UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
No. 93-1911
ELLEN MENDES,
Plaintiff, Appellant,
v.
MEDTRONIC, INC.,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Edward F. Harrington, U.S. District Judge]
Before
Selya, Circuit Judge,
Bownes, Senior Circuit Judge,
and Cyr, Circuit Judge.
John P. LeGrand, with whom Thomas F. Walsh and John P. LeGrand &
Associates, P.C. were on brief for appellant.
Richard H. Bakalor, with whom Quirk & Bakalor, P.C., Michael W.
Gallagher, Andrea Saunders Barisano, Donahue & Donahue, Dan Jarcho and
McKenna & Cuneo were on brief for appellee.
March 9, 1994
BOWNES, Senior Circuit Judge. In this products
BOWNES, Senior Circuit Judge.
liability action against the manufacturer of an allegedly
defective pacemaker, plaintiff-appellant, Ellen Mendes,
appeals from an order granting summary judgment in favor of
defendant-appellee, Medtronic, Inc. The district court
entered summary judgment for Medtronic, ruling that the
express preemption clause of the Medical Device Amendments
(MDA) of the Federal Food, Drug, and Cosmetic Act (the Act),
21 U.S.C. 360k(a), preempted plaintiff's Massachusetts
common law claims.1 We affirm.
I.
BACKGROUND
Congress enacted the MDA to give the Food and Drug
Administration (FDA) comprehensive control over medical
devices for the first time. Slater v. Optical Radiation
Corp., 961 F.2d 1330, 1331 (7th Cir.), cert. denied, 113 S.
Ct. 327 (1992). The MDA reflects Congress's balancing the
need for regulation to protect public health against its
interest in allowing new and improved devices to be marketed
expeditiously without the costs attributable to an excess of
regulation. King v. Collagen Corp., 983 F.2d 1130, 1138-39
1. Jurisdiction is based on diversity of citizenship.
Defendant asserts and plaintiff does not dispute that
Massachusetts law applies. We agree that plaintiff's tort
claims arise under Massachusetts law.
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(1st Cir.) (Aldrich, J., concurring), cert. denied, 114 S.
Ct. 84 (1993).
Pursuant to the MDA, FDA groups medical devices
into three classes based on the degree of regulation
necessary to assure safety and effectiveness. See 21 U.S.C.
360c; H.R. Conf. Rep. No. 1090, 94th Cong., 2d Sess. 55
(1976), reprinted in 1976 U.S.C.C.A.N. 1103, 1107. All
classes of devices are subject to "general controls,"
including labeling requirements and good manufacturing
practices. See, e.g., 21 U.S.C. 360i, 360j. Class III
devices, such as pacemakers, pose the greatest risks. Such
devices may be sold only if FDA finds that they are
"substantially equivalent" in design and function to devices
on the market before the MDA became effective in 1976, or--in
the case of new or improved devices--if FDA grants premarket
approval. Id. 360c(a)(1)(C), 360e(b); 21 C.F.R.
807.100. Devices found to be "substantially equivalent" are
entitled to bypass the premarket approval process unless or
until FDA issues a regulation specifying that the device
undergo the review process.
On May 14, 1986, a Medtronic pacemaker, a Class III
device, was implanted into plaintiff. Medtronic had
distributed the pacemaker since 1981 without premarket
approval because no regulation specifically required
premarket approval, and because FDA found the pacemaker to be
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substantially equivalent to pre-MDA pacemakers. On March 10,
1992, the pacemaker failed, and plaintiff nearly died. The
pacemaker was surgically removed, anda new model implanted.
Plaintiff filed a complaint alleging that Medtronic
was negligent in designing, manufacturing, and distributing
her pacemaker. She also included claims alleging Medtronic's
failure to provide adequate warnings, and breach of the
implied warranty of merchantability. Medtronic moved for
summary judgment on the ground that 21 U.S.C. 360k(a)
preempted all of plaintiff's claims. The district court
granted the motion, and plaintiff appealed.2
Standard of Review
Our review of a district court's summary judgment
decision is plenary. FDIC v. Anchor Properties, No. 93-1542,
slip op. at 9 (1st Cir. Jan. 5, 1993). Summary judgment is
appropriate when the pleadings and affidavits raise no
2. On the date the order granting summary judgment was
entered, plaintiff moved to amend her complaint. The
proposed amended complaint reiterated the claims in her
original complaint and added causes of action for breach of
express warranty, negligent infliction of emotional distress,
and strict liability. The proposed complaint also clarified
that she was alleging that her particular pacemaker, as
opposed to the model, was defective. The district court
denied the motion to amend after plaintiff filed an appeal of
the summary judgment order. Plaintiff's brief neither
challenges the district court's rejection of her proposed
amended complaint, nor refers specifically to any of the
claims raised solely in her amended complaint. Because our
review is limited to the issues raised on appeal, we confine
our analysis to the claims in the original complaint on which
the district court granted summary judgment.
