UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

 _________________

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

Products Liability Litigation )

 )

 ) Phoenix, Arizona

 ) December 15, 2017

 ) 

_____________________________________)

BEFORE: THE HONORABLE DAVID G. CAMPBELL, JUDGE

REPORTER'S TRANSCRIPT OF PROCEEDINGS

MOTION HEARING

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.

By: C. LINCOLN COMBS, ESQ.

2575 E. Camelback Rd., Ste. 1100 

Phoenix, AZ 85016

Lieff Cabraser Heimann & Bernstein

By: DONALD ARBITBLIT, ESQ.

275 Battery St., 29th Fl.

San Francisco, CA 94111

Hausfeld, LLP 

By: STEVEN ROTMAN, ESQ.

1700 K St. NW, Ste. 650

Washington, DC 20006

For the Plaintiffs:

Heaviside Reed Zaic

By: JULIA REED ZAIC, ESQ.

By: LAURA E. SMITH, ESQ.

312 Broadway, Ste. 203

Laguna Beach, CA 92651

Williams Love O'Leary & Powers, PC 

By: LESLIE W. O'LEARY, ESQ.

9735 SW Barnes Rd., Ste. 450 

Portland, OR 97225

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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.

By: ELIZABETH C. HELM, ESQ.

201 17th Street NW, Suite 1700

Atlanta, GA 30363 

Nelson Mullins Riley & Scarborough

BY: JAMES F. ROGERS, ESQ.

1320 Main St.

Columbia, SC 29201

Nelson Mullins Riley & Scarborough 

BY: MATTHEW E. BROWN, ESQ.

1 Post Office Sq.

Boston, MA 02109

Snell & Wilmer

By: AMANDA C. SHERIDAN, ESQ.

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 Products Liability Litigation, on

for motion hearing. 

Will the parties please announce.

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

on behalf of Plaintiffs' Leadership Committee. 

MR. O'CONNOR: Your Honor, Mark O'Connor for

Plaintiffs' Leadership Committee.

MR. ARBITBLIT: Your Honor, Donald Arbitblit for

Plaintiffs' Leadership Committee.

MS. SMITH: Your Honor, Laura Smith for Plaintiffs'

Leadership Committee.

THE COURT: All right. Good afternoon.

MR. ROTMAN: Steve Rotman, Plaintiffs' Steering

Committee.

MS. O'LEARY: I'm Leslie O'Leary. I'm not part of

the Plaintiffs' Steering Committee, but I'm going to be

arguing a motion today, and I've been admitted pro hac vice.

MR. NORTH: Good afternoon, Your Honor. Richard

North on behalf of defendants, and I'm joined by Jim Condo and

my partners James Rogers, Matthew Brown, and Elizabeth Helm.

THE COURT: All right. Good afternoon.

MULTIPLE VOICES: Good afternoon, Your Honor.

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THE COURT: All right. We are going to be addressing

today the motion to disqualify Dr. Kinney; the motion to

disqualify Drs. Resnick, Vogelzang, and Desai; the motion to

exclude Dr. Parisian; the motion to exclude Dr. Kessler; and

the motion to exclude Kinney, Roberts, and Kalva. Those are

the five motions that we've got teed up for today.

What I want to talk to you about as well today is the

timing for the rest of the expert motions that are still

pending; I want to talk about trial scheduling issues in terms

of amount of time and specific day issues I've got in March

just so we can work around them; and I want to talk about the

defendants' motion to certify the preemption ruling for

appeal.

I understand that some of you, I think Mr. Condo and

Mr. Lopez, need to leave by 3:00 or a little bit after. I'm

hoping we're done by then, I'm not sure we'll need more time,

but to make sure we cover what is most important while you

gentlemen are here, is there anything in particular you want

to take up first?

MR. LOPEZ: Not from my -- everything else is

covered, Your Honor, with respect to what's on the Court's

calendar.

THE COURT: Okay. 

MR. LOPEZ: So I'm fine.

MR. NORTH: Your Honor, we're at the Court's

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discretion as well.

THE COURT: Okay. All right.

Let's talk first, then, about the motions to

disqualify Dr. Kinney and Drs. Resnick, Vogelzang, and Desai.

It's the same issue, in effect, with respect to the experts.

On all of these motions I've read the briefs, I've

read relevant exhibits. When it comes to experts, I've read

portions of the expert reports; I've not read them all. Nor

could I, I don't think. I tried to read relevant cases. I

haven't read all of the cases the defendant cites on a portion

of the fifth motion about what an expert can or can't say on a

reasonable physician's view. There's a long string, so I want

to read those cases.

My point is I'm pretty familiar with what the issues

are and arguments are. You don't need to walk me through the

basics. I'm really most interested in what you think are the

key points now that the briefing is done.

So let's start with those two motions to disqualify

and take those together.

MR. NORTH: Your Honor, Ms. Helm will present

argument on those.

THE COURT: All right.

MS. HELM: Thank you, Your Honor.

As the Court has recognized, the basic law is the

same as -- almost as the same as it relates to these two

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motions and the courts have applied two tests. Either the

bright-line test or the two-part test. And I think the issue

under both of those tests, based on the briefing, is whether

the expert -- and I'm going to start with Dr. Kinney --

received confidential information.

Under the bright-line test there's no question that

Dr. Kinney was retained by Bard in IVC filter litigation.

Under the two-part test, there's no question that

Dr. Kinney was retained by Bard in IVC filter litigation and

that Dr. Kinney had multiple consulting agreements with Bard

that included confidentiality provisions. So under the

two-part test there doesn't seem -- the plaintiffs don't

challenge that there were confidential relationships under

each test.

So the question becomes, under the bright-line test,

did he receive confidential information? And under the

two-part test, did he receive confidential information? If he

did, he has a conflict.

And our position is that he in fact did receive

confidential information. The plaintiffs' position is that he

did not receive confidential information that is relevant to

this litigation. And so I'm going to address what

confidential information that he did receive and what evidence

the Court has.

One thing I think is important to note with

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Dr. Kinney, in his report he lists as one of his

qualifications -- the report is broken down in different

categories and they have their qualifications, and he lists as

his qualification the fact that he has done consulting work

with Bard. 

He then, now that we have filed a motion raising that

very issue, tries to back off of it and say, oh, no, no, no,

it was nothing important, I didn't do anything. But it was

important enough for him to list it as a qualification.

When he was retained by counsel he was retained and

had conversations with Mr. North in the two cases in which he

was retained.

In at least one of the cases Mr. North made the

decision of what documents to send to him and what opinions

Mr. North wanted him to evaluate and give in the case. That

in and of itself right there is work product. The choice of

what documents to provide to an expert, the choice of

discussing what opinions the expert should or should not offer

is work product. Everyone in this litigation has taken that

position as it relates to the experts. Except in the context

of this motion they're saying, no, no, no, I didn't get any

work product.

More importantly, if you look at what Dr. Kinney did

when he was consulting with Bard, he touched in the very areas

that they criticize in the expert report. He touched in

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testing. He was involved in testing of IVC filters. The very

filters that are at issue in this case. We then have a report

that says Bard didn't adequately test their filters.

He was involved in analysis of adverse events,

responding to adverse events. Then we have an opinion that

says Bard didn't adequately respond to adverse events.

He was involved in analysis of failure modes of

filters. He had a conversation with the president of Bard

Peripheral Vascular about failure modes of filters and what

was going on and the complications that could come from that

that was then incorporated in an analysis of the filters.

In their expert report, they challenge failure modes.

Bard didn't do enough, Bard didn't analyze what was going on

with the filters. His very work as a consultant. He was

provided test protocols. They challenge testing. He was

provided and discussed information regarding adverse events.

They challenge adverse event analysis. He was involved in

discussion of failure analysis. They say Bard didn't do

enough.

He was involved and received information from the

company on very areas on which they opine in their report.

Dr. Kinney -- we don't have to show -- for the

conflict to exist, we don't have to show that he used that

information or that he relayed it to other people. He has a

conflict. And we believe because of that conflict, because he

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received confidential information, which is the second prong

on whichever test the Court chooses to apply, because he had

that confidential information, he had the conflict. He should

have never been involved in this litigation.

And interestingly, he didn't report, at least in the

report and it appears plaintiffs' counsel didn't know that he

had prior -- previously been retained by Nelson Mullins to

serve as an expert until our motion was filed.

He mentioned his prior consulting in his report but

did not mention his prior employment as a medicolegal expert

for Nelson Mullins.

Dr. Kinney received confidential information.

Dr. Kinney has a conflict.

We are not seeking to exclude Dr. Kalva or

Dr. Roberts because through Dr. Kinney's testimony we're able

to delineate what he did. He testified about what portions of

the report he wrote and what portions of the report the other

doctors were involved in. So they can still testify. We're

not trying to impugn, and frankly we don't have the evidence

to impugn his conflict to them, so we are not seeking to

exclude Dr. Roberts or Dr. Kalva. That's what makes the two

situations a little different.

The plain evidence before the Court is he sat down

either by telephone or in person and met with the defense

lawyer who made decisions about what information to provide

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him. He received that information and provided information

back to -- in the form of a draft report back to defense

counsel. All of that falls into the very definition of work

product.

He consulted with the company. He received test

protocols. He received confidential internal information

that's not available outside to the public. And he did it not

once, not twice, but he did it six times. He had six

different consulting agreements relating to IVC filters.

Dr. Kinney has a conflict. Dr. Kinney should not be

involved in this litigation and the plaintiffs should be

allowed to go forward with Dr. Roberts and Dr. Kalva.

Do you want me to go ahead and address the other one?

THE COURT: Let me ask you one question first.

You've just described what -- you've just described what

Mr. North did and shared with Dr. Kinney. There's no

declaration or affidavit in the record regarding that, is

there?

MS. HELM: No, Your Honor, there's no declaration in

the record. Mr. North is here. He can state in his place.

Dr. Kinney actually admits that he received certain

information from Mr. North. So even using Dr. Kinney's

declaration, it's in the record that he received information

from defense counsel.

THE COURT: Okay. Why don't you address the other

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motion.

MS. HELM: Your Honor, we have the same test to start

with, with Dr. Resnick. A little bit of -- what makes this

one a little bit different is a couple things. Number one,

I'm going to refer to them as the Northwestern doctors rather

than stumbling over each of their names. The Northwestern

doctors made a decision to create an entity. A legal entity.

They're operating under an entity node as SBBK. They're all

four equal partners in this legal entity. The entity is who

bills for the work that they did. The entity has some sort of

a tax ID number or W-9, because if you look at the invoices

they're all in the name of the entity SBBK Consultants LLC.

So you don't have three independent doctors doing

their work and getting paid for what they do, you have four

doctors that have formed one entity.

Regardless of how much each of them works, they're

going to split the profits one fourth, one fourth, one fourth.

That's been testified to by Dr. Vogelzang. 

And what you have here is a situation where

Dr. Resnick, again, should have never been involved.

Dr. Resnick was retained as an expert witness in a Bard case

after this MDL was filed. He met with Mr. Rogers in 2015 for

three hours in a case that's not in the MDL but after the MDL

was pending and filed.

Mr. Rogers, and he admits it in his declaration,

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Mr. Rogers chose what information to provide to him and what

information he wanted him to review.

Again, Mr. Rogers made a work-product decision of

what information to provide to Dr. Resnick and provide it to

him. Dr. Resnick also previously served as a consultant for

Bard. Obviously Bard is talking to doctors who had previously

worked for the company as consultants as potential experts.

We're not out trying to conflict out interventional

radiologists where you -- working with people who had worked

with the company before.

Dr. Resnick did not tell plaintiffs' counsel he had

been retained by Bard and apparently didn't tell plaintiffs'

counsel he had consulted with Bard. Plaintiffs' position in

their papers is they learned it when we filed the motion. And

they have admitted that he shouldn't be involved, because

they've taken the position in their papers that -- to use

their term, they've walled him off. They have told the other

three Northwestern doctors not to consult with him any more.

If there was no problem with Dr. Resnick's

involvement, if he didn't -- if he had not been exposed to

confidential -- and received confidential information, there

was no need to wall him off.

Plaintiffs implicitly admit that there's a problem

there and admit -- and they're going to say it was boots and

suspenders. But if there's no problem, why take him out? The

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prob- -- and, in fact, the problem is they took him out too

late.

If you look at what Dr. Resnick did, he met with

Mr. Rogers for three hours about a case that was pending in

2015. He received information that Mr. Rogers chose to send

to him. This is all in Dr. Resnick's deposition, and

Mr. Rogers can state it in his affidavit or declaration.

Mr. Rogers can state it in his place.

If you look at the consulting he did, he was likewise

involved in testing of filters. Directly involved in the kind

of work and the kind of issues that are in this case.

Here's the difference, though: The Northwestern

doctors, the SBBK report, is, as Dr. Vogelzang testifies at

length in his deposition, a collaborative report.

Dr. Vogelzang cannot tell you who wrote what or who did what.

Dr. Resnick testifies in his declaration that his

role was modest. That's his word that he uses in paragraph 8

of his declaration.

But Dr. Vogelzang's own testimony is contradicted by

the invoices from SBBK.

The other thing that's very important is

Dr. Vogelzang testified, and Dr. Desai testified, that it's

Dr. Resnick who wrote the invoices. He was in charge of the

billing.

So Dr. Resnick's own invoices show that he was

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involved in every aspect of the work that these -- the SBBK

doctors did, except one phone call. There's one phone call

that was Dr. Vogelzang alone.

Every other entry has Dr. Resnick involved and

there's at least one entry where he's the sole person who

billed for the work.

So unlike Drs. Kinney, Kalva, and Roberts where you

can parse out, frankly, based on their testimony who did what,

in this case it is, to use Dr. Vogelzang's own testimony, it

is a collaborative effort and you cannot divide out what

Dr. Resnick influenced, what he didn't, what Dr. Resnick wrote

and what he didn't. And it was interesting because

Dr. Vogelzang seemed to want to emphasize that because he said

it over and over again, and he said "This was a collaborative

effort, I cannot say who did what." Dr. Resnick contributed

to every aspect in some part.

So we have a situation here where we have an entity

where these four doctors have chosen to make themselves an

entity, where the entity has a part of it Dr. Resnick, who the

plaintiffs admit was involved in confidential relationships

with Bard and who his own testimony shows received

confidential information, even more so while the MDL was

pending. And you can't -- there's no way to, using the

doctors own testimony, to parse out and say, well, Resnick was

involved in this or he wasn't involved in that.

