US Supreme Court Briefs

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 theFood and Drug Administration during the regulatory process for marketingclearance applicable to certain medical devices.



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 SolicitorGeneral to file a brief expressing the views of the United States.

STATEMENT

Respondents claim that they suffered injuries from the implantation of orthopedicbone screws into the pedicles of their spines. They allege that petitionerfraudulently obtained regulatory clearance for the manufacturer to marketthe pedicle screws by misrepresenting to the Food and Drug Administration(FDA) that the screws were "intended for use in appropriate fracturesof long bones of both the upper and lower extremity and such other flatbones," even though, respondents contend, the screws were designedand sold "exclusively for use in the spine." Pet. App. 8a. Thequestion presented is whether, as petitioner contends, that claim of "fraudon 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. TheMedical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539,supplemented the FDCA's original provisions by creating a federal programto enhance "the safety and effectiveness of medical devices intendedfor 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 specifiedreview, clearance, approval, and other regulatory activities with respectto medical "devices," which include instruments, implants, andsimilar articles that are intended for use in the treatment, mitigationor 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, basedon the degree of regulation it concludes is necessary to provide reasonableassurance 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 thosethat present "a potential unreasonable risk of illness or injury."21 U.S.C. 360c(a)(1)(C). The makers of Class III devices are subject toa 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, themanufacturer must submit detailed information to provide the FDA with reasonableassurance that the device is safe and effective for its intended use. 21U.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, requiresthe submission of a PMA. 21 U.S.C. 360e(b)(1)(A). In the interest of fairnessand to prevent the "grandfathered" manufacturers from monopolizingthe market, the FDA also permits other manufacturers to distribute similardevices by showing (through a premarket notification process) that theyare "substantially equivalent" to the grandfathered devices. 21U.S.C. 360e(b)(1)(B). That procedure is known as the "Section 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 systemat issue in this case, the FDA had not yet classified that device. The FDAsubsequently classified and reclassified pedicle screw spinal systems intendedfor certain uses as Class II devices, subject to special controls. See 63Fed. Reg. 40,025 (1998); 21 C.F.R. 888.3070(a); pp. 13-14, infra. Pediclescrew 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 politicalsubdivision of a State may establish or continue in effect with respectto a device intended for human use any requirement-

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

(2) which relates to the safety or effectiveness of the device or to anyother matter included in a requirement applicable to the device under thischapter.

See also 21 U.S.C. 360k(b) (permitting FDA to grant exemptions 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 designed, built, and manufactured. The FDAhad cleared the pacemaker, a Class III medical device, for distributionunder Section 510(k) on the ground that it was "substantially equivalent"to a pre-MDA device. Medtronic, the manufacturer, contended that Section360k 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 thusdid not preempt plaintiffs' design defect claims-because the FDA's clearancedid not "require" the pacemaker "to take any particular formfor any particular reason." 518 U.S. at 493; accord id. at 513 (O'Connor,J., concurring in part and dissenting in part) (Section 510(k) process "placesno 'requirements' on a device" and therefore does not preempt designdefect claims). The Court next held that Section 360k did not preempt state-lawclaims in which the duty of care was based on FDA requirements, becausethose claims did not subject Medtronic to state-law requirements that were"different from, or in addition to," the federal requirements.Id. at 495. The Court noted that the FDA's interpretive regulations "expresslysupport the conclusion that § 360k 'does not preempt State or localrequirements that are equal to, or substantially identical to, requirementsimposed 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 manufacturing and labeling medical devices. Id. at 497. It concluded,however, that Section 360k does not mandate preemption of state-law requirementswith respect to a device unless, as suggested in FDA regulations interpretingSection 360k, the FDA has adopted specific counterpart regulations or otherspecific substantive requirements applicable to the particular device. Id.at 498-500 (citing 21 C.F.R. 808.1(d) (1995)). The Court therefore concludedthat the "entirely generic" federal manufacturing and labelingrequirements did not provide a basis for preemption of the general statecommon law duties at issue in that case. Id. at 501; see also id. at 505-507 (Breyer, J., concurring in part and concurring in judgment). In hisseparate opinion, Justice Breyer, agreeing with Justice O'Connor's opinionfor four Justices (see id. at 509-512), concluded that, ordinarily, insofaras 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 standardof care imposed by state tort law, id. at 503-505; but he concurred in theCourt's holding that the federal manufacturing and labeling requirementswere not sufficiently "specific" to trigger preemption, id. at505-508.2

