Lohr v. Medtronic, Inc. ( 1995 )

United States Court of Appeals,
Eleventh Circuit.
No. 94-2516.
Lora LOHR, Michael Lohr, Her Husband, Plaintiffs-Appellants,
v.
MEDTRONIC, INC., a Foreign Corporation, Defendant-Appellee.
July 3, 1995.
Appeal from the United States District Court for the Middle
District of Florida. (No. 93-482-CIV-J-20), Harvey E. Schlesinger,
Judge.
Before BLACK and BARKETT, Circuit Judges, and RONEY, Senior Circuit
Judge.
BLACK, Circuit Judge:
In this case we must decide whether the Medical Device
Amendments of 1976 (MDA or Act), 21 U.S.C.A. §§ 360c-360l (West
Supp.1994) preempt Appellants' state law negligent design,
negligent manufacture, failure to warn, and strict liability claims
against the manufacturer of an allegedly defective pacemaker. The
district court found that they did and dismissed the entire action.
We hold that Appellants' negligent manufacture and failure to warn
claims are preempted and affirm their dismissal. We also hold that
Appellants' negligent design and strict liability claims are not
preempted and therefore reverse their dismissal.
I. BACKGROUND
Because an understanding of the MDA's regulatory scheme is
necessary to resolve the question of preemption, we begin with a
brief outline of the Act.
A. The Regulatory Scheme
The market for medical devices was largely unregulated at the
national level until the MDA's passage in 1976. With the MDA,
Congress gave the federal Food and Drug Administration (FDA)
comprehensive jurisdiction over all "devices intended for human
use." 21 U.S.C.A. § 360c(a)(1). The text of the MDA reveals two
competing congressional purposes relevant to this case:1 (1) the
MDA protects the public from unnecessary illness or injury by
subjecting medical devices to a regulatory scheme designed to
ensure that the devices are safe and effective, see, e.g., 21
U.S.C.A. §§ 360c(a)(1)(A)(i); 360c(a)(1)(B); 360e(d)(2); and (2)
the MDA protects the public by encouraging the development and
marketing of medical devices by crafting a nationally uniform
regulatory scheme that prevents overregulation and thus ensures
that development can be economically feasible, see, e.g., 21
U.S.C.A. §§ 360j(g)(1); 360k(a).
These twin purposes are confirmed by the legislative history
of the Act. For example, the House Report on the Act states:
Those involved in the development, promotion, and
application of medical devices generally agree that the public
deserves more protection against unsafe, unproven,
ineffective, and experimental medical devices. But this
belief is counterbalanced by an equally strong conviction that
excessive or ill-conceived Federal device regulation would
stifle progress in this field.
H.R.Rep. No. 853, 94th Cong., 2d Sess. 10 (1976). Legislative
history from the Senate reflects the same balancing of interests.
See S.Rep. No. 33, 94th Cong., 1st Sess. 5, 12 (1975) U.S.Code
1
Nothing we say here should be interpreted as identifying
the exclusive motives of Congress in passing the Act. Courts
must be mindful of the fact that legislative acts reflect many
competing interests and should not allow vague notions about a
statute's overall purpose to overcome its plain text. Mertens v.
Hewitt Associates, --- U.S. ----, ----, 113 S. Ct. 2063, 2071, 124
L. Ed. 2d 161 (1993).
Cong. & Admin.News 1976 at pp. 1070, 1074, 1081. The need to
balance public safety with continued development was reiterated
when Congress amended the MDA in 1990.
Simply put, the [MDA] sought to avoid overregulation, thus
eliminating unnecessary resource costs to industry and the
government, foster incentives to encourage innovation in a
relatively youthful industry and, most importantly, provide
the public reasonable assurances of safe and effective
devices.
S.Rep. No. 513, 101st Cong., 2d Sess. 13 (1990). The MDA thus
reflects the intent of Congress to scrutinize the medical device
industry to a greater extent without stifling innovation and
development.
All medical devices regulated by the MDA fall into three
statutory categories. Class I devices are those which pose little
threat to the safety of the consuming public. These devices,
including everything from tongue depressors to acoustic chambers,
are subject only to the Act's generally applicable regulations.
See 21 U.S.C.A. § 360c(a)(1)(A). Class II devices are those which
pose enough of a safety hazard to require regulation beyond the
general controls applicable to Class I devices. Class II devices,
like tampons and oxygen masks, are consequently subject to
device-specific special controls. See 21 U.S.C.A. § 360c(a)(1)(B).
Class III devices are those that the FDA determines are too
unproven to be rendered safe by general controls or present a
potential for unreasonable risk of illness or injury. Almost all
life-sustaining medical devices, like pacemakers, are classified as
Class III devices. In addition to the Act's general regulations
and, in some instances, device-specific controls, Class III devices
must generally undergo premarket approval (PMA) before the FDA will
allow them into the marketplace. See 21 U.S.C.A. § 360c(a)(1)(C).
The premarket approval process is a vigorous one, requiring the
applicant to present the FDA with "all information" known or
reasonably knowable about the device, including detailed
information about the design, manufacture, uses, and labeling of
the device. 21 U.S.C.A. § 360e(c)(1).
While the MDA contemplates that most Class III devices will
reach the market through the PMA process, there are important
exceptions. First, the MDA grandfathered into the market all
devices introduced before May 28, 1976—the effective date of the
Act. 21 U.S.C.A. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1) (1994).
Second, the MDA contains an investigational device exemption (IDE)
for new devices under clinical investigation to determine their
safety or effectiveness. 21 C.F.R. § 812.3(g). See 21 U.S.C.A. §
360j(g). In order to foster the development of useful devices, IDE
procedures allow manufacturers to begin limited marketing of new
devices without undergoing the rigorous PMA process. 21 U.S.C.A.
§ 360j(g)(1).
Finally, a Class III device may reach the market without
undergoing the PMA procedures if the device is found to be the
"substantial equivalent" of an already-marketed device, including
a device grandfathered into the market. 21 U.S.C.A. §
360e(b)(1)(B). For a device to qualify as the substantial
equivalent of one which is already being marketed, the FDA must
determine that the new device has the same intended use as the
predicate device and either the same technological characteristics
or the same safety and effectiveness as the predicate device. 21
U.S.C.A. § 360c(i)(1)(A). Every device entering the market as a
substantial equivalent is subject to a premarket notification
process (510(k) process) which allows the FDA to classify the
device and make its substantial equivalence finding. 21 U.S.C.A.
§§ 360(k); 360c(f)(1).
B. Facts2
This case arises from the failure of a pacemaker manufactured
by Appellee Medtronic, Inc. The pacemaker in question, the Model
8403 Activitrax (Activitrax), is a Class III device under the MDA.
21 C.F.R. § 870.3610. The Activitrax has never been subject to the
PMA process. See 21 C.F.R. § 870.3610(c).
Appellant Lora Lohr was implanted with an Activitrax pacemaker
in 1987. The pacemaker failed in 1990, forcing Ms. Lohr to endure
emergency surgery to replace the Activitrax. According to Ms.
Lohr's treating physician, the failure was caused by a defect in
the pacemaker "lead"—the wire carrying electrical impulses from the
pacemaker to the patient's heart tissues.
