Opposition Brief — Riegel v. Medtronic, Inc.

FILED

Oo OCT 5-205 |

OFFICE OF TH LEO:

No. 06-179 SU-REM< CiHv87, LS.

Jn the Supreme Court of the Anited States

CHARLES R. RIEGEL, et al.,

Petitioners,

Vv.

MEDTRONIC, INC.,

Respondent.

On Petition for a Writ of Certiorari to the

United States Court of Appeals for the Second Circuit

BRIEF FOR THE RESPONDENT IN OPPOSITION

MICHAEL K. BROWN KENNETH S. GELLER

LisA M. BAIRD Counsel of Record

Reed Smith LLP DAVID M. GOSSETT

355 S. Grand Avenue ANDREW E. TAUBER

Suite 2900 Mayer, Brown, Rowe &

Los Angeles, CA 90071 Maw LLP

(213) 457-8000 1909 K Street, NW

RICHARD H. BAKALOR Washington, DC 20006

Quirk & Bakalor, PC (202) 263-3000

845 Third Avenue

New York, NY 10022

(212) 319-1000

Counsel for Respondent

WILSON-EPES PRINTING CO., INC. — (202) 789-0096 - WaSsHiNGTON, D.C. 20001

QUESTION PRESENTED

Whether 21 U.S.C. § 360k(a) preempts petitioners’ state

common law damages claims challenging the design, testing,

manufacture, distribution, labeling, and marketing of Med-

tronic’s Evergreen Dilatation Balloon Catheter, when that

device was granted pre-market approval (PMA) by the Food

and Drug Administration (FDA) and when each of petition-

ers’ claims would impose requirements relating to the safety

or effectiveness of the device that would be “different from”

or “in addition to” the federal requirements embodied in the

FDA’s pre-market approval of the device.

ii

RULE 29.6 STATEMENT

Respondent Medtronic, Inc. is a publicly traded corpora-

tion and has no corporate parent. No other publicly held

company owns 10 percent or more of respondent’s stock.

iii

TABLE OF CONTENTS

Page

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T_T ii

ey le ID cccnesensescnccecevetensesssetensnaienvnnn iv

STATEMENT ................ Lidinsisiciuninaiishionisuneiichibdapeiidimtconaenniasiot 2

A. The regulatory structure of the

Medical Device Amendments. ...................+. 2

-B. The Evergreen Balloon Dilatation

Catheter was subject to extensive

regulatory review prior to receiving

FIED siinninstiiissscvermstippnscdsensenasssccccosnen 5

C. Petitioners’ case in the lower courts. ............ 7

REASONS FOR DENYING THE PETITION................... 1]

I. There Is No Reason For This Court To Revisit

Its Ruling In Medtronic, Inc. v. Lohr. ..................+. 12

A. Any disagreements among the lower

courts are minimal and diminishing. .......... 12

B. The lower courts should be allowed to

consider the implications of the FDA’s ,

PS ee 19

Il. The Decision Below, Finding Preemption Of

State Law Claims Based On The

Requirements Imposed By The PMA Process,

ET TITIES cciuisianiestnitanasiniannisessiieciinninienioteuninaiiie 22

SITET tinsccnccsansnsneseninnnnentesmiensatsnnnnetansatonencandenenies

iv

TABLE OF AUTHORITIES

Page(s)

CASES

American Airlines, Inc. v. Wolens, 513 U.S. 219

REAR MSE ESET Sie Dae ena a RO a oe 24

Auer v. Robbins, 519 U.S. 452 (1997) .ccsc.cccssecsssssesssssecessse 21

Bates v. Dow Agrosciences LLC, 544 U.S. 431

ESE AIREY a Oe OY a 18, 19, 27

Brooks v. Howmedica, Inc., 535 U.S. 1056

tk nadia hl aera niintitibiiad l

Brooks v. Howmedica, Inc., 273 F.3d 785

Fe, UPSD sstccnseseccceveseninccseveisinmbereenitesesmencvente 13, 16

Buckman Co. v. Plaintiffs’ Legal Committee,

NG MT fics fecicabicincaniatitatincainentenniniccia passim

Connelly v. lolab Corp., 927 S.W.2d 848

EE I oe eee See aT 15

Cupek v. Medtronic, Inc., 405 F.3d 421 (6th

i aieitiatiahaidinaiaisiacitini ical ihdiatisetiatatiinansidin 12, 13, 16

Fry v. Allergan Med. Optics, 695 A.2d 511

RES an ee a na 13, 16

Geier v. American Honda Motor Co.,

| Ee ener passim

Goodlin v. Medtronic, Inc., 167 F.3d 1367

EEE SSSR pre ean ov onn Ee er ore 14, 16, 19

Green v. Dolsky, 685 A.2d 110 (Pa. 1996)................... 14, 16

Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.

EE ndccenttrninisndutepianitanriintciioiennintineesdiiincnminceeeeseesies passim

Hughes v. Cook, No. 2:06-CV-02027 (W.D.

Se I ares EE chiiccuiieciidanadabedaniiiiiiedbasneensenntnisediacsi 22

Kemp v. Medtronic, Inc., 534 U.S. 818 (2001) ...............00044. l

Kemp v. Medtronic, Inc., 231 F.3d 216

a i islalcieeiateiie passim

Vv

TABLE OF AUTHORITIES—continued

Page(s)

Knisley v. Medtronic, Inc., 126 S. Ct. 420 (2005)..........0:000+. |

Martin v. Medtronic, Inc., 534 U.S. 1078 (2002) ................. ]

Martin v. Medtronic, Inc., 254 F.3d 573 (Sth Cir.

TEETER AGREES Ea EAPO vO SPOOL es HEMT Rare 13, 16

McMullen v. Medtronic, Inc., 126 §. Ct. 1464

ET alllicciublichpadsltiphiteneninatiopcisibiainadiaiiahieiiaiaoehuiiliinasiinpiealenbightla l

McMullen v. Medtronic, Inc., 421 F.3d 482 |

Ea CITT icnisivescenciondeinenendtiiatelisineimnibbanieiemsaliniii 13, 16

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ............. passim

Mitchell v. Collagen Corp., 126 F.3d 902

SF ee SPO ccctnsncinnecsnesnicinitaneniabidéiiiigneis 13, 16, 24, 29

Niehoff v. Surgidev Corp., 950 S.W.2d 816

SEINE: INUIT s dnociniedeennenicsiaadenionsitubiansinesanieanidetdamian 15, 16

Oja v. Howmedica, Inc., 111 F.3d 782

t. i¢ % |. ae sbassihinaiiuans 16, 17, 18, 19

Papike v. Tambrands Inc., 107 F.3d 737

CPOE. 197) 2sccccccssesesecsereccsscccccenereccsecoscscsoaiggescscoooten 16

State ex rel. Miller v. New Womyn, Inc.,

679 N.W.2d 593 (Iowa 2004)..000.0........cccccceeeeeeeceeeee seine

Weiland v. Telectronics Pacing Systems,

Inc., 721 N.E.2d 1149 (Ill. 1999)......00........ 14, 15, 16, 19

Worthy v. Collagen Corp., 967 S.W.2d 360

Pe: Dee vsciussnieasinncihiehnicaciiceslesnspensniiediaansiingabiadeniitaaialldalaa 13, 16

STATUTES, RULES, AND REGULATIONS

Federal Food, Drug, and Cosmetic Act (FDCA),

Fee ee Ce ee CU vcsctnscsinsrccccsescteitipsndpmaniisnecibtintadiaaabail 2

Be ee OF IED sisthindnscsccsisccnditiiinsaidantcindigdiadananaaa 23

Boe We 0b PEED sinnissescscnsssistisiiinsiintenseuniaiiiammeameaiaaa 23

21 U.S.C. § 360(k)(2) ..cecccccscssecss,ceseesessneen EE): 23

vi

TABLE OF AUTHORITIES—continued

Page(s)

Medical Device Amendments (MDA), 21 U.S.C.

re inerlencrice eee crictemineencennannnatentnicins 2

21 U.S.C. § 360c(a)(2)........: SELES Sr Sao 25

TT 23

i esssmemaseeinbimnenian 23

ES 23

A ieee 23

Te 23

Se 5

TT 23

ee Oe ......-ssnscenessheseteeneneussuseensns 3, 23

LS AE 5

ee 23

stil 23

eel 23

ee passim

CC 14, 27

a 26

A 23

I eessenensnsuain 25, 27

SD 5,6

ees 6

I seintemeeniaiaen 5,6

i ssesumenonnene 6, 15, 23, 24

Final Rule, Exemptions From Federal Preemption of

State and Local Device Requirements: Proce-

dures For Consideration of Applications, 43 Fed.

