Lisa GOODLIN, Plaintiff--Appellant, v. MEDTRONIC, INC., Defendant--Appellee.
No. 97-5801.
United States Court of Appeals, Eleventh Circuit.
Feb. 18, 1999.
167 F.3d 1367
Alvin Bruce Davis, Michelle A. Fongyee, Frank R. Jimenez, Steel, Hector & Davis, Miami, FL, for Defendant-Appellee.
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),
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.
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
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.
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 than the 510k process ($50 to $2,000 per device). See Lohr v. Medtronic, Inc., 56 F.3d 1335, 1345 n. 14 (11th Cir. 1995) (citation omitted), aff‘d in part & rev‘d in part, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). 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:
(a) General rule
Except as provided in subsection (b) of this section,6 no 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 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 this chapter.
Nevertheless, the Lohr Court instructed that two broad “presumptions about the nature of pre-emption” inform the interpretation of section 360k(a). Lohr, 518 U.S. at 485, 116 S.Ct. at 2250. First, the Court explained that deference to state sovereignty, particularly in fields that the state governments traditionally have occupied, requires an assumption that Congress will not supersede “the historic police powers” of the states by federal statute without making that purpose “clear and manifest.” Id., 116 S.Ct. at 2250 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). Second, the Court
In considering whether the MDA accords a federal obligation preemptive effect, the Lohr Court read section 360k(a) to demand three things: (1) the imposition of a specific federal requirement that (2) applied to a particular device and (3) focused on the safety and effectiveness of the device. The Court held that the 510k process did not satisfy the preemption provision, in large part, because the FDA’s review addressed substantial equivalence rather than safety and effectiveness. Id. at 492-94, 116 S.Ct. at 2254-55. The PMA process at issue in the case before us addresses safety and effectiveness; indeed, the entire purpose of the PMA process is for the FDA to obtain a “reasonable assurance” that the device is safe and effective. See
In addressing the federal requirement condition of section 360k(a)(1), the Lohr Court sought guidance from an FDA regulation interpreting the preemption provision. The Court noted that the language of section 360k(a) was unclear and that Congress expressly had given the FDA authority to assess the preemptive effect of its own requirements on state laws. Id. at 495-96, 116 S.Ct. at 2255-56 (relying on
State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements.
Considered together, section 360k(a)(1) grants preemptive effect to any federal “requirement applicable under this chapter to the device,” and the FDA regulation reads that language to include only “specific counterpart regulations” or “specific requirements” that apply to “a particular device.”
We address each argument in turn.
A. PMA Approval
In this court’s own review of Lohr, before the Supreme Court considered the case, we voiced substantial doubt that the FDA’s 510k approval process, which permits a successful applicant to market its device, imposed a specific requirement upon the device. See Lohr v. Medtronic, Inc., 56 F.3d 1335 (11th Cir. 1995), aff‘d in part & rev‘d in part, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The majority of our discussion in support of our decision to deny the 510k process preemptive effect addressed our primary concern that the process confines the FDA’s consideration to substantial equivalence rather than safety and effectiveness. Id. at 1348-49. Nevertheless, we also expressed reservations about whether any finding pursuant to the 510k process would constitute a specific federal requirement,9 and we made those misgivings part of our decision by holding that the FDA’s 510k approval, standing alone, “does not impose specific requirements on a device for preemption purposes.” Id. at 1349.10
Similarly, when the Supreme Court considered the preemptive effect of a device’s progress through the 510k process, the Court focused its attention on the scope and focus of the 510k inquiry, which are limited to substantial equivalence rather than safety and effectiveness. See Lohr, 518 U.S. at 492-94, 116 S.Ct. at 2254-55. The Court’s opinion,11 however, also refers to the panel’s concern that the 510k process “imposes no ‘requirement’ on the design of the pacemaker” and the panel’s conclusion that “the requirements with which the company had to comply [as a consequence of 510k review] were not sufficiently concrete to constitute a pre-empting federal requirement.” Id. at 492, 116 S.Ct. at 2254. Moreover, the Court’s analysis of the 510k process explains that the FDA’s finding of substantial equivalence “did not ‘require’ Medtronics’ pacemaker to take any particular form for any particular reason.” Id. at 493, 116 S.Ct. at 2254 (emphases added). Finally, the partial dissenters, who would have found preemption elsewhere in the case far more readily than the majority, concurred in this part of the opinion and rejected preemption as a consequence of surviving the 510k process for both reasons: “Because the § 510(k) process seeks merely to establish whether a pre-1976 device and a post-1976 device are equivalent, and places no ‘requirements’ on a device, the Lohrs’ defective design claim is not pre-empted.”12 Id. at 513, 116 S.Ct. at 2264
