UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

 _________________

In Re: Bard IVC Filters ) MD-15-02641-PHX-DGC

Products Liability Litigation )

 )

 ) Phoenix, Arizona

 ) January 19, 2018

 ) 

_____________________________________)

BEFORE: THE HONORABLE DAVID G. CAMPBELL, JUDGE

REPORTER'S TRANSCRIPT OF PROCEEDINGS

MOTION HEARING and STATUS CONFERENCE

Official Court Reporter:

Patricia Lyons, RMR, CRR

Sandra Day O'Connor U.S. Courthouse, Ste. 312

401 West Washington Street, SPC 41

Phoenix, Arizona 85003-2150

(602) 322-7257

Proceedings Reported by Stenographic Court Reporter

Transcript Prepared with Computer-Aided Transcription

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A P P E A R A N C E S

 

Plaintiffs' Leadership Committee:

Lopez McHugh, LLP

By: RAMON R. LOPEZ, ESQ.

100 Bayview Circle, Ste. 5600 

Newport Beach, CA 92660 

Gallagher & Kennedy

By: MARK S. O'CONNOR, ESQ.

2575 E. Camelback Rd., Ste. 1100 

Phoenix, AZ 85016

Hausfeld, LLP 

By: STEVEN ROTMAN, ESQ.

1700 K St. NW, Ste. 650

Washington, DC 20006

Gallagher & Kennedy 

By: PAUL L. STOLLER, ESQ.

2575 E. Camelback Rd., Ste. 1100 

Phoenix, AZ 85016

For the Plaintiffs:

Heaviside Reed Zaic

By: JULIA REED ZAIC, ESQ.

312 Broadway, Ste. 203

Laguna Beach, CA 92651

Faraci Lange, LLP

By: HADLEY L. MATARAZZO, ESQ.

28 E. Main St., Ste. 1100

Rochester, NY 14614

Lopez McHugh, LLP

By: JOSHUA MANKOFF, ESQ.

1 International Plaza, #550

PMB-059

Philadelphia, PA 19113

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A P P E A R A N C E S (continued)

For the Defendants:

Nelson Mullins Riley & Scarborough

By: RICHARD B. NORTH, JR., ESQ.

201 17th Street NW, Suite 1700

Atlanta, GA 30363 

Nelson Mullins Riley & Scarborough 

By: MATTHEW E. BROWN, ESQ.

1 Post Office Sq.

Boston, MA 02109

Nelson Mullins Riley & Scarborough.

By: PHILIP M. BUSMAN, ESQ.

101 Constitution Avenue NW, Ste. 900

Washington, D.C., 20001 

Snell & Wilmer

By: JAMES R. CONDO, ESQ.

400 East Van Buren 

Phoenix, AZ 85004

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P R O C E E D I N G S

THE COURTROOM DEPUTY: In the matter of MDL

2015-2641, Bard IVC Filters Product Liability Litigation, on

for motion hearing. 

Will the parties please announce.

MR. O'CONNOR: Good afternoon, Your Honor. Mark

O'Connor, co-lead for plaintiffs.

MR. LOPEZ: Good afternoon, Your Honor. Ramon Lopez,

also co-lead for plaintiffs.

MS. REED ZAIC: Julia Reed Zaic on behalf of

plaintiffs' steering committee.

MR. LOPEZ: Do you just want the ones who are going

to speak, Your Honor?

THE COURT: Sure.

MR. MANKOFF: Josh Mankoff on behalf of plaintiff.

MS. MATARRAZO: Hadley Matarrazo on behalf of

plaintiff.

MR. ROTMAN: Steve Rotman on behalf of plaintiffs.

MR. NORTH: Good afternoon, Your Honor. Richard

North on behalf of the defendants, and I'm joined by Mr. James

Condo, and also from my office Mr. Philip Busman and

Mr. Matthew Brown.

THE COURT: All right. Good afternoon, everybody.

MR. LOPEZ: Afternoon.

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THE COURT: We're here to hold oral argument on four

of the expert motions. Those are the motions directed at

Hurst, Muehrcke, Betensky and Eisenberg. I don't have a

preference in the order we follow them. I don't know if you

do. If not, we can just go in that order.

I think we ought to argue them individually; do all

the argument on Hurst and then all of the argument on

Muehrcke, et cetera.

After we've done that, there are some matters I want

to talk to you about in terms of case management, including

some of the things that were raised in your joint report.

I've read the briefs on the motions. In fact, we

have draft orders on all four, so I've spent time drafting

orders as well, so I'm pretty familiar with the issues. You

don't need to sort of start at ground one on acquainting me

with what the issues are. Instead, I'd appreciate you

focusing on the issues you think are most relevant now that

it's briefed.

Why don't we start with Hurst. This is a defense

motion.

MR. NORTH: Your Honor, Matthew Brown will be arguing

that motion.

THE COURT: Okay.

MR. BROWN: Thank you, Judge Campbell. May it please

the Court. In light of what Your Honor just mentioned with

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your familiarity with the issues, I'd like to limit our

argument to two principle issues we think may be helpful to

the Court in considering the motion, the first being

Dr. Hurst's opinions that Bard's filters, quote, have much

higher complication rates in comparison to both permanent and

retrievable filters, and, secondly, Dr. Hurst's opinions about

minor caudal migration.

Taking the first opinion about the higher

complication rates in comparison to both permanent and

retrievable filters, we believe that Dr. Hurst is not

qualified to offer that opinion. This opinion is crucially

different from the other experts' opinions about the medical

literature in this litigation. For example, the opinions that

are offered by Drs. Kinney, Roberts, and Kalva where they

focus on critiquing individual medical articles.

What Dr. Hurst is doing here is purporting to conduct

what we like to call a meta-analysis in saying that he has --

conveying that he has conducted a systematic review and

analysis of the literature concerning IVC filters. And, as

Your Honor knows from science day, there are roughly two dozen

IVC filters that have been available for use and several

thousand articles in the medical literature concerning those

IVC filters.

This type of meta-analysis is something that's

typically done by somebody who is an epidemiologist or

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somebody who has a very high level understanding of

statistics. There's been nothing proffered by the plaintiffs

to suggest that Dr. Hurst has anything in his background,

training, or experience that would allow him to make these

sorts of opinions. He's not an epidemiologist. He does not

have a high level understanding of statistics. Rather, he's a

practicing interventional radiologist in a community-based

practice in Kentucky. And so therefore we feel that

doctors -- Dr. Hurst's opinions about Bard's IVC filters have

a higher rate of complications in comparison to all other

permanent and retrievable filters should be excluded because

he's not qualified to offer them.

We also think that opinion should be disqualified

because it's unreliable. Dr. Hurst, in fact, has not

conducted any kind of systematic review or analysis of the

medical literature for IVC filters.

The articles that he cites in his Rule 26 report are

limited in number, firstly, and, secondly, are almost all

concerning Bard's filters rather than the other 20 or so IVC

filters have that have been available for use.

Additionally, he focuses almost exclusively on an

article by a Dr. Deso, which we attached as Exhibit B to the

reply briefing. And Dr. Deso's article doesn't purport to

identify which filters have higher complication rates than

other filters, and it wasn't designed to do that.

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What Dr. Deso's article was, was a review of the

available medical literature, and he plucked out the articles

that had the highest complication rates and put them into a

table entitled Articles that Have the Highest Complication

Rates. But he omitted all of the articles that have low

complication rates. This is very different from a

meta-analysis.

Bard is not aware of any article in the medical

literature, the plaintiffs haven't identified any article in

the medical literature, that purports to have conducted this

meta-analysis of the available literature for IVC filters.

And so for that reason we think his opinion should be

inadmissible because it's not reliable.

Turning to the second issue, which is Dr. Hurst's

opinion about unacceptable risk of caudal migration. We think

that should be inadmissible because it's unreliable.

Dr. Hurst is using a personal definition of caudal migration.

He defines it as, quote, I mean basically a settling occurs

with the filters, a splaying out of the legs, close quote,

which he discusses in page 231 of his deposition, which we

attached as Exhibit C to the reply brief.

Now, that definition is not found anywhere in the

medical literature. The medical literature defines migration

as movement of an IVC filter by more than 2 centimeters. And

there's good reason for that. There are external factors

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Case 2:15-md-02641-DGC Document 9966 Filed 02/01/18 Page 8 of 96
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related to how the imaging is actually taken that could make a

filter look like it's migrating when in fact it hasn't.

So, for example, a patient's body positioning will be

different from one image to another image. A patient may be

breathing in when one image is taken and breathing out when

another image is taken. There may be minor differences in the

angle of the camera that's taking the various images. Any and

all of these issues can impact the way an IVC filter looks on

the imaging and make it appear it migrated when it hasn't,

which is why the medical community has settled upon this 2

centimeter definition for migration.

Bard has not found any literature, the plaintiffs

haven't identified any literature that supports Dr. Hurst's

definition of caudal migration.

And because Dr. Hurst is offering a personal

definition of what caudal migration is, we think that that

opinion should be inadmissible as unreliable.

We are not saying in cases where there's been a

migration of more than 2 centimeters that his opinion should

be inadmissible, because that is what is consistent with the

available medical literature. Rather, it is his opinions in

cases where the filter has moved less than 2 centimeters that

we think should be inadmissible as unreliable. 

Thank you, Your Honor.

THE COURT: All right. Thank you.

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MS. MATARRAZO: Good afternoon, Your Honor. Hadley

Matarrazo for the plaintiffs.

Dr. Hurst isn't doing a meta-analysis here. He

didn't claim to do a meta-analysis, and one is not required

for him to arrive at his opinion that Bard filters have a

higher complication rate than other IVC filters. This

argument is a red herring.

Dr. Hurst testified that what he did in arriving at

this opinion is look at the medical literature. He relied on

the Deso study that was discussed. He reviewed the 88

articles that underlie the Deso study, and he also conducted

his own literature search and looked at the 70 to 80 articles

that he pulled up in that search and reviewed them. And it is

that that he relied on to arrive at his conclusion that Bard

filters have higher complication rates.

The Deso study is an interesting study. It was

conducted by three physicians, interventional radiologists, at

the Stanford University Medical Center. The goal of that

study, according to what the authors set out to do, was to

evaluate the various FDA-approved IVC filter designs to

determine which device specific risk -- excuse me, determine

device-specific risks and help identify patients who may

benefit from the ongoing followup versus prompt retrieval. In

other words, which of these filters have higher complication

rates and should be followed up and removed.

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In doing this, what the authors did is they did a

literature review. They identified 24 filters they wanted to

look at. They then pulled what they thought were potentially

relevant articles, which were nearly 1500 articles. From

those articles they identified 88 articles and they reviewed

all of those, and they compiled in a chart in that article the

filters that had the highest complication rates based on the

studies they looked at.

They also included a range of the complication rates

in that chart, from the lowest complication rate they saw in a

given study to the highest complication rate they saw in a

given study.

And in doing so, they determined that across the

board, particularly with regard to fracture but also with

regard to tilt and perforation, that Bard filters had the

highest complication rates. 

And, Your Honor, under the Daubert 2 case, which we

cite in our brief, this is sufficient to show -- the fact that

this article was published in the peer reviewed literature is

sufficient to show that it meets at least the minimal criteria

of good science. This alone is sufficient for Dr. Hurst to

rely on for the admissibility of his opinion.

THE COURT: Well, let me ask you a question about

that last sentence.

It seems to me the fact that it's peer reviewed and

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published would be a sound basis for Dr. Deso to give this

opinion. But are you suggesting that any interventional

radiologist can read this article and then give an expert

opinion that is --

MS. MATARRAZO: I think --

THE COURT: -- just repeating what was the conclusion

in the article?

MS. MATARRAZO: Well, yes, Your Honor. I think that,

coupled with the other literature he's reviewed that has

information about Bard's complication rates, as well as his

own experience. And in addition to that, Your Honor, he also

looked at Bard's own internal documents.

Bard's own internal documents, which are on his

reliance list, things like G2 fracture analyses they

conducted, caudal migration analyses, those also show their

own filters have higher complication rates.

THE COURT: What did he do to verify the results in

any of these articles or in any of the Bard documents?

MS. MATARRAZO: With regard to Deso, he looked at the

88 studies that underlied -- underlied that Deso article. So

verified that that information was accurate based on the 88

studies that were in there, Your Honor.

THE COURT: Did he do anything to verify any of the

information in any of those studies himself?

MS. MATARRAZO: Your Honor, all I'm aware of is he

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reviewed the 88 articles that were underlying the Deso study.

THE COURT: Okay.

MS. MATARRAZO: With regard to the rate of G2 caudal

migration, I won't go through all of the documents on his

reliance list, but I want to point out one of them that I

think is particularly important. There's a March 2nd, 2006,

e-mail that attaches design failure mode effects analysis.