| ee 26

vil

TABLE OF AUTHORITIES—continued

Page(s)

Final Rule, Medical Devices, 45 Fed. Reg. 67,321

i Mi Noi ciincsie i isstinieiiaiat eee lial heanalaedinriael 14

Proposed Rules, Exemptions From Federal Preemp-

tion of State and Local Device Requirements:

Proposed Procedures for Consideration of Appli-

cations, 42 Fed. Reg. 30,383 (June 14, 1977) ...........+++ 13

i ce thesedittsesthcendiceisctiengnenconniestaniniinvaninngi 14, 16

DN i cnibesisicssiniaiccasicmeablabelicil 8

MISCELLANEOUS

Brief for United States as Amicus Curiae, 2004 WL

1143720, filed in Horn v. Thoratec Corp., 376

PO fo 0 eee passim

FDA Oversight: Medical Devices: Hrg. Before the

Subcomm. on Oversight & Investigations

of House Comm. on Energy & Commerce,

es, Se I: OP I cctrenibernctnenenesencntensnesenenenes 28

Gregory J. Scandaglia & Therese L. Tully, Express

Preemption and Premarket Approval Under the

Medical Device Amendments, 59 FOOD DRUG L.J.

ST TIT cccsicensststeennceciigininidnoniinianiuniiisbaninasatpenaiimineitinnienniiias 29

ube: GDL DENRA, OMNI NEP PUID cccccceccncccssenessescesvensssnsne 2, 26, 28

BRIEF FOR THE RESPONDENT IN OPPOSITION

On at least five occasions in as many years, this Court

has denied petitions for certiorari raising issues identical to

those presented here. See McMullen v. Medtronic, Inc., 126

S. Ct. 1464 (2006); Knisley v. Medtronic, Inc., 126 §. Ct. 420

(2005); Brooks v. Howmedica, Inc., 535 U.S. 1056 (2002);

Martin v. Medtronic, Inc., 534 U.S. 1078 (2002); Kemp v.

Medtronic, Inc., 534 U.S. 818 (2001). The grounds for deny-

ing certiorari, already ample when those prior petitions were

reviewed, are even stronger today.

Contrary to petitioners’ assertion (Pet. 14), the lower

courts are not “deeply divided” regarding the application of

Medtronic, Inc. v. Lohr, 518 U:S. 470 (1996). Quite the op-

posite. A clear and growing consensus has emerged that—

consistent with this Court’s teaching in Lohr—FDA pre-

market approval (PMA) of a medical device preempts con-

flicting-state law claims arising from the design, manufac-

ture, and labeling of such a device. Every court of appeals to

have considered the issue in the past seven years has con-

cluded, as did the Second Circuit below, that the FDA’s vig-

orous PMA process establishes device-specific federal re-

quirements that, under 21 U.S.C. § 360k(a), preempt state

common law damages claims that would effectively create

State requirements “different from” or “in addition to” the

federal requirements.

Although there is some vestigial inconsistency in the

lower courts’ interpretations of Lohr, the remaining conflict

is increasingly stale and likely to disappear even without this

Court’s intervention. The only cases to hold that state com-

mon law damages claims are never preempted by PMA ap-

proval were decided nearly a decade ago, shortly after this

Court’s decision in Lohr. Since then, this Court’s subsequent

decisions in Geier v. American Honda Motor Co., 529 U.S.

861 (2000), and Buckman Co. v. Plaintiffs’ Legal Committee,

531 U.S. 341 (2001), have given clear guidance on the proper

2

interpretation of Lohr. Moreover, the United States has since

filed an amicus curiae brief in Horn v. Thoratec Corp., 376

F.3d 163 (3d Cir. 2004), setting forth the FDA’s considered

opinion that, under the relevant FDA regulation, approval of

a medical device through the PMA process generally pre-

empts state common law claims arising from the use of such

a device. Given Geier, Buckman, and the government’s

amicus brief in Horn, the few lower courts that had initially

misinterpreted Lohr are likely to revise their aberrant views

without further action by this Court.

STATEMENT

A. The regulatory structure of the Medical Device

Amendments.

In 1976, Congress enacted the Medical Device Amend-

ments (MDA), 21 U.S.C. §§ 360c ef seqg., to the Federal

Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 ef

seq., which vastly expanded the authority of the FDA to

regulate medical devices. At the same time that it established

a comprehensive regulatory regime at the federal level, Con-

gress sought to protect innovations in device technology

from being “stifled by unnecessary restrictions.” H.R. REP.

No. 94-853, at 12 (1976). Specifically, Congress attempted to

shield medical devices from the “undu[e] burden[]” imposed

by differing state regulation by including in the MDA a

“general prohibition on non-Federal regulation.” /d. at 45.

That general prohibition, which also serves to safeguard the

uniformity of the federal regulatory scheme, broadly provides

that no state may impose “any requirement” relating to the

safety or effectiveness of a medica! device that “is different

from, or in addition to, any requirement applicable * * * to

the device” under federal law. 21 U.S.C. § 360k(a).

This Court has twice considered the preemptive scope of

the MDA—in Lohr and, more recently, in Buckman. In a

fractured opinion, the Lohr Court held that the MDA’s ex-

press preemption clause did not bar state law tort actions

challenging the design, manufacture, or labeling of “Class

3

III” devices—i.e., devices that either (1) 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 prevent-

ing impairment of human health,” or (2) “present[] a poten-

tial unreasonable risk of illness or injury,” id.

§ 360c(a)(1)(C)(ii)—if those devices had been approved for

sale through a simple “premarket notification” under the

“510(k)” process as the “substantial[] equivalent” of a device

in existence before the passage of the MDA. See Lohr, 518

U.S. at 492-494.

Explicitly differentiating the 510(k) notification process,

at issue in Lohr, from the PMA process at issue here, the

Lohr Court noted that “(t]he § 510(k) notification process is

by no means comparable to the PMA process.” 518 U.S. at

478-479. Thus, “[b]efore a new Class III device may be in-

troduced to the market” via the far more exacting PMA pro-

cess, |

the manufacturer must provide the FDA with a “rea-

sonable assurance” that the device is both safe and

effective. See 21 U.S.C. § 360e(d)(2). Despite its

relatively innocuous phrasing, the process of estab-

lishing this “reasonable assurance” [in the PMA

process] is a rigorous one. Manufacturers must

submit detailed information regarding the safety and

efficacy of their devices, which the FDA then re-

views, spending an average of 1,200 hours on each

submission.

Id. at 477 (citations omitted). The Court contrasted this “rig-

orous” review with the 20 hours typical for a 510(k) review.

Id. at 479. Because the device at issue in Lohr had been mar-

keted “without running the gauntlet of the PMA process,” id.

at 494, the Lohr Court never addressed the preemptive scope

of the PMA process.

In finding 510(k) approval not preemptive, the Lohr

Court laid out a basic framework for analyzing express pre-

emption under the MDA. First, a majority of the Court held

4

that one must engage in a “careful comparison” of the details

of the federal requirements applicable to the device and the

State requirements that are arguably preempted. 518 U.S. at

500. Second, a majority of the Court specifically found that

state common law tort actions seeking damages could impose

“requirements” and thus be preempted. See id. at 504-505

(Breyer, J., concurring); id. at 509 (O’Connor, J., concurring

in part and dissenting in part). Finally, a majority of the

Court found that only “specific” federal requirements could

be preemptive, and only of “specific” state requirements. See

id. at 500; id. at 506-507 (Breyer, J., concurring). Under this

framework, the Court determined that approval through the

510(k) process—which “is focused on equivalence, not

safety” (id. at 493 (emphasis in original) (internal quotation

omitted)), and which does “not ‘require’”” a medical device

“to take any particular form for any particular reason”

(ibid.)—did not preempt the state law claims raised by the

Lohrs.

