UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

 _________________

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

Products Liability Litigation )

 )

 ) Phoenix, Arizona

 ) November 17, 2017

 ) 

_____________________________________)

BEFORE: THE HONORABLE DAVID G. CAMPBELL, JUDGE

REPORTER'S TRANSCRIPT OF PROCEEDINGS

MOTION HEARING AND SCHEDULING CONFERENCE

Official Court Reporter:

Patricia Lyons, RMR, CRR

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

401 West Washington Street, SPC 41

Phoenix, Arizona 85003-2150

(602) 322-7257

Proceedings Reported by Stenographic Court Reporter

Transcript Prepared with Computer-Aided Transcription

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A P P E A R A N C E S

 

For Plaintiffs:

Gallagher & Kennedy

By: MARK S. O'CONNOR, ESQ.

2575 E. Camelback Rd., Ste. 1100 

Phoenix, AZ 85016

Lopez McHugh, LLP

By: RAMON R. LOPEZ, ESQ.

100 Bayview Circle, Ste. 5600 

Heaviside Reed Zaic

By: JULIA REED ZAIC, ESQ.

312 Broadway, Ste. 203

Laguna Beach, CA 92651

For the Defendants:

Nelson Mullins Riley & Scarborough

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

By: MATTHEW B. LERNER, 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

Snell & Wilmer

By: AMANDA C. SHERIDAN, 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 a motion hearing. 

Will the parties please announce.

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

on behalf of the plaintiffs' leadership committee.

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

Mark O'Connor for plaintiffs' leadership committee.

MS. REED ZAIC: Good afternoon, Your Honor.

Julia Reed Zaic on behalf of plaintiffs' leadership committee.

MR. NORTH: Good afternoon, Your Honor.

Richard North on behalf of the defendants, and I have with me

from my office Elizabeth Helm, James Rogers, Matthew Lerner.

We also have Amanda Shelton from Snell & Wilmer. And we also

have Candace Camarata, the assistant general counsel for Bard

and defendants today.

THE COURT: All right. Good afternoon, everybody,

and welcome to the folks on the phone.

We are here to argue the summary judgment motion on

preemption and the summary judgment motion in the Booker case,

and then to discuss some case management issues.

Counsel, what are your thoughts on how you want to

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the motions. What are your --

MR. NORTH: Your Honor, since we're the movant in

both, we're here at the Court's discretion, whatever the Court

would find helpful. We're prepared to make an argument on

both motions, I would say 15 to 20 minutes each, or we can

just answer questions. Whatever the Court would prefer.

MS. REED ZAIC: I would agree with that, Your Honor.

Our responses will heavily be weighted towards what we might

have to respond to, of course, and the Court's questions.

THE COURT: Well, why don't we go ahead and have you

make the arguments you wish to. I'll ask questions as I see

fit, and then we'll allow the plaintiffs to respond. 15 to 20

minutes per motion is fine.

I've read the motions. I've read the major cases

cited in the motions. I've not read all of the cases. So I'm

familiar with the arguments. And you don't need to sort of

educate me on the arguments. I think I know the issues on

each of the points that are briefed.

Why don't we deal with the general preemption motion

first, argue that, and then deal with the Booker motion.

So, Mr. North, whoever would like to go from your

side, let's get started on that.

MR. NORTH: Thank you, Your Honor.

May it please the Court.

1 3 : 0 3 : 5 6 This motion, based on federal preemption, admittedly

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presents a paradox, we believe. On the one hand the

applicable legal precedent is well established with cases that

this Court has often considered in your past decisions.

Although, as some courts, including the Tenth Circuit, have

noted recently, this precedent perhaps requires revisiting and

reconciliation. But regardless, the precedent is clear,

particularly with Riegel and Lohr as the main two cases. What

is not precedented, we submit, is the factual record presented

in this case.

In scouring the federal authorities, we have not

found a single case that presents an instance of such a

rigorous review by the FDA of a 510(k) product. In fact,

there may not be any comparable scenarios out there where the

FDA has conducted such an extensive and elaborate review of a

510(k) device. But despite this paradox, we believe the

issues before the Court are relatively straightforward. They

are two.

First, can preemption even apply under the medical

device amendments, the MDA, to a 510(k) product, and if so,

can it apply and should it apply to the record that Bard has

presented in this case?

The plaintiffs seem to suggest in their brief that

there is a categorical preclusion about applying preemption to

a 510(k) product. Particularly in their brief at page 20 and

1 3 : 0 5 : 3 0 footnote 19, they say that "fundamentally" -- and I'm

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quoting -- "fundamentally a 510(k) product is equivalence not

safety review and thus cannot preempt plaintiffs' claims,"

suggesting to this Court, at least implicitly, that under no

circumstances can there be preemption with a 510(k) product.

We respectfully submit that is not the law.

Only a plurality in the Medtronic versus Lohr case

seem to base its no preemption decision on the nature of

510(k) review. And even that plurality disclaimed the notion

that general standards could never preempt state law claims.

And the court emphasized that, the Supreme Court did

in Riegel, that even the plurality disclaimed a categorical

rule.

In Medtronic versus Lohr, the fifth concurring

justice, Justice Breyer, the justice that gave the majority

for finding no preemption in that case, did not base his

decision whatsoever on the 510(k) nature of the review.

Instead, he based his decision on the absence in that

particular case of any specific requirements for the device at

issue.

THE COURT: Let me ask you this question, Mr. North:

What do I do with Justice O'Connor's opinion that said 510(k)

would not preempt? Do I add that to the plurality? I know

she found preemption on the basis of broader statutes, which

wasn't adopted by a majority, but she said in her opinion a

1 3 : 0 7 : 1 2 510(k) would not preempt. Do I count that when I'm counting

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noses, if I should be counting noses, in the Lohr case?

MR. NORTH: Well, I think you can't, Your Honor,

because later in the Riegel case, and admittedly the cases and

the opinions are all over the place on this subject, later in

Riegel the clear five justice majority, including

Justice O'Connor, noted that in Lohr even the plurality

disclaimed an application that the notion that general

standards could never preempt.

And so here we have a case where we don't mind if it

had just general standards at play, we have very specific

standards. And I think that you have to look at

Justice O'Connor's dissent, her comments in the dissent there,

which I believe was directed, if I recall correctly, only to

the negligent design claim in that particular instance, but

you have to look at it through the light of Riegel, where she

joined the majority, and those same dissenters joined the

majority noting that even in Lohr there was not a categorical

rule.

The Ninth Circuit has also disclaimed any categorical

prohibition of preemption in the 510(k) context. The Papike

case, which involves tampons, a Class II device, the court in

that case noted that there were specific requirements

applicable to that Class II device, and as a consequence in

that particular case, those requirements were preemptive of

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And then, of course, this Court is familiar with

Ninth Circuit's decision in Degelmann, which of course was

later vacated and therefore is not precedent, but it is

instructive because it also follows the same reasoning as

Papike. In that case once again the Ninth Circuit suggested

there is no categorical prohibition of preemption in the

510(k) context. Instead, they recognized in that case that

the existence of a very specific guideline applicable to the

specific device could be preemptive.

Admittedly, some district courts have suggested out

there that there is a categorical prohibition. But we would

suggest that that's inconsistent with what the Supreme Court

actually said in Lohr and Riegel. It is inconsistent with

what the Ninth Circuit has said in Papike, which is precedent,

in Degelmann, which is at least instructive, and it's

inconsistent with what Justice -- now-Justice Gorsuch recently

commented before his elevation to the Supreme Court in the

Caplinger case on behalf of the Tenth Circuit. In suggesting

that the precedence needed to be reconciled, he said that it

appears under the MDA that preemption is appropriate if there

is premarket approval, PMA review, or something like it.

In other words, if there is, as the Ninth Circuit has

suggested in Papike, a specific standard applicable to a

specific device.

1 3 : 1 0 : 1 7 If you accept the premise there is no categorical

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preclusion of preemption to a 510(k) device, the question

becomes does it apply in this instance. This Court has

already articulated, of course several times, in cases such as

Arvizu and Thibodeaux, what the standard is.

The standard is based on the preemption clause of the

MDA. 21 U.S.C. Section 360. And under that clause, the

standard is whether -- number one, whether the federal

government has established requirements applicable to a

specific device; and, two, whether state claims impose

requirements that are different from or in addition to federal

requirements regarding the safety and effectiveness of the

device.

Now, that's exactly what has happened here, we

submit.

The FDA has enacted a regulation 21 CFR 870.3375,

which identifies special controls for filters. First it

identifies an ISO standard regarding biological evaluation of

medical devices; and, second, it identifies a Sterility Review

Guidance.

Now, admittedly, Your Honor, those first two

guidances are more akin to the sort of standards referenced in

Lohr. The more general standards. But the third item it

references is an IVC Filter Guidance, and that provides the

specific standard in this case.

1 3 : 1 2 : 1 4 In this standard, Your Honor, the plaintiffs attempt

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to paint it as aspirational and maybe just a suggestion by the

FDA. We submit it is anything but. It says that either you

must comply -- it says "you must comply with these specific

recommendations of this guidance or provide the agency with

some alternate control that provides equivalent assurances of

safety and effectiveness." Either/or. It's not telling you

exactly how your test protocol must be done, but it's telling

you what issues regarding the safety and effectiveness of the

device you must do.

And it's not saying you should consider it, it's

saying "you," and I quote, "should demonstrate that the

proposed device complies with either these specific

recommendations or some alternate control that provides the

same assurance." 

And what are some of those considerations that the

FDA is requiring compliance with?

The plaintiffs suggest that this guidance document is

really just a pathway for a manufacturer to show equivalence.

Just simple comparative similarity to a predicate device. To

the contrary, it outlines a number of aspects going to the

heart of the safety and the effectiveness of the device.

It requires certain evaluations of simulated

deployment, which pertains both to safety and to

effectiveness. It requires assessments of the introducer

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It requires testing and assessment of the clot

trapping ability of the device.

Clearly going to the effectiveness.

And it wants and requires an evaluation of many

aspects of safety regarding the filters, including filter

fracture, caval perforation, filter migration,

thrombogenicity, MRI compatibility. These issues do not have

to do with equivalence, Your Honor. They strike at the heart

of the same sort of concerns that underlie PMA review, the

safety and effectiveness of the device.

And the FDA specifically decided this device -- or

this guidance was necessary to ensure the safety and

effectiveness.

According to the FDA memos that we have obtained,

when the filters were being reclassified from Class III to

Class II, which eventually went into effect in 2000, the

agency noted that special controls in the form of standardized

labeling and a device guideline on vena cava filters have been

developed. And those controls provide reasonable assurance of

the safety and effectiveness.

The agency specifically determined that these -- this

filter guidance was going to demonstrate to it safety and

effectiveness. Not just substantial equivalence.

Now, we can't in this case, we submit, though, focus

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extensive record of how the FDA for more than 15 years has

applied that guidance to Bard filters.

And we submitted the lengthy declarations of Rob Carr

and John Van Vleet, two gentlemen employed by Bard who were on

the front lines dealing with the FDA day in and day out

regarding these filters.

We submit that this sort of record showing the day to

day, month by month involvement of the FDA, its review, is

unprecedented. Again, we have not been able to find a single

preemption case that demonstrates this sort of factual record.

And this record has not been challenged by the

plaintiffs. They have quibbled with the meaning of what's

there, but they have not disputed the occurrence of these

events.

What does that record show? It shows that the FDA

with regard to Bard filters has required three clinical

trials: One with the Recovery filter, one with G2 filter, and

one with the Denali filter.

The plaintiffs try to dismiss those clinical trials

as not particularly relevant saying that, Well, they were just

designed to look at retrievability.