2. Petitioner, a regulatory consultant, was retained by the AcroMed Corporation,a medical device manufacturer, to act as its liaison to the FDA. In September1984, petitioner, on behalf of AcroMed, made a submission for Section 510(k)marketing clearance for an orthopedic bone screw device known as the VariableScrew Placement (VSP) Spinal Plate Fixation System. Petitioner's submissionstated that AcroMed intended to market the device for use in spinal surgery.The FDA denied the request, finding that the VSP device was a Class IIIdevice and was not substantially equivalent to any predicate device marketedbefore the MDA's enactment. In September 1985, petitioner filed a secondsubmission for marketing clearance, again stating that the device was intendedfor use in spinal surgery. The FDA again denied the submission on the groundthat the device was not substantially equivalent to any predicate deviceand that it posed potential risks not exhibited by other spinal-fixationsystems. Pet. App. 4a-5a.

In December 1985, petitioner and AcroMed made a different attempt to obtainmarketing clearance through the Section 510(k) process. They split the VSPdevice into its two component parts, which they called "nested boneplates" and "cancellous bone screws," and they filed separateSection 510(k) submissions for each component. Those submissions statedthat the devices were intended to be used in long bones of the arms andlegs. After reviewing the submissions, an FDA official contacted petitionerfor additional information about the intended use of the device. Petitionerresponded that "[t]he proposed indications for use for the AcroMeddevice are the same general indications proposed for the AO system of plates[which were marketed before the MDA's enactment] . . . [and] are intendedfor use in appropriate fractures of long bones of both the upper and lowerextremity and such other flat bones (as in the fractured pelvis)."C.A. App. A58. In February 1986, the FDA granted marketing clearance forAcroMed's bone plates and screws for this stated purpose. Pet. App. 5a.

3. a. Respondents are some of the more than 5000 plaintiffs who filed suitsalleging that they were injured when their doctors inserted the assembledVSP device into their spines. More than 2300 individual suits were broughtagainst multiple defendants, and those suits were consolidated for pre-trialproceedings in the Eastern District of Pennsylvania pursuant to the multi-districtlitigation 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 "fraudon the FDA." Pet. App. 5a. That count asserts that petitioner "intentionallyand falsely" told the FDA that the AcroMed bone plates and screws wereintended for use in fractures of long bones, when, in reality, the "soleintended use of these components was as an assembled [VSP] spinal plate/pediclescrew fixation system." C.A. App. A57, A58. Respondents allege thatAcroMed designed the devices to be used exclusively in the spine and thatpetitioner "sought approval of [the] VSP plates and screws for usein the long bones simply as a pretext in order to market the device forits true intended use in the spine." Id. at A58. Respondents furtherallege that the FDA did not know that the bone plates and screws "wereintended by AcroMed to be used as pedicle screw fixation devices,"and that if petitioner had not made false statements about their intendeduse, the FDA would not have cleared the devices for marketing, the deviceswould not have been sold, and respondents thus would not have been harmedby 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.3d1316, 1329, cert. denied, 516 U.S. 815 (1995), the district court reasonedthat Section 360k "does not permit courts to 'perform the same functioninitially entrusted to the FDA,'" Pet. App. 49a, and that the FDA isin 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 (quotingReeves v. AcroMed Corp., 44 F.3d 300, 306 (5th Cir.), cert. denied, 515U.S. 1104 (1995)).