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genuine issue as to any material fact, and the moving party
is entitled to judgment as a matter of law. Id.; see also
Fed. R. Civ. P. 56(c).
The nonmoving party bears the burden of placing at
least one material fact into dispute after the moving party
shows the absence of material fact. Celotex Corp. v.
Catrett, 477 U.S. 317, 325 (1986). Evidence in the record
supports that plaintiff's pacemaker was defective; that the
defect caused plaintiff's injuries; and that Medtronic was
aware, before the pacemaker failed, that the model might not
work properly.
Medtronic asserted in its motion for summary
judgment that "[t]here are no genuine issues of material fact
since even if plaintiff could prove all her factual
allegations," her claims would be preempted. Medtronic also
stated, "[f]or the purposes of its Motion for Summary
Judgment only," that it did not dispute the following
allegations of plaintiff:
1. [A] Medtronic [pacemaker], model
number 5984LP (the "device"), [was]
implanted into [plaintiff] on May 14,
1986 . . . .
2. [T]he device failed on March 10,
1992 . . . .
3. This alleged failure caused a near
death circumstance and plaintiff was
required to undergo emergency surgery to
remove the . . . device . . . .
4. [Plaintiff's] injuries . . . were
due to defects in the labeling, design
and manufacture of the device . . . .
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Def.'s Mot. for Summ. J., at 2-3 (emphasis in original).
We take these assertions at face value. We assume
plaintiff's factual allegations are true, and we examine the
legal issues in this light. Medtronic does not contend that
plaintiff's allegations fail to state a claim under
Massachusetts law. The sole issue addressed by the parties
and the district court is preemption, which is the key issue
on appeal.
II.
PREEMPTION
Medtronic argues that the Act implicitly and
expressly preempts plaintiff's claims. Congress's intent is
the touchstone of preemption analysis. Cipollone v. Liggett
Group, 112 S. Ct. 2608, 2617 (1992); King v. Collagen Corp.,
983 F.2d at 1133. State common law claims may be preempted
along with state statutes and regulations, if Congress so
intended. See, e.g., Cipollone, 112 S. Ct. at 2620; King v.
E.I. Dupont de Nemours & Co., 996 F.2d 1346, 1349-50 (1st
Cir.), cert. dismissed, 114 S. Ct. 490 (1993); King v.
Collagen Corp., 983 F.2d at 1134-35.
"Congress' intent may be `explicitly stated in the
statute's language or implicitly contained in its structure
and purpose.'" Cipollone, 112 S. Ct. at 2617 (quoting Jones
v. Rath Packing Co., 430 U.S. 519, 525 (1977)). The MDA
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contains an express preemption provision, 21 U.S.C.
360k(a), that states, in pertinent part:
[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 [the Federal Food, Drug, and
Cosmetic Act] 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 [the
Federal Food, Drug, and Cosmetic Act].
Congress's intent in enacting this provision was to prevent
state requirements from unduly burdening interstate commerce.
See H.R. Rep. No. 853, 94th Cong., 2d Sess. 45 (1976),
reprinted in An Analytical Legislative History of the Medical
Device Amendments of 1976, app. III, at 45 (Food & Drug L.
Inst. Series, Daniel F. O'Keefe, Jr. & Robert A. Spiegel
eds., 1976).
We construe this preemption clause with due regard
for the interests of federalism because it affects state
public health regulation. A federal act will supersede "`the
historic police powers of the states,'" only if that is "`the
clear and manifest purpose of Congress.'" King v. Collagen
Corp., 983 F.2d at 1134 (quoting Cipollone, 112 S. Ct. at
2617); see also CSX Transp. v. Easterwood, 113 S. Ct. 1732,
1737 (1993); Greenwood Trust Co. v. Massachusetts, 971 F.2d
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818, 823 (1st Cir. 1992), cert. denied, 113 S. Ct. 974
(1993).
