United States Court of Appeals,

Fifth Circuit.

No. 93-3752.

Dorothy Marie REEVES, Plaintiff-Appellee,

v.

ACROMED CORPORATION, et al., Defendants,

Acromed Corporation, et al., Defendants-Appellants.

Feb. 10, 1995.

Appeal from the United States District Court for the Eastern District of Louisiana.

Before JOHNSON, HIGGINBOTHAM and DAVIS, Circuit Judges.

W. EUGENE DAVIS, Circuit Judge:

This appeal arises from a products liability action filed by

the appellee, Dorothy Marie Reeves ("Reeves"), alleging that a

metal bone implant manufactured and marketed by the appellant,

AcroMed Corporation ("AcroMed") exacerbated injuries in her back.

The central issue presented on appeal is whether the Medical Device

Amendments (the "MDAs") to the Food, Drug, and Cosmetic Act,

et seq. (the "Act"), preempt Reeves' claim that

AcroMed failed to adequately warn her and her physician of the

implant's dangers. AcroMed also challenges the evidentiary

sufficiency of Reeves' defective manufacturing, defective design,

and unreasonably dangerous per se claims. For the reasons stated

below, we conclude that Reeves' failure-to-warn claim is preempted

and that Reeves failed to produce sufficient evidence to recover on

her defective manufacturing and defective design theories. We thus

vacate the district court's judgment and remand this case for

1 retrial of Reeves' action predicated on her unreasonably dangerous

per se theory of recovery.

I.

In December 1985, Dorothy Marie Reeves seriously injured her

back. In an effort to correct Reeves' condition, her neurosurgeon

attempted a complicated surgical procedure designed to fuse the

vertebrae at the four levels of the spine affected by the injury.

As part of this surgery, Reeves' neurosurgeon implanted metal bone

plates and screws manufactured by AcroMed to secure Reeves'

vertebrae while the bone fused. Reeves' condition initially

improved after the surgery. X-rays taken of Reeves' back

throughout the two years following surgery revealed no

complications. Six months after the surgery, however, Reeves

complained of increasing pain in her back that had not existed

before the surgery. In December 1991, Reeves filed the present

suit contending that AcroMed's metal bone implant broke and

prevented the bones in her spine from fusing. She based her claim

on a number of theories, including negligence, strict liability,

breach of warranty, and battery. However, Reeves' primary theory

at trial was that AcroMed failed to warn her that the Food and Drug

Administration (the "FDA") never approved AcroMed's implant for use

in the spine except as part of a controlled investigational study.

At the close of trial, the district court submitted three

special interrogatories on liability to the jury. The jury found

AcroMed's device unreasonably dangerous as a spinal implant and

that AcroMed did not legally obtain FDA approval to market its

2 device as a spinal implant. The jury also found that Reeves would

not have permitted her surgeon to implant AcroMed's device if she

had known that the device was unapproved for use in the spine.1

The jury assessed Reeves' damages at $475,000, and the district

court entered judgment on the verdict against AcroMed for that

amount.

The district court instructed the jury that they could find

AcroMed's product unreasonably dangerous and answer Interrogatory

One "Yes" based on any of Reeves' four theories of recovery:

defective design, defective manufacturing, failure-to-warn, and the

"unreasonably dangerous per se" doctrine. AcroMed contends that

the evidence is insufficient to support Reeves' recovery on three

of the four theories submitted to the jury: defective

1 The jury answered the interrogatories as follows:

INTERROGATORY NO. ONE:

Was the AcroMed product implanted in Dorothy Reeves' spine unreasonably dangerous as a spinal implant?

YES X NO

INTERROGATORY NO. TWO:

Did AcroMed legally obtain FDA approval for the AcroMed product to be implanted in the spine except in an investigative or experimental program, prior to the time it was implanted in Dorothy Reeves?

YES NO X

INTERROGATORY NO. THREE:

If Dorothy Reeves had been informed that the AcroMed product was experimental and under investigation would she have permitted it to be implanted in her back?

