Stefl v. Medtronic, Inc.

916 S.W.2d 879, 1996 Mo. App. LEXIS 307, 1996 WL 81528
CourtMissouri Court of Appeals
DecidedFebruary 27, 1996
Docket68267
StatusPublished
Cited by9 cases

This text of 916 S.W.2d 879 (Stefl v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering Missouri Court of Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Stefl v. Medtronic, Inc., 916 S.W.2d 879, 1996 Mo. App. LEXIS 307, 1996 WL 81528 (Mo. Ct. App. 1996).

Opinion

PUDLOWSKI, Judge.

This is an appeal from the trial court’s entry of summary judgment in favor of respondent Medtronic, Inc. Although the trial court incorrectly declared the law in holding that all claims raised in appellant’s petition were preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetics Act (FDCA), we find that summary judgment was nonetheless cor *881 rectly entered, and affirm the trial court’s order.

The facts of this case are undisputed for purposes of this appeal. 1 On March 3, 1988, appellant Donald Stefl had a 7420 Multi-Programmable Neurological Pulse Generator (the device), which is manufactured and marketed by respondent and which is regulated by the Food and Drug Administration (FDA) under the MDA as a Class III medical device, surgically implanted in his thoracic spine. After having been admitted to the hospital for the operation, but prior to the actual surgery, appellant had a conversation with one of respondent’s representatives wherein the representative told appellant that the device’s past results had been excellent. After appellant’s surgery, it was discovered that the device was not only ineffective in relieving appellant’s back pain, but that the device was experiencing mechanical failure and was not operating at all. The instant lawsuit was subsequently filed.

Although appellant’s petition is rather muddled, it is at least clear that it alleges two counts. The first count advances a products liability theory while count two asserts breach of warranty. As respondent contended, the trial court accepted, as appellant eventually conceded, and we now confirm, the MDA preempts tort claims based on theories of negligent design or manufacture of a product (as well as inadequate labelling or warnings) when the product at issue is a medical device regulated by the FDCA. King v. Collagen Corp., 983 F.2d 1130, 1135-36 (1st Cir.1993); Mendes v. Medtronic, Inc., 18 F.3d 13, 17-19 (1st Cir.1994). Appellant later tried to re-introduce a tort claim into the lawsuit by amending his petition to allege failure to calibrate the device and failure to correctly test and install it, but he did so without leave of the trial court. The trial court dismissed these amended allegations, and appellant does not contest this dismissal, so these attempted amendments are not before this court.

Thus, all that remains of appellant’s lawsuit is his nebulous “breach of warranty” count. Missouri law recognizes causes of action for breach of express warranty, breach of the implied warranty of merchantability, and breach of the implied warranty of fitness for a particular purpose. See RSMo 400.2-313 through 400.2-315 (1993). Appellant’s petition does not specify which warranty was allegedly breached by respondent, though appellant has conceded to both the trial court and this court at oral argument that any claim for breach of an express warranty found in the device’s packaging or labelling would be preempted.

When reviewing a summary judgment, we review the record, including the pleadings, in the light most favorable to the party against whom judgment was entered. ITT Commercial Finance v. Midr-America Marine Supply, 854 S.W.2d 371, 376 (Mo. banc 1993). Therefore, we will treat appellant’s petition as urging all possible breach of warranty theories except those which appellant has specifically abandoned.

Preemption

The implied warranty theories would seem to provide the most appropriate channel for appellant to obtain his remedy, since his complaint is not merely that the device failed to relieve his pain, but that the device did not operate as it was designed. The trial court ruled that appellant’s breach of warranty theories were preempted by the MDA along with his tort claim.

Section 360k(a) of the MDA, an express preemption provision, preempts any state or local requirement which is “different from or in addition to any requirement applicable under this Act to the device and which relates to the safety and effectiveness of the device or any other matter included in a requirement applicable to the device under this Act.” However, this preemption provision does not apply to claims arising from the use of a device unless the FDA has promulgated “specific counterpart regulations or other specific requirements” for that device. *882 See 21 C.F.R. 808.1(d); Oja v. Howmedica, 848 F.Supp 905, 906-07 (D.Colo.1994). Yet, it has been held that the requirements imposed by FDA during its premarket approval process constitute such “specific requirements.” Martello v. Ciba Vision Corp., 42 F.3d 1167, 1169 (8th Cir.1994). It is undisputed that the device at issue in this ease was approved pursuant to FDA’s premarket approval process.

State common law tort claims constitute “state law requirements” within the meaning of the MDA. Gile v. Optical Radiation Corp., 22 F.3d 540, 542-43 (3rd Cir. 1994). The implied warranties of merchantability and fitness for a particular purpose are imposed on contracts by state law. King at 1135. Therefore, a claim for breach of either implied warranty seeks to impose a state law requirement, and since such requirements are necessarily “different from or in addition to” the requirements of the MDA, § 360k(a) preempts claims based on implied warranty theories. Id.

This is not necessarily so in the case of all express warranties, however. As the U.S. Supreme Court instructed in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 524-28, 112 S.Ct. 2608, 2622-23, 120 L.Ed.2d 407 (1992), express warranties are not imposed by state law but rather by the party making the warranty. Numerous courts have distinguished Cipollone when deciding the preemption issue as it applies to claims for breach of express warranties of medical devices regulated under the MDA. King at 1135. Kemp v. Pfizer, 851 F.Supp. 269, 272-73 (E.D.Mich.1994). The reasoning found in these cases is that express labelling and packaging warranties of the product at issue in Cipollone (cigarettes) were not regulated comprehensively and exhaustively, as is the case with Class III medical devices, so that cigarette manufacturers were free to expressly warrant their product (via labelling) in ways that were unreviewed and unapproved by FDA.

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Cite This Page — Counsel Stack

Bluebook (online)
916 S.W.2d 879, 1996 Mo. App. LEXIS 307, 1996 WL 81528, Counsel Stack Legal Research, https://law.counselstack.com/opinion/stefl-v-medtronic-inc-moctapp-1996.