Salazar v. Medtronic, Inc ( 2001 )

IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
_____________________
No. 99-41089
_____________________
BILLYE JEANNE MARTIN,
Plaintiff-Appellant,
versus
MEDTRONIC, INC.,
Defendant-Appellee.
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_____________________
No. 99-41090
_____________________
LIBRA SALAZAR,
Plaintiff-Appellant,
versus
MEDTRONIC, INC.,
Defendant-Appellee.
_________________________________________________________________
Appeals from the United States District Court
for the Southern District of Texas
_________________________________________________________________
June 18, 2001
Before REYNALDO G. GARZA, JOLLY, and HIGGINBOTHAM, Circuit Judges.
E. GRADY JOLLY, Circuit Judge:
In this consolidated appeal,1 we address a question of federal
preemption: whether, based on Medtronic’s compliance with the Food
and Drug Administration’s (“FDA”) rigorous premarket approval
procedure (“PMA”), the plaintiffs’ Texas common law products
liability tort claims are preempted by 21 U.S.C. § 360k, the
Medical Devices Amendments (“MDA”) to the Food, Drug, and Cosmetic
Act (“FDCA”). We have addressed this issue before. In Stamps v.
Collagen Corp., 984 F.2d 1416, 1422 (5th Cir. 1993), we held that
similar state product liability claims were preempted. Since we
decided Stamps, however, the Supreme Court has spoken on the issue.
See Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S. Ct. 2240, 135
L. Ed. 2d 700 (1996). The Supreme Court did not specifically decide
the case before us, yet spoke in a way that overruled Stamps in
part. Lohr is a difficult opinion to apply in this case; first,
because it involves a process far less specific in its requirements
than the PMA process involved in both this case and Stamps, and
second, because on points important to this appeal, the Lohr court
was fractured. In any event, we ultimately determine that for
purposes of deciding this appeal, Stamps is binding precedent that
controls the outcome of the case. Accordingly, we hold that the
1
The cases have been consolidated for the purposes of appeal
only. The appellants, however, brief their appeal as if the
district court considered their cases on a consolidated basis.
Therefore, we treat the procedural history in the same manner.
2
Texas state product liability claims in this case are preempted by
the MDA, and we affirm the judgment of the district court
dismissing the complaint.
I
Billye Jeanne Martin and Libra Salazar each claim that they
were injured by Medtronic’s defective pacemaker (Model 4004). They
allege that the pacemaker contained a defective “ventricular lead,”
the wire that carries current into the heart muscle. Their product
liability claims include negligence, gross negligence, strict
liability, breach of warranty, and violation of the Texas Deceptive
Trade Practices Act; all claims are based on alleged deficiencies
in the safety and effectiveness of the design, manufacturing
process, warnings, and labeling of the lead.
The district court initially granted Medtronic’s motion for
summary judgment only in part, finding that the MDA preempted
Salazar’s and Martin’s design, manufacturing process, and warning
claims. The district court reasoned that in all these areas, the
FDA, through its PMA procedure,2 had approved Medtronic’s product.
The district court, however, denied summary judgment on the
2
Under the FDA’s PMA process, the manufacturer of the medical
device must submit a detailed application to the FDA, including
information on product specifications, manufacturing, intended use
and proposed labeling. Qualified experts review each application
and prepare a report and recommendation. The FDA then has six
months to accept or reject the application. See 21 U.S.C. § 360e;
Stamps v. Collagen Corp., 984 F.2d 1416, 1419 (5th Cir. 1993).
3
plaintiffs’ claims that Medtronic had deviated from FDA
requirements. Following further discovery, Medtronic renewed its
summary judgment motion. The district court then granted the
renewed motion, finding that appellants failed to produce evidence
of alleged deviations, and entered judgment dismissing each
complaint. These appeals, now consolidated, present the single
issue of whether the FDA’s PMA procedure preempts the state law
tort claims.
