Reeves v. AcroMed Corp.

• Decision Date: 10 February 1995
• Docket Number: No. 93-3752,93-3752
• Citation: 44 F.3d 300
• Parties: Prod.Liab.Rep. (CCH) P 14,158 Dorothy Marie REEVES, Plaintiff-Appellee, v. ACROMED CORPORATION, et al., Defendants, AcroMed Corporation, et al., Defendants-Appellants.
• Court: U.S. Court of Appeals — Fifth Circuit

Page 300

44 F.3d 300

Prod.Liab.Rep. (CCH) P 14,158

Dorothy Marie REEVES, Plaintiff-Appellee, v. ACROMED CORPORATION, et al., Defendants AcroMed Corporation, et al., Defendants-Appellants.

No. 93-3752.

United States Court of Appeals Fifth Circuit.

Feb. 10, 1995.

Rehearing Denied April 3, 1995.

Mark Herrmann, Richard I. Werder, Jr., Jones, Day, Reavis & Pogue, Cleveland, OH, B. Frank Davis, Howard B. Kaplan, Robert A. Knight, Bernard, Cassisa & Elliott, Metairie, LA, for AcroMed Corp.

Marshall G. Weaver, Arthur S. Patron, Jr., Henican, James & Cleveland, New Orleans, LA, for St. Paul Fire.

Richard A. Samp, Washington, DC, for amicus curiae Wash. Legal Foundation.

Darryl J. Tschirn, La Jolla, CA, John J. Cummings, III, Frank C. Dudenhefer, Jr., Cummings, Cummings & Dudenhefer, New Orleans, LA, for appellee.

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. Secs. 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 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 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 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.

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. Sec. 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. Sec. 814.20(b)(10). The FDA approves a Pre-Market Approval application only after extensive review by the agency and an advisory committee composed of outside experts. 21 C.F.R. Sec. 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. Sec. 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 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. Sec. 360k(a) (emphasis added). AcroMed argues that Sec. 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.

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