UNITED STATES COURT OF APPEALS

                                  FOR THE   SECOND CIRCUIT

                                       ______________

                                      August Term, 2005

Argued: December 15, 2005                                            Decided: May 16, 2006
                                                                     Errata Filed: July 20, 2006)
                                   Docket No. 04-0412-cv

                                       ______________

                         CHARLES R. RIEGEL AND DONNA S. RIEGEL,

                                                       Plaintiffs-Appellants,

                                            —v.—

                                      MEDTRONIC, INC.,

                                                      Defendant-Appellee.

                                       ______________

                                            Before:

                   POOLER, KATZMANN , AND B.D. PARKER, Circuit Judges

                                       ______________

  Appeal from a judgment of the United States District Court for the Northern District of New
     York (Kahn, J.) granting the defendant’s motion for summary judgment. Affirmed.

            Judge Pooler concurs in part and dissents in part in a separate opinion.
                                      ______________

                                    ALLISON M. ZIEVE , Public Citizen Litigation Group,
                                    Washington, DC (Brian Wolfman, Public Citizen Litigation
                                    Group, Washington, DC; Wayne P. Smith, Schenectady,
                                    NY, of counsel) for Plaintiffs-Appellants

                                    MICHAEL K. BROWN , Reed Smith LLP, Los Angeles, CA
                                    (Richard Bakalor, Quirk and Bakalor, P.C., New York, NY,
                                      of counsel) for Defendant-Appellee

                                      Robert N. Weiner, David M. Orta, Gregory H. Levine,
                                      Arnold & Porter, LLP, Washington, DC; Hugh F. Young,
                                      Jr., Product Liability Advisory Council, Inc., Reston, VA,
                                      on submission, for Amicus Curiae Product Liability
                                      Advisory Council, Inc.

                                        ______________
KATZMANN , Circuit Judge:

       This case calls upon us to determine, inter alia, the scope of the preemption provision set

forth in Section 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and

Cosmetic Act, 21 U.S.C. §§ 301 et. seq. Specifically, we must decide whether Section 360k(a)

preempts common law tort claims regarding medical devices that have entered the market

pursuant to the Food and Drug Administration’s (“FDA”) rigorous premarket approval (“PMA”)

process. The Supreme Court left open this question in Medtronic v. Lohr, 

(1996),

which held that tort claims as to medical devices that have entered the market pursuant to the far

less intensive premarket notification process (often referred to as the “Section 510(k) process”)

are not preempted by Section 360(k)(a). Since Lohr, the majority of circuits addressing this

question have held that claims regarding PMA-approved medical devices are, by contrast,

preempted. See Horn v. Thoratec Corp., 

(3d Cir. 2004); Martin v. Medtronic, Inc.,

(5th Cir. 2001); Brooks v. Howmedica, Inc., 

(8th Cir. 2001); Kemp v.

Medtronic, Inc., 

(6th Cir. 2000); Mitchell v. Collagen Corp., 

(7th Cir.

1997); but see Goodlin v. Medtronic, Inc., 

(11th Cir. 1999).

       We now join this growing consensus and hold that tort claims that allege liability as to a

PMA-approved medical device, notwithstanding that device’s adherence to the standards upon



                                                 2
which it obtained premarket approval from the FDA, are preempted by Section 360(k)(a). We

therefore affirm the district court’s (Kahn, J.) summary judgment dismissal of the plaintiffs-

appellants’ strict liability, breach of implied warranty, and negligent design, testing, inspection,

distribution, labeling, marketing, and sale claims as to the Evergreen Balloon Catheter, a PMA-

approved medical device. With regard to the plaintiffs’ remaining claim for negligent

manufacturing – which premised liability on the theory that the particular Evergreen Balloon

Catheter deployed during plaintiff-appellant Charles Riegel’s angioplasty had not been

manufactured in accordance with the PMA-approved standards – we agree with the district

court that this claim was not preempted, but that no genuine issue of material fact existed, and

thus affirm the district court’s summary judgment dismissal of that claim as well.

       We note that our preemption analysis is quite limited in scope, affecting the small

universe of cases resting on claims alleging liability despite a PMA-approved device’s adherence

to the standards upon which it secured FDA premarket approval. We take care to explain that we

do not hold that all state tort claims as to PMA-approved devices are preempted. Thus, tort

claims that are based on a manufacturer’s departure from the standards set forth in the device’s

approved PMA application – such as the Riegels’ negligent manufacturing claim – are not

preempted.

                                                  I.

                                                  A.

       The Evergreen Balloon Catheter is a prescription medical device that defendant-appellee

Medtronic, Inc. developed for patients with coronary disease. Physicians use it during

angioplasties to open patients’ clogged arteries, essentially by inserting the catheter into the


                                                  3
clogged vessel, inflating the catheter like a balloon, and then deflating and removing the catheter.

The Evergreen Balloon Catheter entered the market pursuant to the PMA process in the mid-

1990s. Specifically, on August 30, 1994, the FDA approved Medtronic’s PMA application for

the Evergreen Balloon Catheter, and on April 27, 1995 and April 18, 1996, the FDA approved

Medtronic’s PMA supplements, which requested approval for revised labeling for the device.

We discuss the PMA process in greater depth infra Part III.A.

        On May 10, 1996, plaintiff-appellant Charles Riegel underwent a percutaneous

transluminal coronary angioplasty, during which his surgeon used an Evergreen Balloon

Catheter. The procedure was intended to dilate Riegel’s right coronary artery, which had been

found to be “diffusely diseased” and “heavily calcified.” The device label for the Evergreen

Balloon Catheter specifies that its use is contraindicated for patients who have “diffuse or

calcified stenoses.” During the procedure, Riegel’s physician, Dr. Eric Roccario, first attempted

to remove the calcium deposits in Riegel’s artery with a rotoblator device, and then

unsuccessfully inserted several different balloon catheters. Dr. Roccario ultimately inserted the

Evergreen Balloon Catheter into Riegel’s artery and inflated the device several times, up to a

pressure of ten atmospheres. The device label for the Evergreen Balloon Catheter specifies that it

should not be inflated beyond the “rated burst pressure” of eight atmospheres. On the final

inflation, the Evergreen Balloon Catheter burst, and Riegel began to rapidly deteriorate. He

developed a complete heart block, lost consciousness, was intubated and placed on advanced life

support, and was rushed to the operating room for emergency coronary bypass surgery. Riegel

survived, but according to his Complaint, he suffered “severe and permanent personal injuries

and disabilities.”


                                                 4
                                               B.

        Riegel and his wife, Donna, subsequently filed suit against Medtronic in the Northern

District of New York, alleging five state common law causes of action: (1) negligence in the

design, testing, inspection, manufacture, distribution, labeling, marketing, and sale of the

Evergreen Balloon Catheter; (2) strict liability; (3) breach of express warranty; (4) breach of

implied warranty; and (5) loss of consortium.1 In its amended answer, Medtronic raised the

affirmative defense of federal preemption by Section 360k(a) of the 1976 Medical Device

Amendments, 21 U.S.C. § 360(c)-(k), to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et.

seq, and subsequently moved for summary judgment on its preemption defense.

       In a March 14, 2002 opinion, the district court (Kahn, J.) ruled that the Riegels’ strict

liability claim, breach of implied warranty claim, and all of their negligence claims except for the

negligent manufacturing claim were preempted by Section 360k(a), and therefore dismissed all of

these claims. The court let stand the Riegels’ breach of express warranty claim. Thus, discovery

continued on the two remaining substantive claims: the negligent manufacturing claim and the

breach of express warranty claim.2

       Medtronic later moved for summary judgment on these two remaining claims, and on

December 2, 2003, the district court granted that motion. The court dismissed the breach of

express warranty claim because the Evergreen Balloon Catheter’s instructions had clearly

disclaimed any express warranty. It dismissed the negligent manufacturing claim on grounds that


       1
        Because the Riegels are residents of New York State, and Medtronic is a Minnesota
corporation, the district court had diversity jurisdiction pursuant to 28 U.S.C. § 1332.
       2
        The loss of consortium claim, a derivative claim, was permitted to remain in connection
with the two remaining substantive claims.

                                                    5
there was insufficient evidence upon which a reasonable fact-finder could conclude that the

Evergreen Balloon Catheter had burst because of negligent manufacture, rather than because it

had encountered a calcium spicule in Riegel’s artery, had been inflated beyond the specified eight

atmosphere limit, or some combination thereof.

