Court Opinion

ID: 2966566
Source: CourtListenerOpinion
Date Created: 2015-09-22 00:47:24.013581+00
Date Added: 2024-06-11T15:27:19.355274
License: Public Domain

Filed:   January 7, 1997

                    UNITED STATES COURT OF APPEALS

                        FOR THE FOURTH CIRCUIT

                           Nos. 94-1520(L)
                           (CA-93-1072-S)

Eugene Duvall, et al,

                                             Plaintiffs - Appellants,

           versus

Bristol-Myers-Squibb Co., etc., et al,

                                              Defendants - Appellees.

                              O R D E R

    The Court amends its opinion filed December 18, 1996, as

follows:
    On page 2, section 4, line 6 -- "Davis S. Toepfer" is cor-

rected to read "David S. Toepfer."

                                       For the Court - By Direction

                                          /s/ Patricia S. Connor

                                                       Clerk
PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

EUGENE DUVALL; PATRICIA SUE
DUVALL,
Plaintiffs-Appellants,

v.

BRISTOL-MYERS-SQUIBB COMPANY, a
Delaware Corporation; MEDICAL
ENGINEERING CORPORATION, a/k/a                  No. 94-1520
Surgitek/Medical Engineering
Corporation,
Defendants-Appellees,

and

FOOD & DRUG ADMINISTRATION,
Amicus Curiae.

EUGENE DUVALL; PATRICIA SUE
DUVALL,
Plaintiffs-Appellants,

v.

BRISTOL-MYERS-SQUIBB COMPANY, a
                                                No. 96-1358
Delaware Corporation; MEDICAL
ENGINEERING CORPORATION, a/k/a
Surgitek/Medical Engineering
Corporation,
Defendants-Appellees.

Appeals from the United States District Court
for the District of Maryland, at Baltimore.
Frederic N. Smalkin, District Judge.
(CA-93-1072-S)
Argued: October 29, 1996

Decided: December 18, 1996

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

_________________________________________________________________

Affirmed in part, reversed in part, and remanded by published opin-
ion. Judge Wilkins wrote the opinion, in which Judge Widener and
Senior Judge Michael joined.

_________________________________________________________________

COUNSEL

ARGUED: David Benjamin Shapiro, Baltimore, Maryland, for
Appellants. Peter Rolf Maier, Appellate Staff, Civil Division,
UNITED STATES DEPARTMENT OF JUSTICE, Washington,
D.C., for Amicus Curiae. Robert T. Shaffer, III, MURPHY & SHAF-
FER, Baltimore, Maryland, for Appellees. ON BRIEF: Lewis J. Saul,
Washington, D.C.; Bruce A. Finzen, Gary L. Wilson, David S. Toep-
fer, ROBINS, KAPLAN, MILLER & CIRESI, Minneapolis, Minne-
sota, for Appellants. Frank W. Hunger, Assistant Attorney General,
Lynne Ann Battaglia, United States Attorney, Douglas N. Letter,
Appellate Staff, Civil Division, UNITED STATES DEPARTMENT
OF JUSTICE, Washington, D.C.; Margaret Jane Porter, Chief Coun-
sel, Beverly Rothstein, FOOD AND DRUG ADMINISTRATION,
Rockville, Maryland, for Amicus Curiae. William James Murphy,
MURPHY & SHAFFER, Baltimore, Maryland; John F. Brenner,
MCCARTER & ENGLISH, Newark, New Jersey, for Appellees.

_________________________________________________________________

                   2
OPINION

WILKINS, Circuit Judge:

These appeals require us to consider anew the effect of the express
preemption provision contained in the Medical Device Amendments
of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539, on Eugene
Duvall's state-law causes of action against Bristol-Myers-Squibb
Company and its wholly owned subsidiary, Medical Engineering Cor-
poration (collectively, "Bristol-Myers").1 See 21 U.S.C.A. § 360k(a)
(West Supp. 1996). In light of the recent decision of the Supreme
Court in Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996), we hold that
§ 360k(a) does not preempt Duvall's claims. We also conclude, how-
ever, that the district court correctly granted summary judgment to
Bristol-Myers on Duvall's assertion that statements allegedly made to
Duvall by a representative of Bristol-Myers constituted an express
warranty. Accordingly, we affirm in part, reverse in part, and remand
for further proceedings.

I.

