No. 98-1768 

In the Supreme Court of the United States 

BUCKMAN COMPANY, PETITIONER 

v. 
PLAINTIFFS’ LEGAL COMMITTEE 

ON WRIT OF CERTIORARI 
TO THE UNITED STATES COURT OF APPEALS 
FOR THE THIRD CIRCUIT 

BRIEF FOR THE UNITED STATES 
AS AMICUS CURIAE SUPPORTING PETITIONER 

MARGARET JANE PORTER 

Chief Counsel 
PATRICIA J. KAEDING 

Associate Chief Counsel 
for Enforcement 
U.S. Food & Drug 

Administration 
Rockville, MD 20857 
SETH P. WAXMAN 

Solicitor General 

Counsel of Record 
DAVID W. OGDEN 

Assistant Attorney General 
EDWIN S. KNEEDLER 

Deputy Solicitor General 
IRVING L. GORNSTEIN 

Assistant to the Solicitor 

General 
DOUGLAS N. LETTER 

PETER J. SMITH 

Attorneys 
Department of Justice 
Washington, D.C. 20530-0001 
(202) 514–2217 

QUESTION PRESENTED 

Whether federal law preempts state-law tort claims 
alleging fraud on the Food and Drug Administration 
during the regulatory process for marketing clearance 
applicable to certain medical devices. 

(I) 

TABLE OF CONTENTS 

Page 

Interest of the United States ...................................................... 
1 

Statement ........................................................................................ 1 

Summary of argument .................................................................. 

9 

Argument ........................................................................................ 11 

I. Respondents’ fraud-on-the-FDA claims are not 
expressly preempted ...................................................... 
11 

A. FDA’s disclosure requirements are not 
specific 11 
B. Respondents’ fraud-on-the-FDA claims 

parallel federal requirements ................................ 
13 

II. Respondents’ fraud-on-the-FDA claims are 
impliedly preempted ...................................................... 
16 

A. Fraud-on-the-FDA claims intrude on an 
area of preeminent federal concern, and 
are therefore subject to a more stringent 

conflict preemption analysis .................................. 

17 

B. Fraud-on-the-FDA claims conflict with the 
important federal interest in permitting 

FDA to decide for itself whether it has been 
defrauded, and, if so, what remedy to seek ........ 

21 
C. Respondents’ fraud-on-the-FDA claims con- 
flict with FDA’s market clearance decision ....... 
25 

D. Fraud-on-the-FDA claims would result in 
undersirable practical consequences ................... 
28 

Conclusion ....................................................................................... 30 

TABLE OF AUTHORITIES 

Cases: 

Arkansas La. Gas Co. v. Hall, 453 U.S. 571 
(1981) .............................................................................. 
25, 26, 27 

Boyle v. United Techs. Corp., 487 U.S. 500 
(1988) .................................................................................... 19, 20 

(III) 

IV 

Cases—Continued: Page 

Chicago & North Western Transp. Co. v. Kalo 

Brick & Tile Co., 450 U.S. 311 (1981) ...................... 
25, 26, 27 

Comsat Corp. v. National Science Found., 190 

F.3d 269 (4th Cir. 1999) ........................................................ 

29 

Crosby v. National Foreign Trade Council, 120 

S. Ct. 2288 (2000) ................................................................... 

24 

Exxon Shipping Co. v. United States Dep’t of 

Interior, 34 F.3d 774 (9th Cir. 1994) .................................. 

29 

Garner v. Teamsters, 346 U.S. 485 (1953) ......................... 
23 

Geier v. American Honda Motor Co., 120 S. Ct. 
1913 (2000) ............................................................................... 
17 

Hancock v. Train, 426 U.S. 167 (1976) .............................. 
20 

Heckler v. Chaney, 470 U.S. 821 (1985) ............................. 
24 

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) .......... 
5, 11, 12, 

13, 17, 18, 23 

Nantahala Power & Light Co. v. Thornburg, 
476 U.S. 953 (1986) ................................................................ 
26 
NLRB v. Sears, Roebuck & Co., 421 U.S. 132 
(1975) ........................................................................................ 28 

Pennsylvania v. Nelson, 350 U.S. 497 (1956) ........ 

20, 24, 25 

San Diego Bldg. Trades Council v. Garmon, 
359 U.S. 236 (1959) ............................................................. 
23, 24 

United States ex rel. Touhy v. Ragen, 340 U.S. 
462 (1951) ................................................................................. 
28 

United States v. Gilliland, 312 U.S. 86 (1941) .................. 
19 

United States v. Locke, 120 S. Ct. 1135 (2000) ................. 
21 

United States v. Yermian, 468 U.S. 63 (1984) ................... 
18 

Constitution, statutes, regulations and rules: 

U.S. Const.: 

Art. IV, Cl. 2 (Supremacy Clause) ................................. 

25, 27 

Administrative Procedure Act, 5 U.S.C. 706(2)(A) ............ 
28 

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
301 et seq. ................................................................................. 
2 

21 U.S.C. 331(q)(2) ............................................ 
4, 13, 15, 22 

21 U.S.C. 332 ................................................................... 4, 22 

V 

Statutes, regulations and rules—Continued: 
Page 

21 U.S.C. 333(a) .............................................................. 
4, 22 

21 U.S.C. 333(f)(1)(A) .................................................... 
4, 22 

21 U.S.C. 334(a)(2)(D) .................................................... 
4, 22 

21 U.S.C. 337(a) .............................................................. 
4, 23 

21 U.S.C. 360(k) ........................................................ 
passim 

21 U.S.C. 360c(a) (1994 & Supp. IV 1998) .................... 
2 

21 U.S.C. 360c(a)(1)(A) .................................................... 
2 

21 U.S.C. 360c(a)(1)(B) .................................................... 
2 

21 U.S.C. 360c(a)(1)(C) .................................................... 
2 

21 U.S.C. 360c(a)(1)(C)(ii)(II) ......................................... 
2 

21 U.S.C. 360c(f)(1) .......................................................... 
2 

21 U.S.C. 360c(i)(1)(A) (1994 & Supp. IV 1998)......... 
3, 15 

21 U.S.C. 360c(i)(1)(E)(i) (Supp. IV 1998) .................... 
15 

21 U.S.C. 360c(i)(1)(E)(i)(I) (Supp. IV 1998) ............... 
16 

21 U.S.C. 360c(i)(1)(E)(i)(II) (Supp. IV 1998) ............. 
16 

21 U.S.C. 360e(a) .............................................................. 
2 

21 U.S.C. 360e(b)(1)(A) ................................................... 
3 

21 U.S.C. 360e(b)(1)(B) .................................................... 
3 

21 U.S.C. 360e(c) (1994 & Supp. IV 1998) .................... 
2 

21 U.S.C. 360e(d) (1994 & Supp. IV 1998) ................... 
2 

21 U.S.C. 360k ............................................................. 
5, 7, 13 

21 U.S.C. 360k(a) .................................... 
1, 4, 11, 12, 13, 14 

21 U.S.C. 372 ................................................................... 
4, 22 

Federal Tort Claims Act, 28 U.S.C. 2680(a) ........................ 
20 

The Medical Device Amendments of 1976, Pub. L. 

No. 94-295, 90 Stat. 539 ......................................................... 

2 

18 U.S.C. 1001 (1994 & Supp. IV 1998) ................. 
3, 13, 18, 22 

28 U.S.C. 1407 (1994 & Supp. IV 1998) ................................ 
7 

21 C.F.R.: 

Pt. 5: 

Section 5.35 ...................................................................... 

4, 22 

Pt. 10: 

Section 10.30 .................................................................... 

4, 22 

Pt. 801: 

Section 801.4 .................................................................. 

14, 15 

Section 801.5 ...................................................................... 14 

VI 

Regulations and rules—Continued: 
Page 

Section 801.410 .................................................................. 
12 

Section 801.420 .................................................................. 
12 

Section 801.421 .................................................................. 
12 

Section 801.437 .................................................................. 
12 

Pt. 807: 

Section 807.87 .................................................................. 