The Activitrax lead component, the Model 4011, is manufactured
by Appellee as part of its pacemaker system. The FDA permitted
marketing of the Model 4011 in 1982 after finding that it was the
substantial equivalent of a device introduced prior to the
effective date of the MDA. In other words, the Model 4011 entered
the market through the 510(k) process as the substantial equivalent
of a device grandfathered into the Act.
C. Procedural History
2
For purposes of this appeal, we accept the facts in
Appellants' complaint as true.
Appellants Lora and Michael Lohr originally brought this
action in a Florida court, but Appellee removed the case to the
Middle District of Florida based on diversity of citizenship. In
their complaint, Appellants seek damages for injuries Lora Lohr
allegedly sustained as a result of the Activitrax's failure and for
Michael Lohr's alleged loss of consortium. The complaint contains
four theories of liability: (1) negligent design; (2) negligent
manufacture; (3) negligent failure to warn; and (4) strict
liability in tort.3
Shortly after removing the case, Appellee moved for summary
judgment, asserting that Appellants' claims were preempted by the
MDA. The district court denied the motion in December 1993, but
reconsidered its decision in light of this Court's decision in
Duncan v. Iolab Corp., 12 F.3d 194 (11th Cir.1994). Upon
reconsideration, the district court granted Appellee's motion for
summary judgment, interpreting Duncan as preempting all state law
claims for negligence and strict liability. This appeal follows.4
3
The original complaint contained a breach of warranty claim
which was dismissed for failure to state a claim under Florida
law and is not at issue in this appeal.
4
Prior to oral argument, Appellants sought to supplement
their submissions to the Court with an additional brief. A
similar request from Appellee and a request to reply to
Appellee's supplemental brief inevitably followed. We carried
these motions with the case.
Appellants' supplemental brief appears to be a vehicle
for bringing before the Court the FDA's amicus brief in
Talbott v. C.R. Bard, Inc., 1st Cir. No. 94-1951, a pending
First Circuit case concerning preemption under the MDA.
Litigating positions of an agency, as distinct from the
agency's regulations, rulings, and practice, are entitled to
no deference. Martin v. OSHRC, 499 U.S. 144, 154-56, 111
S. Ct. 1171, 1178, 113 L. Ed. 2d 117 (1991); Bowen v.
Georgetown University Hosp., 488 U.S. 204, 210-14, 109 S. Ct.
II. DISCUSSION
The sole issue on appeal is whether the district court erred
in holding that the MDA preempts all common law tort claims against
a Class III device which entered the market through the 510(k)
process as the substantial equivalent of a grandfathered device.
A. Standard of Review
Statutory interpretation presents a question of law over
which we exercise de novo review. Barnett Bank of Marion County,
N.A. v. Gallagher, 43 F.3d 631, 633 (11th Cir.1995). We review an
administrative agency's statutory interpretation de novo, but defer
to an agency's interpretation if it is reasonable. Asencio v.
I.N.S., 37 F.3d 614, 616 (11th Cir.1994).
B. Preemption Under the MDA
The Constitution makes the laws of the United States "the
supreme Law of the Land; ... any Thing in the Constitution or Laws
of any State to the Contrary notwithstanding," U.S. Const. art. VI,
cl. 2, and when federal and state laws conflict, the latter must
give way, CSX Transp., Inc. v. Easterwood, --- U.S. ----, ----, 113
S. Ct. 1732, 1737, 123 L. Ed. 2d 387 (1993). Whether a federal
statute preempts state law is a question of congressional intent.
Hawaiian Airlines, Inc. v. Norris, --- U.S. ----, ----, 114 S. Ct.
2239, 2243, 129 L. Ed. 2d 203 (1994); Forbus v. Sears Roebuck & Co.,
468, 473-74, 102 L. Ed. 2d 493 (1988); Alabama Dry Dock and
Shipbuilding Corp. v. Sowell, 933 F.2d 1561, 1563 (11th
Cir.1991). Consequently, Appellants' supplemental brief
would not aid the Court in resolving this case and we deny
the motion to supplement. Appellee's motion to supplement
and Appellants' supplemental reply are premised on
consideration of Appellants' first supplemental brief, and
our decision to reject that brief precludes the other
submissions.
30 F.3d 1402, 1405 (11th Cir.1994), cert. denied, --- U.S. ----,
115 S. Ct. 906, 130 L. Ed. 2d 788 (1995). Congressional enactment of
a provision defining the preemptive scope of a statute implies that
it intended to limit the preemptive scope of the statute to the
express terms of the preemption provision. Freightliner Corp. v.
Myrick, --- U.S. ----, ----, 115 S. Ct. 1483, 1488, 131 L. Ed. 2d 385
(1995); Cipollone v. Liggett Group, Inc., --- U.S. ----, ----, 112
S. Ct. 2608, 2618, 120 L. Ed. 2d 407 (1992). In the absence of a
"general, inherent conflict" between the state and federal law,
review is limited to the express terms of the preemption provision.
Freightliner, --- U.S. at ----, 115 S. Ct. at 1488 (quoting
Cipollone, --- U.S. at ----, 112 S. Ct. at 2618).
In determining the preemptive scope of the express language,
however, several presumptions guide our analysis. First,
preemption is appropriate only if it is the clear and manifest
purpose of Congress. Department of Revenue of Or. v. ACF
Industries, Inc., --- U.S. ----, ----, 114 S. Ct. 843, 851, 127
L. Ed. 2d 165 (1994); CSX, --- U.S. at ----, 113 S. Ct. at 1737;
United States v. Lot 5, Fox Grove, Alachua County, Fla., 23 F.3d
359, 361 (11th Cir.1994), cert. denied, --- U.S. ----, 115 S. Ct.
722, 130 L. Ed. 2d 627 (1995). Second, preemption of actions within
the traditional police powers of a state "should not be lightly
inferred." Hawaiian Airlines, --- U.S. at ----, 114 S. Ct. at 2243
(quoting Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 21, 107
S. Ct. 2211, 2222, 96 L. Ed. 2d 1 (1987)). Finally, there is a
presumption against preemption if it would deny a party all
judicial remedies. Silkwood v. Kerr-McGee Corp., 464 U.S. 238,
251-52, 104 S. Ct. 615, 623, 78 L. Ed. 2d 443 (1984); Michael v.
Shiley, Inc., 46 F.3d 1316, 1326 (3rd Cir.1995). Although the
presumptions against preemption cannot drive our analysis and must
yield to a clear expression of congressional intent, in a close
case the presumptions tip our statutory interpretation against
preemption. See Cipollone, --- U.S. at ----, 112 S. Ct. at 2618;
Morales v. Trans World Airlines, Inc., 504 U.S. 374, 383-85, 112
S. Ct. 2031, 2037, 119 L. Ed. 2d 157 (1992).
Preemption under the MDA is governed by the Act's preemption
provision,5 which states:
Except as provided in subsection (b) of this section
[delineating an exemption procedure not relevant to this
case], 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.A. § 360k(a). To determine whether Appellants' claims are
preempted by the MDA, we must compare the "State ...
requirement[s]" under which the suit was brought with MDA-imposed
requirements. Before comparing Appellants' claims with the
5
Both parties accept the preemption provision as
controlling. Although the Supreme Court recently explained that
implied preemption is sometimes appropriate despite the existence
of an express preemption provision, see Freightliner, --- U.S. at
----, 115 S. Ct. at 1487-88, we doubt that this is such a case.
