Talbott v. C.R. Bard, Inc.

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 whom Frank

W. Hunger, Assistant Attorney General, Donald K. Stern, United

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

United States Department of Justice, and Margaret Jane Porter,

Chief Counsel, and Beverly Rothstein, Attorney, Food and Drug

Administration, were on brief for the United States, amicus
curiae.

August 14, 1995

*Of the Eighth Circuit, sitting by designation.

2

CAMPBELL, Senior Circuit Judge. Section 360k(a) of

the Medical Device 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 a device intended for
human use any requirement --

(1) which is different from,
or in addition to, any
requirement applicable under
this chapter to the device, and
(2) which relates to the
safety or effectiveness of the
device or to any other matter
included in a requirement
applicable to the device under
this chapter.

21 U.S.C. 360k(a) (1988). This appeal presents two

questions: (1) whether the above provision applies to state

tort law claims asserted against a 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. We hold that the answers to the two questions

are, respectively, yes and no. We therefore affirm the

district 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 the district

court's comprehensive opinion. Talbott v. C.R. Bard, Inc.,

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

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To orient the reader of this opinion, we provide only the

following brief summary. On December 28, 1988, Eunice

Beavers died on the operating table during an angioplasty

procedure when a heart catheter failed to deflate while

inserted in one of her coronary arteries. Her heirs, Linda

Talbott et al., sued the manufacturer of the heart catheter,

C.R. Bard, Inc. ("Bard"), and two members of its management

for wrongful death, alleging numerous state tort claims:

negligence, breach of express and implied warranties,

punitive damages, negligent infliction of emotional distress,

fraudulent misrepresentation and concealment, negligent

hiring, civil conspiracy, unfair trade practices. The

district court dismissed the complaint under Fed. R. Civ. P.

12(b)(6), finding that all the claims were preempted by

360k(a) of the MDA. Plaintiffs now appeal.

II.

To determine whether federal law preempts state

law, we look to the intent of Congress: congressional intent

to displace state law must be "clear and manifest" before

preemption is found. Rice v. Santa Fe Elevator Corp., 331

U.S. 218, 230 (1947). Such intent may be expressed either

explicitly, in the language of a statute, or implicitly,

through passage of a statutory scheme that extensively

occupies the field or where the purpose and objectives of

federal law would be frustrated by state law. Here, Congress

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has manifested its intention an explicit preemption clause,

360k(a). Thus, absent any "general, inherent conflict"

between state and federal law, we need only ascertain the

preemption Congress intended. Freightliner Corp. v. Myrick,

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

S. Ct. 2608, 2617-18 (1992). We review the district court's

reading of the clause de novo, taking all of plaintiffs'

factual averments as true and indulging every reasonable

inference in plaintiffs' favor. Garcia Hotel Ltd.

Partnership v. Ponce Federal Bank, 958 F.2d 15, 17 (1st Cir.

1992).

A. State Tort Law Imposes Requirements

Plaintiffs insist that the district court erred in

concluding that state tort law imposes a "requirement" as

that term it used in 360k(a). Plaintiffs argue that

Congress meant "requirement" to include only the state's

positive enactments such as statutes and regulations

and not common law causes of action. This issue, however,

has been resolved against plaintiffs in this circuit in two

decisions: King v. Collagen Corp., 983 F.2d 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). In both,

this court has ruled that Congress understood state tort law

to impose a "requirement" such as to subject state tort law

to the MDA's preemption clause. Where the requirement is

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"different from, or in addition to" the requirement imposed

by the MDA, state tort law will be preempted. A like

construction has been adopted by every other circuit court

that has considered the issue.1 Plaintiffs argue that we

should overrule King and Mendes as having been wrongly-

decided. However, except in certain circumstances not

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

be overruled only by the full court en banc. United States

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

hold that state tort law falls within 360k(a).

B. 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 the provisions of the MDA by fraudulently

obtaining approval from the Food and Drug Administration

("FDA"). Plaintiffs argue that, in enacting 360k(a),

Congress intended to preempt only state laws that sought to

impose liability on manufacturers who were already complying

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

F.3d 806, 809 (9th Cir. 1995) (dicta); Martello v. CIBA

Vision Corp., 42 F.3d 1167, 1168 (8th Cir. 1994), cert.

denied, 63 U.S.L.W. 3904 (1995); Gile v. Optical Radiation

Corp., 22 F.3d 540, 542 (3d Cir.), cert. denied, 115 S. Ct.