3, 21 

Section 807.87(e) .......................................... 
3, 12, 14, 15, 21 

Section 807.87(f) ............................................................ 
3, 21 

Section 807.87(k) .................................................. 
3, 14, 15, 22 

Section 807.87(l) ............................................................ 
3, 22 

Pt. 808; 

Section 808.1 ...................................................................... 

1 

Section 808.1(d).......................................................... 
5, 11, 12 

Pt. 898: 

Section 898 ......................................................................... 

12 

Pt. 814 ...................................................................................... 
2 

Fed. R. Civ. P.: 

Rule 26 ..................................................................................... 

29 

Rule 45 ..................................................................................... 
29 

Miscellaneous: 

56 Fed. Reg. (1991): 
pp. 46,199-46,200 .................................................................. 

4, 22 
63 Fed. Reg. (1998): 

p. 40,027 ................................................................................... 

28 

pp. 40,034-40,038 .................................................................... 
28 

pp. 40,037-40,038 .................................................................... 
27 

Premarket Notification 510(k): Regulatory Require- 
ments for Medical Devices, http://www.fda.gov/ 
cdrh/manual/510kprt1.html ................................................. 22 

In the Supreme Court of the United States 

No. 98-1768 
BUCKMAN COMPANY, PETITIONER 

v. 
PLAINTIFFS’ LEGAL COMMITTEE 

ON WRIT OF CERTIORARI 
TO THE UNITED STATES COURT OF APPEALS 
FOR THE THIRD CIRCUIT 

BRIEF FOR THE UNITED STATES 
AS AMICUS CURIAE SUPPORTING PETITIONER 

INTEREST OF THE UNITED STATES 

This case presents the question whether federal law ex- 
pressly or impliedly preempts state-law tort claims alleging 
fraud on the Food and Drug Administration (FDA) during 
the process of obtaining premarket clearance for certain 
medical devices under the Federal Food, Drug, and Cos- 
metic Act (FDCA). The United States has a substantial 
interest in the resolution of that issue. FDA is responsible 
for administering the premarket-clearance process for 
medical devices, and the decision in this case will affect that 
responsibility. In addition, FDA has issued regulations (21 
C.F.R. 808.1) that interpret the FDCA’s express preemption 
provision, 21 U.S.C. 360k(a). At the Court’s invitation, the 
United States filed a brief as amicus curiae at the petition 
stage in this case, and that brief urged the Court to grant the 
petition for a writ of certiorari. 

STATEMENT 

Respondents are persons who claim that they suffered 
injuries when their physicians implanted orthopedic bone 
screws into the pedicles of their spines. They allege that 

(1) 

2 

Buckman Company (petitioner) fraudulently obtained clear- 
ance from FDA for another company, AcroMed, to market 
the pedicle screws, and they seek to hold petitioner liable 
under state law for its alleged role in causing their injuries. 
The district court granted petitioner’s motion to dismiss, 
holding that respondents’ fraud-on-the-FDA claims are 
preempted by federal law. The court of appeals reversed, 
holding that such claims are not preempted. 

1. a. The FDCA, 21 U.S.C. 301 et seq., regulates food, 
drugs, cosmetics, and medical devices, and authorizes FDA 
to enforce its requirements. The Medical Device Amend- 
ments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539, 
supplemented the FDCA’s medical device requirements. 
The MDA classifies medical devices into three classes based 
on the risk they pose to the public and the controls necessary 
to provide a reasonable assurance of a device’s safety and 
effectiveness. 21 U.S.C. 360c(a) (1994 & Supp. IV 1998). 
Class I devices present no unreasonable risk of illness or 
injury and are subject to regulation through “general con- 
trols.” 21 U.S.C. 360c(a)(1)(A). Class II devices are poten- 
tially more harmful. Such devices are also subject to general 
controls, but FDA in addition has authority to require that 
such devices comply with other requirements known as 
“special controls.” 21 U.S.C. 360c(a)(1)(B). Class III devices 
present “a potential unreasonable risk of illness or injury.” 
21 U.S.C. 360c(a)(1)(C)(ii)(II). All post-1976 devices are ini- 
tially deemed Class III devices. 21 U.S.C. 360c(f )(1). 

In general, before a Class III device may be introduced 
into the market, a manufacturer must obtain a “premarket 
approval” (PMA) from FDA. 21 U.S.C. 360c(a)(1)(C), 
360e(a). To obtain a PMA, the manufacturer must submit 
information to FDA that provides reasonable assurance that 
the device is safe and effective for its intended use. 21 
U.S.C. 360c(a)(1)(C), 360e(a), (c) and (d) (1994 & Supp. IV 
1998); 21 C.F.R. Pt. 814. A “grandfathering” provision per- 
mits Class III devices that were on the market before the 

3 

MDA’s enactment to remain on the market until FDA 
initiates and completes a rulemaking requiring the 
submission of a PMA. 21 U.S.C. 360e(b)(1)(A). In the 
interest of fairness and to prevent “grandfathered” 
manufacturers from monopolizing the market, Congress also 
permitted other manufacturers to distribute similar devices 
by showing through a premarket notification process that 
they are “substantially equivalent” to grandfathered devices. 
21 U.S.C. 360e(b)(1)(B). That premarket notification process 
is known as the “Section 510(k) process,” referring to the 
section of the FDCA codified at 21 U.S.C. 360(k). A device is 
“substantially equivalent” to a grandfathered device only if, 
inter alia, it has the same “intended use” as that device. 21 
U.S.C. 360c(i)(1)(A) (1994 & Supp. IV 1998). 

b. FDA regulations set forth the information that an 
applicant must supply in order to obtain clearance under 
Section 510(k). 21 C.F.R. 807.87. The manufacturer must 
furnish, inter alia, “[p]roposed labels, labeling, and adver- 
tisements sufficient to describe the device, its intended use, 
and the directions for its use,” 21 C.F.R. 807.87(e), “[a] 
statement indicating the device is similar to and/or different 
from other products of comparable type in commercial distri- 
bution, accompanied by data to support the statement,” 21 
C.F.R. 807.87(f), and “[a]ny additional information regarding 
the device requested by [FDA] that is necessary for [FDA] 
to make a finding as to whether or not the device is 
substantially equivalent to a device in commercial distri- 
bution,” 21 C.F.R. 807.87(l). The regulations also require 
each person submitting a premarket notification to state 
that, “to the best of his or her knowledge,” all “data and 
information” are “truthful and accurate” and that “no 
material fact has been omitted.” 21 C.F.R. 807.87(k). 
Federal law generally prohibits persons from making false 
or fraudulent statements in submissions to federal agencies, 
see 18 U.S.C. 1001 (1994 & Supp. IV 1998), and the FDCA 
specifically prohibits, “[w]ith respect to any device, the 

4 

submission of any report that is required by or under this 
chapter that is false or misleading in any material respect.” 
21 U.S.C. 331(q)(2). FDA has authority to investigate sus- 
pected fraud by a person seeking market clearance, 21 
U.S.C. 372; 21 C.F.R. 5.35, and may pursue a wide range of 
remedies and sanctions if it uncovers such fraud, see 21 
U.S.C. 332 (injunctive relief); 21 U.S.C. 333(f)(1)(A) (civil 
money penalties); 21 U.S.C. 334(a)(2)(D) (seizure of the 
device); 21 U.S.C. 333(a) (criminal prosecution). FDA has 
established an enforcement policy concerning fraud in 
premarket submissions that details the kinds of remedies it 
is likely to pursue. See 56 Fed. Reg. 46,191, 46,199-46,200 
(1991). Any citizen who believes that a submitter has com- 
mitted fraud may petition FDA to take administrative 
action. 21 C.F.R. 10.30. All lawsuits to enforce the Act’s 
provisions, however, “shall be by and in the name of the 
United States.” 21 U.S.C. 337(a). 

c. The MDA contains an express preemption provision, 
21 U.S.C. 360k(a), which provides: 
(a) General rule 

Except as provided in subsection (b) of this section, no 
State or political subdivision of a State may establish or 
continue in effect with respect to a device intended for 
human use any requirement— 

(1) which is different from, or in addition to, any 
requirement applicable under this chapter to the 
device, and 

(2) which relates to the safety or effectiveness of 
the device or to any other matter included in a re- 
quirement applicable to the device under this chapter. 

