USCA1 Opinion

UNITED STATES COURT OF APPEALS

FOR THE FIRST CIRCUIT

____________________
No. 94-1951

LINDA TALBOTT, ETC., ET AL.,

Plaintiffs, Appellants,

v.

C.R. BARD, INC., ET AL.,

Defendants, Appellees.
____________________

APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Mark L. Wolf, U.S. District Judge]

___________________

____________________

Before

Stahl, Circuit Judge,

_____________

Campbell, Senior Circuit Judge, and

____________________

John R. Gibson,* Senior Circuit Judge.

____________________
____________________

Jeffrey S. Beeler
_________________

with whom Jeffrey A. Newman and

__________________

Newman,
_______

Heineman & Itzkowitz were on brief for appellants.

____________________
Francis C. Lynch with whom Daryl J. Lapp
________________
_____________

and Palmer & Dodge

______________

were on brief for appellee C.R. Bard, Inc.

Robert D. Keefe with whom
________________

Hale and Dorr

_____________

was on brief

for

appellee David Prigmore.

William H. Kettlewell with whom Dwyer & Collora was on brief

_____________________
_______________
for appellee John Cvinar.
Michael S. Raab,
_______________

Attorney, Civil Division, with

W. Hunger, Assistant Attorney

__________

whom Frank
_____

General, Donald K. Stern, United

________________

States Attorney, Douglas N. Letter, Appellate Litigation Counsel,

_________________
United

States Department of

Justice, and Margaret Jane Porter,

_____________________

Chief Counsel,
Administration,

and Beverly Rothstein, Attorney,

__________________
were

on

brief for

the

United

Food and

States, amicus

curiae.
____________________
August 14, 1995
____________________

*Of the Eighth Circuit, sitting by designation.

____________________

Drug

CAMPBELL, Senior Circuit Judge.

____________________

the Medical Device

Section 360k(a) of

Amendments ("MDA") to the

Food, Drug and

Cosmetic Act ("FDCA") provides:

[N]o State or

political subdivision of a

State may establish or continue in effect

with

respect to

device intended

human use any requirement --

(1)

which

or

in

is different
addition

requirement

to,

applicable

from,
any
under

this chapter to the device, and

(2)

which

relates

safety or effectiveness

to

the
of the

for

device or

to any

included

in

other matter

requirement

applicable to the

device under

this chapter.

21

U.S.C.

360k(a)

questions: (1) whether

tort

law

claims

(1988).

This

appeal

presents two

the above provision applies

asserted

against

to state

medical

device

manufacturer; and (2) if so, whether there is an exception to

the

preemption clause where the manufacturer fails to comply

with the MDA.

are,

We hold that the answers to the two questions

respectively,

district

yes and

no.

We

therefore

affirm the

court's dismissal of this case for failure to state

a claim under Fed. R. Civ. P. 12(b)(6).

I.

It

is

unnecessary

to

set

out

the

facts

and

procedural background at length as these are in

court's comprehensive opinion.

the district

Talbott v. C.R. Bard, Inc.,

_______
________________

865 F. Supp. 37, 39-52 (D. Mass. 1994) (sections I and II.A).

-33

To orient

the reader

of this opinion,

following

brief summary.

On

December

we provide

28,

1988,

only the

Eunice

Beavers died

procedure

on the

when

operating table

heart catheter

during an

failed

to

angioplasty

deflate while

inserted in one

of her coronary arteries.

Talbott et al.,

sued the manufacturer of the heart catheter,

C.R. Bard, Inc. ("Bard"), and

for

wrongful death,

negligence,

breach

two members of its

alleging

of

Her heirs, Linda

numerous

express

and

management

state tort

implied

claims:

warranties,

punitive damages, negligent infliction of emotional distress,

fraudulent

hiring,

misrepresentation

civil

conspiracy,

and

unfair

concealment,

trade

district court dismissed the complaint

12(b)(6), finding

360k(a) of the MDA.

that all the

negligent

practices.

The

under Fed. R. Civ. P.

claims were

Plaintiffs now appeal.

preempted by

II.

To

determine whether

federal

law, we look to the intent of Congress:

to displace

state law

preemption is

U.S. 218,

found.

Rice
____

and manifest"

in the

occupies the

language of

of

field or

before

v. Santa Fe Elevator Corp., 331

________________________

Such intent may be

passage

state

congressional intent

230 (1947).

explicitly,

through

must be "clear

law preempts

statutory

where the

expressed either

statute, or

scheme

that

extensively

purpose and objectives

federal law would be frustrated by state law.

