Mendes v. Medtronic, Inc., 93-1911

Citation18 F.3d 13
Decision Date04 January 1994
Docket NumberNo. 93-1911,93-1911
Parties, Prod.Liab.Rep.(CCH)P. 13,817 Ellen MENDES, Plaintiff, Appellant, v. MEDTRONIC, INC., Defendant, Appellee. . Heard
CourtUnited States Courts of Appeals. United States Court of Appeals (1st Circuit)

John P. LeGrand, with whom Thomas F. Walsh and John P. LeGrand & Associates, P.C., Boston, MA, were on brief for appellant.

Richard H. Bakalor, with whom Quirk & Bakalor, P.C., New York City, Michael W. Gallagher, Andrea Saunders Barisano, Donahue & Donahue, Lowell, MA, Dan Jarcho and McKenna & Cuneo, Washington, DC, were on brief for appellee.

Before SELYA, Circuit Judge, BOWNES, Senior Circuit Judge, and CYR, Circuit Judge.

BOWNES, Senior Circuit Judge.

In this products liability action against the manufacturer of an allegedly defective pacemaker, plaintiff-appellant, Ellen Mendes, appeals from an order granting summary judgment in favor of defendant-appellee, Medtronic, Inc. The district court entered summary judgment for Medtronic, ruling that the express preemption clause of the Medical Device Amendments (MDA) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Sec. 360k(a), preempted plaintiff's Massachusetts common law claims. 1 We affirm.


Congress enacted the MDA to give the Food and Drug Administration (FDA) comprehensive control over medical devices for the first time. Slater v. Optical Radiation Corp., 961 F.2d 1330, 1331 (7th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 327, 121 L.Ed.2d 246 (1992). The MDA reflects Congress's balancing the need for regulation to protect public health against its interest in allowing new and improved devices to be marketed expeditiously without the costs attributable to an excess of regulation. King v. Collagen Corp., 983 F.2d 1130, 1138-39 (1st Cir.) (Aldrich, J., concurring), cert. denied, --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993).

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. Sec. 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. Secs. 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 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.

. 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.

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. Sec. 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.


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. Sec. 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. Sec. 360k(a). This analysis determines whether plaintiff's claims...

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