US Supreme Court: 06-179

8/14/2019 US Supreme Court: 06-179

http://slidepdf.com/reader/full/us-supreme-court-06-179 1/66

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Official - Subject to Final Review

IN THE SUPREME COURT OF THE UNITED STATES

- - - - - - - - - - - - - - - - - x

DONNA S. RIEGEL, INDIVIDUALLY :

AND AS ADMINISTRATOR OF THE :

ESTATE OF CHARLES R. RIEGEL, :

Petitioner :

v. : No. 06-179

MEDTRONIC, INC. :

- - - - - - - - - - - - - - - - - x

Washington, D.C.

Tuesday, December 4, 2007

The above-entitled matter came on for oral

argument before the Supreme Court of the United States

at 10:11 a.m.

APPEARANCES:

ALLISON M. ZIEVE, ESQ., Washington, D.C.; on behalf of

the Petitioner.

THEODORE B. OLSON, ESQ., Washington, D.C.; on behalf of

the Respondent.

EDWIN S. KNEEDLER, ESQ., Deputy Solicitor General,

Department of Justice, Washington, D.C.; on behalf of

the United States, as amicus curiae, supporting the

Respondent.

1Alderson Reporting Company



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C O N T E N T S

ORAL ARGUMENT OF PAGE

ALLISON M. ZIEVE, ESQ.

On behalf of the Petitioner 3THEODORE B. OLSON, ESQ.

On behalf of the Respondent 24EDWIN S. KNEEDLER, ESQ.

On behalf of the United States, as amicus

curiae, supporting the Respondent 41REBUTTAL ARGUMENT OFALLISON M. ZIEVE, ESQ.

On behalf of the Petitioner 50




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P R O C E E D I N G S

(10:11 a.m.)

CHIEF JUSTICE ROBERTS: We'll hear argument

first this morning in case 06-179, Riegel v. Medtronic,

Inc.

Ms. Zieve.

ORAL ARGUMENT OF ALLISON M. ZIEVE

ON BEHALF OF THE PETITIONER

MS. ZIEVE: Mr. Chief Justice, and may it

please the Court:

The question in this case is whether Section

360k(a) of the Medical Device Amendment to the Food,

Drug, and Cosmetic Act preempts State law claims seeking

damages for injuries caused by a device that received

pre-market approval. Medtronic's view of the pre-market

approval process is that it results in an FDA decision

that a particular device must be designed, labeled, and

manufactured in a particular way. This view is

incorrect, and so I want to talk -- begin by talking

about what pre-market approval is and what it isn't.

PMA is FDA's permission to market a Class 3 device. The

manufacturer PMA device develops the design and chooses

the -- choosing it on its own. After the company

submits the application, the FDA evaluates it, based on

information submitted, but it does no independent




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testing, no product development, no comparison with

other products to see if this one is as good as or

better than existing products -- or even if it's the

best that it can be.

If the information submitted by the company

meets the statutory standard, reasonable assurance of

safety and effectiveness, the FDA grants PMA, thus

permitting the device to be sold. So the FDA approves

the design and labeling chosen by the manufacturer, but

the agency doesn't require the manufacturer to choose --

to make those choices.

Once on the market, a PMA device may prove

to be unsafe, because very often problems and hazards

come to light only after the device is in widespread

use. So --

CHIEF JUSTICE ROBERTS: Isn't that situation

addressed by the requirement that the manufacturer alert

the FDA to new information and at least file annual

reports, and then the FDA can pull back the pre-market

approval if they think these problems require it to do

so?

MS. ZIEVE: Well, yes and no. The

requirement about submitting adverse event reports and

the annual report are intended help the FDA to monitor

the device after it's on the market. But the




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responsibility and the opportunity to improve the design

or labeling or to initiate a recall is really on the

manufacturer in the first instance, because the

manufacturer is the first one to learn about the

problem. The FDA has a more passive role. The FDA

receives the information that the manufacturer sends to

it --

JUSTICE SCALIA: What if the manufacturer

wants to make what you call an improvement? Can it

simply market the product with that improvement without

further FDA action?

MS. ZIEVE: Depending on whether it is a

design or labeling change, the answer is different. For

a labeling change, some changes can be made prior to FDA

approval. For design changes, any change that affects

safety and effectiveness can't be made without a further

submission to the FDA.

JUSTICE SCALIA: Even if it is designed to

improve safety and effectiveness?

MS. ZIEVE: That's right. And in that way a

PMA device is no different from the 510(k) device that

this Court considered in Lohr, because with respect to

those devices as well, any change that would have a

significant effect on safety and effectiveness has to

await a new submission and a new --




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JUSTICE SCALIA: Right, but those devices

had not been -- they were just grandfathered. They had

not been specifically approved as safe and effective by

the FDA. Right?

MS. ZIEVE: Right. But the question isn't

what the level of pre-market scrutiny is. The question

is what requirements are imposed on the manufacturer at

the end of the process when the device enters the

market.

JUSTICE KENNEDY: Well, before that decision

is reached, let me ask you this -- under State law,

either generally or specifically under the law of the

State that you are trying to invoke here, does the jury

-- does the finder of fact weigh the potential risks of

injury and illness against the probable benefits to the

health of the patient? Is that one of the things the

jury does? In other words, suppose this was a very

important device, but it had a one percent risk. Does

the jury consider that when it determines whether that's

been negligently sold?

MS. ZIEVE: Well, the standard in New York

is whether the product is unreasonably hazardous. I

think the term unreasonably --

JUSTICE KENNEDY: Alright, now isn't that

exactly what the FDA measured in the PMA process? The




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FDA is specifically charged with weighing the risks

against the probable benefits.

MS. ZIEVE: That's right. And in that way,

the State --

JUSTICE KENNEDY: So the jury is doing the

same thing that the FDA did.

MS. ZIEVE: Yes. And as this Court said in

Lohr and in Bates, when the State law mirrors the

Federal law, there is no preemption.

JUSTICE KENNEDY: Well, but that was under

the expedited 510(k). That's different than PMA,

because in PMA there's a specific weight.

MS. ZIEVE: What the FDA does before the

product reaches the market is different in the PMA

context as opposed to 510(k). But when it comes to

comparing the State and Federal requirements -- I think

is what you are getting at -- Lohr's analysis and the

analysis in Bates v. Dow Agrosciences, Inc. didn't turn

on how rigorous the FDA requirements are, but are they

parallel to the State requirements.

JUSTICE SCALIA: What was the State

requirement there? I mean, what was the Federal

requirement there? It was simply that the device had

been on the market before the law became effective.

Right?

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Alderson Reporting Company



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MS. ZIEVE: The design requirement in Lohr?