-44

implicitly,

of

Here, Congress

has manifested its intention an explicit preemption clause,

360k(a).

between

Thus,

absent

state and

any "general,

federal law, we

preemption Congress intended.

inherent

need only

conflict"

ascertain the

Freightliner Corp. v.
__________________

Myrick,
______

115 S. Ct. 1483, 1488 (1995); Cipollone v. Liggett Group, 112

_________
_____________

S. Ct. 2608, 2617-18 (1992).

reading of

factual

the

clause de
__

averments as

true

We review the district court's

novo, taking
____

and

all of

indulging every

plaintiffs'

reasonable

inference

in

plaintiffs'

favor.

Partnership v. Ponce Federal Bank,

___________
__________________

Garcia
Hotel Ltd.
____________________

958 F.2d 15, 17 (1st Cir.

1992).

A.

State Tort Law Imposes Requirements

___________________________________

Plaintiffs insist

concluding that

that

term it

state tort

used

in

Congress

meant

positive

enactments

and not

has been resolved

law imposes

360k(a).

"requirement" to

such

common law causes

decisions:

that the district court erred in

a "requirement"

Plaintiffs argue

include

only

as statutes and

of action.

This

that

the state's

regulations

issue, however,

against plaintiffs in this circuit

King v. Collagen Corp., 983 F.2d

____
_______________

as

in two

1130, 1135-36

(1st Cir.), cert. denied, 114 S. Ct. 84 (1993), and Mendes v.

____________
______

Medtronic, Inc., 18
_______________

F.3d 13, 16 (1st

Cir. 1994).

this court has ruled that Congress understood state

to impose a

to

"requirement" such as to subject

the MDA's preemption

clause.

-55

Where the

In

both,

tort law

state tort law

requirement is

"different from, or

by

the

MDA,

state tort

construction has

that has

should

decided.

in addition to" the

will

been adopted by

considered the

overrule

law

King
____

However,

as

A like

other circuit court

Plaintiffs argue

and Mendes
______

in

be preempted.

every

issue.1

except

requirement imposed

having

certain

that we

been wrongly-

circumstances

not

present here, the prior decisions of panels of this court may

be overruled only

by the full court en banc.

v. Newman, 49 F.3d 1, 11 (1st Cir. 1995).

______

hold that state tort law falls within

B.

United States
_____________

We accordingly, we

360k(a).

No Exception For Non-Compliance

_______________________________

Plaintiffs next argue that, even assuming

360k(a)

applies to state tort law generally, the district court erred

in holding that it applies where a manufacturer has failed to

comply

with

obtaining

the

provisions

approval

("FDA").

from the

Plaintiffs

Food

argue that,

Congress intended to preempt

impose

of

the

MDA

and

in

by

fraudulently

Drug Administration

enacting

360k(a),

only state laws that

sought to

liability on manufacturers who were already complying

____________________

1.
F.3d

See, e.g., Anguiano v. E.I. Du Pont De Nemours & Co., 44

___ ____ ________
_____________________________
806,

809 (9th

Vision Corp., 42
_____________
denied,
______

Cir.

F.3d

1167, 1168

63 U.S.L.W. 3904

Corp., 22 F.3d
_____
429 (1994);

1995) (dicta);
(8th

Martello
________
Cir. 1994),

(1995); Gile v.
____

Iolab Corp., 12
___________

cert.
_____

Optical Radiation
_________________

540, 542 (3d Cir.), cert. denied,

____________

Duncan v.
______

v. CIBA
____

F.3d 194,

115 S. Ct.
195 (11th

Cir. 1994) (per

curiam); Stamps v. Collagen Corp.,

______
______________

984 F.2d

1416, 1420-21 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993);

____________
Slater v. Optical Radiation Corp., 961 F.2d
______
________________________

1330, 1333 (7th

Cir.), cert. denied, 113 S. Ct. 327 (1992).

____________

-66

with the MDA.

afford

Congress did not, plaintiffs assert, intend to

such protection to manufacturers who failed to comply

with

the

provisions

of

conflict, in plaintiffs'

of

protecting individuals

defective medical devices.

to

comply with the

the

MDA.

Here,

from

result

would

basic purpose

unreasonably dangerous

Where a manufacturer

MDA, state

plaintiffs argue,

provisions of the

view, with the MDA's

tort liability

impose additional state sanctions

MDA.

