US Supreme Court Briefs

No. 98-1768

In the Supreme Court of the United States
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THE BUCKMAN COMPANY,
Petitioner,

v.

PLAINTIFFS' LEGAL COMMITTEE,
Respondent.
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On Writ of Certiorari to
the United States Court of Appeals
for the Third Circuit
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BRIEF FOR PETITIONER

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SCOTT BURESH             KENNETH S. GELLER     FRED FELLER                Counsel of Record     Buresh, Kaplan, Jang,  ALAN E. UNTEREINER        Feller & Austin        SHARON SWINGLE        2298 Durant Ave.         Mayer, Brown & Platt  Berkeley, CA 94704       1909 K Street, N.W.   (510) 548-7474           Washington, DC 20006                           (202) 263-3000      GEORGE P. NOEL                                   Noel & Hackett                                 P.O. Box 1590                                  Media, PA 19063                                (610) 892-7700                               
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QUESTION PRESENTED

Whether federal law preempts state-law tort claims allegingfraud on the Food and Drug Administration during the regulatoryprocess for marketing clearance applicable to certain medicaldevices.

(I)

ii

RULE 29.6 STATEMENT

Pursuant to Supreme Court Rule 29.6, petitioner states that ithas no parent company and that no publicly held company owns10% or more of its stock.

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TABLE OF CONTENTS

                                                          PageQUESTION PRESENTED ........................................  IRULE 29.6 STATEMENT ....................................... iiTABLE OF AUTHORITIES ......................................  vOPINIONS BELOW ............................................  1JURISDICTION ..............................................  1CONSTITUTIONAL AND STATUTORY  PROVISIONS INVOLVED .....................................  1STATEMENT .................................................  1  A. The Regulatory Structure Of The Medical Device     Amendments ...........................................  2  B. The FDA's Clearance Of AcroMed's Devices .............  4  C. The Proceedings In The District Court ................  6     1. Plaintiffs' "Fraud On The FDA" Allegations ........  6     2. The District Court's Decisions ....................  9  D. The Court Of Appeals' Decision ....................... 11  E. The FDA's Reclassification Proceeding ................ 12SUMMARY OF ARGUMENT ....................................... 13ARGUMENT .................................................. 14  I. PLAINTIFFS' "FRAUD ON THE FDA" CLAIM IS     EXPRESSLY PREEMPTED BECAUSE IT IMPOSES     STATE-LAW DISCLOSURE REQUIREMENTS     RELATING TO "INTENDED USE" THAT ARE     "DIFFERENT FROM, OR IN ADDITION TO" THE     DISCLOSURE REQUIREMENTS IMPOSED BY     FEDERAL LAW .......................................... 17

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TABLE OF CONTENTS -- Continued

Page A. Plaintiffs Seek To Impose Disclosure "Require- ments" That Are "Different From, Or In Addition To" The Disclosure "Requirements" Imposed By Federal Law ............................................... 18 B. The State "Requirements" Underlying Plaintiffs' Claim Qualify For Express Preemption Under Med- tronic ............................................ 25 C. The Counterpart Federal "Requirements"Involved In This Case Trigger Express Preemption Under Med- tronic ............................................ 27 II. PLAINTIFFS' "FRAUD ON THE FDA" CLAIM IS IMPLIEDLY PREEMPTED BECAUSE IT IS FLATLY INCONSISTENT WITH THE FEDERAL REGULATORY SCHEME..................................... 31 A. "Fraud On The Agency" Claims Conflict With Federal Agencies' Interest In Valid, Final, And Correct Decisionmaking ............................ 33 B. "Fraud On The Agency" Claims Conflict With The MDA Statutory Scheme .............................. 34 C. "Fraud On The Agency" Claims Interfere Substan- tially With Federal Government Operations ......... 40III. THE COURT SHOULD RECONSIDER ASPECTS OF MEDTRONIC THAT ERRONEOUSLY RESTRICT THE SCOPE OF EXPRESS PREEMPTION UNDER THE MDA .................................................. 45CONCLUSION ................................................ 50

v

TABLE OF AUTHORITIES

PageCases:Allis-Chalmers Corp. v. Lueck, 471 U.S. 202 (1985) ........ 36Arizona v. California, 283 U.S. 423 (1931) ................ 41Arkansas-Louisiana Gas Co. v. Hall, 453 U.S. 571 (1981).................................. 36, 43Bethlehem Steel Co. v. New York State Labor Relations Bd., 330 U.S. 767 (1947)................... 31, 33Boggs v. Boggs, 520 U.S. 833 (1997)........................ 33Boyle v. United Technologies Corp., 487 U.S. 500 (1988) .............................................. 31, 40Chicago & N.W. Transp. Co. v. Kalo Brick &Tile Co., 450 U.S. 311 (1981) ............................. 39Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992) .. 14-15Exxon Shipping Co. v. U.S. Dep't of Interior, 34 F.3d 774 (9th Cir. 1994) ............................. 43Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (1982) ..................................... 32Freightliner Corp. v. Myrick, 514 U.S. 280 (1995).......... 33Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88 (1992) ...................................... 36

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TABLE OF AUTHORITIES -- Continued

PageGarner v. Teamsters Local Union No. 776, 346 U.S. 485 (1953) ..................................... 38Geier v. American Honda Motor Co., 120 S. Ct. 1913 (2000) ......................................... 14, 33Hancock v. Train, 426 U.S. 167 (1976) ..................... 41Heckler v. Chaney, 470 U.S. 821 (1985) .................... 35Hines v. Davidowitz, 312 U.S. 52 (1941) ................... 31Hohn v. United States, 524 U.S. 236 (1998)................. 46Howard v. Lyons, 360 U.S. 593 (1959) ...................... 41International Paper Co. v. Ouellette, 479 U.S. 481 (1987) .............................................. 36Johnson v. Maryland, 254 U.S. 51 (1920) ................... 41Leslie Miller, Inc. v. Arkansas, 352 U.S. 187 (1956) ...... 33Lewis v. Brunswick Corp., 107 F.3d 1494 (11th Cir. 1997), cert. dismissed, 523 U.S. 1113 (1998) ............................ 33, 39, 40Mayo v. United States, 319 U.S. 441 (1943) ................ 41Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) .......... passimMerrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804 (1986) ........................... 36

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TABLE OF AUTHORITIES -- Continued

PageMichael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.), cert. denied, 516 U.S. 815 (1995)..................... 9, 10Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1998) .................................................. 26Monell v. New York City Dep't of Soc. Servs., 436 U.S. 658 (1978) ..................................... 46Morales v. Trans World Airlines, Inc., 504 U.S. 374 (1992) ........................................... 14, 49-50Nantahala Power & Light Co. v. Thornburg, 476 U.S. 953 (1986) ..................................... 39Ortho Pharm. Corp. v. Cosprophar, Inc., 32 F.3d 690 (2d Cir. 1994) .......................................... 4Papas v. Upjohn Co., 985 F.2d 516 (11th Cir.), cert. denied, 510 U.S. 913 (1993)........................ 40Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.), cert. denied, 522 U.S. 862 (1997)........................ 26Patterson v. McLean Credit Union, 491 U.S. 164 (1989) .............................................. 46Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41 (1987)......... 49San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236 (1959) ..................................... 49

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TABLE OF AUTHORITIES -- Continued

PageSchneidewind v. ANR Pipeline Co., 485 U.S. 293 (1988) .................................................. 39United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951) .............................................. 43United States v. Locke, 120 S. Ct. 1135 (2000) ............ 31Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973) ..................................... 35Welchert v. American Cyanamid, Inc., 59 F.3d 69 (8th Cir. 1995) ...................................... 39-40Wilson v. Bradlees of New England, Inc., 96 F.3d 552 (1st Cir. 1996), cert. denied, 519 U.S. 1149 (1997)...... 46Constitutional Provision, Statutes,Regulations, and Rules:U.S. CONST. art. VI, cl. 2................................. 17 U.S.C. § 136v(b) ........................................ 3915 U.S.C. § 1203(a) ....................................... 3915 U.S.C. § 1261 note (b)(1)(A) ........................... 3915 U.S.C. § 1392(d) ....................................... 3915 U.S.C. § 1476(a) ....................................... 3915 U.S.C. § 1075(a) ....................................... 39

ix

TABLE OF AUTHORITIES -- Continued

Page18 U.S.C. § 1001 .......................................... 2821 U.S.C. § 331(a)......................................... 2021 U.S.C. § 336............................................ 3521 U.S.C. § 337(a)......................................... 3521 U.S.C. § 337(b) ........................................ 3621 U.S.C. § 355(d)(1) ..................................... 2221 U.S.C. § 360(k) ........................................ 321 U.S.C. § 360c(a)(1)(A).................................. 221 U.S.C. § 360c(a)(1)(B).................................. 221 U.S.C. § 360c(a)(1)(C).................................. 221 U.S.C. § 360c(a)(2)(B).................................. 2221 U.S.C. § 360c(f)(1)..................................... 321 U.S.C. § 360c(f)(1)(B) ................................. 321 U.S.C. § 360c(i)(1)(A) .............................. 3, 2321 U.S.C. § 360c(i)(1)(D) ................................. 4221 U.S.C. § 360c(i)(1)(E)(i)............................... 2121 U.S.C. § 360e .......................................... 3

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TABLE OF AUTHORITIES -- Continued

Page21 U.S.C. § 360e(a)......................................... 321 U.S.C. § 360e(b)(1)(B)............................... 3, 1921 U.S.C. § 360i........................................... 4121 U.S.C. § 360k(a) ................................... passim21 U.S.C. § 360k(b).................................... 17, 4721 U.S.C. § 360l........................................... 4121 U.S.C. § 360ll.......................................... 4121 U.S.C. § 360nn.......................................... 4121 U.S.C. § 360ss ......................................... 3921 U.S.C. § 371(a)......................................... 3521 U.S.C. § 371(h) ........................................ 3521 U.S.C. § 393............................................ 3521 U.S.C. § 396..................................... 4, 20, 4228 U.S.C. § 1254(1)......................................... 146 U.S.C. § 4306........................................... 3949 U.S.C. App. § 1305(a)(1) ............................... 4921 CAL. HEALTH & SAFETY CODE § 26463(m) (1984) .................................................. 47

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TABLE OF AUTHORITIES -- Continued

Page21 C.F.R. § 10.25(a) ...................................... 3621 C.F.R. § 10.25(b) ...................................... 3521 C.F.R. § 10.30(e) ...................................... 3621 C.F.R. § 20.1 .......................................... 4321 C.F.R. § 20.2 .......................................... 4321 C.F.R. § 801.4 ..................................... 23, 2421 C.F.R. Part 803 ........................................ 4121 C.F.R. Part 804 ........................................ 4121 C.F.R. Part 806 ........................................ 4121 C.F.R. § 807.87 (1986)................................ 3, 721 C.F.R. § 807.87 (1999)............................... 3, 2321 C.F.R. § 807.87(e) (1986, 1989)..................... 25, 2921 C.F.R. § 807.87(h) (1986)........................ 3, 27, 2921 C.F.R. § 807.87(j)...................................... 2821 C.F.R. § 807.87(l)....................................... 321 C.F.R. § 807.100(b)(1).................................. 2321 C.F.R. § 808.1(d) .......................... 17, 25, 29, 48

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TABLE OF AUTHORITIES -- Continued

Page21 C.F.R. § 808.1(d)(1).................................... 2721 C.F.R. § 808.1(d)(2).................................... 1921 C.F.R. § 808.55(b)(1)................................... 4721 C.F.R. § 808.55(b)(2)................................... 4721 C.F.R. Part 820 Subpart M ...............................4121 C.F.R. Part 821 .........................................41FED. R. CIV. P. 9(b) .......................................26FED. R. CIV. P. 54(b) ......................................10Miscellaneous:Callahan, The Process of FDA Approval of a Spinal Implant: Governmental Perspective, 2 J. SPINAL DISORDERS 288 (1989) .................................... 22Center for Devices and Radiological Health, Food & Drug Admin., Premarket Notification Review Program, 510(k) Memorandum #86-3 (June 30, 1986) (reprinted at <http://www.fda.gov/cdrh/ k863.html>) ............................................. 22Comments by Plaintiffs' Legal Committee in In re Orthopedic Bone Screw Prods. Liab. Litig., FDA Dkt. No. 95N-0176 (filed March 1, 1996) ................. 12

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TABLE OF AUTHORITIES -- Continued

PageFDA Oversight: Medical Devices: Hearing before the Subcomm. on Oversight and Investigations of House Comm. on Energy & Commerce, 97th Cong., 2d Sess. (1982) ............................. 34FOOD & DRUG ADMIN., REPORT OF THE HALCION TASK FORCE (1996) ............................... 39FOOD & DRUG ADMIN., UPDATE ON PEDICLE SCREWS (1993) ................................................ 4, 6H.R. REP. NO. 94-853 (1976)............................ passimMore Information for Better Patient Care: Hearings on S. 1477 Before the Senate Comm. on Labor and Human Resources, 104th Cong. (1996) ................. 42Nightingale, Unlabeled Uses of Approved Drugs, 26 DRUG INFO. J. 141 (1992) ...................... 4, 20, 23Pedicle Screws, 24 FED. MED. BULL. 10 (May 1994) .......... 20Sherman, Use of Federal Statutes in State Negligence Per Se Actions, 13 WHITTIER L. REV. 831 (1992)........... 36S. REP. NO. 105-43 (1997).................................. 21U.S. Dep't of Health & Human Servs., Food & Drug Admin., Office of Device Evaluation, Center for Devices and Radiological Health, Determination of Intended Use for 510(k) Devices -- Guidance for Industry and CDRH Staff (Jan. 30, 1998) ................................ 21-22

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TABLE OF AUTHORITIES -- Continued

PageUse of Approved Drugs for Unlabeled Indications, 12 FDA DRUG BULL. 4 (April 1982) ......................... 426A C. WRIGHT & K. GRAHAM, FEDERAL PRACTICE & PROCEDURE (1992) ........................................ 4337 Fed. Reg. 16503 (1972) ................................. 2041 Fed. Reg. 37457 (1976) ................................. 3542 Fed. Reg. 30383 (1977) ................................. 4843 Fed. Reg. 18661 (1978).............................. 30, 4844 Fed. Reg. 19440 (1979) ................................. 4745 Fed. Reg. 67321 (1980).......................... 30, 47, 4855 Fed. Reg. 52323 (1990) ................................. 3556 Fed. Reg. 46191 (1991) ................................. 3557 Fed. Reg. 18062 (1992) ................................. 2260 Fed. Reg. 51946 (1995) .............................. 6, 1263 Fed. Reg. 40025 (1998) ................................. 1263 Fed. Reg. 64556 (1998) ................................. 2265 Fed. Reg. 44540 (2000) ................................. 42

BRIEF FOR PETITIONER

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OPINIONS BELOW

The court of appeals' opinion (Pet. App. 1a-32a) is reported at159 F.3d 817. The opinion of the district court (Pet. App. 33a-44a),which was incorporated in the order granting petitioner's motionfor dismissal (Pet. App. 45a), is unreported. The original opinion ofthe district court (Pet. App. 46a-53a) is also unreported.

