IN THE UNITED STATES DISTRICT COURT FOR THE ...pinnaclehipdocuments.com/Lessons...

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 1, 2016

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TRANSCRIPT OF TRIAL - VOLUME 32

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 32 - TRIAL TRANSCRIPT - MARCH 1, 2016

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

THE SECURITY OFFICER: All rise.

Come to order, please.

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: Okay. Let's bring them in.

(Jury enters the courtroom.)

THE COURT: Morning. Y'all be seated.

My wife actually got me to watch The Bachelor for about

five minutes I believe. That's hard to believe. But Kansas

was already blowing out Texas, so nothing to watch.

Here we go, Mr. Quattlebaum.

MR. QUATTLEBAUM: Thank you.

May it please the Court.

MS. LEANNE TURNER

DIRECT EXAMINATION (Cont.)

BY MR. QUATTLEBAUM:

Q. Ms. Turner, yesterday --

MR. QUATTLEBAUM: Jim, can we go to the ELMO,

please?

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

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BY MR. QUATTLEBAUM:

Q. Yesterday, we created this very messy timeline. So I

want to review, and I tried this morning to create one that's

not so messy, and I think we can walk through it just to get

us back.

So in the mid 1990s is it right -- Did I get it right

that there was JJPI doing some work?

A. Yes.

Q. And that was not part of DePuy?

A. Correct.

Q. And they were working on that Ultima project and had that

taper patent?

A. Correct.

Q. About the same time DePuy was engaged in its alternate

bearings project?

A. Yes.

Q. Move us forward to 1996, what was the DePuy project at

that time?

A. It was the future cup project.

Q. All three of those dealing with metal-on-metal?

A. Yes.

Q. Moving forward to '97, what were we seeing going on at

that time?

A. On the DePuy side, we were working on the development of

the one-piece, 36-millimeter one-piece.


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Q. And is that when the Ultima clinical study in the U.S.

started?

A. That's correct.

Q. And it had about 269 patients implanted with the Ultima

device?

A. In the U.S., yes.

Q. Yeah. 1998 what happened?

A. J&J acquired DePuy.

Q. Okay. 1999 what happened?

A. Pinnacle project is starting.

Q. And what happened with regard to one-piece?

A. We were implanting custom devices.

Q. Okay. And about 157 of those, right?

A. Yes.

Q. 2000 what occurs?

A. In 2000, Ultamet was cleared by the FDA, and an IDE study

for the one-piece started in the U.S.

Q. And was that clearance by the FDA and the one-piece

study -- did that involve the integration of the information

that came from JJPI?

A. Absolutely.

Q. No, is there another Johnson & Johnson company that was

involved as well?

A. Yes.

Q. What was it?


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A. Johnson & Johnson Orthopedics, JJPO.

Q. What role did it have?

A. JJPI and JJPO were similar to sort of the Warsaw and the

DePuy International on the DePuy side. So it was a U.S. and

then a European sort of groups both doing orthopedic products

within Johnson & Johnson.

Q. So they collaborated on Ultima?

A. They did collaborate.

Q. We're up to 2000. 2001 what happens?

A. In 2001, the first Ultamets were implanted.

Q. And where were the Ultamets manufactured?

A. They were manufactured in our DePuy Leeds facility.

Q. And what company is that?

A. Depuy International.

Q. Then 2002 what occurs?

A. The full commercialization of Ultima in the United

States.

Q. What happened to the Ultima clinical study?

A. It was the end of the IDE study.

Q. And then we go forward to 2004. What occurs with regard

to this progression?

A. That was the end of the 36-millimeter one-piece IDE study

in the United States.

Q. Okay. Thank you.

Where we were when we left off yesterday, you were


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telling us about the role of design surgeons, remember?

A. Yes.

Q. For what period of time during that timeline were design

surgeons involved in the development and design of Ultamet and

Pinnacle cup?

A. Considering the design development work for the

predecessor devices, back through 1994.

Q. Did you -- were you there? Did you participate in those

design meetings?

A. I did participate in design meetings, yes.

Q. Did you observe the design surgeons providing input?

A. Yes, I did.

Q. Was the input meaningful?

A. Their input is critical.

Q. Let me hand you this cup.

What is that cup, ma'am?

A. This is a Pinnacle -- Pinnacle sector cup, so sector

meaning three screw holes in one quadrant of the cup.

Q. And is there any particular story about design surgeons'

involvement with that cup?

A. There are a couple.

As I mentioned yesterday, from an engineering perspective

I can do a lot with --

MR. LANIER: Judge, I'm going to object only for

clarification to make sure these stories aren't hearsay and


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that she was actually there.

THE COURT: We don't know yet. Get ready. We're

about to find out.

MR. QUATTLEBAUM: Thank you, Your Honor.

BY MR. QUATTLEBAUM:

Q. That's what we need to know, Leanne. Were you

involved -- there when these --

A. Yes. I was there.

Q. -- this event took place?

A. Yes.

Q. Okay.

A. As I mentioned yesterday, from an engineering and

development perspective we can do a lot with the physical

components. And what we have less direct experience with is

the anatomy and the bone.

So one example, certainly from the DePuy side, we had a

very successful acetabular cup already on the market that was

called Duraloc. It had been available since 1990. Very

successful. And it had a particular pattern for the screw

holes. So where a surgeon might use the screw holes is if

they put the acetabular cup in and just for a belt and

suspenders or maybe the bone quality isn't exactly what they

would like, then they put bone screws from the inside to

firm -- firmly secure the cup into the acetabulum.

So we came to the design surgeons with this is the screw


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hole pattern that is currently available in Duraloc, and it's

very successful, and this is what we propose. And there was

quite a spirited debate about if you look inside the -- the

shell should the screw holes be a smiley face or should they

be a frowny face.

So the Duraloc design had one hole closest to the apex

and two that were more lateral. And what the surgeons told us

on the Pinnacle team is that we actually needed to have the

two holes more towards the dome versus the outside based on

their experience with how they would angle the cup and put the

cup into the acetabulum and where the bone stock behind it

tended to, one, be the thickest, and, two, the best quality.

So what may seem like a very small change was incredibly

impactful for them and was something that we would not have an

inside perspective have sort of intimate knowledge of the

subtlety of that.

Another example also related to the screw holes -- and

unfortunately you -- you wouldn't even be able to see from

here the -- the design change is even more subtle for that.

With the Duraloc cup, the design of the screw hole was

sort of a cylinder and then a radius, and we have screws that

would match -- the radius of the screw head would match the

radius in the screw hole so that when you drive the screw in

you can get some angulation and seat your screw, because they

don't know -- and for patients it would be different, exactly


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where the best bone is going to be.

We late -- also late in the development cycle because we

had already started to actually produce acetabular shells, one

of our surgeons, Dr. Dan Berry, was very emphatic about the

design of the screw hole, that it needed to be a smaller

radius. That sounds like a really small change. But what it

meant was instead of getting 14 degrees that he could angle

his screw, it would give him more like 28 and that was very

significant to him.

We had to change the design of the screws, and we ended

up throwing away a million dollars of inventory that was

sitting on the shelf, our cost, implants ready to go, because

he was so emphatic that the change was needed.

And long story short, I agree. Dr. Berry and I still

talk about that today, how that was a good change to make.

And, again, something that I can design a screw hole and

I can design a screw and the instruments to put it in, and for

me I would not have the expertise from a clinical perspective

to appreciate the difference between 14 degrees and 28 degrees

in terms of what he can do with the screw in the patient's

anatomy.

Q. Thank you. I want to get that back because I want to put

it on the ELMO and have you orient us.

So we can sort of see a smiley face with the three holes.

A. Yes.


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Q. And describe again what you were telling us just now.

Was it this way before?

A. So if you hold the cup in the same orientation --

Q. This one?

A. The change would have been the one hole would have been

closet to the dome and the two holes on the outside. So it

went from a two and one to a one and two.

Q. Okay. So the middle hole would be up higher and the two

outside holes would be lower --

A. Yes.

Q. -- creating a frown?

A. Yes.

Q. Okay. Got it.

And you mentioned Dr. Dan Berry. Where does he practice?

A. He's the chief of the Mayo Clinic in Rochester.

Q. And he was a design surgeon for what?

A. He was a design surgeon for the Pinnacle acetabular

cup.

Q. And was that a royalty-bearing position?

A. It was.

Q. And we've heard a lot about royalties in this trial.

Approximately how much in royalties did Dr. Berry earn?

A. I don't remember the exact number. I think it was in the

neighborhood of 24 million.

Q. And did that go to Mayo?


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A. My understanding is that a significant portion of that

went directly to Mayo.

MR. LANIER: Judge, I object to that as hearsay.

THE COURT: Sustained. The jury is instructed to

disregard unless she knows.

BY MR. QUATTLEBAUM:

Q. Ma'am, have you reviewed the documents in that regard?

A. I through my work on the legacy royalty project, I did

have access and have reviewed all that information. It's been

a significant period of time since I had the exact data in

front of me.

MR. QUATTLEBAUM: Okay. Your Honor, may we try

again?

THE COURT: Sure. Always your call.

MR. QUATTLEBAUM: Thank you, Your Honor.

BY MR. QUATTLEBAUM:

Q. Based upon your review and your role in the legacy

royalty review project, are you aware of the amount that

Dr. Berry received in royalties via the Mayo Clinic?

A. As I recall.

MR. LANIER: And I--

A. -- it was in the mid 20 million.

MR. LANIER: -- and, Your Honor, I'm still going to

object unless she knows what the deal was between the Mayo

Clinic and Dr. Berry. Unless she knows what he received after


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it went through the Mayo Clinic, she's got no basis for

answering that question.

THE COURT: Sustain the objection.

BY MR. QUATTLEBAUM:

Q. Is there a process at DePuy for the development of

products?

A. There is.

Q. And what does it mean when we say there's a process?

A. It means formal documentation which outlines steps or

protocols that should be followed per -- per a procedure.

Q. Is that a written process?

A. It is written.

Q. And was that process followed with regard to the

development of the Pinnacle cup and the Ultamet liner?

A. Yes, it was.

Q. What's the purpose for having a process like that?

A. There are a couple of purposes.

One, it is a requirement by the Food and Drug

Administration, as well as other regulatory authorities to

have these types of processes.

In addition, it's also just good business practice to

have them.

Q. And is that process -- Does it result in documentation

being maintained at DePuy?

A. It does.


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Q. What is that documentation file called?

A. So the design control process, the output of that is

called a design history file or a development history file.

DHF, you'll hear it referred as.

Q. And do you have to keep -- maintain the design history

file?

A. We do have to maintain design history files.

Q. Describe what we're talking about in terms of volume with

regard to the Pinnacle cup.

A. If you look at the iterations of the Pinnacle cup, there

are thousands and thousands of pages in a multitude of design

history files.

Q. And what about for the Ultamet liner?

A. The same.

Q. What are the steps, just in a broad sense, of the design

process?

A. So at a very high level you can sort of break it down

into three stages.

There is a design input and planning phase, which is

where we would identify an unmet clinical need and you would

start the project planning and risk analysis of a project.

The middle phase, the second one, is called verification

and validation.

What that means, verification is technically taking a

customer need and translating it into a design input. So I


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want a bright car, the color should be red, so it takes sort

of a customer input, turns it into an engineering term. The

output then says it's red number 121.

So verification is for us typically a lot of mechanical

testing and prototyping, those type of things.

The validation bit is saying has your engineering output

satisfied your customer need. So now I'm going to give to you

a red car, is that what you wanted, is that the right red.

So for us validation is we put prototypes or components

into a surgeon's hands, they either do saw bones analysis,

they do cadaver labs, they assemble them, they disassemble

them, and so it's the feedback from the direct user to say,

yes, this satisfies their need.

The third step would be transfer to manufacturing, which

is taking an engineering drawing from product development and

actually building and manufacturing the components to those

specifications.

Q. Okay. So on the front end you have written

specifications about how you want to build it?

A. Yes.

Q. In the middle you have did we build it properly according

to the specifications and directions?

A. Yes.

Q. And then on the back end is can we then manufacture that

for commercial use?


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A. That's correct.

Q. Did I get it?

Okay. Are the surgeon design team members involved in

those steps?

A. Yes.

Q. In what way are they involved in each of those steps?

A. So in the first step, design inputs and planning they

bring to us and they help identify clearly what the unmet

clinical needs are.

We translate those sort of into engineering terms and

then help us with that.

Also the early stage is where we would do the beginnings

of our risk analysis. They're very involved in that as well.

In the middle page, verification and validation we would

say to them this is our plan for how we think these components

need to be tested, do you agree with that, are there any

additional steps that need to be done.

After we have tested the products they would review the

results and say yes they are comfortable with the results of

the testing.

And the validation, as I mentioned, we put the components

in their hands and they do evaluations either in cadaver labs

or something similar.

And then in the -- in the final stages they would get a

box, component in a box, and say, yes, the label is right, we


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can read it, the part coming out is packaged appropriately,

those types of things.

Q. Is there any independent review of those steps that takes

place by somebody outside of the team that was involved in

design and development?

A. There is. The design control process, as it's called,

requires that an independent reviewer, so somebody who was not

part of the project core team but is technically competent,

technically capable, independently reviews the -- sits through

the review process and reviews the documentation to make sure

that all of the requirements have been met.

Q. In the design and development of Ultamet was it

exclusively the United States team or was -- were there others

involved?

A. Ultamet was a little bit unique for us in that we had --

at least I can speak very clearly from the DePuy side, from

the DePuy side we had very clearly a team in the U.S. that

tended to develop and manufacturer components. We had a

similar team, a sister company in Leeds, that also did

developments and manufacturing of products.

This was one of the first times when we had very global

collaboration on a single development.

So what I mean was if you look across the project core

team you will see many instances where there were

representatives from the United States and also from


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international on the team. So, for example, product

development and research and quality all had representatives

from both sides of the pond, we would say.

And then the manufacturing of the components happened in

the Leeds facility.

So it was unusual for a project core team at that time to

have such a -- a diverse membership.

Q. And were you leading that team?

A. I was.

Q. At the end of that project, when it's all said and done,

what did you do with regard to your team?

A. So at the end of the project we had a final project

review. And as part of that I wanted to acknowledge the

team's excellent collaboration. So it's -- if you haven't

done it, it's a little bit challenging when we have a team

that's intended to work together but we only have half of our

business day over lapse. By time I'm getting into the office

they're already at lunch.

Q. "They" being the team in Leeds?

A. "They" being the people in Leeds.

Q. In England?

A. Yeah. So with culture differences and time differences,

a whole lot of things, it just was an additional layer of

complexity for the team and I felt like they really did an

outstanding job of collaborating and working through those


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additional hurdles.

So at the end I wanted to specifically acknowledge to

them, hey, I think you did a great job.

Q. Okay. And did you prepare a slide to present to them in

that regard?

A. I did.

MR. QUATTLEBAUM: Jim, if we can bring up 2053.265.

BY MR. QUATTLEBAUM:

Q. It's kind of a bad copy, Ms. Turner, but what are we

seeing here?

A. So what you see on the left is, right, your two people

across the pond on the -- on the phone, right, working through

our issues.

The other thing that you will notice, if you look at the

make up of our project core team, is a lot of folks who work

inside the four walls of DePuy, either in the U.S. or

international. I am very fortunate from a product development

perspective that I get a lot of access to our design surgeons

who can directly relate to me stories of their patients and

patients that they have helped with their products and the

difference that the products that we collaborate on make in

their practices.

My planner, my quality guy, my operations guy or girl,

they don't get that touch with the end user. The way that

they know the product is successful is my planner sees an


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order come through and says, oh, that's a big order so we must

be selling a lot of these.

And my, you know, operations guy say on my shop work

order that's a lot of components. And so my message to them

was you will see how successful this product is and sort of

the fruits of your hard labor you will see as we roll this

product out because we believed it was going to be a

successful product.

So that's -- that was one way I was tending to convey

there was you won't get to talk to the patients and the

doctors, but what you will see is a shop work order come

across your desk that means we are -- we're in fact selling

the product.

Q. Okay. So we've spent in time talking about that design

process and the role of design surgeons.

Were you involved later in reviewing the role of design

surgeons?

A. Yeah.

Q. And in what capacity were you involved in that way?

A. So later, as I described yesterday, some of my work

experience, I was a project manager in the medical affairs

department. One of my projects which was a requirement under

the deferred prosecution agreement was a review of legacy

royalties.

So what we were asked to do was for all instances where


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we had royalty payments due, regardless of the time frame for

when they were initially earned, we had to go through and

validate and certify that all of those payments were proper.

Q. Okay. Let me hand you what's been identified as

Plaintiff's Exhibit 1569.

Do you recognize that, ma'am?

A. I do.

Q. What is it?

A. This is a legacy royalty summary that was prepared for

Pinnacle Ultamet.

So the format of this was -- of the process would have

been we would have prepared the documentation per the six

requirements in the process, we would have presented to two

different committees the outputs of those. Based on that this

summary report would be included with all of those additional

materials and provided to our monitor for review. The monitor

also participated in the live reviews of the projects.

MR. QUATTLEBAUM: Okay. Jim, can we switch to the

ELMO, please.

BY MR. QUATTLEBAUM:

Q. So if you will turn to page 4 of the document you can

walk us through the questions that you had to answer.

A. So the questions we had to answer were -- it was a

process that we had collaborated with the monitor on and

agreed with the monitor.


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The first one is: Was there bona fide commercial need

for surgeon participation on a design team?

Q. And what are you looking at there?

A. So what we're looking at there is was there a commercial

need for the project. So from an anti-kickback statute

perspective we wanted to make sure there weren't unnecessary

projects that were being created in order to have surgeon

designers on the team. So it was business need for the actual

project itself.

Q. One thing I haven't asked you, Ms. Turner is: How many

design projects have you worked on?

A. If I had to add them up, probably 12 to 15.

Q. Okay. Next question, next page.

Did the company have a legitimate basis to select the

consultant who served on the design team?

What did you do in that regard with regard to the design

surgeons participating on the team?

A. So the purpose of this is to review the qualifications of

the particular surgeons that were selected to participate on

the design team, to verify that they were qualified for that

role.

Q. Okay. Next question: Was the consultant selected for an

improper purpose?

What did you have to do in that regard?

A. So the requirement here was that we had a certification


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signed. Again, this is a direct -- a direct requirement

relating to anti-kickback statute, which says if there is --

if one purpose of a payment to a healthcare professional is to

influence their purchasing habits then it's considered a

violation.

So, for example, if we said this is an extremely

qualified surgeon, but we also want his business, even though

he's qualified and there's a need, that would still be a

violation of the anti-kickback statute. So this

certifications were done from both parties because the

violation could occur on the HCP side, it could also occur on

the company side.

So certifications for provided for both of those parties

to verify there was no improper purposes.

Q. HCP?

A. Healthcare provider.

Q. Next: Is there a written agreement with appropriate

approvals?

What were you looking at there

A. So again a requirement is an arms-length negotiation

contract with the healthcare provider to provide services.

Q. Okay. Is there evidence of an appropriate consultant

contribution to the design project?

What were you looking for there?

A. This is probably the most intuitive one. We went through


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records and wanted to find documentary evidence of their

contributions.

Q. And is that what the process consisted of?

A. Yes.

Q. And then there's an overall one: Was the total royalty

load commercially reasonable and do the royalty payment --

payments carve-out sales to the consult's affiliated

hospitals?

What's the purpose of satisfying that question?

A. So that is even if we've all agreed it's a reasonable

project, the people are qualified, they contributed, that the

amount of the payment was fair market value.

Q. How did you verify that the amount was fair market value?

A. There was -- we actually consulted with an independent

organization to do a fair market value analysis with us. That

analysis was then submitted to and approved by the monitor.

Q. And did this process have to take place for all design

surgeons?

A. This process took place for every design surgeon on every

project where there was an active or an outstanding royalty

payment.

Q. Okay. Now I want to talk to you about the 510(k) for

Ultamet, Pinnacle Ultamet. Okay?

A. Yes.

Q. Were you involved in the submission of the 510(k) to the


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FDA?

A. Yes.

Q. Again, remind us when that took place.

A. That took place twice in 2000. The first for the

28-millimeter was in October; the second for the 36 was in

December.

Q. What involvement did simulator testing have with regard

to the submission of the 510(k)?

A. So our 510(k) processes were called a special 510(k),

which meant that the products were -- had a -- the same

scientific sort of function and intended use. So we used

simulator data for our predicate devices as part of our

submission, 510(k) submission.

Q. Okay. Was there an occasion when an issue arose with

regard to the operation of the simulator?

A. Yes.

Q. Tell us about that.

A. What we found when we first tested the 36-millimeter

Ultamet design, there was a test set up to compare

28-millimeter Ultamet and 36-millimeter Ultamet. And when

that test started it was being run in our DePuy Leeds facility

and the tribologist who was running the test noticed that

there was some unexpected motion between the cup fixtures and

the actual simulator itself. When he noticed this he noted

that one potential cause of that would be that the clearances


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between the femoral head and the cup were too small.

If the clearance or the gap between the two components

was too small then high friction under load could be causing

that sort of catching which would lead to motion in the -- in

the fixtures. So the fixtures would be a fixtures in a

simulator, you put the acetabular cup in and the motion was

between the fixture and the actual body of the simulator.

Q. And that would alert to the possibility of loosening?

A. Yes.

Q. Okay. Have you identified a -- a video of the simulator

machine so that we can better understand what they look like

and how they work?

A. Yes.

Q. And I think that's Exhibit 3903.

A. That's an example of a hip simulator.

(Video playing.)

MR. QUATTLEBAUM: Jim, can we pause for a second.

BY MR. QUATTLEBAUM:

Q. Ms. Turner, I notice there's one, two, three, four, five,

six of these. Is that how many operate at one time?

A. It depends on a simulator. It can be up to 10 on a

single simulator, maybe 12.

Q. Is there a name for this particular simulator?

A. This particular simulator is called an AMTI.

MR. QUATTLEBAUM: And, Jim, we can keep going.


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Stop again, please.

BY MR. QUATTLEBAUM:

Q. I notice down here it's spinning or rotating -- like a --

agitating like a washing machine, and up here it's going back

and forth. Why is that?

A. We are trying to simulate different hip motions so it's

not -- it's not a single back and forth there. It's a complex

motion.

MR. QUATTLEBAUM: Okay. Jim, keep going, please.

Now stop again.

BY MR. QUATTLEBAUM:

Q. This is just a closer view, right?

A. Yes.

Q. Start again.

MR. QUATTLEBAUM: Jim, pause for a second.

BY MR. QUATTLEBAUM:

Q. If we look closely it's not going straight back and

forth, is it?

A. Yes.

Q. It's also pivoting a little bit?

A. Multidirectional.

MR. QUATTLEBAUM: Okay. Keep going.

BY MR. QUATTLEBAUM:

Q. Was that the only kind of summation -- simulator machine

that you used?


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A. No.

(Video stopped.)

BY MR. QUATTLEBAUM:

Q. Do you have -- what's the other one called?

A. There's a series of simulators in Leeds called a ProSim,

as well another type of hip simulator that's commonly used is

called an OBM, an orbital bearing machine.

Q. Okay. Let's go back to what you were telling us, we can

sort of see now what we're dealing with.

So the cup was in the machine, right?

A. Yes.

Q. And the question --

MR. LANIER: Your Honor, I'm going to object to him

leading through this.

THE COURT: Sustained.

BY MR. QUATTLEBAUM:

Q. Explain to us how the cup was positioned in the machine

and explain to us what the issue was that was -- that came to

be.

A. So the issue was that as the simulator was going through

its cycle, there was movement that was noticed primarily in

one station and on a -- to a lesser degree in two other

stations in the same simulator, motion between the fixture --

so not the implant but the fixture and the actual simulator.

Q. Okay. Eventually, did you do what was necessary to


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figure out what the problem was?

A. Yes. The tribologist who was running the test tested the

actual simulator with a variety of other components and was

able to determine that the pneumatic cylinder was broken. So

it turned out that the issue that he was seeing was unrelated

to the implants and was a function of the simulator itself.

Q. What time period are we talking about when all of this

occurred?

A. That was in November of 2000.

Q. What does that have to do, if anything, with the 510(k)

submission?

A. I'll try to make a really complicated story as simple as

I can.

So when Andrew Goldsmith, who was the tribologist running

the machine, first noticed the problem with the simulator he

sent a detailed email to Frank Chan, the tribologist on the

DePuy -- on the DePuy/Warsaw side, and said this is what I am

seeing, this is what I think it could be, what do you think it

could be.

And they both agreed that one possible explanation was

the clearance between the head and the liner, that for the

36-millimeter it was too low.

So what we know about clearance for tribology is that the

lower the clearance is for metal-on-metal implants, you get

better wear performance to a point where the components are


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too close in size and then the wear goes back up. So that was

the -- that was the concern, if that was happening.

So what we decided to do was to open the clearance on the

36-millimeter design. There had been conversations and

meetings dating back to the end of 1999 when we first said we

have a 28-millimeter Ultima, we have a 36-millimeter

one-piece. Now as we move into the Ultamet design, how do we

want to relate the clearances between those two components.

There were two schools of thoughts from the tribologists.

One was we should have exactly the same amount of clearance,

which was 40 to 80 microns on the diameter.

Another school of thought was we should have the same

effective clearance -- or effective radius, I'm sorry. What

effective radius means is that in evidence looking at a

discrete clearance value, you're looking at the relative size

of the 28 and 36 and you're attempting --

Q. Let me hand you these two heads or balls and you can tell

us how that will help you explain it.

A. You're looking at the relative difference for a

28-millimeter articulation and a 36, and we're saying that

from a design perspective we want the contact patch to be

exactly the same between these two.

So even with a 36, when you put a 36 head into a 36 liner

and you load it, you don't find that the entire surface is a

bearing area, that it's a localized contact area. That's to


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be expected.

So what we did is changed the clearance of the

36-millimeter component so that the actual contact patch would

be exactly the same, similar -- the same effective radius as a

28.

So what that meant was the amount of wear that you would

expect to see solely from that parameter would be the same.

Q. Okay. So that was complicated --

A. Sorry.

Q. -- but let's see if I can make it -- Let me see if I can

make it less complicated.

If there is contact from the outside edge of the cup all

the way across the top of the ball in all directions, then you

would have one --

MR. LANIER: Judge, I am going to object to him

leading through this.


BY MR. QUATTLEBAUM:

Q. Explain to us how if you had a cup that -- that didn't

have a widening clearance how that would change the contact

patch.

A. Okay. So you -- let's use a nonorthopedic example, more

extreme than the difference in these sizes.

If you have a golf ball and you have a basketball and I

say I'm going to -- I'm going to put a blanket around a golf


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ball, but I'm going to leave a two millimeter gap. And now

I'm going to take a basketball, and I'm going to leave that

exact same two millimeter gap. The relative gap between those

is very different where you would expect only two millimeters

on a basketball to be a much tighter fit for the larger

diameter.

It was the exact same thing. With the exact same

clearance, the relative fit was much tighter than for the 36

than it was for the 28. By using the effective radius, the

relative gap would be the same.

Q. Okay. So what did that do with regard to your submission

to the FDA for the 510(k)?

A. So we had initially prepared the submission for the same

clearance between a 28 and a 36. When we changed the design

to be based on the same effective radius, we changed the

description in the 510(k) to demonstrate the equivalence of

the effective radius of the 36 and the 28 instead of the

clearance.

Q. Okay. And by describing effective radius instead of

clearance, did you have to change particular spots in the

510(k) application where that was described?

A. We did. That change was shown on the engineering

drawings for the components. Those would effect the

clearance.

There was also intended to be a change -- What we found


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later was that in an exhibit to the 510(k) we had not updated

the clearance box to effective radius in the exhibit. So

there was an inconsistency from what we described in the body

of the 510(k) and what was in the supporting exhibit.

Q. Okay. And when did that come to light -- In fact, let me

ask you: Were you the person who was supposed to update the

box?

A. I was the person who was supposed to update the box.

Q. In the attachment to the -- to the application?

A. Yes.

Q. And did you just miss it?

A. I missed it when we submitted -- I didn't see that that

particular nomenclature had been updated.

Q. Okay. When did it come to light?

A. So we discovered this in 2005. So, again, the submission

was in 2000. In 2005, the FDA had contacted us because they

had noticed based on a subsequent submission that we had sent

in that there was an inconsistency in how we called out the

clearance, and they contacted us for clarification.

Q. Okay. 4060. Let me hand you Plaintiff's Exhibit 4060.

What is that, ma'am?

A. This is a letter from the FDA to DePuy. Memorandum.

MR. QUATTLEBAUM: Jim, if you can enlarge the date

at the top, please.

BY MR. QUATTLEBAUM:


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Q. Again, this is when, ma'am?

A. Yes.

Sorry?

Q. The date.

A. Oh, the date is July 29th of 2005.

Q. Okay. And what is the recommendation by the FDA at that

time pertaining to this mistake that was made back in 2000?

A. The recommendation was that the information did not

change the status of the 510(k), no other action was required

by DNC; adding an image to the file. The sponsor will be sent

a 525 letter indicating a new 510(k) is not needed.

Q. Okay. The bottom paragraph --

MR. QUATTLEBAUM: Jim, if you can go to the bottom.

BY MR. QUATTLEBAUM:

Q. Let's take it sentence by sentence. "According to

current practices in ORDB, the diametrical clearance of a

system cannot be changed without clinical data." Correct?

A. Yes.

Q. And then "Therefore, given this new information, the

Pinnacle 36-millimeter system would not have been cleared in

2000." Correct?

A. Correct.

Q. But what did they say after that? What did they do?

A. So they did a search of the medical device reporting

forms, MDRs, for adverse events associated with the Pinnacle


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36-millimeter liners. Only 5 adverse events were reported.

They compare that to adverse events in the same time period

for other metal-on-metal devices, and they concluded that

during the same time period the 36-millimeter Pinnacle system

had a reasonable number of adverse events reported.

Therefore, the sponsor will not need to submit a new 510(k)

based on the information presented for the device already

cleared.

Q. All right. Let's just walk through it if we can.

"However, after searching the medical device reporting

form" -- right -- "program."

A. Yes.

Q. -- "for adverse events associated with the Pinnacle

36-millimeter liners only 5 adverse events were reported."

A. That's correct.

Q. Now, what's an adverse event?

A. An adverse event would be any complication with in this

case total hip replacement. So it could be related to the

device. It could be unrelated to the device.

Q. Okay. "Three of these adverse events were failure for

the liner and shell to line up appropriately. One adverse

event was a patient revised due to pain. One adverse event

gave no details. Over the same time period the comparable

Sulzer" -- That would be the Metasul product?

A. Correct.


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Q. -- "the Sulzer metal-on-metal system had approximately 25

adverse events reported, while Zimmer had 3 reports regarding

the 28-millimeter acetabular insert and 3 reports regarding

their cobalt chrome femoral head. Therefore, during the same

time period the 36-millimeter Pinnacle system had a reasonable

number of adverse events." Right?

A. Correct.

MR. QUATTLEBAUM: Jim, if we go back up one more

time to the recommendation at the top.

BY MR. QUATTLEBAUM:

Q. So in 2005 looking back, what did the FDA require of

DePuy with regard to that 36-millimeter 510(k) submission?

A. We needed to submit a new table to correct the original

510(k).

Q. And all of that started with what?

A. All of that started with a broken pneumatic cylinder in

the simulator.

Q. So speaking of simulators, tell us about what kinds of

testing DePuy did with the Pinnacle Ultamet.

A. So between Pinnacle Ultamet -- yeah, Pinnacle and Ultamet

we did a variety of testing.

It might be easy to think about it in terms of the

features that are affected by the testing. So we looked

certainly at the locking interface between the acetabular

liner and the femoral shell. So we would have done mechanical


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testing related to that. Examples of that kind of testing are

pushing, putting the liner in, push out, what does it take to

extract it, and torque to failure. So torquing the liner to

see what force is required to dislodge the taper interface.

Additional testing that would have been done looking at

the modular interface would be threading corrosion. We worked

with Dr. Jeremy Daubert, who is a world expert on threading

corrosion. He did testing for us looking at mismatched

materials as well as looking at particular features that were

designed into the -- into the cup for the primary purpose of

fixation or locking with polyethylene to make sure that those

features did not have an adverse effect on the locking and

potential for threading and corrosion with the metal insert.

Examples of mechanical, we also did a tremendous amount

of wear testing -- sort of tribology testing -- on the bearing

surface.

Q. Okay. Approximately how many cycles -- a cycle is like a

step, right?

A. Yes.

Q. Okay. How many cycles of simulator testing over the

years was done on Pinnacle Ultamet?

A. Over the years I would say approximately two billion.

Q. And there are varying -- are there varying amounts or

numbers of steps that they attribute to people over a year?

A. Yes. So I would say when I started in the business it


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was believed to be around a million steps per year, and I

think now the current thinking is that it's somewhere between

one and two million steps a year.

Q. So you said two billion cycles of testing?

A. Two billion.

Q. Approximately?

A. Approximately.

Q. And that would equate to -- If we were talking about

steps per year, something in excess of a thousand years?

A. A thousand years.

Q. Did all of that testing that you described take place

before the submission of the 510(k)?

A. It did not.

Q. Okay. Does -- what period of time does it cover?

A. It -- it covers a period from -- for Ultamet

specifically, previous to the launch, certainly testing that

we've already discussed about the Ultima and the 36-millimeter

one-piece up to really present day. Probably 2011, 2012, '13,

we were still doing a variety of tests with Ultamet products.

Q. And what did you do with regard to examining the debris

that is generated from hip simulator tests?

A. We did a couple of things. So very early -- or earlier

in our metal-on-metal program, we had taken particles from the

Sulzer Metasul versus 36-millimeter one-piece simulator

testing. We took samples from those tests, both of those


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components, and sent them to two different laboratories, one

was Pat Campbell's lab and another one to Zivic to look at and

analyze the particles.

Q. Based upon your simulator testing, what material did you

consider to be the best material to use with Ultamet?

A. High carbon cobalt chrome.

Q. Are there standards associated with high carbon cobalt

chrome?

A. There are.

Q. And how do you -- where do you find the standards?

A. So the standard that is commonly used for orthopedic

explants is ASTM 1537.

Q. And is that the standard that would apply to Ultima?

A. Correct.

Q. And to the one-piece?

A. Correct.

Q. So the point of that is you -- what -- what is the point

of that?

A. So the point is that medical devices are very controlled,

that it's important when we manufacture them if we say we're

going to use a cobalt chrome alloy that the alloys that folks

are using and researching and testing meet a standard so that

we know that they're the same.

So ASTM is a widely known and utilized body for

generating and maintaining standards. So what that tells us


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is that the materials that might be used between different

manufacturers, for example, are the same.

Q. Based on your simulator studies what conclusion did you

reach with regard to the volume of wear that would be

generated?

A. Well, consistently the Ultamet products show extremely

low wear in a simulator.

Q. Okay. Now, what about publication of some of those tests

that you did?

Did you publicize them?

A. There have been a number of publications of mechanical

testing that we have either worked on or sponsored, yes.

MR. QUATTLEBAUM: Jim, if we can show G 117.1.

BY MR. QUATTLEBAUM:

Q. What are we seeing here, ma'am?

A. So this is a list of some of the published literature on

our metal-on-metal products.

Q. And when you're talking about publish-- publishing this

information, where does it get published?

A. It can be in a -- in a variety of journals. And you'll

see many peer-reviewed -- peer-reviewed journals on here.

Q. And did the people that you sent the work out to write

the articles, publish the articles?

A. Yes.

Q. What were some of the topics, and just generally, we


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can't go through all of them, but some of the topics involved

in the publications?

A. So we looked at things like lubrication. We looked at

particle analysis, effect of clearance on metal-on-metal wear.

MR. QUATTLEBAUM: And, Jim, are there multiple pages

to that, I think?

If we can go to page 2.

And page 3.

Thank you.

BY MR. QUATTLEBAUM:

Q. What's the significance to the fact that the information

was published, ma'am?

A. It's -- it's a couple of things.

I think it shows that DePuy was working with the right

people, people who are very well-versed and experts in

tribology, orthopedic area; as well as it shows sort of our

equipment to educating and expanding the body of literature in

the public domain around these types of products and the

testing for them.

Q. Were hip simulation studies fully run before the FDA

cleared the -- cleared the Pinnacle Ultamet?

A. There were the 510(k)s and our -- through our design

control process our predicate devices provided the definitive

wear tests for our 28 and 36-millimeter submissions, so we had

simulator testing ongoing as we submitted the 510(k)s.


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Q. And did those simulator -- did the simulator testing run

its course and -- well, let me ask that first.

Did you finish those simulator tests?

A. We did.

Q. And how were the results?

A. They showed very low wear.

Q. Okay. Clinical testing. Did you do a clinical test of

the Pinnacle Ultamet device before it was submitted to the

FDA?

A. We did not.

Q. Was that known to the FDA?

A. That was known to the FDA.

Q. Okay.

So what clinical evidence -- we talked about this some

yesterday, but what clinical evidence did you rely upon with

regard to marketing, selling the Pinnacle Ultamet?

A. The evidence that we relied on came from multiple

sources, certainly from our own internal data.

So we had 28-millimeter Ultima experience both outside of

the United States and inside of the United States.

We had data coming from the original custom implants as

well as the IDE study for the 36-millimeter one-piece.

In addition to that, there was a tremendous amount of

data available on the Metasul product that had been available,

as we discussed yesterday, since 1988 outside of the United


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States.

Q. Okay.

MR. QUATTLEBAUM: Jim, if we can go to 101.34, which

we saw yesterday.

BY MR. QUATTLEBAUM:

Q. So how did Ultamet, Pinnacle Ultamet compare to the

36-millimeter one-piece and the 28-millimeter insert on the

testing that you described?

A. So with respect to testing we found that the

28-millimeter Ultamet tested the same or better, meaning lower

wear, typically from the 28-millimeter Ultima.

In respect to the 36, the 36-millimeter Ultamet also

performed equivalent or better than the 36-millimeter

one-piece in a simulator.

Q. Why did that matter to you?

A. So that was important to us because we wanted to

understand if we have a clinical body of evidence and we make

some changes to the implants to improve them, can we rely on

the clinical information that has already been collected in

terms of how we believe it will impact the performance of the

new device.

Q. Were there clinical studies that were done after the

introduction of Pinnacle Ultamet to the market --

A. Yes.

Q. -- that involved the Pinnacle Ultamet?


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A. Yes.

Q. Describe those for us, please.

A. There were several of those as well. There were ion test

studies that were done with Dr. Andy Engh and Dr. Steve

MacDonald as well as Dr. Tom Schmalzried and with Dr. Jim

Kaderna.

In addition the Ultamet was used as a control device for

a couple of future IDEs that were planned with DePuy -- with

DePuy.

Q. So it was used as the control --

MR. LANIER: Objection, leading.


BY MR. QUATTLEBAUM:

Q. How -- what do you mean when you say it was -- it was

used as a control device?

A. So as I described yesterday, for example, the IDE study

for the one-piece there was -- we talked about control devices

and experimental devices, so in a prospective randomized study

what the FDA likes to see is a control with a -- a --

commercially available component that is known to be

performing well and then you use that to gauge the performance

of your experimental device.

So the DePuy Ultamet became the actual control device for

two other IDE studies that came after.

Q. That were overseen by the FDA?


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A. Overseen by the FDA.

Q. Okay. Educational efforts.

What did you do with regard to educating the sales force

and educating surgeons about Pinnacle Ultamet?

A. So my sort of personal role in had that, and it was more

than just me, obviously, we had one-on-one meetings with

surgeons, so either we would go to a surgeon's facility to

have a conversation with them, many times we had surgeons come

into the DePuy facility for a tour of the facility and we

would go over the metal-on-metal and Pinnacle acetabular cup

projects with them.

There were presentations at national sales meetings, so

those would be sort of the annual --

MR. LANIER: Judge, I object to her testifying about

what other people did at DePuy and ask that she testify about

her own personal experience.

THE COURT: Maybe she was there. Just make that

clear.

BY MR. QUATTLEBAUM:

Q. Yes.

A. These are all my personal experiences.

Q. Okay. Go ahead, ma'am.

A. National sales meetings. So presentations, educating the

sales force and providing materials to the sales force for

them to be able to then take to their surgeons.


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There were dinner meetings, other surgeon meetings where

either through a larger conference, a presentation on Pinnacle

or Ultamet would be part of a larger program or specific

meetings for just the DePuy or Ultamet project with a group of

physicians.

Q. Let me hand you three documents, ma'am.

They are Defendant's Exhibits 931, 54, and 43.

MR. QUATTLEBAUM: Jim, if you can pull up 931,

please.

BY MR. QUATTLEBAUM:

Q. What is that, ma'am?

A. This is a design rationale for the Pinnacle acetabular

cup system.

Q. What involvement, if any, did you have in the creation of

that document?

A. So I -- I'm trying to -- for sort of describing the

engineering aspects related to Pinnacle, I authored portions

of this.

Q. Okay. And then Exhibit 56 is what?

A. That is surgical technique for Pinnacle acetabular cup

system.

Q. How does that get created?

A. So this was created in large part from our surgeon design

team.

Q. And then 54.


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What is 54?

A. This is the insertion technique for the Ultamet product.

Q. How does that get created?

A. Again, this was a collaboration, again, between our

surgeon design team and internal team.

MR. QUATTLEBAUM: And, Jim, if we can go back to 56,

please.

BY MR. QUATTLEBAUM:

Q. What's done with these documents?

A. So these documents are typically used, distributed to the

sales force and they can use these to help educate their

physicians on the products.

Q. And are they available for surgeons?

A. They are.

MR. QUATTLEBAUM: And Jim if we go to 56.46.

BY MR. QUATTLEBAUM:

Q. Are there warning information contained in the surgical

technique?

A. Yes.

Q. And how about the insertion guide, which is Exhibit 54?

And if you look at page 6 on that one.

A. Yes.

MR. QUATTLEBAUM: And, Jim, if you just go to

adverse events.

There we are.


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BY MR. QUATTLEBAUM:

Q. We can see that there are warnings and precautions and

adverse events there as well?

A. That's correct.

Q. Did you also create videos and CDs?

A. We did.

Q. And what did you do with those?

A. So those were used also as training materials for sort of

internal and sales force stakeholders.

Q. Now, let me hand you Exhibit 927.

Tell us what that is, please, ma'am.

A. This is the Ultamet metal-on-metal technical monograph.

Q. What involvement did you have in the creation of that

document?

A. I authored portions of this document.

Q. Was there information contained in that about biological

issues?

A. Yes.

MR. QUATTLEBAUM: And, Jim, if we can go to --

BY MR. QUATTLEBAUM:

Q. Well, first, before we go through that, ma'am, tell us --

MR. QUATTLEBAUM: If we look at page 3, Jim.

BY MR. QUATTLEBAUM:

Q. Tell us what's contained in the technical monograph.

A. The layout of this particular monograph is -- starts with


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a historical review for metal-on-metal implants.

Then it talks about a broad engineering overview for --

it's sort of a tribology overview for metal-on-metal bearing

technology in general.

Then there is a section that talks about the Ultamet

product in specific terms.

Finally, there is the page on biologic issues and

conclusions.

Q. Who else helped you with writing that?

A. Frank Chan also wrote a significant portion of this.

Q. Tell us again who Frank Chan was.

A. Frank Chan was a tribologist, Ph.D. in tribology that

came to DePuy in I believe 1999 time frame.

MR. QUATTLEBAUM: Okay. If we go to page 11, Jim.

BY MR. QUATTLEBAUM:

Q. Why is there a page on fixation, ma'am?

A. Well, what we wanted to convey with Pinnacle as well as

with Ultamet is that there are many considerations in the

design of acetabular cup products and different things that

you would want to consider.

The first one is fixation. So with respect to Pinnacle

is that if your implant does not ever secure to host bone

nothing else is really going to matter, if your cup is loose.

So with respect to Pinnacle that's the case. With

Ultamet, in particular, you may have heard that with early


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generation metal-on-metal designs that fixation was an issue.

So due to bearings that were not properly designed you

could have very high friction. High friction at the articular

interface could cause the cup to actually spin out of the

acetabulum or could cause loosening on the femoral implant

side as well.

So we wanted to acknowledge that fixation was we believed

something that we had addressed with Ultamet.

Q. Okay. And then on page 12 there's a page on modularity?

A. Yes.

Q. Why is that important?

A. Modularity for this project was one of the -- is one of

the key hallmarks for Pinnacle, the three-in-one. And

modularity is what gives surgeons choice in terms of their

intraoperative selection for an implant. As well modularity

leads to the next section of biomechanics.

Q. Next section what?

A. Biomechanics.

Q. Okay. And let's talk about range of motion for just a

moment, which is page 16.

What benefit does the Ultamet liner provide with regard

to range of motion compared to a polyethylene liner?

A. I'm sorry, could you repeat the question?

Q. What benefit does Ultamet provide with regard to range of

motion compared to a polyethylene liner?


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A. So one thing that we were also careful to discuss with

surgeons is around range of motion and the impact of potential

impingement of components, depending on what your bearing

surface is.

So, for example, if I have a patient who either has a

component that is not optimally placed or some sort of

physiological motion that reaches the extremes of the implant,

you can imagine that if I impinge on polyethylene that's very

different than if I impinge on a metal insert in terms of what

potential damage could be at that interface, so we wanted to

ensure with our metal-on-metal components to emphasize not

only cup placement but also we wanted from a design

perspective to try to maximize the motion that you would --

could get between your femoral stem and your bearing before

you would have component interaction.

Q. So contact between the stem and the edge of the cup or

liner?

A. Yes.

Q. So is the -- is the polyethylene liner typically thicker

than the metal liner?

A. It typically extends further beyond the face of the

acetabular shell.

Q. Okay.

A. So when we looked at the Ultamet versus the predicates of

Sulzer and Ultima we were able to increase the range of


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motion, especially for the 28-millimeter articulation

like-to-like components.

Q. How was the technical monograph used or issued?

A. So it was used -- it sort of is reflective of the

information that we gave during a live presentation. It also

was printed and distributed to physicians as an education

tool.

Q. Okay. Did you actually participate with Dr. Chan, Frank

Chan, the Ph.D., in making presentations?

A. Yes.

MR. QUATTLEBAUM: And if we can look at 622, Jim.

BY MR. QUATTLEBAUM:

Q. What is this, ma'am?

A. This is an example of one of the training presentations

that we used. This is one specifically that was given at

sales school in Charlotte.

