PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

CATHERINE W. GRIFFIN,
Plaintiff-Appellant,

v.                                                                    No. 94-1219

MEDTRONIC, INCORPORATED,
Defendant-Appellee.

Appeal from the United States District Court
for the District of Maryland, at Baltimore.
Frederick N. Smalkin, District Judge.
(CA-93-60-S)

Argued: September 27, 1994

Decided: April 30, 1996

Before WIDENER and MOTZ, Circuit Judges, and MICHAEL,
Senior United States District Judge for the Western District of
Virginia, sitting by designation.

_________________________________________________________________

Affirmed by published opinion. Senior Judge Michael wrote the opin-
ion, in which Judge Widener and Judge Motz joined.

_________________________________________________________________

COUNSEL

ARGUED: Kristen Atkins Brinster, SEIDENMAN, SUTHERLAND
& LYNN, P.A., Baltimore, Maryland, for Appellant. Harley Thomas
Howell, Benjamin Rader Goertemiller, HOWELL, GATELY, WHIT-
NEY & CARTER, Towson, Maryland, for Appellee. ON BRIEF:
Jerome J. Seidenman, John R. Sutherland, SEIDENMAN, SUTHER-
LAND & LYNN, P.A., Baltimore, Maryland, for Appellant. John S.
Bainbridge, Jr., HOWELL, GATELY, WHITNEY & CARTER,
Towson, Maryland, for Appellee.

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OPINION

MICHAEL, Senior District Judge:

Catherine Griffin appeals the decision of the district court granting
summary judgment to Medtronic, Inc. ("Medtronic") on the grounds
that Griffin's claims are preempted by 21 U.S.C.A.§ 360k (West
Supp. 1995), enacted as part of the Medical Device Amendments of
1976 (MDA) to the Federal Food, Drug, and Cosmetic Act. On the
recent authority of Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392
(4th Cir. 1995), we affirm in part, reverse in part and remand.

I.

In 1984, a pacemaker, manufactured and sold by Medtronic, was
implanted in Griffin's chest to help regulate and control her heart rate.
The pacemaker consisted of a dual chamber generator and polyure-
thane leads. In 1986, the pacemaker failed and was removed. How-
ever, portions of the leads remained in Griffin's chest. Griffin's
physicians inserted a new Medtronic pacemaker which ultimately
failed in 1989. Doctors removed most of the second pacemaker, but
once again, portions of the leads remained in Griffin's chest. Griffin
then received yet another Medtronic pacemaker which has not func-
tioned properly to date, allegedly because of the remnants of the leads
left in Griffin's chest.

In 1992, Griffin brought the current suit against Medtronic in
Maryland state court. Her complaint states five counts: (1) negligent
design and manufacture; (2) breach of express warranty; (3) breach
of an implied warranty of fitness for a particular purpose; (4) strict
liability for defective manufacture; and (5) intentional misrepresenta-
tion of the defective condition of the pacemakers. Medtronic removed
the case to federal court on the basis of diversity of citizenship.

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The district court, relying on the authority of Stamps v. Collagen
Corp., 984 F.2d 1416 (5th Cir. 1993), and King v. Collagen Corp.,
983 F.2d 1130 (1st Cir. 1993), ruled that Griffin's claims were pre-
empted by § 360k of the MDA1 and, accordingly, granted Medtronic's
motion for summary judgment. No material facts are in dispute. The
appeal presents questions of law subject to de novo review. Higgins
v. E.I. DuPont de Nemours & Co., 863 F.2d 1162, 1166-1167 (4th
Cir. 1988).

II.

A.

The preemption issues presented by this appeal are controlled by
our recent decision in Duvall v. Bristol-Myers-Squibb Co., 65 F.3d
392 (4th Cir. 1995). The plaintiff in Duvall brought several state-law
claims against the manufacturer of a penile prosthesis after undergo-
ing surgery to implant the prosthesis.2 In ruling that the majority of
_________________________________________________________________
1 Subject to a possible exemption not claimed here, section 360k pro-
vides that:

          [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 require-
          ment 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.A. § 360k.
2 Under the framework of the MDA, penile inflatable implants are clas-
sified as "Class III" medical devices, and as such, are subject to the most
rigorous regulation. Duvall, 65 F.3d at 396; 21 C.F.R. § 876.3350
(1995). A manufacturer must generally receive approval from the Food
and Drug Administration ("FDA") before marketing a Class III device.
However, the prosthesis was brought to market via the "substantially
equivalent" mechanism outlined at 21 C.F.R.§ 807.100(a) (1995). Id.
Under this administrative regime, a Class III device for which the FDA
does not yet require the usual premarket approval may be marketed if the