JURISDICTION

The judgment of the court of appealswas entered on November19, 1998, and a timely petition for rehearing was denied onFebruary 3, 1999 (Pet. App. 57a-58a). The petition for a writ ofcertiorari was filed on May 3, 1999, and was granted on June 29,2000. This Court has jurisdiction under 28 U.S.C. § 1254(1).

CONSTITUTIONAL AND STATUTORY
PROVISIONS INVOLVED

The Supremacy Clause of the Constitution provides in relevantpart: "[T]he Laws of the United States * * * shall be the supremeLaw of the Land * * * any Thing in the Constitution or Laws ofany State to the Contrary notwithstanding." U.S.CONST. art. VI, cl.2.

The relevant provision of the Medical Device Amendments of1976 to the Federal Food, Drug and Cosmetic Act, 21 U.S.C.§ 360k(a), is reproduced at Pet. App. 59a.

STATEMENT

This case raises important questions concerning the preemptivescope of the Medical Device Amendments (MDA), the meaning ofthis Court's fractured decision in Medtronic, Inc. v. Lohr, 518 U.S.470 (1996), and the validity of efforts by litigants to circumventCongress's expresspreemption commands through state tort claimsasserting that federal administrative determinations should be

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disregarded because they were the product of "fraud on theagency."

A. The Regulatory Structure Of The Medical DeviceAmendments

In 1976, Congress enacted the MDA, which vastly expandedthe authority of the Food and Drug Administration (FDA) toregulate medical devices. At the same time that it established acomprehensive regulatory regime at the federal level, Congresssought to protect innovations in device technology from being"stifled by unnecessary restrictions." H.R. REP. NO. 94-853, at 12(1976). Specifically, Congress attempted to shield medical devicesfrom the "undu[e] burden[]" imposed by differing state regulationby including in the MDA a "general prohibition on non-Federalregulation." Id. at 45. That general prohibition, which also servesto safeguard the uniformity of the federal regulatory scheme,broadly provides that no State may impose "any requirement"relating to the safety or effectiveness of a medical device that "isdifferent from, or in addition to, any requirement applicable* * * tothe device" under federal law. 21 U.S.C. § 360k(a).

The MDA divides medical devices into three classificationsbased on the possible risks of harm. Devices such as tonguedepressors, which present little likelihood of illness or injury, aredesignated as Class I and subjected only to minimal regulation, or"general controls." 21 U.S.C. § 360c(a)(1)(A). Potentially moredangerous devices, such as tampons, are designated as Class II;they face increased regulation in the form of "special controls,"such as performance standards, imposed by the FDA. Id.§ 360c(a)(1)(B). The FDA designates as Class III those devices thateither (1) are "purported or represented to be for a use in supportingor sustaining human life or for a use which is of substantialimportance in preventing impairment of human health," or(2) "present[] a potential unreasonablerisk of illness or injury." Id.§ 360c(a)(1)(C). All post-1976 devices that are not "substantiallyequivalent" to a pre-1976 device initially are automatically consid-

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ered Class III devices and cannot be marketed without FDAclearance or approval. Id. §§ 360e(a), 360c(f)(1).

Except for certain exempt devices, manufacturers must obtainpermission to market post-1976 devices in one of two ways. First,for certain Class III devices, the FDA may grant approval after athorough premarket approval (PMA) process, in which themanufacturer must present the FDA with "reasonable assurance"that the device is both safe and effective. 21 U.S.C. § 360e. Second,for all other devices, to allow competition with "grandfathered"devices that were on the market in 1976 when the MDA tookeffect, the FDA may permit marketing of a new device if themanufacturer submits a "premarket notification" showing that thedevice is "substantially equivalent" to a pre-1976 device. Id.§§ 360e(b)(1)(B), 360(k), 360c(f)(1)(B). The "premarketnotification" route is often referred to as the "510(k)" process, afterthe section number in the original Act. See Medtronic, 518 U.S. at478.

The FDA has established detailed requirementsfor manufactur-ers' 510(k) notifications. See 21 C.F.R. § 807.87 (1999, 1986).Manufacturers must submit "[p]roposed labels, labeling, andadvertisement sufficient to describe the device, its intended use, andthe directions for its use"; supporting information; comparisonswith currently distributed devices; and data showing the effect onsafety and effectiveness of any significant changes from the pre-1976 device. Ibid. Manufacturers are also required to provide"[a]ny additional information regarding the device requested by theCommissioner that is necessary * * * to make a finding as towhether or not the device is substantially equivalent to a device incommercial distribution." 21 C.F.R. § 807.87(l); id. § 807.87(h)(1986). Substantial equivalence under Section 510(k) requires thata device "ha[ve] the same intended use as the predicate device." 21U.S.C. § 360c(i)(1)(A).

Once a device has been cleared for marketing under Section510(k), the manufacturer may not market or promote it for uses

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other than those specified in the FDA clearance. Physicians,however, remain free under federal law to employ the device forany purpose, including so-called "off-label uses." See OrthoPharm. Corp. v. Cosprophar, Inc., 32 F.3d 690, 692 (2d Cir. 1994).Not only has the FDA recognized the existence of off-label uses(which, as part of the practice of medicine, it cannot regulate, see21 U.S.C. § 396), it has also stated that off-label uses "may beappropriate and rational in certain circumstances, and may, in factreflect approaches * * * that have been extensively reported inmedical literature." Use of Unapproved Drugs for UnlabeledIndications, 12 FDA DRUG BULL. 4, 5 (April 1982). Indeed, FDAofficials have acknowledged that in certain circumstances"prescribing for off-label uses may be the very best medicalpractice." Nightingale, Unlabeled Uses of Approved Drugs, 26DRUG INFO. J. 141, 143 (1992) (FDA Assoc. Comm'r for HealthAffairs). Off-label uses of medical devices have "traditionallybeenregulated by the hospitals in which the physicians practice and notby the FDA." FOOD &DRUG ADMIN.,UPDATE ON PEDICLESCREWS(1993).

B. The FDA's Clearance Of AcroMed's Devices

Petitioner The Buckman Company (Buckman) is a regulatoryconsultant for medical device manufacturers, helping them navigateFDA procedures, plan regulatory strategy, and monitor clinicalinvestigations. In 1984, AcroMed Corporation hired Buckman asits liaison with the FDA in an effort to obtain marketing clearancefor its devices. Pet. App. 4a-5a. Buckman assisted AcroMed inobtaining clearance for the components of two orthopedic bonescrew systems: (1) the Variable Screw Placement Spinal PlateFixation System (VSP), and (2) the ISOLA Spine Fixation System(ISOLA).

1. The VSP System. In September 1984, Buckman, on behalf ofAcroMed, submitted a 510(k) clearance notification for the VSPSystem. The submission stated that AcroMed intended to marketthe VSP as a pedicle screw for use in spinal surgery. Pet. App. 5a.

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The FDA rejected Buckman's submission, finding that the VSPwas a Class III device not substantially equivalent to any pre-1976devices. A year later, AcroMed, through Buckman, submitted asecond 510(k) notification for the VSP, again indicating that thedevice would be labeled as a pedicle screw. The FDA rejected thissubmission as well. Ibid.

In December 1985, following a meeting with FDA officials,AcroMed and Buckman separated the VSP into its component parts-- the screw and the plate -- and sought 510(k) clearance for each.Pet. App. 5a; J.A. 46-57. These submissions, and subsequent corre-spondence from Buckman, identified the devices' intended use asin the arm and leg long bones, rather than in the spine. J.A. 51, 57-58. The FDA determined that the screw and plate were eachsubstantially similar to pre-1976 devices and cleared the productsfor marketing in February 1986. Pet. App. 5a; J.A. 59-62.1

2. The ISOLA System. AcroMed subsequently developed theISOLA System, which uses screws in conjunction with rods and,in some circumstances,hooks. J.A. 17-18. In June 1988, Buckman,on behalf of AcroMed, applied to the FDA for permission toinitiate clinical trials relating to use of the ISOLA in spinalapplications (as it had done with the VSP, see note 1, supra). J.A.18. Three months later, in September 1988, Buckman submittedthree separate 510(k) notifications for the screws, rods, and hooksthat made up the ISOLA System. Ibid. These submissions specifiedthat the devices, like their pre-1976 equivalents, had an intendeduse in locations other than the pedicles of the spine. Ibid. In Apriland May 1989, the FDA determined that the rods, hooks, andscrews were substantially equivalent to pre-1976 devices andcleared them for marketing. Id. at 19.

1 A month before the FDA granted these clearances, AcroMedapplied to the agency for an investigational device exemption (IDE)in order to conduct clinical trials on spinal use of the VSP System.J.A. 63-64. The FDA granted the IDE. J.A. 12, 17-18.

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In granting 510(k) clearance of the iliac screw used in theISOLA System, the FDA informed AcroMed that the device could"not be labeled or promoted for pedicular attachment to, or fixationof, the spine." J.A. 19. The FDA also required "all labeling" of thedevice to "prominently state that the screws * * * are intended forsacral/iliac attachment only" as well as to include the followingstatement: "WARNING -- THIS DEVICE HAS NOT BEENAPPROVED FOR PEDICULAR APPLICATION." Ibid.

Despite the limited nature of the FDA's clearances of Acro-Med's devices and similar products, "[i]n practice, surgeons oftenuse[d] orthopedic screws which FDA ha[d] cleared for otherpurposes * * * as pedicle screws." FOOD & DRUG ADMIN., UPDATEON PEDICLE SCREWS. Indeed, the FDA observed in 1995 that, sinceat least 1992, pedicle fixation with screws has been "considered tobe the standard of care by the surgical community." 60 Fed. Reg.51946, 51947 (1995). These uses, although widespread, were alloff-label, because the FDA did not clear the marketing of bonescrews with a labeled indication for use in spinal surgery untilJanuary 1995. Id. at 51947-51948.

C. The Proceedings In The District Court

After a national television program ran a story on alleged harmcaused by use of bone screws as spinal fixation devices, thousandsof plaintiffs filed state-law suits against doctors, hospitals,universi-ties, manufacturers, and regulatory consultants such as Buckman,alleging product defectsand fraud in the manufacturers' representa-tions to the FDA. The federal suits -- approximately 2,300 civilcases involving 5,041 plaintiffs and 334 defendants -- wereconsolidated in this multidistrict litigation. Pet. App. 55a.

1. Plaintiffs' "Fraud On The FDA" Allegations. Plaintiffs didnot contend that, in applying for 510(k) clearances, Buckman orAcroMed had misrepresented any objective fact, such as the size,shape, or technical characteristics of the screws, plates, rods orhooks, or their equivalence to pre-1976 devices. Rather, plaintiffs

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claimed that Buckman and AcroMed deceived the FDA as to the"intended uses" of the devices, representing that they would belabeled for long bones or other non-spinal applications whileplanning to market them for use in the spine. Pet. App. 6a; J.A. 15-19. In plaintiffs' view, the 510(k) clearances were the product offraud under state law and, but for such fraud, the devices wouldnever have come onto the market or been used in their pediclesurgeries. J.A. 21.