Q. And did you participate in making those presentations?

A. Yes.

Q. Did you prepare aspects of this one?

A. Yes.

Q. What did you and Dr. Chan present?

How did you present the content of this PowerPoint deck?

A. So depending on who was there at any given time, we would

have separated into our sort of areas of specialty in terms of

what we presented.


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MR. QUATTLEBAUM: Okay. If you go to page 3, Jim.

BY MR. QUATTLEBAUM:

Q. What are we seeing here, ma'am?

A. So this is an overall outline of the information that's

contained within this presentation.

Q. And I know that we've walked through the table of

contents of the technical monograph. In some respects, does

this take a similar approach?

A. Yes.

Q. So you look at metal-on-metal design issues in general?

A. Yes.

Q. Just like in the technical monograph?

A. That's correct.

Q. Ultamet design rational?

A. Yes.

Q. And I know we've called a document the design rationale.

Is that what's being addressed here? Is it the document or

the way it works?

A. The way it works.

Q. Okay. Did you also provide information on wear testing?

A. We did.

Q. And then biologic response issues?

A. Yes.

Q. What is positioning Ultamet?

A. So because -- because this was a presentation that was


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specifically directed at our sales force, there are some

comparisons to competitive product as well.

Q. Did you address clinical concerns?

A. Yes.

MR. QUATTLEBAUM: And, Jim, if we can go to page 45,

please.

BY MR. QUATTLEBAUM:

Q. Was there a conference called the World Tribology

Forum?

A. Yes.

Q. And I know that you have citations there, for example,

Jacobs. Does that refer to that conference?

A. Correct.

Q. And did that take place in '01?

A. Yes, it did.

Q. And when was the -- the technical monograph published?

A. It was I believe published in 2002.

Q. And this presentation was in '03; is that right?

A. Yes. June of '03.

Q. Okay. So what's being addressed here under clinical

concerns?

A. On this side, we talk about biological response to

medical -- to metal particles and ions.

And we talk about wear relative to polyethylene.

Q. And did you provide citations to articles that people


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could read if they needed more information?

A. Yes.

Q. Page 46, the next page.

What are we seeing here, ma'am?

A. This is a slide that highlights four major considerations

in terms of a biological response for metal-on-metal implants.

Q. When you made presentations to surgeons, what would be

the forum or venue for those presentations?

A. They could be one-on-one conversations. They could be

groups of surgeons that we would present to as well.

Q. Did you present information just like this?

A. We did.

Q. So did you discuss issues of hypersensitivity?

A. Yes.

Q. And cytotoxicity and carcinogenicity?

A. Yes.

Q. Did you provide citations for those as well?

A. We did.

Q. And under biological response, the next page, what did

you talk about in that regard?

A. So this is just sort of further detail around the

inflammatory response.

Q. And did you provide citations of published literature on

that?

A. We did.


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Q. And page 48, what's being discussed here?

A. Hypersensitivity.

Q. Still more citations to authority?

A. That is correct.

Q. Same kind of thing done for surgeons as sales force?

A. Yes.

Q. And next page, page 49, what's being discussed here?

A. Cytotoxicity.

Q. Citations?

A. Yes.

Q. Next page, carcinogenicity. And so what we've seen, I

think, is an overview of those topics of biological response

and then a more detailed discussion following?

A. That is correct.

Q. And finally page 51.

What are we seeing on 51, ma'am?

A. Sort of a wrap-up slide regarding biologic response.

Q. And page 52, what are we seeing there?

A. Again, a -- sort of a wrap-up related to clinical

issues.

Q. With citations?

A. Yes.

Q. What was the goal of providing that information?

A. A couple of things.

This information was -- and these citations, already


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available in the public domain. Certainly, there was a

tremendous amount of interest in the new metal-on-metal --

sort of the new generation of metal-on-metal implants given

the challenges that were known to exist with polyethylene.

We wanted to be able to provide further information to

surgeons to help them educate themselves about biological and

clinical issues.

Q. Ms. Turner, you oversaw the development of this product,

right?

A. I did.

Q. You lived through it?

A. I did.

Q. How do you respond from your perspective as one of the

engineers and -- and the project core team leader to the -- to

the suggestion that you rushed the product to market?

A. I think that is completely inaccurate and would discount

the volumes of work that had been done from both sides of

Johnson & Johnson, PI, JJO and DePuy, dating back to 1994.

All of that work was used in consideration for the design of

Ultamet. So I -- I wouldn't consider that a short

development.

Q. What about the process that took place from 2001 to 2002

with regard to Ultamet and how does that pertain to that issue

of whether you blitzed the market?

A. I believe that we were very -- we had a very controlled


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launch. And certainly, we are interested in surgeons being

able to get clinical experience with the implants, but we

wanted to do that in a very responsible way. So we -- could

we have sent more product into the market faster? Yes, we

could have. That was not the plan.

The plan was to control the roll-out in the early time

frame just as additional verification that there were no

issues.

Q. Do revisions happen?

A. Revisions happen with every implant.

Q. Okay. So even if there are revisions that are occurring

in the first five years, is that anything that's concerning to

you?

A. That in and of itself is not concerning.

I'm not aware of any implant that has zero failures. It

just -- it's something that is known to happen by us, it's

known to happen by the FDA, it's known to happen by

clinicians.

Q. You can't make a perfect implant?

A. You cannot make a --

MR. LANIER: Objection, leading.


BY MR. QUATTLEBAUM:

Q. How do you as an engineer respond to the claim that you

didn't have enough information available to you, including


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clinical information, to introduce Pinnacle Ultamet to the

market?

A. I also disagree with that suggestion.

Given the information that we had for predicate devices,

I feel like we had certainly sufficient information to give us

confidence in the performance of the product at the time we

launched.

Q. What about the contention that you downplayed or hid risk

information?

How do you respond to that?

A. I absolutely disagree with that.

We -- we have a lot of information in the technical

monograph. We have information IFUs that are contained in the

box with each and every product that is sold. We were very

purposeful in our communication with the sales force as well

as with surgeons in terms of what risks had been identified in

the literature, reported in the literature. We tried to

provide the -- the very best information that we could.

Certainly there is no -- no benefit to us to try to not

disclose that information. I -- I feel like we discussed it

in multiple venues and to the right individuals.

Q. Is it a good product, the Pinnacle Ultamet?

A. I think it's a great product.

Q. And are you proud of the work you did?

A. I think out of all of my time in product development,


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Pinnacle and Ultamet is -- is the development that I'm

actually the most proud of.

MR. QUATTLEBAUM: Your Honor, we pass the witness.

THE COURT: We'll take a break.

15 minutes. Don't talk about the case.


(Recess taken at 10:23.)

(Proceedings resumed at 10:47.)


THE COURT: Mr. Powell?

MR. POWELL: Yes, sir.

THE COURT: Let me tell you before you get too long,

I'm glad to listen. I've gone back and looked at those cases

while I was in the break.

I think this really goes to the failure to warn claim.

Is that right?

Isn't that right?

MR. POWELL: I think it goes to all of the defect

claims and the negligence claim, Your Honor.

THE COURT: Really?

Okay. Well, I think it primarily goes to the defect

claim, and I think most -- most -- this is really going to

come up in the charge more than right now with regard to the

evidence.

I mean, y'all just went into this evidence, didn't you?


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MR. POWELL: No. We went into the evidence of what

we gave to the FDA.

I think what we're going to hear on cross-examination,

though, is you didn't give that to the FDA, you didn't give

that to the FDA, a lot of claims about what was not given to

the FDA and claims about things that were given to the FDA

that may not have been completely correct as the plaintiffs

see them.

So that evidence I think is clearly barred by Buckman

preemption.

THE COURT: Okay.

MR. POWELL: And that's -- that's the issue.

I don't think you can throw to the jury the question of

whether DePuy in some way did not comply, whether it was by

intentional or unintentional noncompliance with some

regulation of the FDA affecting Rule 510(k), because that's

peculiarly a federal question that the Supreme Court has said

really is the business of the agency.

You know, if somebody is going to say that a manufacturer

did not give us the right information, it would have to be the

agency that would say that.

Now, the issue as Your Honor saw in the Lofton case, the

Lofton case is an important part of our argument because there

were two other circuits that created a circuit split, and I

think this is where we might have been back in the Paoli case.


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But the Second Circuit had said, well, that's a pretty

limited thing, it doesn't apply to state tort law claims, it

only applies to a cause of action that someone is bringing

that you defrauded the FDA. And then the Sixth Circuit said

we disagree with that, and then the Fifth Circuit has agreed

with the Sixth Circuit.

So I think -- I think it is a very broad concept. After

you read Lofton in this circuit anyway, there is a unique

circuit split on the question as to how broadly that

preemption sweeps, but at least for us it's answered, you

know, in this circuit.

THE COURT: And I'm not debating that with you.

We're not in Montana right now in this trial.

MR. POWELL: Right.

THE COURT: So -- it might be prettier --

MR. POWELL: It would --

THE COURT: -- to be in Montana right now.

MR. POWELL: Oh, it couldn't be much prettier than

it's been here right now.

THE COURT: Well, I know the weather has been great

here --

MR. POWELL: Right.

THE COURT: -- but the snow would be pretty.

I think it's primarily going to be a charge problem.

I mean, I -- I guess I can't -- I mean, y'all went into


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this FDA and what you did and what you failed to do, we forgot

to do this and at five years we messed up this. Well, I mean,

they can go into that.

How can you go, whoa, whoa, whoa, we can put all that in,

but you can't ask questions about it? Is that what you're

saying?

MR. POWELL: Well, I'm not -- I'm saying that to the

extent that they want to contend -- we -- we were -- that was

sort of preemptive as you might imagine.

There is a letter from the FDA that we put up and read

because they're going to argue that the FDA said something

about 510(k) with respect to the Ultamet.

So what -- the point here is, though, they can't -- I

mean, we heard it all in Paoli that, you know, here's a test

you did. You didn't give that to the FDA. Don't you think

that you ought to give all the tests to the FDA, don't you

think you ought to give everything you know to the FDA.

THE COURT: Okay.

MR. POWELL: And that's precisely what the Supreme

Court talked about in Buckman.

THE COURT: Okay. I get it. Thank you.

All right. Who's arguing for the -- oh, Mr. Arsenault.

Good to see you.

MR. ARSENAULT: Good to see you, Your Honor.

Obviously we just received this this morning, and we'll


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be making a formal response in the next few hours.

This has been addressed in the context of a few MDLs.

And if I could approach with some decisions, Your Honor.

THE COURT: Sure.

MR. ARSENAULT: Both in the Actos and the Baycol

MDLs. And also this was alluded to in -- in opening

statements by Mr. Sarver, and we have those passages as well

for Your Honor.

THE COURT: Okay. Thank you.

MR. ARSENAULT: You're welcome.

(Pause.)

MR. ARSENAULT: So essentially, Your Honor, we're

not advancing any Buckman fraud on the FDA claims. The

defendants, as you can see in the opening, have embraced the

FDA approval. We're simply underscoring the limitations of

the 510(k) process. And as those MDL judges have discussed,

this comes in connection with the marketing issues that we

have.

THE COURT: Okay. Well, I think it comes in in

evidence at this point. I don't -- I'm not sure what will

happen on the charge. I'll have to look at that a little

more, and I hope y'all can get some response for me on that.

Okay? Okay?

MR. ARSENAULT: Yes, Your Honor.

THE COURT: All right. Good to see you making an


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argument.

MR. ARSENAULT: Thank you.

MR. POWELL: Could we have a running objection then

to all testimony about --

THE COURT: No. You make objections at the

appropriate time.

MR. POWELL: All right.

THE COURT: I'm not going to -- that running

objection business, I -- let's just start at the first of the

trial, judge, any ruling you make we'd like to have a running

objection. I don't blame you. I tried to do that too. The

judges never granted me, I'm not granting you that broadly.

So make an objection at the appropriate time.

If it looks like it's going to get a whole bunch of it at

one point, then I'll say yes and I'll do that, but not at this

point.

MR. POWELL: May we just say "objection, Buckman" or

something like that to --

THE COURT: That will be fine. No, that will be

fine.

I'm not trying to keep you from making your objection,

I'm just not saying, hey, judge, anything you've said is -- I

mean, it's just too hard on me to do that. I can't remember

all that. I'm sorry.

Okay. Okay. Are we ready?


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MR. LANIER: I believe so, judge.

THE COURT: Ms. Turner, are you here?

Oh, there you are.

Okay. Good.

THE WITNESS: I'm sorry. I'm short.

THE COURT: Have you still got water up there?

THE WITNESS: I do. Thank you, Your Honor.

THE COURT: Okay. Good.

Okay. Let's bring in the jury.

THE SECURITY OFFICER: Please rise for the jury.


THE COURT: Y'all be seated.

Thank y'all.

Okay. Mr. Lanier.

MR. LANIER: May it please the court. Good morning,

Your Honor.

May it please the jury. Good morning, y'all.

CROSS EXAMINATION

BY MR. LANIER:

Q. Good morning, Ms. Turner. My name is Mark Lanier. I've

not had the privilege of meeting you before. As you can

imagine I have got a lot of matters to cover. Did I spell

your name right?

Do you capitalize that A?

A. I do not.


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Q. So I got it right?

A. Yes.

Q. All right. Ms. Turner, I appreciate it.

Just so that we're all on the same page and we all

understand, you've been prepping for this for a long time,

haven't you?

A. I have.

Q. I know you've been prepping. I notice you've done some

hand motions and all. Have you practiced your testimony at

all?

A. No.

Q. Okay. You have been though prepping for well over a

year, haven't you?

A. My deposition was two and a half years ago. So --

Q. Yeah. So you got at least that.

But what I'm referencing specifically is an email that

you sent. It's Plaintiff's Exhibit 4075 where you were

sending to a Robert Decker back in September of 2013.

You said, "I officially accepted a new job in BI."

What is BI?

A. Business intelligence.

Q. Business intelligence.

Is that with J&J or with DePuy?

A. With DePuy.

Q. "As part of the transformation. I haven't are actually


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started my a few job, as I'm currently spending considerable

time prepping for Pinnacle litigation as well as maintaining

my ASR responsibilities."

Because you had a key role in that ASR metal-on-metal

too, didn't you?

A. My role was in terms of the reimbursement program after

the recall.

Q. All right. And in that regards, ma'am, you've been

spending time getting ready for this. You've got a lot of

areas where you've testified about to the jury and a few other

areas where you've not testified, but you've had involvement.

Is that fair to say?

A. You'll have to let me know what questions you'd like to

answer -- you want me to answer, please.

Q. All right. For example, you testified some about the

royalty work you were doing?

A. Yes.

Q. And we -- we know about that because of not only your

testimony but some of your emails.

"Barry and Leanne," this is from Randy Kilburn, who's

the head of marketing to you and -- I think Barry Schnieders

was also in marketing?

A. Yes.

Q. So the marketing people are meeting with you on the

royalty meeting with a high importance on it back in 2009?


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A. If I can clarify, Barry was not in a marketing role in

2009.

Q. Okay. "Barry, Leanne, are we able to review the aSphere

heads royalty at the next meeting?"

Because you were involved in aSphere at least from a

royalty perspective?

A. I was asked about this because I helped schedule the

reviews. I was not involved with the actual review of aSphere

or any of the development.

Q. Okay. "The development and legal team are in alignment

that aSphere heads are a line extension to Ultamet."

Now, did you have anything to do with the engineering or

the aSphere at all while you were at DePuy?

A. I did not.

Q. We're launching aSphere heads at AAOS and having clarity

on this situation will help immensely."

You at least knew about it from that perspective, fair?

A. I knew that it was a project, yes.

Q. And then I think -- and -- and we'll get into this more

when we get into the royalty testimony you offer, but, "As

stated in our monitor's most recent quarterly report to the

U.S. Attorney's Office, the monitor is requiring all legacy

royalty payments be submitted for her review by March 13th.

"As a result, we lost our long scheduled March RRC

meeting."


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"I appreciate the urgency with which you want to get

Ultamet XL reviewed. I just don't see how we can expand the

agenda to accommodate another project review."

A. Yes.

Q. You then told Randy "Maybe I should tell him I will swap

out Ultamet for Corail. Then they can call all the Corail

guys to tell them they won't be getting any future royalties

because metal-on-metal is more important. Think he'll go for

it?"

I think at that point y'all kind of lapsed into some

frivolity with this, right?

A. Yes.

Q. Barry Schneiders back to you, "Wonder if we'll ever get

to the point where we aren't fighting somebody, anybody at

all . . ."

You asked the Magic 8 ball. You said the magic 8 ball

said no f'ing way.

"Maybe if we fight each other that will count, and

everyone else will leave me alone."

"Power of positive thinking. Let me know how that

works." You said "In the spirit of trying it out, I think you

suck." He's got -- it's basically just you and him going at

it and having some fun, I guess. But as a practical matter

what we can see from this you were knee deep involved in

knowing the concerns of the company, especially around


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marketing and metal-on-metal, weren't you?

A. I'm not sure how this -- I'm not sure how these two

things are connected. I'm sorry.

Q. All right. Let me approach it from the back end then.

I'm sure you've seen Dr. Fehring's PowerPoint. The jury

has seen it multiple times: Metal-on-metal, how did we get

here?

It's Exhibit 1 -- 10. Have you seen this?

A. I think I have seen it.

May I have a copy?

Q. Yeah.

A. Thank you, sir.

Q. "How did we get here?" Dr. Fehring asks.

Dr. Fehring, of course you know him, don't you?

A. I do.

Q. He's a design surgeon, right?

A. Yes. He was a design surgeon --

Q. He got paid royalty money from y'all because he -- was he

one of the ones that helped decide the smiley face or the

frowny face on the holes?

A. Yes.

Q. How many -- how many guys got royalties simply for

deciding whether it was going to be a smiley face or a frowny

face?

A. None of them on that contribution alone.


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Q. Okay. What else did Dr. Fehring contribute beyond that?

A. He contributed in a number of ways.

Q. Right. What?

A. He was instrumental in the test program and set up that

was looking at micromotion of the polyethylene liner interface

with the acetabular cup.

Q. That's the test program. But I'm talking about the

design of the cup. What did he do in the design?

A. That is a hundred percent related to the design of the

cup.

Q. The test program is related to the design?

A. Yes. Because the testing verifies has the design met the

intent.

Q. Which y'all decided the design did. So the design wasn't

changed at all because of anything Thomas Fehring did, right?

A. That's not true.

Q. All right. Well, we'll get to that later on. Let's keep

going.

So he does reveal his disclosure. Very well. Gives the

postmortem overview.

Then he says "How did we get here? Hip surgeons were

seduced into using metal-on-metal."

Now, you were part of that process, weren't you?

A. I can't say I agree with the way that he's characterized

it here. I was involved with metal-on-metal.


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Q. Well, you were not only involved. You were involved in

training the sales force. You were involved in preparing the

literature. You were involved in interfacing with the key

doctors that were out there saying things in the meetings.

You were a project leader for this metal-on-metal hip, weren't

you?

A. Yes.

Q. The idea of leading astray -- to lead someone into a

behavioral choice they might otherwise not have made.

This is one of your design surgeons describing what y'all

did with metal-on-metal, isn't it?

A. He was a design surgeon for the Pinnacle acetabular cup,

not for the Ultamet liner.

Q. Well, what I -- for the Pinnacle acetabular cup which

holds the metal liner.

A. Yes.

Q. Right?

All right. And in this regard you were the project

leader, as we know from Defendant's Exhibit 2053 that you

referenced earlier, page 327. Project leader, Leanne Turner.

This is you, isn't it?

A. Yes.

Q. All right. Now, as project leader you had some -- a lot

of responsibilities, didn't you?

A. Yes.


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Q. And one of those responsibilities was to deal with the

engineering aspect of how this product was going to work.

Correct?

A. That was not a responsibility as a project leader.

Q. It was a responsibility you had on the project, isn't it?

A. Yes. It would have been a responsibility as an engineer.

Q. All right. Now, I've put on the ELMO for the jury to see

the liner and a ball.

This is the liner that goes inside the shell, correct?

A. Yes.

Q. And then we have a ball that goes on the end of the stem.

Correct?

A. Yes.

Q. Now, one of the very, very, very important issues is how

much space is designed to be between the ball and the inside

of the liner. What is the space there. Correct?

A. Yes.

Q. And that space between the ball and the liner is called

clearance?

A. That is correct.

Q. In other words, how much clearance is there is a question

to how much space is there between a working ball and a liner.

What is the -- the spacing in there. Correct?

A. Yes.

Q. Now, you testified yesterday that when it comes to


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clearance, this is very, very, very important in a

metal-on-metal, isn't it?

A. Yes.

Q. In fact, I've titled this sheet I want to walk through

with you, "Coming Clean on Clearance."

In metal-on-metal, clearance must be tightly controlled.

Agreed?

A. Yes.

Q. Ultima, even the little brochure that y'all handed out on

Ultima, said that clearance is an imperative, right?

Right?

A. May I see?

Q. Sure. It's the one you were looking at yesterday, the

design rationale for Ultima.

I'm looking at page 2.

Ultima is one of the devices that y'all said to the FDA

was substantially equivalent in safety and effectiveness or

efficacy, right?

A. Substantially equivalent, yes.

Q. And so this is the device that you talked about some of

the tests y'all did. You talked about the tests on the

Ultima.

A. Yes.

Q. And in this design rationale for the Ultima y'all even

make the statement, "Proper clearance between the head" -- Let


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me see if I can get it focused better.

"Proper clearance between the head and the insert is

imperative to help ensure function and extended clinical

longevity."

Do you see that?

A. Yes.

Q. And by that what you're meaning in that -- and what you

believe to be true and I think everybody agrees is true -- is

that clearance changes the wear, how much debris. True?

A. It is one of the parameters that affects wear, yes.

Q. And it also affects how long the implant works, right?

Right?

A. Yes. If you -- if you read what the brochure references

in terms of clinical longevity.

Q. That's what it says, it is imperative to ensure function

and how long it works.

It's optimized, the Ultima is, for wear reduction with a

28-millimeter articulation. Correct?

A. Yes.

Q. So we've got something here that is critical, tightly

controlled, imperative, can affect the wear -- oops -- can

affect how long the implant works, but y'all did lie to the

FDA about this "imperative," didn't you?

MR. QUATTLEBAUM: Object on the Buckman issue and on

403, 402, and the characterization of lying.


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THE COURT: Overrule your objections.

BY MR. LANIER:

Q. Lie is harsh. Let's make it less harsh, for now.

Didn't tell the truth.

A. My testimony was that there was a mistake in the

submission, yes.

Q. Well, I know you said today it was a mistake. We're

going to go back and look into the document trail to see if it

was a mistake or deliberate. We'll do that in a moment.

But for now can we just agree you did not tell the truth

to the FDA about this "imperative." True?

MR. QUATTLEBAUM: Same objections, Your Honor.

THE COURT: Overruled.

THE WITNESS: I feel like this implies that it was

done purposefully, so if you want to add on there not on

purpose, then I will agree with that.

BY MR. LANIER:

Q. How about if we add on there right now that you didn't

tell the truth to the FDA and then we'll talk about whether or

not it was an accident. Okay?

I'll add it this way. Was this an accident?

Was this accidental, question mark, so that we've got it

on there. Okay?

A. Okay.

Q. Now, I want to give you document 3122. And under


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American law we're allowed under the Freedom of Information

Act to actually get into some FDA files and get their

documents.

Did you know that?

A. I'm not sure if I was aware of that or not.

Q. All right. Well, that's what we've done.

We've asked for their documents from the DePuy

Orthopaedics folder that deals with the prosthesis or the

implant for the hip, metal cemented acetabular, in other

words, the Pinnacle metal-on-metal cup liners. We asked for

their file from DePuy on that.

Do you see that?

A. I see.

Q. And they sent us their file materials, which we've got

here. And I'd like to look at a couple of the things that

we've pulled out of the FDA file with you. Okay?

First, we see that the FDA approved for selling the

Pinnacle Ultamet metal liner. The approval was sent on

December 13th of 2000; is that right?

A. The clearance, yes.

Q. And so that means in the matter -- in the process of just

a month y'all got approval all the way to the letter being

sent out.

And the approval was based upon representations made by

you and your company. Correct?


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A. Yes.

Q. And those representations y'all made was that this

Pinnacle Ultamet liner was identical, substantively, to the

Ultima liner. Correct?

A. Sir, I'm just checking to see if it was to the Ultamet or

to the Ultima.

Q. Oh, because the 36 was to the Ultamet 28; is that right?

A. I believe so. I'm trying to verify.

Q. No, I think you're right. I think you're right.

I think what this was was the company saying that the

Ultamet 36-millimeter liner -- which by the way happens to be

the liner in all of the plaintiffs in this case.

Did you know that?

A. Yes.

Q. The 36-millimeter liner is the same for all intents and

purposes as the Ultamet 28-millimeter liner that had already

been approved; is that right?

A. We specify -- Yes. We specify the specific areas of

equivalence, intended use, surface characteristics, material

locking mechanism.

Q. But that's where y'all didn't tell the truth, isn't it?

A. I don't agree with that.

Q. Well, you have here on page 67 a comparison chart of

Pinnacle 28 and Pinnacle 36, don't you?

A. Yes.


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Q. And on it is this section articulation requirements where

it talks about the clearance. Correct?

A. Correct.

Q. And under Pinnacle 28, which is the first column, you

give the clearance as 40 to 80 microns; is that correct?

A. Yes.

Q. Now, so that we've got this here, Ultamet 28, you give

the clearance as 40 to 80 microns we abbreviate with the Greek

U and then the Latin M; is that right?

A. Yes.

Q. Now, what you've done here is define the clearance, that

really important imperative that affects wear debris and

everything else, correct?

A. Yes.

Q. And then you show for the Pinnacle 28 that it's 40 to 60

microns -- 40 to 80, excuse me, microns clearance.

And then for the Pinnacle 36 --

(Someone sneezes.)

MR. LANIER: Bless you.

BY MR. LANIER:

Q. -- you said "same," didn't you?

A. This is the exact exhibit that I was --

MR. LANIER: Objection, nonresponsive.

THE WITNESS: -- testifying about previously.



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BY MR. LANIER:

Q. Ma'am, please answer the question.

You said "same," didn't you?

A. Yes.

Q. And that is false, isn't it?



BY MR. LANIER:

Q. That is false, isn't it?

A. It is not the same clearance.

Q. Ma'am, please answer my question.

What you told the FDA is false, isn't it?

A. That's true.

Q. All right. Now, you signed off on this yourself, didn't

you?

There we go. You actually signed off on this --

A. I did.

Q. -- yourself, didn't you?

A. I did.

Q. And we can go through here and look, but what we're going

to find out as we do so is you told the FDA, and you gave them

a sheet that was dated May 16th of 2000, that it was 40 to 80

microns clearance. Right?

A. Yes.

Q. But you changed that, Leanne Turner, and you knew that


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the truth was actually 80 to 120. And that's the truth which

is not told to the FDA. Correct?

MR. QUATTLEBAUM: Same objection, Your Honor.


THE WITNESS: I think a more accurate way to say

that is there is conflicting information in the report.

It is accurately reflected earlier in the body of the

description.

BY MR. LANIER:

Q. All right. Which page are you referencing there, ma'am?

(Pause.)

A. Sorry, I'm having a hard time finding the actual

submission in here.

Q. We'll let you do it over the lunch break, because we

won't be through by then, and we'll look at it after lunch.

But let's keep on working right now. All right?

A. I can tell you that what I'm looking for is the reference

to effective radius.

Q. Okay. Maybe it would help if I give you DePuy's 510(k)

submission and you looked for it in your forms.

MR. LANIER: Judge, I didn't ask the first time.

May I approach?

THE COURT: You don't need to ask.

MR. LANIER: Thank you, Judge.

THE WITNESS: Thank you.


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BY MR. LANIER:

Q. Uh-huh. I'm handing you Defendant's Exhibit 467. This

is the submission from DePuy's side as opposed to the -- what

we got through the Freedom of Information Act. We got this

out of your files.

It starts with the acceptance letter. You can work

through it.

Does that -- will you be able to find it quicker, or

should we keep moving?

(Pause.)

A. My apologies. I know I'm looking for the description,

I'm just not able to put my finger on it.

Q. That's all right. Why don't we keep going and maybe it

will crop up in the questioning. And if not, you'll have a

chance to look for it over lunch. Okay?

A. Okay.

Q. All right. Now, meanwhile, ma'am, what we focused on is

what y'all told to the FDA in the comparison chart where

you're comparing Pinnacle 36 to Pinnacle 28, the comparison

chart. Because you're saying they're the same. If the FDA

looks at the comparison chart, the FDA is told the wrong

information, they're told a falsehood. Correct?

A. Correct.

Q. Now, you were the actual source for this falsehood,

weren't you?


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A. I was.

Q. I'm sorry?

A. Yes.

Q. We can look and see that on November 13th -- and this

would be page 71, if you're using the ones we got from the

FDA.

You are the Leanne Turner who is verifying to the best of

your knowledge, as required by the risk analysis, for this

modification were performed and the results demonstrated the

predetermined acceptance criteria were met.

You made that representation, didn't you?

A. Yes.

Q. But you are the actual person who authorized the change,

aren't you?

A. The change to the clearance?

Q. Yes, ma'am.

In other words, the -- you not only signed and said

"approved," you are the person who before you approved the

chart saying "same," you are the person who approved changing

the clearance, aren't you?

A. I am not -- I wouldn't say that's entirely correct.

The change to the clearance --

Q. Hold on, ma'am.

A. -- was made based on the tribology experts on the team.

That's pretty clearly documented.


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Q. Ma'am, you signed the change order.

A. I did.

Q. You signed it?

A. Yes.

Q. That's a part of this process that you were talking

about, that DePuy has this process, remember?

A. Yes.

Q. And part of the process that you said is in writing -- by

the way, the process kind of broke down here, didn't it?

A. I made a mistake.

Q. Okay. The process as it's in writing says there has to

be an engineering change request, like we see on Exhibit 4072,

correct?

A. Yes.

Q. This engineering change request for the Pinnacle metal

insert that's 36 diameters was requested by who?

A. I was the engineer requesting it.

Q. So when I said you signed the change order, you were

responsible for the change. You certainly are the engineer

who requested the change. Correct?

A. I requested the change to the drawing.

Q. Well, if we look at the drawing, ma'am -- go to page --

in the lower right-hand corner there are page numbers here.

Go to page 278, metal-on-metal shell-to-head clearance for the

Pinnacle 36.


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Do you see that?

A. Yes.

Q. This is the chart that should have gone to the FDA, isn't

it?

A. Yes. This is the information that should have gone.

Q. This is a chart that should have gone. You know y'all

sent the FDA a chart, you just sent 'em an old one.

Did you know that?

A. When the chart was updated, I'm not sure that it --



BY MR. LANIER:

Q. Did you know that y'all sent the FDA an old chart instead

of this chart?

A. In 2005 I knew that.

Q. Ma'am, you signed this chart. You updated this chart on

the very same day you signed the verification to the FDA,

didn't you?

A. Yes.

Q. You signed an updated chart that had your updated changes

of the clearance on the same day you verified to the FDA that

what they were getting, the false information, was the truth,

didn't you? Exact same day.

A. It was the same day.

Q. And you said -- not only did you sign this chart for this


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change, but the clearance on this is 80 to 120, almost twice

the clearance on this imperative matter that changes wear and

everything else.

You knew the truth on the same day you told the FDA

differently, didn't you?

A. By mistake, yes.

Q. Well, you're saying "by mistake," that's why I want to

underscore this, Ms. Turner.

Leanne Turner knew and was signing changes to the

imperative the same day as saying the falsehood to the FDA.

That we know, don't we?

That we know, don't we?

A. Yes.

Q. And so I've got up here that you were the source, you

authorized the changes, and then you verified false data to

the FDA. That is all true as well, isn't it?

A. Clearly when I signed that I was not aware that the

incorrect table had been included in the exhibit. That was

certainly not done knowingly.

Q. Well, ma'am, if you've got a brand-new table that is

updated that very day, to reflect the change orders you've

been going back and forth over whether or not to make, knowing

it's an imperative feature, you want us to accept that you

knew about the change but just forgot to tell people to put

the brand-new clearance sheet that you had into the


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submission?

You just -- it lapsed your mind?

This was your project, wasn't it?

A. Yes.

Q. This was your reason for existing at DePuy at the time,

wasn't it?

A. Not sure about that, but it was my project.

Q. Well, ma'am, we're going to get into it in a moment, but

the truth of the matter is you did not do this cavalierly and

you had known about the FDA and whether it might affect the

FDA, and you just decided to stay quiet on it, didn't you?

A. That is absolutely untrue.

Q. Because, ma'am, you were the person the company was

relying upon to use your persuasive powers to get the FDA to

approve the 36 with the new untested data, weren't you?

A. No. No.

Q. I'm going to give you Plaintiff's Exhibit 4070. And see

if it doesn't bear out my question about you were the one the

company was going to rely on to use your persuasive powers.

I'll give you the hint.

Page 2, Jim Lancaster, Leanne Turner, Frank Chan from

Andrew Goldsmith, the tribologist. "I wasn't aware you had

background in the CIA. Anyway, on a need-to-know basis, the

plan is outlined in the previous emails (increase the nominal

clearance to a hundred, continue this present test with the 80


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micron pairs. In the future do a hundred.) This is why we do

tests.

"Consensus: Yes.

"Regulatory: We are reliant on Leanne's persuasive

powers that we know what we're doing."

Do you see that?

A. Yes.

Q. When I said the company even was relying upon your

persuasive powers to deal with the FDA, did you forget about

this email?

A. You said my persuasive powers with the FDA --

Q. Ma'am, doesn't "regulatory" mean FDA?

A. No. No, it does not.

Q. You think it's regulatory within the company?

A. Yes.

Q. All right. So regulatory within the company deals with

the FDA?

A. Yes.

Q. So what your persuasive powers were going to do is

persuade regulatory to try and figure out how to deal with

this with the FDA.

Do you still want us to think now that you had no idea

just the very day before y'all had given and you had signed

off on false information?



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BY MR. LANIER:

Q. Ma'am, you clearly knew this. This isn't a mistake.

This is something you knew, didn't you, Ms. Turner?

A. I'm not sure how any of this clarifies that it's not a

mistake.

Q. Well, let's look at the back and see what the emails are

before this one.

These emails start out -- and so that we've got this date

in front of us, November 13th is the day you verify wrong

clearance to the FDA. Right?

Right?

A. Incorrect table submitted.

Q. Yes. The wrong clearance.

Now, go back to November 10th, three days before.

Are you with me?

A. Yes.

Q. November 10th, three days before, you get an email from

Andrew Goldsmith, who is concerned about friction with the

36-millimeter, and says this is of high importance.

Do you see that?

A. Yes.

Q. And this is where Andrew Goldsmith is saying we're having

a problem in the simulator. The simulator is not working well

on the 36-millimeter. Correct?


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A. Yes.

Q. He doesn't say it's a piston. He says "I'm convinced

it's not the simulator."

Do you see that?

A. Yes.

Q. That's because there are two 36 that are having problems,

both of them are, not just one?

A. As I recall in another -- in another email he describes

that it was obvious in one and potentially occurring in two

others.

Q. Barely noticeable, but noticeable for two others.

A. Yes.

Q. So you've got it in three of the five.

A. Yes.

Q. Correct?

" The key difference between this pair and the rest is

clearance."

This pair has clearance of 52, and the other four pairs

are higher. Again, he's not saying it's a piston. He's

saying the one it's most obvious for is the one with the lower

clearance.

A. That's what this email says.

Q. In fact, what we've got to remember here is the clearance

here y'all were telling the FDA was somewhere between 40 to

80, right?


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A. Yes.

Q. "My best shot for why this is happening is that the

clearance overall towards the rim is too tight. The only

explanation I can see."

Here is his recommendation: "My recommendation is this.

We haven't started making the points here yet for

production." They're just making them for testing at that

point, right?

A. Yes.

Q. "Heads" -- that's the ball, right?

The ball is the head, right?

A. Yes.

Q. -- "will be made before cups. I would recommend that we

increase the inner diameter of the cup." That's actually the

liner. "Increase the inner diameter," is that right?

A. Yes.

Q. -- "to increase the clearance."

Right now the cup clearance is in the 40 to 80 range,

it's 60. "I don't have the drawings or I don't have Agile so

I can't tell you the dimensions. This might lose us some wear

performance." In other words, you may get more debris. These

people may get more debris, right?

That's what that means, lose wear performance, right?

A. Yes.

Q. -- "but not that much and would avoid this frictional


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locking risk. The 36-millimeter one-piece devices I've tested

cleared at 100 to 130 microns.

"Regarding how much we increase the clearance, I'd

suggest 40, but that's just my intuition."

That's what happened November 10th, right?

A. Yes.

Q. So November 10th there's a problem alert and a request to

increase clearance. Right?

Correct?

A. Yes.

Q. Now, if we go to the next email, the next email is from

Frank Chan, "Yikes! I fully share your concern."

Then he talks about how simulators -- "Given that

simulators (under standard or adverse conditions) are still

perfect world," they're controlled scenarios. In other words,

simulators don't really simulate real life, do they?

A. Simulators are designed to be comparative tests. They --

we do the best we can --



BY MR. LANIER:

Q. Simulators don't really simulate real life, do they?

A. I think it's debatable.

Q. Well, we saw the video.

Do you remember watching the video?


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A. Yes.

Q. And when we were watching the video, do you remember

Mr. Quattlebaum telling Jim would you stop it?

A. Yes.

Q. Because the simulator wasn't stopping on its own, was it?

A. Not in this test.

Q. No. Because simulators don't just take a few steps and

stop, they don't turn, they don't bend down, they don't climb

a stair. Certainly not the way you were programmed in testing

back then, correct?

A. Back then sort of those types of things were in their

infancy in the simulator design.

Q. Was that Yes, Mark, you are correct? You've got to

answer my question, ma'am.

A. Could you please ask the question again.

Q. Yes, ma'am.

Real life activities like y'all have on your brochures --

dancing, bowling, bicycling, just walking and stopping, going

up a hill, going down a hill, all the things that change the

way the hip is wearing -- those weren't included in these

simulator studies, were they?

A. They are included in simulator studies. It was not

included in this particular simulator study.

Q. Okay. But y'all were doing that back then in other

simulator studies?


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A. After this date, we did it in other simulator studies.

Q. After this date?

A. Yes.

Q. As in when did you start using simulators with real life

data like I've just described?

A. First, to be clear, many I think of the activities you've

described are contained with a simulator cycle. I will grant

you probably not all of them.

And I would say what we would refer to maybe as adverse

testing for simulators was certainly just being developed in

about this time frame --

Q. Ma'am, I'm just asking, very simple: When did you start

testing the way you said, yes, we were testing that way, the

way I described? When was it?

I want to pull the test and I want to see.

When was it?

A. I'd have to refer to documents to know exactly when.

An example of that is --

Q. I won't ask for a specific date. Give me a year.

Before you started selling Pinnacle metal-on-metal.

A. I think in the 2002 time frame, but I can't promise. I

would need to see the report to give you the exact date.

Q. All right. We'll pull those as well over lunch and see

if we can look at those.

Meanwhile, he said "Those are perfect world controlled


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scenarios, but these implants will be implanted under various

clinical conditions.

"I agree with you this friction issue may have important

clinical ramifications. I think the project core team needs

to address this pronto."

That's what you headed up, isn't it?

A. Yes.

Q. And so Leanne Turner -- you then get the next email in

the chain.

Ah, let's get a date on that last one.

This is, again, November 10th. It's get Leanne Turner to

weigh in, right? Project core team. Correct?

A. Yes.

Q. All right. Then we've got now November 13th is the next

on this chain, and again it's from Andrew Goldsmith. He says,

"The plan was to make some 36-millimeter liners to allow

testing of a hundred micron clearance. This aspect of the

production route was either lost in the telling or

misunderstood because the parts available for testing give us

the smaller spread."

So his recommendation is when new liners are available

test the hundred clearance.

But meanwhile, what he's doing is continuing with the

tests on the smaller clearance, isn't he?

A. As I recall, that test was stopped.


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Q. Jim Lancaster then asked the question: --

THE COURT: Stop. We'll let him ask that question

after lunch.

Don't talk about the case.

See y'all back at 5 after 1:00.

Thank y'all.






THE COURT: Okay. Here we go.

You still got water?

THE WITNESS: Yes. Thank you.

THE COURT: Okay. Here we go.


THE COURT: All right. Y'all be seated.

Thank you.

MR. LANIER: May it please the court.

THE COURT: Mr. Lanier.

MR. LANIER: Thank you.

CROSS EXAMINATION (Cont.)

BY MR. LANIER:

Q. Right before the break I was asking you a question. We

were going through this document that is Exhibit 4070. We


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were looking at the timeline of what went down right up before

and into the time where y'all submitted your five -- your

application to the FDA to sell the Ultamet 36-millimeter

liners.

Remember all of that?

A. Yes.

Q. All right. What we didn't get to is we had just answered

the question about you having to use your persuasive powers on

regulatory to let the regulatory department that deals with

the FDA know what the company is doing, correct?

A. Yes.

Q. And that was on November 14th, the very day after

submission, that you are to use Leanne Turner, use persuasive

powers. Correct?

A. That's what the email says.

Q. Now, I'm sure you did your work well and you tried to use

your persuasive powers, didn't you?

A. That's not the way I would describe it.

Q. Well, I'm sure you at least, however you describe it,

went to regulatory and told them, "We know what we're

doing"?

A. Yes.

Q. So regulatory at that point, on November 14th, is aware

of the fact that incorrect information has been submitted to

the FDA, right?


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A. No.

Q. You didn't tell them?

A. Regulatory knew what the correct information -- we had

discussed with regulatory the change in the design parameters.

We had shared the information. The information did not make

its way into the exhibit as I previously discussed. So I

cannot say that they know, because at that time it was not

known to us, until 2005, that that table had not been properly

updated.

Q. Ma'am, the whole thing you were to let regulatory know

was that you had made a change and testing was going to make a

change. Everything got changed on the Friday before the

Monday submission. Right?

A. Yes.

Q. And these submissions aren't done -- Monday doesn't come

around and they say, okay, time to submit, and they just start

preparing things. That submission had been in preparation for

a long time, hadn't it?

A. It -- it had been in preparation.

Q. And there was a target date for it to be submitted,

wasn't there?

A. Internally we had a date, yes.

Q. And so you had a choice at that point in time. You could

say, time-out, we're not ready to go, we need to revamp the

way we're going to ask the FDA for permission because we may


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have a problem with the product as designed. That's one

choice. The alternative choice is just not to say anything at

all.

A. There wasn't a problem with the product.

Q. Ma'am, y'all made a change to the product for the

testing. You changed the clearance, this tightly controlled

imperative, very important, aspect, didn't you?

A. We did.

Q. And you changed it (indicating) right at the end, Friday

before a Monday submission, right?

A. We changed it consistent with a design strategy that had

been in place --



THE WITNESS: -- since 1999.

BY MR. LANIER:

Q. Ma'am, I'm just asking, you changed it the Friday before.

We've seen the change order. Right?

A. Yes.

Q. And, ma'am, that radically changes the submission that

was going to be sent to the FDA, didn't it?



THE WITNESS: I don't know about radically changes.

BY MR. LANIER:


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Q. Well, did you have a chance over the lunch break to find

where you think you told the FDA about the change?

A. Yes.

Q. All right. Do you have Defendant's Exhibit 467 in front

of you?

A. Yes.

Q. I'll put it up here on the screen for the jury. Tell me

which page to go to.

A. Page 10.

Q. Now, are you using -- which numbers?

These numbers down here in the middle?

A. I'm sorry. Yes.

Q. Okay. Page 10.

Let me get my Post-It note off.

A. Second bullet point, under section 5.

Q. All right. Let's look at section 5.

It's going to be this second bullet point?

A. Yes. Where we reference "same effective radius."

Q. Okay. Now, here's what I'm going to do.

Is there any other place in there you said it?

A. Following to that you see in section 7, on page 11 --

Q. I'm going to put this red Post-It note here for that

second bullet point so we don't lose it -- pink.

And then page which?

A. Page 11.


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Q. Okay. Page 11.

A. For this type of submission you identify verification

activities to verify the impact of the change --

Q. Okay.

A. -- where equivalent or less than the 28.

Q. Which one are you looking at? Which column?

A. The acceptance criteria.

Q. All right. Anywhere else?

A. If you go to -- starting on page 13, pages 13 through 20

show the engineering drawings with the radius marked,

handmarked.

Q. Is that this thing up here you initialed?

A. Yes.

And you can see the dimension circled with the B --

sorry, to your left, 7106. To your left. Up. Right there.

Q. We're going to see that on a number of pages, correct?

A. Yes.

Q. All right. Anywhere else, other than those other pages

that are also those drawings?

A. That's it.

Q. Okay. Great.

Now, let's look at this as a package that was sent to the

FDA, and let's see if it's fair and reasonable to assert that

this package informed the FDA of the difference. Okay?



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BY MR. LANIER:

Q. Are you with me?

A. Yes.

Q. All right. We start with December 13th, 2000.

Now, this is where the FDA says that your device has been

approved. Correct?

A. That it has been cleared, yes.

Q. So we flip through that, and we get to the application

that your company made to the FDA. And it is dated November

13th, and it's on page 1, first page of the actual

application. Correct?

A. Yes.

Q. So we're clear, what we're doing here is y'all are saying

this 36-millimeter liner is substantially equivalent to the

28-millimeter, one that is four millimeters smaller in the

inside, correct?

A. Yes.

Q. In fact, what y'all call it in your application is "a

minor design modification." Is that correct?

A. Yes.

Q. Now, again, all of these pages, this is already prepared

before November 13th, isn't it?

A. If the submission was on November 13th, yes, they would

have been prepared --


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Q. All right.

A. -- prior to that.

Q. So before this Monday that it's submitted, even though

Friday y'all have made a change, you are still telling the FDA

it's only a minor design modification, aren't you?

A. Yes.

If you look down two more paragraphs, you'll see the

eligibility requirements for this particular type of

submission.

Q. Time-out, ma'am. I appreciate that.

And I'm following one train of thought here, and that's

diverting me to another one.