JUSTICE SCALIA: Yeah.

MS. ZIEVE: It had to be substantially

equivalent, safety and effectiveness, to a device that

was grandfathered in, that's right. But Medtronic

argued in that case that it couldn't change the design

of that product without filing another submission to the

FDA, and that that was why there's preemption, and

that's the same argument --

JUSTICE SCALIA: Well, but the point is that

the -- to follow up on Justice Kennedy's question, the

point is that the FDA in Lohr had never made a

determination of weighing the risks against the

benefits, as they do for the issuance of PMA's. And so

the jury was not replowing the same ground that the FDA

had already plowed in Lohr.

MS. ZIEVE: I don't think that goes to

preemption under 360k(a) which looks for a specific

Federal requirement, a State device requirement, and

then looks at -- compares the two to see if there are

counterparts.

JUSTICE GINSBURG: And how does it -- how

does it compare with another process that the FDA looks

at very closely, I think even more closely than new

devices -- new drugs. New drugs also go through a very




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long testing period. Is there -- and the FDA gives its

approval, and the drug is marketed, and it turns out it

has risks people didn't understand and there's a tort

suit. Is there -- is there a defense to the

manufacturer, "I followed to the letter the permission

that the FDA gave me"?

MS. ZIEVE: Under the common law of most or

all States, compliance with Federal law is a defense on

the merits, and it is not usually dispositive, but in

some States -- in some States it is.

JUSTICE GINSBURG: So it would certainly be

at least the same here, right? That compliance with the

Federal law would be a defense on the merits.

MS. ZIEVE: Absolutely. I don't think that

the PMA is irrelevant to the tort suit. It's just not

sufficient for preemption --

JUSTICE GINSBURG: Is there a reason -- as I

understand it, tort suits are not preempted with respect

to new drugs. Is there a reason to treat the two

differently? For new medical devices and the new drugs?

MS. ZIEVE: Well, there is no express

preemption provision in the Food, Drug, and Cosmetic Act

with respect to drugs.

JUSTICE GINSBURG: So that's the difference.

So the question -- what does the express preemption




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provision mean?

MS. ZIEVE: Right. But I think in trying to

figure out what the express preemption provision means,

it's actually useful to consider why there's none for

drugs and there is one for devices. And the reason is

because drugs were regulated by the FDA since 1938.

Devices weren't regulated until 1976. So, in those

intervening 38 years, States had stepped in and started

to do some regulation on their own to fill that

regulatory void.

California is the most notable example, and

the one discussed the legislative history. So, when

drafting the medical device amendments and coming up

with the system for pre-market scrutiny, the question

arose, well, what about California? What about other

States that are regulating good manufacturing practices?

Or California had a PMA scheme of its own. And so the

legislative history makes clear that Congress, faced

with this dilemma, decided California shouldn't be able

to continue to regulate devices in that way. It

shouldn't be able to pre-screen devices once the FDA had

stepped in and filled the Federal void.

And that's why you didn't need an express

preemption provision for drugs. The States weren't

doing that in 1938, but because the government -- the

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Federal government waited so long to regulate devices,

it was necessary to say what are we going to do about

these State regulations?

JUSTICE SCALIA: Does that mean that, under

the Food and Drug regulation, the States can issue their

own regulations that contradict the Federal approval?

MS. ZIEVE: Well, they couldn't issue

regulations that contradict the Federal approvals

because of the express preemption provision. But

without it, California --

JUSTICE SCALIA: No. No. I'm talking about

drugs. Not medical devices. You say that --

MS. ZIEVE: That would be a conflict

preemption question.

JUSTICE SCALIA: Well, no. I mean, you can

comply with both. It's just additional -- you have to

go further to comply with the State rule, so there's no

conflict. It's easy to --

MS. ZIEVE: Well, if there's no conflicts,

then there would be no preemption.

JUSTICE SCALIA: Then the States can issue

regulations that go beyond -- beyond what the FDA says

in drug matters? I would be surprised if that's the

case.

MS. ZIEVE: Well, if there's -- the only

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basis for preemption with respect to drugs is conflict

preemption. So, if your question incorporates if

there's no conflict, then there would no preemption.

But --

JUSTICE SCALIA: And is that the only basis

here? Conflict -- there's no conflict? It's all okay

under the Medical Devices Act?

MS. ZIEVE: Well, here, if there is not a

specific Federal requirement that is the counterpart to

a State requirement, there is no preemption. That's

what -- that's the language that Congress wrote and --

JUSTICE SCALIA: They can add additional

requirements so long as -- and I suppose they can do

this by regulation -- so long as these additional

requirement dos not prevent complying with the Federal

requirements? So long as there's no conflict, the

States can add additional requirements under the Medical

Devices Act? That's not my understanding of it.

MS. ZIEVE: No. That --

JUSTICE SCALIA: It is field preemption,

isn't it?

MS. ZIEVE: No, I don't think so. The --

when the FDA has spoken directly to a question, then the

State cannot impose requirements that are different from

or in addition to what the FDA has said.

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JUSTICE GINSBURG: Take a --

JUSTICE SCALIA: If it --

JUSTICE GINSBURG: Take a concrete situation

where the FDA is asked: We'd like to make this

improvement. And the FDA says no, we don't think that

enhances safety. And then there's a tort suit based on

the failure to make that improvement. Wouldn't the FDA

rejection of permission to make that improvement --

wouldn't that at least be preemptive?

MS. ZIEVE: If the -- if 360k(a) ever

preempts tort claims, I think that would be a situation,

but if -- only the tort claim is -- is specific in that

way, that you -- that the company failed in its duty of

care because it didn't design the device in the specific

way that the FDA had rejected.

JUSTICE SCALIA: Well, that's not the way I

would -- the jury has to say that?

I mean, in fact --

MS. ZIEVE: Well, that --

JUSTICE SCALIA: In fact, that's what's

going on, but it could have been safe if -- if they had

made the change that the FDA rejected. But the case

goes to the jury and that's, in fact, what's going on.

MS. ZIEVE: Well, the --

JUSTICE SCALIA: The trial is, you know, had

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he -- had he made this change, it would have been safe,

but he didn't make the change and, therefore, you,

ladies and gentlemen of the jury, should hold the

company liable.

MS. ZIEVE: But if that's the theory of the

case, I think that's basically the one-inch/two-inch

hearing aid fix of Justice Breyer's example in Lohr.

JUSTICE SCALIA: So it just --

MS. ZIEVE: But most tort claims --

JUSTICE SCALIA: It just has to be the

theory of the case. We have to look at each jury

verdict and decide whether that was the basis on which

the jury made the decision.

