a little bit more -- it's still

related -- but a little bit more about the testing that was

done. And you told the jury yesterday about simulator testing

and about clinical testing. And I challenged you on whether

or not before y'all were selling these y'all had done the

necessary testing to determine if this hurts the body.


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Biological testing.

Remember those questions?

A. I remember the questions.

Q. Now, in the process of that the jury saw a different part

of this exhibit earlier, but here's a chance for them to see a

new part.

It is --

A. Thank you.

Q. -- uh-huh -- Plaintiff's Exhibit Number 6.

These are minutes to a meeting for that one-piece IDE,

2001.

At this point in time y'all are doing that one-piece

test, correct?

A. In 2001 did we have a test ongoing?

Q. Yes, ma'am. You started it in 2000, remember?

A. Oh, sorry. The clinical study.

Q. Yes, ma'am.

A. Yes.

Q. In fact, that clinical study that you started in 2001,

I -- you agreed that the purpose was not for biological

effects, but you said but it still would have been noted in

that study. Remember?

A. Yes.

Q. Ma'am, there is a meeting that took place in Vail,

Colorado, on this one-piece metal-on-metal IDE. You were at


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the meeting.

A. Yes.

Q. Dr. Schmalzried at that meeting: "Dr. Schmalzried had a

question on a metal-on-metal case with pain at six months, but

the patient could not be identified as to whose case it was."

Do you recall about one of the patients having pain at

six months?

A. I don't recall this specifically.

Q. Six months, the study started in 2000. Pretty quick to

have pain, wouldn't you agree?

A. I think pain after total hip surgery is not uncommon.

Q. Well, no, this was "marked pain at 6 months."

A. I think also not uncommon.

Q. Oh, really.

So the fact that Dr. Schmalzried had a question and

everybody was talking about it and it even made the minutes,

you think probably everybody was -- or a good number of people

were having pain --

A. I didn't say --

Q. -- at six months?

A. I didn't say a good number.

I think for a hip replacement patient in general to have

pain at six months would not be an uncommon thing.

Q. Well, this was still the time period where

Dr. Schmalzried was still discussing the need to obtain serum


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and urine ion levels for the patients receiving these devices.

Do you remember that?

A. Yes. I see that.

Q. He stated it's still a major issue for metal-on-metal

hips and more information is needed to assess the associated

risks.

Do you see that as well?

A. Yes, I see that.

Q. And this memo where he's saying it's still a major issue,

more information is needed for assessment of any associated

risks, is happening in 2001 just, what, a few months before

y'all start selling the Pinnacle metal-on-metal?

A. The time frame is correct, yes.

Q. Dr. Schmalzried developed a protocol and a budget for

serum and urine testing. Ideal patients prospective no other

implant. You would need at least 12 patients. Dr. Haas

stated there should be a control group. Dr. Schmalzried to

discuss further with Jorge Ochoa.

Do you see that?

A. I see that.

Q. Now, y'all went to market with these hips without having

done such a study, true?

A. Studies came after we had started implanting, yes.

MR. LANIER: Objection, nonresponsive.

THE COURT: Sustained.


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BY MR. LANIER:

Q. Y'all went to market without having done such a study,

true?

A. True.

Q. The study was also offered to be done by Dr. Haas, and

you were on the email where Dr. Haas offered to do it and to

hide the funding.

Do you recall that?

A. No.

Q. This is an email that you're on, Plaintiff's Exhibit 37.

You are the Leanne Turner. Andrew Ekdahl has sent you this

email.

Do you remember?

A. I'm familiar with the email, yes.

Q. All right. This is the email that he forwarded to you

with a comment, "Encouraging comments from a design

consultant." And those encouraging comments from Dr. Haas to

Andy Ekdahl included his comments about that Vail session.

"One of the issues that needed to be settled --" I said

the Vail session. The Vail session came after this. It was

before the Vail session.

"One of the issues that needs to be settled within the

next calendar year is ion level research. This was brought up

at a meeting," an earlier meeting, "and seems to be a source

of some consternation among the members. I think this can be


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easily done. I think it should be done in house at either

Dr. Engh's or my facility. If funding is a problem, then what

we could do in our lab is if DePuy, Johnson & Johnson gave an

unrestricted grant to the lab, that money could be used for

this project and would not link the company to the project."

Did you remember reading that email?

A. I remember reading that.

Q. Did you take issue with that suggestion?

A. My understanding is that we --



BY MR. LANIER:

Q. Did you take issue with that suggestion?

A. No.

Q. Now, as we look through this, another thing that was left

out yesterday with the jury on the simulator studies. The

simulator studies sometimes gave bad results for the product,

didn't they?

A. I think I would need you to define "bad product" or "bad

results" in order to answer that question.

Q. All right. Let me give you a memo from 2008. I do not

have extra copies of this.

Ma'am, I'm going to come back to it in a little bit.

A. Okay.

Q. Now, while he's doing that, let's go -- stay on the


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subject of the ion testing and the testing for health

purposes, okay?

You're aware of the fact then that y'all were putting

these in people without warning people that you really hadn't

done the testing yet to determine whether or not these parts

would hurt their body?

A. I don't think I agree with the way you've stated that.

Q. Have you seen the testimony of Dr. Thomas Schmalzried in

this regard?

A. No.

Q. Dr. Schmalzried -- I was questioning him about this very

issue, volume 6, page 53, line 12. I said, "Yeah. A

practical matter wouldn't you hope a company is going to get

the information they need to assess associated risks before

they start selling the product, and putting it in the Cathy

Paolis --" in this situation "-- of the world?"

The answer was: "Well, you have to put it in people in

order to get this type of information. So it's kind of a

chicken or egg argument. At some point you've got to put it

in people and find out what it does. I'm simply saying we

need to check ions on these people."

Are you familiar with that testimony?

A. No.

Q. And you certainly see the absurdity of that, don't you?

A. No.


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Q. I mean, ma'am, if you're going to test your product out

on people and put it in people to just see, then that's making

people a guinea pig, isn't it?

A. No.

Q. Ma'am, if you're going to do this, "You just got to put

it into people to get this type of information, it's kind of a

chicken or egg argument, at some point in time you've just got

to put it in people and find out what it does," if that was

the attitude when y'all were selling this, then you at least

owed it to these people to tell them you're our test subject,

we're putting in a device where we don't know what it's going

to do, we're just going to find out by watching you?

You kind of owe that to them, don't you?

A. I think that was communicated.

Q. Do you think that -- where was that communicated to any

of the buyers of the Ultamet that we don't know what will

happen to you, you are our experiment group?

A. They're not an experiment group. And I think through the

biologic issues, for example, in the technical monograph,

where we say the effects of these are unknown is communicating

that point exactly.

Q. You think that the -- what we went through yesterday on

the technical monograph is communicating that, ma'am?

A. I think that's one example of where it was communicated,

yes.


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Q. We looked at the technical monograph yesterday. It's

Defendant's Exhibit 927.

Show me where in the technical monograph anybody is

remotely saying something along the lines of you are the

chicken and the egg, we're just putting it in you to see how

it works and to see if you get hurt.

A. What it says is the full biological response to metal

particles or ions is --

Q. Show me where, ma'am, so I can zoom in.

A. The bottom of the first paragraph, "This may be."

Q. "However, despite"?

A. No. If you go to the last sentence in the first

paragraph --

Q. Let's keep it in context, okay?

"Because of the low wear of metal-on-metal hip implants,

it is anticipated this may reduce the incidence of wear

particle-induced osteolysis."

That's a positive, right? That's not a warning.

"However, despite the lower volume of wear associated

with metal-on-metal, the particles are known to be very small,

possibly resulting in -- possibly resulting in a larger number

of particles --" by the way, y'all know that's not possibly,

everything you had said definitely, right?

"-- resulting in a larger number of particles compared

with metal-on-poly. This may be of some concern because the


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full biological response to metal particles or ions is

unknown."

You think that's warning people we have no clue what's

going to happen when we put this in your body, we got some

serious concerns?

A. I don't think the literature suggests that there's no

clue --



THE WITNESS: Could you ask the question again,

please?

BY MR. LANIER:

Q. Yes, ma'am.

Do you honestly believe that that's telling people you

are an experimental group and we're going to learn whether or

not this hurts by putting it in you?

A. I don't think I can answer the question the way it's been

asked.

Q. Look at what it continues, "In order to characterize the

biological response" -- Okay. So we've got the biological

response, full biological response is currently unknown.

Y'all continued, "In order to characterize the biological

response to metal particles, one study examined the slide

appearance of tissue around retrieved metal-on-metal implants.

They found there were fewer macrophages and wear particles in


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the tissues compared with metal-on-poly."

A. That's what it says, yes.

Q. "In general, the macrophage and giant cell response to

particles from metal-on-metal was described as mild."

I mean, that's the biological response language, isn't

it?

A. That's part of it.

Q. And, ma'am, have you gone back -- Since I'm sure you

worked on this technical monograph did you go back and look at

the citation and see where it says it's described as mild?

A. Yes.

Q. You know that that's a misquote of the article.

A. It is not.

Q. Well, the article continues to say, "However" --

A. It does not.

Q. The article does not?

A. I believe that you're referencing the -- the citation

you're referencing is different from the citation that is

listed here.

Q. Well, actually, ma'am, if you'll look y'all have miscited

it here, but it's the exact article that's got the exact

language.

Which article do you -- See, y'all have put "Data on file

at DePuy"?

A. Yeah. That should be Pat Campbell, the citation just


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below.

Q. Yes. In other words, y'all miscited it, right?

It's 55, it's not 54, correct?

A. It is 55.

Q. So it's miscited by y'all, not by me. Correct?

A. My reference to the miscitation is that Pat Campbell

cites Willert, and that is the exact language from Willert

that does not have the "however" statement after it.

Q. Ma'am, it's the Pat Campbell -- Ma'am, the Pat Campbell

article that y'all are citing, you don't think it's got a

"However"?

A. No.

Q. Okay. I'll have my guys pull it.

At any rate, regardless, what you're saying -- And this

is not, gee, this is a problem. What you're saying in this is

it's actually better than metal-on-poly, aren't you?

A. I don't think that's what it's saying.

Q. Ma'am, look at it carefully.

The study examined the slide appearance around

metal-on-metal, fewer macrophages than metal-on-poly.

Doesn't that mean better?

A. I can't speak --

Q. Isn't that a better response?

A. I can't -- I'm not qualified to speak to that

specifically, to say fewer is better. It's -- this is


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biological response. I believe it's been appropriately

characterized by folks who are qualified to do that.

Q. Okay. Ma'am, you just did that though.

You just said, oh, no, that doesn't say that the

metal-on-poly is worse -- that metal-on-metal is better.

That's your testimony just now.

So when I drill down on it, you say I'm not really

qualified.

A. This doesn't say --

Q. Time out. I got to get a question, ma'am.

A. Okay.

Q. This says to characterize this biological response one

study looked at the tissue and found there were fewer

macrophages and fewer wear particles in the tissues than

metal-on-poly. You don't think that's saying that

metal-on-metal is better than metal-on-poly?

A. I think it's just stating a fact.



BY MR. LANIER:

Q. You don't think that's saying it's better?

A. No.

Q. Okay. So where else did you put this warning to the

patients, other than -- By the way, patients don't get the

technical monograph; doctors do. Right?


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A. Correct.

Q. All right. Where did you give warnings to patients that

you're a guinea pig or that we're experimenting on you?

A. We educate surgeons and surgeons --



THE WITNESS: -- have conversations with their

patients.

BY MR. LANIER:

Q. When I object, you have to stop.

A. I forget that.

Q. I object because your answer is going into areas, and

I've got to stay focused.

Okay. Ma'am, here's my question, very pointed and

direct: Where did you warn the patients?

We've seen countless ads, brochures, all the rest. Any

of them that you want to call out that I should look at to

show the warning to patients?

A. I have to admit I'm less familiar with any

direct-to-patient materials. So I'm not --

Q. So you don't know of any place --

A. -- able to answer that question.

Q. I'm sorry. You don't know of any place where you've

warned the patients?

A. I can't say that we have or haven't based on --


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BY MR. LANIER:

Q. Do you know of any place where you've warned the

patients?

Do you know of any place you've warned the patients?

A. I don't.

Q. Okay. Where else have you warned the doctors, other than

that technical monograph?

A. There are other areas in the technical monograph. Are we

done with that?

Q. Yes, ma'am.

Where else have you warned the doctors other than that

technical monograph?

A. The IFUs.

Q. Okay. We've had testimony from all of your doctors and

ours saying none of them read the IFUs. Any other place where

you -- and we'll look at the IFUs anyway, if you want to,

at -- at some point.

But any other place?

You said not in the design rationale, not in the

insertion technique, not in the surgical technique. Any other

place where you've warned the doctors?

A. We warned them through training.

Q. That we can verify. Let me ask it that way.


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Any other place that we can verify?

We've got a boxful of ads you put into the doctors, the

Journal of Bone and Joint Surgery, April 2008. Big ad here,

Coach K, DePuy hips. Any warning?

A. Not on this -- not located here, no.

Q. 2002, Journal of the American Academy of Orthopedic

Surgeons -- Oh, that's just the decade 2002. This issue is

April 2008. Another Coach K ad. Any warning?

A. Not in this ad.

Q. Plaintiff's Exhibit 685, the canoe lady brochure, any

warning?

A. I'd have to see the document in -- in full to tell you.

I'm sorry. I'm not as familiar with that.

Q. Plaintiff's Exhibit 685. Any warning?

(Pause.)

Q. In the interest of time I'll ask you are you able to find

any warning.

A. Well, I see reference to discussing with your surgeon.

Q. Yeah. Any warning?

MR. QUATTLEBAUM: Your Honor, we object to the

questions regarding the location of warnings in advertisements

because there's no duty under Texas law given a learned

intermediary doctor to notify or warn patients directly.

THE COURT: Overruled.

THE WITNESS: There's important safety information


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in the back.

BY MR. LANIER:

Q. Great. Thank you.

Let me put that up so the jury can see it.

Important safety information.

"As with any medical treatment, individual results may

vary. The performance of hip replacements depends on age,

weight, activity level and other factors. There are potential

risks. Recovery takes time. People with conditions limiting

rehab should not have this surgery. Only an orthopedic

surgeon can tell if hip replacement is right for you."

Surely, you're not telling me and the jury that's the

warning to the patient that says we don't know what this will

do to you?

MR. QUATTLEBAUM: Same objection, Your Honor.


THE WITNESS: We as manufacturers don't practice

medicine --



BY MR. LANIER:

Q. Ma'am, please answer the question.

A. Have we provided a specific warning to a patient?

Q. Yes, ma'am. We went through the warning that the FDA

required when y'all were doing the sister device and


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everything that y'all had to make sure the patient knew.

Right?

A. Yes.

Q. And we went through the technical monograph, where even

in the technical monograph y'all say at the very end that

"Disclosure of associated risks and benefits of metal-on-metal

devices to surgeons and patients is vital."

Right?

That's what you said, right?

A. That's what it says.

Q. All right. So where is this vital disclosure in this

paragraph of "important safety information"?

It's not there, is it?

A. I think we talk about general risks with the intention of

them discussing specific warnings with their surgeons.

Q. Ma'am, so is your testimony under oath, oh, yes, we are

disclosing the vital risks to the patients right here?

You really want to say that?

A. Well, I think you've connected two things --



BY MR. LANIER:

Q. Ma'am, I'm asking you: Is this a disclosure of the vital

risk to the patients?

A. I'm just not sure I can answer that question the way that


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it's been asked.

Q. And then you said the other area it where it says "Talk

to your orthopedic surgeon about your options."

A. Yes.

Q. "Your surgeon will choose the stem and bearing for you

based on durability, level of performance, wear resistance,

their experience or reference and your personal needs. No one

material is right for every patient. Only your surgeon can

determine what's right for you."

That's not warning people that we're experimenting on

you, is it?

A. I don't believe we were experimenting.



BY MR. LANIER:

Q. That's not warning people that we're going to find out by

putting it in you whether or not it works, is it?

MR. QUATTLEBAUM: Assumes facts not in evidence,

Your Honor. Objection.


BY MR. LANIER:

Q. Please answer the question, ma'am. I'm running out of

time.

A. I'm sorry. I'm trying hard to answer it.

Could you ask one more time?


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Q. Yes, ma'am.

This does not -- the language we just looked at -- does

not warn people that we're going to find out if it works by

putting it in you.

A. It does not say those words.

Q. What kind of warning did you give the doctors in this ad

that's demo 4153 in the journal of the American Academy of

Orthopedic Surgeons?

A. I'm not familiar with this ad.

Q. No -- no warning at all, is there?

A. I don't know, I'm not familiar with it.

Q. Well, you can look at it pretty fast. "We take pride in

rigorously testing our products so patients can have

confidence for the real tests that occur every day in real

life" -- for the real tests that occur every day in real life.

And this is actually saying that y'all have tested these

things and -- this isn't telling patients -- telling doctors

that the patients are the test group, is it?

A. It does not say those words.

Q. "In fact, a recent multicenter clinical study conducted

by leading orthopedic surgeons showed eight years after

surgery 96.1 percent of patients still depend on their

Pinnacle hip replacement."

That's not giving them a warning, is it?

A. That is not a warning.


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Q. And that's just footnoted for DePuy's internal data,

right?


Q. Doesn't even have a place you can go look it up, does it?

Does it?

A. It does not.

Q. Now, you were kind of a techno marketer, weren't you?

A. I think that term was used, yes.

Q. You used that term. You called yourself a techno

marketer, didn't you?

A. I think I was called that, and I replied in kind, yes.

Q. Yeah. You had a techno marketing role because you were

not just being technical; you were trying to figure out how to

market these things. Weren't you?

A. I was not trying to figure out how to market; I was

assisting.

Q. Marketing.

A. The marketing materials.

Q. Yeah. You were assisting with marketing materials,

weren't you?

A. Yes. Yes.

Q. That's why you called yourself and others called you a

techno marketer, right?

A. I don't know if they used that term exactly, but techno

marketing was used to describe some of the literature.


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Q. Well, ma'am, I'm just using in the interest of time

Plaintiff's Exhibit 1665. We showed you this in your

deposition -- I thought it might be fresh in your brain --

from you to Jim Lancaster.

"Finally, as my techno-marketing role over the past 12

months has been new to our group, a list of activities I

completed in order to fulfill this role might offer insight

into how this role should or shouldn't be structured

instructed in the future."

This is you expanding the customer/marketplace focus.

Remember?

A. Yes.

Q. These are the activities that consumed the majority of

your time and effort that year, remember?

A. These aren't exactly connected, but yes.

Q. Yeah. In fact, you attached a chart where you talked

about your customer/marketplace focus.

A. Yes.

Q. Remember?

A. Yes.

Q. You talked about your presentations, your sales training.

Remember?

A. Yes.

Q. Okay. That's all I'm driving at, ma'am, is you were not

just technical into this but also in the marketing end,


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weren't you?

A. Not official in marketing. Assisted with the marketing

materials, yes.

Q. Right. You're listed as one of the science people, but

one of the figures that we showed the people was how many more

people worked in sales and marketing than worked in science

and research. You were in science and research, but you were

still doing your share of marketing, weren't you?

A. I'm not sure I'd characterize it that way.

Q. All right. Techno marketing. Is that better?

A. Yes. I was still an engineer.

Q. One last thing I wanted to make sure we covered on

testing is the fact that y'all did have testing data that

showed --

MR. LANIER: Thank you, Richard.

BY MR. LANIER:

Q. -- that showed that -- do you have Plaintiff's Exhibit

189?

Do you have Plaintiff's Exhibit 189?

A. Oh, it's not -- doesn't have a sticker.

Q. Okay.

A. 2/19?

Q. Yes.

A. Yes.

Q. Thank you.


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Now, this is -- let's set this up so the jury understands

it well.

This is a study. Y'all are comparing the wear of ASR,

that's the recalled device -- right?

A. Yes.

Q. You're comparing the wear of ASR to the wear of Pinnacle

metal-on-metal, aren't you?

A. I'm not familiar with this test.

Q. All right. Can you look at page 3 and see that this is

an ASR study --

A. Yes.

Q. -- it's done on a simulator --

A. Yes.

Q. -- one of those machines we saw the video on, right?

A. Yes.

Q. And on different stations there are ASRs -- and each

station is one of those little places where you've got the

head and the -- the liner and the cup and the ball, and it's

one of the rotating, moving stations, right?

A. Yes.

Q. And then you collect and you measure the wear at each of

those stations, don't you?

A. Yes.

Q. All right. So ASR, the recalled device, is being

measured against Pinnacle.


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Do you see that?

A. Yes.

Q. We've got six stations dedicated to ASR and three

dedicated to Pinnacle. Correct?

A. I see that.

Q. And then we see how much wear they have charted on the

chart to the left. Correct?

A. Yes.

Q. Now, it's kind of hard to see this because of the

darkness that's involved in a copy, but there's one of these

that shoots up way higher than every other one.

Do you see that?

A. Yes.

Q. This highest wear line is station number 5-A, Pinnacle,

isn't it?

A. It appears to be.

Q. Pinnacle wears worse in this test than the ASR product

y'all have to recall because of how much it was wearing,

doesn't it?

MR. QUATTLEBAUM: Object, Your Honor. It assumes

facts not in evidence.


THE WITNESS: I think you can't look at one station

and draw that conclusion --



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THE WITNESS: So no.

BY MR. LANIER:

Q. Okay. So this station doesn't show higher wear than the

ASR station?

A. This one Pinnacle station shows higher wear than that one

ASR station, yes.

Q. Yes, ma'am. That was my question.

This Pinnacle station shows higher wear than all of the

ASR stations in this test, doesn't it?

A. On this graph, yes.

Q. So that we're clear, we can see the station 6, this is

ASR, the one next to it is ASR, ASR, that's ASR.

Ah, this is Pinnacle right here, isn't it?

A. Yes.

Q. And it's wearing greater than this ASR, than this ASR,

and this ASR.

Now, here's an interesting one. Look at this. The

bottom line is Pinnacle, isn't it?

A. It appears to be.

Q. And it's hard to see, but see if -- if I'm not outlining

the Pinnacle line right.

Even that Pinnacle jumps up over this bottom ASR line,

doesn't it?

A. In that time frame, yes.


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Q. And in that time frame, that's rather late. That's at 4

million cycles. All of a sudden the Pinnacle starts wearing

worse towards the end.

Do you see that?

A. I see that here.

Q. And y'all quit the test on the Pinnacle there at 4,000 --

or at 5,000 cycles, didn't you?

A. It's hard to say. I don't know if this is a final report

or what this -- without having the full report I can't comment

really any further to that point.

Q. In fact, there's an email about it. I'm going to keep

this up here. I've got an extra copy of the same exhibit,

it's page 2, where the email comes from Catherine Hardaker and

says, "Looking at the results we seem to have strange behavior

on that station 6 Ultamet between 4 and 5 million cycles. Can

you have another look at the data and check to see if this is

a typo."

Do you see that?

A. I see that.

Q. And that is, in fact, the station where the wear jumps up

for the Pinnacle between 4 and 5 million cycles.

Do you see that?

Station 6. Here's 6. Right?

Do you see it, ma'am?

A. Hard to tell from the copy. I think that's correct.


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Q. And look at the response from Martin Hintner, "Cath, I

have double-checked the values and it is no typo. Testing

metal-on-metal hip component it's not unusual we observe again

an increased wear during testing. I assume if testing

continued the wear will decrease again."

Cathy replies or sends it to Mary Stewart and says,

"Mary, they have checked and the results seem okay. This is a

phenomena they have noted before on metal-on-metal. It's

interesting that they get high and low Ultamet like we do,

especially bearing in mind it's a different machine and

different method of loading. It would suggest product

variability."

Do you see that?

A. I see that it says that, yes.

Q. In other words, y'all knew internally that some of your

product based upon your simulators was wearing worse than

others. Correct?

A. That's -- I -- that's not the way that I would say that,

no.

Q. Well, ma'am, you might not say it that way, but it's the

truth. That's what it says, that y'all have some high and

low, suggesting product variability. It's been noted before,

it's been double-checked, it's no typo, it's not unusual.

That's what your simulator tests were showing, right?

A. On a simulator test you would expect to see variation.


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THE WITNESS: Okay.

BY MR. LANIER:

Q. I said, ma'am, that's what your simulator tests were

showing, right?

A. That the components wear differently?

Q. Yes, ma'am.

A. Yes.

Q. That you had high and low wear, that you had product

variability, this was not a typo, this was not unusual.

That's what it said, isn't it?

A. That's what that says, yes.

Q. And, ma'am, you've just suggested to the jury, well,

that's not unusual for you to have -- or not unexpected to

have product variability.

Ma'am, that's the whole point of this email chain is they

didn't know, it was unexpected, they did have to double-check,

they were stunned to find out that this is a reaction that had

been happening on both sides of the water, in England and in

America.

MR. QUATTLEBAUM: Your Honor, I object to the

compoundness of the question. It's compound.

THE COURT: Yeah. Break that question down.

MR. LANIER: All right.


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BY MR. LANIER:

Q. Ma'am, that's what it says.

It says this -- it says we are surprised.

It says can you look again at the data and double-check

to see if it's a typo, doesn't it?

A. Yes. I --

Q. It doesn't say what you just volunteered to the jury, we

would expect that. That doesn't --

A. So --

Q. Time-out. It doesn't say that we would expect that, does

it?

A. May I clarify my point to the jury?

Q. Yes, ma'am. On his time.

It doesn't say we expect that in this first email from

Catherine Hardaker, does it?

A. I can't answer the question.

Q. Yes, ma'am, you can. It doesn't say we expect that. It

seems surprised and wants to know if it's a typo. Fair?

A. Fair.

Q. All right. And then the reply is not, of course, it's

always that way. It's I've double-checked it, it's no typo,

but this is not unusual, we've seen it before.

That's what we see, right?

A. That's what -- that's what he says.


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Q. And then Mary finds out that -- or Cathy writes to Mary

and says, look, they get it like we do on Ultamet, different

machine, different method of loading. This has got to suggest

there's product variability, not all of the products are

working the same.

A. That's not what it says.

Q. It doesn't say it would suggest product variability?

A. Product variability does not mean --

Q. Does it say --

A. -- not working.

Q. Time-out, ma'am. Does it say product variability?

A. Yes.

Q. Which means there's a variance in the products?

A. Yes.

Q. Thank you.

And then this is called a phenomena, not an expected

event, isn't it?

A. That's what they say.

Q. But it's a phenomena that's been noted before. Y'all had

warning about it, didn't you?

A. I don't agree with warning. You've read that

correctly.

Q. Well, ma'am, if it's happened before, you know it can

happen. Correct?

A. I agree with that.


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Q. All right. Next subject.

I want to talk to you about the claims y'all were making,

the engineering claims y'all were making that these Pinnacles,

Ultamet were going to work well because of full fluid film

lubrication.

You know what I'm talking about, right?

A. Yes.

Q. Now, this is a new subject with the jury, and so we need

to take a moment and make sure that we've explained all of the

different terms that we're going to use. Okay?

A. Okay.

Q. The easiest way to do that might be with --

THE COURT: Wait. Wait. Wait.

MR. QUATTLEBAUM: Your Honor, we object to the

scope. It goes beyond the scope of direct.


BY MR. LANIER:

Q. I'm going to give you Exhibit 43. This is one you've

already been using. It's a design rationale.

It's the same one.

For the Pinnacle. Do you see it, ma'am?

A. I see it.

Q. And we can use this to explain these concepts to the

jury. The jury has seen one of these before, one page before,

but we're going to focus a little differently now.


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Y'all were claiming to the doctors in the medical

community that you had this TrueGlide technology. Right?


Q. And we can read about that.

This is what y'all told the doctors: "TrueGlide

technology, optimized diametrical clearance," that's the

critical clearance that y'all changed the Friday before your

submission. Right?

A. Yes.

Q. Improved fluid film lubrication, smooth range of natural

motion.

Now, this lubrication is explained in the next couple of

pictures.

When we're talking about lubrication, what we're talking

about is on a microscopic level, are the ball and the liner

touching or is there some lubrication between them. Right?

A. Yes.

Q. So, for example, you drive a car?

A. Yes.

Q. I suspect you put oil in your car or you have someone do

it for you. Right?

A. Yes.

Q. Because in a car you've got cylinders with pistons in

them. So you've got a cylinder and inside that cylinder,

which is made out of a metal, is a piston that moves up and


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down. Correct?

A. Yes.

Q. And in the process of moving, the metal rubbing against

the metal will cause the engine to break, to seize, if you

don't have some type of oil in there. Correct? Or lubricant.

Right?

A. Yes.

Q. Because when the metal rubs against the metal you have a

problem if there's not lubrication. Correct?

A. In this application I believe that's true.

Q. And it's no different in the body. If you put a metal

ball, no matter how well you smooth, polish it, everything

else, and you put it against a metal or poly, for that matter,

liner, if they're touching when you move it, it's going to

create wear debris, isn't it?

A. Yes.

Q. Now, if the bearing surfaces are fully separated and the

load is fully supported by lubricating fluid, then you don't

have the wear issues that you would have if this lubrication

were not there. Correct?

A. Correct.

Q. In fact, what y'all do in the brochure to the doctors is

you have told them that you've improved the lubrication, which

promotes healthy joints.

And so while we see the improved wear resistance with


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this illustration in blue, we then get to the other types of

lubrication that are not so good. Correct?

A. It describes the other types, yes.

Q. All right. This says that synovial fluid, and that means

you're not pumping oil in the hip but it's the fluid within

that hip that our body produces, right?

A. Yes.

Q. "-- fully separates and lubricates the load-bearing

surfaces in a healthy joint. TrueGlide technology helps

establish fluid film lubrication between bearing surfaces to

minimize wear."

Do you see that?

A. I see that.

Q. And that's what the picture was. That's called fluid

film lubrication, right?

A. I believe this picture would be full fluid film

lubrication.

Q. All right. Let's -- full fluid film lubrication.

Now, full fluid film lubrication is the -- where the

loads are fully separated and the load is fully supported by

the lubricating fluid. Right?

A. Yes.

Q. So this is what you claim, fully separated, load fully

supported.

A. That's the definition of fluid film lubrication.


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Q. By lubricating fluid?

A. Yes.

Q. Yeah, that's the definition that your company gives under

this TrueGlide technology.

A. That's the definition they give as part of that -- this

spread. It's one of the definitions.

Q. Yeah. Ma'am, please answer my question. That's the

definition they give under TrueGlide technology, improved wear

resistance, right?

A. How are you using "defined"?

It's part of this full description, yes.

Q. All right. Now, then the next page we've got two other

kinds of lubrication.

These are smaller pictures.

Conventional boundary lubrication. "Conventional" means

what you normally have, right?

A. I think it's just how it's defined here. I don't know I

can say normally.

Q. Conventional and boundary lubrication. And that's where

you've got some separation, but you've also got small

microscopic places where there's going to be some rubbing,

correct?

A. Yes.

Q. This is where you have substantial direct interaction

between surfaces.


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You've got some lubrication with slippery molecules

adhering to the surfaces, but you still have substantial

direct interaction, right?

A. Yes. That's what it says.

Q. Substantial direct interaction.

And then there is a third engineering term that's used in

lubrication theory called "conventional mixed lubrication."

Right?

A. Yes.

Q. And this is where the load is partially supported by the

fluid, but there's some direct interaction between the

surfaces, requiring boundary lubrication. Right?

A. Yes, that's what it says.

Q. So mixed is kind of where you got a little of both, it's

mixed, right?

A. Yes.

Q. So let's do mixed -- We'll do both. Mixed lubrication.

And with mixed lubrication what we've got is partially

supported by some interaction. So you've got both support,

but instead of being fully supported, it's partially

supported. Right?

A. Yes.

Q. With some direct interaction.

A. Yes.

Q. All right. Ma'am, what y'all did is y'all falsely told


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all of the doctors that you had achieved full fluid film

lubrication?

A. No.

Q. When, in fact, you had not?

A. That's not correct.

Q. You don't think y'all made that claim?

A. No.

Q. Let me give you Defendant's -- Plaintiff's Exhibit 116.

Because such a claim would be false, wouldn't it?

Ma'am, such a claim would be false, wouldn't it?

A. Could you repeat the claim so I'm clear?

Q. That y'all had found full fluid film lubrication where

the parts are fully separated, the load is fully supported by

a lubricating fluid. You've made this so perfectly well that

it was truly a well oiled machine. That would be a false

claim, wouldn't it?

A. I think no. Depending on the full extent and the context

of that, I think that's not false.

Q. Ma'am, look at the picture that y'all give in the

brochure here, Plaintiff's Exhibit 116. You say you haven't

made the claim.

"TrueGlide technology: The Pinnacle hip is unique" --

That means one of a kind, doesn't it? Unique means one of a

kind, right?

A. Not my word.


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Q. Ma'am, please answer my questions.

Unique means one of a kind, doesn't it?

A. I'm not sure that I can speak to that's how it's used

here, I'm sorry.

Unusual. I can -- one of a kind I'm just not sure about.

Q. Unique means one of a kind. Unusual means unusual,

right?

See, this provides, according to y'all, an exclusive

advancement. Exclusive means unique or one of a kind, right?

Called TrueGlide. It helps your body create a thin layer

of natural lubrication between the surfaces of the ball and

socket, results in a more fluid range of natural motion, more

closely matches the feeling and movement of a natural hip.

The exclusive TrueGlide technology keeps the bearing surfaces

fully separated and weight fully supported by the lubricating

fluid.

Do you see that?

A. I see that.

Q. Fully separated, fully supported, is exactly what fluid

film lubrication means. Fully separated, fully supported.

Do you see that?

A. I see that.

Q. Your testimony -- And we'll bring it and put it on the

screen if we need to look at it. I said y'all made that claim

to full fluid film lubrication, didn't you? You said, no, we


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did not.

Now, ma'am, isn't it true that you were wrong and you did

make that claim?

A. May I clarify?

Q. Ma'am, just answer the question.

You made the claim -- the company claimed full fluid film

lubrication, didn't they?

A. In this instance -- on -- that's what it says on this

paper, yes.

Q. And when I told you now your company was claiming it had

made full fluid film lubrication you said, no, they didn't

make that claim.

A. I think I was --

Q. Were you unaware of this?

A. I think I was considering a different context.

Q. Ma'am, your company claimed they had achieved full fluid

film lubrication when such is false. Isn't it?

A. I think that it's true during periods of a gait cycle.

So the question is --



BY MR. LANIER:

Q. Ma'am, your company has not achieved full fluid film

lubrication for this bearing surface where their surfaces are

fully separated and the weight fully supported by lubricating


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fluid. That's not true, is it?

A. I think it is achieved.

Q. When I said your company claimed it you said we didn't

claim that.

When I show you the claim you're saying, oh, yeah, but

we've done it.

A. I'm asked for permission to clarify my statement.

Q. Ma'am, the truth of the matter is y'all make the claim --

You make it over and over.

Here's demonstrative 3747 we looked at earlier, the Coach

K ad. This is in the journal for the doctors.

"TrueGlide technology. Bearing surfaces are fully

separated, the load fully supported by the lubricating fluid,"

again claiming full fluid film lubrication, correct?


Q. Ma'am, you know that y'all's own doctors know that that's

not true and have tested it, don't you?

A. I'm sorry. I couldn't hear the question.

Q. Yes, ma'am.

You know that people that y'all have on retention, that

you pay a lot of money to, have tested this for you. Dr. John

Fisher, for example, over in Leeds, you know him, don't you?

A. I do.

Q. I've handed you Plaintiff's Exhibit 3466. This is a

study by none other than Dr. John Fisher, someone that


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Johnson & Johnson/DePuy have paid a lot of money for and

supported his lab and everything else, right?

A. We've supported his lab.

Q. You've hired him to do testing on the Pinnacle

metal-on-metal, haven't you?

A. Yes.

Q. You've put your own people, your own engineers and

students through him as an academic source, haven't you?

A. Yes. Some of our employees have gone there to pursue

academics, yes.

Q. This is his area of study, isn't it?

A. Yes.

Q. Look what he wrote up in the peer-reviewed literature

about metal-on-metal, your metal-on-metal, and whether it's

full fluid film, boundary or mixed, where it's got some fluid

film and some interaction.

Page 255.

"Analysis of the lubrication regime of metal-on-metal

bearings in the hip, has shown they are" -- Can you read that

word?

A. "Not."

Q. -- "has shown they are not lubricated by a fluid film and

that direct contact of the solid metal surfaces occurs. This

can result in high friction and wear."

It continues on the next page.


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"Essentially metal-on-metal bearings operate in a mixed

lubrication regime in which the level of friction and wear

depends on local tribological conditions." Tribological means

rubbing, friction?

A. Yes.

Q. Your own scientist says no (indicating), yes (indicating)

correct?

A. I'm not familiar with this paper. So I'm afraid I can't

draw that conclusion without further study.

Q. Ma'am, that's exactly what it says right here.

A. I don't know what else this paper says.

Q. Ma'am, that's fine, and you'll have the direct to read

about it and redirect to come back and show all the other

things you want, but certainly the part we're reading

indicates in very clear English that it is not lubricated by

fluid film. Direct contact occurs as opposed to it being

fully separated with the load fully supported and that this

results in high friction and wear. It is a mixed regime. You

got some support, and you got some interaction. That's the

truth, isn't it?

A. You've read that correctly.

Q. Even Frank Chan, when faced with this, in his testimony,

whether he would have said that TrueGlide truly is doing this,

his deposition, page 201, line 2 --

MR. QUATTLEBAUM: Object to the hearsay, Your Honor.


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BY MR. LANIER:

Q. This is talking about describing the -- the surfaces as

fully separated and the load fully supported by the

lubricating fluid, unquote.

"Dr. Chan, if someone had asked you if -- could you as a

scientist support this, could you have done, sir -- what would

you have done?"

His answer:

"A. I would not have used those words."

Ma'am, those -- there's no way that the claims y'all were

making to the doctors in the medical community about the load

being fully separated -- that's just not true, is it?

A. I think it's true at a time point.

Q. Well, in fact, ma'am, this was a marketing gimmick. This

was an effort to sell things that people might not otherwise

buy, wasn't it?

A. I don't know that to be true.

Q. Do you -- Are you familiar with all of the work with

Dr. Schmalzried trying to get him on the bandwagon for this

TrueGlide sales pitch?

A. I'm not.

Q. Paul Berman from marketing, not an engineer -- right?

A. Correct.

Q. Paul Berman from marketing writes to Schmalzried and


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says, "The overwhelming insight from market research was that

patients want pain free natural motion. Last night, we called

it function, but in patients' minds it's a hip that gives

freedom of motion and feels natural. We must communicate that

benefit in our patient media.

"What makes this exercise so exciting is the greatest

differentiator as a company is our bearings --" that's the

kind of maneuver "-- portfolio and the --" rubbing story, the

friction story "-- the very thing that deliver what patients

ask for. You called it last night, the stuff outside the

bone."

Are you following me?

A. I'm following you.

Q. "So our branding is intended to tell patients DePuy hips

are uniquely designed" -- Boy, we've heard those words in the

advertisement, haven't we?

A. We have.

Q. -- "and manufactured to provide pain free natural motion.

This is where Pinnacle TrueGlide comes in. In patients'

minds, TrueGlide will make the link between Pinnacle and the

desired benefit of pain free natural motion and function. In

surgeons' minds, it will make the link to our unique rubbing

and bearing surfaces story . . . something they understand and

believe."

That's what this was. It was a marketing gimmick, wasn't


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it?

A. I was not part of this. I can't answer that question,

I'm sorry.

Q. "After a long process with internal market research and

an ad agency, we're at a point where there is strong alignment

around this brand," this TrueGlide.

Do you see that, ma'am?

A. I see that.

Q. Now, the company -- and we'll maybe get a chance to talk

to another witness about this. So I won't go into a ton of

detail with you. But the company has certain requirements of

what they can run -- Well, I'll wait. I'll save it for

another witness. Let me keep moving on with you.

But I will forecast it.

The FDA told y'all to cut it out when y'all tried to

claim full fluid film lubrication for a different Pinnacle

product, didn't they?

A. I -- I don't know.

Q. Okay. But y'all never cut it out for the metal-on-metal,

did you?

A. I'm afraid I also don't know the answer to that.

Q. Here's the Pat Campbell article that you said didn't have

a "however." This is the one you cite as the footnote even

though you got the citation wrong. This is Defendant's

Exhibit 5174. This is the technical monograph. Let's get


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back to the flow of things on it, and then we'll move to the

next subject.

Do you have the technical monograph in front of you?

Ma'am?

A. I'm looking.

Q. Tell me when you find it.

A. I have it.

Q. All right. If you look at the technical monograph, go

back to that warnings area where you and I were having the

discussion. Specifically I challenged you on whether or not

y'all were being fair here where you say "The biological

response, one study examined around retrieved metal-on-metal,

they found fewer macrophages, fewer wear particles, compared

to metal-on-poly. The macrophage and giant cell response from

metal-on-metal was described as mild." And I said but there's

a however. Do you remember?

A. Yes.

Q. Here's the article that y'all reference by Pat Campbell.

The jury got to meet her, by the way.

"Metal-on-metal hip replacements: Wear Performance and

Cell Response to the Wear Particles."

Do you see that?

A. I see that.

Q. Now, as a practical matter, if we flip to the reference

here -- we're going to find it on page 206.