A. Okay.

Q. So he'll get a chance to come back up if there's

something else you want, but if you'll keep working with me

here, please --

A. Okay.

Q. -- before we move on.

So you tell the FDA this is a minor design modification

when in fact it's something that needs to be tightly

controlled, that is an imperative, where it can change the

wear and how long the implant works, correct?

A. Yes.

Q. That's not a minor design modification, that is actually

significant, isn't it?


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A. No.

Q. Well, ma'am, y'all don't even know how significant it is

yet, because y'all are still trying to figure out how to run

the tests, aren't you?

A. We already had wear tests. At the --

Q. Not at Ultamet, ma'am. On the Ultamet you did not have a

wear test, did you?

A. On an equivalent articular surface.

Q. We'll fuss about the other things you think are

equivalent later. I'm talking about the real deal here, the

product.

You're testing the product, aren't you?

A. Yes.

Q. And you're not testing it with -- actually, the way you

are testing it, it is a minor design modification, but you

need to change it when you sell it and change the clearance,

don't you?

A. I'm sorry, I'm not following the question.

Q. All right. That's all right. We'll keep going.

We'll come back to it.

You've got a table of contents. Again, this isn't

something just done the last day, right?

A. Correct.

Q. You've got all of these exhibits that go with it, don't

you?


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A. Yes.

Q. Then you've got this next page that you submit, which is

the summary, summary of safety and effectiveness. Correct?

A. Yes.

Q. And this is where you say that the 36 is basically the

same, or substantially equivalent, to the 28.

A. Yes.

Q. And you've got it down here.

But look how it says, "The Pinnacle 36 are nearly

identical to the Pinnacle liners that were previously

cleared."

Those are the 28 millimeter, right?

A. Yes.

Q. "The intended use, articular surface characteristics --"

now, the articular surface characteristics, that's going to

include the measurements, aren't they -- isn't it?

A. It's going to include the way that the components

interact with each other. Yes.

Q. Yes. So this is yet another place where it says they're

the same but that is false, because they are different, aren't

they?

A. No.

Q. Ma'am, what is the clearance of the 28 in microns?

A. 40 to 80.

Q. What is the clearance in microns for the 36?


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A. 80 to 120.

Q. There is a difference between 40 to 80 and 80 to 120,

isn't there?

A. There is a difference in clearance. There is not a

difference in effective radius.

Q. Ma'am, I'm not asking about the effective radius. I'm

asking about the clearance.

This is clearance. Do you see that?

A. I do. But the broader topic is surface characteristics.

Q. Ma'am, the clearance is different, isn't it?

A. It is.

Q. And to say that there is no change or no difference in

the clearance would be patently untrue, wouldn't it?



BY MR. LANIER:

Q. Wouldn't it?

A. Which is not what that says.



BY MR. LANIER:

Q. Ma'am, this does not say the radius -- effective radius

is the same, does it?

A. It does not.

Q. When you say, all right, it says the effective radius is


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the same, effective radius isn't anywhere on here, is it?

A. Effective radius is -- is an articular surface

characteristic.

Q. So is clearance.

A. Yes. They both are.

Q. So there's a clear ambiguity here. The clearance is

different, that's one surface characteristic. The effective

radius is not different, that's another surface

characteristic, isn't it?

A. By definition those two things cannot be the same,

ever.



BY MR. LANIER:

Q. Ma'am, those are both -- by the way you're defining them

they're both surface characteristics, aren't they?

A. Yes.

Q. So if we follow your definition, that statement could

never be true, could it?

If we follow your definition --

A. To someone --

Q. Yes, ma'am.

A. To someone who is knowledgeable about the parameters, I

think --



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BY MR. LANIER:

Q. Ma'am, this is a simple question.

If we follow your definition that you want to try and

build into this right now, that statement could never be true,

could it?

A. I guess the only way I can respond to that is to say then

I'm going to disagree with my own definition. I think

articular surface --



BY MR. LANIER:

Q. Ma'am, it's a simple question.

If we follow your definition, that statement could never

be true, could it?

A. No. I retract my definition in that manner then. I'm

trying to be clear about what it means. My apologies.

Q. No. No. No. We want your testimony, but we want it

consistent with what's here.

So the surface characteristics, certainly clearance seems

to be one because it's specifically set out in a chart, isn't

it?

A. Yes.

Q. It doesn't say shell-to-head ratio clearance, does it?

A. This one does not.


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Q. This is what you gave to the -- to the -- actually, this

one comes later. This is the one that you've got in your

files that you don't give the FDA, isn't it?

A. Correct.

Q. But you look at the one you gave the FDA, it doesn't say

ratio clearance, does it?

A. I'm sorry, the chart?

Q. Yes, ma'am.

A. It does not.

Q. All right. So what you're putting as the chart here, if

you continue to look, or if we continue to work through this,

you've got more info, more info, more info that this is true

and accurate and all the rest.

Then you get to the actual device description.

Do you see that?

A. Yes.

Q. Now, here's where you said we alerted them we have

changed the clearance.

That's your first bullet -- or second bullet point,

right, we've changed the clearance?

A. We've said the effective radius is the same.

Q. Does not say you changed the clearance, does it?

A. It does not.

Q. And if we continue to look, even under "modifications,"

does it say that you've modified the clearance?


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A. The modification identified under this 510(k) was the

change --



THE WITNESS: From the 28 to the 36.

BY MR. LANIER:

Q. Ma'am, we've got to get through this fast, please.

Does it say you modified, changed, the clearance?

A. No.

Q. Left it out, didn't you?

A. Not left out in the way that's being suggested.

Q. Ma'am, it's not listed as one of the modifications that

was made, is it?

A. Because the similarity --



BY MR. LANIER:

Q. Ma'am, I'm not asking what the FDA might have been able

to figure out if they had had privy to all that y'all had

done.

I'm asking what they got from you that spells it out.

You do not put in here "We changed the clearance," that

critical imperative that must be tightly controlled.

Doesn't say it, does it?

A. It does not say change clearance.


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Q. And then if we go to the next page, the summary of design

control activities, here's the next one where you said the

acceptance criteria points out the change.

Do you see that?

A. Yes.

Q. The acceptance criteria does not anywhere say we changed

the clearance, does it?

A. Right. I wasn't highlighting this to indicate change in

clearance, only the --



BY MR. LANIER:

Q. Ma'am, it's a simple question.

The acceptance criteria does not anywhere say that you

changed the clearance, does it?

A. It does not.

Q. In fact, what we have here are verification tests. And

the claim that is made by you when you signed and verified

this is, "Test results are on file and available for review at

DePuy."

A. Yes.

Q. The truth of the matter is y'all hadn't even finished the

test, had you?

A. We were referring, as you would see in all of our project

documentation, to the testing for the equivalent surface


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articular devices, the Ultima and the 36 one-piece.

Q. Actually, ma'am, what this says is, "The design

verification tests that were performed as a result of . . .

are listed below"?

A. Yes.

Q. That y'all tested it. Testing of the 36-millimeter inner

diameter shell assembled with the mating.

That doesn't say you tested the one-piece, does it?

A. It does not say that.

Q. So you're saying that that is either false or this

(indicating) is false because you had not finished the test

yet, had you?

A. This particular -- the following Ultamet test, no.

Q. So when y'all told the FDA that we've put the Ultamet

together, we've performed the test, it wears equivalent to or

less than 28, the results are on file, they're available for

review, that's all false --

MR. QUATTLEBAUM: Object --

BY MR. LANIER:

Q. -- isn't it?



BY MR. LANIER:

Q. Ma'am, that's just false, isn't it?

A. I disagree.


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Q. Ma'am, you didn't have test results on file of the

Pinnacle Ultamet 36 insert. You did not have those test

results on file and available for review on November 13th, did

you?

A. The test performed references the 36-millimeter inner

diameter with a 36 head, which we did in fact have.

Q. No, ma'am. Y'all had the one-piece --

A. Which --

Q. -- test.

A. Yes.

Q. That's not what you're trying to get clearance on.

This is not about showing that the one-piece worked.

This is about showing that the Ultamet worked, isn't it?

A. Yes.

Q. And you did not perform a test on the Ultima

36-millimeter liner -- I mean inner diameter shell assembled

with a mating 36-millimeter.

MR. QUATTLEBAUM: Objection, Your Honor, I

apologize --

THE COURT: I'm sorry. Mr. Lanier said Ultima. I'm

sure he meant Ultamet.

MR. LANIER: Yes. Let me reask that, please.

THE COURT: Okay.

BY MR. LANIER:

Q. Ma'am, no tests had been performed with results on file


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and available for review that tested a 36-millimeter inner

diameter Ultamet shell assembled with the mating 36-millimeter

cobalt chrome femoral head. No such test had been finished,

had it?

A. A test meeting that --



-- requirement exists.

BY MR. LANIER:

Q. Ma'am, please answer my question. There wasn't one?

A. For the 36-millimeter Ultamet, no.

Q. Which is what this whole thing is about.

This is not trying to get approval of the one-piece where

these two are combined into one -- it's not trying to get okay

of a one-piece, it's?

A. It is not.

Q. It's trying to get okay of a two-piece?

A. Correct.

Q. The two-piece is different than the one-piece, isn't it?

A. Yes.

Q. It's got even some differences beyond being just -- I

mean, y'all didn't just take the Ultamet liner and stick it in

the shell in the factory and ship it out as one piece?

There are other differences, aren't there?

A. Other differences between the 28 and the 36?


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Q. No. Other differences between this Pinnacle liner and

what you had done tests on, the one-piece.

A. The back side is different, yes.

Q. Yeah. So the bottom line is there had been no wear

testing of the Ultamet liner with test results on file, had

there?

A. I'm sorry, Mr. Lanier, I don't know how to answer your

question. I believe we've met the requirement here, and

you've interpreted it differently. I'm not sure how to

respond.

Q. No, ma'am. It's simple. You're saying, oh, it's okay,

the FDA would have known we were talking about a different

device that we had already filed with them instead of this one

because we did our test on a different device. They would

have understood that.

And I -- I know that that's your position, but that's not

my question.

My question is: You've never done the test on this

device with the results on file, had you?

MR. QUATTLEBAUM: Objection, Your Honor, same

objection as -- as before with regard to Buckman, 402, 403,

and 404.


THE WITNESS: Sir, if the -- if the question is was

the testing done on the Ultamet device prior to this


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submission, no.

BY MR. LANIER:

Q. You have an IDE device that is a one-piece IDE device

that is different. Correct?

A. Yes.

Q. And you have -- and that's already under submission to

the FDA or -- or at least under an IDE being looked at, right?

A. That's correct.

Q. Already before FDA.

But then you've got this brand-new device that you're

trying to get approval for. Right?

A. Yes.

Q. So you're trying to get FDA approval for a 36-millimeter

not one-piece but two-piece Pinnacle device, right?

A. Yes.

Q. And you had no test results on file for that. Correct?

A. Correct.

Q. And if the FDA had been given the test results instead of

saying they're on file and available for review -- if y'all

had actually given 'em to 'em, you'd have had to just give

them test results from a whole different piece of equipment,

wouldn't you?



THE WITNESS: That is the test we would have given


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them, yes.

BY MR. LANIER:

Q. But they have got no way of knowing that based on what

you understand from this reading.

This doesn't say asterisk; it was a different device.

Does it?

A. It does not.

Q. If we continue to look at this, then you tell us, oh, we

told them in the drawings.

And so we've got these drawings. Right?

A. Yes.

Q. Okay. I put the arrow up here.

Where does it say what the radius is?

I'll zoom in.

A. That's --

Q. Not radius, excuse me.

Where does it say what the clearance will be between the

ball and the liner, this critical stuff, clearance? Where

does it say that?

A. It's not on this drawing. The clearance relies on the

mating part as well.

Q. I'm sorry?

A. The clearance relies on information from two different

drawings.

Q. Okay. Which drawing do we need for the information?


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A. So the other -- the corresponding part would be the

femoral head.

Q. Okay. Where is it in here?

A. The list of those relative parts is Exhibit 1, page 12.

Q. Page --

A. Oh, I'm sorry. I'm sorry.

Q. This is page 13.

A. It's further -- it -- the list of mating femoral heads is

Exhibit 2 on page 25.

Q. Page 25. So we can get Exhibit 2, page 25.

Okay. Now, where does it show us what the clearance is?

A. So this provides the K number which would have the

associated engineering drawings --

Q. Wait. Wait. Wait. Are you saying that what you did is

you told the FDA what the radius is and then the FDA could go

to another page to find out what the ball number is, could go

into their files and pull the file for the ball and then rifle

through that to try to find what the measurement is for the

ball and then do the math to figure out what the clearance

would be between the ball and the liner if you can work out

the math after having to chase down the ball that is given by

a file number when there's not even any reference or warning

that you need to do it?

Is that what you're saying?

A. What I'm saying is that information is available. We


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were not hiding the change --



THE WITNESS: -- were not hiding that information.

BY MR. LANIER:

Q. Ma'am, are you saying that what the FDA had an ability to

do is look at another page y'all filed with 'em, find the

ball, find the file number, go back in the FDA archives, pull

that file number, rifle through it to find the drawings for

that one, do the math for the radius on the ball, compare it

to the radius of the liner, and then do the mathematics

necessary to compute the clearance?

Is that what you're saying they had a chance to do?

A. Yes.

Q. I mean, the truth of the matter is, ma'am, you looked at

this submission the day it went in. And you looked at it

carefully, didn't you?

A. At the time I believed I had.

Q. Not only at the time, you know it because you have

initialed it. Aren't those your initials?

A. Yes.

Q. Didn't you make this change?

A. Yes.

Q. So you affirmatively on November 13th -- you knew about

the change, and you altered the submission, didn't you?


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A. Yes.

Q. You hadn't forgotten, had you?

A. No.

Q. It's just the place where you altered the submission

happens to be one where nobody has got a clue unless they go

through that elaborate procedure that I described earlier,

right?



THE WITNESS: The description was also updated, as

we previously discussed.

BY MR. LANIER:

Q. No, ma'am. It doesn't say we changed the clearance.

That's what we previously discussed.

It doesn't, does it?

A. It accurately reflects the effective radius. So we

updated in the submission in two areas --



THE WITNESS: And missed the third.

BY MR. LANIER:

Q. Ma'am, it doesn't say you changed the clearance, does it?

A. It does not.

Q. All right. So you knew and you altered the numbers

without fixing the comparison chart?


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A. Yes.

Q. And we're supposed to think as you went through this and

signed off, not once, but time, after time, after time, after

time, after time, after time, after time that you just failed

to say, gee, I might want to fix the comparison chart?

A. That was my mistake, yes.

Q. You got to change the math, and now you want us to think

y'all changed the language earlier, and you signed off on it

as being accurate, but you made a misrepresentation to the FDA

on the critical?

MR. QUATTLEBAUM: Same objection.

THE COURT: I'm sorry?





THE WITNESS: I made a mistake, yes. Correct.

BY MR. LANIER:

Q. Ma'am, you knew about it. You talked to regulatory the

very next day, didn't you?

A. Yes.

Q. They made a mistake, too?

A. I'm not sure how that happened.

Q. This process that y'all told us about that's in writing

that Mr. Quattlebaum told us about, where you even have people


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who follow up and check to make sure things are done right and

you've got independent checkers you said, nobody caught this

mistake?

A. To be clear, the independent checkers don't review each

and every aspect. They are part of the review process, just

so that's clear.

Yes, we -- in review of the submission we made a mistake.

Q. Ma'am, you knew about this not just then, but this

continued to be an issue that you were having to deal with in

the next few days, wasn't it?

A. I'm not sure what you're referring to.

Q. Ma'am, I'm referring to the fact y'all still had a

problem over there trying to figure out what you were going to

test versus what you were selling. Right?

A. We weren't selling anything at that point.

Q. What you were going to sell.

A. Okay.

Q. By the way, when did you finally start testing what you

were selling?

Let me ask it this way: What was the clearance, assuming

y'all made the parts right, in the 36-millimeters that our

claimants, our patients, have?

What was their clearance?

A. The design specification?

Q. Yes, ma'am.


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A. 80 to 120 microns.

Q. 80 to 120?

A. Yes.

Q. Contrary to what you told the FDA, so they all got the

false one; is that right?



BY MR. LANIER:

Q. They got ones that -- based on the false information,

that had been approved on false information, correct?


THE WITNESS: Inconsistent information.


BY MR. LANIER:

Q. Here's Exhibit Number 4071. This is an email you sent

out two days later. You sent this email out on November 16th

of 2000, didn't you?

A. Yes.

Q. You sent this out about core team meeting minutes because

your entire team met on this issue, didn't it?

A. No.

Q. "Pinnacle metal-on-metal project core team meeting

minutes, November 16th."

Do I have that right?

A. Yes.


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Q. These are the attendees (indicating)?

A. Yes.

Q. You were there Leanne Turner --

A. Yes.

Q. -- correct?

Here are the notes from the meeting. Do you see that?

A. Yes.

Q. One of the things that y'all discussed at the meeting was

the change to the metal-on-metal clearance for 36, correct?

A. Yes.

Q. Here's where you said the anomalies were attributed to

problems with the pneumatic cylinder, but research and

development still recommend changing the clearance from 60 to

a hundred.

Do you see that?

A. Yes.

Q. "The current 36 at 60 will continue to run on the

simulator until a decision is made on replacement parts."

So y'all just continued to run the test on the wrong

parts -- wrong sized parts, right?

A. That's correct. As of that date.

Q. Yeah.

And my point is, ma'am, as of November 16th y'all are

still dealing with this issue, and you still know, as does

your entire team at that point that was there, about this


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problem, don't you?

MR. QUATTLEBAUM: Objection, Your Honor. I don't

know what "this problem" is referring to. We've talked about

different things.

So my objection I guess is to the vagueness of the

question.


BY MR. LANIER:

Q. Your team knows the clearance has changed from what you

told the FDA, right?

A. We believed we had at that point correctly communicated

to the FDA.

Q. Ma'am --

A. The team knew that there was a change to the design, yes.

Q. There's only one place in the FDA submission for you to

compare the clearance. The articulation requirements you said

were the same, 40 to 80 microns clearance on diameter. Do you

see that?

A. Yes.

Q. And that is the articulation requirements, correct?

A. Yes.

Q. Articulation is articular, isn't it?

A. Yes.

Q. The articulation surface requirements. And we are

talking here about the surface, aren't we?


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A. Yes.

Q. You told the FDA the articulation requirements were 40 to

80 microns, the same. And then in your sheet itself said

"same articular requirements," didn't you?

A. Yes.

Q. That's why I'm suggesting to you that that is false,

because if those articular requirements are the articular

requirements that you've listed, it's false, isn't it?



BY MR. LANIER:

Q. If the articular requirements are the articulation

requirements, then what you've told them is false, even where

you think you meant something different, right?



THE WITNESS: Yes.

BY MR. LANIER:

Q. Okay. Now, this problem continued even after November of

2000, because you also had a problem that arose in Canada,

didn't you?


Q. You don't remember the Canadian problem?

A. Can you clarify also "this problem continued"?

I'm not sure the specific problem you're referring to.


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Q. Sure. Let me give you a document that will help refresh

your memory. This is Plaintiff's Exhibit --

A. Thank you.

Q. -- 4074.

You bet.

You got 4074?

A. Yes.

Q. All right. Let's start near the back so that we get a

flow, second from the back, so we can make sense out of what

this is.

September 2001, Ann Williams, she's with Canada, right?

A. Yes.

Q. She's trying to get this Ultamet approved in Canada,

isn't she?

A. Yes.

Q. And in the process she says she has a concern.

"Claudia alludes to the fact the components have changed

recently, the drawings have been marked up. I'm trying to

determine what these changes are, when and why they occurred,

what, if any, additional information has been submitted or

prepared in terms of description, justification, testing."

Do you see that?

A. Yes.

Q. Was she talking about the changes we've been discussing?

A. Yes.


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Q. Then you answer her. You, Leanne Turner, write to her in

2001 about the Ultamet. That's the Pinnacle metal liner,

right?

A. Yes.

Q. And you said, "I'm the development engineer for the

Pinnacle metal liner, Ultamet. The changes to the drawings

have been very minor."

A. Yes.

Q. "There were some changes to tolerances and a change to

the product description on the drawing; none of these changes

warranted additional product testing or FDA submissions."

Ma'am, you don't tell her you changed the clearance, did

you?

A. No.

Q. Even though the clearance must be tightly controlled, is

imperative, and changes wear and how long the implant works.

You don't tell her that, do you?

You don't tell her that, do you?

A. I'm sorry, I'm just trying to pull up my copy of the

engineering drawing, if you don't mind.

So I think that I have misspoke in my email because I

don't see a change to tolerance on this revision, the change

to the spherical radius, so it's possible that I meant change

to clearance.

I'm just trying to -- I don't see a specific tolerance


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change on here. I think I misspoke.

Q. Ma'am, can you answer my question, please?

A. It does not say clearance, no.

Q. You don't tell her you changed the clearance, do you?

A. No, I do not.

Q. In fact, what you say here -- you don't even say it's the

way we submitted it to the FDA.

You said none of these changes warrant FDA submission, in

other words, we don't even need to tell the FDA. That's what

you said, isn't it?

A. So that would mean a submission on top of a submission

that had already been made.

Q. Right. None of the changes --

A. And there had not been a previous submission on those

particular components.

Q. Ma'am, you said none of the changes "warranted"

additional FDA submissions. That's what you said, isn't it?

A. Right. But there was --

Q. We get a glimpse here into -- I'm sorry to interrupt you,

ma'am. I apologize. That's rude, but part of this process,

so please excuse me.

We get a glimpse into your mind at that moment that you

were thinking changes to tolerances, change to the product

description, you don't tell her about changing the clearance,

and you don't tell her that the changes -- you didn't -- you


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tell her I didn't think those changes warranted adding to what

we told the FDA. Right?

A. I don't think that's correct.

Q. All right. Let's be clear on one thing, and that's our

timeline here.

It's always possible that the company can say to the FDA,

FDA, we need to change something, to change what we've

submitted, we need to add to it, take away from it.

The company can say that, but the company did not,

correct?



BY MR. LANIER:

Q. In other words, y'all could have written the FDA on

Tuesday and said time-out, our chart is wrong. Time-out, we

said that it was the same articular requirements, but it's

not.

A. Had we known on the Tuesday, we would have told them.

Q. Ma'am, y'all were having meetings on Wednesday, knew the

clearance had changed from what you gave the FDA. On

Wednesday you didn't tell them, did you?

A. No. We knew that the clearance had changed. We did not

know that it was different from what had been submitted to the

FDA.



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THE WITNESS: The answer was no.

BY MR. LANIER:

Q. Ma'am, and then you get an email back from Ann Williams

who's still struggling with this.

"I have a few more clarifications/requests."

"Drawings - are any final (with new names and tolerances)

available to be sent to me. If not, are `marked up´ versions

available for all Ultamet. Claudia sent me the 28 but I don't

have any for the 36."

Ma'am, were you trying to hide something by not sending

those to her?

A. Absolutely not.

Q. Okay. Continue to chart through this email, please.

That was September 17th.

Do you see the date?

A. Yes.

Q. Then she writes you again. You have not written her as

of September 20th.

She write again, "Leanne, my confusion with this project

grows yet again. I requested test reports from Leeds, and the

only report they provided me with doesn't seem to match any of

those referenced in the 510(k)."

"Help!

"I highly suspect that if I send the submission without


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these test results the government will request them anyway.

How can I find these reports?"

Did I read that correctly?

A. Yes.

Q. And, again, you don't answer.

And so we have the next one, September 26th, "Leanne, I'd

greatly appreciate your advice regarding my previous questions

(see email below) . . . I am extremely anxious to complete

this project."

Do you see that?

A. I do.

Q. Then you do finally answer Thursday the 27th, and you

said, "Ann, the simulator test report referenced below sounds

like the correct one to me. For your information, we did not

submit this report with our 510(k) submission for

28-millimeter components," for the smaller one. "We said they

were equivalent to the Ultima product because the articular

parameters --" and there when you say it, you use the word

"clearance," don't you?

A. That's what it says there.

Q. That's what you said there, isn't it?

A. Yes.

Q. You don't say radius, you say clearance, don't you?

A. I don't list all of the articular parameters there.

Q. "Were identical. Therefore, we submitted the wear data


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for Ultima" for the 28?

A. Yes.

Q. "For the 36-millimeter components we claimed equivalents

to the 28 Ultamet with the only change being inner dimensions

diameter."

Doesn't say clearance, does it?

A. No.

Q. Left it out, didn't you?

A. That is not the way I would say it.

Q. Well, it isn't in there, is it?

I mean, that's a change, right?

A. It would have been a change whether the change was to --

if the clearance was the same or different, by your definition

it would have been a change.

Q. "We referenced 36-millimeter one-piece metal-on-metal

wear data --" of course, nowhere in the submission do you say

that's what you're referencing, do you?

A. We say "data on file."

Q. Right. It doesn't say that it's data for a different

device, do you?

A. It does not specify, no.

Q. Then you get the email back, where she says, "Hi, Leanne,

Now that our recall has calmed down a bit, I'm looking again

to clear up any remaining inquiries on this never ending

project!


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"I still have not had any luck tracking down the actual

reports referenced in the 510(k).

"Is there any way to track down these reports?

Both Warsaw and Leeds are telling me they don't have them at

their facility. I'm quite certain the Canadian government

will want to see detailed reports, rather than just the

`summary´ . . ."

You never answered that, did you?

At least according to this. You just let it lie, right?

A. I don't see a response here.

Q. Now, ma'am, what you did here was something that in

itself shows a bit of a rush to market, wouldn't you agree?

A. No.

Q. I mean, y'all could have run tests on the real deal,

couldn't you?

You had the simulator. You had everything you needed,

didn't you?

A. And we did run tests.

Q. No. Before you sold it and submitted to the FDA. Before

you submitted it to the FDA, you could have run a wear test on

the real deal, couldn't you?

A. We could have.

Q. And you did not?

A. We did not.

Q. You started one, but the one you started you didn't


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finish. Correct?

A. Correct.

Q. And the one you started wound up having the wrong

dimensions anyway, because you had to change the clearance?

Right?

A. Correct.

Q. So y'all went ahead and submitted to the FDA without

having tested the real deal and without having -- I mean,

making a -- a critical change Friday before you submitted.

Correct?

A. I'm sorry. Could you repeat the full question?

Q. Yes, ma'am.

Y'all submitted to the FDA without ever having tested to

completion the real deal and making a critical change Friday

before the Monday submission. Correct?



THE WITNESS: Correct.

BY MR. LANIER:

Q. And you did it because you did have an internal time that

had been set out. There was a calendar of when y'all were

expected to submit, wasn't there?

A. That's not why.

Q. There was an internal calendar, wasn't there?

A. There was a project plan, yes.


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Q. And you could certainly have said, time out, we need to

stop the submission and hold back, we've got a major change

we're making, and we have not had a chance to really test this

product yet. You could have said that, didn't -- couldn't

you?

A. We could have.

Q. But you did not, did you?

A. No.

Q. Instead, y'all continued to market because y'all were

trying to get to that slide with bags of money.

A. So we did not continue to market. The regulatory

submission is not -- did not coincide with releasing the

product to the market.

Q. I'm sorry. Say that again.

A. The regulatory submission did not coincide with the

release of the product to the market.

Q. No. You got permission to release a month later, in

December of 2000?

A. Yes and that still is in advance of when we marketed the

product.

Q. But you still had not finished your test results.

A. When we received clearance?

Q. Right.

A. Correct.

Q. You didn't tell that to the FDA. You told the FDA test


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results are on file --


BY MR. LANIER:

Q. Right?


THE WITNESS: Yes.

BY MR. LANIER:

Q. But we know because of this presentation that you're

looking at -- If we just go back a couple of slides from what

we're looking at there -- go back to page 261 -- this came

about in a big meeting that was held, final design review,

February 23rd, 2001.

This is one where you're there, Mr. Ekdahl that the jury

has met, and others, correct?

A. Yes. So do I have a copy of that?

Q. Yes, ma'am. This is the one you were testifying about

with him, so I've got the copy he gave me. This is 253, it

was like a hundred -- couple hundred pages.

This is the one with your bags of money slide, remember?

I was just backing up. If it helps, I'll put it up here

extra big so you can see it.

A. I'm not sure extra big helps, but I'll try to --

Q. I think this is a set. Maybe he just pulled it out on

the slide and didn't pass it up to you.

The test requirement was met with historical testing on


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the Ultima, that's the 28 inch -- or 28-millimeter Ultima,

right?

Y'all were all being told you didn't have to wait for the

end result because you had already gotten approval by saying

data on file, correct?

A. We weren't saying that we didn't need it for submission

to FDA. What that says --

I'm sorry. Would you mind putting that back up?

Q. I apologize, ma'am. In other words, y'all were saying we

don't have to finish the wear test we're doing. We've already

gotten approval to release the product?

A. Okay. So that is not what that says.

Q. "Completion of wear test indicated on the project plan is

not a requirement for releasing product."

A. Yes. The project plan and the regulatory submission are

not the same thing.

Q. Okay. If you'll look, you'll see what the plan is in the

slides.

Final project review, do you see that?

A. Yes.

Q. And it includes the final review of the project plan.

Do you see that?

A. Yes.

Q. Then if you look at the next one, release. Regulatory

approval. You had already gotten regulatory approval?


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A. Yes.

Q. So there wasn't a need at that point to wait for the test

results. You had gotten regulatory approval, and thanks to

people on both sides of the ocean, y'all are ready to move

towards bags of money. Right?

A. No.

Q. Now, let's try to finish this area up here pretty

quickly.

Y'all got caught, found out, in trouble, with the FDA

because of the next link in the chain, correct?

A. No.



BY MR. LANIER:

Q. When I say this link in the chain, y'all were using this

510(k) process to get your approval, right?

A. Yes.

Q. And here's the way it went.

You just had to say that something was substantially

equivalent in safety and effectiveness to another product,

correct?

A. Yes.

Q. So here's the 510(k) chain.

Your company got, first, approval of the 28-millimeter

Pinnacle metal-on-metal, right?


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That's our first link in the chain, 28-millimeter

Pinnacle metal-on-metal. Correct?

A. That's probably not the first link in the chain, but

we'll see where the chain goes.

Q. The chain has got links going -- You're right. The chain

has got links going back before it, all the way back a long

way in time.

But let's pick up with the first Pinnacle link in the

chain. All right?

A. All right. Yes.

Q. And then the next Pinnacle link in the chain is the

Pinnacle 36, which is the one that y'all said was

substantially equivalent, even though it had the clearance

issues you didn't alert anybody to, right?

It was linked to 28. Right?

A. I will agree that it was linked to 28.

Q. And then off of the Pinnacle is where y'all were coming

with another link, and this was ASR, the recalled product,

right?

A. My understanding is that it was a product that I was not

involved in that submission.

Q. Well, the ASR submission said we're just like the

Pinnacle, and the Pinnacle had said they were just like the

28.

A. Substantially equivalent.


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Q. Yep. The problem arose because of the clearance

difference in ASR.

See, y'all had told the -- let's -- let's -- let's do

here in highlighted yellow. This is the story to the FDA.

This is what y'all told the FDA. Okay?

Do you follow me?

A. Yes.

Q. All right. So FDA is told -- FDA is told that the

Pinnacle metal-on-metal has a clearance of what?

A. 40 to 80 microns.

Q. And the FDA is told that the Pinnacle has a clearance of

40 to 80 as well, right?

A. One of the things they were told, yes.

Q. Now, if we've done that as the -- what's told the FDA,

let's add to our chart here what the truth is. Okay?



BY MR. LANIER:

Q. Do you follow what I mean?

A. Yes.

Q. All right. So here under "truth" the clearance of the

Pinnacle 28 is in fact 40 to 80, isn't it?

A. Yes.

Q. But the truth of the matter is the clearance for the

Pinnacle 36 is much higher. It's 80 to 120, correct?


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A. That is the correct clearance. I wouldn't characterize

it as much higher.

Q. Ma'am, that's two times higher than the low. The low to

low is twice, right?

A. My measure comes from --



BY MR. LANIER:

Q. Ma'am, simple math, low-to-low is twice as much?

A. Yes.

Q. Then the ASR?

A. Not quite twice for the nominal. Twice on just the low

end.

Q. The ASR -- Look at what y'all told the FDA your clearance

was for the ASR. It's on page 10. You'll be able to see on

the chart on page 10 because the FDA has got a question.

The FDA questions on page 10 the following: They said

"The clearances and tolerances" -- See, they use that word

"clearances" like you did in your email. -- "change from 100

to 170." But Pinnacle is just 39 to 60.

So when y'all made the claim that ASR is the same as

Pinnacle, and you made that claim that the ASR -- you showed

it to be 100 to 170, then, of course, the FDA said, whoa, time

out, we've got a problem here, there's a big difference

between those two.


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And that's when y'all had to write the FDA and fix what

you had done, correct?

Do you see that, ma'am?

A. I'm sorry? On page --

Q. This is where y'all had to write the FDA and explain that

y'all had given them the wrong stats?

A. Yes.

Q. You said, ah, we were wrong, turns out Pinnacle is 80 to

120, not what we had previously told you. Right?

A. Yes.

Q. And that's where y'all did the "oops." Right?

A. Yes.

Q. And it's within that framework that the FDA writes the

letter that you were looking at earlier, isn't it?

A. Yes.

Q. And so now the FDA writes a letter -- and then

demonstrative 3122, the FOIA, it's on page 11 -- but the FDA

writes a letter to y'all and says the following, In your

application for the 36 liners, the comparison chart that you

have to file, Exhibit 4, says that the 28 and 36 have

identical diametrical clearances of 40 to 80. However, DePuy

has now told us on the ASR table that the 36 liners actually

have a clearance of 80 to 120. So we called DePuy to clarify

the clearance. DePuy discovered the chart in Exhibit 4 is

incorrect. According to engineering drawings, 36 has 80 to


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120.

"The sponsor has submitted this add-to-file to correct

the mistake."

This is, what, five years later?

A. Yes.

Q. Been selling these things for five years?

A. Yes.

Q. "According to current practices the diametrical clearance

of a system" -- Can you read that?

A. ". . .cannot be changed --"

Q. "-- without clinical data."

That means without testing it in people, doesn't it?

A. Yes.

Q. Doesn't mean without testing another device. It means

without testing that device in people, correct?

A. Actually, having not authored this I can't speak

definitively that that was their intent.

Q. "Given this new information, the Pinnacle 36 would not

have been cleared in 2000."

A. That's what they say.

Q. "However, after searching the Medical Device Reporting

Program for adverse events associated with Pinnacle 36, there

were only 5 adverse events reported."

Do you know what those five events were?

A. Only to the extent that they are referenced in this


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document.

Q. All right. If -- if as I ask you questions you need

them, I've got them with copies.

Let's keep going.

Three were for failure of the liner and shell to line up

appropriately. One was a patient revised due to pain. And

one gave no details. It was actually a split package.

All right?

Over the same period of time the comparable Sulzer

metal-on-metal had 25 adverse events, Zimmer had three

regarding the 28 and three on their head, so during -- Of

course, Sulzer, that's a small one, that's a 28 as well, isn't

it?

A. Yes.

Q. Therefore, during the same period, the 36 Pinnacle system

had a reasonable number of adverse events reported. So the

sponsor will not need to submit a new 510(k) based on the new

information.

In other words, it looks like it's working okay. We'll

let that be the clinical data. That's kind of what it says,

right?

Right?

A. Yes. Based on this document.

Q. Now, your company actually had dozens of adverse event

reports at this point in time that they had not told the FDA


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about on the Pinnacle 36 metal-on-metal liner. Did you know

that?



BY MR. LANIER:

Q. Did you know, for example -- here's Plaintiff's Exhibit

4117, this is in a DePuy complaint database, April 20th,

2004, over a year earlier. It's got the record number.

Territory 217.

"Painful right hip, metallosis on the head, check for

wear. Examination of the returned product could not confirm

the complaint. Exact root cause for this event could not be

firmly established. However, information provided with the

complaint suggests the patient may have experienced an

allergic reaction to the metal. Based on the investigation,

this is the first complaint of this type against either

product code and as such the need for corrective action has

not been indicated."

And it's got the actual complaint itself as opposed to

the way the company construes the data.

MR. QUATTLEBAUM: Object to hearsay, Your Honor.

BY MR. LANIER:

Q. Do you see this?


BY MR. LANIER:


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Q. Do you see this, ma'am?

A. Oh, I'm sorry. You moved it before -- I'm not sure

where --

Q. Oh, I'm sorry. That's because I'm trying to get through

a bunch of these. I'll put it back up there if you see

something and I need to.

I just -- I'm making the point here's a complaint that

wasn't included that the FDA did not know about. Do you see?

MR. QUATTLEBAUM: Same Buckman objection, Your

Honor.


THE WITNESS: Right. So my understanding from the

FDA's correspondence is that they were looking at MDRs, which

is separate from the complaint report system.

BY MR. LANIER:

Q. Well, an MDR is what you do -- what the company files

when the company gets a complaint.

A. No.

Q. The company files a medical device report, correct?

A. Not for every complaint, no.

Q. Ma'am, look at the ones that the company filed. They

came out of the complaint database export.

Let me show you one that the company filed that's

included. I'll give you Plaintiff's Exhibit 4110.

This is the one where the company didn't give the reason


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when they filed the report.

4110, same thing, complaint database export.

This is another one. This is just one where the box's --

outer blister was cracked in the box, so there may be a

problem in the packaging, for example.

Do you see that?

A. Yes.

Q. Okay. That's one that was reported off of the same

complaint database.

Here's another one. Misalignment. Plaintiff's Exhibit

Number 4106. Same database, it's just the company turned in

this report timely.

Do you see 4106, another complaint database?

This is one where the metal insert was locked into the

shell off-axis and could not be removed, February of '03.

MR. QUATTLEBAUM: Objection to hearsay.

BY MR. LANIER:

Q. Do you see that?


THE WITNESS: I see that.

BY MR. LANIER:

Q. Okay. So we've got these complaints, five of which had

been turned into medical device reports, but dozens of which

are not.

A. There are specific criteria around what the FDA expects


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for medical device reports and not all complaints are

specified to be MDR reported.

Q. Ma'am, you don't -- I mean, you don't think that a

metallosis complaint is supposed to be reported to the FDA?

A. I -- this is the first I've seen this. I was not part of

the --

Q. The --

A. -- decision making for if that's submitted, so I'm afraid

it's difficult for me to answer your question.

Q. Ma'am, it's saying MDRs, Medical Device Reporting Program

for adverse events associated with the Pinnacle.

Surely metallosis is an adverse event, isn't it?

A. I don't know under this what the -- what the definitions

that were used in terms of that determination.

Q. Ma'am, you understand the company had dislocations that

were not reported, infection revisions that were not reported,

more dislocation revisions not reported, more, more, seating

and proper seating not reported?

I mean, it goes on and on and on and on.

MR. QUATTLEBAUM: Objection --

BY MR. LANIER:

Q. Did you know that?

MR. QUATTLEBAUM: Objection, Your Honor, hearsay,

the Buckman objections, and lack of foundation.



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BY MR. LANIER:

Q. Ma'am, if there are 46 complaints with 11 revisions for

the Pinnacle 36 inch (sic) Ultamet, do you think maybe the

company when it got this might have said to the FDA, actually,

we've got more than five, we're sitting on about 40 some odd

that we haven't turned in yet?

MR. QUATTLEBAUM: Same Buckman objection.


THE WITNESS: You're comparing apples and oranges.

BY MR. LANIER:

Q. Ma'am, I'm comparing --

A. Medical device reports to complaints are not the same

thing.

Q. Ma'am, I'm comparing adverse events. These are adverse

events in the --

A. And MDRs are --



BY MR. LANIER:

Q. Ma'am, you can't interrupt me. Okay?

A. I apologize.

Q. I've interrupted you all day. You're due a few free of

these. Okay. I'm just telling you she can't type us both at

the same time.

Adverse events, the company is sitting on a boatload of


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'em. Did you know that?

A. I did not.

Q. Okay. One last thing before we move on.

Your work that year and a half was very commendable with

the company, wasn't it?

A. I'm sorry?

Q. You did a good job.

You did a good job with the company?

A. I like to think so.

Q. You got some bonuses for the way you handled all of this

on the FDA clearances, didn't you?

A. I don't think I got a bonus for that specific reason.

Q. Well, what you -- I'm handing you a copy of the -- your

personnel file.

I was looking at 2001, 12/23 of 2001. Looks like you got

a $5,000 bonus as part of the -- you got -- you won the J&J

achievement award. And you got that for your work on the

Pinnacle cup project, didn't you?

A. Yes.

Q. In addition to that, you got another $3,000 that year in

a bonus for another J&J achievement award, this one -- oops.

This one just in general for Pinnacle. Correct?

A. Yes.

Q. And if we look at your review file from December of 2000

when the approval and work came in, you were specifically


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lauded -- this is page 77 of that -- for the way you were able

to balance the art of persuasion with your follow-up required

to confirm that milestones are met.

You kept the project on schedule, didn't you?

A. Yes.

Q. In fact, while you said you were offended by the

suggestion there was a rush to market, that's part of what you

got those bonuses for, isn't it?

A. No.

Q. This is January 2002, the month after the bonuses, when

you get your evaluation. "A challenge with this project was a

final piece of wear data was being established by the Leeds

research group while the components were moving into the

production environment. Leanne found herself in the very

delicate situation of needing to manage the results of the

wear testing with delivering the product to the shelf to allow

for an on-time product introduction. Leanne worked very hard

to keep all members of the project core team focused on the

common goal of balancing on-time delivery with making sure the

supporting research was in place.

"The resulting outcome of this dynamic ultimately meant

delaying the introduction of the product into the marketplace,

but the delay did not have an adverse effect on the sales

performance over the course of the year."

That was your praise, wasn't it?


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A. Yes.

Q. All right. Next subject. Before the break -- and I'm

going back to this to make sure we pull the right things for

you later today, or in the morning.

But before the break you testified to this jury that you

were not involved in aSphere, that head that had the little

bit shaved off. Remember?

A. I was not part of the development team.

Q. "I was not involved with the actual review of aSphere or

any of the development."

And I asked: Did you have anything to do with the

engineering or the aSphere at all -- anything to do with

engineering or the aSphere at all while you were at DePuy?

"I did not."

Do you see that?

A. Yes.

Q. The reason I was asking is because of a document that we

have from the files, Plaintiff's Exhibit 325, where the

worldwide hip business team was meeting around the aSphere

time. And in this meeting you'll see on the second page

strategic priorities, and the strategic priorities then go to

project reviews.

You said you had nothing to do with aSphere at all, but

it shows you on the aSphere head dealing with design

solutions, working around intellectual property; continued to


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move through design verification and validation; 510(k) in

process; with a planned launch.

Is this just a typo?

A. I can honestly say I don't recall this.

Q. Because, I mean, you can see why it would make someone

think you maybe had something to do with aSphere, can't you?

A. I can certainly see that.

Q. All right. Next. You testified yesterday that Johnson &

Johnson is a distinct company from DePuy. Correct?

A. Yes.

Q. But I'd like to talk to you about the real role of

Johnson & Johnson, because Johnson & Johnson is actually

closely involved in the DePuy things, aren't they?

A. I would imagine that -- depends on how you define

"close."

Q. All right. Well, before you testify that they were

separate entities that seem to have nothing to do with each

other, did you take into account Plaintiff's Exhibit 521,

where Johnson & Johnson actually approves marketing the

36-millimeter head even after all of the things you and I went

through this morning?

Do you see the Johnson & Johnson opinion, Plaintiff's

521?

A. Yes.

Q. It's Johnson & Johnson that grants the market clearance


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for the 36-millimeter femoral heads, isn't it?

MR. QUATTLEBAUM: Excuse me, Your Honor.

BY MR. LANIER:

Q. Do you see?

A. I'm sorry, I just need a moment to review this.

MR. QUATTLEBAUM: Your Honor, may we approach on

this document? It has a particular issue.

THE COURT: You can't make your objection?

MR. QUATTLEBAUM: Well, it's attorney-client

privilege -- it's marked attorney-client privilege, so that's

the reason I wanted to approach.

THE COURT: Well, let me see it.

(Pause.)

THE COURT: Okay. I've seen it.

Okay. Make your objection.

Can you make your objection?

MR. QUATTLEBAUM: Yes, Your Honor. Our objection is

that this is apparently an attorney-client privileged document

that was probably inadvertently released, and she has no

personal knowledge of this document, I assume, because there's

no reference to her on it.

THE COURT: What's your response?

MR. LANIER: Your Honor, first of all, this has been

on our exhibit list for a long, long time. If it's an

inadvertent production, then certainly it should have been


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noted and there should have been a claw back or a request like

that.

Number two, this is not an attorney-client privilege

issue in this case in terms of what this lawsuit is about or

anything close. This is just the approval that comes out from

Johnson & Johnson's legal department for DePuy.

For it to be an attorney-client privilege would include

the fact that they've got to admit on the record that

Johnson & Johnson does all of their legal work and are the

lawyers for DePuy, which itself is -- is something.

But the process --

THE COURT: Well, let me stop you. Well, if it's

fits about this, that's not very good for the record.

MR. LANIER: I'm sorry, judge.

THE COURT: We will deal with this when we take

a break.

MR. LANIER: Okay.

THE COURT: Okay.

MR. LANIER: I'll move on to something --

THE COURT: Just come back to it in a little bit.

MR. LANIER: Got it, Your Honor. Got it. Thank

you, judge.

BY MR. LANIER:

Q. All right. Ma'am, Johnson & Johnson owns the web site

hipreplacement.com which is used by DePuy to funnel business


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to various DePuy-approved surgeons. Did you know that?

A. I was not aware of the owner.

Q. I'll show you document demonstrative 3851, the results

for hipreplacement.com, it's a registered domain of Johnson &

Johnson.

Do you see that?

A. I do.

MR. QUATTLEBAUM: Objection, Your Honor, no personal

knowledge and hearsay.


BY MR. LANIER:

Q. YouTube. You're familiar with YouTube?

A. Yes.

Q. You got kids, you got to be familiar with YouTube, right?

Johnson & Johnson has its own YouTube channel or section.

Are you familiar with that?

A. Yes.

Q. And the YouTube Johnson & Johnson section, demonstrative

3847, is an actual Johnson & Johnson video that has video --

or YouTube site that has videos about health, family, and

social responsibility.

Do you see that?