Like Lohr, Buckman addressed preemption when a de-

vice had been approved through the 510(k) process. The

plaintiffs in Buckman alleged that they were injured by a de-

vice manufacturer’s “fraud on the FDA.” But for fraudulent

disclosures to the FDA, they claimed, the agency would not

have approved marketing of a device and thus plaintiffs

would not have been injured. The Court—-noting that “al-

though [Lohr] can be read to allow certain state-law causes of

actions that parallel federal safety requirements, it does not

and cannot stand for the proposition that any violation of the

FDCA will support a state-law claim” (531 U.S. at 353)—

found such claims to be impliedly preempted by the MDA.

Fraud on a federal agency, the Court held, was not a matter

historically of state concern, and “fraud-on-the-FDA claims

would * * * cause applicants to fear that their disclosures to

the FDA, although deemed appropriate by the Agency, will

later be judged insufficient in state court.” Jd. at 351.

5

B. The Evergreen Balloon Dilatation Catheter was

subject to extensive regulatory review prior to

receiving FDA approval.

Both Lohr and Buckman stressed the “thorough review”

(Buckman, 531 U.S. at 344; see also Lohr, 518 U.S. at 477)

that Class III medical devices must undergo before obtaining

approval from the FDA pursuant to the PMA process. Prior

to receiving FDA approval, the Medtronic F vergreen Balloon

Dilatation Catheter (Evergreen Balloon Catheter), a Class III

device used for angioplasty on patients with coronary artery

disease, underwent this thorough review.

To obtain FDA approval via the PMA pane, a manu-

facturer such as Medtronic

must submit a detailed PMA application that con-

tains full reports of all investigations of the safety

and effectiveness of the device; a full statement of

the components, ingredients, properties, and prinici-

ples of operation of the device; a full description of

the methods used in the manufacture and processing

of the device; information about performance stan-

dards of the device; samples of the device; speci-

mens of the proposed labeling for the device; and

any other relevant information.

Pet. App. 8a (citing 21 U.S.C. § 360e(c)). In addition, the

manufacturer “must include data from clinical investigations

to establish the safety and effectiveness of the device.” /bid.

(citing 21 C.F.R. § 814.20(b)(6)(ii)). The FDA closely scru-

tinizes the PMA application. If it is not satisfied with the in-

formation provided, it can demand more information. See

Pet. App. 9a (citing 21 U.S.C. § 360e(d)(3), 21 C.F.R.

§ 814.44(e)). The FDA may also refer the application to an

outside advisory panel. Sce ibid. (citing 21 C.F.R. § 814.44).

If the FDA decides that the device’s design, manufacturing

methods or labeling should be revised, the agency can require

such revisions as a condition of approval. See ibid. (citing 21

C.F.R. § 814.44(e)). In any event, if the device is ultimately

6

approved, “the epplicant is required to comply with the stan-

dards in the PMA approval order.” /bid. (citing 21 C.F.R.

§ 814.80).

If a manufacturer wishes to make any changes that might

affect the safety or efficacy of a device after it has received

PMA approval, the manufacturer must submit a PMA Sup-

plement, which is then subject to renewed FDA scrutiny. The

proposed changes may be made only if they receive FDA ap-

proval. Pet. App. 10a (citing 21 C.F.R. § 814.39(a)). A PMA

Supplement is subject to the same standards of review as an

initial PMA application. See 21 C.F.R. § 814.39(c) (“{a]ll

procedures and actions that apply to an application under

§ 814.20 also apply to PMA supplements”); see also Kemp v.

Medtronic, Inc., 231 F.3d 216, 222 (6th Cir. 2000) (noting

that the “procedures applicable to a PMA Supplement are the

same as those applicable to an original PMA”).

In this case, Medtronic’s initial submission to the FDA

in connection with the Evergreen Balloon Catheter was made

in June 1987, when Medtronic filed a PMA application for an

antecedent catheter system. A109.’ That application was

granted the following year. /bid. In March 1994, Medtronic

submitted a PMA Supplement for the Evergreen Balloon

Catheter. A112. As part of that supplemental application,

Medtronic submitted “extensive information about the safety

and effectiveness” of the device, ali of which was “specific to

the Evergreen Balloon Catheter.” Pet. App. 65a. Thus, Med-

tronic provided the FDA with design details, clinical test

data, proposed product labels, and a precise description of

how the catheter would be produced. See ibid; see also

A422-A427. On August 30, 1994, the FDA approved Med-

tronic’s application for the Evergreen Balloon Catheter. Pet.

App. 3a. The conditions of approval provided that Medtronic

was required to submit a PMA Supplement “[{bJefore making

Citationsto A _ are to the Appendix filed below.

7

any change affecting the safety or effectiveness of the de-

vice.” A116.

C. Petitioners’ case in the lower courts.

1. Petitioners are Charles Riegel (Riegel) and his wife,

Donna. In May 1996, Riegel, who suffers from coronary dis-

ease, underwent surgery intended to unclog his right coro-

nary artery. After several unsuccessful attempts using other

devices, Riegel’s surgeon decided to perform angioplasty us-

ing an Evergreen Balloon Catheter. Pet. App. 4a, 76a; see

also A106—A107.

During angioplasty, the catheter is inserted into the pa-

tient’s. artery and the balloon near its tip is then inflated to

open the clogged vessel. Thereafter, the balloon is deflated

and the device is removed. Pet. App. 3a.

The surgeon’s decision to use the Evergreen Balloon

Catheter on Riegel was directly contfary to the device’s

FDA-approved labeling. Pet. App. 38a—43a; id. at 90a. Prior

to his surgery, Riegel was diagnosed as having a “diffusely

diseased” and “heavily calcified” right coronary artery. Pet.

App. 4a. The FDA-approved labeling specifically warned

that use of the Evergreen Balloon Catheter “is contraindi-

cated” —i.e., is inappropriate—in patients having “diffuse or

calcified stenoses.” Pet. App. 83a. Because calcification is

often associated with hard, sharp points within a clogged ar-

tery, it increases the likelihood that the balloon will burst

when inflated. Pet. App. 82a; see also A237. Thus, Riegel

was not an appropriate candidate for the Evergreen Balloon

Catheter. Pet. App. 90a.

Even if Riegel had been a proper candidate for the Ever-

green Balloon Catheter, the surgeon chose to use the device

* Medtronic subsequently submitted three PMA Supplements in connec-

tion with proposed revisions to the design and labeling of the Evergreen

Balloon Catheter. Two of those Supplements were approved by the FDA

on Apnl 27, 1995; the third was approved on April 18, 1996. See Pet.

App. 3a; A4S.

in a manner inconsistent with its labeling. The FDA-

approved instructions for the device specifically warn that the

“{bjalloon pressure should not exceed the Rated Burst Pres-

sure.” Pet. App. 83a. The specific model used on Riegel, the

3.0-20 mm Evergreen Balloon Catheter (Pet. App. 76a), has

a Rated Burst Pressure of 8 atmospheres (atm). Pet. App.

84a. Despite this fact, which is clearly noted on the FDA-

approved labeling, the surgeon inflated the balloon to 10 atm,

or 25 percent higher than approved. Pet. App. 83a.

As a result, the balloon burst while inside Riegel’s ar-

tery. Pet. App. 43a, 90a; see also A235—A241. As a conse-

quence, Riegel had to undergo emergency bypass surgery. He

recovered, although he asserts that he suffered lasting inju-

ries. Pet. App. 4a.

2. Petitioners sued Medtronic. Riegel alleged that Med-

tronic was “negligent in the design, testing, inspection,

manufacture, distribution, labeling, marketing, and sale” of

the Evergreen Balloon Catheter, that Medtronic had breached

express and implied warranties, and that Medtronic was

strictly liable for Riegel’s alleged injuries. Riegel’s wife as-

serted a derivative claim alleging loss of consortium. Pet.

App. 4a—Sa; see also Al 7—A22.

Medtronic moved for summary judgment on the ground

that all of petitioners’ claims—other than the express war-

ranty claim, which Medtronic moved to dismiss under Fed.

R. Civ. P. 12(b)(6)—-were preempted under 21 U.S.C.

§ 360k(a). In a decision issued on March 14, 2002, the dis-

trict court granted Medtronic summary judgment on the strict

liability and implied warranty claims and on each of the neg-

ligence claims other than negligent manufacturing, holding

that those state-law claims were preempted under § 360k(a).

Pet. App. 68a, 71a.