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Thus the presence of potentially large numbers of

nanometer-sized metal particles -- "Despite the presence" --

excuse me -- "of potentially large numbers, the macrophage and

giant cell response to them could be described as mild."

That's what y'all quote. That's what you reference,

isn't it?

A. No.

Q. "The macrophage and giant cell response to particles from

metal-on-metal articulations was described as mild."

"The macrophage and giant cell response could be

described as mild."

That's what y'all quote from this exhibit.

I mean, here's the footnote. 55, as you pointed out. We

circled it when you pointed it out. That's the very article

we're looking at, isn't it?

A. It is -- it is the article.

Q. Okay. So you show me where in the article this language

is anywhere except where I've highlighted.

A. If you look on page 205.

Q. All right.

A. Of the article?

Q. Yes, ma'am.

A. I think I have found the correct place.

Q. You're going to want right here, if this helps you.

A. Yes.


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Q. "The histological reaction to metal wear particles was

described as mild --

A. Yes.

Q. -- and the predominant macrophage response was to

particles of PMMA"?

A. I believe that's what was referenced.

Q. That's all you got, isn't it?

But, ma'am, that's not what was referenced.

Read it, "The histological reaction to metal wear

particles was described as mild."

"The macrophage and giant cell response" is what you

quoted here. Macrophage and giant cell response.

Do you see the difference?

And look at the one I've shown you, macrophage and giant

cell response could be described as mild.

A. I think you --

Q. Excuse me, ma'am. Do you see the difference?

A. I see what you've pointed out.

Q. Let's be -- let write it down so that we've got it real

clear.

Page 206 says macrophage and giant cell response is mild.

And then it says, "however," and it talks about some bad

stuff.

Are you tracking with me?

A. I see what you're writing.


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Q. Now, the page that you're thinking you quoted was the

page before.

You think that the quotation actually was instead, "The

histological reaction --" page 205.

"The histological reaction to metal wear particles is

mild."

All right. Now, let's see which one you're really

quoting.

A. I believe if you go to Pat Campbell's cite you will

see --

Q. Ma'am, I don't have a question pending.

A. -- the language matches.

Q. What y'all quoted here is "In general, the macrophage and

giant cell response to particles from metal-on-metal was

described as `mild.´"

Y'all do not say here the histological reaction to metal

wear particles was mild, do you?

Do you, ma'am?

A. Campbell is citing Willert.



THE WITNESS: I believe that language is in the

actual --

BY MR. LANIER:

Q. Ma'am, please answer the question.


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A. Sorry. Please repeat the question.

Q. You're an -- you're an engineer, aren't you?

A. I am.

Q. You believe in precision, don't you?

A. I do.

Q. So there is a precise answer to these questions.

A. Not always, I'm afraid.

Q. Ma'am, this one is a no-brainer.

Does it say macrophage and giant cell response in the

warning, just as it does on page 206 with the "however"?

A. It uses those words, yes.

Q. Does it say, "histological reaction to metal wear

particles"? Does it use those words?

A. Not right here it does not.

Q. Thank you.

All right. Next subject.

Oh, I didn't show the "however" language.

MR. LANIER: Thank you, Jayne.

BY MR. LANIER:

Q. So here's what was left out of the "however" language.

Y'all told everybody it was mild and left out, "However,

immunohistochemical studies have indicated that the cobalt

chromium particles can induce the release of potential

osteolytic cytokines and potentially adverse effects including

hypersensitivity, chromosome damage that's been reported in


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the literature." So we need to continue doing more studies.

That's what's left out, isn't it?

A. I still believe the citation is not exactly correct.

Q. That's what's left out of the article. Even if you want

to claim you were just quoting from page 205, you still didn't

put anywhere in here, much less on this paragraph that says

the reaction is mild, in fact, it's better, fewer macrophages

and wear particles than metal-on-poly.

You didn't put anything on there about the studies have

indicated the osteolytic cytokines, did you?

I mean, did you, ma'am?

A. I'm not sure if those were the exact words used in the

technical monograph.

Q. You understand that's what ate up the bone of several of

the plaintiffs in this case, osteolytic cytokines, osteolysis,

eating up the bone.

You understand that?

A. I understand that.

Q. "-- potentially adverse effects including

hypersensitivity."

Do you see that?

A. I see that.

Q. And y'all don't say that in your warnings. In fact, what

y'all said is hypersensitivity is not a problem. Right?

A. Those aren't our words.


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Q. "Hypersensitivity itself is not known to be the cause of

implant failure."

A. Those are words coming from the literature, not from us.

Q. Well, not from this literature. These are potentially

adverse effects.

Chromosomal damage. That's cancer, isn't it?

MR. QUATTLEBAUM: Objection, Your Honor, chromosomal

damage is not cancer.

BY MR. LANIER:

Q. Can be. That's the start of it, damaging the

chromosomes, the reproductive part, right?


THE WITNESS: I don't know.

MR. LANIER: Thank you, Jayne.

BY MR. LANIER:

Q. New subject. Ultima. Ultima. Not the Ultamet Pinnacle,

but the other one.

Remember the Ultima?

A. Yes.

Q. All right. Ultima, that's the one up at the top, the J&J

product that y'all were using, right, studying?

A. Yes.

Q. Didn't tell the jury about the problems y'all had with

Ultima, did you?

A. We talked about the U.S. study only.


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BY MR. LANIER:

Q. Didn't tell the jury about the problems y'all were having

with Ultima, did you?

A. No.

Q. You remember in Australia with the Ultima problems and

the way it was running over into ASR and Pinnacle, that the

Ultima problems were being used to attack ASR and Pinnacle?


A. No.

Q. Here is an email. It is Exhibit 1025. It's an email

chain including Randy Kilburn and Andrew Ekdahl. It's

entitled "Ultima results used to attack ASR and Pinnacle."

Do you see that?

A. I see that.

Q. It's got salespeople on it, among others, Polly Cary,

high importance.

"The attached letter is being used to discredit

Pinnacle/Ultamet and ASR in Australia. I've reported its use

to our regulatory team and steps will be taken if we can

identify the company using it."

"The information is being used to discredit our

metallurgy in ASR --" of course, this is before y'all had to

pull ASR, right?


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2007?

A. Yes.

Q. Okay. "Ultima was designed `after extensive hip

simulator testing that investigated clearance, roughness,

sphericity and metal composition and still failed."

Do you see that?

A. I see that.

Q. Now, this is the Ultima that you tried to tell the jury

was one of the reasons y'all knew Pinnacle was going to work

well, didn't need to test Pinnacle because you had tested

Ultima. Remember?

A. I remember.

Q. Look at the surgeon letter.

DePuy -- this is about Ultima, femoral stem and metal on

metal.

"Our records indicate that you or one of your colleagues

has been a past user of the Ultima. I want to draw your

attention to the possible adverse performance.

"Revision experience. DePuy is currently aware of a

cohort of 637 hips at one center where 60 revisions, 9.4

percent, at 2 to 9 years follow-up have been required for the

Ultima stem and metal-on-metal articulation."

MR. QUATTLEBAUM: Excuse me, Your Honor, Mr. Lanier

left out words from the question, if it's a question.

THE COURT: You can clear that back up on redirect.


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BY MR. LANIER:

Q. I'm sorry, ma'am, if these are critical words, I didn't

mean to leave them out. I didn't think they were critical.

I'll keep reading them.

"-- been required for the Ultima TPS femoral stem and

Ultima metal-on-metal articulation. 21 of these are

considered to be 'normal' revisions (e.g. for infection,

trauma, et cetera). However, 39 revisions have been

associated with extensive periprosthetic --" that means around

the hip implant, right?

A. Yes.

Q. "-- soft tissue necrosis --" that's dead tissue, right?

A. Yes.

Q. "-- sometimes severe. This represents a failure rate of

3.3 percent for the revisions exhibiting no reaction and 6.1

percent for the revisions with a necrotic reaction."

Some have been associated with late dislocation or

periprosthetic fracture.

Now, y'all investigated -- did you know about that, by

the way?

Were you called in to that investigation team?

A. No.

Q. When you were talking to the jury about the Ultima study,

you didn't tell them about not that 269 hips that y'all

followed for a couple of years but the 637 hips at this


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center. Left that out, didn't you?

A. We did not specifically discuss it.

Q. And the truth of the matter is upon investigation the

best light that your company could put on this is that maybe

the problems coming from the metal that's coming off of the

stem combined with the metal that's coming from the

metal-on-metal, and that just the two of them put together

seemed to be putting out that much metal, right?

A. There was an issue with the combination of those two

products together, yes.

Q. Because the interesting thing is that at the same center,

the same stem, with the same head, with the same shell, but

using a poly liner instead of a metal liner, no problems.

Did you know about that?

It's in the investigation, ma'am.

Page 401 in the lower right-hand corner starts, "The

investigation."

And this is your company's stuff. This is your company's

investigation. This isn't independent.

"Extensive investigation has failed to establish

categorically why the tapered polished stem sometimes corrode.

Cobalt chromium molybdenum is generally considered to be

corrosion resistant in a person."

"The clinical --" look at this.

"The clinical performance of the stem with metal-on-poly


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is completely normal.

"Following the investigations and retrievals analysis

DePuy believes the dead tissue, necrosis, observed at revision

is caused by patients reacting to too much higher levels of

metallic ions than normal in a metal-on-metal articulation,

derived principally from the corroded surfaces of the stem"

(indicating) --

MR. LANIER: Sorry, judge.

BY MR. LANIER:

Q. "-- combined with that generated from the normal wear of

the bearing."


A. I see that.

Q. The best thing y'all could put on it was one of don't

throw out the bearing, it must be the stem and the bearing.

Even though you had no trouble with the metal-on-poly.

And that's the Ultima story y'all left out for the jury,

isn't it?

A. I think there's probably more that's been left out of

that story as well.

Q. Do you know any more right now?

A. What I can say is the report that I saw said that

retrievals for --

Q. Time-out, ma'am.

Do you know any more than that report that I just handed


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you?

A. I didn't see that whole report.

I believe that I know more --

Q. Okay.

A. -- I don't know if it's contained in that report.

Q. Fair. That's fine. Thank you.

And I'm sure we'll have a chance to hear about it. I've

got about eight more minutes and then I want to save my last

30 minutes.

So let's talk for a moment about -- eight minutes. See

if I can do this in eight minutes.

Q. Okay. In eight minutes let's talk about the business of

metal-on-metal. All right?

Are you with me?

A. I'm not sure I understand what that means, but I'll see

if I can follow along.

Q. All right. This is business.

You testified with Mr. Quattlebaum that metal-on-metal

was just a small percentage of the company's business,

remember?

A. I don't think I used "small percentage".

Q. No, you didn't.

A. Okay.

Q. Because that wouldn't be accurate.

You talked about it in the early years when y'all were


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first trying to start selling it.

But metal-on-metal became the backbone of the profits for

DePuy, didn't it?

A. I'm not sure about that.

Q. Metal-on-metal started slow, and that's what you told

this jury, it was a low percentage, but it became a major

seller, didn't it?

A. I think I testified that it was up to 35 percent of our

Pinnacle liner units at its peak. That's approximate.

Q. And even higher in its profit because it had a higher

profit margin, didn't it?

A. Yes.

Q. In fact, ma'am, it was the key market driving product

line along with ASR, wasn't it?

The metal-on-metal business is not simply Pinnacle, but

it included ASR for a while, didn't it?

A. We were selling those products simultaneously, yes.

Q. And so that we understand the concept of this,

Plaintiff's Exhibit 1567, the jury is going to see that

metal-on-metal for your company was critical. Wasn't it?

A. If that's the word used here.

Q. Yes, ma'am.

You're copied on this email, 2007, talking about how to

spend money for hips. "Here is more detail on how 750,000

would be spent."


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MR. QUATTLEBAUM: Excuse me, Mr. Lanier. Whatever

you handed me is not that.

MR. LANIER: Not 1567?

MR. QUATTLEBAUM: No.

MR. LANIER: That's okay. I may need this one back.

THE WITNESS: So I think you'll need mine back as

well, sir.

Thank you.

BY MR. LANIER:

Q. Sorry.

A. Wasn't sure where you were going with that.

Q. Do you have 1567?

It should look like this --

A. Yes.

Q. An email from Paul Lewis.

A. Yes. Yes.

Q. I want to look at the third bullet point, "Outside

research. Continue to fund existing metal-on-metal ion

studies" -- Now, look at this. Not to find out the truth.

Y'all were funding them to support your marketing 'em.

You were funding them to get an end result you could use

for marketing, weren't you?

A. We were funding them to get an end result.

Q. "Continue to fund existing metal-on-metal studies that

are critical to support and protect our key market-driving


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Ultamet and ASR product lines."

Do you see that?

A. I see that.

Q. These were key market driving lines, weren't they?

A. That's what this says.

Q. And this was an area where DePuy really seemed to own the

market. Correct?

Y'all were number one.

Weren't you?

I'm handing you Plaintiff's Exhibit 2829, I think. I'm

trying to anyway.

A. Yes.

Q. DePuy U.S. joints, trauma, extremity, board meeting

minutes, 2008.

If you'll look on page 9.

"Leanne Turner presented this initiative which the hip

development team prioritized as `needed.'"

"The board agreed" -- Did you make a presentation to the

board?

A. If that's what it says then I'm sure that's accurate.

Q. This is on cobalt on cobalt.

"The board agrees DePuy owns the hard-on-hard bearing

market and would like to keep our options open in this area to

maintain our ownership."

Your metal-on-metal drove the business such that you


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owned that part of the market, and y'all were trying to figure

out how to continue your ownership by using

ceramic-on-ceramic, right?

A. I see that this was regarding ceramic-on-ceramic, yes.

Q. Because y'all knew that the days for metal-on-metal were

numbered?

A. No.

Q. So you were trying to find a replacement so that you

could maintain that source of income, right?

A. No.

Q. In fact, ma'am, we can see the market assessment and

business plan from 2008 as well.

MR. LANIER: Sorry, Judge.

BY MR. LANIER:

Q. Market assessment and business plan, 2008, DePuy, a

Johnson & Johnson company. Correct?

A. Yes.

Q. And we can work through it. It's got the hip marketing

and the work that's being done headed up by Andrew Ekdahl.

Delivering U.S. hip growth with market share. Do you see

that?

A. I see that.

Q. And so we can see the way DePuy has been gaining market

share and is higher than any of the competitors?

A. For hip.


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Q. Yes. U.S. Hip Growth?

A. Yes.

Q. Then y'all looked at it per quarter and were able to

devise it that way as well.

And then you looked at the metal-on-metal category

ownership and showed how y'all had been gaining ownership of

the marketplace in metal-on-metal year end, year out, quarter

by quarter. Do you see that, ma'am?

A. I see that.

Q. Y'all used as parts of this the anterior approach and the

table that was used, for example, in Ms. Aoki's situation,

correct?

A. I don't have knowledge of that.

MR. LANIER: Your Honor, I've got 30 minutes of time

I'm left with this witness, and if I could have a lunch break.

THE COURT: We are going to break right now.

All right. Be back at 10 after 1:00.

Thank y'all.

(Recess taken at 12:00.)

(Proceedings resumed at 1:17.)

THE SECURITY OFFICER: All rise, come to order,

please.

(Outside the presence of the jury.)

THE COURT: Okay. Here we go.

MR. LANIER: Your Honor, by my count I've got about


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30 minutes left, but I'm going to spend another six and then

I'm going to save 24 back.

THE COURT: Okay.

MR. LANIER: Thank you, Your Honor.

THE COURT: Bring them in.


THE COURT: Y'all be seated.

Thanks.

Go ahead.

CROSS EXAMINATION (Cont.)

BY MR. LANIER:

Q. Ma'am, I'm going to spend six more of my minutes with

you, which will leave me 24 afterwards.

A. Okay.

Q. Six minutes, four documents. Are you ready?

A. I'm ready.

Q. All right. The first thing I want to do is I want the

jury to be aware of the fact that I'm still picking up on that

theme we were talking about of the company knowing

metal-on-metal was a risky business but the company was in it

anyway.

Do you follow?

A. I hear what you're saying.

Q. All right. So I'm handing you a document that's labeled

Plaintiff's Exhibit 638. This is an actual proposal where


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DePuy paid a company called Haztech Consultants. DePuy paid

them to do an assessment of how much DePuy was risking

financially because of its metal-on-metal joint wear problems.

MR. QUATTLEBAUM: Objection, hearsay, Your Honor.


BY MR. LANIER:

Q. Did you know anything about this document?

A. No.

Q. The document goes back to December of 2005. And in 2005,

having been paid by DePuy, DePuy was given this proposal,

which I don't think DePuy ever followed through to get the

final work product, just simply a proposal. But look at what

DePuy is warned about in this proposal, or at least put on

notice of.

"One of the major concerns and problems associated with

joint replacement is the effect of wear produced at the joint

surfaces. The problems and adverse effects associated with

the most common joint replacement materials are understood and

well reported. These adverse effects include a foreign body

reaction to poly debris called osteolysis, which results in

localized bone damage.

"There's been a move towards harder wearing materials and

metal-metal bearing surface joints are being used in ever

larger numbers. There are concerns this results in elevated

metal ions in a variety of tissues in patients where


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metal-metal joints have been used.

"The risks associated with the metal-on-metal joint are

as yet undetermined --" this is 2005, end of 2005 "-- although

the consequences for the patient may or may not be significant

in the long term and the risk to DePuy may be major in terms

of product liability or business impact."

Of course, this is a product liability case we're about

here today, right?

A. Yes.

MR. QUATTLEBAUM: Your Honor, object to 403 as well.


BY MR. LANIER:

Q. "The metal-metal ion risk is a potentially long-term

issue with perhaps very low risk but potentially major

consequences for DePuy and/or the patient."

And so DePuy paid money to this company to discuss that

risk and try to figure out if it was worth it. Do you recall

that?

MR. QUATTLEBAUM: Objection, lack of evidence in the

record, Your Honor.


BY MR. LANIER:

Q. Do you recall anything about this?

A. I'm not familiar with this at all.

Q. The scope, "The science and actual medical implications


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are as yet unknown. The criteria to be used to judge

tolerability of risk are yet to be defined."

Now, that's certainly not what we're reading in any of

the warnings y'all are giving to patients or doctors, is it?

A. I disagree.

Q. Part of the scope of work Haztech will undertake is to

assist DePuy define targets and the type of information that

will be needed to make reasoned judgments about risk."

Now, isn't it true that as of 2005 -- in fact before --

your company is very concerned about the risk of

metal-on-metal for your company's business reasons?

A. I'm not sure what you're referring to.

Q. Well, ma'am, that's one of the documents I'm referring

to.

Your company is worried about the financial harm to the

company of continuing to sell all these metal-on-metal hips.

Right?

A. You've read out of this correctly. I've not read this to

understand its full scope or context.

Q. Well, I'll show you Plaintiff's Exhibit 148.

This is another email chain. Now we're fast-forwarding

two and a half years, actually one and a half. We're in July

of 2007. This has got Graham Isaac, same fellow as the last

one.

That's the man of The End Game fame, right?


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MR. QUATTLEBAUM: Mr. Lanier, is this -- you said

Plaintiff's Exhibit 148?

MR. LANIER: Yes.

MR. QUATTLEBAUM: Is that what you meant?

MR. LANIER: Well, once again, I'll give it to you

this way. See if that's --

BY MR. LANIER:

Q. Ma'am, did I give you a document that looks -- it's got

two numbers. It's the exact same document.

MR. LANIER: Your Honor, it's also Plaintiff's

Exhibit 60.

THE WITNESS: I have a 60.

BY MR. LANIER:

Q. You have a 60. Same document.

Now, this talks about the worldwide hip business team,

bearings update, right?

A. I see that.

Q. Look what they're concerned about now in 2007, a year and

a half later.

"We're getting deeper into metal-on-metal - high risk if

any complications are shown."

Company is analyzing the business model, aren't they?

A. I have not seen. I don't know what they're analyzing.

Q. And instead of just telling everybody, stop, we're

putting hips in people where we don't know what they're going


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to do, the company just stays full speed ahead with the

marketing program, pumping money into direct-to-consumer

marketing, putting ads in all of the doctor journals.

The company is full steam ahead, aren't they?

A. I don't think that's correct.

Q. Ma'am, the company was worried because, if you'll look at

slide 9, they were losing ground on ASR at this point in time,

so they're having to do research on aSphere, research on

ceramic.

Do you see that?

A. I see that.

Q. And then if we continue to chart through, what we're

going to see is the company ultimately develops the aSphere

hip and decides to sell it, right?

A. I don't know.

Q. Remember we showed you the document yesterday where you

were the head of that -- some of that, on aSphere?

A. I re-reviewed that and I believe that was a typo, because

I did not have responsibility for aSphere.

Q. Well, look at this anyway.

This is Plaintiff's Exhibit 86. And this is where the

question about aSphere is being debated by some people over in

England.

The question is whether or not aSphere should be sold in

England.


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And the comment from Raphael Pascaud to Paul Kurring is

"What's our position? Are they --" that's U.S "-- not

compounding their metal-on-metal risk by selling aSphere?"

Do you see the comment back from Paul Kurring?

Do you know Paul?

A. I do.

Q. Paul Kurring sends this email back, including to Graham

Isaac of End Game memo fame, and says, "Raph, others, please

jump in if the following is inaccurate." ASphere head cost is

double that of what they were using.

They would -- in England they could only get a 10 to 15

percent premium if they had a very good marketing story, which

is difficult to prove in people.

So the gross profit would be low about using aSphere in

England because of the high standard cost.

And then he says, "Yes, U.S. are going further into

metal-on-metal with this and effectively acknowledge

metal-on-metal has an issue," that's why they offer this as a

solution.

Did you know about that at the time?

A. I have never seen this.

Q. One last subject, ma'am.

You have talked about the royalties that the doctors

earned and deserved. You didn't tell the jury about some of

the doctors that y'all did not give royalties to, did you?


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That you've given royalties to but then decided it wasn't

right to give 'em, right? There were people like that?

A. I'm not sure what you're referring to.

Q. Well, look, for example, at Exhibit 154.

This is an email, Tony Cutshall, about Dr. Moreland and

his contribution to solution and whether or not he should be

getting a royalty.

It says, "After review it doesn't appear the comments

made by Dr. Moreland during the meeting were used or

implemented. Only one comment during another meeting was

used. So my recommendation at this point would be no to

royalties."

And "at this point" means years later when the U.S.

government is looking over the shoulder with that DPA,

deferred prosecution agreement. Right?

A. Correct.

Q. Now, look at what Dr. Moreland's contribution was that

wasn't followed. It's attached. Here's the email back in

2002 that evidenced it.

"Trip notes from Dr. Moreland visit."

2002. Andrew Ekdahl involved, Leanne Turner involved.

"Dr. Moreland, I want to thank you for your time and

gracious hospitality during my visit Wednesday. It was great

to have the opportunity to review these systems face-to-face.

Your insightful feedback on these and our other product lines,


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as well as technical pearls you shared during surgery, were

extremely beneficial. We appreciate your efforts. To recap

the discussions with Steve and yourself" --

Do you follow me?

A. I follow you.

Q. Now, I want to look at the discussions under the subject

"Other developments."

"Metal-on-metal: Do not use because of increased metal

ion potential."

This is 2002. "(Reduced wear in cross-linked poly is

acceptable)." 2002.

"You noted that as a member of the AAOS review board a

paper was approved that will document evidence to this

effect."

Do you see that?

A. I see that.

Q. Now, it's kind of ambiguous here as to whether that was

an instruction, advice from him, "do not use metal-on-metal,"

or whether that's him saying he does not use it.

Can't really tell from the way it reads, right?

A. Cannot tell.

Q. But regardless, the company is certainly put on notice by

a member of the AAOS review board reduced wear in cross-linked

poly is acceptable and metal ion potential is a reason not to

be using it at least for that surgeon, if not everybody,


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correct?

A. For this surgeon, that's what he says, yes.

Q. Or he's giving advice to the company, do not use. We

can't tell which.

It's ambiguous. Fair?

A. It's ambiguous.

Q. All right. Thank you.

MR. LANIER: Your Honor, I'll save the rest of my

time, please.

Thank you.

THE COURT: Mr. Quattlebaum.

MR. QUATTLEBAUM: It will take me just a minute,

Your Honor, to get my stuff here.

THE COURT: No problem. Take your time.

(Pause.)

MR. QUATTLEBAUM: May it please the Court.

THE COURT: Yes, sir.

MR. QUATTLEBAUM: Thank you.

REDIRECT EXAMINATION

BY MR. QUATTLEBAUM:

Q. Leanne, I'd like to do this in 45 minutes if I can so I

can save 10 or 15.

I want to talk to you about a subject he talked about

yesterday which was the subject of clearance in connection

with the 510(k).


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A. Yes.

Q. So Mr. Lanier pointed out to you that clearance has been

described as -- as an aspect or feature that's tightly

controlled.

A. Right.

Q. That's imperative?

A. Yes.

Q. That's important?

A. Yes.

Q. So with regard to the 36-millimeter head and the

28-millimeter head and interior liner -- interior of the

liner, what's the difference between the wear of the

previously approved 28-millimeter and the 36 with the

diametrical clearance widened like it was described?

MR. LANIER: Judge, I'm going to object to an answer

to this question unless he's got the foundation first.

Inadequate foundation. Hasn't given us the test results or

what tests he's used for this.

This is just a conclusion that would take an hour to

unwind in cross.

THE COURT: I don't know about that. But just

rephrase.


BY MR. QUATTLEBAUM:

Q. Ma'am, have you conducted testing on the 36 and the 28?


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A. Yes.

Q. Is that something you did in your job?

A. Yes.

Q. So my question is what's the difference between the wear

that results from the 28-millimeter head and the 36 when the

diametrical clearance is open?

A. We tend to still consistently see low -- equivalent or

lower wear with the 36.

Q. What's the effect on the pattern or -- or what we might

call the wear patch when you open up the diametrical --

diametrical clearance?

A. So when we opened up the clearance for the 36 from the 40

to 80 microns to the 80 to 120 microns, it made the wear

patches that you would expect between the 28-millimeter

articulation and the 36 to be the same.

Q. Which got cleared through 510(k) with the FDA first, the

28 or the 36?

A. The 28.

Q. Okay. So when you opened up the diametrical clearance on

the 36, how did that relate to the 28?

A. It made the effective radius of the 36 the same as the

28.

Q. How did the testing you conducted on the one-piece device

relate to the diametrical clearance on the 36 after you

determined it should be widened?


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A. The testing we had on the 36 with the same high carbon

cobalt chrome and the same geometry, with nearly equivalent

clearances, the wear was very, very low.

Q. Let me see if I understand.

Why don't you just explain to us what -- why you were

confident that opening up the diametrical clearance wouldn't

change the performance?

A. We were confident because the wear testing that we

already had on the 36-millimeter articulation was a clearance

that was actually more similar than what had been initially

proposed as part of the FDA submission. So by opening up the

clearance, it actually made the component more similar to the

one we had simulator testing for already.

Q. Okay. And what -- how -- how did it -- what effect did

it have with regard to the similarity to the 28 that the FDA

had already approved?

A. It -- it -- it gave it the same -- essentially the same

contact area or the same effective radius.

Q. Now, did you -- After it was cleared, did you continue to

test to determine whether the wear on the 36-millimeter was

low?

A. We did.

Q. And what was the result?

A. Consistently low wear.

Q. Okay. And did you not only test -- and you're talking


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about wear in simulators, I assume?

A. That's correct.

Q. Okay. Did you also -- Are you aware that the explanted

devices from Mr. Klusmann, Dr. Greer, and Captain Peterson

were published in this case?

A. Yes.

Q. And that Pat Campbell did that measurement?

A. Yes.

Q. What did she report regarding their wear characteristics

on the devices that were taken out of their hips?

A. In her opinion, they also exhibited low wear.

Q. Is that consistent with your simulator testing?

A. That is.

Q. Is that consistent with what you saw with both

28-millimeter and 36-millimeter diametrical clearances?

A. Yes, it is.

Q. Does -- Let's make sure we're clear on this, too.

Does diametrical clearance have anything in the world to

do with subluxation or laxity?

A. It does not.

Q. How did the diametrical clearance of the 36-millimeter

after you opened it up compare to other metal-on-metal devices

that were on the market at that time?

A. It -- the clearance is actually still slightly lower on

the high end than the Metasul 28-millimeter metal-on-metal.


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Q. What -- what was the potential effect of the

36-millimeter with the narrower clearance before you widened

it with regard to its friction and seizing?

A. So the -- the potential -- the potential issue with

that -- as I think I discussed the first day I was sitting

here -- was that if the clearance is too small between the

components, there's a risk of high friction and the bearing

seizing, is what you would call it, which was one of the known

issues of the original -- the first-generation metal-on-metal

components.

Q. So did the widening of the clearance -- And I don't think

this was clear --

MR. LANIER: Object to leading.


BY MR. QUATTLEBAUM:

Q. What effect did the widening of the clearance have on the

safety and efficacy of the 36-millimeter Ultamet?

A. So I felt like it actually was a better factor of safety

by -- by opening up the clearance still within a range that we

had already tested, but it significantly reduced any concern

of the component seizing -- seizing, in my opinion, and of

other research folks on the team believed that that was a

better factor of safety for the product. It actually reduced

the risk.

Q. Was the diametrical clearance to which you opened it,


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which I think is 80 to 120 -- right?

A. That's correct.

Q. Okay. Had that been contemplated before that November

2000 time period?

A. Yes. In fact, when the tribologists from the Leeds

organization and the Warsaw organizations came together for a

kick off of sort of the metal-on-metal project in determining

the articular surface parameters, it was very clearly outlined

there by Frank Chan in a technical analysis provided that was

supportive of the effective radius for determining clearance

for the 36-millimeter.

Q. Okay. Now let's go to the 510(k) itself.

The question, Ms. Turner, is whether you tried to

intentionally deceive the FDA. You understand the issue,

right?

A. I understand the issue.

Q. Okay. Did you?

A. I absolutely did not try to fool the FDA.

Q. Okay. Let's look -- let's start here.

MR. QUATTLEBAUM: Jim, can we go to the ELMO,

please?

BY MR. QUATTLEBAUM:

Q. Is this the letter to the FDA?

A. Yes.

Q. This is the -- this is Exhibit 467, Defense Exhibit 467.


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And it's November 13th, 2000. Right?

A. Yes.

MR. LANIER: If we could hang on one sec.

MR. QUATTLEBAUM: I'm sorry. You don't have one?

MR. LANIER: No.

MR. QUATTLEBAUM: My apologies.

MR. LANIER: Judge, I don't want him to lose

downtime on this. You can go ahead and do your questions, as

long as I can have a copy.

MR. QUATTLEBAUM: Thank you, Mr. Lanier.

MR. LANIER: That's okay. I just need a copy.

What's the exhibit number?

MR. QUATTLEBAUM: 467.

BY MR. QUATTLEBAUM:

Q. Okay. Ms. Turner, what I want to draw your attention to

is this sentence where it says, "DePuy believes this

modification is eligible for 510(k) since the product has the

same fundamental scientific technology and intended use as the

predicate device.

What was the predicate device?

A. I'm sorry. Would you mind moving that up on the ELMO,

please?

Q. I'm so sorry.

A. Thank you. The predicate device -- this is the

submission for the 36. The predicate device was the 28


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Ultamet.

Q. So why would you say it has the same fundamental

scientific technology as the predicate device?

A. We believe in terms of their particular surface

parameters, the technology in the application was the same.

Q. You said that really fast.

Say it again.

A. We believed that the scientific technology behind the

articular bearing surfaces was the same.

Q. And why would you think that if you had changed the

diametrical clearance on the 36 from what it had been with the

28?

A. Because we were effectively maintaining the contact area,

what would be the -- the wear area was now being -- was being

maintained between the 28 and the 36, and we believe that to

be equivalent.

Q. Okay. Under "Basis of substantial equivalence: The

intended use, articular surface characteristics, material and

locking mechanism with the outer shell are the same. The only

minor change is to the interior diameter of the cup, which is

now 36-millimeter."

Does that statement in any way relate to the diametrical

clearance of the liner?

A. So the articular surface characteristics, there are many

of them. And as we had discussed, clearance can be one, and


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effective radius is -- is another. So yeah. So I think that

that adequately covers our change in clearance to maintain the

effective radius.

Q. Under "Device description and comparison" it talks about

"Same articular surface requirements, same effective radius."

A. Yes.

Q. What's the effect of putting that in the application?

A. That was our intention to describe to the FDA how the

36-millimeter was substantially equivalent to the

28-millimeter.

Q. They -- they both have the same --

MR. LANIER: Objection, leading.


BY MR. QUATTLEBAUM:

Q. Do they -- Explain whether they have the same effective

radius.

A. They do.

Q. You note under "Verification tests" "Acceptance

Criteria." What are you explaining there?

A. Part of the process for a 510(k) is for us to identify

through our own design control process, which is something we

had also talked about, what the modification is, what the test

or verification that would be performed is and the acceptance

criteria.

So our acceptance criteria for the 36-millimeter was that


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it would have wear equivalent to or less than the

28-millimeter articulation.

Q. And what was your basis for that?

A. We had wear testing for high cobalt chrome 36-millimeter

articular bearing surface.

Q. Okay. So here's -- On this issue of whether you were

trying to fool the FDA, is that your note?

A. That is.

Q. And is it dated and initialed by you?

A. I think it is. If you'll shrink it, yes, I'll be able to

tell you. Yes, it is. November 13th of 2000.

Q. And this is on what we have identified or -- I'm sorry.

Page 361. Let's turn the page.

Is it again?

A. It is. Yes.

Q. Turn the page. Is it there again?

A. It is.

Q. How does that -- How do these notations, these

handwritten notations, relate to the diametrical clearance?

A. These are the changes that were made to the engineering

drawings for the 36-millimeter to open the clearance from 40

to 80 microns to 80 to 120 microns.

Q. Is it on there again?

A. Yes.

Q. Why so many times?


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A. We made the change on each and every 36-millimeter

drawing that would fit the variety of acetabular backside

shell sizes, and each and every drawing was submitted as part

of the 510(k).

Q. Highlighted each one of those?

A. Yes.

Q. Well, if you're trying to slip something by, what's the

effect of making a handwritten notation about it?

A. That feels like it would have been an ineffective way to

do that.

Q. So I noted that those were dated. Let me just go back

and make sure.

A. November 13th, I believe.

Q. Right. And the table -- that's the table where the

mistake was made, right?

A. Yes.

Q. 40 to 80 microns was what was on the 28; is that correct?


THE WITNESS: Yes.


BY MR. QUATTLEBAUM:

Q. What was noted on the 36?

A. Yes. Same.

Q. What was it?

What'd you put there?


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A. Same.

Q. And that was dated 11/6 of 2000, a week earlier, right?

A. Yes.

Q. So here's your chance, did you try to -- did you leave

that that way intentionally?

A. I'm sorry, did I leave --

Q. Yeah. Did you leave the table saying the word "same"

intentionally?

A. I did not.

And as I sit here under oath today, I did not

intentionally try to fool the FDA. This was -- it was a

mistake on my part. I had absolutely no knowledge of this

mistake until it was brought to my attention in 2005.

I would not and did not then and would not ever

intentionally try to falsify information to the FDA. That

would be horrifically irresponsible to my company, and as well

it does not align with my own values.

Q. Okay. Let's move to this issue of warning information.

First, let's put it in context.

Who does DePuy provide warning information to?

A. We provide warning information to our surgeons.

Q. By what means is warning information provided that

accompanies the product?

A. The information -- instructions for use is part of every

product that is sold.


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Q. Is that warning information contained in the IFU?

A. Yes.

Q. How does the IFU get involved with the 510(k) clearance?

A. The IFU is part of a 510(k) clearance submission.

Q. In fact, that document we were just looking at, Exhibit

467, has as part of it a review of the information for use,

correct?

A. That is correct.

Q. In addition to the information contained in the

information for use, what else did DePuy do with regard to

providing information to surgeons?

A. There was a tremendous -- tremendous amount of training

for surgeons, as well as some materials available for their

own consumption that included that information.

Q. You were described earlier as a -- to be involved in

techno marketing, right?

A. Yes.

Q. And Mr. Lanier used exhibit -- Plaintiff's Exhibit 1565

with you. Let's take a look at that quickly.

Were you involved in surgeon visitations?

A. Yes.

Q. Were you involved in surgeon presentations?

A. Yes.

Q. We saw yesterday the PowerPoint slide deck that you used

with the sales force on one occasion, right?


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A. Yes.

Q. What involvement did you have with surgeon presentations

and that slide deck?

A. So that slide deck, that particular one, was labeled for

a particular sales training meeting that that same or very

similar slides would have been sort of used and recycled, for

lack of a better word, with our other surgeon presentations as

well as sales force training.

Q. So that information that was contained in that slide

deck, would the similar information have been contained on

slide decks to surgeons?

A. Yes.

Q. Let me hand you Exhibit 934. What is that, ma'am?

A. This is a Bearings Compendium.

Q. What is a Bearings Compendium?

A. It is a collection of information about a variety of our

bearing products.

Q. Mr. Lanier showed you a video yesterday of a satellite

broadcast that took place. Remember that?

A. Yes.

Q. Where the officer introduced the -- the video?

A. Yes.

Q. What relationship does the Bearings Compendium have to

that satellite broadcast?

A. This Bearings Compendium was distributed to all of the


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attendees of the broadcast.

Q. Was that the only one that was done?

A. The only broadcast?

Q. No.

A. Or the only compendium?

Q. Only compendium.

A. No. There was another one done, an updated one done

several years later.

Q. Okay. Let me have that one back, please, so I can ask

you about it.

Ms. Turner, we've looked at this once before, not you and

I, but in this trial. So what is the metal-on-metal path of

the Bearings Compendium?

A. So this is a collection of papers relating to

metal-on-metal implants.

Q. Does it discuss wear and lubrication?

A. It does.

Q. Does it discuss Metal-on-metal Versus Polyethylene in Hip

Arthroplasty: A Randomized Clinical Trial?

A. Yes, it does.

Q. Does it include papers?

A. Yes.

Q. Reprints of published papers?

A. Yes.

Q. Including papers about metal-on-metal total hip


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replacement?

A. Yes.

Q. About ions?

A. Yes.

Q. About serum cobalt levels --

A. Yes.

Q. -- after metal-on-metal total hip arthroplasty?

A. Yes.

Q. About the risk of cancer?

A. Yes.

Q. About cancer risk after metal-on-metal and

metal-on-poly?

A. Yes.

Q. Did it also have a similar -- another half of it that

related to issues about polyethylene?

A. Yes.

Q. I'm handing you --

A. Thank you.

Q. -- Exhibit 992, ma'am.

Is that a subsequent Bearings Compendium?

A. Yes, it is.

Q. Was that also published by DePuy?

A. Yes.

Q. And if you turn to page 992.11, are there photos of

revision issues?


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A. Yes.

Q. I think that one involves a resurfacing product, right?

A. Yes.

Q. And way back in the back, on page 992.162, more photos

about revisions involving polyethylene, ceramic, and metal.

A. Yes.

Q. Let me hand you Exhibit 2142, ma'am. What is that?

A. Information, the Importance of Correct Acetabular

Component Positioning.

Q. By the way, that second Bearings Compendium, was that in

2008?

A. That's my understanding, yes.

Q. Okay. And if we look at this one, and look down at the

bottom.

Was this one in -- 10,000 copies in February of '09?

A. That's correct.

Q. And this is Exhibit 2142. Does it also talk about metal,

ceramic, and polyethylene adverse issues?

A. It does.

Q. Now, those are -- this document, it's called The

Importance of Correct Acetabular Component Positioning?

A. Yes.

Q. Was that part of a campaign that you did?

A. Yes.

Q. About what?


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A. Exactly what it says, component positioning.

Q. Does that refer to cup angles and things like that?

A. Yes. So --

Q. Positioning of edge loading?

A. Yes.

So when the -- my pieces are gone. The acetabular cup is

positioned, about the sort of inclination and anteversion of

the -- of the cup.

Q. And we've already been over, I think, the issue of

warnings contained at the back of the surgical technique. Do

you recall that?

A. Yes.

Q. And specifically tissue reactions?

A. Yes.

Q. Now, the surgical technique was for the cup, wasn't it?

A. Yes.

MR. LANIER: Object to leading.


BY MR. QUATTLEBAUM:

Q. What was the surgical technique?

A. This was for the acetabular cup system.

Q. Okay. Would that -- how many different liners would that

have included?

A. That would have included all of the bearings that were

available at the time, polyethylene and metal.


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Q. Okay. And so when it's talking about --



BY MR. QUATTLEBAUM:

Q. What's it talking about when it talks about tissue

reactions?

A. Generally speaking, tissue reactions to either of those

bearing surfaces --

Q. Okay.

A. -- or the cup itself.

Q. Let's move to the technical monograph.

There's an issue about the references in the technical

monograph. Right?

A. Yes.

Q. So why do you think the technical monograph was --

accurately recited the literature?

A. Frank Chan was one of the major contributors to this

entire document, and he had an extensive bibliography in terms

of assessing the current literature that was available in

terms of providing at this -- at the time this was created the

most accurate information we could -- we could.

Q. Okay. Let's -- let's look at what's in the technical

monograph. We've been over and over it, but I want us to make

sure.