II
We begin our consideration of this question of preemption by
making a few preliminary observations that serve to place in
context the even more precise issue before us--to what extent is
our case today decided by precedents of this court and the Supreme
Court. The MDA classifies medical devices into three categories
based on the degree of risk they pose to the public. Class I
devices pose little or no risk to public health and are subject
only to general controls on manufacturing. Class II devices are
potentially more harmful and may be subject to regulations and
product specifications. Class III devices, the most strictly
regulated, are “[d]evices that either ‘presen[t] a potential
unreasonable risk of illness or injury,’ or which 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
4
impairment of human health.’” Lohr, 518 U.S. at 477 (quoting 21
U.S.C. § 360c(a)(1)(C)).
A pacemaker is classified as a “Class III” medical device. As
such, it must undergo an indisputably thorough, rigorous, and
costly premarket review (some 1,200 FDA man-hours at hundreds of
thousands of dollars in cost) by the FDA. Under this PMA process,
the manufacturer must give the FDA a “reasonable assurance” that
the product is safe and effective. Although this term does not
sound excessively demanding, the PMA process is rigorous. It
requires manufacturers to submit detailed information regarding the
safety and efficacy of their devices. This includes, among other
things, full reports of all information that is known by the
applicant, samples of both labeling and the device itself, and a
full description of the methods and facilities used for
manufacturing and installation of the device. See 21 U.S.C. §
360e(c)(1) (describing the components of a PMA application). The
FDA then reviews the application, spending an average of 1,200
hours on each submission before granting marketing approval. The
statutory basis for this process, and its exceptions, are set forth
at length in Lohr, 518 U.S. at 477, and need not be reiterated
here.
It is central to our resolution of this appeal that we have
held that § 360k preempts these state products liability claims
5
when the device manufacturer complies with the FDA’s PMA process.
See Stamps, 984 F.2d at 1422. In this appeal, it is not disputed
that Medtronic has complied with the FDA’s PMA process in the
creation of its pacemakers. Thus, based on the holding of Stamps,
the claims here should be preempted.
But yet there is a twist. After Stamps, the Supreme Court
considered the scope of MDA preemption of state law claims in the
“§ 510(k) notification” process,3 an exception to the far more
demanding PMA review process. See Lohr, 518 U.S. 470. The §
510(k) process allows improvements to existing devices to be
rapidly introduced into the market by foregoing the extensive
review in the PMA process. Id. at 478. While the PMA process
requires an inquiry into the risks and efficacy of each device
through a variety of reports and submissions, as described above,
the § 501(k) process only requires the manufacturer to show that
the device is “substantially equivalent” to devices already on the
market. Under the § 501(k) process, the manufacturer must submit
proposed labeling, labels, and advertisements that describe the
device, its intended use and the directions for its use; a
statement indicating how the device is similar to or different from
comparable products; a statement that the submitter believes that
3
The section number refers to the original section of the MDA
containing the provision.
6
the information is accurate and complete; and any additional
information necessary for the FDA Commissioner to make a
determination as to whether the device is “substantially
equivalent.” See Buckman Co. v. Plaintiffs’ Legal Committee, 531
U.S. 341, 121 S. Ct. 1012, 1016, 148 L. Ed. 2d 854 (2001); 21 C.F.R.
§§ 807.87, 807.92. The manufacturer does not have to submit
information on the safety or efficacy of the device. In contrast
to the 1,200 hours that it takes to complete a PMA review, a §
510(k) review takes an average of 20 hours. Lohr, 518 U.S. at 479.
As the Supreme Court has noted, “[t]he § 510(k) notification
process is by no means comparable to the PMA process.” Id. at 478-
79.
Lohr, however, is highly relevant to this appeal because it
considered in some detail the preemption statute that is applicable
both to the § 510(k) process and the PMA process. Notwithstanding
its relevance, the Supreme Court decision must be more than merely
illuminating with respect to the case before us, because a panel of
this court can only overrule a prior panel decision if “such
overruling is unequivocally directed by controlling Supreme Court
precedent.” United States v. Zuniga-Salinas, 945 F.2d 1302, 1306
(5th Cir. 1991). This means that Stamps should apply to this case
unless “an intervening Supreme Court case explicitly or implicitly
overrul[es] that prior precedent.” United States v. Short, 181
7
F.3d 620, 624 (5th Cir. 1999). Thus, the first, and ultimately
only, question we face is the degree to which Stamps retains
precedential value after the Supreme Court’s decision in Lohr.
