No. 98-1768 

In the Supreme Court of the United States 

BUCKMAN COMPANY, PETITIONER 

v. 
PLAINTIFFS’ LEGAL COMMITTEE 

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

BRIEF FOR THE UNITED STATES 
AS AMICUS CURIAE 

SETH P. WAXMAN 

Solicitor General 

Counsel of Record 

DAVID W. OGDEN 

Acting Assistant Attorney 

General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

DOUGLAS N. LETTER 
KATHLEEN MORIARTY MUELLER 
JOCELYN E. STRAUBER 

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 

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

Discussion ........................................................................................ 9 

Conclusion ....................................................................................... 20 

TABLE OF AUTHORITIES 

Cases: 

Boyle v. United Stated Techs. Corp., 487 U.S. 500 

(1988) ........................................................................................ 15 

Chicago & Noth Western Transp. Co. v. Kalo Brick 

& Tile Co., 450 U.S. 311 (1981) ........................................... 

16 

Comsat Corp. v. National Science Found., 190 F.3d 

269 (4th Cir. 1999) .................................................................. 

17 

Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo. 1996), 

cert. dismissed, 520 U.S. 1260 (1997) ................................. 

20 

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

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

17 

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

denied, 520 U.S. 1168 and 1212 ........................................... 

20 

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

16 

Hawkins v. Upjohn Co., 890 F. Supp. 609 

(E.D. Tex. 1994) ..................................................................... 

19 

Learjet Corp. v. Spenlinhauer, 901 F.2d 198 

(1st Cir. 1996) ......................................................................... 

19 

Lewis v. Brunswick Corp., 107 F.3d 1494 (11th 

Cir. 1997), cert. dismissed, 523 U.S. 1113 (1998) .......... 

16, 18 

Mayo v. United States, 319 U.S. 441 (1943) ...................... 

16 

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

2, 3, 4, 

5, 10, 11, 13, 15 

Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.), 
cert. denied, 516 U.S. 815 (1995) ......................................... 

7 

Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 

1997), cert. denied, 523 U.S. 1020 (1998) ......................... 

8, 18 

NLRB v. Sears, Roebuck & Co., 421 U.S. 132 

(1975) ........................................................................................ 16 

(III) 

IV 

Cases—Continued: Page 

Nantahala Power & Light Co. v. Thornburg, 

476 U.S. 953 (1986) ................................................................ 

16 

Orthopedic Bone Screw Prods. Liability Litigation, 

In re, 193 F.3d 781 (3d Cir. 1999) ..................................... 

9, 12 

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

15 

Reeves v. AcroMed Corp., 44 F.3d 300 (5th Cir.), 

cert. denied, 515 U.S. 1104 (1995) ....................................... 

7 

Rice v. Santa Fe Elevator Corp., 331 U.S. 218 

(1947) ........................................................................................ 15 

Sebago, Inc. v. Beazer East, Inc., 18 F. Supp. 2d 

70 (D. Mass. 1998) .................................................................. 

20 

Smiths Indus. Med. Sys., Inc. v. Kernats, 522 U.S. 

1044 (1998) ............................................................................. 

5, 10 

Stanton by Brooks v. Astra Pharm. Prods., Inc., 

718 F.2d 553 (3d Cir. 1983) ................................................... 

19 

United States ex rel. Touhy v. Ragen, 340 U.S. 

462 (1951) ................................................................................. 

17 

Statutes, regulations and rules: 

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

17 

Federal Food, Drug and Cosmetic Act, 21 U.S.C. 
301 et seq. ................................................................................. 
1 

21 U.S.C. 321(h) ................................................................ 
2 

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

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(i)(1)(E)(i) (Supp. IV 1998) .................... 
13 

21 U.S.C. 360c(i)(1)(E)(i)(I)-(II) (Supp. IV 
1998) ................................................................................. 13 

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

2 

21 U.S.C. 360e(b)(1)(A) ................................................... 
2 

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

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

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

21 U.S.C. 360k ............................................................. 3, 4, 5 

V 

Statutes, regulations and rules—Continued: 
Page 

21 U.S.C. 360k(a) .............................................................. 
3 

21 U.S.C. 360k(b) .............................................................. 
3 

Medical Device Amendments of 1976, Pub. L. No. 
94-295, 90 Stat. 539 ................................................................ 
1 

90 Stat. 539 (Preamble) ............................................... 
2 

18 U.S.C. 1001 (1994 & Supp. IV 1998) .............................. 
8, 12 

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

21 C.F.R.: 

Pt. 801: 

Section 801.4 .................................................................... 12 

Section 801.5 .................................................................... 12 

Pt. 807: 

Section 807.87(e) (1986) ................................................. 
10 

Section 807.87(e) (1985 & 1999) .................................... 
10 

Section 807.87(h) (1985) ................................................. 
12 

Section 807.87(k) ............................................................. 12 

Pt. 808: 

Section 808.1(d) (1995) ................................................... 
4-5 

Section 808.1(d)(2) (1995) .............................................. 
4 

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

Pt. 888: 

Section 888.3070(a) ......................................................... 

3 

Section 888.3070(b) ......................................................... 
3 

57 Fed. Reg. (1992): 

p. 18,062 ................................................................................... 

12 

p. 18,064 ................................................................................... 
12 

p. 18,066 ................................................................................... 
12 

63 Fed. Reg. (1998): 

p. 39,789 ................................................................................... 

