Ellen Mendes, Plaintiff, Appellant, v. Medtronic, Inc., Defendant, Appellee, 18 F.3d 13 (1st Cir. 1994)

Pursuant to the MDA, FDA groups medical devices into three classes based on the degree of regulation necessary to assure safety and effectiveness. See 21 U.S.C. § 360c; H.R.Conf.Rep. No. 1090, 94th Cong., 2d Sess. 55 (1976), reprinted in 1976 U.S.C.C.A.N. 1103, 1107. All classes of devices are subject to "general controls," including labeling requirements and good manufacturing practices. See, e.g., 21 U.S.C. §§ 360i, 360j. Class III devices, such as pacemakers, pose the greatest risks. Such devices may be sold only if FDA finds that they are "substantially equivalent" in design and function to devices on the market before the MDA became effective in 1976, or--in the case of new or improved devices--if FDA grants premarket approval. Id. Secs. 360c(a) (1) (C), 360e(b); 21 C.F.R. Sec. 807.100 . Devices found to be "substantially equivalent" are entitled to bypass the premarket approval process unless or until FDA issues a regulation specifying that the device undergo the review process.

On May 14, 1986, a Medtronic pacemaker, a Class III device, was implanted into plaintiff. Medtronic had distributed the pacemaker since 1981 without premarket approval because no regulation specifically required premarket approval, and because FDA found the pacemaker to be substantially equivalent to pre-MDA pacemakers. On March 10, 1992, the pacemaker failed, and plaintiff nearly died. The pacemaker was surgically removed, and a new model implanted.

Plaintiff filed a complaint alleging that Medtronic was negligent in designing, manufacturing, and distributing her pacemaker. She also included claims alleging Medtronic's failure to provide adequate warnings, and breach of the implied warranty of merchantability. Medtronic moved for summary judgment on the ground that 21 U.S.C. § 360k(a) preempted all of plaintiff's claims. The district court granted the motion, and plaintiff appealed.² 

Standard of Review

Our review of a district court's summary judgment decision is plenary. FDIC v. Anchor Properties, 13 F.3d 27, 31 (1st Cir. 1994). Summary judgment is appropriate when the pleadings and affidavits raise no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law. Id.; see also Fed. R. Civ. P. 56(c).

The nonmoving party bears the burden of placing at least one material fact into dispute after the moving party shows the absence of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S. Ct. 2548, 2554, 91 L. Ed. 2d 265 (1986). Evidence in the record supports that plaintiff's pacemaker was defective; that the defect caused plaintiff's injuries; and that Medtronic was aware, before the pacemaker failed, that the model might not work properly.

Medtronic asserted in its motion for summary judgment that "[t]here are no genuine issues of material fact since even if plaintiff could prove all her factual allegations," her claims would be preempted. Medtronic also stated, "[f]or the purposes of its Motion for Summary Judgment only, " that it did not dispute the following allegations of plaintiff:

1. [A] Medtronic [pacemaker], model number 5984LP (the "device"), [was] implanted into [plaintiff] on May 14, 1986....

2. [T]he device failed on March 10, 1992....

3. This alleged failure caused a near death circumstance and plaintiff was required to undergo emergency surgery to remove the ... device....

4. [Plaintiff's] injuries ... were due to defects in the labeling, design and manufacture of the device....

Def.'s Mot. for Summ.J., at 2-3 (emphasis in original).

We take these assertions at face value. We assume plaintiff's factual allegations are true, and we examine the legal issues in this light. Medtronic does not contend that plaintiff's allegations fail to state a claim under Massachusetts law. The sole issue addressed by the parties and the district court is preemption, which is the key issue on appeal.

PREEMPTION

Medtronic argues that the Act implicitly and expressly preempts plaintiff's claims. Congress's intent is the touchstone of preemption analysis. Cipollone v. Liggett Group, --- U.S. ----, ----, 112 S. Ct. 2608, 2617, 120 L. Ed. 2d 407 (1992); King v. Collagen Corp., 983 F.2d at 1133. State common law claims may be preempted along with state statutes and regulations, if Congress so intended. See, e.g., Cipollone, --- U.S. at ----, 112 S. Ct. at 2620; King v. E.I. Dupont de Nemours & Co., 996 F.2d 1346, 1349-50 (1st Cir.), cert. dismissed, --- U.S. ----, 114 S. Ct. 490, 126 L. Ed. 2d 440 (1993); King v. Collagen Corp., 983 F.2d at 1134-35.

"Congress' intent may be 'explicitly stated in the statute's language or implicitly contained in its structure and purpose.' " Cipollone, --- U.S. at ----, 112 S. Ct. at 2617 (quoting Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S. Ct. 1305, 1309, 51 L. Ed. 2d 604 (1977)). The MDA contains an express preemption provision, 21 U.S.C. § 360k(a), that states, in pertinent part:

[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 [the Federal Food, Drug, and Cosmetic Act] 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 [the Federal Food, Drug, and Cosmetic Act].