A
To resolve the impact of Lohr on our precedent in Stamps, we
begin by setting out the relevant statutory and regulatory language
that we must consider. Section 360k(a) (“General Rule”) is the
preemption provision of the MDA governing the extent to which the
MDA preempts state law. It applies both to situations arising
under the § 510(k) process and the PMA process. It states:
[N]o State or political subdivision of a State may
establish or continue in effect with respect to a device
intended for human use any requirement–-
(1) which is different from, or in addition to, any
requirement applicable under 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 FDA has promulgated regulations
interpreting § 360k, which state:
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, 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).
B
8
With both the statute and the regulations in mind, we turn to
consider the intervening Supreme Court decision, Medtronic Inc. v.
Lohr, 518 U.S. 470. In Lohr, the Supreme Court considered whether
state tort claims were preempted when the FDA subjected the medical
device to § 510(k) notification under the MDA, a process, as we
have noted, far less thorough than the PMA process presented in
this case.4 In a five to four decision, the Court held that the
state tort claims in that § 510(k) case were not preempted. The
Court, however, fractured over the question of whether the
preemption section of the MDA would ever preempt general state law
tort claims.
The facts underlying the plaintiffs’ claims in Lohr are
similar to the facts in our case: Lohr and her husband sued on
state law claims over a defective lead in a pacemaker. Their
complaint alleged both negligence and strict liability claims for
defective design, failure to warn, and negligent manufacturing.
Unlike our case, however, which involves a rigorous review under
4
As the Supreme Court itself has observed, the PMA process and
the § 510(k) process are clearly distinguishable. See Lohr, 518
U.S. at 493 (noting that substantially equivalent devices have
“never been formally reviewed under the MDA for safety or efficacy”
and that the FDA does not consider the § 510(k) process “official
FDA approval”); Buckman, 121 S. Ct. at 1017 (“Admittedly, the §
510(k) process lacks the PMA review’s rigor: The former requires
only a showing of substantial equivalence to a predicate device,
while the latter involves a time-consuming inquiry into the risks
and efficacy of each device.”).
9
the PMA process, Medtronic began marketing the pacemaker lead in
Lohr after the FDA had found only that the device was
“substantially equivalent” to devices already on the market under
§ 510(k). Indeed, the FDA itself “emphasized . . . that [the §
510(k) notification process] should not be construed as an
endorsement of the pacemaker lead’s safety.” Lohr, 518 U.S. at 480.
The Court’s reasoning largely focused on the requirements of
the FDA’s regulation interpreting § 360k, cited and quoted earlier
in this opinion. The Court observed that certain factors must be
present, according to the regulations, before § 360k would preempt
state requirements. First, there must be a state requirement
specifically developed with respect to medical devices that is
different from or in addition to federal requirements. Second, the
state requirement must relate to the safety or effectiveness of the
device, or “‘other matter included in a requirement applicable to
the device.’” Lohr, 518 U.S. at 500 (quoting 21 U.S.C. § 360k(a)).
State requirements of “‘general applicability’ are not preempted
except where they have ‘the effect of establishing a substantive
requirement for a specific device.’” Id. Third, the federal
requirement must be specific to the particular device. The Court
held that because neither the federal requirements relating to the
§ 510(k) notification procedure nor the state common law
10
requirements were specific to the device, Lohr’s tort claims were
not preempted.
Although the Court concluded that Lohr’s tort claims were not
preempted, the majority split on the broader question of whether
the duties enforced by common law actions could ever be
“requirements” for the purpose of preemption. The four justice
plurality written by Justice Stevens, distinguishing the MDA from
the statute in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112
S. Ct. 2608, 120 L. Ed. 2d 407 (1992), found that general common law
actions were not the “requirements” that Congress was concerned
about when it enacted the preemption provision. Thus, Justice
Stevens concluded that Ҥ 360k(a) simply was not intended to pre-
empt most, let alone all, general common-law duties enforced by
damages actions.” Lohr, 518 U.S. at 491. That, however, was only
a plurality.