429 (1994); Duncan v. Iolab Corp., 12 F.3d 194, 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).

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with the MDA. Congress did not, plaintiffs assert, intend to

afford such protection to manufacturers who failed to comply

with the provisions of the MDA. Such a result would

conflict, in plaintiffs' view, with the MDA's basic purpose

of protecting individuals from unreasonably dangerous and

defective medical devices. Where a manufacturer has failed

to comply with the MDA, state tort liability would merely

impose additional state sanctions for noncompliance with the

MDA. Here, plaintiffs argue, Bard clearly violated the

provisions of the MDA by submitting false data to the FDA in

order to obtain approval of its heart catheters.

As the district court explained, Talbott, 865 F.

Supp. at 41-42, Bard pled guilty in an earlier proceeding to

a criminal indictment charging it with conspiring to defraud

the FDA in connection with applications for pre-market

approval of its heart catheters. Bard was eventually forced

to pay civil and criminal fines totaling $61 million. United

States v. C.R. Bard, Inc., 848 F. Supp. 287, 289 (D. Mass.

1994). There is some dispute between the parties as to

whether Bard's guilty plea admitted wrongdoing with respect

to the particular heart catheter used in Mrs. Beavers's

angioplasty. As this is a motion to dismiss, however, we

accept plaintiffs' version of the facts. Watterson v. Page,

987 F.2d 1, 3 (1st Cir. 1993). Thus, for present purposes we

shall assume that Bard fraudulently obtained approval for the

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heart catheter by submitting false information to the FDA.

The question is whether 360k(a) applies despite such

fraudulent activity.

The latter issue may already have been resolved in

this circuit against plaintiffs. In King, the plaintiff

contended that the manufacturer had fraudulently obtained FDA

approval and that the MDA's preemption clause therefore did

not apply. Judge(now Chief Judge) Torruella, in the opinion

for the court, did not reach the question, construing the

fraud claim as essentially a failure to warn claim preempted

by the MDA. In what was titled a "concurrence," however, the

two other judges on the panel expressed the opinion that

there was no exception to the MDA's preemption clause for

cases in which the manufacturer failed to comply with the

MDA. As two judges of the panel took this view, it is

arguably now stare decisis.

If so, however, a separate panel in Mendes

overlooked the fact. The plaintiff in Mendes did not make

the exception-for-noncompliance argument made by the

plaintiff in King, arguing merely that the MDA did not apply

to state tort law. 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. The complaint contains
no allegations regarding Medtronic's
noncompliance with FDA regulations, and

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plaintiff has offered no evidence that
Medtronic violated any FDA requirement.
Our holding is limited to the facts and
claims in this case.

Mendes, 18 F.3d at 19-20 (citations omitted). The dicta in

Mendes can be read (and plaintiffs argue should be read) to

indicate that the issue is still open in this circuit.

Alternatively, it might mean only that the panel 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 a

manufacturer fails to comply with the provisions of the MDA

by fraudulently obtaining approval of its device from the

FDA. In 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. See Reeves v.

Acromed Corp., 44 F.3d 300, 307 (5th Cir.) (finding no

exception to preemption where a manufacturer fraudulently

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

Michael v. Shiley, 46 F.3d 1316, 1329 (3d Cir. 1995) (same),

petition for cert. filed, 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

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comprehensive and detailed requirements set forth by federal

law. The terms of the statute make no distinction based upon

whether or not a manufacturer has in fact complied with the

federal standard. We find nothing to indicate that

preemption is conditional upon satisfactory compliance with

the federal standard. Section 360k(a) does not mention

compliance at all. As 360k(a) reads, the relevant inquiry

is simply whether, in the abstract, the state tort law

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

federal requirement. If a device manufacturer fails to meet

the federal requirements, it will be subject to federal

penalties as set forth in the MDA. Nothing in 360k(a)

suggests that the state requirements are somehow revived by

this failure to comply with the federal standard.