       The Riegels proceeded to file the instant appeal, in which they challenge both the March

14, 2002 and December 2, 2003 summary judgment rulings of the district court. With regard to

the March 14, 2002 ruling, they argue that none of their claims was preempted. With regard to

the December 2, 2003 ruling, they argue that there were genuine issues of material fact as to their

negligent manufacturing claim.3


                                                II.

       Initially, we note the applicable standard of review. An order granting summary

judgment will be affirmed only when no genuine issue of material fact exists and the movant is

entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(c); Island Software & Computer

Serv. v. Microsoft Corp., 

, 260 (2d Cir. 2005). With regard to the March 14, 2002

dismissal of many of the Riegels’ claims on preemption grounds, there are no disputed facts, and

“our task is to determine whether the district court correctly applied the law.” Pagan v. NYNEX

Pension Plan, 

, 441 (2d Cir. 1995) (internal quotation marks omitted). With regard

to the December 2, 2003 dismissal of the Riegels’ negligent manufacturing claim, we must

decide whether, “construing the evidence in the light most favorable to the non-moving party and

drawing all reasonable inferences in its favor,” there are any genuine issues of material fact. SCS


       3
        The Riegels do not, however, challenge the summary judgment dismissal of their breach
of express warranty claim.

                                                 6
Communications, Inc. v. The Herrick Co., Inc., 

, 338 (2d Cir. 2004).


                                                III.

                                                 A.

       We begin with the preemption issue, for which, at the outset, it is helpful to review the

overarching regulatory structure. In 1976, Congress enacted the Medical Device Amendments

(“MDA”) to the 1938 Food, Drug, and Cosmetic Act, in order to “provide for the safety and

effectiveness of medical devices intended for human use.” 90 Stat. 539. The MDA established a

regulatory structure pursuant to which the Department of Health and Human Services, through

the FDA, would regulate medical devices.

       Under the MDA, medical devices are categorized into three classes, based on the level of

risk that they pose. 21 U.S.C. § 360c(a)(1). First, those devices that “present minimal potential

for harm to the user,” such as elastic bandages, are classified as “Class I” devices; such devices

can be marketed without prior approval and are subject only to “general controls” that cover all

medical devices. 21 U.S.C. § 360c(a)(1)(A); see also http://fda.gov/cdrh/devadvice/3132.html

(last visited April 28, 2006); 

. Second, devices that are potentially more

harmful, such as powered wheelchairs and infusion pumps, are classified as “Class II” devices.”

These devices can still be marketed without advance approval, but in addition to being subject to

“general controls,” they may also be subject to “special controls,” such as postmarket

surveillance, patient registries, and/or other measures deemed necessary. 21 U.S.C. §

360c(a)(1)(B); see also http://fda.gov/cdrh/devadvice/3132.html; 

. Finally,

those devices for which “general controls” and “special controls” are insufficient to provide



                                                 7
reasonable assurance of safety and effectiveness, and which either “present a potential

unreasonable risk of illness or injury” or are “for a use in supporting or sustaining human life or

for a use which is of substantial importance in preventing impairment of human health” are

classified as Class III devices. 21 U.S.C. § 360c(a)(1)(C). It is undisputed that the Evergreen

Balloon Catheter – the device at issue in this litigation – is a Class III device.4

       A Class III device is required to undergo “premarket approval to provide reasonable

assurance of its safety and effectiveness” before being marketed. 21 U.S.C. § 360c(a)(1)(C).

The premarket approval, or “PMA,” process is lengthy and rigorous. See 

(describing the PMA process as a “rigorous one,” and noting that the FDA spends an average of

1,200 hours on each PMA submission). The manufacturer must submit a detailed PMA

application that contains full reports of all investigations of the safety and effectiveness of the

device; a full statement of the components, ingredients, properties, and principles of operation of

the device; a full description of the methods used in the manufacture and processing of the

device; information about performance standards of the device; samples of the device; specimens

of the proposed labeling for the device; and any other relevant information. 21 U.S.C. § 360e(c).

       There is significant opportunity for interaction between the FDA and the manufacturer

over the course of the PMA process. Typically, the initial PMA application must include data

from clinical investigations to establish the safety and effectiveness of the device, 21 C.F.R. §

814.20(b)(6)(ii); the manufacturer cannot even conduct such a clinical investigation in the first

place without FDA permission, 21 C.F.R. § 812.1(a). The results of such clinical investigations,



       4
        Other examples of Class III devices include replacement heart valves and implanted
cerebella stimulators. See http://fda.gov/cdrh/devadvice/3132.html.

                                                   8
in turn, must be included by the manufacturer in the PMA application, along with all of the

information described above. See 21 C.F.R. § 814.20; 21 U.S.C. § 360e(c). The FDA then

reviews the submission to determine whether it is sufficiently complete to enable a substantive

review; if not, the FDA will refuse to file it. 21 C.F.R. § 814.42. After having accepted the

PMA for filing, the FDA begins its review, which may involve referring the PMA to an advisory

committee. 21 C.F.R. § 814.44; see also www.fda.gov/cdrh/devadvice/pma (“Review Process:

Overview”) (last visited April 28, 2006). On the 100th day after the PMA has been filed, the FDA

will, at the applicant’s request, meet with the applicant to discuss the status of the application and

any deficiencies that need to be addressed. See 21 U.S.C. § 360e(d)(3).

       Once the FDA has concluded its review, it decides whether or not to approve the device

for marketing. This choice is not binary; the FDA has means to impose additional requirements.

For example, the FDA can issue an “approvable letter” stating that the FDA believes it will be

able to approve the application if specific conditions are agreed to by the applicant. See 21

C.F.R. § 814.44(e). Alternatively, if the FDA “believes that the application may not be

approved,” it can “send the applicant a not approvable letter...[that] will describe the deficiencies

in the application...and, where practical, will identify measures required to place the PMA in

approvable form.” 21 C.F.R. § 814.44(f). The FDA thus has quite broad authority to approve,

deny, and effectuate modifications of an application throughout the PMA process.

       In the end, once the FDA has approved a medical device through the PMA process, the

applicant is required to comply with the standards in the PMA approval order. 21 C.F.R. §

814.80 (“A device may not be manufactured, packaged, stored, labeled, distributed, or advertised

in a manner that is inconsistent with any conditions to approval specified in the PMA approval


                                                  9
order for the device.”). Any changes that the applicant believes could affect the safety or

effectiveness of the device must be submitted, via a “PMA supplement,” to the FDA for

approval. 21 C.F.R. § 814.39(a) (“After FDA’s approval of a PMA, an applicant shall submit a

PMA supplement for review and approval by FDA before making a change affecting the safety or

effectiveness of the device for which the applicant has an approved PMA. . . .While the burden

for determining whether a supplement is required is primarily on the PMA holder, changes for

which an applicant shall submit a PMA supplement include, but are not limited to, the following

types of changes if they affect the safety or effectiveness of the device: (1) New indications for

use of the device[;] (2) Labeling changes[;] (3) The use of a different facility or establishment to

manufacture, process, or package the device[;] (4) Changes in sterilization procedures; (5)

Changes in packaging[;] (6) Changes in the performance or design specifications, circuits,

components, ingredients, principle of operation, or physical layout of the device[;] (7) Extension

of the expiration date of the device. . . .”).