In addition to the statements concerning "intended use" in the510(k) submissions, plaintiffs premised their "fraud on the FDA"claim on a follow-up letter relating to the VSP bone plates thatBuckman sent in January 1986. J.A. 15-16. The letter was submit-ted in response to a telephone call from an FDA official indicatingthat there was a "need for a more definitive statement covering theintended 'indications for use' of the AcroMed Nested Bone Plate."J.A. 58. As required by the FDA's regulation (21 C.F.R. § 807.87(1986)), Buckman provided the agency with the informationrequested, stating (J.A. 58):

The proposed indications for use for the AcroMed device arethe same general indications proposed for the AO system ofplates. More specifically, (for purposes of this 510K), theAcroMed plates are intended for use in appropriate fractures oflong bones of both the upper and lower extremity and suchother flat bones (as in the fractured pelvis) that may from timeto time require stabilization with contourable metallic non-compressing plates.

In their complaint, plaintiffs also cited other evidence purporting toshow that Buckman and AcroMed possessed a subjective intentthat the bone screws and plates would be used by doctors in spinalapplications. J.A. 16-20.

In response to plaintiffs' "fraud on the FDA" allegations,Buckman contended that "intended use" is a term of art referring tothe use for which the manufacturer seeks FDA clearance, as

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determined by the indications for use claimed in the proposedlabeling for the device, and does not encompass the manufacturer'ssubjective hopes, desires or expectations about how physicians, inthe exercise of their independent medical judgment, might elect touse a device once it is on the market. Accordingly, Buckmanargued that plaintiffs' state-law claim was preempted by the MDA,because it would impose disclosure requirements regarding adevice's intended use that were "different from, or in addition to"(21 U.S.C. § 360k(a)) the disclosure requirements imposed byfederal law.

Indeed, Buckman pointed out that it was the FDA itself thatproposed, at the December 1985 meeting, that AcroMed separatethe VSP into its component parts -- the screw and the plate -- andseek 510(k) clearance for each. Buckman submitted a memoran-dum written by FDA official Dan McGunagle, who had attendedthe meeting, in which McGunagle recalled:

With the meeting at a stalemate I pointed out the FDA's longstanding policy of evaluating (for not only substantial equiva-lence but safety and effectiveness) a device based on thelabeling submitted for the device and the agreement betweenthe labeling and the device's physical abilities to perform as thelabeling claimed. I also pointed out that because of the physicaland mechanical similarities between the plates and (the originaldesign) screws of the system to ordinary bone plates andscrews these devices, when labeled, indicated and promoted assimple bone screws and plates would, in fact, be substantiallyequivalent to pre-Amendment[] devices and could be shippedin interstate commerce. * * * I pointed to the oft stated FDApolicy of not regulating the practice of medicine by individualphysicians. I said that if individual practitioners, on their ownwithout guidance from labeling or promotion by the manufac-

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turer, chose to use the plates and screws for spinal fixation thatwould fall under the practice of medicine and outside FDA'sauthority.

J.A. 136.

In addition, Buckman explained that there was no possibilitythat the FDA had been misled about AcroMed's subjective hopesor desires that the screws, plates, rods, and hooks in the VSP andISOLA Systems would be used by physicians in spinalapplications. With regard to the VSP System, AcroMed had twicesought FDA clearance for spinal use; spinal applications had beendiscussed again at the December 1985 meeting; and shortly beforethe component plates and screws of the VSP gained 510(k)authorization, the company had asked the FDA for permission tobegin clinical trials on the VSP System for spinal application. J.A.13-16, 135-137. As for the ISOLA System, AcroMed had requestedFDA approval to begin clinical trials concerning spinal use evenbefore filing 510(k) notifications for individual components of theSystem. J.A. 17-18. In clearing the iliac screw component, the FDAhad specifically directed the company to warn that it had "NOTBEEN APPROVED FOR PEDICULAR APPLICATION." J.A.19.

2. The District Court's Decisions. In March 1995, the districtcourt granted judgment on the pleadings on the "fraud on theagency" claim, holding that it was preempted both expressly by theMDA and impliedly by the federal scheme. Pet. App. 46a-53a. Thedistrict court explained that the MDA's express preemptionprovision "does not permit courts to 'perform the same functionsinitially entrusted to the FDA.'" Id. at 49a (quoting Michael v.Shiley, Inc., 46 F.3d 1316, 1329 (3d Cir.), cert. denied, 516 U.S.815 (1995)). Moreover, "[b]ecause the FDA possesses the properauthority to regulate this field, courts are prohibited fromconducting 'a searching state inquiry into the inner workings ofFDA procedures.'" Ibid. (quoting Michael, 46 F.3d at 1329); seealso Pet. App. 50a (reasoning that, "given the FDA's central role in

10

reviewing and approving devices * * * [the agency] is in the bestposition to decide whether [a manufacturer] withheld materialinformation from the agency and, if so, the appropriate sanction"(citation and internal quotation marks omitted)). Finally, the courtnoted that permitting "fraud on the agency" claims would beinconsistent with Congress's decision not to authorize a privateright of action under the Food, Drug and Cosmetic Act. Ibid.

Following this Court's Medtronic decision in 1996, plaintiffssought to revive their "fraud on the FDA" claim. Pet. App. 7a, 33a.Among other things, plaintiffs argued that their claim was notexpressly preempted under Medtronic because it was seeking toenforce state requirements that were "identical" to the federalrequirements and because the pertinent state and federal requirements relating to intended use disclosures were "general" in natureand thus not eligible for express preemption. Buckman respondedthat Medtronic did not involve a "fraud on the agency" claim andthus did not alter prior law in the Third Circuit (and in otherjurisdictions) holding that such claims are preempted.

In March 1997, the district court reaffirmed its ruling thatplaintiffs' "fraud on the agency" claim was preempted. Pet. App.33a-44a. The court agreed that Medtronic had undercut portions ofits previous analysis but held that the claim was still precludedbecause it was inconsistent with Congress's decision not to includea private right of action under federal law. Id. at 36a-37a. The courtadded that plaintiffs' claim was "not interchangeable" with theclaims at issue in Medtronic, which involved no allegation offraudulent procurement of agency clearance and therefore did notamount to a collateral attack on any agency decision. Id. at 40a.

Because "fraud on the FDA" was the sole claim against Buckman, the district court granted Buckman's motion for dismissal forfailure to state a claim on which relief could be granted (Pet. App.45a) and certified the dismissal as a final order under Rule 54(b) ofthe Federal Rules of Civil Procedure. Pet. App. 54a-56a.

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D. The Court Of Appeals' Decision

A panel of the Third Circuit reversed, over a "vehement[]"(Pet. App. 32a) dissent by Judge Cowen. It concluded that Med-tronic undermined the Third Circuit's previous holding in Michaelthat state "fraud on the FDA" claims are expressly and impliedlypreempted. Id. at 13a-17a & n.5.

The court of appeals' reasons for rejecting express preemptionwere set forth in a single paragraph. According to the majority, theMDA did not expressly preempt "fraud on the FDA" claimsbecause the 510(k) process does not establish any "federal'requirement'" that is "'applicableto the device' at issue here." Pet.App. 13a. In equally sweeping fashion, the majority broadlydeclared that plaintiffs' common law fraud claim does not imposeany "state 'requirement' 'with respect to' that device." Ibid.Finally, the majority reasoned that the state requirements plaintiffssought to enforce do not "impose any obligation on Buckman [thatis] inconsistent with federal law," because federal law prohibitsmaking fraudulent statements to the FDA. Ibid.

The Third Circuit also rejected the argument that "fraud on theFDA" claims are impliedly preempted. Pet. App. 16a. The majorityrecognized that "Congress has not created an express or impliedprivate cause of action for violations of the [Federal Food, Drugand Cosmetic Act (FDCA)] or the MDA." Id. at 13a. But it saw"no inconsistency" between Congress's decision to give the FDAthe "exclusive prerogative" and discretion to enforce the require-ments of federal law and allowing individuals to "bring commonlaw fraudulent misrepresentation claims" to "enforce the FDCA."Id. at 18a. The majority relied as well on the "presumption againstpreemption" and the absence of express preemption of plaintiffs'claim, reasoning that Medtronic "teaches that where Congress hasexpressed its intention with respect to preemption, we should lookprimarily to what it said." Id. at 16a.

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Judge Cowen dissented. Unlike the majority, he was troubledby permitting judges and juries hearing "fraud on the FDA" claims"to displace the FDA's judgment about whether a manufacturer hasengaged in improper marketing." Pet. App. 32a. Judge Cowen alsopredicted that the majority's approach "will expose manufacturersto fraud liability for seeking desirable innovations in a product'suse, distort the penalty scheme established by the FDCA and itsregulations, and generate substantial liability when manufacturersrespond to doctors' widely accepted practice of purchasing medicalproducts for off-label uses." Id. at 25a.

E. The FDA's Reclassification Proceeding

Contemporaneous with these judicial proceedings, the FDAconducted a rulemaking in which it reclassified many of the bonescrews challenged by plaintiffs from Class III to Class II when usedto treat certain spinal conditions. See 60 Fed. Reg. 51946 (1995);63 Fed. Reg. 40025 (1998). The FDA's decision, which followedan extensive review of the available medical data, was based uponits conclusion that special controlsalone "would provide reasonableassurance of safety and effectiveness." 63 Fed. Reg. at 40025.

The plaintiffs in this case participated extensively in the FDA'sreclassification proceeding. Plaintiffs' 231-page commentsincludedthe same "fraud on the agency" allegations that they advanced inthe district court, accompanied by an 18-volume appendix consist-ing of more than 400 exhibits, many of which were drawn fromdiscovery in this case. Comments by Plaintiffs' Legal Committeein In re Orthopedic Bone Screw Prods. Liab. Litig., FDA Dkt. No.95N-0176, at 17, 31-39 (filed March 1, 1996). In adopting its finalrule, the FDA declined to creditplaintiffs'allegations and expresslyrejected the argument that bone screws should be banned based on"deception." 63 Fed. Reg. at 40035-40036.

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SUMMARY OF ARGUMENT

I. Plaintiffs' "fraud on the FDA" claim is expressly preemptedby 21 U.S.C. § 360k(a). If allowed to proceed, it would imposestate disclosure requirements relating to the "intended use" of theAcroMed medical devices that are materially different from thefederal disclosure requirements relating to "intended use" thatapply to the very same devices. The essential premise of plaintiffs'claim is that Buckman should have informed the FDA of Acro-Med's subjective hopes, desires and expectations concerning howthe devices might be used by physicians once they were on themarket. Federal law imposes no such disclosure requirement in the510(k) process.

Moreover, the state and federal disclosure requirementsat issuein this case are "specific" in every relevant sense. They arise fromthe particularized application of state and federal laws to individualdevices (and no others); they impose obligations to make specificdisclosures that concern each device's "intended use"; and they arethe product, on the federal side, of active and particularized reviewand consideration by the FDA.

II. Plaintiffs' "fraud on the FDA" claim is also impliedlypreempted. Unlike the traditional state tort requirements involvedin Medtronic, the gravamen of plaintiffs' claim is that petitionerBuckman defrauded a federal agency. That claim amounts to acollateral attack on the FDA's decision to clear the relevant devicesfor marketing. To prevail on their state-law claim, plaintiffs wouldhave to show that the AcroMed devices should not have been onthe market. But, from the perspective of the federal government,these devices were properly on the market. It is difficult to imaginea starker conflict between state and federal law. What is more,plaintiffs' claim would require a judge or jury, applying state law,to decide (1) what disclosures should have been made to the FDA,(2) whether Buckman satisfied those federal disclosure re-quirements,(3) whether the FDA already knew the information thatwas not disclosed, and (4) what the FDA would have done if

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Buckman had disclosed the required information. The potential forsecond-guessing the FDA's own determinations of these issues isobvious.

Plaintiffs' "fraud on the FDA" claim also would conflict withthe FDA's substantial interest in valid, final and correct decision-making as well as with Congress's intent to vest exclusive enforce-ment authority in the FDA. The claim would undermine theuniformity of federal law. And it would interfere substantially withfederal government operations, by subjecting agency personnel tointrusive discovery, creating serious distortions in the FDA'sregulatory process, and constricting the flow of medical informa-tion concerning off-label uses.

III. If the Court concludes that plaintiffs' "fraud on the FDA"claim is not preempted under current law, then it should reexamineMedtronic's conclusion that the MDA's express preemption clauseencompasses only "specific requirements" imposed by state andfederal law. The concept of "specificity" is contrary to the plainlanguage of Section 360k(a); is inherently ambiguous; has spawnedenormous confusion and conflict in the lower courts; and has led touncertainty and serious practical difficulties for devicemanufacturers. It is also based on an erroneous view of the FDA'spast regulatory practice. The Court should eliminate this "utterlyirrational loophole" (Morales v. Trans World Airlines, Inc., 504U.S. 374, 386 (1992)) from the law of MDA preemption.

ARGUMENT

In recent years, this Court has been called upon repeatedly todecide whether Congress, in enacting express preemption clausesaimed at safeguarding the exclusive authority of expert federalregulators and protecting interstate commerce from the burdens ofexcessive or divergent state regulation, meant to nullify state-lawrequirements that are imposed by judges or juries in privatelawsuits. See, e.g., Geier v. American Honda Motor Co., 120 S. Ct.1913 (2000); Medtronic, 518 U.S. 470; Cipollone v. Liggett Group,

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Inc., 505 U.S. 504 (1992). That question has proved to be mostnettlesome where the consequence of a finding of preemption is todeprive injured people of traditional remedies that they wouldotherwise have under state law against the manufacturers ofdangerous or defective products.