Accordingly, although the Lohr case had little to do with the PMA process, which differs in significant ways from the 510k process at issue there, at least eight, and probably all nine, of the otherwise divided Justices expressed reservations as to whether the FDA’s 510k review process and approval, standing alone, imposed any “requirement” on a device. See Worthy v. Collagen Corp., 967 S.W.2d 360, 369-70 (Tex.), cert. denied, --- U.S. ---, 118 S.Ct. 2372, 141 L.Ed.2d 740 (1998) (explaining that the Supreme Court’s decision that the 510k process was “too general to have preemptive effect” was unanimous). As noted above, because the PMA process before us focuses on safety and effectiveness, we must examine these misgivings further to determine whether the FDA’s PMA process, which produces a finding that the manufacturer has provided the reasonable assurances of safety and effectiveness necessary to market the device, translates into the necessary imposition of a “specific requirement.”
Our initial concern with this question is a conceptual one. Absent a more specific statutory definition, we must accord the language at issue its ordinary meaning. See, e.g., Park ‘N Fly, Inc. v. Dollar Park & Fly, Inc., 469 U.S. 189, 194, 105 S.Ct. 658, 661, 83 L.Ed.2d 582 (1985) (“Statutory construction must begin with the language employed by Congress and the assumption that the ordinary meaning of that language accurately expresses the legislative purpose.”). We also may consider Congress’s use of a particular term elsewhere in the statute to determine its proper meaning within the context of the statutory scheme. See, e.g., Estate of Cowart v. Nicklos Drilling Co., 505 U.S. 469, 479, 112 S.Ct. 2589, 2596, 120 L.Ed.2d 379 (1992). In ordinary usage, a requirement refers to “something that is wanted or needed” or “something called for or demanded: a requisite or essential condition.” Webster’s Third New Int’l Dictionary 1929 (1986) (emphases added). Similarly, within section 360k, Congress referred to a requirement as something a state or political subdivision could “establish,” which appears to contemplate the state’s creation of and, thus, identification of some thing.
Medtronic seeks to convert the FDA’s finding and the accompanying permission to market its device into the federal govern
B. The FDA’s Conditions of Approval
Medtronic also points to the “Conditions of Approval” that accompanied the FDA’s approval of the PMA application for the 4004/M lead, as well as the agency’s demand that Medtronic make no changes to the device without first seeking FDA approval, as possible sources for a preempting federal requirement. Although we agree that these conditions constitute specific federal requirements, as discussed in Part II(A) above, we are not convinced that these requirements satisfy section 360k(a)(1)’s further admonition that a preempting requirement be “applicable under this chapter to the device.”
The MDA permits the FDA to impose similar conditions on devices it approves pursuant to the 510k process. See, e.g.,
More significantly, the Lohr Court construed section 360k(a)(1)’s description of a federal requirement “applicable under this chapter to the device” as an instruction to limit preemption to device-specific requirements. To interpret the relevant language, the Court again relied on the FDA’s interpreting regulation, which reads section 360k(a)(1) to demand a specific federal re
Analogously, the restrictions Medtronic proffers in this case are entirely general in nature, and the FDA has not promulgated them with respect to the “particular device” before us, the 4004/M, or even with respect to the class of specific devices at issue, pacemaker leads. The “Conditions of Approval” document enclosed with the letter that noted the FDA’s approval of the 4004/M PMA application sets forth rules and regulations generally applicable to all devices approved through the PMA process. For example, the “Conditions of Approval” remind Medtronic of its obligation to provide post-approval reports, to refrain from changing the device without FDA approval, and to report adverse reactions and device defects.17 The document, dated almost two years before Medtronic submitted its supplemental PMA application, is cast in the most generic of terms and mentions neither the 4004/M nor even pacemaker leads as a class of devices.18 As the Supreme Court explained:
[T]he federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements.