First, it does not seem impossible for a manufacturer to comply
with the MDA's requirements and any additional requirements which
Appellants' suit might add. See id. --- U.S. at ----, 115 S. Ct.
at 1488. Second, it does not appear that Appellants' suit would
frustrate "the full purposes and objectives of Congress." Id.
requirements imposed on the Activitrax by the MDA, however, we must
address two threshold questions: (1) what constitutes a "State ...
requirement" and (2) what constitutes a "requirement" under the
MDA. 21 U.S.C.A. § 360k(a).
1. State Requirement.
To determine what § 360k(a) means by a "State ... requirement
different from, or in addition to" MDA requirements, we must
consider whether Congress intended to include state common law
actions.6 Were we writing on a clean slate, this might present a
difficult question, but we do not write on a clean slate. In
Duncan v. Iolab Corp., 12 F.3d 194, this Court adopted the Seventh
Circuit's reasoning in Slater v. Optical Radiation Corp., 961 F.2d
1330 (7th Cir.), cert. denied, --- U.S. ----, 113 S. Ct. 327, 121
L. Ed. 2d 246 (1992), and held that the MDA preempted a plaintiff's
negligence, strict liability, and breach of implied warranty
claims. Thus, the law of this Circuit is that the phrase "State
... requirement" in § 360k(a) includes state common law tort
actions. See also Cipollone, --- U.S. at ----, 112 S. Ct. at 2620
("The phrase "no requirement or prohibition' sweeps broadly and
suggests no distinction between positive enactments and common
law") (quoting 15 U.S.C. § 1334(b)). Every circuit to consider the
question agrees that common law actions are state requirements
within the meaning of § 360k(a).7
6
Appellants' initial brief did not appear to dispute whether
their claims were based on state requirements within the meaning
of § 360k(a). Their reply brief, however, appears to dispute the
issue in this appeal.
7
See Mendes v. Medtronic, Inc., 18 F.3d 13, 16 (1st
Cir.1994); Michael, 46 F.3d at 1323 (3rd Cir.); Reeves v.
The existence of a savings clause within the MDA cannot alter
this conclusion. The savings clause states that "[c]ompliance with
an order [under the MDA] shall not relieve any person from
liability under Federal or State law." 21 U.S.C.A. § 360h(d).
While the savings clause almost certainly prohibits a holding that
the MDA preempts all state law liability, our interpretation of §
360k(a) does not preclude all liability. Further, nothing in the
savings clause suggests that some tort liability, as opposed to
other types of liability, must be preserved. Interpreting the
savings clause to preserve non-tort liability, such as contract
liability, is not only permissible, but also comports with the
Supreme Court's interpretation of a savings clause in a recent
preemption case. See American Airlines, Inc. v. Wolens, --- U.S.
----, ----, 115 S. Ct. 817, 826, 130 L. Ed. 2d 715 (1995) (holding
that the Airline Deregulation Act preempts claims under the
Illinois Consumer Fraud and Deceptive Business Practices Act but
does not preempt state breach of contract actions). Moreover,
where the preemptive intent of Congress is clear, a general savings
clause cannot supersede the specific preemption provision.
Morales, 504 U.S. at 383-85, 112 S.Ct. at 2037. In short, as long
as we interpret § 360k(a) as permitting some state law liability,
the MDA's savings clause simply begs the question of what liability
it preserves.
Appellants' reply brief suggests that their negligent
Acromed Corp., 44 F.3d 300, 304 (5th Cir.1995); Slater, 961 F.2d
at 1332-33 (7th Cir.); Martello v. CIBA Vision Corp., 42 F.3d
1167, 1168 (8th Cir.1994); Anguiano v. E.I. Du Pont De Nemours &
Co., 44 F.3d 806, 809 (9th Cir.1995).
manufacturing and failure to warn claims are exempt from preemption
under § 360k(a) because the claims may demonstrate a violation of
the MDA's own requirements and, therefore, do not constitute state
requirements "different from, or in addition to" the Act's
requirements. While we ordinarily do not address arguments first
raised in a reply brief, Allstate Ins. Co. v. Swann, 27 F.3d 1539,
1542 (11th Cir.1994), we will exercise discretion to reach this
question because the law in this Circuit forecloses Appellants'
argument.8
Papas v. Upjohn Co., 985 F.2d 516 (11th Cir.), cert. denied,
--- U.S. ----, 114 S. Ct. 300, 126 L. Ed. 2d 248 (1993), considered
the scope of preemption under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). 7 U.S.C.A. §§ 136-136y. In Papas,
the plaintiffs, like Appellants in this case, argued against
preemption by claiming that their common law action would show a
violation of the EPA's own FIFRA labeling standards. Therefore,
the plaintiffs claimed that their suit was not a "requirement ...
in addition to or different from" FIFRA's labeling requirements.
Papas, 985 F.2d at 518-19 (quoting 7 U.S.C.A. § 136v). We rejected
the argument, noting that "it is for [the agency], not a jury, to
determine whether labelling and packaging information is incomplete
or inaccurate, and if so what label changes, if any, should be
made." Id. at 519. We believe Papas controls here and hold that
preemption under the MDA cannot be defeated by a common lawsuit
8
We assume, arguendo, that Florida common law would
recognize an action whose standard of care is defined by the
standards of the MDA and that Appellants' complaint may be read
broadly enough to encompass such an action.
alleging a violation of the statutory standards. Every circuit
court decision addressing this issue under the MDA agrees.9
2. Requirements Under the MDA.
a. The FDA's Preemption Regulations.
Where the plain meaning of the express terms of a statute is
unclear, we may defer to a reasonable interpretation adopted by the
agency charged with enforcing the statute. See Chevron, U.S.A.,
Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843-
44, 104 S. Ct. 2778, 2782, 81 L. Ed. 2d 694 (1984). Appellants insist
that the meaning of "requirements" as used in § 360k(a) is unclear
and that we should therefore defer to the FDA regulations
clarifying the meaning of "requirements."10
Appellee responds that under the express preemption rule
enunciated in Cipollone v. Liggett Group, Inc., our analysis should
be "governed entirely by the express language" of the Act.
Cipollone, --- U.S. at ----, 112 S. Ct. at 2618. Alternatively,
Appellee argues that the FDA's regulations are contrary to the
clear intent of Congress and, therefore, are not entitled to
deference. We disagree.
Cipollone did not prohibit reliance on an agency's preemption
regulations. While the opinion speaks only of "the express
language" of the statutes, neither of the statutes examined in
9
Michael, 46 F.3d at 1328-29; Reeves, 44 F.3d at 307;
National Bank of Commerce of El Dorado v. Kimberly-Clark Corp.,
38 F.3d 988, 992 n. 2 (8th Cir.1994); King v. Collagen Corp.,
983 F.2d 1130, 1140 (1st Cir.) (opinion of Aldrich and Campbell,
JJ.), cert. denied, --- U.S. ----, 114 S. Ct. 84, 126 L. Ed. 2d 52
(1993).