MS. ZIEVE: Well, it's -- it's not actually

that hard, because most tort claims are --

JUSTICE GINSBURG: I thought your response

was it wouldn't go to the jury if the FDA had said no,

you cannot make this, and the plaintiff's point is you

must make it in order to make this device safe.

I thought your answer to me was that the FDA

regulation -- the FDA's action in refusing to allow the

change to be made would be preemptive and you wouldn't

give it to a jury to second-guess that determination by

the FDA.

MS. ZIEVE: Yes. That's right. And I

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thought, Justice --

JUSTICE SCALIA: That's under State law, but

you -- you don't say that Federal preemption requires

that; you say that by the grace of New York State, that

may be the situation, but New York State can change that

law, as far as you're concerned, right?

MS. ZIEVE: Can -- I'm sorry. Can change

which law?

JUSTICE SCALIA: New York State can let it

go to the jury, despite -- despite what the FDA has

done. You've said that it's simply a defense under New

York State law and the law of most States. But it

doesn't have to be a defense under New York State law.

MS. ZIEVE: I think that's a different

point. Generally --

JUSTICE SCALIA: I thought that's the point

Justice Ginsburg was implying.

JUSTICE GINSBURG: I was asking you, if it

was -- as a matter of Federal law, if the FDA says --

rejects.

MS. ZIEVE: Yes.

JUSTICE GINSBURG: -- a proposed change, can

a State court say, well, we think the FDA was wrong in

rejecting that, so we're going to let it go to the jury.

I thought the question I was posing to you is, isn't

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Federal law preemptive in that situation, when the FDA

says you can't do it and the personal injury lawyer

wants it to convince the jury that they had to do it?

MS. ZIEVE: Yes. In a situation where the

FDA has said you are required not to market this

specific device and the State -- the plaintiff is

seeking to impose a common-law duty that you must market

that specific design, then you would have counterpart

State and Federal regulations, but the --

JUSTICE GINSBURG: How about the --

MS. ZIEVE: The relevance of --

JUSTICE GINSBURG: Another variation -- the

FDA says you must include X in this device or we won't

give you the pre-market approval. And so the

manufacturer puts X in, and then there's a lawsuit that

wants to charge that putting X in made the device

dangerous.

Would the FDA's insistence that X be put in

take X out of any State court's tort litigation? That

is, wouldn't -- if the FDA says you must have it, a

State court couldn't put to a jury whether you should

have eliminated it?

MS. ZIEVE: Yes. I think that's Justice

Breyer's two-inch hearing aid fix, when the Federal

government says you must and the State law duty says

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that you cannot.

But the -- that's not how tort claims are

litigated as a general matter. First of all, PMA's

don't say you must have this design feature. There's --

CHIEF JUSTICE ROBERTS: Right. I thought

that was your -- your theory was a little more nuanced.

In other words, they don't require you to market a

particular catheter. And you -- what I understood you

to be arguing is that there may be a better design and

that it was negligent for the manufacturer to market a

particular design, even though they're allowed to; they

don't have to.

MS. ZIEVE: Exactly.

CHIEF JUSTICE ROBERTS: They should have

made the change to make it safer, right?

MS. ZIEVE: That's right.

CHIEF JUSTICE ROBERTS: Well, if that's --

MS. ZIEVE: And if you look at --

CHIEF JUSTICE ROBERTS: Well, if that's what

happens, what, as a -- what's going to happen for

patients at a time when your theory comes up, the

manufacturer looks at it and says, well, maybe this is a

better device; we don't want to risk these tort suits,

so we're going to stop selling our old device that's

been approved, but now we have got to get FDA approval

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of the new device and that might take forever or at

least a year, let's say. And what happens to patients

in that year? They've got no device.

MS. ZIEVE: Well, first of all, if the

device is reasonably safe and effective, then the

company is just not going to stop marketing it because

of tort suits. And we know that because --

CHIEF JUSTICE ROBERTS: But your theory is

that although this device has been approved, here's a

better one. And it's negligent on the manufacturer's

part to market a device, even though approved by the

FDA, when there's a better one that would reduce the

risks.

MS. ZIEVE: Right. But we know that

manufacturers don't respond by taking devices off the

market, because PMA has coexisted with tort suits since

1976. For instance, recently --

CHIEF JUSTICE ROBERTS: What do you want

them to do if you think it's negligent for them to

market the approved product? Don't you want them to

take it off the market?

MS. ZIEVE: Well, I -- they should make

their devices as safe as they can be. And if a tort

suit points out that this device is not reasonably safe,

then the manufacturer --

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CHIEF JUSTICE ROBERTS: It's not that it is

not reasonably safe. It's that another design would be

safer. And you think that's a basis for negligence

because you say, yeah, the FDA approved it, but that

doesn't mean they required the manufacturer to market

that device.

MS. ZIEVE: That's right. And 360k looks to

requirements. It's not a matter of policy what the

effect of tort suits is. The question is what are the

requirements imposed by the PMA, what requirements are

imposed by State law.

JUSTICE SCALIA: Of course, this is all a

little unrealistic. It is not as though some expert

agency of the State has conducted a very scientific

inquiry and decided that there's something safer than

what the FDA approved or that it's negligent to issue

what the FDA approved.

What's going on is simply one jury has

decided that in its judgment, there was a safer device

that should have been used; and because of the judgment

of that one jury, the manufacturer is placed at risk in

selling a device that scientists at the FDA have said is

okay.

I find that extraordinary.

MS. ZIEVE: Well, any one of us might have

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drawn the line differently. But the line Congress drew

was when there is a specific Federal requirement, we

looked for a device counterpart State requirement. And

where they don't exist, there is no preemption.

JUSTICE BREYER: I thought that was

something a little different than that. The question

that I have which might be helpful to me, if you can

answer it, is -- that's being serious about it -- I'd be

helped by knowing what the specific design defect is

that you claim? That is, in what respect was this

catheter -- and I'd like you to refer to the details of

the catheter -- in what respect, what material or what

shape or what -- what it is about this catheter that you

as the plaintiff think was designed defectively, if you

can tell me?

MS. ZIEVE: There's not a lot of discovery

about the design of the catheter.

JUSTICE BREYER: I know. But you must have

a theory.

MS. ZIEVE: The general theory is that the

design was unreasonably safe because the catheter should

not have -- should have been strong enough --

JUSTICE BREYER: What is it about the design

that you are saying is not safe? That is, you can't go

into the court without having in your mind, as the

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counsel, that some kind of specific thing that was wrong

with this catheter, other than just using the words

"design." I mean, how was it designed badly? What part

of the design is not right?