In factual findings that petitioners do not dispute, the

district court found that, as part of the PMA process leading

to FDA approval of the Evergreen Balloon Catheter, Med-

tronic had “submitted extensive information about the safety

9

and effectiveness” of the device. Pet. App. 65a. That infor-

mation, all of which was “specific to the Evergreen Balloon

Dilatation Catheter,” included “test data, the results of clini-

cal investigations and design information” as well as “full

copies of proposed product labels.” /bid. The district court

found that “[t]he Catheter’s design was specifically approved

by the FDA” and—having been determined by the agency

“to provide reasonable assurances of safety’—‘“cannot be

_ changed or modified without FDA approval.” Pet. App. 67a.

The court also found that the same was true of the device’s

manufacturing process and labeling, which were “approved

by the FDA in their entirety.” /bid.

Because Medtronic “was prohibited from changing the

FDA-approved design, labeling, or manufacturing methods

without further FDA approval,” Pet. App. 65a, the district

court found that “[t]he FDA’s approval under the PMA pro-

cess imposes standards on the device manufacturer that are

fixed and required.” Pet. App. 66a. Accordingly, the district

court concluded, “[o]nce the FDA approves these specific

safety requirements for a device, those requirements consti-

tute a specific federal requirement, as contemplated for pre-

emption purposes under Lohr.” Ibid.

Given the FDA’s approval of the catheter’s design,

manufacturing method, and labeling, the district court further

found that a jury verdict holding Medtronic liable for negli-

gent design, improper manufacturing methods, inadequate

labeling, or breach of implied warranty “would necessarily

impose a standard on [Medtronic] different from that im-

posed by the FDA” and would thus “conflict with the federal

requirements already applicable to the device.” Pet. App.

67a—68a.

Consequently, the district court granted Medtronic’s mo-

tion for summary judgment on preemption grounds except

insofar as the Riegels alleged that “the Catheter at issue in

this action was not manufactured in accordance with the

FDA’s requirements as set forth in the PMA process,” a

10

claim that the district court held “the MDA does not pre-

empt.” Pet. App. 71a. Subsequently, in a December 2, 2003,

decision not at issue here, cf. Pet. 12, the district court

granted Medtronic summary judgment on both the negligent

manufacturing claim and the breach of express warranty

claim, finding no factual basis for either claim. Pet. App.

90a. On December 11, 2003, the district court—having

found petitioners’ claims to be preempted and/or without fac-

tual basis—entered judgment for Medtronic. Pet. App. 90a—

9la.

The Riegels appealed the district court’s preemption rul-

ing to the Second Circuit, which affirmed the grant of sum-

mary judgment in its entirety.

The court of appeals began by noting that the PMA pro-

cess “is lengthy and rigorous.” Pet. App. 8a. Not only is the

PMA process ““‘the most stringent’” form of FDA review, but

final ““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 effective for its intended

use(s).’” Pet. App. 25a (quoting http://www.fda.gov/cdrh/

devadvice/pma/). Moreover, the court of appeals noted,

“once a device has obtained PMA approval, the manufacturer

cannot make any changes that might affect the safety and ef-

fectiveness of the device without further FDA approval.” Pet.

App. 26a. Thus, the court found, upon receiving PMA ap-

proval, “the device is clearly subject to the federal device-

specific requirement of adhering to the standards contained in

its individual, federally approved PMA.” /bid.

Turning to petitioners’ claims that the trial court had

held to be preempted, the Second Circuit observed:

These claims do not rest on the premise that the par-

ticular catheter used during Mr. Riegel’s angioplasty

deviated from the standards contained in the ap-

* The district court also dismissed Donna Riegel’s derivative loss of

consortium claim.

proved PMA application for the Evergreen Balloon

Catheter. Rather, the liability-creating premise of all

of these claims is that the Evergreen Balloon Cathe-

ter itself, in its present PMA-approved form, is in

some way defective and therefore requires modifica-

~ tion.

Pet. App. 32a. The court of appeals therefore “conclude[d]

that the Riegels’ claims for strict liability, breach of implied

warranty, and negligent design, testing, inspection, distribu-

tion, labeling, marketing, and sale would, if successful, im-

pose state requirements that differed from, or added to, the

PMA-approved standards for the Evergreen Balloon Cathe-

ter.” Ibid.

Accordingly, the Second Circuit held that petitioners’

“strict liability, breach of implied warranty, and negligent

design, testing, inspection, distribution, labeling, marketing,

and sale claims are preempted by Section 360k(a).” Pet. App.

35a. In so holding, the court of appeals joined what it de-

scribed as the “growing consensus” that state-law “claims |

regarding PMA-approved medical devices are * * * pre-

empted.” Pet. App. 2a. At the same time, the Second Circuit

emphasized that its “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 ap-

proval.” Pet. App. 3a.

REASONS FOR DENYING THE PETITION

Petitioners assert (Pet. 1—3, 15-18) that review is neces-

sary in this case because of the purported disarray in the

lower courts over the interpretation of Medtronic, Inc. v.

Lohr. The Court should deny the current petition, as it denied

the petitions filed in McMullen, Knisley, Brooks, Martin, and

12

Kemp, which raised essentially the same issues.* As we ex-

plain in Part I.A, the lower courts are in significantly less

disarray than petitioners suggest. Moreover, in light of the

amicus brief recently filed by the United States in Horn—as

well as this Court’s decisions in Buckman and Geier—any

lingering disagreement within the lower courts is now likely

to. disappear. See Part 1.B, infra. In any event, given the

FDA’s specific approval of and corresponding requirements

for the Evergreen Balloon Catheter, the Second Circuit’s de-

cision is plainly correct. See Part II, infra.

I. There Is No Reason For This Court To Revisit Its

Ruling In Medtronic, Inc. v. Lohr.

A. Any disagreements among the lower courts are

minimal and diminishing.

Petitioners assert that the lower courts are “deeply di-

vided” on the question whether the FDA’s approval of a

medical device through the PMA process preempts inconsis--

tent state-law damages claims arising from the design, manu-

facture, and labeling of'such devices. Pet. 15-18. Indeed, pe-

titioners assert that there are conflicts as to both whether the

PMA process imposes specific federal requirements and

whether any duties imposed through state law damages ac-

tions can be preempted after Lohr. In fact, although a few

courts, in outdated opinions, have misinterpreted Lohr on

each of these issues, the overwhelming weight of authority—

including a// recent authority—favors the Second Circuit’s

position on each question.

1, On the “federal” side, Lohr held that “specific” fed-

eral requirements applicable to a device are preemptive under

the MDA. See 518 U.S. at 500-501.° Based on this Court’s

* Three of these prior petitions—the ones filed in Knisley, Martin, and

Kemp—were drafted by counsel for petitioners here and were virtually

identical to the current petition.

* In dissent, four Justices in Lohr observed that “[t]he statute makes no

mention of a requirement of specificity, and there is no sound basis for

13

discussion of the “rigorous” nature of the PMA process, and

the Court’s comparison between the 510(k) process (which

“reflect{s] important but entirely generic concerns,” Lohr,

518 U.S. at 501) and the PMA process (which focuses on

“the sort of concerns regarding a specific device or field of

device regulation that the statute or regulations were de-

signed to protect from potentially contradictory state re-

quirements,” ibid.), the vast majority of courts—and ail re-

cent decisions—have found that PMA approval and the resul-

tant bar on changes to a FDA-approved device create specific

federal requirements that preempt conflicting state common

law damages actions. See, e.g., Pet. App. 25a; McMullen v.

Medtronic, Inc., 421 F.3d 482, 487-488 (7th Cir. 2005); Cu-

pek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005);

Horn, 376 F.3d at 171-173; Brooks v. Howmedica, Inc., 273

F.3d 785, 799 (8th Cir. 2001) (en banc); Martin v. Med-

tronic, Inc., 254 F.3d 573, 585 (Sth Cir. 2001); Kemp, 231

F.3d at 226-227; Mitchell v. Collagen Corp., 126 F.3d 902,

911 (7th Cir. 1997); Worthy v. Collagen Corp., 967 S.W.2d.