This is a document -- or an analysis that Bard does where it

predicts its own expected failure rates for all complications

with regard to their filters, and this e-mail attaches one of

those DFMEAs in which the employee, Bard employee, Natalie

Wong, actually concludes that with regard to the G2 caudal

migration that the rate that they're seeing with the G2 caudal

migration exceeds their own anticipated rate in their DFMEA

and actually says this is, quote, unacceptable, unquote. So

it's not just Dr. Hurst that has this opinion, Your Honor.

THE COURT: Well, let me ask you a question on that

as well.

It sounds as though you're suggesting that Dr. Hurst,

as a doctor, can read an internal document at Bard that makes

a factual assertion and then give an expert opinion the

factual assertion is correct, without doing any study of it

himself.

MS. MATARRAZO: Well, Your Honor, I think if you look

at that in conjunction -- it is not just that one statement.

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If you look at that in conjunction with the literature he

reviewed, I think he's found support in both places for his

opinion.

THE COURT: Well, the way that the defendants just

argued it, and I didn't -- I read his report more than a week

ago so I can't remember the answer to this question, but he

seems to opine generally that there are higher complication

rates based on Deso and the other articles, but he also says

there's an unacceptable risk of caudal migration and he gets

the words "unacceptable risk" right out of the Wong e-mail.

Besides the Wong e-mail, what specific information

did he rely upon to reach a professional opinion that there

was an unacceptable risk of caudal migration?

MS. MATARRAZO: Your Honor, he relied primarily on

Bard's documents for that because the study didn't separate

out caudal and cephalad migration.

THE COURT: I guess that gets back to my same

question. You're saying a doctor can read an internal Bard

document that makes a factual assertion and then come into a

court and give that factual assertion as his professional

opinion, without having done anything more. Is that what

you're suggesting?

MS. MATARRAZO: Yes, to some extent, Your Honor,

except it's also supported by the medical literature. So it's

not the Bard document alone; it doesn't separate caudal and

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cephalad migration. However, the literature -- there's

evidence in the literature that Bard also has higher migration

rates.

THE COURT: Does he identify specific articles he

relied upon for that, in addition to the Wong document? I

just can't remember.

MS. MATARRAZO: Yes, Your Honor. His reliance list

has that and he testified about the Deso study as well as the

88 articles underlying them. Underlying the Deso study.

THE COURT: The Deso study, which I have in front of

me, the table in it has just a general category for migration.

MS. MATARRAZO: That's correct, Your Honor.

THE COURT: That's all kinds, correct --

MS. MATARRAZO: Correct.

THE COURT: -- not just caudal?

MS. MATARRAZO: Correct.

THE COURT: Okay.

MS. MATARRAZO: Okay. 

So, Your Honor, to the extent that you have any

concerns about the testimony, the plaintiffs would just

respectfully request that essentially, if it's a close

question, that it be resolved at trial so that the evidence

can be evaluated in the proper context in which it's, offered.

Thank you, Your Honor.

THE COURT: Let me ask you a question before you sit

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down.

I'm looking at page 9 of Dr. Hurst's report in the

Mulkey case.

MS. MATARRAZO: Yes, Your Honor.

THE COURT: I don't know if you have that --

MS. MATARRAZO: I do.

THE COURT: Okay. The way he states this higher

complication rate opinion on that page in paragraph D1 is he

says, "It is my opinion that Bard failed to notify the

operating physicians and the implanted patients of the much

higher complication rates associated with these filters."

That seems to be an opinion not about higher

complication rates but about a failure to notify. And

although I read your brief on this more than a week ago so I

may be incorrectly remembering it, it seems to me you

emphasized that, that what he's testifying about is what

reasonable physicians would expect to receive, not about

actual complication rates.

MS. MATARRAZO: Yes, Your Honor. To the extent that

the complication rates are higher, Your Honor, that is

certainly something that I think Dr. Hurst is qualified to

opine that a reasonable physician would want to know. And I

think that's something Your Honor actually resolved in the

prior order with Kinney, Kalva, and Roberts, that physicians

such as these interventional radiologists are qualified to say

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what they -- what they would expect -- the information they

would want to have or expect to have from Bard related to the

risk of their IVC filters.

THE COURT: It seems to me that there's a difference

between those opinions. On one hand, a doctor could come in

and say something like if there is a higher complication rate,

I would want to know it as an interventional radiologist and I

think my patient would want to know it; it should be

disclosed. Which may go to the failure-to-warn issue.

It's a different thing to come in and say it's my

opinion that there is a higher complication rate for these

filters.

Are you proposing that he do both of those things?

MS. MATARRAZO: We are proposing that he do both.

But we understand if Your Honor's going to limit that

testimony to what a reasonable physician would expect to be

notified about.

THE COURT: Okay. All right. Thank you.

MS. MATARRAZO: Thank you, Your Honor.

MR. BROWN: Nothing further, Your Honor.

THE COURT: Let me ask you a follow-up question on

what was just asked.

Do the defendants object to Dr. Hurst coming in and

saying, in effect, if there are higher complication rates,

interventional radiologists and their patients would want to

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be told that information?

We need you at a mic, if you would, please.

MR. BROWN: I think leaving aside the foundational

issue of whether there are, in fact, higher complication

rates, which would take away what we've argued previously

about him not being qualified and that opinion not being

unreliable, but in that hypothetical situation, if we are to

assume Bard's filters have higher complication rates, then we

think that that would fall under Your Honor's previous ruling

for Drs. Kinney, Roberts, and Kalva that that would be

something that Dr. Hurst would be able to speak to the jury

about what a reasonable physician would want to be informed

about from a medical device manufacturer.

THE COURT: Okay. All right. Thank you.

Let me make a note here before we talk about the next

one.

Okay. Let's take up Muehrcke next. Am I pronouncing

that correctly?

MR. NORTH: I think so, Your Honor. Dr. Muehrcke.

THE COURT: Okay.

MR. NORTH: Your Honor, the motion to exclude certain

opinions of Dr. Muehrcke has six separate points. Four of

those points, however, I believe have been addressed by this

Court already in previous Daubert rulings, and those would be

our contention, number one, that Dr. Muehrcke is not qualified

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to offer design opinions. I believe the Court has already

ruled upon very similar factual circumstances and assertions

in the context of the order regarding Drs. Kinney, Roberts,

and Kalva.

The second point is our argument that Dr. Muehrcke

improperly adopts opinions of other experts. The Court

addressed a very similar argument in the opinion regarding

Dr. Kinney.

The third has to do with the subject the Court just

raised in the last motion discussion which is the testimony

regarding physician expectations, and this Court has already

addressed that in the orders of Dr. Kinney and Dr. Kessler and

Dr. Parisian.

And the fourth point I believe the Court has covered

already is our contention that Dr. Muehrcke should not be

allowed to opine regarding corporate motive, intent, and state

of mind, and this Court has already indicated in the order

regarding Drs. Kessler and Parisian the limitations that will

be put on testimony to that effect.

On those points that have been covered, though, I

would like to adjust just a couple of additional points unique

to Dr. Muehrcke, and that's the fact that as far as his design

opinions, which talk about everything regarding from migration

resistance to weak anchoring hooks to lack of radial force,

the plaintiffs attempt to justify those opinions by saying

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Case 2:15-md-02641-DGC Document 9966 Filed 02/01/18 Page 19 of 96
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that he is testifying based on his clinical experience.

However, I wanted to point out his opinions go far beyond his

clinical experience, quote, unquote, and deal with engineering

and design issues that somebody who's a cardiothoracic surgeon

like Dr. Muehrcke is not simply qualified to give.

The other point I would raise regarding issues that

have already been covered by the Court --

THE COURT: Before you leave design, since you just

mentioned it, let me ask you a question on what you just said.

Dr. Muehrcke clearly does state the opinion that the

filters had inadequate migration resistance and lack of

strength and stability caused by weak anchoring hooks and lack

of radial force and inadequate leg span. But he then says in

the next sentence, "In reaching this opinion, I reviewed

Ms. Booker's medical records and radiology and performed a

differential diagnosis, and there is no other reasonable cause

for the failures of the filter."

I agree with you that he's not a metallurgist, he's

not an engineer, he's not a product designer, and he can't

give opinions from that standpoint. But as a doctor who has

dealt with many cases of implanted filters and removing

filters and problems with filters, does that qualify him to

say, look, I've done this a lot, I've looked at her medical

history, I know what causes filter problems in human bodies,

and looking at her medical history I can't identify any other

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potential cause of this problem than a defect in the design of

the filter?

MR. NORTH: Well, Your Honor, I would submit that

that -- his practical experience as a physician qualifies him

to give an opinion that the filter failed and how it failed as

far as did it fracture or did it migrate. But then to take

that further leap and to say it migrated or it fractured

because of a lack of radial strength, because of weak

anchoring hooks, things that he has never assessed and does

not have the competence or experience in the engineering

fields to assess, that's the leap where he goes too far.

If he wants to give an opinion her medical condition

was caused because this fractured and this migrated and I see

that, that's certainly within his experience. But to say what

engineering attributes of that filter led to that

complication, he's simply not qualified, we would submit.

THE COURT: Okay. Thanks.

MR. NORTH: Turning to another opinion that this

Court has already addressed but I just wanted to point out one

thing different with Dr. Muehrcke, and that has to do with the

adoption of opinions of other experts. 

This Court ruled in the order regarding Drs. Kinney,

Kalva, and Roberts that it was appropriate there, although I

believe the Court said something to the effect that they

couldn't simply narrate or parrot those opinions, it was

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proper for them to rely upon those opinions. But here we have

Dr. Muehrcke going one step further. He adopts and professes

as his own Dr. Kinney's opinions, and -- from that report, and

he basically tries to embrace those and endorse those.

Now, as we know, Dr. Kinney's report is based in

large part on Dr. Kessler's report. But Dr. Muehrcke admits

he never read Dr. Kessler's report.

So he's adopting the opinions of one expert -- or one

group of three experts, Drs. Kinney, Roberts, and Kalva -- and

their endorsement of another expert's report who he has not

read. And we believe that that is an improper attempt to sort

of adopt the expert opinions of someone else, particularly

when, like Dr. Muehrcke here, he's made no effort not only to

corroborate but even to read the central focus of Dr. Kinney's

report.

Turning to the two newer issues raised by

Dr. Muehrcke's -- motion regarding Dr. Muehrcke, the first one

is very similar to what the Court just discussed regarding

Dr. Hurst, and that has to do with Dr. Muehrcke's opinion that

the G2 and the Eclipse had, quote, acceptable, unquote, rates

of caudal migration.

It's very clear that Dr. Muehrcke has made no

independent analysis of the rate of caudal migration. He

can't cite to medical literature dealing specifically with

caudal migration.

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He claims to rely on the analysis and conclusions of

Dr. Betensky, the statistician, but he admits he's never read

Dr. Betensky's report. He simply -- and then he goes further

and says, well, the Bard rate is unacceptable but I don't know

or I refuse to say what would be an acceptable rate, other

than as close to zero as possible.

He has simply made no analysis, no effort, to

determine the rate of caudal migration with regard to Bard's

G2 filter. He's simply taken that statement out of the Wong

e-mail without an understanding of the context, the nature of

that particular analysis that was being done, what

"unacceptable" meant in that particular engineering context.

He doesn't know. He hasn't studied it. He simply has

endorsed it and tries to float this large opinion that there's

an unacceptable rate of caudal migration when he's done

absolutely no background work to make that determination.

The one other unusual or unique issue -- not usual

but unique to Dr. Muehrcke, is really specific to only one of

the bellwether cases. Although possibly to the Booker case

because some of his opinions bled over to Booker, and that has

to do with Ms. Hyde and his opinions regarding her future risk

of arrhythmia. And he also makes some statements about Dr --

I mean Ms. Booker in that regard, but they're focused mostly

on Ms. Hyde. 

The plaintiffs keep saying in their brief that it's

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okay for him to give these opinions because he's a

cardiothoracic surgeon and you don't have to be a very

specific -- in a very specific medical field to necessarily

give opinions in this area. But that is not the basis of our

argument, Your Honor.

The basis of our argument is his own admission in his

deposition that he would have to defer to an

electrophysiologist to quantify the future risk, he would have

to defer to an electrophysiologist to determine whether

automatic implantable defibrillator was even necessary with

Ms. Hyde. He stated these opinions in his report, but when

being deposed admitted that he would have to defer to the true

expert in that field on those areas. So by his own admission,

Your Honor, he's not qualified to give those opinions.

If the Court has no further questions, that concludes

what I wanted to point out.