YES NO X

3 manufacturing, defective design, and the unreasonably dangerous per

se doctrine. AcroMed further maintains that the MDAs preempt

Reeves' failure-to-warn claim.

II.

When a district court submits two or more alternative grounds

for recovery to the jury on a single interrogatory and the

plaintiff prevails, we ordinarily order a new trial if one of the

grounds for recovery is "legally inadequate." Walther v. Lone Star

Gas Co.,

(5th Cir. 1992); Pan Eastern Exploration

v. Hufo Oils,

, 1123 (5th Cir. 1988). In such a case,

"the reviewing court cannot determine whether the jury based its

verdict on a sound or unsound theory." Pan Eastern Exploration,

855 F.2d at 1123; Hayes v. Solomon,

(5th

Cir. 1979) (holding that "the very real likelihood that the jury may

have utilized an unproven or improper theory of liability to reach

its verdict mandates reversal"). In the present case, the district

court submitted four of Reeves' theories of recovery under the

first interrogatory. The first interrogatory inquires whether

AcroMed's product was "unreasonably dangerous as a spinal implant."

The court instructed the jury that proof of one or more of Reeves'

four theories of recovery was sufficient for an affirmative answer

to the first interrogatory. Thus, if the court erroneously

submitted one of the legal theories of recovery to the jury and the

form of the interrogatory prevents us from determining upon which

theory the jury based its verdict, we must vacate the judgment.

Hufo, 855 F.2d at 1123.

4 AcroMed's primary contention on appeal is that the district

court erroneously submitted Reeves' failure-to-warn theory of

recovery to the jury. According to AcroMed, Reeves'

failure-to-warn claim is legally inadequate because it is preempted

by the MDAs. We now turn to the merits of AcroMed's preemption

argument.

III.

A.

Reeves' produced evidence at trial that AcroMed failed to warn

her or her doctor that its metal bone implant was not FDA approved

for use in the spine. This evidence is the basis of her

failure-to-warn claim.

The MDAs establish two separate approval processes for medical

devices: Pre-Market Approval and Pre-Market Notification. The

FDA's Pre-Market Approval process applies to new medical devices

introduced after May 28, 1976, the date the MDAs were enacted.

This process is lengthy and involves extensive investigation by the

FDA. The FDA's Pre-Market Approval application requires

manufacturers to submit extensive animal and human data to

establish their devices' safety and effectiveness.

. Frequently, an experimental program under close FDA

scrutiny must be successfully completed before FDA approval can be

obtained under this process. FDA regulations also require Pre-

Market Approval applicants to submit "[c]opies of all proposed

labeling for the device."

(b)(10). The FDA

approves a Pre-Market Approval application only after extensive

5 review by the agency and an advisory committee composed of outside

experts.

.

In contrast to the FDA's Pre-Market Approval process, the

agency's Pre-Market Notification process is more abbreviated and

involves less FDA oversight. To obtain FDA approval under this

procedure, the applicant must demonstrate that its device is

"substantially equivalent" to a device on the market prior to May

28, 1976.

. The Pre-Market Notification process

requires applicants to submit descriptions of their devices and

other information necessary for the agency to determine whether the

devices are substantially equivalent. As with the Pre-Market

Approval process, Pre-Market Notification applicants must also

submit their proposed labeling.

If the FDA determines that a

device is substantially equivalent to a device that was on the

market prior to the enactment of the MDAs in 1976, the applicant is

free to market the device.

Reeves produced evidence that AcroMed applied twice to the FDA

for approval to market its device as a spinal implant under the

FDA's Pre-Market Notification process, and that the FDA rejected

both applications. The FDA concluded that the implant was not

substantially equivalent to any spinal implant on the market before

1976, and directed AcroMed to obtain additional animal and human

data showing that the implant is safe and effective if used as a

spinal implant. In December 1985, AcroMed submitted a third Pre-

Market Notification application to the FDA covering the same

implant, but omitting any statements identifying the spine as one

6 of the potential uses of the device. In contrast to AcroMed's

prior applications, this application stated that AcroMed intended

to market its implant for use in "appropriate fractures of long

bones of both the upper and lower extremity," and other flat bones.