In 1990, Duvall was implanted with a penile prosthesis manufac-
tured and marketed by Bristol-Myers. The prosthesis never functioned
to Duvall's satisfaction, and eventually Duvall had it removed. There-
after, Duvall filed suit against Bristol-Myers in Maryland state court,
alleging claims for breach of express warranties; breach of implied
warranties of merchantability and fitness for a particular purpose;
strict liability for defective design, defective manufacture, and failure
to warn; and negligent design, manufacture, marketing, promotion,
and sale. Bristol-Myers removed the action to federal court on the
basis of diversity of citizenship.

The district court granted summary judgment to Bristol-Myers on
the basis that all of Duvall's claims were preempted by § 360k(a). On
appeal, we affirmed in part, reversed in part, and remanded. See
Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995)
(Duvall I). We held that the plain language of § 360k(a) mandated
_________________________________________________________________

1 We address Patricia Duvall's claim for loss of consortium separately
below.

                    3
preemption of the majority of Duvall's state-law claims. See id. at
396-400. But, we reversed the grant of summary judgment on the
express warranty claims and remanded for further proceedings, con-
cluding that § 360k(a) preempted an express warranty claim only "to
the extent that [the claim] is based on FDA-mandated labeling, pack-
aging, and advertising." Id. at 401. Duvall then filed a petition for a
writ of certiorari seeking review by the Supreme Court, which granted
the writ, vacated our opinion in Duvall I, and remanded for further
consideration in light of its decision in Medtronic. See Duvall v.
Bristol-Myers-Squibb Co., 116 S. Ct. 2575 (1996) (mem.). While
Duvall's petition for a writ of certiorari was pending before the
Supreme Court, the district court granted summary judgment to
Bristol-Myers on the express warranty claims, and Duvall appealed
that ruling to this court.

We consolidated Duvall's appeal from the decision of the district
court with the action on remand from the Supreme Court. Each case
presents distinct issues. The remand from the Supreme Court requires
us to decide whether, in light of Medtronic, Duvall's state-law claims
for breach of implied warranties, design defect, manufacturing defect,
and failure to warn are preempted by § 360k(a). Duvall's appeal from
the grant of summary judgment to Bristol-Myers on the express war-
ranty claims requires us first to decide whether the district court cor-
rectly held that Duvall failed to establish a genuine issue of material
fact with respect to his assertion of an express warranty based on
statements allegedly made by a Bristol-Myers representative. We
must then determine the effect of Medtronic on our prior decision that
§ 360k(a) preempts express warranty claims that are based on FDA-
mandated labeling, packaging, or advertising.

II.

Congress enacted the MDA in the midst of rising concern regard-
ing the safety and effectiveness of the growing number of medical
devices being introduced into the marketplace. See Medtronic, 116 S.
Ct. at 2246. The MDA "provide[s] for the safety and effectiveness of
medical devices" by classifying them according to the amount of risk
they present to the public and imposing appropriate controls. Id. at
2245, 2246 (internal quotation marks omitted); see 21 U.S.C.A.
§ 360c (West Supp. 1996). Class I devices, such as tongue depressors,

                    4
do not present an unreasonable risk of illness or injury and are subject
only to general controls. 21 U.S.C.A. § 360c(a)(1)(A); 21 C.F.R.
§ 880.6230 (1996). Class II devices, such as bone-conduction hearing
aids, for which "general controls by themselves are insufficient to
provide reasonable assurance of the safety and effectiveness of the
device," are subject to special controls. 21 U.S.C.A. § 360c(a)(1)(B);
21 C.F.R. § 874.3300 (1996). Class III devices are those devices: (1)
for which there is insufficient information to determine that the con-
trols applicable to Class I and II devices are alone enough to provide
reasonable assurance of the safety and effectiveness of the device; and
(2)(a) that are to be used for "supporting or sustaining human life" or
that are "of substantial importance in preventing impairment of
human health" or (2)(b) that "present[ ] a potential unreasonable risk
of illness or injury." 21 U.S.C.A. § 360c(a)(1)(C). Class III devices
are subject to the most stringent MDA controls. See King v. Collagen
Corp., 983 F.2d 1130, 1131 (1st Cir.) (Torruella, J.), cert. denied, 510
U.S. 824 (1993). Penile inflatable implants are classified as Class III
medical devices. 21 C.F.R. § 876.3350 (1996).