        Additionally, the standard FDA “Conditions of Approval” accompanying a PMA order

state that continued approval of the PMA “is contingent on the submission of postapproval

reports required under 21 CFR 814.84 at intervals of 1 year from the date of approval of the

original PMA.” See www.fda.gov/devadvice/pma (“Postapproval (Annual) Reports”) (last

visited April 28, 2006). Such annual reports must (1) identify all changes made to the device

(even if those changes did not affect the device’s safety or effectiveness and therefore did not

first require submission of a PMA supplement), 21 C.F.R. § 814(b)(1); (2) contain a summary

and bibliography of any “unpublished reports of data from any clinical investigations or

nonclinical laboratory studies involving the device or related devices and known to or that


                                                 10
reasonably should be known to the applicant,” 21 C.F.R. § 814(b)(2)(i); and (3) contain a

summary and bibliography of any “reports in the scientific literature concerning the device and

known to or that reasonably should be known to the applicant,” 21 C.F.R. § 814(b)(2)(ii). The

standard PMA “Conditions of Approval” also require the manufacturer to submit an “Adverse

Reaction Report” or “Device Defect Report” to the FDA within ten days after it receives or has

knowledge of information concerning (1) “a mixup of the device or its labeling with another

article”; (2) “any adverse reaction attributable to the device that has not been addressed by the

device’s labeling or is occurring with unexpected severity or frequency”; or (3) “any significant

chemical, or other change or deterioration in the device or any failure of the device to meet the

specifications established in the PMA that could not cause or contribute to death or serious injury

but are not correctable by adjustments or other maintenance procedures described in the

approved labeling.” See www.fda.gov/devadvice/pma (“Adverse Reaction and Device Defect

Reporting”).5 The FDA may also impose other requirements on manufacturers as a condition of

PMA approval, such as restrictions on the sale or distribution of the device; continuing

evaluation; prominent display of warnings; maintenance of records according to specifications

deemed necessary by the FDA; batch testing; and any other requirements that the FDA

“determines are necessary to provide reasonable assurance, or continued reasonable assurance, of


       5
         Manufacturers of PMA-approved devices are also fully subject to the FDA’s general
Medical Device Reporting Regulation, 21 C.F.R. § 803 et. seq., which requires all manufacturers
of medical devices to report to the FDA within 30 days of learning from any source that one of
their devices “(1) may have caused or contributed to a death or serious injury; or (2) has
malfunctioned and this device or a similar device that [it] market[s] would be likely to cause or
contribute to a death or serious injury, if the malfunction were to recur.” 21 C.F.R. § 803.50. In
the event that a manufacturer learns that a reportable event “necessitates remedial action to
prevent an unreasonable risk of substantial harm to the public health,” it is required to submit a
report to the FDA within five days. 21 C.F.R. § 803.53.

                                                 11
the safety and effectiveness of the device.” 21 C.F.R. § 814.82(a). The FDA can impose such

requirements either in the initial PMA approval order, by regulation at the time of PMA

approval, or by regulation subsequent to approval. 

majority of Class III medical devices, however, reach the market without ever

going through the rigorous PMA process described above. This is because the MDA also

includes a “grandfathering” provision that “allows pre-1976 devices to remain on the market

without FDA approval until such time as the FDA initiates and completes the requisite PMA.”

. And, in order to “prevent manufacturers of grandfathered devices from

monopolizing the market while new devices clear the PMA hurdle, and to ensure that

improvements to existing devices can be rapidly introduced into the market,” the MDA also

allows new devices that are “substantially equivalent” to such pre-existing devices to enter the

market without going through the PMA process. 

equivalence” route to the

market is known as the premarket notification, or “§ 510(k),” process.6

       In its decision, the Lohr Court noted that the § 510(k) premarket notification process has

become the means by which most new medical devices enter the market. 

This

observation holds true with full force today. Indeed, from the FDA’s website, it appears that in

the fiscal year 2005, out of the 3,180 new Class III devices that were permitted to enter the

market through either the § 510(k) or PMA processes, 3,148 of them went through the § 510(k)




       6
         The “§ 510(k)” reference stems from the number of the section in the original Act. See

. In addition to covering devices that are substantially equivalent to pre-
1976 devices, the § 510(k) process also covers devices that are substantially equivalent to other
devices not subject to the PMA process, e.g., because those devices were reclassified from Class
III to Class I or II. See http://www.fda.gov/cdrh/devadvice/314.html (last visited April 28, 2006).

                                                12
process and only 32 went through the PMA process.7 In other words, in 2005, approximately

ninety-nine percent of such devices went through the § 510(k) process and only one percent went

through the PMA process.

       As the contrasting terms “premarket notification” and “premarket approval” suggest, the

§ 510(k) process differs dramatically from the PMA process. Unlike the PMA process – which

requires reasonable assurance that the new device is itself safe and effective, and ultimately

results in the FDA’s “approval” of the device – the § 510(k) process simply requires the

manufacturer to show that the device is substantially equivalent to, i.e., as safe and effective as, a

legally marketed device that did not go through the PMA process. As the Supreme Court stated

in Lohr, the § 510(k) process was apparently intended simply to “maintain the status quo with

respect to the marketing of existing medical devices and their substantial equivalents.” 

. To that end, “[t]he § 510(k) notification process is by no means comparable to the

PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k)

review is completed in an average of only 20 hours.” 

see also Buckman v.

Plaintiffs’ Legal Committee, 

, 348 (2001) (“[T]he § 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


       7
         The FDA’s website provides monthly listings of all of the § 510(k)-cleared devices, see
http://www.fda.gov/cdrh/510khome.html#listing (last visited April 28, 2006) and all of the
PMA-approved original devices and supplements, see http://www.fda.gov/cdrh/pmapage.html#
monthly (last visited April 28, 2006). These webpages, along with related information about
recent device approvals by the FDA, can also be accessed via the webpage on the FDA’s website
entitled “Recent Device Approvals.” See http://www.fda.gov/cdrh/consumer/mda/ (“Recent
Device Approvals”) (last visited April 28, 2006). The above numbers were calculated with
reference to the website’s 2005 monthly listings of § 510(k)-cleared devices and PMA-approved
original devices.

                                                 13
device.”).

       In fact, the FDA regulations explicitly prohibit manufacturers of devices that have

reached the market through the § 510(k) process from indicating that the FDA has actually

approved their device on the merits, stating that the § 510(k) determination that a device is

“substantially equivalent” to a pre-existing, non-PMA-approved device on the market “does not

in any way denote approval of the device. Any representation that creates an impression of a

official approval of a device because of complying with the premarket notification regulations is

misleading and constitutes misbranding.” 21 C.F.R. § 807.97 (emphasis added).

       Once a device has entered the market pursuant to the § 510(k) process, its manufacturer

has broader latitude to make changes on its own than does the manufacturer of a PMA-approved

device. As the FDA explained in its Amicus Curiae Letter Brief to the Third Circuit in Horn v.

Thoratec, “[i]n direct contrast to the PMA regime, FDA does not ‘approve’ changes to a Section

510(k)-cleared device. Rather, the manufacturer simply has to demonstrate that its device is still

substantially equivalent to its predicate.” Horn v. Thoratec Corp., 

, 172 (3d Cir.

2004). To that end, whereas a PMA supplement must be submitted for review and approval by

the FDA before any change is made that “affect[s] the safety or effectiveness of the device,” a §

510(k) supplemental submission is required only where the device “is about to be significantly

changed or modified in design, components, method of manufacturer, or intended use,” 21

C.F.R. § 807.81(a)(3) (emphasis added).8



       8
        As examples of such “significant changes or modifications,” the FDA listed a “change or
modification in the device that could significantly affect the safety or effectiveness of the
device,” and a “major change or modification in the intended use of the device.” 21 C.F.R. §
807.81(3)(i)-(ii) (emphasis added).

                                                14
       Having summarized the PMA and § 510(k) routes to market set forth by the MDA, we

now move to one final aspect of the MDA that is crucial for purposes of this case. The MDA

also includes an express preemption provision: Section 360k(a). In relevant part, this provision

states as follows:

       [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 Act 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 Act.

21 U.S.C. § 360k(a).9

       The application of Section 360k(a)’s preemption provision to medical devices that have

entered the market through the two alternate routes described above – the PMA process and the §

510(k) process – forms the crux of this case.

                                                B.

       During the several decades following the 1976 enactment of the MDA, the circuit courts

grappled with how broadly to construe Section 360k(a)’s preemption of state “requirement[s]”

that differed from or added to “requirement[s] applicable under this Act.” Could a state

requirement be created by state common law, or only by state statutes and other enactments? For

that matter, did approval under the PMA process – or, alternatively, clearance under the § 510(k)

process or some other expedited process – amount to a requirement under the Food, Drug, and



       9
         The MDA goes on to provide, in Section 360k(b), that “[u]pon application of a State or a
political subdivision thereof, the Secretary may, by regulation promulgated after notice and
opportunity for an oral hearing, exempt from subsection (a)” certain State regulations from the
preemption provision. 21 U.S.C. § 360k(b). Neither party has argued that Section 360k(b) is
applicable here.

                                                15
Cosmetic Act with which state law could conflict?

       This Court addressed some of these questions in Becker v. Optical Radiation Corp, 

(2d Cir. 1995). There, we stated that state common law claims that alleged product

defects as to a PMA-approved device, notwithstanding that device’s compliance with the PMA

process, would be preempted by Section 360k(a). We explained:

       At the premarket stage, pursuant to the MDA, the FDA reviews a device’s testing, design
       specifications, intended use, manufacturing method, performance standards and labeling,
       and decides whether the device is safe and effective. 21 U.S.C. §§ 360e(c)(1), (2). [The
       plaintiff’s] claims allege defective design, defective manufacture, failure to warn and
       failure to test. If [the plaintiff] were allowed to pursue these claims, and if she were
       successful, the common law of New York would impermissibly add requirements in the
       areas reviewed in the [PMA] process, and thus would impose standards on the [device]
       which are different from those of the MDA.