Plaintiffs argue that state tort claims would not

impose a "requirement" that is "different from, or in

addition to" federal requirements so long as the state judge

instructs the jury that a manufacturer's obligations under

state tort law were defined by the provisions of the MDA.

Given such an instruction, plaintiffs say, state tort law

would not be imposing any additional requirements, but would

only compensate the victim ex post for failure to meet the

MDA standards. This theory of cooperative preemption,

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

One way to ensure that a [state]
factfinder applies a standard not adding

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to or differing from FDA regulations is
to supplant the common law standard with
FDA's requirements. We find nothing to
support that Congress intended such a
radical, unwieldy form of preemption,
however, particularly where Congress did
not intend to create a private right of
action under the Federal Food, Drug, and
Cosmetic Act.

Mendes, 18 F.3d at 19 n.4. It has also been rejected by a

number of other circuit courts of appeal. See Lohr v.

Medtronic Inc., 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 F.3d at 1329 (holding that "states have no

authority to police . . . compliance with the FDA's

procedures").2

Allowing an exception for noncompliance would

disturb the balance Congress struck between the competing

goals of protecting individuals from unreasonably dangerous

medical devices and spurring innovation by ensuring that

device manufacturers are subject to uniform, nationwide

standards. See Mendes, 18 F.3d at 16; S. Rep. No. 33, 94th

Cong., 2d Sess. 5, 12 (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 that are different
from or in addition to those imposed by federal law,
plaintiffs may still recover under state tort law when
defendants fail to comply with the federal requirements");
Slater, 961 F.2d at 1334 (stating in dicta that preemption

under 360k(a) "is limited to efforts by states to impose
sanctions for compliance with federal regulations").

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1070, 1074, 1081). To see how this is so, we need only

imagine how such an exception would operate in practice. If

state tort claims were allowed to go forward, a state court

would initially have to determine whether the manufacturer

had complied with the MDA. If, as in this case, the

plaintiff claimed that the manufacturer had defrauded the

FDA, the state court would need to determine whether the FDA

had in fact been defrauded and whether the FDA would have

approved the device absent the fraud. Under this scheme, a

device manufacturer could potentially be subject to numerous

inconsistent interpretations and applications of the MDA

across different states, thus undermining the MDA's goal of

uniformity. Moreover, if state courts erred in their

application of the MDA, they would effectively be imposing

requirements "different from, or in addition to" those

imposed by federal law. See King, 983 F.2d at 1139-40;

Talbott, 865 F. Supp. at 47.

To avoid the possibility of disuniform treatment,

Congress placed enforcement authority in the FDA. The FDA

has the broad power: to withdraw approval of a device if it

determines that the device is unsafe or its labelling

inadequate, 21 U.S.C. 360e(e); to order a recall of the

device, 360h(e); and to initiate criminal prosecutions

against manufacturers, as it did in this case against Bard.

Bard, 848 F. Supp. at 287. Centrally situated and with the

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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 the law is applied in a uniform

manner. See Michael, 46 F.3d at 1329. Given the FDA's

central enforcement role, the preemptive scope of 360k(a)

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

As applied in this case, the express
preemption provided by 21 U.S.C.
360k(a) manifests a decision by Congress
to replace completely the private rights
of action usually available under state
law with civil and criminal enforcement
by the federal government when thoroughly
regulated devices such as Bard's heart
catheter, are at issue. This judgment
represents a permissible decision by
Congress that the public interest will
best be served by relying exclusively on
the FDA to strike the proper balance
between reasonably assuring safety and
promoting innovation with regard to new
devices that have the potential both to
enhance and injure human health.

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

The United States, as amicus curiae, argues that

such reasoning, while perhaps applicable in King, is not

applicable in this case, because the FDA has already

determined that Bard failed to comply with the requirements

of the MDA by submitting fraudulent data to the FDA. Thus,

the concerns about disuniformity are not implicated in this

case. Under the United States' scheme, then, a plaintiff

would simply need to prove, not that the manufacturer failed

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

the manufacturer failed to comply.