Such

and

has failed

would merely

for noncompliance with the

Bard

clearly

violated the

MDA by submitting false data to the FDA in

order to obtain approval of its heart catheters.

As

the district

Supp. at 41-42, Bard pled

the

court explained, Talbott,

_______

865 F.

guilty in an earlier proceeding to

criminal indictment charging it with conspiring to defraud

FDA

in

connection

with

approval of its heart catheters.

applications

Bard

for

pre-market

was eventually forced

to pay civil and criminal fines totaling $61 million.

States v.
______

1994).

C.R. Bard, Inc., 848

_______________

There

is some

dispute

whether Bard's guilty plea

to

the

particular

angioplasty.

F. Supp. 287,

between the

As this

289 (D. Mass.

parties as

admitted wrongdoing with

heart catheter

is a motion

used

to

respect

Mrs. Beavers's

to dismiss,

accept plaintiffs' version of the facts.

987 F.2d 1, 3 (1st Cir. 1993).

in

United
______

however, we

Watterson
_________

v. Page,
____

Thus, for present purposes we

shall assume that Bard fraudulently obtained approval for the

-77

heart

The

catheter by submitting

question is

whether

false information to

360k(a)

applies

the FDA.

despite

such

fraudulent activity.

The

this

latter issue may already have been resolved in

circuit against

plaintiffs.

In

King, the
____

plaintiff

contended that the manufacturer had fraudulently obtained FDA

approval and that

not apply.

the MDA's preemption clause

therefore did

Judge(now Chief Judge) Torruella, in the opinion

for the court,

fraud

did not

question, construing

the

claim as essentially a failure to warn claim preempted

by the MDA.

In what was titled a "concurrence," however, the

two other

judges on

there was

no exception

cases in

MDA.

reach the

the

panel expressed

to the

MDA's preemption

which the manufacturer

As two

judges of

the

the opinion

failed to

panel took

that

clause for

comply with

this view,

the

it is

arguably now stare decisis.

If

overlooked the

the

so,

however,

fact.

The

to state tort law.

panel

plaintiff in Mendes did

______

exception-for-noncompliance

plaintiff in King, arguing

____

separate

argument

made

in

Mendes
______

not make

by

the

merely that the MDA did not apply

However, at the end of

the opinion, the

panel wrote:

We express no opinion on whether products

liability

claims are

preempted only

if

the manufacturer complied with applicable

FDA regulations.
no

allegations

noncompliance with

The complaint contains

regarding

Medtronic's

FDA regulations,

-88

and

plaintiff

has offered

Medtronic violated
Our holding is

no evidence

any FDA

that

requirement.

limited to the facts

and

claims in this case.

Mendes, 18 F.3d
______

Mendes can be
______

indicate

at 19-20 (citations omitted).

The dicta in

read (and plaintiffs argue should

be read) to

that

the issue

Alternatively, it

is

still

might mean only

open

in this

that the panel

circuit.

in Mendes
______

did not pay close attention to the concurrence in King, since

____

that

issue

was

not

before

it.

Given

the

uncertainty

regarding the precedential status of the King concurrence, we

____

shall address the arguments anew, as the district court did.

We hold that Congress did not intend to provide for

an

exception

to

the

MDA's

preemption

clause

where

manufacturer fails to comply

by fraudulently

FDA.

In

with the provisions of

obtaining approval

of its

the MDA

device from

the

so holding, we reach the same result reached by the

King concurrence and by the two circuit courts of appeal that

____

have expressly

addressed this

exact issue.

Acromed Corp.,
_____________

44

307 (5th

exception

to

F.3d

300,

preemption where

Cir.)

See
___

Reeves v.
______

(finding

no

manufacturer fraudulently

obtained FDA approval), cert. denied, 115 S. Ct. 2251 (1995);

____________

Michael v. Shiley, 46 F.3d

_______
______

petition for cert. filed,

__________________________

1316, 1329 (3d Cir. 1995) (same),

63 U.S.L.W.

3874 (U.S.

June 2,

1995).

Section 360k(a) preempts broadly any state tort law

"requirement" that is "different from, or in addition to" the

-99

comprehensive and detailed requirements

law.

set forth by federal

The terms of the statute make no distinction based upon

whether or not

federal

a manufacturer has in fact

standard.