10
Congress empowered the FDA to promulgate regulations to
enforce the MDA. See 21 U.S.C.A. § 371(a).
Cipollone had regulations interpreting its preemptive scope and
nothing in the opinion indicates that the issue of preemption
regulations was ever raised or considered. Appellee's argument
thus asks us to find a sub silentio holding in Cipollone, something
which courts are reluctant to do. See Federal Election Com'n v.
NRA Political Victory Fund, --- U.S. ----, ----, 115 S. Ct. 537,
542, 130 L. Ed. 2d 439 (1994). Moreover, the Supreme Court has
deferred to FDA preemption regulations in the past, see
Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S.
707, 712-14, 105 S. Ct. 2371, 2375-76, 85 L. Ed. 2d 714 (1985), and
has examined another agency's preemption practices in at least one
post-Cipollone case, see Wolens, --- U.S. at ----, 115 S. Ct. at 825
(discussing the Department of Transportation's interpretation of
its authority to displace courts in air carrier contract disputes).
We are therefore unable to conclude that Cipollone created an
express preemption rule which forecloses our examination of the
FDA's regulations.
The principles guiding deference to an agency's
interpretation of a statute are well established. First we must
ask whether Congress has spoken directly to the precise question.
Nationsbank of N.C., N.A. v. Variable Annuity Life Ins. Co., ---
U.S. ----, ----, 115 S. Ct. 810, 813, 130 L. Ed. 2d 740 (1995);
Chevron, 467 U.S. at 841-43, 104 S.Ct. at 2781. If the statute
does directly address the precise question, an agency
interpretation to the contrary is entitled to no deference; if
not, the Court must inquire into whether the agency's
interpretation is reasonable. Nationsbank, --- U.S. at ----, 115
S. Ct. at 813-14; Chevron, 467 U.S. at 843-44, 104 S.Ct. at 2782.
We defer to the agency's interpretation unless it is "arbitrary,
capricious, or manifestly contrary to the statute." Chevron, 467
U.S. at 844, 104 S.Ct. at 2782.
Congress's choice of the word "requirement" in § 360k(a)(1),
does not speak directly to the precise issue of whether Appellants'
state common law tort claims are preempted by the MDA. As used in
§ 360k(a), a "requirement" refers to a legal obligation, see Brown
v. Gardner, --- U.S. ----, ----, 115 S. Ct. 552, 555, 130 L. Ed. 2d
462 (1994) ("Ambiguity is a creature not of definitional
possibilities but of statutory context") and the corresponding
definition is "something called for or demanded," Webster's New
International Dictionary 1929 (3d ed. 1976). See Asgrow Seed Co.
v. Winterboer, --- U.S. ----, ----, 115 S. Ct. 788, 793, 130 L. Ed. 2d
682 (1995) (stating that undefined statutory terms should be given
their ordinary meaning). Even using this ordinary meaning, the
scope of the word "requirement" is ambiguous and consideration of
the FDA's interpretation is appropriate.
In defining the scope of § 360k(a), the FDA has indicated
that:
State or local requirements are preempted only when the Food
and Drug Administration has established specific counterpart
regulations or there are other specific requirements
applicable to a particular device under the act....
21 C.F.R. § 808.1(d) (emphasis added). We believe that this
narrowing of the meaning of "requirement[s]" applicable ... to the
device" to "specific counterpart regulations" or "specific
requirements applicable to a particular device" is reasonable
because it avoids a host of problems raised by a literal reading of
§ 360k(a). First, an expansive reading of § 360k(a) would infer
broad preemptive intent in the face of well-settled presumptions
against such a construction. See, e.g., ACF Industries, --- U.S.
at ----, 114 S. Ct. at 851. Second, the broadest construction of §
360k(a) would call into question almost all state law liability
pertaining to MDA-regulated manufacturers. Such an interpretation
would render the MDA's savings clause, 21 U.S.C.A. § 360h(d),
meaningless, violating a cardinal rule of statutory construction
which avoids interpretations which render a statutory provision
superfluous. See Ratzlaf v. United States, --- U.S. ----, ----,
114 S. Ct. 655, 659, 126 L. Ed. 2d 615 (1994). Third, although a
state PMA requirement would logically be preempted by a literal
reading of § 360k(a), the Act's legislative history suggests that
such practices should not be preempted. H.R.Rep. 853, 94th Cong.,
2d Sess. 45-46 (1976).11
Because Congress left open the question of what MDA
"requirements" preempt competing state requirements, the FDA's
addition of the word "specific" is a reasonable interpretation of
the statute. By clarifying the statutory term "requirement" to
mean "specific requirements," the FDA's preemption regulation
stayed within the zone of reasonableness required of agency
interpretations. See Chevron, 467 U.S. at 843-44, 104 S.Ct. at
2782-83. Finally, we note that every court decision which the
11
The House Report cited California's premarket clearance
program with approval as an example of practices which the FDA
should exempt from preemption under § 360k(b). H.R.Rep. 853,
94th Cong., 2d Sess. 45-46 (1976). Nevertheless, we believe the
statement is relevant to our interpretation of § 360k(a) by
demonstrating that Congress had no desire to completely occupy
the field of medical device regulation.
parties have brought to our attention either explicitly12 or
implicitly13 regards the preemption regulations as valid. We hold
that the FDA's preemption regulations are a reasonable
interpretation of § 360k(a) entitled to deference by the Court.
b. MDA Specific Requirements.
Although the FDA's clarification of § 360k(a) is helpful, we
must still struggle with defining what "specific requirements"
under the MDA trigger preemption. See 21 C.F.R. § 808.1(d).
Appellants interpret the regulations to mean that in this case
preemption is proper "only if there are federal requirements
imposed specifically upon manufacturers of pacemakers regarding"
design, manufacture, or warnings. In other words, Appellants take
the position that only MDA regulations which state that "a
pacemaker manufacturer must do ..." can constitute "specific
requirements" triggering preemption. Appellees, on the other hand,
argue that the regulations cannot be interpreted to require device
specificity.
A careful reading of the FDA's MDA preemption regulations does
not support the device-specific interpretation Appellants seek to
impose. Significantly, the regulations allow preemption "when [1]
the Food and Drug Administration has established specific
12
See, e.g., Martello, 42 F.3d at 1168; King, 983 F.2d at
1134; Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273, 1281
(Hawaii 1992); Ginochio v. Surgikos, Inc., 864 F. Supp. 948, 952
(N.D.Cal.1994).
13
See, e.g., Michael, 46 F.3d at 1324; Anguiano, 44 F.3d at
809; Gile v. Optical Radiation Corp., 22 F.3d 540, 543-44 (3rd
Cir.), cert. denied, --- U.S. ----, 115 S. Ct. 429, 130 L. Ed. 2d
342 (1994); Mendes, 18 F.3d at 16; Stamps v. Collagen Corp.,
984 F.2d 1416, 1424 n. 8 (5th Cir.), cert. denied, --- U.S. ----,
114 S. Ct. 86, 126 L. Ed. 2d 54 (1993).
counterpart regulations or [2] there are other specific
requirements applicable to a particular device under the act[.]"