This case is entirely different. The gravamen of plaintiffs' state-law claim is that certain participants in a federal regulatory processdefrauded the federal agency. According to the plaintiffs, petitionershould have made certain disclosures and statements (and shouldnot have made others) to the Food and Drug Administration in thecourse of seeking regulatory clearance to market certain medicaldevices. But it is hardly a traditional role of state law to policewhether parties to a federal regulatory process comply withdisclosure requirements imposed by a federal agency. Althoughstate law generally includes protections against fraud, plaintiffs donot claim that they were defrauded; they claim that the FDA wasdefrauded.

This case accordingly bears no resemblance to the productliability suit in Medtronic, which involved routine state-law claimsof design and manufacturing defects. This case also differs fromMedtronic because preempting plaintiffs' claim here would nothave "the perverse effect of granting complete immunity fromdesign defect liability to an entire industry." 518 U.S. at 487. To thecontrary, plaintiffs would still be able to bring product liability suitsagainst the manufacturers, as well as fraud claims for representa-tions made to them or to their physicians. Put another way,preemption here would not eliminate any claim that plaintiffswould have had under state law if the MDA had not been enacted.Indeed, plaintiffs' claim could not exist if there were no federalregulatory process in place; it is entirely dependent upon, andderivative of, a federal regulatory proceeding.

Plaintiffs' "fraud on the agency" claim is even more unlike atraditional tort action because, at bottom, it amounts to a collateralattack on the FDA's clearance decision. To prevail on their claim,

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plaintiffs must prove that, but for Buckman's "fraudulent" submis-sions to the FDA, AcroMed's bone screws would never have beencleared by the FDA and thus would never have been used inplaintiffs' operations. To resolve plaintiffs' claim, then, a judge orjury -- applying state law -- must decide what information shouldhave been submitted to the FDA and whether the agency, if it hadreceived that information, would have reached a different result onAcroMed's 510(k) notifications. Traditional state-law productliability actions, in contrast, do not require judges and juries to stepinto the shoes and minds of federal regulators, interpret the scopeof federal disclosure or other requirements, or second-guessdecisions made by a federal agency.

For all of these reasons, plaintiffs' unorthodox claim isexpressly as well as impliedly preempted by federal law. Plaintiffs'claim is expressly preempted because it imposes disclosurerequirements with respect to medical devices that are plainly"different from, or in addition to" the disclosure requirementsimposed by federal law. 21 U.S.C. § 360k(a). Plaintiffs' claim isimpliedly preempted because it is a collateral attack on themarketing clearance decisions of expert federal regulators; itconflicts with Congress's decision to delegate to the FDA exclusiveregulatory authority over the MDA (and Congress's correspondingdecision not to create a private right of action under the MDA); itthreatens the uniformity of federal law; and it creates distortions inthe federal regulatory process, in the flow of information relating tooff-label uses of devices, and in the agency's allocation of its ownresources.

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I. PLAINTIFFS' "FRAUD ON THE FDA" CLAIM ISEXPRESSLY PREEMPTED BECAUSE IT IMPOSESSTATE-LAW DISCLOSURE REQUIREMENTSRELATING TO "INTENDED USE" THAT ARE"DIFFERENT FROM, OR IN ADDITION TO" THEDISCLOSURE REQUIREMENTS IMPOSED BYFEDERAL LAW

In enacting the MDA, Congress sought to preserve the unifor-mity of the federal regulatory scheme and to protect innovations indevice technology from being "stifled by unnecessary restrictions"by including a "general prohibition on non-Federal regulation."H.R. REP. NO. 94-853, at 12, 45. That "general prohibition" wasexpressed in a broadly worded preemption clause:

[N]o State or political subdivision of a State may establish orcontinue in effect with respect to a device intended for humanuse any requirement --

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

(2) which relates to the safety or effectiveness of the device orto any other matter included in a requirement applicable to thedevice under this chapter.

21 U.S.C. § 360k(a) (emphasis added). The only exception to thissweeping command is for state requirementsthat the FDA elects toexempt from preemption pursuant to 21 U.S.C. § 360k(b).

Plaintiffs'"fraud on the agency" claim falls comfortablywithinthe language of Section 360k(a). That claim rests entirely on thepremise that state law required Buckman to make certain disclo-sures to the FDA about the "intended use" of the componentsof theVSP and ISOLA Systems. As discussed below, these state dis-closure requirements are "different from, or in addition to," thedisclosure requirements about "intended use" that are "applicable* * * to the device" under federal law. There is no dispute that thestate requirements underlying plaintiffs' claim "relate[] to the

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safety or effectiveness of the device or to any other matter includedin a [federal] requirement applicable to the device"; plaintiffs havenever suggested otherwise. Accordingly, this case presents astraightforward example of express preemption.

In Medtronic, a majority of this Court gave a limiting construc-tion to the broad language of Section 360k(a). See 518 U.S. at 496-97. The majority relied, in turn, on a narrow interpretation ofSection 360k(a) adopted by the FDA in setting forth the agency'sprocedures for considering exemptions from preemption. See 21C.F.R. § 808.1(d). The Court also instructed that any inquiry intoexpress preemption requires "a careful comparison between theallegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within theintended pre-emptive scope of the statute and regulations." 518U.S. at 500. We accordingly explain, first, why the federal and statedisclosure "requirements" involved in this case are different and,second, why those requirements fit within the ambit of Section360k(a) as construed in Medtronic.

A. Plaintiffs Seek To Impose Disclosure "Requirements"That Are "Different From, Or In Addition To" TheDisclosure "Requirements"Imposed By Federal Law

1. As an initial matter, we note that plaintiffs have neverdisputed that, at the time of the conduct giving rise to their claim,federal law imposed "requirements" on Buckman to make certaindisclosures to the FDA in the 510(k) process involving theAcroMed devices. Indeed, plaintiffs have consistently maintainedthat Buckman violated the agency's disclosure requirements -- anallegation that would make no sense if disclosure of the informationspecified in the agency regulations were optional. Although theparties vehemently disagree about what disclosures federal law

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requires, there is no dispute that it requires something. This is nota case, then, where federal law imposes no requirement at all.2

Equally clear is the fact that plaintiffs' "fraud on the agency"claim, if allowed to proceed, would impose state-law "require-ments" on Buckman concerning disclosures in FDA proceedings.In Medtronic, a majority of this Court held that state tort dutiesimposed through the common law constitute "requirements"withinthe meaning of Section 360k(a). See 518 U.S. at 509-511 (O'Con-nor, J., joined by Rehnquist, C.J., and by Scalia and Thomas, JJ.,concurring in part and dissenting in part); id. at 504-505 (opinionof Breyer, J.). Indeed, Justice Breyer even gave as an example of aclaim that would be preempted by the MDA "a state law tort actionthat premises liability upon the defendant manufacturer's failure touse a 1-inch wire," where "a federal MDA regulation requires a 2-inch wire." Id. at 504. Plaintiffs' "fraud on the agency" claim,which is similarly premised on state tort law, imposes "require-ments" no less than does the state negligence or strict liability lawin Justice Breyer's hypothetical.

2. These federal and state disclosure "requirements" are not"substantiallyidentical." 21 C.F.R. § 808.1(d)(2). Plaintiffs'"fraudon the agency" claim is predicated on Buckman's purported

2 The Third Circuit apparently concluded otherwise, declaring that"[b]ased on Lohr, * * * there is no federal 're quirement' 'ap plicableto the device' at issue here." Pet. App. 13a (emphasis added). Thatrationale, however, indefensibly transforms this Court's determinationin Medtronic that the 510(k) process imposes no federal design"requirements" into a holding that the 510(k) process imposes nofederal "requirements" at all. See 518 U.S. at 493-494. The ThirdCircuit's logic also should be rejected becau se it would lead toridiculous results. For example, Section 510(k) plainly requires thatdevices be "substantially equivalent" to pre-19 76 devices in ord er toobtain marketing clearan ce. See 21 U .S.C. § 36 0e(b)(1)(B). Yet ifSection 510(k) imposes no requ irements at all, then the MDA wouldnot preempt a state law that instead required a medical device to be"exactly identical" to a pre-1976 device before it could be marketed.

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obligation, under state law, to disclose to the FDA that AcroMedsubjectivelydesired or hoped that the bone screws, plates, rods, andhooks of the VSP and ISOLA Systems -- although labeled for useonly in bones other than the spine -- would be used by physiciansfor spinal fixation. According to plaintiffs, if Buckman haddisclosed this "true" subjective intent as it was required to do, theFDA would have refused to clear the 510(k) submissions and theVSP and ISOLA devices would not have been permitted onto themarket. J.A. 21.

Federal law, in contrast, does not impose any requirement thata 510(k) submission disclose how a manufacturer subjectivelyintends that a device will be used, because subjective intent isirrelevant under the MDA. The FDA's regulatory authority extendsonly to the labeling and marketing of devices in interstatecommerce and not to the practice of medicine (including off-labeluses of approved drugs and devices). See 21 U.S.C. §§ 331(a), 396;37 Fed. Reg. 16503, 16503 (1972) (objective of FDCA is "is toassure that drugs will be safe and effective for use under theconditions of use prescribed, recommended, or suggested in thelabeling thereof," and regulatory authority does not extend tophysicians' off-label use); Pedicle Screws, 24 FED. MED. BULL. 10(May 1994) (noting that "pedicle screws may not be marketed" forspinal fixation because that indication for the devices has not yetbeen cleared by the FDA). So long as a device's labeling and amanufacturer's marketing refer only to cleared uses, the manufac-turer has complied with the federal statute even if it hopes (aswould any rational manufacturer) that physicians engage in off-label uses. See Nightingale, 26 DRUG INFO. J. at 141-143 (FDAAssoc. Comm'r for Health Affairs).

Under the 510(k) clearance process, the manufacturer deter-mines the "intended use" for which it seeks FDA authorization tolabel and market a device. That use -- not the use or uses for whichthe manufacturer hopes that physicians will employ the device --is what must be disclosed to the FDA and evaluated for "substantialequivalence" under Section 510(k). By imposing liability for

21

Buckman's failure to tell the FDA about AcroMed's subjectiveintent regarding its devices' use, state law would establish adisclosure requirement materially "different from, and in additionto" the requirements of federal law.

a. The statutory text strongly confirms our understanding of thescope of the federal disclosure requirement. In its current form, theMDA expressly provides that the "intended use" of a device in the510(k) context is the use designated by the manufacturer in itssubmission to the FDA. The statute provides that "[a]ny determina-tion by the Secretary of the intended use of a device," for purposesof determining whether the device is "substantially equivalent" toa pre-1976 device, "shall be based upon the proposed labeling" inthe 510(k) submission. 21 U.S.C. § 360c(i)(1)(E)(i); see also S.REP. NO. 105-43, at 27 (1997) ("For premarket notification sub-missions, the labeling proposed in the submission will be control-ling of a device's intended use."). The FDA may require a warningstatement on the device's label against foreseeable uses that arepotentially harmful -- just as it did here, in requiring the statement"WARNING -- THIS DEVICE HAS NOT BEEN APPROVEDFOR PEDICULAR APPLICATION" to be included on labeling ofthe iliac screw that was part of the ISOLA System, see J.A. 19 --but it may not require the manufacturer to list those uses in its510(k) submissions. See 21 U.S.C. § 360c(i)(1)(E)(i); S. REP. NO.105-43, at 27.

Although this express statutory limitation of "intended use"postdates Buckman's 510(k) submissions, both Congress and theFDA have made clear that it corresponds to the original intent ofCongress about how Section 510(k) should be applied. Thecommittee report accompanying the clarifying amendment explainsthat it conforms to Congress's understanding of statutory require-ments in enacting the MDA in 1976. See S. REP. NO. 105-43, at 27.The FDA has similarly noted that the statutory requirement that"intended use" for Section 510(k) be determined by the use listedin proposed labeling "is not different from the manner in which510(k)s have traditionally been reviewed." U.S. Dep't of Health &

22

Human Servs., Food & Drug Admin., Office of Device Evaluation,Center for Devices and Radiological Health, Determination ofIntended Use for 510(k) Devices -- Guidance for Industry andCDRH Staff 1 (Jan. 30, 1998); cf. 21 U.S.C. § 360c(a)(2)(B)("safety and effectiveness of a device are to be determined* * * with respect to the conditions of use prescribed, recom-mended, or suggested in the labeling of the device"); id.§ 355(d)(1).

b. Prior FDA pronouncements and applications of the statuteare consistent with the principle that the intended use of a devicefor 510(k) purposes is determined by labeling claims rather than bythe manufacturer's subjective intent. Thus, an FDA officialexplained in 1989 that determining whether the "intended use" ofa device is substantially equivalent to that of a predicate device isestablished by asking whether the new device has the "SameIndication Statements" as the pre-1976 device. Callahan, TheProcess of FDA Approval of a Spinal Implant: GovernmentalPerspective, 2 J. SPINAL DISORDERS 288, 289 (1989); accordCenter for Devices and Radiological Health, Food & Drug Admin.,Premarket Notification Review Program, 510(k) Memorandum#86-3 (June 30, 1986) (reprinted at <http:/www.fda.gov/cdrh/k863.html>). "When the FDA approves products," the agencyofficial noted, "it does so on a device-by-device basis for specificintended uses and not in general terms, e.g., pedicle spinal fixationsystems." Callahan, 2 J. SPINAL DISORDERS at 290 (emphasisadded); see also, e.g., 57 Fed. Reg. 18062, 18063 (1992) ("[i]ndetermining whether the new device has the same intended use asa predicate device" under Section 510(k), FDA assesses "anydifferences in indications for use in terms of the safety andeffectivenessquestions they may raise" (emphasis added)); 63 Fed.Reg. 64556, 64560 (1998) (noting that new "intended use" iscreated when device previouslymarketed for general use is labeledfor use on specific body part).