In order to market a Class III device, a manufacturer generally
must obtain premarket approval from the FDA. Premarket approval
requires submission of a detailed application, including clinical data,
manufacturing processes, and proposed labeling, see 21 U.S.C.A.
§ 360e(c) (West Supp. 1996), and is intended "to provide reasonable
assurance of [the] safety and effectiveness" of the device, 21 U.S.C.A.
§ 360c(a)(1)(C). In the case of a Class III device for which the FDA
does not yet require premarket approval, a manufacturer may market
the item after showing that it is "substantially equivalent" to a device
marketed before the effective date of the MDA. See 21 U.S.C.A.
§ 360e(b)(1)(B) (West Supp. 1996); Medtronic, 116 S. Ct. at 2247. To
do so, a manufacturer must submit a premarket notification, known
as a 510(k) notification, including specified information, at least 90
days before marketing a device; the FDA must then authorize the
marketing of the device. 21 U.S.C.A. § 360(k) (West Supp. 1996); 21
C.F.R. §§ 807.81-807.100 (1996).

Bristol-Myers' prosthesis reached the market through the substan-
tial equivalence process. Upon completion of clinical trials of the
device under an investigational device exemption (IDE), see 21
U.S.C.A. § 360j(g) (West Supp. 1996), Bristol-Myers submitted a

                    5
510(k) notification that included information relating to the design
and engineering of the device, clinical studies under the IDE, the sim-
ilarity of the device to other penile prostheses marketed before pas-
sage of the MDA, and proposed packaging, labeling, and use
instructions. At the FDA's request, Bristol-Myers supplied additional
information on sterilization techniques, testing protocols, design of
specific components of the device, package inserts, indicated uses,
and fluid requirements. The FDA later authorized Bristol-Myers to
market the device on the basis that it was substantially equivalent to
similar devices marketed before passage of the MDA. In its letter
informing Bristol-Myers of the clearance, the FDA noted that "[a]n
FDA finding of substantial equivalence . . . does not mean that FDA
approves your device."

A.

Before turning to an analysis of the holding in Medtronic, we first
briefly review the applicable principles of preemption. The doctrine
of preemption, which is based on the Supremacy Clause of the United
States Constitution,2 provides that a state law is invalid to the extent
that it conflicts with federal legislation. Cipollone v. Liggett Group,
Inc., 505 U.S. 504, 516 (1992). Preemption occurs in any of several
situations. For example, state law is preempted when Congress
expressly so provides, see Jones v. Rath Packing Co., 430 U.S. 519,
525 (1977); when federal regulation of a legislative field is so com-
prehensive that there is no room for supplementary state regulation,
see Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947); or
when the state law is in actual conflict with a federal provision, see
Pacific Gas & Elec. Co. v. State Energy Resources Conservation &
Dev. Comm'n, 461 U.S. 190, 204 (1983).

Because Congress included an express preemption provision in the
MDA, we need consider only the scope of the statutory language. See
Cipollone, 505 U.S. at 517. The determination regarding the scope of
an express preemption provision "does not occur in a contextual vac-
_________________________________________________________________

2 "This Constitution, and the Laws of the United States which shall be
made in Pursuance thereof . . . shall be the supreme Law of the Land . . .
any Thing in the Constitution or Laws of any State to the Contrary not-
withstanding." U.S. Const. art. VI, cl. 2.

                    6
uum," but rather is guided by the twin presumptions "that Congress
does not cavalierly pre-empt state-law causes of action" and "that
`[t]he purpose of Congress is the ultimate touchstone' in every pre-
emption case." Medtronic, 116 S. Ct. at 2250 (alteration in original)
(quoting Retail Clerks Int'l Ass'n, Local 1625 v. Schermerhorn, 375
U.S. 96, 103 (1963)).

B.

Section 360k of the MDA provides in pertinent part:

         Except as provided in subsection (b) of this section, no
        State or political subdivision of a State may establish or con-
        tinue 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.A. § 360k(a).3 In Medtronic, the Supreme Court considered
the preemptive scope of § 360k(a) with respect to state-law claims
against the manufacturer of a pacemaker, a Class III device marketed
pursuant to the substantial equivalence process. A divided court con-
cluded that § 360k(a) did not preempt the plaintiffs' state-law claims
for defective design, defective manufacture, failure to warn, and fail-
ure to comply with FDA standards.

A majority of the Medtronic Court first determined that a state-law
damages action may impose a requirement within the meaning of
§ 360k(a), reasoning that the decision of the Cipollone Court man-
_________________________________________________________________

3 Pursuant to 21 U.S.C.A. § 360k(b) (West Supp. 1996), states and
local governments may apply for an exemption from§ 360k(a) under
certain circumstances.

                    7
dated such a conclusion. See Medtronic, 116 S. Ct. at 2259-60
(Breyer, J., concurring in part and concurring in judgment); id. at
2262-63 (O'Connor, J., concurring in part and dissenting in part). In
Cipollone, the Court concluded that the phrase"requirement or prohi-
bition" in § 5(b) of the Public Health Cigarette Smoking Act of 1969
necessarily included common-law claims:

        The phrase "[n]o requirement or prohibition" sweeps
        broadly and suggests no distinction between positive enact-
        ments and common law; to the contrary, those words easily
        encompass obligations that take the form of common-law
        rules. As we noted in another context, "[state] regulation can
        be as effectively exerted through an award of damages as
        through some form of preventive relief. The obligation to
        pay compensation can be, indeed is designed to be, a potent
        method of governing conduct and controlling policy."

Cipollone, 505 U.S. at 521 (plurality) (alterations in original) (quoting
San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247
(1959)). The members of that Medtronic majority discerned no basis
upon which the language of § 360k(a) could be distinguished from the
language at issue in Cipollone and, accordingly, concluded that state-
law claims are preempted by § 360k(a) to the extent that, if success-
ful, such claims would impose requirements under state law different
from or in addition to requirements applicable to a device under the
MDA. See Medtronic, 116 S. Ct. at 2259 (Breyer, J., concurring in
part and concurring in judgment); id. at 2262-63 (O'Connor, J., con-
curring in part and dissenting in part).

Second, a different majority of the Medtronic Court concluded that
neither the § 510(k) notification process nor the general manufactur-
ing and labeling requirements gave rise to preemption of the plain-
tiffs' claims under § 360k(a). See id. at 2253-58. With respect to the
plaintiffs' design defect claims, the Court determined that the
§ 510(k) process imposed no requirements with respect to the design
of the device and therefore concluded that those claims were not pre-
empted. Id. at 2254-55. The Court reasoned that FDA approval for
marketing a device pursuant to a § 510(k) notification constituted
nothing more than a judgment that the device in question was similar
to a device marketed before passage of the MDA, thus allowing a

                    8
post-MDA Class III device to be marketed on the same terms as a
pre-MDA Class III device until such time as all devices of that type
were required to undergo a more thorough investigation under the
premarket approval process. See id. at 2254. Essentially, the Court
concluded, § 510(k) approval is merely a means of preserving the sta-
tus quo that existed before passage of the MDA, including "the possi-
bility that the manufacturer of the device would have to defend itself
against state-law claims of negligent design." Id. at 2255.

The Court also determined that the plaintiffs' state-law allegations
that the manufacturer failed to comply with FDA requirements were
not preempted. The Court explained that the existence of a damages
remedy "for violations of common-law duties when those duties par-
allel federal requirements" does not necessarily mean that state law
imposes a requirement different from or additional to the require-
ments imposed by the MDA; "rather, it merely provides another rea-
son for manufacturers to comply with identical existing `require-
ments' under federal law." Id. In reaching this conclusion, the Court
found that the ambiguity of § 360k(a) made it appropriate to defer to
the assessment of the FDA that § 360k(a) does not preempt state-law
"`requirements that are equal to, or substantially identical to, require-
ments imposed by or under the act.'" Id. at 2256 (quoting 21 C.F.R.
§ 808.1(d)(2) (1995)).4

Regarding the plaintiffs' claims of negligent manufacturing and
failure to warn, the Court deferred to the determination of the FDA
that § 360k(a) preempts state requirements only when there exist
"`specific counterpart regulations or . . . other specific requirements
are applicable to a particular device'" under the MDA. Id. at 2257
(quoting 21 C.F.R. § 808.1(d) (1995)). Thus, general requirements
imposed pursuant to the MDA--the labeling and good manufacturing
practice (GMP) requirements found in 21 C.F.R. parts 801 and 820
(1996)--do not give rise to preemption of state-law claims.
_________________________________________________________________

4 Thus, had Duvall properly alleged that Bristol-Myers failed to comply
with FDA requirements, that claim would not have been preempted.
However, we previously ruled that Duvall waived this issue by neglect-
ing to present it to the district court. See Duvall I, 65 F.3d at 400 n.7.