Id. (emphasis supplied). The word "or" in the regulation indicates
that the FDA intended the two conditions for preemption to be
alternatives so that the existence of either condition triggers
preemption. See Hawaiian Airlines, --- U.S. at ----, 114 S. Ct. at
2245. While the first condition, the existence of "specific
counterpart regulations," might be read to require device
specificity, the second condition cannot.
The most natural reading of the FDA's "specific requirements"
language requires specificity in the nature of the requirements,
not in their applicability to designated devices. The "applicable
to a particular device" language, mirroring the statute, requires
a court to ask whether the requirements in question apply to the
device in question. See 21 U.S.C.A. § 360k(a); 21 C.F.R. §
808.1(d). That language does not suggest that the requirements
themselves must mention the particular device in question. Our
preemption inquiry must ask whether "specific requirements" apply
to a device, not whether the requirements specify the device.
Construing the FDA's preemption regulations to require device
specificity also contradicts the structure of the Act. Under the
MDA, Class III devices are subject to the highest level of scrutiny
through the PMA process.14 See 21 U.S.C.A. § 360c(a)(1)(C). Accord
14
The comparative costs of market entry under the MDA
supports the conclusion that the PMA process presents the highest
obstacle. While the average price-range of market entry through
the premarket notification 510(k) procedure is $50 to $2,000, the
equivalent range for devices undergoing the PMA process is
$111,000 to $828,000. Robert B. Leflar, Public Accountability
and Medical Device Regulation, 2 Harv.J.L. & Tech. 1, 47 (1989).
Martello, 42 F.3d at 1168; Stamps, 984 F.2d at 1419. Yet the PMA
procedure's "requirements" under the MDA are not device-specific.
Instead, the PMA process requires manufacturers to submit to an
approval process standardized for all Class III devices. See,
e.g., 21 U.S.C.A. § 360e(c)-(d); 21 C.F.R. §§ 814.1-814.45. It
would be anomalous for the MDA to preempt certain claims which
conflict with device-specific requirements placed on Class II
devices, see National Bank, 38 F.3d at 990; Moore v. Kimberly-
Clark Corp., 867 F.2d 243, 247 (5th Cir.1989), but not preempt
claims against devices subject to the MDA's most rigorous, albeit
non-device-specific, procedures.15 Thus, the overall structure of
the MDA supports interpreting the FDA's preemption regulations as
not requiring device specificity.
Finally, a device-specific requirement is contrary to the
clear weight of authority. Although some reported decisions demand
that an MDA's "requirement" be device-specific, see Larsen, 837
P.2d at 1282; Ginochio, 864 F. Supp. at 953; Oja v. Howmedica,
Inc., 848 F. Supp. 905, 906-07 (D.Colo.1994), only the Ninth Circuit
16
appears to accept this position. Anguiano, 44 F.3d at 809.
15
Claiming that the PMA procedures are device-specific
requirements because they subject each device to particularized
attention proves too much. For example, if the device-specific
examination of a PMA application under non-specific regulations
allows us to characterize the PMA procedures as device-specific,
then the individualized examination of a 510(k) application, see
21 U.S.C.A. § 360(k); 21 C.F.R. §§ 807.87-807.100, allows us to
characterize the 510(k) procedure as device-specific.
16
While Lamontagne v. E.I. Du Pont De Nemours & Co., 41 F.3d
846 (2nd Cir.1994) upholds a district court decision requiring
device-specificity, see Lamontagne v. E.I. Du Pont De Nemours &
Co., 834 F. Supp. 576, 582-83 (D.Conn.1993), it does so by
affirming the district court's dismissal of the complaint on
non-preemption grounds and does not address the issue of
Significantly, the First, Third, Fifth, and Eighth Circuits' MDA
preemption decisions reject reading any device-specific requirement
into § 360k(a) and its regulatory clarification. See Michael, 46
F.3d at 1324 (3rd Cir.); Reeves, 44 F.3d at 304-05 (5th Cir.);
Martello, 42 F.3d at 1169 (8th Cir.); Mendes, 18 F.3d at 17-19
(1st Cir.).
Nevertheless, our rejection of Appellants' interpretation of
the FDA regulations does not remove all significance from the FDA's
choice of the word "specific." While a precise definition of what
the FDA means by "specific requirements" is neither possible nor
desirable, the term must at least narrow the potentially unlimited
scope of preemption under § 360k(a). Starting with the plain
meaning of the term "specific," defined inter alia as "having a
real and fixed relationship to [and] restricted by nature to a
particular individual, situation, relation, or effect," Webster's
New International Dictionary 2187 (3d ed. 1976), the FDA's call for
"specific requirements" under the MDA and the interpretive
presumptions against preemption, see Hawaiian Airlines, --- U.S. at
----, 114 S. Ct. at 2243; ACF Industries, --- U.S. at ----, 114
S. Ct. at 851; Silkwood, 464 U.S. at 251-52, 104 S.Ct. at 623,
preclude an overly-broad reading of the Act's preemptive scope.17
preemption under the MDA.
17
For example, equating the FDA's broad power to monitor the
medical device market and intervene in the market when necessary,
see, e.g. 21 U.S.C.A. §§ 331-334, with the type of "specific
requirements" necessitating preemption would stretch the
regulation's language, and the preemptive scope of the MDA,
beyond the bounds of reason. The possession of jurisdiction is
not synonymous with making requirements. A rule equating
jurisdiction with preemption-triggering requirements would infer
absolute preemption whenever Congress legislates. Such a rule
We hold that preemption-triggering requirements should, in some
way, be "restricted by nature" to a particular process, procedure,
or device18 and should not be completely open-ended.
C. Preemption of Appellants' Claims
Having laid out the general rules of preemption under the MDA,
we must now conduct a claim-by-claim inquiry to determine whether
Appellants' state law claims are preempted.
The MDA preempts a state or local "requirement" which is both
"different from, or in addition to" a specific MDA requirement, and
"relates to the safety or effectiveness" or "any other matter"
included in a specific MDA requirement. 21 U.S.C.A. § 360k(a).
See also 21 C.F.R. § 808.1(d). We have already determined that
state common law claims can impose state requirements within the
meaning of the MDA and that these state requirements must be
compared with those specific MDA requirements applicable to the
device at the heart of the suit. We must now determine whether
Appellants' claims are "different from or in addition to" and
"relate to any matter" included in a specific MDA requirement. 21
U.S.C.A. § 360k(a).
The narrow focus of our inquiry should be emphasized. In this
section we examine only preemption of state common law claims
"is virtually tantamount to saying that whenever a federal agency
decides to step into a field, its regulations will be exclusive.
Such a rule, of course, would be inconsistent with the
federal-state balance embodied in our Supremacy Clause
jurisprudence." Hillsborough County, 471 U.S. at 717, 105 S.Ct.
at 2377; Moore, 867 F.2d at 245.
18
Device-specific requirements will often be "specific
requirements" triggering preemption. See 21 C.F.R. § 808.1(d).