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plaintiff's claims were preempted by § 360k, we held that "state-law
claims are preempted by § 360k to the extent that, if successful, such
claims would impose requirements under state law different from or
in addition to requirements applicable to a device under the MDA."
Id. at 398. With this language as a baseline, we concluded that plain-
tiff's breach of implied warranty, strict liability, and negligence
claims were necessarily preempted by § 360k. However, we held with
respect to plaintiff's breach of express warranty claim that "although
§ 360k preempts express warranty claims to the extent that they are
based on FDA-mandated labeling, packaging, and advertising, it does
not preempt an express warranty claim that is based on a manufactur-
er's voluntarily-made representations regarding its product." Id. at
400-401. We therefore reversed and remanded, for further consider-
ation in light of that holding, the district court's grant of summary
judgment for Medtronic on the express warranty claim.

B.

Given the authority of Duvall, we deal only briefly with Griffin's
arguments.3 Griffin's breach of implied warranty, strict liability, and
negligence claims are preempted by § 360k because were Griffin to
prevail on those claims, Medtronic would be burdened with require-
ments different from or in addition to those applicable to pacemakers
under the MDA. As did the plaintiff in Duvall , Griffin here argues
that these state-law claims, if successful, would not impose any differ-
ent or additional requirements on Medtronic because the MDA does
not impose specific requirements on pacemakers in the first instance.
However, we held in Duvall that the premarket notification procedure
under the MDA, codified at 21 C.F.R. § 807.87 (1995) and known as
510(k) Notification, constitutes a requirement applicable to devices
under the MDA because the notification procedure requires a manu-
_________________________________________________________________

manufacturer shows that the device is "substantially equivalent" to a
device marketed before the effective date of the MDA. Id. The pacemak-
ers at issue in this case are also Class III medical devices, 21 C.F.R.
§ 870.3610 (1995), brought to market under the authority of the "sub-
stantially equivalent" process.
3 In fairness to Griffin, we note that argument was heard on Griffin's
appeal before Duvall was decided.

                    4
facturer to submit to the FDA, among other things, certain descriptive
particulars, such as proposed labels and advertisements. Id. at 400
("510(k) Notification is a requirement applicable to the device under
the MDA"). Thus, successful state-law claims would indeed impose
a requirement in addition to a requirement already imposed on pace-
makers under the MDA. Accordingly, Griffin's breach of implied
warranty, strict liability, and negligence claims are preempted by
§ 360k.

With respect to Griffin's express warranty claim, we must return
the case to the district court to determine whether the claim is based
on promises voluntarily made by Medtronic -- and therefore, not pre-
empted by § 360k -- or whether it is based on FDA-mandated label-
ing, packaging, and advertising of Medtronics pacemakers -- and
therefore preempted by § 360k.

III.

Griffin's complaint contains one count of intentional misrepresen-
tation. This claim alleges that Medtronic did not disclose the fact that
the pacemakers were defective and unsafe for human use. Although
we were not presented with an intentional misrepresentation claim in
Duvall, we believe the rationale of Duvall mandates that we affirm
the decision of the district court granting summary judgment for
Medtronic on that claim.

We reach this conclusion because the record in this case reveals no
statements or other communications made to Griffin or to her physi-
cian that are any different from those made to the FDA. Thus, the
premise of Griffin's intentional misrepresentation claim is that
Medtronic had a duty to disclose information to Griffin and to her
physician different from that which Medtronic provided to the FDA.4
If successful, this claim would result in the imposition of a require-
_________________________________________________________________
4 Of course, Griffins claim might also be premised on the notion that
Medtronic did not adequately comply with FDA disclosure requirements.
However, the FDA alone is empowered to enforce its regulations. A pri-
vate right of action seeking enforcement of FDA regulations has not been
recognized. See, e.g., Rodriguez v. SK&F Co., 833 F.2d 8, 9 (1st Cir.
1987), and cases cited therein.

                     5
ment above and beyond those imposed by the MDA. Under Duvall,
such state-law claims are preempted. Accordingly, we conclude that
Griffin's intentional misrepresentation claim is preempted.

IV.

Under the authority of Duvall, we affirm the decision of the district
court granting summary judgment for Medtronic on Griffin's negli-
gence, breach of implied warranty, strict liability, and intentional mis-
representation claims. However, we reverse in part and remand the
case with respect to Griffin's breach of express warranty claim for
further proceedings not inconsistent with this opinion.

AFFIRMED IN PART; REVERSED
AND REMANDED IN PART

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