360, 376 (Tex. 1998); Fry v. Allergan Med. Optics, 695 A.2d

511, 516 (R.I. 1997); Green v. Dolsky, 685 A.2d 110, 117

(Pa. 1996).

determining that such a restriction on ‘any requirement’ exists.” 518 U.S.

at 512 (O’Connor, J., concurring in part and dissenting in part). We agree;

in fact, the history of the FDA regulation relied on by the Court clearly

shows that the “specificity” gloss was designed simply to ensure that a

counterpart federal requirement must be in existence before a state re-

quirement is preempted, not that the federal requirement must be device-

specific. See Proposed Rules, Exemptions From Federal Preemption of

State and Local Device Requirements: Proposed Procedures for Consid-

eration of Applications, 42 Fed. Reg. 30,383 (June 14, 1977). However,

the petition does not present this question, because even if specificity is

required, the FDA's approval of the Evergreen Balloon Catheter through

the PMA process, and the corresponding federal prohibition on any

changes to the device’s design, manufacturing process or labeling, easily

satisfy that requirement.

14

In contrast to the decisions of the Second, Third, Fifth,

Sixth, Seventh, and Eighth Circuits, as well as those of the

Pennsylvania, Rhode Island, and Texas Supreme Courts, pe-

titioners can identify (at Pet. 15) decisions of only one fed-

eral court of appeals and one state supreme court, cf. S. Ct.

R. 10, that did not find PMA approval to be preemptive—

Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999),

and Weiland y. Telectronics Pacing Systems, Inc., 721

N.E.2d 1149 (Ill. 1999). The decisions in these cases, while

at odds with the decision below, are old, internally confused,

and unlikely to survive even absent this Court’s intervention.

For example, the Goodlin court found that the PMA

process “is clearly specific to the device under review” and

that the FDA’s Conditions of Approval “constitute specific

federal requirements,” 167 F.3d at 1376, yet then somehow

concluded that the requirements were not “‘applicable under

[the MDA] to the device,” ibid. (quoting 21 U.S.C.

§ 360k(a)(1)), and did not establish “a specific requirement

that applies to a particular device,” id. at 1377. The decision

is not only internally inconsistent and factually incorrect, but

also contrary to Lohr. The Goodlin court denied preemptive

effect to the concededly specific federal requirements, appar-

ently because the FDA’s Conditions of Approval were “not

promulgated * * * with respect to [a] ‘particular device.”

Ibid. Yet, so long as the specific federal requirement is appli-

cable to a given device, Lohr does not demand that the re-

quirement be applicable exclusively to that device. In fact, the

FDA has frequently held that federal requirements have pre-

emptive effect even though they apply to a wide array of de-

vices. See, e.g., Final Rule, Medical Devices, 45 Fed. Reg.

67,321, 67,322 (Oct. 10, 1980).

Weiland, in contrast, found that no aspect of the PMA

process is specific. See 721 N.E.2d at 1152. It based that

conclusion on two false premises, however: First, the court

held that “[p]remarket approval imposes no ascertainable

substantive requirement on the manufacture or design of the

15

device” (ibid.}—a statement that is untrue both in general

(see 21 C.F.R. § 814.80 (prohibiting the manufacturer from

making any change without FDA authorization to a device

that has been approved by the agency through the PMA pro-

cess if such change would affect the device’s safety or effec-

tiveness)) and in this case, where the FDA specifically ap-

proved the design, manufacturing process, and labeling of the

Evergreen Balloon Catheter (see pages 5—7, supra). Second,

the court held that the PMA process allows the FDA to as-

sure only “the minimal safety of medical devices” (id. at

1153 (emphasis added)), a holding inconsistent with Lohr,

which understood the “reasonable assurance” of safety and

effectiveness to be a significant hurdle. Lohr, 518 U.S. at

477. In light of Buckman’s repetition of the significance of

PMA review, see 531 U.S. at 343, the Weiland decision is

plainly incorrect.°

° Petitioners’ attempt to conflate the investigational device exemption

(IDE) process with the PMA process (see Pet. 16 n.4), in an effort to ex-

pand the scope of any conflict, should be rejected. Both of the decisions

petitioners cite in footnote 4 are IDE rather than PMA cases and both

specifically discuss differences between the PMA process and the IDE

process. See Connelly v. lolab Corp., 927 S.W.2d 848, 850 (Mo. 1996)

(en banc); Niehoff v. Surgidev Corp., 950 S.W.2d 816, 818 (Ky. 1997).

As the Niehoff court explained, the IDE process is designed “to encourage

research and development” (950 S.W.2d at 818), whereas the PMA pro-

cess includes “a determination that the product is safe and effective”

(ibid ). Even were a state requirement not to be preempted based on the

IDE process, then, the FDA’s careful determination at the PMA stage that

a product is safe and effective in light of all known risks should still pre-

empt conflicting state requirements, including requirement: imposed

through common law tort actions. See Lohr, 518 U.S. at 501 (“The gen-

erality of [requirements imposed under the 510(k) process] make this

quite unlike a case in which the Federal Government has weighed the

competing interests relevant to the particular requirement in question,

reached an unambiguous conclusion about how those competing consid-

erations should be resolved in a particular case or set of cases, and im

plemented that conclusion via a specific mandate on manufacturers or

producers.) (emphasis added).

16

In the seven years since they were decided, no other

court of appeals and no other state supreme court has joined

either the Eleventh Circuit’s decision in Goodlin or the IIli-

nois Supreme Court’s decision in Weiland. Given their inter-

nal flaws, this Court’s reminder that the PMA process sub-

jects a device to “thorough review,” Buckman, 531 U.S. at

344, and the FDA’s recent declaration that “through the PMA

approval process [the FDA] certainly establishes ‘specific

requirements’ applicable to a ‘particular device,’” Brief for

United States as Amicus Curiae (Horn Amicus Br.), 2004 WL

1143720, at *16, filed in Horn v. Thoratec Corp., 376 F.3d

163 (3d Cir. 2004) (see also pages 19-22, infra), there is no

reason to believe that any court will repeat the errors in

Goodlin or Weiland.

2. On the “state” side of the Lohr preemption equation,

petitioners assert (Pet. 16) that there is a “profound” split of

authority over whether state law damages claims can ever be

preempted by divergent federal requirements. In fact, the vast

majority of lower courts, and a// courts to have considered

the issue recently, have held that such claims can be pre-

empted,’ a decision that is plainly correct under Lohr (see

pages 26-28, infra). Only one federal court of appeals or

state court of last resort, cf. S. Ct. R. 10, has relied on a con-

trary finding to limit the preemptive scope of the MDA—the

Tenth Circuit in Oja v. Howmedica, Inc., 111 F.3d 782, 789

(10th Cir. 1997).° Oja is one of the earliest appellate deci-

” See, e.g., Pet. App. 30a; McMullen, 421 F.3d at 487; Cupek, 405 F.3d

at 424; Horn, 376 F.3d at 173-177; Brooks, 273 F.3d at 799; Martin, 254

F.3d at 584; Kemp, 231 F.3d at 224; Mitchell, 126 F.3d at 913-914;

Papike v. Tambrands Inc., 107 F.3d 737, 741 (%h Cir. 1997); Worthy,

967 S.W.2d at 376-377; Fry, 695 A.2d at 517; Green, 685 A.2d at 117-

118.

* Neither Niehoff nor State ex rel. Miller v. New Womyn, Inc., 679

N.W.2d 593 (lowa 2004), the only state supreme court decisions cited by

petitioners (Pet. 17), holds that state common law claims are . ot subject

to preemption when a medical device has received FDA appreval through

the PMA process. Petitioners’ parenthetical quotation suggesting that the

17

sions to interpret Lohr, did not involve a device that had been

approved through the PMA process, and plainly misinterprets

Lohr in a variety of ways.

For example, the Tenth Circuit never directly considered

-whether a finding of liability under a state common law duty

would “have the effect of establishing a substantive require-

ment of a specific device”—even though the court earlier had

acknowledged that such an inquiry was necessary. 111 F.3d

at 788 (quoting Lohr, 518 U.S. at 500 (in tur quoting 21

C.F.R. § 808.1(d)(1)) (internal quotation marks omitted).

More importantly, the court failed to appreciate that a major-

ity of this Court had expressly held in Lohr that state com-

mon law damages actions impose “requirements” that can be

preempted by federal requirements. See pages 26-27 & n.15,

infra”

Supreme Court of Kentucky, in Niehoff, held that state law damages

claims are not specific requirements is taken out of context and misread.