The meaning of Lohr as applied to our case becomes confusing
at this point. Concurring with only parts of the majority writing,
Justice Breyer found that the MDA could in fact preempt state tort
suits. Relying on Cipollone, in which the “Court made clear that
similar language ‘easily’ encompassed tort actions,” he reasoned
that a state requirement that takes the form of a duty of care is
essentially no different from a state statute or regulation. Id.
at 504 (Breyer, J., concurring). Justice Breyer noted, however,
11
that the FDA promulgated a regulation that allows preemption when
there are “‘specific [federal] requirements applicable to a
particular device.’” Id. at 506 (quoting 21 C.F.R. § 808.1(d)
(1995)). Because the FDA requirements relating to design,
manufacturing and labeling in the § 510(k) notification process at
issue in Lohr were “not ‘specific’ in any relevant sense,” Justice
Breyer concluded that the FDA did not intend the § 510(k)
notification procedures to preempt state tort claims. Id. at 507.
The four justices concurring in part and dissenting in part,
relying on the § 360k preemption language and not the FDA’s
regulations, concluded that “state common-law damages actions do
impose ‘requirements’ and are therefore pre-empted where such
requirements would differ from those imposed by the FDCA.” Id. at
509 (O’Connor, J., concurring in part, dissenting in part). Justice
O’Connor noted that a majority of the Court in Cipollone agreed
that state common law damages actions do impose “requirements,” and
that the rationale behind that decision was equally applicable in
Lohr. Id. at 510. Thus, given Justice Breyer’s concurrence, five
justices would agree that state common law actions do impose
”requirements” that can be preempted under the statute, as found in
Cipollone.
Because only parts of Justice Stevens’s opinion commanded a
majority, extracting the final meaning of Lohr is no easy task.
12
Assessing Lohr in the light of the three requirements for
preemption described above, the Court first held that general
common law duties do not impose requirements that are different
from or in addition to the § 501(k) process. The Court offers no
clear guidance on when the common law may satisfy the second
factor, that is, that the state requirement relate to the safety or
effectiveness of the device or establish a “substantive
requirement” for a specific device. Although Justice Breyer’s
concurrence very specifically disavows the view that common law
duties cannot provide substantive requirements for the purpose of
preemption, neither his concurrence nor the plurality opinion
offers much help to us in developing the point. As to the third
factor, the Court held that the FDA’s “substantially equivalent”
determination under the § 501(k) process is not a federal
regulation specific to a particular device, at least under the
facts of Lohr. Because these holdings do not explicitly or
implicitly decide the case before us, we must compare Lohr with
Stamps, the circuit precedent that we are required to follow.
C
Our decision in Stamps, 984 F.2d 1416, which relies on
Cipollone and predates Lohr, held that state tort claims in that
case were preempted under the MDA. In Stamps, the plaintiff
contracted a rare autoimmune disease from being injected with
13
defendant’s Class III products. She then filed suit alleging
defective design, inadequate warnings, and negligent failure to
warn. Because the FDA scrutinized the labeling, design, and
manufacturing of a product during the PMA process, we determined
that each of these state claims covered an area stringently
regulated by the FDA.
We then addressed the question of whether state tort claims
could be considered state “requirements” under § 360k. Relying on
the Supreme Court’s preemption doctrine as laid out in Cipollone,
505 U.S. 504, we noted that the term “requirements” in § 360k(a)
“‘sweeps broadly’ and encompasses common law tort actions within
its preemptive scope.” Stamps, 984 F.2d at 1421. Thus, the
specific duties in Texas tort liability create requirements in
addition to the strict requirements of the Class III PMA process.
Stamps concluded that “[s]tate tort causes of action–-to the extent
they relate to safety, effectiveness, or other MDA requirements--
constitute requirements ‘different from, or in addition to’ the
Class III process; they are, therefore, preempted.” Stamps, 984
F.2d at 1424.