Although this may be a workable arrangement, it

still does not get around the problem that neither the

language of 360k(a) nor the legislative history give any

hint of congressional intent to create such a unique

exception to the MDA's preemption clause. It may or may not

be that allowing injured plaintiffs to recover in state

actions when the FDA has determined that a manufacturer

violated the MDA would be a desirable rule, from a policy

standpoint. Congress, however has not provided for such a

remedy, choosing instead to place sole enforcement authority

in the hands of the FDA. See, e.g., Mendes, 18 F.3d at 19 n.

4 (no federal private right of action under the MDA);

Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987) (per

curiam) (same). As the district court aptly noted:

Congress could reasonably decide that
when the FDA has already established it
was defrauded, private rights of action
to recover damages on behalf of injured
individuals are appropriate. Where, as
here, it is well-established that there
is generally no private right of action
to enforce the MDA, if Congress intends
to create an exception 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 have a proper basis for
inferring that such an exception was
intended.

Talbott, 865 F. Supp. at 47.

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The absence of a non-compliance exception does not

mean that individuals injured by noncompliance will always be

without compensation. In a criminal judgment against a

manufacturer, a court may, as part of any sentence, award

restitution to those harmed. See 18 U.S.C. 3663(a)(1);

Bard, 848 F. Supp. at 292-93. While the district court

accepted a binding plea agreement from Bard that contained no

restitution provision, it did so, in part, because it

erroneously believed that civil proceedings could provide

appropriate compensation. Talbott, 865 F. Supp. at 47-48;

Bard, 848 F. Supp. at 293. Courts in future 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 the court below, we cannot find any exception

to 360k(a) where a manufacturer of a Class III device has

failed to comply with the requirements of the MDA.

C. Application of Preemption Clause

Having held that the MDA's preemption clause

applies to state tort law, whether or not the manufacturer

has complied with the provisions of the MDA, we must next

determine whether the requirements imposed by plaintiffs'

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

to" the ones imposed by the MDA. In its opinion below, the

district court did a thorough job of analyzing each of

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plaintiffs' claims, finding that each of them imposed

additional requirements and was therefore preempted. As we

agree with the district court's analysis and as we see no

reason to repeat it here, we adopt those portions of the

district court's opinion. Talbott, 865 F. Supp. at 49-52

(section II.C); 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 opinion that reaches the correct

result, a reviewing court should not write at length merely

to put matters in its own words). We hold that all of

plaintiffs' claims are preempted by 360k(a).

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 are not preempted by

360k(a). The latter claim is not present in this case, as

plaintiffs' fraudulent misrepresentation claim is based on

statements made to the FDA, a claim which the Michael court

agreed is preempted. Id. at 1329. The former claim,

however, is present in this case, and the Third Circuit's

position appears to be inconsistent with this circuit's

position as set forth in King, 983 F.2d at 1135. We affirm

the district court's finding that plaintiffs' express

warranty claim is preempted, as that result accurately

reflects the law in this circuit. Accord Martello v. CIBA

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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 advance a number of constitutional

arguments challenging Congress' power to enact 360k(a) and

to displace state tort law. We have reviewed these arguments

and find them it be without merit.

III.

Because all of plaintiffs' claims are preempted by

360k(a) of the MDA, we affirm the district court's

dismissal of this suit. We end with this quotation from the

district court's opinion:

This is a particularly poignant case in
which the heirs of a 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 F.3d at 1335, in which an Eleventh Circuit panel

held that a plaintiff's negligent design and negligent
failure to warn claims were not preempted by 360k(a). The
court in Lohr, however, explicitly based its holding on the

fact that the device in question had 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 subject to the premarket approval ("PMA")
process, as the Lohr court itself noted. Id. at 1347

("Appellee's heavy reliance on . . . King . . . is misplaced

because the device at issue in [that case] had undergone the
full PMA process before it entered the market.").

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the damages they have undoubtedly
suffered. The government has vigorously
enforced the applicable criminal and
civil laws. Nevertheless this decision
may cause some, including those who
enacted the law, to question whether
complete preemption of private rights of
action is the most fair and effective
means of balancing the legitimate,
competing interests of promoting
innovation and reasonably assuring the
safety of complex medical devices. It is
axiomatic, however, that the courts must
faithfully give effect to the intentions
of Congress when they are clearly
expressed by statute, as they have been
in this case. Defendants' motion to
dismiss, therefore, must be granted.

Talbott, 865 F. Supp. at 40.

Affirmed.

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