Goodlin v. Medtronic, Inc.

PUBLISH
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
_______________________
No. 97-5801 FILED
_______________________
U.S. COURT OF APPEALS
D. C. Docket No. 97-6133-CIV ELEVENTH CIRCUIT
02/18/99
THOMAS K. KAHN
CLERK
LISA GOODLIN,
Plaintiff-Appellant,
versus
MEDTRONIC, INC.,
Defendant-Appellee.
_________________________
Appeal from the United States District Court
for the Southern District of Florida
_________________________
(February 18, 1999)
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. § 301et 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
2
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 (1997), cert. dismissed,
__ U.S. __, 118 S. Ct. 1739 (1998).
DISCUSSION
3
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 (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
4
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. §
1The MDA permits manufacturers to avoid the PMA process by
obtaining approval for devices introduced to the market before
May 28, 1976, when the MDA took effect. See 21 U.S.C. §
360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1). A manufacturer may also
seek approval of a new device by showing that the new device is
the “substantial equivalent” of such a grandfathered device. See
21 U.S.C. § 360e(b)(1)(B)(ii). The FDA's review for substantial
equivalence, dubbed the “510k process” in reference to its
section number in the original Act, is limited in scope. Instead
of the extensive inquiry into safety and effectiveness
contemplated in the PMA process, the FDA completes the average
510k review within 20 hours, and the agency considers only
whether the device is indeed the equivalent of a preexisting
device—regardless of how unsafe or ineffective the grandfathered
device happens to be. See generally Lohr, 518 U.S. at 478-80,
116 S. Ct. at 2247-48 (comparing these two processes). Not
surprisingly, the PMA process represents a much more significant
financial barrier to the market ($111,000 to $828,000 per device)
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 (1996).
2
The FDA also regulates the testing of these devices by
requiring manufacturers to apply for an Investigational Device
Exemption (“IDE”). The application for an IDE is itself fairly
extensive, and the FDA will not approve an IDE if there is reason
5
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
to believe the device will be ineffective or present unreasonable
safety risks to patients. See 21 C.F.R. § 812.30(b)(4).
3
For a detailed description of the PMA process, see Worthy
v. Collagen Corp., 967 S.W.2d 360, 363-64 (Tex.), cert. denied,
__ U.S. __, 118 S.Ct. 2372 (1998).
6
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
7
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 law that conflicts with federal law is
'without effect.'” Cipollone v. Liggett Group, Inc., 505 U.S. 504,
516, 112 S. Ct. 2608, 2617 (1992) (quoting Maryland v. Louisiana,
451 U.S. 725, 746, 101 S. Ct. 2114, 2128 (1981) and citing
M'Culloch v. Maryland, 17 U.S. (4 Wheat.) 316, 427 (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
4
The Supremacy Clause provides that: “the Laws of the
United States . . . shall be the supreme Law of the Land.” U.S.
Const., art. VI, cl. 2.
8
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
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.
21 U.S.C. § 360k(a). The Supreme Court attempted to elucidate the
extent to which section 360k(a) preempts product liability suits
arising under state law in Medtronic, Inc. v. Lohr, 518 U.S. 470,
116 S. Ct. 2240 (1996), which involved a different allegedly
defective Medtronic pacemaker lead. Despite the striking
superficial similarity of the cases, the Supreme Court's
5
This latter form falls under the general heading of
implied preemption. See generally Irving v. Mazda Motor Corp.,
136 F.3d 764 (11th Cir.), cert. denied, __ U.S. __, 119 S. Ct.
544 (1998) (describing and applying the different forms of
preemption). Although Medtronic has raised an implied preemption
argument, we find it to be without merit.
6
Subsection (b) provides a means for a state or political
subdivision thereof to apply for an exemption to preemption when
compelling local conditions require a more stringent requirement.
See 21 U.S.C. § 360k(b).