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Resnick's a non-testifying -- he's a consulting

expert who had his hands in everything. And so there's no way

to resolve this for Bard or to avoid the conflict without

disqualifying the entity as a whole. As opposed to trying to

parse it out. Dr. Vogelzang makes that impossible because,

frankly, it was a collaborative effort.

And plaintiffs are going to argue again that there's

prejudice and that the Court shouldn't do this because they're

prejudiced if they lose Dr. Desai and Dr. Vogelzang, who are

the testifying witnesses.

Plaintiffs still have Dr. Kinney and Dr. Roberts as

interventional radiologists. These are all interventional

radiologists. There's also another interventional radiologist

who is designated and has testified in all of the bellwether

cases in Dr. Hurst. So the plaintiffs are not left without a

medical doctor in that area of expertise in these cases.

The flip side of it is if these three -- if those

four doctors and Dr. Kinney are left in, Bard is faced with

experts who have Bard -- had Bard confidential information

with whom Bard had anticipated and expected confidential

relationship, documented in writing through various consulting

agreements, who have now testified -- who are now either

testifying or participating in testifying against the company.

Through the judicial balance and the integrity of the

system, we believe that the right thing to do is to disqualify

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Dr. Kinney, let Dr. Roberts and Dr. Kalva go forward, pending

the Daubert motion on them, but the entire SBBK doctors should

all four be disqualified.

Thank you.

THE COURT: Okay. Thank you.

MR. ROTMAN: May it please the Court. Good

afternoon, Your Honor.

THE COURT: Good afternoon.

MR. ROTMAN: I'm Steve Rotman and I will be

addressing the Northwestern Group on the facts and the legal

standards for all of the disqualification issues, and then

Laura Smith will be addressing the specific facts and

arguments relating to Dr. Kinney.

I'd like to start by a housekeeping matter.

Yesterday for the first time, in looking over the papers, I

realized that it was possible that we never filed the Resnick

declaration. So we filed it yesterday. It wasn't clear, but

out of abundance of caution, we filed it yesterday. The

reason it wasn't clear is because in looking at the defense

briefs, they responded to comments in the Resnick declaration.

Perhaps we served it and didn't file it. Perhaps we did both.

But the record wasn't clear. So now, Your Honor, we just want

to make sure it's part of the record. We did refer to it in

our brief, in our opposition brief. I have a copies of it

with me, hard copies of it with me here today, so I can also

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provide a copy to Your Honor --

THE COURT: There's no need. Thank you.

MR. ROTMAN: -- if there's any need for that.

I'd like to start by just giving an overview of some

important issues that were perhaps not clear and would not be

clear to the Court from reading the defendants' brief.

Although Bard cited four times to the Hewlett Packard

case, which is a case decided by the Northern District of

California, part of the Ninth Circuit, cited four times in

their initial brief, there's -- there's important legal

standards in the Hewlett Packard case that govern how the

Court should be thinking about both motions. I will start by

pointing out that the court stated the following: That

disqualification is a drastic measure that courts should

impose only hesitantly, reluctantly, and rarely.

They go on and say -- talk about the two-prong test

that is in -- that is in the briefs, but they make the point

that the two prongs are both separate and distinct and you

must prove both.

You can't prove one and then presume the second one.

You can't assume the second one or bootstrap to the second one

from proving the first. So if you prove that there was a

confidential relationship, you can't just assume that there

was confidential information transferred. And the

confidential information has got to be a particular type of

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confidential information, protected information, the type that

is work product, attorney client, not discoverable, and

related to the specific case.

THE COURT: Are you saying only work-product and

attorney-client privileged materials counts?

MR. ROTMAN: Those are -- I'm not saying -- that's

what the court said in Hewlett Packard.

THE COURT: Doesn't it begin the statement by saying

"Information of particular significance or attorney-client

work product"? I mean "attorney work product."

MR. ROTMAN: You might be correct on that, Your

Honor.

So -- so we need to have -- the other thing that's

clear from reading this case as well as all the others is that

the burden's on the moving party. So our main point here

today is that they have to prove both prongs and they have the

burden. And there's no presumption or assumption. There

needs to be specific proof. There wasn't any provided for

prong number 2.

Let's just look at Dr. Vogelzang. There's no

evidence of any confidential relationship, that's prong one,

nor any evidence that he received confidential information.

All of the evidence relates to Dr. Resnick. We took Resnick

off the table. Not because we were admitting that he should

be disqualified, because we could be standing here arguing

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about Dr. Resnick and make the argument they haven't met their

burden that any confidential information was ever provided to

him.

Yes, he had a -- there was a potential for

confidential relationship in that three-hour meeting, but he

submitted a declaration, as did Drs. Vogelzang and Desai,

saying they never received any confidential information from

him, and his declaration states he never provided any to them

nor did he receive any. He had a three-hour meeting in which

they provided him medical records of a plaintiff. That's not

confidential to us. We have the same medical records. It's

our client, this woman, this plaintiff, in the Austin case.

The medical literature, their own experts provide their

medical literature along with their expert reports. That's

not protected confidential information that gives us any

advantage.

If I go to any -- any one of several of their expert

reports and flip to the section on materials relied on and

citations and references, I get over 170 papers cited.

So in -- whereas Dr. Resnick, Vogelzang, and Desai

submitted declarations denying that there was confidential

information, whether or not you call that meeting of three

hours a confidential relationship, there was nothing from

Bard. No declaration.

Now, the fact that Mr. Rogers is here today is a

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little bit late. We wrote our brief, we wrote our opposition.

They had plenty of opportunity to submit.

We wrote in our opposition they hadn't met their

burden. They did a reply brief. They had an opportunity at

that time.

In addition, for Vogelzang -- and on the Vogelzang

issue, they took the deposition of Drs. Vogelzang and Desai.

They didn't ask for the deposition of Dr. Resnick. And asked

neither one of them in two-full day depositions any questions

at all about what information Dr. Resnick did or did not

provide to them that came out of any prior confidential

relationship.

They want the Court to presume that there was

confidential information because there was the opportunity for

it. But they provide no specifics, no declaration. They

didn't inquire in their opportunity to do so to develop a

record, and so their burden is not met.

In addition, Your Honor, in the Vogelzang

Northwestern doctors situation, they received notice on March

2nd in the initial report and then two additional reports

after that, later in March and then in April, all making it

clear that Resnick was a part of the collaboration with

Vogelzang and Desai. And yet they did not provide a letter

notifying us of any concern about conflict until June 29,

after it was too late for us to do anything other than spend a

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considerable amount of money on these experts' fees and time

and resources developing three expert reports, preparing them

for their deposition, and at a point in which it's then too

late for us to name any other alternative experts or rebuttal

experts.

So they had all the information they needed on day 1,

March 2nd, to know that Resnick was involved. 

In the Kinney case, 12 days after they received the

Kinney report they wrote such a letter. But in the

Northwestern Group case, nothing came until June 29.

So what happened with Resnick is on the meeting in

October of 2015 that lasted about three hours, they talked

about they had about 50 cases they might get him involved in.

In this particular meeting in which his declaration states he

was not provided any insight into legal strategies, legal

defense strategies, and so forth, he did impart to Mr. Rogers,

who was the lawyer from Nelson Mullins that met with him, what

he thought about the Bard filters. Critical of the Bard

filters. And he told -- and his declaration states that he

never heard from them again.

All through 2016, when this litigation was in full

throttle and Bard was naming a number of experts on a number

of different cases, Resnick was not part of that.

So I question whether there was a confidential

relationship, even prong one, with Resnick. It looks more

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like it was a screening interview. They were feeling him out.

They were interviewing him. They were trying to decide, was

he going to be one of their experts? He told them something

they didn't want to hear, his opinion about their design,

their filter design, and his experience with their filters

being problematic. The meeting ended and they never heard

from him again.

When we hired Vogelzang, he told us he works with

this group. He never mentioned to us, because he didn't know,

about this meeting in October of 2015. And when we learned

about it after they filed their motion, wrote their letter

filed their motion, I asked Resnick, why didn't you tell us?

He said he didn't even remember it. He didn't -- it didn't --

that was just -- that was how significant it was, this

three-hour meeting.

So we have -- and there's language, by the way, in

this Hewlett Packard case about how the courts want to be

vigilant about the situation where potential experts at a

nominal fee will be disqualified by having meetings such as

this one.

THE COURT: You've talked all about that three-hour

meeting. He was a consultant with Bard between 2003 and 2014;

right?

MR. ROTMAN: He was. And as he states in his

declaration, most of that had nothing to do with IVC filters.

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THE COURT: But are you disputing there was a

confidential relationship? That seems to be what you're

arguing with respect to Dr. Resnick.

MR. ROTMAN: What I'm arguing about Resnick is that

we don't have to spend time on Resnick because we took him

out.

THE COURT: That's fine. We just spent a lot of time

on him and I wasn't quite sure --

MR. ROTMAN: Well, I spent time on him because they

want to bootstrap from Resnick to Vogelzang and Desai and

Lewandowski. They have to prove prong 1 and prong 2 for

Vogelzang and Desai and Lewandowski. And so where was the

confidential relationship with each of those three, and

where's the evidence from Bard there was not only a

confidential relationship with each of them but that each of

them received confidential information from Resnick? Which

they deny and he denied, and they only put it in a brief that

confidential information was provided to Resnick, but they

have no idea whether, if that -- if that is even true whether

he then transferred that information to Vogelzang and Desai

and Lewandowski, and the Court cannot presume that. Is it

possible? That's not the standard. Remember what the court

said, it's a drastic remedy and stringent burden. Courts are

very reluctant and very demanding. It's not nonchalant to

cross over the specific requirements and the burdens.

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I'm going to pass to Ms. Smith who will address the

other experts.

THE COURT: Okay.

MS. SMITH: Good afternoon, Your Honor. I have a

brief PowerPoint presentation to go along with my argument.

Is that all right?

THE COURT: Sure.

MS. SMITH: Your Honor, I'm here to discuss

Dr. Kinney's motion regarding disqualification. My name is

Laura Smith.

First and foremost, what I want to point out is Bard

has not met their burden. They have provided no evidence

there was actual confidential relationship that is relevant to

the current litigation and that is not subject to discovery

that's already been issued in this litigation. They have not

provided any documents, they've not provided any description

of information.

Furthermore, when they found out that Dr. Kinney was

one of plaintiffs' experts they did send us a letter. I have

a copy of the letter here. And initially we asked them right

away to send us information about Dr. Kinney and if he was

exposed to confidential information, please let us know, and

to give us some of that -- to provide us with the information

so that we could then make an assessment of whether we

believed it was confidential and we could move forward.

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There was an opportunity in the very beginning to

mitigate this and the defendants never provided any

information. This was back in March of 2- -- March 22nd,

2017.

You can see here we have a follow-up letter and even

at Dr. Kuo's deposition, Ramon spoke to the attorney there and

asked him to provide this information to us.

If they're going to accuse Dr. Kinney of switching

sides, which is such a serious allegation, they could then

provide us with what confidential information he had been

disclosed with.

They never even mention the manner in which they give

it to Dr. Kinney. There was no request for in-camera review.

There's been no declaration from Bard, although there was an

assertion that Mr. North would be willing to make that today.

And even furthermore, in the expert report they have not

identified any portions of it that they believe came from

confidential information that Dr. Kinney received while he was

an expert. I'm sorry, while he was a consultant for Bard.

After Dr. Kinney's deposition, they did not

supplement their motion with any information and at this point

Bard provided nothing but vague statements.

As I said, Bard has not met their burden. Today I'm

focusing on the second prong of the part 2 test. The

bright-line test tends to apply when there's more of a clear

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and blatant side switching, and then when there's a dispute

the courts tend to apply the two-part test.

We are not arguing about the confidential

relationship, but we are arguing that no confidential

information that is relevant to this litigation that merits

disqualification was disclosed to Dr. Kinney.

One thing is clear, is that courts do require that

parties provide concrete, hard evidence. They're not willing

to look at vague and ambiguous statements, and they need to

represent it with specific facts. And here, as I said, Bard

has yet to provide this evidence.

Furthermore, Bard noticed Dr. Kinney's deposition two

months after receiving their motion, after filing this motion

to disqualify. At that deposition they had the perfect

opportunity to ask Dr. Kinney any kind of questions that would

relate to this. They had the opportunity to get the actual

evidence that they needed, and they chose not to. Dr. Kinney

even provided his report of Mattes at the litigation, his

summary, medical summary. He had it there with him. And I

have it here today. We offered it for in-camera review so it

can be very clear the type of information he was looking at

was only from medical records, and you can see that there's no

other discussion within those papers than medical records.

One thing the plaintiffs have done, because there is

conflicting information here, is we have provided the Court

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with a sworn declaration from Dr. Kinney, and Dr. Kinney has

testified under oath. Courts have found that a sworn

declaration is sufficient to alleviate any concerns and deny a

motion for disqualification.

Further, courts have also found at this late stage

that in order for the parties not to suffer a hardship, the

expert -- for an expert to be disqualified, they can rely on

an expert's declaration.

Here is a copy of the declaration. I know it was an

exhibit and you have reviewed it, but one part I would like to

emphasize is that Dr. Kinney states, "The work I performed for

the plaintiffs is not based on any information I derived or

received when I was a consultant for Bard. The expert report

where I list documents, data, information, facts I considered

for my opinions, none of which I reviewed when I was a

consultant. In fact, I was not even aware of the existence of

this material."

So here we have Bard's assertions that when

Dr. Kinney -- when Dr. Kinney worked for them as a consultant

for two and a half years about ten to 12 years ago, they claim

he received confidential information that is relevant to this

litigation.

Dr. Kinney, from the agreements that we've seen, he

helped implant and teach doctors how to implant and remove

filters. He did work in a lab under two animal studies, which

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Elizabeth Helm mentioned. In that he recorded data. He never

got to see the results. He never was a party to making

decisions about those results. He merely was acting as a lab

assistant.

Further, when Dr. Kinney worked on providing medical

summaries for the Mattes and Ennis case, it's clear by looking

at the facts, and we put this in our brief, that there was

little to no information exchanged between the parties. He

was provided with medical records and then wrote his summary

for Mattes. That case settled before any expert disclosures

happened. 

And then for the Ennis case, Dr. Kinney only billed

one hour of time for it and it settled before there was a case

management conference.