5 

p. 40,025 ................................................................................... 
3 

pp. 40,025-40,026 .................................................................... 
14 

p. 40,027 ................................................................................... 
14 

pp. 40,034-40,038 .................................................................... 
14 

pp. 40,037-40,038 .................................................................... 
14 

Fed. R. Civ. P.: 

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

17 

Rule 45 ..................................................................................... 17 

VI 

Miscellaneous: Page 

Office of Device Evaluation, Center for Devices and 
Radiological Health, FDA, Determination of In- 
tended Use for 510(k) Devices-Guidance for Industry 
and CDRH Staff (Jan. 30, 1998) ......................................... 13 

In the Supreme Court of the United States 
No. 98-1768 
BUCKMAN COMPANY, PETITIONER 

v. 
PLAINTIFFS’ LEGAL COMMITTEE 

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

BRIEF FOR THE UNITED STATES 
AS AMICUS CURIAE 

This brief is filed in response to the Court’s order inviting 
the Solicitor General to file a brief expressing the views of 
the United States. 

STATEMENT 

Respondents claim that they suffered injuries from the 
implantation of orthopedic bone screws into the pedicles of 
their spines. They allege that petitioner fraudulently ob- 
tained regulatory clearance for the manufacturer to market 
the pedicle screws by misrepresenting to the Food and Drug 
Administration (FDA) that the screws were “intended for 
use in appropriate fractures of long bones of both the upper 
and lower extremity and such other flat bones,” even though, 
respondents contend, the screws were designed and sold 
“exclusively for use in the spine.” Pet. App. 8a. The ques- 
tion presented is whether, as petitioner contends, that claim 
of “fraud on the FDA” is preempted by federal law. 

1. a. The Federal Food, Drug and Cosmetic Act (FDCA), 
21 U.S.C. 301 et seq., as amended, empowers the FDA to 
regulate a wide variety of products. The Medical Device 
Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 
539, supplemented the FDCA’s original provisions by creat- 

(1) 

2 

ing a federal program to enhance “the safety and effective- 
ness of medical devices intended for human use” (90 Stat. 539 
(Preamble)). See Medtronic, Inc. v. Lohr, 518 U.S. 470, 475- 
477 (1996). The MDA authorizes the FDA to undertake 
specified review, clearance, approval, and other regulatory 
activities with respect to medical “devices,” which include 
instruments, implants, and similar articles that are intended 
for use in the treatment, mitigation or prevention of disease 
or to affect the structure or function of the body. See 21 
U.S.C. 321(h) (defining “device”), 360c-360l (1994 & Supp. IV 
1998) (regulatory program). 

The MDA directs the FDA to group medical devices into 
three classes, based on the degree of regulation it concludes 
is necessary to provide reasonable assurance of safety and 
effectiveness. 21 U.S.C. 360c(a) (1994 & Supp. IV 1998); see 
Medtronic, 518 U.S. at 475-476. Class III devices are those 
that present “a potential unreasonable risk of illness or 
injury.” 21 U.S.C. 360c(a)(1)(C). The makers of Class III de- 
vices are subject to a variety of controls and to the FDA’s 
statutory “premarket approval” (PMA) process. 21 U.S.C. 
360c(a)(1)(C) and 360e(a). To obtain a PMA, the manu- 
facturer must submit detailed information to provide the 
FDA with reasonable assurance that the device is safe and 
effective for its intended use. 21 U.S.C. 360c(a)(1)(C), 
360e(a) and (c); 21 U.S.C. 360e(d) (Supp. IV 1998); 21 C.F.R. 
Pt. 814.1 

Class III devices that were on the market before the 
MDA’s enactment, however, may be marketed without FDA 
review until the FDA, by rulemaking, requires the submis- 
sion of a PMA. 21 U.S.C. 360e(b)(1)(A). In the interest of 

1 Class I devices are those that present no unreasonable risk of illness 
or injury and are subject to only minimal regulation through “general con- 
trols.” 21 U.S.C. 360c(a)(1)(A). Devices that are potentially harmful are 
Class II devices; they may be marketed without advance approval, but 
manufacturers must comply with federal standards known as “special 
controls.” 21 U.S.C. 360c(a)(1)(B). See Medtronic, 518 U.S. at 476-477. 

3 

fairness and to prevent the “grandfathered” manufacturers 
from monopolizing the market, the FDA also permits other 
manufacturers to distribute similar devices by showing 
(through a premarket notification process) that they are “sub- 
stantially equivalent” to the grandfathered devices. 21 
U.S.C. 360e(b)(1)(B). That procedure is known as the “Sec- 
tion 510(k) process,” referring to the FDCA section codified 
at 21 U.S.C. 360(k). See Medtronic, 518 U.S. at 478-479. 

When respondents were allegedly injured by the pedicle 
screw spinal system at issue in this case, the FDA had not 
yet classified that device. The FDA subsequently classified 
and reclassified pedicle screw spinal systems intended for 
certain uses as Class II devices, subject to special controls. 
See 63 Fed. Reg. 40,025 (1998); 21 C.F.R. 888.3070(a); pp. 13- 
14, infra. Pedicle screw spinal systems intended for all other 
uses are Class III devices. See 21 C.F.R. 888.3070(b). 

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

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 re- 
quirement 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. 

See also 21 U.S.C. 360k(b) (permitting FDA to grant exemp- 
tions from preemption). 

This Court addressed Section 360k’s preemptive effect in 
Medtronic. There, the plaintiffs sought damages for injuries 
caused by a pacemaker, which, they alleged, was defectively 

4 

designed, built, and manufactured. The FDA had cleared 
the pacemaker, a Class III medical device, for distribution 
under Section 510(k) on the ground that it was “substantially 
equivalent” to a pre-MDA device. Medtronic, the manufac- 
turer, contended that Section 360k preempted plaintiffs’ tort 
claims. This Court disagreed. 