9
disposition of Lohr provides little more than a rudimentary
analytical framework to guide our resolution of Medtronic's
preemption claims in this case because Lohr involved the 510k
process rather than the PMA process, and because the Court
fractured in an all but irreconcilable manner over the extent to
which section 360k(a) would ever preempt a general state common law
tort claim. See Mitchell v. Collagen Corp., 126 F.3d 902, 910 (7th
Cir. 1997), cert. denied, __ U.S. __, 118 S. Ct. 1300 (1998).7
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
7
The Lohr Court split 4-4 over whether a jury's imposition
of liability in a product liability suit pursuant to state common
law tort duties would ever amount to a conflicting state
requirement subject to federal preemption. Justice Breyer
provided the fifth vote necessary to support the Court's holding
that none of the Lohrs' claims were preempted but asserted that
he agreed with Justice O'Connor's dissenting opinion on the
extent to which more appropriate FDA requirements might preempt
state law claims. See Lohr, 518 U.S. at 503, 116 S. Ct. at 2259(Breyer, J., concurring). A number of courts have parsed these
opinions and the actual votes only to arrive at conflicting
positions. Compare Mitchell, 126 F.3d at 912 (noting that it
would have made little sense for Justice Breyer to write
separately if he agreed that most state tort claims were not
preempted) with Oja v. Howmedica, Inc., 111 F.3d 782, 789 (10th
Cir. 1997) (finding no preemption of a general state common law
tort claim by relying on Justice Breyer's vote to concur in the
judgment and ignoring the reasoning of his concurring opinion).
Fortunately, we need not enter that particular fray because we
can resolve this case on the basis of the federal requirement
alone.
10
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 (1947)). Second, the Court
cautioned that “'[t]he purpose of Congress is the ultimate
touchstone' in every pre-emption case.” Id., 116 S. Ct. at 2250(quoting Retail Clerks Int'l Ass'n Local 1625 v. Schermerhorn, 375
U.S. 96, 103, 84 S. Ct. 219, 223 (1963)). The MDA's preemption
provision and its surrounding statutory framework, therefore,
provide our primary guide for discerning Congressional intent
regarding the scope of preemption, but we must also examine the
“structure and purpose of the statute as a whole” by reviewing the
“way in which Congress intended the statute and its surrounding
regulatory scheme to affect business, consumers, and the law.” Id.
at 486, 116 S. Ct. at 2251 (internal quotation omitted).
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
11
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 21 U.S.C. § 360c(a)(1)(C).
Accordingly, we now turn to the question of whether the PMA process
satisfies section 360k(a)'s two other conditions by imposing any
specific federal requirement on a particular device.
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 21 U.S.C. §§ 371(a) & 360k(b)). Although the Court
may have avoided the question of whether the FDA's regulations were
due any deference under Chevron, U.S.A., Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837, 104 S. Ct. 2778 (1984), cf.
Lohr, 518 U.S. at 511-12, 116 S. Ct. at 2263 (O'Connor, J.,
concurring in part and dissenting in part), five Justices agreed
that the FDA's “view of the statute” was entitled to “substantial
weight.” Id. at 496, 116 S. Ct. at 2256; see id. at 505-07, 116 S.
Ct. at 2260-61 (Breyer, J., concurring). The FDA's regulation
interpreting section 360k, issued in 1978, advises that:
State or local requirements are preempted only when the
[FDA] has established specific counterpart regulations or
12
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.
21 C.F.R. § 808.1(d).
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.” 21 C.F.R. § 808.1(d).
Accordingly, to prevail on its preemption argument in this case,
Medtronic must identify a specific federal requirement imposed on
its particular device that would preempt any conflicting or
additional state requirement inherent in a jury verdict in
Goodlin's favor. Medtronic argues that the FDA's approval of its
4004/M lead, which required the FDA to find that Medtronic had
provided a reasonable assurance of the device's safety and
effectiveness, amounts to the imposition of such a requirement.
Medtronic also cites the FDA's letter of approval and the attached
“Conditions of Approval,” as well as the FDA's demand that
Medtronic not alter the device in any way affecting the safety or
effectiveness of the 4004/M lead, as preempting requirements.8 We
8
Medtronic also points out that in addition to compelling
manufacturers to submit to the PMA process, the MDA and the FDA's
regulations specifically require manufacturers to provide
substantial relevant information and disclosures. We would have
to consider the MDA's provisions calling for PMA review of the
13
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 (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
type of medical device at issue in this case “specific
requirements,” although it is not obvious that these requirements
are device-specific, see infra Part II(B). These requirements
need not detain us, however, because the state of Florida has
passed no provisions that would conflict with the general PMA
requirement by permitting Medtronic to market the device in
Florida without receiving FDA approval. We presume that such
efforts necessarily would have no effect in view of § 360k(a).