MS. ZIEVE: The strength of the balloon and

the way in which --

JUSTICE BREYER: You are saying the material

of the balloon should have been of a different material

or a different thickness; is that right?

MS. ZIEVE: Or designed to burst in a

different way.

JUSTICE BREYER: What does that mean? How

do you design something to burst?

MS. ZIEVE: I don't know how you design a

balloon. But there --

JUSTICE BREYER: If you don't know how to

design the balloon, what are you basing the design claim

on?

MS. ZIEVE: As I said, the design claim in

this case was not significantly developed. Perhaps it

would help to talk about the design claim in Horn v.

Thoratec, for example, which is another PMA --

JUSTICE GINSBURG: What about the label --

that you're pressing? So you said you really don't know

what the design defect was. How about the label? That

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would be the other thing.

MS. ZIEVE: The labeling claim is that the

label was -- inadequately warned or was misleading

because although at one place it lists among 12

precautions not to inflate the balloon above the rate of

burst pressure, which was eight, at another place it

says to -- it has a chart that shows inflation up to 13

atmosphere, and at another place in the instructions, it

says inflate to the nominal pressure, which is --

CHIEF JUSTICE ROBERTS: So that's just like

a car speedometer. I mean, the speedometer goes up to

120 miles an hour, but that doesn't mean you are

supposed to drive it that fast.

MS. ZIEVE: But the car doesn't come with a

chart that shows you safe usage of up to 100 miles

either. And the instructions --

JUSTICE KENNEDY: Was Medtronic free to

alter this label without the FDA's consent?

MS. ZIEVE: Yes. Under 814.39, Medtronic

could make changes to strengthen the warnings or clarify

the instructions without prior approval. And there's

one other part of the label that --

JUSTICE KENNEDY: What's the citation for

that?

MS. ZIEVE: 21 CFR 814.39(d).

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JUSTICE BREYER: Let me tell you why I asked

my question, because I don't want to leave -- you to

leave with an unfavorable impression in my mind on your

issue without your having a chance to see.

What's worrying me is that, of course, it's

a terrible thing when somebody is hurt in these kinds of

accidents. And the lawyers are trying to help. So the

lawyers will think, look, there's a problem here. There

must be. My client was seriously hurt. And he's not

supposed to be.

And then they'll work backward from that and

say well if he was hurt, there must be something wrong

with the design.

So every time there is an accident or

something bad happens, the lawyers assert a design claim

and they gear up discovery.

And in my mind, could Congress have intended

that kind of thing when what they're trying to do is

have a group of experts really look into this and decide

whether it should marketed or not. That's what's

bothering me. And that's why I would like you to

respond to that.

MS. ZIEVE: Of course, it -- I freely admit

that at trial if the plaintiff couldn't articulate the

design theory any better than I did here, the plaintiff

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is not going to lose on the design claim. But there are

other cases where there is quite a clear theory about

what the design defect is.

There are cases where the products have been

recalled because of a design defect; and in those cases,

could Congress have really intended to protect the

manufacturer from liability? After all, the Dalkon

Shield disaster where tons of people were hurt

because -- women were killed and injured because of a

design defect, was just infamous for the bill.

I would like to reserve the balance of my

time.

CHIEF JUSTICE ROBERTS: Thank you, counsel.

Mr. Olson.

ORAL ARGUMENT OF THEODORE B. OLSON

ON BEHALF OF THE RESPONDENT

MR. OLSON: Mr. Chief Justice, and may it

please the Court:

I think that the key central focus of this

case was touched upon by Justice Kennedy's question.

Congress made a decision that it wanted to balance

reasonable safety and effectiveness of lifesaving

devices with the availability of lifesaving devices to

the public.

They did so by vesting this responsibility

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in the experts, the expertise, the judgment, and the

processes at the FDA.

And preemption of potentially conflicting,

confusing, and burdensome State law requirements is

essential to this scheme.

JUSTICE GINSBURG: Why, Mr. Olson, is it

more essential to this scheme than the new drugs? I

would think that if everything that you said about new

devices would apply in bold letters to new drugs,

because the testing procedures are much longer, are they

not?

MR. OLSON: They're similar, but they're

also quite different, Justice Ginsburg. The principal

difference is this preemption provision that is the

fundamental issue in this case. Section 360k(a)(1),

that similar provision was not put by Congress in the

new drug --

JUSTICE GINSBURG: Well, there's an argument

that what it was intended to do was to cut out State

pre-market approval, where States like California came

in when there was a Federal void and said we shouldn't

let the manufacturers put out whatever they'd like.

Let's have a pre-market approval.

And the argument is, as you well know, which

was presented in Senator Kennedy's brief, that's what we

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meant to do with the preemption provision. Nothing

more.

MR. OLSON: If there was such a State

pre-market approval process, it would be something like

the Federal process which would involve a very detailed

application which would have everything about the

design, the manufacture, and the warning labels in it.

Then California would come up with different

requirements, presumably or potentially, than what the

FDA had decided was a reasonable balance between safety

and effectiveness and availability. And so therefore,

there would be different requirements.

And, as Justice Breyer pointed out in his

concurring and dissenting opinion in the Lohr case, if a

State jury or a State court comes up with those

different requirements, it is the same problem:

Different States, different requirements under different

circumstances.

And it would be quite anomalous for Congress

to have given more power to juries in individual ad hoc

cases which don't do the weighing, Justice Kennedy --

they can't do the same amount of weighing because their

focus --

CHIEF JUSTICE ROBERTS: What if the FDA

hasn't done it? How are newly discovered flaws dealt

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with? I mean, say where you have this catheter, and the

FDA didn't look at the possibility of allergic reactions

to the balloon plastic, and all of a sudden it turns out

to be a serious problem.

How can you say that that's preemptive?

MR. OLSON: This is a continuous process.

Information must be given by the manufacturer. There is

a process by which doctors report consequences to the

FDA. Citizens may report information. This is a

continuous jurisdiction --

JUSTICE KENNEDY: Is the manufacturer free

to continue to sell the device after newly discovered

risks --

MR. OLSON: Yes --

JUSTICE KENNEDY: -- pending the FDA's

acting on the same information?

MR. OLSON: Yes, Justice Kennedy. And let

me explain why I think that is important to this case.

If the -- that information is then in the

possession of the FDA. The FDA can suggest to the

manufacturer -- it can require the recall. It can

change warnings. It can do all of those things. But

what it is doing, because it's continuously involved in

the process --

JUSTICE KENNEDY: It takes time for the FDA

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to act. Let's assume that we know it's going to take

six months for the FDA to do this. The manufacturer

knows that there's a real problem. He can continue to

sell in the face of the knowledge of the real problem?