We

find

nothing

complied with the

to

indicate

that

preemption is

the

federal

conditional upon satisfactory

standard.

compliance at all.

is

simply

federal

the

As

whether,

requirement

Section

in the

requirement.

penalties as

abstract,

from,

not mention

or

the

in

state

tort law

addition

to"

the

If a device manufacturer fails to meet

requirements,

set forth

suggests that the

does

360k(a) reads, the relevant inquiry

is "different

federal

360k(a)

compliance with

it will

in the MDA.

be

subject

Nothing

to federal

in

state requirements are somehow

360k(a)

revived by

this failure to comply with the federal standard.

Plaintiffs argue

impose

"requirement"

addition to"

instructs the

that state tort claims

that

is

"different

would not

from,

or

in

federal requirements so long as the state judge

jury that a

manufacturer's obligations

under

state tort

law were

Given such

an instruction,

would

provisions of

plaintiffs say,

the MDA.

state tort

law

not be imposing any additional requirements, but would

only compensate

MDA

defined by the

the victim ex

standards.

This

post for failure to

theory

of

cooperative

meet the

preemption,

however, was expressly rejected, albeit in dictum, in Mendes:

______

One

way

to

ensure

factfinder applies a

that

[state]

standard not adding

-1010

to or

differing from FDA

to supplant the common

FDA's requirements.
support

that

radical,

regulations is

law standard with

We find

Congress intended

unwieldy

form

of

however, particularly where

not intend

nothing to

to create a

such

preemption,
Congress did

private right of

action under the Federal

Food, Drug, and

Cosmetic Act.

Mendes, 18 F.3d at
______

number

of other

Medtronic Inc.,
______________

19 n.4.

circuit

It

has also been rejected

courts

of appeal.

See Lohr
___ ____

by a

v.

56 F.3d 1335, 1343 (11th Cir. 1995) (holding

that "preemption under the MDA cannot be defeated by a common

lawsuit

alleging a violation

of the

statutory standards");

Michael,
_______

46

authority

F.3d at

to

police

1329

(holding

that "states

compliance

with

have

the

no

FDA's

procedures").2

Allowing

disturb

the balance

goals of

exception

for

Congress struck

and

manufacturers

standards.

noncompliance

between the

protecting individuals from

medical devices

device

an

subject

to

See Mendes, 18 F.3d at 16;

___ ______

Cong., 2d Sess. 5, 12

competing

unreasonably dangerous

spurring innovation

are

would

by

ensuring

uniform,

that

nationwide

S. Rep. No. 33, 94th

(1975), reprinted in 1976 U.S.C.C.A.N.

____________

____________________

2.

But cf.
_______

National Bank of Commerce

___________________________

v.

Kimberly-Clark
______________

Corp., 38 F.3d 988, 992 (8th Cir. 1994) (holding that "when a
_____

statute only

preempts state requirements

from

addition

or

in

plaintiffs

may still

defendants fail to
Slater, 961 F.2d
______
under

to

those

recover

imposed

under

comply with

by

state

the federal

at 1334 (stating

360k(a) "is limited

that are different

federal
tort

law

law,
when

requirements");

in dicta that

preemption

to efforts by states

to impose

sanctions for compliance with federal regulations").

-1111

1070, 1074,

1081).

To see

imagine how such an exception

how this

is so,

we need

would operate in practice.

only

If

state tort claims

would initially

had

complied

plaintiff

were allowed to go forward,

have to determine

with the

claimed that

MDA.

had in

fact been

approved the device

whether the

If,

as

manufacturer

in this

the manufacturer

FDA, the state court would

a state court

had

case,

the

defrauded the

need to determine whether the FDA

defrauded and whether

absent the fraud.

the FDA

Under

would have

this scheme, a

device manufacturer could potentially be subject

inconsistent interpretations

and

applications

to numerous

of

the

across different states,

thus undermining the MDA's

uniformity.

Moreover,

if

application

of the MDA,

requirements

"different

state

courts

erred

they would effectively

from,

or

in

addition

MDA

goal of

in

their

be imposing

to"

those

imposed

by federal

law.

See
___

King, 983
____

F.2d at

1139-40;

Talbott, 865 F. Supp. at 47.

_______

To avoid the

Congress

has the

placed enforcement authority

that

inadequate, 21

against

the

device

U.S.C.

is

to

initiate

manufacturers, as it did

Bard, 848 F. Supp. at

____

unsafe

360e(e); to order

360h(e); and

287.

treatment,

in the FDA.

broad power: to withdraw approval

determines

device,

possibility of disuniform

The FDA

of a device if it

or

its

labelling

a recall

of the

criminal prosecutions

in this case against Bard.