III
When we turn to consider the impact of Lohr on the
precedential effect of Stamps, we can immediately conclude that the
14
Supreme Court did not explicitly overrule the case. Neither do we
think that Lohr implicitly requires us to disregard Stamps as
controlling precedent.5 Although Stamps gave § 360k a somewhat
broader preemptive scope than the Supreme Court’s opinion in Lohr,6
none of the components of the preemption test in Lohr contradict
the holding in Stamps as applied here. As noted above, the Supreme
Court held that for preemption under § 360k, there must be a state
requirement--which does not exclude common law tort duties--with
5
In fact, after Lohr, both the Sixth and the Seventh Circuits
determined that the PMA process constitutes specific federal
requirements that preempt state tort suits. Kemp v. Medtronic, 231
F.3d 216, 226-227 (6th Cir. 2000); Mitchell v. Collagen Corp., 126
F.3d 902, 913 (7th Cir. 1997). These decision parallel our
reasoning in Stamps. Although not all courts have found that
common law tort suits relating to the device are preempted by the
PMA process, see Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th
Cir. 1999) (finding that plaintiffs’ state law tort claims were not
preempted by Medtronic’s compliance with the FDA’s PMA process),
Brooks v. Howmedica, Inc., 236 F.3d 956 (8th Cir. 2001) (finding
that the PMA process constitutes specific federal requirements and
common law tort suits can constitute specific state requirements
but finding no conflict between them), vacated and reh’g en banc
granted by 246 F.3d 1149 (8th Cir. 2001), our question is not
whether the panel in Stamps correctly decided the case, but whether
the Supreme Court overruled Stamps. As long as Stamps is not
inconsistent with the law set out in Lohr, this panel has no
authority to overrule it.
6
For instance, Stamps notes that “section 360(k). . . ‘sweeps
broadly’ and encompasses common law tort actions within its
preemptive scope.” Stamps, 984 F.2d at 1421. In contrast, Lohr
remarks on the FDA’s “narrow understanding” of § 360k and finds
that “it is impossible to ignore [the statutory and regulatory
language’s] overarching concern that pre-emption occur only where
a particular state requirement threatens to interfere with a
specific federal interest.” Lohr, 518 U.S. at 500, n. 18.
15
respect to a medical device that relates to the safety or
efficiency of a device, or establishes a substantive requirement
for the device, that is different from or in addition to a specific
federal requirement. Lohr, 518 U.S. at 500. Stamps is not
contrary to these criteria.
A
First, Stamps found that common law tort suits can impose
state requirements for the purposes of preemption. Stamps, 984
F.2d at 1423. Although not part of the holding of Lohr, a majority
of the justices in Lohr clearly agreed with this proposition. See
518 U.S. at 509 (“I conclude that state common-law damages actions
do impose ‘requirements’ and are therefore pre-empted where such
requirements would differ from those imposed by the
FDCA”)(O’Connor, J., dissenting). Id. at 503 (“[T]he MDA will
sometimes pre-empt a state-law tort suit.”)(Breyer, J.,
concurring). Thus, it seems clear that Lohr did not overrule our
holding in Stamps that state tort suits can constitute specific
state requirements for the purposes of preemption.
B
Second, Stamps found that common law duties could be preempted
“to the extent that they relate[d] to safety, effectiveness, or
other MDA requirements.” Stamps, 984 F.2d at 1423. With some
similarity, Lohr observed that state requirements must, “with
16
respect to” medical devices, establish a “substantive requirement
for a specific device,” and must relate to the “safety or
effectiveness of the device or to any other matter included in a
requirement applicable to the device.” Lohr, 518 U.S. at 500. The
Lohr majority opinion did not articulate when common law
requirements may become “substantive requirements” or under what
circumstances they are considered to be “specifically developed
‘with respect to’ medical devices.” Id. at 501. To determine
whether Stamps’s understanding of common law duties as state
requirements is consistent with Lohr, we must therefore consider
Justice Stevens’s opinion in the light of Justice Breyer’s
concurrence.