Viewing section 306k(a) in light of this
presumption against preemption, we have held that it
expresses Congress's intent to preempt certain common law
claims because such claims may establish state
"requirements." King v. Collagen Corp., 983 F.2d at 1138;
accord Stamps v. Collagen Corp., 984 F.2d 1416, 1420 (5th
Cir.), cert. denied, 114 S. Ct. 86 (1993); cf. CSX Transp.,
113 S. Ct. at 1737 (discussing holding in Cipollone that
"federal statute barring additional `requirement[s] . . .
`imposed under state law'' pre-empts common-law claims"
(citation omitted)).
To determine the extent to which plaintiff's claims
are preempted, we need only identify the preemptive reach of
the statute's express language. Cipollone, 112 S. Ct. at
2618 (plurality); id. at 2625 (Blackmun, J., concurring in
part and dissenting in part). We thus reject at the outset
Medtronic's argument that this is an implied preemption case.
See King v. Collagen Corp., 983 F.2d at 1134; Stamps, 984
F.2d at 1420. When "Congress includes an express preemption
clause in a statute, judges ought to limit themselves to the
preemptive reach of that provision without essaying any
further analysis under the various theories of implied
preemption." Greenwood Trust, 971 F.2d at 823.
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Our first task is to outline the Act's requirements
applicable to the device. Thereafter, we scrutinize
plaintiff's claims, to determine whether the successful
litigation of any of them would "establish or continue in
effect" a "different" or "addition[al]" requirement. 21
U.S.C. 360k(a). This analysis determines whether
plaintiff's claims are preempted. 21 C.F.R. 808.1(d)
(state requirements are preempted where "there are . . .
specific requirements applicable to a particular device under
the act").
The pacemaker at issue is a Class III device.
Although Class III devices are generally subject to stringent
design, manufacturing, and labeling controls pursuant to the
premarket approval process, 21 C.F.R. pt. 814, FDA has never
required that the pacemaker model implanted in plaintiff
comply with the premarket approval regulations. Id.
870.3610(c). The only requirements under the Act applicable
to the device are regulations on labeling and "good
manufacturing practices." Id. pts. 801, 820.
Next, we examine plaintiff's claims to determine
whether their resolution would establish or perpetuate any
requirements under the common law differing from or adding to
the Act's requirements. The complaint states:
Prior to May 14, 1986 the defendant
Medtronic Inc. . . . manufactured a
certain device [known] as a pacemaker.
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As a result of the negligence of the
defendant, Medtronic Inc., in control,
maintenance, inspection, testing, design,
developing, servicing, distribution,
alteration, modification, sale and/or
manufacturing of said device, and as a
result of the negligence of said
defendant . . . in placing said Medtronic
pacemaker model #5984LP in the stream of
medical care and failing to give adequate
and effective warning concerning the
[foreseeable] dangers in the use of said
device, the plaintiff . . . was caused to
be injured on March 10, 1992, by this
defective pacemaker.
. . .
. . . [I]n supplying this said
device the defendant contended [that]
said pacemaker was of good and
merchantable quality and that it was fit
and safe for the normal use for which it
was intended[.] . . . [S]aid device was
not of merchantable quality and was not
fit for safe and normal use in that . . .
the defective pacemaker malfunctioned.
(Emphasis added.) The highlighted statements allege that
plaintiff's particular pacemaker was negligently
manufactured; the reference to the model number of the
pacemaker is consistent with claims that the label carried
inadequate warnings, and that the design of the device was
defective. Plaintiff's complaint thus contains three types
of claims, each sounding in negligence and breach of implied
warranty: design defect, failure to warn, and manufacturing
defect. The complaint contains no allegation regarding
Medtronic's compliance with FDA regulations, and plaintiff
has offered no evidence on that issue.
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In her brief, plaintiff abandoned any claim of
defective design.3 At oral argument, plaintiff contended
that her allegations of Medtronic's negligence in
"alter[ing]" and "modif[ying]" the device survived her
abandonment of the design defect claims. According to
plaintiff, these claims allege that Medtronic failed to
obtain FDA approval prior to distributing the modified
pacemaker model implanted in plaintiff. It is undisputed,
however, that FDA cleared the pacemaker for marketing without
approving the product design, finding it "substantially
equivalent" to pre-MDA devices. See 42 Fed. Reg. 42,520,
42,525 (Aug. 23, 1977) (preamble to final rule) ("[A]
determination of substantial equivalence . . . relates to the
fact that the product can lawfully be marketed without
premarket approval or reclassification."); 21 C.F.R. 807.97
(a finding of substantial equivalence "does not in any way
denote official approval of the device"). FDA regulations
3. Plaintiff's brief states:
Ellen Mendes does not claim that the
entire product line from which her
pacemaker was manufactured was defective.