                     9
In sum, the rule under Medtronic is that state common-law causes
of action may constitute requirements, but such requirements are pre-
empted only when they conflict with a specific regulation promul-
gated by the FDA with respect to the particular device in question or
a device-specific requirement imposed by the MDA. Accordingly,
state-law claims pertaining to medical devices subject only to the gen-
eral controls imposed by the § 510(k) notification process, GMPs, or
labeling requirements are not preempted.

C.

Applying the above analysis to the claims we previously found pre-
empted in Duvall I is a relatively straightforward matter. Here, as in
Medtronic, the device in question was marketed pursuant to a
§ 510(k) notification and thus is subject only to requirements of gen-
eral applicability. Accordingly, we have little difficulty concluding
that, under the reasoning of Medtronic, § 360k(a) does not preempt
Duvall's state-law claims related to the design, manufacture, market-
ing, and sale of the product; his failure-to-warn claim; or his breach-
of-implied-warranties claim.5 Indeed, Bristol-Myers does not dispute
that, to the extent its prosthesis has the same status under the MDA
as the pacemaker at issue in Medtronic, Duvall's state-law claims are
not preempted by § 360k(a).

Bristol-Myers argues, however, that Medtronic does not control the
outcome of this litigation because here, unlike in Medtronic, the med-
ical device in question was tested under an IDE prior to the submis-
sion of a § 510(k) notification. This distinction is important, Bristol-
Myers maintains, because the controls applicable to IDE devices are
sufficiently specific to give rise to preemption under § 360k(a). We
are not persuaded. Regardless of whether the controls applicable to a
_________________________________________________________________

5 Although the Court did not address a claim for breach of implied war-
ranty in Medtronic, we nevertheless determine that the reasoning of that
decision requires a conclusion that state-law claims for breach of implied
warranties are not preempted by § 360k(a). The decision of the Court
cited with approval an FDA regulation listing, inter alia, the Uniform
Commercial Code warranty of fitness as an example of the type of state
regulation that is not preempted by § 360k(a). See Medtronic, 116 S. Ct.
at 2257 (citing 21 C.F.R. § 808.1(d)(1)).

                    10
medical device marketed pursuant to an IDE are "specific" federal
requirements that give rise to preemption under the reasoning of
Medtronic, it is undisputed that the prosthesis implanted in Duvall
was not such a device. Rather, the device purchased by Duvall was
marketed pursuant to the § 510(k) notification process. Bristol-Myers
has provided no support, and we have found none, for the proposition
that the controls applicable to IDE devices remain in effect after the
IDE has expired. Accordingly, we reject Bristol-Myers' attempt to
distinguish this case from Medtronic.

III.

We now turn to the question of whether the district court erred in
granting summary judgment to Bristol-Myers on Duvall's claims for
breach of express warranties. We conclude that the district court cor-
rectly granted summary judgment on Duvall's express warranty claim
based on oral representations allegedly made to Duvall by a Bristol-
Myers representative prior to the implantation of the prosthesis. We
determine, however, that the district court erred in deciding that
§ 360k(a) preempted the express warranty claim based on statements
contained in a brochure regarding the prosthesis.

Under Maryland law, "[a]ny affirmation of fact or promise made
by the seller to the buyer which relates to the goods and becomes part
of the basis of the bargain creates an express warranty that the goods
shall conform to the affirmation or promise." Md. Code Ann., Com.
Law I § 2-313(1)(a) (1992). Breach of an express warranty occurs
"when a product fails to exhibit the properties, characteristics, or
qualities specifically attributed to it by its warrantor, and therefore
fails to conform to the warrantor's representations." Mercedez-Benz
of North America, Inc. v. Garten, 618 A.2d 233, 239 (Md. Ct. Spec.
App. 1993) (internal quotation marks omitted). Here, Duvall asserted
two express warranty claims, one based on oral representations alleg-
edly made to him prior to the surgery and the other based on product
literature distributed by Bristol-Myers:6
_________________________________________________________________

6 Bristol-Myers makes much of the fact that, in response to a discovery
request, Duvall submitted a brochure printed in August 1990, after he
had been implanted with the device. After the close of discovery, Duvall

                    11
        Prior to the March 16, 1990 penile implantation, I was
        given and did read a promotional brochure distributed by
        Bristol-Myers . . . which promised that the implant would
        allow me to resume sexual intercourse and was given further
        assurances about the device and its ability to allow me to
        resume sexual intercourse when I met with . . . a representa-
        tive of [Bristol-Myers]. It was on the basis of the representa-
        tions contained in the brochures and the promises made by
        [Bristol-Myers' representative] that I decided to have the . . .
        device implanted.