Indeed, the FDA regulation governing device labeling expressly provides that "intended use" "refer[s] to the objective intent

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of the persons legally responsible for the labeling of devices," asmanifested by "labeling claims, advertising matter, or oral orwritten statements." 21 C.F.R. § 801.4.3 Although a manufacturermay be required to include warnings in its labeling informingcustomers of dangerous off-label uses, see ibid., there is no FDArequirement that a manufacturer seek FDA clearance for allforeseeable uses by listing them in its 510(k) submission.

c. Determining substantial equivalence under 510(k) byreference to a manufacturer's subjective intent is also difficult toreconcile with the nature of the 510(k) process itself. The substan-tial equivalence inquiry under 510(k) is necessarilycomparative innature: the 510(k) device must "ha[ve] the same intended use as thepredicate device." 21 U.S.C. § 360c(i)(1)(A); see also 21 C.F.R.§ 807.100(b)(1). But the FDA would have no way of knowing howthe manufacturer of a predicate device subjectively intended for itto be used prior to 1976 (or for that matter what the manufacturer'ssubjective intent is today, because the FDA does not requiremanufacturers to seek clearance of new off-label uses for devicesthat are already on the market).4 Accordingly, the intended use ofthe predicate device must necessarily be judged by its labelingclaims. Under plaintiffs' theory, the FDA would have to apply onestandard of "intended use" to the predicate device and another,

3 By its terms, the definition of "intended use" in Section 801.4 doesnot apply to 510(k) premarket notifications. Compare 21 C.F.R.§ 801.4 (defining "intended uses" and similar words "in §§ 801.5,801.119, and 801.122"), with id. § 807.87 (governing informationrequired in a premarket notification subm ission, including "[p]roposedlabels, labeling, and advertisements sufficient to describe the device,its intended u se, and the directions for its use"). Nonetheless, Section801.4 confirms that "intended use" in the MDA does not refer to amanufacturer's subjective intent.

4 The FDA's longstanding position has been that "the decision aboutwhether or not, and when" to apply for approval of off-label uses isthe manufacturer's alone to make. Nightingale, 26 DRUG. INFO. J. at142.

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quite different standard to the device for which 510(k) clearance isbeing sought. There is no basis for such an anomalous result.

d. Plaintiffs' subjective standard also undermines the basicpurpose underlying Section 510(k), which is to ensure that pre-1976 devices are not insulated from competition by later marketentrants. Plaintiffs' definition of intended use would mandaterejection of new devices based on vague notions of subjectiveintent. That, in turn, would have the effect of impeding competitioneven where the proposed 510(k) device has the same labelingclaim as a predicate, pre-1976 device to which the proposed deviceis substantially equivalent. There is no reason to think that Con-gress meant to enhance competition only where manufacturers of510(k) devices have no subjective hope, desire, or expectation thattheir devices, once cleared, might be used by physicians for someoff-label use.

e. Finally, plaintiffs' definition of intended use would bewholly unworkable in practice. Plaintiffs have not explained, forexample, whose subjective intent would have to be disclosed to theFDA. If a corporate director intended one use for a device, whilethe marketing director intended another, which would be subject tomandatory disclosure to the FDA and govern the substantialequivalence inquiry? Cf. 21 C.F.R. § 801.4 (defining intended usefor labeling purposes as "objective intent of persons legallyresponsible for the labeling of devices" (emphasis added)). Whatif corporate officials intended primarily that the device would beused in a well-established manner, but hoped for eventual accep-tance of a now-experimental methodology? Would it make anydifference if the company's subjective intent changed between thetime it filed the 510(k) notification and the FDA's clearance of thedevice for marketing? These questions demonstrate why 510(k)disclosure requirements focus on how a device will be labeled anddo not extend to a manufacturer's subjective intent or hope abouthow a device might be used.

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B. The State "Requirements" Underlying Plaintiffs'Claim Qualify For Express Preemption Under Medtronic

Section 360k(a) covers "any [state or local] requirement" that"relates" either "to the safety or effectiveness of the device or toany other matter included in a [federal] requirement applicable tothe device." There can be no doubt that the state requirements inthis case "relate" to safety and effectiveness concerns. They alsoplainly relate to a "matter" that is "included in" a counterpart fed-eral requirement -- disclosures concerning the device's "intendeduse." See 21 C.F.R. § 807.87(e) (1986, 1999). The state "require-ment" in this case accordingly comes within the plain language ofthe MDA's express preemption clause.

The FDA, however, has taken the position that Section360k(a)'s broad reference to "any requirement" should be inter-preted as meaning "any specific requirement." See 21 C.F.R.§ 808.1(d). In Medtronic, a majority of this Court appeared toendorse the FDA's "specificity" gloss on the statutory text.Compare 518 U.S. at 500, 506-507, with id. at 512 (O'Connor, J.,joined by Rehnquist, C.J., and by Scalia and Thomas, JJ., concur-ring in part and dissenting in part) ("The statute makes no mentionof a requirement of specificity, and there is no sound basis fordetermining that such a restriction on 'any requirement' exists.").Whether Medtronic's actual holding turned on the absence ofspecificity in the state requirements involved in that case is notaltogether clear for at least two reasons.

First, the same majority that appeared to endorse "specificity"in Medtronic elsewhere declared: "[W]e do not believe that th[e]statutory and regulatory language necessarily precludes 'general'federal requirements from ever pre-empting state requirements, or'general'state requirementsfrom ever being pre-empted." 518 U.S.at 500. That statement,of course, reflects a rejection of the idea thatrequirements under Section 360k(a) are preempted or preemptiveonly if they are "specific."

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Second, the overriding focus of Justice Breyer's tie-breakingopinion was almost exclusively on the pertinent federal (asopposed to the state) requirements. 518 U.S. at 507 (Breyer, J.)("Insofar as there are any applicable FDA requirements here, thoserequirements, even if numerous, are not 'specific' in any relevantsense." (emphasis added)). Since Justice Breyer's resolution of thecase turned on the character of the federal requirements at issue,which he concluded were too general to trigger preemption, he hadno occasion to resolve whether express preemption under the MDAalso requires specificity on the state side. Accord Papike v. Tam-brands, Inc., 107 F.3d 737, 742 (9th Cir.) ("Although JusticeBreyer joined in Section V [of Justice Stevens' opinion], * * * it isclear enough that the Court found no preemption of the common-law claims largely because the pacemaker was not subject to anydevice-specific FDA regulations."), cert. denied, 522 U.S. 862(1997).

In any event, the state requirements underlying plaintiffs' claimsatisfy any "specificity" gloss that might apply. In sharp contrast toMedtronic, where "the precise contours of [plaintiffs'] theory ofrecovery" had "not yet been defined" (518 U.S. at 495), plaintiffs'"fraud on the agency" claim has been set forth in minute detail intheir complaint (see J.A. 13-21), as required by Fed. R. Civ. P.9(b). Plaintiffs allege that Buckman and AcroMed should havemade specific disclosures to the FDA in connection with the 510(k)submissions they made for the components of the VSP device andISOLA Systems. In particular, plaintiffs claim that Buckman wasrequired to state precisely that AcroMed had a subjective desire orintent that each of these devices would be used by physicians inspinal applications. That claim is just as "specific" as JusticeBreyer's example of a claim based on the manufacturer's failure touse a 1-inch wire. Indeed, a more precise formulation of the"liability-creating premises" of a plaintiff's "state-law tort suit"(518 U.S. at 508 (Breyer, J.)) is difficult to imagine. See Mitchellv. Collagen Corp., 126 F.3d 902, 912 (7th Cir. 1997), cert. denied,523 U.S. 1020 (1998).

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The state laws underlying plaintiffs' claim have also beenapplied with specificity to each of the AcroMed devices, thussatisfying the "specificity" concept expressed in the FDA'sregulation, 21 C.F.R. § 808.1(d)(1). At some point in the course oflitigation, the general duties that are the basis of a plaintiff's tortclaim become applied with specificity to a particular product thatis at issue in the lawsuit. As the United States recognized in itsbrief at the petition stage, when that occurs "a specific duty ofcare" is "made applicable to a device through a State's commonlaw of torts," and that duty gives rise to a "requirement" within themeaning of the MDA's express preemption clause. U.S. Br. 10 n.4.That plainly has occurred in this case. Plaintiffs' claim thusimposes state-law requirementsthat are "specific" in every relevantsense.

The Third Circuit was accordingly wrong to conclude that"[b]ased on Lohr * * * there is no * * * state 'requirement' 'withrespect to'" AcroMed's medical devices. Pet. App. 13a. To theextent that the court of appeals read Medtronic as shielding allcommon law claims "of general applicability" from expresspreemption, it simply misread the case.

C. The Counterpart Federal "Requirements" Involved InThis Case Trigger Express Preemption Under Medtronic

The federal disclosure requirements at issue in this case arederived from FDA regulations in effect at the time Buckmansubmitted 510(k) notifications for the devices comprising the VSPand ISOLA Systems. Those regulations, which remain in forcetoday, mandated the disclosure for proposed 510(k) devices of "thefollowing information: * * * (e) Proposed labels, labeling, andadvertisements sufficient to describe the device, its intended use,and the directions for its use." 21 C.F.R. § 807.87(e) (1986, 1989)(emphasis added). The FDA's regulations also required regulatedentities to supply "[a]ny additional information regarding thedevice requested by the Commissioner to make a finding as towhether or not the device is substantially equivalent to a device incommercial distribution." 21 C.F.R. § 807.87(h) (1986, 1989).

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Buckman complied with the standard disclosure requirementsby submitting detailed information about the screws, plates, hooksand rods of the VSP and ISOLA Systems (and the pre-1976devices to which those devices were substantially equivalent) in its510(k) submissions. See J.A. 48-51, 54-57. These submissionsincluded information about each device's intended use. See J.A.51, 57. Moreover, according to plaintiffs' own complaint, the FDAinformed Buckman, following the submission of AcroMed's510(k) notifications relating to the VSP System, that there was a"need for a more definitive statement covering the intended'indications for use' of the AcroMed Nested Bone Plate." J.A. 15-16, 57-58. Buckman sent a letter in response to this agency demandfor more information, stating (J.A. 58):

The proposed indications for use for the AcroMed device arethe same general indications proposed for the AO system ofplates. More specifically, (for the purpose of this 510K), theAcroMed plates are intended for use in appropriate fractures oflong bones of both the upper and lower extremity and suchother flat bones (as in the fractured pelvis) that may from timeto time require stabilization with contourable metallic non-compressing plates.

It is beyond dispute that all of these disclosures were required byfederal law.5

In addition, the federal disclosure requirements imposed onBuckman in this case were "specific" in every relevant sense. See

5 In its cursory comparison of the state and federal requirements atissue, the Third Circuit misidentified the pertinent federalrequirements as those imposed by 18 U.S.C. § 1001 and 21 C.F.R.§ 807.87(j), which "make[ ] it a crime to make a fraudulent statementto a federal agency and * * * require[ ] every premarket notificationto contain a statement that the information contained therein isbelieved to be truthful." Pet. App. 13a. The Third Circuit's reliance on21 C.F.R. § 807.87(j) is especially puzzling, because that provisiondid not even exist at the time that the pertinent 510(k) submissionswere made in 1985 and 1988.

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21 C.F.R. § 808.1(d). The FDA's regulation requiring disclosure ofa device's intended use in any 510(k) submission (21 C.F.R.§ 807.87(e) (1986, 1989)) was applied with particularityto each ofthe AcroMed devices. Moreover, the FDA regulation requiring thedisclosure of information specifically requested by the agency (21C.F.R. § 807.87(h) (1986)) was applied to the AcroMed NestedBone Plate when the agency demanded more detailed disclosuresabout that device. These federal disclosure requirements narrowlyand specifically focused upon "intended use" disclosuresconcerning these particular devices. And, in response to thesefederal requirements, Buckman and AcroMed made detailed andparticularized statements about the intended use of the individualdevices -- again, disclosures required by federal law. Theapplicable federal requirements, in short, were "specific" in theircontent as well as in their application to these devices. See 21C.F.R. § 808.1(d) ("State or local requirements are preempted onlywhen the Food and Drug Administration has established specificcounterpart regulations or there are other specific requirementsapplicable to a particular device under the act * * *." (emphasisadded)). They plainly trigger preemption under Section 360k(a).