Well, regardless of whether they were looking at

retrievability, they were also, as required by the FDA,

cataloging and reporting all adverse events. And they were

1 3 : 1 7 : 2 2 reporting that data to the FDA. And the FDA was getting

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monthly reports on those tests, of the clinical studies, about

the adverse events.

The Horn case from the Third Circuit is a PMA

preemption case, but it talks in terms of why there is

preemption for PMA devices on the importance of the FDA's

requirement for clinical studies, just like you had here.

An important point that I think distinguishes filters

from the vast magistrate majority of 510(k) devices is the

fact the statistics show that clinical studies are required by

the FDA in less than 8 percent, around 8 percent of 510(k)

devices. This is a very unusual situation where the FDA has

very proactively required certain instances.

The record also demonstrates that the FDA was

constantly requesting additional information. It was not a

matter of, okay, Bard submits the test results required by the

guidance and the FDA rubber stamps. Beginning with the

Recovery filter from the very first 510(k) submission, the FDA

came back with lengthy questions delving into numerous aspects

about the testing that had been performed, and the vast

majority of the FDA's inquiries went directly to the heart of

the safety and effectiveness of the device, and not focused on

equivalence. And that pattern continued. Continued through

the G2. It continued through the Eclipse. The Meridian, back

and forth, went over a year where the FDA kept going back for

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being evaluated. All for the purpose of assessing safety and

effectiveness, not equivalence.

With the Denali, the FDA said, you're going to have

to do this clinical trial before you can even sell this filter

as a permanent device.

And they make a big point of, well, that clinical

trial wasn't finished when the Denali filter was cleared.

Well, no, because the FDA said, we will not accept your 510(k)

submission -- and this is in the record -- until you have

enrolled 100 patients in this trial, until you have followed

those 100 patients for six months, and until you have

retrieved 45 filters. At that point you may submit with that

data from that part of the test, submit your 510(k), which is

what we did. The study continued and wrapped up later, but

the FDA had that safety and effectiveness data when making its

determination.

The record also shows multiple demands by the agency

regarding labeling, requiring specific language. They say

that's negotiation back and forth. Well, certainly sometimes

the FDA said, we want you to put X, and we said, well, what

about Y, and the FDA might agree or might not agree. But

ultimately the FDA was controlling every step of the way what

we did.

And I think perhaps the best example of this happened

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not have a fracture warning. Bard wanted to add one, and the

record, in the declaration of Rob Carr, shows this.

We called the FDA and we said, hey, just for your

knowledge, we are going to change the IFU to add this warning

and we're going to send out a dear doctor letter. And the FDA

said, whoa, whoa, whoa, we want to see this first and

determine whether you need to submit a new 510(k).

So we sent the package to the FDA. The FDA spent

three months reviewing it, and then around Thanksgiving of

2004 the FDA came back and said, okay, we're going to allow

you to go forward with the revised IFU and you may send out

the dear doctor letter, but we want certain changes in the

dear doctor letter.

Again, they're looking at this device and the

labeling for safety and effectiveness, not for substantial

equivalence. And, in fact, those declarations and the

communications back and forth with the FDA are replete with

the FDA expressing issues focused directly and like a laser on

safety and effectiveness with this device.

In Riegel, the Supreme Court said that PMA review is

preemptive for a PMA device because it is in essence federal

safety review.

We submit, Your Honor, the IVC filter guidance

document developed by the FDA as applied to Bard's filters by

1 3 : 2 2 : 2 8 the FDA over 15 years, and shown in these declarations, show

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the same thing, this is federal safety review and always has

been.

We believe that as a result, the FDA's extensive

regulations, extensive review of safety and effectiveness

should be preemptive of the plaintiffs' claims.

Now, we recognize in the Ninth Circuit there is an

exception growing out of Riegel for parallel claims. I think

it's based on the Stengel case en banc from the Ninth Circuit.

It is possible that some of their claims arguably could be

carved out, but they've not argued that, Your Honor. They did

not even respond to the motion trying to point out any

parallel claims, and I'm not sure that I've seen any that have

been asserted in this particular case that are parallel.

So as a consequence, as we pointed out in great

detail in our briefs in citing cases, we believe that each of

their claims should be preempted.

In conclusion, Your Honor, we believe this is an

unprecedented case. There are precedents to apply, and those

precedents say that there is no categorical prohibition of

preemption in a 510(k) context.

But this case is unprecedented because of the record

that has been demonstrated. It may be unprecedented in the

level of the FDA's review of a 510(k) device in the first

instance. But regardless, this is tantamount to federal

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we believe there should be preemption.

Thank you.

THE COURT: Okay. Thanks Mr. North.

Plaintiffs' argument.

MS. REED ZAIC: Your Honor, I have a PowerPoint that

I -- I'm not giving out a precopy -- I have a precopy if you'd

like to follow along, or your clerk, and to provide to defense

counsel. My concern is if I provide it and don't use all my

slides, if I could -- if the Court would like to hang on to it

I can provide a final --

THE COURT: I don't need a copy, but if you want to

give a copy to --

MS. REED ZAIC: You don't need a copy, I'm sorry,

Your Honor?

THE COURT: I do not. But why don't you give a copy

to defense counsel.

MS. REED ZAIC: Apologize to the Court. Hopefully

that won't happen again.

Again, apologize to the Court.

Your Honor, defendants' motion be denied for several

reasons. To start with, there is no evidence that this case

is unprecedented in its factual record, special controls,

guidance documents, or anything else. There's no evidence

that Bard has demonstrated how it has allegedly conducted an

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from other 510(k) devices that have been cleared to market.

There's no evidence that its 510(k) reviews resulted

in something like PMA approval, and they are actually

forbidden from making that representation.

There is no evidence that Bard's 510(k) endured

rigorous review like PMA review. In fact, what they presented

so the Court is only a protracted reenactment and a blow by

blow of all of their communications under a regulated

environment under which the 510(k) rules and regulations

apply.

There's no evidence of a modern, or now what they

have called in their reply brief a now superseded, 510(k)

process that's contrary to Supreme Court holdings in Lohr and

Riegel, and causing Lohr to be outdated or overruled.

Bard also fails to address the express preemption

test. It focuses on its alleged unprecedented 510(k)'s rather

than actually evaluating the facts under 360(k), which is the

express preemption clause.

They also did not evaluate the facts under 21

CFR 808.1(d), which limits the scope of the express preemption

clause under the MDA.

And Bard is also engaged in improper burden shifting

with regard to the burden that plaintiffs have. Plaintiffs do

not, for example, have the burden to negate Bard's allegations

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compare to other 510(k) applications, which they have not

presented to the Court.

I want to start with the basic concept. I understand

the Court's admonition that you've read the case law, but this

is extremely important, I believe, to our opposition.

The difference between "approval" and "clearance."

These two words are often interchanged, interjected in the

inappropriate circumstances by lawyers, including myself, in

judicial opinions. Sometimes PMA approval is also -- I'm

sorry, the word "approval" is used with 510(k) clearance when

it should be limited to premarket approval applications, and

the FDA is clear, even on their website, that approved medical

devices are those devices for which FDA has approved a

premarket application prior to marketing.

And "cleared medical devices" are medical devices

that FDA has determined to be substantially equivalent to

another legally marketed device, and a premarket notification,

referred to as the 510(k) process, must be submitted in

advance.

The basis of Bard's argument that the Lohr case -- or

the FDA process after 1990 has been superseded lies in the

history of the Medical Devices Act to begin with. In 1976,

when it was promulgated, it included performance standards.

And no one on the plaintiff side is going to come into court

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has nothing to do with safety. Safety underlies these acts.

Lohr says it via the Supreme Court's interpretation of it.

But in 1976, when there were performance standards

required of all medical devices, it was impossible for the FDA

to comply with that standard. A performance standard for

every medical device would require research and review of

every device establishing these standards for every single

device the agency oversaw. That became impossible. And in 

1990, there were further amendments to the Medical Devices Act

via the Safe Medical Devices Act of 1990.

In this act, special controls replaced performance

standards. They are less specific. Special controls can be

any document or information that the FDA cites and identifies

associated with devices.

Special controls are not a tool for express

preemption and to evaluate whether claims against a medical

device are expressly preempted. They're for regulatory

purposes. And the special controls assigned, as Mr. North

indicated, are at 21 CFR 870.3375 and consist of three

guidance documents, one of which seems to be at issue here now

that I've heard counsel say that the first two admittedly

aren't as applicable to their arguments.

Mr. North covered the actual express preemption

clause. He did not cover the regulation that has since

1 3 : 3 1 : 1 3 narrowed it. Lohr and Riegel, the Supreme Court tells us that

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the FDA has given wide latitude with regard to the FDC -- the

medical device amendments with regard to the express

preemption clause.

And CFR 808.1(d) says state or local requirements are

only preempted when the FDA has established specific

counterpart regulations or specific requirements applicable to

a particular device.

The express preemption clause did not change between

1976 and 1990, and neither has this regulation. That is the

test that has been employed by the Supreme Court and courts

long afterwards in evaluating this issue when it comes to

510(k) devices.

I understand the Court has -- of course is familiar

with the major case law, as Your Honor has stated, but I just

want to cover a couple of points here that will be applicable

in my opposition.

510(k) is focused on equivalence, not safety. That

is from the Supreme Court in Lohr. It is not overruled. It

still applies regardless of defendants' claims it is

superseded at this point because of some modernization or

change to the 510(k) process. It does not require the device

take a particular form. It is general. That's why in Lohr

and Riegel, Riegel upholding Lohr, the statute itself and the

regulations are general controls.

1 3 : 3 2 : 3 8 And 510(k) devices can be marketed without running

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the gauntlet of PMA because it's an exception to the premarket

approval process. There is no suggestion in either the

statutory scheme or the legislative history that the 510(k)

exception process -- exemption process, pardon me, was

intended to do anything except maintain the status quo. And

the status quo included the possibility the manufacturer of

the device would have to defend itself against state law

claims of negligent designs. Design.

This is a comparative process. And as I mentioned

before, no one is going to claim here that the MDA has nothing

to do with safety and effectiveness. Lohr actually tells us

the MDA was enacted to provide for the safety and

effectiveness of devices intended for human use.

The 510(k) process, the Supreme Court tells us, is

device specific. But that doesn't mean there's a focus on

safety and effectiveness. The review does not require 510(k)

devices again to take any particular form for any particular

reason. This is why there was no preemption in Lohr based on

the concept of general controls and lack of specificity

between the statute and the regulations unless there was a

specific aspect to it.

That's why the holding was that 510(k) imposed no

device-specific requirements and did not implicate the express

preemption clause.

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Bard alleges that Lohr is superseded. They have no

authority to make that statement. There are a few different

cases that have been brought recently, since 2014. Actually a

total of four. I make that representation with a little

hesitation because I cannot say that I have reviewed all

13,000 times that Lohr has been cited. But since Bard argues

the SMDA overhauled the MDA when it actually relaxed

standards, overhauled the MDA and Lohr, it's important to

point out that Lohr was -- was -- the -- strike that.

The issue in Lohr and the decision was six years

after the SMDA was enacted. And the sweeping language of

Lohr, later upheld by Riegel, did not indicate anything that

the defendants are saying, and the Court certainly had the

opportunity.

Now, Lohr is the law of the land. I don't think

there is a dispute to that. It has been cited over 13,000

times. 2,018 of those citations are judicial opinions. It

has been cited 109 times in 2017 alone. And two months ago I

argued -- I opposed the same motion in the Cook MDL, and it's

been cited 23 times since then, just two months ago.

There have only been four times -- and again not my

extensive search of all 2,000 of these judicial opinions, but

hundreds of them. I've only found four instances where

someone has come forth and made this argument that Lohr's

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modernization to the 510(k) process. Three times the argument

was made by Cook, the other IVC manufacturer for which there

is an MDL in the Southern District of Indiana.