Lohr, 518 U.S. at 501, 116 S.Ct. at 2258. We do not believe that requirements applicable to all devices that receive the FDA’s approval via the PMA process satisfy the Court’s demand for a specific requirement that applies to a particular device. See Kennedy v. Collagen Corp., 67 F.3d 1453, 1458-59 (9th Cir. 1995) (pre-Lohr case expressing doubt that Class III devices collectively constitute a “particular device” within the meaning of section 360k(a)(1) and the FDA’s interpreting regulation), overruled in part on other grounds by Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700.
C. The “Ultimate Touchstone” of Congressional Intent
We recognize that our conclusions on these questions, although not without precedent,19 are at odds with the results reached in a number of cases both before and after the Supreme Court’s decision in Lohr. See Mitchell v. Collagen Corp., 126 F.3d 902, 911 & n. 2 (7th Cir. 1997) (finding that PMA approval constitutes a specific federal requirement and examining cases both in support and to the contrary); Worthy, 967 S.W.2d at 372-74 (surveying cases before and after Lohr). Nevertheless, we remain convinced that our conceptual difficulty with Medtronic’s attempts to divine a specific federal requirement from the FDA’s approval of its PMA application reflects the real difference between the questions at stake during the PMA process and the discrete issues presented in a product liability suit.20 The
Neither the MDA itself nor the FDA’s interpretive regulations directly addresses the question of liability arising in connection with defective medical devices. Instead, the preamble to the MDA states that the amendments are for the purpose of “provid[ing] for the safety and effectiveness of medical devices intended for human use.” Pub.L. No. 94-295, 90 Stat. 539, 539 (1976) (preamble). Similarly, the legislative history of the MDA fails to address issues of liability for defective devices. See Lohr, 518 U.S. at 491, 116 S.Ct. at 2253 (plurality opinion). Instead, the legislative history recounts the difficulty the FDA experienced in its earlier attempts to keep dangerous medical devices out of the marketplace. See S.Rep. No. 94-33 at 2-7 (1976), reprinted in 1976 U.S.C.C.A.N. 1070, 1071-76. This attention to the regulation of medical devices before they reach the marketplace is consistent with the events that prompted Congress to consider the MDA. As the Supreme Court observed in Lohr, several highly publicized incidents involving defective medical devices, particularly the Dalkon Shield intrauterine device, gave rise to Congress’s legislation in this area. See Lohr, 518 U.S. at 475-77, 116 S.Ct. at 2246. It would have been inconsistent for the same Congress that enacted these sweeping reforms, intending to make a potentially dangerous industry safer for patients by blocking the admission of defective devices to the market, then to preempt product liability suits when those devices caused injury. Moreover, we find no support for Medtronic’s assertions that a concern for preserving innovation prompted Congress even to consider, let alone enact, preemption of tort liability in all cases involving devices that survived the PMA process. Id. at 490-91, 116 S.Ct. at 2253 (plurality opinion). Instead it appears that the members of Congress who sought to foster continued innovation in the field focused their efforts on reducing the regulatory burden that manufacturers would have to bear before they could market their products. Id.; 116 S.Ct. at 2253 (plurality opinion). Again, these efforts are consistent with our observation that Congress intended to regulate medical devices before they reached consumers, rather than address their consequences once on the market.
Other provisions of the statutory scheme also indicate that Congress expected some state tort liability to survive the MDA. For example, the statute contains a savings clause that specifically addresses the MDA’s effect on other liabilities arising from defective medical devices: “Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law.”