This case presents an especially strong one for preemptionbecause of the active role played by the FDA in requiring Buckmanto make disclosures about the "intended use" of the AcroMeddevices. It is undisputed that the FDA met with Buckman andAcroMed in December 1985 specifically to discuss the "intendeduse" of the VSP System. It is also undisputed that after Buckmansubmitted the 510(k) notifications for the VSP, the FDA reviewedthose submissions and requested a more detailed disclosure, whichwas provided. With respect to the ISOLA System, moreover,plaintiffs allege that FDA officials engaged Buckman in discus-sions about whether the various 510(k) devices could be combinedinto a single 510(k) submission. J.A. 18. Plaintiffs also allege thatthe FDA, in authorizing the marketing of the iliac screw, imposeda specific warning requirement that plainly indicated an awarenessof the possibility that some physicians might use the screw inpedicle applications. J.A. 19.

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Thus, unlike in Medtronic, where the Court found that federallabeling and good manufacturing practices (GMP) requirementsthat applied generally to all medical devices did not triggerpreemption, this is

a case in which the Federal Government has weighed thecompeting interests relevant to the particular requirement inquestion, reached an unambiguous conclusion about how thosecompeting considerations should be resolved * * *, andimplemented that conclusion via a specific mandate on [the]manufacturer[].

518 U.S. at 501.6

In sum, through the 510(k) clearance process, FDA officialsapplied the "intended use" disclosure requirementswith particular-ity to the specific AcroMed devices involved in this case in amanner that produced specific disclosures.Thus, even as construedin Medtronic, Section 360k(a) plainly preempts plaintiffs' "fraudon the agency" claim.

6 The federal labeling regulations at issue in Medtronic also aredistingu ishable becau se they a pply, "with a few limited exceptions,"to "every medical de vice." 51 8 U.S. at 497; see also ibid. (notingbroad applicability of GMPs). In contrast, the FDA's disclosurerequirem ents involved in this case are limited to devices for which510(k) clearance is sought. The FDA has acknow ledged that "specificFDA requirements applicable to a particular device or class ofdevices" trigger express preemption under the MDA. 43 Fed. Reg.18661, 18662 (1978) (emphasis added); see also id. at 18664 (federalrequirem ents that apply to PMA devices trigger express preemption);45 Fed. Reg. 67321, 67322 (1980) (federal GMP regulations triggerpreemption under the MDA).

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II. PLAINTIFFS' "FRAUD ON THE FDA" CLAIM ISIMPLIEDLY PREEMPTED BECAUSE IT IS FLATLYINCONSISTENT WITH THE FEDERAL REGULATORY SCHEME

The only basis for plaintiffs' claim against Buckman is that theFDA should not have cleared AcroMed's devices for sale underSection 510(k). Plaintiffs do not contend that Buckman is liablebecause the devices were defectivelydesigned or manufactured; asa consultant to AcroMed, involved solely in the regulatory process,Buckman had nothing to do with device design or manufacture.Nor do plaintiffs contend that Buckman is liable because thedevices were marketed for an unapproved use, undoubtedlybecause Buckman had no involvement in marketing. Plaintiffsassert, instead, that Buckman fraudulently misrepresented theintended use of AcroMed's devices in its submissions and state-ments to the FDA and that, but for this fraud, "the FDA would nothave issued 510(k) clearances for AcroMed's pedicle screwfixation devices for any purpose, the devices would not have beenintroduced into interstate commerce, and [individual plaintiffs]would not have been exposed to the dangerous device[s] which[were] surgically implanted" in their spines. J.A. 21. Plaintiffs'injuries thus derive entirely from the FDA's decision to allowAcroMed's devices to be marketed; that is the sole error theychallenge here.

Plaintiffs' attack on the FDA's decisional process intrudes onan area "so 'intimately blended and intertwined withresponsibilities of the national government' that its nature aloneraises an inference of exclusion" of state law. Bethlehem Steel Co.v. New York State Labor Relations Bd., 330 U.S. 767, 772 (1947)(quoting Hines v. Davidowitz, 312 U.S. 52, 66 (1941)); see alsoUnited States v. Locke, 120 S. Ct. 1135, 1147 (2000); Boyle v.United Technologies Corp., 487 U.S. 500, 507 (1988). The basicpremise of plaintiffs' claim is that the States must oversee (andoccasionally override) federal agencies'decisions to ensure faithfulexecution of the agencies' duties. Yet the relationship between afederal agency and the entities it regulates is a matter solely of

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federal concern, governed solely by federal law. The terms of theinteraction between a federal agency and regulated entities --including what the entities must disclose to the agency and howthose disclosures must be made -- are determined entirely byagency-set and agency-enforced rules and requirements. Andbecause it is interests protected by the federal agency that are atstake, the agency is best able to vindicate those interests when itsrules and requirements are violated. See Pet. App. 50a (FDA "is inthe best position to decide whether [a manufacturer] withheldmaterial information from the agency and, if so, the appropriatesanction" (citation and quotation marks omitted)). The States haveno role in policing this area.7

Predictably, then, state "fraud on the agency" claims wouldhave substantial adverse effects on federal law and policy. Ifpermitted, plaintiffs' claim would undermine the validity andfinality of agency decisions and threaten the interests that underliethose decisions; conflict with Congress's intent that the MDA beadministered exclusively by the FDA and with the FDA's ownclaim of primary jurisdiction over regulated matters;contravene theFDA's decision to permit AcroMed to market its devicesnotwithstanding plaintiffs' allegations of fraud; and interferesubstantially with FDA operations by encouraging regulatedentities to flood the agency with unwanted information and byembroiling the agency and its employees in private litigation. Thus,regardless of whether plaintiffs' "fraud on the agency" claim isexpressly preempted, it is impliedly preempted because it would"actually conflict" with federal law (Fidelity Fed. Sav. & LoanAss'n v. de la Cuesta, 458 U.S. 141, 153 (1982)) and would "stand[]"

7 The uniquely federal interests at stake render inapplicable the"presumption against preemption of areas traditionally occupied bystate law," on which the court below relied. See Pet. App. 18a. Thereis no tradition of State oversight of compliance with federalregulations governing submissions to federal agencies (or, indeed,with any other regulations governing the relationship between federalagencies and regulated parties). In fact, plaintiffs' "fraud on theagency" claim would not even exist but for federal law.

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as an obstacle to the accomplishment and execution of the fullpurposes and objectives of Congress." Freightliner Corp. v.Myrick, 514 U.S. 280, 287 (1995) (citation and quotation marksomitted); see Geier, 120 S. Ct. at 1922; Boggs v. Boggs, 520 U.S.833, 841 (1997).

A. "Fraud On The Agency" Claims Conflict With FederalAgencies' Interest In Valid, Final, And CorrectDecisionmaking

1. Our federalist system rests on the principle that "[a] statecourt may not decline to give effect" to a valid decision of thefederal government. U.S. Br. 16 (petition stage). As the SolicitorGeneral has observed, a federal agency's decisions "shouldgenerally be questioned or set aside, if at all, only by the federalgovernment itself." Ibid.

"Fraud on the agency" claims contravene this basic principle.To prevail on their claim, plaintiffs must obtain a determinationunder state law that AcroMed's devices are illegallyon the market,even though the FDA has conclusively determined, under federallaw, that they should be on the market. States lack this "virtualpower of review" over federal agency decisions. Leslie Miller, Inc.v. Arkansas, 352 U.S. 187, 190 (1956); see Bethlehem Steel, 330U.S. at 775-776. It is difficult to imagine a greater conflict betweenstate and federal law.

2. In addition to its interest in the validity of its own decisions,the federal government has a "significant interestin the[ir] finality."U.S. Br. 16 (petition stage) (emphasis added). If plaintiffs andsimilarly situated litigants were permitted to pursue "fraud on theagency" claims, "federal regulatory decisions that Congressintended to be dispositive would merely be the first round ofdecision making, with later more important rounds to be played outin the various state courts." Lewis v. Brunswick Corp., 107 F.3d1494, 1505 (11th Cir. 1997), cert. dismissed, 523 U.S. 1113(1998). Binding federal decisions should not be vulnerableto state-law collateral attacks brought years or even decades later.

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3. "Fraud on the agency" claims require a judge or jury,applying state law, to decide (1) the scope of the federal dutyinvolved; (2) whether that duty was met; and (3) if not, what thefederal agency would have done had it been met. Permitting courtsto engage in this inquiry under state law -- in particular, determin-ing what a federal agency would have done under differentcircumstances -- creates an unacceptablepotential for conflict withthe agency's own assessment of federal interests.

A judge or jury asked to guess what an agency would havedone in a particular factual scenario would have to speculate aboutthe agency's likely rationale and the relative weight that would begiven to different decisional factors -- all without the benefit ofagency expertise. In many cases, the jury would arrive at decisionsat odds with the decision the agency itself would have reached. Ajury applying state law might conclude, for example, that aparticular device as to which certain disclosures were not madeshould not have been allowed on the market, whereas the FDAmight have determined that the nondisclosures were not material orthat, despite the violation, the public health required that the devicebe available. This unacceptable risk of conflict with federalinterests is endemic to state-law claims based on speculation aboutwhat a federal agency would have done under different circum-stances.

B. "Fraud On The Agency" Claims Conflict With TheMDA Statutory Scheme

1. State second-guessing of FDA decisions is particularlytroubling under the regulatory regime at issue in this case. TheMDA strikes a careful balance between shielding the public"against unsafe, unproven, ineffective, and experimental medicaldevices" and ensuring that progress in the development of medicaldevices is not "stifle[d]" by "excessive or ill-conceived" regulation.H.R. REP. NO. 94-853, at 10; see also FDA Oversight: MedicalDevices: Hearing before the Subcomm. on Oversight andInvestigations of House Comm. on Energy & Commerce, 97thCong., 2d Sess. 5 (1982). A key element in striking this balance isCongress's delegation of exclusive authority to the FDA.

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Permitting state review and nullification of FDA enforcementdecisions runs roughshod over this carefully calibrated enforcementscheme.

The FDA is expresslycharged with determining when and howto enforce the Food, Drug and Cosmetic Act, including the MDA.See 21 U.S.C. §§ 371(a), (h), 393; Weinberger v. Hynson, Westcott& Dunning, Inc., 412 U.S. 609, 627 (1973). The FDA has exer-cised this authorityby taking "primary jurisdiction" over all "issueswithin its statutory mandate," including the decision "whether adevice that is marketed for the first time after May 28, 1976, issubstantially equivalent to a previously marketed device." 21C.F.R. § 10.25(b); 41 Fed. Reg. 37457, 37459 (1976); see also H.R.REP. NO. 94-853, at 13. The FDA's domain extends not only to the"initial determination" of these issues, but also to previousdecisions that "the agency conclude[s] should be reconsidered." 21C.F.R. § 10.25(b).

The FDA's enforcement authority is marked by "completediscretion" in responding to statutory or regulatory violations.Heckler v. Chaney, 470 U.S. 821, 835 (1985); see also 21 U.S.C.§ 336 (FDA need not seek sanctions for minor violations of FDCAwhere it "believes that the public interest will be adequatelyservedby a suitable written notice or warning"). Although the FDAtypicallywithdraws clearance of a device upon learning that it wasobtained through fraud or misrepresentation, the agency maychoose not to overturn its prior decision if, in its view, publichealth or other considerations support another course of action. See56 Fed. Reg. 46191, 46192-46194, 46197 (1991); 55 Fed. Reg.52323, 52324 (1990).

The broad enforcement discretion given to the FDA is com-bined with an express exclusion of other would-be litigants. Thus,unlike under the securities law, the antitrust laws, and many otherfederal regulatory schemes, there is no express or implied privateright of action under the FDCA. See Medtronic, 518 U.S. at 487.To the contrary, "all * * * proceedings for the enforcement, or torestrain violations, of [Title 21, Chapter 9] shall be by and in thename of the United States." 21 U.S.C. § 337(a). Although States

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are expressly permitted to enforce a small set of provisions (notincluding Section 510(k)), they may do so only after givingadvance notice to the FDA so that the agency can decide whetherto bring its own enforcement action or to intervene in the stateproceedings. 21 U.S.C. § 337(b). The only mechanism for indivi-dual enforcement of the MDA is a citizen petition to the FDA. 21C.F.R. §§ 10.25(a), 10.30(e).

Plaintiffs' "fraud on the FDA" claim cannot be reconciled withCongress's reservation of exclusive enforcement authority to theFDA or with the FDA's own claim of primary jurisdiction. As thisCourt recognized in Merrell Dow Pharmaceuticals,Inc. v. Thomp-son, 478 U.S. 804 (1986), in the absence of a private right of actionto enforce a federal statute, it would "flout, or at least undermine,congressional intent to conclude that the federal courts mightnevertheless * * * provide remedies for violations of that federalstatute." Id. at 812. In fact, the effect of plaintiffs' "fraud on theagency" claim in this case "is exactly the same as it would be if astate court determined that an implied right of action was createdby a federal statute." Sherman, Use of Federal Statutes in StateNegligence Per Se Actions, 13 WHITTIER L. REV. 831, 890, 902(1992).