Two of those opinions involved a similar -- excuse

me -- the same law review article that Bard cites. They did

not deal with IVC filters. The third argument by Cook did

deal with the IVC filters that I mentioned two weeks ago, and

the fourth one is Bard bringing the argument again.

The Horrillo case is representative of other courts,

although not binding on this Court. It's almost an exact

replay or deja vu of what we have seen here. Defendant argues

the FDCA's express federal preemption provision should apply

to plaintiff's stent, or the product, because the stent was

approved under a revised, more rigorous version of the 510(k)

process, which did, in fact, made a safety and effectiveness

determination.

I'll provide you a copy of my PowerPoint, madam court

reporter. I apologize.

Essentially defendants argue that the analysis set

forth in Lohr is outdated and should not apply to plaintiffs'

claims because the medical device at issue in that case was

approved under the 510(k) process as it existed in 1982, which

should not make a safety and effectiveness determination.

This is the same argument Bard is making.

1 3 : 3 7 : 2 2 Defendant also argues that the FDCA's express federal

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preemption provision should apply to plaintiffs' claims

because the revised, the claim, the alleged revised 510(k)

process which arose out of Congress's passage of the Safe

Medical Device Act in 1990, is more akin to the premarket

approval process.

That summarizes part of Mr. North's argument that

he's made here today.

The result of that case, Horrillo v. Cook, in 2014 is

that the motion was denied, and the reasoning was a cite from

a law journal article, the same one that Bard had cited.

Defendant does not cite any legal authority to support this

argument, nor has defendant presented sufficient evidence to

support this argument. And although the argument raises an

interesting issue, this court does not find that it has the

authority to arrive at a ruling contradictory to Lohr or

Riegel.

Very similarly, in 2015, the same argument was made

again by Cook in the transvaginal mesh case. I will not go

through and quote this exactly, except that Judge Goodwin

found that "the arguments raised by Cook do not persuade me to

abandon the Supreme Court's clear position on this matter."

And that the FDA's 510(k) review continues to

primarily focus on equivalence as opposed to safety, and as a

result, I'm doubtful that the Supreme Court would change its

1 3 : 3 8 : 4 8 clear position on this matter based on the SMDA. In fact, any

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changes imposed by the SMDA, which had already been in place

for six years at the time of the Lohr decision, were available

to the court in interpreting Congress's intent for 510(k).

Our position is the same, Your Honor.

The sweeping language of Lohr and Riegel show that

the Supreme Court was aware at the time in 1996 of things like

special controls and they still issued the sweeping language

they did about 510(k) and the express preemption clause.

The ruling in the Cook MDL two months ago was that

the motion was denied, and Judge Young said to me, "Just to

give you a preview here of my thoughts on preemption, I

believe the law is clear on the subject Lohr is Supreme Court

law at this time."

Bard has taken time in its papers and its oral

argument today to point out to the reclassification process

that occurred with IVC filters, and that process did take

place. Originally IVC filters were Class III devices.

Information was gathered by the FDA to indicate and learn and

decide should it remain a Class III device. They chose to

down-classify it. But this is of no particular moment to a

preemption argument.

Under 21 CFR 807.97, reclassification is treated the

same as pre-MDA, pre-1997 -- 1976 devices. In fact, the

regulation says submission of a premarket notification or a

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"the device is substantially equivalent to a device in

commercial distribution before May 28, 1976, or a device

introduced into commercial distribution after May 28, 1976,

that has subsequently been reclassified into Class I or

Class II does not in any way denote official approval of the

device."

When the FDA is issuing substantial equivalence

decisions on products coming to them via the 510(k) process,

they do not make a distinction. It is substantially

equivalent to either one or the other.

On that note, the reclassification memo that Bard has

submitted as Exhibit H to their reply papers, which was

downloaded from the Cook MDL site, it's actually a new

argument they've made in their reply papers, this

classification and the significance, or potential and alleged

significance of it, that memo was -- the information for it

was gathered and was drafted by the FDA prior to retrievable

filters even being on the market.

Bard has claimed that because it was asked by the FDA

or on its own submitted clinical trial data as part of its

510(k) packages, that it is somehow akin to a PMA approval

application and should enjoy the protections of the express

preemption clause.

But the FDA, in the course of 510(k) review, can

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general controls explored in Lohr and Riegel.

In fact, a request for additional information will

advise the manufacturer there is insufficient information

contained in the original premarket notification submission,

and the manufacturer may either submit the requested data or a

new premarket notification containing the requested

information can be submitted. If the additional information

is not submitted within 30 days following the date of the

request, the commissioner will consider the premarket

notification to be withdrawn.

This is the bulk of the factual record presented to

this Court, is the back and forth descriptions, the letters,

the e-mails, the contact, the submissions themselves that

frankly -- and I'm not trying to make a joke out of this, but

honestly I'm surprised there are not paper cuts right now

because of the 818 facts that have been submitted and the

blow-by-blow reenactment of each one of these applications

that were submitted, and when the FDA requested more

information and Bard's attempts to provide it.

This was all within the 510(k) process. It was all

to establish substantial equivalence. Completely separate

from approved devices under a PMA process and the 510(k)

process. In fact, although those regulatory pathways can be

close in the sense that, yes, they're part of the same act,

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review for safety of devices going forward, when you look

through the lens of express preemption, the PMA process and

the 510(k) process have a continental divide between them.

One is based on equivalence, it's a comparative

process. The other process PMA looks at, as Mr. North quoted

Riegel, it is federal safety review. It is an independent

safety determination, as opposed to a review of a file that

determines is this device as safe and effective as a predicate

device. It's independent safety review versus a comparison.

Bard also furthermore claims and argues that the fact

that it's submitted clinical data makes this unique. Going

along and supporting the argument this is a unique situation.

As I stated before, 21 CFR 807.87 allows the commissioner to

ask for any additional information that he or she may choose

in order to complete the review of a substantially equivalent

510(k) premarket notification.

21 CFR 807.100(b)(2)(ii)(B) states that clinical

data, if necessary, can be requested. In other words,

starting at the top, FDA will determine that a device is

substantially equivalent -- again, in this 510(k) realm where

the standard they have to meet is substantial equivalence --

the device has the same intended use as the predicate device,

and the device has the same technological characteristics as

the predicate device. Or, if it does not, if the device has

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predicate device, the data submitted establishes that the

device is substantially equivalent to the predicate and

contains information including clinical data, if deemed

necessary by the commissioner, that demonstrates that the

device is as safe and as effective as a legally marketed

device.

It does not clarify between reclassified devices,

pre-1976 devices. It doesn't say the clinical data and the

kind of clinical data. It says "if it is deemed necessary,

the commissioner can request it for the purpose of

demonstrating that safety and effectiveness is -- that the

device is as safe and effective as a legally marketed device."

Again, this is Lohr. It is a comparison.

Getting to the factual record that Bard has

submitted, I provided to the Court, and I believe it was

Exhibit R but I will correct that for the record if I'm wrong,

a chart of every single exhibit attached to the declarations

of Mr. Carr and Mr. Van Vleet, and I broke them down into

categories.

The first two categories include the submissions.

There were filter submissions, specifically looking at the

filter to determine if it was as safe and effective as the

predicate, and in the second column there were nonfilter

submissions. Those were 510(k) applications that were

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the delivery device or the brochures involved. It wasn't

actually looking at the filters.

This is not unique. This is -- this happens in every

510(k) device. Presumably the first thing that happens is you

have the submission. So those exhibits do not exhibit or

exemplify or support the argument that this is some unique

510(k) review.

There were also letters issuing a determination of

substantial equivalence. That is also part of the process.

There were also, six devices and 12 submissions

later, several administrative communications, logistical

communications such as transmittal letters of copies and

things like that. Those are not unique.

Furthermore there were interactions between the FDA

and Bard about the general controls under the statute.

Examples of these general control interactions are things such

as FDA sending Bard a letter saying there was a complaint

reported, we need additional information about concerning that

complaint. Simply, under the regulations, following through

and asking questions. Nothing unique.

There were also several Bard internal notes and

e-mails. These were not interactions with the FDA that set

some new bar or standard to make them unique.

So what it boils down to is the communications

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these requests for clinical data were made, when the request

for more information that has built this alleged factual

record that is so completely different than any other 510(k)

for which there is no evidence in the record to show.

There were 17 deficiency letters sent for Bard's 

application -- 510(k) submissions, including filters and some

including the additional submissions I noted that dealt with

the delivery devices and brochures and such.

There were 33 responses from Bard. So the FDA sends

a deficiency letter and Bard doesn't provide the information.

They have to try again, and they have to try again, and they

have to try again. 33 responses. The amount of communication

between the FDA that is relevant to the argument being made,

for which there is no evidence for, boils down to these

interactions.

The bottom line is that these filters received

substantial equivalence. They were cleared medical devices.

There was no distinction whether they were pre-1976 or their

predicates had been reclassified. Every single filter

received substantial equivalence. Not a single PMA.

Let me transition over to what Mr. North said about

the fact that there were two situations. He cited the Papike

case and the Degelmann case, as if they are the same. They

are completely different. Papike dealt with a counterpart

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law state -- state law tort claims were preempted because

there were counterpart regulations specific to a device

promulgated by the FDA in a similar lawmaking progress that

was described in Riegel and Lohr, and therefore those claims

were considered preempted.

Those are limited to warnings. There was warning

language in those counterpart regulations. Completely

different than in Bard's papers where they claim the separate

situation of the Degelmann case, which is vacated and no

longer good law. If it were good law and I had to argue that

the differences are, they are vast.

First of all, Degelmann was a false advertising case,

an unfair competition and false advertising case. It did not

deal with the design of the product at issue. Degelmann

actually says in order for the class to recover in this

lawsuit, a court would have to hold that the California's UCL

and false advertising law required something different than

what the FDA required in order for the defendant to label the

product as a disinfectant. There was an issue with the label

and what was represented in the label and were they

representing the product accurately.

The contact lens guidance is comprehensive and

detailed. And the Degelmann court also said in order for a

contact lens care solution to be labeled as a contact lens

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criteria of the stand-alone procedure for contact lenses in

disinfecting products. Those were contained in the guidance

document.

Primary performance criteria. These are criteria

that no longer exist in the MDA. The contact lens guidance,

as it compared to the IVC guidance, is unbelievably detailed.

There are specific materials and testing agents, the specific

test organisms, the testing and media, and it's specific as to

which ones. They are labeled and documented.

Beyond the testing materials, a testing method is

laid out, which does not occur in the IVC filter guidance.

Culture maintenance. Preparation of microbial challenge. In

other words, if you're disinfecting, how do you infect it

first before you can disinfect it? It's five different

bacteria and fungi that have been known for hundreds of years,

and the testing laid out how to harvest the cultures, how to

suspend the spores, how minutes to keep it there, the gravity

at which to centrifuge it at, and how much to dilute it. And

that's before you even get to the test procedure, which

involves the preparation. I've only included three steps.

There are seven. The preparation, the storage, the actual

collection of samples before you test. It is laid out in this

guidance document. And then, you get to the performance

requirement.

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standards. There are no specific federal requirements.

Riegel tells us that a requirement is created by the PMA

process. Federal requirements are -- are the things that are

promulgated in a lawmaking process.

The IVC filter guidance, Mr. North covered aspects of

things such as the sheath and things like that.

The scope, he -- although he did not point out, is

that it -- it states that this draft guidance has been

developed in an attempt to identify, an attempt to identify,

design considerations. There is nothing specific about it.

It's a submitter's responsibility to conduct testing which

adequately addresses the concerns outlined below, as well as

any others which may arise due to the uniqueness of the

design. It's the manufacturer that has to come up with the

performance standards. They're not federally imposed.