The FDA approved AcroMed's implant for marketing based on the

revised application.2

B.

AcroMed contends that the MDAs expressly preempt Reeves'

failure-to-warn claim. Section 360k(a) of the Act provides:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to this device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a) (emphasis added). AcroMed argues that §

360k(a) preempts Reeves' failure-to-warn claim because her claim,

if successful, would impose a labeling requirement that is "in

addition" to the FDA's labeling regulations.

The touch-stone of preemption analysis is Congressional

intent. Cipollone v. Liggett, --- U.S. ----, ----,

,

(1992). Congressional intent may be

"explicitly stated in the statute's language or implicitly

2 In January 1986, the FDA approved an additional AcroMed application for an investigational study allowing AcroMed to implant its device in the spines of a select group of patients under strict guidelines established by the FDA. Reeves was never a participant in such an investigational study.

7 contained in its structure and purpose."

(quoting Jones v.

Rath Packing Co.,

,

,

(1977)). Where Congress enacts legislation that

specifically addresses the issue of preemption, the express

language of the statute provides a "reliable indicium of

congressional intent with respect to state authority."

at ----

,

(quoting Malone v. White Motor Corp.,

,

,

(1978)).

Consequently, the existence of an express preemption provision

renders it unnecessary for us "to infer congressional intent to

preempt state laws from the substantive provisions" of the MDAs.

Rather, to determine the precise boundaries of § 360k(a) "we

need only identify the domain expressly preempted" by the language

of the statute. Id.

We have previously held that § 360k(a) of the Act preempts

common law failure-to-warn claims involving medical devices subject

to the MDAs. In Moore v. Kimberly-Clark Corp.,

, 246-

247 (5th Cir. 1989), the court held that § 360k(a) preempted a claim

alleging that a tampon manufacturer had failed to provide adequate

warnings concerning the dangers of toxic shock syndrome. The court

based its decision primarily on the fact that FDA regulations

specifically prescribe the form and content of toxic shock warnings

on tampons. Id. Because the plaintiff's claim would essentially

impose labeling requirements beyond those required by the FDA's

regulations, the court concluded that § 360k(a) preempted the

plaintiff's claim.

8 In Stamps v. Collagen Corp.,

(5th

Cir.), cert. denied --- U.S. ----,

,

(1993), this court applied the reasoning of Moore to hold that

preemption barred a failure-to-warn claim brought against the

manufacturer of an anti-wrinkle treatment. We reached this

conclusion even though the FDA had not promulgated regulations that

specifically prescribed the form and content of the product's

labeling and warnings. The court reasoned that the FDA's Pre-

Market Approval process requires agency review and approval of a

device manufacturer's proposed labeling before a medical device can

be marketed.

FDA approval of a device for marketing,

therefore, signifies the agency's determination that the

manufacturer's labeling is sufficient. Because common law

failure-to-warn claims would impose labeling requirements beyond

those required by the FDA, the court concluded that § 360k(a)

preempted the plaintiff's failure-to-warn claim. Id.

C.

We conclude that the reasoning of Moore and Stamps applies to

the present case because Reeves' failure-warn-claim, if successful,

would impose labeling requirements "in addition" to the

requirements of the MDAs and FDA regulations. 21 U.S.C. § 360k(a).

FDA regulations require device manufacturers to submit the proposed

labeling and warnings for their devices to the FDA as part of the

approval process under the MDAs.

(e). FDA

labeling regulations specifically require labels to disclose a

device's uses, hazards, side effects, and any applicable

9 precautions.

. Based on its review of the

manufacturer's proposed labeling, the agency can impose additional

labeling requirements if it determines that a "substantial

deception" or unreasonable health danger could be corrected by

"labeling or a change in labeling."

