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, 21
U.S.C. §§ 301 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?
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., 952 F.2d 119, 126 (5th Cir.1992); Pan Eastern Exploration
v. Hufo Oils, 855 F.2d 1106, 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, 597 F.2d 958, 985 (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. 21 C.F.R. §
814.20. 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." 21 C.F.R. § 814.20(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. 21 C.F.R. § 814.40.
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. 21 C.F.R. § 807.87. 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. Id. 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. ----, ----, 112 S.Ct. 2608,
2617, 120 L.Ed.2d 407 (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." Id. (quoting Jones v.
Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51
L.Ed.2d 604 (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." Id. at ----
, 112 S.Ct. at 2618 (quoting Malone v. White Motor Corp., 435 U.S.
497, 505, 98 S.Ct. 1185, 1190, 55 L.Ed.2d 443 (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.
Id. 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., 867 F.2d 243, 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., 984 F.2d 1416, 1423-24 (5th
Cir.), cert. denied --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54
(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. Id. 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. 21 C.F.R. § 807.87(e). FDA
labeling regulations specifically require labels to disclose a
device's uses, hazards, side effects, and any applicable
9 precautions. 21 C.F.R. § 801.109. 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." 21 C.F.R. § 895.25. The FDA
thus implicitly approves a manufacturer's proposed labeling when
the agency approves a device for marketing. Stamps, 984 F.2d at
1123. 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 21 C.F.R. § 808.1(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, 984 F.2d at 1123. 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." 21 C.F.R. § 807.97.
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 21 C.F.R. §
807.87(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 21 C.F.R. §§ 801 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., 18 F.3d 13, 17-18 (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. 21 C.F.R. § 895.25. 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., 863 F.2d 1173, 1179-1180 (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 ----, 112
S.Ct. at 2618.
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., 983 F.2d
1130, 1139-1140 (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.
Id. at 1140. 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." Id. (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., 985 F.2d 516, 518-519
(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., 38 F.3d 988, 993-94 (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, 38 F.3d at 994. 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 21 U.S.C. §§ 331, 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., 961 F.2d 1330, 1334 (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., 704 F.Supp. 653, 655 (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, 947 F.2d 139, 142-43 (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'
IV.
We conclude, therefore, that the district court erred in
5 21 U.S.C. § 331 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.
21 U.S.C. § 333(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., 484 So.2d 110, 115 (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, 484 So.2d at 115.
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., 875 F.2d 466, 468 (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.
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.
. . . . .