Congress's intent in enacting this provision was to prevent state requirements from unduly burdening interstate commerce. See H.R.Rep. No. 853, 94th Cong., 2d Sess. 45 (1976), reprinted in An Analytical Legislative History of the Medical Device Amendments of 1976, app. III, at 45 (Food & Drug L. Inst. Series, Daniel F. O'Keefe, Jr. & Robert A. Spiegel eds., 1976).

We construe this preemption clause with due regard for the interests of federalism because it affects state public health regulation. A federal act will supersede " 'the historic police powers of the states,' " only if that is " 'the clear and manifest purpose of Congress.' " King v. Collagen Corp., 983 F.2d at 1134 (quoting Cipollone, --- U.S. at ----, 112 S. Ct. at 2617); see also CSX Transp. v. Easterwood, --- U.S. ----, ----, 113 S. Ct. 1732, 1737, 123 L. Ed. 2d 387 (1993); Greenwood Trust Co. v. Massachusetts, 971 F.2d 818, 823 (1st Cir. 1992), cert. denied, --- U.S. ----, 113 S. Ct. 974, 122 L. Ed. 2d 129 (1993).

Viewing section 306k(a) in light of this presumption against preemption, we have held that it expresses Congress's intent to preempt certain common law claims because such claims may establish state "requirements." King v. Collagen Corp., 983 F.2d at 1138; accord Stamps v. Collagen Corp., 984 F.2d 1416, 1420 (5th Cir.), cert. denied, --- U.S. ----, 114 S. Ct. 86, 126 L. Ed. 2d 54 (1993); cf. CSX Transp., --- U.S. at ----, 113 S. Ct. at 1737 (discussing holding in Cipollone that "federal statute barring additional 'requirement[s] ... "imposed under state law" ' pre-empts common-law claims" (citation omitted)).

To determine the extent to which plaintiff's claims are preempted, we need only identify the preemptive reach of the statute's express language. Cipollone, --- U.S. at ----, 112 S. Ct. at 2618 (plurality); id. at ----, 112 S. Ct. at 2625 (Blackmun, J., concurring in part and dissenting in part). We thus reject at the outset Medtronic's argument that this is an implied preemption case. See King v. Collagen Corp., 983 F.2d at 1134; Stamps, 984 F.2d at 1420. When "Congress includes an express preemption clause in a statute, judges ought to limit themselves to the preemptive reach of that provision without essaying any further analysis under the various theories of implied preemption." Greenwood Trust, 971 F.2d at 823.

Our first task is to outline the Act's requirements applicable to the device. Thereafter, we scrutinize plaintiff's claims, to determine whether the successful litigation of any of them would "establish or continue in effect" a "different" or "addition[al]" requirement. 21 U.S.C. § 360k(a). This analysis determines whether plaintiff's claims are preempted. 21 C.F.R. Sec. 808.1(d) (state requirements are preempted where "there are ... specific requirements applicable to a particular device under the act").

The pacemaker at issue is a Class III device. Although Class III devices are generally subject to stringent design, manufacturing, and labeling controls pursuant to the premarket approval process, 21 C.F.R. pt. 814, FDA has never required that the pacemaker model implanted in plaintiff comply with the premarket approval regulations. Id. Sec. 870.3610(c). The only requirements under the Act applicable to the device are regulations on labeling and "good manufacturing practices." Id. pts. 801, 820.

Next, we examine plaintiff's claims to determine whether their resolution would establish or perpetuate any requirements under the common law differing from or adding to the Act's requirements. The complaint states:

Prior to May 14, 1986 the defendant Medtronic Inc.... manufactured a certain device [known] as a pacemaker.

As a result of the negligence of the defendant, Medtronic Inc., in control, maintenance, inspection, testing, design, developing, servicing, distribution, alteration, modification, sale and/or manufacturing of said device, and as a result of the negligence of said defendant ... in placing said Medtronic pacemaker model # 5984LP in the stream of medical care and failing to give adequate and effective warning concerning the [foreseeable] dangers in the use of said device, the plaintiff ... was caused to be injured on March 10, 1992, by this defective pacemaker.

...

... [I]n supplying this said device the defendant contended [that] said pacemaker was of good and merchantable quality and that it was fit and safe for the normal use for which it was intended[.] ... [S]aid device was not of merchantable quality and was not fit for safe and normal use in that ... the defective pacemaker malfunctioned.