The Becker Court was not, however, presented with the question of whether common

law claims as to § 510(k)-cleared devices would be similarly preempted.

       It was this latter question that the Supreme Court considered in Lohr, where the plaintiffs

brought various state tort law claims in regard to the design, manufacturing, and labeling of a

pacemaker that had entered the market pursuant to the § 510(k) process. In the course of

assessing whether these plaintiffs’ tort law claims would – if successful – result in a state law

“requirement” that differed from, or added to, a federal “requirement,” a fractured Court reached

several conclusions.

       All nine justices agreed that the § 510(k) process set forth no federal requirements as to

the design of medical devices, and that clearance through the § 510(k) process simply reflected

the FDA’s conclusion that a new device was substantially equivalent to a pre-existing device.

Thus, the justices unanimously agreed that design defect claims as to § 510(k)-cleared devices



                                                 16
would not be preempted by Section 360k(a) of the MDA because there would be no federal

requirements with which such claims could conflict. See 

(majority

opinion) (stating that clearance via the § 510(k) process “did not ‘require’ Medtronics’

pacemaker to take any particular form for any particular reason; the agency simply allowed the

pacemaker, as a device substantially equivalent to the one that existed before 1976, to be

marketed without running the gauntlet of the PMA 

(O’Connor, J.,

concurring in part and dissenting in part) (“I agree with the Court that the Lohrs’ defective design

claim is not preempted by the FDCA’s § 510(k) ‘substantial equivalency’ process....Because the

§ 510(k) process seeks merely to establish whether a pre-1976 and a post-1976 device are

equivalent, and places no ‘requirements’ on a device, the Lohrs’ defective design claim is not

preempted.”).10

       When the justices moved from a consideration of the plaintiffs’ design defect claims to

their manufacturing and labeling claims, however, they fractured over two issues regarding the

interpretation of Section 360k(a)’s preemption of state “requirements” that were “different from,

or in addition to, any requirement applicable under this Act.” First, the justices diverged over

whether the reference to “requirements applicable under this Act” meant that only device-specific

requirements could give rise to preemption, or instead meant that any FDA requirements could

give rise to preemption. Five of the justices – Justices Stevens, Kennedy, Souter, Ginsburg, and

Breyer – concluded that only federal device-specific requirements could give rise to




       10
            Justice O’Connor was joined by Chief Justice Rehnquist, Justice Scalia, and Justice
Thomas.

                                                  17
preemption.11 

(majority opinion); 

(Breyer, J., concurring in part and

concurring in the judgment). These justices therefore agreed that because the only FDA

manufacturing and labeling requirements12 that covered the pacemaker at issue were general in

nature rather than device-specific, the plaintiffs’ manufacturing and labeling claims were not

preempted. By contrast, the remaining four justices – Justices Rehnquist, O’Connor, Scalia, and

Thomas – concluded that even general FDA requirements could give rise to preemption, and

therefore dissented, in part, on grounds that the plaintiffs’ manufacturing and labeling tort claims

as to the pacemaker were preempted by the general FDA manufacturing and labeling

requirements. 

(O’Connor, J., concurring in part and dissenting in part).

       In addition to their 5-4 split over whether the applicable federal requirement needed to be

device-specific, the justices also divided – again by a 5-4 margin – over whether a state

“requirement,” as that term was used in Section 360k(a), could derive from state common law or

only from state statutes and regulations. Justices Stevens, Kennedy, Souter, and Ginsburg largely

adopted the view that only the latter category would typically give rise to a state requirement for


       11
          In reaching this conclusion, they relied upon 21 C.F.R. § 808.1(d), an FDA regulation
stating that “[s]tate and 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 difference from, or in addition to,
the specific Food and Drug Administration requirements.”
       12
         The relevant labeling regulations were set forth in 21 C.F.R. § 801.109(b) and (c),
pursuant to which manufacturers of medical devices must include labeling that “bears
information for use, including indications, effects, routes, methods, and frequency and duration
of administration, and any relevant hazards, contraindications, side effects, and precautions under
which practitioners licensed by law to administer the device can use the device safely. . . .” The
relevant manufacturing regulations were set forth in the “Good Manufacturing Practices,” or
“GMP’s,” which are set forth in 32 sections of the Code of Federal Regulations. See 

.

                                                 18
purposes of the MDA, stating in Part IV of the opinion that “when Congress enacted § 360k, it

was primarily concerned with the problem of specific, conflicting state statutes and regulations

rather than the general duties enforced by common-law actions,” 

(plurality opinion),

and subsequently stating in part VI of the opinion that “it is apparent that few, if any, common-

law duties have been preempted by this statute. It 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,’” 

(plurality opinion).

       Justice Breyer, however, declined to join Parts IV and VI of the opinion, and wrote

separately to emphasize that he was “not convinced that future incidents of MDA preemption of

common-law claims will be ‘few’ or ‘rare.’” 

(Breyer, J., concurring in part and

concurring in the judgment). He stated, with reference to the Court’s prior holding in Cipollone

v. Liggett Group, Inc., 

(1992),13 that “[o]ne can reasonably read the word

‘requirement’ as including the legal requirements that grow out of the application, in particular

circumstances, of a State’s tort law.” 

Justice Breyer further illustrated this point with

the following hypothetical situation:

       Imagine that, in respect to a particular hearing aid component, a federal MDA regulation
       requires a 2-inch wire, but a state agency regulation requires a 1-inch wire. If the federal
       law, embodied in the “2-inch” MDA regulation, pre-empts the state “1-inch” agency
       regulation, why would it not similarly pre-empt a state-law tort action that premises
       liability upon the defendant manufacturer’s failure to use a 1-inch wire (say, an award by
       a jury persuaded by expert testimony that use of more than 1-inch wire is negligent)? The
       effects of the state agency regulation and the state tort suit are identical....Consequently, I
       believe that ordinarily, 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.


       13
            The Cipollone decision is discussed in greater depth infra.

                                                   19


Finally, Justices Rehnquist, O’Connor, Scalia, and Thomas also adopted the view

that, pursuant to Cipollone, “[i]f § 360(k)’s language is given its ordinary meaning, it clearly pre-

empts any state common-law action that would impose a requirement different from, or in

addition to, that applicable under the FDCA – just as it would preempt a state statute or

regulation that had that effect.” 

(O’Connor, J., concurring in part and dissenting in

part). In sum, therefore, five justices endorsed the proposition that a state “requirement,” for

purposes of the MDA, could stem from state common-law actions as well as from state statutes

or regulations.14

        We thus interpret Lohr as setting forth two main principles, each endorsed by five

justices, for determining whether a common law tort action over a medical device is preempted


       14
          We note that although Justice Breyer authored a separate concurrence as to this point,
and declined to join Parts IV and VI of the Lohr opinion, he did join Part V of the Lohr opinion,
which included the statements that “the general state common-law requirements in this suit were
not specifically developed ‘with respect to’ medical devices,” but would simply stem from
“general state common-law requirements,” such as “the general duty of every manufacturer to
use due care to avoid foreseeable danger in its products,” and that “[t]hese state requirements
therefore escape preemption, not because the source of the duty is a judge-made common-law
rule, but rather because their generality leaves them outside the category of requirements that §
360k envisioned to be ‘with respect to’ specific devices. . . .” 

         There is, undeniably, a certain degree of tension between Justice Breyer’s joining of Part
V of the opinion and his separate concurrence. We resolve that tension in favor of the latter.
Given that Justice Breyer wrote separately to assert that “the MDA will sometimes preempt a
state-law tort suit,” 

(Breyer, J., concurring in part and concurring in the judgment), that
he was “not convinced that future incidents of MDA pre-emption of common-law claims will be
‘few’ or rare,’”id. at 508, 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,” 

and – most explicitly – that he “basically agree[d] with Justice O’Connor’s
discussion of the point and with her conclusion,” 

, we believe that Justice Breyer’s
crucial fifth vote endorsed the proposition that a state requirement could stem from a state
common law tort action premised on the breach of a standard of care. See also Horn v. Thoratec
Corp., 

, 175-76 (discussing this tension in detail and reaching the same conclusion);
but see 

and n. 30 (Fuentes, J., dissenting).