. The FDA

thus implicitly approves a manufacturer's proposed labeling when

the agency approves a device for marketing. Stamps,

. Because Reeves' failure-to-warn claim would impose labeling

requirements beyond those required by the FDA, her claim runs afoul

of § 360k(a) of the MDAs. Id.; see also

(d)(6)

(the MDAs preempt state requirements that have "the effect of

establishing a substantive requirement for a specific device.")

Reeves attempts to distinguish this case from Moore and Stamps

on three grounds. Reeves first argues that we should not give

preemptive effect to the FDA's approval of AcroMed's labeling

because the FDA approval process involved in this case is

considerably less stringent than the review processes involved in

Stamps. The anti-wrinkle treatment in Stamps was approved through

the FDA's Pre-Market Approval process. In contrast, AcroMed's

implant was approved through the FDA's Pre-Market Notification

process. Stamps,

. In support of her argument,

Reeves points out that the FDA's approval of a device under the

Pre-Market Notification process "does not in any way denote

official approval of the device."

.

Reeves' attempt to distinguish this case on the basis of the

type of FDA approval process at issue is unpersuasive. The FDA

10 labeling requirements that prompted this court to apply preemption

in Stamps also apply to products approved under the FDA's Pre-

Market Notification process. Even if the FDA's Pre-Market

Notification process does not result in the FDA's "official

approval" of a device, the agency subjects the manufacturer's

proposed labeling to extensive scrutiny. As discussed above, FDA

regulations required AcroMed to submit its proposed labeling with

its Pre-Market Notification application. See

(e). The regulations also required the FDA to review

AcroMed's labeling to ensure that it was in compliance with the

general labeling regulations set out in

et seq.

Therefore, despite the differences between the FDA's Pre-Market

Approval and Pre-Market Notification procedures, our preemption

analysis remains the same. The First Circuit used this same

reasoning in holding that the preemptive effect of FDA labeling

regulations apply equally to devices approved under the FDA's Pre-

Market Approval and Pre-Market Notification procedures. Mendes v.

Medtronic, Inc.,

(1st Cir. 1994).

Reeves also contends that preemption should not apply in this

case because the AcroMed implant was used in the spine—an

"off-label" use—rather than in the long bones of the upper or lower

extremities, as stated in AcroMed's December 1985 application to

the FDA. But, Reeves' attempt to distinguish this case based on

the off-label use of AcroMed's implant is also flawed. FDA

labeling regulations specifically address off-label uses of medical

devices. For example, FDA regulations require manufacturers to

11 provide appropriate labeling if the manufacturer has reason to

believe that its medical device might be used for purposes

different from the purposes for which the device is approved. 21

C.F.R. 801.43. Similarly, the FDA can require a manufacturer to

provide additional labeling that addresses potential off-label

uses.

. Consequently, the fact that AcroMed's

implant might have been used for an off-brand propose is not

sufficient to distinguish this case from Moore and Stamps.

Finally, Reeves argues that preemption should not apply in

this case because AcroMed misled the FDA and violated FDA

regulations by withholding material information from the FDA

concerning the intended uses of its product. Reeves argues that

AcroMed failed to inform the FDA that they intended to market their

device as a spinal implant. In support of this argument, Reeves

produced evidence that AcroMed removed all references to spinal

uses from its December 1985 Pre-Market Notification application to

gain FDA approval after the FDA had rejected two prior applications

to market the device as a spinal implant.

Reeves essentially invites us to create an exception to

preemption under § 360k(a) in cases where a manufacturer withholds

material information from the FDA during the approval process.

3 According to § 801.4:

[I]f a manufacturer knows, or has knowledge of facts that would give it notice that a device introduced into interstate commerce by a manufacturer is to be used for conditions, or uses other than the ones for which he offers it, he is required to provide adequate labeling ... which accords with such other uses to which the article is to be put.

12 Whether such an exception is warranted in a case involving a

medical device subject to the MDAs is a question of first

impression in this circuit. In Hurley v. Lederle Lab. Div. of

American Cyanamid Co.,

(5th Cir. 1988) we

declined to preempt a failure-to-warn claim brought against a

vaccine manufacturer. We based our holding on the plaintiff's

allegations that the manufacturer withheld material information

from the FDA during the vaccine's approval process.