The claims in this action do not allege
that the safety and effectiveness of
Medtronic, Inc.'s pacemaker device, as it
was designed and approved by the FDA,
caused Ellen Mendes's injuries. The
claims in her complaint allege that Mrs.
Mendes was injured because Medtronic,
Inc. manufactured and distributed this
specific pacemaker device which was
itself individually defective and the
direct cause of her injuries.
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have never required that the pacemaker of the model implanted
in plaintiff receive premarket approval. See 21 C.F.R.
870.3610(c). Moreover, plaintiff has not alleged that FDA's
substantial equivalence finding was improper. Therefore,
plaintiff's product line alteration and modification claims
fall from this case. If the claims are design defect claims,
they have been abandoned. And if the claims allege that FDA
failed to grant the device premarket approval, they are
meritless.
Plaintiff's abandonment of her design defect claims
also forecloses our consideration of her argument that, in
the absence of a requirement that the device receive
premarket approval, her design defect claims are not
preempted. The cases cited by plaintiff to support that
argument are thus inapposite. See, e.g., Larsen v.
Pacesetter Systems, 837 P.2d 1273, 1282 (Haw. 1992) (design
defect claims are not preempted where FDA never approved
device design because device was found to be substantially
equivalent to pre-MDA devices); see also Stamps, 984 F.2d at
1419, 1421-22 (discussing Moore v. Kimberly-Clark Corp., 867
F.2d 243, 246 (5th Cir. 1989) (design defect claims are not
preempted by requirements applicable to tampons, which are
Class II devices not subject to premarket approval)).
Plaintiff's only remaining common law claims,
sounding in negligence and breach of warranty, are
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allegations of inadequate warnings and a manufacturing
defect. In this connection, the MDA provides that a state
requirement, if different from or in addition to an FDA
requirement, is preempted only if it "relates to" the safety
or effectiveness of the device or to any other requirement
under the Act. 21 U.S.C. 306k(a)(2). All of plaintiff's
claims relate to the pacemaker's safety and effectiveness.
See Stamps, 984 F.2d at 1422. Consequently, to complete our
preemption analysis, we must determine whether plaintiff's
negligence and implied warranty claims, if successful, would
impose requirements on Medtronic's pacemaker "different from,
or in addition to" those in the Act. 21 U.S.C. 306k(a)(1).
The common law, no less than agency regulations and
statutes, can impose "requirements" on a manufacturer. King
v. Collagen Corp., 983 F.2d at 1135; see also 21 C.F.R.
808.1(b) (MDA preempts any state requirement "whether
established by statute, ordinance, regulation, or court
decision"). The tort and implied warranty theories of
products liability are regulatory in that the "`obligation to
pay compensation can be . . . a potent method of governing
conduct and controlling policy.'" Cipollone, 112 S. Ct. at
2620 (quoting San Diego Bldg. Trades Council v. Garmon, 359
U.S. 236, 247 (1959)). Products liability "regulation" under
the common law imposes requirements by case law precedent.
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Comparing the requirements imposed by the Act with
plaintiff's claims, we hold that her negligence and implied
warranty claims premised on inadequate warnings are
preempted. FDA regulates the content and appearance of
prescription medical device labels, including pacemaker
labels. 21 C.F.R. 801.1, 801.15, 801.109. These
regulations, which were in effect when plaintiff's particular
pacemaker was implanted, exempt such devices from the
requirement that there be directions to a layperson on how to
use the product safely, if the package describes, inter alia,
"any relevant hazards, contraindications, side effects, and
precautions" for the prescribing physician. Id. 801.109.
Plaintiff's implied warranty and negligent failure
to warn claims are premised on the manufacturer's duty to
disclose to a physician any latent, foreseeable dangers
associated with the use of a prescription product. Knowlton
v. Deseret Medical, Inc., 930 F.2d 116, 120 & n.2 (1st Cir.
1991) (discussing Massachusetts law). Although this standard
resembles the FDA requirement, the two may differ as applied.
See Jones, 430 U.S. at 526 (in determining preemption issue,
it is necessary "to consider the relationship between state
and federal laws as they are interpreted and applied, not
merely as they are written"). Applying Massachusetts law, a
factfinder could find a label deficient that complies with
FDA requirements. MacDonald v. Ortho Pharmaceutical Corp.,
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475 N.E.2d 65, 70-71 (Mass.) (holding that "compliance with
FDA requirements, though admissible to demonstrate lack of
negligence, is not conclusive on this issue, just as
violation of FDA requirements is evidence, but not conclusive
evidence, of negligence"), cert. denied, 474 U.S. 920 (1985).