MR. OLSON: What I'm suggesting is that the

FDA can act as promptly or as slowly --

JUSTICE KENNEDY: I was asking you about the

manufacturer's duty pending the FDA's action.

MR. OLSON: It's dependent upon the

manufacturer providing information to the one

centralized agency --

JUSTICE STEVENS: Mr. Olson, suppose the

manufacturer did not provide information. Would the

preemption nevertheless exist?

MR. OLSON: Yes, Justice Stevens, because in

that case --

JUSTICE STEVENS: At least as a theoretical

possibility, there could be a newly discovered risk that

the FDA never knew about. And, nevertheless, the claim

would be preemptive.

MR. OLSON: Yes. And that's a judgment that

Congress made, because with the -- the manufacturer then

would be violating the law, failing to tell the FDA what

was going on, perhaps comitting fraud, and be subject to

criminal penalties, recall penalties, civil penalties,

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and that sort of thing.

The choice is, Justice Stevens, in that

situation -- is to allow the agency that has the

expertise, that has spent 1200 hours or so on this

particular device, according to your opinion in the Lohr

case, to make a judgment with respect to whether this

product should be on the market or not.

Because as I --

JUSTICE SOUTER: Mr. Olson, that still

leaves the -- sort of the hiatus that Justice Kennedy's

question was addressed to. And I -- I don't think I

understand your answer to it.

His question was what if the manufacturer

has learned that there is -- that there's a problem that

somebody hadn't anticipated? The manufacturer has told

the FDA, and the FDA has not yet acted.

Leave open the question of whether the FDA

is slow or whether it just takes time, but there's a --

there's a hiatus here. And an injury occurs because of

marketing that took place during the hiatus.

Does preemption still apply?

MR. OLSON: Yes, it does.

JUSTICE SOUTER: Okay.

MR. OLSON: And the reason for that, Justice

Souter, is that someone must make a judgment. That --

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the information that the manufacturer may have learned

may be -- have some aspect of the safety or

effectiveness of the device, but it still might be the

best product available.

As the government points out in its brief,

there are some devices that are used in situations where

a child might die. There's a 50-percent mortality rate

even with using the device. So there's got to be

individual judgments with respect to variations of risk

and safety and availability.

JUSTICE ALITO: Do you know whether the PMA

process in this case considered the design defects that

the Petitioner seems to be relying on?

MR. OLSON: Well, all -- no, I don't know

the answer to that specifically, Justice Alito. But I

do know -- and this is the application, itself, which is

not, unfortunately, in the record, but is available

through the FDA. It goes into elaborate detail with

respect to the burst pressures. This device -- the

label on this device -- and that is in the record at

A-174 of the court of appeals appendix -- specifically

says it shouldn't be inflated higher than a burst

pressure or atmospheric risk pressure at 8 atmospheres.

This one was inflated to 10 atmospheres, notwithstanding

the label requirements.

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So what -- what I am saying is that the

elaborate nature -- everything in the label has to be

approved by the FDA. The safety indications, the

precautions, the hazards, the counter --

counterindications, and that sort of thing, there's a

professional judgment there.

My colleague says that well, it's not the

FDA's not imposing requirements, because this is a

design submitted by the manufacturer. Of course, it's a

design submitted by the manufacturer. That's how

devices are made.

But the FDA examines every little part of

that design -- the way it's manufactured, the way it's

labeled, the way it's marketed, the way it's going to be

used.

And it can say no, change that part of it,

or have you considered this? It's a dialogue between

the manufacturer and the FDA.

And then when the FDA is satisfied that it's

reasonably safe and effective -- and the word

"reasonable" is important. Nothing is perfectly safe.

You can make a car weigh a hundred tons, and it might be

perfectly safe, but balances have to be made, the same

with drug devices. So --

JUSTICE ALITO: If you look at the file of a

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PMA proceeding after it is concluded, can you tell

exactly which design features and which risks the FDA

has considered?

MR. OLSON: No, I don't think you can. What

you can do, Justice Alito, is examine -- and Justice

Breyer's example of the two-inch versus one-inch wire in

the Lohr case is a good example.

The FDA will have examined, and presumably

done its job, with respect to every aspect of the

design, manufacture, and labeling and marketing of the

device.

Now, the choice is between that -- and I

think Congress made this judgment quite consciously,

because if a -- if a jury comes along in a particular

case, examining a particular infant or a particular ill

person and the facts of a particular situation, and says

well, the device should have had a one-inch nail -- a

wire, or it should have had a different tensile strength

of the balloon, or something like that, then the

manufacturer is in this dilemma.

JUSTICE GINSBURG: Why isn't there -- to --

to take care of that kind of hypothetical where the FDA

says this isn't it, to say that kind of suit can't be

brought. But it is, indeed, mentioned that there's a

category of suits that is simply saying: Manufacturer,

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you didn't do what's in that pre-marketing approval?

So we're kind of a backup to not doing

anything in conflict with the FDA's approval. We're

simply saying you didn't follow the labeling

requirement, or you didn't follow the design submission

that you --

MR. OLSON: I think if there's a violation

of the requirements -- now, it's no -- there's no

question that there are requirements, because every

aspect of this approval incorporates the design and all

of those things.

If the manufacturer fails to comply with

those requirements, that's a parallel suit that may be

brought.

Now, in this case, the negligent

manufacturer -- a claim was made. It was dismissed on

summary judgment, which was affirmed by the Second

Circuit because there was no evidence to support it. So

CHIEF JUSTICE ROBERTS: You -- you agree

that that was not preemptive.

MR. OLSON: That was -- we agree that was

not preempted, and -- and the court of appeals came to

that same conclusion, but affirmed the district court

that dismissed it on summary judgment because there was

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no evidence to support it.

JUSTICE GINSBURG: You would say the same

thing for -- for design and labeling if the manufacturer

did not do what the FDA approved?

MR. OLSON: That's correct, Justice

Ginsburg.

Now our -- the statute, I think, could not

be more clear with respect to every aspect of what the

Court talked about in the Lohr case. And I think that

the analysis that this Court articulated in the Geier

case having to do with the air bags, although that was

an implied preemption and conflict preemption case and

this is an express preemption case, is very

illustrative.

The Court went through an analysis of what

manufacturers might do if they were required to put an

air bag in the car when the Department of Transportation

had decided that it wanted a little bit of play in the

marketplace with respect to different types of

restraints of individuals.

And the Court made it very clear that if a

trial court in Kansas or some other place decides that

cars must be manufactured in a certain way, that's what

would happen.

And then the judgment of the Department of

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Transportation, which was considering all of these

things and wanting to encourage innovation with respect

to restraints -- the same thing is true here.

