Goodlin v. Medtronic, Inc., 97-5801

Citation167 F.3d 1367
Decision Date18 February 1999
Docket NumberNo. 97-5801,97-5801
Parties12 Fla. L. Weekly Fed. C 497 Lisa GOODLIN, Plaintiff-Appellant, v. MEDTRONIC, INC., Defendant-Appellee.
CourtUnited States Courts of Appeals. United States Court of Appeals (11th Circuit)

Daniel C. Shaughnessy, Cowles & Shaugnessy, P.A., Jacksonville, FL, Kenneth M. Suggs, Suggs & Kelly, Lawyers, P.A., Columbia, SC, Allison M. Zieve, Public Citizen Litigation Group, Washington, DC, for Plaintiff-Appellant.

Alvin Bruce Davis, Michelle A. Fongyee, Frank R. Jimenez, Steel, Hector & Davis, Miami, FL, for Defendant-Appellee.

Appeal from the United States District Court for the Southern District of Florida.

Before TJOFLAT and EDMONDSON, Circuit Judges, and KRAVITCH, Senior Circuit Judge.

KRAVITCH, Senior Circuit Judge:

This appeal requires us to determine the preemptive effect of the Medical Device Amendments ("MDA"), 21 U.S.C. § 360c et seq., to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. Lisa Goodlin brought suit against Medtronic, Inc. ("Medtronic"), alleging that her Medtronic cardiac pacemaker lead was defective in a way that gave rise to two causes of action under Florida common law. Medtronic argues that because the United States Food and Drug Administration (the "FDA") approved the device pursuant to the MDA's premarket approval process, section 360k(a) of the MDA preempts Goodlin's state law claims. The district court agreed and granted summary judgment to Medtronic. We reverse.

BACKGROUND

In January 1991, Goodlin received a Medtronic pacemaker and its related components, including Medtronic's 4004/M lead. The pacemaker lead is a wire that transmits the heartbeat-steadying electrical impulse from the pulse generator to the heart. Goodlin depends on the pacemaker to support her life.

The FDA approved Medtronic's 4004/M lead for use in the United States on February 10, 1989. Sometime after Goodlin received her pacemaker, however, an FDA inspection revealed a significant risk that the 4004/M lead would fail due to degradation of the lead's polyurethane insulating material.

The FDA, therefore, instructed Medtronic to issue a Health Safety Alert letter to inform physicians about the risk of defect in the lead. The letter advised physicians to consider prophylactic replacement for pacemaker dependent patients and advised them to replace the lead if the risk of its continued use outweighed the risks associated with its replacement. Upon the advice of her physician, Goodlin underwent open-heart surgery to replace the lead. The lead that the surgeons removed from Goodlin showed no signs of failure.

Goodlin brought suit against Medtronic in 1997. Her amended complaint asserts claims for negligent design and strict product liability, both of which arise under Florida common law. Medtronic moved for summary judgment on the basis of federal preemption, arguing that section 360k(a) of the MDA expressly preempted Goodlin's claims. The district court found that because the FDA had reviewed and approved the safety and effectiveness of the 4004/M device pursuant to its premarket approval process, the MDA preempted Goodlin's claims. The court, therefore, entered summary judgment in Medtronic's favor. We review the district court's decision to grant summary judgment on the issue of preemption de novo and apply the same standards that bound the district court. See Lewis v. Brunswick Corp., 107 F.3d 1494, 1498 (11th Cir.), cert. granted, --- U.S. ----, 118 S.Ct. 439, 139 L.Ed.2d 337 (1997), cert. dismissed, --- U.S. ----, 118 S.Ct. 1793, 140 L.Ed.2d 933 (1998).

DISCUSSION
I. Regulatory Overview

Despite the historical prominence of the states in matters concerning the health and safety of their citizens, the federal government has expanded its role in this field over the past century. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 475, 116 S.Ct. 2240, 2245-56, 135 L.Ed.2d 700 (1996) (providing a survey of the federal government's legislation in this area). In the 1970s, against the backdrop of several highly publicized events involving defective medical devices, including the tragedies connected to the Dalkon Shield intrauterine device, Congress turned its attention to the regulation of medical devices. Id. at 476, 116 S.Ct. at 2246. In 1976, Congress passed the MDA, the statute at issue here, which categorizes medical devices according to the risk they pose to the public. The MDA classifies devices that either "present a potential unreasonable risk of illness or injury" or that are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" as Class III devices. Id. at 477, 116 S.Ct. at 2246 (quoting 21 U.S.C. § 360c(a)(1)(C))(internal quotation omitted). Pacemakers, such as the one at issue here, are Class III devices. See 21 C.F.R. § 870.3610(b).