The Court first held that Medtronic’s compliance with the 
Section 510(k) process did not impose any “requirements” on 
the device—and thus did not preempt plaintiffs’ design de- 
fect claims—because the FDA’s clearance did not “require” 
the pacemaker “to take any particular form for any par- 
ticular reason.” 518 U.S. at 493; accord id. at 513 (O’Connor, 
J., concurring in part and dissenting in part) (Section 510(k) 
process “places no ‘requirements’ on a device” and therefore 
does not preempt design defect claims). The Court next held 
that Section 360k did not preempt state-law claims in which 
the duty of care was based on FDA requirements, because 
those claims did not subject Medtronic to state-law require- 
ments that were “different from, or in addition to,” the 
federal requirements. Id. at 495. The Court noted that the 
FDA’s interpretive regulations “expressly support the con- 
clusion that § 360k ‘does not preempt State or local require- 
ments that are equal to, or substantially identical to, require- 
ments imposed by or under the Act.’ ” Id. at 496-497 (quoting 
21 C.F.R. 808.1(d)(2) (1995)). 

Finally, the Court held that Section 360k did not preempt 
the plaintiffs’ claims based on negligent manufacturing and 
labeling. 518 U.S. at 497-502. The Court recognized that 
FDA regulations set out general “requirements” for manu- 
facturing and labeling medical devices. Id. at 497. It con- 
cluded, however, that Section 360k does not mandate pre- 
emption of state-law requirements with respect to a device 
unless, as suggested in FDA regulations interpreting Sec- 
tion 360k, the FDA has adopted specific counterpart regu- 
lations or other specific substantive requirements applicable 
to the particular device. Id. at 498-500 (citing 21 C.F.R. 

5 

808.1(d) (1995)). The Court therefore concluded that the “en- 
tirely generic” federal manufacturing and labeling require- 
ments did not provide a basis for preemption of the general 
state common law duties at issue in that case. Id. at 501; see 
also id. at 505- 507 (Breyer, J., concurring in part and con- 
curring in judgment). In his separate opinion, Justice 
Breyer, agreeing with Justice O’Connor’s opinion for four 
Justices (see id. at 509-512), concluded that, ordinarily, 
insofar as the MDA preempts a state requirement embodied 
in a statute or regulation, it also preempts a similar state 
requirement that takes the form of a standard of care 
imposed by state tort law, id. at 503-505; but he concurred in 
the Court’s holding that the federal manufacturing and 
labeling requirements were not sufficiently “specific” to trig- 
ger preemption, id. at 505-508.2 

2. Petitioner, a regulatory consultant, was retained by 
the AcroMed Corporation, a medical device manufacturer, to 
act as its liaison to the FDA. In September 1984, petitioner, 
on behalf of AcroMed, made a submission for Section 510(k) 
marketing clearance for an orthopedic bone screw device 
known as the Variable Screw Placement (VSP) Spinal Plate 
Fixation System. Petitioner’s submission stated that Acro- 

2 As we informed the Court in a response to the Court’s invitation in a 
subsequent case presenting preemption issues under the MDA, in 1997 the 
FDA proposed an interpretive rule to give further guidance on the mean- 
ing of Section 360k. See U.S. Amicus Br. 19-20, Smiths Indus. Med. Sys., 
Inc. v. Kernats, cert. denied, 522 U.S. 1044 (1998) (No. 96-1405). That rule 
would have expressly construed Section 360k, consistent with the opinions 
in Medtronic, to preempt a common law duty only when (1) the FDA has 
imposed, by regulation or order, a specific substantive requirement 
applicable to a particular medical device, and (2) state common law 
imposes a substantive requirement applicable to the same medical device 
that is different from, or in addition to, the FDA’s counterpart require- 
ment. 96-1405 U.S. Br. App. 9a-15a, 17a-18a. After further consideration, 
the FDA withdrew that proposed rule. See 63 Fed. Reg. at 39,789. That 
withdrawal has no bearing on the preemption question presented here, 
and the interpretation of Section 360k in this brief is consistent with the 
interpretation in the proposed rule and in our brief in Smiths Industries. 

6 

Med intended to market the device for use in spinal surgery. 
The FDA denied the request, finding that the VSP device 
was a Class III device and was not substantially equivalent 
to any predicate device marketed before the MDA’s enact- 
ment. In September 1985, petitioner filed a second sub- 
mission for marketing clearance, again stating that the 
device was intended for use in spinal surgery. The FDA 
again denied the submission on the ground that the device 
was not substantially equivalent to any predicate device and 
that it posed potential risks not exhibited by other spinal- 
fixation systems. Pet. App. 4a-5a. 

In December 1985, petitioner and AcroMed made a differ- 
ent attempt to obtain marketing clearance through the 
Section 510(k) process. They split the VSP device into its 
two component parts, which they called “nested bone plates” 
and “cancellous bone screws,” and they filed separate Sec- 
tion 510(k) submissions for each component. Those sub- 
missions stated that the devices were intended to be used in 
long bones of the arms and legs. After reviewing the sub- 
missions, an FDA official contacted petitioner for additional 
information about the intended use of the device. Petitioner 
responded that “[t]he proposed indications for use for the 
AcroMed device are the same general indications proposed 
for the AO system of plates [which were marketed before 
the MDA’s enactment] . . . [and] are intended for use in 
appropriate fractures of long bones of both the upper and 
lower extremity and such other flat bones (as in the 
fractured pelvis).” C.A. App. A58. In February 1986, the 
FDA granted marketing clearance for AcroMed’s bone 
plates and screws for this stated purpose. 