By infringing on the FDA's exclusive authority to decidewhether a device is substantially equivalent to a pre-1976 deviceand to respond to fraud or misrepresentation in the clearanceprocess, and by asking a court to nullify an FDA decision understate law, plaintiffs' claim "interferes with the methods by whichthe [MDA] was designed" to be carry out Congress's goals.International Paper Co. v. Ouellette, 479 U.S. 481, 494-495(1987); see also Gade v. National Solid Wastes Management Ass'n,505 U.S. 88, 103-104 (1992) (plurality); Allis-Chalmers Corp. v.Lueck, 471 U.S. 202, 211 (1985). The Supremacy Clause does notpermit a court applying state law to "usurp[] a function thatCongress has assigned to a federal regulatory body." Arkansas-Louisiana Gas Co. v. Hall, 453 U.S. 571, 580-582 (1981).

2. The Third Circuit recognized that there was no private rightof action under the FDCA, but held that, under Medtronic, this

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could not be a basis for implied preemption. See Pet. App. 15a. Thecourt of appeals reasoned that the Medtronic plurality had "viewedCongress' failure to provide a federal remedy [under the FDCA] aspersuasive evidence of an intent not to preempt common lawliability for the same conduct." Ibid. Given the Medtronicplurality's conclusion that Section 360k(a) did not bar "'atraditional damages remedy for violations of common-law dutieswhen those duties parallel federal requirements,'" the courtexplained, "[r]efusing to entertain Buckman's fraudulent misrepre-sentation claim solely because the statutory scheme does notcontain a private cause of action would be * * * contrary to[Medtronic's] clear holding." Pet. App. 16a (quoting Medtronic,518 U.S. at 495).

The Third Circuit's reasoning suffers from several fatal flaws.To begin with, the language quoted from Medtronic was concernedentirely with the applicability of express preemption of commonlaw claims under 21 U.S.C. § 360k(a). This Court had no occasionin Medtronic to consider the consequences for implied preemptionof Congress's decision to preclude a private right of action underthe FDCA. Indeed, even the Justices who concluded that expresspreemption did not apply agreed that a common law claim mightnonetheless be impliedly preempted because of its conflict with thefederal regulatory scheme. 518 U.S. at 503, 508.

Moreover, and more important, Medtronic did not involve a"fraud on the agency" claim, which is qualitatively different fromthe routine product liability claims that were then before the Court.Medtronic upheld against preemption "a traditional damagesremedy for violations of common-law duties," so long as thoseduties "parallel federal requirements." 518 U.S. at 495. Commonlaw claims alleging liabilityfor design defect or negligent manufac-ture -- i.e., claims like the ones in Medtronic, id. at 481 -- arewithin the core of the State's police power. They rest on state-imposed duties of care, derived from state standards. They do notrequire a state judge or jury to evaluate the wisdom of the FDA'sdecision to grant marketing clearance under 510(k), and a judgment

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in favor of the plaintiff would not reflect on the FDA's decisionalprocess.

The claim at issue here is of a very different sort. It involves theFDA's enforcement of its requirements governing the federalregulatory process, an area of longstanding and exclusive federalauthority. It seeks to impose liability for violation of a dutyimposed by federal, not state, law. And the crux of the claim is achallenge to the propriety of an FDA clearance decision and theintegrity of the FDA decisional process. In this sense, plaintiffs'"fraud on the agency" claim is similar to a claim challenging adevice's 510(k) clearance on the grounds that the employeeresponsible for the decision was not hired in accord with FDArequirements. Like the FDA's compliance with its own internalhiring policies, Buckman's compliance with FDA regulatoryrequirements is an area of exclusively federal concern, properlypoliced by the agency itself and not by judges and juries applyingthe laws of the 50 States.

Congress's decision to centralize all FDCA enforcementauthority in the FDA, and to preclude private rights of action toenforce the federal statute, might not be frustrated by allowingtraditional state law claims, such as those involved in Medtronic,to proceed. But it is quite another matter to allow plaintiffs' "fraudon the agency" claim, which (while nominally based on state law)could not exist apart from the FDCA, which seeks to enforcerequirements imposed by the FDCA, and which in essentially allrespects is indistinguishable from a private cause of action underthe FDCA.

3. The very purpose of the FDCA's exclusive enforcementscheme is to ensure consistency and uniformity of interpretation.As this case demonstrates, "[a] multiplicity of tribunals and adiversity of procedures are quite as apt to produce incompatible orconflicting adjudications as are different rules of substantive law."Garner v. Teamsters Local Union No. 776, 346 U.S. 485, 490-491(1953). A judge or jury asked to reevaluate an FDA decision understate law may have to consider events going back years or evendecades; with "regulatory and scientific approaches [changing]

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over time," "[a]ctions or choices that may seem clear today mayhave been less obvious to the decision makers involved in theissues at the time decisions were being made." FOOD & DRUGADMIN., REPORT OF THE HALCION TASK FORCE i (1996).

In this case, the potential inconsistency has become actual.Plaintiffs pursue a "fraud on the FDA" claim despite the fact thatthe FDA has already thoroughly considered their allegations offraud and concluded that AcroMed's devices should remain on themarket. As noted above (at 11-12), plaintiffs submitted lengthycomments in recent FDA proceedings to reclassify bone screws, inwhich plaintiffs raised each of their allegations of fraud againstBuckman; after reviewing the evidence, the FDA nonethelessdecided that -- far from being removed from the market -- bonescrews should be subject to less regulation and labeled for use inthe spine. "It is difficult to escape the conclusion that the [state]litigation [is] * * * an attempt by a disappointed [litigant] to gainfrom the [state] courts the relief it was denied by the [federalagency]," a result barred by the Supremacy Clause. Chicago &N.W. Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 324,326-327 (1981); see also Schneidewind v. ANR Pipeline Co., 485U.S. 293, 310 (1988); Nantahala Power & Light Co. v. Thornburg,476 U.S. 953, 968-969 (1986).

4. The express preemption provision in the MDA, like those inmany other statutes,8 manifests Congress's intent to shield

8 Numerous federal regulatory statutes contain express preemptionprovisions similar or identical to Section 360k(a). E.g., FIFRA, 7U.S.C. § 136v(b); Flammable Fabrics Act, 15 U.S.C. § 1203(a); Fed-eral Hazardous Substances Act, id. § 1261 note (b)(1)(A ); NationalTraffic and Motor Vehicle S afety Act, id. § 1392(d); Poison Preven-tion Packaging Act, id. § 1476(a); Consumer Product Safety A ct, id.§ 1075(a); Electronic Product Radiation Control Act, 21 U.S.C.§ 360ss; Federal Boat Safety Act, 46 U.S.C. § 4306. "Fraud on theagency" claims have been brought under many of these statutes aswell. E.g., Lewis, 107 F.3d at 1505; Welchert v. American Cyanamid,(continued...)

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regulated entities against inconsistent state laws. Yet "[v]irtuallyany federal agency decision that stood in the way of a lawsuit couldbe challenged indirectly by a claim that the industry involved hadmisrepresented the relevant data or had otherwise managed to skewthe regulatory result." Lewis, 107 F.3d at 1505. Under the MDAand analogous federal statutes, "fraud on the agency" claims thusprovide a ready means to circumvent almost any preemptivefederal requirement. "Congress could not have intended for theprocess it so carefullyput in place" by adopting express preemptionprovisions "to be so easily and thoroughly undermined." Ibid.

Even unsuccessful claims of "fraud on the agency" imposetremendous burdens on regulated entities. Allegations of incom-plete disclosure in the MDA context, for example, can triggerburdensome, intrusive, and expensive discovery into productdevelopment files, covering multi-year periods and evolvingscientific evaluations of complex formulas and patient reactions.Often, such claims can be rejected only after a full trial. And ofcourse, companies may be charged with "fraud on the agency" notjust by disgruntled consumers but also by industry competitors.Suits such as these, which represent collateral attacks on agencydecisions, cannot be reconciled with Congress's decision topreempt inconsistent state laws and to centralize all enforcementauthority in the FDA.

C. "Fraud On The Agency" Claims Interfere Substantially With Federal Government Operations

Federal agencies are charged by statute with faithful executionof federal law -- "getting the Government's work done." Boyle,487 U.S. at 505. Permitting private litigants to pursue "fraud on theagency" claims would impede those agencies' ability to carry outtheir statutory and regulatory duties. Under the Supremacy Clause,States may not "interrupt the acts of the general government" in

8 (...continued)
Inc., 59 F.3 d 69, 73 (8th Cir. 1995 ); Papas v. Upjohn Co., 985 F.2d516, 518-519 (11th Cir.), cert. denied, 510 U.S. 913 (1993).

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this manner. Johnson v. Maryland, 254 U.S. 51, 55 (1920); see alsoMayo v. United States, 319 U.S. 441, 445 (1943); Arizona v.California, 283 U.S. 423, 451 (1931); cf. Howard v. Lyons, 360U.S. 593, 597 (1959) (refusing to apply state law that wouldinterfere with the "effective functioning of the FederalGovernment"); Hancock v. Train, 426 U.S. 167, 178 (1976)(same).

In some instances, federal safety requirements might reason-ably be viewed as "minimum" or "baseline" standards, to besupplemented by additional, more stringent requirements understate law. It is inconceivable, however, that Congress intendedfederal requirements governing interaction with a federal agency --such as requirements about what information must be submitted ina 510(k) application -- to function as a "minimum" to be supple-mented by state law. To the contrary, state "supplementation"under these circumstances is a recipe for chaos.

1. If courts applying state law, in the guise of deciding "fraudon the agency" claims, were permitted to interpret federal require-ments governing 510(k) submissions, it is inevitable that theywould disagree with the FDA and each other about what thoserequirements entail. Rather than run the risk of liability for "de-frauding" the FDA by not submitting information that a court orjury might subsequently find material, manufacturers would seekto comply with the most expansive interpretation.

Thus, manufacturers would inundate the FDA with documenta-tion that the agency itself does not require. Faced with this overloadof information, neither the FDA nor consumers would be able toseparate wheat from chaff, thus defeating the entire point of theregulatory scheme. And the deluge of paper would not stop with510(k) clearance, because manufacturers would approach post-clearance reporting obligations9 with the same incentive to floodthe agency with information of uncertain and attenuated relevance.

9 E.g., 21 U.S.C. §§ 360i, 360l, 360ll, 360nn; 21 C.F.R. Parts 803,804, 806, 820 Subpart M, and 821.

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Section 510(k) submissions, intended to be a quick and simplemeans to FDA clearance, would turn into mini-premarket approvals, and the FDA would be drowned in backlogged submissions.10The FDA, not state law, should control how much information isprovided to the agency.

The threat of state-law liability for "fraud on the FDA" wouldhave negative effects extending beyond this immediate context. AsJudge Cowen noted in dissent (Pet. App. 29a-31a), manufacturersmight well be reluctant to research and develop new off-label uses,since each such use would be potential evidence of a new "intendeduse" that, under plaintiffs'theory, should have been disclosed to theFDA and placed on the device's labeling regardless of its safety orefficacy. Even where off-label uses were known, device manufac-turers would be loathe to disseminate information about them (bysending reprints of scientific articles in response to physicianinquiries or otherwise), for fear that such communications wouldbe taken as evidence of the manufacturer's "true" "intended use"for the device. As a result, physicians would make less informedtreatment decisions or simply shy away from off-label uses. Thisoutcome would not only impair the public health -- for, as theFDA has recognized, off-label use of devices and drugs can bebeneficial to patients, see page 4, supra -- it would also thrustjudges and juries into regulation of medical practice (i.e., off-labeluse of devices) under the guise of "protecting" the FDA, eventhough the FDA itself is prohibited from regulating in this area. See21 U.S.C. § 396; More Information for Better Patient Care:Hearings on S. 1477 Before the Senate Comm. on Labor andHuman Resources, 104th Cong. 82 (1996) (William B. Schultz,

10 This outcome would not only b urden the FD A, but also interferewith Congress's clear intent to stream line th e regulatory pr ocess. In1997 amend ments to the MDA, Congress provided that manufacturersshould be permitted to estab lish "sub stantial equivalence" underSection 510(k) by the "least burdensome means" possible. See 21U.S.C. § 360c(i)(1)(D). The FDA has recently implemented regu-latory reforms for the specific purpose of expediting clearancedecisions. See 65 Fed. Reg. 445 40 (2000).

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FDA Deputy Comm'r); cf. Arkansas-Louisiana Gas Co., 453 U.S.at 580 (holding that federal law preempts state breach-of-contractclaim that "permit[s] a state court to do * * * what the [federalagency] itself may not do").

2. As noted above (at 33), "fraud on the agency" claims requireproof of an agency's regulatory requirements, the applicant'sfailure to satisfy those requirements, and the way in which theagency would have acted differentlyin the absence of wrongdoing.In every case, the best source of evidence as to these factors --indeed, often the only source of credible evidence -- would be theagency itself. Accordingly, if these claims were allowed to goforward, private litigants would routinely seek discovery fromfederal agencies and agency officials to shed light on these crucialissues.

Even if the discovery attempts were unsuccessful,11 they woulddrain agency resources. The agency would be obliged to contestdiscovery requests and to litigate ensuing efforts to obtain compliance. And if the FDA ultimately were not required to provide thecritical evidence, the result would be flawed decisionmaking andenormous harm to defendants charged unfairly with havingdefrauded the agency.