THE COURT: Thank you.

MS. MATARRAZO: Your Honor, I'm going to start with

the design argument. I think this Court has already decided

that and I just wanted to touch on that briefly, that

Dr. Muehrcke isn't going to be offering any opinions such as

the one that this Court -- the ones that this Court describes

on page 10 of the prior order.

What Dr.--

THE COURT: Which order -- which order are you

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referring to?

MS. MATARRAZO: I'm sorry. The Kinney, Kalva, and

Roberts order. If it's okay with the Court, I'll just refer

to it as the prior order rather than trip over the names every

time I have to say it.

What Dr. Muehrcke does, and it was just discussed so

I won't go over in detail, but it gives opinions about

performance flaws from a clinical perspective and and how --

what the clinical effect of those particular issues are with

the filter and how that manifests in the plaintiff.

And so I understand the Court on page 11 of that

prior order didn't say this testimony was something the Court

was necessarily going to allow in, but I believe what the

Court wanted to do is hear that testimony in the context it

was going to be offered at trial and make that decision, and

plaintiffs would respectfully request, to the extent

Dr. Muehrcke is going to offer any of that testimony at trial,

that it be handled at that time. And certainly there are ways

to question that witness outside of the presence of the jury

to establish that there is -- that that -- that the opinion

being offered and is reliable and that the witness has -- is

qualified to give that opinion.

With regard to the reliance on other experts,

Dr. Muehrcke -- what Dr. Muehrcke said is he reviewed, agrees

with, and adopts the opinions of Kinney, Roberts, Kalva, and

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Eisenberg. None of Dr. Muehrcke's opinions rely solely or

even primarily on the reports of other experts. Nor does he

intend to parrot those experts' opinions. So we believe that

the prior order governs in that situation.

With regard to the argument on the caudal migration

rate, it's pretty much the exact same argument I just made

with regard to Dr. Hurst, so I won't reiterate that with the

Court. The only thing I want to point out is -- well, two

things: The Wong document really speaks for itself. And with

regard to Dr. Betensky, he had not read her report at the time

that he signed his report. My understanding is that he had

read her report prior to his deposition and that what

Dr. Muehrcke essentially said is that his opinion is supported

by Dr. Betensky's report, that she found the same thing.

Okay. So with regard -- I think that leaves us,

really, just with Plaintiff Hyde. And in this situation what

Dr. Muehrcke did is he offered the opinion that as a result of

the failure of her G2 filter and resulting heart surgery,

she's at risk for future arrhythmias and automatic implantable

cardiac defibrillator and sudden death. He's a cardiothoracic

 surgeon. I think he's certainly qualified to opine about

future risks that a patient who has heart surgery would face.

The defendants' real issue here is that they didn't

quant- -- he didn't quantify the risk. When he was asked to

quantify the risk, he said an electrophysiologist would be

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better suited to quantify that risk.

Physicians make risk assessments like that all the

time without quantifying the risk in their daily practice; a

patient's at an increased risk of a particular outcome and

treat that patient accordingly.

The fact he didn't quantify the risk and said he's

not the person that should quantify that risk doesn't

disqualify him from giving his opinion. This is really an

issue for cross-examination, Your Honor.

And unless Your Honor has any questions, that's all I

have on Dr. Muehrcke.

THE COURT: Okay. Thank you.

MS. MATARRAZO: Thank you, Your Honor.

MR. NORTH: Nothing further, Your Honor.

THE COURT: Okay.

All right. Let's talk about Dr. Betensky.

MR. NORTH: Your Honor, Mr. Busman will argue this

motion.

THE COURT: All right.

MR. BUSMAN: Good afternoon, Your Honor. May it

please the Court. I understand the Court is quite familiar

with the briefing and has largely made up its mind on how it's

going to rule on this. I will, however, highlight a couple of

issues I think are particularly important with respect to

Dr. Betensky's opinion.

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The first, of course, has to do with Dr. Betensky's

failure to consider data for the Simon Nitinol filter for the

ten-year period prior to 2000 when it was on the market. To

review the bidding a bit, Dr. Betensky calculated what she

styled a reporting risk ratio. She then inferred, based on

that reporting risk ratio, something called a risk ratio.

Now, in order to do this, she took a look at adverse

events reported for each of the retrievable filters starting

at market introduction carried through all the way to the

present or when they were removed from the market. For the

Simon Nitinol filter, however, she omitted a decade's worth of

adverse events.

When we confronted her at deposition with this

omission, she clearly admitted that failure to consider these

data could have invalidated her opinions entirely.

In fact, as we quote in our papers, she testified

that the number she calculated could have gone up, could have

gone down. She has no idea where those numbers would have

gone.

The fact of the matter is, Your Honor, this is not an

issue that can be remedied on cross-examination. Any opinion

with respect to an RRR let alone an RR is now completely

speculative. She simply doesn't know the answer. It runs

afoul of Rule 702's prescription. You've got to have

sufficient facts and data. She simply does not.

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Another point that I would like to highlight is

Dr. Betensky's failure to employ reliable assumptions.

THE COURT: Before you leave the Simon Nitinol

filter --

MR. BUSMAN: Yes.

THE COURT: -- what you argue in your brief and in

your reply is that it is, quote, entirely possible, close

quote, that this decade of data would change the result of her

analysis.

You've got the data. You've got a biostatistician

expert. I don't see any suggestion that you had them look at

the data to see if, in fact, it did change the result of her

analysis.

MR. BUSMAN: Your Honor's correct. We didn't employ

that analysis. But it's plaintiffs' burden. They're the ones

who are moving to introduce this evidence. They're the ones

who had to account for it. We don't have the burden of proof

on that issue. If they want to present this evidence to the

jury, it has to be both relevant and reliable. She simply

didn't account for it.

THE COURT: Well, but if Dr. Betensky says, as I

think she did, that her review of this data suggests that the

Weber effect doesn't apply, this isn't an instance where there

are more reports up front and fewer later, in fact she says

the data tends to suggest it's the opposite, there are fewer

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at the start and more later, and therefore she doesn't believe

that the data from that ten-year period would show any

different result because it would have been lower, not higher,

for the Simon Nitinol.

If she states that opinion and as a biostatistician

says "I'm comfortable with my opinion because of that fact,"

isn't that for the jury to evaluate whether that's a

reasonable basis for her to stand on the Simon Nitinol data

she's used?

MR. BUSMAN: No, Your Honor, I don't think so. With

due respect, that is runs counter to her clean admission that

she has no idea what her calculations would have shown. She

simply doesn't know the answer. And she admitted cleanly that

she would have employed these date had she had them. So, no,

I do not think it is a question for the jury. It is entirely

speculative at this point.

THE COURT: Okay.

MR. BUSMAN: Now, with respect to the second issue

I'd like to highlight, having to do with the assumptions that

she employed, as we set forth in our brief, Dr. Betensky

explains that assumptions are necessary. They're necessary to

go from the RRR she calculated to any inference with respect

to an actual RR. And she further explained that the reporting

risk ratio is not the quantity of interest in this case, it's

not at all. It's a crude estimate. It's truly the risk ratio

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that is informative.

Now, in order to extrapolate at all from a reporting

risk ratio to a risk ratio she was required to employ certain

assumptions. Now, plaintiffs have not contested the portion

of our brief where we explain potential differences between

detection of adverse events in the Simon Nitinol permanent

filter and various retrievable filters.

In order to make those assumptions requires

collaboration with the subject matter expert. This is

something Dr. Betensky does routinely in her professional

capacity outside of the courtroom. She collaborates with

subject matter experts. They provide the assumptions, she

runs the analysis. That did not happen in this case. She

simply employed assumptions that made sense to her.

She's not a medical doctor. She's not an expert in

these products. And because of that, any assumptions she

employed are simply ipse dixit. They just seemed reasonable

and she employed them. And, in fact, when we questioned her

about this at deposition, she admitted she didn't control for

any of those issues.

For example, she claims she did not have the data to

render an opinion one way or another whether differences in

detection would have impacted her opinions.

She also testified that she didn't have any

information and therefore could not control for the

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possibility that notoriety surrounding, for example, lawsuits

related to these products may have impacted reporting.

I want to take a step back with respect to notoriety

and increased reporting. Your Honor mentioned the Weber

effect. I find plaintiffs' position on the Weber effect to be

a little bit curious.

Dr. Betensky herself in her report described the

Weber effect. She's the one in the limitations sections of

her report who first put it out there. It was only when Bard

posited that it was entirely possible there could have been

increased reporting when the Simon Nitinol filter first hit

the market that plaintiffs have countered it. But these

assumptions are simply things she didn't account for and

render her opinions speculative and unreliable.

The final point I'd like to make -- again, I'm

limiting this to issues I think might assist Your Honor in

completing the order -- to be clear, Bard is not attacking

MAUDE data at large. That's not anything that we're intending

to do here. What we are attacking is the manner and the way

in which Dr. Betensky employed it.

The briefs are replete on both sides with admonitions

on the MAUDE home page and/or from FDA guidance documents

cautioning -- cautioning anyone from using MAUDE data in a way

to compare rates.

For example, in a direct quote from Dr. Betensky's

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rebuttal report in this case with respect to Dr. Thisted and I

believe the same language also appears in her rebuttal to

Dr. Feigal, FDA notes such comparisons are subject to

substantial limitations and interpretation. As a result, FDA

suggests a comparison of two or more reporting rates be viewed

with, they use the words "extreme caution." They go on to say

any such comparison of rates is generally considered

exploratory and hypothesis generating.

In essence, MAUDE data enables the reviewer to come

up with a question that then must be answered using additional

or other data.

Dr. Betensky did it exactly the opposite way.

She had a pre-determined hypothesis that she

attempted to confirm with these data. And that is

specifically what FDA admonishes that a party should not do.

Unless the Court has any further questions, that

concludes my presentation.

THE COURT: Okay. Thank you.

MR. MANKOFF: Good afternoon, Your Honor. Josh

Mankoff for plaintiffs.

Before I dive in and respond specifically to the

points just raised, I wanted to take one step back and frame

the issues here.

Counsel just ended by talking about the MAUDE data.

Dr. Betensky didn't look at the MAUDE data, which, by the way,

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the FDA in its 2005 guidance specifically states they

recommend that sponsors calculate adverse event reporting

rates.

So despite some cautionary language, when you don't

have access to the denominator to calculate a ratio, they do

recommend that manufacturers do this analysis.

But in any event, she relies on Bard's own data and

she models her analysis after the analysis that Bard did

internally. So for them to get up and say this is so

unreliable as to be not as admissible is to say their own

analysis is not good. And they make marketing claims based on

these analyses, and so perhaps plaintiffs could get directed

verdict on some of those claims.

One other background point is that Dr. Betensky

actually offers three opinions and Bard doesn't really offer

any argument for the first two of her opinions that they

should be excluded, but they do claim in their reply in

footnote 8 that they are asking for exclusion of those

opinions.

The Ninth Circuit has said that argument -- it's not

even an argument, but a claim made for the first time in reply

need not be considered. So I'll leave those aside. Those are

her bench test analysis looking at the migration resistence

bench testing and she also does an analysis of the design

failure mode and effects analysis documents which are, as you

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heard before, Bard's predictions about failures that are going

to occur with their filters.

Dr. Betensky did, in fact, consider each of the

limitations that she outlined in her report and she used

statistical techniques to assess whether they're occurring or

not.

So, for example, whether there's -- Bard speculates

there's maybe detection bias or reporting bias and she looked

at the variability across adverse events and strong evidence

across time periods and across different adverse events and

different severities to conclude that it's unlikely that this

is happening. And the judicial reference manual on

epidemiology counsels that this is appropriate science to use

in litigation.

Similarly, she looked at some of the adverse events

are unlikely to be found due to detection. For example, a

filter death caused by a filter or filter embolization is

detected because someone comes in with symptoms or has died.

So it's not about any kind of surveillance that's detecting

these differently in one filter or another.

With regard to the SNF data, as you noted, they're

speculating this is in effect. If they have data to show it

would influence their results, they ought to come forward at

trial and cross-examine her on it.

This ties in with the speculation about the Weber

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effect, which, again, she looked at and she considered. She

conducted a sensitivity analysis to see if she varied various

assumptions would that change her conclusions, and she found,

no, they don't.

She -- after the issue of this SNF data before 2000

was raised at her deposition, she looked at it, and so did

Dr. Eisenberg, and they both concluded there are very, very

few -- that's a quote from Dr. Eisenberg's deposition, "very,

very few" -- adverse events that occurred during that time

period and they wouldn't change the conclusions.