Rather, the Niehoff court held that the IDE process (not the PMA process)

imposes no specific federal requirement against which to compare Ken-

tucky’s common law damages claims. See 950 S.W.2d at 822 (“[t]he

claim * * * of preemption to the defective design allegation fails because

there is no specific federal requirement”). As discussed above (at page 15

n.6), the Niehoff court also focused on the significant differences between

the PMA process and the IDE process. In New Womyn, a case brought by

the state attorney general under the state’s consumer fraud statute, the

device at issue had not been approved by the FDA at all, let alone after

“running the gauntlet of the PMA process.” Lohr, 518 U.S. at 494. In-

deed, an FDA “employee with extensive experience in the review of ap-

plications regarding new medica! devices” testified that a device similar

to that at issue in New Womyn “was on display in the public lobby of the

FDA building in a collection of what the FDA labeled ‘quack devices.’”

New Womyn, 679 N.W.2d at 597. Thus, even if the Supreme Court of

lowa had discussed whether a state law damages claim could in theory be

preempted (which it did not), there was no specific federal requirement in

New Womyn to preempt any state law claim.

* The Oja court was confused not only about what state requirements

may be preempted but also about what federal requirements are preemp-

tive. Thus, though the court was confronted with a claim (for failure to

18

This single aberrant decision by a federal court of ap-

- peals, rendered shortly after Lohr, does not warrant this

Court’s attention. In the nine years since Oja, there has been

no movement by any other court toward that court’s errone-

ous analysis. Moreover, given this Court’s holding in Bates

v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005), that the

term “requirements” in the identically-worded FIFRA in-

cludes common law claims, the unanimous view of the other

courts of appeals that such claims may be preempted, and the

United States’ similar view as expressed in its amicus brief in

Horn (see pages 21-23, infra), there is no reason to believe

that the Tenth Circuit would continue to follow Oja after fur-

ther analysis of this Court’s holding in Lohr.

exexe*e*

Petitioners, who suggest that review is warranted in this

case because Goodlin, Weiland, and Oja “remain the law in

those jurisdictions,” summarily dismiss the prospect that “the

courts that found no preemption might change their minds or

be overturned en banc.” Pet. 2-3. Petitioners’ pessimism,

however, is unwarranted. The issue of preemption in the

PMA context arises relatively infrequently.'° Thus, the courts

warm) arising from a device approved, at the time it was implanted, only

through the 510(k) process (see 111 F.3d at 787 n.2), it held that the

FDA’s 510(k) review led to specific federal requirements—despite this

Court's contrary holding in Lohr. See 111 F.3d at 789.

'© As the Second Circuit noted below, last year “approximately ninety-

nine percent of [Class III] devices went through the § 510(k) process and

only one percent went through the PMA process.” Pet. App. | 3a (empha-

sis in original). See also Lohr, 518 U.S. at 479 (“the § 510(k) premarket

notification process became the means by which most new medical de-

vices—including Class II] devices—were approved for the market"). Be-

cause “the vast majority of Class III medical devices” enter the market

via the § 510(k) process (Pet. App. 12a), and because the § 510(k) proc-

ess is in essence a grandfathering provision that allows devices “substan-

tially equivalent” to pre-MDA devices to enter the market without PMA

approval (ibid.), it is not surprising that PMA-based preemption claims

did not arise immediately afler passage of the MDA. The first opportunity

to assert preemption based on PMA approval would not have arisen until

19

that issued those early, anomalous decisions have had no op-

portunity to revisit their holdings.'' Given the fact that no

federal court of appeals and no state supreme court has fol-

lowed—and, indeed, each such court has specifically re-

jected—those decisions in the years since they were issued, it

is highly unlikely that they will be reaffirmed when the op-

portunity arises. On the contrary, given this Court’s subse-

quent guidance in Geier, Buckman, and Bates, and the FDA’s

authoritative declaration in Horn, any vestigial conflict that

still exists will almost certainly disappear without it@rven-

tion by this Court.

B. The lower courts should be allowed to consider

the implications of the FDA’s amicus brief in

- Horn.

In Lohr, this Court recognized that “Congress has given

the FDA a unique role in determining the scope of § 360k’s

pre-emptive effect.” 518 U.S. at 495-496. The Court further

recognized that, as the federal agency to which Congress has

delegated the authority to implement the MDA, the FDA “is

uniquely qualified to determine whether a particular form of

state law ‘stands as an obstacle to the accomplishment and

execution of the full purposes and objectives of Congress,’

after a device had both “run{] the gauntlet of the PMA process,” 518 U.S.

at 494—a process that may take many years, see, e.g., Kemp, 231 F.3d at

219 (regulatory review culminating in PMA approval lasted eight

_ years)—and had allegedly caused injury to a patient. Therefore, contrary

to petitioners’ suggestion (Pet. 23), the fact that no court addressed PMA-

based preemption in the years immediately following enactment of the

MDA in no way undermines the fact that § 360k(a) clearly preempts state

law claims that would impose requirements “different from” or “in addi-

tion to” the federal requirements embodied in the FDA's pre-market ap-

proval of their devices.

'' & thorough review of the Westlaw Keycite database performed on

October 3, 2006, reveals that no Tenth Circuit case citing Oja, no Elev-

enth Circuit case citing Goodlin, and no IIlinois Supreme Court (or even

appellate court) case citing Weiland has concerned common law damages

claims in connection with a PMA-approved device.

20

and, therefore, whether it should be pre-empted.” /d. at 496

(quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

Given “the ambiguity in the statute” and “the congressional

grant of authority to the agency on the matter contained

within it,” the Court found it appropriate to “giv[e] substan-

tial weight to the agency’s view of the statute.” /bid.

The FDA has recently provided authoritative guidance

on the scope of § 360k’s preemptive effect in the PMA con-

text. At the request of the Third Circuit, the. United States

submitied an amicus brief or behalf of the FDA in Horn v.

Thoratec Corp., 376 F.3d 163 (2004). The FDA’s amicus

brief explains at length and in detail why “FDA pre-market

approval for a new medical device preempts state law tort

judgments.” Horn Amicus Br., 2004 WL 1143720, at *2.

With respect to the federal side of the equation, the FDA

stated unequivocally that “through the PMA approval process

{the FDA] certainly establishes ‘specific requirements’ appli-

cable to a ‘particular device.’” Jd. at *16. The FDA noted that

“{a]lthough the PMA approval order does not itself expressly

reiterate all of the specific features the device’s design, label-

ing, and manufacturing processes must have, it specifically

approves as a matter of federal law those features as set forth

in the application and binds the manufacturer to produce and

market the product in compliance with the specifications as

approved by [the] FDA.” /d. at *24.

With respect to the state side of the preemption equation,

the FDA endorsed the view—subscribed to by a majority of

the Justices in Lohr—that “state tort law judgments do im-

pose a requirement for purposes of preemption under the

MDA when a common law action ‘would impose a require-

ment different from, or in addition to, that applicable under

the FDCA.’” /d. at *18 (quoting Lohr, 518 U.S. at 511

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

The FDA observed that, absent an allegation that the device

in question deviated from the requirements imposed by the

FDA through the PMA process, “any finding of liability

21

*** would necessarily rest upon an implicit requirement

that [the] device be designed, manufactured, or marketed in a

way that differs from the way approved by [the] FDA.” /bid.

The FDA also emphasized in its brief the “very strong

public policy considerations” that support finding PMA ap-

proval preemptive of state common law claims. /d. at *25.

According to the FDA—the agency charged with implement-

ing the MDA—“{s]tate common law tort actions threaten the

statutory framework for the regulation of medical devices.”

Ibid. As the agency explained, during the PMA process it

conducts “a thorough review of a substantial scientific re-

cord” (id. at *16) and performs a “careful balancing” of the

benefits and risks associated with a particular device (id. at

*29). State tort actions, however, usurp “the central role of

[the] FDA” by requiring “lay judges and juries to second-

guess the balancing of benefits and risks of a specific de-

vice.” /d. at *25. Because such second-guessing “may disrupt

the careful balancing performed by the FDA in the PMA

process” (id. at *29), state common law claims such as those

asserted in Horn—and here—“are preempted under federal

law.” Jd. at *31.