Our holding in Hurley however is distinguishable from the

present case. In contrast to the present case, Hurley did not

involve a medical device subject to approval under the MDAs. More

importantly, because the vaccine at issue in Hurley was not subject

to the express statutory preemption provision in § 360k(a) of the

MDAs, we based our analysis on implied preemption principles. As

the Supreme Court made clear in Cipollone, implied preemption

analysis is inapplicable where a statute contains an express

preemption provision. Therefore, the focus of our preemption

analysis must be the language of § 360k(a). --- U.S. at ----,

.

Only one other circuit has specifically addressed whether

evidence of fraud on the FDA is sufficient to defeat preemption

under § 360k(a) of the MDAs. In King v. Collagen Corp.,

(1st Cir. 1993), the First Circuit declined to

create an exception to preemption under the MDAs where the

plaintiff alleged that the manufacturer fraudulently withheld

material safety information from the FDA during the approval

13 process. The court reasoned that the FDA was in the best position

to determine whether a manufacturer has withheld material

information:

[W]here the FDA was authorized to render the expert decision on Collagen's use and labeling, it, and not some jury or judge, is best suited to determine the factual issues and what their effect would have been on its original conclusions.

. The court also observed that an erroneous jury

finding that a manufacturer failed to disclose material information

would be tantamount to imposing a requirement "that is different

from, or in addition to, any requirement applicable ... to the

device."

(quoting 21 U.S.C. § 360k(a)). The court concluded,

therefore, that a fraud-on-the-FDA exception to preemption would

inevitably run afoul of the MDA's express preemption provision in

§ 360k(a). See also, Papas v. Upjohn Co.,

(11th Cir. 1993) (declining to find an exception to an express

preemption provision under the Federal Insecticide, Fungicide, and

Rodenticide Act based on allegations that a pesticide manufacturer

withheld material information from the Environmental Protection

Agency).

Other courts have declined to create an exception to

preemption under the MDAs in cases where manufacturers allegedly

violated FDA labeling regulations. In National Bank of Commerce of

El Dorado v. Kimberly-Clark Corp.,

(8th

Cir. 1994) the Eighth Circuit held that the plaintiff's

failure-to-warn claim was preempted under § 360k(a) even though the

plaintiff alleged that the defendant manufacturer had violated FDA

labeling regulations. The court reasoned that the MDAs require the

14 FDA to determine whether a manufacturer's proposed labeling

complies with FDA labeling regulations when the agency approves a

device for marketing. Accordingly, permitting a state law

failure-to-warn claim based on allegations that a manufacturer

violated FDA labeling regulations would essentially constitute a

collateral attack on the FDA's original determination that the

manufacturer was in compliance with all applicable regulations.

Id. The court concluded that such an attack on the FDA's

determination of compliance is preempted by § 360k(a).4

We agree with the reasoning of King and El Dorado and,

therefore, decline Reeves' invitation to create a unwieldy

exception to Moore and Stamps in cases where manufacturers attempt

to mislead the FDA or violate FDA regulations. The MDAs establish

an extensive enforcement scheme under which the FDA bears the

primary responsibility for policing violations of its regulations.

El Dorado,

. In fact, the MDAs specifically

proscribe the submission of fraudulent forms to the FDA and

establish civil and criminal penalties for intentionally defrauding

or misleading the FDA. See

, 333(a)(2), 333(g);

4 Other courts have questioned the applicability of preemption in cases where a manufacturer has violated FDA regulations. However, most of the statements favoring an exception to preemption under these circumstances are in dicta. See Slater v. Optical Radiation Corp.,

(7th Cir. 1992) (Posner, J.) (reasoning that preemption under § 360k(a) "is limited to efforts by states to impose sanctions for compliance with federal regulations."); see also Tarallo v. Searle Pharmaceutical, Inc.,

(D.S.C. 1988). However, as of the date of this opinion, no court has squarely held that a violation of FDA labeling regulations defeats preemption of state failure-to-warn claims.