Finally, and as the Lohr plurality observed, the MDA provides no federal means by which injured plaintiffs can pursue legal remedies against the manufacturers of defective medical devices. See Lohr, 518 U.S. at 487, 116 S.Ct. at 2251 (plurality opinion) (“[T]here is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action....”). Reading the PMA process to impose specific federal requirements that enjoy preemptive effect under section 360k, therefore, would deprive all persons suffering injury as a result of a defective device—the very class of persons that Congress intended to protect by enacting the MDA—of “most, if not all relief.” Id. at 487, 116 S.Ct. at 2251 (plurality opinion). The Supreme Court considered an analogous situation in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984). In that case, Congress had enacted the Atomic Energy Act (the “AEA”) “to prohibit the States from regulating the safety aspects of nuclear development,” on the premise that the federal government’s commission was more qualified to define the safety standards that should control the industry. Id. at 250, 104 S.Ct. at 622. To support its conclusion that the statute did not preempt state tort remedies and punitive damage awards against the nuclear power industry, the Court observed that Congress had provided no indication that it even had considered preempting state tort law liability. Id. at 251, 104 S.Ct. at 623. Moreover, the Court refused to attribute any intent to preempt state tort claims after observing that preemption would leave the public—the target of Congress’s safety concerns—without a remedy, because Congress had not enacted a federal private cause of action for injured plaintiffs: “It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct.” Id., 104 S.Ct. at 623, quoted in Lohr, 518 U.S. at 487, 116 S.Ct. at 2251 (plurality opinion). We too are reluctant to conclude that Congress sought to remove all remedies available to the very class of persons that it sought to protect when it enacted the MDA.
In its attempts to discern Congress’s intentions regarding the preemption of tort liability, the Silkwood Court also looked to Congress’s subsequent legislation in the field. The Court observed that Congress had passed the Price-Anderson Act to provide a federal indemnification regime to encourage private companies to enter the nuclear power industry despite the risk of significant state tort liability. See Silkwood, 464 U.S. at 251, 104 S.Ct. at 623. Although the indemnification provisions had no application to the case at hand, the Court explained that their very existence demonstrated that Congress never intended to preempt state tort remedies when it passed the AEA. Id. at 251-56, 104 S.Ct. at 623-25. We find similar evidence of Congress’s intent with regard to the MDA in its 1994 attempt, albeit failed, to enact the Product Liability Fairness Act (“PLFA”).
These factors indicate beyond any doubt that, at least with respect to the FDA’s PMA authority, Congress was deeply concerned with assuring the minimal safety of medical devices that enter the marketplace but gave no appreciable thought to the effect such regulation should have on any liability that might result from the sale and use of such medical devices. As a result, the PMA process is proactive rather than reactive; it concerns the manufacturers’ ability to market minimally safe devices but makes no attempt to announce substantive safety standards that might determine the outcome of a product liability suit. See S.Rep. No. 94-33 at 2 (1976), reprinted in 1976 U.S.C.C.A.N. 1070, 1071 (“Medical device legislation is intended to assure that medical devices ... meet the requirements of safety and effectiveness before they are put in widespread use throughout the United States.”)(emphasis added). This view of the statutory scheme and the purposes behind the MDA is in harmony with our reading of section 360k(a)(1)’s limitation on the type of specific federal requirements to which Congress intended to grant preemptive effect and with our conceptual objection to conjuring such specific federal requirements from the FDA’s approval of particular devices.