Labeling. There is nothing in the IVC filter

labeling for IVC guidance that is specific. It just considers

category, indications for use, contraindications, and

warnings. This is not a federal requirement, as Mr. North

alleged. It has a section for indications for use. It has a

section for contraindications, with one in particular.

And with regard to claims that have been made in this

case, again, there are no design performance standards here,

nothing about the design of a filter is addressed, much less

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retrievable filters were even on the market.

And the only specific warnings, the only potential

crossover, again, in the world if Degelmann were still good

law, is that there is specific labeling language for MRI

compatibility. There is no labeling language here at all for

any disease state or injury at issue in this case.

They are completely different.

Furthermore, guidance is not law.

The footnote actually says "this document is intended

to provide guidance. It represents the agency's current

thinking. It does not create or confer any rights for or on

any person, and does not operate to bind the FDA or the

public. Alternatives approaches may be used if such approach

satisfies the requirements of the applicable statute,

regulations, or both."

This is Lohr.

Statutes and regulation are general controls. Riegel

tells us -- actually, Lohr told us and Riegel upheld it 15

years later, that the MDA does not require a device maker to

make a device that takes any particular form for any

particular shape.

Guidance is not law, it's not a federal requirement.

And according to Lohr, because the federal government did not

weigh the competing interests relevant to the particular

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how those competing considerations should be resolved in a

particular case, or a set of cases, and implement that

conclusion via specific mandate on manufacturers or producers.

The guidance document does not do that. It is not a

federal requirement. Special controls are not federal

requirements. Special controls were mentioned in Lohr, and in

the midst of the sweeping language the Supreme Court made, it

did not say special controls were federal requirements. They

were regulatory tools.

Your Honor, we saw this light earlier with regard to

the difference between, or the alleged difference between

reclassified devices and any impact that might make on this

case. Again, this is of no particular moment.

This guidance also states -- I'm sorry, this

regulation also states that "any representation that creates

an impression of official approval of the device because of

complying with premarket notification regulations is

misleading and constitutes misbranding."

Any representation.

Bard has made representations throughout their motion

that they are something like PMA, they are akin to PMA, that

they should enjoy the protections of the express preemption

clause because what they went through and how unique their

record is, they should be -- these claims should be preempted.

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This language that I just quoted was in every single

substantial equivalence letter. They are prohibited. It's

not a -- not often quoted or forgotten regulation. They saw

it every single time they received substantial equivalence.

Yet they're making the representation that their application

is something like PMA approval. That is the continental

divide. You -- the FDA says each time they give you clearance

for your device to get to market you cannot say in any way any

representation that creates an impression that you are like

the PMA process.

Furthermore, if Bard wanted to enjoy the express

preemption protections, they could have submitted a PMA

application.

When we looked at the 807.87(l), which is the

regulation that allows for the commission -- for the FDA to

ask for any additional information for a 510(k) application,

they can submit the requested data, a new premarket

notification, or submit a premarket approval application in

accordance with Section 515 of the Act. If the additional

information is not submitted within 30 days, we covered that.

Bard had 33 opportunities to submit a premarket

approval application each time they responded to the

defendant -- I'm sorry, to the FDA's deficiency letters. They

did not do so.

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there are so many responses and that is why there are so many

exhibits attached to their motion. This is, again, the blow

by blow by blow rendition of what their product went through.

Your Honor, defendants' motion should be denied for

the initial statements I made at the outset of my argument.

There is absolutely no evidence in the record of what they're

claiming. They have not properly applied the express

preemption test. And they have engaged in improper burden

shifting, asking plaintiffs to provide what they have not in

the record.

THE COURT: All right. Thank you.

Mr. North, I'll give you about five minutes to reply,

but then I want you to address Booker.

As I understand or my review of the motion shows that

the manufacturing defect claims of Ms. Booker, which are in

Counts 1 and 5, have been withdrawn. The failure to recall or

retrofit in Count 6 has been withdrawn. Breach of warranty

claims in Counts 10 and 11 have been withdrawn. Bard is not

moving for summary judgment on the design defect claims in

Counts 3 and 4.

And so the only things we need to address are the

failure-to-warn claims in Counts 2 and 7, the

misrepresentation claims in Counts 8 and 12, the negligent per

se -- negligence per se claims in Count 9, and punitive

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

THE COURT: So it seems to me we can maybe take 10 or

15 minutes for that argument since it is a more discrete

group.

Mr. North, why don't you go ahead and give the reply

you would like to on the preemption motion.

MR. NORTH: Sure, Your Honor, and I will be brief.

I just wanted to point out three things. Revisiting

the Court's question about Justice O'Connor's dissent in Lohr,

I do note that she says that the 510(k) process standing alone

does not indicate -- have a preemptive effect, but she goes on

to find that other claims are preempted because of specific

standards that she thought should apply.

So we're not arguing here that just the general

510(k) process by itself results in preemption, but the

application of the specific standards in this case, the

guidance as applied by the FDA over the 15 years. And that

same point, I think, is relevant to all of the cases cited by

the plaintiffs.

These were cases where a manufacturer came in and

argued the SDMA, the 1990 revision, a modification of the Act,

somehow rendered Lohr incorrect.

We're not saying that that alone, the enactment of

the SDMA, somehow justifies preemption. We're saying that's a

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have in this case with a specific standard, the FDA guidance

for IVC filters, and how the agency has applied that. And in

none of those cases is there that sort of circumstance.

And lastly, Your Honor, with regard to the standard,

the FDA guidance, I would note that the plaintiffs say this is

not a performance standard. Well, it has a lengthy section on

filter performance. It addresses many different aspects of

filter performance. It gives the manufacturer very specific

instructions as to how these performance attributes should be

evaluated.

And then it also -- and this is the next page --

under that general heading of filter performance, it lists the

ones I mentioned earlier: Simulated deployment, introducer

sheath suitability, a test regarding clot trapping ability.

It says "this test should demonstrate that the device

can capture clinically significant emboli yet still permit

sufficient blood flow." It is a performance test that is

being required.

The same thing with regard to filter fracture, caval

perforation, Thrombogenicity.

In short, this FDA guidance is a performance

standard, and it's very specific to filters. And it's not

just aspirational, Your Honor. The record in this case makes

it clear that if we had not complied with that -- and even

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deficiencies. We presented tests in our original submissions

that fulfilled each and every one of these criteria. But they

wanted additional information because they were assessing the

safety and effectiveness of this device.

So this is, we submit, one of those rare instances of

something more or something like it, as Justice Gorsuch

mentioned in Caplinger. It may not be a PMA review, but it is

certainly something like it. And because of the application

of this specific standard, we would ask that the Court grant

this motion.

Thank you.

THE COURT: Okay. Thanks, Mr. North.

MS. HELM: Good afternoon, Your Honor. I'm

Elizabeth Helm.

And you are correct that we are down to just a few

issues on the motion for partial summary judgment: The

misrepresentation claim, the negligence per se claim, the

failure-to-warn claim, and punitive damages. And I'm going to

address them in that order.

The misrepresentation claim fails as a matter of law.

This is basically a no-evidence motion. Under Georgia law,

reliance is a necessary element, whether it's negligent

misrepresentation or fraudulent misrepresentation.

Ms. Booker -- and the case cite for that is Potts

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Court of Appeals case from 2002.

Ms. Booker's testimony is she didn't even know she

had a Bard filter until after her -- until her lawyer told her

after she filed suit, or contacted her lawyer. She received

no information from Bard. She never had any communications

with Bard.

As to Dr. D'Ayala, the implanting physician, his

testimony was that he did not rely on any information from

Bard, and he specifically did not recall any conversations

with the Bard sales representative, who would have been his

only source of communication with Bard.

So as a matter of law they have failed to establish

that crucial element of any reliance for misrepresentation.

As far as plaintiffs' negligence per se claim --

THE COURT: Before you leave misrepresentation, the

argument you just described was the second argument in your

brief. The first one was that misrepresentation doesn't exist

under Georgia law in a product liability case. Are you no

longer asserting that argument?

MS. HELM: Your Honor, actually, in the interest of

brevity, whether it exists separately or as an element of

product liability, reliance is a necessary element, and they

can't meet that either way.

THE COURT: Well, but so are you still arguing there

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distinct from failure-to-warn claims?

MS. HELM: No, Your Honor.

THE COURT: You are not making that argument?

MS. HELM: No, Your Honor.

THE COURT: Okay. 

MS. HELM: As to their negligence per se claim,

Your Honor, the official code of Georgia Annotated 51-1-6

codifies negligence per se, but it requires as a prerequisite

an underlying statute or law that gives a private cause of

action.

The plaintiffs concede that their negligence per se

claim is based on the Federal Drug and Cosmetic Act, which the

United States Supreme Court has said in Buckman, at

531 U.S. 341, does not give a private cause of action. So as

a matter of law they don't have a negligence per se claim

under Georgia law because it requires an underlying law or

statute that gives a private cause of action. They have a

negligent design claim. It's just not as a violation of a

statute because they concede in their response that the only

thing they're rely on is a violation of the FCDA -- excuse me,

FDCA. So they don't have an underlying statute that gives a

private cause of action. As a result, under Georgia law and

under 51-1-6, they don't have a negligence per se claim.

It does not create a separate cause of action,

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in Georgia.

Your Honor, that brings to us the failure-to-warn

claim. And both parties spent a tremendous amount of time in

our briefs addressing this issue of rates and comparative

rates of filters. And I want to back up. And the important

time period here is June 21, 2007, when Ms. Booker was

implanted with her G2 filter.

Under Georgia law, to prove -- to survive summary

judgment on a negligent to warn claim, the plaintiffs have to

prove a duty, breach, and proximate cause. Basically the

three elements of negligence.

In this case, I think we all agree that the duty was

to the learned intermediary, Dr. D'Ayala, who implanted the

filter.

If you reed Dr. D'Ayala's testimony in his

deposition, he was a true learned intermediary. He was well

versed on filters, he was well educated on filters. He

testified unequivocally that he was aware of the risks of

filters at the time he implanted Ms. Booker's filter on

June 21, 2007. 

He also testified unequivocally that he made a

risk/benefit analysis, that she needed a filter, he decided to

use a G2 filter, and he communicated to her through the

informed consent process the risks associated.

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very complications that resulted -- Ms. Booker ultimately

experienced with her G2 filter.

Bard met its duty. It provided information to

Dr. D'Ayala. He admitted he had access to the IFU, which

included the risks at issues, the complications that

Ms. Booker experienced.

He also admitted that he relied on information from

the -- from his colleagues, from the FDA, and from his

experience, and he had all of that in 2007, when he implanted

Ms. Booker's filter.

This question of rates, we argue that the plaintiffs

are trying to create a new duty. A duty to warn of rates.

Plaintiffs argue no, it's not a duty, it goes to the adequacy

of the warning.

But based on the record in this case, while we

disagree rates should be a part of a warning, and I'll be

happy to address that, based on the record in this case, the

third element, whether it's a duty or it goes to the adequacy

of the warning, the plaintiffs cannot meet that third element

of proximate cause because under George law, the plaintiffs

have to show that but for the inadequate warning or but for

the missing information, the doctor would have changed his

prescribing habit.

In other words, they have to show that had

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he would not have implanted Ms. Booker with a G2 filter. 

Dr. D'Ayala testified to the contrary. His testimony

is -- when asked, after being provided with some internal Bard

documents relating not to the G2 filter but to the Recovery

filter, "After seeing this information would that have been

enough for you to use another filter?" 

His answer is, "Difficult to say with certainty. It

would depend upon what other filters we had and what their

problems would have been."