It is clear there would be no need at this point in

time for Bard to provide Dr. Kinney with any of their work

product, any mental impressions, any strengths and weaknesses

of their case. These cases weren't even developed to get to

that stage in the litigation.

So as I said, Bard has had many opportunities to

provide supportive evidence for this motion. Documents --

they could provide their billing records to show us the time

they've worked with Dr. Kinney, request an in-camera review,

at his deposition they could have elicited testimony. Submit

a sworn affidavit or declaration from any of the attorneys

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 29 of 112
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that worked on Ennis or Mattes, from any attorneys in the MDL,

or from any Bard employees.

So, once again, Bard has not -- has no authority

right here. None of the cases that plaintiff or defendant

cite is analogous to the position here. They all require some

sort of evidence. And in the absence of evidence, a sworn

declaration is sufficient.

One thing I noted when I was reading the cases is

that the longest period of time between when an expert worked

as a consultant and worked for another party was about four

years. Right now we're dealing with a time period of 10 to 12

years.

This is greatly prejudicial to the plaintiffs.

Disqualifying Dr. Kinney would be fundamentally unfair and

serve as a severe sanction there currently is no time to

repair.

And Dr. Kinney offers a very unique value as an

expert with Dr. Kalva and Dr. Roberts. He is highly

specialized in his field. Besides having a medical degree, he

is a mechanical engineer and he has a degree in physics. He's

designed medical devices. And he is -- was our lead attorney

in this project. He was responsible for involving Dr. Roberts

and Dr. Kalva.

Dr. Roberts is his supervisor and boss and Dr. Kalva

he's known for years, 13 years, and they worked in the angio

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 30 of 112
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clinic in San Diego. And because of their experiences with

Bard filters and their complications, that is why he reached

out to them and got them involved in this.

So, in summary, Bard has not met their burden, they

have not produced any evidence, it's very prejudicial to

plaintiffs. Dr. Kinney has signed a sworn declaration and

testified under oath. The Mattes and Ennis cases only

involved medical summaries.

For the expert report, the Kinney-Kalva-Roberts

report does not reflect or reveal any confidential

information, nor as Bard asserted that, nor does it reveal

Bard's mental impressions, and it does not discuss any of the

topics that Dr. Kinney consulted on.

Dr. Kinney has been transparent from the very

beginning by outlining his role as a Bard -- his role working

with Bard and his involvement. And any indication that

confidentiality still exists has either been extinguished by

time or by publication.

So we believe it is clear Dr. Kinney should not be

disqualified because Bard has not met their burden and

Dr. Kinney did not receive any confidential information that

is relevant to this lawsuit that was not subject to discovery

in this case. Thank you.

THE COURT: All right. Thank you.

MS. HELM: Your Honor, may I briefly address --

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THE COURT: Yes.

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

Dr. Kinney and plaintiffs continue to argue there's no

evidence that the expert used confidential information he

received.

THE COURT: I think the argument was there is no

evidence he received confidential information.

MS. HELM: I'll address that first, Your Honor.

The evidence is in the form of the declaration of

Dr. Kinney. In his declaration he testifies that he worked as

a consultant for Bard relating to IVC filters, that he

performed an animal study evaluating filters, that he was

asked to evaluate various performance characteristics of IVC

filters, that he was asked to provided advice and consultation

regarding the use of filters to other people, that he, again,

was asked to perform another animal study and, in fact, the

consulting agreement that he refers to there includes the test

protocol, which is clearly confidential information. He was

asked to provide research related to another animal study and

asked to evaluate various performance characteristics of a

filter, another IVC filter.

He admits he had access to test protocol, he had

access to analysis of Bard's product. He admits he met with

the president of Bard Peripheral Vascular and talked about

adverse events. Dr. Kinney himself admits in his declaration

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that he had access to and received confidential information

from Bard while working as a consultant.

He also admits that he received work product while

working as a medicolegal expert for Bard because he admits

that he reviewed documents provided to him by defense counsel.

Documents chosen by defense counsel to give to an

expert are work product. That fact alone shows that he

received work product information in his capacity as a

medicolegal expert for Bard.

All of this is in Dr. Kinney's declaration: "I met

with John McDermott, the president of BPV. We talked about

issues related to IVC filter fractures."

Those are the very issues in this case.

He asked questions about whether fragment filters

could cause additional issues. Those are very issues in this

case, can fracture lead to something else.

He was involved in confidential internal information,

internal conversations, in the company about the company's

filters and its performance of its filters. He had access to

test protocol. He had access to company documents.

So, again, the test is not did he use it. They admit

he had a confidential relationship. The test is, in that

confidential relation did he receive confidential information?

And he also admits that in his declaration.

Interestingly, Ms. Smith argued Dr. Kinney has been

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transparent. Apparently he wasn't transparent until he got

caught because he either didn't tell plaintiffs' counsel or

they didn't ask him if he had previously worked for Bard or

for Nelson Mullins as a medicolegal expert, and in fact he

had. And then once we raised the issue, once we learned about

it and raised the issue, he remembered it.

Now I'm going to switch to Dr. Resnick because the

issue is a little different. Again the test is the same. As

to Dr. Resnick himself, did he have access -- did he have a

confidential relationship? There's no question he did. He

admits to it.

Did he receive confidential information? Again, the

very simple, very easy one is Mr. Rogers chose what medical

records to send to him to review. That is work product in and

of itself.

In the analysis of the Austin case, which, by the

way, Your Honor, is still pending and many of the lawyers in

the room are attorneys of record in the Austin case. The

Austin case is the case which Mr -- Dr. Resnick met with

Mr. Rogers.

We did not know Dr. Resnick's full involvement and

how intertwined he was in the SBBK reports until the

depositions of Dr. Desai and Dr. Vogelzang and until we

received the invoices, and it was at those depositions that we

received the invoices. And the invoices are exhibits to our

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motion.

Those invoices --

THE COURT: I've read them.

MS. HELM: And it was at that deposition of

Dr. Vogelzang that Dr. Vogelzang testified over and over and

over again that his reports, their reports, are a

collaborative effort that all four of them were involved in

and you can't parse out who wrote what. And looking at the

invoices, clearly Dr. Resnick had his hand in every aspect of

their expert work.

Dr. Resnick, according to Mr. Rotman, didn't remember

that he'd served as a consultant at Bard and didn't remember

that in 2015 he'd met for three hours with Mr. Rogers. Again,

that begs the question why wasn't he asked? And also, when

asked to write a declaration, Dr. Resnick suddenly remembered

all of the details of those meetings and his consulting

agreements.

But, again, if you look at his declaration, he says,

"I met with Mr. Rogers. We discussed the Austin case.

Mr. Rogers -- we talked about causation, we discussed the

case."

The Austin case is a G2 Express or G2X case, like

many of the cases in the MDL.

He also testified that when he worked for Bard he did

a product line review. He had discussions with Bard about

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 35 of 112
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filters. He did an animal study. He participated in a

preexisting animal study on two separate occasions.

Again, to participate in the study he had to have

access to test protocol, test requirements, test results, all

of that is conf- --

THE COURT: Let me interrupt you for a minute.

Even if we assume he had all of that information, and

even if we know that he collaborated on the report, don't we

have to make an assumption that he shared the confidential

information with the others?

MS. HELM: No, Your Honor, because they're an

entity --

THE COURT: What's the proof he shared it?

MS. HELM: We don't have to prove that he shared it.

We have to prove they had access to it.

THE COURT: Well --

MS. HELM: Under both tests the standard is

confidential information and -- I'm sorry. Confidential

relationship and did you receive confidential information.

THE COURT: Well, did you receive. My point is what

is the proof that Vogelzang and Desai received confidential

information, other than the assumption that they learned it

during this collaborative effort?

MS. HELM: I think -- Your Honor, I think you have to

make an assumption if you treat Vogelzang and Desai as

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separate from Dr. Resnick but --

THE COURT: I want to talk about the entity issue in

a minute. I just want to focus on that first.

MS. HELM: Okay.

You are correct that we don't have evidence showing

that Dr. Resnick shared confidential information directly with

Vogelzang and Desai. What we have is that his hand was in

everything and that they -- I mean, other than one phone call,

if you look at the billing records, other than one phone call

there is nothing that Vogelzang or Desai did on the their own.

THE COURT: Right. I understand that. But there's

still an assumption that that led to the sharing of

information, if I'm looking at Vogelzang and Desai

individually.

MS. HELM: Yes, Your Honor.

THE COURT: The Ninth Circuit handed down a decision

on this issue last week. It's an unpublished decision, but it

adopts the Hewlett Packard test --

MS. HELM: Yes, Your Honor.

THE COURT: -- and says the information that

confidential information was shared has to be proven with

specific and unambiguous evidence.

And it seems to me if I focus on them as individuals,

there is no specific and unambiguous evidence that they ever

received Bard confidential information. Do you agree with

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that?

MS. HELM: Your Honor, I think I have to agree with

that.

THE COURT: On the entity issue, which I wanted to

talk to you about and where you were going a minute ago, I

read, I think, the three entity cases that you cited. They

absolutely talk about an entity being disqualified, but I

didn't see in any one of them an analysis or discussion of why

that works or whether everybody in the entity is disqualified

and, if so, how that's consistent with this requirement that

the drastic remedy requires specific and unambiguous evidence.

My question is, are you aware of a case that's

wrestled with the question of how the entity doctrine applies

in this setting, and why it is that it would be fair to say

that everybody in the entity is disqualified?

MS. HELM: Your Honor, the first part is other than

the cases we cited, I'm not aware of any other case.

The second part of your question is why does it make

sense to disqualify the entity for the acts of one doctor.

And I think in the facts of this case it doesn't make sense to

do any other. To reach any other result. And I think, again,

Dr. Vogelzang tells you that. And in his deposition, and it's

page 28 and page 40, he says over and over again this was a

collaborative effort. And you have a situation here where if

you let Dr. Vogelzang and Dr. Desai testify, the entity is

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going to benefit from that.

Dr. Resnick, who everyone admits shouldn't have been

involved and apparently is no longer involved, is a one-fourth

owner in the entity. The entity is who's billing, the entity

is who's set up to do the consulting work in this case. So

you have a situation where you're going to let two people

testify but the entity benefit.

And I think in this situation, based on

Dr. Vogelzang's testimony "we did this together," based on the

evidence that is before the Court that it's clear "we did this

together," that you can't benefit part of the entity and you

have to treat them as a whole. They acted as a whole. They

collaborated. They billed as whole. They all worked on it

together. And so the entity itself has to be disqualified.

Thank you.

THE COURT: Okay. Thanks.

Let's talk about the motions to exclude Parisian and

Kessler. 

MR. ROTMAN: There is nothing further we can add on

to the entity issue.

THE COURT: I don't think you need to. I think I

understand your position and what your arguments are on that.

I will tell you that what I don't need to hear

argument on are the number of cases that have disqualified

Dr. Parisian and why; we've read them all. Or the number of

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cases where she's been permitted; we've looked at those, too.

I don't need to hear argument about whether or not

narrative testimony is permissible or about whether experts

can venture outside of their area of expertise. None of that

is controversial.

It seems to me with respect to Parisian there are

those general arguments and there's -- it's virtually

impossible for me to do line drawing now and say what would or

would not be a permissible description of the facts in an

answer or to try to enumerate all of the places in her

testimony or Kessler's testimony where they might be stepping

outside of the bounds of their expertise. There's just too

many of them in the 547 pages of expert reports that the two

of them produced.

So what I'm going to end up doing on those issues is

some general statements. I'll say that an expert can give an

opinion and can explain the factual, the medical, the

technical basis for the opinion. Where that kind of an

explanation crosses the line between properly supporting an

opinion and venturing into a narrative about the facts or

gratuitous argument about the facts can only be determined at

trial in the middle of a question. I'm not going to let

experts wander all over the map. I'm not going to let them

give gratuitous narratives or comment on evidence or argue

evidence to the jury. But they've got to be able to support

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their opinions and explain to the jury why their opinions are

justified.

So it seems to me, given the fact that I'm going to

provide that general guidance and we're just going to have to

draw those lines at trial, with respect to Parisian there's an

argument defendants have made that she doesn't identify her

methodology. I've read her methodology description in her

report. I've read it in her deposition. I understand the

argument. That may be a point that folks want to address

further.

There is this argument with respect to both Parisian

and Kessler about what is or is not a legal conclusion. I

might as well share with you some thoughts now so you can

address them -- you can come to the lectern -- when you make

the argument.

On the legal conclusion issue, there is some

unhelpful and unilluminating case law out there, including a

very recent case from the Ninth Circuit.

I'll tell you my view of legal conclusions. If

you're going to have an FDA expert on the stand and the FDA

expert is going to be describing how the FDA works, how the

510(k) process works, whether or not Bard complied with it,

and I want to talk in a minute in response to questions about

whether that's relevant, but if an expert's going to do that,

the expert's going to be talking about legal issues. All of

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those procedures are set by regulations. You can't talk about

procedures without talking about the law, the regulations,

that creates them.

And so it's going to be impossible for us to try this

case in a way, I think, unless we get the FDA out of it

entirely, which I don't think is going to work, without having

experts on the stand who are discussing concepts and standards

and procedures that are set by law, and are in the

regulations, and probably are opining on whether Bard did or

did not comply with certain of those.

Those are not improper legal opinions, in my view.

That's an expert in a regulated area giving opinions on a

regulated area.

Obviously the expert can't instruct the jury on the

standards that apply, but those will be state law standards.

In the Booker case they'll be the Georgia law standards for

the two claims that remain: Design defect and failure to

warn.

I think it is impermissible for an expert to give an

ultimate opinion on a question of law that answers a liability

question for the jury. But the Ninth Circuit has just held

that an expert can use the very language that's in the jury

instructions in an element of a claim in describing their

opinion and why it's met. That's not inappropriate.

And I say all of that so you can help me understand

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this area, but I'll tell you, I think that's another area

where we've just got to make calls at trial. We can't say

none of it can happen, we can't say all of it can happen,

we're just going to have to make judgments as we go forward.

So with that monologue, let's hear your argument.

MR. ROGERS: Thank you, Your Honor. Jim Rogers on

behalf of C.R. Bard here to address Dr. Parisian and

Dr. Kessler. And I'm assuming Your Honor would like for us to

do that all together; there's no reason to parse out those two

individual motions?

THE COURT: I agree with you. I agree. And I do

have some real specific questions for both sides about their

opinions, about strategies in the case that will inform my

decision, but I want to make sure you first get to cover the

points you think are most important.