9
We wrote, “[e]ven assuming that a safety and effectiveness
finding would constitute a specific design requirement under the
MDA, we are not convinced that 510(k) approval constitutes a
finding of safety and effectiveness.” Id. at 1348 (emphasis
added).
14
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
10
In another section of our Lohr opinion, in which we
rejected the plaintiff's assertion that § 360k and the FDA's
interpreting regulation contemplated a device-specific federal
requirement, we suggested that the PMA process was a much better
candidate for preemption than the 510k process because of its
heightened rigor. Id. at 1345-46 & nn.14 & 15. Given our
subsequent misgivings about converting the FDA's 510k approval
into a specific requirement, however, we cannot read this portion
of our opinion to suggest that the PMA process is itself
preemptive. Instead, the Lohr panel used the PMA process as an
example to support its view that the federal requirement in §
360k(a)(1) need not be device-specific. Based on this
understanding, the Lohr panel held that the MDA's good
manufacturing practices (“GMPs”), which apply generally to almost
all manufacturers of medical devices, were specific requirements
and thus entitled to preemptive effect. Id. at 1350. The
Supreme Court, however, held that § 360k(a)(1) does demand
device-specificity and reversed the panel on this point. See
Lohr, 518 U.S. at 500-01, 116 S. Ct. at 2257-58.
11
The relevant discussion appears in section V of the
plurality opinion, in which Justice Breyer concurred. Id. at
508, 116 S. Ct. at 2261-62 (Breyer, J., concurring).
15
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(emphases added); cf. id. at 507, 116 S. Ct. at 2261 (Breyer, J.,
concurring) (“Insofar as there are any applicable FDA requirements
12
Of these two bases for deciding that the 510k process has
no preemptive effect, the latter finds far more support in the
language of § 360k(a). That section provides that no state may
establish a requirement that (1) is different from a federal
requirement and (2) relates to safety and effectiveness. Section
360k(a)(1) contemplates a federal requirement, which the FDA
reads to mean a specific requirement. See 21 C.F.R. § 808.1(d).
Section 360k(a)(2) demands that the requirement relate to safety
and effectiveness, but it is at least ambiguous whether §
360k(a)(2) modifies the state or federal requirement at issue.
The Supreme Court plainly read the provision to apply to the
federal requirement, but an argument could be made that the more
natural reading of the provision is as a limitation on the state
requirement.
16
here, those requirements . . . are not 'specific' in any relevant
sense.”). See also In re Orthopedic Bone Screw Prods. Liab.
Litig., 159 F.3d 817, 823 (3d Cir. 1998) (stating that the Lohr
Court gave the 510k process no preemptive effect because it imposed
no requirement).
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 (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,
17
Inc. v. Dollar Park and Fly, Inc., 469 U.S. 189, 194, 105 S. Ct.
658, 661 (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 (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. 21 U.S.C. § 360k(a). Finally, the FDA's interpretive
regulation, which describes the federal requirement as “specific
counterpart regulations” that the FDA “has established,” or
“specific requirements” that apply to the device under the MDA, 21
C.F.R. § 808.1(d), also indicates that a section 360k(a) preempting
federal requirement must be some ascertainable condition.13 The
13
The FDA's interpretive regulation also speaks of the
conflicting state regulation in terms that contemplate an
ascertainable condition that the state must establish in one
manner or another. See 21 C.F.R. § 808.1(b) (explaining that
federal law preempts requirements “having the force and effect of
18
ordinary construction of the language of section 360k, as well as
the use of the term “requirement” in the broader statutory context
and its interpretation in the FDA's regulation, therefore, all
contemplate the imposition of some identifiable precondition that
applies to the device in question. Indeed, the statute, the FDA's
regulation, and the Supreme Court's analysis in Lohr instruct us to
conduct a “careful comparison” between the state and federal
requirements at issue. Lohr, 518 U.S. at 500, 116 S. Ct. at 2257-
58. Such a comparison is impossible if we cannot identify or
ascertain the precise federal requirement at issue. Our conceptual
difficulty with Medtronic's argument stems from our inability to
ascertain any such identifiable requirement from the FDA's approval
of Medtronic's 4004/M lead.