We want in this country for devices to be as

safe and effective as they possibly can be. But we

don't want to discourage the marketing of products that

might save our lives. And these are -- Class 3 devices

are all in the category of life-threatening or

life-saving devices here. So we want those available.

They may not all be perfect. They may work in some

situations and not work in other situations, but some

expert, centralized, that can take into consideration

all of those factors should be the place where that

decision is made.

JUSTICE GINSBURG: Mr. Olson, what about the

argument that once you've got this very valuable

pre-market approval, even though you could make that

device safer, you have no incentive to do that. You

have permission to market this product as is. Even if

you know that there's a better way to do it, there's a

disincentive to try to go through the process and make

the change. Why should you, when you have carte blanche

to continue without making the change?

MR. OLSON: Well, I think the real world

answers that question. The manufacturers of these

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products are always trying to produce better products

that will be safer. They of course have to go through

the process to justify to the experts at the FDA that

they are indeed safe, or -- and the FDA then may make a

judgment that the reasonableness -- if there is a much

safer device that doesn't have the risks of the previous

device, they can -- they can withdraw the approval of

the previous device.

But the FDA may at the same time say well,

this one device might be safer under some circumstances

but less safe under other circumstances. It might work

in this critically ill patient, but not in this

critically ill patient. So the marketplace of doctors

and patients deserves to have more than one product out

there, even though someone might decide this one is

safer than the other one. That is the way Congress made

this judgment. And --

JUSTICE KENNEDY: If the manufacturer finds

just from its own laboratory experiments and not because

of any data it's received from doctors and patients that

there's a better way to do this, does it have the

obligation to notify the FDA?

MR. OLSON: I don't think so,

Justice Kennedy. I think that there may be marketplace

incentives and other things that would cause a --

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someone in the marketplace to say I found a better way.

Someone in the marketplace might say well, it might be

better, but it might be prohibitively expensive. There

are all kinds of those judgments, and I think that

illustrates the point.

The FDA is the right place for these

decisions to be made and this balancing process to

occur, because an individual ad hoc -- not

scientifically trained jury that is not required to

consider the consequences for the marketplace as a

whole, cannot make those judgments.

As conscientious as a jury might be, that

judgment is in for that case and for that patient and

might say well gee, it should have been done differently

in this particular situation; a one-inch wire might have

been better in this particular case. But the --

CHIEF JUSTICE ROBERTS: Mr. Olson, I'm

looking at the Government's brief on page 4 which says

that in the annual reports, the -- the manufacturer has

to disclose unpublished reports of data from clinical

investigations or nonclinical laboratory studies

involving the device.

So presumably that includes any nonclinical

laboratory studies that the manufacturer itself

conducted.

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MR. OLSON: Yes. I believe that's true, but

I think that was a slightly different point than

Justice Kennedy's one; what was -- if it is the same

point, I agree with you, that there is an elaborate

process of information exchange from the manufacturer

and from doctors and from all over with respect to these

medical devices. It's described in considerable detail

in about six pages in the court of appeals decision, and

the Government's brief describes it quite thoroughly as

well.

That same balancing, the Government filed a

brief last week in this Court in the Warner Lambert

case, that this Court will be hearing, I think in

January, which describes in even greater detail than it

does in the brief filed here about that balancing

process and the importance of the centralized --

JUSTICE STEVENS: Could you answer one thing

for me on that? Is that a -- as soon as they get the

information requirement, or is it an annual requirement

that they have to take --

MR. OLSON: That -- what the Chief Justice

was referring to was an annual requirement --

JUSTICE STEVENS: Right.

MR. OLSON: -- but there also are

requirements -- and I haven't -- can't give you the

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exact citation, there's a lot of subparagraphs in these

sections -- with respect to information that comes into

the possession of the manufacturer that's pertinent to

adverse consequences or effects of the device that must

be given promptly to the FDA.

JUSTICE SCALIA: Mr. Olson, the other side

says well, you know, these are all horribles but, in

fact, we have had tort suits and manufacturers haven't

taken their products off the market. This is all just a

Chicken Little kind of a --

MR. OLSON: Well, I don't agree with that,

Justice Scalia. In the first place, I don't think we

know. Secondly, there are six of the seven circuits

that have considered this case, found that those tort

suits were preempted. So to the degree to which they

are out there, there is one circuit in which they might

JUSTICE STEVENS: But of course the FDA took

this contrary position some years ago.

MR. OLSON: Yes, it did, and it -- and it

learned from experience -- the unique experience that

you described the FDA having, in your opinion in the

Lohr case, has been brought to bear in this case; and

there's a reasoned explanation for the FDA's -- the

Government's position today, as to why it took one

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position then -- there were some proposed regulations

that are no longer on the table -- but there's a

reasoned explanation by the agency that you said and

quite correctly in my judgment had a unique experience,

and unique capability of determining the effect of

take -- State court suits on the process that it's

involved in, and that's reflected in the Government's

briefs that are filed in this case just earlier.

The fact is that there are specific detailed

requirements with respect to every aspect of the device

that's approved by the FDA; and any jury, just like any

regulatory body, Justice Breyer, will impose a different

requirement. The fundamental that you asked about,

what's the basis of this suit, there was some answer to

it, but the fact is there's some effort to explain why,

if it was designed according to the approval, by the

FDA, that wasn't good enough.

There was something wrong with that design

that was approved. Something wrong with that label that

was approved. And a jury at the end of the day will be

expected then to render a different requirement by

saying you are liable for damages because you did it the

way the FDA approved.

That is a State requirement which is a

counterpart to the Federal requirement, and this -- and

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Congress made it explicitly clear that any requirement

that is different or in addition to the Federal

requirement is preempted if it has to do with safety or

effectiveness of the device.

And if juries require products to be

changed, they will by definition be either less safe or

less available than the FDA has determined is in the

best interests of the public according to the

responsibility vested in them by Congress.

Thank you, Mr. Chief Justice.

CHIEF JUSTICE ROBERTS: Thank you,

Mr. Olson.

Mr. Kneedler.

ORAL ARGUMENT OF EDWIN S. KNEEDLER,

ON BEHALF OF THE UNITED STATES,

AS AMICUS CURIAE,

SUPPORTING THE RESPONDENT

MR. KNEEDLER: Mr. Chief Justice, and may it

please the Court:

I think it might be useful to begin by

focusing on the consequences of Petitioner's argument

that the PMA approval of an application does not result

in requirements that are preemptive for purposes of the

preemptive provision. Under Petitioner's view, the day

after the FDA gave PMA approval to a particular device,

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State legislatures or State regulatory agencies could

adopt laws or regulations that would direct the

manufacturer to manufacture or design the product or to

give labeling that would conflict with what the FDA had

just approved. And we don't think that Congress could

have intended in enacting the express preemption

provision here to allow State regulatory agencies or,

even more so, individual juries that could very within a

State --

JUSTICE GINSBURG: I thought that you

conceded that there would be conflict preemption, that

the States could not -- either through a State agency or

through a jury -- come up with a requirement that would

conflict with an FDA requirement.