Centrally situated and with

-1212

the

requisite expertise,

the

FDA is

in

the best

position

to

determine whether the provisions of the MDA have in fact been

violated and to ensure that

manner.

See Michael,
___ _______

the law is applied in a

46 F.3d

central enforcement role,

at

1329.

Given the

the preemptive scope of

uniform

FDA's

360k(a)

becomes clear, as the districtcourt in this case aptly noted:

As

applied

preemption

in

this case,

provided

by

the
21

express
U.S.C.

360k(a) manifests a

decision by Congress

to replace completely
of action

the private rights

usually available

law with

civil and

under state

criminal enforcement

by the federal government when thoroughly

regulated

devices such

catheter,

are

at issue.

represents

permissible

Congress

that the

as Bard's
This

heart

judgment

decision

public interest

by
will

best be served by relying exclusively

the

FDA

between

to

strike the

reasonably

assuring

promoting innovation
devices that

proper

on

balance

safety and

with regard

have the potential

to new
both to

enhance and injure human health.

Talbott, 865 F. Supp. at 40; see also Reeves, 44 F.3d at 307.

_______
___ ____ ______

The

such

United States, as

reasoning, while

applicable

in

this

determined that Bard

amicus curiae,

perhaps applicable

case,

because

the

failed to comply with

in

FDA

argues that

King, is
____

has

not

already

the requirements

of the MDA by submitting fraudulent

the concerns about

case.

disuniformity are not implicated

Under the United

would simply need

data to the FDA.

States' scheme,

then, a

Thus,

in this

plaintiff

to prove, not that the manufacturer failed

-1313

to comply with the MDA, but that the FDA had determined

that

the manufacturer failed to comply.

Although this

still

does

not get

language of

hint

of

that

actions

around

360k(a) nor

congressional

exception to

be

may

workable arrangement,

the

problem that

the

intent

to

create

injured plaintiffs

FDA has

determined

violated the

MDA would

standpoint.

Congress, however has

remedy,

neither

the legislative history

the MDA's preemption clause.

allowing

when

be a

be a desirable

to

such

it

the

give any

unique

It may or may not

recover

that

in state

a manufacturer

rule, from

not provided for

a policy

such a

choosing instead to place sole enforcement authority

in the hands of the FDA.

See, e.g., Mendes, 18 F.3d at 19 n.

___ ____ ______

(no

federal

private

right

of

action

Rodriguez v. SK & F Co., 833 F.2d 8, 9

_________
___________

curiam) (same).

under the

(1st Cir. 1987) (per

As the district court aptly noted:

Congress

could

when the

FDA has already

was defrauded,
to recover

decide

that

established it

private rights

damages on behalf

individuals are
here, it

reasonably

of action
of injured

appropriate.

Where, as

is well-established

that there

is generally

no private right

to enforce

the MDA, if

to create

an exception

of action

Congress intends
for fraud

which

has already been demonstrated by the FDA,

it should say so clearly.

In view of the

unqualified language of the MDA's present

preemption provision, however, this court
does

not

inferring

have
that

a
such

intended.

Talbott, 865 F. Supp. at 47.

_______

proper
an

MDA);

basis

for

exception

was

-1414

The absence of a

non-compliance exception does not

mean that individuals injured by noncompliance will always be

without

compensation.

In a

manufacturer, a

court may,

restitution to

those harmed.

Bard,
____

848 F.

Supp. at

criminal

as part

292-93.

judgment

of any

See 18
___

While

U.S.C.

against a

sentence, award

3663(a)(1);

the district

court

accepted a binding plea agreement from Bard that contained no

restitution

provision,

erroneously

believed

appropriate

compensation.

Bard,
____

848

F. Supp.

it

did

that civil

at

so,

part,

proceedings

Talbott,
_______

293.

in

because

could provide

865 F. Supp.

Courts in

it

future

at 47-48;

criminal

proceedings will, or should, be aware that restitution may be

the only redress

for those harmed by

manufacturers who have

failed to comply with the provisions of the MDA.

Like

to

360k(a)

the court below, we cannot find any exception

where a manufacturer of a Class

III device has

failed to comply with the requirements of the MDA.

C.