Pet. App. 5a. 

3. a. Respondents are some of the more than 5000 plain- 
tiffs who filed suits alleging that they were injured when 
their doctors inserted the assembled VSP device into their 
spines. More than 2300 individual suits were brought 
against multiple defendants, and those suits were consolidat- 
ed for pre-trial proceedings in the Eastern District of Penn- 

7 

sylvania pursuant to the multi-district litigation statute, 28 
U.S.C. 1407 (1994 & Supp. IV 1998). Pet. App. 1a; Pet. 6. 

The only count against petitioner is one that respondents 
call “fraud on the FDA.” Pet. App. 5a. That count asserts 
that petitioner “intentionally and falsely” told the FDA that 
the AcroMed bone plates and screws were intended for use 
in fractures of long bones, when, in reality, the “sole in- 
tended use of these components was as an assembled [VSP] 
spinal plate/pedicle screw fixation system.” C.A. App. A57, 
A58. Respondents allege that AcroMed designed the devices 
to be used exclusively in the spine and that petitioner 
“sought approval of [the] VSP plates and screws for use in 
the long bones simply as a pretext in order to market the 
device for its true intended use in the spine.” Id. at A58. 
Respondents further allege that the FDA did not know that 
the bone plates and screws “were intended by AcroMed to 
be used as pedicle screw fixation devices,” and that if peti- 
tioner had not made false statements about their intended 
use, the FDA would not have cleared the devices for mar- 
keting, the devices would not have been sold, and respon- 
dents thus would not have been harmed by them. Id. at A63. 

The district court initially dismissed the “fraud on the 
FDA” claims on the ground that they were preempted by 
the MDA. Pet. App. 53a. Relying on the Third Circuit’s 
decision in Michael v. Shiley, Inc., 46 F.3d 1316, 1329, cert. 
denied, 516 U.S. 815 (1995), the district court reasoned that 
Section 360k “does not permit courts to ‘perform the same 
function initially entrusted to the FDA,’ ” Pet. App. 49a, and 
that the FDA is in the “best position” to decide whether 
a manufacturer “withheld material information from the 
agency and, if so, [to determine] the appropriate sanction.” 
Id. at 50a (quoting Reeves v. AcroMed Corp., 44 F.3d 300, 
306 (5th Cir.), cert. denied, 515 U.S. 1104 (1995)). 

After this Court decided Medtronic, respondents asked 
the district court to reinstate their “fraud on the FDA” 
claims. Pet. App. 7a. Although the court indicated that this 

8 

Court’s decision in Medtronic foreclosed a finding of express 
preemption under Section 360k, id. at 40a, it nevertheless 
dismissed respondents’ claims on the grounds that they 
improperly assert a private right of action for violation of the 
MDA and that the target of the alleged fraud was the FDA, 
not respondents. Id. at 36a-40a. In the alternative, the court 
dismissed the claims because “the alleged fraud * * * 
cannot be said to have been a proximate cause of [respon- 
dents’] alleged injuries.” Id. at 41a. 

b. A divided panel of the court of appeals reversed. Pet. 
App. 1a-32a. The court held that Section 360k does not 
expressly preempt the claims, because there is neither a 
federal “requirement” “applicable to the device” nor a state 
“requirement” “with respect to” that device. Id. at 13a. 
Moreover, the court reasoned, the “state common law relied 
upon [by respondents] does not impose any obligation on 
[petitioner] inconsistent with federal law,” because it is a 
crime to make a false statement to a federal agency, see 18 
U.S.C. 1001 (1994 & Supp. IV 1998), and because FDA regu- 
lations require those who seek FDA clearance of devices 
under Section 510(k) to vouch for the truthfulness and accu- 
racy of their submissions. Pet. App. 13a; see note 5, infra. 
The court of appeals also rejected the district court’s con- 
clusion that the “fraud on the FDA” claims constitute an 
impermissible attempt to obtain a private right of action for 
violations of the MDA. Pet. App. 14a-17a. Although the 
court of appeals itself had relied on similar reasoning in 
Michael, the court found such reasoning inconsistent with 
this Court’s intervening decision in Medtronic. Id. at 16a. 
The court therefore disagreed with Mitchell v. Collagen 
Corp., 126 F.3d 902, 914 (7th Cir. 1997), cert. denied, 523 U.S. 
1020 (1998), a post-Medtronic decision in which the Seventh 
Circuit had followed Michael and held that a “fraud on the 
FDA” tort claim was preempted. Pet. App. 17a n.5. 

Finally, the court of appeals reversed the district court’s 
decision to dismiss the claims for the additional reason that 

9 

they fail to allege a sufficient causal connection between the 
asserted fraud and respondents’ injuries. Pet. App. 19a-21a. 
Because neither the parties nor the district court had 
analyzed the choice-of-law issues raised by the complaint or 
discussed the law of any particular jurisdiction that would 
govern the causation element of such a claim, the court of 
appeals found it impossible to determine whether respon- 
dents “have or have not alleged a legally sufficient causal 
nexus.” Id. at 21a. 

Judge Cowen dissented. Pet. App. 25a-32a. He expressed 
concern that “recognizing a state cause of action for viola- 
tions of FDA regulations will greatly distort the penalty 
scheme established by the statute,” because the “penalties 
attached to a violation of the FDA’s regulations will often be 
substantially increased, and enforcement of violations will no 
longer be controlled by the FDA’s prosecutorial discretion.” 
Id. at 28a.3 

DISCUSSION 

As petitioner correctly contends, the decision below 
squarely presents at least one issue that has divided the 
lower courts: whether federal law preempts a state-law 
cause of action based on a defendant’s alleged fraud on the 
FDA during the regulatory process for marketing clearance 
applicable to certain medical devices. That issue is impor- 
tant, and this Court should grant certiorari to resolve it. 

