USCA1 Opinion
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
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No. 94-1951
LINDA TALBOTT, ETC., ET AL.,
Plaintiffs, Appellants,
v.
C.R. BARD, INC., ET AL.,
Defendants, Appellees.
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APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Mark L. Wolf, U.S. District Judge]
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Before
Stahl, Circuit Judge,
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Campbell, Senior Circuit Judge, and
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John R. Gibson,* Senior Circuit Judge.
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Jeffrey S. Beeler with whom Jeffrey A. Newman and Newman,
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Heineman & Itzkowitz were on brief for appellants.
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Francis C. Lynch with whom Daryl J. Lapp and Palmer & Dodge
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were on brief for appellee C.R. Bard, Inc.
Robert D. Keefe with whom Hale and Dorr was on brief for
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appellee David Prigmore.
William H. Kettlewell with whom Dwyer & Collora was on brief
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for appellee John Cvinar.
Michael S. Raab, Attorney, Civil Division, with whom Frank
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W. Hunger, Assistant Attorney General, Donald K. Stern, United
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States Attorney, Douglas N. Letter, Appellate Litigation Counsel,
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United States Department of Justice, and Margaret Jane Porter,
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Chief Counsel, and Beverly Rothstein, Attorney, Food and Drug
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Administration, were on brief for the United States, amicus
curiae.
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August 14, 1995
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*Of the Eighth Circuit, sitting by designation.
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2
CAMPBELL, Senior Circuit Judge. Section 360k(a) of
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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.,
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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
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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,
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115 S. Ct. 1483, 1488 (1995); Cipollone v. Liggett Group, 112
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S. Ct. 2608, 2617-18 (1992). We review the district court's
reading of the clause de novo, taking all of plaintiffs'
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factual averments as true and indulging every reasonable
inference in plaintiffs' favor. Garcia Hotel Ltd.
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Partnership v. Ponce Federal Bank, 958 F.2d 15, 17 (1st Cir.
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1992).
A. State Tort Law Imposes Requirements
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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
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(1st Cir.), cert. denied, 114 S. Ct. 84 (1993), and Mendes v.
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Medtronic, Inc., 18 F.3d 13, 16 (1st Cir. 1994). In both,
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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-
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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
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v. Newman, 49 F.3d 1, 11 (1st Cir. 1995). We accordingly, we
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hold that state tort law falls within 360k(a).
B. No Exception For Non-Compliance
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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
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1. See, e.g., Anguiano v. E.I. Du Pont De Nemours & Co., 44
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F.3d 806, 809 (9th Cir. 1995) (dicta); Martello v. CIBA
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Vision Corp., 42 F.3d 1167, 1168 (8th Cir. 1994), cert.
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denied, 63 U.S.L.W. 3904 (1995); Gile v. Optical Radiation
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Corp., 22 F.3d 540, 542 (3d Cir.), cert. denied, 115 S. Ct.
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429 (1994); Duncan v. Iolab Corp., 12 F.3d 194, 195 (11th
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Cir. 1994) (per curiam); Stamps v. Collagen Corp., 984 F.2d
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1416, 1420-21 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993);
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Slater v. Optical Radiation Corp., 961 F.2d 1330, 1333 (7th
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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.
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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
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States v. C.R. Bard, Inc., 848 F. Supp. 287, 289 (D. Mass.
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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,
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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
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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
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overlooked the fact. The plaintiff in Mendes did not make
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the exception-for-noncompliance argument made by the
plaintiff in King, arguing merely that the MDA did not apply
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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
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Mendes can be read (and plaintiffs argue should be read) to
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indicate that the issue is still open in this circuit.
Alternatively, it might mean only that the panel in Mendes
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did not pay close attention to the concurrence in King, since
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that issue was not before it. Given the uncertainty
regarding the precedential status of the King concurrence, we
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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
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have expressly addressed this exact issue. See Reeves v.
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Acromed Corp., 44 F.3d 300, 307 (5th Cir.) (finding no
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exception to preemption where a manufacturer fraudulently
obtained FDA approval), cert. denied, 115 S. Ct. 2251 (1995);
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Michael v. Shiley, 46 F.3d 1316, 1329 (3d Cir. 1995) (same),
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petition for cert. filed, 63 U.S.L.W. 3874 (U.S. June 2,
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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:
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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
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number of other circuit courts of appeal. See Lohr v.
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Medtronic Inc., 56 F.3d 1335, 1343 (11th Cir. 1995) (holding
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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
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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
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Cong., 2d Sess. 5, 12 (1975), reprinted in 1976 U.S.C.C.A.N.
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2. But cf. National Bank of Commerce v. Kimberly-Clark
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Corp., 38 F.3d 988, 992 (8th Cir. 1994) (holding that "when a
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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
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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;
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Talbott, 865 F. Supp. at 47.
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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
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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.
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The United States, as amicus curiae, argues that
such reasoning, while perhaps applicable in King, is not
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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.
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4 (no federal private right of action under the MDA);
Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987) (per
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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);
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Bard, 848 F. Supp. at 292-93. While the district court
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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;
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Bard, 848 F. Supp. at 293. Courts in future criminal
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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
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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
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(section II.C); see In re San Juan Dupont Plaza Hotel Fire
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Litig., 989 F.2d 36, 38 (1st Cir. 1993) (where district judge
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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
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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
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agreed is preempted. Id. at 1329. The former claim,
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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
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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
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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
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at 11.3
D. Remaining Claims
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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
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3. After oral argument, plaintiffs brought to our attention
Lohr, 56 F.3d at 1335, in which an Eleventh Circuit panel
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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
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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
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the device was subject to the premarket approval ("PMA")
process, as the Lohr court itself noted. Id. at 1347
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("Appellee's heavy reliance on . . . King . . . is misplaced
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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.
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Affirmed.
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