Subsection (b) authorizes the Secretary to grant exemptions 
to the preemption provision in certain circumstances. FDA 
has issued regulations that interpret the scope of Section 
360k(a). Under FDA’s interpretation, State or local require- 

5 

ments are preempted only when FDA “has established 
specific counterpart regulations or there are other specific 
requirements applicable to a particular device under the 
act.” 21 C.F.R. 808.1(d). 

This Court addressed Section 360k’s preemptive effect in 
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). The Medtronic 
plaintiffs filed state common law tort actions for injuries 
caused by a pacemaker that FDA had cleared for distribu- 
tion under Section 510(k). Plaintiffs asserted causes of 
action based on defective design, negligent manufacturing, 
and negligent labeling. The Court first held that Medtronic’s 
compliance with the Section 510(k) premarket clearance 
process did not preempt plaintiffs’ defective design claims, 
because FDA’s clearance did not “require” the pacemaker 
“to take any particular form for any particular reason.” Id. 
at 493; accord id. at 513 (O’Connor, J. concurring in part and 
dissenting in part). The Court next held that Section 360k 
did not preempt state-law claims in which the duty of care 
paralleled FDA requirements. Id. at 495; accord id. at 513 
(O’Connor, J., concurring in part and dissenting in part). The 
Court explained that common law duties that “parallel” 
federal requirements are not “different from, or in addition 
to,” the federal requirements. Ibid. 

Finally, the Court held that Section 360k did not preempt 
plaintiffs’ state-law claims based on negligent manufacturing 
and labeling. 518 U.S. at 497-502. The Court recognized that 
FDA regulations impose general manufacturing and labeling 
requirements. The Court noted, however, that under Sec- 
tion 360k, “federal requirements must be ‘applicable to the 
device’ in question, and, according to [FDA] regulations 
[construing Section 360k], pre-empt state law only if they 
are ‘specific counterpart regulations’ or ‘specific’ to a ‘par- 
ticular device.’ ” Id. at 500. The Court therefore concluded 
that the “entirely generic” federal manufacturing and label- 
ing requirements did not preempt the Medtronic plaintiffs’ 
negligent manufacturing and labeling claims. Id. at 501. 

6 

2. a. Petitioner, a regulatory consultant, was retained by 
the AcroMed Corporation to act as its liaison to FDA. Pet. 
App. 4a. In September 1984, petitioner, on behalf of 
AcroMed, made a Section 510(k) submission to FDA to 
obtain marketing clearance for an orthopedic bone screw 
device known as the Variable Screw Placement (VSP) Spinal 
Plate Fixation System. Ibid. Petitioner’s submission stated 
that AcroMed intended to market the device for use in spinal 
surgery. Id. at 4a-5a. FDA denied the request, finding that 
the VSP device was a Class III device and was not sub- 
stantially equivalent to any predicate device marketed 
before the MDA’s enactment. Id. at 5a. In September 1985, 
petitioner filed a second submission for marketing clearance, 
again stating that the device was intended for use in spinal 
surgery. Ibid. FDA denied the submission on the same 
ground. Ibid. 

In December 1985, petitioner and AcroMed made a differ- 
ent attempt to obtain marketing clearance. Pet. App. 5a. 
They split the VSP device into its two component parts, 
which they called “nested bone plates” and “cancellous bone 
screws,” and they filed separate Section 510(k) submissions 
for each component. Ibid. Those submissions stated that the 
devices were intended to be used in long bones of the arms 
and legs. Ibid. In responding to an FDA request for addi- 
tional information about the devices’ intended use, petitioner 
stated that they “are intended for use in appropriate frac- 
tures of long bones of both the upper and lower extremity 
and such other flat bones (as in the fractured pelvis).” J.A. 

16. In February 1986, FDA granted marketing clearance for 
AcroMed’s bone plates and screws for that stated purpose. 
Pet. App. 5a. 

b. Respondents are plaintiffs who filed lawsuits alleging 
that they were injured when their doctors inserted the 
assembled VSP device into their spines. Pet. App. 1a. More 
than 2300 individual lawsuits were brought against multiple 
defendants, and those suits were consolidated for pre-trial 

7 

proceedings in the Eastern District of Pennsylvania pursu- 
ant to the multi-district litigation statute, 28 U.S.C. 1407 
(1994 & Supp. IV 1998). Pet. App. 1a. The only count 
against petitioner is one that respondents call “fraud on the 
FDA.” Id. at 5a. That count asserts that petitioner inten- 
tionally and falsely represented to FDA that the devices for 
which it sought clearance were “intended for use” in the long 
bones, when, in fact, the devices were “intended exclusively 
for use in the spine.” J.A. 15-16. Respondents further allege 
that FDA did not know that the devices were intended 
exclusively for use in the spine, and that if petitioner had not 
made false statements about their intended use, FDA would 
not have cleared the devices for marketing, the devices 
would not have been sold, and respondents would not have 
been injured. J.A. 21. Respondents’ claim does not depend 
on any allegation that the device itself was defective under 
state law or had been manufactured or labeled in a manner 
that was negligent or illegal under state law. 

c. The district court dismissed the fraud-on-the-FDA 
claims on the ground that they were expressly preempted 
under 21 U.S.C. 360k. Pet. App. 53a. The district court rea- 
soned that the MDA “does not permit courts to ‘perform the 
same function initially entrusted to the FDA,’ ” id at 49a, and 
that FDA is in the “best position” to decide whether a 
manufacturer has “withheld material information from the 
agency and, if so, [to determine] the appropriate sanction,” 
id. at 50a. After this Court decided Medtronic, respondents 
asked the district court to reinstate their fraud-on-the-FDA 
claims. Id. at 7a. The district court concluded that Med- 
tronic foreclosed a finding of express preemption. Id. at 40a. 
It nevertheless refused to reinstate respondents’ claims on 
the ground that they constituted an impermissible attempt 
to assert a private right of action for a violation of the MDA. 
Id. at 36a-40a. 

3. A divided panel of the court of appeals reversed. Pet. 
App. 1a-32a. The court first held that respondents’ fraud-on- 

8 

the-FDA claims are not expressly preempted, because there 
is neither a “federal ‘requirement’ ‘applicable to the device’ 
at issue,” nor “a state ‘requirement’ ‘with respect to’ that 
device.” Id. at 13a. The court further held that the “state 
common law relied upon [by respondents] does not impose 
any obligation on [petitioner] inconsistent with federal law,” 
because “18 U.S.C. § 1001 makes it a crime to make a fraudu- 
lent statement to a federal agency and 21 C.F.R. § 807.87(j) 
requires every pre-market notification to contain a state- 
ment that the information contained therein is believed to be 
truthful.” Ibid. The court of appeals also rejected the dis- 
trict court’s conclusion that fraud-on-the-FDA claims consti- 
tute an impermissible attempt to obtain a private right of 
action for violations of the MDA. Id. at 13a-17a. The court 
concluded that such reasoning is inconsistent with 
Medtronic. Id. at 16a. 

The court of appeals also held that respondents’ fraud-on- 
the-FDA claims are not impliedly preempted. Pet. App. 18a. 
The court saw “no inconsistency between the FDA having 
the exclusive prerogative of bringing actions to enforce the 
FDCA” and “common law fraudulent misrepresentation 
claims.” Ibid. Finally, the court rejected petitioner’s conten- 
tion that a statement of intended use refers to the use for 
which an applicant seeks market clearance. Id. at 22a-24a. 
The court held that a statement of intended use refers to an 
applicant’s marketing intentions. Id. at 22a-23a. The court 
therefore concluded that, if AcroMed intended at the time of 
the application to market its device solely for use in the 
spine, petitioner’s statement that the device was intended 
for use in the long bones would have constituted a material 
misrepresentation. Id. at 23a-24a. 

Judge Cowen dissented. Pet. App. 25a-32a. Judge Cowen 
concluded that fraud-on-the-FDA claims conflict with federal 
law because they “greatly distort the penalty scheme estab- 
lished by the statute.” Id. at 28a. In particular, the “penal- 
ties attached to a violation of the FDA’s regulations will 

9 

often be substantially increased, and enforcement of viola- 
tions will no longer be controlled by the FDA’s prosecutorial 
discretion.” Ibid. Judge Cowen also concluded that fraud- 
on-the-FDA claims conflict with federal law because they 
permit juries to impose “[m]assive liability” when FDA 
“would not find any misconduct.” Id. at 31a. 