So while it's not in Dr. Betensky's report, if she's

asked at her dep- -- at trial about these events, she will be

able to say that she looked at it, she saw, for example, five

migrations occurred in that whole first decade and three

perforations and I believe one fracture in that whole first

decade. So even if you assume there were no sales during that

decade, they would not influence her conclusions.

And one of her sensitivity analyses was to assume

there were unreported events for SNF. She added five events

to every SNF failure that she looked at. And she concluded

that that did not change her conclusions either. So there

really is nothing there.

Dr. Eisenberg was asked at his deposition whether he

had any idea about the data before 2000. He testified, yes,

he looked at it and they wouldn't change the conclusions based

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on his expertise in epidemiology.

Counsel said that the reporting rate ratio, which is

what Dr. Betensky calculated, is not of interest. It is of

interest. It's relevant. It goes to notice, it goes to

signal that there's a very great signal of a problem here and

what Bard should have done based on that information, what

actions they should have taken. So while she does then take a

step and say, well, this is based on her statistical

expertise, it says there's a problem with these filters, that

there's higher failures with the Recovery and later filters,

both opinions are certainly relevant and ought to be

admissible.

I wanted to provide a little context on the

speculation about the Weber effect because the idea of this

effect stems from a 1987 paper that was done in the UK, and it

was looking at drug adverse event reports not at medical

devices, and there's a big difference there because with drugs

there's almost always a question about whether the drug is

causing the adverse event or whether it's a coincidence.

In 1987, in UK, the regulatory authority there

encouraged physicians to report adverse events for the first

two years that a drug was on the market. So it's not a big

surprise that when Dr. Weber looked at this information he saw

that there was an increase and then it tailed off after about

two years. But what he found was this only occurred for

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non-serious events. When he looked at serious adverse events

he found it was consistent across time.

So you take the fact we're looking at drugs -- at

devices here and serious adverse events, there's -- and there

are no papers Bard has come forward with that this effect

occurs with medical devices. When it's been looked at in the

US recently, it doesn't occur as much for drugs either. So

speculation that this is occurring and having an effect is

really on Bard to come forward with some evidence that this is

occurring. Again, that's an issue for cross-examination.

Finally, with respect to whether clinical review is

necessary and the idea that statisticians usually collaborate

with other experts in the field, that is occurring here but it

has to be done a little differently in the context of

litigation. So Dr. Betensky writes a report and, as you

heard, others have reviewed it and relied on it, and in

particular Dr. Eisenberg and Dr. Kessler have rendered their

clinical -- have used their clinical experience to render

opinions about whether any of these speculated biases would be

occurring and they concluded it's unlikely any of those alone

or in combination could explain the results that are being

calculated here.

Finally, the case law and the peer review literature

support use of adverse event analysis comparative rates using

MAUDE data, and in particular I'll direct your attention to

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Exhibits 32 through 36 where we cite papers that have done

similar analyses, and that's support for the reliability and

admissibility of this type of opinion.

If the Court has no further questions, I would rest.

THE COURT: Thank you.

MR. BUSMAN: May I approach?

THE COURT: Yes.

MR. BUSMAN: Your Honor, just a couple quick points

as I wrap up.

Regarding Dr. Betensky's failure to collaborate with

the subject matter expert to determine whether her assumptions

were reliable or not, counsel mentioned that both doctors

Eisenberg and Kessler took a look at her assumptions and

validated them.

I don't recall anything in either of those reports

discussing whether or not Dr. Betensky's assumption about

detection of asymptomatic adverse events are valid. And, in

fact, neither Drs. Eisenberg nor Kessler are even proffered as

subject matter experts. So I'm not sure how they would even

be qualified to vet the assumptions that she employed.

With respect to Dr. Eisenberg's review of the data

prior to 2000, I think Your Honor would appreciate that it is

not Dr. Eisenberg but rather Dr. Betensky who would have to

review these data. Dr. Eisenberg never rendered an opinion in

his expert report having anything whatsoever to do with

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Dr. Betensky's actual analysis. All he ever did was quote it

chapter and verse and say he agreed. We never had an

opportunity to cross-examine Dr. Betensky because she never

considered these data. And it's not possible to do that on

the stand. She'd have to run her calculations, she'd have to

come up with her numbers, and we'd then have to examine her.

That's not something that can be practically accomplished

during the trial, which is why it is not a cross-examination

issue.

With respect to plaintiffs' distinction between

Bard's data and the data coming from MAUDE, I suggest it's a

distinction without a difference. Plaintiff -- excuse me.

Dr. Betensky herself quotes liberally from the FDA guidance

documents in support of her opinions and we're simply pointing

out to the Court other aspects of the guidance that run

counter to what it is she's attempting to accomplish.

And, finally, it was Dr. Betensky's own words that

the reporting risk ratio is not the calculation of interest.

That's not counsel's argument, that's her own testimony.

Unless the Court has any further questions, that will

complete my presentation.

THE COURT: Okay. Thank you.

All right. Let's talk about Eisenberg.

MR. BUSMAN: I'll stay here.

MR. ROTMAN: I'll be arguing for the plaintiffs on

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the Eisenberg motion, but would the Court allow a short break

so I can be here? I need to use the men's room.

THE COURT: Sure. We'll come back in ten minutes.

(Recess taken from 2:00 to 2:12.)

THE COURT: All right, let's talk about Eisenberg.

MR. BUSMAN: Good afternoon again, Your Honor.

I'll limit my presentation to the issues I think

might be of interest to the Court as it wraps up completing

its order. 

To review the bidding just a little bit,

Dr. Eisenberg is by no stretch a subject matter expert in IVC

filters. He admits it. He's never implanted a filter. He's

never retrieved a filter. He's never prescribed a filter.

He's got nothing whatsoever to do with filters.

The Court has already ruled on virtually everything

that pertains to our argument for the exclusion of

Dr. Eisenberg with respect to ethics, and the Court's order on

Drs. Parisian and Kessler, in particular page 17 in the

Kessler section, the Court held that neither side would be

permitted to offer an expert witness to render opinions

sounding in ethics. But that's exactly what Dr. Eisenberg is

doing notwithstanding plaintiffs' claim to the contrary.

In the opening portion of Dr. Eisenberg's report he

delineates the foundation for his opinion, the various

documents that underlie his opinions and form the foundation

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for them. They all sound in ethics. Most of them have the

word "ethics" in the title. He admitted that the driving

force for the majority of his opinions are that companies

should be honest, companies should be responsible, companies

should follow up the way a responsible and ethical

manufacturer would do.

So, as I said, the Court's already ruled on this --

and the Trasylol court that excluded Dr. Eisenberg for

virtually the same reasons contended with the same argument.

Plaintiffs in that case also claimed that Dr. Eisenberg was

not rendering ethical opinions. But the court looked beyond

plaintiffs' claims to the substance of his actual opinions and

determined they were ethical nonetheless.

With respect to Dr. Eisenberg's myriad opinions on

physician and patient expectations, the Court again in the

Parisian-Kessler order ruled that Dr. Parisian -- and this is

on page 8, Dr. Parisian was not allowed to talk about

physician expectations. And it's important to note

Dr. Parisian is not a subject matter expert just like

Dr. Eisenberg is not a subject matter expert, which

distinguishes this, for example, from the Kinney, Roberts, and

Kalva opinion.

Now, with respect to Dr. Eisenberg's review of

corporate documents, he reviewed those documents to foster his

ethical opinions. He's got no basis or foundation for

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reviewing any of Bard's internal corporate documents. He's

not a regulatory expert, not a subject matter expert. There's

nothing that he can add to these documents that sound in any

experience that he has that could inform the jury and help

them decide any issue.

The only thing that would be left here are his

epidemiologic opinions. Dr. Eisenberg is an epidemiologist.

That is true. But he reviewed various articles in the

literature, not to give some opinion on the safety of these

devices at large but, as he describes in paragraph 172 which

sums up his review of the literature, quote, this is the type

of investigation and communications that physicians expect a

responsible manufacturer to undertake. The Trasylol court

excluded that opinion. And, again, this sounds in ethics and

this Court has already ruled that ethical opinions are not

going to be admissible in this case.

Unless the Court has any questions, that concludes my

presentation.

THE COURT: Okay. Thank you.

MR. ROTMAN: Good afternoon, Your Honor. Steve

Rotman. I'll be arguing for the plaintiffs on the Eisenberg

motion. I'm going to start with the issue of ethics opinions.

Plaintiffs agree that Dr. Eisenberg is not permitted

to give ethics opinions. We're not challenging the rule.

What we're challenging is the characterization of his opinions

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as ethics opinions.

The plaintiffs' claims that Dr.-- the plaintiffs

claim and contend that Dr. Eisenberg's opinions are not ethics

opinions and Bard is arguing that we are blatantly

side-stepping this issue and attempting to recast what his

opinions are to call them anything else.

The fact is that we're not doing that at all, that

we're simply reporting and repeating what Dr. Eisenberg has

stated in his report repeatedly. And that is what

distinguishes this case from the Trasylol case.

So first, to place this issue in context,

Dr. Eisenberg's opinion is 47 pages long, over 200 paragraphs,

and covers a wide range of issues and offers many different

opinions about Bard's filters, that are not even remotely

ethics opinions. Essentially, it is the opinions that begin

with the words "Bard should have" that are at issue.

And as to those "Bard should have" opinions, they

almost entirely fall into two categories. Those categories

are opinions about what Bard should have done to learn more

after it learned about filter fractures and migrations, and

what information about those problems Bard should have passed

along and disclosed to doctors.

Bard claims that these opinions are actually based on

Dr. Eisenberg's undisclosed views about ethical obligations

because it's clear that in the report itself there -- the

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basis for these opinions are not stated as ethical

obligations.

Plaintiffs suggest that Dr. Eisenberg's report itself

provides the best evidence to help the Court answer the

question about what -- how to characterize these opinions.

What we learned when we read that report is that throughout

the report Dr. Eisenberg provides the basis for these "Bard

should have" opinions.

And to simplify the task for the Court of sorting

this out given the length and level of detail in

Dr. Eisenberg's report, I have created a compendium of

excerpts, which I'm prepared to give to the Court, and to

counsel, which is just four pages long and provides excerpts

and paragraph numbers, that makes it clear and will aid the

Court in deciding how to in fact characterize these challenged

opinions, and to determine whether they're in fact ethics

opinions, which should be excluded, or whether they're based

on other foundations which are permissible and entirely

appropriate.

So I'm going to offer this compendium when I wrap up

at the end of my presentation, and I suggest that a review of

these excerpts will make it clear that the challenged opinions

are based on four grounds, all of them appropriate: 

One, what is required for patient safety. 

Two, what is required for informed consent.

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Three, what is required based on the principles of

pharmacovigilance. 

And, four, what is required based on Bard's own

articulated internal standards.

None of these are ethics opinions grounds. All of

them are within the expertise of Dr. Eisenberg. He is a

clinical epidemiologist. And he explained at his deposition

and in his report, and we think we covered in our brief, that

the focus of clinical epidemiology is patient safety, and his

focus in his work over decades has been medical device,

patient safety, clinical epidemiology.

So it should be clear to the Court after reviewing

these excerpts and any other part of Dr. Eisenberg's actual

report that there is no basis to conclude that these "Bard

should have" opinions are actually somehow masquerading as

Dr. Eisenberg's views on Bard's ethical obligations.

For example, on paragraph 42 of his report he states

that "The standards that underlie my opinions in this report

for monitoring for safety signals, following up on those

signals, and disclosing important safety concerns to doctors

form the foundation of our medical system, are essential for

informed consent and patient safety, and constitute generally

accepted standards for pharmacovigilance."

And in paragraph 37 --

THE COURT: Well, let me interrupt you for a minute.

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After that statement he cites an FDA guidance

document.

MR. ROTMAN: On pharmacovigilance.

THE COURT: No. It's the World Health Organization

he cites on pharmacovigilance. But he cites those too.

He's not an FDA expert and doesn't claim to be a

pharmacovigilance expert. He's just citing other sources.

Are you suggesting that you should be able to argue

to the jury that what the World Health Organization has said

in a document establishes the legal standard that Bard must

have complied with in this case?

MR. ROTMAN: No.

THE COURT: Isn't that what he's saying when he says

they should have?

MR. ROTMAN: No. What he's saying is that based on

his expertise in clinical epidemiology and expertise as a

clinical physician in interventional cardiology and his

knowledge of patients having the very problems that these

filters are being used for and his treatment of these patients

with alternative therapy, that is -- that is the

anticoagulation, and his having patients in his practice that

have these filters, that what is required for patient safety,

what is required for informed consent, what other physicians

need and expect for informed consent, and what is consistent

with the internal standards articulated by Bard's own

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president, former head of regulatory, former director of

research and development, they -- they are mirroring what

Dr. Eisenberg is saying. And what Dr.-- and with respect to

pharmacovigilance, pharmacovigilance and clinical epidemiology

go hand in hand. It is the foundation of what pharmaco-- of

what clinical epidemiologists are concerned with.