In another question he was asked, "If there was a

25 percent risk of filter fracture, can we safely say you

would not have used that filter?" 

And his answer is, "Most likely. But you have to

understand that you have to have a way of treating these

difficult patients. Some filter has to be used and it becomes

a matter of deciding which filter is best, so to speak. And

sometimes that's not entirely clear."

Nowhere in his testimony, after being provided with

hypotheticals, after being provided with internal documents

about the Recovery filter, after being provided with articles

that were written three years after Ms. Booker's filter was

implanted, nowhere in his testimony does Dr. D'Ayala say "I

would not have used a G2 filter even knowing all of that

information today." He doesn't say it.

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proximate cause that is necessary under Georgia law to survive

summary judgment on a failure-to-warn claim.

Plaintiffs rely on two other cases involving Bard,

Cisson versus Bard, which was women's health mesh case, and

Cason versus Bard, which was a filter case decided in Georgia.

Both of those are factually distinguishable from this case.

Summary judgment is based on the facts of this case.

It's not based on Cisson, not based on the facts of Cisson.

It's not based on the facts of Cason. In both of those cases,

the doctor testified completely differently than what

Dr. D'Ayala said. In both of those cases, the doctor

testified that he would have made a different prescribing

decision based on the information provided to him during his

deposition or trial testimony.

So while -- while there's a debate and, respectfully,

we do not believe rates should be considered as part of either

the duty to warn or as part of the adequacy of the warning for

a number of reasons. And, frankly, both the FDA and

plaintiffs' experts agree with us. Plaintiffs' regulatory

expert has testified you cannot use rates for comparison. You

can't compare apples and oranges. The FDA has said you can't

use the MAUDE data for rates purposes.

So it should not be a part of the warning, it should

not be a part of the duty. Neither of the courts, neither

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addressed it in the proximate cause prong of the duty to warn.

They both addressed it saying the doctor would have made a

different decision based on the information.

Your Honor, because they can't meet proximate cause,

it's an "and" standard. It's duty, breach, and proximate

cause. Because as a matter of law, based on Dr. D'Ayala's

testimony, they can't meet the proximate cause prong, their

failure-to-warn claim fails as a matter of law.

And then finally, Your Honor, their punitive damages

claim also fails as a matter of law. It's again based on

rates, and if you look at their brief they spend pages

outlining information. And if you look -- you don't even have

to look carefully, but if you look at their bullet points it

says, Recovery filter, Recovery filter, Recovery filter,

Recovery filter. And then there's a couple of bullet points

where they conflate the Recovery and the G2. But their

punitive damages claim is, again, based on rates and problems

they contend existed in the Recovery filter, not in the G2

filter.

And their punitive damages claim is based on the

Georgia statute that uses this language, "conscious

indifference." And the Cisson court actually addressed this

question of conscious indifference and said "to have conscious

indifference, you have to find, the Court has to find, that

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danger, and took no action to remedy the danger."

In other words, the Cisson court said that the

defendant did nothing.

In this case, the plaintiffs admit that the G2 filter

that was implanted in Ms. Booker is actually a redesign of the

Recovery filter on which they base their punitive damages

claim.

They also admit that the IFU that was with the G2

filter contained warnings of the very complications that

Ms. Booker experienced in this case. So their conscious

indifference, their failure -- their Bard did nothing, fails.

They admit Bard warned. They admit the language was

in the warning. They admit Dr. D'Ayala was warned. They

admit that Bard actually did something. The G2 design itself

was -- addressed all of those bullet points on the pages of

their brief.

Then they go forward and say, Well, wait, wait. Bard

made design changes in the future. So they were consciously

indifferent in 2007 because they continued to evaluate their

product and made subsequent design changes in the future.

That is not a basis for punitive damages. You can't impugn

future knowledge back to 2007 at the time Ms. Booker's filter

was implanted.

Your Honor, their design claim, we agree, is probably

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remaining claims that we moved on -- negligent

misrepresentation, negligence per se, failure to warn, and

punitive damages -- we believe fail as a matter of law, and

we'd ask the Court to grant the motion.

THE COURT: All right. Thank you.

MR. O'CONNOR: Your Honor, just one moment. I just

need to get set up here.

Your Honor, I'm going to start with the failure to

warn, if that's okay with you. And as I get into that

argument, I think one of the most important aspects of the

learned intermediary doctrine is the importance that it

accords the patient/physician relationship, that the -- one of

the most important communications that can occur between a

doctor and the patient has to do with risk and benefits. And

that's why it becomes even more critical that when a doctor

goes through the risk/benefit analysis that he has the best,

the most updated, the most recent information on risk

associated with the device that he's going to use. And if

there are increased risks, then they need to be communicated

to that doctor.

There's a lot more to a warning than just an IFU.

Labeling encompasses everything that a manufacturer says about

a filter or a product. Whether it's touting it, it should be

also talking about information that it knows that a doctor

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analysis in meeting with a patient.

And as we were talking today -- and I just want to

make sure I can get this up --

MS. REED ZAIC: Show you the trick. Stand here and

go forward with this. Point behind you.

MR. O'CONNOR: Going through what was filed here.

The argument that was made today is identical to an argument

that was made in Georgia, before a Georgia judge applying

Georgia law. And Pamela Cason, like Sherry Booker, was

another patient who received the G2 filter. Like Sherry

Booker, her filter failed and fractured and migrated. And

that's what happened to Sherry Booker.

And -- and the information in the IFU, while it does

cover those risks, what the court in Cason found is that --

rejected the argument that was made then, rejected the

argument that was made here, that there was a genuine issue

whether the warnings provided by Bard were adequate.

Reviewing their argument about the IFU. There, the

judge in Cason found that there was evidence that the G2

filter had a significantly greater propensity to fracture,

migrate, and perforate the IVC other than IVC filters. And

given this evidence combined with the evidence that the

defendants did not warn Ms. Cason's doctor about the increased

risk associated with the G2 filter, a reasonable fact finder

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warning regarding the G2 failure.

THE COURT: I have read the Cason case.

MR. O'CONNOR: And there they made the same arguments

that they've made here.

Your Honor, when I was looking at other cases that

they were citing, and I looked at the Wyeth case and the Ellis

case, and Wyeth, that had to deal with a diet drug. Ellis had

to do with a pain pump. But the common theme in that case was

the use by those manufacturers of their sales force. How

important the sales force was to communicate the risks, the

complications, to continually warn the medical staff about

problems associated with third-party activation, to

continually update doctors about complications that were being

found about the particular diet drug in Wyeth.

And here, Bard really hasn't cited anything from

their sales force. But we have. And we cited testimony from 

Robert Cortelezzi, testimony from Jack Sullivan, testimony

from Dan Orms, testimony from Dan Fischer -- excuse me,

Tim Fischer. Testimony from Robert Ferrara, the sales rep in

this case.

With respect to the first sale -- regional sales

managers, what they acknowledged is that relationship with the

doctor is important, it's based on trust, and they know that

doctors rely upon them. Rely heavily on them to provide them

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recognized that that was a very effective means to communicate

information to doctors. And despite the evidence that we've

shown here that was shown in the Cason case, that Bard was

well aware of increased rates of failures in its G2 filter,

that it was not resistant to migration, that it was not as

resistant to fracture, none of that information was given to

the sales force. And it became a very effective way to keep

the doctors in the dark.

And that's what happened in this case. Because as

you can see from the record we provided, Dr. D'Ayala testified

he would have liked to have known about increased complication

rates. He would have found important information contained in

health hazard evaluations. But he wasn't given that

information. 

And when you look at the informed consent process, it

really is an objective process. And -- and -- and even

Dr. Grassi, an expert of the defendants, testified, and we

gave that you testimony, that the issue is what would a

reasonable patient want to know? And along those lines,

asking a doctor today questions about what he would have

wanted to know then is one piece of it.

And Dr. D'Ayala's testimony definitely creates a

question for this jury who's going to hear this case to hear

and review.

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entitled to every reasonable inference in our favor. But as

you saw, Dr. D'Ayala said that there was important

information, it would have affected his decisions, but it gets

to be more than that.

Chris Ganser, the vice president of regulatory

affairs, provided testimony that, yes, doctors would want

information about failure rates. Yes, doctors would want

information about test results. Yes, doctors would want to

know if Bard was aware that its filter wasn't, in fact,

bringing strength and stability to a new level, but was having

increased rates of failure in terms of fracture, migration,

penetration, which was the case here.

And in December of 2005, it's no wonder that the

medical director in this case, Dr. Ciavarella, asked the

question knowing that there was so many increased rates of

failures with the G2, knowing that they were marketing and

implanting these filters and that they were being held out as

permanent filters, knowing that the G2 was not behaving at all

like a permanent filter because they had one, the

Simon Nitinol, he asked the question, why shouldn't doctors be

using the Simon Nitinol filter which literally has no

complaints.

So when we look here at the learned intermediary

doctrine, and we look at what Bard was well aware of, and --

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than in the Cason case of the knowledge this company had, Bard

had, of the G2 -- which, by the way, the predicate device for

the G2 was the Recovery. And as a matter of fact -- let me

find my note -- when the G2 first came out, they were calling

it the Recovery G2.

These filters were all in the same family. And the

G2 wasn't behaving any better than its relative, the Recovery.

In fact, it was behaving worse in terms of things like

[[caudal migration. And Bard knew that. And that's

information that doctors not only would have wanted to know,

it's information that doctors had to know. Because when

everybody wants to talk about risk and benefit and a doctor

needs to make that important decision and then have that ever

important conversation with his patient, he needs to know what

are the risks. And if there is an increased risk that the

company Bard is aware of, he is not only entitled to know

that, but he has an absolute right to know that. Because Bard

had all sorts of effective measures to communicate this

information.

And like what happened to Mrs. Cason, the same thing

happened to Sherry Booker. And just like there was a question

of fact whether that warning was adequate based upon what Bard

knew and didn't disclose in any form, much less the IFU, about

the increased risk of the G2 filters, that is a question that

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And if you look at the evidence and you look at

Dr. D'Ayala's testimony, and you consider the testimony of

experts in this case, including Dr. Kinney and Dr. Roberts,

who talked about why it's important for doctors to know about

increased risk, if you look at testimony from their own

expert, Dr. Moritz, who agreed that Bard's internal

information is information he would have wanted to know in

making those decisions, then certainly that is an issue that

reasonable minds should consider, and certainly reasonable

minds can certainly have different -- different views on that.

So we believe we have established questions of fact

on both the inadequacy of the warnings, the complete failure

of Bard to keep the medical community apprised of the

increased failure rates of these filters, beginning with the

Recovery and then going into the G2, and how those filters

compared worse than the Simon Nitinol and even with other

filters. Bard had that information and they had that

information in their possession.

Now, on this issue of expert testimony, I can

supply --

THE COURT: We're at about 15 minutes, Mr. O'Connor.

MR. O'CONNOR: Pardon me?

THE COURT: We're at about 15 minutes on your --

MR. O'CONNOR: Let me just get to the next issue,

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If negligent misrepresentation is encompassed by

failure to warn, that just goes to the point that the doctor

is the party that needs to have the accurate and truthful

information. And if that's not getting to the doctor, then

those claims should go to toward forward to the jury.

On the issue of negligence per se, Your Honor, when

we were doing research we found a case from the Ninth Circuit,

and it is McClellan Versus I-Flow Corporation, 776 F.3d 1035.

I have a copy if you would like it.

THE COURT: Actually, we've seen that case.

MR. O'CONNOR: Pardon me?

THE COURT: We found that case.

MR. O'CONNOR: You have the case?

THE COURT: Yeah.