SUMMARY OF ARGUMENT 

I. Respondents’ fraud-on-the-FDA claims are not ex- 
pressly preempted by FDA’s Section 510(k) disclosure 
requirements. Under Medtronic, express preemption occurs 
only when (1) the federal requirement is specific, and (2) the 
counterpart state requirement is different from, or in addi- 
tion to, that specific federal requirement. Neither of those 
prerequisites for express preemption is present here. 

First, FDA’s Section 510(k) disclosure requirements are 
not specific. They are stated in general terms, and they 
apply to all devices that must undergo the Section 510(k) 
clearance process, not just pedicle screw devices. Second, 
respondents’ common law theory of liability does not impose 
a duty that is different from, or in addition to, the applicable 
federal requirements. Federal law requires a manufacturer 
to truthfully disclose a device’s intended use in its sub- 
mission for Section 510(k) clearance. Respondents’ claim 
that petitioner falsely represented to FDA that its devices 
were intended for use in the long bones, when, in fact, they 
were intended exclusively for use in the spine, does not 
impose any requirement that is different from an applicable 
federal requirement. 

II. Respondents’ fraud-on-the-FDA claims nonetheless 
are impliedly preempted by federal law. When Congress 
legislates in a field of traditional state concern, there is a 
presumption against preemption. That presumption applied 
to the defective design, negligent manufacturing, and failure 
to warn claims at issue in Medtronic. Respondents’ claims, 
however, focus on an entity’s obligations to truthfully dis- 

10 

close information to a federal regulatory agency. That field 
is not one that States have traditionally occupied; instead, it 
is one of preeminent federal concern. Under this Court’s 
cases, when state law intrudes on an area of preeminent fed- 
eral concern, the presumption against preemption disap- 
pears, and the danger of a fatal conflict significantly in- 
creases. 

Applying the preemption analysis that is appropriate 
when state law intrudes on an area of preeminent federal 
concern, respondents’ fraud-on-the-FDA claims conflict with 
federal law. In particular, they conflict with the important 
federal interest in permitting FDA to decide for itself 
whether it has been defrauded, and, if so, what sanction is 
appropriate. If a State attempted to establish its own 
administrative agency to monitor fraud on the FDA, and 
devised its own set of sanctions for punishing such fraud, the 
conflict between that system and the federal interest in 
uniform enforcement would be apparent. That conflict is not 
lessened simply because the state scheme for regulating 
fraud on the FDA takes the form of a common law cause of 
action. 

Respondents’ fraud-on-the-FDA claims also conflict with 
FDA’s decision to grant market clearance for AcroMed’s 
pedicle screw devices. Respondents’ claims proceed on the 
assumption that AcroMed should not have received market 
clearance for its pedicle screws from FDA, and that respon- 
dents should receive damages as if the marketing of the 
pedicle screws cleared by FDA was unlawful under the 
FDCA. Those assumptions directly conflict with FDA’s 
decision clearing the devices for marketing under the FDCA. 

Fraud-on-the-FDA claims also invite highly intrusive 
discovery concerning federal agency officials’ states of mind 
and the courses of action that agency decisionmakers might 
have taken under various hypothetical scenarios. Such 
claims therefore pose a real danger of diverting FDA’s 
resources from the important health mission that Congress 

11 

has assigned to it and of distorting FDA’s internal decision- 
making process. 

ARGUMENT 

I. RESPONDENTS’ FRAUD-ON-THE-FDA CLAIMS 
ARE NOT EXPRESSLY PREEMPTED 

Petitioner contends (Pet. 26-27) that respondents’ fraud- 
on-the-FDA claims are expressly preempted. In particular, 
petitioner argues that the federal requirement that an 
applicant for Section 510(k) marketing clearance submit 
information concerning a device’s “intended use” preempts 
respondents’ fraud-on-the-FDA claims. Under the MDA, 
however, express preemption occurs only when there is (1) a 
federal “requirement applicable to the device,” and (2) the 
state requirement is “is different from, or in addition to,” 
that federal requirement. 21 U.S.C. 360k(a). Neither of 
those prerequisites for express preemption is present here. 

A. FDA’s Disclosure Requirements Are Not Specific 

In Medtronic, the Court held that federal “require- 
ment[s]” are “applicable to the device” within the meaning of 
the MDA’s express preemption provision only when they are 
“ ‘applicable to the device’ in question,” 518 U.S. at 500, and, 
in accordance with FDA regulations, only when they are 
“ ‘specific counterpart regulations’ or ‘specific’ to a ‘particular 
device,’ ” ibid. (quoting 21 C.F.R. 808.1(d)). Federal require- 
ments therefore can have preemptive force under Section 
360k(a) when “the Federal Government has weighed the 
competing interests relevant to the particular requirement 
in question, reached an unambiguous conclusion about how 
those competing considerations should be resolved in a par- 
ticular case or set of cases, and implemented that conclusion 
via a specific mandate on manufacturers or producers.” Id. 
at 501. Federal requirements do not have a preemptive 
effect under Section 360k(a), however, when they “reflect 
important but entirely generic concerns about device regula- 

12 

tion generally.” Id. at 501-502; see also id. at 506-507 
(Breyer, J., concurring in part and concurring in the judg- 
ment). 

Medtronic establishes a sensible and administrable line for 
determining the kind of federal requirements that can have 
preemptive force under Section 360k(a). For example, 
FDA’s requirements concerning hearing aids (21 C.F.R. 
801.420, 801.421), cables and leads (21 C.F.R. 898), impact- 
resistant lenses (21 C.F.R. 801.410), and devices containing 
natural rubber (21 C.F.R. 801.437) preempt counterpart 
state requirements that are different from, or in addition to, 
those requirements. Those federal requirements are stated 
with specificity and apply to a specific device or set of 
devices. In contrast, as the Court explained in Medtronic, 
FDA’s general manufacturing and labeling requirements do 
not have preemptive force. 518 U.S. at 501. Those require- 
ments are stated at a high level of generality and apply to all 
devices. 

Under the interpretation of the express preemption 
provision adopted in Medtronic, the requirement that an 
applicant submit information concerning a device’s “intended 
use” does not have preemptive force. That requirement is 
stated in general terms, and it applies to all devices that 
must undergo the Section 510k clearance process, not just 
pedicle screw devices. See 21 C.F.R. 807.87(e). Thus, like 
the general manufacturing and labeling requirements at 
issue in Medtronic, the statement of intended use required of 
applicants in the Section 510k process is not a “ ‘specific 
counterpart regulation[]’ or ‘specific’ to a ‘particular device.’ ” 
Medtronic, 518 U.S. at 500 (quoting 21 C.F.R. 808.1(d)). It is 
therefore not the kind of federal requirement that can have a 
preemptive effect under the MDA’s express preemption 
provision.1 

1 As we explain in our amicus brief at the petition stage (at 10-11 n.4), 
Section 360k(a) does preempt a specific duty of care that is made applica- 

13 

B. Respondents’ Fraud-On-The-FDA Claims Parallel 

Federal Requirements 

Even if the general duty to provide information to FDA 
about a product’s “intended use” were the kind of federal 
requirement that could have a preemptive effect under Sec- 
tion 360k(a), respondents’ fraud-on-the-FDA claims would 
still not be expressly preempted. As construed in Med- 
tronic, Section 360k does not deny a State “the right to pro- 
vide a traditional damages remedy for violations of common- 
law duties when those duties parallel federal requirements.” 
518 U.S. at 495. Such common law duties are not “different 
from, or in addition to,” federal requirements within the 
meaning of Section 360k. Ibid. 