Nevertheless, we can conceive of a situation in which Congress may have intended to establish an exemption from state tort liability as a trade-off for imposing the PMA system upon new medical devices. Congress would have been aware of such litigation given the backdrop of high profile cases involving defective medical devices, and that experience could have led Congress to substitute regulation for litigation by preempting all claims involving devices that received PMA approval. Indeed, Congress recently attempted an ambitious, but more limited, attempt to make such a trade-off by enacting the proposed Universal Tobacco Settlement Act and thereby bring a negotiated resolution to years of tobacco litigation. See S. 1415, 105th Cong. (May 14, 1998). Congress’s controversial and ultimately unsuccessful experience with this particular attempt to provide even limited immunity from suits arising under state product liability laws, however, only bolsters our conviction that the 1976 Congress contemplated no such consequences under the MDA.22 It is difficult
Finally, we are loath to infer a tacit trade-off between regulation and liability when it appears that even the regulated industry was unaware of the purported bargain until relatively late in the day. Our research reveals that the first reported decisions on the industry’s attempts to assert federal preemption of state product liability claims for devices subject to the FDA’s approval regimes did not appear until 1991, fifteen years after Congress passed the MDA. See Slater v. Optical Radiation Corp., 756 F.Supp. 370 (N.D. Ill. 1991), aff‘d, 961 F.2d 1330, 1331 (7th Cir. 1992) (recognizing that the preemptive effect of an FDA issued IDE presented a matter of first impression at the appellate level). We recognize that the costs and delays associated with the PMA process have led the industry to avoid it when possible. See Lohr, 518 U.S. at 479, 116 S.Ct. at 2248 (noting that in 1990 eighty percent of new medical devices had entered the market without undergoing PMA review). Even so, it seems unlikely that the industry would have ignored its immunity under the MDA for so long after the statute’s enactment if Congress, in fact, had intended to provide immunity in 1976.
Just beneath the surface of Medtronic’s arguments in support of preemption lies a relatively appealing policy argument in favor of immunity for devices that receive the FDA’s most extensive review and approval. It seems presumptuous, to say the least, to permit a jury composed of ordinary citizens, none of whom we can expect to have significant medical training, to second-guess a decision, already extensively and rigorously considered by some of the most qualified minds in the relevant medical and scientific fields, regarding the rather complicated question of the safety of a particular medical device. As Medtronic described the PMA process for the 4004/M lead, a number of government and independent experts, as well as Medtronic’s own scientists, examined, over several years, the performance of the Pellethane 80-A polyurethane insulating material at issue in Goodlin’s complaint and came to the conclusion that Medtronic had reasonably assured its safety. Goodlin’s complaint, however, demands that a jury—a much less scientifically qualified body—decide whether the 4004/M lead was unreasonably dangerous because it used the Pellethane 80-A insulating material and, if so, to award damages.
No matter how compelling we might find Medtronic’s policy objections as citizens, as judges, bound to apply the law rather than create it, we may not act on those objections here. The jury system, although imperfect, is the method by which we resolve an ever increasing number of disputes, many of which might more appropriately be resolved by experts. We cannot accept that Congress intended to exempt the manufacturers of medical devices from tort liability for all devices subject to the PMA process on the scant evidence presented here. We also read the Supreme Court’s most recent admonition that “[t]he purpose of Congress is the ultimate touchstone in every pre-emption case,” Lohr, 518 U.S. at 485, 116 S.Ct. at 2250 (internal quotation omitted), and the Court’s instruction that deference to state sovereignty requires us to assume that Congress does not preempt the states’ “historic police powers” without making its purpose “clear and manifest,” id., 116 S.Ct. at 2250 (internal quotation and citations omitted), as unmistakable directions that lead us to today’s decision. Accordingly, we may not bend the language of section 360k(a)(1) to permit the manufacturers of medical devices to infer from the FDA’s approval of a PMA application specific federal requirements that remain unstated and unascertainable until an injured consumer brings a lawsuit alleging a defect.
Our decision does not mean that Medtronic’s efforts to provide the FDA with reasonable assurances regarding the 4004/M lead’s safety and effectiveness have no bearing on the question of its liability on Goodlin’s claims. To the contrary, to prevail at trial, Goodlin must show either that Medtronic designed the lead negligently or that the lead
CONCLUSION
We conclude that the FDA’s approval of a medical device pursuant to the PMA process, standing alone, imposes no specific federal requirement applicable to a particular device and, therefore, has no preemptive effect under section 360k(a) of the MDA. Accordingly, we REVERSE the district court’s entry of summary judgment in Medtronic’s favor and REMAND the case for further proceedings consistent with this opinion.