This does not mean that specific requirements must be
device-specific.
against the manufacturer of a Class III device which entered the
market via the 510(k) process as the substantial equivalent of a
grandfathered device. This narrow focus often limits the
usefulness of the authorities both parties rely upon. For example,
Appellee's heavy reliance on Stamps, 984 F.2d 1416, and King, 983
F.2d 1130, is misplaced because the device at issue in those cases
had undergone the full PMA process before it entered the market.
Our narrow focus also precludes Appellants' reliance on Smith
v. Pingree, 651 F.2d 1021 (5th Cir., Unit B 1981). First, Smith
was decided prior to the Supreme Court's Cipollone decision and
relied on implied preemption principles to reach its decision.
Smith, 651 F.2d at 1024 (citing Chemical Specialties Mfrs. Assn.,
Inc. v. Clark, 482 F.2d 325, 327 (5th Cir.1973)). See also id. at
1025. Cipollone made clear that in the absence of some "cause to
look beyond" an express preemption provision, implied preemption
principles should not be used to decide the preemptive scope of a
statute in which Congress provided an express preemption
provision.19 Cipollone, --- U.S. at ----, 112 S. Ct. at 2618. See
also Freightliner, --- U.S. at ----, 115 S. Ct. at 1488. Second,
Smith is factually distinguishable from the instant case because it
considered the preemptive scope of the MDA's Class II regulations
on a state regulatory statute. Smith, 651 F.2d at 1022 (citing
Fla.Stat. §§ 468.135(7); 468.136(1)-(2)). Third and most
importantly, the result in Smith relies on the fact "that the
Florida statute does not relate "to a matter included in a federal
19
We also note that the Fifth Circuit has ignored Smith in
its post-Cipollone MDA preemption cases. See Reeves, 44 F.3d
300; Stamps, 984 F.2d 1416.
requirement applicable to a device.' " Smith, 651 F.2d at 1025
(quoting 21 U.S.C.A. § 360k(a)(2)). See also id. at 1024 (holding
that § 468.135(7) is not preempted because it addresses a different
concern than does the MDA). In other words, Smith found that the
state statute at issue did not relate to the safety and
effectiveness or to "any other matter" within the MDA. See 21
U.S.C.A. § 360k(a)(2). In contrast, Appellants cannot seriously
dispute that their tort action relates to the safety of the
Activitrax. Thus, Smith provides no guidance in deciding the case
before us.
1. Negligent Design.
Appellants' complaint alleged that Appellee breached its duty
of care to Lora Lohr by negligently designing and testing the
Activitrax pacemaker. Appellants contend that the district court
erred by dismissing this claim because the Activitrax and its Model
4011 lead were never subject to any specific requirements under the
MDA within the meaning of the Act's preemption provision. Appellee
responds that the district court correctly found Appellants' claim
preempted because the Activitrax is subject to numerous
requirements under the MDA. We conclude that none of the
regulations applicable to the Activitrax constitute specific
requirements under the MDA and therefore reverse the district
court's preemption of Appellants' negligent design claim.
Appellants' Florida law negligent design claim could certainly
impose a "State ... requirement" upon the Activitrax. 21 U.S.C.A.
§ 360k(a). As explained above, congressional use of the term
"requirement" sweeps broadly to encompass common law, as well as
statutory and regulatory requirements. Cipollone, --- U.S. at ----
, 112 S.Ct. at 2620, Duncan, 12 F.3d at 195. Appellants' negligent
design action would ask the jury to decide if Appellee did
"something that a reasonably careful person would not do under like
circumstances or ... fail[ed] to do something that a reasonably
careful person would do under like circumstances." Florida
Standard Jury Instructions in Civil Cases § 4.1. If the MDA
establishes specific requirements that apply to the design of the
Activitrax, Appellants' action would ask the jury to declare what
constitutes a reasonable design after the MDA already set the
standard. By doing so, Appellants' claim would be "different from
or in addition to" the MDA standard, would "relate ... to [a]
matter included" in the MDA, and would, therefore, be preempted.
See 21 U.S.C.A. § 360k(a). See, e.g., National Bank, 38 F.3d at
991; Gile, 22 F.3d at 544; Slater, 961 F.2d at 1333. In sum, if
the FDA, pursuant to its authority under the MDA, has imposed
specific requirements on the Activitrax, a jury cannot add any
requirements. See, e.g., Papas, 985 F.2d at 518. Appellee
identifies four ways in which the MDA allegedly imposes specific
requirements on the Activitrax and its Model 4011 lead. We
consider each in turn.
First, Appellee insists that the FDA's approval of the Model
4011's 510(k) submission constitutes a finding that the device is
safe and effective under the Act—a finding Appellee equates to a
specific requirement. Even 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.
A finding of "substantial equivalence" by the FDA means that
the new device has the same intended use as the original device and
that the new device either has the same technological
characteristics as the original or is demonstrated to be as safe
and effective as the original device. 21 U.S.C.A. § 360c(i)(1)(A)
(emphasis supplied).20 Thus, while a substantial equivalence
finding can be a finding of safety and effectiveness, there is no
way to tell whether a given substantial equivalence finding is a
finding of safety and effectiveness. Moreover, the FDA's
regulations explain that approval of a device under 510(k)
procedures as the substantial equivalent to a grandfathered device
"does not in any way denote official approval of the device." 21
C.F.R. § 807.97. This regulation makes obvious sense because the
FDA could hardly find a device "as safe and effective" as a
grandfathered device whose safety and effectiveness were never
established by MDA procedures. See 21 U.S.C.A. §
360c(i)(1)(A)(ii)(I). The lack of any official approval under the
510(k) procedure was made clear to Appellee when the Model 4011 was
approved in 1982. The FDA's clearance letter, tracking the
language of the regulations, cautioned Appellee that "[t]his letter
does not in any way denote official FDA approval of your device."
The regulations governing the form and content of a 510(k)
submission state that the "summary shall be in sufficient detail to
20
This section did not exist when the Model 4011 was
approved, but we accept for these purposes that the new section
only codified the prior practice of the FDA. See S.Rep. No. 513,
101st Cong., 2d Sess. 28 (1990).
provide an understanding of the basis for a determination of
substantial equivalence." 21 C.F.R. § 807.92(a). Thus, the MDA's
510(k) submission regulations clarify what should be obvious from
the statute: The 510(k) process is focused on equivalence, not
safety, and the question of whether a device has been deemed safe
and effective cannot be resolved by looking at the 510(k) process,
but must be determined by looking at the process through which the
original device entered the market. We therefore reject Appellee's
argument that 510(k) approval constitutes a finding of safety and
effectiveness within the Act.21 Cf. National Bank, 38 F.3d at 998
(Loken, J., concurring) (noting that "an FDA order permitting the
new device to be marketed as substantially equivalent to existing
devices would not normally reflect agency approval"). We hold that
510(k) approval under the MDA, standing alone, is not a finding of
safety and effectiveness and does not impose specific requirements
on a device for preemption purposes.
Second, Appellee suggests that by grandfathering pre-MDA
devices into the market, the Act recognized their safety and
effectiveness as historically established. We disagree. "[T]he
absence of a federal standard cannot implicitly extinguish state
common law." Freightliner, --- U.S. at ----, 115 S. Ct. at 1485.