MR. O'CONNOR: Well, Your Honor, that case basically

in the Ninth Circuit said that the court in that case should

have instructed the jury with negligence per se that relied

upon FDA regulations. And it noted that Buckman really wasn't

applicable because Buckman concerned claims of fraud on the

FDA, and the reason why that claim couldn't go forward is

because the recognition by the court said the FDA is equipped

to police its system for fraud.

But in terms of allowing a negligent per se case to

go forward, McClellan in 2015 found that it certainly should

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Finally, Your Honor, in terms of punitive damages, we

have provided replete record of evidence that shows a complete

conscious want of care by Bard stemming from the failures to

disclose the known increased complications of its filters,

ignoring suggestions by independent doctors that the filter

should be redesigned. Even its own engineering staff.

Bard was in a race to a market. The optional filter

was a great idea; it meant major profit. And they did that at

the expense of safety. And the evidence in this case shows

clearly and convincingly that what Bard knew about its filters

was not good, and that what Bard did, rather than taking them

off the market, rather than holding off on sales for a while,

it continued to tout them as bringing strength and stability

to a new level, and it worked in a very strategic way to keep

the medical community in the dark by keeping their own sales

force in the dark.

As a matter of fact, even in the cases we've gone

through discovery and deposed experts, we find they're not

even giving their experts the internal information that they

have been well aware of.

So once again, Your Honor, I think -- I'm sure my

time is up now and I'm willing to sit down, but here we are

responding to this motion for summary judgment, and as the

plaintiffs in this case we must receive every reasonable

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Bard, the warnings that were given doctors, were entirely

inadequate, they did not talk about what Bard knew about

increased failure rates, and that in terms of punitive damages

that Bard was keeping information away from the medical

community and consequently the patients.

And there was evidence that that was a conscious want

of care, a conscious and deliberate indifference to not only

the rights of doctors and patients, most importantly, but also

to their safety, and that's what it case is about.

THE COURT: Okay. Thank you.

Any brief comments?

MS. HELM: Very brief, Your Honor. 

Your Honor, on the failure-to-warn claim, plaintiffs

rely on Cason very heavily and make the argument that the

identical argument was made to a judge in Georgia. What's

different about Cason is the record. The record in Booker is

different than the record in Cason. And, respectfully, this

Court has to decide the failure-to-warn claim on the record in

Booker, not the record in Cason.

And if you look at -- we submitted Dr. D'Ayala's

entire deposition. It's not incredibly long. But the entire

deposition is before the Court, and I think if you read his

entire deposition you will not find anywhere in there where he

says "I would not have used the G2 filter." Knowing all of

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during the deposition about the Recovery filter, about rates,

about articles, after being told all of that, he never said "I

wouldn't have used it." He said that might have been

important information, but he never said he wouldn't have used

the G2 filter.

The other thing --

THE COURT: Let me ask you a question on that, if I

can.

My only citation here is to, I think, a statement of

facts, if that's the document at 8169. It's paragraph 333.

It's a quote from Dr. D'Ayala's testimony, where he says, "The

answer would have to be yes...I would have used a different

filter if there was a different filter that I knew of that was

better, in terms of its safety profile."

What is your -- I don't know if you can find that. 

MS. HELM: I --

THE COURT: I don't have a deposition page cite.

Check pages 32 and 33 of your deposition, see if that's where

it is.

MS. HELM: I have the statement of facts, Your Honor.

THE COURT: It was pointed out I said 333. It's

paragraph 338.

MS. HELM: If the Court will indulge me, Your Honor,

I'll find it.

1 4 : 4 0 : 3 9 Your Honor, the testimony -- I found it. It's

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actually his deposition testimony on pages 62 and 63.

THE COURT: Can you read the question and answer

there. I've only got the excerpt in my notes in front of me.

I don't have the actual exhibit.

MS. HELM: Your Honor, the question and answer is

very long. I'll be happy to read it.

THE COURT: Well, there's a place where he begins in

the answer "With regards to the Bard filter would I have used

a different device if I knew at the time that the Bard filter

was not ideal or as good as some of the other implants? The

answer would have to be yes."

MS. HELM: That is the answer -- that is the last

sentence of a page-and-a-half answer.

And the answer -- they're talking about a clinical

trial and he says the trial is a great study and it's very

interesting but there are problems with the study, as there

are problems with every study, and the fundamental problem you

have with this trial is that it's randomized. Patients who

were candidates for caval interruption are not -- in other

words -- I mean, he goes on and on and on. Says Ms. Booker

needed a filter.

You have to back way up and -- I apologize. You have

to back way up to get into the question of if you had known

fracture rates from this study would you have used a different

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He then gets asked the next question if it -- now

that you've seen these documents and it had -- would you have

not used a Bard filter. All of these documents collectively.

And that's on that same page, on page 63 he says, "It's

difficult to say with certainty. It would depend on what

other filters we had at the time and what their problems would

have been."

And then he goes on later to say, "I can't say."

So -- and under Watkins versus Eli Lilly, which is a

Northern District of Georgia case from 2012, the court held

you can't speculate, you have to -- the plaintiff has to show

that the doctor would have changed his prescribing habits,

would have used a different product, and Dr. D'Ayala simply

didn't say it.

He -- Your Honor, he was actually truly a true

learned intermediary. He was very smart, he was very well

versed on filters. And a complete reading of his deposition,

he told us what he relied on and what he knew.

He admitted he was aware of the risks in 2007 when he

implanted the filter, and that he addressed those risks with

Ms. Booker. He also admitted that he never relied on and

never requested information, internal information, from a

company. And when asked about a specific document, he gave a

great answer --

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MS. HELM: I think you should, Your Honor, because I

believe the record is very different from Cason.

And I want to point out one more thing in Cason, and

that is Judge Shoob never addressed whether comparative rates

are part of the duty or part of the adequacy of the warning.

Judge Shoob went right to proximate cause. And I think that

he said "based on this record I find a question of fact."

Frankly, that's what happened in Cisson too. And

Cisson was a posttrial motion, it was not a motion for summary

judgment.

The other difference between Cason and this case is

there was expert testimony in Cason relating to the use of

rates. In this case, the experts, plaintiffs' own experts,

Dr. Parisian says you can't do what the plaintiffs are asking

you to say that Bard had an obligation to do. She says you

can't use comparative rates.

The FDA says, and it's cited in our brief, you can't

use the MAUDE database for comparative rates.

So that's a difference in the record in Cisson than

the record before this Court.

And then finally, Your Honor, as to punitive damages,

Mr. O'Connor based his entire punitive damage argument on two

things: One, the Recovery filter, and there's been no showing

that it's substantially similar. It should be considered for

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issue that will likely get briefed at length in this case.

And the second is on the fact that Bard --

THE COURT: Wait a minute. Get briefed when at

length?

MS. HELM: Your Honor, to the extent that you're

going to rely on the Recovery filter for making a decision on

punitive damages, we would ask you to hold off until we have

an opportunity to brief in a motion in limine, explain why the

Recovery filter is not a substantially similar to it filter to

the G2.

THE COURT: But you argued that in these briefs;

right?

MS. HELM: We argued that it was not, yes,

Your Honor. We did. That's fair.

The other argument he made today is that we -- the

plaintiff's entitled to punitive damages because Bard did not

take the product off the market. Well, they've withdrawn that

claim. They withdrew their failure-to-recall claim, and

that's how Bard would take it off the market. And so the

basis of their punitive damages, again, is based on the claim.

And then finally, Your Honor, in the Jones case and

the records before the case, we cited a long list of cases

outside of Georgia because Georgia -- there's -- about the

rates issue, and I just wanted to make sure the Court was

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THE COURT: I have looked at the long footnote and

the cases in the text that you cite, so I know what those are.

And I've read about half of them so far.

MS. HELM: Thank you, Your Honor.

THE COURT: Okay. We're going to take a break for 15

minutes for the benefit of the court reporter. We'll resume

at 3 p.m. And we'll then talk about case management matters.

(Recess taken from 2:47 to 3:01.)

THE COURT: Thank you. Please be seated.

All right. Counsel, I'd like to talk to you about

the case management issues that were raised in your joint

status report. One of the issues that I think we need to

address is the order in which I should continue working on the

filed motions. We've got a hearing on December 15th. I am

confident I will not be able to finish the four motions

planned for today plus the five or six that were scheduled for

December 15th by the 15th.

We have left in the motions that were set for today

the two disqualification motions with respect to experts, and

then the motion on David Kessler and Suzanne Parisian. Those

were also set for today.

I guess the question is do you want me to turn to

those next for December 15th, or is there some reason you

think it would be better for me to jump to the list of motions

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MR. LOPEZ: From the plaintiffs' perspective, Your

Honor, I think we ought to keep this order. We kind of

negotiated this order; it seems to make sense for both sides.

THE COURT: Okay. 

MR. LOPEZ: So we'd like to keep that order.

MR. LERNER: We agree, Your Honor.

THE COURT: So what we'll do is we will work on those

four, and we will aspire to work on the first two in the

December 15th list, which are the opinions of Kinney, Roberts,

and Kalva, and then the opinion of Muehrcke, M-U-E-H-R-C-K-E.

MS. REED ZAIC: Muehrcke, Your Honor.

THE COURT: I don't know if we'll get to those, but

what I'll try to do is let you know a week or so ahead of time

how we're doing so you know what we're going to argue on the

15th.

But a bigger question, obviously, that this presents

is I'm just not going to be able to get all of the issues, all

of the motions on this list, decided by the January 19th or as

of the January 19th argument that we had talked about. It's

just not going to be physically possible for me.

So a second question I have for you is whether you

think all of the issues on the list now for those hearings

need to be decided before the Booker bellwether trial,

assuming I don't -- well, Booker's going in part in any event

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So the question is do we need to get all of those

motions resolved in order to do the first bellwether trial, or

are there some that don't apply to the Booker case that we

could hold off on so we can still try to get everything done

we need to before the Booker trial?

MR. LOPEZ: Well, sadly, probably most of them,

Judge. I can see maybe two or three we might reserve, I'm not

sure how much that will help.

THE COURT: Well, anything helps. What are the two

or three you think would not need to be resolved before

Booker? 

MR. LOPEZ: There's a couple of -- I don't want to

say quite yet, but I think one of them would certainly be, and

then maybe one we think December 15th, whether or not both

Dr. Kessler and Dr. Parisian will be testifying in the Booker

case. So we can probably make that decision certainly by next

week.

And then we want to use one of the Doctors Kinney,

Roberts, and Kalva report because it's relied upon by so many

of our other experts. So we want that resolved.

And then you would probably want us to choose which

one of those doctors would testify in the Booker case, and we

can probably make that decision.

THE COURT: Well, why don't I do this: I'm going to

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it to me. If you decide there are experts on this list that

won't be needed for Booker, let me know and I'll jump over

those motions as we move forward. That will save us some

time.

We still, though, even if we knock out two or three

of them, are not going to get everything decided as of the

January 19th oral argument. And we've got a month, we've got

February in there, before we get to the March trial date for

Booker.

That leads to a second question which I have, and

that is how many motions in limine do you all anticipate

filing before a trial like the Booker case?

I will tell you that another fact is I typically

limit parties to three-page motions in limine. I want it to

just cut right to the very heart of the issue so we don't have

15, 20 page motions in limine. If it's a Daubert motion,

obviously I don't hold folks to that limit, but we've got the

Daubert motions briefed. Now, if there is an unusual motion

that can't be done in that amount of space, I'll certainly

consider that. But I try to really focus them and target

them.

But still, if you're going to file 10 motions in

limine, that's one thing; if you're going to file 30, it's a

different thing. I need to factor that in in trying to get

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MS. REED ZAIC: Let me take a stab at it, Your Honor.

Just in preparation for Austin trial, the case in

Florida that was about to go and didn't, plaintiffs only filed

four motions in limine. Now, that was also the product of

nego- -- pre-negotiation before the filing date of things we

were able to work out. 