Respondents’ sample complaint includes allegations that 
petitioner committed common law fraud when it falsely 
informed FDA that AcroMed’s devices were intended for 
use in long bones when, in fact, they were intended 
exclusively for use in the spine. Pet. App. 8a-9a; J.A. 15-16. 
Since federal law requires a manufacturer to truthfully 
disclose a device’s intended use in its submission for Section 
510(k) clearance (see 21 U.S.C. 331(q)(2); 18 U.S.C. 1001; 21 

ble to a device through application in litigation of a State’s common law of 
torts, if that requirement is different from, or in addition to, a specific 
requirement imposed by FDA. It does not follow from the fact that a 
general state tort duty may be preempted as applied in a particular case 
that the existence of general federal standards have preemptive force. 
The Court rejected that contention in Medtronic. 518 U.S. at 501-502; id. 
at 506-507 (Breyer, J., concurring in part and concurring in the judgment). 
Similarly, the fact that a device has been cleared by FDA through the 
Section 510(k) process does not mean that any general rules and duties 
governing that process have thereby been made “specific” to the device. 
At most, FDA would have determined only that any preexisting require- 
ments governing the process (whether general or “specific”) were sat- 
isfied. In any event, there is no indication in this case that FDA deter- 
mined when it cleared the device under Section 510(k) that petitioner and 
AcroMed had satisfied all applicable duties of disclosure. 

14 

C.F.R. 807.87(e); 21 C.F.R. 807.87(k)), respondents’ common 
law fraud theory parallels the applicable federal require- 
ments. It is therefore not “different from, or in addition to,” 
the applicable federal requirements within the meaning of 
Section 360k(a). 

Petitioner argues (Pet. 27; Reply Br. Pet. Stage 9-10) that 
respondents’ common law theory imposes a requirement that 
is different from the applicable federal requirement because, 
under federal law, “intended use” refers to the use set forth 
in the labeling, while respondents’ common law theory 
equates intended use with a manufacturer’s subjectively 
desired off-label uses. Petitioner’s contention misreads both 
the applicable federal standards and the allegations in 
respondents’ complaint. 

Under FDA’s regulations, the “intended use” of a medical 
device is defined by the “objective intent of the persons 
legally responsible for the labeling of [the] device[],” and 
objective intent “is determined by such persons’ expressions 
or may be shown by the circumstances surrounding the 
distribution of the article.” 21 C.F.R. 801.4. Because objec- 
tive intent is determined in part by reference to a manufac- 
turer’s “expressions,” a device’s “labeling” is relevant in 
determining a device’s intended use. 21 C.F.R. 801.4. But a 
device’s labeling is not the exclusive source for determining 
intended use. Also relevant are, inter alia: (1) “advertising 
matter,” (2) a manufacturer’s “oral or written statements,” 
(3) the manufacturer’s “knowledge” that a product is “of- 
fered and used for a purpose for which it is neither labeled 
nor advertised,” and (4) the manufacturer’s “knowledge” of 
facts that would give him “notice” that a product “is to be 
used” for purposes other than those for which the manufac- 
turer offered it. 21 C.F.R. 801.4. See also 21 C.F.R. 801.5 
(discussing adequate directions for use of a device for its 
intended use). 

Thus, when FDA seeks from an applicant a statement of a 
device’s intended use, it is not simply asking for the use that 

15 

will appear on the labeling. It is asking for the intended use 
that will be revealed by all the manufacturer’s “expressions” 
and “the circumstances surrounding” the device’s “distribu- 
tion.” 21 C.F.R. 801.4. Under the regulations, a manufac- 
turer is not required to disclose every foreseeable use of a 
device that it secretly desires. Physicians often use medical 
devices for purposes that are not identified in the labeling, 
and manufacturers may seek Section 510(k) clearance for the 
use identified in the labeling without setting forth every 
possible off-label use to which the device might be put after 
it reaches the market. But whatever may be the full scope of 
a manufacturer’s duty to disclose possible uses of the device 
beyond those stated in the labeling the manufacturer has 
submitted, when, at the time of the application, a manufac- 
turer plans to promote and distribute a device exclusively 
for one use, it must disclose to FDA that intended use. A 
statement to FDA that the device has a different intended 
use would be false and misleading. The intended use stated 
in the premarket notification must be a bona fide use; it 
cannot be a pretext calculated to clear the device for distri- 
bution for other uses.2 

2 That conclusion is not affected by the 1997 amendments to the 
FDCA. Those amendments were not in effect at the time of petitioner’s 
alleged misconduct. In any event, the amendments do not alter the analy- 
sis for devices subject to the Section 510(k) process after they were en- 
acted. Under 21 U.S.C. 360c(i)(1)(A), as amended in 1990, a device can be 
found to be substantially equivalent to a pre-1976 device only if it “has the 
same intended use as the predicate device.” The 1997 amendments pro- 
vide only that (for a period of five years), in making a “substantial equiva- 
lence” determination, FDA’s determination concerning a device’s “in- 
tended use * * * shall be based upon the proposed labeling.” 21 U.S.C. 
360c(i)(1)(E)(i) (Supp. IV 1998). That provision does not relieve manufac- 
turers of their obligation under 21 C.F.R. 807.87(e), 807.87(k) and 21 
U.S.C. 331(q)(2) to truthfully inform FDA of a device’s “intended use” as 
that term is defined in FDA’s “intended use” regulation, 21 C.F.R. 801.4. 
The manufacturer must continue to furnish proposed labeling that 
accurately reflects the device’s intended use, and FDA then determines 

16 

Respondents’ sample complaint includes allegations that 
petitioner engaged in just such misleading conduct. Respon- 
dents do not claim that AcroMed intended to market its 
devices for use in the long bones, but secretly hoped that 
they would be used in spinal surgery as well. Rather, re- 
spondents claim that, while petitioner represented to FDA 
in its Section 510(k) submission that AcroMed’s devices were 
intended to be used in the long bones, in fact, AcroMed 
planned to promote and distribute the devices exclusively 
for use in the spine. J.A. 15-16. That common law theory of 
liability does not rest on the imposition of a duty that is 
“different from” or “in addition to” federal requirements. 
Instead, that common law theory is consistent with the 
duties imposed by applicable federal requirements. It is 
therefore not expressly preempted. 

II. RESPONDENTS’ FRAUD-ON-THE-FDA CLAIMS 
ARE IMPLIEDLY PREEMPTED 

The absence of express preemption, however, does not 
exhaust the preemption inquiry. An express preemption 
provision “does not bar the ordinary working of conflict pre- 

substantial equivalence based on the proposed labeling. The amendments 
also authorize FDA to require a statement in a device’s labeling con- 
cerning “a use of the device not identified in the labeling” if FDA deter- 
mines “that there is a reasonable likelihood that the device will be used for 
an intended use not identified in the proposed labeling” and “such use 
could cause harm.” 21 U.S.C. 360c(i)(1)(E)(i)(I) and (II) (Supp IV 1998). 
That statutory authority confirms that a device’s intended use may be 
determined from evidence other than a device’s proposed labeling and that 
FDA is required to confine its inquiry to the intended use identified in the 
proposed labeling only when it makes a substantial equivalence deter- 
mination. That statutory authority concerning other potentially harmful 
intended uses also underscores why a manufacturer seeking Section 510(k) 
clearance for a device must disclose all intended uses of the device, not 
merely those set forth in whatever proposed labeling the manufacturer 
chooses to submit in the Section 510(k) clearance process. 

17 

emption principles.” Geier v. American Honda Motor Co., 
120 S. Ct. 1913, 1919 (2000). Those principles preclude re- 
spondents’ fraud-on-the-FDA claims. 

A. Fraud-On-The-FDA Claims Intrude On An Area Of 

Preeminent Federal Concern, And Are Therefore 

Subject To A More Stringent Conflict Preemption 

Analysis 

1. When Congress legislates “in a field which the States 
have traditionally occupied,” preemption analysis begins 
“with the assumption that the historic police powers of the 
States were not to be superseded by the Federal Act unless 
that was the clear and manifest purpose of Congress.” 
Medtronic, 518 U.S. at 485. That assumption “is consistent 
with both federalism concerns and the historic primacy of 
state regulation of matters of health and safety.” Ibid. The 
Medtronic plaintiffs’ claims of defective design, negligent 
manufacturing, and negligent failure to warn all implicated 
core areas of traditional state concern. The Court therefore 
began its analysis in Medtronic with a “presumption” that 
Congress did not intend to preempt those claims. Ibid. 