A. The Premarket Approval Process

Before a manufacturer can introduce a new Class III medical device into the marketplace, the manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective. 21 U.S.C. § 360c(a)(1)(C). Manufacturers may furnish this assurance through the FDA's premarket approval process, commonly referred to as the "PMA" process. 1 As the Supreme Court observed in Lohr, and as Medtronic has reminded us in its briefs, the PMA process is rigorous because it permits the FDA to demand the submission of detailed information

                regarding the safety and effectiveness of the device under review. 2  See 21 U.S.C. § 360e(c)(1) (describing the required contents of a PMA application).  The FDA then spends substantial time and resources reviewing these applications;  indeed, the average submission requires 1,200 hours of review.  See Lohr, 518 U.S. at 477, 116 S.Ct. at 2246-47.   Ordinarily, the FDA refers the device to an independent panel of experts, which prepares a report and recommendation on whether to approve the device.  See 21 U.S.C. § 360e(c)(2).  The FDA may also advise an applicant of deficiencies in the PMA application and notify the applicant of any measures necessary to put the application in approvable form.  Id. § 360e(d)(2).  Once the FDA determines that the manufacturer has provided the required reasonable assurances, the agency issues an order that permits the manufacturer to market the device, exactly as approved.  Thereafter, the manufacturer may not change the approved labeling, product design, or manufacturing process in any way that would affect the safety or effectiveness of the device.  See 21 C.F.R. § 814.80.  The FDA may withdraw its marketing approval if the manufacturer makes any such changes without prior approval.  See 21 U.S.C. § 360e(e)(1);  21 C.F.R. § 814.46(a)(2). 3
                
B. The PMA Process for the 4004/M Lead

The PMA process preceding the FDA's approval of Medtronic's 4004/M pacemaker lead was an extensive one. In 1982, the FDA approved Medtronic's application for an IDE to conduct clinical tests on a predecessor lead, the Model 4003 lead; Medtronic submitted the results of those trials to the FDA when it filed a PMA application for the Model 4003. During that process, the FDA asked Medtronic to submit information that addressed the effect of long-term degradation of the insulating materials on the Model 4003 lead. In February 1984, Medtronic responded with studies and reports that revealed that some of the leads experienced environmental stress cracking failures but supported Medtronic's view that Pellethane 80-A polyurethane, the Model 4003 lead's insulating material, was biostable and suitable for long-term implants. The FDA requested still further tests involving the performance of similar leads with identical insulation materials and referred the Model 4003 application to an outside panel of experts, which concluded that Medtronic had provided the requisite reasonable assurances of safety and effectiveness. The FDA approved the Model 4003 PMA application on July 29, 1986.

On July 15, 1988, Medtronic filed a PMA application for the 4004/M as a supplement to the Model 4003 PMA application. The supplemental PMA application relied on the information that Medtronic already had submitted to the FDA and identified the lead's insulating material as Pellethane 80-A. The supplemental PMA application also described Medtronic's research and testing on environmental stress cracking and metal-induced oxidation, both known as potential causes of defects in leads that used polyurethane insulating material. On February 10, 1989, the FDA approved the supplemental application for the 4004/M with an order that included a list of "Conditions of Approval." Medtronic now seeks to use the FDA's approval to preempt Goodlin's claims concerning the 4004/M lead.

II. Preemption Under the MDA

By virtue of the Constitution's Supremacy Clause, 4 it long has been settled that "state The MDA contains an express provision that governs the extent to which the federal statute preempts state law:

                law that conflicts with federal law is 'without effect.' "  Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992) (quoting Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 2128, 68 L.Ed.2d 576 (1981) and citing M'Culloch v. Maryland, 17 U.S.  (4 Wheat.) 316, 427, 4 L.Ed. 579 (1819)).  A federal statute may preempt state law either expressly, by the statute's language, or implicitly, by the statute's structure and purpose.  Id., 112 S.Ct. at 2617.   In the absence of an express command, federal law will preempt state law if that law actually conflicts with federal law or if the federal law "so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it."  Id., 112 S.Ct. at 2617 (internal quotations and citations omitted). 5
                

(a) General rule

Except as provided in subsection (b) of this section, 6 no State or political subdivision of a State may...

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