(Emphasis added.) The highlighted statements allege that plaintiff's particular pacemaker was negligently manufactured; the reference to the model number of the pacemaker is consistent with claims that the label carried inadequate warnings, and that the design of the device was defective. Plaintiff's complaint thus contains three types of claims, each sounding in negligence and breach of implied warranty: design defect, failure to warn, and manufacturing defect. The complaint contains no allegation regarding Medtronic's compliance with FDA regulations, and plaintiff has offered no evidence on that issue.

In her brief, plaintiff abandoned any claim of defective design.³  At oral argument, plaintiff contended that her allegations of Medtronic's negligence in "alter[ing]" and "modif[ying]" the device survived her abandonment of the design defect claims. According to plaintiff, these claims allege that Medtronic failed to obtain FDA approval prior to distributing the modified pacemaker model implanted in plaintiff. It is undisputed, however, that FDA cleared the pacemaker for marketing without approving the product design, finding it "substantially equivalent" to pre-MDA devices. See 42 Fed.Reg. 42,520, 42,525 (Aug. 23, 1977) (preamble to final rule) ("[A] determination of substantial equivalence ... relates to the fact that the product can lawfully be marketed without premarket approval or reclassification."); 21 C.F.R. Sec. 807.97 (a finding of substantial equivalence "does not in any way denote official approval of the device"). FDA regulations have never required that the pacemaker of the model implanted in plaintiff receive premarket approval. See 21 C.F.R. Sec. 870.3610(c). Moreover, plaintiff has not alleged that FDA's substantial equivalence finding was improper. Therefore, plaintiff's product line alteration and modification claims fall from this case. If the claims are design defect claims, they have been abandoned. And if the claims allege that FDA failed to grant the device premarket approval, they are meritless.

Plaintiff's abandonment of her design defect claims also forecloses our consideration of her argument that, in the absence of a requirement that the device receive premarket approval, her design defect claims are not preempted. The cases cited by plaintiff to support that argument are thus inapposite. See, e.g., Larsen v. Pacesetter Systems, 74 Haw. 1, 837 P.2d 1273, 1282 (1992) (design defect claims are not preempted where FDA never approved device design because device was found to be substantially equivalent to pre-MDA devices); see also Stamps, 984 F.2d at 1419, 1421-22 (discussing Moore v. Kimberly-Clark Corp., 867 F.2d 243, 246 (5th Cir. 1989) (design defect claims are not preempted by requirements applicable to tampons, which are Class II devices not subject to premarket approval)).

Plaintiff's only remaining common law claims, sounding in negligence and breach of warranty, are allegations of inadequate warnings and a manufacturing defect. In this connection, the MDA provides that a state requirement, if different from or in addition to an FDA requirement, is preempted only if it "relates to" the safety or effectiveness of the device or to any other requirement under the Act. 21 U.S.C. § 306k(a) (2). All of plaintiff's claims relate to the pacemaker's safety and effectiveness. See Stamps, 984 F.2d at 1422. Consequently, to complete our preemption analysis, we must determine whether plaintiff's negligence and implied warranty claims, if successful, would impose requirements on Medtronic's pacemaker "different from, or in addition to" those in the Act. 21 U.S.C. § 306k(a) (1).

The common law, no less than agency regulations and statutes, can impose "requirements" on a manufacturer. King v. Collagen Corp., 983 F.2d at 1135; see also 21 C.F.R. Sec. 808.1(b) (MDA preempts any state requirement "whether established by statute, ordinance, regulation, or court decision"). The tort and implied warranty theories of products liability are regulatory in that the " 'obligation to pay compensation can be ... a potent method of governing conduct and controlling policy.' " Cipollone, --- U.S. at ----, 112 S. Ct. at 2620 (quoting San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247, 79 S. Ct. 773, 780-81, 3 L. Ed. 2d 775 (1959)). Products liability "regulation" under the common law imposes requirements by case law precedent.

Comparing the requirements imposed by the Act with plaintiff's claims, we hold that her negligence and implied warranty claims premised on inadequate warnings are preempted. FDA regulates the content and appearance of prescription medical device labels, including pacemaker labels. 21 C.F.R. Secs. 801.1, 801.15, 801.109. These regulations, which were in effect when plaintiff's particular pacemaker was implanted, exempt such devices from the requirement that there be directions to a layperson on how to use the product safely, if the package describes, inter alia, "any relevant hazards, contraindications, side effects, and precautions" for the prescribing physician. Id. Sec. 801.109.