1. On the merits, we agree with petitioner that respon- 
dents’ “fraud on the FDA” claim is foreclosed by federal law, 
but we disagree on why that is so. 

a. Contrary to petitioner’s contention (Pet. 26-27), the 
court of appeals was correct in holding that the claim is not 
expressly preempted by Section 360k. As a general matter, 

3 The Third Circuit returned to this case in In re Orthopedic Bone 
Screw Prods. Liability Litigation, 193 F.3d 781 (1999), which involved 
issues arising under certain of plaintiffs’ other claims against a variety of 
defendants. That decision has no bearing on this petition. 

10 

a defendant claiming preemption under Section 360k must 
show, at a minimum, that the application of state law would 
impose obligations in addition to or different from “specific 
counterpart regulations” or a federal requirement that is 
“specific” to a “particular device.” Medtronic, 518 U.S. at 
500 (internal quotation marks omitted); accord id. at 506-507 
(opinion of Breyer, J.). 

Petitioner has identified no such specific federal require- 
ment applicable here. It contends instead that respondents’ 
claim is preempted because it “would threaten to impose 
liability for failing to disclose in the 510(k) process infor- 
mation that the FDA itself does not require.” Pet. Reply Br. 

10. But the federal requirement that petitioner argues 
would be impermissibly supplemented by respondents’ state 
law theory of liability—the requirement that the person 
making a Section 510(k) submission identify the device’s “in- 
tended use”—applies to such devices generally; it does not 
impose a requirement specifically with respect to the VSP 
device that is the subject of these consolidated cases. See 21 
C.F.R. 807.87(e) (1985 & 1999). Compare Medtronic, 518 
U.S. at 501; id. at 506-507 (opinion of Breyer, J.). For that 
reason, even if (as petitioner contends) respondents’ claim 
depends upon the existence of a state-law duty to provide 
the FDA with information about intended or “off-label” uses 
in addition to the information that federal law requires to be 
disclosed, that claim would not be expressly preempted, 
because the federal duty of disclosure is insufficiently de- 
vice-specific to trigger preemption under Section 360k.4 

4 Petitioner argues that this case implicates a conflict concerning a 
separate issue: whether Medtronic exempts from express preemption all 
state requirements that are imposed through state tort law of general 
applicability. See Pet. 19-25. As we explained in our brief in Smiths 
Industries (at 17-18, 19), it is our view that Section 360k does preempt a 
specific duty of care that is made applicable to a device through a State’s 
common law of torts if that requirement is different from, or in addition to, 
a specific requirement imposed by the FDA. See Medtronic, 518 U.S. at 
503-505 (opinion of Breyer, J.); id. at 509-512 (O’Connor, J., concurring in 

11 

In any event, even if the general duty to provide truthful 
information to the FDA about a product’s “intended use” 
were device-specific enough to preempt state-law duties to 
provide additional information, respondents’ claim still might 
not fall within the scope of Section 360k, because, on the 
present record, it is not clear that the asserted state common 
law duty on which respondents rely would, as applied here, 
be “different from, or in addition to,” that federal duty. See 
Medtronic, 518 U.S. at 495; see also id. at 513 (O’Connor, J., 
concurring in part and dissenting in part). Petitioner argues 
that those state and federal duties are in fact different. 
Petitioner reasons that it did disclose the “intended use” of 
the device at issue—which petitioner appears to equate with 
whatever use is stated in the device’s labeling (Pet. 27)— 
and that any liability must therefore rest on a violation of a 
further duty under state law to disclose any foreseeable off- 
label uses and any plans to market the device for those uses. 
See ibid.; Pharmaceutical Research and Manufacturers of 
America (PhRMA) Br. at 10-11. 

That argument is unavailing, at least at this stage of the 
litigation. As the court of appeals recognized (Pet. App. 23a- 
24a), respondents’ theory of liability does not appear to be 
that petitioner and its clients obtained a Section 510(k) clear- 
ance for one bona fide intended use while failing to disclose a 
foreseeable off-label use. Nor, in the claim at issue here, do 
respondents seek to hold petitioner liable for giving a physi- 

part and dissenting in part). See note 2, supra. Although we agree that 
the lower courts are divided on that issue, this case would likely prove to 
be an inappropriate vehicle for trying to resolve it. The cases underlying 
that conflict generally involve ordinary product defect claims. As dis- 
cussed in the text, Section 360k is inapplicable here for reasons indepen- 
dent of whether the application of state tort law is insufficiently specific to 
be preempted by that provision, and this Court would therefore probably 
find it unnecessary to resolve the latter issue. As we discuss below, 
however, this case does implicate a separate conflict concerning whether 
federal law preempts state-law claims of fraud on a federal agency, and 
certiorari would be appropriate to resolve that issue. 

12 

cian information about an off-label use that was not identi- 
fied in the Section 510(k) submission. See id. at 24a n.7; cf. 
In re Orthopedic Bone Screw Prods. Liability Litigation, 193 
F.3d 781, 787 (3d Cir. 1999). Instead, respondents claim that 
AcroMed’s bone plates and screws were never meant to be 
used at all for the intended use set forth in the Section 510(k) 
submissions; instead, respondents contend, the ostensible 
intended use was merely a pretext to get the device on the 
market, where it would be used exclusively for other (un- 
cleared) uses. See Pet. App. 23a-24a; C.A. App. A57, A58. 