A. I see that.

Q. And that Johnson & Johnson web site on YouTube has all of

these DePuy patient testimonials about total hip replacement


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and how well it works, including this fellow who rode his

bicycle 512 miles after a hip replacement. Did you know about

these?

MR. QUATTLEBAUM: Objection to the hearsay, Your

Honor, and to 403 and 402.


THE WITNESS: I was not aware of these.

BY MR. LANIER:

Q. I mean, that puts Captain Peterson to shame. 512 miles.

Hear from John, an avid cyclist who returned to his active

lifestyle after a double hip replacement. Empowered by his

two DePuy Pinnacle hips John was able to continue.

Bonnie's journey with her golfing and traveling.

Alvin's journey.

Michelle's journey.

Coach K.

All of these are on the Johnson & Johnson web site. Did

you know that?

A. No.

Q. When you said Johnson & Johnson is a distinct company,

had you considered how they have all of these different videos

for DePuy on Johnson & Johnson's YouTube station?

A. Still separate companies.

Q. Well, ma'am, are you considering though the way Johnson &

Johnson reached into the DePuy company and orchestrated events


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for DePuy, not simply through advertising but others as well?

MR. QUATTLEBAUM: Objection, assumes facts not in

evidence, Your Honor.


THE WITNESS: I'm sorry. The question again,

please?

BY MR. LANIER:

Q. Yes, are you familiar -- Well, let's do, for example. In

2006, there was this big webcast with 1,500 surgeons from the

U.S. and Canada tuned in, and it was introduced by none other

than the CEO of Johnson & Johnson before Dr. Schmalzried and

Graham Isaac and others started talking about how useful

metal-on-metal is.

Do you know about this?

A. No.

MR. LANIER: Juan, if we could have that ready to

play, please.

My team, what's the exhibit number on the video? 122,

Your Honor -- 121, Your Honor, for the record.

THE COURT: Okay.

MR. LANIER: And can we turn down the lights?

(Video playing.)

MR. LANIER: Pause this for a moment.

BY MR. LANIER:

Q. Now, this gentleman who is talking is actually the Graham


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Isaac who wrote the End Game memo, isn't he?

A. Yes.

Q. He's going to talk here about fluid film lubrication.

You understand that for most of the cycle the DePuy Pinnacle

metal-on-metal works in the mix or boundary lubrication

regime, right?

A. I know the lubrication varies throughout the cycle. I'm

not sure -- I can't speak to what percentage. I'm sorry.

Q. The gentleman who started this launch -- the gentleman

who started this launch was the CEO of Johnson & Johnson,

wasn't he?

A. Opened the session, yes.

Q. Yes, ma'am.

The doctor we saw up there if we were going to listen for

an hour -- Dr. Schmalzried, Graham Isaac, Dr. Andy Engh -- a

lot of people up there who get a lot of royalty money off of

those products, aren't there?

A. They receive royalties on those products -- on

metal-on-metal products, yes.

Q. All right. If we continue to look at the Johnson &

Johnson involvement, Johnson & Johnson would step in if they

thought there was an issue with the media and the way the

media was handling DePuy's Pinnacle metal-on-metal hips,

wouldn't it?

A. I believe that depending -- we had some corporate


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communications. So a particular department might report up

through a different area.

Q. Well, on document number 595, we see a letter from

Johnson & Johnson to CBS television because there had been

some question about the direct-to-consumer advertising by

Pinnacle -- by DePuy, correct?

A. That's what it says.

Q. The letter says "Dear Ms. Allio, As regulatory counsel

for DePuy, I'm writing in regards to a direct-to-consumer

advertisement entitled `Never Stop Moving 60 Seconds.' Please

not that direct-to-consumer advertisements for medical devices

are not required to be sent to the FDA for preclearance. I

have reviewed this advertisement and believe that it meets the

regulatory requirements for advertisements for medical

devices."

Do you see that?

A. I see that.

Q. So the advertisements are being reviewed and being

approved by Johnson & Johnson, aren't they?

A. That's what the letterhead says. I'm not sure about the

reporting structure for the individual who wrote this.

Q. Ma'am, you can see the signatory on it, Marlene Tandy,

assistant general counsel, Johnson & Johnson. Do you see

that?

A. Johnson & Johnson Services, Inc.


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Q. Yes, ma'am.

Then she goes on -- she talks about the knee. I'm going

to skip through the knee part and get to the hip part.

"DePuy Orthopaedics commercially distributes a hip

implant with the lowest reported wear and friction from

movement as measured by ion levels in blood."

And we could fuss about this if you want to later. I

don't want you to think I agree with that, but regardless,

it's a claim that's being made by the Johnson & Johnson lawyer

on behalf of DePuy, isn't it?

A. Yes.

Q. "This hip implant, the metal Pinnacle hip bearing, uses

TrueGlide technology, which refers to exclusive design and

manufacturing tolerances including optimized clearance."

And here y'all claim optimized clearance to be between 80

and 120, correct?

A. Yes.

Q. She says, "These features allow the hip bearing to

achieve a state of natural lubrication."

Do you see that?

A. I see that.

Q. Now, ma'am, you know for a fact that the lubrication is

not all that is claimed -- it -- it is not full fluid

lubrication throughout the cycle, walking cycle, correct?

A. That's my understanding.


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Q. Now also, DePuy itself, every package that DePuy ever

has, DePuy, a Johnson & Johnson company, correct?

A. Yes.

Q. In fact, it's well-known and your company has made it a

point to trade off the strength of the Johnson & Johnson name.

Isn't that true?

A. I'm afraid I can't speak to that.

Q. Johnson & Johnson has approved as well the 99.9 percent

claim from the PIN study. You're familiar with that study I

know. Did you know Johnson & Johnson approved that?

A. I'm not aware of any of the approval process for that.

Q. Did you know that Johnson & Johnson's CEO was actually

involved in monitoring and keeping track of the aSphere head

that Margaret Aoki has and how it was coming out on the

market?

Did you know about that?

A. I have not.

Q. I showed you the document, Plaintiff's Exhibit 496.

The jury has seen other documents but not this one

dealing with aSphere. So we'll put it into context.

"Team" -- This is Paul Berman. "Midyear sales meetings will

mark the official launch of aSphere metal bearings. Michael

Rhee and Polly Cary will partner with Tom Schmalzried to

deliver the power of aSphere message to all our

representatives."


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Do you see that?

A. I see that.

Q. Now, did you know Dr. Schmalzried at this point had

already quit using metal-on-metal?

A. No.

Q. It may have been 2010, but at least some of the designers

had quit as of 2009. Did you know that?

A. No.

Q. "To prepare for this official launch, our partners in

operations have stretched their capacity to double the aSphere

supply commitment in 2009. They're ready to deliver as much

demand as we can create over the next 24 months.

"With growing price pressure and lingering questions

about metal debris and ions, we must strike fast and hard with

this launch to sustain our metal bearing surfaces growth and

capture maximum unit growth and market share."

Boy, it sure seems like he's hurrying this to market?

A. In 2009?

Q. Yes, ma'am.

A. I'm failing to see the connection of our earlier rush to

market in 2001 to 2009.

Q. Oh, I think the theme would be that it was constant.

Each time you had a new product, you wanted to get it out as

quickly as you could, didn't you?

A. I can't speak to that. I was not involved in this.


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Q. All right. "To capture maximum unit growth and market

share. To this end, the bearings team has developed the

attached price and targeting strategy document to help your

teams expedite." That means make it faster, right?

A. Yes.

Q. -- "adoption. This document clearly articulates where

you should fight for price and where it is appropriate to

match price to the older head."

Do you see that?

A. I see that.

Q. "This is a strategy to help remove barriers and speed the

process."

Here are the targets: "First, competitive metal bearings

users." Those are your competition, try to get their

customers, right?

A. Yes.

Q. "Or current metal customers who are concerned about ions

and wear.

"Or current metal customers who are interested and

willing to pay extra for new technology.

Do you see that?

A. I see that.

Q. This is sent by Paul Berman to the president of the

company, Alex Gorsky. "Alex, as a follow-up to our hip

discussion in Warsaw" -- And when I say president of the


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company, Johnson & Johnson, right?

Right?

A. Yes, he was. Yes.

Q. All right. So head of marketing for hips sends this to

the president of Johnson & Johnson on the pricing and

targeting strategy for aSphere?

"Alex, as a follow-up to our hip discussion in Warsaw,

below is an update on our new aSphere metal bearing launch.

I've also attached a supporting aSphere print ad that will run

in July in key trade journals."

The president writes back, "Thanks, Paul . . . I'll

review and let you know if I have any comments."

A. I'm sorry. If I can correct one thing.

In this time frame I'm -- I'm not aware of what Alex

Gorsky's position was in the organization at that time.

Q. He's president today, isn't he?

A. Not president, I don't believe.

Q. What is he today? CEO?

A. I think that's correct.

Q. Chairman -- chief executive -- He's the top, the top of

big momma company Johnson & Johnson, right?

A. Yes.

Q. So you don't know if he was the president at the time or

where he was on that track, but he's clearly Johnson &

Johnson. He's not DePuy?


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A. Not DePuy.

Q. Do you know about --

MR. LANIER: Your Honor, I'm going to move on from

Johnson & Johnson to another subject matter.

THE COURT: You can go back to this other one. I've

done some research on it.

MR. LANIER: Okay.

THE COURT: Overrule your objection.

BY MR. LANIER:

Q. Ma'am, with that, Johnson & Johnson was approving a lot

of different stuff, weren't they?

Let's go back. We'll do some documents now. I'm handing

you Plaintiff's Exhibit 517. Here we see Johnson & Johnson

approving the Pinnacle survival poster presentation that was

at least by our allegations false.

Do you see it?

Final approval?

A. I see that.

Q. Marlene Tandy. She has to give the approval and the

sign-off. She's with Johnson & Johnson, correct?

A. I believe it is Johnson & Johnson Services, Inc., was on

her previous --

Q. Yes, ma'am. Part of the legal team there, right?

A. Yes.

Q. The design rationale booklet that you testified you had


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involvement with, Plaintiff's Exhibit 57, do you recall that?

A. Yes.

Q. Had to be approved by Johnson & Johnson lawyer, Marlene

Tandy, didn't it?

Plaintiff's Exhibit 467.

A. Yes.

Q. This is the design rationale for the Pinnacle booklet.

Johnson & Johnson had to give approval for the aSphere

design rationale as well, didn't it?

Plaintiff's Exhibit 518. ASphere design rationale.

First signature. First approval. Do you see that?

A. I see that.

Q. Johnson & Johnson had to approve an email with the Coach

K ad. The jury has seen Plaintiff's Exhibit 45 --

A. Thank you.

Q. -- which is the Coach K ad. Let me give you the cover

and that page. That is Plaintiff's Exhibit 3860.

Marlene Dawn -- "Please take a look at the revised ad and

give me your approval or changes by email, Marlene Tandy,

Johnson & Johnson." Correct?

A. Johnson & Johnson Services, yes.

Q. In fact, there's a little edit that's made on here.

This "Pinnacle has a 99.9 percent survivorship at five

years," we know that's bogus, don't we?

A. I don't agree with that.


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Q. Ma'am, you know they're referencing the PIN study, don't

you?

A. Yes.

Q. And, ma'am, the PIN study only dealt with the cups. It

didn't deal with the entire system, did it?

A. My understanding of the PIN study is that it incorporated

multiple bearings.

Q. I'm sorry. I can't hear you.

A. I thought in the full PIN study that there were different

bearings.

Q. Yes, there is, ma'am.

My point is the 99.9 percent survivorship, that was based

on only on survivorship of the cup.

A. The Pinnacle as highlighted, yes.

Q. In other words, you can't sit there next to the picture

of the ball, the liner, and the shell -- You can't sit there

in the paragraph talking about TrueGlide technology which

optimizes the clearance between the ball and the liner and say

you've got 99.9 percent survivorship because even if that

study were correct, it's only talking about the shell, not the

liner, not the ball, right? At 99.9 percent.

A. Yes. My understanding is that applies to the shell.

Q. Yeah. By the way, when this got approval somehow from

Ms. Tandy. Coach K doesn't even have a Pinnacle hip, does he?

A. That, I don't know.


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Q. Well, he got his first hip in the 1990s from DePuy,

late'90s. Didn't have Pinnacle then --

MR. QUATTLEBAUM: Object to the lack of personal

knowledge, Your Honor.

THE COURT: I don't know if she knows or not.

Overruled.

BY MR. LANIER:

Q. You know, the evidence is already out there for the jury

that his first hip implant was in the end of the '90s.

A. Okay.

Q. Couldn't be Pinnacle, could it?

A. That would not be Pinnacle.

Q. And then his second one, the documents say it wasn't

Pinnacle in I think 2001 or '2. You don't know one way or the

other, do you?

A. I don't know.

Q. But we've got J&J editing this ad. Do you see that?

A. Marlene Tandy, yes.

Q. We've got J&J, Marlene Tandy, also approving another

advertisement.

I'm handing you Plaintiff's Exhibit 520. This is the

Floyd hip patient story where Marlene Tandy says it's okay

with her. Do you see that?

A. I'm sorry. I was looking at this. I missed the first

part of your question.


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Q. Yes. Do you see that on the Floyd hip patient story

Marlene Tandy with J&J also says it's okay with her, assistant

counsel Johnson & Johnson. Do you see that?

A. I see that.

Q. Doesn't even say Johnson & Johnson services this time,

does it?

A. It does not.

Q. And if you look to see what they're talking about,

they're talking about misusing that 99.9 percent again, aren't

they?

MR. QUATTLEBAUM: Objection, mischaracterization.


BY MR. LANIER:

Q. "Hello! I know you're probably about to kill us all, but

could you change our favorite sentence a little? It still

doesn't read well. How about: `One study conducted since the

device was approved in 2002 observed that an estimated 99.9

percent of Pinnacle hip components remain in use."

Do you see that?

A. I see that.

Q. When in fact the 99.9 percent, even if it's true, only

deals with cup survival, not ball or liner components. Right?

A. That's my understanding.

Q. And yet it is Johnson & Johnson who among -- is one of

the parties saying it's okay, go ahead and make that


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representation that way.

Do you see that?

THE COURT: All right. Take a break. Take a break.

Take 15 minutes. Thank y'all.





Okay. Are you ready?

MR. LANIER: Yes, sir.

THE COURT: Have you got plenty of colored pens?

MR. LANIER: Running a little low on one, but I've

got it covered. I've got a little extra in my --

THE COURT: I've got one or two up here.

(Laughter)

Bring them in.


THE COURT: Y'all be seated.

Thank y'all.

Go ahead, Mr. Lanier.

MR. LANIER: Thank you, Your Honor.

CROSS EXAMINATION (Cont.)

BY MR. LANIER:

Q. Johnson & Johnson had to sign-off on the letters that

DePuy wanted to send out to doctors concerning hip issues,


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didn't they?

A. I'm sorry, I'm not familiar with this document.

Q. This is specifically those surgeon consultants that you

were saying you worked with closely. Email from Paul Berman

to Marlene Tandy at Johnson & Johnson about inputs on an email

for surgeon consultants.

"Marlene and Janet, Randy, Mindy and I have developed

the below email, intended only for DePuy hip consultants.

This will provide additional context and position the ASR

decision --" that's the ASR recall you worked on. Remember?

A. I worked on the reimbursement program.

Q. Yeah.

"-- in the appropriate positive light with our

consultants. Please read through and let us know your comfort

level before this is sent to our DePuy consultants."

So we're getting comfort level before this action by

Johnson & Johnson, correct?

A. That's what this says.

Q. And this is the letter where they urged the consultants

to start using Pinnacle metal-on-metal and aSphere since ASR

seemed to be going away, correct?

A. That I don't know. I haven't read this.

Q. You can at least look at it right now and see that.

"DePuy continues to advocate metal bearing technology,

particularly the new aSphere, which provides an 80 percent


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reduction in wear debris, 77 percent reduction in metal ions

versus the Ultamet."

Do you see that?

A. I see that.

Q. And "Pinnacle Ultamet bearings durability, wear

resistance, reduced risk of location." Then they quote that

PIN study again.

"Free of component revision after five years." Well,

now you know that's false. It's not component revision, is

it?

A. I'm afraid I'm not familiar with the details of that

study.

Q. I'm having a lot of trouble hearing you, ma'am.

A. I'm sorry. I don't know the details of -- I don't know

the details of that.

Q. Well, ma'am, you were on the original PIN study email,

weren't you?

A. I was part of early discussions, yes.

Q. Okay. All right. And you just got out of the equation

at some point?

A. Yes.

Q. Johnson & Johnson dealt with the push back from the

Journal of Bone and Joint Surgery issues on the 99.9 percent

poster. Did you know about that?

A. Don't know anything about that, sir.


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Q. By the way, you understand Dr. Plouhar has already

testified that this poster was inaccurate. Did you know that?

A. I'm not familiar with her testimony, no.

Q. You didn't read it before you took the stand?

A. I did not.

Q. Here's a response that Marlene Tandy has okayed as

assistant general counsel for Johnson & Johnson -- by the way,

she's a medical doctor as well as a lawyer. Do you see that?

A. That is what is here, yes.

Q. Do you know her?

A. I do know her.

Q. Did you know that about her?

A. I'm not sure if I ever knew it. I didn't recall. I

didn't remember that.

Q. "Following DePuy's response to your letter about the

Pinnacle ad that appeared in the JBJS on the 99.9 percent

survivorship, please see the attached reference." And they

cite the poster.

Do you see that?

A. I see that.

Q. Again, Johnson & Johnson signed off on any number of

different things, the Pinnacle brochure, or a number of

Pinnacle brochures. Do you know about that?

A. I would need to see the documentation. I'm not sure.

Q. All right. Well, I -- let's move on in this real role of


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Johnson & Johnson.

DePuy would also trade upon the Johnson & Johnson name

and reputation. I asked you that earlier. Did you know about

anything about that?

A. I'm sorry, "trade upon"?

Q. Yes. It was a reality, Plaintiff's Exhibit 400, DePuy, a

Johnson & Johnson company. Like we're seeing at the bottom of

all of those letters, right?

A. Yes.

Q. "Our own realities, September 2008."

Do you have this?

A. I have it in front of me, yes.

Q. If you'll look on page 22.

"J&J is an attractive organization to work for."

Do you see that?

A. I see that written here.

Q. The company, DePuy people, this is DePuy's realities.

DePuy is working for J&J, aren't they?

A. I'm not sure what this document is. If I just see people

insights, I don't know that that's referring to DePuy or --

I'm not sure what that's referring to.

Q. Well, ma'am, "The Department of Justice agreement is

putting more strain on resources."

That was that deferred prosecution agreement that you've

testified about, correct?


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Where you were having to go through and justify paying

doctors and things like that. Remember?

A. I was just checking the time frame of this.

Q. 2008.

A. I bet that's probably a fair assumption.

Q. If you'll continue to look, on page 24 -- 22, 23, 24,

"Our own realities, here are our strengths.

"The strength of DePuy as a company is being part of

Johnson & Johnson, because they can get that -- they can trade

on the brand and the corporate identity and the trust, the

reputation for quality, competence and ethical behavior, the

reach and continuity around the world, financial strength and

resources, recruiting the best, the overall J&J portfolio."

Those are all strengths that the company would trade upon

or rely upon. Fair?

A. That's what's written here. Again, I don't have any idea

who this was intended for or what the context is.

Q. Well, ma'am, in September of 2008 you worked for DePuy,

didn't you?

A. I did.

Q. Weren't you then part of that business intrigue --

business insight? What was it called?

A. Business intelligence?

Q. Yes. Business intelligence.

A. In 2008, no.


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Q. That was 2009 you made the switch?

A. Yes.

Q. All right. And then you, yourself, even won the

Johnson & Johnson award, didn't you?

A. Yes.

Q. For your work on the Pinnacle metal-on-metal. Right?

A. No.

Q. It was for something else?

A. If you can be specific about the award, I can be specific

about what it was for.

Q. Okay. I've shown you Plaintiff's Exhibit 797. This is

the DePuy's Joint News that y'all were putting out for a

while. Remember?

You got the big thing on page 4 with Pinnacle acetabular

cup survivorship. And we got this, Johnson medals awarded to

three DePuy Orthopaedics scientists.

"Award recognizes research and development excellence

within Johnson & Johnson."

Do you see that?

A. I see that.

Q. But you worked for DePuy, didn't you?

A. I did.

Q. But you got awarded the award for excellence for those

people who are within Johnson & Johnson. Right?

A. That's what it says.


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Q. It says, "At the 28th annual award ceremony, held

November 7, 2005, six outstanding Johnson & Johnson

researchers were presented with their medals by Christine

Poon, named in honor of Robert Wood Johnson. The prize is

conferred upon those scientists whose extraordinary creativity

have opened significant new doors for J&J products. Three

scientists from DePuy Orthopaedics have been awarded Johnson

medals for their innovative work in the development of the

Pinnacle acetabular cup system," you, Leanne Turner.

"Along with the 2005 winners, a total of 219 scientists

have received the corporation's most prestigious award."

Do you see that?

A. I see that.

Q. Now, ma'am, while Johnson & Johnson may have different

articles of incorporation that you testified to, the role of

Johnson & Johnson on the Pinnacle is intimately involved

whether on video talking about metal-on-metal, writing news

companies about metal-on-metal, giving away awards on

metal-on-metal, approving studies.

All of these things have Johnson & Johnson involved.

Fair?

A. One -- one correction to that.

Q. Okay. Which one?

A. The Johnson medal was for the Pinnacle.

Q. Right. But it was awarded by Johnson & Johnson.


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A. It was.

Q. That's my point.

So Johnson & Johnson picks?

A. I'm sorry?

Q. It was awarded by Johnson & Johnson, wasn't it?

A. It was.

Q. All right. Next subject. I want to talk to you about

testing. You gave a good bit of testimony about testing

earlier today and yesterday, and I'd like to clarify a couple

of things if we can. Okay?

A. Okay.

Q. First of all, you pointed out the company was doing

testing. I think we even had Mr. Quattlebaum's timeline. And

I only got a copy of yesterday's. I don't have the

new-fangled one. But you remember this?

A. Yes.

Q. And on here we're reading about testing. We have --

where do we have testing?

Oh, testing one-piece implants, one-piece IDE. Do you

see those?

A. Yes.

Q. The Ultima. Right?

A. Yes.

Q. What I'm looking for on here is the Pinnacle

metal-on-metal test. Where is it?


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A. It's not written on here.

Q. Okay. When did it start?

A. I'm afraid I would need you to be more specific. There

have been numerous metal-metal tests.

Q. When was the clinical study for Pinnacle metal-on-metal,

where they put the Pinnacle metal-on-metal device in people

and studied it?

A. So I would say the start of that was with probably the

surgeons who followed their patients early with the PIN study.

Q. So we don't have it until after it's being sold?

A. Correct.

Q. And if we do look at the studies that were being done on

other metal products, which would be the Ultima, the

one-piece, those are the two that were being done; is that

right?

A. The two done, yes, within DePuy.

Q. Yes. Or Johnson & Johnson. Either one. Right?

A. Yes.

Q. All right. So with those, those studies were not really

being done to measure the biological effects of the debris on

any kind of even a medium term basis, correct?

A. That was not the purpose of the study, correct.

Q. Right.

So the purpose of those studies is not to measure the

biological effects, right?


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A. Correct.

Q. The purpose of those studies is just to see what the wear

amounts are to see if they can be sold and if they'll function

in the body, right?

A. No.

Q. You understand that the issue back then -- or one of the

key issues is whether or not the metal debris would prove to

be toxic to the body?

A. Yes, that was one concern.

Q. I mean, we -- I don't think anybody has ever suggested

y'all didn't do a test. I think the suggestion has been made

you never did the right test on the right product to see how

it would affect people's health. That's the assertion we've

made, do you understand that?

A. I understand the assertion.

Q. Okay. So where before the product was sold was there a

test on the DePuy Pinnacle metal-on-metal, or any other

metal-on-metal product of DePuy, that was targeting whether or

not it would hurt people's health?

A. Oh, I do -- I do think that that is incorporated in the

IDE studies. There's not a specific purpose of the test that

requires biologic effects, but the studies themselves are

outcome studies with a comparator device, so I would say that

very much incorporates -- incorporates patients' health.

Q. No, ma'am. Even those, if you look, for example, at the


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IDE study, the one-piece IDE, that's the one that you claim to

be basically the same as the Pinnacle, just one piece instead

of two?

A. We claim equivalence, yes, to the articulation.

Q. All right. But, ma'am, that study didn't even start

until 2000, did it?

A. Correct.

Q. So how are you going to get, let's say, five-year results

before you start selling the DePuy Pinnacle metal-on-metal in

2001 for a study that you start in 2000? You can't do it, can

you?

A. We had some information. We had information from

other sources.



BY MR. LANIER:

Q. Go ahead.

A. I'm sorry, could you please repeat your question?

Q. I said how could you get five-year results if you've only

been starting the study a few months before you start selling

the Pinnacle metal-on-metal hip?

A. We cannot get five-year results.

Q. So if we want to look at the truth behind the testing,

can we agree that there was some simulator testing that was

done? You talked about that with the jury, right?


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A. Yes.

Q. Showed them the video, correct?

A. Yes.

Q. But that simulator was using the wrong clearance, wasn't

it?

A. It depends on which test you're speaking of.

Q. I'm talking about the ones that were done before you

started selling the Pinnacle metal-on-metal 36-millimeter

liner.

A. So that is incorrect.

Q. All right. So you were using simulator studies with the

right clearance that were finished before you started selling

the metal-on-metal liner?

A. I believe that's correct.

Q. You realize that's contrary to everything you've

testified to up to this point?

Did you find something over the break?

A. I think we've had an ongoing disagreement about the

difference between testing and articulation and the actual

part. I'm speaking of the 36-millimeter metal-on-metal

articulation clearance with the testing with the clearances

that are covered by the product.

Q. Ma'am, I'm talking -- let's be real clear.

A. Okay.

Q. I'm talking about the Ultamet, also known as the Pinnacle


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metal liner.

A. Yes.

Q. Now, are you telling me that you had simulator studies

that were done with the right clearance before you went to

market?

On the Pinnacle metal liner, the Ultamet.

A. Yes. So I would need to review the exact report. I

believe that is correct.

Q. Okay. You realize that's not what you testified to

earlier today?

A. I believe the question you asked --

Q. Before the break.

A. I believe what I was asked before the break was if we had

the testing before the regulatory submission, not before we

sold the product.

Q. So you think that you had testing done with the right

clearance before you sold the product, just not before you got

approval. Is that what you're saying?

A. Yes.

Q. We'll add "before approval," and what is the test result

you think you had before you sold the product?

A. We had a test report clearly with the 36-millimeter

Ultamet product prior to -- we had that data prior to the

release of that product.

Q. And we know that simulators are best-case scenario for


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wear, according to the email at least from Frank Chan. That's

the yikes email, right?

A. Yes. According to his email.

Q. Now, in addition to that you talked about clinical

studies. The clinical studies, so that we're clear, you were

going to market or not from simulator studies, not from

clinical, correct?

A. I think the more correct way to say that is from not

Ultamet clinical but not from no clinical. We believed we did

have clinical information.

Q. Well, actually not for the Ultamet liner?

A. Right. That's -- I'm sorry. That's where I was trying

to clarify.

Q. Yeah. Ma'am that's what I'm trying to qualify here.

In other words, y'all are selling a liner that you

haven't tested in people, and you don't alert folks that are

taking that into their body, hey, we've never tested this in

people until you came along.

You're not telling that to people, are you?

A. We don't say that to anybody about any product.

Q. Okay. Ultima. You stopped the Ultima test once you got

510 clearance, didn't you?

A. The Ultima test?

Q. I mean the Ultima clinical study. You stopped it once

you got 510(k) clearance because you didn't need it anymore,


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right?

A. The study -- the final report wasn't until 2002. So I

would have to verify -- I believe the study accrual period was

over. That data was submitted as part of the 510(k).

Q. Yes. And once you got approval you quit the study?

A. This study --

Q. All I'm driving at, y'all were just doing these studies

to get the product approved. You weren't doing these studies

to figure out what was going on with the people?

A. That's not true.

Q. You didn't do 10-year, 15-year follow-ups to that Ultima

study, did you?

A. To the Ultima study?

Q. To the Ultima study, did you do 10- and 15-year reports?

A. Oh, I'm not aware if there have been 10- and 15-year

reports.

Q. The study stopped once y'all got clearance from the FDA,

true?

A. We continued to follow those patients. So we did not

accrue any new patients to the study, but the study itself did

not stop.

Q. And then those studies, again, limited numbers and a

limited time. You don't have long-term results, right?

A. Correct.

Q. And it is -- Ultima is a different product. True?


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A. Yes.

Q. The IDE study, too little, too late. Do you agree?

A. No.

Q. You start the IDE study in the year 2000.

Ma'am --

A. Sir, if you -- are you speaking about one-piece now

versus Ultima?

Q. Yes. The one-piece IDE study. Ultima is not the

one-piece IDE.

A. No. But I thought we were -- I'm sorry. I'm having

trouble following you.

Q. No. No. No. That's fine. Then this is why we -- we --

Let me be clear.

The one-piece IDE study, too little, too late. Would you

agree?

A. No.

Q. It doesn't even start until 2000, does it?

A. The IDE study, correct.

Q. There's no way you're even going to have one-year data at

the time you start selling Pinnacle Ultamet, is there?

A. For some patients.

Q. For some patients.

Not very many.

I mean, one-year data is not -- You understand these hips

fail in years 5, 6, 7, generally, right?


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MR. QUATTLEBAUM: Objection, Your Honor, lack of

evidence in the record.


THE WITNESS: Yeah, I can't say.

BY MR. LANIER:

Q. Ma'am, you've seen the U.K. registry results, haven't

you?

A. Yes.

Q. You've -- you know that's when these things really start

failing in mass, don't you?

A. No.

MR. QUATTLEBAUM: Objection, Your Honor. Lack of

evidence in the record.


BY MR. LANIER:

Q. The IDE study is also different because it gave a real

warning to the people who were getting those metal hips,

didn't it?

A. I'm not sure what you mean by that.

Q. Well --

A. And, I'm sorry -- May I ask a clarifying question?

Q. Sure.

A. So we talk about Ultima and then we talk about the IDE,

but the 2000 date is for the one-piece, not for the Ultima IDE

which was started in 1997.


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Q. That's what I was talking about here, ma'am, is the

one-piece. Let me add that on it.

A. Okay.

Q. All right.

You had to give a real warning because the FDA was

looking over that, correct?

A. I wouldn't say that's the reason we gave warnings.

Warnings are given with all products.

Q. Well, ma'am, we're going to compare the warnings in a

little bit that y'all were giving with the IDE the very same

year you're giving warnings in the Pinnacle metal-on-metal,

and we'll compare the two.

Will you be stunned to find out the IDE warning is a

whole lot more inconclusive?

A. No.

Q. None of this is the toxicity testing that you all knew

would be a problem with ions and debris, is it?

A. No, I don't agree with that.

Q. I think this predates you. Going back to the meeting --

The jury has seen this. I think you have as well --

Plaintiff's Exhibit 667. This is a meeting where the

discussions were being held about the idea of a

metal-on-metal. Frank Bono talked about how the lubrication

is so important with hard metal-on-metal contact.

And then on page 2 we read from Dr. Peters, "We need to


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be cautious of the legal/litigation issues, lawyers, et

cetera . . . perception of metal debris and metal ion

release."

"Toxicity/ion release is a fact of metals. Didn't see

lymphatic tumors with Farrar, but these issues must be

addressed."

Do you see that?

A. I see that.

Q. Now, ma'am, there's no way that the toxicity issue was

being addressed by the one-piece IDE study that's the

equivalent of the Pinnacle 36-millimeter metal-on-metal,

because it doesn't have time to do it before you start

selling, does it?

A. May I have just a moment to read these notes?

Q. Sure. But, I mean, it's pretty simple. There's no time

to check toxicity in a test that's going on for at most a

year.

A. I'm sorry. I'm missing the quote on here that you just

said specifically relating to the toxicity.

Q. Which one are you missing?

A. The very last one that you highlighted.

Q. From Dr. Peters.

Dr. Peters says --

A. I see. So I think --

Q. "Toxicity/ion release, a fact with metals."


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A. Yes.

Q. "Saw no lymphatic tumors with Farrar." That's a

different kind of old metal-on-metal hip.

A. Yes.

Q. "But these matters need to be addressed."

Do you see that?

A. Yes.

Q. Here's the question: There's no way those toxicity

issues are being addressed by this one-piece study or Ultamet

because there's simply not enough time to get definitive

answers. Agreed?

A. Not to the ones you've pointed out here.

Q. What do you mean?

A. I -- I believe that his concerns were broad about

metal-on-metal devices, and so a narrow view of what would

have been available with just the one-piece IDE study, and

Ultamet when it was launched is not inconclusive of the

information available regarding metal-on-metal implants for

ion release and toxicity.



BY MR. LANIER:

Q. Ma'am, the question I asked you was real simple. I said

the one-piece IDE study could not have delivered toxicity

information to those who were going to get Pinnacle


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metal-on-metals because there wasn't enough time by the time

you started selling, correct?

A. For that study, yes.

Q. Yeah. That was my question. Now you want to say, oh,

but we could have gotten it from other products, or studies,

right?

A. I'm saying there is more information about the topic than

that single study.

Q. Actually, the information that's out there continues to

say that there are problems with metal debris and concerns.

Those questions were not answered, were they?

A. It continued to be a question I think depending on your

source. I'm not sure I would characterize it as a problem so

much as a -- something that was continuing to be investigated.

Q. Well, ma'am, yes, that's true. Maybe the people selling

it didn't call it a problem, but in terms of the rest of the

scientific world, and even internally within your own

documents, y'all continue to say it's a problem.

A. We all continued to say it's something that should be

investigated.

Q. Exactly.

So the answers aren't there, are they?

A. Not all of the answers.

Q. And we can look at the published literature on DePuy

metal-on-metal testing, how many of these are the Ultamet 36


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millimeter on page 1?

A. Without seeing these studies, I'm afraid I can't tell you

which product is which.

Q. Ma'am, these are the ones that y'all put up there, not

me.

This was your exhibit.

A. About DePuy metal-on-metal testing?

Q. Did you not look at these before you put them up there?

A. I've seen them. I -- I apologize. I've read many

studies.

Q. Okay. Ma'am --

A. For me to know off the top of my head, it's just

difficult.

Q. I'm just assuming before you testified to this with the

jury with three pages real fast, acting like y'all had done

all of this testing, you would be able to tell us which in

fact were the tests done on the product at issue in this case

instead of something else.

Can you tell us that?

A. This covers a lot of metal-on-metal testing --



BY MR. LANIER:

Q. Can you tell us that, ma'am?

A. On quick glance of this, I would need to see the reports


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to tell you.

Q. In other words, you don't know. Is that what -- if these

are even the ones in our case.

A. I would need to review these studies. I'm sorry. By

title alone I can't tell you which the individual products

were.

Q. Okay. But I'm -- You do understand this is your slide.

These are the studies you brought us in this case.

A. Yes.

Q. But we don't know that these studies were about the

product in this case.

A. Yes, there are studies about the product in this case --

Q. Which ones?

A. -- on that list.

Q. All of them?

A. Not all of them.

Q. Now, there was a study that I just handed you a moment

ago that you were on the list for that the jury has seen, and

that is this Pinnacle study that wound up producing the

poster. That's a seeding study though, isn't it?

A. I don't know what that means.

Q. That means the purpose of the study isn't really to get

results; the purpose of the study is to get people to buy the

implants.

A. Okay. So I disagree with that.


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Q. Did you see the financial analysis on this study?

A. Yes.

Q. It's going to cost us $345,000 to do it, but the sales

revenue estimate is 4.2 million.

Net/net, good thing.

Do you see that?

A. I see what it says.

Q. Makes money and gets the hips out there, doesn't it?

A. Not the purpose of the study.

Q. Ma'am, did you see the -- even the Mayo Clinic's IRB --

The jury got to see this document earlier -- the Mayo Clinic's

Institutional Review Board said they wouldn't approve this

study because it's just a marketing ploy?

A. I don't have knowledge of that. I'm sorry.

Q. You're on this email list, aren't you?

Aren't you the Leanne Turner on this?

A. Yes.

Q. You didn't know that this study that you were being

filled in on was being rejected by an IRB because it's just a

sales study?

MR. QUATTLEBAUM: Objection, Your Honor. That

misstates the facts.

MR. LANIER: No, it doesn't.

MR. QUATTLEBAUM: I understand the Mayo Clinic

issue, but that wasn't in 2000.


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BY MR. LANIER:

Q. Did you know that, ma'am?

A. No. I was involved in early planning and discussions of

what the study would look like.

Q. All right. One other thing while I'm asking you about

all of this metal-on-metal testing. I asked you which are

Pinnacle. You don't know.

Which of these are 36-millimeter, the same size as

Pinnacle?

Are they at least all the same size?

A. I suspect there's a combination of 36-millimeter and

28-millimeter on this list.

Q. So they're not all the same size as this case either.

Pinnacle? Size?

How about clearance? Are all of these the same clearance

as what you ultimately had in this case, not what y'all had

planned on for years ahead of time?

A. I believe some of these studies specifically look at

different clearances.

Q. So which ones are at the right clearance is my question.

A. I would need to review these studies to be able to

effectively answer your questions, Mr. Lanier.

Q. Okay. In other words, you don't know?

A. Off the top of my head, I do not know.


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Q. Now, if we look at your final reports on Ultima, for

example, the final report did not show any revisions.

Remember you showed us that yesterday?

I think it was page 22. Ultima, no revisions.

A. Yes.

Q. Do you see that?

A. Yes.

Q. I mean based on this, Ultima is a safer device than

DePuy's Pinnacle metal-on-metal, too.

A. I'm afraid I don't understand your meaning.

Q. But you sure can't say that about the DePuy Pinnacle, can

you?

A. I'm afraid I don't understand.

Q. Ma'am, if you're really saying that y'all don't have any

divisions on Ultima, then Ultima is a safer device than what

y'all were selling these people.

A. Oh, what I testified to was no revisions at this time

period in the IDE study.

Q. Well, yeah, but 60 months, no revisions, that's five

years.

If there are no revisions in five years, that's a heck of

a lot better product than what y'all were selling in Pinnacle,

isn't it?

A. No.

Q. Yes, ma'am. You would get revisions in five years in


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Pinnacle.

A. You're comparing apples and oranges here.

Q. No. All I'm doing is pointing out that y'all were

comparing apples and oranges, because that's what this is.

These are apples to oranges, aren't they?

A. I disagree with your comparison here.

Q. Ma'am, it's not my comparison. It's y'all's.

Y'all said that based upon this you knew that Pinnacle

would be safe, because you didn't have any revisions in five

years.

And I'm saying to you, if you can really make the

comparison here of apples to apples, then what we learn from

this is Pinnacle stinks, Ultima is really good.

A. I think if you want to make that comparison then you

would need to limit -- you would need to have comparative

patient populations and study controls the same as the IDE for

Pinnacle.

Q. Thank you.

Which is the very reason that the comparison y'all were

making that said, oh, we knew it was safe because of this

Ultima study, has got to be thrown away.

A. So those were not my words. My words --

Q. No. They were what was left --

A. -- were that --

Q. Excuse me, ma'am.


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If that impression was left, then you will be quick to

say, no, apples and oranges, you can't compare the two.

Right?

A. May I tell you what I believe my testimony yesterday was

that this study gave us confidence that given the other

comparisons we would see good, positive clinical results with

Ultima, it was not based on zero revisions.

Q. Ma'am, what you told us yesterday, what you told us

today, is that you could even determine if there were

biological problems from that Ultima study that would do with

Pinnacle, and yet when I say do you really want to say

these -- that Ultima and Pinnacle are comparable, you're quick

to say, no, they're not, apples and oranges.

A. The apples and oranges is comparing one clinical dataset

to a different clinical dataset.

Q. Exactly. You just can't do it.

I mean, you understand, y'all put this up yesterday.

Y'all highlighted that line.

Mr. Quattlebaum had you answer the question about no

revisions.

A. Yes.

Q. And you did not say to him, Mr. Quattlebaum, not really

relevant, that's apples to oranges, we can't compare that, we

can't use that to say Pinnacle is going to work well.

You didn't say that to him, did you?


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A. So I think we're talking about two different things.



BY MR. LANIER:

Q. Ma'am, answer the question.

You didn't say that to him, did you?

A. I did not.

Q. IDE, the one-piece study. Same thing. Y'all turned up

the results and you showed no revisions after, what was it, a

few years? Right?

A. Yes.

Q. Does that mean that the IDE one-piece is a much better

device than Pinnacle and we've got another safer alternative

design, just use the one-piece instead of the Pinnacle; is

that what you're saying?

A. No.

Q. You understand the jury is going to be asked a question

about whether or not the product, Pinnacle metal-on-metal, was

defective, and part of what we have to show the jury is that

there was a safer alternative design.

We think the metal-on-poly is the cleanest example of a

safer alternative design, but maybe it's the Ultima. Maybe

it's the IDE one-piece. Are you saying that they were safer?

MR. QUATTLEBAUM: Object to the argument, Your

Honor.


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THE WITNESS: I believe all of them to be safe.

BY MR. LANIER:

Q. Safer, ma'am, was the question.

Can you answer the question, please?

A. I don't have enough information to answer that question.

Q. All right. So the IDE study results don't answer that

question either in your mind, do they?

That was Exhibit 361, page 24, where you and

Mr. Quattlebaum put this up and said, look, in that limited

IDE study there were no revisions. Remember?

A. Yes.

Q. Now, what y'all didn't tell the jury is this study was

being done by the guys who are going to make a royalty

interest, a cut on the Pinnacle. It's in their best interest

for that no revisions to be there, isn't it?

A. I completely disagree with that.

Q. Dr. Wasielewski, he was one, wasn't he?

A. Yes.

Q. Dr. Barrett, was he one?

Let's stick with people the jury has heard of, perhaps.

Dr. Haas, he was one, wasn't he?

A. Yes.

Q. Now, you say that the Ultima -- I mean, excuse me -- the

36-piece millimeter Ultamet insert marries up to the one-piece


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for comparative purposes, correct?

A. This shows how there are similarities for the articular

surface parameters.

Q. Yes. Because that's not what y'all gave the FDA, is it?

A. I'm sorry?

Q. Just so we're clear, for the FDA y'all said surface

finish clearance -- oops. No. No. No. I'm sorry.

Clearance, surface finish, geometry, carbon. Y'all were

comparing the Ultamet 36 to the Ultamet 28 for the FDA's

purposes, weren't you?

A. Yes.

Q. But for the jury and the world you want to say they

compare with the one-piece, then we ought to find the same

warning, shouldn't we?

A. The purpose of this --



BY MR. LANIER:

Q. We ought to find the same warning, shouldn't we?

Same carbon, cobalt, chromium, molybdenum; same geometry;

same clearance; same surface finish. Ought to get the same

warning, shouldn't it?

A. I'm sorry, between which products?

I'm not sure what you're referring to.

Q. I messed up the sheet. It looks kind of icky now. Let's


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do it this way.

THE COURT: There's this stuff called White Out.

MR. LANIER: Judge, they don't make enough for me.

BY MR. LANIER:

Q. If the Ultamet is comparable to the one-piece, as you are

claiming in this nice exhibit that y'all made for the jury, if

they have got the same material, the same geometry, the same

clearance, and the same finish, they ought to get the same

warning, shouldn't they?

A. No, not necessarily.

Q. Well, you're suggesting that they're going to have the

same wear, aren't you?

A. Similar wear, yes.

Q. So you're saying it's got the same wear. And the same

wear has the same wear debris, doesn't it?

Same type of material, right?

A. Yes.

Q. And the same wear, the same wear debris, the same body

reactions are possible, right?

A. Yes.

Q. Which says that they ought to carry the same warning,

doesn't it?

A. No.

Q. You're just saying that because y'all didn't give the

same warning, don't you agree?


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A. No.

Q. The jury saw, for example, Dr. Haas's warning.

Dr. Haas's warning is for that one-piece IDE, isn't it?

A. I'll let you know as soon as I see it.

Q. All right.

A. Thank you.

Q. You bet.

You got it?

A. Yes.

Q. All right. So here we have Dr. Haas's warning,

Plaintiff's Exhibit 3045. This is for the IDE, correct?

A. Yes.

Q. You can see on page 475 we've got a section that includes

this DePuy metal-on-metal information in the middle of the

page.

Can you find that for me?

A. Yes.

Q. "The DePuy metal-on-metal device is investigational"?

A. Yes.

Q. Y'all never told that to the people that were putting in

the DePuy, did you? That y'all were investigating how it

would work, that -- in the Pinnacle, did you?

A. I'm afraid I don't answer the question -- or don't

understand the question.

Q. All right. With the one-piece y'all are warning the


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patients that this is an investigation into its safety and

effectiveness, right?

A. Yes.

Q. You don't make any such warning when people start using

the Ultamet, do you?

A. The warnings are different between an IDE study and

the --



BY MR. LANIER:

Q. Ma'am, please answer the question.

You don't tell people that you're investigating how the

Pinnacle is going to work in them, do you?

A. I don't know how to answer that question. It wasn't an

IDE study.

Q. Right. In other words, y'all are just doing this because

you have to, FDA made you?

If you don't have to, you're not going to tell them?

A. No.

Q. The -- the jury will have a chance, I hope, to hear some

testimony in this regard from some people, but let's just

stick with this.

So investigational, you don't say that to the patients

who get a Pinnacle, do you?

A. No.


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Q. "There may be potential problems that are unknown in

addition to the known risks that are listed for any total hip

replacement."

You didn't tell that to people back in the 2000/2004

range for Pinnacle metal-on-metal, did you?

A. I think we did provide warnings. We didn't call it

investigational.

Q. Where did you provide those warnings?

A. For Ultamet?

Q. Yes, ma'am.

A. There are warnings in the IFU. There are warnings in the

technical monograph, in the surgical technique.

Q. All right. We're going to look in the technical

monograph and surgical technique in a moment.

The IFUs, just so we're clear, those are those things

that -- wrong one. Those are those things that come inside

the package, the box, right?

A. Yes.

Q. You understand that doctors don't even read those. You

know that, right?

A. I understand that's been said here. It was not my

understanding as we develop IFUs.

Q. Okay. Well, that's your doctors who've said it here,

that they don't even read them.

I mean, as a practical matter they can't read them, they


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have scrubbed up for surgery before the box is opened, right?