15 see also United States v. Arlen,

(5th

Cir. 1991).5 Given the FDA's central role in reviewing and

approving devices under the MDAs, the FDA is in the best position

to decide whether AcroMed withheld material information from the

agency and, if so, the appropriate sanction. Allowing a jury or

court to second-guess the FDA's enforcement of its own regulations

contravenes Congress' expressly stated intent in § 360k(a) to

eliminate attempts by states to impose conflicting requirements on

medical device manufacturers. See H.R.Report No. 853, 94th Cong.,

2d Sess. 9 (1976) (explaining that the principal purpose of §

360k(a) is to eliminate conflicting regulations). For these

reasons, we conclude that § 360k(a) of the MDAs preempts Reeves'

failure-to-warn claim.

IV.

We conclude, therefore, that the district court erred in

5

states:

The following acts and the causing thereof are prohibited:

(q)(2) With respect to any device, the submission of any report that is required by or under this chapter that is false and misleading in any material respect.

(a) establishes criminal penalties for violations of § 331:

(a)(1) Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1), if any person ... commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.

16 submitting Reeves' failure-to-warn theory of recovery to the jury.

Because we cannot determine whether the jury based its affirmative

answer to Interrogatory One on Reeves' legally inadequate

failure-to-warn theory of recovery, we must vacate the district

court's judgment and remand the case for retrial. The only

remaining issue is which of the three remaining theories of

recovery the district court must retry on remand.

AcroMed contends that Reeves failed to introduce sufficient

evidence to recover on the basis of a design or manufacturing

defect. We have carefully reviewed the record and find no evidence

to support a recovery on the basis of a defect in the fabrication

or manufacture of AcroMed's implant. On appeal, Reeves points to

no evidence that would support a recovery on this theory.

Consequently, there is insufficient evidence to retry this theory

of recovery on remand.

Reeves also failed to establish all the elements required by

Louisiana law to recover on a defective design theory. To prevail

on this theory, Louisiana law requires a plaintiff to establish the

existence of an alternative safer design for the product. Halphen

v. Johns-Manville Sales Corp.,

(La. 1986).

Reeves introduced no evidence of an alternative safer design.

Indeed, she does not argue on appeal that she satisfied this

requirement.

Finally, AcroMed contends that Reeves failed to produce

sufficient evidence at trial to support her recovery under the

theory that AcroMed's implant is unreasonably dangerous per se. A

17 product is unreasonably dangerous per se if "[a] reasonable person

would conclude that the danger-in-fact, whether foreseeable or not,

outweighs the utility of the product." Halphen,

.

While this theory of recovery eliminates the "state of the art"

defense, the plaintiff is not relieved of the burden of proving

that the product is defective. Valenti v. Surgiteck-Flash Medical

Eng. Corp.,

(5th Cir. 1989). Thus, in order to

carry her burden, Reeves must establish that some inherent

characteristic of AcroMed's implant renders it unreasonably

dangerous for use in the spine.

We conclude that Reeves' evidence is sufficient to support

submitting her unreasonably dangerous per se claim to the jury. In

support of her claim, Reeves points to an October 1985 FDA letter

rejecting AcroMed's original application to have its implant

approved as a spinal implant. In this letter, the FDA cites

several potential health hazards of AcroMed's device as a spinal

implant. The FDA specifically referred to its concern about the

stability of the device and that the screws could break and damage

the bones in the spine. This evidence, together with evidence that

allowed the jury to infer that the screws broke and exacerbated

Reeves' back pain, is sufficient to create a jury issue. We

conclude, therefore, that there is sufficient evidence to retry

Reeves' unreasonably dangerous per se theory of recovery on remand.

V.

For the reasons stated above, we must VACATE the judgment and

REMAND this case for retrial of Reeves' unreasonably dangerous per

18 se theory of recovery. Pan Eastern Exploration, 855 F.2d at 1123.

VACATED and REMANDED.

. . . . .

19