The situation here is fundamentally different. Respon- 
dents’ fraud-on-the-FDA claims do not depend on any show- 
ing that the device had a defective design, was negligently 
manufactured, or did not bear adequate warnings under 
state law. Pet. App. 8a-9a. Instead, respondents simply con- 
tend that, but for petitioner’s alleged misrepresentations to 
FDA, the agency would not have cleared the device for 
marketing, the device would not have been marketed, and 
they would not have been injured. Ibid. Respondents’ claim 
therefore does not focus on the device itself, on the manner 
in which it was designed, produced, and distributed, or on a 
State’s legitimate interest in those subjects. It focuses, 

18 

rather, on the relationship between the federal government 
and the entities it regulates. 

The field involving an individual’s obligations to the 
federal government, and, more particularly, an individual’s 
obligation to provide accurate information to a federal regu- 
latory agency, is not one “which the States have traditionally 
occupied.” Medtronic, 518 U.S. at 485. Unlike the tradi- 
tional common law torts at issue in Medtronic, the newly 
fashioned state-law tort of committing fraud on a federal 
regulatory agency has no existence that is independent of 
the federal statutes that establish federal regulatory 
agencies and require regulated entities to make certain dis- 
closures to those federal agencies. In this case, for example, 
a holding that fraud-on-the-FDA claims are preempted 
would not eliminate any claim that existed under state law 
before the MDA was enacted. Conversely, the field involv- 
ing an individual’s obligation to provide accurate information 
to a federal regulatory agency is one in which there is an 
overriding and longstanding federal interest. If federal 
regulatory agencies are to perform the important functions 
assigned to them by Congress, they must have the ability to 
decide, free from hindrances imposed by state law, how best 
to obtain the information they need and how to sanction 
those who fail to provide such information. 

In enacting the 1934 amendment to 18 U.S.C. 1001, Con- 
gress recognized the paramount need of federal regulatory 
agencies to receive accurate information from entities they 
regulate. The 1918 version of Section 1001 had prohibited 
false statements to government officials made for the pur- 
pose of cheating the government out of property or money. 
That restricted scope “became a serious problem with the 
advent of the New Deal programs in the 1930s.” United 
States v. Yermian, 468 U.S. 63, 80 (1984) (Rehnquist, J., dis- 
senting). Because the new regulatory agencies relied heav- 
ily on the reports filed by regulated entities to ensure com- 
pliance, the filing of false reports could readily defeat the 

19 

agency’s regulatory objectives. United States v. Gilliland, 
312 U.S. 86, 92-93 (1941). To address that concern, Congress 
amended Section 1001 to prohibit the making of any false 
statement or the filing of any false writing or document on 
any matter within the jurisdiction of any department or 
agency of the United States. Ibid. That amendment con- 
firms the importance that federal law places on a regulatory 
agency’s ability to obtain accurate information from those it 
regulates. 

2. Because respondents’ fraud-on-the-FDA claims impli- 
cate an area of paramount federal interest, they are subject 
to a more stringent conflict preemption analysis. Under this 
Court’s cases, when state law implicates an area of preemi- 
nent federal concern, the presumption against preemption 
disappears and the likelihood of a fatal conflict between state 
and federal law significantly increases. 

For example, in Boyle v. United Techs. Corp., 487 U.S. 500 
(1988), the Court noted that, while “[i]n most fields of 
activity,” the Court has “refused to find federal pre-emption 
of state law in the absence of either a clear statutory 
prescription * * * or a direct conflict between federal and 
state law,” in areas involving “unique federal interests”, the 
Court has more readily determined that state law is pre- 
empted. Id. at 504. The Court explained that the presence 
of a “unique federal concern changes what would otherwise 
be a conflict that cannot produce pre-emption into one that 
can.” Id. at 508. Applying that analysis, the Court held that 
design defect suits against government contractors implicate 
unique federal interests that require the displacement of 
state law. Id. at 511-512. In reaching that conclusion, the 
Court noted that such suits border on two areas that it had 
previously found to involve uniquely federal interests: the 
obligations and rights of the United States under its con- 
tracts, which are governed exclusively by federal law, and 
the civil liability of federal officers for actions taken in the 
course of their official duty, which in many contexts is con- 

20 

trolled by federal law. Id. at 505. Just as federal law pre- 
sumptively defines the duties owed by federal employees 
and contractors to the federal government, so too here fed- 
eral law presumptively defines the duties owed to the fed- 
eral government by entities regulated by the federal govern- 
ment. Cf. Hancock v. Train, 426 U.S. 167, 178-179 (1976). 

Moreover, in Boyle, the plaintiff sought to hold the manu- 
facturer liable for injuries caused by a product that allegedly 
was defective—a field generally subject to state law—and 
that state law was displaced only to the extent necessary to 
give effect to the countervailing federal interests.3 Here, by 
contrast, respondents’ fraud-on-the-FDA count does not 
depend on any claim that the product itself was independ- 
ently defective under state law or on any claim that the 
distribution of the product independently violated any duty 
owed under state law. The concerns about the displacement 
of state law in Boyle are therefore largely inapplicable here. 

In Pennsylvania v. Nelson, 350 U.S. 497 (1956), the Court 
held that federal sedition laws preempt comparable state 
prohibitions. The Court reasoned that the federal sedition 
laws “touch a field in which the federal interest is so domi- 
nant that the federal system [must] be assumed to preclude 
enforcement of state laws on the same subject.” Id. at 504. 
The Court further explained that “[s]edition against the 
United States is not a local offense. It is a crime against the 
Nation. * * * It is not only important but vital that such 
prosecutions should be exclusively within the control of the 
Federal Government.” Id. at 505. 

3 In fashioning the scope of the government-contractor defense to 
liability under state law in those circumstances, the Court in Boyle relied 
on the discretionary function exemption under the Federal Tort Claims 
Act, 28 U.S.C. 2680(a), which exempts the United States from liability for 
performing the discretionary function of selecting an appropriate design. 
The Court held that to subject a federal contractor to liability for a design 
that was selected by the federal agency would undermine that exemption. 
487 U.S. at 511-512. 

21 

And, in United States v. Locke, 120 S. Ct. 1135, 1151-1152 
(2000), the Court held that Coast Guard regulations con- 
cerning the reporting of marine casualties preempted a state 
regulation that imposed similar requirements. The Court 
reasoned that the “assumption” of non-preemption does not 
apply “in an area where there has been a history of signifi- 
cant federal presence,” id. at 1147, that maritime commerce 
constitutes such an area, id. at 1148, and that, in an area of 
preeminent federal concern, even state laws that mirror 
federal requirements can conflict with the intent to create “a 
workable, uniform system,” id. at 1151. 

B. Fraud-On-The-FDA Claims Conflict With The 

Important Federal Interest In Permitting FDA To 

Decide For Itself Whether It Has Been Defrauded, 

And, If So, What Remedy To Seek 

Applying the analysis that is appropriate in cases involv- 
ing an area of preeminent federal concern, respondents 
fraud-on-the-FDA claims are preempted. The FDCA estab- 
lishes a comprehensive scheme to regulate the information 
that an entity must submit to FDA, and respondents’ fraud 
on the FDA claims conflict with the strong federal interest 
in uniform enforcement of that comprehensive scheme. 

1. FDA has issued regulations that set forth the infor- 
mation that an applicant must supply in order to obtain 
clearance under Section 510(k). 21 C.F.R. 807.87. The manu- 
facturer must furnish, inter alia, “[p]roposed labels, labeling, 
and advertisements sufficient to describe the device, its 
intended use, and the directions for its use,” 21 C.F.R. 
807.87(e), “[a] statement indicating the device is similar to 
and/or different from other products of comparable type in 
commercial distribution, accompanied by data to support the 
statement,” 21 C.R.F. 807.87(f), and “[a]ny additional infor- 
mation regarding the device requested by [FDA] that is 
necessary for [FDA] to make a finding as to whether or not 
the device is substantially equivalent to a device in com- 

22 

mercial distribution,” 21 C.F.R. 807.87(l). FDA has issued 
guidance on how to supply the information required by its 
regulations. See Premarket Notification 510(k): Regulatory 
Requirements for Medical Devices, http://www.fda.gov 
/cdrh/manual/510kprt1.html. FDA’s regulations also require 
each person submitting a premarket notification to state 
that, “to the best of his or her knowledge,” all “data and 
information” are “truthful and accurate” and that “no 
material fact has been omitted,” 21 C.F.R. 807.87(k), and the 
FDCA specifically prohibits, “[w]ith respect to any device, 
the submission of any report that is required by or under 
this chapter that is false or misleading in any material 
respect,” 21 U.S.C. 331(q)(2). 

The FDCA also contains a comprehensive scheme for en- 
forcing those obligations. FDA has authority to investigate 
suspected fraud by a person seeking market clearance, 21 
U.S.C. 372; 21 C.F.R. 5.35, and may pursue a variety of 
remedies and sanctions if it uncovers such fraud, including 
injunctive relief, 21 U.S.C. 332, civil money penalties, 21 
U.S.C. 333(f)(1)(A), seizure of the device, 21 U.S.C. 
334(a)(2)(D), and criminal prosecution, 21 U.S.C. 333 (a), 18 
U.S.C. 1001 (1994 & Supp. IV 1998). FDA has adopted an 
enforcement policy concerning fraud and untrue statements 
of material facts in premarket submissions. 56 Fed. Reg. 
46,191, 46,199-46,200 (1991). Under that policy, when FDA 
finds that a submission contains fraudulent and unreliable 
data, it may withdraw clearance of a device cleared for 
marketing under Section 510(k) and seek voluntary correc- 
tive action from the submitter, such as removal of the per- 
sons involved in the wrongdoing from substantive respon- 
sibility for matters under FDA’s jurisdiction. Ibid. Any 
citizen who believes that a submitter has committed fraud 
may petition FDA to take administrative action. 21 C.F.R. 

10.30. But there is no private right of action to enforce the 
FDCA’s prohibitions. Medtronic, 518 U.S. at 487. FDA and 
the United States have exclusive authority to determine 

23 

how the provisions of the Act should be enforced. See 21 
U.S.C. 337(a). 

2. Respondents’ fraud-on-the-FDA claims conflict with 
that comprehensive federal scheme for regulating the 
information that a regulated entity must submit to FDA. In 
particular, they conflict with the strong federal interest in 
permitting FDA to decide for itself whether it has been 
defrauded, and, if so, what statutorily authorized remedy to 
seek. That conflict manifests itself in three ways. 

First, fraud-on-the-FDA claims would permit juries in 
different States to reach judgments that differ from FDA’s 
concerning whether an entity has actually committed fraud 
on the FDA. As Judge Cowen observed in his dissenting 
opinion in this case, juries could “impose massive liability,” 
when FDA “would not find any misconduct.” Pet. App. 31a. 
Even if juries in different States applied the same sub- 
stantive standards as FDA, it would not eliminate that con- 
flict. As this Court has explained, “[a] multiplicity of tribu- 
nals and a diversity of procedures are quite as apt to produce 
incompatible or conflicting adjudications as are different 
rules of substantive law.” Garner v. Teamsters, 346 U.S. 
485, 490-491 (1953). 

Second, allowing fraud-on-the-FDA claims would “distort 
the penalty scheme established by the statute.” Pet. App. 
28a (Cowens, J., dissenting). While the FDCA contains a 
wide range of possible remedies for fraud on the FDA, 
neither compensatory relief nor punitive damages is among 
them. “[S]ince remedies form an ingredient of any integrated 
scheme of regulation, to allow the State to grant a remedy 

* * * which has been withheld from the [FDA], * * * 
accentuates the danger of conflict.” San Diego Bldg, Trades 
Council v. Garmon, 359 U.S. 236, 247 (1959); see also Crosby 

v. National Foreign Trade Council, 120 S. Ct. 2288, 2298 
(2000) (“[C]onflict is imminent when two separate remedies 
are brought to bear on the same activity.”) 

24 

Third, if common law fraud-on-the-FDA claims are per- 
mitted, it would interfere with FDA’s discretion to decide 
which of the statutorily prescribed remedies, if any, to pur- 
sue. The FDCA allows FDA to pursue the remedies that, in 
FDA’s judgment, best fit the violation and the overall 
purposes of the Act. See Heckler v. Chaney, 470 U.S. 821, 
831 (1985). For example, FDA may decide in a particular 
case in which fraud has been identified that the established 
health benefits of the device concerned counsel against 
removing the device from the market or imposing a severe 
penalty, and that removing the persons involved in the 
wrongdoing from responsibility for submissions is a more 
appropriate sanction. If fraud-on-the-FDA claims may be 
brought, the juries in 50 States could substitute their judg- 
ments for FDA’s as to the appropriate sanction. Since fraud 
on the FDA “is not a local offense,” but an offense against 
the United States, it is “vital” that enforcement “should be 
exclusively within the control of the Federal Government.” 
Nelson, 350 U.S. at 505. 

3. Because there is a strong federal interest in permit- 
ting FDA to decide for itself whether it has been defrauded, 
and, if so, what sanction is appropriate, state regulation of 
fraud on the FDA is preempted. If a State attempted to 
establish its own administrative agency to monitor fraud on 
the FDA, and devised its own set of sanctions for punishing 
such fraud, the conflict between that system and the federal 
interest in uniform enforcement would be apparent. That 
sharp conflict is not lessened simply because the state 
scheme for regulating fraud on the FDA takes the form of a 
common law cause of action. See Garmon, 359 U.S. at 247 
(“The obligation to pay compensation” is “a potent method of 
governing conduct and controlling policy.”). On the contrary, 
permitting private prosecution of fraud on the FDA only 
exacerbates the conflict, since private parties have no obliga- 
tion to take into account the public interest before filing suit. 
Nelson, 350 U.S. at 507-508. 

25 

C. Respondents’ Fraud-On-The-FDA Claims Conflict With 

FDA’s Market Clearance Decision 

Respondents’ fraud-on-the-FDA claims are preempted for 
another reason. They conflict with FDA’s decision to grant 
market clearance for AcroMed’s pedicle screw devices. 

1. Under basic principles grounded in the Supremacy 
Clause, a federal administrative decision that has neither 
been rescinded by the agency nor set aside by a federal court 
in accordance with the procedures for review established by 
Congress has a preemptive effect. A State may not provide 
a common law cause of action that fails to give effect to such 
a decision. Arkansas La. Gas Co v. Hall, 453 U.S. 571 (1981) 
(Arkla); Chicago & North Western Transp. Co. v. Kalo Brick 
& Tile Co., 450 U.S. 311 (1981). 

Arkla and Kalo Brick illustrate the preemptive effect of 
federal administrative decisions on state common law causes 
of action. In Arkla, Hall contracted to sell natural gas to 
Arkla at a specified rate, but the contract provided that, if 
Arkla purchased natural gas from another party at a higher 
rate, Hall would be entitled to that rate. 453 U.S. at 573. 
Hall filed the agreed-upon rate with the Federal Power 
Commission, and the Commission authorized the sale of gas 
at that rate. Id. at 574. Some years later, Arkla purchased 
gas from another party at a higher rate, but did not inform 
Hall of that fact or increase its payments to Hall. When Hall 
learned of Arkla’s higher payments to the other party, he 
filed a state court breach of contract action, and the Louisi- 
ana Supreme Court awarded as damages the difference 
between what Arkla paid Hall and what it paid to the third 
party. Id. at 574. 

This Court reversed, holding that the state contract action 
was preempted by the Commission’s approval of Hall’s filed 
rate. Arcla, 453 U.S. at 578-579. The Court reasoned that 
the “filed rate doctrine” forbids a regulated entity to charge 
rates for its services other than those filed with the 

26 

appropriate federal regulatory agency, and that it would 
undermine the federal scheme to allow a state court to 
award as damages a rate never filed with the Commission 
and never found by the Commission to be reasonable. Id. at 
578-579. The Louisiana Supreme Court’s determination that 
the Commission would have approved the higher rate as 
reasonable had it known about the circumstances of the case 
did not eliminate the conflict, id. at 580-581, since “under the 
filed rate doctrine, the Commission alone is empowered to 
make that judgment, and until it has done so, no rate other 
than the one on file may be charged,” id. at 581. By awarding 
damages based on an assumption about what the Commis- 
sion might have done, the Louisiana Supreme Court had 
“usurped a function that Congress ha[d] assigned to a federal 
regulatory body.” Id. at 582; see also Nantahala Power & 
Light Co. v. Thornburg, 476 U.S. 953, 963-964 (1986). 