A. They have scrubbed up before, yes.

Q. All right. But here we've got IFUs. Here's the warning

that comes out of the actual IDE.

Then we've got the IFU warnings down here. So we'll be

looking at the warnings in the IFUs for those that went in

during the time period of the plaintiffs in this case. All

right?

A. Okay.

Q. Now, in this regard, ma'am, nothing on those that says

here are potential problems unknown in addition to known risks

for total hip replacement, is there?

A. I'm not sure. I'm having a little bit of trouble

following your poster.

Q. Well, here we've got adverse effects.

All right. Peripheral neuropathy, deep wound infection,

and heterotopic bone formation have been reported following

hip replacements. That's not distinct to metal-on-metal, do

you see that?

A. Yes.

Q. Subclinical nerve damage has also been reported more

frequently, often associated with surgical trauma. That's not

unique to metal-on-metal, is it?

A. Correct.

Q. Dislocation, subluxation resulting from improper


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positioning or muscle, fibrous tissue laxity may also occur.

As reactions have been -- as -- may also occur -- let me put

my finger down here so I can follow it.

Loosening and subsequent failure of the total hip

prosthesis. Again, that's not unique to Pinnacle -- to a

metal-on-metal, is it?

A. Correct.

Q. Histological reactions have been reported as an apparent

response to exposure to a foreign material. That's true for

any hip implant, right?

A. Yes.

Q. The actual clinical significance of these reactions is

unknown.

Okay. Implanted metal alloys, now we've got something

about metal, release metallic ions into the body. In

situation -- all right. Let's underline that so that we've

got it.

"Implanted metal alloys release metallic ions into the

bone. In situations where bone cement is not used higher ion

release due to increased surface area of a porous-coated

prosthesis is possible."

That's true regardless of metal-on-metal or

metal-on-poly, right?

A. Yes.

Q. "There have been reports of failure or bone to grow into


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porous surfaces and fix components."

That's true for both, isn't it?

A. Yes.

Q. "Shredding or fragmentation of the porous surface has

been reported with potential for release of metal debris into

the joint space."

I mean, that says metal debris, so maybe that's

metal-on-metal alone. Do you see that?

A. I see that.

Q. "Radio lucencies," that's an x-ray, right, "of bone

adjacent to porous surfaces have been noted, although the

clinical significance of this observation is uncertain in many

cases. Serious adverse effects may necessitate surgical

intervention."

Do you see that?

A. Yes.

Q. Now, with that in your brain as the 2002 to 2009 adverse

effects --

A. Can you clarify if that is -- what IFU that product

belongs to?

Q. That IFU I believe is the one that's been stipulated to

be used in this case, but we'll pull it out overnight if it's

different, okay?

A. I'm sorry, I guess my question is I'm not certain that

the same IFUs were used for the Pinnacle cup and for the metal


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liners and for the heads.

Q. All right.

A. So there could be multiple.

Q. That's fair. We'll -- we'll pull those out as well.

We're looking though for implant longevity; corrosion of

the metal components; rejection by your body of the implant

parts; cancer caused by tiny pieces of the implant breaking

down and moving about in the body; metal ions collecting in

blood, urine, or tissue, with it not known what the

unfavorable effects, if any, would be from the collection of

these; bone breakdown caused by tiny pieces of metal worn away

from the device; lack of motion or movement; an increased pain

or deformity; a lack of natural moisture in the ball and

socket.

Do you see that?

A. I see that.

Q. Now, we can look at it in terms of the IFUs, but even

beyond the IFUs we can look specifically at the brochures that

you're talking about where you said the warning was given.

Right?

A. That warnings were given.

MR. QUATTLEBAUM: Objection to warnings contained in

an IDE study that go to a patient and comparing that to

warnings that go to a surgeons. Under 403 --

THE COURT: Oh, it's a 403 objection?


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MR. QUATTLEBAUM: Yes, Your Honor.


BY MR. LANIER:

Q. Ma'am, lest anybody be thinking right now that these are

distinctions, the FDA made the company give this information

to the surgeons, correct?

A. Yes.

Q. All right. So we've got the surgeons getting it as well

as the patient getting it. Because the patient had to

sign-off on this, correct?

A. Yes.

Q. Now, in this regard, ma'am, let's look at your materials

that you say give the warning.

We'll start with the technical monograph. Okay?

A. Yes.

Q. You surely with a straight face are not going to tell

this jury that the technical monograph contains these

warnings, are you?

A. Those warnings. There are warnings in the biologic

considerations portion of the technical monograph. They may

not be called the exact same thing. I believe the elements

are covered.

Q. Ma'am, the way that whole technical monograph was written

was to try to entice people to use this product and not scare

them off.


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A. And I completely disagree with that.

Q. Ma'am, that's exactly what Andrew Goldsmith said.

Plaintiff's Exhibit 1274, "Attached is the Pinnacle

monograph with my minor comments.

"It reads fine, a good start. I think I would be tempted

to include a few more biological effects referenced in the

final version, but not so many as to scare the readers."

Did you know about this?

A. One person's opinion --

Q. No, not one person --

A. -- in an email.

Q. This is the fellow over there doing your testing for you

in Leeds. He is your tribologist, the one who is actually

doing the testing?

A. And not responsible for that portion of the technical

monograph --



BY MR. LANIER:

Q. Ma'am, I didn't send it to him and ask for his comments.

Frank Chan did?

A. Yes.

Q. Okay. That's not me, is it? Ma'am --

A. That's not you.

Q. Yeah. Look at the response. We don't talk that way. It


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doesn't say that.

"Hi, Andrew, Ought to have a meeting. Thanks kindly for

your comments and suggestions. I'll incorporate them and ask

you for more input as this evolves into the final product."

That's not I'm shunning that, is it?

A. Could you please tell me what page you're on?

Q. Yes, ma'am. That was page number 14. It's the first

email in the chain.

A. I see. Thank you.

Q. So Andrew Goldsmith starts out attaching it, says he

would be tempted to include a few more warnings, but not so

many as to scare the reader.

A. So he doesn't say more warnings. He says more

references.

Q. He says a few more of the biological effects references?

A. References, yes.

Q. Yeah. References to the biological effects, that's what

it will do to the body, right?

A. Yes. But that doesn't mean more effects. It's more

references. Those are two different things.

Q. Well, we'll see as we keep going.

What you failed to tell the jury as you talked to them

about your role in this is you failed to tell the jury about

the role of the advertising agency that was putting it

together.


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Didn't you?

A. I don't believe it came up. I commented on my

participation in the generation of the document.

Q. No, ma'am. What I'm talking about is the way y'all used

an advertising agency to cleverly word and structure this so

that it would make people have great desire to use the

product.

A. That is completely incorrect.

Q. Well, that's what it says on an email addressed to you.

You're copied on this from Frank Chan back to Andrew

Goldsmith, you and Andrew Ekdahl. "As it stands currently

with the advertising agency, we have given them some

literature to read and drafts of several sections. Overall,

the technical monograph is organized such that it leads the

reader from a broad perspective of metal-on-metal to a highly

focused view of our design rationale followed by solid

mechanical and wear data and ending with some clever

summarizing statements that would elicit great desires to use

our product . . ."

I didn't make that up. Did I?

A. No. No, but Frank says --



BY MR. LANIER:

Q. I didn't make that up, did I?


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A. No.

Q. When you say "I really disagreed with that elicit great

desires to use our product." I was quoting that word for

word, wasn't I?

A. You said that came from the advertising agency.

Q. No, ma'am. I said the advertising agency was working on

this brochure, that y'all were structuring it in such a way

where y'all were going to have the structuring and the

summarizing statements that would elicit great desires to use

the product. That comes from the email of Frank Chan, who's

putting it together, right?

A. That's what this email says.

Q. Ma'am, not only that, but you know from your work with

this that y'all put a bunch of things in there that are at

least misleading and deceptive, if not outright false, right?

A. Disagree.

Q. What?

A. I disagree.

Q. Ma'am, you got the technical monograph still in front of

you or do you need another copy?

A. I think we have it here somewhere.

Q. Here. It may be quicker if I give you another copy.

A. Thank you.

Q. I mean, you know this brochure, don't you?

A. I do.


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Q. You know where I'm going, table 9.

This is, by the way, for the Ultamet metal-on-metal

articulation. Do you see that?

A. Yes.

Q. That's exactly what we're here about, correct?

A. Yes.

Q. Table 9, wear reduction.

Let's at least read the highlighted parts. If you think

that the unhighlighted parts have anything to add to context,

tell me because I want to make sure we get this exactly right.

Okay?

"The Ultamet metal inserts" -- And that's what we're

about here -- "for the Pinnacle acetabular cup system have

been designed for optimized wear performance with respect to

the engineering issues previously outlined. Sophisticated

equipment, precision craftsmanship, extensive quality control

ensure Ultamet meet these rigorous specifications."

Talks about what they're made out of.

And then it says, "While the effects of clearance and

surface finish have been independently identified as critical

to the performance, the true wear performance is dependent on

the interaction of these two variables.

"Ultamet metal inserts maintain optimum clearances to

ensure that the bearings receive adequate lubrication for

reducing wear and friction (Graph 9)."


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Here is graph 9. Do you see it?

A. Yes.

Q. Ma'am, are you willing to admit that these datapoints on

graph 9 are not even the Ultamet?

A. These are not -- These are not the Ultamet.

Q. Yeah. That's what I'm asking you. Will you admit that,

that what y'all have said is that Ultamet metal liners

maintain optimum clearances, and you reference it to graph 9.

That's not the Ultamet. That's a lie, isn't it?

A. The reference to graph 9 is the circle that you see, the

red oval that you see, is identifying the Ultamet clearance

range. Graph 9 is the same graph that is shown as graph 3 in

the same technical monograph that is talking about the overall

engineering parameters.



BY MR. LANIER:

Q. Answer the question, please.

No gobbly gook. Just straight up and down.

These are not Ultamet dots, are they?

A. Those are not Ultamet dots.

Q. This is not diametrical clearance for the Ultamet

implant, is it?

A. That's correct.

Q. Surface roughness, is this Ultamet?


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A. The red oval represents Ultamet. The dots do not.

Q. Yes. These dots are not Ultamet, are they?

A. No.

Q. Now, ma'am, that's not the only place where y'all took

some shortcuts and liberties --

A. I disagree --

Q. -- and warnings here, is it?

A. -- that that was a shortcut and liberty.

Q. The biological issues page where you claim you're giving

the warning, do you want to go ahead and just tell the jury

what y'all took out or shall I walk through it with you?


Q. I'm referring to the fact y'all took out the stuff about

cancer, the more serious stuff about cancer. Do you remember?

A. No.

Q. Let me give you the email that you're on or referenced

in, I should say. Plaintiff's Exhibit 1274.

Do you have this email in front of you

A. I have it in front of me.

Q. This is the one from Frank Chan, who again was putting

this together with you, right?

A. Yes.

Q. "You're right, Andrew, I spoke with Andy Ekdahl about his

trip to Germany and Leeds (those marketing guys and their

budgets-unbelievable). I think you, Andy, Leanne, and myself


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can pool our respective knowledge bases on hard bearings and

compile a credible, high impact technical monograph."

Do you see that

A. I do.

Q. Originally, there are going to be biological issues that

are suggested here on page 12.

It says, "The potential benefits of improved wear

properties, less periprosthetic bone resorption and lower

revision rates with metal-on-metal bearings must be weighed

against a slight increase in risk of cancer. It is important

to notify patients about possible long-term risks of cancer

due to metallic degradation products. This should be

expressed as a range of both relative and absolute risk.

Current evidence is compatible with a very small increase in

relative risk, but uncertainty remains, and these risks are

currently unknown."

Do you see that in the email chain, ma'am?

A. I do.

Q. But the decision was made not to put that in the

biological issues, to take it out. Wasn't it?

A. That specific language I believe is not included in the

final.

Q. In fact, we can see -- this is in that same chain that I

gave you earlier where it talked about clever summarizing

statements that would elicit great desires to use our product


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and that we need to do this in a way not to drive the reader

off. Right?

Same chain.

A. I see where it says that.

Q. Ma'am, y'all took out the language on cancer, didn't you?

A. There's different language on cancer.

Q. Yeah. Let's compare it.

Where's the language on cancer for you?

This highlighted area?

A. Yes.

Q. "From the standpoint of carcinogenicity" -- causing

cancer -- "the available epidemiological data does not appear

to demonstrate an increase in cancer risk."

Huh. That seems a little different than what it

originally said where it said "It is important to notify

patients about long-term risk of cancer due to metal

degradation products. This should be expressed as a range of

both relative and absolute risk."

Look at this, "Current evidence is compatible with a very

small increase in relative risks."

Do you know what "is compatible" means?

A. Yes.

Q. It means that there's evidence, current evidence, is

consistent with a very small increase in risk. Doesn't it?

A. This is -- I'm not sure --


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A. -- what citation for this is.

BY MR. LANIER:

Q. Ma'am, this means that current evidence is compatible or

consistent with a very small increase in relative risk?

A. That's what that says.

Q. And yet y'all changed it to say, "the available

epidemiological data does not appear to demonstrate an

increase in cancer risk."

Do you see that change?

A. I see the change. And I see different citations.

Q. Now, where in the technical monograph, as we just --

just -- Just look at the whole page together. You've got it

in front of you. And I'll zoom in wherever you tell me to.

Where does it talk about ions?

I'll give you a hint.

A. So I see ions in the last paragraph.

Q. The one I've highlighted there?

Anything else?

A. I see it in the very last paragraph.

Q. All right.

A. The one that starts, "Overall."

Q. Right here -- Oh, in the very last paragraph as well?

A. Yes.


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Q. The ionic metal, that reference?

A. Yes.

Q. Now, compare to what it says here with what we know about

metal ions just from the IDE warning. Okay?

"In terms of toxicity, it was recognized that metal

particles could cause a macrophage -- macrophage-mediated

inflammatory response while metal ions can elicit an immune

response." That's what it says, right?

A. Yes.

Q. It doesn't tell you what that is. Doesn't tell you what

Type IV hypersensitivity is. Doesn't even tell you it's a

Type IV hypersensitivity response.

A. It doesn't say that.

Q. Doesn't tell you it can eat away the muscle, does it?

A. Oh, sorry, it does not.

Q. In fact, if you get to the next section on ions, what it

says is overall the biologic effects of debris or ion in the

context of metal-on-metal are somewhat uncertain.

"There is an absence of strong data showing an adverse

biological response, particularly with well-functioning hip

implants. But certain risks are present, and we need to

disclose those risks. It's vital that we do so to patients

and surgeons." Right?

A. Yes. There is one additional reference to ions in the

first paragraph as well.


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Q. Yes. Again, it says the same thing "This may of some

concern because the full biological response to metal debris

or ions is currently unknown."

Do you see that?

A. Yes.

Q. Now, did you know that the company had spent four weeks

putting on their case and four weeks cross-examining our case

trying to tell everybody everyone knew about the problems from

metal particles and debris. They had been well-known for a

long time. Did you know that?

A. Yes.

Q. But y'all say in here that it's unknown, don't you?

A. I believe that's what the literature says.

Q. And it says in here that y'all -- It is vital that you

disclose to the surgeons and patients, right?

A. Yes.

Q. But you don't do it, do you?

A. We do that right here.

Q. Actually, no, ma'am. Here it says that it's not a

problem. Nothing is known -- You can elicit an immune

response, whatever that may be. And it's somewhat uncertain.

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

A. That -- that doesn't sound like not a problem to me.

Q. Ma'am, just compared to what you were telling your sales

force in Exhibit 622 -- Now, this isn't going out to the


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doctors. This is going out to the salespeople, right?

A. Similar information went to doctors as well.



BY MR. LANIER:

Q. Ma'am, please answer my question.

A. It did go to surgeons.

Q. This PowerPoint?

A. That information.

Q. No, ma'am. I'm talking about this PowerPoint.

A. I can't say if that specific PowerPoint is one that went

to surgeons.

Q. Well, no. This PowerPoint is one that was at the

Charlotte Advanced Sales School. That's -- that's not

surgeons. Those are your salespeople. That's your sales

force, right?

A. It is.

Q. Okay. So let's -- let's stay straight with this now.

So this is a PowerPoint that went to your sales force.

Talked about the problems with old poly -- right?

That's old poly, right?

You talked about it earlier today. Go ahead.

A. Old poly -- okay. Yes. Yes.

Q. Talked about history. In here under the history of

metal-on-metal, y'all gave a whole different set of history


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than Graham Isaac does in his End Game memo, right?

Picked the best studies possible for you. Correct?

A. No.

Q. Okay. Which ones are better?

A. I could just say this is meant to be a representation --



BY MR. LANIER:

Q. Which ones are better?

A. I would need to review them all. I don't know.

Q. Okay. Have you--

A. I was disagreeing with the characterization that

we've --

Q. Picked the best ones?

A. -- cherry-picked.

Q. I can't find any better, can you?

A. I would need to review them to tell.

Q. How about the End Game?

You didn't use the End Game, did you?

A. No.

Q. Those are the studies that Graham Isaac put in there.

You're familiar with him?

A. I'm familiar.

Q. By the way a copy of the End Game was found in Jim

Lancaster's file. Did you have a copy in yours?


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A. I don't know if I did or not.

Q. Okay. He doesn't give McKee-Farrar 77 percent survival

at 20 years, does he?

A. No, he does not.

Q. He gives McKee-Farrar 27.5 percent at 20 years, right?

A. That's what he says.

Q. He doesn't give Charnley 73 percent survival at 20 years.

He gives it anywhere from 84 to 89 percent at 20 years.

Doesn't he?

A. That's what he says.

Q. So you continue to tell your sales force -- look at what

y'all say about biological response. You talk about

hypersensitivity. Right?

A. Yes.

Q. Where is hypersensitivity mentioned in the technical

monograph?

Help us find that.

A. I'm not sure it's used in that exact word.

It is in the upper right hand.

Q. Right here (indicating)?

A. Top paragraph. Yes.

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

cause of implant failure."

Well, you know that's false, don't you?

A. No.


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Q. Ma'am, look what you're telling your sales force.

Hypersensitivity is a cause of failure, isn't it?

A. It says hypersensitivity allergic reaction.

Q. Allergic reaction, you understand that's a major cause of

failure of an implant, right?

A. I don't believe those are the same thing.

Q. Inflammatory responses. Y'all were even telling your

sales force about granulomas, weren't you?

A. Yes.

Q. Doesn't say those are sarcoidosis. That's a biological

response to metal-on-metal (indicating), isn't it?

Right?

A. I'm not a biological expert, so probably Frank would be

the better one to answer this on this slide.

Q. Ma'am, you were the one testifying about this in the

courtroom today. I didn't bring this up to you, did I?

When he brought it up, he said, didn't you even prepare

some of these slides?

You said?

A. Yes.

Q. Were you testifying about things you didn't even know

anything about?

A. No.

Q. Then let's stay with things you were testifying about,

ma'am. I didn't show you one slide that he didn't show you.


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MR. QUATTLEBAUM: Object to the sidebar, stay with

whatever we're talking about or whatever that instruction was.

MR. LANIER: I'll withdraw it, Your Honor.

THE COURT: Okay.

BY MR. LANIER:

Q. Hypersensitivity, 10 to 15 percent is what you told your

sales force, isn't it?

A. Yes.

Q. But you said as a result of this that there are certain

things and that this is linked to failed metal-on-metal.

Do you see that?

A. I see that.

Q. So hypersensitivity linked to failed metal-on-metal, but

what you told the doctors is it's not known to cause failure.

A. But I don't think the slide says --



BY MR. LANIER:

Q. Do you see that, ma'am, where you said not known?

A. I see what you've underlined.

Q. It says, "Not known," doesn't it?

A. Yes.

Q. And the slide itself that we were looking at to the sales

force says with hypersensitivity it happens twice for

metal-on-metal but five times for failed metal-on-metal.


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So the ratio is a lot higher with the failed

metal-on-metal?

A. Yes. It doesn't say as a cause.



BY MR. LANIER:

Q. Ma'am, cytotoxicity, killing cells. See that?

A. Yes.

Q. With necrosis seen in tissues around failed implants.

Where in the biological issues does it talk about

cytotoxicity?

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

didn't read that. It said failed polyethylene implants.


BY MR. LANIER:

Q. "Necrosis is also seen in tissues around failed

metal/polyethylene implants."

No fuss about that. We don't fuss that point in the

trial, so I'm not fussing that.

But that "also seen" means that you do see necrosis

around metal-on-metal implants. Do you see that?

A. Yes.

Q. All right. So where do we find cytotoxicity? This

biological issues?

A. I think you see it in the bottom paragraph to the left.


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Q. "In terms of toxicity, it was recognized metal particles

could cause a macrophage-mediated inflammatory response while

metal ions can elicit an immune response."

Now, do you have anything in here that says it will kill

tissue, necrosis?

A. I don't think we used those words.

Q. So the necrosis that's linked to cytotoxicity to the

sales force is not told to the doctors in the biological

issues either, is it?

A. Not described in the same way, no.

Q. So the bottom line, ma'am, is this warning --

By the way, the jury, just as a reminder to them and --

and to the court, do you know whether or not you're the person

who cut off the quotation that's being used in the paragraph

that "The macrophage and giant cell response to particles from

metal-on-metal was described as mild"?

Are you the one who left out the real source that says

"however" and then talks about when it's really bad?

Was that you who --

A. I was not the author of this particular page.

Q. Okay. Are you the one who took metallosis out of the

technical monograph?

A. I did not author this page.

Q. All right. That's the technical monograph warning.

Now, you said there were other things that gave the


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warning. Let's look at them. I was having trouble keeping

up. The design rationale, Defendant's Exhibit 931, where are

the warnings in here?

A. That was not one that I listed.

Q. This is the design rationale that y'all handed out to

doctors. Just tell us where the warnings are in here.

Do you have it in front of you or do you need a copy?

A. I do not have it in front of me. If I do, it's --

Q. 931. They handed it out to me earlier.

A. Okay. Let me see.

I have it.

Q. You got it? Great.

Tell us where the warnings are in here. This is one of

those brochures you said went out to all the doctors.

A. This is one I said is available to doctors. I'm not sure

that this one incorporates the warnings.

Q. I'm sorry?

A. This was not on the list of documents that I had listed.

I'm not sure --

Q. Are you saying that this doesn't have any warnings?

A. I don't think the warnings are listed in this document.

Q. Y'all spend a whole stinking page on who the design team

is, pointing them out, right?

A. We do.

Q. And that's page 1.


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You got all these other things about how it works and the

pyramid for success and all of these different features about

the shell and all these different ways it works with the taper

that you told us about, the different kinds of liners that can

be used, the metal inserts of Ultamet. Where's the warning?

A. Well, this is a design rationale.



BY MR. LANIER:

Q. Where's the warning?

A. They are not in this particular document.

Q. As in there are none?

A. They are not in this document, that's correct.

Q. All right. Then we've got the -- what was it? Then

we've got the insertion technique that we were given this

morning, how to insert it.

I found the warnings for that, D 54.6. These are your

warnings?

Is this it?

Is this it, ma'am?

A. Those are the warnings in this particular document.

Q. Look at what you're warning. "These conditions adversely

affect hip replacement implants: If the patient weighs too

much, is too active, falls down, has bad bones, bad metabolic

disorders or other disability." That's your first warning.


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That's not useful for metal-on-metal wear debris, is it?

A. That's more warnings for total hip replacement.

Q. Yeah. I mean this whole subject is that these are the

Ultamet metal-on-metal essential product information.

This is the essential stuff.

"The inner diameter of the metal-on-metal insert must

correspond to the hip head size. If you use an insert with a

nonmatching size, it's will wear faster and fail sooner."

Use the 28 with the 28, use the 36 with the 36.

That's not helpful in terms of these biological Issues,

is it?

A. Not for that particular purpose, no.

Q. And the final warning and precaution, the highly polished

bore should not come into contact with something abrasive.

This could damage the bore. It could affect the performance.

The surfaces should be clean before you put them together. If

the insert is not properly seated, it can become loose.

Now, you pointed to this for the jury today and said,

yes, we put warnings in there. That's not a warning for

metal-on-metal debris, is it?

A. It's a warning for the product.

Q. Sure. Don't rub something rough on this before you stick

it in there, but that's not a warning about biological issues

for debris, is it?

A. Not about that specific thing, no.


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Q. Now we've got adverse events.

"The following are the most frequent adverse events

after hip arthroplasty." That's not dealing specifically with

metal-on-metal, is it?

A. Not specifically.

Q. The position of the components can change. They can get

loose. They can break. They could dislocate. There could

be -- get an infection, a tissue reaction.

That's it?

That's what you think is the adequate warning you were

sending out to all the doctors and patients?

A. Well, what's also noted at the top of --

MR. LANIER: Objection --

BY MR. LANIER:

Q. Oh, go ahead. Is there more warning here?

A. "This information sheet does not include all of the

information necessary for selection and use of a device.

Please see fully" --

Q. Oh, so here's where your warning is. The warning y'all

put in here is to say this isn't a full warning. That's what

you're saying your warning is?

A. I'm just saying that the warnings at the bottom are

inclusive.

Q. Well, in big bold print you say this is the essential

product information, but then you say but it doesn't include


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everything necessary to select and use a device. It doesn't

say we left out critical warnings, does it?

A. I would consider that part of selection and use of a

device.

Q. But, ma'am, this is one example that you and

Mr. Quattlebaum used to show the jury warnings. Y'all just

didn't read it. You just read the jury the title and said

didn't we put in warnings and precautions and adverse events

with tissue reaction.

But if you read it, this doesn't do anything, does it?

A. I think it does.

Q. Okay. Then there's the surgical technique --

THE COURT: Stop.

We'll hear about that tomorrow.

See you back at 9:00 o'clock.

Don't talk about the case.


(End of proceedings.)


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INDEX - VOLUME 32

WITNESS NAME Page Line

LEANNE TURNER

DIRECT EXAMINATION (CONT.) BY MR. QUATTLEBAUM... 4 21

CROSS EXAMINATION BY MR. LANIER.................... 67 18

CROSS EXAMINATION (CONT.) BY MR. LANIER .......... 98 22

CROSS EXAMINATION (CONT.) BY MR. LANIER .......... 174 22


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PLAINTIFF EXHIBITS

Exhibit Description Identified Admitted Denied

121 Video ................... 161

467 Design rationale...... 170approval

496 aSphere memo, Paul ... 165Berman

518 ASphere design ........ 170

520 Floyd hip patient..... 172

521 Opinion................. 156

595 Letter, DePuy to CBS . 163

1274 Email, Frank Chan..... 221

1569 Legacy royalty ........ 22

3122 FDA documents ......... 79

3860 Coach K ad ............. 170

4060 Letter FDA to DePuy .. 34

4071 Email ................... 125

4106 Report.................. 150

4110 Report.................. 149

4117 Database ............... 148

DEFENSE EXHIBITS

Exhibit Description Identified Admitted Denied

56 Surgical Technique ... 47

117.1 List, metal-on-metal . 41literature

931 Design Rationale...... 47

4075 Email Turner/Decker .. 68


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< Dates >February 23rd, 2001 139:12January 2002 154:10July 29th 35:5MARCH 1, 2016 1:14, 4:1March, 2016. 242:8May 16th 82:22November 14th 99:12, 99:23November 16th 125:16, 126:23November 16th. 125:23November 7, 2005, six 181:2one, September 26th 134:6September 17th 133:15September 2001 129:11September 2008. 178:10"three 36:20#1900 2:45$3,000 153:20$345,000 198:3$5,000 153:16'01 55:14'03 55:18'03. 55:19, 150:15'13 39:18'2. 172:14'97 5:22.cannot 146:10

< 1 >1 72:8, 104:11, 120:4, 196:11,500 161:91. 234:2510 27:21, 144:16, 144:17, 231:6

10- 189:14, 189:1510-year 189:1110. 72:8, 102:9, 102:13, 144:15100 94:2, 144:19, 144:2310016 2:23101.34 44:310:23. 61:710:47. 61:810th 91:15, 91:18, 94:5, 94:7, 97:1111 3:18, 50:14, 102:21, 145:17, 152:211-CV-1941 1:1411-CV-2800 1:1311-MD-2244-K 1:711. 102:25, 103:11100 3:41111 2:45112 2:21117.1 241:45117.1. 41:131193 1:4011:45. 98:812 23:12, 51:912-CV-1672 1:1212. 27:22, 120:4, 222:612/23 153:15120 88:1, 108:2, 125:1, 125:2, 143:25, 145:9, 164:16120. 83:1, 108:1, 145:23, 146:1121 161:19, 241:5121. 16:3122 161:181274 215:3, 241:211274. 221:1713 103:913-CV-1071 1:10

13. 120:7130 94:213th 70:23, 79:19, 85:4, 91:10, 97:14, 104:5, 104:11, 104:23, 104:24, 115:3, 121:2414 11:7, 11:1914-CV-1994 1:1114. 216:714th 2:1315 61:5, 174:4, 231:615-year 189:11, 189:14, 189:1515. 23:121525 3:411537. 40:121569 241:231569. 22:5157 6:1316. 51:20170 144:23170. 144:2018 240:101960 1:331988 43:251990. 9:181990s 5:6, 172:11994. 8:7, 58:181996 5:171997. 191:251998 6:71999 6:9, 31:5, 50:131999. 101:151:00. 98:51:12. 98:91st 242:8

< 2 >2 89:21, 120:9, 120:10, 192:252. 42:7, 76:1520 13:22, 103:9, 229:3, 229:5, 229:7, 229:82000 6:15, 6:16,

30:9, 35:7, 79:19, 82:22, 125:17, 128:20, 138:18, 153:24, 185:6, 185:10, 190:17, 191:242000. 7:9, 26:4, 34:16, 35:21, 104:5, 146:19, 190:4, 198:252000/2004 209:42001 7:9, 7:10, 58:22, 130:2, 153:15, 166:21, 172:14, 185:102001. 153:152002 7:15, 58:22, 96:21, 173:17, 212:172002. 55:17, 189:22004 148:82004. 7:202005 34:16, 37:11, 87:15, 100:8, 181:102005. 34:15, 35:52006 161:92008 179:18, 179:252008. 179:42009 69:25, 166:18, 180:1, 212:172009. 70:2, 166:7, 166:11, 166:212010 166:62011 39:182012 39:182013. 68:182053 74:192053.265. 20:720th 133:19, 148:721 240:8212-784-6410 2:24214.662.1557

241

3:43214/740-8453 3:13214/740-8520 2:38217. 148:9219 181:1022 179:6, 240:12, 240:1422. 178:13, 200:42200 2:35, 2:36, 3:112220 2:523 179:624 12:24, 166:12, 179:6, 204:92400 3:425 37:1, 147:1025. 120:9, 120:10253 139:17254-918-1006 1:42261 139:10269 6:427.5 229:52777 2:13278 86:2427th 134:1228 11:8, 11:19, 31:16, 33:14, 33:17, 42:24, 80:7, 80:24, 81:4, 81:7, 81:15, 84:19, 107:12, 107:23, 112:5, 114:16, 116:25, 133:9, 135:1, 135:4, 140:1, 143:22, 145:20, 147:11, 147:12, 205:9, 236:928-millimeter 26:5, 26:20, 31:6, 31:20, 37:3, 43:19, 44:7, 44:10,

44:11, 53:1, 77:18, 80:16, 104:16, 134:16, 140:1, 141:24, 142:1, 199:1328. 32:5, 33:9, 103:5, 107:6, 142:15, 142:16, 142:2428th 181:1

< 3 >3 37:2, 37:3, 49:22, 54:1, 220:123. 42:83045. 207:113122 145:17, 241:253122. 78:25317.236.1313 3:2032 1:19, 4:1, 240:1325 155:18327. 74:2036 26:5, 31:16, 31:20, 31:23, 33:8, 33:17, 44:12, 80:7, 80:24, 81:17, 84:19, 86:16, 89:15, 92:6, 107:5, 107:9, 107:25, 114:1, 115:2, 115:6, 116:25, 126:9, 126:17, 142:12, 143:25, 145:19, 145:20, 145:22, 145:25, 146:18, 146:22, 147:15, 148:1, 152:3, 195:25, 205:9, 236:936-millimeters 124:2136-piece 204:2536. 33:14,

86:25, 112:5, 133:10, 236:9361 204:93847 159:193851 159:33860 241:273860. 170:1739 144:203903. 27:143: 1:7, 1:10, 1:11, 1:12, 1:13, 1:143:04. 174:63:27. 174:7

< 4 >4 22:21, 145:20, 145:24, 180:144.2 198:440 31:11, 81:5, 81:8, 81:15, 81:16, 82:22, 92:24, 93:18, 94:4, 107:24, 108:2, 127:17, 128:2, 143:10, 143:12, 143:22, 145:21, 152:5400 178:6402 77:25, 117:21402. 160:5403 77:25, 117:21, 160:5, 213:24, 213:25404. 117:224060 241:294060. 34:204070. 89:17, 98:254071 241:314071. 125:154072 86:124074 129:64074. 129:44075 241:5040754075 68:174106 150:13, 241:33

4106. 150:114110 150:2, 241:354110. 149:244117 148:7, 241:3743. 47:74350 3:3245 55:5, 170:1446 56:3, 152:246204-3535 3:19467 102:4, 241:7467. 84:2, 170:5475 207:1348 57:149 57:7496 241:10496. 165:18

< 5 >5 36:1, 36:14, 98:5, 146:23, 190:255. 102:15, 102:16501.379.1707 2:47504.589.9733 3:651 57:1651. 57:15510 188:22510(k 25:22, 25:25, 26:8, 26:9, 26:13, 30:10, 33:12, 33:16, 33:21, 34:1, 34:4, 35:9, 35:11, 36:6, 37:12, 37:14, 39:12, 62:16, 64:12, 65:16, 83:19, 112:1, 134:15, 136:2, 141:16, 141:23, 147:17, 156:1, 188:25, 189:4510(k). 133:23510(k)s 42:22,

242

42:25512 160:2, 160:9517. 169:13518 241:13518. 170:1052 57:18, 92:18520 241:15520. 172:21521 156:18, 156:23, 241:17525 35:1154 47:7, 48:1, 48:2054. 47:2554.6. 235:1756 47:19, 48:6, 241:4356.46. 48:1557 170:1595 163:3, 241:19

< 6 >6 48:21, 190:2560 81:15, 126:13, 126:17, 163:10, 200:1960. 93:19, 144:20622 53:11, 226:25667. 192:2167 80:236810 1:33

< 7 >7 102:21, 190:2570112 3:571 85:57106. 103:15713.400.4001 2:15713/659-5200 1:3571309 2:672201 2:4673 229:775001 3:33

75201-6776 2:3775204 3:1275242 3:4276401 1:4177 154:1, 176:1, 229:277019-2129 2:1477069 1:34797. 180:117th 2:22

< 8 >8 71:1680 31:11, 81:5, 81:8, 81:16, 82:22, 83:1, 88:1, 89:25, 92:25, 93:18, 108:1, 108:2, 125:1, 125:2, 127:17, 128:3, 143:10, 143:12, 143:22, 143:25, 145:8, 145:23, 145:25, 164:15, 175:2580. 107:24, 145:21800/256-1050 2:784 229:889 229:8

< 9 >9 219:7, 220:4, 220:10, 220:129). 219:259. 219:1, 220:1, 220:8909 3:490s 172:9927. 49:10931 47:7, 47:8, 234:2, 241:48931. 234:9972/233-2300 3:3499.9 165:8, 170:23, 171:12,

171:19, 171:21, 173:9, 173:17, 173:21, 176:23, 177:169:00 238:15`marked 133:8`never 163:10`one 173:16`summary 136:7

< A >AAOS 70:15abbreviate 81:8ability 121:6able 10:18, 30:4, 46:25, 52:25, 58:5, 59:2, 70:3, 84:8, 84:12, 112:18, 144:15, 154:1, 160:12, 196:16, 199:22abrasive 236:14absence 225:19absolute 222:13, 223:18Absolutely 6:21, 60:11, 89:12, 133:13accept 88:23acceptance 84:6, 85:10, 103:7, 113:3, 113:6, 113:14accepted 68:19access 13:9, 20:18accident 78:20, 78:21accidental 78:22accommodate 71:3According 16:21, 35:15, 136:9, 145:25, 146:8, 188:1, 188:3account 156:18accrual 189:3accrue 189:20accurate 83:5,

111:13, 123:9accurately 83:7, 122:16acetabular 9:17, 9:21, 11:3, 12:17, 27:6, 37:3, 37:24, 46:10, 47:12, 47:20, 50:19, 52:22, 73:6, 74:12, 74:14, 79:9, 180:14, 181:9, 219:13acetabulum 9:24, 10:11, 51:5achieve 164:19achievement 153:17, 153:21acknowledge 19:13, 20:2, 51:7acquired 6:8across 18:23, 20:12, 21:12, 32:13Act 79:2, 84:4acting 196:15action 35:9, 63:3, 148:17, 175:16active 25:20, 160:10, 235:24activities 95:17, 96:6, 103:3, 113:2Actos 65:5actual 23:8, 26:24, 27:7, 29:24, 30:3, 32:3, 45:23, 70:8, 83:12, 84:24, 85:13, 104:11, 111:14, 136:1, 148:19, 155:9, 159:19, 186:19, 210:4, 211:12Actually 4:14, 9:1, 10:8, 11:3, 16:16, 25:14,

243

51:4, 53:8, 61:2, 68:25, 79:2, 82:16, 83:1, 93:14, 105:24, 106:14, 111:1, 114:2, 118:20, 145:22, 146:16, 147:7, 147:24, 152:4, 156:12, 156:19, 161:25, 165:12, 188:11, 195:9, 215:13, 226:19ad 168:9, 170:14, 170:16, 170:18, 172:17, 177:16, 241:27ad170 241:27add 23:12, 78:15, 78:18, 78:21, 132:8, 143:15, 187:20, 192:2, 219:9add-to-file 146:2adding 35:10, 132:1Addison 3:33addition 14:21, 43:23, 45:7, 153:20, 188:4, 209:2, 210:11Additional 17:17, 19:23, 20:1, 22:15, 38:5, 59:7, 129:20, 130:11, 131:17, 175:9, 225:24address 55:3, 97:5addressed 51:8, 54:17, 55:20, 65:2, 193:10, 194:9, 217:9addressed. 193:6, 194:5adequate 219:24, 237:10adjacent 212:11

Administration 14:19admit 158:8, 220:3, 220:6Admitted 241:3, 241:41adoption 167:6advance 138:19Advanced 227:14advancing 65:13Adverse 35:25, 36:1, 36:2, 36:5, 36:13, 36:14, 36:16, 36:17, 36:20, 36:21, 36:22, 37:2, 37:6, 38:12, 48:24, 49:3, 94:14, 96:9, 146:22, 146:23, 147:10, 147:16, 147:24, 151:11, 151:12, 152:14, 152:25, 154:23, 210:15, 212:13, 212:17, 225:19, 237:1, 237:2, 238:8adversely 235:22advertisement 163:10, 163:13, 172:20advertisements 163:11, 163:14, 163:18advertising 161:1, 163:5, 216:24, 217:5, 217:12, 218:5, 218:6advice 134:7advocate 175:24affairs 21:21affect 77:21, 77:22, 89:10, 184:13, 235:23, 236:15affected 37:23affecting 62:16affects 77:10,

77:11, 81:12affiliated 25:7affirmatively 121:24afraid 151:8, 165:7, 176:11, 183:3, 196:2, 200:10, 200:13, 207:23agency 62:18, 62:21, 216:24, 217:5, 217:12, 218:5, 218:6agenda 71:3Agile 93:19agitating 28:4ago 68:14, 197:18agree 11:14, 17:16, 73:24, 78:10, 78:16, 80:22, 97:3, 136:12, 142:16, 164:8, 170:25, 185:24, 190:2, 190:15, 192:18, 206:25Agreed 22:25, 25:10, 30:20, 63:5, 76:7, 194:11agreement 21:23, 24:17, 178:22, 178:24agrees 77:8Ah 97:10, 145:8ahead 46:22, 137:7, 173:25, 174:20, 185:17, 199:18, 221:10, 227:22, 237:[email protected] 1:36alert 27:8, 94:7, 142:14, 188:16alerted 111:17Alex 1:31, 167:24, 168:7, 168:14

Alexandria 2:6alignment 70:10allegations 169:15Allen 2:13Allergic 148:15, 230:3, 230:4Allio 163:8allow 97:16, 154:16, 164:18allowed 79:1alloy 40:21alloys 40:21, 211:14, 211:18alluded 65:6alludes 129:17almost 88:1alone 72:25, 197:5, 212:8alone. 71:19Already 4:16, 9:17, 11:3, 19:18, 36:7, 39:17, 44:19, 57:25, 80:16, 104:22, 106:5, 117:13, 118:6, 118:9, 131:12, 140:4, 140:10, 140:25, 166:4, 172:8, 177:1altered 121:25, 122:4, 122:24alternate 5:14alternative 101:2, 203:13, 203:20, 203:22although 212:11Alvin 160:14ambiguity 109:6American 79:1among 173:24amount 13:18, 25:12, 25:13, 31:10, 32:6, 38:14, 43:23, 58:2amounts 38:23, 184:3AMTI 27:24

244

analysis 15:21, 16:10, 17:13, 25:15, 25:16, 42:4, 85:8, 198:1analyze 40:3anatomy 9:15, 11:21Andrew 3:24, 30:14, 89:22, 91:19, 91:23, 97:15, 215:2, 216:2, 216:10, 217:10, 217:11, 221:23Andy 45:4, 162:15, 221:23, 221:25angle 10:10, 11:7angulation 10:24Ann 129:11, 133:4, 134:13annual 46:13, 181:1anomalies 126:11Answer 22:22, 22:23, 69:14, 82:2, 82:11, 95:14, 116:10, 117:7, 130:1, 131:2, 133:2, 134:5, 134:12, 151:9, 199:23, 202:19, 203:5, 204:5, 204:6, 204:7, 207:23, 208:11, 208:14, 220:18, 227:6, 230:14answered 63:10, 99:7, 136:8, 195:11answering 14:2answers 194:11, 195:22, 195:23anti-kickback 23:5, 24:2, 24:9anxious 134:8anybody 71:14,

142:14, 184:10, 188:20, 214:4Anyway 63:8, 89:23, 134:1, 137:4Aoki 1:10, 165:14apex 10:6apologies 84:11, 110:17apologize 115:19, 131:20, 140:9, 152:21, 196:9apparent 211:8apparently 157:18appear 223:12, 224:9appeared 177:16apples 152:9, 201:2, 201:4, 201:5, 201:12, 202:2, 202:13, 202:14, 202:23application 33:21, 34:9, 99:3, 104:9, 104:12, 104:19, 145:19applies 63:3, 171:22apply 40:13, 63:2appreciate 11:19, 68:3, 71:1, 105:10, 134:7approach 54:8, 65:3, 72:4, 83:22, 157:6, 157:11appropriate 24:17, 24:22, 66:6, 66:13, 167:7, 175:13appropriately 18:1, 36:21, 147:6approval 65:15,

79:18, 79:22, 79:24, 116:13, 118:11, 118:13, 140:4, 140:11, 140:25, 141:3, 141:16, 141:24, 153:25, 158:5, 165:11, 169:17, 169:19, 170:8, 170:11, 170:19, 171:23, 187:18, 187:20, 189:5, 241:8approvals 24:18approve 89:15, 170:13, 198:12approved 25:16, 79:17, 80:17, 85:18, 85:19, 104:7, 125:10, 129:13, 163:19, 165:8, 165:10, 170:3, 173:17, 189:8approves 156:19approving 169:10, 169:14, 172:19, 181:19Approximately 12:22, 37:1, 38:17, 38:22, 39:6, 39:7April 148:7AR 2:46archives 121:8area 31:25, 42:16, 141:7, 163:2, 211:20, 223:9areas 53:24, 69:10, 69:11, 80:18, 122:17argue 64:11arguing 64:22argument 62:23, 66:1, 203:24arms-length 24:20arose 26:14, 128:20, 143:1

around 32:25, 39:1, 42:18, 52:2, 56:21, 71:25, 100:16, 150:25, 155:19, 155:25, 179:12, 232:9, 232:16, 232:21arrow 119:12ARSENAULT 2:2, 2:4, 64:22, 64:24, 65:5, 65:12art 154:2arthroplasty. 237:3articles 41:23, 55:25, 181:15articular 51:3, 106:8, 107:14, 107:15, 109:2, 110:9, 114:1, 127:22, 128:4, 128:7, 128:12, 132:16, 134:17, 134:24, 205:2articulates 167:6Articulation 31:20, 53:1, 77:18, 81:1, 127:16, 127:20, 127:22, 127:24, 128:2, 128:12, 185:4, 186:19, 186:21, 219:3asks 72:13aspect 75:2, 97:17, 101:7, 124:5aspects 47:17, 53:19Asphere 70:3, 70:5, 70:8, 70:11, 70:13, 70:15, 155:6, 155:9, 155:12, 155:13, 155:19, 155:23, 155:24, 156:6, 165:13,

245

165:20, 165:22, 165:24, 166:10, 168:6, 168:8, 168:9, 170:8, 170:10, 175:20, 175:25, 241:10, 241:13ASR 69:3, 69:4, 142:18, 142:22, 143:2, 144:11, 144:14, 144:15, 144:21, 144:22, 145:22, 175:9, 175:10, 175:20assemble 16:11assembled 114:7, 115:16, 116:2assert 103:23assertion 184:13, 184:15assistant 163:23, 173:2, 177:7associated 35:25, 36:13, 40:7, 120:13, 146:22, 151:11, 210:22ASSOCIATES 1:39assume 157:20assumes 161:2assuming 124:20, 196:14assumption 179:5asterisk 119:5ASTM 40:12, 40:24astray 74:8Attached 167:3, 168:9, 177:17, 215:3attaching 216:10attachment 34:9attempting 31:16attendees 126:1Attorney 70:22attorney-client 157:9, 157:10, 157:18, 158:3, 158:7

attractive 178:14attribute 38:24attributed 126:11author 233:20, 233:23authored 47:17, 49:15, 146:16authorities 14:19authority 57:3authorized 85:13, 88:15available 9:18, 10:1, 43:24, 45:20, 48:13, 58:1, 59:25, 97:19, 97:21, 113:19, 114:16, 115:3, 116:1, 118:19, 120:25, 133:8, 133:9, 194:16, 194:18, 223:12, 224:8, 234:15Ave 2:21, 2:35Ave. 3:11avid 160:10avoid 93:25Award 153:17, 153:21, 180:4, 180:9, 180:17, 180:23, 181:1award. 181:11awarded 180:15, 180:23, 181:7, 181:25, 182:5awards 181:18aware 13:18, 59:15, 79:5, 88:17, 89:22, 99:23, 159:2, 160:7, 165:11, 168:14, 189:15away 11:11, 132:8, 175:21, 181:18, 201:21, 213:11, 225:14