MR. ROGERS: Thank you, Your Honor. And it's very

helpful to have your framework of how you're viewing this

moving into the argument. And I will take you up a little bit

to talk about the methodology for Dr. Parisian since you kind

of invited me to do so.

And, Your Honor, I'm sure you've probably seen in

both the case law and in Dr. Parisian's report where there are

these narrative portions of her -- both the report and then

the testimony that she gives which are long recitations of

various bits and pieces of documents and then kind of

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concludes all of this in a very sort of Grisham-like fashion

to sort of weave a story of corporate malfeasance.

And, Your Honor, the things that sort of need to be

there as the glue to hold those opinions together just are

absent. And Your Honor has probably noticed that in her

report she will often start with these general opinions and

sort of give a brief summary of what they are, and then below

each of those there's just sort of a string cite of federal

statutes from the FTCA and also from FDA regulations, and

there's really nothing that connects those things. And that's

really the problem with the methodology, that it's really not

there --

THE COURT: Let me interrupt you and have you address

something specific.

I agree that's an accurate description. And somebody

ought to help Dr. Parisian learn how to write an expert

report. I mean, the problem she has in this report is exactly

the problem judges have stumbled over again and again where

she'll announce an opinion, she'll have a one-paragraph

description that says nothing about legal standards, she'll

have a string cite of regulations and then 50 pages of factual

discussion. It is very hard to figure out where she's coming

from.

However, if you read the 30 some odd pages at the

beginning of her opinion where she talks about the FDA process

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as well as her qualifications where she says where she worked

in that process and she says in that description that what

these different divisions that review 510(k) proposals do is

review various categories of information, if you put that in

your mind and then you start reading her opinion and her

factual discussion, it makes more sense as to how she is

coming up with her opinion. I think she's saying I'm doing

here what the FDA taught me to do in the 510(k) process and

here are all of the problems I see.

So the question is can I -- why can't I look to that

description of FDA procedures, her role in it, and then look

at her opinion, factual basis, and see if they mesh to close

the analytical gap?

MR. ROGERS: Your Honor, I would certainly agree with

you, and we're certainly familiar with your opinion in the

Placencia case versus I-Flow where Dr. Parisian nor

Dr. Kessler was at issue but Peggy Pence was, who is a similar

type regulatory expert. And Your Honor held that there was

certainly things about the FDA regulatory process that are

beyond the ken of your average juror, that it would be helpful

for them to hear about that process. And I think that that is

correct, that it would be perfectly okay for regulatory

experts to talk about how these products come to market, what

they look at, what FDA evaluates.

But the disconnect that I see with what you're

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talking about as setting up that as the framework and sort of

filtering the rest of the report through that framework is

that Dr. Parisian, the vast majority of what she addresses in

her report are not things that the FDA typically ever sees and

probably doesn't want.

I mean, she does not talk about FDA regulatory

filings. Instead, Your Honor, it is a litany of internal

documents, e-mails, PowerPoints, deposition testimony, things

of that nature, that are not ever part of an FDA regulatory

record and that are not things that FDA would ever -- would

ever cross anybody's desk at the FDA. And so it is sort of an

after the fact thematic presentation of the plaintiffs'

theories and themes in the litigation and how it all ties up.

And, really, Your Honor, what is, in effect, essentially it's

doing a attorney argument or closing argument in the middle of

trial.

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

based on that. Absolutely an expert can't give a lawyer's

closing argument at trial, and if you read just some of those

narrative portions, it looks like that's what she's doing.

I have assumed, and I want to know if this assumption

is correct, that what Bard wants to do at trial, part of what

Bard wants to do, is help the jury understand that the device

in issue went through the FDA 510 clearance process, was

cleared by the FDA, the warning that was given was cleared by

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the FDA, and that what Bard wants to assert to the jury

through that information is we did exactly what we're supposed

to do and a federal agency confirmed that we'd done what we're

supposed to do.

I'm assuming Bard wants to say that to the jury.

If that assumption is correct, it seems to me it's

entirely appropriate for the plaintiffs to then say to the

jury, no, they didn't do exactly what they're supposed to do

with the FDA, and here's why. Here's the information they

should have told the FDA that they didn't tell the FDA.

Here's what should have been a warning on these issues that

they never raised with the FDA.

If Bard is going to use the FDA as part of its

defense, isn't it appropriate for the plaintiffs to say they

didn't comply with what the FDA requires?

MR. ROGERS: Your Honor, I think they go much, much

further than that, and that kind of also dovetails into what

you said earlier about legal opinions. And it's not just

here's this piece of information that I think FDA would have

liked to have known that FDA was not provided. I mean it

moves into these legal determinations as to the violation of

regulations, the determination that products were adulterated

and misbranded and, Your Honor, I believe that moves into the

province of the fact finder and not the expert.

I mean those are legal determinations that should be

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left up to the jury to determine if there is some sort of

violation or some sort of determination that a product should

be adulterated or misbranded.

THE COURT: Will you have an expert at trial that

will say to the jury Bard complied with the FDA 510(k)

process?

MR. ROGERS: We certainly have experts that walk

through the process and describe what the regulatory filings

were, how the process worked, and what the ultimate

determination was by the FDA.

THE COURT: And will they give opinions that Bard

complied with what the FDA required?

MR. ROGERS: Your Honor, there are probably things

like that that are in their reports right now, but, you know,

that's also -- they were prepared also in response to the

reports of Dr. Parisian and Dr. Kessler. Obviously those

types of issues, our folks have to respond to.

But I don't think that it is necessarily appropriate

for anybody to really determine for the jury if there was

compliance or not compliance.

THE COURT: Well, let me try give you a hypothetical.

Let's assume that the Bard expert testifies, perhaps

without stating an express opinion on compliance, that this is

what the 510(k) process is, these various steps, this is what

Bard did at each of those steps. The result was the FDA

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cleared this product. The clear implication to the jury being

Bard complied with the FDA 510(k) process.

And let's say the plaintiffs then want to put an

expert on the stand to say at the time Bard engaged in this

step that the defense expert described, it knew a lot of

information about failure rates and harmed patients that it

did not disclose to the FDA, and under FDA requirements or

regulations it was required to disclose that information.

Is that objectionable for them to do those two

things?

MR. ROGERS: I certainly think the latter part is,

Your Honor. If you're talking about perhaps things that here

is a part of information that I as a regulatory expert believe

that the FDA would have liked to have known, I think that that

is much more on the side of acceptable methodology as far as a

legal opinion is concerned versus compliance or noncompliance

with the regulation.

THE COURT: Let's assume the expert says that but

then says Bard was required to disclose these additional

failure rates under the regulation which reads as follows,

which is part of the 510(k) process. 

Objection from the defense.

What's the basis upon which I sustain the objection?

MR. ROGERS: That the -- the evidence that the jury's

about to hear states a legal conclusion and that that violates

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the province of the fact finder as well as to whether or not

there was a violation.

THE COURT: Are you suggesting that at trial I'm

going to be instructing the jury on all of the regulations

that apply in the 510(k) process, and I'm going to be telling

the jury you have to decide whether or not Bard complied with

the 52 pages of regulations that make up the 510(k) process?

MR. ROGERS: Your Honor, I agree with you that that

would be unwieldy. But recently, and I don't know if Your

Honor followed it but there was a another trial involving a

different defendant in Indiana --

THE COURT: I didn't follow it.

MR. ROGERS: -- in the Cook IVC filter MDL. And,

Your Honor, in that case, as I understand it, Dr. Kessler

testified and he was allowed to talk about the regulatory

standards.

In other words, he was allowed to put up for the jury

here is the statute that says what "adulteration" is under the

regulatory scheme and here's the statute that says what

"misbranded" is under the regulatory scheme, but he was not

allowed to tell the jury in a conclusory opinion fashion that

this statute was violated by Cook and hence the products were

adulterated or misbranded.

THE COURT: Well, okay. Going back to my

hypothetical, would it be all right, then, for a plaintiffs

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expert to say FDA regulations requires a 510(k) applicant to

provide the following three categories of information, and

here is information in those three categories that Bard had,

describe all three categories, that was not disclosed. Is

that okay? Never states at the end it's my opinion the

regulation's violated.

MR. ROGERS: Understand, Your Honor. I think that

falls into the much more acceptable category as opposed to

saying this was a violation of a regulatory standard.

THE COURT: The quid pro quo for that would have to

be no Bard expert can say Bard did comply with the 510(k)

process. Do you agree?

MR. ROGERS: Absolutely, Your Honor. I think we're

going to have to recognize the well-known and loved

goose-gander rule, that I don't think that either party is

going to be able to do something that the other party's not

going to be allowed to do.

THE COURT: Well, obviously I'll hear from the

plaintiffs in a minute, but assuming that's where we draw the

line at trial, that experts can describe the legal standard

and describe the facts in each of those categories and let the

jury draw the conclusion as to whether the standard was or was

not violated, there certainly would seem to me to be ample

materials on that very approach in both the Kessler and

Parisian reports so that if they were to follow that approach,

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they're not lacking on information with which to do that.

MR. ROGERS: Your Honor, I would have to agree with

you in that regard.

THE COURT: So isn't this really, then, a matter of

our deciding how FDA experts should testify on each side?

MR. ROGERS: I think you're right.

THE COURT: Let me ask you one other question. And

this is going to be a question for the plaintiffs as much as

for you.

As I'm sure you know from that Placencia decision

that I issued, Arizona law, when it's addressing the standard

of care in a case, allows a jury to hear about federal law

requirements, federal regulations, to help establish the

standard of care.

I don't know what Georgia law says on that subject.

But if Georgia law, like Arizona law, says a jury can consider

federal legal standards in deciding what the standard of care

is, then do you agree that experts on each side should be able

to testify about what the federal legal standards or

requirements are under the FDA?

MR. ROGERS: Your Honor, I don't know the answer in

Georgia, either. I think you're certainly correct that -- you

know, as far as today is concerned, I think we're kind of

talking about these issues sort of globally, but when it gets

down to the case-by-case determination, obviously there's

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going to be individual differences in state law that will

determine some of these issues that we'll have to address via

motions in limine or other lawyer argument down the road.

But to address your question, if there is a specific

state law that says that federal standards can be considered,

I think that obviously the jury's going to be allowed to hear

something about the federal standards. And then it depends on

what that is that the jury actually gets to hear.

And, Your Honor, I believe in the Placencia case, I

mean, obviously you were dealing with it from an FDA

perspective, but the underlying case law that came from the

Ninth Circuit dealt with it from a OSHA perspective, is my

understanding of the reading of that case. And, again, there

may be some differences. Meaning that I think your opinion

relied on a Ninth Circuit opinion that dealt with the

admissibility of some OSHA standards.

THE COURT: I can't remember. I don't doubt you're

right. What I do remember --

MR. ROGERS: I wouldn't bet on it, Your Honor, my

memory's not that good.

THE COURT: What I do remember, though, and I think

this is important for this case going forward, is specifically

to be looking at Arizona law and asking, since it was Arizona

law governing the claim, are federal legal standards relevant

in this state that that was a negligence claim, and the

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Arizona case law said yes, they are, that goes to the standard

of care.

If Arizona law had said no, then I don't think any of

that FDA stuff could go to the standard of care. Now, it

might still go to the defense issue we were talking about a

minute ago.

And, yeah, I don't remember the Ninth Circuit law I

was looking at.

Did you have other points you wanted to make? And

I'm happy to hear your thoughts as well after I hear from

plaintiffs on this issue.

MR. ROGERS: Your Honor, the only thing I will do

that might be helpful for the Court, I think Your Honor's

clearly got the legal issues perhaps not completely sorted out

in your own mind but I think you have really read what you

needed to read and I think you have arrived at sort of a

construct of the way you think this ought to look. And, Your

Honor, what I will hand up, if it's okay, is a couple of

charts that we had prepared that really just sort of bucket by

bucket of the various legal arguments that we made by expert

that really identifies, using their reports, the specific

portions of their report that we believe fall into each of

those buckets.

THE COURT: That's fine.

Mr. Rogers, did you have other points you wanted to

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make besides those?

MR. ROGERS: Your Honor, I really don't. I think

Your Honor obviously realizes we're not plowing any new ground

here. There's a lot of cases that you can find regarding both

of these experts that go each way and it's really a question

of trying to dial it in appropriately for this case, and I

think Your Honor's done that.

THE COURT: Okay. Thank you.

MR. ROGERS: Thank you.

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

please the Court. Don Arbitblit for plaintiffs.

I think I will not use the PowerPoint I had prepared

because most of it Your Honor covered in your preliminary

remarks. I would like to respond to some of the colloquy that

just took place. I'll start with the last point, which was

Mr. Rogers' assertion that you could find cases going both

ways on both of these experts.

I'm not aware of any case that's ever said

Dr. Kessler's excluded. There have been cases in the past

that have excluded Dr. Parisian entirely, and Your Honor has

stated what the issues have been and some of the concerns that

you have.

However, in my research on Dr. Kessler, which I tried

to be as thorough as possible, I have seen occasional

opinions, such as Judge Goodwin in West Virginia and a recent

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Indiana case, that have guided what he can and can't testify

to, in particular as to the issue you raised concerning what

is and is not a legal conclusion, as to which I agree there

are cases that are not particularly helpful. But there's no

case out there I'm aware of where anyone has said Dr. Kessler

can't testify, and I think that is important for the Court to

understand. Thank you.

On the particular issue of what is or is not a legal

conclusion, I do think that the Placencia case is relevant and

not only Placencia itself but the case Your Honor relied upon,

which is the Wendland case. That's one of two that were cited

for the proposition --

THE COURT: What's the court for that one? Is that

Ninth Circuit or is that an Arizona --

MR. ARBITBLIT: That is the Arizona case involving

failure to put up OSHA standard protection around the --

THE COURT: That's the one that said federal law can

inform the standard of care?

MR. ARBITBLIT: Yes, but it went beyond that, Your

Honor. And specifically, the important part that went beyond

for our purposes today goes to another point that was

discussed a few minutes ago, and that was how far can the

expert go in testifying. And what the court allowed in the

Wendland case was specifically that the expert testified that

the defendant, quote, did not comply with OSHA standards, end

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quote. That was permitted.