In Mrs. Booker's case there might be some specific

ones we would move on, that we would first negotiate with the

defendants to see if we need to move at all, or we can reach

an agreement via stipulation that certain evidence wouldn't be

presented at the time of trial.

So to make an estimate, I would say, and this is very

rough, maybe six, five or six or --

THE COURT: I won't hold you to it. I'm just trying

to get --

MS. REED ZAIC: Right. Again, it all depends on the

negotiations we engage in.

MR. LERNER: Your Honor, I would estimate about eight

to 10.

THE COURT: Could you pull the mic over.

MR. LERNER: I estimate eight to 10 motions in

limine.

THE COURT: And that's after discussions with

plaintiffs you think there will be that many left?

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THE COURT: I'll tell one other thing. My view is

that motions in limine should not be used to pre-try the case.

So if a motion in limine can be stated as an objection at

trial that I can rule on, typically it ought not be a motion

in limine, unless it's truly unduly prejudicial. Motions in

limine, in my view, instead should be used for evidentiary

issues that will assist you in preparing the case, that may

deal with categories of evidence. So keep that in mind.

But it sounds like we may have 10 to 15, or maybe

even a few more, motions in limine to resolve.

What do you think about the three-page limit? Do the

kinds of motions you're thinking of lend themselves to that

sort of targeted briefing?

MR. LOPEZ: I can think of one exception right now,

and that would be the Cisson motion.

THE COURT: That's the one you mentioned in the

footnote --

MR. LOPEZ: Right. There's like three cases. It's

basically our motion to exclude 510(k) and FDA process

evidence.

THE COURT: Okay.

MR. LOPEZ: That's going to need more than three

pages, I'm afraid.

MR. LERNER: Your Honor, I think three-page limit

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we file that we might ask for additional pages.

THE COURT: What would that be for?

MR. LERNER: A motion in limine related to the

Recovery filter. Evidence of migration and things like that.

THE COURT: Okay. We're going to come back and talk

about these again, but let me ask the next question. I was

surprised when I read the joint report and there was a

suggestion made that the Booker case may settle between now

and trial. I guess I had assumed that we'd pick the

bellwethers to try them and weren't going to be doing

settlement negotiations on a case-by-case basis between now

and trial, so I had never factored in the thought we may lose

a bellwether trial on the eve of the March trial date.

MR. LOPEZ: Well, the best way for me to address that

is to discuss what has happened historically in these cases

over the last six years, and that is both sides get geared up

for trial and they don't settle until they get to the

courthouse steps. Or until you're in trial.

So we had this case in March that got continued, the

judge there had another calendar, he had to take another case.

We were pretty -- we were pretty much -- we were inching

together. We were getting closer in our negotiations in that

case and, of course, as soon as the case got kicked, there's

no more discussion from Bard about their interest in settling

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But I think the best way to respond to that, Judge,

is this: I could just tell you based on history, we can't

tell our client not to -- once we get to a certain level of

negotiations -- the lawyers want to try the case. We just --

we think it's important to try the case, get the evidence in

front of Your Honor and a jury, and whatever the verdict is,

it is, because it will instruct everyone as to where this case

might be going.

But I think the reason we suggested that is because

historically that happens. I mean, the cases could settle as

you get to trial.

THE COURT: But does it happen on bellwether cases?

I mean, are you talking settlement on an individual bellwether

basis?

MR. LOPEZ: No. My point to you is this: We never

do. There's never an interest in settling these cases until

we get well in- -- either at trial or well into trial when all

of a sudden things change.

I can't -- I can't predict what's going to happen in

this case other than the fact that I know historically what's

happened in the past is that the settlement posture -- and I'm

just going to say it, on Bard changes. Not the plaintiffs.

THE COURT: Well, but if -- if Bard were to come in

on the eve of one of your stronger bellwether cases and make

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whole bellwether process? I mean, what's the point of

carefully picking these bellwether cases if one side or the

other is going to try to pick off a few of them individually

through settlement? Then we skew everything we tried to

achieve by carefully selecting these five cases. And if we're

going to do, I may as well just remand all the cases and send

them back to state court, because there is no point in a

bellwether process designed to get a representative look at

how the cases play in front of a jury.

MR. LOPEZ: Your Honor, we have representative cases

that have been either in trial, close to trial, courthouse

steps. There are no secrets in this case. They know how

we're going to try this case; we know how they're going to

defend it. There have been values set on cases very similar

to what Mrs. Booker's case is about.

Again, I agree with you. I think the bellwether

process should work to determine what the risks are to both

sides and how cases should settle. We want the Booker case to

go to verdict. But we also understand -- there's been no

offer. I don't want to you think we're negotiating. And it

could be there is no offer. But I just think based on

historical data that as we get involved in that case, that

could happen. And that's why I think it's important, and this

is not unusual in an MDL or in a mass tort where you have

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to sticking with it and not taking maybe an offer that they

want. Our obligation, of course, is to Mrs. Booker.

Do which have Mrs. Booker's agreement that under all

circumstances she's going to go to a jury verdict on this

case? We can't possibly do that. That would be something

probably -- I mean, we don't. Even if we did, it could change

in the middle of that trial.

And that's why I have some of these other topics on

there. I think it's important -- we've got to have a little

bit of -- I don't want to call it chaos, but the parties have

to feel the heat of more than just one case going to trial

next year. Both plaintiffs and defendants. That's why I

wanted to talk about the early remands. That's why I wanted

to talk about maybe having additional bellwether cases ready

to go to trial.

We were able to talk -- discuss with Judge Brodman

the idea of we've got this trial date in August reserved.

We've got three other cases that are basically on the same

track. We're going to -- all four of those cases are going to

be getting ready to go to trial --

THE COURT: Well, that, to me, is a very different

situation. He does not have an MDL. He hasn't gone through a

bellwether process. He's got a collection of cases he needs

to resolve.

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this idea of sort of selectively settling bellwether cases.

MR. NORTH: Your Honor, first of all, we don't need

to argue the point now, but I disagree with a lot of what

Mr. Lopez said about our settlement history. We've settled

many, many cases with many attorneys well in advance of trial

dates.

Now, with regard to the concern the Court raises,

that is a concern. But it's a concern on both sides of the

table.

Many MDL judges in the past have bemoaned the fact

that defendants have settled cases in an effort to manipulate

the bellwether pool, and many judges have bemoaned the fact

that the plaintiffs have dismissed cases on the eve of trial

in a bellwether context because they're cases they didn't want

to try. It is a problem on both sides of the fence. It does

happen sometimes.

We certainly are not intending to do that. We are

happy with the bellwether selections. We are committed to the

process to try some bellwether cases.

As Mr. Lopez says, can you never say never? I don't

think you can. But that's not the intention now of Bard, to

pull out the rug from Booker, just as I hope it's not his

intent to dismiss Booker at the last minute or dismiss Jones

at the last minute. So it is certainly not our intention to

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MR. LOPEZ: Well, Judge, can I just -- if we're going

to talk about historical, the reason we have an MDL is because

when this was 150-case litigation, after trying a case for 11

days in front of Judge Jones, after the defense verdict he got

against someone completely different than us four years ago

here in Arizona, and after getting the motions in limine and

Daubert and motions for summary judgment on a half dozen other

cases, and now having 10 MDL cases, I mean now MDL cases ready

to go to trial as soon as they get remanded, Bard said, We

have enough history here to settle your cases, and then three

times, without any explanation, they just said, We're not

interested in discussing settlement with you. And now we're

setting the next six cases for trial, which is when I said I

can't do this for 150 different people with five law firms;

we've got to get an MDL. So that's why we have an MDL, is

because I think that was -- I've never had a bellwether

process like we had before an MDL that basically described

what these cases were about and basically what the risks were

to both sides.

So I bring that up because I -- my personal opinion

is one bellwether trial is not going to change what happens to

the other 3,000 plaintiffs. If Bard's plan is to try three or

four cases a year, then, I mean, I -- my grandson is not --

he'll be too old some day to try the last case. So --

1 5 : 1 9 : 3 1 THE COURT: Well, nobody's ever suggested, Mr. Lopez,

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that we're going to bellwether trial every case in the MDL.

My view is we'll do five bellwether trials, I'll pick a sixth

if we need it, and then we're done with bellwether trials.

Assuming we can try all those cases.

You've got a fair representative. If you can't

settle it on that basis, we send them back to their districts

because we've tried hard in this setting not only to make

decisions on the common issues and get those resolved, but

we've tried a sample of cases to help inform the parties of

how they play in front of a jury. If that doesn't help you

settle it, we just don't keep trying bellwether cases here.

That's not what an MDL is for. We send them home, and you can

deal with them in their home districts.

MR. LOPEZ: Right. 

THE COURT: Which is why the notion was a surprise to

me that we may in some way pick off some of these five cases

that we've gone through a fairly lengthy process to identify

for the bellwether process.

MR. LOPEZ: Your Honor, that's why I'm suggesting

what I suggested. The plaintiffs' position in the joint

statement. We have to have some kind of fail-safe process in

place in the event -- it's going to happen on some of these

cases. If we --

THE COURT: What's going to happen?

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picked off and get resolved before we get a jury to tell us --

THE COURT: Some of the bellwether cases?

MR. LOPEZ: Possibly. I mean, I can't predict that

one way or another. All I can tell you is we want to try the

Booker -- we'll try every bellwether case. The lawyers want

these cases to go to verdict because we think that is going to

be instructive and it's going to serve the purpose of what you

want to get from a bellwether trial.

But we can't -- our ethical obligation is to the

plaintiff. And I don't -- I can't predict what Bard's going

to do once these cases are in the middle of trial. What I'm

suggesting to you is that happens all the time. And in order

to have kind of a backup to that, kind of a fail-safe system

in place, we've got 10 cases that are -- we're going to talk

about, I hope, today that are pretty close to trial. One of

them, we're just waiting for our judge in Jacksonville to make

a ruling on motions in limine.

We should talk about that. And even counsel in their

papers said the spring of this year we can remand those cases

back.

I think what I'm trying to say to Your Honor is five

cases may not do it. The five bellwether cases set here may

not actually get us a case to trial. But I think 15 or 20

would. Whether it be in Arizona, whether it be here, whether

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THE COURT: I will tell you, Mr. Lopez, if we have

cases settling in the middle of trial like that, I'm going to

strongly tempted to say we're done, this bellwether process is

not working, these are all going back to their districts.

Because the whole idea here -- we don't do trials in MDL's.

The whole notion behind a bellwether trial process is to,

while we're together, give you a fair sampling of how the

defenses and the claims play. And if that's not working

because parties are withdrawing cases or settling cases in the

bellwether process, my view is we shouldn't be playing that

game. We should finish the work of the common issue

discovery, the common issue rulings, and terminate the MDL.

MR. LOPEZ: Your Honor, let me make sure that I'm

making myself clear. We -- the plaintiffs 100 percent endorse

what you just said. We want a bellwether process that works.

We do. And if it doesn't work, at no fault of maybe either of

the parties, we're prepared for these cases to be remanded.

But, look, I understand that the idea of having an

MDL and having an MDL judge is to prevent that from happening.

I mean, we've brought all the cases here to relieve the

pressure in 50 other states and I don't know how many hundreds

of different courthouses. We get it. And the plaintiffs want

the case to resolve here. And, again, we agree that the

bellwether process is what we hope will make that happen.