< B >Bachelor 4:14background 89:23backing 139:20bad 20:9, 233:18, 235:24bags 138:10, 139:19, 141:5balance 154:2balancing 154:19ball 32:13, 32:24, 33:1, 71:16, 75:8, 75:11, 75:15, 75:18, 75:22, 93:10, 93:11, 119:18, 120:16, 120:17, 120:19, 120:20, 120:21, 121:8, 121:10, 171:16, 171:18, 171:21, 173:22, 213:13balls 31:17Barely 92:11Barnes 3:17Barrasso 3:2barred 62:9Barrett 204:20barriers 167:11Barry 69:20, 69:21, 70:1, 70:3, 71:13Based 10:9, 13:17, 22:14, 33:15, 34:17, 36:7, 40:4, 41:3, 79:24, 85:24, 119:3, 125:9, 147:17, 147:23, 148:15, 171:12, 200:8, 201:8, 202:7bases 222:1basically 71:22, 107:5, 185:2basis 14:1, 23:14, 89:23, 183:21

basketball 32:24, 33:2, 33:5Baycol 65:5bear 89:18Beard 2:4bearing 29:7, 31:25, 38:15, 50:3, 52:3, 52:14, 164:12, 164:18, 166:15, 168:8, 175:24bearings 5:15, 51:2, 165:22, 167:2, 167:13, 171:7, 171:10, 176:5, 219:24, 222:1, 222:9became 45:23become 236:17beginnings 17:12behalf 164:10behavior 179:11behavioral 74:9behind 10:11, 185:23believe 4:15, 44:20, 50:13, 55:17, 58:25, 67:1, 77:8, 80:8, 117:8, 162:25, 163:13, 168:17, 169:21, 186:14, 187:8, 187:11, 187:13, 189:3, 194:14, 199:19, 202:4, 204:2, 212:21, 214:21, 217:2, 222:21, 226:13, 230:6believed 21:7, 39:1, 51:7, 121:18, 127:11, 188:9belongs 212:20below 114:4, 134:8, 134:13, 168:8, 175:8belt 9:21

246

Beltway 3:32bend 95:8benefit 51:21, 51:24, 60:19benefits 222:7Berman 165:21, 167:23, 175:4, 241:11Berry 11:4, 11:14, 12:14, 12:22, 13:19, 13:25best 10:12, 11:1, 40:5, 60:18, 85:7, 93:2, 94:18, 179:13, 204:15, 228:2, 228:14best-case 187:25bet 129:5, 179:5, 207:7better 27:11, 30:25, 44:10, 44:13, 77:1, 200:22, 203:12, 228:4, 228:9, 228:16, 230:14beyond 52:21, 73:1, 116:21, 213:18BI 68:20BI. 68:19bicycle 160:2bicycling 95:18big 21:1, 139:11, 139:21, 139:22, 144:24, 161:9, 168:21, 180:14, 237:24billion 38:22, 39:4, 39:5biologic 50:7, 54:22, 57:17, 184:22, 214:19, 225:17biological 49:16, 55:22, 56:6, 56:19, 57:12, 58:6, 183:20, 183:25,

202:10, 215:6, 216:15, 216:17, 221:9, 222:5, 222:20, 225:20, 226:2, 229:12, 230:10, 230:13, 232:10, 232:24, 233:8, 236:10, 236:23Biomechanics 51:16, 51:18Bissell 2:34, 3:10bit 16:6, 18:15, 19:15, 28:20, 135:23, 136:12, 155:7, 158:20, 182:8, 192:10, 210:13blame 66:11blanket 32:25Bless 4:9, 81:19blister 150:4blitzed 58:24blood 213:9blood. 164:6blowing 4:16Board 198:12boatload 152:25body 27:7, 34:3, 40:24, 42:17, 44:17, 83:7, 184:4, 184:8, 188:17, 206:18, 211:15, 213:6, 213:8, 216:18bogus 170:24bold 237:24bona 23:1Bonaventure 2:5Bone 9:15, 9:22, 9:23, 10:11, 11:1, 50:22, 176:23, 210:17, 211:19, 211:25, 212:10, 213:11, 222:8bones 16:10, 235:24Bonnie 160:13

Bono 192:23bonus 153:12, 153:16, 153:21bonuses 153:10, 154:8, 154:10booklet 169:25, 170:7bore 236:14, 236:15bottom 35:12, 35:13, 117:4, 178:7, 232:25, 233:11, 237:22boundary 162:5bowling 95:18Box 1:40, 17:25, 34:2, 34:7, 34:8, 60:14, 150:3, 150:4, 209:17, 210:1Boy 166:17Boyd 2:11brain 212:17brand 179:10brand-new 88:20, 88:25, 118:10break 15:17, 61:4, 61:14, 83:14, 98:24, 102:1, 155:2, 155:5, 158:16, 174:3, 186:17, 187:12, 187:13, 237:7breakdown 213:11breaking 213:7bright 16:1Bring 4:11, 17:8, 20:7, 67:9, 174:16, 230:16bringing 63:3broad 15:15, 50:2, 63:7, 194:14, 217:15broader 108:9broadly 63:9, 66:12brochure 76:9, 77:13, 177:22,

218:7, 218:24brochures 95:17, 177:23, 213:18, 234:14broke 86:9broken 30:4, 37:16brought 197:8, 230:17BROWN 1:31Buckman 62:9, 64:20, 65:13, 66:17, 77:24, 117:21, 149:9, 151:24, 152:7budgets-unbelievable 221:25build 16:19, 16:21, 110:5building 16:16bullet 102:15, 102:17, 102:23, 111:19bunch 66:14, 149:5, 218:14Burrow 2:44Business 14:21, 19:17, 23:8, 24:7, 38:25, 62:18, 66:9, 68:21, 68:22, 155:19, 158:25, 179:21, 179:22, 179:23, 179:24buy 197:23

< C >cadaver 16:11, 17:22calendar 137:21, 137:24call 13:14, 71:6, 104:19, 195:16, 209:6called 9:18, 15:1, 15:3, 15:22, 18:6, 26:9, 27:24, 29:4, 29:5,

247

29:7, 34:18, 54:16, 55:8, 75:18, 145:23, 179:22, 206:2, 214:21calmed 135:23Campbell 40:2Canada 128:20, 129:11, 129:13, 161:10Canadian 128:23, 136:5cancer 213:7, 221:14, 222:10, 222:11, 223:5, 223:6, 223:8, 223:12, 223:13, 223:16, 224:10CANNON 1:38, 1:39capable 18:9capacity 21:19, 166:10capitalize 67:24Captain 160:9capture 166:16, 167:1car 16:1, 16:8carbon 40:6, 40:7, 205:8, 205:20carcinogenicity 56:15, 57:11, 223:11careful 52:1carefully 121:17carry 206:21carve-out 25:7Cary 165:23case 36:18, 50:24, 61:5, 62:22, 62:23, 62:25, 80:12, 98:4, 158:4, 196:17, 197:3, 197:8, 197:11, 197:12, 199:14, 199:17, 210:7, 212:22, 226:7, 238:16

cases 61:13, 212:13catching 27:4caught 124:2, 141:9cause 26:25, 51:4, 51:5, 63:3, 148:12, 225:6, 229:23, 230:2, 230:4, 231:14, 232:3, 233:2caused 213:7, 213:11causing 27:3, 223:11cautious 193:1cavalierly 89:9CBS 163:4, 241:19CBS163 241:19Cds 49:5cell 233:15cells 232:7cement 211:19cemented 79:9Center 2:45CEO 161:11, 162:10, 165:12, 168:18ceremony 181:1certain 136:5, 212:24, 225:21, 231:9Certainly 9:16, 37:24, 39:16, 43:18, 58:1, 59:1, 60:5, 60:19, 86:19, 88:19, 95:9, 96:10, 110:20, 138:1, 156:7, 157:25certification 23:25certifications 24:10, 24:13certify 22:3, 242:2, 242:5cetera 193:2

chain 97:9, 97:15, 141:10, 141:15, 141:23, 142:1, 142:3, 142:4, 142:5, 142:9, 142:11, 216:8, 222:17, 222:23, 223:3Chairman 168:20challenge 154:11challenges 58:4challenging 19:15Chan 30:16, 50:10, 50:11, 50:12, 53:8, 53:9, 53:21, 89:21, 94:12, 188:1, 215:21, 217:10, 218:10, 221:20, 241:21Chan221 241:21chance 84:15, 102:1, 105:14, 121:13, 138:3, 208:20changed 32:2, 33:14, 33:15, 35:17, 73:15, 82:25, 100:12, 101:6, 101:9, 101:11, 101:17, 111:18, 111:20, 111:22, 112:8, 112:22, 113:6, 113:15, 122:13, 122:22, 123:8, 127:9, 129:17, 130:12, 131:4, 132:20, 132:22, 146:10, 224:8changes 44:18, 77:9, 87:20, 88:2, 88:9, 88:15, 101:20, 101:24, 129:19, 129:24, 130:6, 130:9, 130:10, 130:16, 131:8, 131:13, 131:16,

131:23, 131:25, 132:1, 170:19changing 85:19, 126:13, 131:24channel 159:15characteristic 109:3, 109:7, 109:9characteristics 80:19, 107:14, 107:15, 108:9, 109:16, 110:20characterization 77:25, 228:12characterize 144:1, 195:13characterized 73:24charge 61:23, 63:24, 65:21Charlotte 53:16, 227:14Charnley 229:7chart 80:23, 84:18, 84:20, 84:21, 85:19, 87:3, 87:6, 87:7, 87:9, 87:13, 87:14, 87:16, 87:20, 87:25, 110:21, 111:7, 111:10, 122:25, 123:5, 132:15, 133:14, 143:15, 144:16, 145:19, 145:24chase 120:21check 124:1, 148:10, 193:16checkers 124:2, 124:4checking 80:5, 179:3cherry-picked 228:15chief 12:15, 168:20choice 51:14, 74:9, 100:23, 101:2

248

Christine 181:3CHRISTOPHER 1:11chrome 37:4, 40:6, 40:8, 40:21, 116:3chromium 205:20CIA 89:23circle 220:10circled 103:14CIRCSH 2:29Circuit 62:24, 63:1, 63:4, 63:5, 63:6, 63:8, 63:9, 63:11circuits 62:24citation 224:3Citations 55:11, 55:25, 56:17, 56:23, 57:3, 57:9, 57:21, 57:25, 224:12cite 177:18claim 59:24, 61:15, 61:19, 61:22, 113:18, 144:21, 144:22, 164:9, 164:15, 165:9, 185:1, 185:4, 221:9claimants 124:22claimed 135:3, 164:23claiming 206:6claims 61:19, 62:5, 62:6, 63:2, 65:13clarification 8:25, 34:19clarifications/requests. 133:6clarifies 91:5clarify 70:1, 128:24, 145:23, 182:9, 188:13, 212:19clarifying 191:21clarity 70:15Claudia 129:17,

133:9claw 158:1Clean 76:5, 236:16cleanest 203:21clear 46:18, 96:6, 104:14, 109:6, 110:17, 124:4, 124:6, 132:4, 135:24, 186:23, 188:5, 190:13, 205:6, 209:15Clearance. 76:5, 92:17, 93:17, 164:14clearances 26:25, 31:8, 144:18, 144:19, 145:21, 153:11, 186:21, 199:20, 219:23, 220:8cleared 6:16, 35:20, 36:8, 42:21, 94:2, 104:8, 146:19cleared. 107:11Clearly 17:8, 18:16, 18:17, 62:9, 85:25, 88:17, 91:3, 167:6, 168:24, 187:22clever 217:17, 222:24cleverly 217:5climb 95:8Clinic 12:15, 13:19, 13:25, 14:1, 198:10, 198:11, 198:24Clinical 6:1, 7:18, 11:18, 15:20, 17:9, 35:17, 43:7, 43:14, 43:15, 44:17, 44:19, 44:22, 55:3, 55:20, 57:19, 58:7, 59:2,

60:1, 77:3, 77:14, 97:2, 97:4, 146:11, 147:20, 183:5, 188:4, 188:5, 188:7, 188:9, 188:10, 188:24, 202:6, 202:14, 202:15, 211:12, 212:12clinicians 59:18close 31:1, 158:5close. 156:15closely 28:17, 156:13, 175:4closer 28:12closest 10:6closet 12:6clue 122:5Coach 160:16, 170:13, 170:16, 171:24, 241:27cobalt 37:4, 40:6, 40:7, 40:21, 116:3, 205:20code 148:17coincide 138:12, 138:15collaborate 7:8, 20:21collaborated 7:7, 22:24collaborating 19:25collaboration 18:22, 19:14, 48:4collected 44:19collecting 213:8collection 213:10color 16:1colored 174:11column 81:4, 103:6combination 199:12combined 116:14

comes 65:17, 65:19, 75:25, 111:2, 144:5, 158:5, 210:4, 218:10comfort 175:14, 175:16comfortable 17:19Coming 18:1, 43:21, 76:5, 142:17, 165:14commendable 153:4commented 217:2comments 215:4, 215:20, 216:3comments. 168:12Commerce 3:41commercial 16:25, 23:1, 23:4commercialization 7:16commercially 25:6, 45:20, 164:4commitment 166:11committees 22:14common 154:19commonly 29:6, 40:11communicated 127:11communication 60:15communications 163:1companies 160:23, 181:18comparable 36:23, 147:9, 202:12, 206:5comparative 94:17, 201:15, 205:1comparator 184:23compare 26:19,

249

36:2, 44:6, 121:10, 127:16, 192:9, 192:12, 202:2, 202:23, 205:13, 223:7, 225:3compared 51:22, 51:25, 226:24comparing 84:19, 152:9, 152:11, 152:14, 201:2, 201:4, 202:14, 205:9, 213:23comparison 80:23, 84:18, 84:19, 84:21, 122:25, 123:5, 145:19, 201:6, 201:7, 201:12, 201:14, 201:19comparisons 55:2, 202:6compatible 222:14, 223:19, 223:21, 224:5competence 179:11competent 18:8competition 167:14competitive 55:2, 167:13compile 222:2complaint 148:7, 148:12, 148:14, 148:16, 148:19, 149:7, 149:14, 149:17, 149:20, 149:22, 150:2, 150:9, 150:13, 151:4complaints 150:22, 151:1, 152:2, 152:12complete 134:8completely 58:16, 62:7, 204:17, 215:1, 217:8Completion

137:14, 140:13complex 28:7complexity 19:24complicated 30:12, 32:8, 32:11complication 36:17comply 62:14, 242:5component 17:25, 32:3, 45:20, 52:6, 52:15, 176:8, 176:9components 9:14, 16:9, 16:16, 17:15, 17:21, 18:18, 19:4, 21:4, 27:2, 30:3, 30:25, 31:8, 33:23, 40:1, 52:3, 52:11, 53:2, 107:17, 129:17, 131:15, 134:16, 135:3, 154:13, 173:18, 173:22, 213:6, 237:6components. 212:1compute 121:12computer 3:47concept 63:7concern 31:2, 129:16, 184:9, 226:2concern. 94:12concerned 91:19, 167:17concerning 59:12, 59:14, 174:25concerns 55:3, 55:21, 71:25, 194:14, 195:10concluded 36:3conclusion 41:3conclusions 50:8conditions 94:14, 97:2,

235:22conducted 173:16Conference 47:2, 55:8, 55:12, 242:6conferred 181:5confidence 60:6, 202:5confirm 148:11, 154:3conflicting 83:6confusion 133:20connected 72:3connection 65:17, 166:20Conroy 2:19, 2:20Consensus 90:3consider 40:5, 50:20, 58:20, 238:3considerable 69:1consideration 58:19considerations 50:18, 56:5, 214:20considered 24:4, 160:21Considering 8:6, 160:24consisted 25:3consistent 101:11, 110:19, 223:24, 224:6consistently 41:6constant 166:22construes 148:20consult 25:7consultant 23:15, 23:22, 24:22consultants 175:3, 175:6, 175:8, 175:14, 175:19consultants. 175:15

consulted 25:14CONT. 4:21, 98:22, 174:22, 240:8, 240:12, 240:14contact 31:21, 31:25, 32:3, 32:12, 32:20, 52:16, 192:24, 236:14contacted 34:16, 34:19contained 48:17, 49:16, 49:24, 54:5, 60:13, 96:7, 213:22contains 214:17contend 64:8content 53:22contention 60:8contents 54:7, 106:21context 65:2, 165:20, 175:9, 179:17, 219:9, 225:18Continue 89:25, 111:11, 111:24, 119:8, 126:17, 133:14, 138:11, 160:12, 162:20, 179:6, 195:18, 229:11continued 124:9, 126:19, 128:19, 128:24, 138:9, 155:25, 189:19, 195:12, 195:19continues 175:24, 195:9continuing 97:23, 195:14continuity 179:12contract 24:21Contrary 125:4, 186:15contribute 73:1contributed 25:11, 73:2

250

contribution 24:23, 72:25contributions 25:2control 15:2, 18:6, 42:23, 45:7, 45:10, 45:15, 45:17, 45:19, 45:23, 59:6, 113:2, 219:16controlled 40:19, 58:25, 76:6, 77:21, 94:15, 96:25, 101:6, 105:21, 112:23, 130:15controls 201:16conversation 46:8conversations 31:4, 56:9convey 21:9, 50:17convinced 92:2copied 217:10copies 147:3copy 20:9, 72:10, 130:19, 139:15, 139:17, 153:13, 182:14, 218:20, 218:22, 228:24, 228:25, 234:7Corail 71:6core 18:8, 18:23, 19:6, 20:15, 58:14, 97:4, 97:12, 125:19, 125:22, 154:18corner 86:23corporate 162:25, 179:10corporation 181:11correction 181:22corrective 148:17

correctly 127:11, 134:3correspond 236:7correspondence 149:13corresponding 120:1corrosion 38:6, 38:8, 38:13, 213:5cost 11:12, 198:3counsel 163:8, 163:23, 173:3, 177:7count 71:18couple 8:21, 14:17, 39:22, 42:13, 45:8, 57:24, 79:15, 139:9, 139:18, 182:9course 43:2, 72:14, 135:16, 144:23, 147:12, 154:24courtroom 230:16courtroom. 4:12, 67:11, 98:16, 174:17cover 39:14, 67:22, 170:16covered 174:13, 186:22, 214:22covers 39:15, 196:20cracked 150:4craftsmanship 219:16create 5:3, 49:5, 166:12created 5:2, 23:7, 47:22, 47:23, 48:3, 62:24creating 12:11creation 47:14, 49:13creativity 181:5credible 222:2

criteria 85:10, 103:7, 113:3, 113:6, 113:14, 150:25critical 8:14, 77:20, 112:23, 119:18, 123:10, 137:9, 137:14, 219:20, 238:2crop 84:14CROSS 67:18, 98:22, 174:22, 240:10, 240:12, 240:14cross-examination 62:3cross-examining 226:7CRR 3:40, 242:13CSR 242:2culture 19:22cup. 93:14cups 93:13, 171:4Current 35:16, 39:2, 126:17, 146:8, 167:17, 167:19, 222:14, 223:19, 223:23, 224:5currently 10:1, 69:1, 217:11, 222:16, 226:3custom 6:12, 43:21customer 15:25, 16:2, 16:7customers 167:15, 167:17, 167:19cut 204:15, 233:14cycle 11:2, 29:21, 38:17, 96:7, 162:4, 162:7, 164:24cycles 38:17, 38:20, 39:4cyclist 160:10cylinder 10:21,

30:4, 37:16, 126:12Cytotoxicity 56:15, 57:8, 232:7, 232:11, 232:23, 233:7

< D >Dallas 1:3, 2:37, 3:12, 3:42, 4:6, 242:16damage 52:10, 210:21, 236:15Dan 11:4, 12:14dancing 95:18data 13:10, 26:12, 43:18, 43:21, 43:24, 88:15, 89:15, 96:5, 134:25, 135:16, 135:18, 135:19, 140:5, 147:20, 148:20, 154:12, 187:23, 189:4, 190:19, 190:24, 217:17, 223:12, 224:9, 225:19data. 35:17, 146:11Database 148:7, 149:22, 150:2, 150:9, 150:11, 150:13, 241:37Database148 241:37datapoints 220:3dataset 202:14, 202:15date 34:23, 35:4, 35:5, 91:9, 96:1, 96:2, 96:19, 96:22, 97:10, 100:20, 100:22, 126:21, 133:16, 191:24dated 82:22,

251

104:10dating 31:5, 58:18Daubert 38:7Dawn 170:18day 19:17, 39:18, 87:17, 87:21, 87:23, 87:24, 88:4, 88:10, 88:21, 90:23, 91:10, 99:12, 106:22, 121:16, 123:20, 152:22, 242:8days 91:15, 91:18, 124:10, 125:16deal 13:24, 75:1, 90:9, 90:20, 106:10, 124:9, 136:14, 136:21, 137:8, 137:14, 158:15, 171:5dealing 5:20, 29:9, 126:24, 155:24, 165:20, 237:3deals 79:8, 90:16, 99:9, 173:22dealt 171:4, 176:22Dear 163:8debatable 94:23debate 10:3debating 63:12debris 39:20, 77:9, 81:12, 93:21, 93:22, 166:14, 176:1, 183:20, 184:7, 192:17, 193:2, 195:10, 206:15, 206:18, 212:5, 212:7, 225:17, 226:2, 226:9, 236:1, 236:20, 236:24December 26:6,

79:19, 104:5, 138:18, 153:24deceptive 218:15decide 72:19decided 31:3, 73:14, 89:11deciding 72:23decision 126:18, 151:8, 175:10, 222:19decisions 65:3deck 53:22Decker 68:18deep 71:24, 210:16defect 61:18, 61:21defective 203:19Defendant 47:7, 74:19, 84:2, 102:4, 234:2DEFENDANTS 2:33, 65:14DEFENSE 241:39deferred 21:23, 178:24define 81:11, 156:14defining 109:15definition 109:10, 109:18, 109:20, 110:4, 110:8, 110:14, 110:16, 135:13definitions 151:13definitive 42:23, 194:10definitively 146:17deformity 213:13defrauded 63:4degradation 222:12, 223:17degree 29:22degrees 11:7, 11:19delay 154:23delaying 154:22deliberate 78:9

delicate 154:15deliver 165:24, 166:11delivered 194:24delivering 154:16delivery 154:19demand 166:12demonstrate 33:16, 223:13, 224:9demonstrated 85:9demonstrative 145:17, 159:3, 159:18Denied 241:3, 241:41DENNIS 3:26Department 21:22, 99:9, 158:6, 163:1, 178:22dependent 219:21depending 52:3, 53:23, 162:25, 195:12depends 27:21, 156:14, 186:6deposition 68:14Depuy-approved 159:1Depuy. 113:20Depuy/warsaw 30:17Depuy34 241:29Describe 12:1, 15:8, 45:2, 99:18, 99:19described 21:20, 33:21, 34:3, 39:11, 44:8, 45:16, 96:5, 96:7, 96:14, 122:6, 233:10, 233:16describes 92:8describing 33:19, 47:16, 74:10

Description 33:16, 83:8, 84:11, 111:14, 122:10, 129:21, 130:10, 131:24, 241:3, 241:41design170 241:13designed 38:10, 51:2, 75:15, 94:17, 101:1, 219:14designers 23:8, 166:6designs 51:1desire 217:6desires 217:18, 218:3, 218:9, 222:25desk 21:12detail 56:21detailed 30:16, 57:13, 136:6details 36:23, 147:7, 176:11, 176:14, 176:15determination 151:14determine 30:4, 129:19, 202:9develop 18:18, 209:22developed 96:10, 167:2, 175:7development 5:24, 8:4, 8:6, 9:13, 11:2, 14:5, 14:14, 15:3, 16:15, 18:5, 18:12, 18:22, 19:2, 20:17, 58:8, 58:21, 60:25, 61:1, 70:9, 70:10, 126:13, 130:5, 155:8, 180:17, 181:8development. 155:10developments 18:20

252

devices 6:12, 8:7, 26:12, 36:3, 40:19, 42:23, 45:17, 45:18, 60:4, 76:16, 94:1, 114:1, 163:11, 194:15devices. 163:15DHF 15:4diameter 31:11, 33:6, 93:14, 93:15, 114:7, 115:6, 115:16, 116:2, 127:17, 236:6diameter. 135:5diameters 86:16diametrical 35:16, 145:21, 146:8, 220:22difference 11:19, 20:21, 31:19, 32:23, 92:16, 103:24, 108:2, 108:4, 108:5, 108:12, 143:2, 144:24, 186:19differences 19:22, 116:21, 116:24, 116:25, 117:1differently 88:5, 117:9difficult 151:9, 196:13dimension 103:14dimensions 93:20, 135:4, 137:4dinner 47:1DIRECT 4:21, 9:14, 16:12, 24:1, 240:8direct-to-consumer 163:5, 163:9, 163:11directed 55:1directions

16:22, 32:13directly 13:2, 20:19disability. 235:25Disagree 60:3, 60:11, 63:5, 110:8, 114:25, 197:25, 201:6, 204:17, 215:1, 218:16, 218:18, 221:6disagreed 218:2disagreeing 228:12disagreement 186:18disassemble 16:11disclose 60:20, 225:22, 226:15disclosure 73:19discount 58:16discovered 34:15, 145:24discrete 31:15discuss 52:1, 56:13discussed 39:17, 43:25, 57:1, 57:7, 60:20, 65:16, 100:4, 100:6, 122:11, 122:14, 126:8discussing 129:24discussion 57:13, 167:25, 168:7discussions 176:18, 192:22, 199:4dislocate 237:7Dislocation 151:17, 210:25dislocations 151:15dislodge 38:4disorders 235:25disregard 13:5

distinct 156:9, 160:20, 210:18distinctions 214:5distributed 48:10, 53:6distributes 164:4District 1:1, 1:2, 1:21, 4:5, 4:6, 4:7, 242:15diverse 19:7diverting 105:12Division 1:3, 242:16divisions 200:15DNC 35:10Docket 1:4doctor 162:14, 177:8doctors 21:11, 74:4, 174:25, 179:2, 209:19, 209:23, 227:1, 227:2, 231:14, 233:8, 234:6, 234:14, 234:15, 237:11Document 1:9, 22:21, 47:15, 49:14, 49:15, 54:16, 54:17, 78:8, 78:25, 98:25, 129:1, 147:1, 147:23, 155:17, 157:7, 157:18, 157:20, 159:3, 163:3, 165:18, 167:3, 167:6, 175:2, 178:19, 198:11, 217:3, 234:21, 235:11, 235:13, 235:21documentary 25:1documentation 14:9, 14:23, 15:1, 18:10, 22:12, 113:25, 177:24

documented 85:25documents 13:7, 47:6, 48:9, 48:10, 79:3, 79:7, 96:17, 165:19, 169:12, 172:13, 195:18, 234:18, 241:25documents79 241:25doing 5:7, 7:5, 39:19, 69:16, 95:24, 97:23, 99:10, 99:21, 104:14, 140:10, 182:12, 189:7, 189:8, 201:3, 208:16, 215:12, 215:14doing. 90:5dollars 11:11domain 42:18, 58:1, 159:4dome 10:9, 12:6done 17:17, 19:10, 19:15, 24:10, 37:25, 38:5, 38:21, 44:22, 45:4, 48:9, 57:5, 58:17, 68:8, 78:15, 79:6, 81:11, 88:19, 100:15, 106:22, 112:20, 117:2, 117:18, 117:25, 124:1, 143:14, 145:2, 169:6, 183:12, 183:14, 183:16, 183:20, 185:25, 186:7, 187:4, 187:16, 196:15, 196:17, 204:14doors 181:6dots 220:20, 220:21, 221:1, 221:2double 160:11, 166:10

253

down 15:17, 28:3, 86:9, 95:8, 95:19, 99:1, 102:11, 105:7, 107:8, 120:21, 135:23, 136:1, 136:3, 161:21, 210:5, 211:3, 213:8, 220:19, 235:24downplayed 60:8dozens 147:24, 150:23drafts 217:13drawing 16:15, 86:21, 86:22, 119:20, 119:25, 130:10, 130:20Drawings 33:23, 93:19, 103:10, 103:19, 119:9, 119:10, 119:24, 120:13, 121:9, 129:18, 130:6, 133:7, 145:25Drive 3:32, 10:23, 223:1driving 189:7Drug 14:18due 22:1, 36:22, 51:2, 147:6, 152:22, 211:20, 222:12, 223:16durability 176:5Duraloc 9:18, 10:1, 10:6, 10:20during 8:3, 36:4, 37:4, 53:5, 147:11, 147:15, 210:7dynamic 154:21

< E >E. 3:1earlier 39:22, 74:20, 83:7, 122:6, 123:8, 145:14, 148:8,

166:20, 178:3, 182:9, 187:10, 198:11, 222:24, 227:22, 234:9early 17:12, 39:22, 50:25, 59:6, 176:18, 183:9, 199:4earn 12:22earned 22:2easy 37:22eat 225:14Ed 1:20, 4:7edge 32:12, 52:16edit 170:22editing 172:17educate 48:11, 58:6educating 42:17, 46:3, 46:4, 46:23education 53:6Educational 46:2effect 33:23, 38:12, 42:4, 154:23Effective 31:13, 31:14, 32:4, 33:9, 33:15, 33:17, 33:19, 34:2, 83:18, 102:18, 108:5, 108:6, 108:22, 108:25, 109:1, 109:2, 109:7, 111:21, 122:16effectively 199:23effectiveness 76:17, 107:3, 141:20, 208:2effects 183:20, 183:25, 184:22, 210:15, 212:13, 212:18, 213:10, 215:6, 216:15, 216:17, 216:19, 219:19, 225:17efficacy 76:18

efforts 46:2Either 16:10, 17:22, 20:16, 41:12, 46:7, 47:2, 52:5, 97:18, 114:10, 148:16, 183:17, 199:14, 204:8, 233:9Ekdahl 139:13, 217:11, 221:23elaborate 122:6elements 214:21elicit 217:18, 218:2, 218:9, 222:25, 225:7, 226:20, 233:3eligibility 105:8ELMO 4:24, 11:23, 22:19, 75:7em 87:7, 118:20, 121:7, 153:1Email 3:14, 3:35, 30:16, 68:16, 90:10, 91:18, 92:8, 92:22, 94:11, 97:8, 99:15, 125:15, 125:16, 130:21, 133:4, 133:14, 134:8, 135:22, 144:19, 170:13, 170:19, 175:4, 175:5, 175:8, 176:16, 188:1, 188:2, 188:3, 198:15, 215:11, 216:8, 217:9, 218:10, 218:12, 221:16, 221:18, 222:17, 241:21, 241:31, 241:50Email125 241:31emails 69:19, 89:24, 91:7, 91:9embraced 65:14

emphasize 52:11emphatic 11:4, 11:13Empowered 160:11End 7:19, 7:22, 16:18, 16:24, 19:10, 19:12, 20:2, 20:24, 31:5, 72:4, 75:11, 101:9, 140:4, 144:13, 162:1, 167:2, 172:9, 228:1, 228:18, 228:19, 228:24, 238:18ended 11:10ending 135:24, 217:17engaged 5:14Engh 45:4, 162:15engineer 59:24, 75:6, 86:17, 86:19, 130:5engineering 8:22, 9:12, 16:2, 16:6, 16:15, 17:10, 33:22, 47:17, 50:2, 70:12, 75:2, 86:12, 86:15, 103:10, 120:13, 130:20, 145:25, 155:12, 155:13, 219:15, 220:14engineers 58:14England 19:21enlarge 34:23enough 59:25, 194:10, 195:1, 204:6, 206:3ensure 52:11, 77:3, 77:15, 219:17, 219:24enters 4:12, 67:11, 98:16, 174:17entice 214:24entire 31:24,

254

125:20, 126:25, 171:5entirely 85:21entities 156:17entitled 163:10, 242:4environment 154:14epidemiological 223:12, 224:9equate 39:8equation 176:19equipment 42:17, 118:21, 219:16equivalence 33:16, 80:19, 185:4equivalent 44:13, 76:17, 76:19, 103:5, 104:15, 106:8, 106:10, 107:6, 113:25, 114:15, 134:17, 141:20, 142:13, 142:25, 193:11equivalents 135:3ERNEST 1:38, 1:39especially 53:1, 71:25essential 236:4, 236:5, 237:24essentially 65:12established 148:13, 154:12estimate 198:4estimated 173:17et 193:1ethical 179:11European 7:5evaluation 154:11evaluations 17:22event 9:9, 36:16, 36:17, 36:22, 147:24,

148:12, 151:12events 35:25, 36:1, 36:2, 36:5, 36:13, 36:14, 36:20, 37:2, 48:24, 49:3, 146:22, 146:23, 146:24, 147:10, 147:16, 151:11, 152:14, 152:15, 152:25, 160:25, 237:1, 237:2, 238:8events. 37:6Eventually 29:25everybody 77:8, 226:8everyone 71:19, 226:8Everything 64:17, 81:13, 88:3, 100:12, 136:16, 186:15, 238:1evidence 24:22, 25:1, 31:14, 43:14, 43:15, 43:17, 44:17, 61:24, 61:25, 62:1, 62:9, 65:20, 161:3, 172:8, 191:2, 191:13, 222:14, 223:19, 223:23, 224:5evolves 216:4Exact 12:23, 13:10, 33:3, 33:7, 81:22, 87:23, 96:22, 148:12, 187:7, 214:21, 229:18Exactly 9:22, 10:25, 31:10, 31:22, 32:4, 96:17, 195:21, 202:16, 215:2, 219:5, 219:10EXAMINATION 4:21, 67:18,

98:22, 148:11, 174:22, 240:8, 240:10, 240:12, 240:14examining 39:20example 9:16, 10:17, 19:1, 24:6, 27:15, 32:22, 41:2, 45:16, 52:5, 53:14, 55:11, 69:15, 96:18, 148:6, 150:5, 161:8, 184:25, 200:2, 203:21, 207:2, 238:5Examples 38:1, 38:14excellence 180:17, 180:23excellent 19:14excess 39:9exclusive 164:13exclusively 18:13Excuse 81:16, 119:16, 131:21, 157:2, 201:25, 204:24, 232:12executive 168:20EXHIBITS 47:7, 106:24, 241:1, 241:39exist 58:4existing 89:5exists 116:8expand 71:2expanding 42:17expect 32:7, 33:4expected 32:1, 137:22expects 150:25expedite. 167:4experience 9:14, 10:10, 21:21, 43:19, 46:16, 59:2experienced 148:14

experiences 46:21experimental 45:18, 45:22expert 38:7, 230:13expertise 11:18experts 42:15, 85:24Explain 29:17, 29:18, 31:18, 32:19, 145:5explanation 30:20, 93:4explants 40:12export 149:22, 150:2exposure 211:9expressed 222:13, 223:17extended 77:3extends 52:21extension 70:11extensive 219:16extent 64:8, 146:25extra 139:21, 139:22, 167:20, 174:13extract 38:3extraordinary 181:5extreme 32:23extremely 24:6, 41:6, 134:8extremes 52:7

< F >f'ing 71:17face 10:4, 10:5, 11:24, 52:21, 72:19, 72:20, 72:23, 72:24, 214:16facility 7:12, 19:5, 26:21, 46:7, 46:9, 136:5fact 21:12,

255

34:5, 42:11, 76:4, 92:23, 99:24, 104:19, 105:20, 113:17, 115:6, 124:12, 129:17, 131:6, 143:22, 154:6, 158:8, 164:22, 165:4, 170:22, 173:21, 193:4, 193:25, 196:17, 221:13, 222:23, 225:16factory 116:23facts 161:2, 198:22fail 190:25, 236:8failed 64:1, 123:4, 216:22, 216:23, 231:10, 231:13, 231:25, 232:1, 232:9, 232:13, 232:16failing 166:20, 191:10failure 36:20, 38:3, 61:15, 147:5, 211:4, 211:25, 230:2, 230:5, 231:14failure. 229:23failures 59:15Fair 25:12, 25:13, 25:15, 69:12, 70:17, 103:23, 179:5, 179:15, 181:21, 213:4falls 235:24false 82:5, 82:9, 82:12, 87:22, 88:15, 90:24, 107:20, 114:10, 114:11, 114:17, 114:24, 125:5, 125:9, 125:10, 128:6, 128:8, 128:13, 169:15, 176:9,

218:15, 229:24falsehood 84:22, 84:24, 88:10familiar 159:12, 159:14, 159:16, 161:8, 165:9, 175:2, 176:11, 177:3, 228:22, 228:23family 159:20Farrar 193:5Farrar. 194:2fast 112:7, 166:14, 196:15faster 59:4, 167:4, 236:8favorite 173:15feature 88:23features 37:23, 38:9, 38:12, 164:18, 235:2February 150:15federal 62:17feedback 16:12feel 60:5, 60:20, 78:14fees 242:5Fehring 72:5, 72:13, 72:14, 73:1, 73:15fellow 160:1, 215:12felt 19:24femoral 27:1, 37:4, 37:25, 51:5, 52:14, 116:3, 120:2, 120:8, 157:1few 65:1, 65:2, 69:1, 69:10, 95:7, 124:10, 133:6, 152:22, 185:20, 203:10, 215:6, 216:11, 216:15fibrous 211:1fide 23:1Fifth 63:5fight 71:18, 167:7

fighting 71:14figure 30:1, 90:20, 106:3, 112:19, 120:19, 124:13, 189:9file 15:1, 15:3, 15:6, 35:10, 79:11, 79:14, 79:16, 113:19, 114:16, 115:1, 115:3, 115:25, 117:5, 117:19, 118:16, 118:19, 120:17, 120:22, 121:8, 121:9, 139:1, 140:5, 145:20, 153:14, 153:24, 228:25file. 135:18filed 117:13, 121:7, 149:21, 149:23, 150:1files 15:7, 15:12, 79:2, 84:5, 111:3, 120:17, 149:16, 149:19, 155:18filled 198:19film 162:3Final 17:24, 19:12, 133:7, 139:11, 140:19, 140:21, 154:12, 169:17, 189:2, 200:1, 200:2, 215:7, 216:4, 222:22, 236:13Finally 50:7, 57:15, 124:18, 134:12financial 179:12, 198:1find 9:3, 25:1, 31:24, 40:10, 82:21, 84:8, 102:1, 120:16, 120:18, 121:7, 121:8, 121:9, 134:2, 186:17, 192:13, 205:13,

205:19, 207:16, 228:16, 229:17, 232:23finding 83:12fine 66:19, 66:20, 190:12, 215:5finger 84:12, 211:3finish 43:3, 137:1, 140:10, 141:7, 205:7, 205:8, 205:21, 206:8, 219:20finished 113:22, 114:11, 116:3, 138:21, 186:12Firm 1:32, 3:31, 9:24firmly 9:24, 148:13First 7:10, 17:7, 18:21, 23:1, 26:4, 26:18, 30:15, 31:5, 43:2, 49:21, 50:21, 59:12, 66:9, 79:17, 81:4, 83:21, 96:6, 104:11, 111:19, 141:24, 142:1, 142:3, 142:8, 148:16, 151:5, 157:23, 167:13, 170:11, 172:1, 172:9, 172:24, 182:12, 216:7, 225:25, 235:25Fisher 2:10, 2:11fit 33:5, 33:8fits 158:13five 4:15, 27:19, 59:12, 64:2, 99:2, 146:4, 146:6, 146:24, 150:22, 152:5, 170:23, 176:8, 200:19,

256

200:21, 200:25, 201:9, 231:25five-year 185:8, 185:19, 185:22five. 92:13fix 123:5, 145:1, 212:1fixation 38:11, 50:16, 50:21, 51:1, 51:7fixing 122:25fixture 27:7, 29:23, 29:24fixtures 26:23, 27:5flip 104:9Floor 2:13, 2:22flow 129:9Floyd 172:22, 173:1, 241:15fluid 162:3, 164:23FM 1:33focused 77:1, 84:17, 154:18, 217:16FOIA 145:17folder 79:8folks 20:15, 40:21, 188:16follow 109:18, 109:20, 110:4, 110:14, 124:1, 143:6, 143:19, 189:19, 211:3follow-up 154:2, 167:24, 168:7follow-ups 189:11followed 14:10, 14:13, 183:9, 217:16Following 57:13, 102:21, 105:11, 106:18, 114:13, 144:17, 145:18, 177:15, 190:11, 210:14, 210:17, 237:2Food 14:18

for. 178:14force 38:4, 46:3, 46:24, 48:11, 49:9, 55:1, 57:5, 60:15, 74:2, 226:25, 227:16, 227:19, 229:11, 230:1, 230:8, 231:7, 231:24, 233:8foregoing 242:2, 242:3foreign 211:9forget 90:9forgot 64:1, 88:24forgotten 122:2form 36:11formal 14:9, 65:1format 22:11, 242:5formation 210:17forms 35:25, 83:20forth 28:5, 28:7, 28:18, 88:22fortunate 20:17Forum 55:9, 56:8forward 5:17, 5:22, 7:20found 26:18, 33:25, 44:9, 141:9, 154:14, 228:24, 235:17foundation 151:24four 20:16, 27:19, 56:5, 92:18, 104:16, 226:6, 226:7fragmentation 212:4frame 22:1, 50:13, 59:7, 96:11, 96:21, 168:14, 179:3framework 145:13

Frank 30:16, 50:10, 50:11, 50:12, 53:8, 89:21, 94:12, 188:1, 192:23, 215:21, 217:10, 217:21, 218:10, 221:20, 230:13, 241:21fraud 65:13Free 152:22, 176:8Freedom 79:1, 84:4Freeman 3:3frequent 237:2frequently 210:22friction 27:3, 51:3, 91:19, 97:3, 164:5, 219:25frictional 93:25Friday 100:12, 101:9, 101:17, 105:4, 137:9, 137:14frivolity 71:11front 13:11, 16:18, 91:10, 102:4, 178:12, 218:19, 221:18, 221:19, 224:15, 234:7, 234:8frown 12:11frowny 10:5, 72:20, 72:23fruits 21:6full 7:16, 137:11, 164:23, 171:9, 226:2, 237:20fully 42:20, 94:12, 237:18fun 71:23function 26:11, 30:6, 77:3, 77:15, 184:3funnel 158:25fuss 106:9,

164:7, 232:18fussing 232:19future 5:19, 45:8, 71:7, 90:1

< G >Game 162:1, 228:1, 228:18, 228:19, 228:24gap 27:2, 33:1, 33:3, 33:10gauge 45:21gave 36:23, 53:5, 62:2, 82:21, 111:1, 111:5, 132:20, 139:17, 147:7, 182:8, 191:16, 192:7, 202:5, 205:4, 222:24, 227:25, 233:25gee 123:5general 50:4, 54:10, 153:22, 163:23, 177:7generally 41:25, 190:25generated 39:21, 41:5generating 40:25generation 51:1, 58:3, 217:3gentleman 161:25, 162:9geometry 205:8, 205:20, 206:7Germany 221:24gets 149:17, 198:8getting 11:7, 19:17, 69:9, 71:7, 87:22, 175:16, 191:17, 214:8, 214:9giant 233:15girl 20:23Give 11:8, 16:7, 60:5, 62:4, 62:20, 64:15,

257

64:16, 64:17, 78:25, 81:5, 81:7, 83:19, 89:17, 89:20, 96:19, 96:22, 97:19, 111:3, 118:20, 129:1, 149:24, 149:25, 169:19, 170:8, 170:16, 170:19, 192:5, 206:24, 214:5, 214:13, 218:22, 221:16, 224:17, 229:2, 229:7Given 35:19, 53:15, 53:23, 58:3, 60:4, 62:5, 62:6, 90:23, 94:13, 118:18, 118:20, 118:25, 120:21, 145:6, 146:18, 192:8, 202:5, 213:19, 213:21, 217:12, 235:15Gives 51:14, 73:19, 229:5, 229:8giving 181:18, 192:10, 192:11, 221:9glad 61:13glance 196:25glimpse 131:19, 131:22global 18:21goal 57:23, 154:19gobbly 220:19God 4:9Goldsmith 30:14, 89:22, 91:19, 91:23, 97:15, 215:2, 216:10, 217:11golf 32:24, 32:25golfing 160:13gook 220:19

Gorsky 167:24, 168:15gotten 140:4, 140:11, 140:25, 141:3, 195:5government 134:1, 136:5Graham 161:12, 161:25, 162:15, 228:1, 228:21grant 96:7granted 66:12granting 66:12grants 156:25granulomas 230:8Graph 219:25, 220:1, 220:4, 220:8, 220:10, 220:12Great 20:3, 60:23, 63:20, 103:21, 217:6, 217:18, 218:2, 218:9, 222:25, 234:12greatly 134:7Greek 81:8GREER 1:12Grooms 2:44group 47:4, 154:13groups 7:5, 56:10grow 211:25growing 166:13grows 133:21growth 166:15, 166:16, 167:1guess 63:25, 71:23, 110:7, 127:5, 212:24guide 48:20guy 20:23, 21:3guys 71:7, 72:22, 204:14, 221:24

< H >H. 1:38, 3:16

Haas 204:22, 207:2, 207:3, 207:10habits 24:4half 19:16, 68:14, 153:4hallmarks 51:13hand 8:15, 22:4, 31:17, 34:20, 47:6, 49:10, 68:9, 229:19handed 76:9, 197:17, 234:5, 234:9handing 84:2, 153:13, 169:12, 172:21handled 153:10handling 162:23handmarked 103:11hands 16:10, 17:22Hanly 2:20happen 59:9, 59:10, 59:16, 59:17, 65:21happened 6:7, 6:9, 6:11, 7:18, 19:4, 94:5, 123:23happening 31:2, 93:2happens 7:9, 80:11, 122:5, 231:24hard 4:15, 21:6, 66:23, 83:12, 154:17, 166:14, 192:24, 222:1harsh 78:3HCP 24:11, 24:15he'll 71:8, 105:14head 10:22, 27:1, 30:21, 31:23, 37:4, 69:21, 76:25, 77:2, 93:11, 115:6, 116:3,