And I agree with Mr. Rogers' characterization of what

happened in the Indiana Cook filter case, which is that the

judge allowed Dr. Kessler to put up the regulations, say what

they meant as far as adulteration, meaning it's not what it

purports to be, misbranding, meaning it was misleading in some

particular relevance to the doctors and patients and to the

FDA, and to describe the conduct, but he wasn't allow to make

the connection and say I believe that this product was

misbranded or this product was adulterated or this product was

not substantially equivalent, which would be the counterpart

aspect for the 510(k) process of regulations.

I think that was a mistake in ruling. I think that

if you look at other cases, such as the Phillips case, which

is a specific case involving Bard and Judge Jones in Nevada,

Judge Jones specifically said, and this is with Dr. Parisian

as the expert, "This Court" -- "The Court disagrees that

Dr. Parisian's conclusions that defendants violated this or

that regulation amount to legal conclusions on ultimate

issues. Defendants are not charged in the present case with

violations of any regulations. Their alleged violations of

regulations are merely relevant to whether they satisfied the

standard of care, and" --

THE COURT: Let me interrupt you for just a minute.

I've read Judge Jones' decision, and I know him and I have a

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high regard for him.

MR. ARBITBLIT: Yes.

THE COURT: But it seems to me this is an area where

when you're doing legal research you're just searching for

friends. You can find a case that will support almost any

position when it comes to what is or is not a legal

conclusion.

What's the guiding principle?

MR. ARBITBLIT: Fair enough, Your Honor. I've been

trying to wrestle with that question myself. I've even read a

couple law review articles on the subject. One was from

Cleveland State law review. Basically the author's position

was that Rule 704 had not gone far enough in clarifying that

the ultimate issues that are not inappropriate for testimony

should include legal conclusion so long as the expert is aware

what the Court will instruct and issues opinions that are in

conformity, in congruence with the Court's instructions. As

long as -- if the expert's qualified and the opinion is

helpful to the jury, those would be the standards this

particular reviewer -- definitely would be a friend to the

plaintiffs, Your Honor, since we're looking for friends.

But the standard I think has been applied by several

courts that I think can draw the line is that the legal

conclusions have to do with the state law that applies to the

plaintiffs' claims.

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In other words, in the Actos litigation where

Dr. Kessler testified to the violation of 201.57, had the duty

to warn, the court said that's not a legal conclusion because

the legal conclusion is whether the product was defective

under New York state tort law or whether the defendant was

negligent under New York state tort law.

I believe Judge Jones was saying pretty much the same

thing in the Nevada District Court case, and in particular

said that Dr. Parisian was permitted to testify to the FDA

regulations and whether defendants violated them.

That's also the case in the Tillman v Bard case in

the Middle District of Florida where the expert was permitted

to testify to his opinion as to whether Bard complied with all

regulatory requirements applicable to the G2 filter.

So the line that I've seen drawn that I think is

helpful, to the extent there can be some clarity, is that the

legal conclusions have to do with how the court instructs the

jury on the elements of a state law tort claim.

THE COURT: I assume you agree that if a judge

allowed those kinds of opinions that -- well, you'd agree on

two things, I think. One, it's got to be reciprocal. Both

sides can have that opinion given. So Bard can have their

experts say Bard did comply.

MR. ARBITBLIT: Yes, Your Honor.

THE COURT: But, secondly, it seems I would need to

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instruct the jury that whether or not Bard did or did not

comply with an FDA regulation, or an expert's opinion on that,

should not control your verdict in this case; you may consider

it only in deciding whether or not Bard failed to warn within

the meaning of the Georgia state law explanation. Or designed

defectively within the meaning.

I mean, there would have to be a careful limiting

instruction on that. Don't you agree?

MR. ARBITBLIT: I do agree, Your Honor, and I think

that that is consistent with the Wendland case that Your Honor

referred to in Placencia to the extent that the court there

said that the violation of the OSHA regulation as to which the

expert said you can testify that the defendant did not comply,

that was only evidence toward the legal standard and that the

defendant was permitted to put on its own case as to why that

was not a sufficient basis or the only evidence that the jury

could consider.

So, yes, I do think that that is an appropriate

limiting instruction as Your Honor has stated.

THE COURT: Well, let me ask this question to both

sides: It seems on this issue, and this is painting with a

broad brush, but we could either say experts can do what was

allowed in the Cook case, they can lay out the standard, they

can lay out the parallel facts, and let the jury line them up,

or they can add to that, "and I think it did comply" or "I

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think it didn't comply," but then I instruct the jury very

carefully what to do with that opinion.

As between those alternatives, is that something on

which the parties could reach agreement as to which of those

approaches makes the most sense?

MR. ARBITBLIT: I would be very doubtful about it,

Your Honor. My guess is the plaintiffs would argue strongly

for having the experts be able to say that there was a

violation of applicable regulations. And I think it goes --

THE COURT: You say they would argue to it?

MR. ARBITBLIT: The plaintiffs' experts would argue

for the position they be permitted. The plaintiffs' lawyers

would argue for the position --

THE COURT: I know what you're arguing for. I

understand.

MR. ARBITBLIT: The experts should be permitted to

say the regulations were violated because -- 

THE COURT: With a limiting instruction.

MR. ARBITBLIT: With a limiting instruction, but

specifically because of the laws saying -- the precedent

saying that compliance is part of that overall presentation

and because of the complexity of the entire area, which, as

Your Honor pointed out in the Placencia case, and many other

as well have, this is a very complicated area.

So to ask the jury to take the facts -- they've got

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an 800 paragraph, 800-pound gorilla, of a declaration they

submitted to Your Honor for the preemption motion. We've got

the 540 pages of expert reports. It's not a simple matter to

just line up the facts with those regulations.

THE COURT: Time limits are going to help on both of

those.

MR. ARBITBLIT: It's on us to make the presentation

reasonable. And I did want to mention that I actually looked

at the time at one of Dr. Kessler's direct examinations and it

was two hours including voir dire.

THE COURT: Let me interrupt you for a minute because

Mr. Rogers has been standing to say something.

MR. ROGERS: Your Honor, I stood up because you said

you were asking both sides. And as I understand your

question, you were asking whether or not the parties could at

least potentially agree on a system by which both sides would

have an expert who would testify that here's what the standard

is, it was either violated or it was not, and that there be a

limiting instruction as to what that means.

THE COURT: Right.

MR. ROGERS: Your Honor, I think that's something we

can talk about. I wouldn't just out of hand say it's not

possible that we would ever agree. But I also think, Your

Honor, as we move closer and closer towards trial and there

are going to be probably additional rulings about the

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regulatory world as it is going to be presented to the jury, I

think inevitably the parties are going to have to have

discussion about, you know, what the world is going to look

like as various issues start to sort out.

THE COURT: I agree with that. It will have to

happen.

And I am not going to try to decide on the basis of

today's argument which of these two approaches makes sense. I

need to know more about the case if I'm going to be making

that decision. I'll obviously make it before trial. But I

would encourage you to think about that because, well --

MR. ARBITBLIT: If I could make one more point, Your

Honor. And it has to do with the argument made by defense

counsel having to do with information that would not -- that

the FDA would never normally see, and because it's not

required under the regulations.

There's -- there are a few specific areas where that

should be looked at in a different light, and that has to do

with something that happened in the Actos litigation that's in

the ruling that we provided to the Court, and that has to do

with an analogy -- an analogous internal assessment of adverse

events. Analogous to what Bard had done here.

And having done that analysis Takeda, the defendant

in that case, found some things it didn't like, in particular

that there was a higher reporting rate of bladder cancer,

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which was the alleged injury associated with that drug.

When they submitted to the FDA six months later a

summary of information about bladder cancer, they had done a

revised analysis that left out some of the important facts.

And so the FDA never knew that Takeda had analyzed the

information in a different way and found a statistically

significant increased reporting rate for bladder cancer. So

that -- and their defense was, we didn't have to do it so

there's no reason why there should be a problem and

Dr. Kessler should not be allowed to testify to it.

The court disagreed and said that regardless of

whether they had to do it, they did it, and having done it,

they should have provided it. And Dr. Kessler was permitted

to testify to that effect.

And same thing holds true with a number of things in

this case: The statistical analysis of May 2004 showing

statistically significantly higher reporting rates of deaths

with the Recovery filter; the bench testing at the same time

that showed weaker migration resistence; and the internal

worrying about the fact you had those two contemporaneous

signals of a problem at the same time, the weaker migration on

bench testing supporting and mutually reinforcing the higher

reports of death, the bench testing in the G2 case showing

failure on the caudal migration in 2006.

Those are not required and they weren't required to

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produce them. But having done them, it's hard to think that

the FDA wouldn't have wanted to know or doctors and patients

wouldn't have wanted to have known about those results.

THE COURT: Okay.

MR. ARBITBLIT: Thank you.

THE COURT: Let me ask you a couple of other

questions.

MR. ARBITBLIT: Yes, Your Honor.

THE COURT: I have long had a rule in trials that I

don't allow more than one expert on a subject. There is a lot

of overlap between the Kessler and Parisian reports and

between some of the other reports I've seen so far.

I guess the question is, was that done out of

abundance of caution? Or does either side think you should be

allowed in a trial to have two experts get on the stand and

express the same opinion?

MR. ARBITBLIT: Certainly with the regulatory experts

I cannot imagine a situation in which both Dr. Kessler and

Dr. Parisian would be asked to testify. I think the situation

with MDL's is multiple experts are useful for multiple trials

and you can't count on one to be present on all occasions.

I wouldn't want to speak too much on the other

experts that are not my bailiwick because they may have other

areas of expertise to address the same subject. For example,

a radiologist or some other expertise might be talking about

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the same thing from a slightly different perspective. And

others my address that more properly than I.

THE COURT: Do defendants have a disagreement -- any

disagreement on --

MR. ROGERS: No, Your Honor. We agree. I don't

think we envision a scenario where you'll have two regulatory

experts testifying at one trial.

THE COURT: Let me -- let me ask a couple specific

questions about Kessler that I was thinking about in trying to

start formulating my views on where lines should be drawn in

all of this. I'll pick examples. There are a number of

these.

But, for example, there are several different places

in his report where Dr. Kessler states the opinion that the

Recovery filter and the G2 filter should not or could not have

been legally marketed. Why is that relevant in a case of

failure to worn and design defect?

MR. ARBITBLIT: Well, it's relevant to at least

punitive damages because the conduct in keeping it on the

market for profit would be relevant at least to that extent.

Obviously, if it weren't on the market there wouldn't be any

reason to warn because no one could use it. I don't know if

that's the point Your Honor was trying to make with that

question.

THE COURT: Well, setting aside punitive damages, and

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it's apparent to me there's much in here that may be argued to

go to punitive damages, whether or not a filter could or

should have been on the market, how does that help the jury

decide whether there was a failure to warn to cause the injury

or whether there was a design defect that caused the injury?

MR. ARBITBLIT: Well, I think it goes back to the

argument about relevance of the regulation and its violation

to the standard of care.

In the case of legally marketed, the reason it can't

be legally marketed is because it's adulterated and that is

the consequence of adulteration. Adulteration itself means

the item is not what it's purported to be or represented to

be. So that the violation of that regulation is part and

parcel of the relevance to the standard of care that --

THE COURT: How? The standard of care, I assume,

will be on the failure to warn claim, Georgia law, which says,

if I remember it correctly from a Booker motion, I think it

says that if there's a significant increase in the risk, then

the manufacturer has a duty to make an adequate disclosure.

Something like that.

How does the fact that the product could or could not

have been on the market say anything about that standard of

care?

MR. ARBITBLIT: Well, I do think that the violation

of the regulation in itself is relevant to the standard of

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care. I can see I haven't convinced you of that position.

But I would also add to that that in the case of the G2, the

fact -- and I imagine Your Honor's familiar with this position

either from these motions or previous motions, that the

plaintiffs' position is that if the Recovery could no longer

be legally marketed, then the G2 had no predicate to which it

could be called substantially equivalent and shouldn't have

been on the market either. So there's a larger issue in the

case, especially since, as I understand it, G2 is in the

bellwether cases as well as the plaintiff population as a

whole.

THE COURT: All right. This will be a discussion

that will continue. I'm not going to come to any final

conclusion, I'm just trying to understand positions.

I mean, it seems to me an opinion that it couldn't be

legally marketed, whether expressed in that term, may be

relevant to a defense that Bard is making that this was all

FDA cleared. But I'm having trouble seeing how a number of

these things go to at least the claims in the Booker case.

Let me give you a second example. I'm reading --

actually, I'm reading from your summary of his opinions, but

they're consistent with what I saw in his opinions. And I

don't know that you need to look at it, but what it says at

the bottom of page 4 of your brief is Dr. Kessler will give

the opinion that Bard had an obligation to share the testing

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information with patients and physicians. And throughout his

report, Dr. Kessler says similar things, Bard had an

obligation.

When I hear that my question is, an obligation under

what law? Is he saying he had an obligation because

reasonable interventional radiologists would want to know it?

And, if so, is he qualified to give that opinion? Is he

saying Bard had a duty to disclose under Georgia law? And

isn't that a legal opinion? Is he somehow saying Bard had an

obligation under the FDA regulations to tell the physician and

patient something?

Can you help me with that?

MR. ARBITBLIT: Okay. There are a number of

responses. I'll try not to forget any in my answer.

On the issue of federal regulations, it goes to

substantial equivalence and lack thereof. If there are

problems with the Recovery vis-a-vis SNF or if there's

problems with the G2 vis-a-vis Recovery in the sense G2 had a

much higher rate of caudal migration than Recovery did, it

raises new questions of safety and efficacy, which means that

it violates the substantial equivalence requirement for

clearance of that product.

From the sense of an obligation, as opposed to a

duty, he's not going to testify as to a legal duty, but his

expertise is not limited to FDA regulatory matters. He serves

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on the board of private device and drug companies and advises

them on compliance issues and has been permitted to testify on

the standard of care generally. Not simply as a matter of

regulatory law, but also as a matter of whether there was a

failure to warn under a state law standard.

So the -- these go to whether doctors and patients

would have wanted to know that there was a higher rate of

failure with the Recovery than SNF, whether there was a higher

rate of failure with the G2 than SNF or Recovery as far as

caudal migration.

THE COURT: So when he says Bard had an obligation to

disclose this to doctors, what's the source of the obligation

he's talking about?

MR. ARBITBLIT: I think the source is the standard of

care for a reasonably prudent manufacturer would be to

disclose to doctors and patients information that would be

relevant to their prescribing decisions.