MR. KNEEDLER: But we think that the express

preemption provision embodies that very important

conflict, or maybe in this context it is best to

conceptualize it as field preemption, of the things that

are included within the application that is submitted to

the FDA and the labeling.

JUSTICE SCALIA: Additional requirements are

not necessarily conflicting requirements. You

can comply with --

MR. KNEEDLER: Yes, that is -- that is

definitely true.

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JUSTICE SCALIA: It is clear that Congress

didn't want additional requirements.

MR. KNEEDLER: That's -- that's entirely

correct, and if I could just elaborate on that --

JUSTICE BREYER: How are they not

conflicting? Go ahead; go ahead -- elaborate.

MR. KNEEDLER: Well, what I was going to say

-- to elaborate on the point that I made, Petitioner

concedes that if there is an FDA PMA requirement, the

State may not impose its own PMA requirement; and that

has to be correct, because in the State PMA approval,

the State could withhold its approval unless the

manufacturer changed the device or changed the labeling

in some way to get it cleared through --

JUSTICE GINSBURG: Everybody agrees that

far, that the States were not to be in the business of

issuing PMA's. The question is does the preemption

clause mean any more than that?

MR. KNEEDLER: But it's important to

understand why. Congress was not concerned about the

PMA in the abstract or as a process; it was concerned

about what the consequences of requiring the

manufacturer to go through the PMA process were. And

that was precisely because the result of the State PMA

process could be to impose different requirements. The

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labeling should read differently --

JUSTICE GINSBURG: Isn't it -- isn't it --

MR. KNEEDLER: -- the product should be

differently.

JUSTICE GINSBURG: If you compared drugs,

which -- I think you will -- you will concede -- go

through a very arduous process, new drugs, why -- maybe

you think that the same preemption applies there,

although there's no preemption clause.

MR. KNEEDLER: There is -- there is no

express preemption clause there. One -- one possible

explanation might be is that a -- that a device is a

tangible concrete item, an item of commerce that is --

that has extensive design and planning and blueprints in

a way that a drug doesn't quite have that same -- that

same characteristic. I mean, like other -- like

automobiles or something, that they have a tangible

aspect and a long lead time in the design and

manufacture.

That may be one explanation for why Congress

wanted to be especially firm about imposing preemption

with respect to Federally approved devices.

JUSTICE SCALIA: It was also a different

Congress.

MR. KNEEDLER: It was a different Congress.

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JUSTICE SCALIA: How much -- how many years

later?

MR. KNEEDLER: This was 1976 when we --

JUSTICE SCALIA: Why did we expect them to

come out with the same --

MR. KNEEDLER: Right, and they were only

addressing devices in that -- these were not general FDA

amendments; they were addressing -- they were addressing

the --

JUSTICE GINSBURG: Did anyone -- when this

preemption clause was put in the new Medical Device, did

the government -- when was the government change? Was

it 2004? The government's position, the FDA's position,

was 180 degrees different --

MR. KNEEDLER: Well, the government filed a

brief in -- in late 1997 taking a position that PMA

approval did not -- did not have preemptive effect.

That was issued together with FDA's issuance of a

proposed rule to the same effect. FDA withdrew that

proposed rule 7 months later. The government did not

address this question again until 2004 in the brief

you're referring to in the court of appeals.

And due in large part to examining the very

things that I've been talking about, that in FDA's

judgment, which this Court in the Lohr case said was

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entitled to considerable deference, FDA recognized that

there would be a serious undermining of FDA's approval

authority and its balancing of the risks and benefits,

if a State jury could reweigh those -- the balance that

FDA had struck in the new Medical Device --

JUSTICE KENNEDY: Suppose a label is

approved in a very specific form under PMA, and then a

year later, it turns out, unforeseen by anyone, that

doctors are just -- many good doctors are just reading

it the wrong way and it's dangerous.

Can the manufacturer continue to sell new

devices with the same label pending the annual report?

MR. KNEEDLER: Yes. I mean, let me just

clarify.

If the -- if the -- there are incident

reports that -- that a manufacturer is supposed to give

to FDA. There is often a difficult judgment as to

whether the injury that is associated with a device is

some problem of the device or whether it's some problem

JUSTICE KENNEDY: Just take --

MR. KNEEDLER: -- with what --

JUSTICE KENNEDY: Just take my hypothetical.

MR. KNEEDLER: And it -- what I was going to

say is it's possible that the labeling would be regarded

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as misleading for some reason. In that event, the

manufacturer should apply to -- should submit what's

called a supplemental PMA and request that the labeling

be changed to clarify that.

JUSTICE KENNEDY: And you could -- and the

manufacturer continued to sell the device knowing that

the label is being misconstrued by very good doctors

pending FDA action?

MR. KNEEDLER: Ordinarily, yes. If there

was -- if there was a very serious risk to health and

safety --

JUSTICE KENNEDY: Yes, it's very serious.

MR. KNEEDLER: In that event, FDA has

variety of tools that it can take and so does the

manufacturer. One of them is what's sometimes called a

"Dear Doctor" letter, which is notification -- this is

provided for under 360h(a) of the Act -- is a

notification to physicians or other users of a product

that there may be some previously unrecognized problem

or misrepresentation or what could be misconstruction of

the label.

JUSTICE KENNEDY: Does the failure to give

that notice subject the manufacturer to liability if the

manufacturer continues to sell the device?

MR. KNEEDLER: It would not subject it to

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State tort liability, no. If there was -- if there was

a situation where the manufacturer knew of a serious

problem and did not report it to it FDA, that could

subject the manufacturer to criminal penalties with

respect to FDA for either misrepresenting or withholding

information. But that's really the Buckman -- this

Court's Buckman decision, that that's the relationship

between FDA and the manufacturer, and that's the

incentive.

I think someone asked about what incentives

does the manufacturer has. The manufacturer has a

powerful incentive because of the criminal penalties and

other sanctions that can be taken by FDA if -- if the

manufacturer does not report something to the FDA.

Plus, manufacturers have an important reputational

interest, that they don't want to be seen to be flouting

possible problems.