120:2, 147:11, 148:10, 155:6, 155:24, 156:20, 165:13, 168:4, 196:12, 199:25, 236:7head. 167:8headed 97:6Heads 31:17, 70:4, 70:11, 70:15, 93:10, 120:8, 157:1, 213:1health 159:20, 184:13, 184:19, 184:24Healthcare 24:3, 24:16, 24:21Hear 15:4, 62:3, 160:10, 171:8, 208:20, 238:14heard 12:21, 50:25, 64:14, 204:21hearing 176:13hearsay 8:25, 13:3, 148:21, 150:16, 151:23, 159:9, 160:4heck 200:21held 139:11, 181:1, 192:22Hello 173:14Help 17:8, 17:11, 31:18, 48:11, 58:6, 70:16, 77:3, 83:19, 129:1, 133:24, 167:3, 167:11, 229:17helped 20:20, 50:9, 70:7, 72:19helpful 236:10helps 139:20, 139:22herself 154:14heterotopic 210:17hid 60:8

258

hide 133:11hiding 121:1, 121:4High 15:17, 27:3, 40:6, 40:7, 51:3, 69:25, 91:20, 222:2higher 12:8, 92:19, 143:25, 144:2, 144:3, 211:19, 232:1highlighted 143:4, 171:14, 193:21, 202:18, 219:8, 223:9, 224:19highlighting 113:8highlights 56:5highly 133:25, 217:15, 236:13hill 95:19hint 89:20, 224:17hipreplacement.com 158:25, 159:4hips 160:12, 162:23, 168:4, 190:24, 191:17, 198:8HIRSCHHORN 2:28Histological 211:8historical 50:1, 139:25history 15:3, 15:5, 15:7, 15:12, 227:24, 227:25HOEKSTRA 2:3Hold 12:3, 85:23, 138:2holds 74:15hole 10:1, 10:6, 10:20, 10:23, 11:5, 11:16, 12:5, 12:8holes 8:18, 9:20, 10:4,

10:9, 10:17, 11:24, 12:6, 12:9, 72:20honestly 156:4Honorable 1:20, 4:6, 4:9hope 65:22, 208:20hospitals 25:8host 50:22hour 162:15hours 65:1Houston 1:34, 2:14Huguenard 2:12hundred 73:9, 89:25, 97:17, 97:22, 139:18hundred. 90:1, 126:14hurdles 20:1hurrying 166:17hurt 184:19Hypersensitivity 56:13, 57:2, 225:11, 225:12, 229:13, 229:15, 229:22, 230:2, 230:3, 231:6, 231:13, 231:24

< I >I-- 13:21icky 205:25IDE 6:16, 7:19, 7:22, 43:22, 45:16, 45:24, 118:3, 118:7, 182:19, 184:21, 185:1, 190:2, 190:4, 190:8, 190:9, 190:14, 190:18, 191:16, 191:23, 191:24, 192:10, 192:13, 193:10, 194:16, 194:24, 200:18, 201:16, 203:8, 203:12, 203:23,

204:7, 204:11, 207:3, 207:11, 208:6, 208:15, 210:4, 213:23, 225:4idea 74:8, 90:22, 179:16, 192:22identical 80:3, 107:10, 134:25, 145:21Identified 22:4, 27:10, 60:16, 112:1, 219:20, 241:3, 241:41identify 15:20, 17:8, 103:2identifying 220:11identity 179:10Ides 45:8IFU 209:11, 210:5, 212:19, 212:21Ifus 60:13, 209:15, 209:22, 210:3, 210:6, 212:25, 213:17, 213:18image 35:10imagine 52:8, 64:9, 67:22, 156:14immensely. 70:16immune 225:7, 226:20, 233:3impact 44:20, 52:2, 103:3, 222:2impactful 10:14imperative 76:10, 77:3, 77:15, 77:21, 77:23, 81:12, 88:2, 88:10, 88:23, 101:7, 105:21, 112:23, 130:16imperative. 78:11

impinge 52:8, 52:9impingement 52:3IMPLANT 1:5, 29:24, 50:22, 51:5, 51:15, 52:7, 59:10, 59:15, 59:19, 77:11, 77:22, 79:9, 105:22, 130:16, 164:5, 164:12, 172:9, 211:10, 213:5, 213:6, 213:7, 220:23, 229:23, 230:5Implanted 6:4, 7:10, 97:1, 211:14, 211:18implanting 6:12implants 11:12, 30:6, 30:24, 43:21, 44:18, 50:1, 56:6, 58:3, 59:2, 97:1, 182:19, 194:18, 197:24, 225:21, 232:9, 232:13, 232:21, 235:23implants. 232:17implies 78:14importance 69:25, 91:20important 40:20, 44:16, 51:11, 62:23, 71:8, 75:14, 76:1, 81:12, 97:3, 101:7, 192:24, 222:10, 223:15impression 202:1improper 23:23, 24:14, 210:25improve 44:18improved 222:7in. 4:11, 119:14, 121:16, 174:16inaccurate

259

58:16, 177:2inadvertent 157:25inadvertently 157:19Inc. 1:5, 163:25, 169:21inch 140:1, 152:3include 107:16, 107:17, 158:7, 215:6, 216:11, 237:16, 237:25included 22:15, 88:18, 95:20, 95:22, 95:23, 149:8, 149:24, 222:21includes 140:21, 207:13including 59:25, 160:1, 164:14inclusive 237:23inconclusive 192:14, 194:17inconsistency 34:3, 34:18Inconsistent 125:12incorporate 216:3incorporated 171:6, 184:20incorporates 184:24, 234:16incorporation 181:15Incorrect 88:18, 91:13, 99:24, 145:25, 186:10, 217:8Increase 52:25, 89:24, 93:14, 93:15, 93:17, 94:3, 94:8, 222:10, 222:14, 223:13, 223:20, 223:24, 224:6, 224:10increased

211:20, 213:12incredibly 10:13independent 18:3, 18:7, 25:14, 124:2, 124:4independently 18:9, 219:20INDEX 240:1Indianapolis 3:19indicate 113:8indicated 140:13indicated. 148:18indicating 35:11, 101:9, 114:11, 126:1, 229:20, 230:11individual 163:21, 197:5individuals 60:21infancy 95:12infection 151:16, 210:16, 237:8Inflammatory 56:22, 225:7, 230:7, 233:2influence 24:4info 111:12informed 103:24initialed 103:12, 121:20initially 22:2, 33:13initials 121:20inner 93:14, 93:15, 114:6, 115:5, 115:16, 116:1, 135:4, 236:6innovative 181:8input 8:11, 8:13, 8:14, 15:19, 15:25, 16:2, 216:4inputs 17:7, 175:5

inquiries 135:24insert 37:3, 38:13, 44:7, 52:9, 77:2, 86:16, 115:2, 150:14, 204:25, 235:16, 236:6, 236:7, 236:17insertion 48:2, 48:20, 235:15inserts 219:12, 219:23, 235:5inside 9:23, 10:3, 10:15, 20:16, 43:20, 75:9, 75:15, 104:17, 209:16insight 179:22insights 178:20INSKEEP 3:16instances 18:24, 21:25Instead 11:7, 33:17, 33:19, 87:13, 117:13, 118:18, 138:9, 185:2, 196:18, 203:14Institutional 198:12instructed 13:4instruction 231:2instrumental 73:4instruments 11:17integration 6:19intellectual 155:25intelligence 68:21, 68:22, 179:23, 179:24intended 19:16, 26:11, 33:25, 80:19, 107:14, 175:8, 179:17intent 73:13, 146:17intentional

62:15intents 80:15interact 107:18interaction 52:15, 219:22interest 58:2, 204:15interested 59:1, 167:19interface 37:24, 38:4, 38:6, 51:4, 52:10, 73:5interfacing 74:3internal 43:18, 48:5, 49:9, 137:20, 137:24Internally 100:22, 195:17International 7:4, 7:14, 19:1, 20:17interpreted 117:9interrupt 131:19, 152:20interrupted 152:22intervention. 212:14intimate 10:15intimately 181:16intraoperative 51:15intrigue 179:21introduce 60:1introduced 161:10introduction 44:23, 154:17, 154:22intuition. 94:4intuitive 24:25inventory 11:11investigated 195:14, 195:20investigating 207:21, 208:12investigation

260

148:15, 208:1investigational 207:18, 208:23, 209:7involve 6:19involved 6:23, 8:4, 9:7, 17:3, 17:6, 17:13, 18:4, 18:14, 21:16, 21:19, 25:25, 42:1, 44:25, 70:5, 70:8, 71:24, 73:25, 74:1, 74:2, 74:3, 142:21, 155:6, 155:9, 156:13, 165:13, 166:25, 181:16, 181:20, 199:4involvement 8:20, 26:7, 47:14, 49:13, 69:11, 162:21, 170:1ion 45:3, 164:6, 193:2, 194:19, 211:19, 225:17ionic 225:1ions 55:23, 166:14, 167:17, 176:1, 192:17, 211:15, 211:18, 213:8, 224:16, 224:18, 225:4, 225:7, 225:16, 225:24, 226:3, 233:3IRB 198:10, 198:19Isaac 161:12, 162:1, 162:15, 228:1, 228:21issue 26:14, 29:18, 29:20, 30:5, 51:1, 58:23, 62:12, 62:22, 77:24, 97:3, 124:9, 125:20, 126:24,

157:7, 158:4, 162:22, 184:6, 193:9, 196:17, 198:25issued 53:3Issues 20:13, 49:17, 50:7, 54:10, 54:22, 56:13, 57:20, 58:7, 59:8, 65:17, 75:14, 142:14, 174:25, 176:23, 184:7, 193:1, 193:5, 194:9, 219:15, 221:9, 222:5, 222:20, 232:10, 232:24, 233:9, 236:10, 236:23iterations 15:10itself 23:9, 26:24, 30:6, 59:14, 128:3, 136:12, 148:19, 158:10, 165:1, 189:20, 229:22, 231:23IV 225:11, 225:12

< J >J&J 6:8, 68:23, 153:16, 153:21, 172:17, 172:19, 173:2, 178:14, 178:18, 179:13, 181:6J. 3:40, 242:2, 242:12, 242:13Jacobs 55:12JAMES 3:30Janet 175:7JAYNE 2:19JBJS 177:[email protected] 2:25JENNIFER 2:3Jeremy 38:7Jim 4:24, 20:7,

22:18, 27:17, 27:25, 28:9, 28:15, 34:23, 35:13, 37:8, 41:13, 42:5, 44:3, 45:5, 47:8, 48:6, 48:15, 48:23, 49:19, 49:22, 50:14, 53:11, 54:1, 55:5, 89:21, 95:3, 98:1, 228:24JJO 58:18JJPI 5:7, 6:20, 7:3JJPO 7:1, 7:3job 19:25, 20:3, 68:19, 69:1, 153:7, 153:8John 3:25, 160:10, 160:12Johnson. 170:20, 180:18Joint 176:23, 180:12, 212:6Journal 176:23journals 41:20, 41:21journals. 168:10journey 160:13, 160:14, 160:15Juan 161:16Judge 1:21, 4:7, 8:24, 13:3, 32:15, 46:14, 66:10, 66:22, 67:1, 83:21, 83:24, 158:14, 158:22, 206:3judges 65:16, 66:12Judicial 242:6July 168:10June 55:19Jury 1:21, 4:12, 13:4, 62:13, 67:9, 67:10, 67:11, 67:17, 69:10, 72:5,

75:7, 98:16, 102:7, 139:13, 155:5, 165:19, 170:14, 172:8, 174:17, 185:25, 192:20, 196:15, 197:18, 198:11, 203:17, 203:19, 204:13, 204:21, 205:12, 206:6, 207:2, 208:20, 214:17, 216:22, 216:23, 221:10, 233:12, 236:18, 238:6, 238:7jury. 4:10, 61:9, 98:11Justice 178:22justification 129:21justify 179:1

< K >K. 160:16Kaderna 45:6Kansas 4:15Keep 15:5, 27:25, 28:9, 28:22, 66:21, 73:17, 83:16, 84:9, 84:13, 105:15, 106:19, 147:4, 154:18, 216:21keeping 165:13, 234:[email protected] 3:21KENNETH 3:16kept 154:4key 51:13, 69:4, 74:3, 92:16, 168:10, 184:7kids 159:14Kilburn 69:20kill 173:14, 233:4killing 232:7kind 20:9,

261

28:24, 38:1, 57:5, 71:10, 86:9, 147:20, 183:21, 194:3, 205:25kindly 216:2kinds 37:18, 235:4Kinkeade 1:20, 4:7KLUSMANN 1:13knee 71:24, 164:2, 164:3knowing 71:25, 88:22, 119:3knowingly 88:19knowledge 10:15, 85:8, 157:20, 159:9, 172:4, 198:14, 222:1knowledgeable 109:23known 40:24, 43:11, 43:12, 45:20, 58:4, 59:16, 59:17, 89:10, 100:8, 117:12, 132:18, 186:25, 209:2, 210:11, 213:9, 226:20, 229:22, 231:14, 231:19, 231:21knows 13:5, 13:24, 13:25, 127:9, 172:5Kupperman 3:2

< L >lab 40:2label 17:25labor 21:6laboratories 40:1labs 16:11, 17:22Lack 151:24, 172:3, 191:1, 191:12, 213:12,

213:13Lancaster 89:21, 98:1, 228:25language 123:8, 222:21, 223:5, 223:6, 223:8LANIER174 240:14LANIER67 240:10LANIER98 240:12lapse 19:17lapsed 71:10, 89:2large 47:23larger 33:5, 47:2, 47:3last 97:10, 106:22, 153:3, 193:21, 224:18, 224:21, 224:24late 11:2, 190:2, 190:14late'90s 172:2later 21:16, 21:20, 34:1, 73:17, 106:10, 111:2, 125:16, 138:17, 146:4, 155:4, 164:7lateral 10:7Latin 81:9lauded 154:1Laughter 174:15launch 39:16, 59:1, 156:2, 162:9, 162:10, 165:22, 166:9, 166:15, 168:8launched 60:7, 194:17launching 70:15Law 1:32, 3:31, 63:2, 79:1lawsuit 158:4lawyer 164:9, 170:3, 177:8lawyers 158:10, 193:1laxity 211:1layer 19:23layout 49:25

lead 27:4, 74:8leader 58:14, 74:5, 74:19, 74:20, 74:23, 75:4leading 19:8, 29:14, 32:16, 45:11, 59:21, 74:8leads 51:16, 217:14LEANNE 4:20, 9:6, 69:20, 70:3, 74:20, 82:25, 85:7, 88:9, 89:21, 90:4, 97:8, 97:11, 99:13, 126:3, 130:1, 133:20, 134:6, 135:22, 154:14, 154:17, 181:9, 198:16, 221:25, 240:6learn 201:12least 18:16, 63:10, 68:15, 70:5, 70:17, 99:19, 118:7, 136:9, 166:6, 169:15, 175:23, 188:1, 199:11, 218:15, 219:8leave 33:1, 33:2, 71:19LEE 2:29Leeds 7:12, 18:19, 19:5, 19:19, 19:20, 26:21, 29:5, 133:21, 136:4, 154:12, 215:13, 221:24Left 7:25, 20:11, 103:15, 112:10, 112:11, 135:8, 201:23, 202:1, 232:25, 233:17, 238:2Legacy 13:8,

13:17, 21:23, 22:9, 70:22, 241:23legal 70:10, 158:6, 158:9, 169:23legal/litigation 193:1legitimate 23:14LEONE 2:30less 9:14, 32:11, 78:3, 103:5, 114:16, 222:8lesser 29:22lest 214:4Letter 34:22, 35:11, 64:10, 79:22, 84:6, 145:14, 145:16, 145:18, 163:3, 163:8, 175:19, 177:15, 241:19, 241:29letterhead 163:20letters 174:24, 178:8level 15:17, 175:15, 175:16levels 164:6LIABILITY 1:6liberties 221:5liberty 221:8Liddell 2:34, 3:10Lie 77:22, 78:3, 136:9, 220:9life 94:16, 94:22, 95:17, 96:4lifestyle 160:11light 34:5, 34:14, 175:13lights 161:21like-to-like 53:2likes 45:19limit 201:15limitations

262

65:15limited 63:2, 189:22, 189:23, 204:10Line 36:21, 70:11, 117:4, 147:5, 202:18, 233:11, 240:4liners 36:1, 36:14, 79:10, 97:16, 97:21, 99:4, 107:10, 145:19, 145:22, 213:1, 220:7, 235:4lingering 166:13link 141:10, 141:15, 142:1, 142:3, 142:8, 142:11, 142:18linked 142:15, 142:16, 231:10, 231:13, 233:7links 142:5, 142:6List 41:16, 120:4, 120:8, 134:24, 157:24, 197:14, 197:18, 198:15, 199:13, 234:18, 241:45listed 112:12, 114:4, 128:8, 209:2, 234:4, 234:18, 234:21listen 61:13, 162:14literature 41:16, 42:17, 56:23, 60:17, 74:3, 195:24, 217:13, 226:13, 241:46LITIGATION 1:6, 69:2Little 2:46, 18:15, 19:15, 28:20, 65:21, 76:9, 155:6, 158:20, 170:22,

173:15, 174:12, 174:13, 190:2, 190:14, 192:10, 210:13, 223:14live 22:17, 53:5lived 58:11LLC 2:20LLP 2:12, 2:34, 3:10, 3:17load 25:6, 27:3, 31:24localized 31:25location. 176:6Locke 2:34, 3:10locked 150:14locking 37:24, 38:11, 38:12, 80:20, 94:1Lofton 62:22, 62:23, 63:8long 11:14, 61:12, 68:5, 70:24, 77:11, 77:16, 77:22, 100:18, 105:22, 130:16, 142:6, 157:24, 226:10long-term 189:23, 222:11, 223:16longevity 77:14, 213:5longevity. 77:4looked 37:23, 42:3, 52:24, 61:13, 83:20, 118:7, 121:15, 121:16looking 23:3, 23:4, 24:19, 24:24, 31:14, 31:15, 31:19, 37:11, 38:5, 38:8, 38:9, 73:5, 76:13, 76:15, 83:17, 84:11, 99:1, 103:6, 135:23, 139:9, 139:10, 145:14, 149:13,

153:15, 172:24, 182:24, 192:6, 210:6, 213:5, 231:23Looks 66:14, 84:21, 147:19, 153:15, 205:25loose 50:23, 236:17, 237:7Loosening 27:8, 51:5, 211:4Lord 2:34, 3:10lose 93:20, 93:23, 102:23lost 70:24, 97:18lot 8:23, 9:13, 12:21, 16:4, 19:23, 20:15, 20:18, 21:2, 21:4, 60:12, 62:5, 67:22, 69:9, 74:23, 162:16, 169:10, 176:13, 192:14, 196:20, 200:22, 232:1Louisiana 2:6, 3:5low 30:22, 41:7, 43:6, 144:3, 144:4, 144:12, 174:12low-to-low 144:9lower 12:9, 30:24, 44:10, 86:23, 92:20, 222:8lowest 164:5lubrication 42:3, 162:3, 162:5, 162:7, 164:22, 164:24, 192:23, 219:24lubrication. 164:19lucencies 212:10luck 136:1lunch 19:18, 83:14, 83:15,

84:15, 96:23, 98:3, 102:1lying 77:25lymphatic 193:5, 194:2

< M >M. 2:3, 3:30Macdonald 45:5machine 27:11, 28:4, 28:24, 29:7, 29:10, 29:17, 30:15macrophage 225:6, 233:15macrophage-mediated 225:6, 233:2Madison 2:21Magic 71:16maintain 15:5, 15:7, 219:23, 220:8maintained 14:24maintaining 40:25, 69:2major 56:5, 138:2, 230:4manage 154:15manager 21:21manner 110:16manufacture 16:24, 40:20manufactured 7:11, 7:12manufacturer 18:18, 62:19manufacturers 41:2manufacturing 16:14, 16:16, 18:20, 19:4, 164:14March 70:23, 70:24Margaret 165:14Mark 1:30, 67:20, 78:22, 95:13, 165:22marked 103:10,

263

129:18, 157:10market 9:17, 25:12, 25:13, 25:15, 44:23, 58:15, 58:24, 59:4, 60:2, 136:12, 138:9, 138:11, 138:13, 138:16, 154:7, 156:25, 165:15, 166:16, 166:17, 166:21, 167:1, 187:5, 188:6marketed 138:19marketing 43:16, 65:17, 69:21, 69:22, 69:24, 70:1, 72:1, 156:19, 168:4, 198:13, 221:24marketplace 154:22Marlene 163:22, 169:19, 170:3, 170:18, 170:19, 172:18, 172:19, 172:22, 173:2, 175:5, 175:7, 177:6marries 204:25mass 191:10MASTER 3:30match 10:22, 133:22, 167:8material 40:4, 40:5, 80:19, 206:7, 206:16, 211:9materials 22:16, 38:9, 41:1, 46:24, 49:8, 79:14, 214:12math 120:19, 120:21, 121:10, 123:7, 144:9mathematics 121:11mating 114:7, 115:17, 116:2, 119:21, 120:8

matter 44:15, 50:23, 71:23, 79:21, 88:2, 89:9, 113:22, 121:15, 143:24, 169:4, 209:25, 242:4matters 67:22, 194:5maximize 52:13maximum 166:16, 167:1Mayo 12:15, 12:25, 13:2, 13:19, 13:24, 14:1, 198:10, 198:11, 198:24Mckee-farrar 229:2, 229:5MDL 1:4, 65:16Mdls 65:2, 65:6MDR 149:16, 151:2Mdrs 35:25, 149:13, 151:10, 152:16mean 14:8, 18:23, 45:14, 61:25, 63:25, 64:2, 64:14, 66:23, 90:12, 115:16, 116:22, 121:15, 131:11, 135:11, 136:14, 137:8, 143:19, 146:14, 151:3, 151:19, 156:5, 160:9, 184:10, 188:24, 190:24, 191:19, 193:15, 194:13, 200:8, 202:17, 203:12, 204:24, 209:25, 212:7, 216:19, 218:24, 236:3meaning 8:18, 44:10, 77:7, 200:10meaningful 8:13means 14:9,

15:24, 21:12, 31:14, 79:21, 93:23, 110:17, 146:12, 146:14, 167:4, 197:21, 197:22, 223:21, 223:23, 224:5, 232:20meant 11:7, 26:10, 32:6, 115:21, 128:14, 130:23, 154:21, 228:5Meanwhile 84:17, 96:25, 97:23measure 144:5, 183:20, 183:24measured 164:6measurement 120:18measurements 107:16mechanical 3:46, 16:4, 37:25, 38:14, 41:11, 217:17mechanism 80:20medal 181:24medals 180:15, 181:3, 181:8media 162:22, 162:23Medical 21:21, 35:24, 36:10, 40:19, 55:23, 146:21, 149:19, 150:23, 151:1, 151:10, 152:12, 163:11, 163:14, 177:8medium 183:21meet 40:22, 219:17meeting 67:21, 69:24, 69:25, 70:4, 116:5, 125:19, 125:22, 126:6, 126:8, 139:11, 155:19, 155:20, 192:19,

192:21, 216:2meeting. 70:25meetings 8:9, 8:10, 31:5, 46:6, 46:12, 46:23, 47:1, 47:4, 74:4, 132:19, 165:21meets 163:13members 17:3, 154:18membership 19:7memo 162:1, 228:1, 241:10Memorandum 34:22memory 129:2mentioned 8:22, 9:12, 12:14, 17:21, 229:15Meridian 3:18message 21:4, 165:24messed 64:2, 205:25messy 5:2, 5:4met 18:11, 73:12, 85:10, 117:8, 125:20, 139:14, 139:25, 154:3metabolic 235:24metal-metal 183:4metal-on-metal. 73:22metal-on-metal41 241:45metal-on-metals 195:1metal-on-poly 203:21, 211:23metal/polyethylene 232:17metallic 211:15, 211:18, 222:12metallosis 148:10, 151:4, 151:12, 233:21metals 193:4metals. 193:25

264

Metasul 36:24, 39:24, 43:24Michael 2:33, 3:9, 165:22Michelle 160:15micromotion 73:5micron 90:1, 97:17microns 31:11, 81:5, 81:8, 81:16, 82:23, 94:2, 107:23, 107:25, 125:1, 127:17, 128:3, 143:10mid 5:6, 13:22middle 12:8, 15:22, 16:21, 17:14, 102:11, 207:14Midyear 165:21mild 233:16miles 160:2, 160:9milestones 154:3millimeter 33:1, 33:3, 107:12, 196:1, 204:25millimeters 33:4, 104:16million 11:11, 12:24, 13:22, 39:1, 39:3, 198:4mind 89:2, 130:20, 131:22, 140:8, 204:8Mindy 175:7minor 104:20, 105:5, 105:19, 105:24, 106:15, 215:4minor. 130:7minutes 4:15, 61:5, 125:19, 125:23, 174:4Misalignment 150:10mischaracterization 173:11

misleading 218:15mismatched 38:8misrepresentation 123:9missed 34:12, 122:20, 172:24missing 193:18, 193:20misspoke 130:21, 131:1misstates 198:22mistake 35:7, 78:5, 78:7, 78:9, 86:10, 88:6, 88:7, 91:3, 91:6, 123:6, 123:17, 123:22, 124:3, 124:7mistake. 146:3misunderstood 97:19misusing 173:9mix 162:5modification 85:9, 105:5, 105:19, 105:24, 106:15, 112:1modification. 104:20modifications 111:24, 112:12modified 111:25, 112:8modular 38:6Modularity 51:9, 51:12, 51:14, 51:15moisture 213:13molybdenum 205:20moment 51:20, 78:9, 89:8, 131:22, 157:5, 161:23, 193:14, 197:17, 209:14momma 168:21Monday 100:13, 100:15, 101:10,

105:3, 137:15money 72:18, 138:10, 139:19, 141:5, 162:16, 198:8monitor 22:16, 22:24, 22:25, 25:16, 70:21, 70:22monitoring 165:13monograph 49:12, 49:24, 49:25, 53:3, 54:7, 54:12, 55:16, 60:13, 209:12, 209:14, 214:14, 214:17, 214:20, 214:23, 215:4, 215:16, 217:14, 218:19, 220:13, 224:13, 229:16, 233:22, 233:24monograph. 222:2Montana 63:13, 63:17month 79:22, 138:17, 154:10months 166:12, 185:20, 200:19Morning 4:13, 5:3, 64:25, 67:15, 67:17, 67:20, 155:4, 156:21, 235:16motion 26:23, 27:4, 27:6, 28:8, 29:23, 51:19, 51:22, 51:25, 52:2, 52:7, 52:13, 53:1, 213:12motions 28:6, 68:9Move 5:17, 31:7, 105:18, 141:4, 153:3, 156:1, 158:19, 169:3, 177:25moved 149:2

movement 29:21, 164:6, 213:12Moving 5:22, 84:9, 154:13, 163:10, 213:[email protected] 2:39MR. ARSENAULT 65:10, 65:24, 66:2MR. POWELL 61:11, 61:18, 62:1, 62:12, 63:14, 63:16, 63:18, 63:22, 64:7, 64:19, 66:3, 66:7, 66:17Ms 4:20, 4:23, 20:9, 23:10, 27:19, 58:8, 67:2, 67:20, 68:3, 88:8, 91:4, 163:8, 171:24Multidirectional 28:21multiple 42:5, 43:17, 60:21, 72:6, 171:7, 213:3multitude 15:11muscle 211:1, 225:14myself 221:25

< N >NAME 27:23, 67:20, 67:23, 165:5, 178:2, 240:4named 181:4names 133:7narrow 194:15National 46:12, 46:23natural 164:19, 213:13near 129:8

265

nearly 107:9Neblett 2:4necessarily 206:10necessary 29:25, 121:12, 237:17, 238:1necessitate 212:13Necrosis 232:9, 232:16, 232:20, 233:5, 233:7need-to-know 89:23needed 10:8, 11:5, 11:13, 35:11, 37:13, 56:1, 136:16needing 154:15needs 17:9, 97:4, 105:20negligence 61:19negotiation 24:20neighborhood 12:24nerve 210:21Net/net 198:5neuropathy 210:16New 2:23, 3:5, 35:11, 35:19, 36:6, 37:13, 44:21, 58:2, 58:3, 68:19, 89:15, 97:21, 133:7, 146:18, 147:17, 166:23, 167:20, 168:8, 175:25, 181:6, 189:20new-fangled 182:15News 180:12, 181:17Next 23:13, 23:22, 24:17, 51:16, 51:17, 56:3, 56:19, 57:7, 57:11,

65:1, 70:4, 94:11, 97:8, 97:14, 107:2, 113:1, 113:2, 123:20, 124:10, 134:6, 140:24, 141:10, 142:11, 155:2, 156:8, 166:12, 171:15, 182:7, 225:16nice 206:6nobody 122:5, 124:2nomenclature 34:13nominal 89:24, 144:12noncompliance 62:15None 72:25, 130:10, 131:8, 131:13, 131:16, 161:10, 192:16, 235:12nonmatching 236:8nonorthopedic 32:22nonresponsive 81:23, 87:10, 94:19, 101:13, 108:19, 109:12, 109:25, 110:10, 112:3, 112:15, 113:10, 116:6, 121:2, 122:18, 132:25, 144:6, 152:17, 185:14, 194:20, 196:21, 203:2, 205:16, 208:8, 215:17, 217:22, 220:15, 224:1, 227:3, 228:6, 231:16, 232:4, 235:7Northern 1:2, 4:5, 242:15not. 155:14note 102:14, 102:22

noted 26:24, 158:1, 212:11, 237:12notes 126:6, 193:14Nothing 4:16, 50:23, 155:23, 156:17, 210:10, 226:20notice 20:14, 27:19, 28:3, 68:8noticeable 92:11noticed 26:22, 26:24, 29:21, 30:15, 34:17notify 222:11, 223:15November 30:9, 85:4, 91:10, 91:15, 91:18, 94:5, 94:7, 97:11, 97:14, 104:10, 104:23, 104:24, 115:3, 121:24, 128:19nowhere 135:16Number 12:23, 16:3, 36:5, 37:6, 41:11, 73:2, 103:16, 120:12, 120:16, 120:22, 121:8, 121:9, 125:15, 147:16, 148:8, 150:11, 158:3, 161:18, 163:3, 177:21, 177:22, 216:7numbers 38:24, 86:23, 102:10, 102:11, 122:24, 189:22numerous 183:4NY 2:23

< O >o'clock 238:15Object 8:24,

13:3, 13:24, 29:13, 32:15, 46:14, 77:24, 114:18, 148:21, 172:3, 203:24, 231:1objections 66:5, 78:1, 78:12, 82:6, 101:22, 103:25, 151:24OBM 29:7observation 212:12observe 8:11observed 173:17obvious 92:9, 92:20Obviously 46:6, 64:25occasion 26:14occur 24:11, 211:1, 211:2occurred 30:8, 129:19occurring 59:11, 92:9occurs 6:15, 7:15, 7:20ocean 141:4October 26:5odd 152:5off-axis 150:15offended 154:6offer 70:20Office 19:17, 70:22OFFICER 4:3, 61:6, 67:10, 98:7, 98:10, 174:5, 174:8, 238:17Official 165:22, 166:9, 242:14officially 68:19often 210:22okayed 177:6Old 87:7, 87:13, 194:3, 227:20, 227:21, 227:23older 167:8

266

on-time 154:17, 154:19once 123:3, 188:21, 188:24, 189:5, 189:17one-on-one 46:6, 56:9one-year 190:19, 190:24one. 24:25, 48:21, 87:7, 91:8, 97:10, 105:12, 134:16, 150:3, 150:10, 169:5, 182:15, 183:17, 209:16one: 25:5ones 72:19, 85:5, 125:9, 149:21, 186:7, 194:12, 196:4, 197:3, 197:13, 199:21, 228:4, 228:9, 228:14ongoing 42:25, 186:18oops 77:21, 153:21, 205:7oops. 145:11open 31:3Opened 162:12, 181:6, 210:1opening 65:6, 65:14operate 27:20operation 26:15operations 20:23, 21:3, 166:10Opinion 156:22, 215:9, 241:17Opinion156 241:17opposed 84:3, 148:19optimally 52:6optimized 77:17, 164:14, 164:15, 219:14optimizes 171:18

optimum 219:23, 220:8oranges 152:9, 201:2, 201:4, 201:5, 202:2, 202:13, 202:14, 202:23orbital 29:7orchestrated 160:25ORDB 35:16order 4:4, 21:1, 21:4, 21:11, 23:7, 86:1, 86:18, 101:18orders 88:21organization 25:15, 168:15, 178:14organized 217:14orient 11:23orientation 12:3original 37:13, 43:21, 176:16Originally 222:5, 223:15Orleans 3:5Orthopaedics 1:4, 79:8, 164:4, 180:16, 181:7orthopedic 7:5, 40:11, 42:16Orthopedics 7:1others 18:13, 92:10, 92:11, 139:14, 161:1, 161:12otherwise 74:9Ought 64:16, 64:17, 205:13, 205:19, 205:21, 206:8, 206:21, 216:2outcome 154:21, 184:23outer 150:4outline 54:4outlined 89:24, 219:15

outlines 14:9output 15:2, 16:3, 16:6outputs 22:14outright 218:15Outside 4:10, 10:9, 12:6, 12:9, 18:4, 32:12, 43:19, 43:25, 61:9, 98:11outstanding 19:25, 25:20, 181:2oval 220:11, 221:1Overall 25:5, 54:4, 93:3, 179:13, 217:13, 220:13, 225:17Overall. 224:23overnight 212:22Overrule 78:1, 169:8Overruled 78:13, 82:7, 83:4, 91:1, 101:23, 104:1, 108:15, 114:22, 117:23, 118:24, 122:9, 123:14, 123:16, 125:7, 125:13, 127:7, 128:10, 128:16, 132:12, 137:17, 139:5, 141:13, 143:17, 148:4, 148:24, 149:11, 150:19, 151:25, 152:8, 159:10, 160:6, 161:4, 172:6, 173:12, 191:3, 191:14, 199:1, 204:1, 214:2, 232:14oversaw 58:8Overseen 45:25, 46:1overview 50:2, 50:3, 57:12,

73:20own 43:18, 46:16, 95:5, 110:8, 159:15, 178:10, 179:7, 195:17owner 159:2owns 158:24

< P >package 103:22, 103:24, 147:7, 165:1, 209:17packaged 18:1packaging 150:5pages 15:11, 42:5, 103:9, 103:16, 103:18, 104:22, 139:18, 196:15paid 72:18pain 36:22, 147:6, 213:12Painful 148:10pair 92:16, 92:18pairs 90:1, 92:[email protected] 3:44PAMELA 3:40, 242:2, 242:13Paoli 62:25, 64:14paragraph 35:12, 171:17, 224:18, 224:21, 224:24, 225:25, 229:21, 232:25, 233:14paragraphs 105:7parameter 32:7parameters 77:10, 100:4, 109:23, 134:18, 134:24, 205:3, 220:14Parkway 2:13Part 5:9, 18:1,

267

mailto:pam_wilson@txnd.

18:8, 19:13, 26:12, 47:3, 47:23, 62:23, 68:25, 73:23, 86:5, 86:8, 119:21, 120:1, 124:5, 131:20, 151:5, 153:16, 154:7, 155:8, 164:3, 169:23, 172:25, 176:18, 179:8, 179:21, 186:20, 189:4, 203:19, 238:3participate 8:8, 8:10, 23:19, 53:8, 53:17participated 22:17participating 23:17participation 23:2, 217:3particle 42:4particles 39:23, 40:3, 55:23, 225:6, 226:9, 233:1, 233:15particular 8:19, 9:19, 23:19, 27:23, 27:24, 33:20, 34:13, 38:9, 49:25, 50:25, 95:23, 105:8, 114:13, 131:15, 157:7, 163:1, 233:20, 235:11, 235:21, 236:12particularly 175:25, 225:20parties 24:10, 24:13, 173:25partner 165:23partners 166:9parts 97:19, 120:4, 124:21, 126:20, 213:7, 219:8, 219:9parts. 126:18

pass 61:3, 139:24passages 65:7Pat 40:2patch 31:21, 32:3, 32:21patent 5:12patently 108:13patient 11:20, 36:22, 52:5, 147:6, 148:14, 159:25, 172:22, 173:1, 201:16, 213:23, 214:9, 235:23, 241:15patient172 241:15patients 6:4, 10:25, 20:19, 20:20, 21:10, 124:22, 183:9, 184:24, 189:19, 189:20, 190:21, 190:22, 208:1, 208:23, 222:11, 223:16, 225:22, 226:15, 237:11pattern 9:19, 10:1Paul 165:21, 167:23, 168:11, 175:4, 241:10Paul165 241:10Pause 27:17, 28:15, 161:23Pause. 65:11, 83:11, 84:10, 157:13pay 167:20paying 179:1payment 24:3, 25:6, 25:12, 25:21payments 22:1, 22:3, 25:7, 70:23PC 3:31peculiarly 62:17peer-reviewed 41:21

pens 174:11people 19:20, 20:11, 25:11, 38:24, 41:22, 42:15, 46:15, 55:25, 69:24, 88:24, 93:22, 123:25, 141:4, 146:12, 146:15, 162:16, 178:17, 178:19, 180:24, 183:6, 184:13, 184:19, 188:16, 188:18, 188:19, 189:9, 191:17, 195:15, 197:23, 200:16, 204:21, 207:20, 208:4, 208:12, 208:21, 209:4, 214:24, 217:6per 14:10, 22:12, 39:1, 39:9percent 73:9, 165:8, 170:23, 171:12, 171:19, 171:21, 173:9, 173:18, 173:21, 175:25, 176:1, 176:23, 177:16, 229:2, 229:5, 229:7, 229:8, 231:6percentage 162:8perception 193:2perfect 59:19, 94:15, 96:25perform 115:15performance 30:25, 44:20, 45:21, 60:6, 93:23, 154:24, 219:14, 219:21, 236:15performance. 93:21performed 44:13, 85:9, 114:3, 114:15, 115:5,

115:25performing 45:21perhaps 204:21period 8:3, 13:10, 30:7, 36:2, 36:4, 36:23, 37:5, 39:14, 39:15, 147:9, 147:15, 189:3, 200:18, 210:7Peripheral 210:16periprosthetic 222:8permission 100:25, 138:17person 34:6, 34:8, 85:13, 85:18, 85:19, 89:13, 215:9, 215:10, 233:13personal 46:5, 46:16, 46:21, 157:20, 159:8, 172:3personnel 153:14perspective 8:22, 9:13, 10:15, 11:18, 20:18, 23:6, 31:21, 52:13, 58:13, 70:6, 70:17, 217:15persuade 90:20persuasion 154:2persuasive 89:14, 89:19, 90:4, 90:9, 90:11, 90:19, 99:8, 99:13, 99:17pertain 58:23pertaining 35:7Peters 192:25, 193:22, 193:23Peterson 1:14, 160:9Ph 50:12, 53:9phase 15:19,

268

15:22phone 20:12physical 9:13physicians 47:5, 48:12, 53:6physiological 52:7PI 58:18pick 142:8Picked 228:2, 228:14picks 182:3picture 171:15piece 116:23, 118:21, 154:12, 185:2pieces 213:7, 213:11PIN 165:9, 171:1, 171:4, 171:6, 171:9, 176:7, 176:16, 183:9pink 102:23piston 92:2, 92:19pivoting 28:20place 9:9, 18:4, 25:17, 25:19, 26:3, 26:4, 39:11, 55:14, 58:22, 101:12, 102:20, 107:19, 122:4, 127:15, 154:20, 221:4placed 52:6placement 52:12PLAINTIFF 22:5, 34:20, 68:17, 89:17, 129:2, 148:6, 149:24, 150:10, 155:18, 156:18, 156:22, 165:18, 169:13, 170:1, 170:5, 170:10, 170:14, 170:17, 172:21, 178:6, 180:11, 192:21, 207:11, 215:3, 221:17,

241:1PLAINTIFFS 1:30, 62:7, 80:12, 210:7plan 17:15, 59:5, 59:6, 89:24, 97:16, 137:25, 140:13, 140:15, 140:17, 140:21planned 45:8, 156:2, 199:18planner 20:23, 20:25planning 15:19, 15:21, 17:7, 199:4play 161:17playing. 27:16, 161:22Please 4:4, 4:19, 4:25, 22:19, 28:1, 28:9, 34:24, 45:2, 47:9, 48:7, 49:11, 55:6, 67:10, 67:15, 67:17, 69:14, 82:2, 82:11, 95:15, 98:19, 105:16, 112:7, 115:22, 116:10, 131:2, 131:21, 133:14, 161:6, 161:17, 163:10, 170:18, 175:14, 177:17, 185:18, 204:5, 208:11, 216:6, 220:18, 227:6, 237:18plenty 174:11PLLC 2:44Plouhar 177:1ploy 198:13pneumatic 30:4, 37:16, 126:12PO 1:40point 30:25, 40:17, 40:19,

64:13, 66:15, 71:10, 71:14, 93:8, 99:23, 100:23, 102:15, 102:17, 102:23, 111:19, 126:23, 126:25, 127:11, 141:2, 147:25, 149:7, 165:5, 166:3, 171:12, 176:20, 186:16, 232:18point. 65:20, 66:16, 124:15, 182:2pointed 182:12, 194:12, 236:18pointing 201:3, 234:23points 93:6, 113:3polished 236:13Polly 165:23poly 227:20, 227:21, 227:23polyethylene 38:11, 51:22, 51:25, 52:8, 52:19, 55:24, 58:4, 73:5, 232:13pond 19:3, 20:12pool 222:1Poon 181:4populations 201:16porous 212:1, 212:4, 212:11porous-coated 211:20portfolio. 179:13portion 13:1, 50:10, 214:20, 215:15portions 47:17, 49:15position 12:19, 117:16, 168:15, 175:9, 237:6

positioned 29:17positioning 54:24, 211:1positive 71:20, 175:13, 202:6possibility 27:8possible 30:20, 130:23, 132:6, 206:19, 222:11, 228:2possible. 211:21Post-it 102:14, 102:22poster 169:14, 176:24, 177:2, 177:18, 197:20, 210:14postmortem 73:20potential 26:25, 38:13, 52:2, 52:10, 209:1, 210:11, 212:5, 222:7potentially 92:9Powell 2:33, 61:10Power 71:20, 165:24Powerpoint 53:22, 72:5, 227:8, 227:10, 227:11, 227:13, 227:19powers 89:14, 89:19, 90:5, 90:9, 90:11, 90:19, 99:8, 99:14, 99:17Poydras 3:4practical 71:23, 209:25practice 12:14, 14:21practiced 68:9practices 20:22, 35:16, 146:8praise 154:25pray 4:8precaution 236:13

269

precautions 49:2, 238:8precisely 64:19precision 219:16preclearance 163:12predates 192:19predecessor 8:7predetermined 85:10predicate 26:12, 42:23, 60:4predicates 52:24preemption 62:10, 63:10preemptive 64:9preparation 100:17, 100:19prepare 20:4, 53:19, 166:9, 230:17prepared 22:9, 22:12, 33:13, 104:22, 104:25, 129:21preparing 74:2, 100:17prepping 68:5, 68:8, 68:12, 69:2prescribed 242:6presence 4:10, 61:9, 98:11PRESENT 2:28, 3:24, 20:4, 39:18, 53:21, 53:22, 56:10, 56:11, 89:25, 225:21presentation 47:2, 53:5, 54:5, 54:25, 55:18, 139:8, 169:14presentations 46:12, 46:23, 53:9, 53:14, 53:17, 56:7, 56:8presented 22:13,

36:7, 53:25, 181:3president 167:23, 167:25, 168:5, 168:11, 168:16, 168:17, 168:23presiding 4:7pressure 166:13prestigious 181:11prettier 63:15, 63:18pretty 63:1, 63:23, 85:25, 141:7, 193:15previous 39:16, 89:24, 131:14, 134:7, 169:22previously 81:24, 100:6, 107:10, 122:11, 122:14, 145:9, 219:15price 166:13, 167:3, 167:7, 167:8pricing 168:5primarily 29:21, 61:21, 63:24primary 38:10print 168:9, 237:24printed 53:6prior 105:2, 117:25, 187:23priorities 155:21privilege 67:21, 157:10, 158:3, 158:7privileged 157:18privy 112:19prize 181:4Probably 23:12, 24:25, 39:18, 96:8, 142:3, 157:19, 173:14, 179:5, 183:8,

230:13problem 30:1, 30:15, 63:24, 91:24, 94:7, 101:1, 101:4, 124:13, 127:1, 127:3, 128:19, 128:20, 128:23, 128:24, 128:25, 143:1, 144:24, 150:5, 192:17, 195:13, 195:16, 195:18, 226:20, 226:23problems 92:6, 126:12, 195:10, 202:10, 209:1, 210:11, 226:8, 227:20procedure 14:10, 122:6Proceedings 3:46, 61:8, 98:9, 174:7, 242:3proceedings. 238:18process 14:5, 14:8, 14:11, 14:13, 14:16, 14:23, 15:2, 15:16, 18:6, 18:10, 21:15, 22:11, 22:13, 22:24, 25:3, 25:17, 25:19, 42:23, 58:22, 65:16, 73:23, 79:21, 86:5, 86:6, 86:8, 86:9, 86:11, 123:24, 124:5, 129:16, 131:20, 141:16, 156:2, 158:11, 165:11process. 167:12processes 14:20, 26:9produce 11:3produced 3:47

producing 197:19product. 140:14, 216:4, 218:3production 97:18, 154:14, 157:25production. 93:7PRODUCTS 1:6, 7:5, 14:6, 17:18, 18:20, 20:20, 20:21, 26:10, 39:19, 41:6, 41:17, 42:18, 48:12, 50:19, 162:17, 162:18, 162:19, 181:6, 183:13, 192:8, 195:5, 197:5, 205:23, 222:12, 223:17professional 24:3Program 39:23, 47:3, 69:6, 73:4, 73:7, 73:11, 146:22, 151:10, 175:11program. 36:11programmed 95:9progression 7:21project. 134:9projects 21:22, 22:17, 23:7, 23:11, 46:11promise 96:21pronto. 97:5Proper 22:3, 76:25, 77:2, 151:18properly 16:21, 51:2, 100:8, 236:17properties 222:8property 155:25propose 10:2prosecution 21:23, 178:24Prosim 29:5prospective 45:18