Plaintiff's implied warranty and negligent failure to warn claims are premised on the manufacturer's duty to disclose to a physician any latent, foreseeable dangers associated with the use of a prescription product. Knowlton v. Deseret Medical, Inc., 930 F.2d 116, 120 & n. 2 (1st Cir. 1991) (discussing Massachusetts law). Although this standard resembles the FDA requirement, the two may differ as applied. See Jones, 430 U.S. at 526, 97 S. Ct. at 1310 (in determining preemption issue, it is necessary "to consider the relationship between state and federal laws as they are interpreted and applied, not merely as they are written"). Applying Massachusetts law, a factfinder could find a label deficient that complies with FDA requirements. MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65, 70-71 (holding that "compliance with FDA requirements, though admissible to demonstrate lack of negligence, is not conclusive on this issue, just as violation of FDA requirements is evidence, but not conclusive evidence, of negligence"), cert. denied, 474 U.S. 920, 106 S. Ct. 250, 88 L. Ed. 2d 258 (1985). Such a finding would establish a standard for an adequate warning "in addition to" the requirements applicable under the Act.

Similarly, plaintiff's negligent manufacturing claim (including her allegations of negligent manufacturing, control, maintenance, inspection, testing, servicing, distribution, and sale of the device) is preempted by FDA regulations on good manufacturing practices. 21 C.F.R. Secs. 820.1-820.198. Medtronic's duty under the common law of negligence is to use reasonable care in inspecting, testing, and producing pacemakers. This standard and FDA's good manufacturing practices impose analogous, but not identical duties. FDA's good manufacturing practices regulations require manufacturers to develop and implement "appropriate," "adequate," or "sufficient" quality control, quality assurance, personnel training, environmental controls, equipment maintenance, testing, inspection, and storage and distribution procedures, to assure that devices are safe and effective. See, e.g., id. Secs. 820.1, 820.5, 820.20, 820.25. The quality assurance requirement, for example, mandates that manufacturers devise and implement a protocol to ensure, among other things, that all components, labels, packaging, and finished devices are inspected, and either approved or rejected. Id. Sec. 820.20(a). A factfinder could find liability on plaintiff's negligent manufacturing claims, applying standards differing from or adding to FDA's.

Plaintiff's implied warranty claim is also preempted by FDA's good manufacturing practices. A factfinder considering that claim could find Medtronic liable if a manufacturing defect rendered plaintiff's pacemaker unreasonably dangerous. See Mass.Gen.L. ch. 106, Sec. 2-314; Colter v. Barber-Greene Co., 403 Mass. 50, 525 N.E.2d 1305, 1313 (1988) (noting that Massachusetts law on implied warranty is "congruent, in all material respects, with the principles expressed in Restatement (Second) of Torts Sec. 402A (1965), the Restatement's definition of a seller's strict liability for harm suffered by a user or consumer of a seller's product"). This means that under Massachusetts law Medtronic could be found liable even if it meticulously followed FDA's good manufacturing practices. For these reasons, plaintiff's breach of implied warranty claim is preempted.⁴ 

Plaintiff argues that her claims are not preempted because she is alleging that her particular device is defective. This claim, according to plaintiff, is analogous to a claim that the device is contaminated. She argues that her claims are not preempted because King v. Collagen Corp., 983 F.2d at 1134-35, excised claims arising from contaminated devices from the body of claims preempted by the MDA.

Plaintiff's argument is based on a misunderstanding of our remarks in King v. Collagen Corp., 983 F.2d at 1134-35. We stated:

The language of [the MDA preemption clause] ... demonstrate[s] a field of preemption which is broad, but limited. Any state requirement which, in effect, establishes a new substantive requirement for the device in a regulated area such as labeling, is preempted. 21 C.F.R. Sec. 808.1(d) (6) (ii). As the Seventh Circuit noted, however, [the clause] does not preempt such claims as negligent implantation or removal of devices, or claims arising out of contaminated devices.

Id. (emphasis added) (citing Slater v. Optical Radiation Corp., 961 F.2d at 1334).

The sentence regarding contaminated devices follows our statement that "[a]ny state requirement which, in effect, establishes a new substantive requirement for the device in a regulated area such as labeling, is preempted." Plaintiff's claims in this case, if successful, would establish requirements in areas that FDA already regulates, i.e., labeling and manufacturing. Accordingly, this is not a case where plaintiff may maintain a claim arising out of an individually defective device. We need not address in this case which, if any, "claims arising out of contaminated devices" might not be preempted.

We express no opinion on whether products liability claims are preempted only if the manufacturer complied with applicable FDA regulations. See Reiter v. Zimmer, 830 F. Supp. 199, 204 (S.D.N.Y. 1993) (refusing to extend preemptive reach of MDA to negligence claim against manufacturer that allegedly violated FDA requirements); see also Slater, 961 F.2d at 1334 (scope of preemption under MDA "is limited to efforts by states to impose sanctions for compliance with federal regulations"). The complaint contains no allegations regarding Medtronic's noncompliance with FDA regulations, and plaintiff has offered no evidence that Medtronic violated any FDA requirement. Our holding is limited to the facts and claims in this case.

For the foregoing reasons, the order granting summary judgment for defendant is

Affirmed.