Pharmacovigilance is not his specific field of expertise, but

he is quite familiar with it.

THE COURT: Well, let me -- let me ask you a question

that is at the heart of my concern over his opinion. Let me

make a note, first.

The way you characterize his opinions are "Bard

should have." I agree he says that throughout his report.

"Bard should have" is a different way of saying "Bard

had a duty to." Or "Bard had a responsibility to."

When I read his report -- I haven't read all of it.

I read the first 50 paragraphs that are the summary of his

opinions, and I've looked at other parts, but those are the

ones I read line by line.

He repeatedly asserts Bard should have done this,

Bard had a responsibility to do this.

MR. ROTMAN: Yes.

THE COURT: When I ask the question what is the

source of the responsibility he is citing, the duty he is

citing, the ones I can see are he cites American Medical

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Association Code of Ethics for doctors and practice guidelines

from the American College of Radiology.

Those are standards for doctors to adhere to, not

medical device manufacturer.

MR. ROTMAN: Your Honor --

THE COURT: Let me finish my thought and have you

comment on all of it.

MR. ROTMAN: I thought you were done.

THE COURT: He then cites that one FDA guidance

document and the World Health Organization document. But he's

not an expert in either of those areas.

It seems to me what it comes down to is his opinion

is, as a doctor, Bard should have done these things. Why is

that relevant in this case? The jury is not going to be

instructed you are to hold Bard to the standard that a

reasonable doctor would have applied. That's not going to be

the standard in this case.

MR. ROTMAN: Your Honor, as it will perhaps become

clearer to the Court when you review the four-page compendium,

the phrasing of the opinions comes in various forms, but it's

frequently "Bard should have." That's not the critical point.

The critical point that Dr. Eisenberg is making is that what

it is -- what is necessary for patient safety is followup to

safety signals.

THE COURT: Necessary according to whom? According

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to what authority?

MR. ROTMAN: According to Dr. Eisenberg based on his

expertise in clinical epidemiology.

THE COURT: Well, but how does a clinical

epidemiologist have expertise to opine on what the duty is of

a corporate medical device manufacturer?

MR. ROTMAN: It's not about duty. As I said, the

same point can be made without using the word "should have" or

without using the word "duty." The same point can be made

using a statement like, Patient safety is compromised when a

manufacturer has information about a safety signal that is not

followed up with studies. Or Patient safety is compromised

when a manufacturer has information about -- about

complications and risks in its product which are not passed

along to physicians. And informed consent, which is necessary

for the doctor-patient relationship and is the foundation of

medicine, is compromised when a medical device manufacturer

does not pass along information about risks.

So if the problem -- if the issue here is the "should

have" opinions, plaintiffs are very comfortable with a

stipulation that these statements by Dr. Eisenberg at trial

will be recast in a way that he's not talking about duty and

he's not talking about their obligation, but he's talking

about the consequence in terms of patient safety and in terms

of informed consent of not -- of not doing the necessary

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studies to follow up on safety signals and not passing along

information about risk.

THE COURT: Well, let's take that point you made for

a moment.

So let's assume for a minute there's a doctor who

gets on the stand and says "My opinion is patient safety is

compromised if a large medical device manufacturer has safety

signals and does not conduct a large prospective safety study

and randomized controlled clinical trials," which are words

right out of his report. Why is that relevant to the jury?

They're not going to be asked to decide whether or

not Bard compromised patient safety. I don't think that's the

issue in the case. The issue is going to be whether they

defectively designed the product, which presumably includes

testing that leads to design and, in the Booker case, whether

they failed to warn a doctor.

What the doctor is opining about is, whether you say

it as patient safety is compromised, he's still saying they

should have done a study, should have done controlled clinical

trials. And he's saying to the jury, "As a doctor, I'm

telling you this manufacturer should have done that."

MR. ROTMAN: You're -- you're going back to "should

have" when I'm saying we can leave that and talk about a

different way.

THE COURT: But it's the same message, isn't it? 

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MR. ROTMAN: But the question is what's the

relevance? Have we decided there's not negligence in this

case?

THE COURT: Well, there's a negligent failure to warn

and a negligent design defect claim in the case. I went back

through them and I don't think there is just a generic

negligence claim. I haven't seen one in the master complaint.

We can talk about that if you think it's in there, but I went

through, when I did the jury questionnaire and rewrote the

statement of the case --

MR. ROTMAN: So based on negligence failure to warn,

these issues about investigation of risks and reporting and

disclosing is part of warnings.

THE COURT: Well, but a negligence claim requires a

duty. What you're saying is he can establish the

manufacturer's duty by stating his opinion of when patient

safety is compromised.

MR. ROTMAN: If the issue is that he's not qualified

to address the manufacturer's duty, then that's going to have

to come from somewhere else.

THE COURT: But isn't that exactly what his whole

report is about? At least all of these sections?

MR. ROTMAN: No.

THE COURT: My problem is when I read it -- let me

just read you the points I excerpted into my order, and I want

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you to comment on these because this is where I'm getting hung

up -- 

MR. ROTMAN: Okay. 

THE COURT: -- and I want to get it right.

He says -- now, most of this is in quotes. Some of

it's my words: In light of various safety signals, Bard had a

responsibility to perform large prospective safety studies and

randomized controlled clinical trials.

That's from about nine different paragraphs in his

report.

MR. ROTMAN: If I can comment on that --

THE COURT: Let me --

MR. ROTMAN: Should I comment on that?

THE COURT: Let me go through this and then let you

respond.

He devotes an entire section of his report, section

4K, to the responsibility Bard had to do safety studies.

He says that rather than conducting such studies,

quote, Bard downplayed the documented high rates of adverse

events with the Recovery and G2 filters and had a corporate

policy to not share any of these complication rate analyses

with anyone outside the company.

He states Bard looked for ways to avoid being

forthright and spent time, money, and company resources on

media company and PR for spin control.

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He claims that Bard performed no studies because it

did not want to know the answer. Quote, if you don't want to

know the answer, then don't look, close quote. And that Bard

effectively allowed patients to be experimental subjects.

What he's saying to the jury is, "It's my

professional opinion that Bard had a duty to perform all of

these safety studies and that Bard didn't do it because they

didn't want to find the answer, they didn't want to spend the

money, and they wanted to use the patients as guinea pigs." 

How is that not an opinion about what Bard had a

responsibility to do as a corporate manufacturer, and how Bard

as a corporate manufacturer failed to comply with that duty?

MR. ROTMAN: So as written in his report, he is

stating exactly what you just read, and he is addressing

responsibility. Not as an ethical responsibility but as

what's necessary for patient safety, for informed consent, for

pharmacovigilance, and to comport with its own internal

standards. Its own internal standards as articulated by its

president and other high officials.

If the problem is the Court doesn't want to the jury

to hear this expert talk about obligation or duty in those

terms, there's still an important relevant and appropriate

statement based on his expertise that can be articulated based

on the foundations that he established, and those -- much of

what the Court read are not just opinions from -- that he's

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grabbing out of the air, they're opinions based on support,

and he cites the support for them.

And so the point is, if this will satisfy the Court's

concern, tell us to go back and take out those obligation

sentences and take out those "should" sentences and change

them to -- to avoid any reference to obligation or duty.

THE COURT: What would they then say?

MR. ROTMAN: They would then say, "Failure to do a

study compromises patient safety." "Failure to pass this

information to doctors prevents necessary informed consent and

prevents meaningful informed consent and is inconsistent with

the company's own internal standards articulated by its

president and other high officials."

So that is an example how it can be done.

THE COURT: The middle of the three ideas you just

expressed where he would say failure to inform doctors

prevents informed consent seems to me like a fair opinion for

a doctor to give. He's saying "If I don't get the

information, I can't confer with my client and get informed

consent."

By the way, I think by my count we have seven experts

giving opinions on that issue. We're going to have to talk

about that.

MR. ROTMAN: Because this is an MDL, we're --

THE COURT: I know you have to have lots of

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coverage --

MR. ROTMAN: Need a bullpen. Right.

THE COURT: But on the other two points you made,

failure to perform a study compromises patient safety, how is

that different from him saying Bard should have performed a

study?

MR. ROTMAN: Because it's -- it's up to the jury to

decide that. He's not saying it. He's saying that there's a

consequence based on his expertise of not doing it and I'm

explaining to the jury -- he's explaining to the jury what

that consequence is. 

And the source -- the -- there's different ways to

view a set of issues and it's not limited to, well, you either

say you have the duty to do it and you didn't do it or you say

nothing. And what we're saying here is a clinical

epidemiologist who's reviewed the file and has familiarized

himself with the facts and with the literature and is very

familiar with patient safety pharmacovigilance issues can

opine and point out to the jury that there are consequences to

this lack of followup.

THE COURT: Okay. I understand that point. I want

to thank about that. I appreciate you explaining that. Let

me ask a question related to that.

How does that expertise allow him to render opinions

about why Bard did certain things? Such as they did it to

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save money, they didn't want to know the answer, they wanted

to use patients as guinea pigs. How does his medical

expertise allow him to form those opinions?

MR. ROTMAN: He has a sophistication in -- in what --

of what's going on based on his review of a substantial amount

of internal documents.

Now, issues like that are the kinds of issues where

there might be statements like that where the Court's going to

say we're not going to permit this or not going to permit

that, and there's certain statements like the one -- like the

one you just mentioned about if you don't look you won't find,

or however that was phrased. If the Court doesn't want that,

then we could certainly, on a specific point-by-point basis,

not have him say these things at trial.

He was -- he was given the documents, he reviewed

them, and this is what his take was. And it -- it's --

different judges might have different views of whether that's

something that the jury should hear from this witness or not.

He put it in. If it's going outside of a boundary for Your

Honor, then it can be cut back. The point is, there's a lot

of meat in the Eisenberg report that you wouldn't want to

throw out the baby with the bathwater. That's my point.

THE COURT: Okay. Did you have other points you

wanted to make? I kind of highjacked your argument.

MR. ROTMAN: That's fine. I'm pleased you did ask

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the questions. I think that was helpful to the Court and

that's why I'm here.

So, again, this whole thing about ethical, the --

Bard took a deposition where they asked a lot of questions --

THE COURT: Maybe I can save some time on this. I

don't find this discussion about ethical or unethical helpful.

To me the key is what I just talked about --

MR. ROTMAN: Okay.

THE COURT: -- what is the basis for a specific

opinion.

I've read the deposition excerpts. I know the

ethical question -- or the "ethical" word was often introduced

in the question. But, to me, it's not a matter of ethics.

The question is when he's opining that the corporation has a

responsibility or duty, what is the source of that and is he

an expert to give that opinion. That's the focus for me.

MR. ROTMAN: Okay. So the focus, Your Honor -- to

the extent that the Court is interested in the fact that in

this deposition Dr. Eisenberg was not what was pushing -- in

this deposition, Bard was aggressively trying to get him to

say, yes, this is an ethical -- this is an ethical obligation,

those are not in his report and he was pushing back on that. 

And I put together a compendium of excerpts and

highlighted them so if the Court wants to see he was

specifically saying, "Look, I'm not an expert in ethics and

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what's the reason for my opinion is X," something other than

ethics, that's available to the Court, too. So there's those

two compendiums.

On the issue of the Trasylol case, that's, again, all

about ethics. If the Court's not interested in that, I --

THE COURT: It's phrased that way. So is the Rezulin

case it relies on. But I think it's the same issue, which is

what's the source of the duty the expert is discussing and is

there a foundation for it. Which, to me, is the more helpful

way to think about it than just ethics versus not ethics.

MR. ROTMAN: All right.

So I would say -- what I was going to say about the

Trasylol case is simply that the court didn't -- we don't know

what the report said. And we know that the court says it

looked at it and concluded that this was really his ethical

opinions.

What I'm saying is in this case we have his report,

and, as the compendium will show, Dr. Eisenberg makes it clear

that he has these four foundations for these types of

opinions. And if it comes back to the issue of what's his

authority for saying X is necessary for patient safety or X is

necessary for informed consent, those opinions at trial can be

recast so that we're not talking about duty or obligation.

I would also like to briefly address for the Court

the other issues that Bard has challenged in Dr. Eisenberg's

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opinion, his reliance on internal documents. Again, we'll

rest on our brief and the Court's prior decisions on that.

Common sense opinions. We recognize that Eisenberg's

testimony should be limited to that which is needed to assist

the jury and matters that are common sense to jurors and which

do not require an expert are not proper subject matter, and so

we don't believe he's addressing issues that are common sense.