After this Court decided Medtronic, respondents asked the district courtto reinstate their "fraud on the FDA" claims. Pet. App. 7a. Althoughthe court indicated that this Court's decision in Medtronic foreclosed afinding of express preemption under Section 360k, id. at 40a, it neverthelessdismissed respondents' claims on the grounds that they improperly asserta private right of action for violation of the MDA and that the target ofthe alleged fraud was the FDA, not respondents. Id. at 36a-40a. In the alternative,the court dismissed the claims because "the alleged fraud * * * cannotbe said to have been a proximate cause of [respondents'] alleged injuries."Id. at 41a.

b. A divided panel of the court of appeals reversed. Pet. App. 1a-32a. Thecourt held that Section 360k does not expressly preempt the claims, becausethere is neither a federal "requirement" "applicable to thedevice" nor a state "requirement" "with respect to"that device. Id. at 13a. Moreover, the court reasoned, the "state commonlaw relied upon [by respondents] does not impose any obligation on [petitioner]inconsistent with federal law," because it is a crime to make a falsestatement to a federal agency, see 18 U.S.C. 1001 (1994 & Supp. IV 1998),and because FDA regulations require those who seek FDA clearance of devicesunder Section 510(k) to vouch for the truthfulness and accuracy of theirsubmissions. Pet. App. 13a; see note 5, infra.

The court of appeals also rejected the district court's conclusion thatthe "fraud on the FDA" claims constitute an impermissible attemptto 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 reasoningin Michael, the court found such reasoning inconsistent with this Court'sintervening decision in Medtronic. Id. at 16a. The court therefore disagreedwith 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 SeventhCircuit 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 todismiss the claims for the additional reason that they fail to allege asufficient causal connection between the asserted fraud and respondents'injuries. Pet. App. 19a-21a. Because neither the parties nor the districtcourt had analyzed the choice-of-law issues raised by the complaint or discussedthe law of any particular jurisdiction that would govern the causation elementof such a claim, the court of appeals found it impossible to determine whetherrespondents "have or have not alleged a legally sufficient causal nexus."Id. at 21a.

Judge Cowen dissented. Pet. App. 25a-32a. He expressed concern that "recognizinga state cause of action for violations of FDA regulations will greatly distortthe penalty scheme established by the statute," because the "penaltiesattached to a violation of the FDA's regulations will often be substantiallyincreased, and enforcement of violations will no longer be controlled bythe FDA's prosecutorial discretion." Id. at 28a.3

DISCUSSION

As petitioner correctly contends, the decision below squarely presents atleast one issue that has divided the lower courts: whether federal law preemptsa state-law cause of action based on a defendant's alleged fraud on theFDA during the regulatory process for marketing clearance applicable tocertain medical devices. That issue is important, and this Court shouldgrant certiorari to resolve it.

1. On the merits, we agree with petitioner that respondents' "fraudon the FDA" claim is foreclosed by federal law, but we disagree onwhy that is so.

a. Contrary to petitioner's contention (Pet. 26-27), the court of appealswas correct in holding that the claim is not expressly preempted by Section360k. As a general matter, a defendant claiming preemption under Section360k must show, at a minimum, that the application of state law would imposeobligations in addition to or different from "specific counterpartregulations" or a federal requirement that is "specific"to a "particular device." Medtronic, 518 U.S. at 500 (internalquotation marks omitted); accord id. at 506-507 (opinion of Breyer, J.).

Petitioner has identified no such specific federal requirement applicablehere. It contends instead that respondents' claim is preempted because it"would threaten to impose liability for failing to disclose in the510(k) process information that the FDA itself does not require." Pet.Reply Br. 10. But the federal requirement that petitioner argues would beimpermissibly supplemented by respondents' state law theory of liability-therequirement that the person making a Section 510(k) submission identifythe device's "intended use"-applies to such devices generally;it does not impose a requirement specifically with respect to the VSP devicethat 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 (opinionof Breyer, J.). For that reason, even if (as petitioner contends) respondents'claim depends upon the existence of a state-law duty to provide the FDAwith information about intended or "off-label" uses in additionto the information that federal law requires to be disclosed, that claimwould not be expressly preempted, because the federal duty of disclosureis insufficiently device-specific to trigger preemption under Section 360k.4