                                                 20
by the MDA. First, on the federal side of the analysis, courts must consider whether there are

any device-specific federal requirements with respect to the device at hand. If so, courts must

then turn to the state side to determine whether there would be a conflict between that device-

specific federal requirement and “any of the liability-creating premises of the plaintiffs’ state-law

tort suit.” 

(Breyer, J., concurring in part and concurring in the judgment).

       Since Lohr, the majority of circuits have applied the above-described framework to

conclude that common law tort actions as to PMA-approved devices, in contrast to § 510-cleared

devices, are preempted by the MDA. See Horn v. Thoratec Corp., 

(3d Cir. 2004);

Martin v. Medtronic, Inc., 

(5th Cir. 2001); Brooks v. Howmedica, Inc., 

(8th Cir. 2001); Kemp v. Medtronic, Inc., 

(6th Cir. 2000); Mitchell v. Collagen

Corp., 

(7th Cir. 1997).15 These circuits have all concluded that (1) approval

through the PMA process, unlike the § 510(k) process, amounts to a federal device-specific

requirement, and (2) common law tort actions that allege liability as to a PMA-approved device,

notwithstanding that device’s compliance with the PMA-approved standards, would conflict with

that federal device-specific requirement. See 

; 

; 

; 

; 

-

914. Only the Eleventh Circuit has reached the opposite conclusion, holding that approval

through the PMA process does not constitute a federal device-specific requirement. See Goodlin

v. Medtronic, Inc., 

, 1376-77 (11th Cir. 1999).16


       15
        The Seventh Circuit recently reaffirmed that conclusion in McMullen v. Medtronic, 

(7th Cir. 2005).
       16
         The Tenth Circuit has also indicated, in a non-PMA context, its agreement with the
principle that state common law actions premised on the breach of a general duty of care cannot

                                                 21
                                                 C.

       We now turn to the instant appeal of the district court’s March 14, 2002 order dismissing

many of the Riegels’ claims on preemption grounds. We note, initially, that our Becker decision

clearly indicated that tort law claims as to a PMA-approved device would be preempted by

Section 360k(a) of the MDA. See 

. Because the Supreme Court

subsequently spoke to the issue of Section 360k(a)’s preemptive scope in Lohr, however, we

must revisit the issue to determine whether Becker is still good law. See, e.g., Taylor v. Vt. Dep’t

of Educ., 

, 782-83 (2d Cir. 2002).

       Thus, following the Lohr Court, our analysis proceeds in two parts. First, we must

consider whether, when a device such as the Evergreen Balloon Catheter obtains approval

pursuant to the PMA process, it is subject to a “requirement applicable under this Act,” i.e., a

federal device-specific requirement. Second, we must analyze the Riegels’ tort claims to

determine whether there is a conflict between that device-specific requirement and “any of the

liability-creating premises of the [Riegels’] state-law tort suit.” 

(Breyer, J.,

concurring in part and concurring in the judgment).



be preempted by the MDA. See Oja v. Howmedica, Inc., 

, 789 (10th Cir. 1997).
          Meanwhile, in the years since Lohr was decided, various state courts have divided over
this issue. Compare, e.g., Worthy v. Collagen Corp., 

, 376-77 (Tex. 1998)
(holding that common-law claims that alleged liability notwithstanding device’s adherence to
PMA-approved standards were preempted); Steele v. Collagen Corp., 

, 887-
88 (Cal. Ct. App. 1997) (same); Green v. Dolsky, 

, 117-18 (Pa. 1996) (same) with
Weiland v. Teletronics Pacing Sys., Inc., 

, 1152-53 (Ill. 1999) (holding that such
claims as to PMA-approved devices were not preempted); Sowell v. Bausch & Lomb, Inc., 

, 20-21 (N.Y. App. Div. 1997) (same); Wutzke v. Schwaegler, et. al., 

,
1390-92 (Wash. Ct. App. 1997) (same); Mears v. Marshall, 

, 992-996 (Or. Ct. App.
1997) (same); Armstrong v. Optical Radiation Corp., 

, 771-773 (Cal. Ct.
App. 1996) (same).

                                                 22
                                                1.

       We agree with the majority of circuits that have held that the relatively small subset of

PMA-approved devices – in contrast to the much larger population of § 510(k)-cleared devices –

are subject to federal device-specific requirements. In holding that § 510(k) clearance did not

give rise to a federal device-specific requirement, the Lohr Court explicitly distinguished

between the § 510(k) process and the PMA process, stating that the two processes were “by no

means comparable.” 

-79. Indeed, the Lohr Court expressly emphasized

that (1) the § 510(k) process was focused on equivalence rather than safety; (2) the FDA itself

stated that § 510(k) clearance did not “denote official FDA approval”; (3) the § 510(k) exemption

did not appear to have been “intended to do anything other than maintain the status quo with

respect to the marketing of existing medical devices and their substantial equivalents”; and (4) §

510(k) clearance could not be viewed as “requir[ing] [the device] to take any particular form for

any particular reason.” 

.

       The PMA process utterly diverges from the § 510(k) process in each of these respects.

First, although clearance through the § 510(k) process simply means that a device is substantially

equivalent to a pre-existing device – which may or may not be safe and effective – approval

through the PMA process requires reasonable assurance of the device’s substantive safety and

effectiveness. Second, whereas § 510(k) clearance does not indicate official FDA approval, the

FDA has made clear that approval through the PMA process does denote such official approval.

Indeed, the FDA explains on its website that “PMA is the most stringent type of device

marketing application required by FDA. . . . PMA approval is based on a determination by FDA

that the PMA contains sufficient valid scientific evidence to assure that the device is safe and


                                                23
effective for its intended use(s).” See http://www.fda.gov/cdrh/devadvice/pma/ (last visited April

28, 2006). Third, although the § 510(k) process essentially froze the status quo with respect to

pre-1976 devices and their substantial equivalents, the PMA process was created as an entirely

new regime for devices that were not substantially equivalent to older devices. Finally, whereas

§ 510(k) clearance does not reflect the FDA’s determination that the device should “take any

particular form for any particular reason,” 

, the PMA process expressly

provides the FDA with the power to require the device to take a particular form in order to be

approved as safe and effective. As noted above, once the FDA has concluded its review, it can

issue an “approvable letter” stating that the FDA believes it can approve the application if

“specific conditions” are agreed to by the applicant. See 21 C.F.R. § 814.44(e). Alternatively, if

the FDA “believes that the application may not be approved,” it can “send the applicant a not

approvable letter. . . .[that] will describe the deficiencies in the application...and, where practical,

will identify measures required to place the PMA in approvable form.” 21 C.F.R. § 814.44(f).

        Moreover, once a device has obtained PMA approval, the manufacturer cannot make any

changes that might affect the safety and effectiveness of the device without further FDA

approval. At that point, therefore, the device is clearly subject to the federal, device-specific

requirement of adhering to the standards contained in its individual, federally approved PMA.

        The Riegels have argued that manufacturers of § 510(k)-cleared devices are also

precluded from making changes without FDA approval, and that this did not prevent the Lohr

Court from finding that § 510(k) clearance imposed no device-specific requirements. But their

premise is not entirely accurate. As noted above, manufacturers of § 510(k)-cleared devices have

broader latitude to make changes without FDA approval than do manufacturers of PMA-


                                                  24
approved devices, given that they must only obtain approval when making significant changes,

see 21 C.F.R. § 807.81(a)(3), as opposed to any change that “affect[s] the safety or effectiveness

of the device,” see 21 C.F.R. § 814.39(a). This distinction makes sense: the only issue governing

§ 510(k) clearance is whether the device is substantially equivalent to a pre-existing device that

did not go through the PMA process. Thus, unless a significant change is made to a § 510(k)-

cleared device, it will presumably still be substantially equivalent to the pre-existing device, and

there is no need for further FDA review. By contrast, PMA approval explicitly signifies the

FDA’s substantive approval of the device’s reasonable safety and effectiveness, as the device is

currently constituted, and it therefore naturally follows that any changes to a PMA-approved

device that might affect the device’s safety and effectiveness will require further FDA approval.

