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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.
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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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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.
JUSTICE SOUTER: Okay.
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.
CHIEF JUSTICE ROBERTS: Thank you,
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.
JUSTICE SOUTER: Okay.
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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.
CHIEF JUSTICE ROBERTS: 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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Page 56
A able 10:19,21above-entitled
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