THE COURT: So your view is that he is qualified to

step out of the FDA box and give opinions about what medical

product manufacturers should and should not do as a matter of

standard of care?

MR. ARBITBLIT: Yes, Your Honor. He has done that in

the past and I believe that as a -- he is a physician. He has

testified in his deposition to what he's read about the

subject. He is not a radiologist, but there are -- there's an

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interesting quote, I think it actually has to do with a

defense expert in the Marina case that the defense cited. If

I may just take a look for that. On the very question of

qualifications -- let's see if I can find it. In the Marina

case, the plaintiffs challenge the qualifications of the

defense expert, Dr. Feigal, who is a defense expert in this

litigation, and the court said at 169 F.Supp. 3d 396 at 463,

Dr. Feigal is opining on the adequacy of the Marina label from

a regulatory perspective, a field in which he is qualified,

which means he does not need to have equally specialized

knowledge in a particular medical field.

I think that even though that was particularly about

the regulations, the take-home message from that is that if

your expertise is in the federal regulations and standard of

care and what doctors would want to know and you look at bunch

of information that says this product's not as good as what

you could have used, which is the issue in the Booker case,

that the doctor would have wanted to know, is there a safer

filter, and that's -- that's the kind -- that is what

Dr. Kessler's testimony would go to, in addition to

regulatory. It would be what does the doctor want to know

when the company knows that it has information that the

product's not as good.

THE COURT: Okay. We probably could do this all

afternoon, but let me ask one more.

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MR. ARBITBLIT: I'm not sure I could, but I

appreciate the opportunity.

THE COURT: It's got two parts to it. He testifies

in a number of places in his report something Bard did was

misleading, he uses that word. Misrepresentation/fraud claim

is out of this case for Booker.

And he also testifies in a number of places that Bard

engaged in off-label marketing.

If Ms. Booker's use was not off label, why is that

relevant? Why is any testimony about what is or is not

misleading relevant?

MR. ARBITBLIT: So, again, more than one answer.

I'll try not to take all afternoon. On the question of

whether it's about the Booker case or globally, I use the

Booker case as an example, but as defense counsel said, we're

sort of here on global issues. If there's no off-label

marketing happening in a particular plaintiff's case, whether

Booker or someone else, I don't think that he would testify to

off-label marketing, but I see Ramon thinking he might

disagree.

Again, Your Honor, I don't want to make that

representation if lead counsel's going to stand up and say we

think it's relevant because it goes to bad behavior. It

might. It might well go to bad behavior.

THE COURT: Meaning punitive damages?

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MR. ARBITBLIT: Yes.

THE COURT: Bad behavior is not a basis for proving a

claim. It may be relevant on punitive damages.

MR. ARBITBLIT: Fair enough.

Now, there was another aspect to your question?

THE COURT: Misleading.

MR. ARBITBLIT: Misleading is misbranding, which is a

violation of regulation.

THE COURT: Why is that relevant?

MR. ARBITBLIT: Again, it's relevant globally.

THE COURT: Why is it relevant in Booker where there

is no misrepresentation claim remaining?

MR. LOPEZ: Your Honor --

THE COURT: Go ahead, Mr. Lopez.

MR. LOPEZ: There's still exists a negligence claim.

I know we've been focusing on failure to warn and design

defect --

THE COURT: Those are the only two claims left in

Booker; right?

MR. LOPEZ: They didn't challenge our negligence

cause of auction, just negligence per se.

THE COURT: Negligent what? Negligent design defect,

negligent failure to warn. I think those are the only --

MR. LOPEZ: I think we have a general negligence

cause of action.

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THE COURT: My order doesn't -- it identifies what's

left in the case at the end, and it doesn't mention any sort

of general negligence.

MR. LOPEZ: But they didn't challenge general

negligence in the their motion for summary judgment. I

don't -- I'm going to have to check the record, but I'm fairly

certain their master complaint --

THE COURT: Let's assume --

MR. LOPEZ: -- includes general negligence --

THE COURT: Let's assume there is a negligence claim.

Negligent what?

MR. LOPEZ: Negligent conduct. That could embrace a

whole host of things with respect to what a reasonable

manufacturer would do under the same or similar circumstance.

THE COURT: Well, if you're going to have Dr. Kessler

as part of a negligence claim, if it exists in the case, opine

that what Bard did in a particular instance was misleading,

aren't you going to have to prove that misleading statement

caused Mrs. Booker's doctor to implant the device? And isn't

that exactly why I knocked out the misleading claim in Booker,

because you couldn't prove that he relied on anything for

purposes of a misrepresentation or misleading claim?

MR. LOPEZ: Well, I think you knocked out the

misrepresentation cause of action. There's misleading -- it

could be negligent. If something is misleading, then it's --

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it's conduct that we believe, under the negligence cause of

action, is what a reasonably prudent manufacturer would not

do.

For example, if they're going to write a label --

there is a federal regulation that says you're not supposed to

be misleading when you --

THE COURT: Let's assume --

MR. LOPEZ: -- in Dr. Kessler's report.

THE COURT: I'm not making my question clear.

Even if we assume for a minute I allowed him to say

it was misleading, wouldn't you have to prove for the

causation part of negligence that that misleading statement

caused Mrs. Booker's doctor to put the filter in her?

MR. LOPEZ: Well, we have to relate it to causation.

I think we can. I'm not sure I'm prepared to try that part or

argue that part of the case right now --

THE COURT: Again, we don't need to debate this

further --

MR. LOPEZ: It goes to the label. It really does

relate to what's in the label, whether or not the label was

misleading, whether or not the information the doctor had in

the label was misleading with respect to the true risks and

the effectiveness of the device. That's a negligence cause of

action.

THE COURT: Okay. I don't -- I don't want to spend

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more time on this. I know we could talk about it at length.

I don't know whether there's a negligence claim left. I

didn't think there was --

MR. LOPEZ: I know they didn't challenge it.

THE COURT: I guess you can tell from this line of

questioning that when we get to trial relevancy is something I

believe in. And either side, if you're going to be putting in

evidence, I'm going to want to know how it is relevant to a

claim you are proving in the case or defense you are

asserting, rather than something atmospheric that I'm seeing

in these expert reports.

MR. LOPEZ: We understand that completely, Your

Honor.

MR. ARBITBLIT: Thank you, Your Honor.

THE COURT: Did I cut you off?

MR. ARBITBLIT: I was going to ask, at the risk of

extending my appearance, whether omission has been also ruled

out by Your Honor's ruling.

THE COURT: Failure to warn is an omission, in my

view. You omitted saying something. In that respect --

MR. ARBITBLIT: That goes back to what Dr. Kessler's

report is about on certain things being misleading because

they omitted to state important facts in addition to what was

stated.

THE COURT: I understand that point.

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MR. ARBITBLIT: Thank you, Your Honor.

THE COURT: All right. We've been talking a lot

about all these issues. I don't know if the defendants want

to say anything on these things.

MR. ROGERS: Your Honor, I get the strong sense you

probably heard all you want to hear on those issues.

THE COURT: This has been more for my education in

the last 20 minutes.

MR. ROGERS: Right.

MR. COMBS: Your Honor, I wanted to address

Dr. Parisian you talked about with Mr. Rogers.

THE COURT: What are you going to say? You're not

going to stand up and say we should allow liberal narrative

testimony from Dr. Parisian, are you?

MR. COMBS: If you want to hear what I have to say

I'm happy to say it.

THE COURT: I thought I understood the point, but go

ahead.

MR. COMBS: Couple quick points, Your Honor. Number

one, I think the Court's characterization of her report is a

little unfair. I know there is a format to it of citing --

giving an opinion, listing some regulations and getting into

the narrative, but I went through it and flagged, green

flagged, all the other times in the body of the report where

she cites a regulation. "Bard was required to," and then

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cites a regulation. So I think her methodology in her report

is fine. To say this isn't enough gets into the defense

writing our reports for us. I think that's going a little too

far.

But in the big picture, Your Honor -- I'm sorry.

Lincoln Combs for the plaintiffs, if I didn't say that at the

beginning. I know we're short of time and trying to do this a

little informally.

Dr. Parisian's opinions and her testimony is not a

secret in this case. In this litigation. You know she was

admitted in Phillips, she testified, and it was fine. We're

happy to submit the transcript if you want to review it. I

think I counted 22 or 25 objections in about 140 pages of

testimony. Some of them were sustained, some of them were

overruled.

So she comes in and testifies and they're free to

make objections. And I know Your Honor generally has a

preference going by your past Daubert rulings and motion in

limine rulings for reviewing it as it comes in in trial. And

that was the case in Placencia with Dr. Pence, who's a very

similar expert to Dr. Parisian.

So I think a lot of this is premature in the big

picture. Bard is well positioned. Mr. North cross-examined

her and objected at trial and it came in and it was fine.

There wasn't just an overwhelming abundance of objections. It

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was normal testimony. And certainly we can now, with the

benefit of that transcript in Judge Jones' rulings on her

testimony as it came in, as well as guidance from the Court,

I'm sure we can have her testimony come in properly without

being narrative or anything like that regardless what's in her

report, which is not a legal brief or evidence.

THE COURT: All right. Thank you.

Let's talk for a minute, and then do a break for the

benefit of the court reporter, just about some of those issues

I put at the end before we talk about the final motion.

I'd like to talk to you about what we're doing from

here on out in terms of expert motions. And here are my

thoughts on that: In January we have a hearing.

January 19th. My intention would be to hear the motions on

Muehrcke, M-U-E-H-R-C-K-E, Hurst, H-U-R-S-T, Eisenberg,

Betensky, and McMeeking. M-c-M-E-E-K-I-N-G. Those five

motions.

You've already indicated you don't think we need oral

argument on Morris, Grassi, the Garcia and Streiff opinion,

and on the criminal law standard. And so that would leave

only one other motion, which would be the Ritchie motion.

I don't know if we can be ready to hear six motions

by January 19th or not. It depends what happens with a trial

I've got the two weeks before that.

And then we would just rule on the motions submitted

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without oral argument as we can get to them. I suspect we'll

get better at it and move more quickly as we get through the

Daubert motions.

Is there any concern about that schedule, taking up

those motions January 19? We'll just have to find a place to

do Ritchie when we can. Any thoughts on all of that?

MR. NORTH: No, Your Honor. That sounds fine. And

we will go back and take a look at Ritchie one more time and

see if that perhaps could be submitted without argument.

THE COURT: Ritchie or one of the other five I just

mentioned for January 19.

MR. NORTH: Okay.

THE COURT: Any thoughts from plaintiffs on that?

MR. LOPEZ: Plaintiff will be prepared with whatever

the Court ends up having on that day.

THE COURT: Okay.

In terms of timing, when we set these trials, the

ones in March and May, I set three weeks, that was your

thought about what it would take. I have a small conflict the

first week in March. We're set to begin on March 13th and I

have to be in Washington, D.C. on March 13th at the meeting of

the Judicial Conference of the United States, which is the

governing body for the federal courts. I'll get back that

night. So we could start on the 14th and miss a day, which

would be my intention. If we could miss two days, there's

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other meetings on the 14th that I don't have to be at but it

would be helpful. Which means we'd start on the 15th.

I guess my question to you is if we do three weeks of

trial four days week, that's 12 days of trial total. As I

mentioned before, I do five and a half hours of trial time a

day.

Can we lose a day or two at the beginning or is that

going to create problems? I'll tell you at the end I have no

availability. The week after we end trial I'm out of town all

week in rules committee meetings.

MR. LOPEZ: I missed that, Your Honor, that last

thing that you just said.

THE COURT: I have no flexibility to push it into

April. The first week of April I've got meetings out of town

all week. So we've got to do it in March. Which means if we

start on the 14th or 15th we're compressing the time.

MR. LOPEZ: I don't want -- I don't have a calendar.

Is there a day beyond that last day you have that's still

March? I don't know.

THE COURT: No. Trial would end on Friday,

March 30th, and I'm out of town on Monday, April 2nd. So

there's -- we've got to get the case concluded by Friday,

March 30th.

MR. LOPEZ: Mr. O'Connor's going "we can do it, we

can do it." I think we can live with that, Your Honor. I'd

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rather keep that and discipline ourselves to squeeze it in to

one less day.

MR. NORTH: Certainly, Your Honor, I think as long as

the time, of course, is split evenly, which I know it will be,

we'll be fine.

MR. LOPEZ: We may get a couple more hours; we get

rebuttal.

THE COURT: Okay. So we'll start the trial on

March 14th. I'll come back on the evening of the 13th,

American Airlines willing.

On the hours point, as I think I might have mentioned

to you before, I allocate hours and I keep track of them. I

tell you at noon each day and end of the day how much time

you've used so you can budget your time.

Typically when I divide time between plaintiffs and

defendants, because plaintiffs have the burden of proof I give

plaintiffs a couple more hours than I give defendants. So

that would be my intent, to take these remaining days and

allocate it in that way. Are there any concerns about that?

MR. LOPEZ: No, Your Honor.

MR. NORTH: None, Your Honor.

THE COURT: You mentioned in your joint report a jury

questionnaire.

MR. O'CONNOR: We filed those this morning. I have

copies for you, Your Honor. We have a joint set we agreed to

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and then we filed a separate set where we couldn't reach

agreement on part of the plaintiffs.

THE COURT: That's been filed?

MR. O'CONNOR: Yes. I have copies for you, if you

like.

THE COURT: Okay. You can leave them with Traci.

I'll look at those next week. We have to decide if we're

going to do it. If we're going to do it we've got to get it

out mid-January, I think, Traci? So it's not something I can

sit on very long.

THE COURTROOM DEPUTY: Yes.

THE COURT: I will look at it. If I think we need to

talk over whether or not we ought to do it I'll get you on the

phone so we can get it decided in time to get it out if we're

going to use it.

MR. NORTH: Your Honor, we sort of resolved most of

this last night as far as how we were going to submit it and

we haven't had the time to prepare formal objections to the

questions we couldn't agree upon. If the Court needs us to we

can. If not, we're fine.

THE COURT: You don't need to.

MR. NORTH: Thank you.

THE COURT: In a three-week trial I would sit an

eight or nine person jury so we can lose two or three and

still have enough for verdict at the end. If the flu season

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continues to progress as it has, I'll probably seat nine. Is

there any concern about that? And the reason I ask that is

that will influence my thought on jury questionnaires and how

long it will take us to pick a jury.

MR. LOPEZ: We're okay with that, Your Honor.

MR. NORTH: Certainly, Your Honor.