Tell me what's -- if we were to sum up the first


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paragraph, how could we sum it up?

A. I think in terms of the first paragraph we talk about

that it's -- that it's very low wear but that there are still

unknowns, known unknowns, related to biological issues.

Q. Read the last sentence for us, please.

A. "This may be of some concern because the full biological

response to metal particles or ions is currently unknown."

Q. Was that consistent with your understanding?

A. Yes.

Q. Second paragraph, what are we talking about here?

A. Biological response to metal wear particles.

Q. What does "histological" mean?

A. Body response.

Q. And tissues around the metal-on-metal hip implants is

also referred to as what?

A. I'm sorry, I don't understand the question.

Q. Right. So what are -- what is periprosthetic area?

A. Oh, around the implant.

Q. It talks about this mild response, right?

A. Yes.

Q. Why do you think that was accurate?

A. I think that the reference to the Campbell paper and

Campbell references the Willert paper, and I believe that --

Q. Let me stop you because I don't think we heard that.

Campbell references what?


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A. Willert.

Q. Okay. The Willert paper?

A. Yes.

Q. Okay.

A. Willert paper.

Q. Keep going.

A. And I believe that the language in the Willert paper

matches this.

Q. Okay. Does it stop there and just say it's mild?

A. Yes.

Q. Okay. Does the technical monograph stop there?

A. Yes.

Q. And what does the next paragraph concern?

A. It talks about concerns with potential biological

implications of metal degradation products.

Q. What are metal degradation products?

A. Ions.

Q. Does it note that they could corrode intracellularly?

A. Yes.

Q. Does it note about biological effects?

A. Yes.

Q. What does it say about toxicity?

A. "It was recognized that metal particles could cause a

macrophage-mediated inflammatory response where metal ions can

elicit an immune response with the production of various


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cytokines."

Q. Did Dr. Campbell's article say anything about cytokines,

if you recall?

Let me see if I can --

A. I'm sorry, I don't -- I need a reference.

Q. That's fair enough. I'll try to find it and come back to

it in a minute.

A. Thank you.

Q. Next paragraph.

Does it talk about toxicity?

A. Yes.

Q. And this last sentence, read that sentence for us,

please.

A. "There is some data suggesting increased metal levels in

serum and urine in patients with metal-on-metal hips, but the

clinical significance of these increased levels is unknown."

Q. Did -- is this something that was addressed when you

would do those presentations to sales force and surgeons?

A. Yes.

Q. Do you -- do you know whether that's accurate?

A. Yes.

Q. That sentence?

A. I believe that is accurate.

Q. Ma'am, let me hand you Dr. Campbell's article, which is

Defendant's Exhibit 5174. I think you had it earlier.


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A. Yes.

Q. Let's look real quick.

Again, this is page 205.

Are you with me?

A. Yes.

Q. What's it say about the histological reactions?

A. "The histological reaction to metal wear particles was

described as mild."

Q. And then what does it go on to say?

A. "And the predominant macrophage response was particles of

PMMA.

Q. What's PMMA?

A. Bone cement.

Q. Was histology discussed?

A. Yes.

Q. Up above the mild part?

A. "The periprosthetic histology and wear particle

morphology of the second generation metal-metal total hip

replacements were consistent with the low wear of these

bearings in vivo and were similar to those reported for first

generation metal-metal THRs."

Q. If we go to the next page, I'm looking for the mild part.

Here it is.

Read the part that Mr. Lanier took you to.

A. "Thus, despite the presence of potentially large numbers


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of nanometer-sized metal particles in the periprosthetic

tissues, the macrophage and giant cell response to them could

be described as mild."

Q. Okay. Now let's read the next sentence.

A. "However, immunohistochemical studies have indicated that

cobalt chrome particles can induce the release of potentially

osteolytic cytokines."

Q. Okay. And?

A. "And potentially adverse effects including

hypersensitivity and chromosomal damage have been reported in

the literature."

Q. Okay. And if we go back to the technical monograph for a

moment, does it again address cytokines?

A. Yes.

Q. At the bottom of the left column, ma'am.

A. I'm sorry, yes.

Q. The particles?

A. "While metals ions can elicit an immune response with the

production of various cytokines."

Q. Now, you did note hypersensitivity itself is not known to

be a cause of implant failure, right?

A. Yes.

Q. Why?

Why did you note that?

Or why did Dr. Chan note it and why did you talk about


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it?

A. He noted it because there was information in the

literature. A specific reference I'm aware of is in the CORR

1996 document that states to this effect.

Q. Is there a difference between an IDE study and a cleared

device?

A. Yes.

Q. Does that affect the warnings in your experience?

A. Yes.

Q. How?

MR. LANIER: Your Honor, I'm going to object to her

testifying unless she's proven up as an expert on the FDA. I

think we have one of those coming.

She said she was not in regulatory. She didn't interface

with the FDA. This is outside her area.

MR. QUATTLEBAUM: I'm not offering her as an expert,

Your Honor. I'm asking her about what her experience and her

level of experience is with it.

THE COURT: I'll let her answer that one question,

and then we'll see where she is.


BY MR. QUATTLEBAUM:

Q. Ma'am, go ahead.

A. In my experience specifically with the IDE study for the

one-piece metal-on-metal that there are -- because it's an


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investigational device, there is a different set of warnings

or a different level of warnings that would be approved by

the -- the FDA. The FDA mandates some of those. Versus for

an investigational device, you need to include a more broad

spectrum of any possible complication versus typical warnings

for devices that are things that are more known to be a risk.

MR. LANIER: Your Honor, I object to the answer as

nonresponsive. It went beyond the scope of what you allowed

her to answer and called for expert opinions in an area she

has no expertise.

THE COURT: Sustain the objection. The jury is

instructed to disregard the last answer.

Go ahead.

BY MR. QUATTLEBAUM:

Q. I want to talk to you about the Ultima and the Ultima TPS

stem.

A. Okay.

Q. Tell us about the Ultima and the Ultima TPS stem.

A. Ultima -- Ultima hip is the 28-millimeter metal-on-metal

device that was a predicate, as we discussed, to Ultamet.

The Ultima TPS stem was a highly polished cemented stem

that was only available outside of the United States.

Q. Was there a study in the U.K.?

A. There was a study in the U.K. on the Ultima

metal-on-metal hip. One of the stems that could be utilized


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with that product was the Ultima TPS stem.

Q. Was there an issue with the TPS stem?

A. We found that there was, yes, an issue with the

combination of those two products.

Q. And what was the issue?

A. The issue was that in -- in one center it was found that

there was a significant amount of corrosion at the TPS

polished stem interface. So the interface between the stem

and the bone cement, there was a significant amount of

corrosion noted in some cases.

Q. Was that issue studied?

A. It was studied.

Q. Did DePuy help fund the study?

A. Yes.

Q. And let me show you what we've identified as Defendant's

Exhibit -- I'm sorry, Plaintiff's Exhibit 178.

A. Thank you.

Q. What is that, ma'am?

A. This is a study, an investigation into the performance of

the Ultima TPS metal-on-metal hip replacement, July of 2008.

Q. So Mr. Lanier asked you earlier if the problem occurred

when there was a poly liner. Right?

A. Correct.

Q. Did the problem occurred when there was a poly liner?

A. Correct.


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Q. Did the problem occur when they didn't use a TPS stem,

when they used a different stem?

A. We did not see this problem with Ultamet metal-on-metal

with a different stem.

Q. Is the TPS stem sold in the U.S.?

A. It is not.

Q. Has it ever been?

A. No.

Q. So if you had the Ultima cup, the Ultima liner, a femoral

head and a stem other than the TPS, was there an issue?

A. We found very good results with that type of combination.

Q. And who is -- I think it's Bryant.

I'm trying to remember who wrote the -- who conducted the

study and published the paper.

Here. Let me hand you Defendant's Exhibit 5157.

What is that?

A. Thank you.

This is a publication by Michael Bryant

Q. Is --

A. I'm sorry. "Crevice Corrosion of Biomedical Alloys."

Q. Is it about that very issue with the TPS stem?

A. Yes, it is.

Q. And if you referred back to exhibit -- Plaintiff's

Exhibit 178 -- if we can go back there, is this part of that

investigation?


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A. Yes.

Q. And if you look at page -- down at the bottom it has 005.

A. Yes.

Q. What was the conclusion at the very bottom.

A. "These patients do not appear to be" -- Sorry.

"These problems do not appear to be related to the Ultima

metal-on-metal bearing itself."

Q. What is the bearing itself?

A. Bearing means the combination of the head and the metal

liner.

Q. What effect, if any, did that have on your comfort level

with regard to Ultamet?

A. I was comfortable relying on the clinical results of

Ultima with other femoral stems.

Q. You were asked about TrueGlide, remember?

A. Yes.

Q. And you were shown that brochure with TrueGlide on it?

A. Yes.

Q. Remember that?

What was your understanding regarding lubrication of hips

when you made presentations on that -- in that regard?

A. So my understanding is that throughout the hip cycle or

throughout a motion cycle that you will go between various

lubrication regimes within a single cycle.

So it is difficult to say does it have this without


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specifying more contextually the time period you're speaking

of.

Q. Are you familiar with a publication by Sontag?

A. Yes.

Q. Let me hand you what I've identified as 6031.

What was the topic of conversation in Sontag?

A. "Hard-on-hard Lubrication in the Artificial Hip Under

Dynamic Leading Conditions."

Q. And did Sontag model lubrication regimes?

A. He did.

Q. And without going into great detail, because I'm running

out of time, tell us what Sontag found, and it's on page 7 of

that article, ma'am.

A. So what you see here is an analysis that says which part

of the lubrication regime -- whether boundary, mixed or fluid

film lubrication -- you would see under various conditions --

walking, climbing stairs, descending stairs or the standard

iso protocol that you might see in a simulator.

Q. All right. Quickly looking at that design rationale

which Mr. Lanier showed you, Plaintiff's 43, if we look under

the issue of tribology, my question for you is: Did you ever

say -- did DePuy ever say that there was no friction?

A. No.

Q. Described less friction?

A. Less friction.


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Q. What about wear?

A. Producing wear.

Q. Did it describe improved resistance?

A. Improved resistance, yes.

Q. What did it say about wear on the next page?

A. Dramatically decreased wear.

Q. Okay. Did you -- did you ever claim that you had a

wear-free device?

A. No.

Q. If it had full fluid film lubrication all the time what

would that be?

A. If it had full fluid film lubrication all the time, there

would be no wear.

Q. Is there such a thing as a wear-free device?

A. Not for a total hip.

Q. When did the TrueGlide brand, or whatever you want to

call it, the TrueGlide technology -- when did those words get

used by DePuy?

A. I believe it was in the mid-to-late 2000s.

Q. Let me show you Plaintiff's Exhibit 174 that Mr. Lanier

talked to you about. This was where Paul Berman was

describing TrueGlide, I believe.

A. Yes.

Q. That's in 2007?

A. Yes.


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Q. Is that consistent with your understanding?

A. Yes.

Q. Of course that would be after 2004, '5 and '6?

A. Yes.

MR. QUATTLEBAUM: Your Honor, I'll save whatever

time I have left, which I think is about nine minutes, but I'm

not positive.

THE COURT: Y'all are doing so much better watching

the clock. I'm so proud of y'all.

MR. QUATTLEBAUM: Pass the witness, Your Honor.

MR. LANIER: Don't start my clock yet. I'm getting

warmed up.

THE COURT: I started it 30 minutes ago.

MR. QUATTLEBAUM: Judge, I don't want to be a

distraction, but I'm going to reorganize over here.

THE COURT: You're not a distraction. It's fine.

Mercy, the jury kind of knows all everywhere. It's fine.

MR. LANIER: They're picking up that you've been

cracking the whip at us.

THE COURT: Oh, no. Not me. I'm a sweetheart.

MR. LANIER: May it please the sweetheart.

THE COURT: She didn't come today.

(Laughter)

THE WITNESS: I'm not sure how to take that, Your

Honor.


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THE COURT: Oh, wow. I didn't mean you. No. No.

No, ma'am.

(Laughter)

MR. LANIER: All right. May it please the court.

THE COURT: Yes.

MR. LANIER: And go.

RECROSS EXAMINATION

BY MR. LANIER:

Q. Okay. Ma'am, by my count there's five areas I need to

talk to you about. All right?

I've got 24 minutes. I may even save one or two back, if

I can.

Let's start with TrueGlide where y'all left off. We'll

go backwards.

It's real clear what y'all were claiming to doctors. All

we have to do is look at the ads.

For example, 3728, one of the Coach K ads in the Journal

of Bone and Joint Surgery. We can look at the ad. This

doesn't have the three pictures. It's just got one.

TrueGlide technology, "Bearing surfaces are fully separated

and the load fully supported by the lubricating fluid."

That's the only thing y'all say in there, isn't it?

A. That's the only picture we have reflected in this ad.

Q. Yes, ma'am.

And you don't say anything about, well, that happens


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sometimes maybe on the right day for the right, precise moment

when your leg is swung back right here in a walking stage.

Doesn't say that, does it?

A. It does not say that.

Q. But the fact that there is this mixed regime where

sometimes the load is supported and sometimes it's not, we

covered that earlier. That's called mixed lubrication,

partially supported, some interaction. Mixed, isn't it?

A. Well, I think what we find is that --



BY MR. LANIER:

Q. It's called mixed lubrication, where it's partially

supported with some interaction, correct?

A. At a point in time, yes.

Q. All right. Now, in that regard, ma'am, the company tried

to use the same theory and the company had to run its ad on

ceramic-on-metal past the FDA. Did you know that?

A. Yes.

Q. The company never had to run the metal-on-metal ad past

the FDA. FDA never got to see metal-on-metal. But the FDA

got to see ceramic-on-metal, correct?

A. They saw this, yes.

Q. And y'all made the same claim in the ceramic-on-metal.

You made the claim of fluid film -- full fluid film


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lubrication, didn't you?

Do you remember?

A. I -- I'm not actually familiar with this specific -- I

don't know if you can refer me to a page, please.

Q. Do you recall making the claim to the FDA of full fluid

film lubrication and the FDA telling you you're not allowed to

make that claim? No such thing?

A. So I did not personally make the claim. I'm aware of the

topic.

Q. When y'all tried to tell the FDA you were going to make

the claim of TrueGlide and fluid film lubrication -- I've

handed you Plaintiff's 613 -- the FDA wrote back and the FDA

said no.

Here was your claim, "Only Pinnacle hips feature

TrueGlide technology, allowing the body to create a thin film

of lubrication."

"To establish true fluid film lubrication between the

surfaces."

Do you see that?

A. I see that.

Q. And the FDA said no?

A. No for this bearing combination, yes.

Q. Well, no. Period. You can't make that claim based upon

your theoretical calculation. "Claims cannot be made based

on" that.


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Do you see that?

A. I think my understanding is that only theoretical

calculations --



THE WITNESS: I see that.

BY MR. LANIER:

Q. And if you try to make the claim you just made to the

jury, "If the fluid film height is improved over

metal-on-metal, fluid film generation still will only be 1 to

5 percent of a step," one step.

That's the gait cycle, right?

Swing phase -- well, lift phase, swing phase, plant

phase.

A. Yes.

Q. That's the gait cycle, right?

A. Yes.

Q. So the FDA said if you're right that you have some fluid

film lubrication, at best it's over 1 to 5 percent of a single

step as long as you continue to move, because once you stop

you lose it.

So 95 percent of the time it's operating under mixed

lubrication. And the FDA won't allow you to say that. Y'all

were --

A. In this combination, that's correct.


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Q. Right. Because this is the ceramic-on-metal, but the FDA

said even -- that they -- y'all were claiming that this was

improved over metal-on-metal, that this was actually better in

ceramic than it was in metal.

Do you see that?

A. I see what it says.

Q. So y'all told the FDA, please, please, please, we know

it's not there on metal-on-metal, but this is improved, can we

say it's full fluid film lubrication.

The FDA says there's no way you can say that.

Then your company is stuck. Because you got all these

ads about metal-on-metal claiming it, and you've been told by

the FDA you're not allowed to claim it on the ceramic. So all

of the thinkers back at the company start saying, what are we

going to do? Should we pull it down?

A. I was not part of any of these conversations. I can't

speak to what was said.

Q. Well, they're right here. They're on the front of this.

Johnson & Johnson is a part of it.

"Marlene and Nancy --" explain to us -- that's Marlene,

the Johnson & Johnson lawyer, right?

A. Johnson & Johnson Services, yes.

Q. Well, no, Johnson & Johnson period on a bunch of those

emails, not just services. Right?

A. Services is part of the --


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Q. Momma company.

"Marlene and Nancy explained to us what was happening

with the FDA and TrueGlide. We removed the TrueGlide section

from our new patient education brochure."

"We're now running into several brochures in other

materials --" metal-on-metal "-- that contain TrueGlide.

What's the protocol for how we handle the preexisting material

while we're waiting for the FDA to approve this new device?"

Do you remember that quandary?

A. I was not involved in that.

Q. You don't know about the company deciding just run with

it, the FDA will never know?

A. No.

Q. All right. Next subject. Ultima.

Ma'am, the point of the Ultima -- I told the jury with

you that it seemed to be the stem and the bearing in tandem,

right?

A. Yes.

Q. But the point of this: It was not found with

metal-on-poly, but this shows wear, doesn't it?

The wear was important from the metal-on-metal.

A. My recollection of the conclusion was that the bearing --

the wear at the bearing surface was extremely low.




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BY MR. LANIER:

Q. Ma'am, you got to answer my questions. I'm short in

time.

The conclusion was that the metal-on-metal wear between

the bearings and the metal off of the stem in tandem were the

problem, correct?

A. I'm -- I'm -- I'm not sure of the exact language.

Q. All right. Regardless, here's the key. This is what I

was showing.

This showed that the metal debris hurts. It doesn't

matter if the metal debris is coming off of the stem and the

ball or the ball and the liner, or some combination thereof.

Y'all knew as of March 2004, before any of these plaintiffs

got their implants, y'all knew the metal debris caused

problems, didn't you?

A. No.

Q. Ma'am, it's in the exhibit. It's in Plaintiff's Exhibit

178, the investigation y'all did.

"This began in March 2004 --"

A. Yes.

Q. "-- with the recommendation to only use the implant in

patients expecting it."

"By August 2004 it was clear the problem was greater than

originally thought. The implant's use was discontinued."

What's the problem you say?


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Included is this, "The metal ions released have killed

the bone, they have killed the soft tissues around the hip,

they have resulted in pseudotumors, they have resulted in the

tendons ripping away and they have resulted in bone death."

Everything the plaintiffs in this case y'all knew were

coming from metal ions as of March 2004, didn't you?

MR. QUATTLEBAUM: Object to the compound question.


THE WITNESS: You've read this correctly.

BY MR. LANIER:

Q. All right. That's the point of the Ultima, ma'am.

The key is it's metal debris causing it. Whatever piece

it's coming off of, metal ions will rip these people up. And

y'all knew it, didn't you?

A. No.

Q. And you're still parading around, next subject, the

technical monograph, in spite of what you know in Ultima. And

you've got this bad warnings in the back. Not one whisper of

what you've learned about metal ions from Ultima.

You're still saying the full biological response is

unknown.

Do you see that?

A. I see that.

Q. You're not telling people, well, we've been investigating

a problem overseas for some time and the metal ions released


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killed the bone; killed the soft tissue; you've got a fluid

collection, tendon rupture, bone death.

Naw. Y'all are telling all the doctors, hey, it's

unknown. Right?

A. My understanding is that this comment is based on a --



BY MR. LANIER:

Q. That's what you're telling the doctors, the full

biological response is unknown?

A. That's what this says.

Q. And then you lapse into this paragraph about how it looks

like it's better than metal-on-poly, though, because it's

mild, and you leave out the "however."

A. No.

Q. Well, you say no because of the other article. You're

saying we're actually not quoting the article we say we're

quoting. We're quoting the Willert article that's -- this is

like a chain reaction. We're quoting Pat Campbell -- or not

quoting Pat Campbell, we just listed her so people would go to

her and find out she's quoting someone else and then they

would go to that other article and they would read it and they

would understand.

That's your argument, isn't it?

A. Yes.


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Q. Here's the Willert article. Y'all didn't show this to

the jury.

Where does Willert say it's mild?

It's demonstrative 338.

A. They say cellular reaction to the medical -- metal

particles was regarded as mild. It's in the abstract.

Q. Yes. On the abstract is the language you want to use?

A. I believe that's the correct place.

Q. All right. Now, where in the abstract?

I'm going to put it up here for the jury.

A. If you go just --

Q. Right here, "The cellular reaction"?

A. Yes.

Q. ". . . the metal wear particles was regarded as mild."

That's it?

That's what we're supposed to believe y'all are quoting

here?

Where it says the macrophage and giant cell response to

particles was described as mild?

Macrophage and giant cell is not here in Willert. It's

only found on page 206 of the article y'all actually cited,

right in front of that word, "however."


A. I see that.

Q. And even if -- even if it said it exactly the way you got


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it, you still owe the -- the users of this the "however,"

because surely y'all didn't quit reading her article on page

205 and just ignore it from there on out, did you?

A. No. There are no --

Q. All right.

A. -- references.

Q. Next subject.

Now we got handed finally at the end of the trial -- near

the end of the trial, the end of your testimony, a stack of

things where y'all issued the warnings, starting with this

handout brochure and then another big thick one and then a

small one.

Do you remember these?

A. Yes.

Q. You just testified about them.

A. Yes.

Q. All right. Let's be real honest with the jury. There's

a lot to be gained by doing something more than reading a

table of contents, isn't there?

These are sales efforts. This isn't warnings. These are

anti-warnings, aren't they?

A. No.

Q. Yeah. Y'all are telling people don't worry about what

you're hearing, everything is going to be fine.

A. No.


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Q. Look at the first article.

The first article. Not the index, not the title. The

first line of the first article, Thomas Schmalzried.

By the way, doesn't say, hey, I'm going to make 25

million bucks off of this, buy some more.

No disclosure here, is there?

No disclosure, is there?

A. I don't see one.

Q. Yeah.

A. I don't think I have that in front of me anymore, sir.

Q. All right. I don't know how -- oh, that's right. He

took it away from you. I'm sorry, he only gave me one copy,

so I have to read it together.

This is the very first thing that says -- this is one of

these things where supposedly y'all are warning people, "The

choice of bearing surface for total hip arthroplasty involves

an analysis of relative risks and benefits.

"The benefits of metal-on-metal include more than 30

years of clinical experience, consistently low wear rates,

wear occurrence of osteolysis, no reports of gross material

failure, runaway wear."

He must not have seen y'all's simulator studies, huh?

"Favors large diameters. For these reasons

metal-on-metal bearings, especially those with larger

diameters provide a very high-level of performance with


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advantages over other options especially for younger and

active patients."

That's not a warning, is it?

A. That specific language is not.

Q. Look at the next one.

"In view of the problems associated with polyethylene

wear particles, metal-on-metal implants may represent a more

favorable bearing combination because of the potential for

reductions in wear."


A. That specific language is not.

Q. Look at the next one.

"Autopsy analysis after metal-on-metal hips --" by

another doctor who is going to make the billions of dollars

off of this without telling anyone.

"Although this elderly female is not representative of

the younger more active patients that currently are getting

metal-on-metal, there are some important aspects in this. The

main concerns with metal-on-metal bearings are local --"

THE COURT: I think you said billions.

MR. LANIER: Millions.

THE COURT: You said billions --

MR. LANIER: Okay.

THE COURT: -- or it sounded like that.

MR. LANIER: I meant millions. I apologize, Your


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Honor.

THE COURT: Okay.

MR. LANIER: Thank you for fixing it.

"Metal-on-metal bearings are the local and systemic

effects of long-term exposure to cobalt or chromium ions.

Despite the potentially higher metal ion release from this

patient's femoral components there was hardly any evidence of

metallic debris in the nodes or organs. There was no evidence

of abnormal histology. These findings combined with the

polished surfaces showing very low wear are encouraging and

support the continued use of metal-on-metal bearings."

Do you see that?

A. I see that.

Q. This isn't a warning, this is propaganda --

A. No.

Q. -- isn't it?

A. No.

Q. This doesn't say, hey, we just finished an analysis over

in Australia and we figured out that these metal ions are

causing all of the problems everybody worries about, does it?

Doesn't say it, does it?

A. It does not say that.

Q. Next, Defendant's 992, advancing high stability and low

wear.

Look at what it says. Dr. Schmalzried again, 24 million


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dollar man.

"Section 1" -- section 1 is not warnings. It's benefits

of metal-on-metal, isn't it?


Q. "The intent of this is to review the benefits of

metal-on-metal. It's important to remember why the market

moved to swiftly to metal-on-metal."

Section 2, considerations.

"Section two addresses considerations today's surgeons

should understand."

Two subsections. Adverse response. Now if you just read

the title it looks like this is a warning. But read the

substance.

"This section is intended to bring background and

perspective to the topic of adverse tissue response and

hypersensitivity. The data in this section reinforces the

relatively low incidence of metal reactivity, .24 percent,

and notes the positive benefit-to-risk ratio."

That's not warning. That's an anti-warning, isn't it?

A. I think it's meant to provide data.



BY MR. LANIER:

Q. Answer, please.

A. I'm not comfortable calling it an anti-warning.


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Q. Look at section 3, Alternatives. Because y'all did sell

more than metal-on-metal.

"Metal-on-metal is a great option for today's active

patients. However, it is not the only option." So here are

some alternates if you still don't want to use it.


A. No.

Q. Okay. Next. The third one that we just got handed.

You can tell by looking, "The importance of correct

positioning."

This is the one that had the pictures of edge-loading and

poly breaking and all the rest.

Tell the jury what that device is.

A. That's ASR resurfacing.

Q. Excuse me. That's an ASR?

A. Well, I think -- I'm not sure what that is.

Q. Yes, it's ASR. Not resurfacing. It's the ASR XL.

A. XL.

Q. That's what y'all recalled.

A. It was recalled.

Q. This isn't even Pinnacle metal-on-metal, is it?

A. No, it is not.

Q. Next subject, final subject. Testing and clearance.

The point of the matter is, ma'am, with all of your

comments now about, oh, the testing showed this or that, you


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didn't tell the FDA the reality, did you?

A. I don't agree.

Q. Well, here's the right chart. Defendant's Exhibit 2053,

page 125.

And the right chart, ma'am, has a date on it of November

13th. Y'all made the right chart.

A. Yes.

Q. But it's not what you gave the FDA.

A. Correct.

Q. The right chart shows 80 to 120. You gave the FDA 40 to

80.

A. Yes.

Q. Correct?

A. Yes.

Q. And all of these documents that you were walked through

by Mr. Quattlebaum just now, these are all the same documents

I walked through with you yesterday. Aren't they?

A. Yes. Yes.

Q. Yeah. This same articular surface, that's the same line

you and I discussed yesterday. This isn't something new in

the document. You're just saying the same thing you did

yesterday, aren't you?

A. I think I'm finishing what I tried to say yesterday.

Q. Ma'am, it's the same thing here. We even determined that

this was false because you had not done any tests with results


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on file on the Ultamet itself. Y'all were extrapolating your

results from a different device, right?

A. Our testing was on a different device, yes.

Q. And then you were asked, well, why would you have made

this change if you were trying to hide it in these drawings

after drawings after drawings. Remember?

A. Yes.

Q. I went over those with you yesterday, didn't I?

A. Yes.

Q. You have to make those changes. Because if you don't

make those changes, then anybody who measures the device is

able to say the device is, quote, out of spec. And there's

lots of bad stuff that happens if the device is out of spec,

correct?

A. I'm not sure what you mean.

Q. Oh, like FDA does -- comes down, inspects all your

manufacturing, inspects everything you've done. Any time you

get a head back that's out of spec or a liner out of spec, you

get those over and over. You're in trouble.

So you told the FDA what the right specs are for the

liner. What you didn't tell them is that you have changed the

clearance, did you?

A. Clearance is not listed on the engineering drawing, no.

Q. Exactly.

MR. LANIER: Thank you, Your Honor. I'll save my


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last minutes.

THE COURT: Mr. Quattlebaum, you got anything else?

MR. QUATTLEBAUM: Yes, sir.

THE COURT: Okay.

REDIRECT EXAMINATION

BY MR. QUATTLEBAUM:

Q. Ultima, Ms. Turner?

A. Yes.

Q. I handed you just a minute ago Plaintiff's Exhibit 178.

Right?

A. Okay.

Q. Turn to page -- it has 32 down at the bottom.

Last metal hip.

A. I'm sorry. I've got a big pile here. I think I found

it.

Q. Page 32, comments.

Again, this is part of the study of the Ultima TPS issue.

A. Got it.

Q. Read for us what it says where it starts, "The reason."

A. "The reason for the failure was excessive corrosion from

the cobalt chromium femoral stem causing metal ionosis from 39

percent of the histological specimens showed -- only 39

percent of the histological specimens showed obvious metal

fragments."

Q. Keep going.


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A. "The bearing surfaces were pristine with the corrosion

confined to where the femoral stem is in direct contact with

the acrylic cement."

Q. Tell us what that last sentence means.

A. That the source of the ions was not the bearing surface.

Q. It was where the stem --



BY MR. QUATTLEBAUM:

Q. What -- what -- what happened between the stem and the

cement?

A. The corrosion was at the interface between the femoral

stem and the cement.

Q. Read the next sentence.

A. "The corrosion led to a massive metal ionosis which

caused necrosis in the periprosthetic tissues."

Q. What does that mean?

A. Death around the tissue around the implant.

Q. Where did -- what was the source of the ions?

A. The source was the corrosion -- corrosion of the femoral

stem.

Q. Again, tell us about that stem and whether it was sold in

the U.S.

A. That stem was not ever sold in the United States.

Q. Testing. Did you test the Ultamet 36-millimeter device?


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A. Yes.

Q. Mr. Lanier showed you something earlier regarding testing

of the 36-millimeter device. Is that right?

A. Yes.

Q. Was that a test report?

A. Yes -- No.

Q. What was it?

A. An email, one graph, that was attached to an email.

Q. Have you done tests of the 36-millimeter device?

A. Yes.

Q. Head-to-head with what?

A. Head-to-head with a variety of things, head-to-head with

28, head-to-head with the 36 device, head-to-head with Sulzer,

head-to-head with Ultima, head-to-head with 28 Ultamet.

Q. How been ASR?

A. ASR, yes.

Q. When I say 36 millimeter device, what are we talking

about?

A. The Ultamet.

Q. The Ultamet?

A. Yes.

Q. With the opened up diametrical clearance?

A. Yes.

Q. How did it do?

A. It did well.


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Q. What do you mean well?

A. Most tests head-to-head for 36 Ultamet versus ASR showed

lower wear with the Ultamet device.

Q. Now, Mr. Lanier showed you a test where there was a graph

that showed a line going up for Ultamet?

A. Yes.

Q. What's the significance of that graph?

I think you were trying to explain that earlier.

A. Right. I think what I was trying to explain earlier was

he alluded to one particular ASR component versus one

particular Pinnacle component and said -- or ASR, I'm sorry --

see that this one wore less than that one, and with a wear

test all of your components are going to have slightly lower

wear.

I've never seen a wear test where all simulator stations

and all the data lines up exactly on top of each other. And

so what is done is you run typically multiple specimens --

unless sometimes in this -- in the case of the control only

one -- multiple specimens and then you report your results per

specimen, not individual components.

Q. Okay. So I found it.

There it is.

A. Yes.

Q. Is that -- does that surprise you?

A. What -- to be honest what surprises me most on this is


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the overall low volumetric wear.

If you look at the scale on the left-hand side, we're

looking at 4 plus million cycles, and none of the specimens

have exceeded two cubic millimeters. That's extremely low.

So when you're looking at such a narrow window -- what

looks really big here is really not that big of a change on a

scale of wear.

Q. So let me make sure I -- I got that.

We heard earlier --

MR. LANIER: I'm going to object to leading --

THE COURT: Sustained

MR. LANIER: -- making sure he got it.


BY MR. QUATTLEBAUM:

Q. So how many cubic millimeters of wear are expected in

vivo per year?

A. Depending on the bearing surface --

Q. Well, metal-on-metal.

A. -- I believe what Pat Campbell had indicated her

definition for low wear would be 1 to 3 cubic millimeters per

year.

Q. 1 to 3?

A. Yes. I believe that's --

Q. Per year?

A. Per year.


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Q. What are the anticipated cycles per year in vivo?

A. One to two million.

Q. This ran how many cycles?

A. We can see components out to 5 million cycles.

Q. So at one year, if it were two, what would be represented

on this graph?

Would it be -- would that be it?

A. Yes. Yes.

Q. And this represented -- This was out to here

(indicating), was how many cycles?

A. 5 million.

Q. Which would be the equivalent of what?

A. Two and a half.

Q. Two and a half years?

A. Two and a half years.

Q. Okay. So that could be as high as seven and a half?

A. Yes.

Q. And it only got to what?

A. .8.

Q. And then that one got to what?

A. 1.8.

Q. So you said what was most remarkable to you about this

graph was what?

A. The overall low wear for all components.

MR. QUATTLEBAUM: Pass the witness, Your Honor.


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THE COURT: Anything else?

MR. LANIER: Yes, Your Honor.

RECROSS EXAMINATION

BY MR. LANIER:

Q. Ma'am, y'all have just mixed apples and oranges to quote

you from yesterday, didn't you?

A. I'm not sure. Help me with it.

Q. What you've done is taken Pat's wear figures for wear in

a human and compared them to wearing in a simulator machine

which is by y'all's own acceptance best-case scenario, right?

A. Yes.

Q. Okay. Next subject.

Did y'all look at this before you read it to the jury?

And by "this" I'm talking about the conclusions that

y'all knew and what you found as of March 2004.

I mean, you understand the section y'all read is the

section I didn't know I had time to read. I wanted it read.

This is March 2004.

You say you didn't sell this metal stem in the U.S.,

right?

A. Correct.

Q. But you sold one made of the same substance as a metal

stem with Pinnacle, right?

A. How do you mean?

Q. I mean it's a different shape. It's got some different


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taper issues and things like that, but the metal is the same.

A. The raw material?

Q. Yes.

A. Yes. If the raw material was a cobalt chrome.

Q. Exactly.

Then the corrosion from this same material. Massive

metal ionosis caused necrosis, massive fluid collections under

pressure, caused pain, the pain was temporarily relieved when

they took the fluid. No obvious abnormalities on the x-rays.

However, it did lead to fractures and failure of the

mechanism. There was dead bone. These are all the things you

knew back on Johnson and Johnson's work on this?

A. That's correct.

MR. LANIER: Pass the witness.

MR. QUATTLEBAUM: One question.

THE COURT: I'm going to hold it to you. I've never

had a lawyer ask one question, not in 35 years.

MR. QUATTLEBAUM: About to set a record.

BY MR. QUATTLEBAUM:

Q. Did you sell a highly polished cobalt chrome taper in the

United States?

A. No.

THE COURT: Come on, ask one more.

MR. QUATTLEBAUM: I want to stand on my record.

(Laughter)


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THE COURT: Okay. We'll take a break.

15 minutes. Don't talk about the case.

(Proceedings resumed at 3:25.)


MR. POWELL: The defense calls Mr. Jim Lancaster by

video.

THE COURT: Okay.

(Video playing.)

"Q. Your Honor, members of the jury, I'd like to introduce

myself. My name is Tom Shea and I'm here on behalf of DePuy.

Mr. Lancaster, could you reintroduce yourself?

A. My name is Jim Lancaster.

Q. Okay. And, sir, who do you work for?

A. I work for Biomet Orthopedics right now.

Q. And how long have you worked for Biomet?

A. About six and a half years.

Q. And before that who did you work for?

A. I worked for DePuy Orthopaedics.

Q. And for about how many years did you work for DePuy?

A. I worked from about -- from 1992 to 2007, so . . .

Q. Let's take a step back in time, shall we?

Where'd you grow up?

A. I grew up in Warsaw, Indiana.

Q. And where is Warsaw?

A. It's kind of between Fort Wayne and South Bend.


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Q. And are you a married man?

A. I am.

Q. And do you have any kids?

A. I have three daughters.

Q. And why don't you explain to the court and the jury your

educational background, please.

A. My -- I graduated from Warsaw High School. I did my

undergraduate studies at Valparaiso University. I have a

bachelor's degree in mechanical engineering from Valparaiso

University, and then I did my graduate research -- my graduate

work was done at Leeds University in Leeds, England.

Q. Now, did you participate in the varsity football team

while you were at Valparaiso?

A. I did. I played all four years and was captain my last

two years.

Q. Very good.

Did you also work during the time you were getting your

undergraduate degree at Valparaiso?

A. Yes, I did.

Q. And where did you work?

A. I worked for DePuy.

Q. And what did you do for DePuy?

A. I was an engineering intern working in the product

development group.

Q. And for about what period of time did you work for DePuy


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as an intern?

A. I started working for DePuy as an intern the summer of

1988, up until I graduated in December of 1991.

Q. And what types of projects did you work on as an intern?

A. I did a lot of product development projects looking at --

all of my time was in the hip development group, but I looked

at a lot of surgeon -- what we called surgeon-specific

instrument projects. I worked on some acetabular cup

projects, you know, in general worked on hip projects.

Q. Okay. What is an acetabular cup?

A. A acetabular cup is the socket part of the hip joint, the

ball and socket joint. An acetabular cup is the socket part

of that.

Q. Very good.

Now, after you graduated with your bachelor's degree in

mechanical engineering, who did you go to work for?

A. I -- I started full-time for DePuy in January of 1992.

Q. Why did you choose DePuy?

A. I had a very positive experience during my engineering

intern time. I liked the fact that I could as an engineer,

you know, work in a -- work in a trade like orthopedics where

you're helping people as an engineer.

Q. Now, how long did you work in Warsaw at DePuy the first

time you were employed there?

A. I started full-time in January of 1992, and I worked


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there until August of 1993.

Q. And what was your official title?

A. Product development engineer.

Q. And what type of projects did you work during that time

frame?

A. I -- I picked up a lot of the projects on the acetabular

cup side of the business, the socket part of the hip. There

was a Duraloc project that I had been involved with. I worked

a lot of -- I spent a lot of time on that. I did spend a lot

of time in this one program we called surgeon service, which

was basically making instruments for surgeons for their

specific needs.

Q. Now, you mentioned the word Duraloc.

What is the Duraloc cup system?

A. The Duraloc cup system was a system that DePuy had

developed in the late '80s, early '90s time frame that was,

again, a metal shell. It had -- it's a polyethylene insert as

the bearing.

Q. And what was the material of the shell?

A. It was a titanium alloy.

Q. Now, at some point did you decide that you wanted to go

back to graduate school?

A. Yes.

Q. And what made you make that decision?

A. When I was -- when I was an engineering intern, I


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realized that -- because Valparaiso was a relatively small

school, I didn't have -- really have access to do research,

and I -- and my big motivation professionally for wanting to

go and do graduate work was to be able to do research projects

and understand how research worked.

Q. And I think you mentioned this earlier, but where did you

go for your graduate work?

A. To the University of Leeds in Leeds, England, which is in

the north part of England.

Q. And what was the focus of your study?

A. The focus of my study was tribology.

Q. And what is tribology?

A. Tribology is defined as the -- it's the study of wear,

friction, and lubrication.

Q. And, now, this was a master's program; is that correct?

A. It was a master's of mechanical engineering, yes.

Q. And did it have two phases to it?

A. Yes, it did.

Q. What were those phases?

A. There was a lecture part of the course and then a

research component of the -- of the course.

Q. Okay. And did you have a supervisor or someone who

mentored you during the time that you were at Leeds

University?

A. I did.


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Q. And who was that?

A. My academic supervisor was Professor John Fisher.

Q. And if you could explain to the court and jury who is

John Fisher?

A. When I -- John Fisher is the chair of the department at

the University of Leeds, and when I got -- the year I got

there he had just come in as the new chair of the

department.

Q. Now, did you have any unofficial mentors or supervisors

as well?

A. Yeah. I had -- I had an emeritus professor, which was

professor Duncan Dowson. As he had just left the chair

position and Professor Fisher had just come in, Professor

Dowson was also one of my supervisors for my graduate studies.

Q. What type of background did Dr. Dowson have?

A. Dr. -- Professor Dowson is pretty well-known within

the -- I'd say the engineering community as somebody who

really kind of fathered the -- the idea of tribology.

Q. And you said that Dr. Fisher was the -- for lack of

better words, the person who trained under Dr. Dowson and then

became head of the department; is that -- is that a fair

description?

A. Actually, Professor Fisher did a lot of his prior studies

at Strathclyde in Scotland and then was on faculty for several

years before Professor Dowson decided to retire.


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Q. Did he train under Dr. Dowson at University of Leeds?

A. I believe so, yes.

Q. Now, during this time when you were getting your master's

did you also work?

A. I did.

Q. And where did you work?

A. I worked for DePuy International.

Q. And where is that?

A. That was based on in Leeds, England, as well.

Q. And what did you do for Depuy International?

A. I worked in the hip development group and specifically

worked on, again, some of the cup projects, some of the

acetabular cup projects. I also did some cemented stem

projects and did some general development work within the hip

development team.

Q. So approximately what year did you finish your master's

degree?

A. Actually, September of 1995 is when my master's degree

was completed.