Application of Preemption Clause

________________________________

Having

applies to

that

state tort law,

has complied

determine

held

with the

the

MDA's

whether or not

provisions of the

whether the

requirements

preemption

clause

the manufacturer

MDA, we

imposed by

must next

plaintiffs'

numerous state law claims are "different from, or in addition

to" the ones imposed

by the MDA.

district

court

did

In its

thorough job

-1515

of

opinion below, the

analyzing

each of

plaintiffs'

claims,

finding

additional requirements and

agree with

reason

the district

to repeat

district court's

(section II.C);

that

each

of

them

was therefore preempted.

court's analysis and

it here,

we adopt

opinion.

Talbott,
_______

imposed

As we

as we

see no

those portions

of the

865 F.

Supp. at

49-52

see In re San Juan Dupont Plaza Hotel Fire

___ ________________________________________

Litig., 989 F.2d 36, 38 (1st Cir. 1993) (where district judge
______

produces

a well-reasoned

result, a reviewing court

to

put matters

in its

opinion that

reaches the

should not write at

own

words).

plaintiffs' claims are preempted by

We hold

360k(a).

correct

length merely

that

all of

We

note,

briefly,

that

the

Third

Circuit

in

Michael, 46 F.3d at 1328, 1331, though agreeing in large part

_______

with our analysis, has held that claims for breach of express

warranty

and fraudulent advertising

360k(a).

The latter claim is

plaintiffs' fraudulent

statements made to

agreed

is

position

position as

the

present in

appears

district

not present in this

misrepresentation claim

the FDA, a claim which

preempted.

however, is

are not preempted

to

Id.
___

at

1329.

this case,

set forth in King, 983 F.2d

____

court's

finding

that

case, as

is based

on

the Michael court

_______

The

and the

be inconsistent

by

with

former

claim,

Third Circuit's

this

circuit's

at 1135.

We affirm

plaintiffs'

express

warranty

claim

reflects the

is

preempted,

law in this

as

circuit.

that

result

accurately

Accord Martello
______ ________

v. CIBA
____

-1616

Vision Corp.,
____________

42 F.3d at 1167, 1169 (8th

Cir. 1994).

As we

noted previously, prior decisions by panels of this court may

be overruled only

by the full court sitting

en banc, absent

exceptional

circumstances not present here.

Newman, 49 F.3d
______

at 11.3

D.

Remaining Claims
________________

Plaintiffs

arguments

advance

number

of

challenging Congress' power to enact

to displace state tort law.

constitutional

360k(a) and

We have reviewed these arguments

and find them it be without merit.

III.

Because

360k(a)

of

the

all of plaintiffs' claims are preempted by

MDA,

dismissal of this suit.

we

affirm

We end with

the

district

this quotation from the

district court's opinion:

This is

court's

a particularly poignant

case in

which

the heirs

of

woman

who

died

during angioplasty are being found not to

have the

right to seek

compensation for

____________________

3.

After oral argument, plaintiffs brought to our attention

Lohr, 56
____
held

F.3d at

that

1335, in which

plaintiff's

an Eleventh

negligent

design

failure to warn claims were not preempted

court in Lohr, however, explicitly
____
fact that

the device

Circuit panel
and

360k(a).

The

based its holding on

the

in question had

by

negligent

not gone

through the

pre-market approval process, but instead was marketed under

510(k) as

"substantially equivalent" to

an existing device.

Lohr is thus distinguishable from cases, like this one, where

____
the

device was

process,

as

subject to

the Lohr
____

court

the

premarket approval

itself

("Appellee's heavy reliance on . . .

because the device at issue

noted.

Id.
___

("PMA")
at

1347

King . . . is misplaced
____

in [that case] had undergone the

full PMA process before it entered the market.").

-1717

the

damages

suffered.

The

enforced

cause

enacted

the

have

applicable

is

means

of

competing
innovation

criminal

Nevertheless
some,
law,

to

the most

and

this decision

including

those

question

complete preemption of
action

undoubtedly

government has vigorously

the

civil laws.
may

they

who

whether

private rights of
fair

and effective

balancing

the

legitimate,

interests

of

promoting

and

reasonably

assuring the

safety of complex medical devices.

axiomatic, however, that
faithfully give effect

It is

the courts must

to the intentions

of

Congress

expressed by
in

this

when

they

are

statute, as they

case.

Defendants'

clearly
have been
motion

dismiss, therefore, must be granted.

Talbott, 865 F. Supp. at 40.

_______

Affirmed.
_________

to

-1818