Medtronic points out that even a cursory review of the
statutory framework reveals that the MDA imposes a legion of
readily identifiable requirements upon the PMA applicant. See
generally supra Part I(A); Worthy, 967 S.W.2d at 363-64 (providing
an overview). Despite the specificity and considerable rigor of
these conditions, see supra note 8, however, neither the FDA's
actual review of a device and its supporting information nor the
agency's eventual approval of the device imposes any ascertainable
law (whether established by statute, ordinance, regulation or
court decision).”). Furthermore, the FDA's description of state
requirements in the remainder of the interpretive regulation
refers only to concrete and identifiable rules and regulations.
Id. at § 808.1(d)(1-10).
19
requirement upon the device. In the typical PMA review and
approval and, more particularly, in the context of the 4004/M PMA,
the FDA issues no regulation, order, or any other statement of its
substantive benchmark. Cf. Papike v. Tambrands Inc., 107 F.3d 737,
740-41 (9th Cir.), cert. denied, __ U.S. __, 118 S. Ct. 166 (1997)
(finding preemption based on an ascertainable requirement in an
express FDA regulation requiring specific warnings on a device's
packaging); Lohr, 518 U.S. at 489 n.9, 116 S. Ct. at 2252 n.9
(plurality opinion) (“In the MDA, no . . . specifics exist until
the FDA provides them.”). The approval represents only a finding
that the manufacturer's proposal to market a device has reasonably
assured the FDA of the device's safety and effectiveness. Nor does
the FDA's willingness to notify an applicant of deficiencies and to
propose modifications to the PMA application add any further force
to Medtronic's argument for preemption, because an applicant who
corrects or modifies a deficient PMA application before receiving
the FDA's approval stands in no better position than an applicant
whose initial PMA application was flawless.14 In either case, the
14
In this vein, Medtronic argues that the FDA imposed a
number of specific requirements on the 4004/M during the process
of reviewing the PMA application. Our review of the record,
however, reveals that these requirements amounted to nothing more
than requests for further information and explanations of data
already before the FDA. These requests for information may shed
light upon the issues the FDA examined but do not impose any
specific requirement upon the device. We also note that the Lohr
Court did not consider the FDA's power to make similar requests
for additional information during the 510k review, see 21 C.F.R.
§ 807.87(l), as a factor that would support according that
20
FDA enters a finding that the applicant has furnished the relevant
assurances and therefore may begin to market its device. In
neither case, however, does the approval provide any indication of
what (if any) specific substantive requirements the FDA may have
applied to reach that result.15 Compare Hurley v. Lederle Lab. Div.
of Am. Cyanamid Co., 863 F.2d 1173, 1177 (5th Cir. 1988)
(explaining that the FDA's approval of a certain form of vaccine
provides “no basis for finding a federal interest in” that form)
with Lohr, 518 U.S. at 500, 116 S. Ct. at 2257 (“[P]re-emption
[must] occur only where a particular state requirement threatens to
process preemptive effect.
15
In 1997, the FDA promulgated a proposed rule on the
preemption of state product liability claims under the MDA. See
62 Fed. Reg. 65,384 (1997). In that proposed rule, the FDA's
analysis of its general approval processes (the 510k, the IDE,
and the PMA) echoed our concern regarding the imposition of an
ascertainable “specific requirement” as contemplated in §
360k(a)(1). Id. at 65,387. As a result of irregularities in the
timing and circumstances of the FDA's action and in response to
Congressional criticism of those circumstances, however, the FDA
withdrew the proposed rule in July 1998. See 63 Fed. Reg. 39,789(1998). Accordingly, we have given the FDA's expression of its
views in this proposed rule no authoritative weight or deference.
Nor do we defer to any position the FDA may have taken as an
amicus curiae in cases involving issues of preemption. See McKee
v. Sullivan, 903 F.2d 1436, 1439 n.3 (11th Cir. 1990)
(“[E]vidence of a litigating position is insufficient to
establish an agency's interpretation.”).
Nevertheless, we find the analysis of the PMA process
presented in the FDA's proposed rule interesting for two reasons.