In Kalo Brick, the Interstate Commerce Commission 
approved a rail carrier’s request to abandon service on a 
particular rail line. 450 U.S. at 314-315. Rather than seeking 
judicial review of the Commission’s decision, a shipper who 
used that line asserted a common law tort action against the 
rail carrier for damages resulting from the abandonment of 
service. Id. at 315. The Court held that the common law tort 
action was preempted by the Commission’s decision. Id. 324- 
327. The Court rejected the argument that the state tort 
remedy merely complemented the federal abandonment 
remedy. Id. at 324. The Court reasoned that the Act grants 
“exclusive discretion” to the Commission to decide whether 
a carrier should be permitted to abandon service on a line, 
and that it would be contrary to that feature of the Act “to 
permit litigation challenging the lawfulness of the carrier’s 
actions to go forward when the Commission has expressly 
found them to be reasonable.” Id. at 326. 

2. Under the principles applied in Arkla and Kalo Brick, 
respondents’ fraud-on-the FDA claims are preempted. FDA 
granted market clearance for AcroMed’s pedicle screws, and 

27 

that decision has not been rescinded by FDA or set aside by 
a federal court in accordance with the procedures for judicial 
review established by Congress. Accordingly, under Arkla 
and Kalo Brick, FDA’s clearance decision is entitled to 
respect under the Supremacy Clause, and no State may 
provide a common law cause of action that fails to give effect 
to that decision. 

Respondents’ fraud-on-the-FDA claims, however, fail to 
give effect to FDA’s market clearance decision. Those 
claims proceed on the assumption that AcroMed should not 
have received market clearance for its pedicle screws from 
FDA, and that respondents should receive damages as if the 
marketing of the pedicle screws cleared by FDA was unlaw- 
ful under the FDCA. C.A. App. A63. Those assumptions 
directly conflict with FDA’s decision clearing the devices for 
marketing under the FDCA. Litigation “challenging the 
lawfulness” of petitioner’s actions in obtaining market clear- 
ance for the devices under the FDCA cannot “go forward” 
when FDA has “expressly found” that the devices should be 
cleared for marketing under that Act. Kalo Brick, 450 U.S. 
at 326. Respondents’ assertion that FDA would not have 
cleared the devices had it known that petitioner misrepre- 
sented their intended use, moreover, does nothing to avert 
the conflict. FDA “alone is empowered” to decide whether a 
device should be cleared for marketing under the FDCA, 
and, by seeking damages based on an assumption concerning 
what FDA “might have done,” respondents seek to “usurp[] 
a function that Congress has assigned to a federal regulatory 
body.” Arkla, 453 U.S. at 581-582.4 

4 Respondents’ claims do not conflict with FDA’s 1998 decision to clas- 
sify and reclassify pedicle screw spinal systems for certain uses as Class II 
devices. FDA’s classification and reclassification decision occurred after 
the underlying events at issue here (see Pet. App. 5a), and it was not 
intended to legitimize conduct that was unlawful at the time it occurred. 
63 Fed. Reg. 40,025, 40,037-40,038 (1998). We also note that FDA classi- 
fied and reclassified pedicle screw spinal systems as Class II devices only 

28 

D. Fraud-On-The-FDA Claims Would Result In Undesir- 
able Practical Consequences 

A holding that fraud-on-the-FDA claims are not pre- 
empted would also produce undesirable practical conse- 
quences. Absent an applicable privilege, NLRB v. Sears, 
Roebuck & Co., 421 U.S. 132, 150-151 (1975), such claims 
would invite highly intrusive inquiries into FDA’s internal 
deliberations. For example, respondents assert, as neces- 
sary elements of liability, that FDA did not know about the 
true intended use of the device in question; that FDA relied 
on petitioner’s misrepresentation about that intended use; 
and that FDA would not have cleared the device for 
marketing in the absence of petitioner’s alleged fraud. Pet. 
App. 8a-9a. 

In litigating those issues, the parties would very likely 
seek discovery from FDA concerning agency officials’ states 
of mind and the courses of action that agency decisionmakers 
might have taken under various hypothetical scenarios. It is 
the position of the United States that employees of the 
federal government are immune from third-party subpoenas 
issued in private litigation, that testimony must be sought 
under an agency’s Touhy regulations, see generally United 
States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951), and that 
an agency’s denial of a request for testimony by agency 
employees is subject to review only in federal court and only 
under the “arbitrary” or “capricious” standard of the Admin- 
istrative Procedure Act, 5 U.S.C. 706(2)(A). The lower fed- 
eral courts, however, have taken divergent views on issues 
concerning third-party subpoenas issued by a federal court 
to federal employees. Compare, e.g., Comsat Corp. v. Na- 
tional Science Foundation, 190 F.3d 269, 277-278 (4th Cir. 
1999) (applying APA standard), with Exxon Shipping Co. v. 

for certain spinal uses, and it imposed four “special controls” for those 
uses. Id. at 40,027, 40,034-40,038. The record in this case does not address 
whether the devices that AcroMed marketed satisfied those limitations. 

29 

United States Dep’t of Interior, 34 F.3d 774, 778-780 (9th Cir. 
1994) (agency must produce evidence in response to a federal 
court subpoena, subject only to court’s discretion to limit 
discovery under Fed. R. Civ. P. 26 and 45). Regardless of 
how that issue is ultimately resolved, widespread litigation 
could be expected on whether testimony and other evidence 
could be secured from FDA. This multidistrict litigation 
alone involves thousands of plaintiffs in more than 2000 cases 
that could be tried in several dozen different judicial dis- 
tricts. The prospect of such intrusive inquiries and atten- 
dant litigation would pose a significant potential for divert- 
ing FDA’s resources from the important health mission that 
Congress has assigned to it and for distorting FDA’s internal 
decisionmaking processes. 

Nor would the undesirable consequences of fraud-on-the- 
FDA claims abate if the courts ultimately accept the govern- 
ment’s position on when its officials can be required to 
testify. Parties would still be free to challenge any refusal to 
testify under the Administrative Procedure Act, and would 
retain every incentive to do so. And, in cases in which a gov- 
ernment claim of privilege is sustained, a jury could only 
speculate about the crucial issues in the case. Such specula- 
tion would increase the danger that the jury’s decision would 
conflict with FDA’s judgment concerning whether it was 
defrauded and, if so, what should be done. 

Permitting state-law suits for fraud on a federal agency 
could also distort the behavior of regulated entities. Those 
entities base their behavior largely on their understanding of 
how federal law has been applied in the past and how it will 
likely be applied in the future. If a regulated entity knows 
that juries applying the tort law of any one of the 50 States 
will play a central role in interpreting the entity’s duties to 
the federal government, that concern could cause it to alter 
its behavior in unpredictable ways that may well be 
inconsistent with the efficient administration of the federal 
regulatory scheme. For example, if, in order to avoid a risk 

30 

that a jury in one of 50 States might conclude that they have 
withheld relevant information, regulated entities began to 
flood FDA with information that FDA does not need, it could 
significantly complicate the clearance process. 

Fraud-on-the-FDA claims therefore pose a real danger of 
making it more difficult for FDA to perform its central 
mission of protecting the public health. That consequence 
can be avoided by a holding that such claims are impliedly 
preempted. 

CONCLUSION 

The judgment of the court of appeals should be reversed. 

Respectfully submitted. 

MARGARET JANE PORTER 

Chief Counsel 
PATRICIA J. KAEDING 

Associate Chief Counsel 
for Enforcement 
U.S. Food & Drug 

Administration 
SETH P. WAXMAN 

Solicitor General 
DAVID W. OGDEN 

Assistant Attorney General 
EDWIN S. KNEEDLER 

Deputy Solicitor General 
IRVING L. GORNSTEIN 

Assistant to the Solicitor 

General 
DOUGLAS N. LETTER 

PETER J. SMITH 

Attorneys 

SEPTEMBER 2000