In at least some instances, moreover, discovery attempts wouldsucceed, and federal agencies would become embroiled in privatelitigation. Government employees would be burdened with havingto testify; relevant agency documents would have to be produced;internal deliberations and discussions would have to be revealed;

11 The Department of Justice has taken the position that federalemployees cannot be forced to testify or produ ce records in privatelawsuits with respect to their official duties. See, e.g., 21 C.F.R.§§ 20.1, 20.2 ; see gen erally United States ex rel. Touhy v. Ragen, 340U.S. 462 (1951). Some courts have rejected this claim of blanketprivilege to resist third-party discovery. E.g., Exxon Shipping Co. v.U.S. Dep't of Interior, 34 F.3d 774, 778 (9th Cir. 1994); see also 26AC. WRIGHT & K. GRAHAM, FEDERAL PRACTICE & PROCEDURE § 5682,at 206 (19 92).

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and the agency's ability to obtain expert scientific and technicaladvice from private advisors would be diminished. See J.A. 31-33.As the Solicitor General observed at the petition stage, "[t]heprospect of such intrusive inquiries" would "pose a significantpotential * * * for distorting [the agency's] decision-makingprocesses." U.S. Br. 17.

This case presents a telling example of the way in whichfederal agencies would be burdened by private litigants pursuing"fraud on the agency" claims. Plaintiffs sought documents from theFDA covering 28 separate topics, including all premarket notifica-tions submitted for spinal use of pedicle screws from January 1,1993 onward; "[a]ll documents reflecting, relating or referring toany communications regarding each of the relevant premarketnotifications and any agency action thereon"; "[a]ll documentsreflecting, relating or referring to each 'predicate device' for whichsubstantial equivalence was claimed in each of the relevantpremarket notifications"; and "[a]ll documents reflecting, relatingor referring to the justification for any agency action taken inresponse to each of the relevant premarket notifications." J.A. 25-30. Plaintiffs also sought testimony from 14 FDA employees,including five "special" employees who comprised an advisorycommittee that reviewed pedicle screw systems. J.A. 25-26. Thefederal government sought a protective order, submitting evidencethat special employees would be "hesitant to serve" on advisorypanels if they could be subjected to depositions in private lawsuits.J.A. 25, 33, 34-35. Nonetheless,the district court allowed discoveryto go forward against all but a single government employee. See Inre Orthopedic Bone Screw Prods. Liab. Litig., MDL 1014, slip op.at ¶ 2 (E.D. Pa. Aug. 21, 1995) (PTO 92).

The FDA's regulatory decisions about pedicle screws also fellsubject to judicial monitoring and supervision as a result of thislitigation. At the request of the district court, the FDA extended theperiod for filing public comments on the FDA's proposal toreclassify pedicle screws. See In re Orthopedic Bone Screw Prods.Liab. Litig., MDL 1014, slip op. at 1 (E.D. Pa. Jan. 2, 1996) (PTO188). The FDA was ordered to turn over to plaintiffs its internal

45

files on an FDA-monitored study on pedicle screw safety, see In reOrthopedic Screw Prods. Liab. Litig., MDL 1014, slip op. at 2(E.D. Pa. Oct. 16, 1995) (PTO 147), and ultimately to discloseinformation about the study sufficient to allow identification ofparticipating physicians in breach of the agency's promise ofconfidentiality. See Pl. Mem. in Support of Pl. Mtn. for OrderRequiring Disclosure of Additional Confidential Info. at 4-6, 18-24,Docket No. 1184, In re Orthopedic Screw Prods. Liab. Litig., MDL1014 (E.D. Pa. filed Dec. 6, 1995).

The interference that this litigation has caused with FDAoperations is not aberrational. If state "fraud on the agency" claimswere permitted to go forward, their predictable effect would be toswamp federal agencies with information they do not want andhave not requested, and generally to interfere with agencies'abilities to carry out their mandated duties. The States have nopower, under the Supremacy Clause, to impose these harmfuleffects on the federal regulatory process.

III. THE COURT SHOULD RECONSIDER ASPECTS OFMEDTRONIC THAT ERRONEOUSLYRESTRICT THESCOPE OF EXPRESS PREEMPTION UNDER THEMDA

As we have explained, plaintiffs' "fraud on the FDA" claim isexpressly preempted under Section 360k(a) and this Court'sdecision in Medtronic, as well as impliedly preempted by federallaw. But if the Court disagrees with our preemption argumentsunder current law, it should take this opportunity to revisit andreconsider its conclusion in Medtronic that express preemptionunder Section 360k(a) applies only to "specific" requirements.Seepage 24, supra. With all due respect, the four dissenting Justices inMedtronic were correct when they observed that "[t]he statutemakes no mention of a requirement of specificity, and there is nosound basis for determining that such a restriction on 'any require-ment' exists." 518 U.S. at 512 (opinion of O'Connor, J.).

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1. Stare decisis "is a principle of policy rather than an inexora-ble command." Hohn v. United States, 524 U.S. 236, 251 (1998)(citation and quotation marks omitted). Although the doctrine hasmore force in statutory cases, this Court has not hesitated to reviseits construction of a statute when "a precedent may be a positivedetriment to coherence and consistency in the law * * * because ofinherent confusion created by an unworkable decision." Pattersonv. McLean Credit Union, 491 U.S. 164, 173 (1989); see alsoMonell v. New York City Dep't of Soc. Servs., 436 U.S. 658, 695(1978).

Experience has proven this Court's fractured decision inMedtronic to be just such a case. As demonstrated in the petition(at 14-16, 19-25), the lower courts have had tremendous difficultyunderstanding what the decision means and how it should beapplied. See also Wilson v. Bradlees of New England, Inc., 96 F.3d552, 559 (1st Cir. 1996) (per Boudin, J.) (this Court's "divisions"in Medtronic "make even more general forecasts shaky"), cert.denied, 519 U.S. 1149 (1997). In this respect as well, the Medtronicdissenters have turned out to be correct. See 518 U.S. at 509(opinion of O'Connor, J.) (describing majority's analysis as"bewildering").

The problem lies not just in understanding how the threeseparate opinions interact to dispose of the issues before the Court(although that has been difficult enough for the lower courts). SeePet. 19-25. It also lies in the hopelessly ambiguous concept of"specificity" itself, which could refer either to the content of arequirement (as in Justice Breyer's 2-inch wire, which is "specific"when compared to a more generalized duty to use care in thedesign of a product) or to a requirement's applicability to morethan a single device, a single class of devices, or to products inaddition to medical devices. As the United States acknowledged atthe petition stage (U.S. Br. 10 n.4), even a requirement that isgeneral in content or that applies broadly to products other thanmedical devices can (and usually does) become "specific" over thecourse of litigation as the plaintiff develops his precise theory of

47

liability and as general duties are applied to the individual deviceat issue.

2. This aspect of Medtronic should also be revisited because itrests on an erroneous premise. In adopting the "specificity"requirement as a gloss on Section 360k(a), the majority reasonedthat "the FDA has never granted, nor, to the best of our knowledge,even been asked to consider granting, an exemption for a state lawof general applicability." 518 U.S. at 499-500. In fact, the FDA hasrepeatedly treated state requirements that are not "specific" --because they are not limited to a single medical device, class ofmedical devices or even to medical devices in general, or becausethey are general in content -- as eligible for exemption fromexpress preemption. Perhaps the best example of the former isCalifornia's Sherman Food, Drug and Cosmetic Law, whichcontains numerous provisions that are couched in general termsand/or pertain to drugs as well as to medical devices -- provisionsthat the FDA has considered for exemption under Section 360k(b).See 44 Fed. Reg. 19440 (1979); 21 C.F.R. § 808.55(b)(1).12

In addition, as noted above (see note 6, supra), the FDA hastaken the position in regulatory notices, as well as in its brief inMedtronic (Nos. 95-754 and 95-886 U.S. Br. 24-25 & nn.19-20),that the federal GMP requirements trigger express preemption andthat state GMP regulations are susceptible to express preemption.Indeed, the FDA has indicated that if California -- which inpassing the Sherman Law "adopt[ed] the FDA GMP regulations asits own" -- either "interprets or applies the GMP regulations in

12 For example, the FDA has determined that Section 360k(a)preempts a California provision that makes it unlawful "for anyperson to advertise any drug or device represented to have any effectin any of the following con ditions, disorders, o r diseases: * * * (m)[d]iseases or disorders of the ear or auditory apparatus, includinghearing loss and deafness." 21 CAL. HEALTH & SAFETY CODE§ 26463(m) (1984 ) (emphasis added). According to the FD A, thisprovision is preempted "to the extent that it app lies to hearing aids."21 C.F.R. § 808.55(b)(2); 45 Fed. Reg. at 67322.

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such a way as to make them different from or in addition to theFederal regulations, then the California requirements will bepreempted to that extent." 45 Fed. Reg. 67321, 67322 (1980)(emphasis added). That plainly indicates that state and federal"requirements" that are expressed generally and that apply to awide array of medical devices as well as other products fall withinthe scope of Section 360k(a).

It is no small irony, then, that a majority in Medtronic --relying principally on deference to the FDA -- held that the federalGMPs do not impose "requirements" that are sufficiently"specific"to trigger express preemption. 518 U.S. at 501. That holding is infact contrary to the FDA's own longstanding position. For thatreason as well, Medtronic's endorsement of the specificity conceptshould be reconsidered. Deference, in other words, required theopposite result.

In fact, a close examination of the regulatory record indicatesthat the FDA's "specificity" concept never was intended to be alimitation on the type of federal requirements that trigger expresspreemption under Section 360k(a). Language in the pertinentregulation (21 C.F.R. § 808.1(d)) that was interpreted in Medtronicas recognizing a "specificity" limit merely stated that a counterpartfederal requirement must be in existence before state requirementsare preempted. See 43 Fed. Reg. 18661, 18662, 18664 (1978); 42Fed. Reg. 30383, 30383-30384 (1977). In other words, the relevantFDA regulation, read against the backdrop of its regulatory history,was designed to ensure that there would not be a regulatoryvacuum immediately after the MDA was passed, in which all staterequirements relating to medical devices would be preempted(even before the FDA took any regulatory action to implement theMDA).

3. The final reason why the Court should abandon the "specific-ity" gloss is that it makes no sense. On the state side, why wouldCongress have meant to preempt "different" or "additional" staterequirements imposed by laws that apply exclusively to medicaldevices, but to preserve the very same requirements if imposed by

49

laws that apply to other products as well? In either case, the impacton uniformity and the harm to the federal scheme is exactly thesame. On the federal side, why would Congress have meant todisable the FDA from issuing a preemptive requirement inregulations that are applicable to all or many devices, but to allowthe agency to preempt state law if it imposed exactly the samerequirement in a thousand separate regulations, each applicable toa single device? There is simply no reason to attribute to Congresssuch an absurd design, which would empower States to avoidpreemption through skillful drafting and would place formalisticrestrictions on the FDA's power to issue preemptive requirements.And if "specificity" relates to the content (as opposed to theapplicability) of state and federal requirements covered by Section360k(a), how would a court determine when a requirement is"specific" enough to come within Section 360k(a)?

Not surprisingly, this Court has repeatedly rejected invitationsto read similar limitations into other express preemption provisions.Illustrative is Morales v. Trans World Airlines, Inc., 504 U.S. 374(1992), which involved a provision of the Airline Deregulation Actof 1978 ("ADA") that "pre-empts the States from 'enact[ing] orenforc[ing] any law, rule, regulation, standard or otherprovision * * * relating to rates, routes, or services of any aircarrier.'" Id. at 383 (quoting 49 U.S.C. App. § 1305(a)(1)). TheCourt categorically rejected the argument that "only state lawsspecifically addressed to the airline industry are pre-empted,whereas the ADA imposes no constraints on laws of generalapplicability." Id. at 386.13 Such an interpretation, this Court noted,

13 Accord Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 47-48 (1987)(ERISA preemption is not limited to state measures targeting ERISAplans but also includes more general common law tort and contractcauses of action); San Diego Bldg. Trades Council v. Garmon, 359U.S. 236, 244 & n.3 (1959) ("Nor has it mattered [in cases involvingNLRA preemption] whether the States have acted through laws ofbroad general application rather th an laws specifically directed
(continued...)

50

would create "an utterly irrational loophole." Ibid. (emphasisadded). That criticism applies with equal force to the interpretationof Section 360k(a). The Court should take this opportunity toeliminate this "utterly irrational loophole" from the law of expresspreemption under the MDA.

CONCLUSION

The judgment of the court of appeals should be reversed.

Respectfully submitted.

SCOTT BURESH             KENNETH S. GELLER     FRED FELLER                Counsel of Record     Buresh, Kaplan, Jang,  ALAN E. UNTEREINER        Feller & Austin        SHARON SWINGLE        2298 Durant Ave.         Mayer, Brown & Platt  Berkeley, CA 94704       1909 K Street, N.W.   (510) 548-7474           Washington, DC 20006                           (202) 263-3000      GEORGE P. NOEL                                   Noel & Hackett                                 P.O. Box 1590                                  Media, PA 19063                                (610) 892-7700    SEPTEMBER 2000

13 (...continued)
towards the governance of industrial relations.")

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