Given the agency’s “unique role in determining the

scope of § 360k’s pre-emptive effect” (Lohr, 518 U.S. at

495-496), the FDA’s clear guidance in Horn further demon-

strates that there is no need for this Court to grant review in

this case. The FDA’s “reasoned analysis” (Horn Amicus Br.,

2004 WL 1143720, at *30) is entitled to substantial weight as

“the agency’s fair and considered judgment on the matter in

question.” Auer v. Robbins, 519 U.S. 452, 462 (1997) (defer-

ring to agency interpretation of ambiguous regulation con-

tained in amicus brief submitted in dispute between private

parties). This is especially true when coupled with this

Court’s renewed recognition of “the PMA review’s rigor”

(Buckman, 531 U.S. at 348), and Justice Stevens’ reminder

that “in Medtronic, Inc. v. Lohr, [this Court] recognized that

the statutory reference to ‘any requirement’ imposed by a

22

State ** * may include common-law duties” (Geier, 529

U.S. at 897 (Stevens, J., dissenting); see also n.15, infra).

There is simply no reason to believe that those few

courts that misinterpreted Lohr soon after it was decided will

not now take heed of the FDA’s amicus brief in Horn and

join the clear consensus finding state common law claims

that would impose requirements that are “different from” or

“in addition to” the federal requirements embodied in the

FDA’s pre-market approval of a aevice to be preempted by

federal law.'? In the unlikely event that those courts, upon

reconsideration, choose to adhere to ineir prior decisions, the

Court can grant review at that time.

Il. The Decision Below, Finding Preemption Of State

Law Claims Based On The Requirements Imposed

By The PMA Process, Is Plainly Correct.

Review is also unwarranted because the decision below

is consistent with Lohr, with Congress’s intent in passing the

MDA, with the views of the FDA, and with common sense.

Section 360k(a) prohibits any state “requirement” that is “dif-

ferent from, or in addition to, any requirement applicable un-

der [the MDA] to the device” and “which relates to the safety

or effectiveness of the device or to any other matter included

in a requirement applicable to the device under [the MDA].”

Thus, for preemption to occur, there must be a federal re-

/

'? Notably, each circuit to have considered the question since the filing of

the FDA’s amicus bnef in Horn has embraced the government's view

that PMA approval preempts state common-law claims that would im-

pose requirements “different from, or in addition to” the requirements

imposed through the PMA process. See, e.g., Pet. App. 37a—-38a; Horn,

376 F.3d at 177. Petitioners do not cite, and respondent is not aware of,

any district court or state court decision to arrive at a contrary conclusion

since the filing of the FDA’s amicus brief in Horn. Cf. Hughes v. Cook,

No. 2:06-CV-02027, slip op. at 13 (W.D. Tenn. Sept. 27, 2006) (holding

state common-law claims to be preempted by PMA approval based on

Kemp, which, the court explained, “1s heavily reenforced by the FDA’s

amicus curiae brief submitted in Horn”).

23

quirement, a state requirement, and some “differen[ce]” be-

tween the two. See 518 U.S. at 500. These criteria are easily

satisfied here.

1. The Second Circuit correctly held that FDA approval

of a medical device through the PMA process can create fed-

eral requirements applicable to the device that would preempt

conflicting state requirements. Although the Court in Lohr

did not directly reach that question, both the majority and the

dissenting opinions are fully consistent with a finding that the

PMA process can impose preemptive federal requirements.

See 518 U.S. at 501 (discussing preemption where “the Fed-

eral Government has weighed the competing interests rele-

vant to the particular requirement in question,” in contrast to

the 510(k) process); id. at 512 (O’Connor, J., concurring in

part and dissenting in part) (disputing requirement that fed-

eral requirements need to be specific). Moreover, the deci-

sion below is entirely consistent with the views of the FDA,

which has declared that the PMA process “establishes ‘spe-

cific requirements’ applicable to a ‘particular device.’” Horn

Amicus Br., 2004 WL 1143720, at *16."*

It is clear that the PMA process in fact established spe-

cific requirements applicable in particular to the Evergreen

Balloon Catheter. During that process, Medtronic Submitted

“test data, the results of clinical investigations and design in-

formation” as well as details of the device’s manufacturing

‘> The FDA’s view is well supported by statute. Many provisions of the

MDA refer to “requirements” imposed by the FDA through the PMA

process (pursuant to 21 U.S.C. § 360e). See 21 USC. §§ 331(e),

351(f(1 KAM), 360(k)(2), 360c(b)(1 (A), 360c(c)( 2A), 360c(e)(1)(B),

360e(b), 360e(c)(2), 360e(d\2(C), 360e(f), 360j(a), 360)(m)(2),

382(a)(2)(A). Under federal law, moreover, a device that is approved for

marketing through the PMA process cannot be “manufactured, packaged,

stored, labeled, distributed, or advertised in a manner that is inconsistent

with any conditions to approval specified in the PMA approval order for

the device.” 21 C.F.R. § 814.80; see also id. § 814.39. Put differently, the

manufacturer is required to follow the design and other specifications

embodied in the PMA application and approved by the FDA.

24

process and “full copies of proposed product labels.” Pet.

_ App. 65a-67a. After a “rigorous review” of this information,

all of which “was specific to the Evergreen Balloon Cathe-

ter,” the FDA “explicitly approved”>the device’s design,

manufacturing method, and labeling. Pet. App. 28a, 65a—67a.

Because Medtronic was thereafter prohibited from making

any changes that might affect the safety or efficacy. of the

Evergreen Balloon Catheter, “the device is clearly subject to

the federal, device-specific requirement of adhering to the

standards contained in its individual, federally approved

PMA.” Pet. App. 26a. See also Kemp, 231 F.3d at 226-227

(“PMA approval by the FDA constitutes approval of the

product’s design, testing, intended use, manufacturing meth-

ods, performance standards and labeling’ and is ‘ pecific to

the product.””) (quoting Mitchell, 126 F.3d at 913).'

Significantly, approval through the PMA process en-

tailed a finding, based on the FDA’s painstaking review of an

immense amount of scientific data, that “ihe device is both

'* Petitioners assert (Pet. 20) that “the PMA process itself does not im-

pose specific federal ‘requirements’ * * * because the device’s specifica-

tions originate with the manufacturer, not the FDA.” Petitioners are

wrong. Once the PMA application has been approved, often after pro-

longed discussions and agency-directed modifications, the device's

manufacturer is legally obligated to adhere tothe specifications set forth

in the application and may not change them without FDA approval. See

21 C.F.R. § 814.80; see also Horn, 376 F.3d at 171-172. Moreover, the

case that petitioners cite, American Airlines, Inc. v. Wolens, 513 U.S.

219, 228-229 (1995), does not suggest otherwise. In that case, this Court

held that the Airline Deregulation Act preempted certain claims but did

not preempt a breach of contract claim based on the defendant's “self-

imposed undertakings.” In so holding, however, the Court specifically

noted that the defendant's contractual duties were “privately ordered ob-

ligations”; furthermore, there was no dispute that ihe defendant in that

case could have unilaterally revised its self-imposed duties on a prospec-

tive basis without obtaining regulatory approval. /d. Here, by contrast,

Medtronic could not—either unilaterally or in agreement with petition-

ers—alter its obligations after receiving PMA approval without first ob-

taining the FDA’s consent.

25

safe and effective.” Lohr, 518 U.S. at 477 (citing 21 U.S.C.

§ 360e(d)(2)). See also Pet. App. 25a (“‘PMA approval is

based on a determination by FDA that the PMA contains suf-

ficient valid scientific evidence to assure that the device is

safe and effective for its intended use(s).””); Horn Amicus

Br., 2004 WL 1143720, at *16 (“The approval perforce em-.

bodies the agency’s conclusion that there is a ‘reasonable as-

surance of safety and effectiveness’ of the device.”). The de-

termination that a product is safe and effective, made after

weighing “any probable benefit to health from the use of the

device against any probable risk of injury or illness from

such use” (21 U.S.C. § 360c(a)(2)(C))—in a process charac-

terized by this Court as “running the gauntlet” (Lohr, 518

US. at 494) and “exhaustive” (Buckman, 531 U.S. at 349)—

is of necessity the determination that the attributes of that de-

vice are an appropriate compromise that should not be modi-

fied by state law. See Horn Amicus Br., 2004 WL 1143720,

at *29 (“state co-regulation” through tort actions “may dis-

rupt the careful balancing performed by [the] FDA in the

PMA process”).