First, we are convinced that the proposed rule's analysis is
faithful to the language of § 360k(a)(1), the broader statutory
framework, and Congress's purpose in passing the MDA. Second, we
find it unsettling that the agency charged with conducting PMA
review has doubts regarding whether an approval pursuant to that
process should preclude subsequent state tort liability.
21
interfere with a specific federal interest.”) (emphasis added).
Medtronic seeks to convert the FDA's finding and the
accompanying permission to market its device into the federal
government's implied validation of the safety of its device and
every step of its manufacture and, then, to use that validation as
a shield against liability in tort. The FDA's approval is clearly
specific to the device under review, but because the approval
itself neither reveals nor imposes any ascertainable substantive
prerequisite for approval that we could compare to a purportedly
conflicting state requirement, the approval itself does not fit
within section 360k(a)(1)'s demand for a specific federal
requirement. As the New York Appellate Division persuasively
explained, “while a PMA review is considerably more rigorous and
detailed than the premarket notification [510k] process at issue in
[Lohr v.] Medtronic, it is, in fact, no more 'specific' a
requirement.” Sowell v. Bausch & Lomb, Inc., 646 N.Y.S.2d 16, 20
(N.Y. App. Div. 1997).16
16
Medtronic argues that our adoption of Slater v. Optical
Radiation Corp., 961 F.2d 1330 (7th Cir. 1992) in Duncan v. Iolab
Corp., 12 F.3d 194, 195 (11th Cir. 1994) precludes our analysis
and conclusions here. Slater, however, involved the preemptive
effect of the IDE process, not the PMA process, and therefore
does not control our disposition of this case. Moreover, Slater
explicitly relied on the experimental nature of the device
undergoing IDE review. See Slater, 961 F.2d at 1333.
Nevertheless, we acknowledge that part of the reasoning in
Slater is at odds with our analysis today because the Slater
court implied a specific federal requirement from the FDA's
determination that the device was sufficiently safe and effective
to permit experimental use. Id. Given our analysis, in section
22
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.” 21 U.S.C. § 360k(a)(1).
The MDA permits the FDA to impose similar conditions on
devices it approves pursuant to the 510k process. See, e.g., 21
U.S.C. § 360j(e) (giving the FDA the authority to impose conditions
on the sale of any device); cf. id. § 396 (referring to the FDA's
II(A), of the manner in which the Supreme Court addressed section
360k(a)(1)'s demand for a specific federal requirement in its
intervening Lohr decision, however, we do not believe that
Slater's reasoning on this point has survived. See Niehoff v.
Surgidev Corp., 950 S.W.2d 816, 819-20 (Ky. 1997), cert. denied,
__ U.S. __, 118 S. Ct. 1187 (1998) (rejecting Slater in light of
the Supreme Court's demand for a specific federal requirement).
On this point, we part company with the Seventh Circuit, which
continues to apply the relevant portion of Slater despite Lohr.
See Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997)
(applying Slater's approach without citing the case); Chambers v.
Osteonics Corp., 109 F.3d 1243, 1246-47 (7th Cir. 1997)(relying
on the case explicitly). In any event, to the extent Slater is
at odds with our decision today, we believe the Supreme Court's
reasoning in Lohr calls that case, and thus our adoption of it in
Duncan, into question.
23
existing authority to enforce restrictions on the sale or
distribution “of a device that are part of a determination of
substantial equivalence, established as a condition of approval, or
promulgated through regulations”). Moreover, the Supreme Court in
Lohr took note of these conditions and the FDA's “continuing
authority to exclude the device from the market if its design is
changed” and recited Medtronic's arguments in favor of construing
these factors as preemptive requirements. Lohr, 518 U.S. at 492,
116 S. Ct. at 2254; see also 21 C.F.R. § 807.81(a)(3) (requiring
premarket notification for the reintroduction into commercial
distribution of any device that is about to be significantly
changed or modified). Nevertheless, the Court found these
arguments insufficient to fit the 510k approval process within the
confines of section 360k(a)(1) and declined to grant the 510k
process preemptive effect. See Part II(A), supra.
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 requirement “applicable to a particular device.” 21 C.F.R.