Q. Okay. And what did you do for work at that point?

A. After I had finished my master's agree, I had stayed on

full-time. I had secured a work permit and stayed on

full-time at Depuy International.

Q. And how long did you remain at Depuy International?

A. For about -- almost another year.


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Q. At some point did you then return to the United States?

A. Yes.

Q. And approximately when did you return to the United

States?

A. I moved back to the U.S. in July of 1996.

Q. And who did you work for at that point?

A. I came back and worked for DePuy Orthopaedics.

Q. And what was your role when you came back to DePuy

Orthopaedics in Warsaw, Indiana?

A. I came back as a product development engineer in the hip

group.

Q. And what product or projects did you begin working on at

that point?

A. I came back specifically and took over some acetabular

cup projects and some projects that were specifically looking

at alternative bearing technologies.

Q. And is there a name for that particular project that you

just mentioned about alternative bearings?

A. It -- we -- well, we called it -- there was AB project.

Sometimes it was referred to as Aunt Bea project, had many

different names.

Q. Now, was there someone who was running that project

before you returned to Warsaw?

A. There was.

Q. Who was that?


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A. Frank Bono had the project before I came back.

Q. And do you know about how long the project had been going

prior to your arrival?

A. Actually, I think the project may have even started as I

was leaving for the -- for the U.K., so I would say it was

going for several years prior to I -- prior to me coming back

and picking it up.

Q. Now, prior to assuming your role as leader of the

alternate bearing project, did you have discussions with Frank

Bono?

A. I had discussions with Frank Bono. Once I knew I was

coming back to the U.S. and knew I would be picking up this

project, I had several conversations with Frank, yes.

Q. Did you discuss where he was in the project and his team

was on the project?

A. Yes, I did.

Q. Did you have an opportunity to review any of the

materials that the alternate bearing project team had

formulated at that point?

A. Yes, I did.

Q. And did you have an opportunity to review any of the

literature that was in place at the time in 1996 when you

returned on alternate bearings?

A. Yes, I did.

Q. Okay. And did you continue to review alternate bearing


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literature even beyond 1996?

A. Yes, I did.

Q. Now, there's a reference to something that's called the

future cup system, and I just want to make sure we understand

what that is at this point.

What was the future cup system as of 1996?

A. The future cup system was an idea that we could create

one acetabular shell, one socket, if you will, that would

allow multiple different bearings to be used by the surgeon

based on their -- their choices.

Q. So by the time you assumed the lead role for alternate

bearing and future cup, about how many years experience did

you have in acetabular cup system work?

A. Oh, I would say I probably had six, seven years'

experience.

Q. Now, ultimately did the alternate bearing project result

in a product that was implanted in a clinical trial and in

people?

A. Yes, it did.

Q. And what was that called?

A. That was a one-piece cup project.

Q. Now, we'll turn back to that in a few minutes. I'd like

to get some more information with regard to the alternate

bearing projects. So let's start there.

At the time that you came back to the United States, what


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was your understanding as to why the company was doing an

alternate bearing project?

A. My understanding was that there was -- one of the big

clinical concerns at the time was something called osteolysis,

and typically -- well, it's polyethylene-induced osteolysis.

So the idea with trying to understand how alternative bearings

perform clinically was to -- was to look at a way to design a

system where you could eliminate polyethylene as a bearing

option.

Q. Now, what is polyethylene?

A. Polyethylene is basically plastic that's used in a -- in

a hip construct, hip joint.

Q. What is a bearing for purposes of a hip construct?

A. So if you think about the joint being a ball and socket,

there's a ball that goes on the -- you know, the -- your leg

part, the femur part, the socket is in your -- in your pelvis,

and the bearing is the part that kind of goes in between the

two. It's -- it's where the -- the head, the ball that's on

the -- the end of the stem rubs against.

Q. Now, where does the stem fit into this?

A. The stem goes inside the patient's femur, inside their --

their thigh bone.

Q. And where does the ball sit?

A. The ball sits on the end of the stem.

Q. Was dislocation also a challenge for surgeons at the time


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you came back?

A. Absolutely. Dislocation still was and still continues to

be a -- a real clinical challenge for surgeons to overcome.

Q. And were surgeons seeking options other than

polyethylene?

A. They were, yes.

Q. Now, at the time you came back in 1996, was research

underway on something called cross-linked polyethylene?

A. Yes, there was.

Q. Now, was there any indication at the time you came back

that cross-linked polyethylene would be a complete resolution

of issues of dislocation osteolysis?

A. No. At the time I came back, cross-linked technology --

or cross-linked -- the technology to cross-link polyethylene

was for the most part still something being done in a

laboratory environment.

Q. Is cross-linked polyethylene's research still undergoing

research today?

A. Yes.

Q. Are companies, from your understanding, still trying to

find ways to make cross-linked polyethylenes?

A. Yes.

Q. Now, we've heard words in -- in this case such as

metal-on-metal. When we refer to metal-on-metal, what does

that refer to from your understanding?


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A. It refers to the type of bearing, type of bearing between

the -- the -- the ball and socket.

Q. From your understanding, when were the first

metal-on-metal hip products introduced for clinical use?

A. I would estimate sometime in the -- probably the

mid-'60s.

Q. And did metal-on-metal products generally allow for the

use of larger heads than polyethylene?

A. Yes.

Q. And why is that?

A. Because the idea of how the two surfaces interact

together, it allows you to use bigger diameters, bigger sizes.

And you don't -- also, you don't have this piece of plastic in

between the two that you have to worry about how thick it is.

Q. Now, is -- is a larger head generally beneficial?

A. A larger -- a larger size femoral head offers you better

joint stability.

Q. And what does that mean, sir?

A. It means that when you go about your normal daily

routine, your hip -- the ball stays in the socket and

doesn't -- doesn't come out.

Q. Now, did metal-on-metal technology allow for bigger heads

whereas bigger heads with polyethylene would be a problem?

A. Yes at the time one of the -- again, one of the

challenges with polyethylene-induced osteolysis was that if


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you went to a larger diameter -- a larger size head, your

poly -- and based on the size of the socket for that patient,

oftentimes you would get relatively thin polyethylenes, and at

the time, you know, one of the real clinical concerns were

wear of polyethylene liners, fracture of polyethylene liners.

So how thin you could go was a real -- was a real challenge.

Q. Now, did larger heads with polyethylene have the opposite

effect of larger heads with metal?

A. From a wear standpoint, yes.

Q. Now, you mentioned osteolysis a couple of times. Please

explain what osteolysis is.

A. Osteolysis is effectively a -- the body's response to

dealing with, you know, debris or -- or foreign bodies inside

the body.

So, for instance, if I had a polyethylene has a bearing

and -- and I generated polyethylene wear or wear debris as I

walked in the course of my daily routine, those wear

particles -- the body would see those and they would try to

deal with those and basically get them outside of the body,

and it's -- so it's a biological response to debris.

Q. Particularly polyethylene debris?

A. Yes.

Q. Now, did some of the earlier generations of

metal-on-metal products have some manufacturing challenges?

A. Yes, they did.


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Q. And did they have some tolerancing challenges?

A. Yes, they did.

Q. Now, what is tolerancing?

A. Tolerancing is basically how you size the two components.

So, for instance, you would tolerance the head compared to the

cup to make sure that the head wasn't bigger than the cup so

they always fit together.

Q. Now, from your understanding, did any of the challenges

that faced the earlier generation metal-on-metal products

relate to the bearing surface themselves?

A. I would say most of the challenges related to the

tolerancing, the sizing, and not necessarily the -- the

bearing surface, so to speak.

Q. From your understanding -- when I say first generation,

I'm talking from the 1960's through roughly the 1980s. Do you

know what the bearing surfaces of those metal-on-metal

products were primarily made of?

A. They were typically made of cobalt chrome.

Q. And has cobalt chrome been used in other orthopedic

applications, from your understanding --

A. Yes.

Q. -- beyond bearings?

A. Yes.

Q. About how long?

A. I would estimate probably from the mid -- mid-'60s time


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frame.

Q. Now, did some of the earlier generation metal-on-metal

products have good clinical success from your viewpoint?

A. Yeah. There were -- there were designs out there that

I've -- I've seen -- I've seen literature that's followed

long-term survivorship, 30-year survivorship. I've actually

been in cases where I've seen some of those 30-plus year hips

revised for -- for different reasons. So that they've --

they've performed well in some cases, yes.

Q. Which particular products are you -- are you thinking of

when you think of those that did well clinically?

A. I think McKee-Farrar is probably the one that comes to

mind most as a -- as a -- as one of the systems that had wider

use and did well.

There were others. There was one called Ring prosthesis.

There was one called Sivash.

It all had different ranges of, you know, survivorship.

Q. Now, let's turn back to when you assumed the role of

leadership for the alternate bearing project. You mentioned

that you reviewed some -- or spoke with Mr. Bono. We talked a

little bit about literature. Did you review any literature

specifically in 1996 when you returned on metal-on-metal?

A. There were some very specific references that I looked

at, yes.

Q. And what did you look at?


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A. The one that I referred to quite often as kind of a -- a

very complete, inclusive reference at the time was a

supplement in the Clinical Orthopaedics Related Research

Journal.

Q. And what did it relate to?

A. It was a -- it was basically a -- a summary of a

metal-on-metal symposium that had taken place the prior

year.

Q. And did it address -- what kind of topics did it address?

A. It addressed everything from the design parameters to

biological response of -- of these bearing surfaces through

clinical results.

Q. And did those materials indicate any heightened risk for

use of metal-on-metal over the risks that were -- the industry

was facing with polyethylene at the time?

A. No, I don't think so. I think there were papers in there

that talked about in some instances a theoretical of the use

of those materials.

Q. Was there any indication of significant problems in early

generation metal-on-metal in that particular periodical or

group of articles relating to specific tissue reactions?

A. No, not that I recall.

Q. In addition to literature, did you attend any symposium

or symposia, I should say, during the period in which you were

on the alternate bearing project?


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A. Yes, I did.

Q. And what did you attend?

A. I would attend specific sessions at the -- at the

American Academy of Orthopedic Surgeons meeting, the annual

meeting in the United States.

I would attend Hip Society meetings, which was a

specialty group for hip surgeons to attend.

I would go to specific either metal-on-metal or

ceramic-on-ceramic symposiums that were being held.

Sometimes I would often go to ASTM meetings looking at

standards around, you know, this area as well.

Q. Okay. And what does ASTM stand for, roughly?

A. I believe it's the American Society for Testing of

Materials.

Q. About how often did you attend a meeting or a symposium

during the time you were running the alternate bearing

project?

A. I would say probably about once every three months.

Q. Now, let's talk a little bit about the alternate bearing

project team. Did that team have representatives from DePuy's

research department?

A. Yes.

Q. Did it have representatives from tribology?

A. Yes.

Q. Did it have representatives from -- from the clinical?


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A. Yes.

Q. Did it have representatives from product development?

A. Yes.

Q. Did it have any other areas such as quality engineering?

A. Yes.

Q. Did it have any other areas that I haven't mentioned?

A. From an internal team --

Q. Correct.

A. -- perspective?

Yeah, clinical -- we had clinic representatives,

regulatory representatives, production, you know,

manufacturing representatives. Research, I think we talked

about.

Q. Did you also have meetings with outside personnel such as

surgeons?

A. Yes, we did.

Q. And did you have meetings with the following group of

people: Dr. Andy Engh, Dr. John Fenning, Dr. Brian Haas,

Dr. Paul Peters and Dr. Tom Schmalzried?

A. Yes, we did.

Q. And who were they?

A. At the time they were developing surgeons for this

project.

Q. I'm not sure we've defined this yet. I want to make sure

we have this.


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The word "articulation," what does that mean?

A. Articulation basically means when two surfaces move

against each other.

Q. Okay. Now, what does the term "clearance" mean with

respect to a total hip replacement?

A. Clearance would be the definition of the -- the space

between the -- the head and the cup, the head and the liner.

Q. How about the term "surface finish," what does that mean?

A. Surface finish would be the measure of the surface

roughness.

Q. What about radius? What does that refer to with respect

to the socket side of a total hip replacement?

A. Radius?

Q. Radius.

A. It would be the -- the dimension we would call out to

measure or design the specific size.

Q. Now, with respect to a femoral head, we've -- you

mentioned that earlier. What would be the radius of a femoral

head?

So if it was a 28-millimeter head, what would be the

radius?

A. It would be half of that. It would be a 14-millimeter

radius.

Q. And if it were a diameter, what would that be?

A. Well, for 28 would be -- we would -- we'd refer to the


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size in the diameters. So a 28-millimeter head would be a

28-millimeter diameter.

Q. Now, there's reference to hardness. Why would you look

at hardness?

A. We would look at hardness as a parameter that we could

control that might yield different results based on how these

metal-on-metal devices performed in a wear environment.

Q. Now, these different definitions we just talked about,

clearance, surface finish, radius and diameter, hardness, were

each of those parameters in what became the one-piece cup?

A. Yes, they were.

Q. And did you continue to study those parameters throughout

the course of the alternate bearing project until that product

was complete?

A. Yes, we did.

Q. Did someone from the alternate bearing project also

continue to investigate ways to manufacture the heads and the

one-piece cup?

A. Yes, they did.

Q. And were different processes for finishing these

materials also analyzed throughout the course of the project?

A. Yes, they were.

Q. And by finishing, what does that mean in this context?

A. Finishing would be the -- the -- kind of the final

machining process. It would be the way that you would lap or


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polish the femoral head or the metal insert.

Q. And was the goal to make the insert in the head as smooth

as possible?

A. Yes, it was.

Q. And do you feel like for purposes of the one-piece cup

you accomplished that?

A. Yes, we did.

Q. Now, at some point did a research fellow from the

University of Leeds join the alternate bearing project?

A. Yes.

Q. Okay. And who was that?

A. Andrew Goldsmith.

Q. Okay. And who was Andrew Goldsmith?

A. He was a research fellow who was working on his Ph.D.

through the University of Leeds.

Q. And what was his role in the team?

A. He -- at our international headquarters in Leeds,

England, at Depuy International, he was responsible for the --

the wear testing and the tribology group we were -- we were

working on this project with.

Q. Now, what is pretest form metrology?

What does that mean?

A. Pretest form metrology would refer to making all the

measurements; size, surface roughness, you know, roundness,

things like that, that the parts were before we started


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testing them against each other.

Q. Now, what is a Sulzer Metasul?

A. A Sulzer Metasul was a product that was available for

clinical use in Europe at the time. A metal-on-metal

component.

Q. And at some point during the course of the alternate

bearing project were you able to do some hip simulator testing

utilizing the one-piece and Sulzer Metasul products?

A. Yes, we did.

Q. And can you explain just generally what hip simulator

testing is?

A. Hip simulator testing is a -- is a -- a test station

where you can put the socket part of the hip joint and the --

the ball part of the hip joint together and run it through

a -- basically a -- a walking cycle, if you will.

Q. Now, it appears that you tested the one-piece and the

Sulzer Metasul in a hip simulator in the Leeds facility; is

that right?

A. Correct.

Q. Okay. And it looks like it ran somewhere in the

neighborhood between three and five million cycles, depending

on the number of -- of components. Does that sound about

right?

A. Yes, that sounds about right.

Q. Do you know generally what the results were of the


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comparison of wear between the one-piece in the simulator and

the Metasul?

A. My recollection is that the -- that -- in that specific

test that our one-piece design was actually generating less

wear and were performing better from a wear standpoint than

what the Sulzer component was.

Q. And was the Sulzer product already on the market?

A. It was on the market in Europe, yes.

Q. And do you know roughly how long it had been on the

market?

A. Well, I think it had been on the market for many years,

because metal-on-metal had continued to be in use in Europe

for many, many years.

Q. Now, did you run additional wear testing on the one-piece

design beyond just the one wear test?

A. Yes.

Q. Did you test various clearances of that design?

A. Yes, we did.

Q. And, again, what is clearance?

A. It's the -- it's the difference between the size of the

head and the size of the cup.

Q. Now, what were your impressions of the simulator testing

that was performed on the one-piece?

A. Well, we did -- we had several different simulators we

were running testing on. We had done -- we had looked at


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different -- kind of several different inputs or changes, you

know, different parameters, clearance, roughness, and then run

millions of cycles to try to understand how these devices

would -- would -- would wear.

Q. Now, explain to the court and to the jury, when you say

you run millions of cycles, what does that mean in -- in daily

life?

What does that equate to?

A. I mean, in -- in general terms, it equates to walking.

So it's typically -- these simulators you had the ability to

program in what we -- what we call a gait cycle or a walking

cycle, and it was -- you know, the conventional thinking was

that roughly a million cycles might represent about a year's

worth of service for that hip joint.

Q. So if you tested for over ten million cycles, we're

talking approximately ten years of the evaluation?

A. Yeah. That's -- that's -- I said that's the conventional

thinking, is, you know, roughly that would be about ten

million years or -- I'm sorry, ten years of use.

Q. Well, it would be -- it would be more than one year,

certainly?

A. Sure.

Q. Now, during the course of the alternate bearing project

did you also work some -- with some outside experts other than

surgeons?


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A. We did.

Q. Did you work with John Fisher at the University of Leeds?

A. Yes, we did.

Q. Did you work with doctor -- Dr. Duncan Dowson?

A. Yes, we did.

Q. And did Dr. Dowson supervise Andrew Goldsmith while he

was a Ph.D. student and working on the alternate bearing

project?

A. Yes, he did.

Q. Did you work with Anthony Unsworth from the University of

Durham in the United Kingdom?

A. We did, yes.

Q. Who is Dr. Unsworth?

A. Dr. Unsworth was somebody who was responsible for

Durham's testing lab. Specifically, they did a lot of work

looking at friction.

Q. And did he or his lab do some friction analysis for the

alternate bearing project?

A. Yes, they did.

Q. Did you also work with Dr. Pat Campbell?

A. Yes, we did.

Q. What did Dr. Campbell do?

A. She worked with us to look at the fluids that would be

removed from the wear simulators to see if we could do debris

analysis of the -- of the wear particles.


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Q. And did she actually conduct some wear particle analysis?

A. She did.

Q. Did you meet with Dr. John Collier?

A. Yes, we did.

Q. Who is Dr. Collier?

A. Dr. Collier is in charge of the biomedical engineering

program at Dartmouth College.

Q. And what type of work did you do with Dr. Collier?

A. With Dr. Collier we looked at his retrieval database to

understand how the -- the bone responded to, you know,

titanium or cobalt chrome as it related to the cup part.

Q. Now, did you also enroll the one-piece cup into what is

called an IDE?

A. Yes, we did.

Q. What is an IDE?

A. An IDE stands for an investigational device exemption.

It's a -- a regulated clinical study that you work with the

FDA to get approval to be able to start using.

Q. And -- and did you meet with the FDA on occasion in

preparation for the clinical trial for the one-piece cup?

A. Yes, we did.

Q. And did the FDA approve the clinical trial or the

clinical study?

A. They did approve the IDE, yes.

Q. Now, do you know roughly how many patients were enrolled


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in that clinical study?

A. I think we enrolled over -- just over a hundred.

Q. Now, did any of the design surgeons also order any of the

one-piece cups to implant on a custom basis?

A. Yes, they did.

Q. And do you know roughly how many of those were

implanted?

A. I think it was some place close to a hundred as well.

Q. Let's talk about the future cup system for a minute. We

mentioned that a little bit earlier.

What was -- you mentioned briefly the concept. Explain

again what the concept was behind the future cup system.

A. So the idea was having a metal shell, or the socket part

of the hip, that you could put in different types of bearings,

whether it be polyethylene, ceramic, or metal. So you could

use -- one -- one shell system would give surgeons the ability

to choose what they wanted their bearing material to be.

Q. During the course of the future cup system, approximately

what duration, what time frame are we talking about for future

cup?

A. Oh, I would -- I would say that the future cup, in my

mind, kind of started when I moved back from the U.K. So we

really kind of started that project in earnest in the -- in

the 1996 time frame.

Q. Did you work with any outside experts on that particular


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project?

A. Yes, we did.

Q. Did you work with Jeremy Gilbert?

A. Yes, we did.

Q. Who is Jeremy Gilbert?

A. Jeremy Gilbert when we worked with him was an academic

researcher at Northwestern University in Chicago.

Q. And what -- what area was his specialty?

A. His -- his specialty of research was in corrosion.

Q. And what did Dr. Gilbert do for you in the future cup

system?

A. Dr. Gilbert looked at several different studies of how a

metal insert might interact with a metal shell and looked at

different parameters of corrosion to make sure that the

combination of the two materials together was going to be

fine.

Q. And which two materials are you referring to?

A. The socket side being the titanium material and the --

the insert, bearing side, being cobalt chrome.

Q. Now, at some point during the course of 1998 did

Johnson & Johnson through some acquisition acquire DePuy

Orthopaedics?

A. Yes, it did.

Q. As a result of that acquisition what happened to the

future cup system?


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A. The -- well, the future cup system, at the time of the

acquisition, we had -- there were some patent challenges with

a feature which was referred to as the self-locking taper

which Johnson & Johnson owned the patents to. So once DePuy

became acquired by Johnson & Johnson that project then had

access to those patents.

Q. And you mentioned a taper. What do you mean by a taper?

A. A taper basically being a conical section within the cup

that would allow the two components to lock together.

Q. And by conical section, what does that mean?

A. Meaning, you know, like part of a -- part of a cone.

Q. And as a result of that acquisition, were you able to

obtain additional research regarding other metal-on-metal

products?

A. Yes. Johnson & Johnson Orthopedics had a project called

Ultima.

Q. What is the Ultima cup system?

A. The Ultima cup system was a titanium acetabular shell,

titanium cup, that had a cobalt chrome bearing insert.

Q. And what was the diameter of the head used and the inside

diameter of the liner used in the Ultima cup system?

A. The Ultima metal-on-metal combination was a 28-millimeter

diameter.

Q. And, again, the one-piece diameter was what dimension?

A. 36-millimeters.


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Q. Now, was the Ultima cup system enrolled in a clinical

study as well?

A. Yes, it was.

Q. So by the time -- well, strike that.

So when -- when did the future cup system essentially end

and the Pinnacle acetabular cup system begin?

A. I would say that probably sometime in the middle of 1999.

Q. By the middle of 1999 had you completed research and

testing on the alternate bearing project and the one-piece

cup?

A. We had, yes.

Q. At that time did you obtain the research and testing that

had been already accomplished on the Ultima cup system?

A. Yes.

Q. And the Ultima cup system, was that already in a clinical

study?

A. In the U.S., yes.

Q. And was the one-piece cup about to begin a clinical study

at that point?

A. Yes, it was.

Q. Now, what was your role on the Pinnacle acetabular cup

system project?

A. I was the project leader.

Q. Okay. And let's take a step back.

What is the Pinnacle acetabular cup system?


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A. The Pinnacle acetabular cup system basically became what

we had called previously the future cup system. So the idea

that you could have one metal shell that could incorporate

either polyethylene or plastic, metal or ceramic inserts for

bearings.

Q. Is the cup in front of you an example of one of the cup

options for the Pinnacle acetabular cup system?

A. Yes, it is.

Q. Do you mind showing it to the jury?

A. Sure.

Q. There's a white object. Could you explain what that is?

A. Yeah. This is the polyethylene component that would fit

inside the shell like that (indicating). This is the metal

shell that I referred to that's titanium.

And then this is the femoral head, or the ball part that

would actually go inside the -- the liner.

Q. And what is the other metal piece that you have in front

of you?

A. The -- if a surgeon decided not to use the polyethylene,

this is a metal insert that they could use that would go

inside the shell like that and lock in, and then the metal

head would go inside that bearing.

Q. Now, let's talk about the Pinnacle acetabular cup system

team.

You said you were the project leader; is that correct?


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A. Correct.

Q. Okay. Did you -- did you also have representatives from

research?

A. Yes, we did.

Q. Did you have representatives from product development?

A. Yes, we did.

Q. Did you have representatives from clinical?

A. Yes, we did.

Q. Did you have representatives from regulatory?

A. Yes.

Q. Did you have representatives from tribology?

A. Yes.

Q. Did you have representatives from quality engineering?

A. Yes.

Q. What is quality engineering?

A. Quality engineering is -- it's the discipline of making

sure that we can -- we can check and control the parts we're

going to make so that we as development engineers can design

something.

They're basically the interface between development

engineering and manufacturing engineering to help us check

what we make.

Q. Did you have representatives from manufacturing

engineering?

A. Yes.


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Q. Did you have any other areas of specialty that I have not

mentioned?

A. No, that was pretty -- pretty extensive.

Q. Now, did the Pinnacle acetabular cup system offer

multiple cup options?

A. Yes. The -- the cup system had many different types of

shells.

Q. And did it offer different bearing options?

A. Yes.

Q. And what were those options?

A. Polyethylene, or the plastic component, metal, and a

ceramic component.

Q. And what, again, was material for the acetabular cup?

A. The shell part was made from titanium.

Q. And why was that material selected?

A. That material was selected because as we went back and

looked at the retrieval analysis we had done with Dr. Collier,

we felt that that gave the -- the best interface for

biological ingrowth or for the bone to actually grow into this

part of the shell.

Q. And what was the metal selected for the metal insert?

A. Cobalt chrome.

Q. Is that the same cobalt chrome that you mentioned earlier

that had been in place for many years?

A. Yes.


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Q. Did you perform any what's sometimes referred to as

mechanical testing on the -- on the cup system?

A. We did.

Q. Did you do push-in and push-out testing?

A. Yes.

Q. What did that involve?

A. Push-in and push-out testing would have been inserting

this piece of plastic liner into the shell and then pushing it

out through a hole in the back to see how much force it took

to actually push the liner out.

Q. Did you conduct lever-out testing?

A. We did.

Q. What is that?

A. Lever-out testing would have been pushing the liner into

the shell and then trying to put an object in here to try to

lever or cant -- you know, kind of tip the liner out of the

shell.

Q. Did you conduct fatigue testing?

A. We did.

Q. What is fatigue testing?

A. Fatigue testing would have been again inserting the liner

into the shell and just loading it under a -- under kind of a

rapid -- rapid cycle load to see if it was going to break over

time.

Q. Did you also evaluate the hardness of the materials


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throughout the course of the project?

A. We did.

Q. Did you evaluate surface roughness of each of the

materials -- excuse me -- each of the components over the

course of the project?

A. Yes, we did.

Q. What is finite element analysis?

A. Finite element analysis is basically a software program

that allows -- allows you to model stresses and strains that

components or products see.

Q. Did you have any finite element analyses performed on the

Pinnacle acetabular cup system during its development?

A. We did.

Q. For what reason?

A. We -- we wanted to look at how the interface between

the -- the polyethylene insert and the metal shell was going

to perform under -- We wanted to look at the stress and the

interface in those two components.

Q. Now, did you do any consulting with any outside experts

during the course of the Pinnacle acetabular cup system

development?

A. Yes.

Q. Did you work again with Dr. Jeremy Gilbert?

A. We did.

Q. And what did Dr. Gilbert do?


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A. He did some similar further testing of what we had done

with the future cup system and more or less kind of ran the

similar protocols to what we considered to be our final

design, looking at corrosion.

Q. And was a micromotion program undertaken?

A. Yes, it was.

Q. Let me restate that.

Was any micromotion testing performed?

A. Yes.

Q. And who was that performed by?

A. Dr. Allen Litsky at Ohio State University in Columbus,

Ohio.

Q. Now, what is micromotion?

A. For the purposes of our testing, micromotion referred to

if you put this polyethylene, this plastic insert, into the

shell, and if you loaded it, would it -- would it move --

would there -- would there be motion between the shell --

between the polyethylene insert and the shell, did it move on

some microscopic level.

Q. Okay. And again, where was that performed?

A. At Ohio State University.

Q. By who?

A. Allen Litsky.

Q. And what generally were the results from your

understanding?


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A. The results were that there was very little to no

micromotion, no motion between the polyethylene insert and

the -- the metal shell.

Q. Now, did the Pinnacle acetabular cup system, in

particular the metal-on-metal components, undergo hip

simulator testing as well?

A. Yes.

Q. And were both the 28-millimeter and the 36-millimeter

tested in hip simulators?

A. Yes.

Q. And were they tested against any other product?

A. I mean, comparative-wise, yes, they were tested against

different products, yes.

Q. Which products were they tested against?

A. We ran some testing against Ultima.

Q. Now, was simulator testing undertaken at -- at the Leeds

facility?

A. Yes, it was.

Q. And do you know roughly how many millions of cycles were

run?

A. About -- tens of millions of cycles over the period of

the testing that we had done.

Q. Was testing performed at any other locations other than

at the Leeds -- at the Leeds facility?

A. Yes. We did -- So within the DePuy facilities -- We did


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testing at Depuy International in Leeds, and we did testing in

the research facility in Warsaw, Indiana.

Outside of that, there was some testing that was done at

the University of Leeds as well.

Q. Was any testing performed at the University of Waterloo?

A. Yes, there was.

Q. And where is the University of Waterloo?

A. It's in Canada. Ontario, Canada.

Q. Were different clearances tested in the simulator?

A. Yes.

Q. Were stopping and starting the simulator -- also known as

start-stop-dwell, I believe it's called -- was that done?

A. Yes, it was.

Q. Was the system tested for many years after it was

initially launched?

A. Yes. I -- I stopped working with the -- with the project

sometime in the middle of 2002, and I know there was testing

that was conducted well beyond that.

Q. Now, I know you're not -- weren't in the regulatory area,

but do you have an understanding as to whether the Pinnacle

acetabular cup system, in particular the metal-on-metal

components, received FDA clearance?

A. Yes, they did.

Q. Okay. And do you know when they received FDA clearance?

A. I believe it was in the late 2000 time frame.


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Q. And were separate regulatory clearances achieved for the

28- and 36-millimeter metal-on-metal components?

A. Yes, they were separate.

Q. Now, they were cleared at the end of 2000, I believe was

your testimony. Were any sold immediately upon clearance by

the FDA?

A. No.

Q. Was there any restriction by the FDA saying that you

couldn't sell them immediately?

A. No.

Q. Why did you continue to investigate and test them at that

point?

A. Well, we -- we would have had a series of tests or

studies we wanted to do to -- to make sure we were confident

that the product was ready for -- for clinical use. So even

though we would have had regulatory approval, we wouldn't

have -- we wouldn't have allowed them to be used clinically

until unless we were satisfied we had those tests in place.

Q. Do you know the word "Ultamet"?

A. Yes.

Q. What is Ultamet?

A. Ultamet refers to the metal insert for the Pinnacle

acetabular cup system.

Q. When the Pinnacle acetabular cup system refers to a

metal-on-metal, what does that involve?


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A. That would involve a shell, a cup, a Ultamet insert, and

a cobalt chrome femoral head.

Q. Now, do you know when the first Ultamet -- Pinnacle

Ultamet metal-on-metal was implanted?

A. I believe it was in the late spring of 2001.

Q. Now, do you know when overall global sales of Ultamet

began?

A. I don't believe we sold any or commercially made it --

made it available until the summer of 2002.

Q. So implantations -- strike that.

Were -- were your design surgeons implanting the Ultamet

during the time frame between April 2001 and commercialization

in July 2002?

A. Yes, our design surgeons would be able to use it.

Q. So in addition to the clinical study that you had on

one-piece, the clinical study you had on the Ultima cup

system, did you also have over a year of clinical experience

with the Ultamet before commercialization in July 2002?

A. Yes, we did.

Q. Sir, are you proud of the team that you assembled for the

Pinnacle acetabular cup system?

A. Yes, I am.

Q. Are you proud of the work that you performed and that

your team performed on the Pinnacle acetabular cup system?

A. Yes, I am.


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Q. Do you feel that you created a safe and effective product

for use by surgeons?

A. Absolutely.

Q. Now, you indicated that in 2002 you took on a different

role DePuy; is that correct?

A. That's correct.

Q. Okay. What did you do after you stopped working on the

Pinnacle acetabular cup system, generally?

A. I moved into a different product development group. I

wasn't focused on hips anymore.

Q. Now, you mentioned that -- earlier that you left DePuy in

2007 and went to work for Biomet; is that correct?

A. That's correct.

Q. Okay. Why did you -- why did you leave DePuy?

A. I just had a different opportunity at a -- at a different

orthopedic company.

Q. Mr. Lancaster, you were asked some questions earlier in

your testimony by Mr. Lanier regarding a document that he

ended up marking as Exhibit Number 22. Let me zoom out on

this for you.

What was your understanding of what Exhibit 22 was?

A. It was just notes he was taking as I gave my testimony.

Q. And did you have an opportunity to review Exhibit 22?

A. No.

Q. Would you like a chance to look at it right now?


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A. Sure.

Q. Does Exhibit 22 fairly and accurately represent your

testimony?

A. I wouldn't -- no, not my testimony, no.

MR. SHEA: I'd like to mark an exhibit, please.

Do you know where we're leaving off?

Is it 23?

MR. PRESNAL: That's what I understand, yeah.

MR. SHEA: 23. Okay. Thank you.

BY MR. SHEA:

Q. Sir, I'm going to hand you what I've marked as Exhibit

Number 23, which is a copy --

MR. SHEA: Trent, would you mind handing him that?

BY MR. SHEA:

Q. Actually, let me go ahead and keep the original and give

you a copy, sir. This will be 23. A document of Mr. Lanier's

notes.

You can see here as we focus in there's reference to

historical pre-1995 metal-on-metal that had low or normal

failure rate.

Was Sulzer Metasul the only metal-on-metal that would fit

that category?

A. No.

Q. What else would fit?

A. I would say that the McKee-Farrar would fit in that


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category, the Ring prosthesis, and even in some cases the

Sivash components.

Q. Okay. Let's take a look at page 2, if you will.

You see the question right underneath "Jim Lancaster"?

A. Yes.

Q. Can you read that for me?

A. "Did the company ignore patient safety in trying to get

to market quickly?"

Q. And were you asked that question prior in your testimony?

A. Yes.

Q. And did you give an answer?

A. Yes.

Q. Do you recall what that answer was?

A. I believe my answer was absolutely not.

Q. Now, if we turn to the -- the left side of Exhibit 23,

there's a reference to "Trying to develop products as timely

as we could."

Does that reflect your testimony?

A. Yes.

Q. There's a quote, "Beat competition to punch."

Is that testimony you gave?

A. No.

Q. Are those your words?

A. No.

Q. Was that your reason for conducting the alternate bearing


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project?

A. No.

Q. The next quote, "Opportunity to significant increase

market share," were those your words?

A. No.

Q. Was that your reason for conducting the alternate bearing

project?

A. No.

Q. I'm sorry, let me zoom back out so the jury can see here.

Finally, it says, "Maintain competitive advantage."

Was that your testimony?

A. No.

Q. Those were not your words?

A. No, they were not.

Q. Was that the reason you conducted the alternate bearing

project?

A. No.

Q. For the jury I will use JL to represent Jim Lancaster.

Now let's turn to "beat the competition to the punch."

We know those weren't your words.

Did DePuy, in fact, beat the competition to putting a

metal-on-metal product on the market?

A. No, they did not.

Q. What companies had metal-on-metal products on the market

before DePuy?


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A. Biomet did. Johnson & Johnson prior to the DePuy

acquisition. There were other products outside the U.S. as

well.

Q. Was Sulzer Metasul one of them?

A. Yes.

Q. So, in fact, DePuy did not beat the competition to the

punch, did it?

A. No.

Q. Now, how long in total from the beginning of the

alternate bearing project until the Pinnacle Ultamet was

commercially launched, how long was that period?

A. I would estimate probably about seven years.

Q. Seven years from ABP to Ultamet.

Would you consider that a rush to market, si

A. No, I would not.

Q. Now, let's look on the right side of this document. Do

you see reference to "Nobody on internal team with specialty

or expertise in biology toxicology"?

Do you see that?

A. Yes.

Q. There's reference to orthopedic surgeons Pat Campbell and

Jeremy Gilbert. Was that your testimony?

A. Yes.

Q. There's reference to a Dr. Peters. I mentioned him

earlier.


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Who was Dr. Peters?

A. He was one of the early developing surgeons for the

one-piece metal-on-metal project.

Q. Now, Exhibit 5, which I will hand you, which was marked

previously in your deposition, made reference to Dr. Peters in

the middle of the second page, which I will show to the jury

here. This is Exhibit 5.

Do you see the reference to Dr. Peters in the middle?

A. Yes.

Q. Can you read what it says, please?

A. "Spent time in England with Watson Farrar. Fractured

cement and cup loosening were modes of failure. Toxicity/ion

release a fact of metals. Saw no lymphatic tumors with

Farrar, but these issues must be -- must be addressed, et

cetera . . ."

Q. Now, Dr. Peters saw no lymphatic tumors relating to what?

What do you understand Farrar to mean?

A. What I understand that to mean is he saw no lymphatic

tumors relating to the Farrar device, the McKee-Farrar

device.

Q. Now, there were some questions raised earlier in your

testimony about the concept of toxicity.

Now, can you say truthfully and accurately that anything

is toxic without knowing more about what the substance is and

the amount of the substance -- of the substance?


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A. No, I don't think you can.

Q. And please explain that.

A. Well, I think it would depend upon what the host body is.

It would depend upon that individual's threshold for toxicity.

It could depend upon the size of the debris, or particles, or

whatever the material is that's being put into the -- into the

biological system.

Q. From your understanding is cobalt chromium in and of

itself toxic?

A. No, it's not.

Q. Sir, can salt be toxic in enough of a volume?

A. Yes, I believe it can.

Q. Can water kill you if you drink too much of it?

A. Yes, I believe it can.

Q. Do you consider salt or water to be toxic?

A. I do not.

Q. Now, there was some reference earlier in your testimony

that toxicity automatically meant something was poisonous. Do

you agree with that?

A. Not necessarily, no.

Q. Would that also require an explanation of what the

substance was, the amount of the substance, and its use?

A. Yes.

Q. So would you equate automatically the concept of toxicity

with the concept of poison?


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A. No.

Q. Now, Dr. Peters references on this page -- you were

working with Dr. Peters on these very issues, were you not?

A. Yes, on this project, yes.

Q. Now, there's a reference to "eliminate debris."

Do you see that?

Up here on Exhibit 23. I'm sorry.

A. Oh, yeah. I'm sorry. Yes.

Q. That's fine.

Now, can any total hip replacement have no debris at all?

A. No, it cannot.

Q. And what was the goal, knowing that to be true, of the

Pinnacle acetabular cup system?

A. To optimize the design as much as possible to minimize or

reduce any potential for debris.

Q. And do you believe that the design of the Pinnacle

acetabular cup system, in fact, optimized -- was optimized

such that it minimized debris as much as possible?

A. Yes, I do.

Q. Now, in addition to Dr. Peters and Dr. Andy Engh, who I

believe made reference on Exhibit 5 to the concept of trying

to eliminate debris as much as possible, you were working with

Dr. Schmalzried as well; is that correct?

A. That's correct.

Q. Now, is Dr. Schmalzried the same Dr. Schmalzried listed


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as an author on this particular paper titled Biological Issues

on Metal-on-metal Total Hip Arthroplasty?

Do you see his name in the upper right corner?

A. Yes.

Q. That's the same Tom Schmalzried who was working with you

on the Pinnacle project and alternate bearing project?

A. Yes.

Q. Was Dr. Schmalzried also the very same surgeon who was

working and wrote this document, "The Risk of Cancer Following

Total Hip or Knee Arthroplasty?"

A. Yes.

Q. Could you see the date of this particular paper?

A. It looks like it's May of 2001.

Q. And was that during the Pinnacle project?

A. Yes.

Q. And do you see what I'm highlighting, this language here,

what the conclusions were from Dr. Schmalzried's work?

A. Yes.

Q. What does it read?

A. "In summary, all available data do not support a causal

link between total hip or knee arthroplasty and the

development of cancer."

Q. And for the record I'm going to go ahead and mark these

as Exhibits 24 and 25.

So turning back to Exhibit 23 for a moment, do you think


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it was appropriate to rely on folks such as Jeremy Gilbert,

Pat Campbell, and orthopedic surgeons when analyzing issues

such as biology and toxicology?

A. Yes.

Q. And why is that?

A. Because they're -- they're either medical doctors,

orthopedic surgeons or medical doctors who had specialty

training in those areas, or specialty academic researchers who

have a focused area of concentration.

Q. Now, Mr. Lanier in his questioning and during the course

of writing his notes on what was Exhibit 22, which we have now

marked Exhibit 23, seemed to suggest that if the word

"toxicology" did not appear in a meeting minute that the

Pinnacle acetabular cup team and the alternate bearing team

did not even consider patient safety or clinical issues. Is

that fair?

A. No.

Q. In fact, throughout the course of the alternate bearing

project and the Pinnacle acetabular cup system project was

clinical -- were clinical issues considered?

A. Yes.

Q. Were they considered throughout the entire process?

A. Absolutely, yes.

Q. And, again, during the course of this time frame that was

selected, August '96 through July of '97, did you have


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meetings with designing surgeons during the alternate bearing

project?

A. Yes, we did.

Q. I'm going to mark what's -- Exhibit 26 and hand it to

you.

If you could take a minute to look at Exhibit 26, which I

am putting up on the camera.

Mr. Lancaster, do you see the highlighted text

referencing Phase III?

A. Yes, I do.

Q. And what does "Phase III: Clinical Trial" mean?

A. I would -- I would understand that to mean that we would

be going through a clinical trial as part of the evaluation

and -- and development of the overall system.