In any event, even if the general duty to provide truthful information tothe FDA about a product's "intended use" were device-specificenough to preempt state-law duties to provide additional information, respondents'claim still might not fall within the scope of Section 360k, because, onthe present record, it is not clear that the asserted state common law dutyon 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 inpart). Petitioner argues that those state and federal duties are in factdifferent. Petitioner reasons that it did disclose the "intended use"of the device at issue-which petitioner appears to equate with whateveruse is stated in the device's labeling (Pet. 27)- and that any liabilitymust therefore rest on a violation of a further duty under state law todisclose any foreseeable off-label uses and any plans to market the devicefor those uses. See ibid.; Pharmaceutical Research and Manufacturers ofAmerica (PhRMA) Br. at 10-11.

That argument is unavailing, at least at this stage of the litigation. Asthe court of appeals recognized (Pet. App. 23a-24a), respondents' theoryof liability does not appear to be that petitioner and its clients obtaineda Section 510(k) clearance for one bona fide intended use while failingto disclose a foreseeable off-label use. Nor, in the claim at issue here,do respondents seek to hold petitioner liable for giving a physician informationabout an off-label use that was not identified 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'sbone plates and screws were never meant to be used at all for the intendeduse set forth in the Section 510(k) submissions; instead, respondents contend,the ostensible intended use was merely a pretext to get the device on themarket, where it would be used exclusively for other (uncleared) uses. SeePet. App. 23a-24a; C.A. App. A57, A58.

Under the FDA's regulations, the "intended use" of a medical deviceis defined by the "objective intent of the persons legally responsiblefor the labeling of [the] device[]." 21 C.F.R. 801.4. That objectiveintent may be determined by (for example) labeling claims, advertising materials,written or oral statements, or the circumstances in which the device isoffered and used. Ibid.; see also 21 C.F.R. 801.5. The complaints in thiscase allege that the devices at issue were meant solely for use in the spine,and that petitioner's representation to the FDA that the devices were intendedfor use in long bones was therefore false and misleading. C.A. App. A57,A58. Because that factual allegation has not been fleshed out in proceedingsin the various district courts, it is impossible on the present record tosay that any duty under state law would be "different from, or in additionto," applicable duties under federal law.5

That is not to say that any representation to the FDA about a device's intendeduse must disclose every foreseeable use of the device. Physicians oftenemploy medical devices for uses that are not identified in the labeling,and manufacturers may seek Section 510(k) clearance for the use identifiedin the labeling without setting forth every possible off-label use to whichthe 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 fideuse of the device; it cannot be a mere pretext calculated to clear the devicefor distribution exclusively for other uses.6

b. The present record also provides little support for petitioner's alternativecontention (Pet. 27-29) that respondents' claim would "conflict"with the FDA's 1998 decision to classify and reclassify pedicle screw spinalsystems for certain uses as Class II devices.7 The FDA's classificationand reclassification decision-which occurred long after the underlying eventsat 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. Thatdecision operates prospectively and does not legitimize conduct that waspreviously impermissible. Id. at 40,037-40,038. Moreover, the FDA classifiedand reclassified pedicle screw spinal systems as Class II devices only forcertain spinal uses, and it imposed four "special controls" requiringthat the devices' labeling contain a special warning and that they complywith material standards, mechanical testing standards of performance, andbiocompatibility standards. See id. at 40,027, 40,034-40,038. The samplecomplaint relied on by the court of appeals does not indicate whether AcroMed'sdevices were marketed for the uses for which the devices are now classifiedas Class II or whether their manufacture and composition were consistentwith 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 establishedthat 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 principles do preclude respondents'"fraud on the FDA" claim.