THE COURTROOM DEPUTY: There's nothing on the docket

about jury questionnaires.

THE COURT: There's been no jury questionnaire put on

the docket yet, so you might want to make sure it got filed.

MR. LOPEZ: Not to take back what I said earlier

about the time, but might there be times in that three weeks

if we needed -- maybe I should ask this outside of the

presence of your staff, but where if we needed an extra hour

we can start early, end maybe an hour early.

THE COURT: Yeah, I'll try to be flexible. The

limiting factor, in addition to our physical energy, is all

the other cases that we've got. And when I'm in trial I tend

to schedule hearings starting at 4:00 and 4:30 at the end of

the trial day because I've got to do hearings during those

weeks. But, yeah, I'll try to be flexible. If we need to

start a little earlier some days, like 8:30, we can work with

that.

THE COURTROOM DEPUTY: We found the questionnaires.

THE COURT: Okay. We found the questionnaires.

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They're on the docket.

All right. Let's take a break for the benefit of

Tricia and then come back and talk about the motion to exclude

Kinney, Roberts, and Kalva, and the motion to certify the

preemption ruling, and any other matters you want to take up.

We'll come back at quarter after 3:00.

(Recess taken from 3:02 to 3:15.)

THE COURT: Defense counsel -- plaintiffs' counsel, I

forgot to ask this during the earlier discussions, but it's a

matter I'm curious about. In the joint report for today's

hearing, you indicate that you want to file a motion under the

Cisson case, C-I-S-S-O-N, which I infer would be a motion

saying I should preclude Bard from talking about the FDA?

MS. REED ZAIC: Yes, Your Honor. Well, two aspects

of it, Your Honor. The 510(k) clearance process and any

evidence suggesting any lack of follow up or enforcement by

the FDA.

THE COURT: And if I were to grant that motion would

Dr. Kessler and Dr. Parisian become irrelevant?

MS. REED ZAIC: Unfortunately, because of flights, my

two colleagues that could probably better answer that are no

longer here, so I'm not prepared to say they're not completely

relevant, but obviously relevance with regard to FDA would be

limited.

THE COURT: If I granted that motion, I'm assuming

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the plaintiffs would be agreeable that you don't mention the

FDA warning letter.

MS. REED ZAIC: I believe, Your Honor, I believe so.

With regard to follow up and enforcement it would seem to come

under that, but I would have to give that some more thought.

THE COURT: I assume you don't put Kay Fuller on the

stand to talk about her concerns with FDA compliance?

MS. REED ZAIC: Again, I'm not prepared to give an

absolute on that, but any premarket activity would seem less

relevant, Your Honor, absolutely.

THE COURT: And why is it you think we should be

filing or hearing that motion now?

MS. REED ZAIC: I believe that it would be more

efficient for the parties to have that ruling now, Your Honor,

because with regard to preparing deposition cuts and things

like that, pretrial preparations, we would have a better sense

of the scope of the evidence and order of proof.

THE COURT: Okay.

MS. REED ZAIC: Gives us more time, Your Honor. And,

again, I believe in the joint statement we included the

plaintiffs would be ready to file that relatively immediately,

and the only request, which I believe was a joint request, is

some additional pages, which I believe the plaintiffs could

make that motion, and I know Your Honor prefers three pages, I

think we can probably do it in eight.

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THE COURT: Okay. Mr. North, you were going to say

something on this?

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

THE COURT: Do you agree getting that issue decided

sooner rather than later would be a good idea?

MR. NORTH: It might make our jobs a little bit

easier when it comes to deposition cuts and things of that

nature, but I worry about trying to expedite a motion with

everything else on the Court's plate. I think that's your

choice because it is a meaty motion and there are obviously

about ten more Daubert motions to be decided at this point.

THE COURT: Okay. Let's talk about the motion to

exclude Kinney, Roberts, and Kalva.

MR. NORTH: Your Honor, my colleague, Matt Brown, is

going to address this motion.

MR. BROWN: Thank you, Your Honor.

Given what you've said previously about some issues

that you've already thought about, I was going to limit the

motion to just a couple of issues that I think may be helpful

for the Court.

THE COURT: Okay.

MR. BROWN: The first being Dr. Kinney, Roberts, and

Kalva's reliance on the reports of Drs. Kessler, Betensky, and

McMeeking, which we think should be excluded under two

independent grounds, the first under Rule 703 and the second

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under Rule 702. 

Taking Rule 703 first and reliance on these

litigation consultants' opinions, Dr. Kessler, Betensky, and

McMeeking, whose opinions were formed solely for purposes of

this litigation, under Rule 703 it's the plaintiffs' burden to

be able to prove that experts other than Drs. Kinney, Roberts,

and Kalva would rely and act upon those litigation

consultants' opinions for matters other than litigation.

THE COURT: Let me -- let me ask you a question on

that.

If I look at the language of Rule 703, the first

sentence says, "An expert may base an opinion on facts or data

in the case that the expert has been made aware of or

personally observed," period.

That would seem to include a report from Dr. Kessler

discussing facts in the case.

The part you're relying upon says if experts in a

particular field would reasonably rely on those kinds of facts

or data in forming an opinion on the subject, they need not be

admissible for the opinion to be admitted.

It seems to me the requirement that facts be the kind

that an expert relies upon in a particular field only applies

if they're inadmissible. Do you agree with that?

MR. BROWN: I don't agree with that, Your Honor. And

looking at Judge Weinstein's treatise on this rule --

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THE COURT: I've read his treatise. He doesn't

address this issue.

MR. BROWN: We do identify it in our -- I believe

it's the reply brief. But it's Judge Weinstein's treatise, he

writes, quote, Rule 703 is concerned with the trustworthiness

of the resulting opinions. The proponent of the expert must

establish that experts other than the proposed witness would

act upon the information relied upon and would do so for

purposes other than testifying in a lawsuit. And that's

really the heart of the issue.

And in addition, Your Honor, the Central District of

California addressed this issue in In Re Imperial Credit

Industries Securities Litigation in 2003, and in that case

there was the accountant who was needing to provide a residual

evaluation opinion for a securities case and he relied upon an

expert's report filed in another case related to a residual

evaluation --

THE COURT: I read that case. That seems to me to be

a different problem because what he -- the accountant was

taking the valuation that another expert gave and using it as

the valuation in this case and the court said you can't do

that, you didn't form that valuation opinion.

MR. BROWN: Yes. That goes to the other issue, which

is under Rule 702. But specifically Central District of

California excluded that opinion under Rule 703 because it was

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an expert -- an expert opinion formed for litigation and that

is something that's not appropriate to rely upon under

Rule 703.

And that's the same issue here, which is that

Drs. Kessler, Betensky, and McMeeking formed their opinions

specifically for litigation and interventional radiologists

would not be relying on that type of information generally in

their private practices and there's been no evidence in the

record to suggest otherwise.

The plaintiffs cite several portions of Dr. Kinney's

deposition in their response. That doesn't bear on the issue.

And then they make an unsupported assertion of counsel that

interventional radiologists would have welcomed this

additional information, which we don't think is sufficient

under Rule 703.

THE COURT: Well, doesn't this happen all the time in

cases? For example, I had a case where a tire defect expert

opined that the tire was improperly designed, was defective

and dangerous, and then I had a separate industry standard

expert who said assuming it's defective, I will assume it's

defective as the first expert said and, if so, there should

have been disclosures. Are you saying that second expert

couldn't rely upon the first expert to establish the defect

for purposes of his opinion?

MR. BROWN: I think that that's an issue the parties

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could raise, certainly, whether an opinion that's formed

specifically for litigation is something that can be relied

upon.

Now, if that second expert is relying on the first

expert's opinion-considered material other than that initial

expert's opinion in forming his opinion, then that may be

something that the expert could do under Rule 702, which is

what we get to next with Drs. Kinney, Roberts, and Kalva.

Under Rule 702 we think that Drs. Kessler, Betensky,

and McMeeking should not be able to have their reports relied

upon by Dr. Kinney, Roberts, and Kalva because under multiple

decisions within the Ninth Circuit and Central District of

California the discussions about an expert relying upon

opinions of others if other evidence supports the opinion and

the record demonstrates that the expert undertook an

independent evaluation of that evidence. And the record here

suggests strongly that there was no independent evaluation of

the evidence that Drs. Kinney, Roberts, and Kalva performed.

THE COURT: Let me interrupt you one more time. What

I have understood those cases to mean is that the second

expert cannot testify to the opinion of the first expert as

though it's the second expert's opinion unless the second

expert did the work necessary to form the opinion. For a

whole host of reasons.

Is that what you think Kinney, Kalva, and Roberts are

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doing here?

MR. BROWN: That's exactly what we think they're

doing and the record, I think, supports our thoughts on that

process. Dr. Kinney testified repeatedly at his deposition

the primary source that he used to write the first 110 pages

or so of the Rule 26 report was Dr. Kal- -- Dr. Kessler's

report, rather, and that --

THE COURT: Was he saying "I looked to Dr. Kessler's

report to develop the factual basis upon which I now state my

interventional radiologist opinion?" Or was he saying

"Dr. Kinney opined to Proposition A and I'm opining to

Proposition A"?

MR. BROWN: It's a mixture of both, Your Honor.

There are large portions of the reports of Drs. Kinney,

Roberts, and Kalva that are copied and pasted from the report

of Dr. Kessler.

For example, beginning portions of the Rule 26

report, Dr. Kinney writes that Dr. Kessler said so-and-so and

provides a long block quotation and says we fully endorse that

opinion. Similarly -- and they go on and make similar long

block quotes of Dr. Kessler, Betensky, and McMeekings reports.

THE COURT: If we were in trial and Dr. Kinney was

attempting to do that on the stand and said "Let me describe

to you jurors now the ten paragraphs Dr. Kinney wrote on this

subject" and started reciting, I'd sustain that objection in a

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hot second because he can't be the mouthpiece for Dr. Kessler.

I can understand why they might do it in a report, so

that they're disclosing to you what he took into account in

forming his separate opinions. Clearly he couldn't do it at

trial.

If that's a correct statement of the law, then is

there a basis for excluding what Kinney could testify from his

own expertise?

MR. BROWN: I think so, Your Honor, because the issue

is does Dr. Kinney have the baseline level of information that

he evaluated in forming his opinions as expressed in the

Rule 26 report that he arrived at independently after his

independent evaluation, and the answer to that is no. All he

did was review the reports of Dr. Kessler, largely, followed

by Dr. Betensky and Dr. McMeeking.

The Facts and Data Considered list of their Rule 26

reports list only 42 internal Bard documents and all but two

of those documents are also identified in other experts

reports, principally Dr. Kessler's report. Dr. Kinney also

testified in his deposition that he didn't even read all 42 of

those internal Bard documents because he relied so heavily on

Dr. Kessler's report and that material was provided to him as,

quote/unquote, backup material. We think that is what the key

issue is. Drs. Kinney, Roberts, and Kalva also identify a

number of depositions they reviewed but, again, Dr. Kinney

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said that material was backup material and there's not been

any type of showing by the plaintiffs in the response brief as

to how that deposition material independently supports the

opinions that Drs. Kinney, Roberts, and Kalva arrive at as

identified in their Rule 26 report.

Turning now to the second issue which I think may be

helpful for the Court is this issue of informed consent and

what a reasonable physician would want, how a reasonable

physician would think, and how a reasonable physician would

act and we think those opinions should be excluded under

Rule 702 because they're not based on any objective standards

but, rather, their just the ipse dixit of Drs. Kinney,

Roberts, and Kalva. 

This presents a classic joiner issue for the Court

and something that the Ninth Circuit has addressed in the

post-Daubert remand where they wrote, quote, We've been

presented only with the experts' qualifications, their

conclusions, and their assurances of reliability. And under

Daubert, that's not enough. But this is exactly what Drs.

Kinney, Roberts, and Kalva are purporting to offer the Court

and the jury with regard to what a reasonable physician would

think, how a reasonable physician would act, if provided

additional information from Bard.

This fails every Daubert factor that we have.

There's no methodology that they've identified to arrive at

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those opinions, there's no scientific principle to support

their opinions, other than informed consent, which I'll get to

in a moment. The opinions haven't been tested, there's no

known rate of error, they haven't been peer reviewed, there is

nothing to suggest the opinions they provide are generally

accepted in the community of interventional radiologists. 

What they do is point to an informed consent document

entitled ACR SIR Practice Parameter on Informed Consent for

Image Guided Procedures, which we attached as Exhibit D to the

reply brief as their, quote/unquote, scientific principle to

get over the 702 hurdle. We think this is a red herring for

several reasons. First is that informed consent is strictly a

medical malpractice concept. It's a different issue, there's

a different legal test than what constitutes a duty in a

failure to warn case, which is what's left in Ms. Booker's

case, for example.

In the plaintiffs' response brief, they go on at

length about the informed consent process and the informed

consent doctrine and why it's important. But notably absent

from that lengthy discussion is a single case that discusses

informed consent in the context of a product liability failure

to warn case.

Secondly, if you look at the guidance documents

Drs. Kinney, Roberts, and Kalva cite, it's a guidance document

that talks about the informed consent process, not the

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informed consent content. And it's an important distinction

because the language of the guidance document itself as it

pertains to risks says physicians should inform patients

about, quote, the risks, complications, and expected benefits

or effects of such procedures or treatment, close quote.

But there's nothing in that guidance document that

speaks to what is sufficient to satisfy that informed consent

process.

For example, does a risk of 0.1 percent need to be

disclosed to a patient? What about 5 percent? Or 10 percent?

The guidance document simply doesn't say, and so Drs. Kinney,

Roberts, and Kalva are using this process related informed

consent document as a vehicle to put their personal opinions

about what is sufficient to arrive at an informed consent

process before the jury. We think that that is not

appropriate because it's not based on any type of objective

standard. They're simply saying, well, this is what we think

having looked at this document and looked at the material that

we've been -- received from Bard.

And finally, you alluded to this at the beginning of

today about the long string cite that we provide in the motion

as relates to the informed consent doctrine. The three most

important decisions there are the Rezulin case from 2004 from

the Southern District of New York and the two in re diet drug

MDL decisions from the Eastern District of Pennsylvania from

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the early 2000s.

The courts there confronted a very similar issue

where the experts for the plaintiffs purported to say that had

physicians across the country had additional information from

the manufacturer, they would not have prescribed Rezulin, for

example. And the courts in those cases said that that is

impermissibly speculative, you can't do that under Rule 702,

those are personal opinions, they're not reliable, and you

can't make them.