§ 808.1(d) (emphasis added), quoted in Lohr, 518 U.S. at 498, 116
S. Ct. at 2257. The Court then noted the FDA's “overarching
24
concern” regarding a broader construction of preemption and
determined that the FDA's general labeling requirements and its
Good Manufacturing Practices (“GMPs”) were too general to merit
preemptive effect under the statute and regulation. See Lohr, 518
U.S. at 497-501, 116 S. Ct. at 2256-58. A similar concern animates
the Court's discussion of the general nature of the conditions the
FDA imposed in its letter notifying Medtronic of its approval of
the device pursuant to the 510k process. Id. at 493, 116 S. Ct. at
2254 (“That letter only required Medtronic to comply with 'general
standards'—the lowest level of protection 'applicable to all
medical devices' . . . .”).
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
17
See R1-24, Ex. E-3.
25
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.
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
18
Id. at 1, 3.
19
See Kennedy, 67 F.3d at 1458-59 (pre-Lohr case finding
that the PMA process imposes no specific federal requirement),
overruled in part on other grounds by Lohr, 518 U.S. 470, 116 S.
Ct. 2240; Lakie v. SmithKline Beecham, 965 F. Supp. 49, 54
(D.D.C. 1997) (“The fact that the PMA process requires certain
information and mandates certain procedures from manufacturers
26
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 regulation 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 PMA process permits the FDA to regulate the
does not transform the PMA process itself into a specific federal
requirement which triggers preemption and protects a manufacturer
from suit.”); accord Sowell, 656 N.Y.S.2d at 20; Walker v.
Johnson & Johnson Vision Prods., Inc., 552 N.W.2d 679 (Mich. App.
1996).
20
We recognize that our decision may have implications
beyond the preemption of state tort suits. Our analysis of the
PMA review process and our decision that the FDA's approval
imposes no preemptive requirement might preclude the express
preemption of any conflicting state requirement, no matter how
the state asserts it. Although we find it difficult to conceive
of any such hypothetical state requirement that actually would
conflict with the FDA's approval rather than the federal laws
preventing the sale of unapproved devices, see supra note 8, we
note the Supreme Court's recent teaching that the presence of an
express preemption provision in a federal statute does not
preclude field or conflict preemption. See Freightliner Corp. v.
Myrick, 514 U.S. 280, 115 S. Ct. 1483 (1995), cited in Lohr, 518
U.S. at 503, 116 S. Ct. at 2259 (plurality opinion). To the
extent, therefore, that a state's law “'stands as an obstacle to
the accomplishment and execution of the full purposes and
objectives of Congress'” as embodied in the PMA approval process,
the state's efforts still may fall to preemption. Freightliner
Corp., 514 U.S. at 287, 115 S. Ct. at 1487 (quoting Hines v.
27
introduction and sale of medical devices to assure their minimal
safety for public consumption—it does not appear to address the
appropriate standards of liability once the product enters the
marketplace. Our inability to discern a specific requirement that
fits the demands of section 360k(a) in the FDA's approval process,
therefore, finds broader support in the language and structure of
the MDA and is consistent with the factual backdrop that prompted
Congress to enact the MDA.
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
Davidowitz, 312 U.S. 52, 67, 61 S. Ct. 399, 404 (1941)).
28
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
29
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.” 21 U.S.C. § 360h(d). The
effect of this savings clause is somewhat ambiguous because it
appears in a section that addresses the FDA's powers to provide
notification and other remedies when the agency discovers that a
medical device (presumably including one that received PMA
approval) presents an “unreasonable risk of substantial harm to the
public health.” Id. § 360h(a). As a matter of careful statutory
construction, therefore, we would have to read section 360h(d) to
refer only to compliance with FDA orders regarding notification,
repair, replacement, refund, or reimbursement—and not to include
compliance with the PMA process, which arises under a different
section of the MDA. This limitation on section 360h(d)'s technical
application, however, need not compel us to ignore the provision's
broader implications because product liability in tort is the most
immediately obvious source of state law liability that ordinarily
would arise in a situation implicating the FDA's section 360h
authority. Moreover, although the Lohr panel refused to read
section 360h(d) as a vehicle to reject all preemption under the MDA
because that section does not speak to the type of state liability
contemplated and because a general savings clause cannot supersede
a more specific preemption provision, see Lohr, 56 F.3d at 1342-43,
30
rev'd in part and aff'd in part, 518 U.S. 470, 116 S. Ct. 2240, the
Supreme Court never addressed the impact of section 360h(d) on its
preemption analysis. Despite these lingering concerns, we would
misread neither the plain language of section 360h(d) nor the Lohr
panel's interpretation of the law by concluding that the savings
clause casts real doubt on the idea that Congress intended to
preempt state tort liability for all PMA approved devices. Cf.