       For these reasons, we conclude that the Evergreen Balloon Catheter, a PMA-approved

device, was subject to the federal device-specific requirement of complying with the particular

standards set forth in its approved PMA application. It is true that, as the dissent states, see post

at [9], here the FDA approved Medtronic’s PMA application for the Evergreen Balloon Catheter

without invoking its power to require additional alterations. As such, the only documents in the

record from the FDA to Medtronic are generic letters informing Medtronic that the Evergreen

Ballon Catheter has obtained PMA approval and that Medtronic must comply with the generally

applicable “Conditions of Approval” governing all PMA devices. We believe, however, that this

is not relevant to the analysis. Had the FDA believed that the Evergreen Balloon Catheter, as

constituted at the time Medtronic submitted its PMA application for the device, was not

reasonably safe and effective, it certainly would have had the power to condition PMA approval

on implementation of the changes that the FDA believed were necessary. Alternatively, as the


                                                 25
dissent points out, the FDA could also have deemed it appropriate to promulgate performance

standards applicable to catheters such as the Evergreen Balloon Catheter, pursuant to 21 C.F.R. §

861.1(b)(3). Post at [9]. Apparently, however, the FDA concluded that the Evergreen Balloon

Catheter was safe and effective as currently constituted. It would be illogical to hold that because

the FDA, after rigorous review, deemed the PMA application for the Evergreen Balloon Catheter

acceptable in its present form, the Evergreen Balloon Catheter is less subject to a device-specific

regulation than are devices whose initial PMA applications are inadequate and which obtain

PMA approval only after significant back-and-forth with the FDA. Once the PMA process is

complete, all PMA-approved devices are subject to the same federal device-specific regulation:

complying with the standards set forth in their individual approved PMA applications.

       The Riegels have also argued that with regard to their failure-to-warn claim relating to the

labeling of the Evergreen Balloon Catheter, there is no applicable federal device-specific

requirement because (1) the only federal regulation governing the substance of the Evergreen

Balloon Catheter’s label was 21 C.F.R. § 801.109, the same general regulation that the Lohr

Court found not to be sufficiently device-specific to warrant preemption of the labeling claims as

to the § 510(k)-cleared pacemaker device at issue, see 

-501; and (2) under

21 C.F.R. §§ 814.39(d)(1)-(2), manufacturers of PMA-approved devices can make certain

labeling changes without pre-approval from the FDA, such as labeling changes that add or

strengthen a contraindication, add or strengthen an instruction, or delete misleading, false, or

unsupported information. The flaw in this argument is that, unlike in Lohr, here the FDA

explicitly approved the labeling of the Evergreen Balloon Catheter through the PMA process.

Indeed, when Medtronic wanted to revise the Evergreen Balloon Catheter’s label, it submitted


                                                 26
PMA supplements that requested approval for those revisions, and the FDA granted that

approval. Thus, we need not reach the question of whether, had Medtronic subsequently changed

the catheter’s label pursuant to the §§ 814.39(d) process that permits certain changes without

FDA approval, failure-to-warn claims as to that label would be preempted, because here there is

no evidence that Medtronic ever made changes to the catheter’s label other than through the

PMA process.

       Finally, we note the dissent’s concern about the FDA’s ability to “do an adequate job of

ensuring the safety of medical devices,” and its discussion of specific instances in which the FDA

approved, via the PMA process, medical devices that were later proven unsafe. Post at [5-7]. We

agree that it is imperative for the FDA to protect consumers’ safety by exercising careful and

reasoned judgment both in (1) evaluating whether to grant PMA approval in the first place (and

determining which, if any, changes must be made in the device for it to obtain such approval) and

(2) reviewing the postapproval annual reports, adverse reaction reports, and device defect reports

that must be submitted by manufacturers of PMA-approved devices in order to determine whether

the continuation of such approval is appropriate. As a court, we are constrained to observe,

however, that the FDA’s level of success in carrying out these responsibilities, rather than bearing

on the legal question of whether PMA approval reflects a federal device-specific requirement, is

ultimately a policy matter for Congress and the Executive to address.

                                                 2.

       Having ruled that the Evergreen Balloon Catheter was subject to the federal device-

specific requirement of complying with the standards in its approved PMA application, we now

move to the question of whether the Riegels’ claims would, if successful, result in state


                                                 27
“requirements” that differed from or added to those standards. We conclude that they would.

       The Supreme Court first addressed the issue of whether a preemption provision’s reference

to state “requirements” encompasses state common law tort suits, in addition to state statute or

other positive enactments, in Cipollone v. Liggett Group, Inc., 

(1992). There, in the

context of interpreting the preemption provision contained in the Public Health Cigarette Smoking

Act of 1969, 15 U.S.C. § 1334(b), a majority of the Court answered that question in the

affirmative. See 

(“The phrase ‘no requirement or prohibition’ sweeps broadly and

suggests no distinction between positive enactments and common law; to the contrary, those

words easily encompass obligations that take the form of common-law rules. . . . [C]ommon-law

damages actions of the sort raised by petitioner are premised on the existence of a legal duty, and

it is difficult to say that such actions do not impose ‘requirements or prohibitions.”) (plurality

opinion); see also 

(Scalia, J., concurring in the judgment in part and dissenting in part).

       In Lohr, the five justices who endorsed the view that § 360k(a)’s reference to state

“requirements” encompassed state common law tort lawsuits explicitly invoked Cipollone in

reaching that conclusion. See 

(Breyer, J., concurring in part and

concurring in the judgment) (“[I]n Cipollone. . ., the Court made clear that similar language

‘easily’ encompassed tort actions because ‘[state] regulation can be as effectively exerted through

an award of damages as through some form of preventative relief.’ This rationale would seem

applicable to the quite similar circumstances here.”) (internal citations omitted; alteration in

original); 

(O’Connor, J., concurring in part and dissenting in part) (“We recently

addressed a similar question in Cipollone. . . .A majority of the Court agreed that state common-

law damages actions do impose ‘requirements.’. . .That rationale is equally applicable in the


                                                  28
present context.”).

       Since Lohr, the Supreme Court has held firm to the view that state “requirements” can be

created by state common law actions. Just last year in Bates v. Dow Agrosciences LLC, the Court

held – in the context of interpreting the Federal Insecticide, Fungicide, and Rodenticide Act’s

provision that “State[s] shall not impose or continue in effect any requirements for labeling or

packaging in addition to or different from those required under this Act,” 7 U.S.C. § 136v(b) –

that the Fifth Circuit had “correctly [held] that the term ‘requirements’ in § 136v(b) reaches

beyond positive enactments, such as statutes and regulations, to embrace common-law duties.”

, 1798 (2005). Thus, the Bates Court explained that the plaintiffs’ fraud and

negligent-failure-to-warn claims, which were premised on a deficiency in the labeling or

packaging of the product at issue, would be preempted by FIFRA, unless the duties that the claims

implicated were simply equivalent to FIFRA’s own misbranding provisions, rather than adding to

or differing from the FIFRA provisions. 

       We thus conclude that the Riegels’ claims for strict liability, breach of implied warranty,

and negligent design, testing, inspection, distribution, labeling, marketing, and sale would, if



       17
           By contrast, the Court held that the plaintiffs’ claims for defective design, defective
manufacture, and negligent testing were not preempted, because those claims did not relate to the
labeling and packaging of the product, and FIFRA’s preemption provision only preempted
“requirements for labeling or packaging.” 

The Court acknowledged that the
plaintiffs’ success on those claims might prompt the manufacturer to alter its product in ways
that, in turn, would induce the manufacturer to voluntarily make corresponding changes in its
label. 

The Court explained, however, that this did not mean that such claims
could be viewed as setting forth labeling and manufacturing requirements: “[a]n occurrence that
merely motivates an optional decision does not qualify as a requirement.” 

The Court
also held that the plaintiffs’ breach of express warranty claim was not preempted, because that
claim asked only that “a manufacturer make good on the contractual commitment that it
voluntarily undertook by placing that warranty on its product.” 

                                                 29
successful, impose state requirements that differed from, or added to, the PMA-approved

standards for the Evergreen Balloon Catheter. These claims do not rest on the premise that the

particular catheter used during Mr. Riegel’s angioplasty deviated from the standards contained in

the approved PMA application for the Evergreen Balloon Catheter. Rather, the liability-creating

premise of all of these claims is that the Evergreen Balloon Catheter itself, in its present PMA-

approved form, is in some way defective and therefore requires modification.