The district court granted summary judgment to Bristol-Myers on
the express warranty claim based on oral representations by Bristol-
Myers' agent because, it concluded, Duvall had failed to create a gen-
uine issue of material fact. Specifically, the district court held that the
conclusory allegations contained in Duvall's affidavit were insuffi-
cient to allow a jury to conclude that the representative had made an
affirmation of fact or promise regarding the performance of the pros-
thesis. We agree. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
248 (1986) (explaining that summary judgment is appropriate when
"the evidence is such that a reasonable jury could [not] return a ver-
dict for the nonmoving party"). Moreover, the assertions contained in
Duvall's affidavit are contrary to his sworn deposition testimony. See
Barwick v. Celotex Corp., 736 F.2d 946, 960 (4th Cir. 1984) (noting
that "[a] genuine issue of material fact is not created where the only
issue of fact is to determine which of the two conflicting versions of
the plaintiff's testimony is correct").

The district court concluded that Duvall's second express warranty
claim was preempted under the reasoning of Duvall I because Bristol-
Myers had submitted a similar brochure with the materials supporting
_________________________________________________________________

produced a substantially similar brochure printed in 1989, prior to his
surgery. We agree with the district court that Bristol-Myers could not
possibly have been harmed by the late submission of the 1989 brochure
because it was virtually identical to the 1990 brochure previously submit-
ted by Duvall. Moreover, Bristol-Myers authored and distributed both
brochures and thus cannot colorably claim that it was unaware of the
existence of the 1989 brochure.

                     12
its § 510(k) notification. Thus, the statements contained in the bro-
chure were mandated by the FDA and could not support an express
warranty claim. See Duvall I, 65 F.3d at 401. At the time of its deci-
sion, the district court did not have the benefit of Medtronic. And, in
light of that decision, we conclude that the district court erred in rul-
ing that Duvall's express warranty claim based on the brochure was
preempted by § 360k(a).

We begin our analysis of this issue by noting that nothing in
Medtronic calls into question our holding in Duvall I that § 360k(a)
preempts an express warranty claim to the extent that the claim is
based on FDA-mandated labeling, packaging, or advertising. Indeed,
the essence of the holding in Medtronic--that § 360k(a) gives rise to
preemption when the FDA has imposed specific requirements on a
particular device--lends credence to our previous conclusion that
when the FDA requires the manufacturer of a device to employ cer-
tain words to convey information about its product, § 360k(a) oper-
ates to preempt differing or additional state-law requirements.
However, the decision of the Court in Medtronic constrains us to
reconsider the view we expressed in Duvall I that statements con-
tained in proposed labeling, packaging, and advertising submitted
with a § 510(k) notification become "FDA-mandated" statements
when the FDA clears the device for marketing. To the contrary,
Medtronic explicitly holds that neither the § 510(k) notification pro-
cess nor the general controls on labeling found in 21 C.F.R. part 801
impose requirements on a device sufficient to result in preemption of
additional or different state requirements. See Medtronic, 116 S. Ct.
at 2254-55, 2258. In light of Medtronic, we hold that Duvall's express
warranty claim based on statements included in the brochure advertis-
ing the prosthesis is not preempted.

IV.

As construed by the Supreme Court in Medtronic, § 360k(a) of the
MDA preempts state-law causes of action to the extent that, if suc-
cessful, they would impose requirements different from or additional
to requirements specifically applicable to the particular device under
the MDA. The state-law claims pressed by Duvall in this action, if
successful, surely would impose requirements on Bristol-Myers' pros-
thesis. They are not preempted, however, because there are no spe-

                     13
cific federal requirements applicable to the prosthesis.7 Accordingly,
we remand for further proceedings, with the exception of Duvall's
assertion of an express warranty based on oral representations alleg-
edly made to Duvall prior to his surgery; as to this claim, we affirm
the decision of the district court granting summary judgment to
Bristol-Myers.

AFFIRMED IN PART, REVERSED IN PART,
AND REMANDED

_________________________________________________________________

7 In view of this holding, we reverse the decision of the district court
dismissing Patricia Duvall's claim for loss of consortium and remand it
for further proceedings consistent with this opinion.

                    14