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.

ORDER

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

follows:

On page 2, section 4, line 6 -- "Davis S. Toepfer" is corrected 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 opinion. 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 & SHAFFER, Baltimore, Maryland, for Appellees. ON BRIEF: Lewis J. Saul,

Washington, D.C.; Bruce A. Finzen, Gary L. Wilson, David S. Toepfer, ROBINS, KAPLAN, MILLER & CIRESI, Minneapolis, Minnesota, 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 Counsel, 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 Corporation (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, however, 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 manufactured and marketed by Bristol-Myers. The prosthesis never functioned

to Duvall's satisfaction, and eventually Duvall had it removed. Thereafter, 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

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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, concluding that § 360k(a) preempted an express warranty claim only "to

the extent that [the claim] is based on FDA-mandated labeling, packaging, 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 warranty claims requires us first to decide whether the district court correctly 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 FDAmandated labeling, packaging, or advertising.

II.

Congress enacted the MDA in the midst of rising concern regarding 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 controls 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 substantial 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 similarity of the device to other penile prostheses marketed before passage 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 comprehensive 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 notwithstanding." 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 preemption 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 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.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 concluded that § 360k(a) did not preempt the plaintiffs' state-law claims

for defective design, defective manufacture, failure to warn, and failure 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 prohibition" 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 enactments 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 statelaw claims are preempted by § 360k(a) 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. See Medtronic, 116 S. Ct. at 2259 (Breyer, J., concurring in

part and concurring in judgment); id. at 2262-63 (O'Connor, J., concurring 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 manufacturing and labeling requirements gave rise to preemption of the plaintiffs' 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 preempted. 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 status quo that existed before passage of the MDA, including "the possibility 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 parallel federal requirements" does not necessarily mean that state law

imposes a requirement different from or additional to the requirements imposed by the MDA; "rather, it merely provides another reason for manufacturers to comply with identical existing `requirements' 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, requirements 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 neglecting 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 preempted only when they conflict with a specific regulation promulgated 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 general 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 preempted 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 general 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, marketing, and sale of the product; his failure-to-warn claim; or his breachof-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 medical device in question was tested under an IDE prior to the submission of a § 510(k) notification. This distinction is important, BristolMyers 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 warranty 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 correctly granted summary judgment on Duvall's express warranty claim

based on oral representations allegedly made to Duvall by a BristolMyers 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 allegedly 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 representative of [Bristol-Myers]. It was on the basis of the representations 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 BristolMyers' agent because, it concluded, Duvall had failed to create a genuine issue of material fact. Specifically, the district court held that the

conclusory allegations contained in Duvall's affidavit were insufficient to allow a jury to conclude that the representative had made an

affirmation of fact or promise regarding the performance of the prosthesis. 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 verdict 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 BristolMyers 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 submitted 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 brochure 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 decision, the district court did not have the benefit of Medtronic. And, in

light of that decision, we conclude that the district court erred in ruling 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 certain words to convey information about its product, § 360k(a) operates 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 contained 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 process 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 advertising 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 successful, 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' prosthesis. 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 allegedly 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

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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