Irving v. Mazda Motor Corp., 136 F.3d 764, 767-68 (11th Cir. 1998)
(holding that a federal regulatory statute that includes a
preemption clause and a savings clause is ambiguous on the
preemption of state common law claims).
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
31
situation in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S. Ct.
615 (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
32
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”). The proposed act, which sought to
create federal standards of product liability,21 would have
prevented private litigants from recovering punitive damages from
the manufacturers of medical devices in cases where the “drug or
device” that caused a plaintiff's harm “was subject to pre-market
approval by the [FDA] with respect to the safety of the formulation
or performance of the aspect of such drug or device which caused
the claimant's harm . . . .” S. 687, 103d Cong. § 203 (1994).
21
The PLFA would not have created a new federal cause of
action but rather would have imposed uniform standards of
liability for product manufacturers and sellers. See S. 687,
103d Cong. § 202. The proposed law would have permitted
plaintiffs to bring causes of action pursuant to applicable state
law, to the extent not in conflict with the PFLA's provisions.
Id. § 201. Similarly, a plaintiff could also pursue punitive
damages under “applicable law” to the extent not in conflict with
the PFLA. Id. § 203.
33
Although the bill never became law, section 203's attempt to
prevent plaintiffs suing the manufacturers of PMA devices under
state tort law (to the extent not inconsistent with the proposed
federal standard) from recovering punitive damages is significant
because, if the 1976 Congress truly had intended section 360k(a) of
the MDA to preempt all or most state law claims involving PMA
approved devices, then there would have been no need for the 1994
Congress to include those devices in its proposed solution to the
more general travails of product liability law.
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
34
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 to believe that
22
We note that the 1998 Congress that considered granting a
number of domestic tobacco companies immunity against state-
initiated litigation and class actions (but not private,
35
Congress struck a similar bargain—regulation in exchange for
immunity from state tort suits—in the area of medical devices
without mentioning its aspirations in the statute or its
legislative history and with nary a comment in the FDA's
interpretive regulations or in the contemporary reviews of industry
observers. See Lohr, 518 U.S. at 490-91 & n.13, 116 S. Ct. at 2253
& n.13 (plurality opinion).
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
individual lawsuits) did so directly and unambiguously. See S.
1415, 105th Cong. §§ 701-703. We further observe that Congress
rigorously defined this immunity in the proposed statute, id.,
even though it also planned to subject new tobacco products to
FDA regulation and review through a process akin to the MDA's PMA
process, id. §§ 901-910. Finally, we observe that the debate
over granting even this limited immunity to tobacco
manufacturers, and the price Congress properly should have
demanded for it, were matters of extreme and extended
controversy. Moreover, the FDA's concurrent attempts to regulate
nicotine as a drug prompted a blizzard of commentary from the
legal academy and industry observers.
36
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.
37
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
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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 was inherently dangerous because the
risks it imposed outweighed its benefits.23 Medtronic's efforts to
improve its product and the information it collected in support of
its safety will be relevant to these questions. The FDA's approval
of the device, particularly after an independent panel of experts
recommended that approval, should impress the jury that must
evaluate the reasonableness of Medtronic's actions at the time it
manufactured and marketed the 4004/M lead. Although the task of
presenting this information in a manner that a jury can understand
may make for a lengthy and complicated trial—and may even demand a
better solution—section 360k(a) of the MDA provides no means to
avoid it.
CONCLUSION
We conclude that the FDA's approval of a medical device
23
Goodlin also will have to prove that Medtronic's
negligence or the device's inherent danger caused her harm. As
the district court observed, but did not decide, Goodlin's case
faces some serious causation problems under Florida law.
39
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.
40