270

prosthesis 79:8, 211:5, 211:21protocols 14:10prototypes 16:9prototyping 16:5proud 60:24, 61:2prove 184:7provide 24:21, 51:21, 51:24, 54:20, 55:25, 56:17, 56:23, 58:5, 60:18, 175:9, 209:6, 209:8provided 22:16, 24:13, 42:23, 133:22, 148:13provider 24:16, 24:21provides 120:12, 175:25providing 8:11, 46:24, 57:23public 42:18, 58:1publication 41:8publications 41:11, 42:2publicize 41:10publish 41:23publish-- 41:18published 41:16, 41:19, 42:12, 55:16, 55:17, 56:23, 195:24publishing 41:18pull 47:8, 96:15, 96:23, 120:17, 121:8, 130:19, 155:3, 212:22, 213:4pulled 79:16, 139:23purchasing 24:4purpose 14:16, 23:18, 23:23, 24:3, 25:9, 38:10, 78:16, 183:22, 183:24,

184:2, 184:21, 197:22, 197:23, 198:9, 205:15, 236:12purposeful 60:15purposefully 78:15purposes 14:17, 24:14, 80:16, 205:1, 205:10push 38:2, 176:22pushing 38:2put 9:21, 9:23, 10:10, 11:17, 11:22, 16:9, 17:21, 27:6, 31:23, 32:25, 64:4, 64:10, 75:7, 84:12, 88:24, 102:7, 102:22, 112:22, 114:14, 119:12, 139:20, 149:5, 165:20, 183:6, 196:4, 196:8, 202:17, 204:10, 211:2, 218:14, 222:19, 228:21, 236:16, 236:19, 237:20, 238:8puts 160:9putting 38:2, 111:10, 140:8, 178:23, 180:12, 207:20, 216:24, 218:11, 221:20, 226:7pyramid 235:2

< Q >quadrant 8:18qualifications 23:18qualified 23:20, 24:7, 24:8, 25:11qualify 188:14quality 9:22,

10:12, 19:2, 20:23, 179:11, 219:16quarterly 70:21QUATTLEBAUM 2:43, 2:44, 4:17, 28:15, 95:3, 123:13, 123:25, 173:11, 182:13, 202:19, 202:22, 204:10, 238:6, 240:8QUATTLEBAUM4 240:8questioning 84:14questions 22:22, 22:23, 64:5, 69:13, 134:7, 144:17, 147:2, 166:13, 195:11, 199:23quick 196:25, 202:1, 202:12quicker 84:8, 218:22quickly 141:8, 166:24quiet 89:11quit 166:4, 166:7, 189:5quite 10:3, 136:5, 144:12quotation 233:14quote 176:6, 193:18quoting 218:3

< R >radically 101:20, 101:24Radio 212:10radius 10:21, 10:22, 10:23, 11:6, 31:13, 31:14, 32:4, 33:9, 33:15, 33:17, 33:19, 34:2, 83:18,

103:10, 108:5, 108:6, 108:22, 108:25, 109:1, 109:2, 109:8, 111:21, 119:13, 119:16, 120:15, 121:10, 121:11, 122:16, 130:23, 134:23radius. 102:18ramifications 97:4randomized 45:18Randy 69:20, 71:5, 175:7range 51:19, 51:22, 51:24, 52:2, 52:25, 93:18, 209:5, 220:12, 222:13, 223:[email protected] 2:8rates 222:9rather 136:6ratio 110:24, 111:6, 232:1rational 54:14Rationale 47:12, 54:16, 76:14, 76:24, 169:25, 170:7, 170:9, 170:10, 217:16, 234:2, 234:5, 235:6, 241:7, 241:48rationale170 241:7Rationale47 241:48RE 1:4reach 41:4, 179:12reached 160:25reaches 52:7reaction 148:15, 230:3, 230:4, 237:8, 238:9reactions 206:19, 211:2,

271

211:8, 211:12read 18:1, 56:1, 63:8, 64:10, 77:13, 134:3, 146:9, 173:16, 175:14, 175:22, 177:4, 192:25, 193:14, 196:9, 209:19, 209:24, 209:25, 217:13, 219:8, 232:13, 238:7, 238:10reader 216:12, 217:15, 223:1readers. 215:7reading 119:4, 182:17reads 215:5ready 9:2, 11:12, 66:25, 69:9, 100:24, 141:4, 161:16, 166:11, 174:9Real 94:16, 94:22, 95:17, 96:4, 106:10, 136:14, 136:21, 137:8, 137:14, 156:11, 177:25, 186:23, 191:16, 192:5, 194:23, 196:15, 233:17realities 178:10, 178:17, 179:7reality 178:6realize 186:15, 187:9Really 11:6, 19:24, 30:12, 39:18, 50:23, 61:15, 61:20, 61:22, 62:18, 81:12, 94:16, 94:22, 138:3, 183:19, 191:9, 197:22, 200:14, 201:11, 201:13, 202:11, 202:22, 218:2, 233:18

reask 115:22reason 89:5, 149:25, 153:12, 155:17, 157:11, 192:7, 201:19reasonable 25:6, 25:10, 36:5, 37:5, 103:23, 147:16recall 13:20, 69:7, 92:8, 97:25, 135:23, 156:4, 170:1, 175:10, 177:13recalled 142:18receive 162:18, 219:24received 13:19, 13:25, 64:25, 138:22, 181:11recent 70:21recently 129:18Recess 61:7, 98:8, 174:6recognize 22:6recognized 225:5, 233:1recognizes 180:17recommend 93:13, 126:13recommendation 35:6, 35:8, 37:9, 93:5, 97:21record 148:8, 158:8, 158:13, 161:19, 191:2, 191:13, 242:3records 25:1recruiting 179:13red 16:1, 16:3, 16:8, 102:22, 220:11, 221:1reduced 176:6reducing 219:25reduction 77:17, 176:1, 219:7refer 55:12,

96:9, 96:17reference 83:17, 102:18, 120:22, 157:21, 220:8, 220:10, 225:1, 225:24reference. 177:17referenced 74:20, 133:23, 134:13, 135:15, 136:2, 146:25, 215:6, 221:16References 77:13, 115:5, 216:14, 216:15, 216:16, 216:17, 216:20referencing 68:16, 83:10, 135:17, 171:1referred 15:4referring 113:24, 124:11, 124:12, 127:3, 128:22, 128:25, 178:20, 178:21, 205:24, 221:12, 221:13refers 164:13reflect 88:21reflected 83:7reflective 53:4reflects 122:16refresh 129:1regard 6:11, 7:20, 13:7, 14:13, 15:9, 19:11, 20:5, 23:16, 23:24, 26:7, 26:15, 33:11, 37:12, 39:20, 41:4, 43:16, 46:3, 51:21, 51:24, 56:20, 58:23, 61:23, 74:18, 117:21, 208:21, 210:10, 214:12Regarding 37:2,

37:3, 57:17, 94:3, 134:7, 147:11, 194:18regardless 22:1, 164:8, 211:22regards 69:8, 163:9regime 162:6registered 159:4registry 191:6regulation 62:16Regulatory 14:19, 90:4, 90:12, 90:14, 90:16, 90:20, 99:9, 99:20, 99:23, 100:3, 100:4, 100:10, 123:19, 138:11, 138:15, 140:15, 140:24, 140:25, 141:3, 163:8, 163:14, 187:14reimbursement 69:6, 175:11rejected 198:19rejection 213:6relate 20:19, 31:8related 10:17, 36:18, 38:1, 47:17, 57:19, 73:9, 73:11Relates 1:9relating 24:2, 193:19relative 31:15, 31:19, 33:3, 33:8, 33:10, 55:24, 120:4, 222:13, 222:15, 223:18, 223:20, 224:6release 138:16, 138:17, 140:11, 140:24, 187:24, 193:4, 193:25, 194:19, 211:15, 211:18, 211:20, 212:5

272

release. 193:3released 157:19releasing 138:12, 140:14relevant 202:23reliant 90:4relied 43:17relies 119:20, 119:23rely 43:15, 44:18, 89:19, 179:15relying 89:14, 90:8remain 173:18remaining 135:24remains 222:15Remember 8:1, 12:23, 66:23, 86:6, 92:23, 94:25, 95:2, 99:5, 128:23, 139:19, 155:7, 175:10, 177:14, 179:2, 180:13, 182:15, 200:3, 204:11, 221:14remind 26:3reminder 233:12remove 167:11removed 150:15repeat 51:23, 137:11, 185:18replacement 36:18, 126:18, 159:25, 160:2, 160:11, 210:12, 235:23, 236:2replacement. 209:3replacements 210:18Report 22:15, 70:21, 83:6, 96:22, 133:22, 134:13, 134:15, 149:14, 149:19, 150:1, 150:12, 163:1, 187:7, 187:22, 189:2,

200:2, 241:33, 241:35Report149 241:35Report150 241:33reported 3:46, 36:1, 36:5, 37:2, 60:17, 147:16, 150:8, 151:2, 151:4, 151:16, 151:17, 151:18, 164:5, 210:17, 210:21, 211:8, 212:5reported. 36:14, 146:23Reporter 3:40, 242:14Reporting 35:24, 36:10, 146:21, 151:10, 163:21reports 37:2, 37:3, 133:21, 134:2, 136:2, 136:3, 136:6, 147:25, 150:23, 151:1, 152:12, 189:14, 189:16, 196:25, 200:1, 211:25representation 85:11, 174:1, 228:5representations 79:24, 80:2representatives 18:25, 19:2representatives. 165:25represents 221:1reputation 178:3, 179:11request 86:12, 86:15, 94:7, 134:1, 158:1requested 86:16, 86:20, 86:21, 133:21requesting 86:17require 37:11required 35:9,

38:4, 85:8, 154:2, 163:12requirement 14:18, 21:22, 23:25, 24:1, 24:20, 116:8, 117:8, 139:25, 140:14requirements 18:11, 22:13, 81:1, 105:8, 127:16, 127:20, 127:24, 128:2, 128:4, 128:7, 128:8, 128:12, 128:13, 132:16, 163:14requires 18:7, 184:22requiring 70:22research 19:2, 126:12, 154:13, 154:20, 169:6, 180:17researchers 181:3researching 40:22resistance 176:6resorption 222:8resources 179:13resources. 178:23respect 44:9, 44:12, 50:21, 50:24, 64:12, 219:14respective 222:1respects 54:7respond 58:13, 59:24, 60:10, 110:7, 117:10response 54:22, 55:22, 56:6, 56:19, 56:22, 57:12, 57:17, 65:1, 65:22, 136:10, 157:22, 177:6, 177:15, 211:9, 215:25,

225:7, 225:12, 225:20, 226:2, 226:21, 229:12, 230:11, 233:2, 233:15response. 225:8, 233:3responses 230:7responsibilities 74:24, 75:1responsibilities. 69:3responsibility 75:4, 75:5, 75:6, 159:21responsible 59:3, 86:19, 215:15rest 92:16, 111:13, 195:16result 14:23, 70:24, 114:3, 140:4, 187:20, 231:9resulting 154:21, 210:25results 17:19, 43:5, 85:9, 113:19, 114:16, 115:1, 115:3, 115:25, 117:5, 117:19, 118:16, 118:18, 118:21, 134:1, 138:21, 139:1, 141:3, 154:15, 159:3, 185:8, 185:19, 185:22, 189:23, 191:6, 197:23, 202:6, 203:9, 204:7resumed 61:8, 98:9, 174:7retract 110:16returned 148:11, 160:10revamp 100:24reveal 73:19revenue 198:4Review 5:3,

273

13:17, 13:18, 17:18, 18:3, 18:10, 19:13, 21:23, 22:16, 23:18, 50:1, 70:3, 70:8, 70:23, 113:19, 114:17, 115:3, 116:1, 118:19, 124:4, 124:5, 124:7, 139:11, 140:19, 140:21, 153:24, 155:9, 157:5, 168:12, 187:7, 197:4, 198:12, 199:22, 228:10, 228:17review. 71:3reviewed 13:7, 13:9, 71:2, 163:13, 163:18reviewer 18:7reviewing 21:16reviews 18:9, 18:10, 22:17, 70:8, 155:22revised 36:22, 147:6, 170:18revision 130:22, 176:8, 176:9, 222:9Revisions 59:9, 59:10, 59:11, 151:16, 151:17, 152:2, 200:2, 200:4, 200:17, 200:19, 200:21, 200:25, 201:9, 202:7, 202:20, 203:9, 204:11, 204:16Rhee 165:23RICHARD 2:2, 3:1rifle 120:17, 121:9right-hand 86:23rigorous 219:17rim 93:3rise 4:3, 61:6, 67:10, 98:7,

98:10, 174:5, 174:8, 238:17risk 15:21, 17:13, 60:8, 85:8, 94:1, 176:6, 222:10, 222:13, 222:15, 223:16, 223:24, 224:6risk. 223:13, 223:18, 224:10risks 60:16, 209:2, 210:11, 222:11, 222:15, 225:21, 225:22risks. 223:20RMR 3:40, 242:13Robert 2:28, 2:30, 68:18, 181:4ROBERTS 3:9Rochester 12:15Rock 2:46rode 160:1role 7:2, 8:1, 13:17, 21:15, 21:16, 23:21, 46:5, 69:4, 69:6, 70:1, 156:11, 177:25, 181:15, 216:23, 216:24roll 21:6roll-out 59:6Room 3:41root 148:12Ross 2:35, 3:11rotating 28:3rough 236:22roughness 220:25route 97:18royalties 12:21, 12:22, 13:19, 21:24, 71:7, 72:22, 162:18royalty 13:8, 13:18, 22:1, 22:9, 25:5, 25:6, 25:20, 69:16, 69:25,

70:4, 70:6, 70:20, 70:23, 72:18, 162:16, 204:14, 241:23royalty-bearing 12:19royalty22 241:23RRC 70:[email protected] 3:7rub 236:22rude 131:20Rule 62:16ruling 66:10run 26:21, 42:20, 43:1, 106:3, 126:17, 126:19, 136:14, 136:18, 136:20, 168:9Running 26:22, 30:2, 30:14, 66:3, 66:8, 66:10, 174:12rush 136:12, 154:7, 166:20rushed 58:15

< S >s/pamela 242:12safe 201:9, 201:20, 204:2Safer 200:8, 200:15, 203:13, 203:20, 203:22, 203:23, 204:4safety 76:17, 107:3, 141:20, 208:1Sales 25:7, 46:3, 46:12, 46:23, 46:24, 48:11, 49:9, 53:16, 55:1, 57:5, 60:15, 74:2, 154:23, 165:21, 198:3, 198:20, 226:24, 227:14, 227:15,

227:19, 229:11, 230:1, 230:8, 231:7, 231:23, 233:8salespeople 227:1, 227:15samples 39:25sarcoidosis 230:10Sarver 3:1, 3:3, 65:7satisfied 16:7satisfies 16:13satisfying 25:9Saw 16:10, 44:4, 62:22, 94:24, 162:14, 194:2, 207:2saying 16:6, 31:20, 64:6, 64:7, 66:22, 74:4, 80:10, 84:20, 85:19, 88:7, 88:10, 91:23, 92:19, 92:20, 104:14, 114:10, 117:11, 118:19, 120:14, 120:24, 120:25, 121:6, 121:13, 140:4, 140:6, 140:9, 151:10, 173:25, 175:4, 187:18, 195:7, 200:14, 201:11, 203:15, 203:23, 206:14, 206:24, 234:20, 237:21, 237:22scare 214:24, 215:7, 216:12scenario 187:25scenarios 94:15, 97:1schedule 70:7, 154:4scheduled 70:24Schmalzried 45:5, 161:11, 162:15, 165:23,

274

166:3Schneiders 71:13Schnieders 69:21School 31:12, 53:16, 227:14schools 31:9scientific 26:11, 195:17scientists 180:16, 181:5, 181:7, 181:10screen 102:7screw 8:18, 9:19, 9:20, 9:25, 10:4, 10:17, 10:20, 10:22, 10:23, 10:24, 11:5, 11:8, 11:16, 11:17, 11:20screws 9:23, 10:21, 11:10scrubbed 210:1, 210:2search 35:24searching 36:10, 146:21seat 10:24seated 4:13, 67:12, 98:17, 174:18, 236:17seating 151:17, 151:18Second 15:22, 26:5, 27:17, 28:15, 63:1, 102:15, 102:17, 102:23, 111:19, 129:9, 155:20, 172:13Seconds. 163:10section 50:5, 51:16, 51:17, 81:1, 102:15, 102:16, 102:21, 159:15, 159:18, 207:13, 225:16sections 217:13sector 8:17secure 9:24,

50:22SECURITY 4:3, 61:6, 67:10, 98:7, 98:10, 174:5, 174:8, 238:17seduced 73:22see. 93:4seeding 197:20seeing 5:22, 20:10, 30:5, 30:18, 41:15, 54:3, 56:4, 57:16, 57:18, 178:7, 196:2seem 10:13, 133:22, 156:17seemed 175:21seems 110:20, 166:17, 223:14seen 57:11, 72:5, 72:6, 72:8, 72:9, 101:18, 151:5, 157:14, 165:19, 170:14, 191:6, 192:20, 196:9, 197:18, 232:9, 232:16, 232:20sees 20:25select 23:14, 238:1selected 23:19, 23:22selection 51:15, 237:17, 238:3sell 99:3, 106:16, 124:16selling 21:2, 21:12, 43:16, 79:17, 96:20, 124:14, 124:15, 124:19, 146:6, 185:9, 185:20, 186:8, 186:12, 188:15, 190:20, 193:13, 195:2, 195:15, 200:16, 200:22send 133:25,

174:25, 215:20sending 68:18, 133:11, 237:11sends 168:4sense 15:15, 129:9sent 30:16, 34:17, 35:10, 40:1, 41:22, 59:4, 68:17, 79:14, 79:18, 79:23, 87:7, 87:13, 101:21, 103:22, 125:15, 125:16, 125:19, 133:8, 133:9, 163:12, 167:23, 175:15sentence 35:15, 173:15separate 149:14, 156:17, 160:23separated 53:24September 68:18, 133:19, 179:18series 29:5Serious 212:13, 221:14served 23:15Services 24:21, 163:25, 169:21, 170:21, 173:5session 4:6, 162:12set 26:19, 73:4, 110:21, 137:21, 139:23, 227:25SETH 3:9several 45:3, 217:13shall 221:11shame 160:9share 94:12, 167:2share. 166:16shared 100:5shaved 155:7sheet 76:4, 82:22, 88:25, 128:3, 205:25,

237:16shelf 11:12, 154:16shell 10:4, 36:21, 37:25, 52:22, 75:9, 114:7, 115:16, 116:2, 116:23, 147:5, 150:15, 171:16, 171:20, 171:22, 235:3shell-to-head 86:24, 110:24shells 11:3ship 116:23shop 21:3, 21:11short 11:14, 58:20, 67:5shortcut 221:8shortcuts 221:5shot 93:2shouldn't 205:14, 205:19, 205:22, 206:9show 41:6, 41:13, 81:15, 103:10, 120:11, 149:23, 159:3, 200:2, 203:19, 230:25, 238:6Showed 43:6, 144:22, 165:18, 186:2, 200:3, 203:9showing 115:12, 115:13, 225:19shown 33:22, 180:11, 220:12shows 42:14, 42:16, 136:12, 155:24, 205:2Shredding 212:4shunning 216:5sic 152:3side 5:24, 7:4, 9:16, 18:16, 18:17, 24:11, 24:12, 30:17, 51:6, 55:22, 84:3, 117:3

275

sidebar 231:1sides 19:3, 58:17, 141:4sign 87:25sign-off 169:20, 174:24, 214:10signatory 163:22signature 170:11signed 24:1, 82:14, 82:16, 85:17, 86:1, 86:3, 86:18, 87:16, 87:17, 87:20, 88:17, 90:23, 113:18, 123:3, 123:8, 177:21significance 42:11, 211:12, 212:12significant 11:9, 13:1, 13:10, 50:10, 105:25, 106:2, 181:6signing 88:9Similar 7:3, 17:23, 18:19, 32:4, 54:8, 206:13, 227:2similarities 205:2similarity 112:14Simmons 2:20simple 30:12, 96:12, 110:3, 110:13, 113:13, 117:11, 144:9, 193:15, 194:23simply 65:15, 72:22, 161:1, 194:10simulate 28:6, 94:16, 94:22simulation 42:20simulator. 92:3Simulators 29:5, 37:18, 94:13, 94:14, 94:16,

94:17, 94:22, 95:7, 96:4, 96:10, 187:25single 18:22, 27:22, 28:7, 195:8Sir 61:11, 72:12, 80:5, 117:24, 174:10, 176:25, 190:6sister 18:19sit 171:15, 171:16site 158:24, 159:20, 159:24, 160:17sits 18:9sitting 11:12, 152:5, 152:25situation 70:16, 154:15, 211:16situations 211:19six 22:12, 27:20Sixth 63:4, 63:6Size 31:1, 31:15, 199:9, 199:11, 199:14, 199:15, 236:7, 236:8sized 126:20sizes 32:23skip 164:3slide 20:4, 56:5, 57:17, 138:10, 139:19, 139:24, 197:7, 230:14, 230:25, 231:15, 231:23slides 139:9, 140:18, 230:18slight 222:10small 10:13, 11:6, 27:1, 27:3, 147:12, 222:14, 223:20, 223:24, 224:6smaller 11:5, 97:20, 97:24, 104:16, 134:16

smiley 10:4, 11:24, 72:19, 72:23sneezes. 81:18snow 63:23social 159:21socket 213:14sold 60:14, 136:19, 183:10, 184:3, 184:16, 187:15, 187:17, 187:21solely 32:7solid 217:16solutions 155:25somebody 18:4, 18:7, 62:19, 71:14somehow 171:23Someone 63:3, 74:8, 81:18, 109:21, 109:23, 156:5somewhat 225:18, 226:21somewhere 39:2, 92:24, 218:21soon 207:4sooner. 236:8Sophisticated 219:15Sort 7:3, 7:5, 10:15, 10:21, 11:24, 15:17, 16:1, 17:10, 21:5, 26:11, 27:4, 29:9, 38:15, 42:16, 46:5, 46:13, 47:16, 49:8, 50:3, 52:6, 53:4, 53:24, 56:21, 57:17, 57:19, 58:3, 64:9, 95:11sound 226:23sounds 11:6, 134:13source 84:24, 88:14, 195:13,

233:17sources 43:18, 185:13South 3:18space 75:15, 75:16, 75:18, 75:22space. 212:6spacing 75:23speaking 37:18, 186:6, 186:20, 190:6SPECIAL 3:30, 26:9specialty 53:24specific 47:3, 50:6, 80:18, 96:19, 128:25, 130:25, 150:25, 153:12, 180:9, 183:3, 184:21, 222:21, 227:11, 236:25specifically 20:2, 39:16, 53:15, 55:1, 68:16, 110:21, 153:25, 175:3, 193:19, 199:19, 213:18, 237:3, 237:5specification 124:24specifications 16:17, 16:19, 16:22specifications. 219:17specified 151:2specify 80:18, 135:21speed 167:11spell 67:22spells 112:21spend 234:22spending 69:1, 69:9spent 21:14, 226:6spherical 130:23

276

spin 51:4spinning 28:3spirit 71:21spirited 10:3split 62:24, 63:9, 147:7spoke 221:23sponsor 35:10, 36:6, 146:2, 147:17sponsored 41:12spots 33:20spread. 97:[email protected] 3:14St 2:45stage 17:12stages 15:18, 17:24stair 95:9stakeholders 49:9stand 177:4standard 40:11, 40:13, 40:22, 94:14standards 40:7, 40:10, 40:25standpoint 223:11stands 217:11Stanton 3:30, 3:[email protected] 3:35Start 15:21, 28:14, 66:9, 91:9, 96:4, 96:12, 100:16, 104:5, 124:18, 129:8, 175:20, 183:2, 183:8, 185:5, 185:9, 185:10, 185:20, 190:4, 190:17, 190:20, 191:9, 193:12, 208:4, 214:14, 215:5started 6:2,

6:17, 11:3, 26:21, 37:15, 37:16, 38:25, 69:1, 93:6, 96:20, 136:25, 137:3, 161:12, 162:9, 162:10, 186:8, 186:12, 191:25, 195:2starting 6:10, 103:9, 185:20starts 49:25, 84:6, 216:10, 224:23state 63:2, 164:19stated 70:21statement 76:25, 109:18, 110:5, 110:14statements 65:7, 217:18, 218:9, 222:25States 1:1, 1:21, 4:5, 4:7, 4:9, 7:17, 7:23, 18:13, 18:25, 43:20, 44:1, 242:7station 29:22, 160:22stations 29:23stats 145:6status 35:9statute 23:5, 24:2, 24:9stay 89:11, 227:18, 230:24, 231:1stem 52:14, 52:16, 75:11stenography 3:46step 16:14, 17:7, 38:18, 162:21Stephenville 1:41steps 14:9, 15:15, 17:4, 17:6, 17:17,

18:3, 38:24, 39:1, 39:3, 39:9, 95:7Steve 45:4STEVEN 2:43stick 116:22, 204:21, 208:22, 236:22stinking 234:22stinks 201:13stipulated 212:21stock 10:11STOLLE 3:26Stop 28:1, 28:10, 95:3, 95:8, 98:2, 138:2, 158:12, 163:10, 189:21, 238:13stopped 97:25, 188:21, 188:24, 189:17stopped. 29:2stopping 95:5, 95:18stories 8:25, 20:19story 8:19, 11:14, 30:12, 143:4, 172:22, 173:1straight 28:17, 214:16, 220:19, 227:18strain 178:23strategic 155:21strategy 101:11, 167:3, 167:11, 168:6Street 3:4, 3:18, 3:41strength 165:5, 179:8, 179:12strengths 179:7, 179:14stretched 166:10strike 166:14strong 225:19structure

163:21, 217:5structuring 218:7, 218:8struggling 133:5studied 183:7studies 41:3, 42:20, 44:22, 45:4, 45:24, 95:21, 95:22, 95:25, 96:1, 181:19, 183:12, 183:19, 183:24, 184:2, 184:21, 184:22, 184:23, 186:11, 187:3, 188:5, 188:6, 189:7, 189:8, 189:22, 195:5, 196:2, 196:10, 197:4, 197:8, 197:10, 197:12, 199:19, 199:22, 228:2, 228:21stuff 119:18, 169:11, 206:2, 221:13, 221:14, 236:5stunned 192:13Subclinical 210:21subject 155:2, 169:4, 182:7, 236:3subluxation 210:25submissions 42:24, 100:15, 131:17submissions. 130:11submit 36:6, 37:13, 100:16, 107:2, 134:15, 137:22, 147:17submitted 25:16, 34:12, 42:25, 43:8, 70:23, 91:13, 99:2, 99:24, 100:20, 105:3, 129:20,

277

131:7, 132:8, 132:23, 134:25, 136:19, 136:20, 137:7, 137:9, 137:13, 146:2, 151:8, 189:4subsequent 34:17, 211:4Substantially 76:17, 76:19, 104:15, 107:6, 141:19, 142:13, 142:25substantively 80:3subtle 10:19subtlety 10:16success 235:2successful 9:17, 9:19, 10:2, 20:25, 21:5, 21:8suck. 71:22sufficient 60:5suggest 94:4suggested 112:11, 184:10, 222:6suggesting 128:6, 206:11suggestion 58:15, 60:3, 154:7, 184:11suggestions 216:3suggests 148:14Suite 2:36, 3:4, 3:11Sulzer 36:24, 37:1, 39:24, 52:25, 147:9, 147:12summarizing 217:18, 218:9, 222:24summary 22:9, 22:15, 107:3, 113:1summation 28:24supply 166:11

supporting 34:4, 154:20, 168:9supposed 34:6, 34:8, 123:2, 151:4Supreme 62:17, 64:19Surely 151:12, 214:16Surface 31:24, 38:16, 52:4, 80:19, 106:8, 107:14, 107:15, 108:9, 109:2, 109:7, 109:8, 109:16, 110:9, 110:20, 113:25, 127:24, 127:25, 205:3, 205:6, 205:8, 205:21, 211:20, 212:4, 219:20, 220:25surfaces 166:15, 212:1, 212:11, 236:16surgeon 9:20, 12:16, 12:17, 16:10, 17:3, 23:2, 23:7, 24:7, 25:19, 46:7, 47:1, 47:23, 48:5, 72:16, 72:17, 74:12, 175:3, 175:6surgeons 8:1, 8:4, 8:11, 8:19, 9:25, 10:7, 11:4, 20:18, 21:15, 21:17, 23:17, 23:19, 25:18, 46:4, 46:7, 46:8, 46:25, 48:13, 51:14, 52:2, 56:7, 56:10, 57:5, 58:6, 59:1, 60:16, 73:21, 74:10, 159:1, 161:9,

183:9, 213:24, 214:6, 214:8, 226:15, 227:7, 227:12, 227:15surgeons. 225:23Surgery 176:23, 210:1Surgical 47:20, 48:17, 209:12, 209:14, 210:22, 212:13, 238:12, 241:43survival 169:14, 173:22, 229:2, 229:7survivorship 170:23, 171:12, 171:13, 171:19, 177:17, 180:15suspect 133:25, 199:12suspenders 9:22Sustain 14:3, 166:15Sustained 13:4, 29:15, 32:17, 45:12, 59:22, 81:25, 87:11, 94:20, 101:14, 108:20, 109:13, 110:1, 110:11, 112:4, 112:16, 113:11, 116:7, 121:3, 122:19, 133:1, 144:7, 152:18, 185:15, 194:21, 196:22, 203:3, 205:17, 208:9, 215:18, 217:23, 220:16, 224:2, 227:4, 228:7, 231:17, 232:5, 235:8swap 71:5sweeps 63:10switch 22:18, 180:1system 35:17, 35:20, 36:4, 37:1, 37:5,

47:13, 47:21, 146:9, 147:15, 149:14, 171:5, 181:9, 219:13

< T >Table 37:13, 54:6, 88:18, 88:20, 91:13, 100:8, 106:21, 145:22, 219:1, 219:7Talked 43:14, 45:17, 64:20, 76:20, 76:21, 123:19, 127:3, 185:25, 188:4, 192:23, 216:22, 222:24, 227:20, 227:22, 227:24Talks 50:2, 50:5, 81:2, 94:13, 164:2, 219:18, 233:18Tandy 163:22, 169:19, 170:4, 170:19, 171:24, 172:18, 172:19, 172:22, 173:2, 175:5, 177:6taper 5:12, 38:4, 235:3target 100:20targeting 167:3, 168:6, 184:18targets 167:13teams 167:4technical 49:12, 49:24, 53:3, 54:7, 54:12, 55:16, 60:12, 209:12, 209:13, 214:14, 214:17, 214:20, 214:23, 215:15, 217:14, 218:19, 220:13, 222:2, 224:13, 229:15, 233:22, 233:24

278

technically 15:24, 18:8, 18:9Technique 47:20, 48:2, 48:18, 209:12, 209:14, 235:15, 238:12, 241:43Technique47 241:43technology 50:4, 164:13, 167:20, 171:17, 175:24television 163:4tells 40:25tempted 215:5, 216:11tended 10:12, 18:18tending 21:9term 16:2, 183:21terms 11:20, 15:8, 17:10, 37:22, 44:20, 50:6, 51:14, 52:9, 53:24, 56:6, 60:16, 69:6, 77:14, 129:21, 151:14, 158:4, 195:16, 213:17, 225:5, 233:1, 236:10Territory 148:9tested 17:16, 17:18, 26:18, 30:2, 44:10, 94:1, 114:6, 114:8, 116:1, 137:8, 137:13, 188:16, 188:17testified 69:10, 69:11, 69:15, 75:25, 155:5, 156:8, 169:25, 177:2, 178:25, 181:15, 186:16, 187:9, 196:14, 200:17testify 46:15,

156:16testifying 46:14, 81:24, 139:16, 230:15, 230:21, 230:24testimonials 159:25testimony 66:4, 68:9, 69:19, 70:20, 78:5, 110:18, 177:3, 182:8, 202:4, 208:21testing. 129:21tests 39:19, 39:21, 39:25, 41:8, 42:24, 43:3, 64:16, 76:21, 90:2, 94:17, 97:24, 106:4, 106:5, 113:17, 114:3, 115:25, 117:2, 136:14, 136:18, 183:4, 196:17Texas 1:2, 2:14, 3:42, 4:6, 4:16, 242:15Thanks 141:3, 168:11, 216:2theme 166:22themselves 58:6, 184:22they'll 184:3they've 158:8thicker 52:19thickest 10:12thinking 39:2, 71:20, 131:23, 214:4third 16:14, 122:20Thomas 73:15Thornburg 3:17though 24:7, 62:4, 64:13, 68:12, 105:3, 130:15, 142:13, 160:24, 197:20, 213:5

thoughts 31:9thousand 39:9, 39:10thousands 15:11threading 38:6, 38:7, 38:13Three 5:20, 8:18, 11:24, 15:18, 27:19, 47:6, 91:15, 91:18, 92:13, 147:5, 147:10, 147:11, 180:16, 181:6, 196:15three-in-one 51:13throughout 162:7, 164:24throw 62:13throwing 11:11thrown 201:21Thursday 134:12tight 93:3tighter 33:5, 33:8tightly 76:6, 77:20, 101:6, 105:20, 112:23, 130:15Time-out 100:24, 105:10, 132:15timeline 5:2, 8:3, 99:1, 132:5, 182:13timely 150:12tiny 213:7, 213:11tissue 211:1, 213:9, 233:5, 237:8, 238:9tissues 232:9, 232:16title 197:5, 238:7titled 76:4today 11:15, 78:7, 155:4, 168:16, 168:18, 182:9, 187:10, 202:9, 227:22,

230:16, 236:18together 19:16, 114:15, 216:25, 218:11, 221:21, 224:14, 236:16tolerance 130:22, 130:25tolerances 130:9, 131:23, 133:7, 144:18, 164:14Tom 45:5, 165:23tomorrow 238:14took 9:9, 25:19, 26:3, 26:4, 39:25, 58:22, 177:4, 221:4, 221:11, 221:13, 223:5, 233:21tool 53:7Top 32:13, 34:24, 37:9, 131:11, 168:20, 196:12, 199:25, 229:21, 237:12topic 108:9, 195:7topics 41:25, 42:1, 57:12torque 38:3torquing 38:3tort 63:2total 25:5, 36:18, 159:25, 181:10, 209:2, 210:12, 211:4, 236:2touch 20:24tour 46:9towards 10:9, 93:3, 141:5toxic 184:8toxicity 192:16, 193:9, 193:16, 193:19, 194:8, 194:19, 194:24, 225:5, 233:1Toxicity/ion 193:4, 193:25track 136:3,

279

165:13, 168:24tracking 136:1trade 165:5, 168:10, 178:2, 178:5, 179:9, 179:14trail 78:8train 105:11training 49:8, 53:14, 74:2TRANSCRIPT 1:19, 3:47, 4:1, 242:3, 242:5transfer 16:14transformation 68:25translate 17:10translating 15:25trauma 210:22traveling 160:13tremendous 38:14, 43:23, 58:2TRIAL 1:19, 4:1, 12:21, 63:13, 66:10, 232:19tribologist 26:22, 30:2, 30:14, 30:16, 50:12, 89:22, 215:13tribologists 31:9Tribology 30:23, 38:15, 42:16, 50:3, 50:12, 55:8, 85:24tried 5:3, 60:17, 66:11, 99:16trip 221:24trouble 141:9, 176:13, 190:11, 210:13, 234:1True 73:16, 77:8, 77:9, 78:11, 82:13, 88:16, 109:19, 110:5, 110:15,

111:12, 165:6, 173:21, 189:10, 189:18, 189:25, 195:15, 211:9, 211:22, 212:2, 219:21Trueglide 164:13, 171:17trust 179:10truth 78:4, 78:10, 78:19, 80:21, 83:1, 87:22, 88:4, 89:9, 113:22, 121:15, 143:15, 143:21, 143:24, 185:23try 13:12, 30:12, 52:13, 60:19, 90:20, 110:4, 120:18, 139:22, 141:7, 167:14, 214:24trying 28:6, 47:16, 66:21, 71:21, 80:8, 106:3, 110:17, 115:11, 116:13, 116:14, 116:17, 118:11, 118:13, 124:13, 129:13, 129:18, 130:19, 130:25, 133:11, 138:10, 149:4, 188:12, 188:14, 226:8Tuesday 132:15, 132:18TULL 2:44, 3:25tumors 193:5, 194:2tuned 161:10turn 22:21, 95:8, 161:21turned 30:5, 150:11, 150:23, 152:6, 203:8TURNER 4:20, 4:23, 20:9, 23:10, 27:19,

58:8, 67:2, 67:20, 68:3, 74:20, 82:25, 85:7, 88:8, 88:9, 89:21, 91:4, 97:8, 97:11, 99:13, 126:3, 130:1, 181:9, 198:16, 240:6Turner/decker 241:50Turner/decker68 241:50turns 16:2, 145:8Twice 26:4, 88:1, 144:4, 144:9, 144:12, 231:24two-piece 116:17, 116:19, 118:14two. 12:7, 31:22, 144:25, 192:12, 202:2TX 1:34, 1:41, 2:37, 3:12, 3:33Type 16:5, 29:6, 103:2, 105:8, 148:16, 152:23, 206:16, 225:11, 225:12types 14:20, 18:2, 42:18, 95:11typically 16:4, 44:11, 48:10, 52:19, 52:21typo 156:3

< U >Ultamet. 70:11, 176:2Ultamets 7:10, 7:11ultimately 154:21, 199:17uncertain

212:12, 225:18, 226:21uncertainty 222:15underline 211:16underlined 231:20underscore 88:8underscoring 65:15understand 27:11, 44:17, 68:5, 119:4, 151:15, 162:4, 177:1, 184:6, 184:14, 184:15, 190:24, 197:7, 198:24, 200:10, 200:13, 202:17, 203:17, 207:24, 209:19, 209:21, 230:4understanding 13:1, 142:20, 149:12, 164:25, 171:6, 171:22, 173:23, 209:22understood 117:15unexpected 26:23unfavorable 213:10unfortunately 10:18unhighlighted 219:9unintentional 62:15unique 18:15, 63:8, 210:23, 211:5unit 166:16, 167:1United 1:1, 1:21, 4:5, 4:7, 4:9, 7:16, 7:23, 18:13, 18:25, 43:20, 43:25, 242:7unknown 209:1,

280

210:11, 211:13, 226:12unknown. 222:16, 226:3Unless 13:5, 13:24, 13:25, 122:5unmet 15:20, 17:8unnecessary 23:6unrelated 30:5, 36:19untested 89:15until 100:8, 126:18, 183:10, 185:6, 188:18, 189:2, 190:17untrue 89:12, 108:13unusual 19:6update 34:6, 34:8, 168:8updated 34:1, 34:13, 87:9, 87:16, 87:20, 88:21, 100:9, 122:10, 122:17upper 229:19urged 175:19urgency 71:1urine 213:9Usdin 3:2use. 173:18useful 161:12, 236:1user 16:12, 20:24users. 167:14uses 164:12using 33:9, 40:22, 73:22, 85:5, 96:4, 102:10, 141:15, 166:4, 175:20, 186:4, 186:11, 208:4utilized 40:24

< V >

V. 2:33vagueness 127:5validate 22:3validation 15:23, 16:6, 16:9, 17:14, 17:21, 156:1value 25:12, 25:13, 25:15, 31:15variables 219:22varies 162:7variety 30:3, 37:21, 39:19, 41:20various 97:1, 159:1varying 38:23venue 56:8venues 60:21verification 15:22, 15:24, 16:4, 17:14, 59:7, 87:17, 103:2, 113:17, 114:3, 156:1verified 87:21, 88:15, 113:18verifies 73:12verify 23:20, 24:14, 25:13, 80:8, 91:10, 103:3, 189:3verifying 85:7version 215:7versions 133:8versus 10:9, 39:24, 52:24, 124:14, 176:2, 190:7via 13:19Video 27:10, 27:16, 29:2, 94:24, 94:25, 95:2, 159:19, 161:18, 161:22, 181:17, 186:2, 241:5Video161 241:5videos 49:5,

159:20, 160:21view 28:12, 194:15, 217:16violation 24:5, 24:9, 24:11vital 225:22, 226:14VOLUME 1:19, 4:1, 15:8, 41:4, 240:1volumes 58:17

< W >W. 2:43Wait 120:14, 140:3, 141:2walk 5:4, 22:22, 36:9, 76:4, 221:11walked 54:6walking 95:18, 164:24walls 20:16wanted 16:8, 19:13, 20:2, 23:6, 25:1, 44:16, 50:17, 51:7, 52:10, 52:12, 58:5, 59:3, 157:11, 166:23, 174:25warn 61:15warning 48:17, 120:22, 191:17, 192:5, 192:13, 205:14, 205:19, 205:22, 206:9, 206:21, 206:25, 207:2, 207:3, 207:10, 207:25, 208:4, 210:3, 213:19, 214:13, 221:10, 225:4, 233:11, 233:24, 234:1, 235:5, 235:10, 235:22, 235:25, 236:13, 236:19, 236:21, 236:23, 237:10,

237:15, 237:19, 237:20, 237:21Warnings 49:2, 192:7, 192:8, 192:9, 192:11, 208:6, 209:6, 209:8, 209:11, 210:5, 210:6, 213:21, 213:22, 213:24, 214:18, 214:19, 216:11, 216:13, 221:7, 234:3, 234:6, 234:13, 234:16, 234:20, 234:21, 235:17, 235:18, 235:21, 236:2, 236:19, 237:22, 238:2, 238:6, 238:8warrant 131:8warranted 130:11, 131:16, 132:1Warsaw 7:3, 136:4, 167:25, 168:7washing 28:4Wasielewski 204:18watch 4:14, 4:16watching 94:25, 95:2water 67:6, 98:13WAYNE 2:10ways 73:2, 235:3wearing 95:20wears 114:15weather 63:20web 158:24, 159:24, 160:17webcast 161:9Wednesday 132:19, 132:21weeks 226:6, 226:7weigh 97:12weighed 222:9weighs 235:23

281

welcome 65:10well-functioning 225:20well-known 165:4, 226:9well-versed 42:15West 1:[email protected] 2:16whatever 226:21, 231:2wherever 224:15whether 58:24, 62:14, 72:23, 78:19, 88:22, 89:10, 135:12, 181:17, 184:7, 184:18, 203:18, 233:13White 3:24, 206:2who've 209:23whoa 64:4, 144:23whole 19:23, 66:14, 100:10, 116:12, 118:21, 192:14, 214:23, 224:14, 227:25, 234:22, 236:3widely 40:24widening 32:20wife 4:14Williams 129:11, 133:4willing 167:20, 220:3WILSON 3:40, 242:2, 242:12, 242:13winners 181:10withdraw 231:3within 7:6, 54:5, 90:14, 90:16, 145:13, 180:18, 180:24, 183:16, 195:17Without 35:17, 122:25, 133:25,

137:7, 137:8, 137:13, 146:11, 146:12, 146:14, 146:15, 196:2WITNESS 61:3, 67:5, 67:7, 78:14, 81:24, 83:5, 83:25, 98:14, 101:15, 101:24, 112:5, 117:24, 118:25, 121:4, 122:10, 122:20, 123:17, 125:12, 128:17, 133:2, 137:18, 139:6, 149:12, 150:20, 152:9, 160:7, 161:5, 191:4, 204:2, 240:4won 153:16, 180:3Wonder 71:13Wood 181:4word 134:18, 144:18, 217:5, 218:3, 218:4, 229:18words 75:21, 79:10, 85:17, 93:21, 94:15, 131:9, 132:14, 140:9, 147:19, 171:15, 188:15, 197:2, 199:24, 201:22, 208:16, 233:6work 5:7, 8:6, 13:8, 19:16, 20:15, 21:3, 21:11, 21:20, 27:12, 41:22, 58:17, 58:19, 60:24, 69:16, 75:2, 84:6, 99:16, 111:11, 120:20, 153:4, 153:17, 153:25, 158:9, 178:14, 180:6, 181:8,

202:24, 207:22, 208:13, 218:13worked 23:11, 38:6, 41:12, 115:12, 115:13, 154:17, 175:4, 175:10, 175:11, 179:18, 180:21working 5:11, 5:24, 19:25, 20:12, 42:14, 75:22, 83:16, 91:24, 105:15, 147:19, 155:25, 178:18, 218:6works 54:18, 54:19, 77:11, 77:16, 77:22, 105:22, 130:16, 160:1, 162:5, 235:1, 235:3works. 71:21World 38:7, 55:8, 94:15, 96:25, 179:12, 195:17, 205:12worldwide 155:19worn 213:11wound 137:3, 197:19, 210:16wrap-up 57:17, 57:19write 41:22, 130:1, 133:20, 145:1, 145:5writes 133:18, 145:13, 145:16, 145:18, 168:11writing 50:9, 86:8, 86:11, 123:24, 163:9, 181:17written 14:11, 14:12, 16:18, 24:17, 132:14, 133:18, 178:16, 179:16, 183:1, 214:23wrote 50:10, 162:1, 163:21

< X >x-ray 212:10XL 71:2

< Y >year 38:24, 39:1, 39:3, 39:9, 68:13, 96:19, 148:8, 153:4, 153:20, 190:4, 192:11, 193:17year. 154:24years 38:21, 38:22, 39:9, 39:10, 59:12, 64:2, 68:14, 146:4, 146:6, 170:24, 190:25, 199:18, 200:20, 200:21, 200:25, 201:10, 203:10, 229:3, 229:5, 229:7, 229:8years. 176:8yellow 143:4Yep 143:1Yesterday 4:23, 5:2, 7:25, 8:22, 9:12, 21:20, 43:15, 43:25, 44:4, 45:16, 75:25, 76:13, 156:8, 182:9, 182:14, 200:3, 202:4, 202:8, 202:17Yikes 94:12, 188:2York 2:23you-- 228:11yourself 82:14, 82:18, 180:3Youtube 159:12, 159:14, 159:15, 159:18, 159:20, 159:24, 160:22

282

< Z >zero 59:15, 202:7Zimmer 37:2, 147:10Zivic 40:2zoom 119:14, 224:15

283

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 1st 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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