Q. This is dated October of 1996. It pretty quickly after

you returned from England, was it not?

A. Yes, it was.

Q. It appears to be the first meeting you had with design

surgeons on the alternate bearing project. Would that be

right?

A. I believe so, yes.

Q. And in that first meeting with designing surgeons you're

already referring to a clinical trial as part of the process;

is that correct?

A. That's correct.


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Q. And you're talking about the IDE preparation. Again,

that would be preparation of the clinical trial itself?

A. Yes, for submission to the FDA.

Q. And one phase of the entire project was dedicated to a

clinical trial. Is that correct?

A. That's correct.

Q. Now, what is a clinical trial?

A. A clinical trial is a clinical study. It's -- it's when

we would actually work with orthopedic surgeons to have very

controlled and specific factors or parameters so we could put

the -- we could have the device implanted and then study it

and follow it for some period of time.

Q. Let me ask it a different way.

This was the first meeting of the alternate bearing

project in which you met with surgeons, correct?

A. Yes.

Q. And this was one of the topics you discussed at that very

first meeting?

A. Yes.

Q. Is it one of the topics you addressed at one of the very

first meeting?

A. Yes.

Q. Did you continue to address these issues throughout the

course of the project?

A. Yes, we did.


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Q. Now, in addition to the first meeting, did you have

meetings with surgeons who were implanting the one-piece cup

during the course of the clinical study?

A. Yes, we did.

Q. Now, let's take a look at what has been previously marked

as Exhibit Number 16. I'll just put that up on the ELMO, if

you don't mind.

And as a refresher, what is Exhibit 16?

A. It looks like meeting minutes from a one-piece

metal-on-metal IDE clinical investigators. So the clinical

investigators that were part of the study had a meeting.

Q. Okay. And I think it would be easier if you take that,

and I'll put my copy up.

You see the highlighted language in that first paragraph?

A. Yes.

Q. What does that read?

A. "Dr. Haas made a few opening remarks and concluded that

the early results for his IDE study cases looked very good,

but that longer follow-up is required before any conclusions

could be made. Dr. Engh concurred with Dr. Haas' comments

with respect to his study cases."

Q. Let me ask it a different way, sir.

What did you understand those remarks to relate to?

A. I understood those remarks to relate to their study cases

that they had enrolled for this device.


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Q. The metal-on-metal?

A. The one-piece metal-on-metal, yes.

Q. Now, regardless if the word "toxicity" appeared in a

internal meeting, during the course of the alternate bearing

project, did you, in fact, discuss clinical and biological

issues?

A. Yes, we did.

Q. Sir, I'm going to hand you what was previously marked as

Exhibit 7 to your deposition.

The jury can see Exhibit 7. Take a moment to read that

if you will, please.

A. Okay.

Q. Do you see the highlighting down here development JL?

A. Yes.

Q. Do you know what it refers to?

A. It refers to the function of product development and to

myself as the responsible or point person.

Q. Now, could you read the first couple of sentences of the

opening paragraph for this, please?

A. "Thanks go out to everyone for the information which was

presented at this week's PCT meeting. It appears as though we

have all had a better appreciation as to what activities need

to take place to allow our objectives to be met."

Q. Now, if we turn to page 2, under "Long-Term," I have

highlighted some language right here. What does that refer


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to?

A. "Support IDE/clinical trial." That would refer to

product development as a function having the responsibility to

support those activities as a longer term part of the project.

Q. What is the reference to clinical, CH? What does that

mean?

A. It refers to the clinical function. And CH would refer

to Cheryl Hastings.

Q. And did Cheryl Hastings in the clinical role have an

ongoing role in the meetings of the alternate bearing project?

A. Yes, she did.

Q. So notwithstanding the fact that September 9 was written

here by Mr. Lanier, there was a discussion -- was there a

discussion of clinical issues?

A. At this meeting, yes.

Q. So, in fact, something relating to biology or toxicity

was discussed during the September 6th meeting?

A. Yes.

Q. Let me ask it a different way.

Was something related to biology/toxicology discussed at

this meeting?

A. Yes.

Q. I hand you what has been marked as Exhibit 8, previously

marked.

Meeting minutes dated September 10. Do you see that?


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A. Yes.

Q. Do you see the reference to "Clinical" where I am

pointing?

A. Yes.

Q. What do you understand that to relate to?

A. I understand that to relate to the clinical function and

activities discussed at that core team meeting associated with

the clinical function.

Q. And so this would relate to the September meeting

referenced in Mr. Lanier's notes. Clinical was again

discussed?

A. Correct.

Q. I'll hand you what was previous marked as Exhibit Number

10, which I will put up for the jury.

Do you see the highlighted language I have on this

document?

A. Yes.

Q. What does phase two read?

A. "Phase two defines the actions associated with the IDE

preparation, submission and approval process.

Q. And what does Phase III relate to?

A. Phase III will include activities related to the

production of clinical product and initiation of the clinical

(IDE) trial."

Q. This was an alternate bearing team meeting, internal


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meeting; is that correct?

A. That's correct.

Q. Were there discussions about biological or clinical

issues?

A. Yes, there were.

Q. Sir, I'm not going to go through every single one of

these.

Did the team discuss clinical trial issues related to

patient safety and -- and biological potential issues

throughout the course of this project?

A. Yes, we did.

Q. Now let's turn to page 3 of Exhibit 23.

Now, the language in red, is any of this your language?

Anything you testified to?

A. No, it's not.

Q. Let's turn to page 4.

Now, prior to 2003, did you or your team study the

literature relating to the potential effect of the debris on

patients?

A. Yes, we did.

Q. Did Dr. Campbell conduct analysis of the wear debris in

the simulator relating to the one-piece cup?

A. Yes, she did.

Q. Were the Ultima cup system and the one-piece enrolled in

clinical trials?


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A. Yes, both systems were.

Q. By clinical trials that would mean clinical study; is

that right?

A. Correct.

Q. Were clinical studies conducted on the Ultamet Pinnacle

metal-on-metal after sales began?

A. Yes, there were.

Q. Was Pinnacle metal-on-metal the control product in a

clinical study relating to ceramic-on-metal?

A. Yes, it was.

Q. What does the control product mean?

A. It means for the sake of that clinical study it was used

as the baseline or standard product for the analysis to be

done.

Q. And prior to 2003, how many years of research from the

beginning of the alternate bearing project had taken place?

A. Probably 9 to 10 years.

Q. And during the course of that period, was the potential

toxicity of the wear debris analyzed?

A. Yes.

Q. Let's turn to page 5.

Sir, was this your testimony?

A. No, it was not.

Q. In fact, do all the activities listed on the page of --

page 4 likewise belong on page 5?


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A. Yes.

Q. Now, let's look at page 6 for a moment.

I believe you testified earlier about some work that

Dr. Gilbert did both in conjunction with future cup and

Pinnacle Ultamet. Is that correct?

A. That's correct.

Q. Now, did anyone investigate corrosion of the articulating

surfaces?

A. Yes.

Q. Who did?

A. We did, as we looked at our wear simulator studies.

Q. Could you explain to the jury what you mean?

A. We would often as part of the standard protocol, test

protocol, we would -- between wearing -- between measuring and

checking the simulator components of the metal-on-metal

components in a wear simulator study, we would do analysis of

the surface to look and see if there was any -- any

indications of any kind of corrosive activity taking place on

the surface.

Q. Just turning to the last page, do you know if the

delivery date of September 30, 1996, for the first simulator

in DePuy Leeds is accurate?

A. I don't recall exactly the actual date.

Q. Was this just a date that Mr. Lanier provided?

A. Yeah.


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Q. So turning back to page 2, Biomet, J&J and Sulzer

Metasul, at a minimum were on the market first with the

metal-on-metal product. Correct?

A. Correct.

Q. And this was seven years from the beginning of the

alternate bearing project until Ultamet sales?

A. Correct.

Q. Do the additions I've made to what was Exhibit 22, and is

now Exhibit 23, more accurately reflect your testimony?

A. Yes, it does.

MR. POWELL: Your Honor, that concludes our part of

the testimony of Mr. Jim Lancaster.

THE COURT: We'll go ahead and start the other.

JIM LANCASTER BY VIDEO DEPOSITION

(Video playing.)

Q. Good morning, sir. I met you, I guess, as you walked in

the room briefly. I assume for the jury's benefit though they

have not yet.

So you are Jim Lancaster; is that right?

A. I am.

Q. Mr. Lancaster, I show you at least in '96 to be the

project leader for DePuy in their alternative bearings

project; is that right?

A. Well, I think -- at that point in time I was a product

development engineer. That was one of my projects, yes.


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Q. Yeah. You were also the product development engineer and

a project leader? Is that -- am I wrong calling you the

leader?

A. No, I would have been the project leader for that

project.

Q. Now, you as a project leader for the alternative bearings

work, you're dealing in what ultimately became some of the

Pinnacle metal-on-metal projects; is that right?

A. Yes, some of that project was early work for that, yes.

Q. And not all of it. You had -- you had other things as

well that came out of it. I think some ceramic work came out

of it also, didn't it?

A. Yeah, the alternative bearings would refer to that as

well.

Q. And, of course, you have a specialty in polyethylene, at

least your master's thesis looked like it to me.

A. Well, I did a -- my master's prosthesis is in tribology.

Q. Okay. But you specifically studied some polyethylene

issues in the tribology thesis, right?

A. Correct.

Q. Now, I'd like to look with you and the jury at whether or

not your company ignored safety as it developed this product.

Do you understand what I mean by saying we're going to

look at that issue?

A. Well, I'm assuming you'll explain it further as we get


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into it.

Q. Well, let's break this down and -- and look at it from a

couple of different angles. Okay?

First, would you agree with me that your company was

trying to get to market quickly?

A. I would say that we were always trying to design and

develop products as timely as we could.

Q. All right. So, in your words, you're trying to develop

products as timely as we could; is that right?

A. Yes.

Q. But we have already seen your company using language of

trying to beat competition to the punch, right?

A. In a prior exhibit.

Q. And that prior exhibit said trying to beat them to the

punch to increase market share; is that right?

A. Actually, I think it said -- I'd have to find the

reference.

Q. Yeah. That's -- I put -- I think market share was

actually at the beginning of the comment.

A. I don't recall. I didn't -- that wasn't a form I was --

Q. Yeah. Hang on. It's Exhibit 4. Let's see what we have

here.

"Significantly increased market share if we can beat our

competition to the punch."

Do you see that?


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A. Um-hum.

Q. So "beat competition to the punch" and that will

"significantly increase market share" or "opportunity to

significantly increase market share," right?

A. That's what the statement says.

Q. Okay. So would you at least agree with me the company

was trying to get to market quickly or beat the competition to

the punch, significantly increase market share as timely as we

could?

A. What I would say, my words were trying to develop

products as timely as we could. The other words you've lifted

off of the exhibit which I wasn't involved with creating.

Q. The one you were involved with we should add as well, and

that was to maintain competitive advantage, right?

A. There's a reference to that, yes.

Q. In the one where you're project leader listed on the

form?

A. Correct.

Q. Let's get that language just right.

"Maintain competitive advantage."

Now, let's zoom in on whether or not the company ignored

patient safety. Let's look at that part of my question. All

right?

We'll do it over here in blue ink.

Are you with me?


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A. Okay.

Q. Okay. You've got a team, a development team, we see that

on this Exhibit Number 1 where you're listed as team leader.

Project leader, right?

A. Project leader, yes.

Q. All right. Who on this development team deals with

biology and toxicology?

A. Well, we had -- underneath the development team, we had a

materials person in Bernice Aboud and then we would have had

others. I mean, this was our internal development team. Kind

of what we would call a core team, so to speak.

Q. All right. I'm not looking for a materials person. I'm

looking for someone who deals with biology and toxicology

issues.

Who's going to know whether or not the metal debris is

poisonous to the body?

A. Well, those -- for that kind of expertise we would have

worked with external experts.

Q. So nobody on the development team deals with those

issues; is that fair to say?

A. I think it's fair to say that we really didn't have

anybody on that core team listed there that had maybe that

specific expertise.

Q. All right. So nobody on -- and this is called the

development team?


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A. It's part of -- yeah, part of the development team, the

internal development team.

Q. With a specialty or expertise in biology, toxicology;

fair to say?

A. Well, I would say nobody on the internal development team

as listed for this.

Q. All right. We'll start out with internal, nobody on

internal development team. Is that better?

A. Yes.

Q. All right. Now, I notice in the commentary section it

talks about some external consultants. It talks about surgeon

consultants to include Brian Haas, Dr. Peters, Engh, Fenning,

and Schmalzried.

Do you see that?

A. Yes.

Q. None of those gentlemen, even though they're medical

surgeons, medical doctors, none of those are -- have a

specialty or an expertise in biology/toxicology. Would you

agree with me?

A. I'm not sure I would agree. I think that some of those

individuals were very -- as physicians and orthopedic surgeons

were very knowledgeable and had a certain level of expertise

in that area.

Q. Okay. Good.

So now I've deposed so far two of these, Dr. Schmalzried


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and Dr. Haas, and they've both said, "Not me" on this issue.

Are you saying that your company thought that they were

guys that had the specialty?

A. No. No. I'm suggesting that there would be some level

of clinical knowledge and a certain level of expertise that

they would bring to that discussion.

Q. So you think that the orthopedic surgeons, the bone

surgeons, the guys who cut the bone and put in the new piece,

are supposed to be specialists on whether or not the metal

debris is toxic to the body?

A. I would -- I think orthopedic surgeons certainly have a

knowledge of the implants they put into the body and the

reaction to those -- possible reactions to those implants,

yes.

Q. All right. So your company is relying on the orthopedic

surgeons to do that; is that fair to say?

A. Well, that's -- that would be one source that we would

have relied on.

Q. All right. What other sources was your company relying

on?

A. Well, we were -- we would have worked with -- there were

some other external -- so I would say academic experts that we

were working to understand the -- that part, the biology and

toxicology, looking at debris analysis, things of that nature.

Q. Who?


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A. Well, we -- I know we would -- had done some work with

Pat Campbell's lab looking at debris analysis.

Q. All right. So you're looking to Pat Campbell to be the

expert.

Who else?

A. We were also doing some work with Jeremy Gilbert on part

of the -- part of that on the corrosion side.

Q. I mean, Jeremy Gilbert is the Syracuse fellow who dealt

with corrosion?

A. Well, he was at Northwestern at the time.

Q. Yeah. But I mean he's -- he's an engineer, isn't he?

A. Yeah. He's an academic professor.

Q. All right. So you were expecting Jeremy Gilbert to be

able to tell you whether or not the debris is biologically

poisonous or toxic?

A. No. What I'm suggesting is that the combination of all

of these different experts coming together would help and form

that view.

Q. Well, you have multiple degrees, don't you?

A. Pardon?

Q. You have multiple college degrees, don't you?

A. Yes.

Q. You understand there are college degrees in biological

sciences, right?

A. Yes.


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Q. You understand there's an entire group of educated people

that are called toxicologists, right?

A. Yes.

Q. You haven't listed one of them yet for us, have you?

A. Not that I recall.

Q. In fact, if we just start honing in on what you said, for

example, relying on the orthopedic surgeons, these are those

orthopedic surgeons, Dr. Haas, Peters, Engh, Fenning and

Schmalzried that we looked at in Exhibit 1. Remember?

A. Yes.

Q. You had a meeting with those gentlemen, a document we'll

mark as Exhibit Number 5 in May of 1995.


A. I do not. I was not involved with the project.

Q. All right. This is right before you got started as

project leader?

A. No. This was in May of '95.

Q. April of '95, sir --

A. Oh, okay.

Q. -- is the actual meeting.

A. Okay.

Q. The minutes were done in May. Do you see that?

A. Yes.

Q. But these are the doctors that you said y'all were

looking to on your team, right?


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A. I said one of the sources, yes.

Q. Well, these are the orthopedic surgeon sources. Relying

on orthopedic surgeons, we have Haas, Peters, Engh, Fenning,

Schmalzried.

Haas, both Haases, Engh, Fenning, Peters. The only one

missing is Schmalzried, right?

A. Okay.

Q. If you'll look at Exhibit 5 on the back, look at some of

the comments here by your doctors you're relying on.

Do you see the comment by Dr. Peters that I've just

highlighted?

THE COURT: Stop.

Okay. Ladies and gentleman, don't talk about the case.

See you back on Monday.

The lawyers are going to work real hard over the next

couple of days, the weekend. They're shortening some things.

They're working hard. We'll give them some time to get that

done. And so we'll see you back Monday.

And have a great few days. Work hard. Make up for all

those days you missed.

Thank y'all. See you back then.

(End of proceedings.)


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INDEX - VOLUME 33

WITNESS NAME Page Line

LEANNE TURNER

CROSS EXAMINATION (CONT.) BY ....................... 14 20

CROSS EXAMINATION (CONT.) BY MR. LANIER .......... 82 10

REDIRECT EXAMINATION BY MR. QUATTLEBAUM .......... 91 19

RECROSS EXAMINATION BY MR. LANIER ................. 124 7

REDIRECT EXAMINATION BY MR. QUATTLEBAUM .......... 142 5

RECROSS EXAMINATION BY MR. LANIER ................. 148 3

JIM LANCASTER

EXAMINATION BY DEPOSITION........................... 210 14


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PLAINTIFF EXHIBITS

Exhibit Description Identified Admitted Denied

6 Minutes................. 19

86 Email ................... 87

148 Email ................... 85

154 Email ................... 89

178 Study 7-2008........... 118

338 Article................. 133

638 Proposal ............... 82

1567 Email 2007 marketing . 77

1665 Email,.................. 39Turner/Lancaster

2142 Compendium ............. 108

DEFENSE EXHIBITS

Exhibit Description Identified Admitted Denied

467 DePuy letter to FDA .. 98

5157 Michael Bryant ........ 119publication

5174 Campbell article...... 113

6031 Sontag article ........ 121

934 Compendium ............. 105


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< Dates >April 2001 190:12April 2008 33:3, 33:8August '96 200:25August 2004 130:23July 2002 190:13, 190:18MARCH 2, 2016 1:14, 4:1March 2004 130:13, 130:19, 131:6, 148:15, 148:18March 3rd 4:23March 9th 4:22March, 2016. 222:5November 2000 97:3September 10 205:25September 30, 1996 209:21September 6th 205:17September 9 205:12"one 22:19, 22:22, 83:15#1900 2:45'09 108:15'5 123:3'6 123:3'95 218:18'95. 218:17'96 210:21'97 200:25(reduced 90:10.24 138:17.8. 147:19

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154:4, 172:7, 176:18, 179:12, 190:14, 217:14abnormal 137:9abnormalities 149:9Aboud 214:9above 114:16ABP 195:13Absolutely 12:20, 97:18, 103:12, 161:2, 191:3, 193:14, 200:23abstract 133:6, 133:7, 133:9absurdity 24:24academic 59:8, 155:2, 178:6, 200:8, 216:22, 217:12academics 59:10Academy 33:6, 37:7, 167:4acceptable 90:24acceptable). 90:11Acceptance 100:18, 100:23, 100:25, 148:10access 154:2, 179:6accompanies 103:23accomplished 171:6, 180:13according 56:8accurate 10:10, 10:11, 76:24, 79:20, 110:21, 111:21, 113:20, 113:23, 209:22accurately 110:16, 192:2, 196:23, 210:9Acetabular 102:2, 108:8, 108:21, 109:6, 109:21, 152:8, 152:10, 152:11,

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224

advice 90:18, 91:3advise 4:14, 4:16advised 4:21, 5:1, 5:5affect 16:6, 116:8afraid 60:8, 63:21, 68:7afternoon 6:8, 6:9, 6:14, 7:16, 7:19, 7:20, 7:21, 8:4, 8:23, 9:1afterwards 82:13again. 45:5age 34:7agency 63:5ago 123:13, 142:9agree 15:10, 15:14, 15:18, 17:24, 20:10, 24:7, 48:21, 48:25, 140:2, 156:21, 197:19, 212:4, 213:6, 215:19, 215:20agreed 8:16, 19:20, 79:18agreeing 9:16agreement 12:16, 89:15agreements 8:11agrees 79:22Ah 43:14ahead 82:9, 87:1, 87:4, 98:8, 116:23, 117:13, 192:15, 199:23, 210:[email protected] 1:36ALEX 1:31Alexandria 2:6align 103:17alignment 63:5Allen 2:13, 186:11, 186:23

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117:9, 117:12, 130:2, 138:24, 193:11, 193:13, 193:14answers 14:25, 15:1anterior 81:10anteversion 109:7Anthony 175:10anti-warning 138:19, 138:25anti-warnings 134:21anticipated 26:16, 147:1anybody 26:3, 141:11, 214:22anyway 32:18, 79:11, 82:21, 87:20Aoki 1:10, 81:11apologies 98:6apologize 136:25appear 89:8, 120:5, 120:6, 200:13appearance 27:24, 29:19appeared 204:3appears 42:16, 43:20, 172:16, 201:18, 204:21apples 148:5application 51:10, 99:5, 100:7applications 164:20appreciate 90:2appreciation 204:22approach 81:10appropriate 200:1appropriately 30:1approval 176:18, 189:16, 206:20approve 129:8,

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145:11Asrs 41:16assembled 190:20assess 21:5, 24:14assessing 110:19assessment 21:10, 80:11, 80:15, 83:2assist 85:7Assisted 40:2assisting 38:16, 38:19associated 21:5, 21:10, 24:14, 26:19, 35:6, 73:9, 73:17, 83:15, 83:17, 84:2, 136:6, 206:7, 206:19ASSOCIATES 1:39assume 45:4, 95:1, 210:17assumed 159:11, 165:18Assumes 36:18, 42:20assuming 158:8, 211:25ASTM 167:10, 167:12ate 69:14attached 39:16, 71:19, 89:18, 144:8attack 71:9, 71:14attend 166:23, 167:2, 167:3, 167:6, 167:7, 167:15attendees 106:1attention 72:18, 98:15, 103:13attitude 25:9August 153:1Aunt 157:20Australia 71:7, 71:20, 137:19author 199:1

automatically 197:18, 197:24Autopsy 136:13available 6:8, 7:19, 104:13, 109:25, 110:19, 117:22, 172:3, 190:9, 199:20Ave 2:21, 2:35Ave. 3:11aware 24:3, 72:19, 82:18, 95:3, 116:3, 126:8away 131:4, 135:12

< B >bachelor 151:9, 152:15backbone 77:2background 138:14, 151:6, 155:15backing 12:12backside 102:2backwards 124:14bad 7:11, 23:17, 23:19, 66:22, 131:18, 141:13ball 41:18, 50:15, 51:12, 56:11, 130:12, 152:12, 160:14, 160:15, 160:18, 160:23, 160:24, 162:2, 162:20, 172:14, 181:15bandwagon 61:20Barnes 3:17Barrasso 3:2Barrett 9:17based 31:25, 36:6, 45:16, 126:23, 126:24, 132:5, 156:9, 159:10, 163:2, 170:6baseline 208:13

226

basically 153:11, 160:11, 163:19, 164:4, 166:6, 169:2, 172:15, 179:8, 181:1, 182:20, 185:8Basis 99:17, 101:3, 177:4be. 26:10Bea 157:20Beard 2:4bearing. 75:11Bearings 59:19, 60:1, 62:7, 86:16, 105:14, 105:15, 105:23, 105:25, 106:13, 107:20, 108:10, 109:24, 114:20, 130:5, 135:24, 136:19, 137:4, 157:18, 158:23, 159:9, 160:6, 164:22, 177:14, 181:5, 210:22, 211:6, 211:13bearings. 137:11Beat 193:20, 194:19, 194:21, 195:6, 212:12, 212:14, 212:23, 213:2, 213:7became 77:2, 77:6, 155:21, 170:10, 179:5, 181:1, 211:7began 130:19, 190:7, 208:6begin 157:12, 180:6, 180:18beginning 195:9, 208:16, 210:5, 212:19behalf 150:10behavior 44:14behind 99:8, 177:12believe 27:14, 28:17, 30:1,

36:12, 51:10, 52:16, 66:6, 67:9, 67:22, 68:4, 69:3, 76:3, 87:18, 99:4, 99:15, 102:13, 111:23, 112:7, 113:23, 122:19, 122:22, 133:8, 133:16, 146:19, 146:23, 156:2, 167:13, 188:12, 188:25, 189:4, 190:5, 190:8, 193:14, 197:12, 197:14, 198:16, 198:21, 201:21, 209:3believe. 62:24believed 96:22, 99:8believes 75:3, 98:16belong 208:25below 29:1Beltway 3:32Bend 150:25beneficial 90:2, 162:15benefit 62:5, 62:21, 210:17benefit-to-risk 138:18benefits 35:6, 135:17, 135:18, 138:2, 138:5Berman 61:23, 61:25, 122:21Bernice 214:9best 12:15, 15:4, 74:4, 75:14, 127:19, 183:18best-case 148:10better 29:16, 29:21, 29:23, 29:25, 30:5, 30:16, 30:21, 40:10, 69:7, 96:18, 96:23,

105:7, 123:8, 128:3, 132:13, 155:20, 162:16, 173:5, 204:22, 215:8beyond 49:15, 117:8, 159:1, 164:22, 173:15, 188:18bibliography 110:18Big 33:3, 134:11, 142:14, 146:6, 154:3, 160:3bigger 162:12, 162:22, 162:23, 164:6billions 136:14, 136:20, 136:22biologic 25:19Biological 19:1, 19:20, 26:7, 27:1, 27:20, 27:21, 27:22, 28:5, 30:1, 30:12, 64:11, 111:4, 111:6, 111:11, 112:14, 112:20, 131:20, 132:10, 163:20, 166:11, 183:19, 197:7, 199:1, 204:5, 207:3, 207:9, 217:23biologically 217:14biology 195:18, 200:3, 205:16, 214:7, 214:13, 215:3, 216:23biology/toxicology 205:20, 215:18Biomedical 119:20, 176:6Biomet 150:14, 150:15, 191:12, 195:1, 210:1Bissell 2:34,

3:10bit 4:13, 18:20, 18:21, 23:23, 165:21, 167:19, 177:10bless 4:9blue 52:1, 213:24board 79:13, 79:18, 79:19, 79:22, 90:12, 90:23bodies 163:13Body 18:25, 24:6, 27:4, 51:11, 52:6, 56:10, 83:19, 111:13, 126:15, 163:12, 163:14, 163:18, 163:19, 197:3, 214:16, 216:10, 216:12Bonaventure 2:5Bone 16:5, 16:19, 17:3, 33:3, 69:14, 69:16, 83:21, 114:13, 118:9, 124:18, 131:2, 131:4, 132:1, 132:2, 149:11, 160:22, 176:10, 183:19, 216:7, 216:8bone. 62:11Bono 158:1, 158:10, 158:11, 165:20bore 17:9bottom 26:10, 43:19, 43:23, 108:14, 115:15, 120:2, 120:4, 142:12boundary 53:15, 53:19, 54:12, 59:15, 121:15Box 1:40boxful 33:2Boy 62:15

227

Boyd 2:11brain 39:3brand 8:21, 63:6, 122:16branding 62:14Break 8:20, 17:19, 46:24, 51:4, 81:15, 81:16, 150:1, 184:23, 212:2breaking 139:12Brian 168:18, 215:12briefing 9:10briefly 177:11, 210:17Bring 11:3, 11:14, 12:4, 12:7, 14:5, 56:23, 82:5, 138:14, 216:6broad 117:4broadcast 105:19, 105:24, 106:1, 106:3brochure 33:10, 51:22, 55:20, 120:17, 134:11brochure. 129:4brochures 31:16, 129:5brought 22:23, 103:13BROWN 1:31Bryant 119:12, 119:18, 221:35Bryant119 221:35bucks 135:5budget 21:14bullet 78:17bunch 128:23Burrow 2:44business 76:12, 76:17, 76:19, 77:15, 79:25, 80:12, 80:15, 82:20, 84:6, 85:11, 86:15, 86:22, 153:7buy 61:17, 135:5

buyers 25:16BY14 220:7

< C >calculation 126:24calculations 127:3calendar 22:23call 7:18, 7:19, 31:17, 93:10, 96:8, 122:17, 169:15, 174:11, 214:11Called 38:9, 38:11, 38:22, 48:16, 52:14, 54:7, 56:10, 62:2, 62:10, 73:21, 83:1, 83:20, 108:20, 117:9, 125:7, 125:13, 152:7, 153:10, 157:19, 159:3, 159:20, 160:4, 161:8, 165:15, 165:16, 176:13, 179:15, 181:2, 188:12, 214:24, 218:2calling 138:25, 211:2calls 150:5camera 201:7campaign 108:23Campbell 28:25, 29:6, 29:9, 63:22, 64:18, 67:9, 67:19, 95:7, 111:22, 111:23, 111:25, 113:2, 113:24, 132:19, 132:20, 146:19, 175:20, 175:22, 195:21, 200:2, 207:21, 217:2, 217:3, 221:38Canada 188:8

Cancer 70:6, 70:8, 107:9, 107:11, 199:9cancer. 199:22CANNON 1:38, 1:39canoe 33:10cant 184:16Captain 95:4, 151:14car 50:18, 50:20, 50:23carbon 94:1carefully 15:25, 29:18carried 8:3Cary 71:17case 5:13, 5:21, 8:19, 11:15, 11:16, 20:4, 20:5, 69:15, 84:7, 95:5, 131:5, 145:18, 150:2, 161:23, 219:13cases 118:10, 165:7, 165:9, 193:1, 203:18, 203:24cases. 203:21categorically 74:21category 81:5, 192:22, 193:1Cath 45:1Catherine 44:13, 47:16Cathy 24:15, 45:6, 48:1causal 199:20cause 51:4, 70:1, 112:23, 115:21caused 75:4, 130:14, 143:16, 149:7, 149:8causing 131:12, 137:20, 142:21Cell 28:3, 64:14, 64:21,

65:4, 65:8, 65:10, 66:11, 66:12, 66:15, 66:21, 67:14, 68:9, 115:2, 133:18, 133:20cellular 133:5, 133:12cement 8:23, 16:22, 17:3, 114:13, 118:9, 143:11, 143:13, 196:12cement. 143:3cemented 16:22, 17:3, 117:21, 156:13Center 2:45, 72:20, 74:1, 74:11, 118:6ceramic 87:9, 108:5, 108:18, 128:4, 128:13, 177:15, 181:4, 183:12, 211:11ceramic-on-ceramic 80:3, 80:4, 167:9ceramic-on-metal 125:18, 125:22, 125:24, 128:1, 208:9certain 4:17, 63:11, 215:22, 216:5certainly 5:24, 10:17, 24:24, 60:14, 85:3, 90:22, 174:21, 216:11certify 221:45, 222:2cetera 73:8, 196:15CH 205:5, 205:7chain 46:17, 71:13, 85:21, 132:19chair 155:5, 155:7, 155:12

228

challenge 160:25, 161:3, 163:6challenged 18:23, 64:10challenges 162:25, 163:24, 164:1, 164:8, 164:11, 179:2Chan 60:22, 61:6, 97:9, 110:17, 115:25chance 8:6, 19:5, 63:9, 76:7, 103:4, 191:25change 17:18, 94:7, 99:20, 100:2, 102:1, 141:5, 146:6changed 50:7, 99:10, 141:21changes 101:20, 141:10, 141:11, 174:1changing 11:14, 11:20characteristics 95:9, 99:18, 99:24characterize 27:19, 27:22, 30:12, 40:9characterized 30:2charge 176:6chart 39:16, 42:7, 87:12, 140:3, 140:5, 140:6, 140:10charted 42:6check 24:21, 44:16, 182:17, 182:21checked 45:7checking 209:15Cheryl 205:8, 205:9Chicago 178:7chicken 24:19,

25:7, 26:5choice 13:24, 14:2, 14:4, 135:16choices 159:10choose 36:5, 152:18, 177:17CHRISTOPHER 1:11chrome 94:2, 101:4, 115:6, 149:4, 149:20, 164:18, 164:19, 176:11, 178:19, 179:19, 183:22, 183:23, 190:2chromium 68:23, 74:22, 137:5, 142:21, 197:8Chromosomal 70:6, 70:7, 115:10chromosome 68:25chromosomes 70:11circled 65:14CIRCSH 2:29citation 28:10, 28:17, 28:18, 28:25, 63:24, 69:3citations 10:8, 10:13cite 63:23, 67:9cited 133:21cites 29:7citing 29:10, 67:19claim 52:23, 55:6, 55:9, 55:10, 55:11, 55:16, 55:21, 56:24, 57:3, 57:6, 57:12, 58:4, 58:5, 58:8, 63:16, 69:5, 122:7, 125:24, 125:25, 126:5, 126:7, 126:8, 126:11, 126:14, 126:23,

127:8, 128:13claimed 57:6, 57:16, 58:3claiming 50:1, 57:10, 58:14, 124:15, 128:2, 128:12Claims 49:2, 49:3, 61:11, 126:24clarify 47:13, 57:4, 58:7clean 17:12clear 43:12, 55:11, 60:15, 66:20, 72:25, 95:17, 96:12, 124:15, 130:23clearances 94:3, 95:15, 173:17, 188:9, 189:1cleared 93:16, 94:19, 116:5, 189:4clearly 97:8climbing 121:17clinic 168:10clinically 160:7, 165:11, 189:17clock 123:9, 123:11close 13:1, 177:8closely 56:13clue 27:3, 27:7Coach 33:4, 33:8, 58:10, 124:17Cobalt 68:22, 74:22, 79:21, 94:2, 101:4, 107:5, 115:6, 137:5, 142:21, 149:4, 149:20, 164:18, 164:19, 176:11, 178:19, 179:19, 183:22, 183:23, 190:2, 197:8

cohort 72:20colleagues 72:16collect 41:21collection 105:16, 106:14, 132:2collections 149:7College 176:7, 217:21, 217:23Collier 176:3, 176:5, 176:6, 176:8, 176:9, 183:17Colorado 19:25Columbus 186:11column 115:15combination 74:9, 118:4, 119:11, 120:9, 126:22, 127:25, 130:12, 136:8, 178:15, 179:22, 217:16combined 74:6, 75:10, 137:9comes 44:13, 62:19, 141:16, 165:12comfort 120:11comfortable 120:13, 138:25coming 4:22, 70:3, 74:5, 74:6, 116:13, 130:11, 131:6, 131:13, 158:6, 158:12, 217:17comment 22:16, 44:9, 88:1, 88:4, 89:10, 132:5, 212:19, 219:10commentary 215:10comments 22:16, 22:17, 22:18, 89:8, 139:25, 142:16, 203:20, 219:9

229

Commerce 3:41commercialization 190:12, 190:18commercially 190:8, 195:11common 83:18communicate 62:4communicated 25:14, 25:15, 25:24communicating 25:20, 25:23community 50:2, 61:12, 155:17companies 161:20, 194:24comparative-wise 187:12compare 95:22compared 26:24, 28:1, 64:13, 148:9, 164:5comparing 41:3, 41:6comparison 16:11, 18:9, 100:4, 173:1Compendium 105:14, 105:15, 105:23, 105:25, 106:5, 106:6, 106:13, 107:20, 108:10, 221:24, 221:42Compendium105 221:42Compendium108 221:24competition 193:20, 194:19, 194:21, 195:6, 212:12, 212:24, 213:2, 213:7competitive 194:10, 213:14, 213:20competitors 80:24complete 161:11, 166:2, 170:14

completed 39:7, 156:19, 180:8completely 75:1completion 4:21compliance 5:6, 12:5complication 117:5complications 86:21comply 222:2Component 45:3, 94:12, 96:21, 108:9, 108:21, 109:1, 145:10, 145:11, 154:21, 172:5, 173:6, 181:12, 183:11, 183:12components 17:19, 46:7, 96:7, 96:10, 137:7, 145:13, 145:20, 147:4, 147:24, 164:4, 172:22, 179:9, 185:4, 185:10, 185:18, 187:5, 188:22, 189:2, 193:2, 209:15, 209:16composition 72:5compound 46:23, 131:7compounding 88:3compoundness 46:23computer 3:47concentration 200:9concept 77:18, 177:11, 177:12, 196:22, 197:24, 197:25, 198:21concepts 49:23concern 26:25, 96:20, 111:6, 112:13concerned 11:2, 11:3, 85:10,

86:18concerns 27:5, 83:15, 83:24, 112:14, 136:19, 160:4, 163:4concluded 203:17concludes 210:11conclusion 42:24, 60:9, 92:19, 120:4, 129:22, 130:4conclusions 148:14, 199:17, 203:19concurred 203:20conditions 34:9, 121:16Conditions. 60:3, 121:8conduct 176:1, 184:11, 184:18, 207:21conducted 37:20, 92:25, 93:23, 119:13, 188:18, 194:15, 208:5conducting 193:25, 194:6cone 179:11Conference 222:3confidence 37:14confident 94:6, 94:8, 189:14confined 143:2conical 179:8, 179:10conjunction 209:4connected 35:19, 39:15connection 91:24Conroy 2:19, 2:20consequences 84:4, 84:15consider 195:14, 197:15, 200:15considerable 8:8considerations 138:8, 138:9

considered 73:7, 74:22, 186:3, 200:20, 200:22considering 57:15consistent 9:9, 95:12, 95:14, 111:8, 114:19, 123:1Consistently 93:7, 94:24, 135:19consternation 22:25construct 160:12, 160:13consultant. 22:17Consultants 83:1, 215:11, 215:12consulting 185:19consumed 39:13consumption 104:14Cont'd 14:20CONT. 82:10, 220:7, 220:9contact 59:23, 60:16, 94:18, 99:13, 143:2contain 129:6contained 76:5, 104:1, 104:9, 105:9, 105:10, 109:10contemplated 97:3contents 134:19context 26:14, 55:17, 57:15, 85:19, 103:19, 170:23contextually 121:1Continue 69:1, 78:18, 78:24, 80:2, 87:12, 94:19, 127:20,

230

158:25, 170:12, 170:17, 189:11, 202:23continued 27:22, 45:5, 137:11, 173:12continues 27:19, 28:14, 59:25, 161:2continuing 85:16contribution 89:6, 89:17contributors 110:17control 21:17, 100:21, 145:18, 170:6, 182:17, 208:8, 208:11controlled 92:4, 202:10Conventional 53:15, 53:19, 54:7, 174:12, 174:17conversation 121:6conversations 8:8, 31:7, 128:16, 158:13copied 77:23copies 23:22, 108:15copy 42:10, 44:12, 44:25, 98:9, 98:11, 135:12, 192:12, 192:16, 203:13core 206:7, 214:11, 214:22corner 74:16, 199:3corporate 5:5CORR 116:3correctly 17:24, 48:22, 60:21, 85:18, 131:9correspond 17:5corrode 74:21, 112:18corroded 75:6

Corrosion 74:23, 118:7, 118:10, 119:20, 142:20, 143:1, 143:12, 143:15, 143:20, 149:6, 178:9, 178:14, 186:4, 209:7, 217:7, 217:9corrosive 209:18cost 88:9, 88:15could. 193:17counsel 6:21, 6:24, 8:9, 10:25count 81:25, 124:9countless 31:16couple 50:12, 73:25, 163:10, 204:18, 212:3, 219:16course 47:21, 71:24, 84:7, 123:3, 154:20, 154:21, 163:17, 170:13, 170:21, 172:6, 174:23, 177:18, 178:20, 185:1, 185:5, 185:20, 200:10, 200:18, 200:24, 202:24, 203:3, 204:4, 207:10, 208:18, 211:15courthouse 10:13courtroom. 14:15, 82:6, 150:4covered 40:12, 125:7covers 100:2cracking 123:19create 51:15, 56:10, 126:15, 159:7created 11:11, 12:19, 13:24, 110:20, 191:1creating 213:12Crevice 119:20

criteria 85:1, 100:24, 100:25Criteria. 100:19critical 50:7, 73:2, 73:3, 77:20, 78:25CROSS 5:2, 5:8, 6:4, 8:16, 13:19, 14:20, 82:10, 92:20, 220:7, 220:9cross-examine 8:20cross-link 161:14cross-linked 90:10, 90:23, 161:8, 161:11, 161:13, 161:14, 161:17, 161:21crossed 13:23CRR 3:40, 222:10CSR 221:45cubic 146:4, 146:15, 146:20cups 177:4current 110:19currently 27:21, 72:19, 111:7, 136:17custom 177:4customer/marketplace 39:10, 39:17cut 8:16, 11:18, 63:15, 63:19, 216:8Cutshall 89:5Cvs 11:5cycle 57:18, 120:22, 120:23, 120:24, 127:12, 127:16, 172:15, 174:11, 174:12, 184:23cycles 44:2, 44:7, 44:15, 44:21, 146:3, 147:1, 147:3, 147:4, 147:10,

172:21, 174:3, 174:6, 174:13, 174:15, 187:19, 187:21cylinder 50:24cylinders 50:23cytokines 68:24, 69:10, 69:15, 113:2, 115:13cytokines. 113:1, 115:7, 115:19