But to the extent that there are individual points that might

concern the Court in that regard, they can be addressed in an

isolated fashion or taken up at trial based on those broad

principles.

Other physician's expectations, similarly, that was

addressed by a prior -- by prior orders. We agree with that.

And Dr. Eisenberg's opinions about informed consent and what

doctor's need and expect for informed consent. 

And then it's parallel -- or the corollary of that is

then, therefore, what's necessary for them to receive from the

company. The Court has already said those types of issues are

appropriate and what is more problematic is when an expert

testifies about what other doctors would do if they had the

additional information.

So, again, we believe Dr. Eisenberg will toe the line

at trial and stipulate that he will toe the line at trial in

terms of physician expectations to follow the guidelines and

parameters set by the Court.

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THE COURT: All right. I'm happy to look at the

compendiums if you want to give defense counsel a copy --

MR. ROTMAN: Yes. So the first compendium I'll hand

the Court and opposing counsel is the excerpts from the

Eisenberg report. 

And the second will be excerpts from the deposition

that show that Dr. Eisenberg was not merely going along with

the suggestions that everything was an ethics opinion, but

rather was -- was based on the foundations that I mentioned

and that are mentioned in his report.

And the third thing I have are portions of his

deposition -- and, again, these were not part of what the --

what Bard pointed out when it was doing the recitation of his

deposition.

By the way, there's one other thing, Your Honor, that

you brought up that I didn't address, and that is he cites to

guidelines that say "ethics" in them, and so -- as authority.

And I think it's misunderstood what they're there for.

They're there for establishing objective standards for what

doctors need to give informed consent. That's not in a

vacuum. They need the information. The reason it's there is

because there's the objective standard of what the doctors

need. It's not there because it's a standard for what the

medical device manufacturer's obligations are. It's there

because it's an objective standard of what the doctors need,

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and that is part of the equation for saying, okay, if this is

what the doctors need and this is what they expect, then the

jury has information about what kind of disclosures were

required.

So it's sort of a two-step process to say, well, he

cited these because these are authority for Bard's duty, it

kind of misses the nuance of what was intended.

And so -- and then the third compendium I have, Your

Honor, is further excerpts from the deposition of

Dr. Eisenberg where it was really -- a lot of it is from the

redirect where he testified about his expertise in clinical

epidemiology and his focus on patient safety, informed

consent, the nonbinding nature of these guidelines but why he

used them, and common sense issues that are raised in the --

by the defendants in their motion, and also pharmacovigilance

issues.

In each of these, Your Honor, I highlighted so that

the Court and counsel are looking at the same thing and the

highlights make it so that the -- so that the Court can see

why these are attachments. And I did the highlights in all

three hand-ups.

MR. BUSMAN: Mr. Rotman, there's no highlighting in

this.

MR. ROTMAN: I may have given the Court two copies.

THE COURT: You did. You gave me three.

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MR. ROTMAN: Thank you, Your Honor. I have no

further presentation unless the Court has questions.

THE COURT: Okay. Thank you.

MR. ROTMAN: Your Honor, would the Court like the

plaintiffs to submit a revision of the Eisenberg report on

certain issues?

THE COURT: No.

MR. ROTMAN: Okay. Thank you, Your Honor.

MR. BUSMAN: I think Your Honor's discussion about

duty was instructive, and I'd simply note that none of the

proposed stipulations change the basis of these opinions which

are contained in the section of the report that Your Honor did

have an opportunity to read.

Plaintiffs still have yet to articulate any duty that

would be binding on Bard. And, in fact, Dr. Eisenberg has

admitted that the objective standards that he cites in his

report are not, in fact, binding on Bard.

That said, unless Your Honor's got additional

questions, I've got nothing further.

THE COURT: All right. Thank you.

Counsel, let's run through a few additional issues.

As I mentioned a moment ago, and I think this is

understood by all, my intent at trial is to have one expert

per subject. I don't think there's any reason we should take

the jury's time with more than one expert stating an opinion.

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And so that will be the approach I will plan to take.

We have now remaining, after I rule on these four

motions, I think six additional motions that are focused on

expert testimony: There's the motion directed at Garcia and

Streiff or Streiff, S-T-R-E-I-F, that's one motion; there's

the McMeeking M-c-M-E-E-K-I-N-G motion; there's the Ritchie

motion; there's the Morris motion; the Grassi, G-R-A-S-S-I,

motion; and then the motion on the use of criminal law

standards.

And my understanding from what you communicated to my

office after the last hearing is that you're okay with my

ruling on all of those without oral argument. Is that

correct?

MR. NORTH: Yes, Your Honor.

MR. LOPEZ: Yes, Your Honor.

THE COURT: We'll get the decisions from today's

hearing out next week and then we'll just start getting those

out to you. My hope is we can get all those done before the

end of February so you'll know in advance, well in advance,

hopefully, of the final pretrial conference where I've ruled

on those.

We've got several summary judgment motions that are

still pending with respect to bellwether plaintiffs that we

will address when we approach those bellwether trials.

The motion in limine filed by the plaintiffs on the

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FDA 510(k) clearance that's been referred to as the Cisson

motion is being briefed. It's going to be briefed by the end

of January. I saw, I think, in your joint report a request

there be oral argument on that; is that correct?

MS. REED ZAIC: Your Honor, the plaintiffs' position

is, because of the timing that we're bumping up against, which

I'm assuming, I hope not gratuitously, why the Court is

bringing this up, we're bumping up to the time of trial,

plaintiffs would be willing to forgo oral argument unless the

Court would like us here at any time, we could do it

telephonically, to answer any particular questions.

THE COURT: Okay. How about the defense?

MR. NORTH: Your Honor, we defer to the Court's

preference on that.

THE COURT: All right. Let's assume, then, that I'm

going to decide that without oral argument. If I think I need

it, we'll schedule a phone conference so I can get each side's

views.

MS. REED ZAIC: Yes. 

For the court reporter, Julia Reed Zaic.

THE COURT: Thank you.

Okay. That takes care of all of the pending motions.

There's one motion to substitute a party in an individual case

that we don't need to deal with.

The defendants indicated you wanted to file an

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over-length motion in limine. What's going to be the topic on

that one?

MR. NORTH: Your Honor, we were not asking to do it

early so much as just page expansion. We can do it with a

regular time frame.

The import of that one is the scope of evidence

regarding the Recovery filter that should be admissible in a

case like Ms. Booker's which involves the G2 filter.

THE COURT: Okay. How many pages do you think you

need on that?

MR. NORTH: We would just ask for the same that they

got on their FDA motion. And we would try to take less than

that.

THE COURT: What was that?

MR. NORTH: I think it was ten. 

Was it?

MS. REED ZAIC: I believe you gave each side ten and

five pages for the plaintiffs for reply.

MR. NORTH: It's in the Court's last order. I can

find that.

THE COURT: That's all right. Let's say it will be

10, 10, and five.

And we'll just -- well, let me think for a minute.

Under our existing schedule, motions in limine are

due on January 26, and responses are due on February 9th. And

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I didn't set a reply brief date because I typically don't have

reply briefs on motions in limine.

Do you think you need one on this one, Mr. North?

MR. NORTH: No, Your Honor. I think we can do

without.

THE COURT: Okay. So let's just say 10 page motion,

10 page response.

And, as you know, these will all -- well, to the

extent they're clear and I think I can rule, I'll try to rule

before the final pretrial conference. Otherwise, I'll want to

hear any argument on them at the final pretrial conference.

Plaintiffs would like to file a motion in limine on a

nonparty at fault in the Booker case; is that right?

MS. REED ZAIC: Correct, Your Honor.

THE COURT: And can that happen under the regular

schedule? I think you wanted five pages?

MS. REED ZAIC: Yes. We want just two additional

pages, Your Honor. My understanding, there's no objection

from the defense.

THE COURT: We'll say five page motion and five page

response on that issue.

MS. REED ZAIC: Thank you, Your Honor.

THE COURT: And I'm assuming this is the Georgia

nonparty at fault statute?

MS. REED ZAIC: Yes, Your Honor.

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THE COURT: The bifurcation motion. As I understand

what you said in the papers, Mr. North, your understanding of

that bifurcation under Georgia law would be that the only

thing we reserve for a second hearing is evidence on the

defendants' worth; is that right?

MR. NORTH: Yes, Your Honor. Generally speaking,

that's how it operates.

THE COURT: So whatever evidence they're going to

rely upon to argue whatever the Georgia standard is for

punitive damages would come in during the first part of the

trial.

MR. NORTH: Yes.

THE COURT: All right.

And what you would propose is that we would ask the

jury after the first part of the trial, do you believe that

the standard for punitive damages has been met? If they say

no, we don't have the second part. If they say yes, then we

put on evidence of Bard's worth and the jury decides the

amount.

MR. NORTH: Yes, Your Honor.

THE COURT: Okay.

Yeah. I think we ought to brief that. I know

nothing about Georgia law. I'm happy to consider it and

whether it applies here.

We're still going to have to do it within that time

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period we've set for the trial. We're still kind of boxed in

by the fact by that first week in April I've got to be out of

Phoenix at --

MR. NORTH: I would say, Your Honor, I've never

personally, even though I am a Georgia lawyer, fortunately,

thus far, I've never been involved in a Georgia case that went

into that punitive damage stage. But I'm familiar with some.

And the punitive damage phase under the Georgia procedure

often takes an extra hour or two hours. It's not a lengthy

process because the evidence is so limited and there might be

ten or 15 minutes of argument or something like that. But it

usually does not add to the length of the trial anything

significant.

THE COURT: All right.

I think we should brief it.

Let's do it on the same schedule as the motions in

limine. Let's have defendants file the motion for

bifurcation, have the plaintiffs oppose. So it would be

January 26 and February 9th for the response.

MR. LOPEZ: Your Honor, I'm not sure we're on

opposite ends about this issue. I think, at least as I read

our -- what we've proposed, the evidence comes in, and whether

or not that's punitive or not will be in the eyes of the jury.

And the second phase is purely focused on the amount of the

net worth and the basis for and argument as to what the

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plaintiffs believe should be an appropriate amount of punitive

damages. I'm not even sure what we're briefing so --

THE COURT: So you're in agreement it should be

bifurcated?

MR. LOPEZ: The second -- I read Georgia law. I

agreed in the statement that it's pretty clear. We got advice

from Georgia counsel -- pardon me?

They're telling me to wait to see the brief.

Your Honor, look, again, I wouldn't be standing up

saying this just in a whim. I've spoken to Georgia counsel.

It's pretty clear when you see Georgia law that the second

phase of this is going to be the amount of punitive damages.

The bigger issue is what evidence are we going to have for

that second phase of trial.

THE COURT: Well, we'll talk about that in just a

minute.

MR. LOPEZ: Sometimes the motion is anything that

tends to be something that goes to punitive damages we can't

put that evidence in. And then you've got to -- you've got to

draw the line. Usually people don't know where to draw the

line.

THE COURT: I understand defendants are not say

evidence of defendants' conduct would be reserved for the

second part, only evidence of defendants' net worth.

MR. LOPEZ: Right. Again, that's --

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THE COURT: Let's do this --

MR. LOPEZ: I would prefer to hear how much money

they're worth in the first phase of the trial, Your Honor, but

Georgia law seems to be pretty clear that that's in a

different phase.

Now, we want the same jury, of course, to consider

that part of the evidence.

THE COURT: Well, it's going to happen in the same

trial, it's going to happen with the same jury, and it's going

to happen under the time limits. So your 27 hours and your 25

hours would have to include whatever time you want to spend in

that second phase.

MR. LOPEZ: Right.

THE COURT: Let's do this: Let's say you confer. If

you can agree that's the right approach to take, then don't

file the brief on January 26. If there's a disagreement then

go ahead and brief it.

But it will be with the understanding that we're

still doing it within these time limits, which means you'll

have to rest at 26 and 24 hours so you've each got an

additional hour for the net worth issue. And I'm okay with

doing that if you all agree that's the right approach.

All right.

MR. LOPEZ: We'll confer and maybe draft a

stipulation, Your Honor.

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THE COURT: Okay.

The second issue -- or I should say the other issue

on the punitive damages is, as I understand, a request from

plaintiffs to conduct discovery on the net worth issue.

I will tell you, Mr. Lopez, when I read that, the

question that popped into my mind is that's fact discovery.

We had a fact discovery period. Why wasn't that done during

the fact discovery period if you knew you were going to be

seeking punitive damages?

MR. LOPEZ: Well, because I think if we would have

asked for that kind of discovery before you ruled on the

motion for summary judgment as to whether or not we were going

to get punitive damages, they would have said it's too soon

for us to take that kind of testimony.