Moreover, Appellee identifies nothing in the statute's text, or
even in its legislative history, to suggest that grandfathering
21
Surprisingly, Appellee does not cite to 21 C.F.R. §
807.94, which requires Class III 510(k) submissions to be
identified as such. While that regulation provides a scintilla
of support to Appellee's argument that a 510(k) submission is a
safety and effectiveness finding, it is not enough to overcome
our conclusion.
constitutes a safety and effectiveness finding. Given the strong
presumptions against the preemption of state common law claims, we
find this argument without merit.
Recognition of the MDA's competing purposes supports our
conclusion that grandfathering, without more, cannot justify
preemption under the Act. The MDA represents congressional
balancing of at least two competing purposes: the desire to
protect the public from unsafe devices and the desire to encourage
innovation and development in the biomedical technology field.
See, e.g. H.R.Rep. No. 853, 94th Cong., 2d Sess. 10-11 (1976);
S.Rep. No. 33, 94th Cong. 1st Sess. 10 (1975). In light of this
balancing, we can view the MDA as a compromise between device
manufacturers and Congress. In exchange for the financial and time
burdens placed upon manufacturers by the MDA, the manufactures were
assured a nationally uniform and predictable regulatory and
liability climate. A rule preempting liability based on
grandfathering would give the benefits of a uniform, predictable
liability climate to devices that never paid the MDA's regulatory
"price" for market entry. Additionally, allowing state tort suits
based upon the failure of pre-MDA devices would not disturb a
manufacturer's developmental calculus because presumably, when such
devices were first introduced, the devices were considered a wise
business investment despite state-imposed tort liability. In
short, preempting claims against grandfathered pre-MDA devices
would give their manufacturers a regulatory windfall.
Third, Appellee points to continued FDA surveillance of
devices like the Activitrax as constituting specific requirements
under the Act. See, e.g., 21 C.F.R. §§ 807.81(a)(3)(i) (requiring
FDA approval for any design changes); 895.25 (granting FDA
authority to order labeling changes). As already explained above,
these provisions cannot constitute specific requirements within the
meaning of the MDA's preemption regulation. At best, they are
general requirements because they have no "fixed relationship" and
are not "restricted by nature to" a particular process, procedure,
or device. See Webster's New International Dictionary 2187 (3d ed.
1976). In light of the presumption against preemption, the FDA's
jurisdiction to monitor the market is too slender a regulatory
strand to support preemption.
Finally, Appellee suggests that MDA procedures for
classifying devices impose specific requirements. See 21 U.S.C.A.
§ 360c(a); 21 C.F.R. § 860.7. As we have previously noted, a
"requirement" is best understood as "something called for or
demanded." Webster's New International Dictionary 1929 (3d ed.
1976). Putting a device into Class III, without more, places no
demands on the device's manufacturer. Accord National Bank, 38
F.3d at 997. The classification of devices under the Act is
similar to a regulatory census; while the classification may have
significant regulatory consequences, it creates no requirements by
itself.
Accordingly, we hold that Appellants' negligent design claim
is not preempted by the MDA because the Act does not establish any
specific design requirements, through a finding of safety and
effectiveness or otherwise, which conflict with the state law
claim.
2. Negligent Manufacture.
Appellants' complaint alleged that Appellee breached its duty
of care to Lora Lohr by negligently manufacturing and assembling
the Activitrax and Model 4011. The district court found that the
MDA preempted this negligent manufacturing claim. After reviewing
the requirements the MDA places on the manufacturing processes of
suppliers like Appellee, we affirm the district court.
Like their negligent design claim, Appellants' negligent
manufacturing claim could create state requirements because it
would ask a jury to determine how a reasonable manufacturer should
build the Activitrax. Therefore, the negligent manufacturing claim
is preempted if the jury could create a standard of conduct
"different from, or in addition to" a specific MDA requirement.
See 21 U.S.C.A. § 360k(a).
As we have already concluded, nothing in the MDA's 510(k)
approval procedures, grandfathering provision, oversight and
enforcement powers, or classification requirements constitutes a
"specific requirement" justifying preemption under the Act. See 21
C.F.R. § 808.1(d). In the case of manufacturing, however, Appellee
also points to the MDA's good manufacturing practice (GMP)
regulations as specific requirements justifying preemption. See 21
U.S.C.A. § 360j(f); 21 C.F.R. §§ 820.1-820.198.
The GMP regulations monitor the "methods used in, and
facilities and controls used for, the manufacture, pre-production
design validation ( ... but not including an evaluation of the
safety or effectiveness of a device), packing, storage, and
installation of a device ... to assure that the device will be safe
and effective...." 21 U.S.C.A. § 360j(f)(1)(A). As the statute's
text makes clear, although GMP requirements do not evaluate the
safety and effectiveness of the device, the GMP requirements do
ensure that the manufacturing, packing, and other processes
associated with a manufacturing enterprise are conducted safely and
effectively. Id. The GMP regulations include requirements
affecting a manufacturer's organization, personnel, building,
equipment, component controls, production and process controls,
packaging, labeling controls, holding, distribution, installation,
device evaluation, and record keeping. See 21 C.F.R. §§ 820.20-
820.198.
We believe the GMP requirements are specific requirements
which preempt Appellants' negligent manufacturing claim. Accord
Michael, 46 F.3d at 1324; Mendes, 18 F.3d at 19. While the
requirements are not device-specific, they are certainly specific
to manufacturing. Moreover, while the GMP regulations are written
in necessarily broad language22 to accommodate the myriad of
different producers covered by the MDA, the GMP regulations create
standards for almost every aspect of the manufacturing process.
See 21 C.F.R. §§ 820.20-820.198. The FDA's forfeiture actions
against non-complying manufacturers foreclose any suggestion that
22
For example, the regulation on personal sanitation within
buildings states:
Washing and toilet facilities shall be clean and
adequate. Where special clothing requirements are
necessary to assure that a device is fit for its
intended use, clean dressing rooms shall be provided
for personnel.
21 C.F.R. § 820.56(a).
the GMP regulations are hortatory and without substantive effect.
See, e.g., United States v. Laerdal Manufacturing Corp., 853
F. Supp. 1219, 1222-23, 1227-35 (D.Or.1994); United States v.
Undetermined Quantities of Var. Articles, 800 F. Supp. 499, 502-503
(S.D.Tex.1992); United States v. 789 Cases, 799 F. Supp. 1275,
1287-1293 (D.Puerto Rico 1992).
Appellants' negligent manufacturing claim constitutes a state
requirement "different from, or in addition to" the GMP
regulations' specific manufacturing requirements. We therefore
hold that the district court properly granted summary judgment on
this claim because it is preempted by the MDA.
3. Negligent Failure to Warn.
Appellants' complaint alleged that Appellee breached its duty
of care to Lora Lohr by negligently failing to warn and instruct
Ms. Lohr or her physicians about the dangers of the Activitrax
pacemaker. The district court found that the MDA preempted this
claim. A review of the MDA's warning and labeling requirements
convinces us that the district court was correct.