Respondents' claim is quite peculiar. It is independent of any claim againstthe manufacturer of the device in question, and it apparently does not dependon any showing that the device was somehow defective, or falsely advertised,under state law. See Pet. App. 8a-9a. Instead, respondents simply contendthat, but for petitioner's alleged misrepresentations to the FDA, the agencywould not have cleared the device for marketing, the device would not havebeen 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 provisionsof state law that might apply directly to the device or to its manufacturingand distribution, but rather solely on the character of the relationshipbetween petitioner and the federal government. Absent a contrary directionby Congress, that relationship is, as a general matter, governed by federalnot state law.

In the typical preemption context, when Congress legislates "in a fieldwhich the States have traditionally occupied," preemption analysisbegins "with the assumption that the historic police powers of theStates were not to be superseded by the Federal Act unless that was theclear and manifest purpose of Congress." Medtronic, 518 U.S. at 485(quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). Thecommon law duties at issue in Medtronic, concerning the manufacture anddistribution of a device that was allegedly defective under state law, fellsquarely within such a field. By contrast, the field of relationships betweenthe federal government and persons who are subject to regulation by it-and,more particularly, the field of submissions made by such persons to a federalagency-is not one "which the States have traditionally occupied."Ibid. Like issues concerning the relationship of the United States withits contractors and employees, the duties of persons in connection withtheir submission of applications to a federal agency for benefits or regulatoryapproval involve "uniquely federal interests" that "warran[t]the displacement of state law." See Boyle v. United Techs. Corp., 487U.S. 500, 504-505 (1988). Those "uniquely federal interests" remainpredominant when questions concerning that relationship are raised, as here,in private civil litigation. Compare id. at 506-507. Thus, duties concerningthe submission of information to a federal agency are, at least as a generalmatter, appropriately defined and enforced by the federal government. Seealso Pennsylvania v. Nelson, 350 U.S. 497, 505 (1956) (state laws criminalizingsedition against the United States, the subject of federal legislation,are preempted because sedition is "not a local offense," but isa "crime against the Nation," and thus "prosecutions shouldbe exclusively within the control of the Federal Government") (internalquotations 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 lawcompletely occupies the field of submissions made by or on behalf of regulatedparties to a federal agency, either generally or specifically with respectto the FDA. That is so because the premise of respondents' state-law causeof action is that particular agency action should not and would not havebeen taken by a federal agency, and that damages should be awarded as ifthe conduct of petitioner that the FDA had cleared under the FDCA-introducingthe product onto the market-was unlawful under the FDCA. A state court maynot decline to give effect to an FDA decision that has not been rescindedby 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 governmenthas a significant interest in the finality of its own administrative determinations,and under the Supremacy Clause those determinations should generally bequestioned 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 consequences. In theabsence 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 inquiriesinto their internal deliberations. For example, respondents assert, as necessaryelements of liability, that the FDA "was ignorant" of the trueintended use of the device in question; that the FDA "reli[ed]"on petitioner's misrepresentation about that intended use; and that theFDA "would not have issued § 510(k) clearances" for the device in the absence of petitioner'salleged fraud. Pet. App. 8a-9a.

In litigating those issues, the parties would undoubtedly seek discoveryfrom the FDA concerning agency officials' states of mind and the hypotheticalcourses of action that agency decisionmakers might have taken under variouscounterfactual scenarios. It is the position of the United States that itsemployees are immune from third-party subpoenas issued in private litigation,that testimony must be sought under an agency's Touhy regulations, see generallyUnited States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951), and that an agency'sdenial of a request for testimony by agency employees is subject to reviewonly under the "arbitrary and capricious" standard of the AdministrativeProcedure 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. NationalScience Found., 190 F.3d 269, 277-278 (4th Cir. 1999) (applying APA standard),with Exxon Shipping Co. v. United States Dep't of the Interior, 34 F.3d774, 778-780 (9th Cir. 1994) (agency must produce evidence in response tosubpoena, subject only to court's discretion to limit discovery under Fed.R. Civ. P. 26 and 45). And, in any event, widespread litigation could beexpected on whether testimony and other evidence could be secured from theFDA and other federal regulatory agencies in cases such as this; this multidistrictlitigation alone involves thousands of plaintiffs in more than 2000 casesthat could be tried in several dozen different judicial districts. The prospectof such intrusive inquiries and attendant litigation would pose a significantpotential for diverting an agency's resources and for distorting its internaldecisionmaking processes.8