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here might get that done, and you don't necessarily have to

remand everything. The idea is to make sure we get maybe

three or four cases, different cases, maybe on different

products, to a jury verdict. It may not happen here. We want

it to. We're happy to try five cases here next year. But I

think it would be -- it would certainly serve the purpose for

which Your Honor just stated, that in the event that that

doesn't happen, say in March or May, for whatever reason,

we've got five or six other cases that are putting pressure on

both sides. One will have a greater opportunity to -- I think

the Austin case probably would have gone to trial. I wish it

had. I think it was heading in that direction. I know that

wasn't a federal court case, wasn't an MDL case, but the

Austin case or a lot of cases like that in this MDL certainly

would have been instructive.

I hear what you're saying. I understand that the

obligation is try to get everything resolved here. The

plaintiffs are fully committed to that process. I just want

you to know that. We're not asking for remands, but I

understand if you have to do it, I mean, that's -- we can't

drag this thing on forever in this MDL because we can't

possibly try 3,000 cases here.

THE COURT: Any other comments? 

MR. NORTH: Your Honor, I'll just reiterate what I

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THE COURT: Well, I am not going to start us down the

road of bellwether group 2 at this point. We've got five

bellwether cases with a sixth to be selected. There's no way

we're going to get those six cases tried any sooner than the

end of 2018, if we can get it done in 2018, and that will

require the help of some other judges, as I've already

indicated.

So we are more than a year away from a bellwether

group 2, if we are even going to do that. And as I've

indicated, I'm not sure there's a point for that. These seem

to me to be pretty representative cases, and if these can't

help you settle it I'm not sure we should spend more time here

trying to do that.

So I'm not going to do a bellwether group 2 at this

point.

We've got our first two cases. I'm going to plan on

Booker going and not settling. We're going to do the motions

in limine in light of that plan. It's still going to be a

challenge to get all of the Daubert motions decided by then,

but I'm going to do my best so we don't to have bump that

trial date.

And we'll just have to see how we're doing on that

come January, probably.

In terms of the mature cases, I don't see why we

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to me if there is additional case-specific discovery to be

done in cases in the MDL, that gets done in the home court.

We were holding those mature cases until we got the Daubert

motions decided and the preemption motion decided in cases

that could affect them. Once we finish that process, my

understanding has been we ought to go ahead and remand them,

unless that's going to cause you problems in trying the

bellwether cases because you're running up against another

trial in one of those districts. But that doesn't sound very

likely. But I don't see a reason we should start

case-specific discovery here. Is there a reason we ought to

do that in this MDL?

MR. LOPEZ: I think -- let's just assume that the

cases are -- have been remanded. I don't think it makes any

difference whether or not they're still sitting here. Whether

or not the judge who originally had the case is now -- or has

officially received the case back in remand.

My idea was if these cases are going to be remanded

and Your Honor thinks it's a good idea to do that, why not

have them trial ready? Why not -- if there's a deposition

here or there that needs to be taken of a lay witness or

there's an expert still pending with respect to that case, why

not, by the spring of this year, whatever date it is that

we -- I think we could probably agree they could be remanded,

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to the judge in these 10 different districts, and we'll just

get on their trial docket.

THE COURT: If you guarantee there's no discovery

issues I'll have to rule on, I'm all for that.

I'm not going to say that's a joke.

MR. LOPEZ: Well, I understand that.

THE COURT: That's one of my concerns. If one of

those cases blows up over a discovery issue, we just added to

a pretty heavy workload in this court. Maybe it won't. You

have had very few discovery issues. You guys have done a

great job, in my view, of handling discovery.

MR. LOPEZ: I kind of have an idea.

THE COURT: Okay.

MR. LOPEZ: Why don't we just do it. If we do, we

just save that. In other words, let's say we have -- we've

gone through this process, we've got issues with a witness,

we've got issues -- at least that deposition's been taken. At

least that discovery's been sought. And now when the judge

gets it back, it's not, well, now let's take the depositions

and see how big of a fight it's going to be to get certain

evidence or get certain testimony.

At least -- I guess what I'm trying to say, Judge,

let's try to get -- they're just sitting there languishing.

Some of these cases are five years old. Most of them are four

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filed in 2013. And like I said, we've designated, we've

stipulated these are early remands because they had made so

much progress to get towards -- I think we may have had trial

dates in most of them, if not all of them.

At the very least maybe we can sit down with counsel

and see if we can come up with or devise some kind of a plan

to at least move the ball closer to at least the 20-yard line

on these cases so that if we send them back there's a minimum

amount of work to be done for the remand judge to set them for

trial.

I'm just suggesting that. Because like I said, some

of them have motions in limine that have already been heard.

Some we're still playing with experts.

THE COURT: All right.

MR. NORTH: Your Honor, there certainly could be no

guarantee that there wouldn't be discovery issues. But not

only would it be a distraction -- of course, that's most

important, we don't need distractions for the Court right

now -- but I think it will be a distraction for the parties to

run around and take a update deposition of a plaintiff.

Let's be realistic. We're only talking about three

to four more months probably at most when these cases are

going to be ripe for remand after the Daubert rulings are

made.

1 5 : 3 0 : 2 2 I think virtually none of these federal judges

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sitting around the country in these eight or nine cases are

going to be able to put us on an immediate docket. They've

got full trial schedules, just like most members of the

federal judiciary. There's going to be lag time. There's

going to be plenty of time to do what little discovery is

necessary in front of those judges, who then can monitor and

handle the situation.

And I just think we all need to focus here on this

first bellwether trial in March, and not have that distraction

right now.

THE COURT: All right. I will think about this issue

and I will include a decision on it in the ruling or the order

that comes out after today's hearing.

What I do want to do is set a final pretrial

conference for the Booker case. We're scheduled to start on

March 13th.

The tension is that I want it to be far enough -- or

close enough to the trial that I have time to get all of these

Daubert motions decided, but far enough in advance of trial to

inform you for your trial preparation. So my inclination

would be to set it about two weeks before trial. That would

be where I would hear the motions in limine. That would leave

you a couple of weeks to do your final preparation in light of

my ruling, but yet it wouldn't crowd any more of February that

1 5 : 3 2 : 4 1 we will probably have to spend on some of these Daubert

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motions.

Do you have any thoughts on that approach?

MR. LOPEZ: I mean, I know there's one date at the

end of February where it's a personal family thing with some

surgery, but if we can do it before that date, I think it's

like the 25th or 26th of February, which is maybe a little bit

more than two weeks before the 13th. If we could push it

maybe two days before that date.

THE COURT: I was thinking of Friday the 23rd.

MR. LOPEZ: Yeah, that's works.

THE COURT: Does that work?

MR. NORTH: Yes, Your Honor.

THE COURT: All right. So let's set it for Friday

the 23rd at 2:00 p.m.

Now, I will tell you I am scheduled that day to be in

the middle of a two-week environmental trial that has not

settled for two and a half years. It's a pretty hard fight

between some companies and the federal government. If it

goes, I won't be able to do it, I'll have to push it closer to

trial. But they're having a big mediation in early December

and that case may resolve, in which event we'll have that date

available. So I'll set that date, but it may get bumped if

that trial goes.

You all raised in the joint report the idea of me

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that. And I'm all for you sitting down and stipulating on

foundation issues, agreeing on every evidentiary issue you

can.

I will tell you that I do -- I think I might have

mentioned this to you before -- I do typically set time

limits, hour time limits for civil trials. I'll do that based

on the assumption of a three-week trial. But I'll do that

after I get your final pretrial -- proposed final pretrial

order, which will be filed in advance of that February 23rd

final pretrial conference.

We will send out an order that tells you what we need

for that final pretrial conference, and one of it will be an

estimate of how that time ought to be divided up. But I will

keep track of your time. I'll tell at noon and at the end of

the day how you're doing so you can budget things as we go

through the trial.

My thought would be with a three-week jury trial,

that we would probably seat a jury of nine people. That way

we can lose three and still have six to deliberate at the end,

but obviously if we don't lose any, the nine deliberate at the

end.

Do you have -- we don't need to decide that finally

now, but do you have strongly different views on that issue?

Well, we can think more about that.

1 5 : 3 5 : 4 1 Is there any sense that we need a jury questionnaire

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in this case as opposed to just typical voir die?

MR. LOPEZ: I think we want a questionnaire,

Your Honor.

THE COURT: Why? What is your thought? I typically

don't do it. I've done it in a half dozen cases where there

were particularly sensitive issues, but I'm interested in your

thoughts as to why we need it here.

MR. LOPEZ: I guess the best response I can give you

is we customarily do do those in these complex cases.

Does Your Honor have, like, his own standard set of

voir dire questions?

THE COURT: Well, yeah, I do. I mean, they're pretty

generic. Typical voir dire questions.

MR. LOPEZ: And would the alternative to a

questionnaire be submitting to you additional questions that

parties --

THE COURT: Yeah, that's one -- one of the things I

would ask you for in preparation for that final pretrial

conference is your proposed voir dire questions. And I would

go through and decide which to ask. I typically ask, and let

you ask follow-up questions.

But if you think we need a jury questionnaire, I'm

happy to consider that. The logistics are that we need to

have that finalized about a month before trial. 

1 5 : 3 6 : 5 9 Is that right, Traci? I think it's about a month,

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five weeks.

Because it's got to be mailed out by the jury office,

it's got to be mailed back, they've got to follow up, we've

got to then get it to you, we then have to have a hearing

where we talk through what we've learned and who we're going

to knock out and who we're not. It just adds time to getting

ready for trial.

MR. LOPEZ: Can we meet and confer on that,

Your Honor --

THE COURT: Absolutely.

MR. LOPEZ: -- maybe come together with a stipulated

questionnaire that you think is okay.

THE COURT: Why don't you -- let's make that one of

the topics you'll meet and confer about between now and the

next hearing date, which I think is December 15th. And if you

think there should be a questionnaire, I would encourage you

to come up with a proposed questionnaire so I can look at what

you think is needed. That will leave us time, if we decide to

go down that road, to get it out before the end of January,

and I'll decide then whether it's needed or whether voir dire

will do.

MR. LOPEZ: One other suggestion, Your Honor, to help

maybe expedite this process, I understand the biggest burden

is you preparing for the hearing, not the two hours we spend

1 5 : 3 8 : 0 9 here, so maybe this isn't going to help much, but maybe

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counsel and I can get together and talk about some of these

motions where we can just submit on the papers and you can

just rule on those.

THE COURT: That's fine. I mean, that does -- the

advantage then is I can work on it and issue a ruling and I

don't have to wait two weeks for the argument, by which time

I've forgotten 75 percent of what I read.

But yeah, it really just does save the hearing time.

I don't know that we'll be able to get more motions decided

that way, but we'll get them out more quickly if we do that.

MR. LOPEZ: We'll talk about it, then, and see if we

can.

THE COURT: Okay. All right. So I then will plan on

the remaining four motions we had scheduled today plus the

next two for December 15th, but I'll let you know if I'm

falling short of that as we get close to it.

We'll get the order out setting the final pretrial

conference.

In fact, Traci, I'll just put that into this case

management order, if you could just send me the template.

THE COURTROOM DEPUTY: Okay.

THE COURT: I want to go on the assumption that we're

trying Booker in March. If there's changed thinking between

now and the December 15th hearing, we can always move Jones up

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these motions by March, which I'm going to do my best to do,

but there are a lot of them.

What else do we need to talk about today? Well,

yeah, I'm going to decide the mature case discovery issue

after I think about it a bit more.

Do you have other matters we need to address on the

plaintiff side?

MR. LOPEZ: No, Your Honor, not on the plaintiff

side.

MR. NORTH: Nothing for the defendants, Your Honor.

THE COURT: Okay. I should get you a decision on

these two motions argued today within the next two weeks.

Maybe sooner than that.

Thank you all.

MR. NORTH: Thank you.

MR. LOPEZ: 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 27th day of November,

2017.

 s/ Patricia Lyons, RMR, CRR

Official Court Reporter 

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