< D >daily 162:19, 163:17, 174:6Dallas 1:3, 2:37, 3:12, 3:42, 4:6, 222:13damage 68:25, 70:6, 70:8, 83:21, 115:10damaging 70:10darkness 42:10Dartmouth 176:7Data 28:23, 38:1, 40:13, 44:16, 47:5, 113:14, 138:16, 138:20, 145:16, 199:20database 176:9date 140:5, 199:12, 209:21, 209:23, 209:24dated 101:9, 102:11, 103:2, 201:15, 205:25daughters 151:4day 5:2, 5:7, 5:12, 8:17, 37:14, 37:15, 96:5, 125:1, 222:5days 4:23, 5:17, 5:19, 5:20, 5:22, 5:23, 8:24, 12:14,

231

80:5, 219:16, 219:19, 219:20dead 73:12, 75:3, 149:11deadline 4:21, 7:24deal 163:19dealing 163:13, 211:7deals 214:6, 214:13, 214:19dealt 217:8Death 132:2, 143:18death. 131:4debated 87:22debris 51:15, 83:20, 130:10, 130:11, 130:14, 131:12, 137:8, 163:13, 163:16, 163:20, 163:21, 175:24, 197:5, 198:10, 198:15, 198:18, 198:22, 207:18, 207:21, 208:19, 214:15, 216:10, 216:24, 217:2, 217:14debris. 198:5decade 33:7deceive 97:14December 83:9, 152:3decide 153:21decided 89:1, 155:25, 181:19decides 87:14deciding 129:11decision 14:2, 153:24deck 104:24, 105:3, 105:4, 105:10decks 105:11decrease 45:5decreased 122:6dedicated 42:3, 42:4, 202:4deeper 86:20

Defendant 15:9, 15:13, 15:24, 26:2, 55:8, 63:24, 113:25, 118:15, 119:15, 137:23, 140:3DEFENDANTS 2:33, 8:18, 9:10DEFENSE 5:13, 8:1, 8:8, 13:4, 97:25, 150:5, 221:28deferred 89:15define 23:19, 85:7defined 53:10, 53:17, 154:13, 168:24defined. 85:2defines 206:19definitely 26:23definition 52:25, 53:3, 53:5, 53:8, 146:20, 169:6definitions 53:6, 170:8degradation 112:15, 112:16degree 151:9, 151:18, 152:15, 156:17, 156:18degrees 217:19, 217:21, 217:23deliver 62:9Delivering 80:20delivery 209:21demo 37:7demonstrative 58:10, 133:4Denied 221:3, 221:31DENNIS 3:26deny 13:12department 155:5, 155:8, 155:21, 167:21depend 37:22, 197:3, 197:4, 197:5

Depending 55:17, 146:17, 172:21depends 34:7, 60:3depose 11:4deposed 6:24, 11:1, 215:25DEPOSITION 7:14, 10:18, 39:3, 60:24, 196:5, 204:9, 210:14, 220:21DEPOSITION210 220:21depositions 6:15, 6:18, 6:20, 7:2, 7:8, 7:10, 7:15, 8:18, 8:25, 9:4, 9:21, 10:21, 10:23derived 75:6descending 121:17describe 38:25, 100:8, 122:3Described 28:4, 28:10, 64:15, 65:4, 65:9, 65:11, 66:2, 66:10, 66:15, 67:15, 92:3, 92:14, 104:15, 114:8, 115:3, 121:24, 133:19describes 52:3describing 61:3, 122:22Description 53:11, 100:4, 155:22, 221:3, 221:31deserved 88:24design 6:17, 11:25, 15:8, 15:12, 22:16, 32:21, 49:19, 100:21, 121:19, 160:7, 166:10, 169:16, 173:4,

173:15, 173:17, 177:3, 182:18, 186:4, 190:11, 190:14, 198:14, 198:16, 201:18, 212:6designated 7:8, 7:9designations 6:19, 7:1, 10:20designed 62:15, 72:3designing 201:1, 201:22designs 165:4desired 62:21Despite 26:11, 26:19, 65:2, 114:25, 137:6detail 63:11, 77:24, 121:11determine 18:25, 24:5, 36:9, 94:20determined 93:25, 140:24determining 97:7, 97:10develop 193:16, 212:7, 212:8, 213:10developed 21:14, 153:16, 211:22developing 168:22, 196:2development 79:17, 151:24, 152:5, 152:6, 153:3, 156:11, 156:14, 156:15, 157:10, 168:2, 182:5, 182:18, 182:20, 185:12, 185:21, 191:9, 199:22, 201:14, 204:13, 204:16, 205:3, 210:25, 211:1, 214:2, 214:6, 214:8, 214:10, 214:19,

232

214:25, 215:1, 215:2, 215:5, 215:8developments. 90:7develops 87:13Device 18:3, 25:11, 34:25, 41:4, 41:24, 93:23, 98:19, 98:20, 98:24, 98:25, 99:3, 100:4, 116:6, 117:1, 117:4, 117:20, 122:8, 122:14, 129:8, 139:13, 141:2, 141:3, 141:11, 141:12, 141:13, 143:25, 144:3, 144:9, 144:13, 144:17, 145:3, 176:16, 196:19, 196:20, 202:11, 203:25devices 21:1, 35:7, 95:4, 95:10, 95:22, 117:6, 170:7, 174:3devise 81:4diameter 17:5, 99:20, 163:1, 169:24, 170:2, 170:9, 179:20, 179:21, 179:23, 179:24diameters 135:23, 135:25, 162:12, 170:1diametrical 50:6, 92:14, 93:6, 93:10, 93:11, 93:19, 93:24, 94:6, 95:15, 95:18, 95:21, 96:25, 99:11, 99:22, 101:19, 144:22difference

18:12, 18:15, 18:18, 66:13, 66:17, 92:12, 93:4, 116:5, 173:20differentiator 62:7differently 14:1, 46:7, 49:25difficult 88:13, 120:25dimension 169:15, 179:24Direct 5:7, 6:9, 13:20, 31:15, 49:15, 53:24, 54:3, 54:5, 54:11, 54:23, 59:23, 60:12, 60:16, 143:2direct-to-consumer 87:2direct-to-patient 31:20directed 15:1directly 33:23disabilities 16:20disagree 85:5discipline 182:16disclosing 35:17Disclosure 35:6, 35:11, 35:23, 135:6, 135:7discontinued. 130:24discredit 71:19, 71:23discuss 21:18, 74:2, 84:16, 106:16, 106:18, 158:14, 204:5, 207:8discussed 96:5, 99:25, 114:14, 117:20, 140:20, 202:17, 205:17, 205:20, 206:7,

206:11discussing 20:25, 33:18, 35:15discussion 64:10, 205:13, 205:14, 216:6discussions 90:3, 90:6, 158:9, 158:11, 207:3dislocate 17:19Dislocation 73:17, 160:25, 161:2, 161:12dislocations 16:7disorders 16:19disregard 117:12distraction 123:15, 123:16distributed 105:25District 1:1, 1:2, 1:21, 4:5, 4:6, 4:7, 222:12Division 1:3, 222:13Docket 1:4doctor 33:23, 87:3, 136:14, 175:4doctors 15:7, 30:25, 32:8, 32:13, 32:16, 32:23, 33:2, 37:6, 37:17, 50:1, 50:5, 51:22, 55:1, 58:11, 58:16, 61:12, 85:4, 88:23, 88:25, 124:15, 132:3, 132:9, 200:6, 200:7, 215:17, 218:24, 219:9Document 1:9, 15:19, 16:14, 33:12, 82:24, 83:7, 83:9,

86:8, 86:9, 86:14, 87:16, 90:13, 104:5, 108:20, 110:18, 116:4, 140:21, 191:18, 192:16, 195:16, 199:9, 206:16, 218:11documents 6:25, 11:6, 82:15, 85:13, 140:15, 140:16doing 19:12, 23:25, 34:25, 40:8, 60:23, 69:1, 123:8, 134:18, 160:1, 217:6dollar 138:1dollars 136:14done 6:9, 9:4, 10:23, 13:5, 18:22, 18:24, 21:22, 22:2, 22:5, 23:1, 24:5, 32:11, 41:12, 58:6, 61:7, 61:8, 80:19, 106:2, 106:7, 140:25, 141:17, 144:9, 145:17, 148:8, 151:11, 161:15, 173:25, 183:17, 186:1, 187:22, 188:3, 188:12, 208:14, 217:1, 218:22, 219:18double 88:10double-check 46:18, 47:5double-checked 45:2, 45:23, 47:22down 9:16, 14:13, 17:22, 30:7, 46:24, 51:1, 66:19, 108:13, 120:2, 128:15, 141:16,

233

142:12, 204:13, 212:2downtime 98:8Dowson 155:12, 155:14, 155:15, 155:16, 155:20, 155:25, 156:1, 175:4, 175:6DPA 89:14Dramatically 122:6draw 42:24, 60:9, 72:17, 98:15drawing 102:2, 102:3, 141:23drawings 101:21, 141:5, 141:6drill 30:7drink 197:13Drive 3:32, 50:18driving 39:24, 77:13, 79:4drove 79:25Drs 10:3, 10:21Duncan 155:12, 175:4durability 36:6Duraloc 153:8, 153:13, 153:14, 153:15duration 177:19Durham 175:11, 175:15During 45:4, 57:18, 89:9, 89:10, 89:23, 90:1, 151:17, 152:19, 153:4, 154:23, 156:3, 166:24, 167:16, 172:6, 174:23, 177:18, 178:20, 185:12, 185:20, 190:12, 199:14, 200:10, 200:24, 201:1, 203:3, 204:4, 205:17, 208:18

duty 33:22Dynamic 121:8

< E >E. 3:1earlier 19:5, 22:24, 58:10, 103:2, 104:15, 113:25, 118:21, 125:7, 144:2, 145:8, 145:9, 146:9, 154:6, 163:23, 164:9, 165:2, 169:18, 177:10, 183:23, 191:11, 191:17, 195:25, 196:21, 197:17, 209:3early 76:25, 153:16, 166:19, 196:2, 203:18, 211:9earned 88:24earnest 177:23easier 203:12easiest 49:12easily 9:5, 23:1eating 69:16Ed 1:20, 4:7edge 109:4edge-loading 139:11educate 31:4educated 218:1education 129:4educational 151:6effect 6:21, 9:23, 10:23, 83:16, 93:9, 94:14, 96:1, 96:16, 100:7, 102:8, 116:4, 120:11, 163:8, 207:18effect. 90:14effective 93:21, 94:18, 97:10, 100:1, 100:3,

100:5, 100:15, 191:1effectively 88:17, 99:13, 163:12effects 19:21, 25:20, 68:24, 69:19, 70:5, 83:17, 83:19, 112:20, 115:9, 137:5efficacy 96:17effort 39:14, 61:16efforts 90:2, 134:20egg 24:19, 25:7, 26:5eight 37:21, 76:8, 76:10, 76:11, 76:12either 13:21, 23:1, 110:7, 167:8, 181:4, 200:6Ekdahl 22:11, 22:18, 71:13, 80:19, 89:21elderly 136:16element 185:7, 185:8, 185:11elevated 83:24elicit 112:25, 115:18eligible 98:17eliminate 6:16, 160:8, 198:5, 198:22ELMO 97:20, 98:21, 203:6em 6:24, 78:20, 89:2Email 3:14, 3:35, 22:6, 22:10, 22:12, 22:14, 22:15, 23:6, 44:11, 44:13, 46:17, 47:15, 71:12, 77:23, 78:15,

85:21, 88:7, 89:5, 89:18, 144:8, 221:7, 221:9, 221:11, 221:19, 221:21Email85 221:9Email87 221:7Email89 221:11emails 128:24emeritus 155:11Emerson 5:11, 7:18, 7:22employed 152:24employees 59:9Encouraging 22:16, 22:17, 137:10End 35:5, 39:25, 44:3, 78:21, 78:23, 81:7, 84:3, 85:25, 88:8, 95:25, 134:8, 134:9, 160:19, 160:24, 180:5, 189:4, 219:22ended 191:19Engh 23:2, 168:18, 198:20, 203:20, 215:12, 218:8, 219:3, 219:5engine 51:4engineer 18:10, 40:11, 61:23, 68:2, 152:20, 152:22, 153:3, 157:10, 210:25, 211:1, 217:11engineering 49:3, 54:6, 101:20, 141:23, 151:9, 151:23, 152:16, 152:19, 153:25, 154:16, 155:17, 168:4, 176:6, 182:13, 182:15, 182:16, 182:21, 182:24engineers 59:7,

234

182:18England 46:20, 87:23, 87:25, 88:11, 88:15, 151:11, 154:8, 154:9, 156:9, 171:18, 196:11, 201:16English 60:15enough 113:6, 197:11enroll 176:12enrolled 176:25, 177:2, 180:1, 203:25, 207:24entered 9:7, 9:9enters 14:15, 82:6, 150:4entire 110:18, 200:22, 202:4, 218:1entitled 71:14, 222:1environment 161:16, 170:7equate 174:8, 197:24equates 174:9equivalence 99:17equivalent 93:7, 94:2, 99:16, 100:9, 101:1, 147:12ERNEST 1:38, 1:39especially 45:10, 135:24, 136:1Essentially 60:1, 94:17, 180:5establish 52:10, 74:20, 126:17estimate 162:5, 164:25, 195:12et 73:8, 196:14Europe 6:12, 172:4, 173:8, 173:12

evaluate 184:25, 185:3evaluation 174:16, 201:13event 48:17events 5:6, 17:17everybody 16:16, 20:16, 20:17, 68:21, 86:24, 90:25, 137:20everyone 204:20Everything 6:12, 10:23, 12:10, 13:21, 26:23, 35:1, 51:12, 59:2, 131:5, 134:24, 141:17, 166:10everywhere 123:17evidence 4:22, 36:18, 42:21, 84:19, 90:13, 137:7, 137:8evidenced 89:19exact 28:21, 29:7, 69:12, 86:9, 130:7Exactly 7:4, 10:19, 25:21, 38:24, 39:15, 56:19, 60:10, 69:3, 109:1, 133:25, 141:24, 145:16, 149:5, 209:23EXAMINATION 14:20, 82:10, 91:19, 124:7, 142:5, 148:3, 220:7, 220:9, 220:11, 220:13, 220:15, 220:17, 220:21examined 27:23, 29:19, 64:12example 7:8, 25:19, 25:24, 50:18, 58:22,

81:11, 89:4, 124:17, 181:6, 218:7exceeded 146:4Except 9:16, 65:18excessive 142:20exciting 62:6Exclusive 56:8, 56:9, 56:14Excuse 13:7, 65:3, 66:17, 72:23, 78:1, 139:15, 185:4exemption 176:16exercise 7:4, 10:16, 10:17, 62:6exhibited 95:11exhibiting 73:15EXHIBITS 199:24, 221:1, 221:28existing 78:18, 78:24expanding 39:10expect 13:23, 45:25, 47:9, 47:11, 47:15, 47:18, 93:14expected 48:16, 146:15expecting 130:22, 217:13expects 5:5, 5:7experience 36:7, 72:19, 116:8, 116:17, 116:18, 116:24, 135:19, 152:19, 159:12, 159:15, 190:17experiment 25:17, 25:18experimental 27:15experimenting 31:3, 36:10, 36:12expert 116:12, 116:16, 117:9, 217:4

expertise 117:10, 195:18, 214:17, 214:23, 215:3, 215:18, 215:22, 216:5experts 13:22, 174:24, 177:25, 185:19, 214:18, 216:22, 217:17Explain 49:23, 94:5, 100:15, 128:20, 145:8, 145:9, 151:5, 155:3, 163:11, 172:10, 174:5, 177:11, 181:11, 197:2, 209:12, 211:25explained 49:9, 50:12, 129:2explaining 100:19explanation 197:21explanted 95:3exposure 137:5Extensive 72:3, 73:9, 74:20, 110:18, 183:3extent 55:17external 214:18, 215:11, 216:22extra 23:22, 44:12extrapolating 141:1extremely 90:2, 129:23, 146:4extremity 79:13

< F >face-to-face 89:24faced 60:22, 164:9facilities 187:25facility 23:2, 172:17, 187:17,

235

187:24, 188:2facing 166:15fact 19:19, 20:15, 24:3, 30:17, 37:20, 39:16, 40:13, 44:11, 44:20, 51:22, 55:4, 61:15, 69:7, 69:23, 77:13, 80:11, 82:18, 85:9, 97:5, 104:5, 125:5, 152:20, 194:21, 195:6, 196:13, 198:17, 200:18, 204:5, 205:12, 205:16, 208:24, 218:6factor 96:18, 96:23factors 34:8, 202:10facts 36:18, 42:21faculty 155:24failed 74:20failed. 72:5failure 73:14, 115:21, 135:21, 142:20, 149:10, 192:20, 196:12failure. 70:2Fair 7:25, 15:3, 18:7, 47:19, 47:20, 64:11, 76:6, 91:5, 113:6, 155:21, 200:16, 214:20, 214:21, 215:4, 216:16fairly 192:2faith 8:11falls 16:5, 16:19false 55:9, 55:10, 55:15, 55:18, 57:17, 140:25falsely 54:25

falsify 103:15fame 85:25, 88:8familiar 22:14, 24:22, 31:19, 33:13, 37:9, 37:11, 41:8, 60:8, 61:19, 84:24, 121:3, 126:3far 8:11, 215:25Farrar 196:11, 196:14, 196:17, 196:19fast 37:12, 99:6fast-forwarding 85:21fathered 155:18Fatigue 184:18, 184:20, 184:21favorable 136:8Favors 135:23FDA98 221:33feature 92:3, 126:14, 179:3February 108:15feedback 89:25feel 11:11, 171:5, 191:1feeling 56:13feels 62:4, 102:9fees 222:2Fehring 6:16, 7:7, 7:8, 9:1, 10:21, 11:7fellow 12:5, 85:23, 171:8, 171:14, 217:8felt 96:18, 183:18female 136:16femoral 72:14, 73:5, 119:9, 120:14, 137:7, 142:21, 143:2, 143:12, 143:20, 162:16, 169:17, 169:18, 171:1, 181:15, 190:2femur 160:16,

160:21Fenning 168:18, 215:12, 218:8, 219:3, 219:5few 21:11, 159:22, 203:17, 219:19fewer 27:25, 29:20, 29:25, 30:13, 30:14, 64:13, 69:7fight 11:9figure 38:13, 38:15, 80:1, 84:17figured 137:19figures 40:5, 148:8file 28:23, 141:1filed 9:10, 13:13film 49:4, 50:10, 52:10, 52:15, 52:16, 52:18, 52:19, 52:25, 55:1, 55:12, 56:20, 56:25, 57:6, 57:11, 57:17, 57:23, 58:14, 59:15, 59:16, 59:22, 60:16, 63:16, 121:16, 122:10, 122:12, 125:25, 126:6, 126:11, 126:15, 126:17, 127:9, 127:10, 127:19, 128:9final 44:8, 83:12, 139:23, 170:24, 186:3Finally 39:5, 134:8, 194:10financial 85:15financially 83:3find 24:20, 25:8, 25:12, 33:16, 36:16,

37:3, 46:19, 64:6, 64:25, 78:19, 80:8, 113:6, 125:9, 132:21, 161:21, 212:16findings 137:9finds 48:1fine 60:12, 76:6, 123:16, 123:17, 134:24, 178:16, 198:9finish 5:3, 6:6, 6:10, 7:21, 14:22, 156:16, 169:8, 169:9, 170:9finished 11:15, 137:18, 156:21Finishing 140:23, 170:20, 170:23, 170:24Finite 185:7, 185:8, 185:11Firm 1:32, 3:31First 26:10, 26:12, 47:15, 77:1, 82:17, 92:16, 93:16, 96:5, 103:19, 110:25, 111:2, 114:20, 135:1, 135:2, 135:3, 135:14, 152:23, 162:3, 164:14, 190:3, 201:18, 201:22, 202:14, 202:18, 202:21, 203:1, 203:14, 204:18, 209:21, 210:2, 212:4first-generation 96:9Fisher 2:10, 2:11, 58:22, 58:25, 155:2, 155:4, 155:5, 155:13, 155:19, 155:23, 175:2fit 7:15, 102:2,

236

160:20, 164:7, 181:12, 192:21, 192:24, 192:25fits 17:6five 13:5, 13:22, 13:23, 124:9, 172:21five. 12:15fixing 137:3flip 64:24Floor 2:13, 2:22flow 64:1fluid. 124:21fluids 175:23FM 1:33focus 39:10, 39:17, 49:25, 154:10, 154:11, 192:18focused 31:13, 191:10, 200:9folks 13:21, 30:2, 96:22, 200:1follow 76:16, 82:22, 90:4, 90:5, 202:12follow-up 72:21, 203:19followed 73:25, 83:11, 89:18, 165:5Following 62:12, 62:13, 75:2, 88:9, 168:17, 199:9fool 97:18, 101:7, 103:11football 151:12footnote 63:23, 65:13footnoted 38:1force 9:11, 104:25, 105:8, 113:18, 184:9forecast 63:14foregoing 221:45, 221:46foreign 83:19, 163:13

forget 31:11forgot 14:8form 10:4, 171:21, 171:23, 212:20, 213:17, 217:17format 222:2formulated 158:19Fort 150:25forward 6:3forwarded 22:15found 16:24, 27:25, 30:13, 55:12, 64:13, 65:23, 118:3, 118:6, 119:11, 121:12, 129:19, 133:21, 142:14, 145:21, 148:15foundation 92:16, 92:17four 8:24, 13:22, 13:23, 82:15, 151:14four-day 8:20fractions 16:6fracture 73:18, 163:5Fractured 196:11fractures 149:10fragments. 142:24frame 21:13, 43:25, 44:1, 153:5, 153:16, 165:1, 177:19, 177:24, 188:25, 190:12, 200:24Frank 60:22, 97:9, 110:17, 158:1, 158:9, 158:11, 158:13free 62:2, 62:18, 62:21freedom 62:4Freeman 3:3fresh 39:3friction 59:24, 60:2, 60:4,

60:18, 62:9, 96:3, 96:7, 121:22, 121:24, 121:25, 154:14, 175:16, 175:17Friday 13:5, 13:6, 50:7front 64:3, 128:18, 133:22, 135:10, 181:6, 181:17fulfill 39:7full 8:17, 18:3, 26:7, 27:1, 27:21, 33:12, 44:9, 49:4, 52:16, 52:18, 52:19, 53:11, 55:1, 55:12, 55:17, 56:25, 57:6, 57:11, 57:16, 57:23, 58:14, 59:15, 63:16, 85:19, 87:1, 87:4, 111:6, 122:10, 122:12, 125:25, 126:5, 128:9, 131:20, 132:9full-time 152:17, 152:25, 156:22, 156:23Fully 51:17, 51:18, 52:8, 52:20, 52:23, 54:20, 55:13, 56:15, 56:19, 56:20, 57:25, 58:12, 58:13, 60:17, 61:4, 61:13, 124:20, 124:21function 62:3, 62:21, 204:16, 205:3, 205:7, 206:6, 206:8fund 78:18, 78:24, 118:13fundamental 98:18, 99:2

funding 22:7, 23:2, 78:20, 78:21, 78:23futile 7:4, 10:16, 10:17future 159:4, 159:6, 159:7, 159:12, 177:9, 177:12, 177:18, 177:19, 177:21, 178:10, 178:25, 179:1, 180:5, 181:2, 186:2, 209:4future. 39:9

< G >gained 134:18gaining 80:23, 81:6gait 57:18, 127:12, 127:16, 174:11Game 7:3, 85:25, 88:8gave 9:3, 10:12, 16:15, 23:3, 23:17, 94:17, 135:12, 140:8, 140:10, 183:18, 191:22, 193:21gee 29:15general 17:17, 20:22, 28:3, 35:14, 67:13, 152:9, 156:14, 174:9Generally 74:22, 110:7, 162:7, 162:15, 172:10, 172:25, 186:24, 191:8generated 75:10, 163:16generating 173:4generation 114:18, 114:21, 127:10, 164:9, 164:14, 165:2,

237

166:20generations 163:23gentleman 14:19, 219:13gentlemen 215:16, 218:11geometry 94:2getting 14:3, 86:20, 89:7, 123:11, 136:17, 151:17, 156:3giant 28:3, 64:14, 65:4, 65:8, 65:10, 66:11, 66:12, 66:14, 66:21, 67:14, 68:9, 115:2, 133:18, 133:20Gilbert 178:3, 178:5, 178:6, 178:10, 178:12, 185:23, 185:25, 195:22, 200:1, 209:4, 217:6, 217:8, 217:13gimmick 61:15, 62:25give 13:16, 15:7, 23:21, 31:2, 37:6, 49:18, 53:5, 53:8, 55:8, 55:19, 86:5, 86:8, 88:25, 89:2, 177:16, 192:15, 193:11, 219:17given 10:4, 11:5, 11:6, 13:17, 16:17, 33:22, 83:10, 89:1, 92:17gives 53:3, 62:3giving 37:24, 85:4, 91:3global 190:6goal 171:2, 198:12

God 4:9Goldsmith 171:12, 171:13, 175:6goodness 12:9gotten 10:2government 89:14gracious 89:23graduate 151:10, 153:22, 154:4, 154:7, 155:14graduated 151:7, 152:3, 152:15Graham 85:23, 88:7grant 23:4graph 43:11, 144:8, 145:4, 145:7, 147:6, 147:23Great 15:7, 34:3, 89:23, 121:11, 139:3, 219:19greater 43:16, 130:23greatest 62:6Greer 1:12, 95:4grew 150:23Griffin 6:16, 7:7, 7:10, 7:18, 9:1, 10:21Grooms 2:44gross 88:14, 135:20ground 87:7group 21:17, 25:17, 25:18, 27:15, 37:18, 39:6, 151:24, 152:6, 156:11, 157:11, 166:21, 167:7, 168:17, 171:19, 191:9, 218:1grow 150:22, 183:19Growth 80:20, 81:1guess 210:16

guinea 25:3, 31:3guy 12:4, 12:5, 12:7guys 29:13, 216:3, 216:8

< H >H. 1:38, 3:16Haas 10:14, 10:15, 21:16, 22:5, 22:6, 22:17, 168:18, 203:17, 203:20, 215:12, 216:1, 218:8, 219:3, 219:5Haases 219:5half 7:9, 14:23, 85:22, 86:19, 107:14, 147:13, 147:14, 147:15, 147:16, 150:16, 169:22hand 105:13, 108:7, 113:24, 119:15, 121:5, 192:11, 196:4, 201:4, 204:8, 205:23, 206:13handed 58:24, 75:25, 78:2, 126:12, 134:8, 139:8, 142:9handing 11:9, 79:10, 82:24, 107:17, 192:13handle 129:7handout 134:11handwritten 101:19, 102:8Hang 98:3, 212:21Hanly 2:20happen 25:17, 27:4, 48:24happened 6:13, 11:4, 11:5, 48:23, 143:10,

178:24happening 21:11, 46:20, 129:2happens 124:25, 141:13happy 13:2, 13:16Hard 36:24, 42:9, 43:21, 44:8, 44:25, 219:15, 219:17, 219:19Hard-on-hard 79:22, 121:7Hardaker 44:13, 47:16hardened 8:24harder 83:22hardly 137:7hardness 170:3, 170:4, 170:5, 170:9, 184:25harm 85:15Hastings 205:8, 205:9Haztech 83:1, 85:6head 17:6, 41:18, 74:12, 87:17, 88:9, 92:10, 92:11, 93:5, 119:10, 120:9, 141:18, 155:21, 160:18, 162:15, 162:16, 163:1, 164:5, 164:6, 169:7, 169:17, 169:19, 169:20, 170:1, 171:1, 171:2, 173:21, 179:20, 181:15, 181:22, 190:2Head-to-head 144:11, 144:12, 144:13, 144:14, 145:2headed 80:19headquarters 171:17

238

heads 162:8, 162:22, 162:23, 163:7, 163:8, 170:17health 24:1healthy 51:24, 52:9hear 58:18, 76:7, 82:23heard 8:5, 8:7, 8:22, 62:15, 111:24, 146:9, 161:23hearing 134:24hearsay 60:25, 83:4height 127:9heightened 166:13held 167:9Help 118:13, 148:7, 182:21, 217:17helped 9:11helpful 10:5helping 152:22helps 52:9, 56:10, 65:24hide 22:7, 141:5High 16:5, 16:18, 45:9, 45:21, 46:10, 59:24, 60:18, 71:18, 86:20, 88:15, 94:1, 95:25, 96:7, 101:4, 137:23, 147:16, 151:7high-level 135:25higher 42:11, 43:4, 43:6, 43:9, 75:4, 77:10, 80:24, 137:6highest 42:14Highlighted 65:18, 102:5, 201:8, 203:14, 204:25, 206:15,

219:11highlighting 199:16, 204:13highly 17:9, 117:21, 149:20Hintner 45:1hips 21:5, 21:21, 33:4, 62:14, 72:20, 73:24, 73:25, 77:24, 85:16, 86:25, 95:10, 113:15, 120:20, 126:14, 136:13, 165:7, 191:10hired 59:4HIRSCHHORN 2:28histological 66:1, 66:9, 67:4, 67:5, 67:16, 68:12, 111:12, 114:6, 114:7, 142:22, 142:23histology 114:14, 114:17, 137:9historical 192:19HOEKSTRA 2:3hold 149:16hole 184:9honest 134:17, 145:25honestly 27:14honing 218:6Honor 4:13, 5:19, 8:6, 9:8, 9:14, 12:21, 13:12, 14:16, 33:20, 34:15, 36:19, 42:20, 46:22, 49:14, 60:25, 70:7, 72:23, 81:14, 81:25, 82:4, 83:4, 84:10, 84:20, 86:10, 91:8, 91:13, 116:11, 116:17,

117:7, 123:5, 123:10, 123:25, 137:1, 141:25, 147:25, 148:2, 150:9, 210:11Honorable 1:20, 4:6, 4:9hope 24:13horrifically 103:16hospitality 89:23host 197:3hour 6:6, 7:9, 7:11, 14:23, 92:19hours 6:5, 7:10, 8:9house 23:1Houston 1:34, 2:14however. 63:23, 132:14, 133:22Huguenard 2:12human 148:9hundred 177:8hundred. 177:2hurt 24:6, 26:6hurts 18:25, 27:16, 130:10Hypersensitivity 68:25, 69:24, 70:1, 115:10, 115:20, 138:16hypersensitivity. 69:20

< I >IDE 19:10, 19:25, 116:5, 116:24, 176:13, 176:15, 176:16, 176:24, 202:1, 203:10, 203:18, 206:19, 206:24Ide/clinical 205:2idea 155:18, 159:7, 160:6,

162:11, 177:13, 181:2Ideal 21:15Identified 20:5, 101:12, 118:15, 121:5, 221:3, 221:31identify 71:22, 100:20IFU 104:1, 104:3, 104:4Ifus 32:15, 32:17, 32:18ignore 134:3, 193:7ignored 211:22, 213:21III 201:9, 201:11, 206:21, 206:22illustration 52:1immediately 189:5, 189:9immune 112:25, 115:18immunohistochemical 68:22, 115:5impact. 84:6imperative 92:6IMPLANT 1:5, 21:16, 70:2, 73:10, 111:18, 115:21, 130:21, 130:24, 143:18, 177:4implantations 190:10implanted 159:17, 177:7, 190:4, 202:11implanting 21:23, 190:11, 203:2implants 26:15, 27:24, 106:15, 111:14, 130:14, 136:7, 216:12, 216:13implemented

239

89:10implications 84:25, 112:15Importance 71:18, 108:8, 108:21, 139:9Important 8:10, 33:25, 34:5, 35:12, 92:8, 129:21, 136:18, 138:6important. 18:1impressions 173:22Improved 50:10, 51:23, 51:25, 53:8, 122:3, 122:4, 127:9, 128:3, 128:8in. 14:5, 26:9, 62:19, 82:5inaccurate. 88:9Inadequate 92:17INC. 1:5incidence 26:16, 138:17inclination 109:7include 18:2, 83:19, 106:21, 117:4, 135:18, 206:22, 215:12Included 22:18, 77:16, 104:14, 109:23, 109:24, 131:1Including 68:24, 69:19, 71:13, 88:7, 106:25, 115:9inclusive 166:2income 80:9incorporate 181:3increase 194:3, 212:15, 213:3, 213:4, 213:8increased 45:4, 90:8, 113:14, 113:16, 212:23

independent 74:19INDEX 135:2, 220:1Indiana 150:23, 157:9, 188:2Indianapolis 3:19indicate 72:16, 166:13indicated 68:22, 69:10, 115:5, 146:19, 191:4indicates 60:15indicating 60:6, 75:7, 147:10, 181:13indication 161:10, 166:19indications 209:18individual 34:6, 145:20, 197:4individuals 215:21induce 68:23, 115:6industry 166:14ineffective 102:9infection 16:7, 17:20, 73:7inflammatory 112:24info 18:2Information 18:4, 21:5, 21:10, 24:14, 24:18, 25:6, 33:25, 34:5, 35:12, 71:23, 85:7, 103:15, 103:18, 103:20, 103:21, 103:22, 103:24, 104:1, 104:6, 104:9, 104:10, 104:11, 104:14, 105:9, 105:10, 105:16, 108:8, 110:21,

116:2, 159:23, 204:20ingrowth 183:19initialed 101:9initially 94:10, 188:15initiation 206:23initiative 79:16ink 213:24inner 17:5inputs 174:1insert 153:17, 171:1, 171:2, 178:13, 178:19, 179:19, 181:20, 183:21, 185:16, 186:15, 186:18, 187:2, 189:22, 190:1inserting 184:7, 184:21insertion 15:16, 15:20, 16:1, 32:22inserts 181:4inside 50:24, 160:21, 163:13, 179:20, 181:13, 181:16, 181:21, 181:22insight 39:7, 62:1insightful 89:25INSKEEP 3:16inspects 141:16, 141:17instance 57:8, 163:15, 164:5instances 166:17instead 8:18, 54:20, 67:3, 74:13, 86:24instructed 39:9, 117:12instruction 90:18instructions 103:24instrument 152:8

instruments 153:11intended 62:14, 98:18, 99:18, 138:14intent 138:5intention 35:14, 100:8intentionally 97:14, 103:5, 103:8, 103:11, 103:15interact 162:11, 178:13interaction 53:24, 54:3, 54:5, 54:11, 54:19, 54:23, 59:16, 60:19, 125:8, 125:14interest 16:12, 33:16, 39:1interesting 43:18, 45:9, 74:11interface 116:14, 118:8, 143:12, 182:20, 183:18, 185:15, 185:18interior 92:11, 99:20intermediary 33:23intern 151:23, 152:1, 152:2, 152:4, 152:20, 153:25internal 38:1, 63:4, 168:7, 195:17, 204:4, 206:25, 214:10, 215:2, 215:5, 215:7, 215:8internally 45:15International 156:7, 156:10, 156:23, 156:24, 171:17, 171:18, 188:1

240

interpretation 5:14, 5:23intracellularly 112:18introduce 150:9introduced 105:21, 162:4investigate 170:17, 189:11, 209:7investigated 72:4, 73:19investigating 131:24investigation 73:21, 74:3, 74:15, 74:19, 74:20, 118:19, 119:25, 130:18investigation. 74:17investigational 117:1, 117:4, 176:16investigations 75:2investigators 203:10, 203:11involve 184:6, 189:25, 190:1involved 42:10, 89:21, 104:3, 104:15, 104:20, 104:22, 129:10, 153:8, 213:12, 213:13, 218:14involvement 105:2involves 108:2, 135:16involving 108:5ion 21:1, 22:23, 24:1, 78:18, 84:13, 90:9, 90:24, 137:6ionosis 142:21, 143:15, 149:7Ions 24:21, 26:8, 27:1, 75:5, 83:25,

107:3, 111:7, 112:17, 112:24, 115:18, 131:1, 131:6, 131:13, 131:19, 131:25, 137:5, 137:19, 143:5, 143:19irresponsible 103:16Isaac 85:23, 88:8iso 121:18issue 15:6, 21:4, 21:9, 23:8, 23:13, 24:12, 33:7, 74:9, 84:14, 88:18, 96:4, 97:14, 97:16, 101:6, 103:18, 109:9, 110:12, 118:2, 118:3, 118:5, 118:6, 118:11, 119:10, 119:21, 121:21, 142:17, 211:24, 216:1issued 134:10Issues 22:19, 22:22, 25:19, 51:19, 96:9, 107:15, 107:25, 108:18, 111:4, 149:1, 161:12, 196:14, 198:3, 199:1, 200:2, 200:15, 200:20, 202:23, 204:6, 205:14, 207:4, 207:8, 207:9, 211:19, 214:14, 214:20it. 71:22, 130:22itself 70:1, 97:12, 110:10, 115:20, 120:8, 141:1, 197:9, 202:2itself. 120:7

< J >J&J 70:20, 210:1J. 3:40, 221:45, 222:9, 222:10JAMES 3:30January 152:17, 152:25Jayne 2:19, 68:18, 70:[email protected] 2:25JENNIFER 2:3Jeremy 178:3, 178:5, 178:6, 185:23, 195:22, 200:1, 217:6, 217:8, 217:13JIM 39:4, 97:20, 150:5, 150:12, 193:4, 194:18, 210:12, 210:14, 210:19, 220:19JL 194:18, 204:13job 11:20, 93:2John 3:25, 58:21, 58:25, 155:2, 155:4, 155:5, 168:18, 175:2, 176:3Johnson 2:11, 23:3, 59:1, 80:16, 128:19, 128:21, 128:22, 128:23, 149:12, 178:21, 179:4, 179:5, 179:15, 195:1Johnson/depuy 59:1join 171:9Joint 16:19, 33:3, 52:9, 83:3, 83:16, 83:18, 84:2, 124:18, 152:11, 152:12, 160:12, 160:14, 162:17,

172:13, 172:14, 174:14joints 51:24, 79:13, 83:23, 84:1Jorge 21:18Journal 33:3, 33:6, 37:7, 58:11, 124:17, 166:4journals 87:3Judge 1:21, 4:7, 12:10, 75:8, 80:13, 85:1, 92:15, 98:7, 123:14judgments 85:8Judicial 222:3July 85:22, 118:20, 157:5, 200:25jump 88:9jumps 43:23, 44:20jury. 4:10, 81:23

< K >Keep 14:25, 26:14, 44:11, 63:13, 73:4, 79:23, 112:6, 142:25, 192:15keeps 56:[email protected] 3:21KENNETH 3:16key 77:13, 78:25, 79:4, 130:8, 131:12kick 97:7kids 151:3Kilburn 71:13kill 197:13killed 131:1, 131:2, 132:1Kind 8:22, 24:18, 25:6, 25:13, 37:6,

241

38:7, 38:11, 42:9, 54:14, 55:23, 55:24, 56:2, 56:5, 56:6, 56:9, 62:8, 90:17, 123:17, 150:25, 155:18, 160:17, 166:1, 166:9, 170:24, 174:1, 177:22, 177:23, 184:16, 184:22, 186:2, 209:18, 214:10, 214:17kinds 53:13Kindsfater 9:17Kingdom 175:11Kinkeade 1:20, 4:7Klusmann 1:13, 95:4Knee 199:10, 199:21knowing 82:19, 196:24, 198:12knowledge 81:13, 103:12, 216:5, 216:12knowledgeable 215:22known 26:20, 70:1, 96:8, 111:4, 115:20, 117:6, 188:11knows 123:17Kupperman 3:2Kurring 88:1, 88:4, 88:7

< L >lab 23:3, 23:4, 59:2, 59:3, 175:15, 175:17, 217:2labeled 17:2, 82:24, 105:4labeling 18:3laboratory 161:16

lack 84:19, 105:7, 155:19Ladies 14:19, 219:13lady 33:10LANCASTER 39:4, 150:5, 150:11, 150:12, 191:17, 193:4, 194:18, 201:8, 210:12, 210:14, 210:19, 210:21, 220:19language 28:5, 28:22, 29:7, 37:2, 65:17, 67:12, 67:22, 68:17, 68:20, 112:7, 130:7, 133:7, 136:4, 136:11, 199:16, 203:14, 204:25, 206:15, 207:13, 212:11, 213:19LANIER124 220:13LANIER148 220:17LANIER82 220:9lap 170:25lapse 132:12large 65:1, 65:3, 114:25, 135:23largely 7:4larger 26:21, 26:24, 83:24, 135:24, 162:8, 162:15, 162:16, 163:1, 163:7, 163:8Last 11:10, 26:12, 40:12, 62:2, 62:10, 76:8, 85:23, 88:22, 111:5, 113:12, 117:12, 142:1, 142:13, 143:4, 151:14, 209:20late 44:1, 73:17, 153:16, 188:25, 190:5

later 8:24, 14:12, 86:19, 89:13, 106:8Laughter 123:23, 124:3, 149:25launched 188:15, 195:11Law 1:32, 3:31, 11:10, 33:22lawyer 18:11, 128:21, 149:17lawyers 219:15laxity 95:19layer 56:10lead 149:10, 159:11leader 158:8, 180:23, 181:25, 210:22, 211:2, 211:3, 211:4, 211:6, 213:16, 214:3, 214:4, 214:5, 218:16leadership 165:19Leading 37:21, 96:13, 100:12, 102:18, 109:17, 110:2, 121:8, 143:7, 146:10LEANNE 22:11, 79:16, 89:21, 91:21, 220:5learn 27:15learned 33:22, 131:19least 11:1, 21:16, 25:9, 83:13, 90:25, 210:21, 211:16, 213:6leave 73:3, 82:13, 103:4, 103:6, 103:7, 132:14, 191:14leaving 158:5, 192:6lecture 154:20led 143:15LEE 2:29