We just did this in the Florida case that we had set

for trial last week. Right after the motion for summary

judgment -- not last week. Last year. The motion for summary

judgment, once it was denied we approached the court and the

court agreed to give us a deposition. We put it together very

quick. I think it was an hour, hour and a half.

Not to mention there's been a significant change of

circumstances with this defendant. I mean, they've now been

purchased by another corporation. And whatever amount of

information we may have gotten regarding this company's

financial status is significantly changed since we took that

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deposition on January 26, 2017. So the Court will recall that

we just received our ruling allowing us to have punitive

damages I think the end of November. We're talking about a

two-hour deposition.

THE COURT: Well --

MR. LOPEZ: The announcement of the final acquisition

by Becton Dickinson was December 29, 2017.

THE COURT: What I'm not understanding, because I

haven't gone back and looked at it, is did I rule that you can

do punitive damages discovery at some point?

MR. LOPEZ: Not that we could do discovery, but

you -- they made a motion for summary judgment to get punitive

damages out of the case. We won that motion. And I can just

tell you --

THE COURT: That was back at the end of 2016?

MR. LOPEZ: No. '17. We just got that ruling, I

think it was the day before Thanksgiving.

THE COURT: Are you talking their preemption motion?

MR. LOPEZ: No. The Booker motion --

THE COURT: Oh, in Booker specifically.

MR. LOPEZ: Yes.

THE COURT: I'm sorry, I thought you meant in the

case as a whole.

MR. LOPEZ: No, no. The Booker motion for summary

judgment. It was just granted --

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THE COURT: What is the January 26, 2017, deposition

you're referring to?

MR. LOPEZ: We had a trial in Florida, state court

Florida, scheduled for end of February, March. The same

motion for summary judgment. Ruled in our favor. After it

was ruled in our favor we asked the Court to allow us to take

a deposition like the one we're suggesting here. The Court

allowed it. I think we asked for two hours, the Court gave us

one.

I mean, the financials -- obviously, if the financial

status of this company was basically the same today as it was

then, we probably could live with that deposition, but there's

been significant changes in that status, I mean significant,

since then.

THE COURT: Okay. I understand what you're saying.

MR. LOPEZ: Usually, Judge, they won't allow you to

ask questions like that before it becomes relevant. It only

becomes relevant if the court allows punitive damages. That's

been -- that's pretty consistent.

THE COURT: Okay. I understand your position.

MR. NORTH: Couple points, Your Honor. First of all,

with all due respect to Mr. Lopez, in Florida there is a

specific procedure, as I understand it, that says discovery

about net worth cannot be conducted until the court makes a

threshold determination that punitives are available.

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That's obviously not what we have here. We had a

lengthy fact discovery period, we had a lengthy case specific

fact discovery period for the five bellwethers, and not once

did they do that.

I really am reluctant to be chasing around on

depositions. Here we are almost six weeks before trial when

we are engaged in trial preparations. I think it's

disruptive. 

But I think I have a proposal that ought to satisfy

them and render this question moot. I've consulted with my

client. The last available data as to C.R. Bard's net worth

are the third quarter 2017 quarterly reports, SEC filings, as

to assets and net worth and all of the value of

assets/liabilities. It's all there in the SEC filings. Why

can't we just provide them -- they're public records anyway,

but I can obtain a copy of those, give them those filings, and

then they've got the best available evidence that there is at

this point.

THE COURT: And would you stipulate to their

admission?

They need a witness if they're going to present the

evidence or need stipulation of what comes in.

MR. NORTH: I'm reluctant to say, Your Honor, only

because I haven't seen the document. I need to look at the

document. I suspect I would because that evidence -- if we

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got to the punitive phase, that evidence would be relevant.

So it's just a matter of stipulating as to the form of it.

THE COURT: What about their point there's a new

parent corporation?

MR. NORTH: I did want to bring that up with Your

Honor. There is a new parent corporation, Becton Dickinson.

First of all, Becton Dickinson is not sued and should not be

sued in any of these cases.

My understanding, and I did some due diligence to be

able to represent this to the Court accurately, I believe,

that C.R. Bard incorporated is still a separate corporate

entity. Bard Peripheral Vascular Incorporated, the other

defendant here, is still a separate corporate entity.

Bard Peripheral Vascular remains a wholly owned

subsidiary of C.R. Bard. In turn, C.R. Bard now is a wholly

owned subsidiary of Becton Dickinson.

So the only change we have is Bard now has a parent

company. But it is still a separate corporation and BPV is

its own subsidiary. So there's no change for purposes of what

would be relevant for this jury, and the value of Bard is what

would be relevant. Certainly not the value -- we would object

strenuously to any suggestion, if they were to make it, that

the net worth of Becton Dickinson should somehow be relevant

here.

THE COURT: Mr. Lopez.

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MR. LOPEZ: I think the last thing he said is

probably what we should focus on, and that is the value of --

we're fine with the value of C.R. Bard. The third quarter

financial report from this company is not going to tell the

true story of the value and the financial status of this

company when this -- should this case go to the jury on

punitive damages.

This deal closed the end of December. C.R. Bard

received like a 4 -- I don't misquote this, Mr. North, I'm

just reading what's in the newspaper. Got a premium on their

stock of about somewhere between 4 and 6 billion dollars.

That's not going to be reflected on their third quarter 2017

financial statement.

What I'm suggesting, Your Honor, I don't mind working

this out with a stipulation and with documents that we can

have, if we need an expert to look at them and say these

accurately reflect the net worth and financial status of the

company and we've agree that that document can come in the

way -- or we have an expert testify to it, I don't care. But

I'm not going to accept a third quarter financial statement of

C.R. Bard for their current financial status what or what it

might be, you know, a month from now.

I know we've got to stop somewhere, but it's not

going to be the third quarter of 2017 when we're looking at a

4 to 6 billion-dollar premium.

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MR. NORTH: I would just note for the record, Your

Honor, if there was a 4 to 6 billion dollar premium, and I

don't know what the number was, that wasn't paid to C.R. Bard,

that was paid to the stockholders, because C.R. Bard was

purchased by Becton Dickinson. It doesn't affect the value of

the company, it just affects what the former Bard stockholders

received.

But the fact of the matter is that the third quarter,

as I understand it, financials are the best we have right now.

There are no financials for C.R. Bard entity that have been

computed for the fourth quarter as of yet. There may be prior

to trial and I can find out the time frame for that, if

they're still doing that now that they're a wholly owned

subsidiary. I'm not even sure about that. I can find that

out. 

But I was told in no uncertain terms, and I trust

this to be correct from in-house counsel, that the latest data

they have is the third quarter data.

These payments that Mr. Lopez are talking about

wouldn't have gone to Bard stockholders. They don't have

anything to do with the value of the company as it exists

today or as it existed then.

THE COURT: All right. I understand your positions.

I want to think about this. I'll put something in my order

after today.

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All right. So let's talk just a minute about the

overall schedule to make sure we're all on the same page.

We're going to get -- you know the schedule for the

jury questionnaire stuff. We went over that last week. That

order went out. The jury questionnaires have been mailed.

That's all in the works.

Motions in limine are due on January 26. Responses

February 9th. We have moved the date for the final pretrial

order to February 23rd, and the final pretrial conference is

now set for March 2nd.

Traci, would you look at March 2nd. We set it for 2

p.m.

THE COURTROOM DEPUTY: Yes, 2 p.m.

THE COURT: I think we need to have it start earlier

than that. Is there time in the day --

THE COURTROOM DEPUTY: All day.

THE COURT: Let's set it at 10:00 a.m. on March 2nd,

if that's all right for everybody, just because I want to make

sure we've got time enough to cover all of the details that we

need to before trial.

And I think that's everything we've got scheduled.

We don't have any other hearings set. So the next time you

would be in this courtroom would be the final pretrial

conference on March 2nd.

Are there any concerns about that? Do we need to

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have a status conference in mid-February just to make sure

we're not missing issues?

MR. LOPEZ: Well, one second just in response to

that. I hesitate to say this because it's going to sound like

I'm asking the Court to rush something, but I think I should

bring it to your attention. A lot of what we're doing, the

documents, the deposition cuts, even the witnesses, are going

to really depend what kind of ruling we get in the pending

motions before you on the FDA presence in this case, via

Cisson and all those other cases that we cited.

I don't know whether to ask you when you think that

might be.

THE COURT: Why don't we do this -- that's not going

to be fully briefed until the 26th, I think.

MR. LOPEZ: We'll try to get it in sooner, right?

MS. REED ZAIC: I'm doing my best to get it to you by

Tuesday, Your Honor.

THE COURT: Okay. How about if I just say we will

rule on that before the other expert motions. Because I

understand that one really does affect the overall nature of

the trial. So we'll move that to the front of the queue and

as soon as it's fully briefed we'll get it done. We usually

can get a matter decided and out within a week. I'm guessing

you'll have it certainly before the middle of February.

MR. LOPEZ: Let me ask you this, then, Judge. I

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don't want to move dates but we may have to because we're

supposed to get together by the 9th. Mr. North and I just

spoke about this trying to figure out the date, time, location

to put together our joint exhibit list and make sure we don't

have duplicates and get those marked. That is going to change

dramatically depending on a ruling like that.

So we can do it as if we -- neither side knows and

then we can go back and start pulling things out. I'm just

thinking of a more efficient way of us to do it as parties --

THE COURT: What I don't -- what I don't want to push

off is the February 23rd submission date for that stuff

because I need it a week before the final pretrial conference.

So if you all think you can get it done starting later than

February 9th -- you're optimistic.

MR. LOPEZ: We're not -- I don't think -- we're well

on our way. I mean, we are ready. But I think before the

defense and we can put that together in what would ultimately

be the Court's exhibits, I think we need to have that. So if

we can have relief on the February 9th. We don't want to move

the February 23rd any more than you do. But it could be we

may have to. We may have to move that goalpost a little bit,

Your Honor.

THE COURT: Well, I think what you are talking about

is one of my orders which says you have to meet two weeks --

yeah. It's paragraph C(6) in Case Management Order 28. You

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have to meet in person no later than 14 days before submission

of the final pretrial order.

MR. LOPEZ: Right.

THE COURT: You're experienced attorneys. If you

don't want to do it on the 9th, that's okay. But what I'm

confident I won't see here but I see too often is we get to

the final pretrial order that gets submitted and then I hear

at the final pretrial conference, oh, you know, we left out

some stuff, or we had this dispute and never worked it out,

and you defeat the whole purpose of the final pretrial order

when you do that.

So if you all want to do it a week beforehand and

just make sure you put in whatever time is needed to get it in

to me by the 23rd, that's okay.

MR. LOPEZ: Okay. Your Honor, thank you.

MS. REED ZAIC: Thank you, Your Honor. 

THE COURT: Let me mention something else while its

on my mind and then I'll hear from you, Mr. North.

There was a suggestion made during one of the

arguments today that there may come a point in trial where we

would hear testimony from an expert with the jury out of the

courtroom to establish foundation. I will just tell you if

that becomes necessary -- I've never done that. But if we

were to do it, the clock's still running on your time.

MR. LOPEZ: On the challenger?

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THE COURT: Pardon?

MR. LOPEZ: We actually had a conversation about

that. Would it be the person challenging or --

THE COURT: I don't assign it 50/50. I assign it to,

in my judgment at the time, the party responsible. So, like,

if we have a ten-minute bench conference, if you all go back

and I think that was totally frivolous objection, I give all

ten minutes to the person who made the objection. If I think

that was a well-founded objection, we didn't need a bench

conference, I give it to other side. I just make my best

judgment along the way. And I would do the same thing if we

had to send the jury out to hear from an expert.

I only mention it because we can't afford to spend

time with the jury outside of the room and still get the trial

done in the amount of time we do unless the clock is running

while the jury's out of the room.

I won't run the clock when we're meeting in the

morning or meeting after the jury has gone home for the day.

But if it's during those trial hours, we're going to be

counting everybody's time.

MR. LOPEZ: All right. Understand.

THE COURT: Mr. North, you wanted to raise something?

MR. NORTH: Your Honor, I was wondering if I could

beseech the Court to allow me to ask for reconsideration on

the question of that reply brief to that one motion in limine,

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and maybe if we can just file a five-page reply brief, if we

thought necessary, within seven days or their filing. The

response would be due February 9th. We would file a reply by

February 16th, if deemed necessary.

THE COURT: And that's on your motion in limine --

MR. NORTH: Right. Scope of Recovery filter --

THE COURT: Recovery. That's fine.

MR. NORTH: Okay. Thank you.

THE COURT: Did we set a date for when you're going

to file that notion? It's just January 26; right?