Like their other negligence claims, Appellants' failure to
warn claim could constitute a "State ... requirement" and is
preempted if the jury could conclude that a reasonable
manufacturer's warnings and labels would be "different from, or in
addition to" a specific MDA requirement. See 21 U.S.C.A. §
360k(a). Nothing in the MDA's 510(k) approval procedure,
grandfathering provision, oversight and enforcement powers, or
classification requirements constitute "specific requirements"
justifying preemption under the Act. See 21 C.F.R. § 808.1(d).
Like the manufacturing claim, however, Appellee points to
additional MDA regulations governing labeling as specific
requirements justifying preemption. See 21 C.F.R. §§ 801.109,
807.87(e).
Every prescription device like the Activitrax must comply with
an MDA imposed labeling requirement. 21 C.F.R. § 801.109. The
label on the device itself must inform the reader about the
prescription-only nature of the device and the method of its
application or use. 21 C.F.R. § 801.109(b). More importantly,
labeling "on or within" the device's packaging must contain (1)
usage information, "including indications, effects, routes,
methods, and frequency and duration of administration," and (2)
warning information, including any "relevant hazards,
contraindications, side effects, and precautions." 21 C.F.R. §
801.109(c). The FDA screens the premarket submissions of all
devices for compliance with labeling requirements, including 510(k)
submissions. 21 C.F.R. § 807.87(e).
We believe these labeling requirements constitute specific
requirements for preemption purposes. Accord Michael, 46 F.3d at
1324; Reeves, 44 F.3d at 305; Mendes, 18 F.3d at 18. As we have
made clear, the labeling regulations' lack of device specificity
does not dictate that they cannot be specific requirements for
preemption purposes. Instead, the regulations are quite specific
about what standards a manufacturer must follow when designing the
packaging and labeling for its product. See 21 C.F.R. §
801.109(b), (c). As with the GMP regulations discussed above, the
fact that the regulations are broadly phrased does not obviate
their effectiveness, but rather reflects the need to encompass many
thousands of devices within their requirements. Further, the FDA's
record of taking action against mislabeled devices forecloses the
argument that the Act's labeling requirements lack substantive
"bite." See, e.g., United States v. Various Articles of Device,
814 F. Supp. 32, 33 (E.D.Tenn.1992); United States v. Articles of
Device [Acuflex; Pro-Med], 426 F. Supp. 366, 370-71
(W.D.Penn.1977).
Appellants' failure to warn claim constitutes a state
requirement "different from, or in addition to" the MDA's specific
labeling requirements. We therefore hold that the district court
properly granted summary judgment on this claim because it is
preempted by the MDA.
4. Strict Liability in Tort.
Appellants' complaint alleged that Appellee is strictly
liable for Lora Lohr's injuries because it introduced an
unreasonably dangerous product—the Activitrax—into the market. As
with Appellants' other claims, the district court concluded that
the MDA preempted this claim. A comparison of Florida's strict
liability law and the regulatory scheme applicable to the
Activitrax convinces us that the district court was incorrect and
that Appellants' strict liability claim, insofar as it alleges that
the Activitrax and Model 4011 are unreasonably dangerous as
designed, should be allowed to proceed.
Like Appellants' other claims, a Florida strict liability
action could impose a "State ... requirement" on the Activitrax.
21 U.S.C.A. § 360k(a). A strict products liability action under
Florida law would ask the jury "whether the [Activitrax] supplied
by [Appellee] was defective when it left the possession of
[Appellee]." Florida Standard Jury Instructions, § PL. The jury
can find a product defective "if it is in a condition unreasonably
dangerous to the user [and reaches] the user without substantial
change" or "if by reason of its design the product is in a
condition unreasonably dangerous to the user [and reaches] the user
without substantial change." Florida Standard Jury Instructions,
§§ PL 4, PL 5. A product may be unreasonably dangerous due to
defects in its design, manufacture, or labeling. See, e.g.,
Radiation Technology, Inc. v. Ware Const. Co., 445 So. 2d 329, 331
(Fla.1983); Brown v. Glade and Grove Supply, Inc., 647 So. 2d 1033,
1035 (Fla.App.1994).
Under Florida's strict liability doctrine, the burden of
rendering a product safe is placed in the hands of the entities "in
a better position to ensure the safety of the products." Samuel
Friedland Family Enterprises v. Amoroso, 630 So. 2d 1067, 1068
(Fla.1993). A finding that defects in a product render it
unreasonably dangerous is necessarily a finding that the product is
unsafe. The word "dangerous" itself is defined in terms of safety:
"exposing to danger, involving risk, demanding caution or care as
extremely unsafe." Webster's New International Dictionary 573 (3d
ed. 1976). Thus, if the MDA establishes specific requirements
designed to avoid having unsafe products reach users, then
Appellants' strict liability action would be "different from, or in
addition to" the MDA standard and is therefore preempted. See 21
U.S.C.A. § 360k(a).
Our analysis of Appellants' three negligence claims guides our
strict liability inquiry. Because the 510(k) process,
grandfathering provision, oversight and enforcement powers, and
classification requirements do not impose specific safety
requirements on the Activitrax's design, it follows that they do
not prevent that design from creating an unreasonably dangerous
product. In contrast, because the GMP and labeling requirements
create standards of care for manufacturing and labeling drafted to
ensure that devices are manufactured and labeled in a safe manner,
it follows that these requirements should prevent the manufacturing
or labeling of the Activitrax from creating an unreasonably
dangerous product.23
Accordingly, we hold that Appellants' strict liability claim
arising from an allegedly unreasonably dangerous design is not
preempted, but any contentions that the manufacture or labeling of
the Activitrax created an unreasonably dangerous product are
preempted by the MDA. On remand, the district court should ensure
that Appellants' strict liability claim is limited to proving that
the Activitrax and Model 4011 lead are unreasonably dangerous as
designed. Appellants should not be allowed to revive their
preempted negligent manufacturing and failure to warn claims in the
form of a strict liability claim.
III. CONCLUSION
23
Preempting strict liability claims arising from some
processes, but not others, is consistent with Florida caselaw.
See ISK Biotech Corp. v. Douberly, 640 So. 2d 85, 88-89
(Fla.App.1994) (preempting, under FIFRA, failure to warn claim
but allowing strict liability claim "based solely on the
product's defective condition" to proceed); Brennan v. Dow
Chemical Co., 613 So. 2d 131, 132 (Fla.App.1993) (same).
The Court's decision to preempt some, but not all of
Appellants' claims is sure to please neither party. Nevertheless,
as the Supreme Court noted in its latest preemption decision,
"[t]he middle course we adopt seems to us best calculated to carry
out the congressional design." Wolens, --- U.S. at ----, 115 S. Ct.
at 827. Any displeasure with that design should be directed toward
Congress. The lines and distinctions we draw in today's decision
are not always neat or easy, but "in our system of adjudication,
principles seldom can be settled "on the basis of one or two cases,
but require a closer working out' " Id. (quoting Pound, Survey of
the Conference Problems, 14 U.Cin.L.Rev. 324, 339 (1940)).
In conclusion, we hold that the district court properly held
that Appellants' negligent manufacture and negligent failure to
warn claims are preempted by the MDA. But the district court erred
when it held Appellants' negligent design claim and strict
liability claim arising from an unreasonably dangerous design were
preempted by the Act.
AFFIRMED in part, REVERSED in part, and REMANDED.