Permitting state law suits for fraud on a federal agency could also distortthe behavior of regulated entities. If a regulated entity knows that a juryapplying the tort law of one of 50 States will play a central role in interpretingthe entity's duties to the federal government, that concern would causeit to alter its behavior in unpredictable ways that may well be inconsistentwith the efficient administration of the federal regulatory scheme.

2. The petition for certiorari should be granted. As the court of appealsacknowledged (Pet. App. 17a n.5), its decision squarely conflicts with Mitchellv. 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 process." Id. at 914;see also Lewis, 107 F.3d at 1505 (finding analogous fraud-on-the-agencyclaim preempted under Boat Safety Act). We agree with petitioner (see ReplyBr. 3-4) that the Seventh Circuit would be bound to follow that precedenttoday, even though the abbreviated analysis in Mitchell II placed some relianceon a prior Third Circuit decision overruled by the decision below. We alsoagree with petitioner (see Reply Br. 4 n.2) that the decision below squarelyconflicts with Mitchell II even though the latter decision involved thePMA process and this case involves the Section 510(k) process. Finally,we agree that the subject-matter of the conflict is sufficiently importantto warrant this Court's review; if other courts were to follow the ThirdCircuit's lead and permit state-law suits in this context, the result couldbe an unwelcome proliferation of similar claims asserting fraud on a varietyof federal agencies.

To be sure, this particlar case arrives here in an interlocutory posture.The court of appeals remanded respondents' individual claims for trial,at which it would be determined, among other things, whether "the statelaw of fraudulent misrepresentation applicable in one or more of these caseswould impose liability on [petitioner] in the circumstances alleged."Pet. App. 25a. Because the court of appeals "d[id] not hold that anyof the plaintiffs have stated a claim under state law upon which reliefcould 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 mightwell be cognizable under the law of at least some States.9 In our view,this Court therefore should grant certiorari now to decide whether suchclaims are foreclosed by federal law, rather than after years of what isvery likely to be burdensome litigation under this and other federal statutoryschemes-including numerous individual cases in numerous district courtswith 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


1 Class I devices are those that present no unreasonable risk of illnessor injury and are subject to only minimal regulation through "generalcontrols." 21 U.S.C. 360c(a)(1)(A). Devices that are potentially harmfulare Class II devices; they may be marketed without advance approval, butmanufacturers must comply with federal standards known as "specialcontrols." 21 U.S.C. 360c(a)(1)(B). See Medtronic, 518 U.S. at 476-477.

2 As we informed the Court in a response to the Court's invitation in asubsequent case presenting preemption issues under the MDA, in 1997 theFDA proposed an interpretive rule to give further guidance on the meaningof 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 rulewould have expressly construed Section 360k, consistent with the opinionsin Medtronic, to preempt a common law duty only when (1) the FDA has imposed,by regulation or order, a specific substantive requirement applicable toa particular medical device, and (2) state common law imposes a substantiverequirement applicable to the same medical device that is different from,or in addition to, the FDA's counterpart requirement. 96-1405 U.S. Br. App.9a-15a, 17a-18a. After further consideration, the FDA withdrew that proposedrule. See 63 Fed. Reg. at 39,789. That withdrawal has no bearing on thepreemption question presented here, and the interpretation of Section 360kin this brief is consistent with the interpretation in the proposed ruleand in our brief in Smiths Industries.