Leeds 58:22, 97:5, 151:11, 154:8, 154:23, 155:6, 156:1, 156:9, 171:9, 171:15, 171:17, 172:17, 175:2, 187:16, 187:24, 188:1, 188:4, 209:22Left 23:15, 42:7, 68:20, 68:21, 69:2, 69:4, 72:24, 74:1, 75:17, 75:19, 81:15, 82:1, 115:15, 123:6, 124:13, 155:12, 191:11, 193:15left-hand 146:2leg 125:2, 160:15LEONE 2:30Less 31:19, 69:6, 101:1, 121:24, 121:25, 145:12, 173:4, 186:2letter 71:19, 72:13, 97:23, 221:33level 22:23, 34:8, 36:6, 50:15, 60:2, 116:18, 117:2, 120:11, 186:19, 215:22, 216:4, 216:5levels 16:5, 16:18, 21:1, 75:4, 107:5, 113:14, 113:16lever 184:16Lever-out 184:11, 184:14Lewis 78:15LIABILITY 1:6, 84:6, 84:7Liddell 2:34,

242

3:10life 37:15, 174:7lift 127:13lifted 213:11light 74:4likewise 208:25limit 6:4, 6:5limiting 34:9limits 7:14Line 24:12, 42:14, 43:19, 43:22, 43:23, 60:24, 77:14, 135:3, 140:19, 145:5, 220:3liner 41:18, 50:15, 51:14, 74:13, 77:9, 92:11, 92:12, 99:23, 118:22, 118:24, 119:9, 120:10, 130:12, 141:18, 141:21, 169:7, 179:21, 181:16, 184:8, 184:10, 184:14, 184:16, 184:21liners 109:22, 163:5lines 12:24, 26:4, 79:4, 89:25, 145:16lines. 79:1link 23:5, 62:20, 62:22, 199:21list 39:6listed 28:19, 40:4, 132:20, 141:23, 198:25, 208:24, 213:16, 214:3, 214:22, 215:6, 218:4literature 27:6, 38:25, 59:13, 70:3, 70:4, 110:16, 110:19, 116:3, 158:22, 159:1, 165:5,

165:21, 166:23, 207:18literature. 69:1, 115:11LITIGATION 1:6Litsky 186:11, 186:23Little 2:46, 4:13, 8:12, 18:20, 18:21, 23:23, 41:17, 49:25, 54:14, 165:21, 167:19, 177:10, 187:1live 5:10LLC 2:20LLP 2:12, 2:34, 3:10, 3:17load 51:18, 52:20, 52:23, 54:10, 55:13, 58:13, 60:17, 61:4, 61:12, 124:21, 125:6, 184:23load-bearing 52:8loaded 186:16loading 45:11, 48:3, 109:4, 184:22loads 52:20local 60:3, 136:19, 137:4localized 83:21located 33:5location 33:21locations 187:23lock 179:9, 181:21Locke 2:34, 3:10locking 99:19long 7:10, 63:4, 84:5, 98:9, 127:20, 150:15, 152:23, 156:24, 158:2, 164:24, 173:9, 195:9, 195:11Long-term 84:13,

137:5, 165:6, 204:24longer 13:20, 203:19, 205:4looked 15:7, 15:15, 18:7, 26:1, 30:13, 37:2, 58:10, 81:3, 81:5, 106:11, 152:6, 165:23, 173:25, 176:9, 178:12, 178:13, 183:17, 203:18, 209:11, 211:16, 218:9Looking 15:19, 18:14, 44:14, 64:5, 65:15, 89:14, 104:5, 114:22, 121:19, 139:9, 146:3, 146:5, 152:5, 157:15, 167:10, 175:16, 186:4, 214:12, 214:13, 216:24, 217:2, 217:3, 218:25looks 86:8, 132:12, 138:12, 146:6, 172:20, 199:13, 203:9loose 17:19loosening 196:12Lord 2:34, 3:10lose 98:7, 127:21losing 87:7lot 58:21, 59:1, 134:18, 152:5, 152:7, 153:6, 153:9, 155:23, 175:15lots 141:13Louisiana 2:6, 3:5low 26:15, 45:9, 45:22, 46:10, 77:6, 84:14, 88:14, 93:7, 94:3, 94:21,

94:24, 95:11, 111:3, 114:19, 129:23, 135:19, 137:10, 137:23, 138:17, 146:1, 146:4, 146:20, 147:24, 192:19lower 26:19, 74:16, 93:8, 95:24, 145:3, 145:13lubricant 51:5lubricated 59:22, 60:15lubricates 52:8lubricating 51:18, 52:21, 53:1, 55:14, 56:15, 57:25, 58:13, 61:5, 124:21lubrication. 54:7, 126:16lunch 81:15lymphatic 196:13, 196:16, 196:18

< M >M. 2:3, 3:30machine 45:10, 48:3, 55:15, 148:9machines 41:14machining 170:25Macrophage 28:3, 64:14, 65:3, 65:8, 65:10, 66:4, 66:11, 66:12, 66:14, 66:21, 67:13, 68:9, 114:10, 115:2, 133:18, 133:20macrophage-mediated 112:24macrophages 27:25, 29:20, 30:14, 64:13,

243

69:7Madison 2:21main 136:19Maintain 79:24, 80:9, 100:2, 194:10, 213:14, 213:20maintained 99:15maintaining 99:13major 21:4, 21:9, 77:6, 83:15, 84:5, 84:14, 110:17majority 39:13man 85:25, 138:1, 151:1mandates 117:3maneuver 62:8manufacture 170:17manufactured 62:18manufacturers 34:17manufacturing 141:17, 163:24, 168:12, 182:21, 182:23margin 77:11MARK 1:30, 192:5, 199:23, 201:4, 218:12marked 20:12, 192:11, 196:4, 200:12, 203:5, 204:8, 205:23, 205:24, 206:13Market 21:21, 22:2, 38:14, 38:15, 62:1, 63:4, 77:13, 79:4, 79:7, 79:23, 80:1, 80:11, 80:15, 80:20, 80:23, 95:23, 138:6, 173:7, 173:8, 173:10, 173:11, 193:8, 194:4,

194:22, 194:24, 195:14, 210:2, 212:5, 212:15, 212:18, 212:23, 213:3, 213:4, 213:7, 213:8market-driving 78:25marketer 38:7, 38:10, 38:23Marketing 38:12, 38:17, 38:18, 38:19, 38:25, 39:25, 40:2, 40:6, 40:8, 40:10, 61:15, 61:23, 61:25, 62:25, 78:20, 78:22, 80:18, 87:2, 87:3, 88:12, 104:16, 221:19marketing77 221:19marketplace 81:7marking 191:19Marlene 128:20, 129:2married 151:1Martin 45:1Mary 45:6, 45:7, 48:1Massive 143:15, 149:6, 149:7MASTER 3:30, 6:21, 9:3, 154:15, 154:16, 156:3, 156:16, 156:18, 156:21, 211:16, 211:17match 16:3matches 56:13, 67:12, 112:8material 36:8, 99:18, 129:7, 135:20, 149:2, 149:4, 149:6, 153:19, 177:17, 178:18, 183:13, 183:15, 183:16,

197:6Materials 31:20, 38:18, 38:19, 40:3, 83:18, 83:22, 104:13, 129:6, 158:18, 166:13, 166:18, 167:14, 170:21, 178:15, 178:17, 184:25, 185:4, 214:9, 214:12matter 24:13, 51:12, 51:13, 58:8, 64:24, 74:3, 130:11, 139:24, 222:1matters 6:12Mckee-farrar 165:12, 192:25, 196:19MDL 1:4Meaning 179:11means 48:13, 52:4, 53:15, 55:23, 56:2, 56:6, 56:9, 56:20, 60:3, 73:9, 76:15, 89:13, 103:22, 120:9, 143:4, 162:19, 169:2, 208:12meant 86:4, 136:25, 138:20, 197:18measure 41:21, 169:9, 169:16measured 41:25measurement 95:7measurements 171:24measures 141:11measuring 209:14mechanical 3:46, 151:9, 152:16, 154:16, 184:2mechanism 99:19, 149:11media 62:5medical 34:6,

50:1, 61:12, 84:25, 133:5, 200:6, 200:7, 215:16, 215:17medicine 34:18meet 64:19, 176:3, 176:19Meeting 19:10, 19:24, 20:1, 20:3, 22:24, 79:13, 89:9, 89:10, 105:5, 167:4, 167:5, 167:15, 200:13, 201:18, 201:22, 202:14, 202:18, 202:21, 203:1, 203:9, 203:11, 204:4, 204:21, 205:15, 205:17, 205:21, 205:25, 206:7, 206:9, 206:25, 207:1, 218:11, 218:20meetings 167:6, 167:10, 168:14, 168:17, 201:1, 203:2, 205:10member 90:12, 90:23members 22:25, 150:9memo 21:9, 23:21, 88:8mentioned 153:13, 154:6, 157:18, 163:10, 165:19, 168:6, 169:18, 177:10, 177:11, 179:7, 183:2, 183:23, 191:11, 195:24mentored 154:23mentors 155:9Mercy 123:17Meridian 3:18merits 8:21met 202:15, 210:16met. 204:23

244

metabolic 16:19metal-metal 83:23, 84:1, 84:13, 114:18, 114:21metal-on-metal. 138:7metal-on-poly 26:25, 29:16, 29:20, 30:5, 30:15, 30:16, 64:14, 69:8, 74:25, 75:16, 107:12, 129:20, 132:13metal-on-poly. 28:1metallic 75:5, 137:8metallurgy 71:24metals 115:18, 196:13Metasul 95:25, 172:2, 172:3, 172:8, 172:17, 173:2, 192:21, 195:4, 210:2method 45:11, 48:3metrology 171:21, 171:23Michael 2:33, 3:9, 119:18, 221:35micromotion 186:5, 186:8, 186:13, 186:14, 187:2microns 93:13, 101:22, 102:17microscopic 50:15, 53:21, 186:19mid 164:25mid-'60s 162:6, 164:25mid-to-late 122:19middle 11:16, 180:7, 180:8,

188:17, 196:6, 196:8mild 28:10, 66:2, 66:15, 66:21, 67:17, 68:21, 69:7, 111:19, 112:9, 114:16, 114:22, 132:14, 133:3, 133:6, 133:19mild. 28:4, 64:15, 65:4, 65:9, 65:11, 66:10, 67:6, 114:8, 115:3, 133:14millimeter 144:17millimeters 146:4, 146:15, 146:20million 44:2, 44:15, 44:21, 135:5, 137:25, 146:3, 147:2, 147:4, 147:11, 172:21, 174:13, 174:15, 174:19Millions 136:21, 136:25, 174:3, 174:6, 187:19, 187:21mind 17:22, 45:10, 98:21, 165:13, 177:22, 181:9, 192:13, 203:7minds 62:3, 62:20, 62:22mine 15:20, 78:6minimize 52:11, 198:14minimized 198:18minimum 210:2minor 99:20minute 11:10, 14:7, 91:12, 113:7, 142:9, 177:9, 200:13, 201:6

Minutes 7:12, 14:23, 19:10, 20:16, 76:8, 76:9, 76:10, 76:11, 76:12, 79:14, 81:14, 82:1, 82:12, 82:15, 91:21, 123:6, 123:13, 124:11, 142:1, 150:2, 159:22, 203:9, 205:25, 218:22, 221:5Minutes19 221:5miscitation 29:6miscited 28:20, 29:2, 29:5misquote 28:12missed 219:20missing 219:6mistake 102:15, 103:12, 103:13Mixed 54:7, 54:14, 54:15, 54:17, 54:18, 59:15, 60:1, 60:18, 121:15, 125:5, 125:7, 125:8, 125:13, 127:22, 148:5model 86:22, 121:9, 185:9modes 196:12modification 9:24, 98:17, 100:22molecules 54:1molybdenum 74:22moment 49:9, 76:10, 115:13, 125:1, 199:25, 204:10, 209:2Momma 129:1Monday 5:6, 5:7, 6:10, 6:14, 7:16, 12:4, 219:14, 219:18money 23:4, 58:21, 59:1, 77:24, 84:16,

87:2monograph 25:19, 25:23, 26:1, 26:3, 28:9, 30:25, 32:9, 32:10, 32:14, 35:4, 35:5, 63:25, 64:3, 64:8, 69:13, 110:11, 110:13, 110:15, 110:23, 112:11, 115:12, 131:17months 20:4, 20:7, 20:9, 20:20, 20:23, 21:11, 39:6, 167:18months. 20:12Moreland 89:5, 89:9, 89:17, 89:20, 89:22morning 5:13, 5:15, 5:16, 6:15, 7:17, 8:9, 14:19, 210:16morphology 114:18Morrey 10:3, 11:9motion 13:13, 50:11, 56:12, 62:2, 62:4, 62:18, 62:21, 120:23, 186:17, 187:2motivation 154:3move 4:17, 8:2, 8:14, 51:14, 64:1, 83:22, 103:18, 110:11, 127:20, 169:2, 186:16, 186:18moved 138:7, 157:5, 177:22, 191:9movement 56:13moves 50:25moving 17:22, 41:19, 51:3,

245

63:13, 98:[email protected] 2:39MR. POWELL 4:12, 4:16, 4:20, 5:1, 5:15, 5:19, 5:22, 9:14, 9:16, 9:23, 10:2, 10:7, 10:11, 10:15, 11:21, 11:24, 12:21, 13:6, 13:9, 13:12, 13:15, 150:5, 210:11MR. QUATTLEBAUM 33:20, 34:15, 36:18, 42:20, 46:22, 49:14, 60:25, 70:7, 72:23, 78:1, 78:4, 83:4, 84:10, 84:19, 86:1, 86:4, 102:21, 109:19, 110:4, 116:16, 116:21, 116:22, 117:14, 123:5, 123:10, 123:14, 131:7, 142:3, 142:6, 143:9, 146:14, 147:25, 149:15, 149:18, 149:19, 149:24Ms 5:2, 5:4, 8:16, 14:22, 81:11, 97:13, 98:15, 106:11, 142:7multicenter 37:20multiple 145:17, 145:19, 159:9, 183:5, 217:19, 217:21myself 150:10, 204:17

< N >

NAME 150:10, 150:12, 157:17, 199:3, 220:3names 157:21Nancy 128:20, 129:2nanometer-sized 65:2, 115:1narrow 146:5narrower 96:2natural 50:10, 56:11, 56:12, 56:13, 62:2, 62:4, 62:18, 62:21nature 13:20, 216:24Naw 132:3near 134:8nearly 7:11, 94:2Neblett 2:4necessarily 164:12, 197:20necessary 18:4, 18:25necrosis 73:12, 75:3, 143:16, 149:7necrotic 73:16need 12:13, 15:1, 18:3, 20:25, 21:16, 23:19, 24:14, 24:21, 49:8, 56:24, 69:1, 72:10, 78:5, 78:6, 98:11, 113:5, 117:4, 124:9, 204:22needed 21:5, 21:10, 22:19, 85:8needs 22:22, 36:7, 153:12neighborhood 172:21net/net 5:12New 2:23, 3:5, 8:21, 9:19,

11:9, 16:15, 18:19, 19:6, 39:6, 49:8, 70:16, 129:4, 129:8, 140:20, 155:7, 216:8Next 4:23, 5:10, 5:15, 5:16, 8:3, 12:15, 13:5, 13:6, 13:7, 14:22, 22:23, 43:13, 49:1, 50:12, 53:12, 59:25, 64:2, 68:16, 112:13, 113:9, 114:22, 115:4, 122:5, 129:14, 131:16, 134:7, 136:5, 136:12, 137:23, 139:8, 139:23, 143:14, 148:12, 194:3, 219:15nice 13:8night 8:9, 9:2, 62:2, 62:10nine 123:6no-brainer 68:8Nobody 195:17, 214:19, 214:24, 215:5, 215:7nodes 137:8None 32:17, 58:25, 146:3, 215:16, 215:17nonresponsive 21:24, 23:10, 27:8, 30:18, 31:5, 32:1, 34:19, 35:20, 36:13, 42:25, 46:1, 57:20, 67:20, 71:1, 117:8, 125:10, 127:4, 129:24, 132:6, 138:21noon 6:6normal 73:7, 75:1, 75:5, 75:10, 162:19,

192:19normally 53:16, 53:18north 154:9Northern 1:2, 4:5, 222:12Northwestern 178:7, 217:10Not. 59:21notation 102:8notations 101:18, 101:19note 100:18, 101:7, 112:18, 112:20, 115:20, 115:24, 115:25noted 19:21, 45:8, 45:22, 48:19, 90:12, 102:11, 102:22, 116:2, 118:10notes 89:20, 138:18, 191:22, 192:17, 200:11, 206:10notice 83:14, 90:22, 215:10notify 33:23notwithstanding 205:12November 98:1, 101:11, 102:13, 140:5Number 6:4, 12:14, 19:9, 20:17, 20:21, 26:21, 26:24, 42:14, 79:8, 98:12, 172:22, 191:19, 192:12, 203:6, 206:13, 214:3, 218:12numbered 80:6numbers 65:1, 65:3, 83:24, 86:9, 114:25NY 2:23

< O >

246

o'clock 7:20, 8:3oath 35:16, 103:10Object 5:25, 31:10, 31:12, 33:20, 42:20, 46:22, 49:14, 60:25, 84:10, 92:15, 96:13, 109:17, 116:11, 117:7, 131:7, 146:10, 181:11, 184:15Objection 21:24, 23:10, 27:8, 30:18, 31:5, 32:1, 34:15, 34:19, 35:20, 36:13, 36:19, 42:25, 46:1, 57:20, 67:20, 70:7, 71:1, 83:4, 84:19, 100:12, 102:18, 110:2, 117:11, 125:10, 127:4, 129:24, 132:6, 138:21, 143:7objectives 204:23observe 45:3observed 75:3obtain 20:25, 179:13, 180:12obvious 142:23, 149:9occasion 104:25, 176:19occur 37:14, 37:15, 119:1occurred 118:21, 118:24occurrence 135:20occurs 59:23, 60:16Ochoa 21:18October 201:15offer 39:7,

88:18, 183:4, 183:8offered 12:7, 12:8, 22:5, 22:6offering 116:16offers 162:16OFFICER 4:3, 14:6, 81:21, 105:21Official 40:2, 153:2, 222:11often 166:1, 167:10, 167:15, 209:13oftentimes 163:3Ohio 186:11, 186:12, 186:21oil 50:20, 51:5, 52:5oiled 55:15Once 11:1, 86:5, 106:11, 127:20, 158:11, 167:18, 179:4one-piece 19:10, 19:12, 19:25, 93:23, 116:25, 159:21, 170:10, 170:18, 171:5, 172:8, 172:16, 173:1, 173:4, 173:14, 173:23, 176:12, 176:20, 177:4, 179:24, 180:9, 180:18, 190:16, 196:3, 203:2, 203:9, 204:2, 207:22, 207:24one. 42:11, 43:18, 49:20, 70:17, 79:8, 85:24, 124:19, 134:12, 135:8, 136:5, 136:12ones 12:19, 15:15ongoing 19:14, 205:10Ontario 188:8

open 79:23, 93:6, 93:10, 101:21opened 13:21, 93:12, 93:19, 95:22, 96:25, 144:22opening 94:6, 94:11, 96:19, 203:17, 204:19operate 60:1operating 127:22opinion 95:11, 96:21opinions 8:21, 117:9opportunities 7:2Opportunity 89:24, 158:17, 158:21, 191:15, 191:23, 194:3, 213:3opposed 60:16opposing 6:21opposite 163:7optimize 198:14optimized 50:6, 198:17option 139:3, 160:9option. 139:4options 79:23, 136:1, 161:4, 181:7, 183:5, 183:8, 183:10options. 36:3oranges 148:5order 4:3, 6:3, 6:11, 8:2, 9:7, 9:9, 9:13, 9:22, 9:24, 9:25, 11:2, 11:21, 12:9, 13:11, 13:16, 13:17, 16:6, 23:20, 24:18, 27:19, 27:22, 39:7, 81:21, 177:3ordered 11:22

ordering 11:22orders 12:10, 12:18organization 97:6organizations 97:6organs 137:8original 96:9, 192:15originally 130:24Orleans 3:5Orthopaedics 1:4, 150:18, 157:7, 157:9, 166:3, 178:22Orthopedic 33:6, 34:10, 36:3, 37:8, 37:21, 164:19, 167:4, 191:16, 195:21, 200:2, 200:7, 202:9, 215:21, 216:7, 216:11, 216:15, 218:7, 218:8, 219:2, 219:3Orthopedics 150:14, 152:21, 179:15Osteolysis 69:15, 83:20, 135:20, 160:4, 160:5, 161:12, 162:25, 163:10, 163:11, 163:12osteolysis. 26:17osteolytic 68:24, 69:10, 69:15, 115:7others 6:16, 38:22, 45:17, 71:17, 88:8, 165:15, 214:10otherwise 61:16outer 99:19outlined 97:8outlining 43:21

247

Outside 4:10, 4:15, 14:8, 62:10, 78:17, 81:23, 116:15, 117:22, 163:19, 168:14, 174:24, 177:25, 185:19, 188:3, 195:2overall 146:1, 147:24, 190:6, 201:14overcome 161:3Overruled 33:24, 34:16, 36:20, 42:22, 49:16, 61:1, 70:12, 83:5, 84:11, 84:21, 131:8overseas 5:6, 131:25overwhelming 62:1owe 25:13, 134:1owed 25:10own 58:16, 59:7, 60:6, 79:6, 100:21, 103:17, 104:14, 148:10owned 80:1, 179:4ownership 80:2, 81:6ownership. 79:24owns 79:22

< P >p.m. 4:22, 7:23pages 10:3, 15:14, 15:21paid 59:1, 83:1, 83:10, 84:16pain 20:4, 20:6, 20:10, 20:11, 20:12, 20:18, 20:23, 62:2, 62:18, 62:21, 149:[email protected]

3:44PAMELA 3:40, 221:45, 222:10Paolis 24:16paper 57:9, 60:8, 60:11, 90:13, 111:22, 111:23, 112:2, 112:5, 112:7, 119:14, 199:1, 199:12papers 106:14, 106:21, 106:23, 106:25, 166:16parading 131:16paragraph 26:10, 26:13, 35:12, 69:6, 111:1, 111:2, 111:10, 112:13, 113:9, 132:12, 203:14, 204:19parameter 170:5parameters 97:8, 99:5, 166:10, 170:10, 170:12, 174:2, 178:14, 202:10Pardon 217:20Parkway 2:13partially 54:10, 54:18, 54:20, 125:8, 125:13participate 151:12particle 114:17, 176:1particle-induced 26:17particles 26:8, 26:20, 26:22, 26:24, 27:1, 27:23, 27:25, 28:4, 30:14, 64:13, 65:2, 65:8, 66:1, 66:5, 66:10, 67:5, 67:14, 67:17, 68:13, 68:23, 69:8,

111:7, 111:11, 112:23, 114:7, 114:10, 115:1, 115:6, 115:17, 133:6, 133:14, 133:19, 136:7, 163:18, 175:25, 197:5Particles. 64:21particular 99:4, 105:4, 105:5, 145:10, 145:11, 157:17, 165:10, 166:20, 177:25, 187:5, 188:21, 199:1, 199:12Particularly 163:21parts 24:5, 55:13, 81:10, 171:25, 182:17Pascaud 88:1Pass 123:10, 147:25, 149:14past 39:5, 72:17, 125:18, 125:20Pat 28:25, 29:6, 29:9, 63:22, 64:18, 67:9, 95:7, 132:19, 132:20, 146:19, 148:8, 175:20, 195:21, 200:2, 217:2, 217:3patch 93:10patches 93:14patent 179:2patents 179:4, 179:6path 106:12patient 16:18, 20:5, 20:22, 34:13, 34:23, 35:1, 36:8, 62:5, 84:4, 129:4, 137:7, 160:21, 163:2, 193:7, 200:15, 207:9, 213:22

patient. 84:15patients 20:6, 21:1, 21:15, 21:16, 30:24, 31:2, 31:8, 31:15, 31:18, 31:24, 32:5, 32:6, 33:23, 35:7, 35:17, 35:24, 37:13, 37:17, 37:18, 37:22, 62:2, 62:3, 62:9, 62:14, 62:19, 75:4, 83:25, 85:4, 113:15, 120:5, 130:22, 136:17, 139:4, 176:25, 207:19patients. 136:2pattern 93:9Paul 61:23, 61:25, 78:15, 88:1, 88:4, 88:5, 88:7, 122:21, 168:19Pause. 33:15, 91:15pay 58:21PC 3:31PCT 204:21peak 77:9pearls 90:1peer-reviewed 59:13pelvis 160:16pending 67:11People 20:17, 24:4, 24:17, 24:20, 25:2, 25:3, 25:6, 25:8, 25:10, 27:3, 27:14, 34:9, 36:10, 36:16, 37:3, 40:4, 40:5, 40:6, 58:20, 59:7, 61:16, 86:25, 87:22, 88:13, 89:2,

248

mailto:pam_wilson@txnd.

131:13, 131:24, 132:20, 134:23, 135:15, 152:22, 159:18, 168:18, 218:1people. 24:21Per 81:3, 145:19, 146:16, 146:20, 146:24, 146:25, 147:1percent 37:22, 72:21, 73:15, 73:16, 77:8, 88:12, 127:11, 127:19, 127:22, 138:17, 142:22, 142:23percentage 76:19, 76:21, 77:6perfectly 55:14perform 160:7, 184:1, 185:17Performance 34:7, 36:6, 64:20, 72:18, 74:25, 94:7, 118:19, 135:25performed 100:23, 165:9, 170:7, 173:23, 185:11, 186:8, 186:10, 186:20, 187:23, 188:5, 190:23, 190:24performing 173:5perhaps 84:14Period 11:13, 12:12, 20:24, 97:4, 121:1, 126:23, 128:23, 151:25, 166:24, 187:21, 195:11, 202:12, 208:18periodical 166:20periods 57:18periprosthetic 73:9, 73:18, 111:17, 114:17,

115:1, 143:16permission 58:7permit 156:22person 155:20, 204:17, 214:9, 214:12person. 74:23personal 36:7personally 126:8personnel 168:14perspective 138:15, 168:9Peters 168:19, 195:24, 196:1, 196:5, 196:8, 196:16, 198:2, 198:3, 198:20, 215:12, 218:8, 219:3, 219:5, 219:10Peterson 1:14, 95:4Ph 171:14, 175:7Phase 127:13, 127:14, 201:9, 201:11, 202:4, 206:18, 206:19, 206:21, 206:22phases 154:17, 154:19phenomena 45:8, 48:16, 48:19photos 107:24, 108:4physicians 215:21picked 153:6picking 82:18, 123:18, 158:7, 158:12picture 52:14, 52:16, 55:19, 124:23pictures 50:13, 53:14, 124:19, 139:11piece 131:12, 162:13, 181:17, 184:8, 216:8pieces 109:6

pig 25:3, 31:3pile 142:14Pinnacle. 71:14Pinnacle/ultamet 71:20Pinnacles 49:3piston 50:25pistons 50:23pitch 61:21place 19:24, 31:21, 31:23, 32:4, 32:6, 32:17, 32:20, 32:23, 33:1, 38:4, 65:23, 105:19, 133:8, 158:22, 166:7, 177:8, 183:24, 189:18, 204:23, 208:16, 209:18placed 4:21places 41:17, 53:21PLAINTIFF 19:9, 22:10, 33:10, 33:14, 39:2, 40:17, 40:19, 55:8, 55:20, 58:24, 77:19, 79:10, 82:25, 85:20, 86:2, 86:10, 87:21, 104:18, 118:16, 119:23, 121:20, 122:20, 126:12, 130:17, 142:9, 221:1PLAINTIFFS 1:30, 6:24, 7:9, 69:15, 130:13, 131:5plan 80:12, 80:15plans 5:1plant 127:13plastic 160:11, 162:13, 181:4, 183:11, 184:8, 186:15play 6:15, 7:15,

8:18, 8:25, 9:21, 10:18, 11:24playable 9:4played 151:14playing 6:17playing. 150:8, 210:15Please 4:4, 13:10, 14:16, 27:11, 34:22, 36:22, 53:7, 56:1, 67:25, 68:1, 81:22, 88:8, 91:9, 91:16, 97:21, 98:22, 106:9, 111:5, 113:13, 123:21, 124:4, 126:4, 128:7, 138:24, 151:6, 163:10, 192:5, 196:10, 197:2, 204:11, 204:19PLLC 2:44plus 146:3PMMA 66:5, 114:11, 114:12PO 1:40point 19:12, 24:19, 25:7, 25:21, 46:17, 47:13, 63:5, 78:17, 87:7, 89:11, 125:15, 129:15, 129:19, 131:11, 139:24, 153:21, 156:20, 157:1, 157:6, 157:13, 158:19, 171:8, 172:6, 178:20, 180:19, 189:12, 204:17, 210:24point" 89:13point. 32:19, 44:10, 61:14, 159:5pointed 31:14, 65:13, 65:14,

249

66:18, 92:2pointer 11:7pointing 206:3points 11:18poison 197:25poisonous 197:18, 214:16, 217:15polish 51:12, 171:1polished 17:9, 74:21, 117:21, 118:8, 137:10, 149:20Polly 71:17poly 51:13, 74:13, 83:20, 90:10, 90:24, 118:22, 118:24, 139:12, 163:2Polyethylene 106:18, 107:15, 108:5, 108:18, 109:25, 136:6, 153:17, 160:8, 160:10, 160:11, 161:5, 161:8, 161:11, 161:14, 161:17, 162:8, 162:23, 163:5, 163:7, 163:15, 163:16, 163:21, 166:15, 177:15, 181:4, 181:12, 181:19, 183:11, 185:16, 186:15, 186:18, 187:2, 211:15, 211:18polyethylene-induced 160:5, 162:25polyethylenes 161:21, 163:3poor 16:19portfolio 62:8position 17:18, 88:2, 155:13positioned 109:7Positioning 108:9, 108:21,

109:1, 109:4positioning. 139:10positive 26:18, 123:7, 138:18, 152:19possible 72:18, 117:5, 171:3, 198:14, 198:18, 198:22, 216:13possibly 26:21, 26:22potential 34:8, 68:23, 90:24, 96:1, 96:4, 112:14, 136:8, 198:15, 207:9, 207:18, 208:18potential. 90:9potentially 65:1, 65:3, 68:24, 69:19, 70:4, 84:13, 84:14, 114:25, 115:6, 115:9, 137:6poured 8:23Powell 2:33, 8:12, 9:13, 11:8, 12:23Powerpoint 104:24Poydras 3:4practical 24:13, 64:24practice 34:17pray 4:8pre-1995 192:19precautions 16:13, 17:16precise 68:6, 125:1precisely 18:11precision 68:4predicate 98:19, 98:20, 98:24, 98:25, 99:3, 117:20predominant 66:4, 114:10

preexisting 129:7premium 88:12preparation 176:20, 202:1, 202:2, 206:20prescribed 222:3presence 4:10, 4:15, 65:1, 65:2, 81:23, 114:25PRESENT 2:28, 3:24, 5:13, 8:1presentation 79:18presentations 39:21, 104:22, 105:2, 105:7, 113:18, 120:21presented 79:16, 204:21presiding 4:7PRESNAL 192:8pressure 149:8Pretest 171:21, 171:23Pretty 13:1, 20:9, 37:12, 155:16, 183:3, 201:15previous 206:13previously 92:13, 181:2, 196:5, 203:5, 204:8, 205:23pride 37:12primarily 164:17principally 75:6prior 12:9, 155:23, 158:3, 158:6, 158:8, 166:7, 193:9, 195:1, 207:17, 208:15, 212:13, 212:14prioritized 79:17pristine 143:1Probably 6:8, 15:1, 20:17,

75:19, 159:14, 162:5, 164:25, 165:12, 167:18, 180:7, 195:12, 208:17problem 7:7, 9:8, 11:12, 23:2, 29:15, 51:9, 69:24, 91:14, 118:21, 118:24, 119:1, 119:3, 130:6, 130:23, 130:25, 131:25, 162:23problems 70:23, 71:4, 71:7, 71:9, 74:5, 74:13, 83:3, 83:15, 83:17, 120:6, 130:15, 136:6, 137:20, 166:19Proceedings 3:46, 81:20, 150:3, 221:46proceedings. 219:22process 19:4, 51:3, 63:4, 100:20, 100:21, 170:25, 200:22, 201:23, 206:20processes 170:20produce 6:11produced 3:47, 6:25, 83:16produces 52:6Producing 122:2production 112:25, 115:19, 168:11, 206:23PRODUCTS 1:6, 37:13, 48:4, 48:13, 74:10, 77:17, 105:17, 112:15, 112:16, 118:4, 162:4, 162:7, 163:24, 164:9, 164:17, 165:3, 165:10,

250

172:8, 179:14, 185:10, 187:13, 187:14, 193:16, 194:24, 195:2, 212:7, 212:9, 213:11professionally 154:3Professor 155:2, 155:11, 155:12, 155:13, 155:16, 155:23, 155:25, 217:12profit 77:10, 77:11, 88:14profits 77:2program 87:2, 153:10, 154:15, 174:11, 176:7, 185:8, 186:5project. 23:5projects 152:4, 152:5, 152:8, 152:9, 153:4, 153:6, 154:4, 156:12, 156:13, 156:14, 157:12, 157:15, 159:24, 210:25, 211:8promotes 51:24propaganda 137:14properly 17:14Proposal 6:1, 82:25, 83:10, 83:12, 83:13, 221:17Proposal82 221:17propose 6:2, 6:19, 7:13proposed 94:11proposing 9:12, 10:17prosecution 89:15prospective 21:15prosthesis 165:15, 193:1,

211:17protect 78:25protocol 21:14, 121:18, 129:7, 209:13, 209:14protocols 186:3proud 123:9, 190:20, 190:23prove 88:13proven 116:12provide 62:18, 103:20, 103:21, 135:25, 138:20provided 6:20, 34:23, 97:9, 103:22, 209:24provides 56:8providing 104:11, 110:20pseudotumors 131:3publication 119:18, 121:3, 221:36published 95:5, 106:23, 107:22, 119:14pull 9:16, 29:13, 71:25, 128:15pumping 52:5, 87:2punch 195:7, 212:12, 212:15, 213:2, 213:8punch. 193:20, 194:19, 212:24purpose 19:20purposes 24:2, 160:13, 171:5, 186:14pursue 59:9push 9:18, 184:10Push-in 184:4, 184:7push-out 184:4, 184:7pushing 184:8, 184:14

putting 5:20, 24:3, 24:15, 25:11, 26:5, 27:16, 36:17, 37:4, 74:8, 86:25, 87:3, 100:7, 194:21, 201:7

< Q >Q. 156:3qualified 29:24, 30:2, 30:8Quality 168:4, 182:13, 182:15, 182:16quandary 129:9quarter 81:3, 81:7, 81:8QUATTLEBAUM 2:43, 2:44, 14:24, 76:18, 91:11, 91:12, 91:16, 91:18, 91:20, 92:23, 92:24, 96:15, 97:20, 97:22, 98:4, 98:6, 98:10, 98:13, 98:14, 100:14, 140:16, 142:2, 220:11, 220:15QUATTLEBAUM142 220:15QUATTLEBAUM91 220:11question 10:16, 20:4, 20:15, 23:20, 27:10, 27:17, 30:10, 31:14, 31:22, 34:22, 35:25, 36:22, 43:8, 46:23, 46:24, 47:17, 53:7, 57:5, 57:19, 58:18, 63:2, 67:11, 67:25, 68:1, 72:24,

87:22, 87:24, 92:16, 93:4, 97:13, 111:16, 116:19, 121:21, 131:7, 149:15, 149:17, 193:4, 193:9, 213:22questioning 24:11, 200:10questions 14:23, 15:2, 19:2, 19:3, 33:21, 56:1, 68:6, 98:8, 130:2, 191:17, 196:21quick 20:9, 114:2Quickly 104:19, 121:19, 193:8, 201:15, 212:5, 213:7quit 15:9, 44:6, 134:2quite 166:1quotation 67:3quote 65:5, 65:12, 141:12, 148:5, 193:20, 194:3quoted 66:12, 67:1, 67:13quoting 67:8, 69:5, 132:17, 132:18, 132:19, 132:20, 132:21, 133:16

< R >Radius 93:21, 94:18, 97:10, 100:1, 100:3, 100:16, 169:11, 169:13, 169:14, 169:18, 169:21, 169:23, 170:9radius. 100:5raised 196:21ran 147:3, 172:20, 186:2,

251

187:15Randomized 106:19Randy 71:13range 50:10, 56:12, 96:19ranges 165:17Raph 88:8Raphael 88:1rapid 184:[email protected] 2:8rate 29:14, 73:14, 192:20rates 135:19rather 44:1ratio. 138:18rationale 15:8, 15:12, 32:21, 49:19, 121:19raw 149:2, 149:4RE 1:4re-reviewed 87:18reach 8:11reacting 75:4reaction 17:20, 46:19, 66:1, 66:9, 67:4, 67:5, 67:16, 68:12, 69:7, 73:15, 83:20, 114:7, 132:19, 133:5, 133:12, 216:13reaction. 73:16reactions 16:8, 109:13, 110:6, 110:7, 114:6, 166:21, 216:13reactivity 138:17Read 16:1, 16:2, 17:24, 32:17, 48:21, 50:4, 59:19, 60:12, 60:21, 66:9, 85:18, 111:5, 113:12, 114:24, 115:4, 131:9,

132:22, 135:13, 138:11, 138:12, 142:19, 143:14, 148:13, 148:16, 148:17, 193:6, 196:10, 199:19, 203:16, 204:10, 204:18, 206:18reading 23:6, 23:7, 60:14, 73:4, 85:3, 134:2, 134:18reads 90:20ready 18:15, 82:15, 82:16, 189:15real 14:11, 37:14, 37:15, 66:19, 114:2, 124:15, 134:17, 161:3, 163:4, 163:6, 219:15reality 140:1realized 154:1really 15:16, 20:14, 24:4, 30:7, 35:18, 44:10, 67:7, 79:6, 90:20, 99:6, 146:6, 154:2, 155:18, 177:23, 214:21reason 90:24, 142:20, 185:14, 193:25, 194:6, 194:15reason. 142:19reasoned 85:8reasons 72:9, 85:11, 135:23, 165:8recall 20:6, 20:8, 22:8, 42:18, 84:17, 84:23, 109:11, 113:3, 126:5, 166:22, 193:13, 209:23, 212:20, 218:5recalled 41:4,

41:24, 139:19, 139:20recap 90:2received 188:22, 188:24receiving 21:1recent 37:20Recess 14:14, 81:19recited 110:16recognize 16:2recognized 112:23recollection 129:22, 173:3recommendation 89:11, 130:21record 10:13, 12:25, 13:2, 14:12, 84:20, 149:18, 149:24, 199:23, 221:46records 72:16Recovery 34:9RECROSS 124:7, 148:3, 220:13, 220:17recycled 105:6red 207:13REDIRECT 5:3, 6:5, 60:13, 72:25, 91:19, 142:5, 220:11, 220:15reduce 26:16, 198:15reduced 90:23, 96:20, 96:23reductions 136:9refer 109:2, 126:4, 161:24, 161:25, 169:11, 169:25, 171:23, 204:25, 205:2, 205:7, 211:13reference 16:7, 29:6, 33:18, 36:7, 64:18, 64:24, 65:5, 111:22, 113:5,

116:3, 159:3, 166:2, 170:3, 192:18, 193:16, 195:17, 195:21, 195:24, 196:5, 196:8, 197:17, 198:5, 198:21, 205:5, 206:2, 212:17, 213:15referenced 66:6, 66:8, 206:10references 110:12, 111:23, 111:25, 134:6, 165:23, 198:2referencing 28:17, 28:18, 201:9referred 111:15, 119:23, 157:20, 166:1, 179:3, 181:14, 184:1, 186:14referring 85:12, 85:13, 89:3, 178:17, 201:23refers 162:1, 189:22, 189:24, 204:15, 204:16, 205:7reflect 193:18, 210:9reflected 124:23refresher 203:8regard 9:7, 11:9, 11:10, 14:25, 24:9, 92:10, 94:15, 96:3, 104:10, 120:12, 120:21, 125:16, 159:23regarded 133:6, 133:14regarding 33:21, 80:4, 95:9, 120:20, 144:2, 179:13, 191:18Regardless 29:14, 90:22, 130:8, 204:3