Under the FDA’s regulations, the “intended use” of a 
medical device is defined by the “objective intent of the per- 
sons legally responsible for the labeling of [the] device[].” 21 
C.F.R. 801.4. That objective intent may be determined by 
(for example) labeling claims, advertising materials, written 
or oral statements, or the circumstances in which the device 
is offered and used. Ibid.; see also 21 C.F.R. 801.5. The 
complaints in this case allege that the devices at issue were 
meant solely for use in the spine, and that petitioner’s rep- 
resentation to the FDA that the devices were intended for 
use in long bones was therefore false and misleading. C.A. 
App. A57, A58. Because that factual allegation has not been 
fleshed out in proceedings in the various district courts, it is 
impossible on the present record to say that any duty under 
state law would be “different from, or in addition to,” appli- 
cable duties under federal law.5 

5 See 18 U.S.C. 1001 (1994 & Supp. IV 1998) (prohibiting false or 
fraudulent statements on any matter within the jurisdiction of a federal 
agency); 21 C.F.R. 807.87(k) (promulgated in 1992, see 57 Fed. Reg. 18,062, 
18,064, 18,066 (1992)) (requiring each person submitting premarket noti- 
fication 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(h) (1985) (requiring, during the period 
relevant here, that parties submitting premarket notification must pro- 
vide the FDA with “[a]ny additional information regarding the device 
requested by the Commissioner that is necessary for the Commissioner to 

13 

That is not to say that any representation to the FDA 
about a device’s intended use must disclose every foresee- 
able use of the device. Physicians often employ medical 
devices for uses 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, for obvious reasons, the intended use 
stated in the premarket notification must be a bona fide use 
of the device; it cannot be a mere pretext calculated to clear 
the device for distribution exclusively for other uses.6 

b. The present record also provides little support for 
petitioner’s alternative contention (Pet. 27-29) that respon- 
dents’ claim would “conflict” with the FDA’s 1998 decision to 
classify and reclassify pedicle screw spinal systems for cer- 
tain uses as Class II devices.7 The FDA’s classification and 

make a finding as to whether or not the device is substantially equivalent 
to a device in commercial distribution”). 

6 It is inaccurate to suggest, as petitioner does (Pet. 27; see also 
PhRMA Br. 10-11 & n.6), that the FDA never inquires, and lacks author- 
ity to inquire, into off-label uses in connection with premarket notification 
submissions under Section 510(k). Although 1997 amendments to the 
FDCA confine FDA’s determination of the intended use of a device, for 
purposes of a Section 510(k) clearance, to its proposed labeling, see 21 
U.S.C. 360c(i)(1)(E)(i) (Supp. IV 1998), the FDA may nonetheless “require 
a statement in labeling that provides appropriate information regarding a 
use of the device not identified in the proposed labeling” if the 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 for the device,” and 
“that such use could cause harm.” 21 U.S.C. 360c(i)(1)(E)(i)(I)-(II) (Supp. 
IV 1998). FDA recently explained that, “[w]hile this is a new statutory 
requirement, it is important to note that it is not different from the 
manner in which 510(k)s have traditionally been reviewed.” Office of 
Device Evaluation, Center for Devices and Radiological Health, FDA, 
Determination of Intended Use for 510(k) Devices—Guidance for Indus- 
try and CDRH Staff 1 (Jan. 30, 1998). 

7 Tort claims may be subject to conflict preemption under the MDA 
even if they are not expressly preempted under Section 360k. See Med- 
tronic, 518 U.S. at 502-503; id. at 507-508 (opinion of Breyer, J.). 

14 

reclassification decision—which occurred long after the un- 
derlying events at issue here (see Pet. App. 5a)—was based 
on “new information,” including studies conducted years after 
petitioner obtained Section 510(k) clearance for AcroMed’s 
devices. See 63 Fed. Reg. at 40,025-40,026. That decision 
operates prospectively and does not legitimize conduct that 
was previously impermissible. Id. at 40,037-40,038. More- 
over, the FDA classified and reclassified pedicle screw spinal 
systems as Class II devices only for certain spinal uses, and 
it imposed four “special controls” requiring that the devices’ 
labeling contain a special warning and that they comply with 
material standards, mechanical testing standards of per- 
formance, and biocompatibility standards. See id. at 40,027, 
40,034-40,038. The sample complaint relied on by the court 
of appeals does not indicate whether AcroMed’s devices 
were marketed for the uses for which the devices are now 
classified as Class II or whether their manufacture and com- 
position were consistent with the special controls that the 
FDA has now prescribed. See Pet. App. 8a-9a; C.A. App. 
A42-A131. For these reasons, petitioner has not established 
that a tort judgment for respondents would contradict the 
FDA’s 1998 determination; and, in any event, the allegedly 
tortious actions occurred before that determination. 

c. Nevertheless, in our view, federal supremacy princi- 
ples do preclude respondents’ “fraud on the FDA” claim. 
Respondents’ claim is quite peculiar. It is independent of 
any claim against the manufacturer of the device in question, 
and it apparently does not depend on any showing that the 
device was somehow defective, or falsely advertised, under 
state law. See Pet. App. 8a-9a. Instead, respondents simply 
contend that, but for petitioner’s alleged misrepresentations 
to the FDA, the agency would not have cleared the device 
for marketing, the device would not have been marketed, 
and it therefore would not have harmed respondents. Ibid. 
The focus of the claim is therefore not on the device itself or 
on any provisions of state law that might apply directly to 

15 

the device or to its manufacturing and distribution, but 
rather solely on the character of the relationship between 
petitioner and the federal government. Absent a contrary 
direction by Congress, that relationship is, as a general 
matter, governed by federal not state law. 