       The Riegels assert that a verdict in their favor would simply stem from generally

applicable state common law duties, such as the duty to use due care and the duty to inform users

and purchasers of about relevant risks. Therefore, they argue, such a verdict could not possibly

create a state “requirement” that adds to, or differs from, any federal device-specific requirements

for the Evergreen Balloon Catheter. We disagree. The Supreme Court made clear in Cipollone,

Lohr, and Bates that common law actions, which are premised on the alleged violation of a legal

duty, do impose requirements. As Justice O’Connor put it in Lohr, “state common-law damages

actions operate to require manufacturers to comply with common-law duties.” 

(O’Connor, J., concurring in part and dissenting in part). Indeed, a verdict in the Riegels’

favor on any of these claims would represent a finding that the Evergreen Balloon Catheter had

not adhered to the various state common law duties implicated by those claims, e.g., that its

design did not comport with the duty of due care, or that its labeling did not comport with the duty

to warn. Such a verdict would clearly differ from the FDA’s PMA approval of the device (and its

related packaging, labeling, distribution, and so on) as being reasonably safe and effective, and,

moreover, from the FDA’s prohibition against making any modifications affecting the device’s

safety and effectiveness without first obtaining FDA approval.


                                                 30
       Indeed, such a situation would be quite analogous to the hypothetical situation posed by

Justice Breyer in his Lohr concurrence, in which, notwithstanding a federal requirement for a 2-

inch hearing wire in a particular hearing aid, a plaintiff brought a tort claim relating to the same

hearing aid that premised liability on the manufacturer’s failure to use a wire that was 1-inch or

less. 

(Breyer, J., concurring in part and concurring in the judgment).

Justice Breyer clearly thought that such a claim would be preempted. 

there is

a federal requirement that the Evergreen Balloon Catheter adhere to the standards set forth in its

approved PMA application, absent further FDA approval. Yet the Riegels’ claims would premise

liability on Medtronic’s failure to have done something with the Evergreen Balloon Cather other

than adhere to the PMA-approved standards.

       In fact, it is unclear what a manufacturer of a PMA-approved medical device would do

when faced with such a jury verdict on a plaintiff’s common law claims, given that the

manufacturer would nonetheless be unable to make any modifications affecting the device’s safety

and effectiveness without obtaining further FDA approval. Moreover, it is certainly conceivable

that different juries would reach conflicting verdicts about the same medical devices, thus

rendering it almost impossible for a device to comply simultaneously with its federal PMA

(which, after all, can only change after an extensive process) and with the various verdicts issued

by different juries around the country. In this regard, a finding of preemption is consistent with

another purpose evident in the MDA’s legislative history: its desire to ensure that “innovations in

medical device technology are not stifled by unnecessary restrictions,” and its corresponding

recognition that “if a substantial number of differing requirements applicable to a medical device

are imposed by jurisdictions other than the Federal government, interstate commerce would be


                                                  31
unduly burdened.” H.R. Rep. No. 94-853, at 12, 45.

       As such, although we agree with the dissent’s recognition of a general presumption against

preemption, and with the dissent’s comment that the legislative history of the MDA is silent as to

the specific issue of preemption of state tort liability, see post at [1-4], we believe that the above-

discussed Supreme Court precedent makes clear that Section 360k(a)’s reference to state

“requirements” should be interpreted to encompass state common law actions. We note, too, that

the dissent’s argument regarding legislative history and intent is far more persuasive with respect

to § 510(k)-cleared devices than with PMA-approved devices. As the Supreme Court stated in

Lohr, the § 510(k) process appears to have been designed to “maintain the status quo with respect

to the marketing of existing medical devices and their substantial equivalents. That status quo

included the possibility that the manufacturer of the device would have to defend itself against

state-law claims of negligent design.” 

. By contrast, the PMA regime

represented an entirely new approach of ensuring consumer safety through increased federal

regulation and oversight. It is thus much less clear that the continuation of the previous tort

remedies in the PMA context is consistent with the MDA’s purpose. See Benjamin A.

Goldberger, The Evolution of Substantial Equivalence in FDA’s Premarket Review of Medical

Devices, 56 FOOD DRUG . L.J. 317, 332-33 (2001) (“Finding preemption for devices that received

PMAs while holding that 510(k)’d devices cannot benefit from preemption is consistent entirely

with the original purpose of substantial equivalence doctrine. Developed as a method to ensure

economic parity between post-enactment and pre-enactment devices, a substantial equivalence

finding allows a company to market devices as others did before the MDA, complete with

exposure to tort liability. A PMA, on the other hand, brings a device completely within the scope


                                                  32
of the federal regulation as Congress had envisioned it, and, thus is preemptive.”).

       For these reasons, we adhere to the rationale initially set forth by this Court in Becker, and

hold that the Riegels’ strict liability, breach of implied warranty, and negligent design, testing,

inspection, distribution, labeling, marketing, and sale claims are preempted by Section 360k(a) of

the MDA. We thus affirm the district court’s March 14, 2002 order granting summary judgment to

Medtronic on these claims on preemption grounds.

       By the same token, we agree with the district court’s conclusion that the Riegels’ negligent

manufacturing claim was not preempted, to the extent that it rested on the allegation that the

particular Evergreen Balloon Catheter that was deployed during Mr. Riegel’s angioplasty had not

been manufactured in accordance with the PMA-approved standards. A jury verdict in the

Riegels’ favor on this claim would not have imposed state requirements that differed from, or

added to, the PMA-approved standards for this device, but would instead have simply sought

recovery for Medtronic’s alleged deviation from those standards. See 

(O’Connor, J., concurring in part and dissenting in part) (“Where a state cause of action seeks to

enforce an FDCA requirement, that claim does not impose a requirement that is ‘different from, or

in addition to,’ requirements under federal law. To be sure, the threat of a damages remedy will

give manufacturers an additional cause to comply, but the requirements imposed on them under

state and federal law do not differ. Section 360k does not preclude States from imposing different

or additional remedies, but only different or additional requirements.”) (emphasis in original).

       We conclude this portion of our analysis by emphasizing that – contrary to the dissent’s

fear that “the decision today will deprive those who were injured by an unreasonably dangerous

medical device of any remedy whatsoever,” post at [3] – the scope of our decision is actually quite


                                                  33
limited. As noted above, the vast majority of Class III medical devices enter the market pursuant

to the § 510(k) process, not the PMA process. The Supreme Court has already held in Lohr that

tort claims as to § 510(k)-cleared devices are not preempted. Moreover, our decision today does

not even hold that all state tort claims as to PMA-approved devices are preempted. On the

contrary, as set forth above, tort claims that are premised on a manufacturer’s deviation from the

standards set forth in the device’s approved PMA application – such as the Riegels’ negligent

manufacturing claim – are in no way preempted. Only those claims that allege liability despite a

PMA-approved device’s adherence to those standards are, pursuant to this decision, preempted.

As one article recently noted, “[t]his is a relatively small universe of cases.” See Gregory J.

Scandaglia and Therese L. Tully, 59 FOOD DRUG L.J. 245, 263-64 (2004).

       We also question the dissent’s conclusion that our holding will necessarily remove the

incentives for manufacturers of PMA-approved devices to continue improving the safety of their

products once they obtain approval and to alert the FDA of the need for changes as new data

becomes available. See post at [5, 10]. As a condition of continued approval, manufacturers of

PMA-approved products are already required to provide the FDA with annual reports that

summarize any “unpublished reports of data from any clinical investigations or nonclinical

laboratory studies involving the device or related devices,” 21 C.F.R. § 814(b)(2)(i); and any

“reports in the scientific literature concerning the device,” 21 C.F.R. § 814(b)(2)(ii). Such

manufacturers are also specifically required, as a condition of continued approval, to notify the

FDA within ten days of any adverse reactions or device defects. See supra page 11. Additionally,

such manufacturers are also likely to be in competition with other manufacturers of similar

devices, providing another incentive for them to continue improving their own devices. In any


                                                 34
event, we ultimately view this as a policy issue for the legislative and executive branches rather

than a legal question. Should Congress conclude that the preemption of the state tort actions at

issue in this case creates undesirable incentives for manufacturers of PMA-approved devices, it is

entirely free to amend Section 360k(a) to make clear that its reference to state “requirements”

does not include state tort actions.

       Finally, we note that our conclusion is further supported by the FDA’s recent

determination that preemption is warranted with respect to this universe of cases, as indicated by

the content of the May 14, 2004 amicus curiae brief that the FDA submitted upon request to the

Third Circuit in connection with the Horn case, which implicated the same issue that we address

here. See 

(amicus brief); 

(“The FDA has clearly

expressed its view that PMA approval in this particular case requires preemption. The FDA

conceives of [the plaintiff’s] state common law claims as imposing a ‘requirement’ which is

‘different’ from that imposed by the FDA in the PMA process, and thus requiring preemption. . .

