Martin v. Medtronic, Inc.

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

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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).

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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.”).

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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.

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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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