In the typical preemption context, when Congress legis- 
lates “in a field which the States have traditionally occu- 
pied,” 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 
(quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 
(1947)). The common law duties at issue in Medtronic, con- 
cerning the manufacture and distribution of a device that 
was allegedly defective under state law, fell squarely within 
such a field. By contrast, the field of relationships between 
the federal government and persons who are subject to 
regulation by it—and, more particularly, the field of submis- 
sions made by such persons to a federal agency—is not one 
“which the States have traditionally occupied.” Ibid. Like 
issues concerning the relationship of the United States with 
its contractors and employees, the duties of persons in con- 
nection with their submission of applications to a federal 
agency for benefits or regulatory approval involve “uniquely 
federal interests” that “warran[t] the displacement of state 
law.” See Boyle v. United Techs. Corp., 487 U.S. 500, 504- 
505 (1988). Those “uniquely federal interests” remain pre- 
dominant when questions concerning that relationship are 
raised, as here, in private civil litigation. Compare id. at 506- 
507. Thus, duties concerning the submission of information 
to a federal agency are, at least as a general matter, ap- 
propriately defined and enforced by the federal government. 
See also Pennsylvania v. Nelson, 350 U.S. 497, 505 (1956) 
(state laws criminalizing sedition against the United States, 
the subject of federal legislation, are preempted because 
sedition is “not a local offense,” but is a “crime against the 

16 

Nation,” and thus “prosecutions should be exclusively within 
the control of the Federal Government”) (internal quotations 
omitted). Cf. Hancock v. Train, 426 U.S. 167, 178-179 (1976); 
Mayo v. United States, 319 U.S. 441, 445-446 (1943). 

There is no occasion in this case to decide, however, 
whether federal law completely occupies the field of sub- 
missions made by or on behalf of regulated parties to a 
federal agency, either generally or specifically with respect 
to the FDA. That is so because the premise of respondents’ 
state-law cause of action is that particular agency action 
should not and would not have been taken by a federal 
agency, and that damages should be awarded as if the 
conduct of petitioner that the FDA had cleared under the 
FDCA—introducing the product onto the market—was 
unlawful under the FDCA. A state court may not decline to 
give effect to an FDA decision that has not been rescinded 
by the FDA or set aside by a court. Cf. Nantahala Power & 
Light Co. v. Thornburg, 476 U.S. 953 (1986); Chicago & 
North Western Transp. Co. v. Kalo Brick & Tile Co., 450 
U.S. 311 (1981). The federal government has a significant 
interest in the finality of its own administrative determina- 
tions, and under the Supremacy Clause those determinations 
should generally be questioned or set aside, if at all, only by 
the federal government itself. See, e.g., Lewis v. Brunswick 
Corp., 107 F.3d 1494, 1505 (11th Cir. 1997), cert. dismissed, 
523 U.S. 1123 (1998). 

A contrary rule could produce undesirable practical con- 
sequences. In the absence of an applicable privilege, see 
generally NLRB v. Sears, Roebuck & Co., 421 U.S. 132, 150- 
151 (1975), “fraud on the agency” claims could subject federal 
agencies to countless, highly intrusive inquiries into their 
internal deliberations. For example, respondents assert, as 
necessary elements of liability, that the FDA “was ignorant” 
of the true intended use of the device in question; that the 
FDA “reli[ed]” on petitioner’s misrepresentation about that 
intended use; and that the FDA “would not have issued 

17 

§ 510(k) clearances” for the device in the absence of peti- 
tioner’s alleged fraud. Pet. App. 8a-9a. 

In litigating those issues, the parties would undoubtedly 
seek discovery from the FDA concerning agency officials’ 
states of mind and the hypothetical courses of action that 
agency decisionmakers might have taken under various 
counterfactual scenarios. It is the position of the United 
States that its employees are immune from third-party sub- 
poenas 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 under the 
“arbitrary and capricious” standard of the Administrative 
Procedure Act, 5 U.S.C. 706(2)(A). The lower federal courts 
have, however, taken divergent views on that question. 
Compare, e.g., Comsat Corp. v. National Science Found., 
190 F.3d 269, 277-278 (4th Cir. 1999) (applying APA stan- 
dard), with Exxon Shipping Co. v. United States Dep’t of the 
Interior, 34 F.3d 774, 778-780 (9th Cir. 1994) (agency must 
produce evidence in response to subpoena, subject only to 
court’s discretion to limit discovery under Fed. R. Civ. P. 26 
and 45). And, in any event, widespread litigation could be 
expected on whether testimony and other evidence could be 
secured from the FDA and other federal regulatory agencies 
in cases such as this; this multidistrict litigation alone in- 
volves thousands of plaintiffs in more than 2000 cases that 
could be tried in several dozen different judicial districts. 
The prospect of such intrusive inquiries and attendant litiga- 
tion would pose a significant potential for diverting an 
agency’s resources and for distorting its internal decision- 
making processes.8 

8 We have pointed to similar concerns in suggesting, in response to the 
Court’s invitation in Armstrong Surgical Ctr. v. Armstrong Cty. Mem. 
Hosp. (No. 99-905), that there is reason for caution in fashioning any 

18 

Permitting state law suits for fraud on a federal agency 
could also distort the behavior of regulated entities. If a 
regulated entity knows that a jury applying the tort law of 
one of 50 States will play a central role in interpreting the 
entity’s duties to the federal government, that concern 
would cause it to alter its behavior in unpredictable ways 
that may well be inconsistent with the efficient administra- 
tion of the federal regulatory scheme. 