Such a finding would establish a standard for an adequate
warning "in addition to" the requirements applicable under
the Act.
Similarly, plaintiff's negligent manufacturing
claim (including her allegations of negligent manufacturing,
control, maintenance, inspection, testing, servicing,
distribution, and sale of the device) is preempted by FDA
regulations on good manufacturing practices. 21 C.F.R.
820.1-820.198. Medtronic's duty under the common law of
negligence is to use reasonable care in inspecting, testing,
and producing pacemakers. This standard and FDA's good
manufacturing practices impose analogous, but not identical
duties. FDA's good manufacturing practices regulations
require manufacturers to develop and implement "appropriate,"
"adequate," or "sufficient" quality control, quality
assurance, personnel training, environmental controls,
equipment maintenance, testing, inspection, and storage and
distribution procedures, to assure that devices are safe and
effective. See, e.g., id. 820.1, 820.5, 820.20, 820.25.
The quality assurance requirement, for example, mandates that
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manufacturers devise and implement a protocol to ensure,
among other things, that all components, labels, packaging,
and finished devices are inspected, and either approved or
rejected. Id. 820.20(a). A factfinder could find
liability on plaintiff's negligent manufacturing claims,
applying standards differing from or adding to FDA's.
Plaintiff's implied warranty claim is also
preempted by FDA's good manufacturing practices. A
factfinder considering that claim could find Medtronic liable
if a manufacturing defect rendered plaintiff's pacemaker
unreasonably dangerous. See Mass. Gen. L. ch. 106, 2-314;
Colter v. Barber-Greene Co., 525 N.E.2d 1305, 1313 (Mass.
1988) (noting that Massachusetts law on implied warranty is
"congruent, in all material respects, with the principles
expressed in Restatement (Second) of Torts 402A (1965), the
Restatement's definition of a seller's strict liability for
harm suffered by a user or consumer of a seller's product").
This means that under Massachusetts law Medtronic could be
found liable even if it meticulously followed FDA's good
manufacturing practices. For these reasons, plaintiff's
breach of implied warranty claim is preempted.4
4. One way to ensure that a factfinder applies a standard
not adding 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. See
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Plaintiff argues that her claims are not preempted
because she is alleging that her particular device is
defective. This claim, according to plaintiff, is analogous
to a claim that the device is contaminated. She argues that
her claims are not preempted because King v. Collagen Corp.,
983 F.2d at 1134-35, excised claims arising from contaminated
devices from the body of claims preempted by the MDA.
Plaintiff's argument is based on a misunderstanding
of our remarks in King v. Collagen Corp., 983 F.2d at 1134-
35. We stated:
The language of [the MDA preemption
clause] . . . demonstrate[s] a field of
preemption which is broad, but limited.
Any state requirement which, in effect,
establishes a new substantive requirement
for the device in a regulated area such
as labeling, is preempted. 21 C.F.R.
808.1(d)(6)(ii). As the Seventh Circuit
noted, however, [the clause] does not
preempt such claims as negligent
implantation or removal of devices, or
claims arising out of contaminated
devices.
Id. (emphasis added) (citing Slater v. Optical Radiation
Corp., 961 F.2d at 1334).
The sentence regarding contaminated devices follows
our statement that "[a]ny state requirement which, in effect,
establishes a new substantive requirement for the device in a
regulated area such as labeling, is preempted." Plaintiff's
claims in this case, if successful, would establish
Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987).
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requirements in areas that FDA already regulates, i.e.,
labeling and manufacturing. Accordingly, this is not a case
where plaintiff may maintain a claim arising out of an
individually defective device. We need not address in this
case which, if any, "claims arising out of contaminated
devices" might not be preempted.
We express no opinion on whether products liability
claims are preempted only if the manufacturer complied with
applicable FDA regulations. See Reiter v. Zimmer, 830 F.
Supp. 199, 204 (S.D.N.Y. 1993) (refusing to extend preemptive
reach of MDA to negligence claim against manufacturer that
allegedly violated FDA requirements); see also Slater, 961
F.2d at 1334 (scope of preemption under MDA "is limited to
efforts by states to impose sanctions for compliance with
federal regulations"). The complaint contains no allegations
regarding Medtronic's noncompliance with FDA regulations, and
plaintiff has offered no evidence that Medtronic violated any
FDA requirement. Our holding is limited to the facts and
claims in this case.
For the foregoing reasons, the order granting
summary judgment for defendant is
Affirmed.
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