The regulatory history confirms this point. Petitioners

rely on 21 C.F.R. § 808.1(d), cf. Pet. 15, but—as evidenced

by the FDA’s amicus brief in Horn—that regulation is en-

tirely consistent with holding that the PMA process estab-

lishes device-specific requirements. Section 808.1(d) ex-

plains that state or local requirements will be preempted

when the FDA “has established specific counterpart regula-

tions or there are other specific requirements applicable to a

particular device under the [MDA].” (emphasis added). The

preamble to section 808.1(d) notes that a state cannot,

through its own premarket approval process, establish re-

quirements inconsistent with the FDA’s premarket approval

process, and further explains:

For a device classified in class III under section

513(d) of the act, the counterpart FDA requirement

is established on the date the device can not lawfully

26

be marketed without application for premarket ap-

proval. * * * Once these FDA requirements are es-

tablished, different or additional State requirements

are preempted.

Final Rule, Exemptions From Federal Preemption of State

and Local Device Requirements: Procedures For Considera-

tion of Applications, 43 Fed. Reg. 18,661, 18,664 (May 2,

1978) (emphasis added).

Finally, Congress viewed the PMA process as imposing

“requirements” that would trigger preemption. For example,

prior to passage of the MDA, California’s “Sherman Food,

Drug, and Cosmetic Law” required pre-market approval of

all new devices sold in the state. Congress specifically re-

ferred to this requirement as one that the FDA should allow

to continue by expressly exempting it (under 21 U.S.C.

§ 360k(b)) from preemption by the PMA process. See H.R.

REP. No. 94-853, at 45-46. No such exemption would have

been thought necessary if the PMA process did not establish

requirements otherwise preemptive of the state law.

2. The Second Circuit also correctly found that petition-

ers’ state law claims, to the extent those claims were based

on a showing that the device should have been manufactured,

designed, or labeled in a manner different from that required

by the PMA, were preempted under § 360k. A majority ot

this Court held in Lohr that “the MDA will sometimes pre-

empt a state-law tort suit” (518 U.S. at 503 (Breyer, J., con-

curring)), because “insofar as the MDA pre-empts a state re-

quirement 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 be-

havior imposed by a state-law tort action” (id. at 504—505);

accord id. at 509 (“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., concurring in part and dissenting in

27

part).'> When a state law tort action is based on a requirement

that is not identical to a federal requirement, that claim would

seem definitionally to be “different from, or in addition to”

(21 U.S.C. § 360k(a)(1)) the federal requirement. Indeed, as

noted by the FDA, “any finding of liability * * * would nec-

essarily rest upon an implicit requirement that [the] device be

designed, manufactured, or marketed in a way that differs

from the way approved by [the] FDA.” Horn Amicus Br.,

2004 WL 1143720, at *18.

Here, the PMA process imposed specific requirements

on Medtronic, including the requirement to label the Ever-

green Balloon Catheter in precisely the manner approved in

its PMA application, with, for example, warnings that the

device not be used in patients with calcified stenoses and not

be inflated to more than the Rated Burst Pressure. See pages

7-8, supra. The district court found that petitioners had prof-

'S Indeed, contrary to what petitioners suggest (Pet. 20-21), a// members

of the Lohr Court agreed that state common-law claims could potentially

be preempted under the MDA. Thus, in Section V of the Lohr decision,

the Court, referring to § 360k(a) and 21 C.F.R. 808.1(d), observed that

“we do not believe that this statutory and regulatory language necessarily

precludes . . . ‘general’ state requirements from ever being preempted.”

‘518 U.S. at 500. Significantly, Justice Stevens, who wrote the opinion in

Lohr, has himself stated that Lohr “recognized that the statutory reference

to ‘any requirement’ imposed by a State * * * may include common-law

duties.” Geier, 529 U.S. at 897 (Stevens, J., dissenting). See also Geier,

529 U.S. at 867 (noting that “a majority of this Court” in Lohr recognized

that state tort actions may be preempted as imposing conflicting “re-

quirements”); cf. Bates, 544 U.S. at 443 (“the term ‘requirements’ * * *

reaches beyond positive enactments, such as statutes and regulations, to

embrace common-law duties”). Because the entire Lohr Court agreed that

state common-law claims could, at least potentially, be preempted, the

fact that Justice Breyer’s articulation of this proposition ts contained in a

concurrence is beside the point. Cf. Pet. 21. The Lohr Court was not-di-

vided over the question whether state common-law claims might be pre-

empted; the Justices disagreed only over the frequency with which they

would be preempted. See 518 U.S. at 502-503 (Stevens, J., plurality); id

at 508 (Breyer, J., concurring); id. at 509 (O’Connor, J., dissenting).

28

fered no evidence suggesting that Medtronic had deviated

from the requirements imposed by the FDA through the

PMA process. Pet. App. 90a. Thus, were a jury to impose

liability on Medtronic under state law, that jury would of ne-

cessity be imposing a requirement “different from” or “in

addition to” that imposed by the FDA under federal law.

3. Putting aside the legalisms of Lohr, petitioners’ posi-

tion cannot possibly be consistent with Congress’s decision

to enact the MDA and to make that statute preemptive. The

MDA strikes a careful balance between shielding the public

“against unsafe, unproven, ineffective, and experimental

medical devices” and ensuring that progress in the develop-

ment of medical devices is not “stifle[d]” by “excessive or

ill-conceived” regulation. H.R. REP. NO. 94-853, at 10; see

also FDA Oversight: Medical Devices: Hrg. Before the Sub-

comm. on Oversight & Investigations of House Comm. on

Energy & Commerce, 97th Cong., 2d Sess. 5 (1982). A key

element in striking this balance is Congress’s delegation of

exclusive authority to the FDA. Permitting state review and

nullification of the FDOA’s PMA decisions would run rough-

shod over this carefully calibrated enforcement scheme and

would impose the “undu[e] burden[]” of differing state regu-

lation that Congress aimed to avoid by including in the MDA

a “general prohibition on non-Federal regulation.” H.R. REP.

No. 94-853, at 45.

Moreover, petitioners raise a red herring when they as-

sert that “the decision below leaves patients injured by the

most risky devices with no remedy.” Pet. 22. As the Second

Circuit itself emphasized, the scope of its decision is “quite

limited.” Pet. App. 36a. First, it affects only those devices

that the FDA deems safe and effective after rigorous PMA

review; it does not apply to the vast majority of Class III de-

vices, 99% of which enter the market via the less-exacting

510(k) process. Second, the decision “does not even hold that

all state tort claims as to PMA-approved devices are pre-

empted.” /bid.

29

On the contrary, * * * 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 Riegel’s negligent manufacturing

claim—are in no way preempted. Only those claims

that allege liability despite a PMA-approved de-

vice’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.”

Ibid. (quoting Gregory J. Scandaglia & Therese L. Tully, Ex-

press Preemption and Premarket Approval Under the Medi-

cal Device Amendments, 59 FOOD DRruG L.J. 245, 263-264

(2004)). See also Lohr, 518 U.S. at 495 (“Nothing in § 360k

denies [a state] the right to provide a traditional damages

remedy for violations of common-law duties when those du-

ties parallel federal requirements.”); Mitchell, 126 F.3d at

914 (“to the degree that these claims may be read to allege

that [the device manufacturer] failed to meet the standards set

forth in the PMA process, the allegations are not pre-

-empted”). Thus, contrary to petitioners’ assertion, patients

remain fully protected, both by the FDA’s rigorous scrutiny

of PMA-approved devices and by the ability to enforce FDA-

imposed requirements through common law claims.

x**eeke

In the final analysis, petitioners present this Court little

evidence of a significant split in authority below; what incon-

sistencies there may be in the interpretation of Lohr are likely

to be resolved in light of the FDA’s amicus brief in Horn and

through further litigation in the lower courts. Petitioners pro-

vide no good reason why the Court, having repeatedly de-

clined to review this issue, should grant review here, or why

the issue deserves the Court’s attention at the present time.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

MICHAEL K. BROWN

LISA M. BAIRD

Reed Smith LLP

355 S. Grand Avenue

Suite 2900

Los Angeles, CA 90071

(213) 457-8000

RICHARD H. BAKALOR

Quirk & Bakalor, PC

845 Third Avenue

New York, NY 10022

(212) 319-1000

OCTOBER 2006

KENNETH S. GELLER

Counsel of Record

DAVID M. GOSSETT

ANDREW E. TAUBER

Mayer, Brown, Rowe &

Maw LLP

1909 K Street, NW

Washington, DC 20006

(202) 263-3000