2. The petition for certiorari should be granted. As the 
court of appeals acknowledged (Pet. App. 17a n.5), its deci- 
sion squarely conflicts with Mitchell v. Collagen Corp., 126 
F.3d 902 (7th Cir. 1997) (Mitchell II), cert. denied, 523 U.S. 
1020 (1998), in which the Seventh Circuit held that, despite 
Medtronic, the MDA preempts claims of “fraud through 

* * * representations to the FDA during the PMA pro- 
cess.” Id. at 914; see also Lewis, 107 F.3d at 1505 (finding 
analogous fraud-on-the-agency claim preempted under Boat 
Safety Act). We agree with petitioner (see Reply Br. 3-4) 
that the Seventh Circuit would be bound to follow that 
precedent today, even though the abbreviated analysis in 
Mitchell II placed some reliance on a prior Third Circuit 
decision overruled by the decision below. We also agree 
with petitioner (see Reply Br. 4 n.2) that the decision below 
squarely conflicts with Mitchell II even though the latter 

theory of federal antitrust liability that would allow a plaintiff to recover 
damages from a private defendant for competitive injuries most directly 
caused by state administrative or adjudicatory action. 99-905 U.S. Br. at 
16-18. At the same time, however, other circumstances counsel caution in 
concluding that claims like that in Armstrong may never be meritorious: 
antitrust claims are made within a well-developed legal framework, and 
are based on a federal statute that specifically prohibits concerted private 
conduct in restraint of trade, quite apart from any involvement by gov- 
ernment actors. Those circumstances are not present in this case. 
Furthermore, antitrust cases, unlike this case, raise no question under the 
Supremacy Clause; and, unlike in this case, any conflict in the circuits on 
the question presented in Armstrong is not current or well-defined 
enough to require immediate review. See 99-905 U.S. Br. at 14-16, 20. 

19 

decision involved the PMA process and this case involves the 
Section 510(k) process. Finally, we agree that the subject- 
matter of the conflict is sufficiently important to warrant 
this Court’s review; if other courts were to follow the Third 
Circuit’s lead and permit state-law suits in this context, the 
result could be an unwelcome proliferation of similar claims 
asserting fraud on a variety of federal agencies. 

To be sure, this particlar case arrives here in an inter- 
locutory posture. The court of appeals remanded respon- 
dents’ individual claims for trial, at which it would be 
determined, among other things, whether “the state law of 
fraudulent misrepresentation applicable in one or more of 
these cases would impose liability on [petitioner] in the cir- 
cumstances alleged.” Pet. App. 25a. Because the court of 
appeals “d[id] not hold that any of the plaintiffs have stated a 
claim under state law upon which relief could be granted” 
(id. at 24a-25a), it is theoretically possible that, on remand, 
petitioner could prevail in every case on state law grounds. 
Nonetheless, the court of appeals concluded (id. at 19a-24a) 
that respondents’ claims against petitioner have a plausible 
basis in common law tort principles, and we agree with 
respondents (Br. in Opp. 10 n.6) that those claims might well 
be cognizable under the law of at least some States.9 In our 

9 See, e.g., Learjet Corp. v. Spenlinhauer, 901 F.2d 198, 201 (1st Cir. 
1990) (“[i]f, as [plaintiff] alleges, the [Federal Aviation Administration] 
relied on Learjet’s fraudulent misrepresentations when it certified the 
[airplane model], and [plaintiff] purchased the [airplane] in reliance on the 
FAA’s certification, then he has indirectly relied on Learjet’s fraudulent 
misrepresentations” and has stated a cause of action under Kansas law); 
Stanton by Brooks v. Astra Pharm. Prods., Inc., 718 F.2d 553, 569 (3d Cir. 
1983) (recognizing state-law cause of action for negligent failure to file 
certain reports with the FDA, where, but for that negligence, the FDA 
“would have required notice to the medical community” of certain drug 
risks and “physicians receiving this information would have considered it” 
in deciding whether and how to administer the drug); Hawkins v. Upjohn 
Co., 890 F. Supp. 609, 612 (E.D. Tex. 1994) (recognizing state-law cause of 
action for fraud where “[p]laintiffs assert that the FDA relied on defen- 
dants’ representations in permitting the distribution of the drugs in 

20 

view, this Court therefore should grant certiorari now to 
decide whether such claims are foreclosed by federal law, 
rather than after years of what is very likely to be burden- 
some litigation under this and other federal statutory 
schemes—including numerous individual cases in numerous 
district courts with respect to pedicle screws alone. 

CONCLUSION 

The petition for writ of certiorari should be granted. 

Respectfully submitted. 

SETH P. WAXMAN 

Solicitor General 

DAVID W. OGDEN 

Acting Assistant Attorney 

General 

EDWIN S. KNEEDLER 

Deputy Solicitor General 

DOUGLAS N. LETTER 
KATHLEEN MORIARTY MUELLER 
JOCELYN E. STRAUBER 

Attorneys 

JUNE 2000 

question * * * and that plaintiffs[] relied on the FDA’s assessment as to 
the drugs’ safety in choosing to use the drugs”); see also Connelly v. Iolab 
Corp., 927 S.W.2d 848, 855 (Mo. 1996), cert. dismissed, 520 U.S. 1260 
(1997); Green v. Dolsky, 685 A.2d 110, 117 n.7 (Pa. 1996), cert. denied, 520 
U.S. 1168, 1212 (1997). But cf. Sebago, Inc. v. Beazer East, Inc., 18 F. 
Supp. 2d 70, 86-88 (D. Mass 1998).