Justice Breyer joined in the majority’s finding that “general
state common-law requirements in this suit were not specifically
developed ‘with respect to’ medical devices,” and that “these state
requirements escape preemption . . . because their generality
leaves them outside the category of requirements that § 360k
envisioned to be ‘with respect to’ specific devices such as
pacemakers.” Lohr, 518 U.S. at 501. Justice Breyer’s separate
concurrence, however, which recognizes that common law tort suits
may be preempted, does not support a conclusion that common law
claims are invariably too general for preemption. Indeed, Justice
Breyer noted that he “basically agree[d] with Justice O’Connor’s
17
discussion” of whether the MDA can preempt a state law tort suit
Id. at 503, which observed that “state common-law damages actions
do impose ‘requirements’ and are therefore pre-empted where such
requirements would differ from those imposed by the FDCA.” Id. at
509. Furthermore, Justice Breyer specifically disavowed the
portions of the opinion finding that “[i]t will be rare indeed for
a court hearing a common-law cause of action to issue a decree that
has ‘the effect of establishing a substantive requirement for a
specific device,’” Id. at 502 (plurality) (citing CFR §
808.1(d)(6)(ii)(1995)), and that the term “‘[r]equirement appears
to presume that the State is imposing a specific duty on the
manufacturer.” Id. at 487. As noted by the Ninth Circuit, these
apparently conflicting positions make analysis difficult:
[I]t makes little sense to argue that Justice Breyer
would write separately to make clear his position that
duties arising under state common law can constitute
state law “requirements” which can be preempted by the
MDA, and then agree that because tort law consists of
generally applicable principles, it is always preempted,
even in the face of specific federal requirements.
Papike v. Tambrands Inc., 107 F.3d 737, 742 (9th Cir. 1997).
Of course, we are plainly bound to follow the majority opinion
in Lohr; yet, we cannot fully grasp the opinion’s interpretation of
when state common law requirements are considered “specifically
developed with respect to medical devices” without Justice Breyer’s
concurrence. The majority opinion says that general common law
18
obligations are not a threat to federal requirements. Id. at 501.
Justice Breyer joins in the opinion, but, in his concurrence, he
points out that these general common law requirements are not a
threat because there is no potential for them to conflict with the
federal requirements at issue in Lohr, namely, the requirements
under the § 501(k) process. He also notes that while common law
duties may seem general, they can result in the imposition of
standards that are very device-specific. Justice Breyer takes the
position that there is no preemption in Lohr because there is no
conflict between the § 501(k) process and general common law
duties. See Lohr, 518 U.S. at 508 (Breyer, J., concurring)(“I can
find no actual conflict between any federal requirement and any of
the liability-creating premises of the plaintiffs’ state-law tort
suit”). Justice Breyer’s emphasis on the juxtaposition of the
state and federal duties suggests that the Court would be less
sanguine about the generality of common law duties if the federal
requirements were specific, say, as in the PMA process.7
7
Justice Breyer even notes that “it is possible that the
plurality also agrees” that
insofar as the MDA pre-empts a state requirement embodied
in a state statute, rule, regulation, or other
administrative action, it would also pre-empt a similar
requirement that takes the form of a standard of care or
behavior imposed by a state-law tort action.
Lohr, 518 U.S. at 504-05 (Breyer, J. concurring). This observation
suggests that it was important to Lohr’s conclusion that both state
and federal requirements were general.
19
We think it is important to read the portion of the majority
opinion addressing specific state requirements narrowly to avoid
adopting as controlling law the broadly worded plurality opinion.
Using Justice Breyer’s concurrence as a guide, we can conclude only
that general duties of care can generate specific requirements that
conflict with specific FDA requirements. We read Justice Breyer’s
special concurrence to recognize that, although a manufacturer’s
general duty of care to avoid foreseeable dangers may be too
general to merit preemption when there is no specific federal
requirement, the proof required to establish a particularly alleged
common law claim can be specific enough that the claim becomes
preempted as an “additional” or “different” requirement than the
FDA requirement.8 This reasoning is consistent with the majority
opinion; while the general duty, standing on its own, is not a
threat to federal requirements and is not developed specifically
“with respect to” medical devices, the elements needed to prove a
violation of that general duty may be very specifically tailored to
the device, and the state court action may therefore threaten
specific federal requirements. Because the federal § 510(k)
8
However, common law duties that incorporate the PMA process,
such as the general duty to take due care to comply with the PMA
process in labeling or manufacturing, will never contain specific
requirements that are additional to or different from federal
requirements. Therefore, claims based on those duties are not
preempted. See Lohr, 518 U.S. at 495.
20
requirements were not specific, it was unnecessary in Lohr to reach
that conflict. For instance, as an example of a general common law
duty, the majority opinion uses a “general duty to inform users and
purchasers of potentially dangerous items of the risks involved in
their use.” Id. at 501. While this duty does not seem “developed
with respect to” a medical device specifically, proving a violation
of that duty would require a jury to determine precisely what
information users should have been provided. Those determinations
would not conflict with the § 510(k) process, because that process
does not determine or approve what information consumers of the
product should be provided. On the other hand, however, a jury’s
determination may directly conflict with FDA determinations and
approvals made during the PMA review process.
Thus, reading the language in the majority opinion through the
lens of Justice Breyer’s concurrence, we cannot say that Lohr
overruled the holding of Stamps that common law tort claims
challenging the safety or effectiveness of a device create specific
requirements under state law. After Lohr, however, we need to
consider more than whether the common law duties relate to safety,
effectiveness, or other MDA requirements; we need to focus on
whether the specific requirements imposed by those common law
duties threaten to interfere with specific federal requirements.
C
21
Third, Stamps interpreted state tort causes of action as
requirements “different from, or in addition to” the PMA process,
thereby meriting preemption. Stamps, 984 F.2d at 1423. This
holding reflects a comparison of state and federal requirements and
a consideration of how additional state common law requirements
could undermine the FDA’s detailed PMA review process. On the
other hand, Lohr compared common law duties with the § 510(k)
process, which imposes relatively minor disclosure requirements,
and found that preemption was not appropriate. Given the
difference between the intensive PMA review and the minimal
requirements under the § 510(k) process, Lohr does not call into
question the holding of Stamps, that common law duties can impose
requirements different from or in addition to the PMA process.
Stamps, however, specifically disagreed with the proposition
that “the lack of direct conflict between the state and federal
regulations compel[led] a finding of no preemption.” Id. at 1424.
On the other hand, this proposition seems to have been adopted by
the Supreme Court; Lohr notes that “[n]othing in § 360k denies
Florida the right to provide a traditional damages remedy for
violations of common-law duties when those duties parallel federal
requirements.” Lohr, 518 U.S. at 495. This language tells us that
tort suits based on a manufacturer’s failure to follow the FDA’s
regulations and procedures are not preempted. Indeed, that is
22
precisely what the district court held in this case, and that
holding has not been appealed. In the context of the PMA process,
we agree that state tort suits that allege, as the basis of their
claim, that the approved FDA requirements have not been met are not
preempted. Thus, Lohr narrows the language in Stamps’s preemption
analysis to allow for state actions that parallel federal
requirements. This holding of Lohr, although overruling Stamps in
that specific matter, does not, however, overrule Stamps as it
applies to the case before us.
D
Fourth, Stamps held that the PMA process imposed specific
federal requirements as to labeling, manufacturing, and design for
the purposes of preemption.9 Here, too, there is no conflict with
Lohr. Although Lohr considered the application of the identical
FDA regulation governing labeling, the labeling requirements in
Lohr under the § 510(k) process were general; as it did not go
through the PMA process, the labeling in Lohr was not specifically
reviewed by the FDA.
9
During the PMA process, the FDA reviews the proposed labeling
as well as the ingredients, components, methods, controls, and
facilities used in the manufacture and processing of the device.
21 U.S.C. § 360e(c)(1)(B)-(C),(F). If any element of the
manufacturing does not comply with regulations, or labeling is
found to be false or misleading, the application for approval is
denied. Id. § 360e(d)(2)(A)-(D).
23
On its face, therefore, Lohr is limited to a finding that the
§ 501(k) process does not create specific federal requirements that
conflict with state tort actions. Indeed, the plurality’s opinion
itself seems to leave this suggestion when it notes at several
points in the course of its writing the very significant
differences between the FDA’s § 510(k) approval and a PMA approval.
See, e.g., 518 U.S. at 492-94 (noting that the § 510(k) process “is
focused on equivalence, not safety. As a result, substantial
equivalence determinations provide little protection to the
public”) (internal quotations and citations omitted).10 The PMA is
specifically focused on safety and requires a significant weighing
of considerations specific to the device before approval is
granted. Thus, the fact that the § 510(k) process did not preempt
state causes of action in Lohr does not indicate that the PMA
process cannot preempt state tort causes of action.
Thus, for all these reasons, we are fully convinced that
Stamps has not been overruled and remains viable authority in this
circuit to the extent that we have described. Instead of
overruling Stamps, Lohr should be read to implicitly affirm our
holding in Feldt v. Mentor Corp., 61 F.3d 431 (5th Cir. 1995), in
which we reached the same conclusion as did the Court in Lohr, that
10
See also id. at 480 (“The agency emphasized, however, that
this determination [of substantial equivalence] should not be
construed as an endorsement of the pacemaker lead’s safety.”).
24
the § 510(k) process did not create preemptive “requirements.” 518
U.S. at 484 n.6.11 We think that our separate preemption treatment
of the differing processes to device approval is further reflection
and acknowledgment of the fact that the PMA process is of an order
that is a magnitude apart from § 510(k) approval.
In sum, we simply cannot read Lohr as establishing a new rule
of law that contradicts our preexisting case law as it applies in
this appeal. Thus, although the broad holding of Stamps that the
PMA process preempts state tort causes of action to the extent that
they relate to safety, effectiveness or other MDA requirements is
narrowed by Lohr’s finding that preemption requires substantive
requirements imposed by common law duties to threaten federal
requirements, Stamps remains controlling precedent for the purpose
of this appeal.
IV
We turn now to apply Stamps, as narrowed by Lohr, to the case
before us. The plaintiffs allege that Medtronic breached state law
duties by designing a pacemaker lead that contained certain
materials, by labeling the lead with certain warnings, and by
manufacturing the lead in a certain way. The design of the lead,
11
Our decision in Feldt explicitly discusses our decision in
Stamps, 61 F.3d at 435, but, after analyzing the § 510(k) process,
states, “there are, in short, no requirements or prohibitions
specifically regarding the design of non-PMA Class III devices.”
Id. at 438.
25
the labeling on the lead, and the manner of manufacturing of the
lead were all submitted to the FDA in great detail and approved by
the FDA in the PMA process. Like the inadequate labeling, failure
to warn, and defective design claims in Stamps, the plaintiffs’
claims that the district court found to be preempted relate to
areas specifically covered in the PMA process, and seek to impose
requirements that are different from and, indeed, conflict with the
PMA process.
The district court specifically found those claims that
paralleled the federal process--the claims that Medtronic did not
adequately comply with the PMA process--were not preempted under §
360k. This finding comports with Lohr, that general duties of care
that parallel federal requirements are not “different from, or in
addition to” federal requirements, and are therefore not preempted.
In Stamps, our circuit spoke to the precise question presented
in this appeal. And we have concluded here that the Supreme
Court’s fractured ruling in Lohr does nothing to upset Stamps’s
binding authority as respects this particular appeal. We therefore
reaffirm that a medical device manufacturer’s compliance with the
FDA’s PMA process will preempt state tort law claims brought with
respect to that approved device and relating to safety,
26
effectiveness or other MDA requirements when the substantive
requirements imposed by those claims potentially conflict with PMA
approval. Thus, the plaintiffs’ tort law claims relating to
design, manufacturing process, and failure to warn are preempted by
the MDA.
V
For the reasons stated above, the judgment of the district
court is
A F F I R M E D.
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