A majority of the Court in Lohr emphasized that the FDA is ‘uniquely qualified to determine

whether a particular form of state law. . .should be pre-empted.’”) (quoting 

). It is certainly true that the FDA previously took a different view, but as the Third Circuit

noted in Horn, “an agency may change its course so long as it can justify its change with a

‘reasoned analysis,’” a standard satisfied here. 

Vehicle Mfrs. Ass’n v. State

Farm Mut. Auto. Ins. Co., 

, 42 (1983)).

                                                 IV.

       We now turn to the December 2, 2003 order that granted summary judgment to Medtronic

on the Riegels’ non-preempted negligent manufacturing claim.


                                                 35
       The legal framework governing this claim is undisputed. Because the Riegels do not have

the actual Evergreen Balloon Catheter that was used during Mr. Riegel’s angioplasty, they can

prevail only by proving by circumstantial evidence that it must have been defective. As the New

York Court of Appeals recently explained, “[i]n order to proceed in the absence of evidence

identifying a specific flaw, a plaintiff must prove that the product did not perform as intended and

exclude all other causes for the product’s failure that are not attributable to defendants.” Speller v.

Sears, Roebuck and Co., 

, 41 (N.Y. 2003).

       Medtronic, with reference to expert opinions, has argued that the Evergreen Balloon

Catheter used during Mr. Riegel’s angioplasty burst not because it was negligently manufactured,

but rather because (1) it was inflated to 10 atmospheres, even though the label stated that it should

not be inflated more than 8 atmospheres; (2) it was inserted into an artery that was “diffusely

diseased” and “heavily calcified,” even though the label stated that it should not be used in such

instances (because calcium spicules can puncture the catheter); and/or (3) Dr. Roccario used metal

stents that could have punctured the catheter.

       Thus, to overcome Medtronic’s arguments and survive summary judgment, the Riegels

had to come forward with competent evidence excluding Medtronic’s proferred alternative causes

as the actual origin of the catheter’s rupture. See 

(holding that where

the defendants argued that the fire in question had been caused not by their refrigerator’s wiring,

but rather by the plaintiff’s stove, “[i]n order to withstand summary judgment, plaintiffs were

required to come forward with competent evidence excluding the stove as the origin of the fire”).

       We agree with the district court that the Riegels did not come forward with competent

evidence excluding Medtronic’s proffered causes as the origin of the rupture. It is undisputed that


                                                  36
Dr. Roccario, in performing Mr. Riegel’s angioplasty, inflated the balloon catheter to ten

atmospheres, which is two atmospheres and approximately 29.4 pounds per square inch beyond

the maximum rated burst pressure explicitly specified on the device label. The Riegels have

argued, through Dr. Roccario’s affidavit, that “exceeding the maximum recommended

atmospheres of eight (8) to ten (10) atmospheres was not outside the window of [the device’s]

testing in laboratory settings. . . and inflations to ten (10) atmospheres was based upon my past

experience with the product and was called for in the circumstances herein presented in order to

attempt to obtain the angiographic appearance that I desired rather than what I was presented with

at the time and instead of reintroducing still another balloon.” Although it may well be that

inflating the balloon catheter up to ten atmospheres was the best decision under the circumstances,

this does not indicate that the inflation was not the cause of the catheter’s rupture.

       It is similarly undisputed that Mr. Riegel had heavily calcified arteries, and that the label

for the Evergreen Balloon Catheter contraindicated its use in such an instance. Dr. Roccario has

stated that “it is all but routine today at this point in the development of the medical science in

question for a PTCA [percutaneous transluminal coronary angioplasty] to go forward under such

circumstances.” Again, however, this does not mean that in this particular instance, we can

exclude the calcified nature of Mr. Riegel’s artery as a cause for the catheter’s rupture. Indeed,

Dr. Roccario himself – while stating that “there was simply nothing about the procedures that I

undertook or the medical decisions and choices that I made on May 10, 1996 which in my

professional medical opinion in any way contributed to the bursting of this particular Evergreen

3.0-20mm balloon” – has not actually opined that the catheter must have burst as a result of a

manufacturing defect.


                                                  37
       The only affirmative evidence that the Riegels have adduced in support of their claim that

the catheter must have had a manufacturing defect is the report of their expert, engineer Ted Milo,

who offered the view that based on the nature of Mr. Riegel’s injury, the catheter must have burst

not longitudinally, but radially, which – in his view – apparently signified a manufacturing defect.

The district court found, however, that Milo’s conclusion that the catheter had burst radially was

based on “sheer surmise and conjecture rather than on any scientific basis,” and therefore found it

to be insufficiently substantiated to be admissible as expert testimony. We agree, and thus

conclude that the district court did not abuse its discretion in refusing to admit this evidence. See

Raskin v. The Wyatt Co., 

, 65-66 (2d Cir. 1997) (explaining that district court has

broad discretion in deciding whether to admit evidence, that we therefore review evidentiary

rulings for manifest error, and that this “same standard of review applies to a district court’s

evidentiary rulings on expert testimony”).

       The district court identified serious flaws in Milo’s expert opinion. First, Milo did not

explain the basis of his conclusion that Mr. Riegel’s injury was more indicative of a radial failure

than a longitudinal failure. Second, even assuming arguendo that the balloon burst radially rather

than longitudinally, Milo did not explain why a radial failure could not itself result from the

causes that Medtronic proffers here: namely, overinflation of the catheter or by punctures caused

by calcifications. Indeed, the district court also pointed out that Milo’s own exhibit indicated that

even some non-longitudinal failures are caused not by manufacturing defects, but rather by

overpressurization or punctures from calcified lesions.18 The Riegels have not responded to this


       18
         We note that Milo seems to have simply assumed that because Dr. Roccario used a
rotoblator to remove the calcium deposits from Mr. Riegel’s artery before inserting the Evergreen
Balloon Catheter, the device’s contraindication for patients with calcified arteries “would no

                                                  38
point on appeal. We also note that in his deposition, when Milo was asked for his response to

another expert opinion that “the probable cause of rupture of the balloon catheter was not a

manufacturing defect, but rather puncture of the balloon by either a spicule of calcium in the

vessel wall or a portion of the previously implanted metal stents,” he responded, “I have no

opinion.”

        Although the Riegels argue that Milo’s theories should have been evaluated by a jury

rather than the district judge, this Circuit has explained that it is appropriate for the district court

to determine the admissibility of scientific evidence and to rely only on admissible evidence in

ruling on summary judgment. See, e.g., Amorgianos v. National Railroad Passenger Corp., 

, 271 (2d Cir. 2002) (affirming grant of summary judgment after district court had ruled

the plaintiff’s expert report inadmissible); 

(stating that “an expert’s report

is not a talisman against summary judgment”). We believe that the district court was well within

its discretion in concluding that Milo’s opinion was not an admissible expert opinion and

therefore could not serve as a basis for demonstrating a manufacturing defect. An expert opinion

requires some explanation as to how the expert came to his conclusion and what methodologies or

evidence substantiate that conclusion. See Fed. R. Evid. 702 (“If scientific, technical, or other

specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact

in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education,

may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon

sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3)



longer be relevant.” He did not even address the possibility that some calcium spicules could
have remained.

                                                   39
the witness has applied the principles and methods reliably to the facts of the case”). In this case,

Milo essentially provided no explanation as to how he had reached his conclusion that the rupture

must have been caused by a manufacturing defect, and himself seems to have backed away from

this conclusion in his deposition. It was therefore appropriate for the district court to exclude his

opinion.

       As a result, because there was no competent evidence excluding Medtronic’s proffered

causes – particularly, encounter with a calcium spicule in the artery and/or the over-inflation of

the catheter – as the origin of the rupture of the Evergreen Balloon Catheter, there were no

genuine issues of material fact for a jury on this claim. Therefore, we agree with the district court

that the Riegels “failed to submit sufficient evidence from which a fair-minded trier of fact

[could] reasonably conclude that Plaintiff excluded all other causes of the burst,” and affirm the

court’s December 2, 2003 dismissal of their negligent manufacturing claim.

                                                  V.

       For the foregoing reasons, we hereby affirm the district court’s March 14, 2002 and

December 2, 2003 orders that, collectively, granted summary judgment to Medtronic on all of the

Riegels’ claims.




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