JUSTICE SOUTER: Mr. Kneedler, let me ask

you to -- a textual question which perhaps would be

better directed to counsel for the Petitioner, but let

me get your take on it.

If the only objective in the -- in the

preemption clause were to preclude State PMA in addition

to Federal PMA, there would have been no reason to

include the phrase -- would there have been any reason

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to include a preclusion of a requirement that is

different from in addition to a preclusion of something

which is in addition to?

MR. KNEEDLER: I -- if it was just -- I

think that's a good point. If it was just a question of

going through a duplicative State PMA process --

JUSTICE SOUTER: "Addition to" would be --

MR. KNEEDLER: Right. Right. Right.


MR. KNEEDLER: And also I think the FDA

regulations promulgated when this was put out, soon

after the '76 amendments were passed, I think reinforced

the conclusion that -- and, in fact, there was a

regulation that specifically talks about the application

of general adulteration standards in a way that might

require a specific label change to be made by a

manufacturer, and we think that's basically precisely

this lawsuit. It's the application of general tort law

that would require the manufacturer or a standard of

care under common law that would say that what the

manufacturer had done specifically approved by FDA was

-- was improper as a matter of State law. We think that

that is in the teeth of the preemption provision. I

think Justice Alito asked the question about the issue

of whether FDA focused or didn't focus on a particular

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aspect of the design. We don't think that a preemption

test can really realistically turn on that. That would

require extensive and intrusive inquiry into what FDA

had done. We think that the best way to look at this is

what the end product was; what was the application that

was finally approved and the labeling associated with

it, much like the filed rate doctrine. You look at what

was put before the agency and what was approved, not

what might have gone into -- into consideration.


Mr. Kneedler.

MR. KNEEDLER: Thank you.

CHIEF JUSTICE ROBERTS: Ms. Zieve, you have

4 minutes remaining.

REBUTTAL ARGUMENT OF ALLISON M. ZIEVE

ON BEHALF OF THE PETITIONER

MS. ZIEVE: First of all, it's not our

position, Justice Souter, that only State PMA's are

preempted. California has good manufacturing practice

requirements that were preempted to the extent they were

different from or in addition to the Federal

requirement.

Some States had hearing aid packaging

requirements. There was a State that had a requirement

about the grants of prescription glasses, lenses. So

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it's -- it is broader than just --

JUSTICE SOUTER: And how do you draw the

line between those instances and the ones that you say

are not preempted?

MS. ZIEVE: Those were specific requirements

for devices, and they had counterparts --

JUSTICE SOUTER: They -- they were

requirements, in other words, of positive law? They

were State regulations?

MS. ZIEVE: Addressed specifically to

devices, and they had --

JUSTICE SOUTER: So the --

MS. ZIEVE: -- direct Federal counterparts.

JUSTICE SOUTER: Okay. So the line is

simply enactment of positive law versus jury award?

That's the line?

MS. ZIEVE: I think that's what Congress was

intending.

JUSTICE SOUTER: No, I just want to make

sure --

MS. ZIEVE: I think under --

JUSTICE SOUTER: -- what your position is.

That is where you draw the line then?

MS. ZIEVE: Yes.


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MS. ZIEVE: I don't --

CHIEF JUSTICE ROBERTS: Didn't the Court --

didn't the majority of the Court reject that line in

Lohr?

MS. ZIEVE: The holding of Lohr didn't

reject it. Five justices disagreed with me, and I don't

think you need to agree with me on that point to find

for me here. We talked about some examples that Justice

Ginsburg offered, in which a State common-law duty could

become so specific that it effectively imposed a State

device requirement.

I also want to correct the point that

manufacturers can't make labeling changes without FDA

approval. Again, 814.39(d) allows them to do so. And

so the catheter's label, where it says "inflate the

balloon gradually to higher pressure up to the rated

burst pressure or until the stenosis resolves," the

narrowing resolves, to me that's ambiguous as to whether

you can go above the rated burst pressure. Medtronic

could have clarified that instruction without running

afoul of any FDA regulation.

As for the FDA's current views, it is not

actually correct that in Lohr the government gave weight

to the FDA's amicus brief. The government gave weight

to the FDA's regulation, 808.1(d). That regulation is

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still in effect, and it hasn't been modified since --

since Lohr was issued.

JUSTICE KENNEDY: What do I read in order to

verify your statement that the -- that manufacturers can

cure the label without FDA approval? Where do I find

that?

MS. ZIEVE: Without prior approval?

JUSTICE KENNEDY: Yes.

MS. ZIEVE: 814.39(d).

CHIEF JUSTICE ROBERTS: Thank you.

MS. ZIEVE: After FDA approved the PMA, any

of the listed changes can be placed into effect prior to

the receipt of a written FDA order approving the PMA

supplement.

CHIEF JUSTICE ROBERTS: If I could -- I'm

sorry -- I've been thinking about your example of

ambiguity. You're saying it is ambiguous when they say

you can inflate it up to the bursting pressure or until

the blockage is cleared?

MS. ZIEVE: Right.

CHIEF JUSTICE ROBERTS: Well, doesn't that

obvious mean if the blockage is clear, you don't keep

inflating it to the bursting pressure. You think that

doctors read that as saying you can inflate it past the

bursting pressure unless -- if the blockage isn't

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cleared?

MS. ZIEVE: Yes. It says either one. It

doesn't say up to a maximum. There is testimony from

the doctor in this case that he thought that the label

showed testing up to 13. And that based on the

directions, he thought that going up to 10 was fine and

that it was standard use among the cardiologists.

CHIEF JUSTICE ROBERTS: Even though the

label said eight is the bursting pressure?

MS. ZIEVE: The rate at burst pressure,

yeah.

CHIEF JUSTICE ROBERTS: Okay.

MS. ZIEVE: I also want to mention -- we

don't come to this case on a blank slate. We come to it

in light of Lohr. The Court has already interpreted

Section 360k(a). In finding no preemption in Lohr of

any of the claims, the Court looked to the labeling

regulation 801.109 was applicable to the device there.

That is the same exact regulation that is applicable to

the device here.

If Medtronic's PMA device complies with

801.109, then it is deemed to be not misbranded, but

that is a moving target. What is adequate instructions

for use changes as the manufacturer learns about use of

its product in the real world. The same process for

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making design changes exists in this case as existed in

Lohr.

And on the State law side, we really are

talking about identical State duties of care, which this

Court said their generalities majority held that the

generality of these duties left them outside the

category of requirements that 360k envisioned to be with

respect to the device.

Thank you.


Ms. Zieve.

The case is submitted.

(Whereupon, at 11:11 a.m. , the case in the

above-entitled matter was submitted.)

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US Supreme Court: 06-179

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