MR. NORTH: Right.

All right. So that reply, if you need it, will be

February 16th.

What else do we need to address? Anything?

MR. O'CONNOR: Your Honor, I was just reminded Jones

is coming up pretty quick, too, and there is, as you noted, an

outstanding summary judgment on that. We think that -- we

request you start to consider a date that we can have an oral

argument on that with that trial coming up May 15th just on

the heels of that.

THE COURT: I don't think I'm going to be able to

give you one. I'll do my best, but the reason is we finish

trial on March 30th and I get on a plane and I'm gone for

three of the four weeks in April. I've got to be at every

advisory committee federal court meeting around the country

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that three weeks. So I'm back the last week, maybe it's the

third week, of April and it's just jammed, as you can imagine.

And then we're into May, which is when Jones is to be heard.

And you certainly don't want to be getting my motion for

summary judgment ruling in early May, I don't think.

MR. O'CONNOR: No.

THE COURT: So I honestly don't know how to do it. I

suppose we could try to set it before the Booker trial, but

that's -- we've got a pretty full plate with everything else

we're doing and that, to me, is a lower priority.

MR. STOLLER: Your Honor, I'm sorry, we're conferring

over here.

THE COURT: I can tell. Go ahead. 

MR. STOLLER: The obvious concern we have is that

trial is going to go forward May 15. We're today four months

from the trial. Obviously everybody on both sides of the

aisle would like some clarity in terms of what counts are

going to go forward in that case, and if we wait until after

Booker we're at the six-week mark. And I don't have my

calendar in front of me, but my guess is we've probably got

pretrial order due to you in that case sometime in the middle

of April.

THE COURT: We haven't set it yet.

MR. STOLLER: Right. But regardless, May 15, I'm

just working back from that date. Realistically, for us to

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get there we've got to find a way to get that resolved more

than -- well, probably before the Booker trial starts, would

be my guess. Realistically to do the things that need to be

accomplished to get Jones ready for trial.

THE COURT: Well, I understand what you're saying.

All I can say is I -- I think you want rulings on all of the

Daubert motions. I'm going to have to rule on all of the

motions in limine. I've got 350 other cases. If I can get it

done, I sure will.

But to me -- maybe you disagree with this. To me,

the Jones summary judgment ruling is a lower priority than the

remaining Daubert motions and the remaining motions in limine.

MR. LOPEZ: Yes. 

THE COURT: Does anybody disagree with that?

MR. O'CONNOR: No.

MR. STOLLER: No.

THE COURT: So if I can get through all of that in

February and have time -- or early March and have time to

decide Jones before the Booker trial starts, I will do it. I

just honestly don't know if I'll have time.

MR. O'CONNOR: Well, I guess the only point there is

Jones, like Booker, is Georgia law, so --

THE COURT: What I thought you had originally said,

you want a hearing on it. I don't think I'm going to be able

to squeeze in a hearing. But I can do my best to get it

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decided before we start the Booker trial.

MR. O'CONNOR: That's fine.

MR. LOPEZ: I think it's the same motion as Booker.

MR. O'CONNOR: I think there's was -- it's pretty

close. Yeah, it's pretty close to the Booker motion, as I

understand.

THE COURT: Okay. Well, maybe it won't be as much

work, then, as a typical summary judgment motion.

The last thing that occurs to me, and then I'll be

happy to hear your point, Mr. Lopez, is we need to be thinking

about the third bellwether trial. I have had two judges on

this court volunteer to take a bellwether trial this year.

My anticipation has been that we would do the third

bellwether trial sometime in the summer. Probably in August.

And I don't know if I could do it or if I need to get another

judge to do it. My thought is we'd then do a fourth

bellwether trial in the fall. Probably with another judge

because my fall is pretty jammed up.

And we would then have four of the bellwether trials

done this year and we'd get the other two done early in 2019.

Obviously, we need to still pick the sixth.

Do you have thoughts on that overall schedule and on

the idea that we talked about briefly once before of having

another judge step in to do a couple of those?

MR. LOPEZ: I know we've had this discussion before,

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Your Honor. Plaintiffs are fine with that.

MR. NORTH: We're fine with that, Your Honor.

THE COURT: Okay.

My intention would be to have that judge -- or put in

a form where that judge can review all of my rulings on the

Daubert motions, all of my rulings on the motions in limine,

and I would keep track of significant evidentiary rulings I

make in the other two bellwether trials so I can share them

with that judge. Obviously that judge would make his or her

own decision on issues at trial, but at least they'd be

educated by what we've done in the first couple of trials.

Mr. Lopez, did you have another point?

MR. LOPEZ: Yes, Your Honor.

I know this issue keeps coming up about whether or

not we have a negligence claim, and it's clear we have two, at

least two, causes of action with the title, I think it's

negligent failure to warn and negligent design. Within the

body of those two counts are a lot of general negligence type

concepts. Concepts like failure to test, the marketing, the

way they marketed the product. A lot of things that, if you

had a general negligence count, you'd probably put it in

there. They're fashioned under design and failure to warn.

So my comment to you, Your Honor, is that those two

causes of action, even though they may be -- they may sound in

failure to warn or design, allege general negligence concepts.

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Now, those two counts were not challenged in summary judgment,

there's not been a demure brought against those to change the

language or motion to strike or motion -- in other words,

there's been no motion on the allegations as they're set forth

in those two causes of action.

So I think it is plaintiffs', certainly, position

that to the extent Georgia law would allow both a general

negligence count or instruction to a jury in addition to

negligence for failure to warn and design. I just want to

make sure Your Honor knows that we want to still be able to

get in evidence that deal with those allegations as they're

set forth in those two causes of action, even though they may

sound in general negligence.

Let me put it this way: They all relate to those

causes of action. In other words, the fact you have a

negligent design, if you're negligent in the way you test,

you're negligent in the way you go about your investigation

and due diligence, I understand that goes to the design, but

you and I have had this discussion before about whether or not

we have a general negligence cause of action. Technically we

do even though we don't title it that in the master complaint.

THE COURT: Well, let me ask you a question on that,

Mr. Lopez.

Give me, if you would, a 60-second argument you would

make to the jury on how they should find Bard negligent that

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does not relate to a design defect or failure to warn.

MR. LOPEZ: Well, their marketing practices. I mean

I think a large focus of our case is going to be on what they

did with respect to the way they marketed this device. In

other words, certainly the way they tested it. There's going

to be significant issues about the way they tested. I

understand that goes to design.

THE COURT: What is -- what is a negligent marketing

claim that is different from a negligent failure to warn

claim?

MR. LOPEZ: Well, I mean, you know, failing to warn

is an issue of where they had an obligation -- they had an

obligation based on what they knew about the product to warn

doctors. And maybe what I'm really talking about here, Your

Honor, and maybe the discussion we should be having, because I

thought of it when you and Mr. Rotman were talking about

Dr. Eisenberg and the fact that we have a

pharmacoepidemiologist talking about patient safety, and the

issue there is we still have a punitive damages count. And in

Georgia, the law in Georgia, and there's a lot of things I can

read, all the typical language of malice, but it's evidence

that would raise the presumption of conscious indifference to

consequence.

So there's going to be a lot of conduct. What I'm

reacting to, Your Honor, I don't know if it was the last

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hearing or the hearing before, you ask what does their conduct

have to do with failure to warn or design defect. I just want

the Court to understand that in our negligence causes of

action, we're going to have a lot of conduct. I mean, in

fact, plaintiffs' case is primarily going to be about conduct. 

We're going to focus on the product and it's design,

we're going to focus on the warnings, but one of the main

focuses of our case is going to be what Bard did or didn't do

in view of some -- the information they had about the risks of

their products.

THE COURT: I understand what you just said about

conduct. And I don't remember what I said at a previous

hearing, but I understand that you are going to seek to put in

evidence that Bard knew of problems in its product, that it

didn't test them and therefore it didn't redesign them, didn't

disclose these problems to doctors. That's all over the

reports we've been dealing with. I'll obviously rule on what

is or is not admissible along those lines as we get into

trial.

What I'm struggling with is where we started, and

that is this notion that there's some sort of negligence cause

of action that the jury could find Bard liable on that does

not involve a failure to warn or a design defect. I'm not

seeing what that is.

I mean, if there's a negligent marketing claim, for

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example, it seems to me that's the same as a failure to warn

because the duty that you would define for the jury in

marketing is a duty to be honest and truthful in marketing

your product.

MR. LOPEZ: Right.

THE COURT: Same thing on failure to design. If --

well, let me state it this way: Let's assume for a minute

that you convince the jury that Bard was really negligent in

failing to conduct two kinds of tests and in conducting a

third, but you don't convince the jury there was any defect in

design. Are you suggesting that the jury could find Bard

liable for negligent testing?

MR. LOPEZ: Well, let's put it -- what if, in fact,

there's evidence that Bard spent more money on marketing than

they did research and development. That Bard's first go-to

response to a significant safety issue with their product was

not to go to scientists to figure out what they had wrong or

pull the product back to evaluate it, but to go to a PR outfit

to determine how you're going to get that message out to the

public and to the doctors. Or -- and what that message was

going to say. And within the message was going to be how we

can manipulate the evidence that we have about our product so

that our company and this product does not have -- that news

does not have an effect on our stock price or on the market

share of this product.

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I don't know that -- that's certainly not a design

defect, and certainly not a failure to warn. That's a

different type of conduct. I mean, that's conduct that

certainly goes to punitive damages.

And -- but what if the jury doesn't think that's

punitive? What if they think that conduct is you just

shouldn't have done that, shame on you, you're bad, that's

negligent, a reasonably prudent company would not do that. I

mean, we should win that case, I think, if under those

circumstances the jury finds that that's negligent and, well,

doesn't have anything to do with the design or the warnings,

and but -- but it maybe doesn't raise to the level that it's

punitive damages.

THE COURT: Well, let's assume we gave them a series

of interrogatories: Do you find that Bard product at issue

was defectively designed? No.

Do you find that Bard failed to warn appropriate

medical community? No.

Do you find that Bard is liable for punitive damages?

No.

You're saying that the jury could nonetheless say we

are going to hold Bard liable for $5 million because we don't

like the way they did their business?

MR. LOPEZ: No. No. I mean, that's --

THE COURT: Okay, then finish my sentence. We find

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they're liable for $5 million because --

MR. LOPEZ: They didn't properly test this. When

they did test it, they used an inappropriate standard or

threshold of safety. Of course, that's all design, isn't it?

THE COURT: Well, yeah. I mean, it seems to me

testing only bears fruit in your claim if the product was

improperly designed.

MR. LOPEZ: Right.

THE COURT: Otherwise -- and let's say they did a

test completely negligently but the product was properly

designed. That negligent test didn't harm the plaintiff.

MR. LOPEZ: Okay. Again, Your Honor, I know we've

talked about this more than once. I'm still kind of reacting

to the hearing we had two or three -- it was probably two

hearings ago when you said what does conduct have to do with

this case if we're only talking about warnings and only

talking about design. And maybe I should just take comfort in

the fact we still have a punitive damage claim in the case.

THE COURT: Like I'm saying, I don't remember what I

was thinking, if I was thinking anything clearly, when I said

that. But it seems to me you've pled a negligent design

defect and negligent failure to warn claim and that

everything -- in terms of causes of action, everything that's

going to come in at trial has to focus on those claims. And

you've also pled a non-negligent design defect and a

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non-negligent failure to warn that are both still in the case

as well.

MR. LOPEZ: And we pled, of course, punitive damages,

which is conduct.

THE COURT: Right. But is not a separate cause of

action.

MR. LOPEZ: Right. All right. Thank you, Your

Honor.

THE COURT: Okay.

Other thoughts? Anything else we need to address?

MR. NORTH: Nothing further, Your Honor.

THE COURT: Okay. Let me just say this: Between now

and March 2nd, which may be the next time you're here, if you

think we need to talk through any issues that are coming up,

give me a call and we'll set a telephone conference so that we

can get those issues addressed before we get to the final

pretrial conference.

All right. Thank you all.

MS. REED ZAIC: Thank you, Your Honor.

(End of transcript.)

* * * * *

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C E R T I F I C A T E

I, PATRICIA LYONS, do hereby certify that I am duly

appointed and qualified to act as Official Court Reporter for

the United States District Court for the District of Arizona.

I FURTHER CERTIFY that the foregoing pages constitute

a full, true, and accurate transcript of all of that portion

of the proceedings contained herein, had in the above-entitled

cause on the date specified therein, and that said transcript

was prepared under my direction and control, and to the best

of my ability.

DATED at Phoenix, Arizona, this 1st day of February,

2018.

 s/ Patricia Lyons, RMR, CRR

Official Court Reporter 

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