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

4 Petitioner argues that this case implicates a conflict concerning a separateissue: whether Medtronic exempts from express preemption all state requirementsthat 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 thatis made applicable to a device through a State's common law of torts ifthat requirement is different from, or in addition to, a specific requirementimposed by the FDA. See Medtronic, 518 U.S. at 503-505 (opinion of Breyer,J.); id. at 509-512 (O'Connor, J., concurring in part and dissenting inpart). See note 2, supra. Although we agree that the lower courts are dividedon that issue, this case would likely prove to be an inappropriate vehiclefor trying to resolve it. The cases underlying that conflict generally involveordinary product defect claims. As discussed in the text, Section 360k isinapplicable here for reasons independent of whether the application ofstate tort law is insufficiently specific to be preempted by that provision,and this Court would therefore probably find it unnecessary to resolve thelatter issue. As we discuss below, however, this case does implicate a separateconflict concerning whether federal law preempts state-law claims of fraudon a federal agency, and certiorari would be appropriate to resolve thatissue.

5 See 18 U.S.C. 1001 (1994 & Supp. IV 1998) (prohibiting false or fraudulentstatements on any matter within the jurisdiction of a federal agency); 21C.F.R. 807.87(k) (promulgated in 1992, see 57 Fed. Reg. 18,062, 18,064,18,066 (1992)) (requiring each person submitting premarket notificationto state that, "to the best of his or her knowledge," all "dataand information" are "truthful and accurate" and that "nomaterial fact has been omitted"); 21 C.F.R. 807.87(h) (1985) (requiring,during the period relevant here, that parties submitting premarket notificationmust provide the FDA with "[a]ny additional information regarding thedevice requested by the Commissioner that is necessary for the Commissionerto make a finding as to whether or not the device is substantially equivalentto a device in commercial distribution").

6 It is inaccurate to suggest, as petitioner does (Pet. 27; see also PhRMABr. 10-11 & n.6), that the FDA never inquires, and lacks authority toinquire, into off-label uses in connection with premarket notification submissionsunder Section 510(k). Although 1997 amendments to the FDCA confine FDA'sdetermination of the intended use of a device, for purposes of a Section510(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 labelingthat provides appropriate information regarding a use of the device notidentified in the proposed labeling" if the FDA determines "thatthere is a reasonable likelihood that the device will be used for an intendeduse not identified in the proposed labeling for the device," and "thatsuch 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 statutoryrequirement, it is important to note that it is not different from the mannerin which 510(k)s have traditionally been reviewed." Office of DeviceEvaluation, Center for Devices and Radiological Health, FDA, Determinationof Intended Use for 510(k) Devices-Guidance for Industry and CDRH Staff1 (Jan. 30, 1998).

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

8 We have pointed to similar concerns in suggesting, in response to theCourt's invitation in Armstrong Surgical Ctr. v. Armstrong Cty. Mem. Hosp.(No. 99-905), that there is reason for caution in fashioning any theoryof federal antitrust liability that would allow a plaintiff to recover damagesfrom a private defendant for competitive injuries most directly caused bystate administrative or adjudicatory action. 99-905 U.S. Br. at 16-18. Atthe same time, however, other circumstances counsel caution in concludingthat claims like that in Armstrong may never be meritorious: antitrust claimsare made within a well-developed legal framework, and are based on a federalstatute that specifically prohibits concerted private conduct in restraintof trade, quite apart from any involvement by government actors. Those circumstancesare not present in this case. Furthermore, antitrust cases, unlike thiscase, raise no question under the Supremacy Clause; and, unlike in thiscase, any conflict in the circuits on the question presented in Armstrongis not current or well-defined enough to require immediate review. See 99-905U.S. Br. at 14-16, 20.

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 onthe FAA's certification, then he has indirectly relied on Learjet's fraudulentmisrepresentations" 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 filecertain reports with the FDA, where, but for that negligence, the FDA "wouldhave required notice to the medical community" of certain drug risksand "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 actionfor fraud where "[p]laintiffs assert that the FDA relied on defendants'representations in permitting the distribution of the drugs in 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); Greenv. 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).

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