The plaintiffs don't say a thing about any of those

decisions in the response brief.

The remainder of the long string cite is a CF

citation where we're citing to additional cases where the

courts have said you need some type of objective standard to

be able to offer opinions to the jury.

Unless the Court has any specific questions about the

other portions of the motion, that's all I wanted to address

with you.

THE COURT: Okay. Thank you.

MR. BROWN: Thank you, Your Honor.

MS. O'LEARY: Good afternoon, Your Honor. I'm Leslie

O'Leary. I think I've been before you one time in a pain pump

case, other than that I'm new here.

I would like to address the reliance on other experts

argument. I think I can make it a little bit clearer what

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happened.

In our response brief we did present testimony by

Drs. Kinney and Kalva and Roberts saying in addition to

reading the reports of these other experts, they also looked

at their underlying documents, all their references, too, and

so that's part of the record.

To make it clear, the plaintiffs' counsel provided

them a Dropbox database and it included not just the reports

but all of the references. So if they wanted to look up a

reference to Dr. Kessler's report at page -- at paragraph 55,

they could click on that and have all the documents. So

that's what they did. They looked at the documents that

supported their opinions.

In fact, they reviewed a lot of them. Dr. Kinney

said in addition to looking at all of the medical literature

which he pulled and reading the 510(k)s and studies supporting

the 510(k)s for these devices, he also looked at the

underlying references in these reports.

So when you look at the cases the defendant cited

saying that these are the examples of how experts are not

allowed to rely on other experts' reports and testimony, those

cases made exceptions where, and I think you pointed this out,

Your Honor, where they're not just basically adopting

wholesale their reports and acting as their mouthpiece but

they actually looked at the underlying data to make sure it

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was coherent with what they were saying. So they did rely on

all of that.

Unfortunately, their List of Facts and Data

Considered list was only the documents that they referenced in

their reports. They actually looked at a much larger

collection than that. So I just wanted to make that clear,

that they aren't just blindly looking at reports and just

accepting them at face value. They actually did look at the

documents supporting them.

THE COURT: I read the deposition sections you cited.

It seemed to me the one exception to what you just said was

Dr. Roberts. She said, I looked at some of the documents that

Kinney cited -- or Kessler cited to satisfied myself that he

was being accurate. That's all she really said, I think.

MS. O'LEARY: And her role in drafting the report

itself was a little bit different because she didn't actually

do the drafting. She worked with the other experts and she

reviewed what they said and went back and fact checked and

looked at the underlying documents and things like that, but

she wasn't actually writing the report itself.

But one thing that's interesting is that defense

experts had testified that they had looked at Dr. Kessler's

report and Dr. Kinney's, Roberts', and Kalva's reports and

were asked if they looked at any underlying documents, just to

make sure that the factual basis for their opinions were

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correct, and these -- I think it was Dr. Moritz said, Oh, I

did look at them. I looked at both of their reports, and they

were so detailed that I had no question to -- no reason to

question the factual basis for them.

And I think what happens to make -- I think these

other cases the defendants relied upon had a major concern

which was the factual basis for the reports they're relying on

might be unreliable. But if defense experts don't have any

basis to question that and if Dr. Kessler's underlying facts

are reliable, then we're not looking at something that's shady

or irrelevant to begin with.

So this is just a huge compilation of factual data

that they did look at. They didn't -- they didn't ignore it.

They had a lot of it that they sifted through. Unfortunately,

they didn't keep track of what they looked at and decided not

to include in their reports versus what they just glanced at.

But they did look at a tremendous volume of data, and also

looked at expert -- at employee witness depositions and their

underlying documents. So they had a big trove of materials

that they looked at and then they culled them down when they

wrote their report.

So the bottom line is this really comes down to the

factual basis for their opinions, which is more a matter of

cross-examination than it would be for exclusion.

In terms of reasonable expectations, the standard of

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care they articulate, I think that the defendants have

raised -- they seem to express confusion over informed

consent.

Counsel had talked about how informed consent is

really an individual judgment not a collective one. But there

are two sides to informed consent, and I think they're

confusing what the manufacturer must disclose to the physician

versus what the physician has an obligation to disclose to the

patient.

So there's two parts of the equation. There's how

does a physician become informed enough to give -- obtain

informed consent from the patient and so it's the first part

of the equation that Drs. Roberts, Kalva, and Kinney are

talking about. They're not talking about what they would have

done or what any particular individual physician would have

done with that information. That's more of a question that

would come up at trial. That's more of a causation question.

The question is what is the type of information that

physicians in this field of interventional radiology need to

know in order to do what these experts do.

They train their colleagues on how to insert these

devices, the types of patients they're indicated for, under

what circumstances certain types of these filters should be

used. It's that body of information they need to be able to

inform themselves and help inform their colleagues and then

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inform their patients and make that decision. But it's really

hard to get proper informed consent if you're not informed.

So that's -- that's the -- that's the first half of

the informed consent equation that they're offering their

expertise in.

And it may very well be that an informed physician

may decide in light of all of the information on all of the

complication rates and everything else, might decide in a

particular patient, you know, I know all of this but I'm going

to recommend putting this filter in any way, and that's an

individual judgment. And -- but that's not what we're talking

about here. These experts aren't going to come and talk about

what I would have done with my individual patients. They're

saying this is the information we rely on because otherwise we

lack the ability to do our jobs as physicians and give our

patients important information that they would want to know.

So that's where they're coming from. And there's

also similar confusion over this learned intermediary

doctrine. The defendants in their reply brief cited Fields

versus Eli Lilly, which is a Ninth Circuit decision, and

they're saying this really -- that it really has to do with,

well, had I gotten that information what would I have done

with it? 

Again, we're talking about the duty to give adequate

information, the duty to warn the physician first. That's a

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duty and a breach question, and that's what the experts are

here to talk about. Whether or not -- what an informed

physician would have done with that information is a causation

question and our experts aren't here to testify about

causation.

This is not a make believe standard that the experts

have come up with. The sources of this are implicit in their

SIR guidelines that we -- that they had mentioned informed

consent for one thing. They explain that the patients have to

have every opportunity to fully understand the treatment and

procedure and its reasonable risks. But those patients won't

get the informed consent they need unless physicians get the

information they need to fulfill their obligations.

So, again, it's the first side of the equation, not

the second side of the equation.

Another source is their quality improvement standards

that the SIR developed, and they've developed these for other

physicians. It wasn't developed for manufacturers, but it was

basically to help them determine when and how to use these

filters and under what circumstances based on the information

they had available to them from the manufacturers and all of

the studies.

But they also issued publications and articles

strongly encouraging manufacturers to come forward and do

studies, more studies were needed, because there isn't enough

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 103 of 112
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to be able to compare the safety and efficacy of all these

different filter types.

So the statement that was in these SIR guidelines

that these weren't intended to establish legal duties of care

was directed at the second step of that informed consent which

is we're not meaning these regulations or these standards to

be duties of care to determine the liability of a physician

who makes a decision on behalf of one particular patient. It

was never intended to be that way. So that cautionary note is

really irrelevant to the discussion.

Another source of this reasonable expectation, this

duty of care to interventional radiologists and cardiologists

is from Bard's own internal documents. We had cited this in

our brief, but basically Bard had put -- had brought together

a group of physicians, interventional radiologists and

cardiologists and said, hey, what do you think about the

design of our products? And they came away with the

understanding that these doctors insist on knowing what the

failure rates are of their devices and they need to know if

there's any problem with them, that there's zero tolerance for

complications that arise and they need to know about them.

Another source of this is from Bard's own employees.

They testified that of course physicians have a reasonable

expectation that they will be informed of any risks or

complications as they arise. And so they were -- they were

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 104 of 112
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aware of that. That was something that they adopted.

In addition, defendants' own experts have articulated

this standard. Dr. Feigal, who's one of Bard's experts,

actually published an opinion piece in the New England Journal

of Medicine, and this was basically about the importance of

forthcoming and honest of disclosure of risks and

complications of implantable cardiac devices. And he stated

from the perspective of physicians and patients' expectations,

corporate responsibility and public perception, we believe

active communication policies centering on the proper use of

active and passive transparency should be the norm. So this

is a statement that just wasn't drawn out of thin air.

I'd also like to address the criticism that defense

raises about the reliability under Rule 702 of this standard.

They basically attack it because it doesn't meet the four

Daubert criteria, but the case U.S. v Hankey really addresses

this issue and it's when an expert's testimony isn't based on

a scientific principle but on their own experience and

knowledge. Then these Daubert factors are not really

applicable. The four Daubert criteria are helpful but when

the reliability depends on the knowledge and experience of the

expert rather than methodology behind it, then those factors

don't come into play so much.

I might add that this duty to warn, this standard of

care is consistent with other duties and concepts in common

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law. It's certainly similar to the duty under FDA regulations

to adequately inform physicians -- adequately inform the FDA

and also prescribing physicians, but, again, under learned

intermediary and informed consent doctrines this duty to be

forthcoming and provide relevant material information is

entirely consistent with this duty of care. And it's not

simply a medical malpractice standard. This is a standard

that I've had cases involving what -- you know, what a

physician would expect under the circumstances, what they

expect to be told.

So this isn't something that is ipse dixit, it's a

duty that common law and that imposes on any manufacturer, any

reasonable manufacturer, to convey information that is

important to their practice.

So these experts testimony on the standard of care

provide a helpful framework for the jury to decide in

determining whether Bard breached its duties of care in

disclosing important safety information about the

complications and so Bard's criticism of that is best left to

cross-examination but not exclusion.

THE COURT: Okay. Thank you.

MS. O'LEARY: Any other questions?

THE COURT: No. Thank you.

MR. BROWN: Your Honor, I think we've adequately

responded to all of the points that plaintiffs' counsel made

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 106 of 112
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in our reply brief.

THE COURT: All right. Thank you.

Counsel, let's talk about briefly the motion to

certify the preemption ruling. And I'd like to address it to

Bard, particularly in light of a couple of facts that you may

already be aware of.

This week I received two Ninth Circuit rulings on

decisions I had made. One I made in September of 2014, second

I made in April of 2015. Two and a half plus years.

I certified -- I had a big securities fraud class

action. I certified the class but then came upon a loss

causation issue that was very confused in Ninth Circuit law.

I certified that issue to the Ninth Circuit in August of 2015,

telling them that I wasn't going to hold trial until I knew

what the -- actually, depending which way they went, I would

either grant summary judgment or not and we were going to hold

off until they answered. I still don't have a decision. That

was 28 months ago. And they took it. They took it within a

month. I thought great, we'll get a quick decision. 28

months and nothing.

It's not unusual. I had a case recently that was a

2013 decision that was just affirmed.

I am confident if I certify this issue to the Ninth

Circuit, we will be here two or two and a half years from

now -- well, I don't know if we will be, but it will be two or

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Case 2:15-md-02641-DGC Document 9776 Filed 01/17/18 Page 107 of 112
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two and a half years before we get a decision. That's just

unfortunately the workload they face and the pace at which

they get things decided.

I don't know how much that affects -- and there's one

other question I'd appreciate your thoughts on, Mr. North, is

if the jury in the Booker case or the Jones case were to rule

against Bard, presumably I enter a judgment, you appeal and

that takes with it the preemption motion so it would get there

then as well. Obviously, if you win at those two cases, that

wouldn't be situation.

In light of those Ninth Circuit realities, would you

tell me why you think it's a good idea to certify the matter.

MR. NORTH: Well, I was not familiar with that sort

of backlog, Your Honor.

I would recognize, based on what the Court has

reported, that is a risk and probably a substantial risk.

With all due respect to this Court, my client is determined to

present this case -- issue at some point to the U.S. Supreme

Court and invite that court to address the very problems in

this area of the law that then-Judge Gorsuch mentioned in the

Caplinger case. The question is how do we get there.

We're not asking, of course, for any stay of

proceedings in this court. We recognize that's not a prudent

thing to do with an MDL of this magnitude. But what we are

looking for is what avenue we pursue this issue -- again, with

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due respect to the Court's ruling -- up to the U.S. Supreme

Court.

THE COURT: It doesn't bother me you want to appeal

it.

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

THE COURT: I could have guessed that you disagree

with the decision. That's fine.

MR. NORTH: I once clerked for an Eleventh Circuit

judge who didn't have that same view necessarily, I'll just

say that.

And what I'm concerned about, too, is given the

nature of an MDL, and I think that's why a lot of cases have

said 1292(b) appeals are so important in the MDL context --

for example, we can find ourselves pursuing this issue in a

number of circuits, to be honest with you. I think three of

the mature cases are in Florida and Georgia. So if those were

to be remanded at some point this year and tried, we would

either -- could have an appeal if we lost or a cross-appeal if

we won and they appealed, raising that issue in front of the

Eleventh Circuit.

There are a couple cases in the Fifth Circuit.

It's -- we are going to pursue this case, or intend

to pursue this issue in whatever forum we first receive the

opportunity to.

I would submit to the Court that, while recognizing

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the realities of what the Court said and what's happened

before, that we could at least try with the Ninth Circuit. As

opposed to trying to piecemeal it. And it may be a race to

see which case court addresses the issue first, appellate

court circuit, and it ends up in the Supreme Court or on a

certiorari petition to see if that court is interested in

reviewing it.

But I guess what I'm thinking, even though I

understand the impediment the Court says as far as timing, I

don't know that I see a negative in at least presenting it to

the Ninth Circuit since it's not going to stay proceedings

here. Maybe this is one of those times they move quickly.

Who's to say.

THE COURT: Okay, I understand that. There's also

the question of whether I think reasonable jurists could

disagree. But I understand your argument on that,

particularly in light of the Tenth Circuit decision from

Justice Gorsuch. 

Plaintiffs, did you want to saying anything on this

motion?

MS. REED ZAIC: Your questions were addressed to the

defense. We have nothing additional to add to our papers.

THE COURT: That covers everything on my list. Do

you all have matters you want to take up before we break?

MR. O'CONNOR: I think we covered everything. I

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think on plaintiffs end we're good, Your Honor.

MR. NORTH: Nothing further for the defense, Your

Honor.

THE COURT: Okay. Thank you all. Have a great

holiday. We'll see you in January.

MR. NORTH: Thank you, Your Honor.

MR. O'CONNOR: 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 17th day of January,

2018.

 s/ Patricia Lyons, RMR, CRR

Official Court Reporter 

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