252

regime 59:18, 60:2, 60:18, 121:15, 125:5regimes 120:24, 121:9regulated 176:17regulatory 71:21, 116:14, 168:11, 182:9, 188:19, 189:1, 189:16rehab 34:10reinforces 138:16reintroduce 150:11relate 93:20, 93:24, 99:22, 101:19, 164:10, 166:5, 203:23, 203:24, 206:5, 206:6, 206:9, 206:21Related 18:21, 107:15, 111:4, 120:6, 164:11, 166:3, 176:11, 205:20, 206:22, 207:8Relates 1:9relating 106:14, 166:21, 196:16, 196:19, 205:16, 207:18, 207:22, 208:9relationship 105:23relative 135:17relatively 138:17, 154:1, 163:3release 68:23, 115:6, 137:6, 196:13released 131:1, 131:25relied 216:18relief 4:17relieved 149:8reluctant 18:10

rely 200:1Relying 120:13, 216:15, 216:19, 218:7, 219:2, 219:9remain 156:24remarkable 147:22remarks 203:17, 203:23, 203:24Remember 19:2, 19:3, 19:15, 19:22, 21:2, 22:13, 23:6, 23:7, 39:11, 39:14, 39:19, 39:22, 64:16, 70:18, 71:7, 71:10, 72:11, 72:12, 76:20, 87:16, 105:19, 119:13, 120:15, 120:19, 126:2, 129:9, 134:13, 138:6, 141:6, 218:9, 218:13remotely 26:4removed 129:3, 175:24reorganize 123:15repeat 55:11, 68:1rephrase 92:22replacement 16:18, 20:22, 34:11, 80:8, 83:16, 83:18, 107:1, 118:20, 169:5, 169:12, 198:10replacement. 37:23replacements 17:18, 34:7, 64:20, 114:19replied 38:11replies 45:6reply 47:21report 7:3,

10:5, 11:16, 11:17, 44:8, 44:9, 75:22, 75:25, 76:2, 76:5, 95:9, 144:5, 145:19reported 3:46, 68:25, 71:20, 83:19, 114:20, 115:10Reporter 3:40, 222:11reports 6:22, 10:3, 10:22, 11:13, 135:20represent 136:7, 174:13, 192:2, 194:18representative 136:16representatives 167:20, 167:23, 167:25, 168:2, 168:10, 168:11, 168:12, 182:2, 182:5, 182:7, 182:9, 182:11, 182:13, 182:23represented 147:5, 147:9represents 73:14Reprints 106:23reproduction 15:25reproductive 70:11requested 4:13require 197:21required 34:25, 72:21, 73:5, 203:19requirements 63:11, 100:5requiring 54:12Research 22:23, 40:7, 62:1, 63:4, 78:18, 87:8, 96:22, 151:10, 154:2, 154:4, 154:5,

154:21, 161:7, 161:17, 161:18, 166:3, 167:21, 168:12, 171:8, 171:14, 178:9, 179:13, 180:8, 180:12, 182:3, 188:2, 208:15researcher 178:7researchers 200:8resistance 36:6, 51:25, 53:9, 122:3, 122:4resistant 74:23resolution 161:11respect 4:17, 169:5, 169:11, 169:17, 203:21responded 176:10responsibility 87:19, 205:3responsible 171:18, 175:14, 204:17rest 7:25, 31:16, 91:8, 139:12restate 186:7restrict 6:17restriction 189:8result 59:24, 78:21, 78:23, 94:23, 159:16, 178:24, 179:12resulted 131:3, 131:4resulting 26:21, 26:24results 23:17, 23:20, 34:6, 44:14, 45:7, 56:12, 60:18, 71:14, 83:20, 83:24, 92:17, 93:5, 119:11, 120:13, 140:25, 141:2, 145:19,

253

166:12, 170:6, 172:25, 186:24, 187:1, 203:18resumed 81:20, 150:3resurfacing 108:2, 139:14, 139:17retention 58:20retire 155:25retrieval 176:9, 183:17retrievals 75:2, 75:23retrieved 27:24, 64:12return 157:1, 157:3returned 157:23, 158:23, 165:22, 201:16review 89:8, 89:24, 90:12, 90:23, 104:6, 138:5, 158:17, 158:21, 158:25, 165:21, 191:23reviewed 165:20revised 165:8Revision 72:19, 75:3, 107:25revisions 72:20, 73:7, 73:8, 73:15, 73:16, 108:5Richard 2:2, 3:1, 40:15right-hand 74:16rigorously 37:13Ring 165:15, 193:1rip 131:13ripping 131:4rise 4:3, 14:6, 81:21Risk 35:24, 84:5, 84:13, 84:14, 84:17, 85:2, 85:10, 86:20, 88:3,

96:7, 96:24, 107:9, 107:11, 117:6, 166:13, 199:9risk. 85:8risking 83:2risks 21:6, 21:11, 24:14, 34:9, 35:6, 35:14, 35:17, 84:2, 135:17, 166:14risky 82:20RMR 3:40, 222:10ROBERT 2:28, 2:30ROBERTS 3:9Rock 2:46role 38:12, 39:5, 39:7, 39:8, 157:8, 158:8, 159:11, 165:18, 171:16, 180:21, 191:5, 205:9, 205:10Room 3:41, 14:11, 210:17Ross 2:35, 3:11rotating 41:19roughly 164:15, 167:12, 173:9, 174:13, 174:18, 176:25, 177:6, 187:19roughness 72:4, 169:10, 171:24, 174:2, 185:3roundness 171:24routine 162:20, 163:17royalties 88:23, 88:25, 89:1royalties. 89:12royalty 89:[email protected] 3:7rubbing 51:3, 53:21, 60:4, 62:8, 62:22rubs 51:8,

160:19rules 9:9run 63:12, 125:17, 125:20, 129:11, 145:17, 172:14, 173:14, 174:2, 174:6, 187:20runaway 135:21running 36:22, 71:8, 121:11, 129:5, 157:22, 167:16, 173:25runs 15:14rupture 132:2rush 195:14

< S >s/pamela 222:9safe 191:1safety 33:25, 34:5, 35:12, 96:17, 96:18, 96:23, 193:7, 200:15, 207:9, 211:22, 213:22sake 208:12sales 39:21, 40:6, 61:21, 104:25, 105:5, 105:8, 113:18, 134:20, 190:6, 208:6, 210:6salespeople 71:17salt 197:11, 197:15sanction 12:6Sarver 3:1, 3:3satellite 105:18, 105:24satisfied 189:18save 14:23, 63:12, 76:8, 82:2, 91:8, 91:22, 123:5, 124:11, 141:25Saw 19:4, 41:14, 75:22, 95:14,

104:24, 125:23, 196:13, 196:16, 196:18saying 21:9, 24:20, 26:4, 29:14, 29:15, 29:17, 30:15, 30:21, 32:17, 37:16, 58:5, 82:23, 90:19, 103:7, 128:14, 131:20, 132:17, 140:21, 189:8, 211:23, 216:2scale 146:2, 146:7scenario 148:10schedule 6:3, 7:24, 7:25, 8:2scheduled 4:23scheduling 4:16, 4:18Schmalzried 20:3, 20:15, 20:25, 21:14, 21:17, 24:8, 24:11, 61:20, 61:25, 135:3, 137:25, 168:19, 198:23, 198:25, 199:5, 199:8, 199:17, 215:13, 215:25, 218:9, 219:4, 219:6School 151:7, 153:22, 154:2science 40:4, 40:6, 40:7, 84:25sciences 217:24scientific 98:18, 99:3, 99:8scientist 60:6, 61:7scope 49:15, 84:25, 85:6, 85:19, 117:8Scotland 155:24scratch 16:4

254

scratched 17:10screen 56:24seated 82:7seats 17:14sec 98:3Second 108:10, 111:10, 114:18, 196:6Section 129:3, 138:2, 138:8, 138:9, 138:14, 138:16, 139:1, 148:16, 148:17, 179:8, 179:10, 215:10secured 156:22SECURITY 4:3, 14:6, 81:21seeking 161:4Seem 15:3, 15:16, 44:14, 45:7seemed 74:8, 79:6, 129:16, 200:12seems 7:3, 22:24, 47:19seen 24:8, 31:16, 47:23, 49:24, 86:23, 88:21, 135:22, 145:15, 165:5, 165:7, 212:11seize 51:4seizing 96:3, 96:8, 96:21select 18:3selected 183:15, 183:16, 183:21, 200:25self-locking 179:3sell 61:16, 85:16, 87:14, 139:1, 148:19, 149:20, 189:9seller 77:7selling 18:24, 21:12, 24:15, 25:9, 77:1,

77:17, 88:3send 13:3sends 45:6, 88:7sent 22:11sentence 26:12, 98:16, 111:5, 113:12, 113:22, 115:4, 143:4, 143:14sentences 204:18separate 189:1, 189:3separated 51:17, 52:20, 52:23, 55:13, 56:15, 56:19, 56:20, 57:25, 58:13, 60:17, 61:4, 61:13, 124:20separates 52:8separation 53:20September 156:18, 206:9series 189:13serious 27:5serum 20:25, 21:15, 107:5, 113:15serve 6:21service 153:10, 174:14Services 128:22, 128:24, 128:25session 4:6, 22:18, 22:20, 22:21sessions 167:3set 6:2, 41:1, 117:1, 149:18SETH 3:9settled 22:19, 22:22Seven 13:22, 147:16, 159:14, 195:12, 195:13, 210:5several 69:14, 106:8, 129:5, 155:24, 158:6, 158:13, 173:24,

174:1, 178:12severe 73:14shall 150:21shape 8:24, 148:25share 40:8, 80:20, 80:24, 194:4, 212:15, 212:18, 212:23, 213:3, 213:4, 213:8shared 90:1SHEA 150:10, 192:5, 192:9, 192:10, 192:13, 192:14sheet 15:25shell 74:12, 99:19, 102:3, 153:17, 153:19, 159:8, 177:13, 177:16, 178:13, 179:18, 181:3, 181:13, 181:14, 181:21, 183:14, 183:20, 184:8, 184:15, 184:17, 184:22, 185:16, 186:16, 186:17, 186:18, 187:3, 190:1shells 183:7shoots 42:11short 8:16, 14:25, 130:2shortening 219:16shoulder 89:14shouldn't 17:10, 39:8Show 26:3, 26:9, 31:18, 43:4, 58:5, 60:13, 65:17, 68:17, 85:20, 118:15, 122:20, 133:1, 196:6, 210:21showed 37:21, 39:2, 40:5, 40:14, 40:17,

81:6, 87:16, 105:18, 121:20, 130:10, 139:25, 142:22, 142:23, 144:2, 145:2, 145:4, 145:5showing 45:24, 46:6, 130:9, 137:10, 181:9shown 59:19, 59:22, 66:14, 120:17shown. 86:21shows 43:6, 43:9, 129:20, 140:10shrink 101:10si 195:14side 10:25, 18:15, 18:18, 146:2, 153:7, 169:12, 178:18, 178:19, 193:15, 195:16, 217:7side-by-side 16:10, 18:9sides 7:14, 46:20significance 113:16, 145:7significant 84:4, 118:7, 118:9, 166:19, 194:3Significantly 96:20, 212:23, 213:3, 213:4, 213:8Similar 18:8, 94:10, 94:12, 105:6, 105:10, 107:14, 114:20, 186:1, 186:3similarity 18:17, 94:15Simmons 2:20simply 24:20, 77:15, 83:12simulator 18:22, 23:16, 23:17,

255

41:12, 45:24, 45:25, 46:5, 72:4, 94:13, 95:12, 121:18, 135:22, 145:15, 148:9, 172:7, 172:10, 172:12, 172:17, 173:1, 173:22, 187:6, 187:16, 188:9, 188:11, 207:22, 209:11, 209:15, 209:16, 209:21simulators 45:16, 95:1, 173:24, 174:10, 175:24, 187:9simultaneously 77:17single 120:24, 127:19, 207:6Sir 9:13, 61:7, 78:7, 91:17, 135:10, 142:3, 150:13, 162:18, 190:20, 192:11, 192:16, 197:11, 203:22, 204:8, 207:6, 208:22, 210:16, 218:18sister 34:25sit 103:10, 160:23sits 160:24sitting 18:14, 96:5situation 4:17, 4:20, 5:24, 5:25, 24:16, 81:11situations 6:2Sivash 165:16, 193:2Six 13:22, 13:23, 20:4, 20:7, 20:9, 20:20, 20:23, 42:3, 82:1, 82:12, 82:15, 150:16, 159:14

size 17:6, 162:16, 163:1, 163:2, 164:4, 169:16, 170:1, 171:24, 173:20, 173:21, 197:5sizes 102:3, 162:12sizing 164:12slide 27:23, 29:19, 87:7, 104:24, 105:3, 105:4, 105:9, 105:11slides 105:6slight 9:24slightly 95:24, 145:13slip 102:7slippery 54:1slow 77:5small 26:20, 53:20, 76:19, 76:21, 96:6, 134:12, 154:1smaller 53:14smooth 50:10, 51:12, 171:2Society 167:6, 167:13socket 56:12, 152:11, 152:12, 153:7, 159:8, 160:14, 160:16, 162:2, 162:20, 163:2, 169:12, 172:13, 177:13, 178:18soft 73:12, 131:2, 132:1software 185:8sold 87:24, 103:25, 119:5, 143:22, 143:24, 148:22, 189:5, 190:8solid 59:23solution 12:7, 12:8, 88:19, 89:6

somebody 13:3, 155:17, 175:14someone 50:20, 58:25, 61:6, 132:21, 154:22, 157:22, 170:16, 214:13sometime 162:5, 180:7, 188:17Sometimes 23:17, 73:14, 74:21, 125:1, 125:6, 145:18, 157:20, 167:10, 184:1somewhere 172:20Sontag 121:3, 121:6, 121:9, 121:12, 221:40Sorry 11:11, 11:12, 15:19, 15:23, 16:10, 17:1, 19:16, 31:23, 33:13, 36:24, 56:4, 58:18, 63:3, 68:1, 73:2, 75:8, 78:10, 80:13, 98:4, 98:21, 98:23, 101:12, 103:6, 111:16, 113:5, 115:16, 118:16, 119:20, 120:5, 135:12, 142:14, 145:11, 174:19, 194:9, 198:7, 198:8sort 10:16, 97:7, 105:6, 109:7sound 172:22sounded 136:24sounds 172:24source 22:24, 59:8, 80:9, 143:5, 143:19, 143:20, 216:17sources 216:19, 219:1, 219:2South 3:18,

150:25space 169:6speaking 110:7, 121:1spec 141:13, 141:18spec. 141:12SPECIAL 3:30, 6:21, 9:3specialists 216:9specialty 167:7, 178:8, 178:9, 183:1, 195:17, 200:7, 200:8, 211:15, 215:3, 215:18, 216:3specific 34:23, 35:15, 116:3, 126:3, 136:4, 136:11, 153:12, 165:23, 166:21, 167:3, 167:8, 169:16, 173:3, 202:10, 214:23Specifically 20:8, 29:25, 64:10, 74:2, 109:13, 116:24, 156:11, 157:14, 157:15, 165:22, 175:15, 211:18specifying 121:1specimen 145:20specimens 142:22, 142:23, 145:17, 145:19, 146:3specs 141:20spectrum 117:5speed 87:1spend 77:24, 82:1, 82:12, 153:9Spent 153:9, 196:11spent. 77:25sphericity 72:5spite 131:17split 5:9, 7:20

256

spoke 165:20spread 53:6spring 190:[email protected] 3:14St 2:45stability 137:23, 162:17stack 134:9stage 7:3, 125:2stairs 121:17stand 149:24, 167:12standard 88:15, 121:17, 208:13, 209:13standards 167:11standpoint 163:9, 173:5stands 176:16Stanton 3:30, 3:[email protected] 3:35start 8:18, 21:12, 24:15, 70:10, 77:1, 97:19, 123:11, 124:13, 128:14, 159:24, 176:18, 210:13, 215:7, 218:6start-stop-dwell 188:12started 11:8, 19:15, 19:19, 20:9, 21:23, 77:5, 123:13, 152:2, 152:17, 152:25, 158:4, 171:25, 177:22, 177:23, 218:15starting 7:19, 134:10, 188:11starts 44:2, 74:16, 142:19State 186:11, 186:21stated 21:4,

21:17, 24:7statement 17:25, 29:8, 58:7, 99:22, 213:5States 1:1, 1:21, 4:5, 4:7, 4:9, 116:4, 117:22, 143:24, 149:21, 157:1, 157:4, 159:25, 167:5, 222:4stating 30:17Station 41:17, 42:14, 42:23, 43:4, 43:5, 43:6, 43:7, 43:9, 43:12, 44:15, 44:20, 44:23, 172:12stations 41:16, 41:19, 41:22, 42:3, 43:10, 145:15stay 9:2, 11:19, 23:25, 31:13stayed 156:21, 156:22stays 87:1, 162:20steam 87:4stem 36:5, 72:14, 72:22, 73:5, 74:6, 74:12, 74:21, 74:25, 75:6, 75:15, 117:16, 117:18, 117:21, 118:1, 118:2, 118:8, 119:1, 119:2, 119:4, 119:5, 119:10, 119:21, 129:16, 130:5, 130:11, 142:21, 143:2, 143:6, 143:10, 143:13, 143:21, 143:22, 143:24, 148:19, 148:23, 156:13, 160:19, 160:20, 160:21,

160:24stems 117:25, 120:14stenography 3:46step 14:13, 127:11, 127:20, 150:21, 180:24Stephenville 1:41steps 71:21Steve 90:3STEVEN 2:43Stewart 45:6sticker 40:20stock 16:6, 16:19STOLLE 3:26Stop 31:10, 86:24, 111:24, 112:9, 112:11, 127:20, 219:12stopped 15:6, 188:16, 191:7stopping 188:11story 62:8, 62:9, 62:23, 75:17, 75:20, 88:12strains 185:9strange 44:14Strathclyde 155:24Street 3:4, 3:18, 3:41stress 185:17stresses 185:9strike 180:4, 190:10strong 63:5structured 39:8stuck 128:11student 175:7students 59:8studied 118:11, 118:12, 211:18Studies 21:23, 23:16, 23:17, 68:22, 69:1, 69:9, 78:19, 78:24, 115:5,

135:22, 151:8, 155:14, 155:23, 178:12, 189:14, 208:5, 209:11studying 70:21stuff 8:22, 62:10, 66:23, 74:18, 91:13, 141:13stunned 46:19subject 18:19, 24:1, 25:10, 49:1, 49:8, 64:2, 68:16, 70:16, 88:22, 90:6, 91:23, 91:24, 129:14, 131:16, 134:7, 139:23, 148:12subluxation 95:19submission 50:8, 94:11, 98:25, 104:4, 202:3, 206:20submitted 102:3subsections 138:11subsequent 107:20substance 138:13, 148:22, 196:24, 196:25, 197:22Substantial 53:24, 54:2, 54:5, 99:17substantially 100:9success 165:3sudden 44:2suggest 12:23, 45:11, 48:3, 48:7, 200:12suggested 8:14, 8:25, 46:14suggesting 8:12, 12:24, 45:22, 113:14, 216:4, 217:16

257

suggestion 13:2, 23:8, 23:13suggests 27:6Suite 2:36, 3:4, 3:11Sulzer 144:13, 172:2, 172:3, 172:8, 172:17, 173:6, 173:7, 192:21, 195:4, 210:1sum 110:25, 111:1summarized 10:7, 10:12summary 166:6, 199:20summer 152:2, 190:9supervise 175:6supervisor 154:22, 155:2supervisors 155:9, 155:14supplement 166:3Support 54:19, 60:19, 61:7, 78:20, 78:25, 137:11, 199:20, 205:2, 205:4supported 51:18, 52:20, 52:24, 54:10, 54:19, 54:20, 54:21, 55:13, 56:15, 56:19, 56:20, 57:25, 58:13, 59:2, 59:3, 60:17, 61:4, 124:21, 125:6, 125:8, 125:14supportive 97:10supposed 133:16, 216:9supposedly 135:15Surely 34:12, 134:2Surface 57:24, 83:23, 97:8,

99:4, 99:18, 99:24, 100:5, 101:5, 129:23, 135:16, 140:19, 143:5, 146:17, 164:10, 164:13, 169:8, 169:9, 170:9, 171:24, 185:3, 209:17, 209:19surfaces 51:17, 52:9, 52:10, 53:25, 54:2, 54:12, 56:11, 56:14, 57:24, 58:12, 59:23, 61:3, 62:23, 75:6, 83:17, 99:9, 110:8, 124:20, 137:10, 143:1, 162:11, 164:16, 166:11, 169:2, 209:8surfaces. 126:18surgeon 6:17, 11:25, 33:18, 34:11, 36:3, 36:5, 36:8, 72:13, 90:25, 91:2, 104:20, 104:22, 105:2, 105:7, 152:7, 153:10, 159:9, 181:19, 199:8, 215:11, 219:2surgeon-specific 152:7Surgery 20:11, 33:3, 34:10, 37:22, 90:1, 124:18Surgical 15:13, 15:22, 16:14, 32:22, 109:10, 109:15, 109:20surprise 145:24surprised 47:4, 47:19surprises 145:25survivorship

165:6, 165:17suspect 50:20Sustain 117:11Sustained 21:25, 23:11, 27:9, 30:19, 31:6, 32:2, 34:20, 35:21, 36:14, 43:1, 46:2, 47:1, 57:21, 67:21, 71:2, 96:14, 100:13, 102:20, 109:18, 110:3, 125:11, 127:5, 129:25, 132:7, 138:22, 143:8, 146:11, 146:13sweetheart 123:20, 123:21swiftly 138:7Swing 127:13sworn 10:22swung 125:2symposia 166:24symposium 166:7, 166:23, 167:15symposiums 167:9synovial 52:4Syracuse 217:8systemic 137:4systems 89:24, 165:13, 208:1

< T >table 81:11, 102:14, 103:7, 134:19talked 16:3, 17:25, 39:16, 39:21, 70:25, 76:25, 88:23, 91:23, 100:22, 122:21, 165:20, 166:17, 168:12, 170:8Talks 16:22, 17:5, 17:9, 66:22, 86:15,

100:4, 110:5, 111:19, 112:14, 215:11tandem 129:16, 130:5taper 149:1, 149:20, 179:3, 179:7, 179:8tapered 74:21targets 85:7team 71:21, 73:21, 79:17, 86:15, 96:22, 151:12, 156:15, 158:14, 158:18, 167:20, 168:7, 171:16, 181:24, 190:20, 190:24, 195:17, 200:14, 206:7, 206:25, 207:8, 207:17, 214:2, 214:3, 214:6, 214:8, 214:10, 214:11, 214:19, 214:22, 214:25, 215:1, 215:2, 215:5, 215:8, 218:25technical 25:19, 25:23, 26:1, 26:3, 28:9, 30:25, 32:9, 32:10, 32:14, 35:4, 35:5, 38:13, 39:25, 63:25, 64:3, 64:8, 69:13, 90:1, 97:9, 110:11, 110:12, 110:15, 110:22, 112:11, 115:12, 131:17technique 15:13, 15:17, 15:20, 15:22, 16:1, 16:14, 32:22, 109:10, 109:15, 109:20Techno 38:7, 38:9, 38:12,

258

38:23, 38:24, 40:10, 104:16techno-marketing 39:5technologies 157:16technology 50:2, 50:6, 52:9, 53:4, 53:8, 55:22, 56:14, 58:12, 98:18, 99:3, 99:5, 99:8, 122:17, 124:20, 126:15, 161:13, 161:14, 162:22temporarily 149:8ten 174:15, 174:16, 174:18, 174:19tend 93:7tender 10:20tendon 132:2tendons 131:4tens 187:21term 38:8, 38:9, 38:24, 54:6, 84:5, 169:4, 169:8, 205:4terms 49:10, 84:5, 99:4, 110:18, 110:20, 111:2, 174:9test 19:13, 19:14, 25:1, 25:10, 37:18, 41:8, 42:17, 43:10, 44:6, 45:25, 72:10, 92:17, 94:20, 94:25, 100:22, 143:25, 144:5, 145:4, 145:13, 145:15, 172:12, 173:4, 173:15, 173:17, 189:11, 209:13tested 37:16, 58:17, 58:21,

72:10, 96:20, 172:16, 174:15, 187:9, 187:11, 187:12, 187:14, 188:9, 188:14testified 76:18, 77:8, 134:15, 207:14, 209:3testify 18:15, 18:17testifying 116:12testimony 7:14, 10:8, 10:12, 24:8, 24:22, 30:6, 32:16, 35:16, 56:23, 60:22, 134:9, 189:5, 191:18, 191:22, 192:3, 192:4, 193:9, 193:18, 193:21, 194:11, 195:22, 196:22, 197:17, 208:22, 210:9, 210:12tests 37:14, 37:15, 45:24, 46:5, 92:18, 100:18, 140:25, 144:9, 145:2, 189:13, 189:18Texas 1:2, 2:14, 3:42, 4:6, 33:22, 222:12text 201:8Thanks 82:8, 204:20theme 82:19themselves 164:10theoretical 126:24, 127:2, 166:17theory 54:7, 125:17thereof 130:12thesis 211:16, 211:19they've 165:8,

165:9, 216:1thick 134:11, 162:14thigh 160:22thin 56:10, 126:15, 163:3, 163:6thinkers 128:14thinking 67:1, 165:10, 174:12, 174:18third 54:6, 78:17, 139:8Thomas 24:8, 135:3Thornburg 3:17though 15:14, 30:3, 63:24, 75:16, 132:13, 189:16, 204:21, 210:17, 215:16three 7:10, 42:3, 124:19, 151:4, 167:18, 172:21threshold 197:4throughout 120:22, 120:23, 170:12, 170:21, 185:1, 200:18, 200:22, 202:23, 207:10throw 75:15Thrs. 114:21tightly 92:3Time-out 47:11, 48:11, 75:24timely 193:16, 212:7, 212:9, 213:8, 213:11tip 184:16tissue 16:7, 17:20, 27:24, 30:13, 73:12, 75:3, 109:13, 110:5, 110:7, 132:1, 138:15, 143:18, 166:21tissues 28:1, 30:14, 83:25,

111:14, 115:2, 131:2tissues. 143:16titanium 153:20, 176:11, 178:18, 179:18, 179:19, 181:14, 183:14title 135:2, 138:12, 153:2titled 199:1today 5:4, 6:6, 8:16, 8:18, 18:14, 84:8, 103:10, 123:22, 138:9, 139:3, 161:18together 74:7, 74:10, 97:6, 135:13, 162:12, 164:7, 172:14, 178:15, 179:9, 217:17tolerability 85:2tolerance 164:5Tolerancing 164:1, 164:3, 164:4, 164:12Tom 150:10, 168:19, 199:5ton 63:10tonight 11:19Tony 89:5took 19:24, 105:19, 114:24, 135:12, 149:9, 157:14, 184:9, 191:4top 10:25, 17:25, 70:20, 145:16topic 121:6, 126:9, 138:15topics 166:9, 202:17, 202:20Total 7:13, 20:11, 106:25, 107:7, 114:18, 122:15, 135:16, 169:5, 169:12,

259

195:9, 198:10, 199:2, 199:10, 199:21touch 9:2touching 50:16, 51:14towards 44:3, 83:22toxic 196:24, 197:9, 197:11, 197:15, 216:10, 217:15toxicity 112:22, 113:10, 196:22, 197:4, 197:18, 197:24, 204:3, 205:16, 208:19Toxicity/ion 196:12toxicologists 218:2toxicology 195:18, 200:3, 200:13, 214:7, 214:13, 215:3, 216:24TPS 73:5, 117:15, 117:18, 117:21, 118:1, 118:2, 118:7, 118:20, 119:1, 119:5, 119:10, 119:21, 142:17tracking 66:24trade 152:21train 156:1trained 155:20training 32:24, 39:21, 104:12, 105:5, 105:8, 200:8TRANSCRIPT 1:19, 3:47, 4:1, 6:22, 10:4, 10:8, 221:46, 222:2trauma 73:8, 79:13treatment 34:6tremendous 104:12

Trent 192:13Trial 1:19, 4:1, 11:3, 106:12, 106:19, 134:8, 134:9, 159:17, 176:20, 176:22, 201:11, 201:13, 201:23, 202:2, 202:5, 202:7, 202:8, 207:8trial. 205:2, 206:24trials 207:25, 208:2Tribological 60:3tribologists 97:5Tribology 121:21, 154:11, 154:12, 154:13, 155:18, 167:23, 171:19, 182:11, 211:17, 211:19tried 8:10, 63:15, 72:8, 97:13, 125:16, 126:10, 140:23Trip 89:20trouble 75:16, 141:19True 21:22, 22:3, 22:4, 51:10, 57:2, 57:18, 58:1, 58:17, 61:13, 61:14, 61:18, 85:9, 126:17, 198:12Trueglide 50:2, 50:5, 52:9, 53:4, 53:8, 55:22, 56:10, 56:14, 58:12, 60:23, 61:21, 62:19, 62:20, 63:6, 120:15, 120:17, 122:16, 122:17, 122:22, 124:13, 124:20,

126:11, 126:15, 129:3, 129:6truly 55:15, 60:23truth 45:21, 58:8, 60:20, 74:3, 78:19truthfully 196:23try 8:23, 9:17, 12:16, 12:25, 14:22, 14:25, 84:17, 97:18, 103:4, 103:11, 103:15, 113:6, 127:8, 163:18, 174:3, 184:15Trying 36:24, 38:13, 38:15, 61:20, 77:1, 79:11, 80:1, 80:8, 101:7, 102:7, 119:13, 141:5, 145:8, 145:9, 160:6, 161:20, 184:15, 193:7, 193:16, 198:21, 212:5, 212:6, 212:8, 212:12, 212:14, 213:7, 213:10Tuesday 5:10, 5:13, 5:15, 6:15, 7:16, 7:17, 7:19, 7:20, 7:21TULL 2:44, 3:25tumors 196:13, 196:16, 196:19Turn 101:13, 101:16, 107:24, 142:12, 159:22, 165:18, 193:15, 194:19, 204:24, 207:12, 207:16, 208:21TURNER 5:2, 5:4, 6:5, 8:16, 14:22, 22:11, 79:16, 89:21,

97:13, 98:15, 106:11, 142:7, 220:5Turner/lancaster 221:22turning 199:25, 209:20, 210:1twice 6:24, 11:1Two 4:23, 5:10, 5:22, 6:5, 7:2, 7:15, 9:22, 10:3, 35:19, 53:12, 74:7, 74:9, 85:22, 86:9, 118:4, 124:11, 138:9, 138:11, 146:4, 147:2, 147:5, 147:13, 147:14, 147:15, 151:15, 154:17, 162:11, 162:14, 164:4, 169:2, 178:15, 178:17, 179:9, 185:18, 206:18, 206:19, 215:25two. 6:18, 9:18, 160:18TX 1:34, 1:41, 2:37, 3:12, 3:33type 24:18, 25:6, 51:5, 85:7, 119:11, 153:4, 155:15, 162:1, 176:8types 52:1, 52:3, 152:4, 177:14, 183:6typical 117:5typically 145:17, 160:5, 164:18, 174:10typo 45:2, 45:23, 46:11, 47:6, 47:19, 47:22, 87:18typo. 44:17

< U >

260

U.S 88:2Ulatowski 5:11, 6:7, 6:10, 8:19Ultamet 25:16, 44:15, 45:9, 48:2, 49:4, 70:16, 79:1, 96:17, 99:1, 117:20, 119:3, 120:12, 141:1, 143:25, 144:14, 144:19, 144:20, 145:2, 145:3, 145:5, 189:19, 189:21, 189:22, 190:1, 190:3, 190:4, 190:6, 190:11, 190:18, 195:10, 195:13, 208:5, 209:5, 210:6ultimately 87:13, 159:16, 211:7Um-hum 213:1unaware 57:14uncommon 20:11, 20:13, 20:23undergo 187:5undergoing 161:17undergraduate 151:8, 151:18underneath 193:4, 214:8understand 8:10, 62:23, 69:14, 69:17, 69:18, 76:15, 77:18, 85:19, 94:4, 97:14, 97:16, 111:16, 132:23, 148:16, 154:5, 159:4, 160:6, 174:3, 176:10, 192:8, 196:17, 196:18, 201:12, 203:23, 206:5, 206:6, 211:23, 216:23, 217:23,

218:1understand. 138:10understanding 8:17, 9:3, 23:9, 108:12, 111:8, 120:20, 120:22, 123:1, 127:2, 132:5, 160:1, 160:3, 161:20, 161:25, 162:3, 164:8, 164:14, 164:20, 186:25, 188:20, 191:21, 197:8understands 41:1understood 9:20, 83:18, 203:24undertake 85:6undertaken 186:5, 187:16underway 161:8undetermined 84:3unexpected 46:15, 46:18Unique 55:22, 55:23, 56:2, 56:6, 56:9, 62:22uniquely 62:15United 1:1, 1:21, 4:5, 4:7, 4:9, 117:22, 143:24, 149:21, 157:1, 157:3, 159:25, 167:5, 175:11, 222:4units 9:4, 77:9University 151:8, 151:10, 151:11, 154:8, 154:24, 155:6, 156:1, 171:9, 171:15, 175:2, 175:10, 178:7, 186:11, 186:21, 188:4, 188:5, 188:7unknown 25:20,

27:21, 85:1, 131:21, 132:4, 132:10unknown. 27:2, 111:7, 113:16unknowns 111:4Unless 12:5, 12:16, 92:16, 116:12, 145:18, 189:18unofficial 155:9unquote 61:5unrestricted 23:4Unsworth 175:10, 175:13, 175:14untenable 5:24until 103:13, 152:3, 153:1, 170:13, 189:18, 190:9, 195:10, 210:6Unusual 45:3, 45:23, 46:11, 46:15, 47:23, 56:5, 56:6unwind 92:20update 86:16updated 106:7upper 199:3urine 21:1, 21:15, 113:15Usdin 3:2user 72:17users 134:1uses 68:11using 39:1, 49:19, 53:10, 70:21, 71:22, 74:13, 80:2, 88:10, 88:14, 90:25, 176:18, 212:11utilized 117:25utilizing 172:8

< V >V. 2:33Vail 19:24,

22:18, 22:20, 22:21Valparaiso 151:8, 151:9, 151:13, 151:18, 154:1values 45:2, 103:17variability 45:22, 46:11, 46:16, 48:4, 48:7, 48:8, 48:11variability. 45:12variance 48:13variation 45:25variety 83:25, 102:2, 105:16, 144:12various 112:25, 115:19, 120:23, 121:16, 173:17varsity 151:12vary 34:7verbatim 6:22Verification 100:18, 100:23verify 32:25, 33:1Versus 106:18, 117:3, 117:5, 145:2, 145:10Video 41:14, 105:18, 105:21, 150:6, 150:8, 210:14, 210:15view 136:6, 217:18viewpoint 165:3violated 12:12violating 12:8visit 89:23visit. 89:20visitations 104:20vital 35:11, 35:17, 35:23vital. 35:7vivo 114:20,

261

146:16, 147:1VOLUME 1:19, 4:1, 24:12, 26:19, 197:11, 220:1volumetric 146:1volunteered 47:8

< W >W. 2:43Wait 14:7, 49:13, 63:12waiting 129:8walked 140:15, 140:17, 163:17, 210:16walking 121:17, 125:2, 172:15, 174:9, 174:11wanted 4:11, 7:1, 40:12, 148:17, 153:21, 177:17, 185:15, 185:17, 189:14wanting 154:3wants 47:19warmed 123:12warn 31:15, 33:23, 37:3warned 31:24, 32:4, 32:6, 32:8, 32:13, 32:23, 32:24, 83:13warning 15:24, 24:4, 26:18, 27:3, 30:23, 31:18, 33:4, 33:8, 33:11, 33:14, 33:17, 33:19, 34:13, 34:23, 34:24, 36:10, 36:16, 37:6, 37:10, 37:24, 37:25, 48:20, 48:21, 68:10, 103:18, 103:20, 103:21, 103:22, 104:1,

135:15, 136:3, 136:10, 137:14, 138:12, 138:19, 139:6Warnings 15:7, 15:10, 15:15, 16:13, 16:16, 16:17, 17:15, 31:2, 33:21, 35:15, 64:9, 69:23, 85:4, 109:10, 116:8, 117:1, 117:2, 117:5, 131:18, 134:10, 134:20, 138:2Warsaw 97:6, 150:23, 150:24, 151:7, 152:23, 157:9, 157:23, 188:2was. 20:5watching 25:12, 123:8water 46:20, 197:13, 197:15Waterloo 188:5, 188:7Watson 196:11Wayne 2:10, 150:25ways 161:21, 170:17wear-free 122:8, 122:14wear. 52:11, 59:24, 135:21, 136:9wearing 42:18, 43:16, 44:2, 45:16, 83:22, 148:9, 209:14wears 42:17Wednesday 4:22, 5:10, 5:16, 7:21, 7:23, 8:3, 12:15, 13:7, 89:23wee 8:9week 5:10, 5:15,

5:16, 12:2, 103:2, 204:21weekend 219:16weight 16:18, 34:8, 56:15, 57:25well-known 155:16West 1:[email protected] 2:16What'd 102:25Whatever 13:4, 13:24, 78:1, 122:16, 123:5, 131:12, 197:6whenever 12:4Where'd 150:22whereas 162:23whether 14:3, 18:23, 24:5, 27:15, 36:17, 59:14, 60:23, 64:10, 87:24, 89:6, 90:17, 90:19, 94:20, 97:13, 100:15, 101:6, 113:20, 121:15, 143:22, 177:15, 188:20, 211:21, 213:21, 214:15, 216:9, 217:14whip 123:19whisper 131:18WHITE 3:24, 181:11whole 46:17, 76:2widened 92:14, 93:25, 96:2widening 96:11, 96:16wider 165:13will 5:3, 5:9, 6:16, 13:18, 25:16, 34:13, 36:5, 45:5, 51:4, 62:20, 62:22, 63:14,

67:9, 71:21, 82:13, 85:6, 85:8, 90:13, 91:12, 120:23, 127:10, 129:12, 131:13, 159:8, 172:15, 192:16, 193:3, 194:18, 196:4, 196:6, 204:11, 206:14, 206:22, 213:2Willert 29:7, 67:19, 111:23, 112:1, 112:2, 112:5, 112:7, 132:18, 133:1, 133:3, 133:20willing 9:2WILSON 3:40, 221:45, 222:9, 222:10window 146:5within 9:13, 22:22, 52:5, 96:19, 120:24, 155:16, 156:14, 179:8, 187:25without 16:10, 18:9, 18:13, 18:18, 21:21, 22:2, 24:4, 44:9, 60:9, 120:25, 121:11, 136:15, 196:24WITNESS 5:6, 6:11, 10:12, 10:19, 17:2, 27:10, 31:7, 33:25, 34:17, 42:23, 43:2, 46:3, 63:10, 63:13, 67:22, 70:13, 78:6, 81:15, 86:12, 102:19, 123:10, 123:24, 127:6, 131:9, 147:25, 149:14, 220:3witnesses 5:11, 7:5, 9:7

262

word 55:25, 59:20, 77:21, 103:7, 105:7, 133:22, 153:13, 169:1, 189:19, 200:12, 204:3words 18:6, 29:2, 37:5, 37:19, 45:15, 62:15, 68:11, 68:13, 69:12, 69:25, 70:3, 72:24, 73:2, 122:17, 155:20, 161:23, 193:23, 194:4, 194:13, 194:20, 212:8, 213:10, 213:11words. 61:10wore 145:12worked 28:9, 40:6, 150:15, 150:18, 150:20, 151:21, 152:8, 152:9, 152:25, 153:8, 154:5, 156:7, 156:11, 156:12, 157:7, 175:23, 178:6, 214:18, 216:21working 48:5, 48:10, 151:23, 152:2, 157:12, 171:14, 171:20, 175:7, 188:16, 191:7, 198:3, 198:22, 199:5, 199:9, 216:23, 219:17works 26:6, 36:17, 37:3world 24:16, 95:18worldwide 86:15worried 85:15, 87:6worries 137:20worry 134:23, 162:14worse 30:5,

42:17, 44:3, 45:16worth 84:17, 174:14wow 124:1write 66:19writes 48:1, 61:25writing 66:25, 200:11written 205:12wrote 59:13, 119:13, 126:12, 199:9

< X >x-rays 149:9XL 139:17, 139:18

< Y >year 22:23, 39:14, 81:7, 86:18, 146:16, 146:21, 146:24, 146:25, 147:1, 147:5, 155:6, 156:16, 156:25, 165:7, 166:8, 174:13, 174:20, 190:17years 37:21, 72:21, 73:25, 76:25, 85:22, 89:13, 106:8, 135:19, 147:14, 147:15, 149:17, 150:16, 150:19, 151:14, 151:15, 155:25, 158:6, 159:12, 159:14, 173:11, 173:13, 174:16, 174:19, 183:24, 188:14, 195:12, 195:13, 208:15, 208:17, 210:5yesterday 12:24,

15:6, 18:22, 23:16, 25:22, 26:1, 87:16, 91:24, 104:24, 105:18, 140:17, 140:20, 140:22, 140:23, 141:8, 148:6yield 170:6York 2:23you. 34:11, 36:9younger 136:1, 136:17yourself 38:9, 38:22, 90:3, 150:11

< Z >zoom 26:9, 191:19, 194:9, 213:21

263

C E R T I F I C A T I O N

I, PAMELA J. WILSON, CSR, certify that the foregoing is a

transcript from the record of the proceedings in the foregoing

entitled matter.

I further certify that the transcript fees format comply

with those prescribed by the Court and the Judicial Conference

of the United States.

This the 2nd day of March, 2016.

s/Pamela J. WilsonPAMELA J. WILSON, RMR, CRR Official Court ReporterThe Northern District of Texas

Dallas Division


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pinnaclehipdocuments.compinnaclehipdocuments.com/Lessons Learned/16-03-02PetersonVol3… · IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION