Brief - Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001)
|||IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT
|||No. 99-41089, No. 99-41090
|||June 18, 2001
|||BILLYE JEANNE MARTIN, PLAINTIFF-APPELLANT,
MEDTRONIC, INC., DEFENDANT-APPELLEE.
LIBRA SALAZAR, PLAINTIFF-APPELLANT,
MEDTRONIC, INC., DEFENDANT-APPELLEE.
|||Before Reynaldo G. Garza, Jolly, and Higginbotham, Circuit Judges.
|||The opinion of the court was delivered by: E. Grady Jolly, Circuit Judge
|||Appeals from the United States District Court for the Southern District
|||In this consolidated appeal,*fn1 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 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.
|||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,*fn2
had approved Medtronic's product. The district court, however, denied summary
judgment on the 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
|||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
impairment of human health.'" Lohr, 518 U.S. at 477 (quoting 21 U.S.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 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,*fn3 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 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 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.
|||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).
|||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.*fn4 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 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
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 "§ 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, 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. 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
|||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 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.
|||When we turn to consider the impact of Lohr on the precedential effect
of Stamps, we can immediately conclude that the Supreme Court did not explicitly
overrule the case. Neither do we think that Lohr implicitly requires us
to disregard Stamps as controlling precedent.*fn5
Although Stamps gave § 360k a somewhat broader preemptive scope than the
Supreme Court's opinion in Lohr,*fn6 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 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.
|||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.
|||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 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
|||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 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
|||[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 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.*fn7
|||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.*fn8
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) 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.
|||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 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.
|||Fourth, Stamps held that the PMA process imposed specific federal requirements
as to labeling, manufacturing, and design for the purposes of preemption.*fn9
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.
|||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).*fn10
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 the § 510(k) process did not create preemptive "requirements."
518 U.S. at 484 n.6.*fn11 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 pre-existing 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.
|||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, 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, 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.
|||For the reasons stated above, the judgment of the district court is
|||*fn1 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.
|||*fn2 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).
|||*fn3 The section number refers to the
original section of the MDA containing the provision.
|||*fn4 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.").
|||*fn5 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.
|||*fn6 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.
|||*fn7 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.
|||*fn8 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.
|||*fn9 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).
|||*fn10 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.").
|||*fn11 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.
The Law, Science & Public
Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster