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                               

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

(I)

ii

Pursuant to Supreme Court Rule 29.6, petitioner states that it has no parent company and that no publicly held company owns 10% or more of its stock.

iii

                                                          Page

QUESTION PRESENTED ........................................  I

RULE 29.6 STATEMENT ....................................... ii

TABLE OF AUTHORITIES ......................................  v

OPINIONS BELOW ............................................  1

JURISDICTION ..............................................  1

CONSTITUTIONAL AND STATUTORY
  PROVISIONS INVOLVED .....................................  1

STATEMENT .................................................  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 ................ 12

SUMMARY OF ARGUMENT ....................................... 13

ARGUMENT .................................................. 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



iv

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 ......... 40

III. THE COURT SHOULD RECONSIDER ASPECTS OF
     MEDTRONIC THAT ERRONEOUSLY RESTRICT THE
     SCOPE OF EXPRESS PREEMPTION UNDER THE
     MDA .................................................. 45

CONCLUSION ................................................ 50



v

TABLE OF AUTHORITIES
                                                          Page

Cases:

Allis-Chalmers Corp. v. Lueck, 471 U.S. 202 (1985) ........ 36

Arizona v. California, 283 U.S. 423 (1931) ................ 41

Arkansas-Louisiana Gas Co. v. Hall,
  453 U.S. 571 (1981).................................. 36, 43

Bethlehem Steel Co. v. New York State Labor
  Relations Bd., 330 U.S. 767 (1947)................... 31, 33

Boggs v. Boggs, 520 U.S. 833 (1997)........................ 33

Boyle v. United Technologies Corp., 487 U.S. 500
  (1988) .............................................. 31, 40

Chicago & N.W. Transp. Co. v. Kalo Brick &
Tile Co., 450 U.S. 311 (1981) ............................. 39

Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992) .. 14-15

Exxon Shipping Co. v. U.S. Dep't of Interior,
  34 F.3d 774 (9th Cir. 1994) ............................. 43

Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta,
  458 U.S. 141 (1982) ..................................... 32

Freightliner Corp. v. Myrick, 514 U.S. 280 (1995).......... 33

Gade v. National Solid Wastes Management Ass'n,
  505 U.S. 88 (1992) ...................................... 36



vi

TABLE OF AUTHORITIES -- Continued
                                                          Page

Garner v. Teamsters Local Union No. 776,
  346 U.S. 485 (1953) ..................................... 38

Geier v. American Honda Motor Co., 120 S. Ct.
  1913 (2000) ......................................... 14, 33

Hancock v. Train, 426 U.S. 167 (1976) ..................... 41

Heckler v. Chaney, 470 U.S. 821 (1985) .................... 35

Hines v. Davidowitz, 312 U.S. 52 (1941) ................... 31

Hohn v. United States, 524 U.S. 236 (1998)................. 46

Howard v. Lyons, 360 U.S. 593 (1959) ...................... 41

International Paper Co. v. Ouellette, 479 U.S.
  481 (1987) .............................................. 36

Johnson v. Maryland, 254 U.S. 51 (1920) ................... 41

Leslie Miller, Inc. v. Arkansas, 352 U.S. 187 (1956) ...... 33

Lewis v. Brunswick Corp., 107 F.3d 1494
  (11th Cir. 1997), cert. dismissed,
  523 U.S. 1113 (1998) ............................ 33, 39, 40

Mayo v. United States, 319 U.S. 441 (1943) ................ 41

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

Merrell Dow Pharmaceuticals, Inc. v.
  Thompson, 478 U.S. 804 (1986) ........................... 36
  


vii

TABLE OF AUTHORITIES -- Continued
                                                          Page

Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.),
  cert. denied, 516 U.S. 815 (1995)..................... 9, 10

Mitchell v. Collagen Corp., 126 F.3d 902 (7th
  Cir. 1997), cert. denied, 523 U.S. 1020
  (1998) .................................................. 26

Monell v. New York City Dep't of Soc. Servs.,
  436 U.S. 658 (1978) ..................................... 46

Morales v. Trans World Airlines, Inc., 504 U.S. 374
  (1992) ........................................... 14, 49-50

Nantahala Power & Light Co. v. Thornburg,
  476 U.S. 953 (1986) ..................................... 39

Ortho Pharm. Corp. v. Cosprophar, Inc., 32 F.3d 690
  (2d Cir. 1994) ..........................................  4

Papas v. Upjohn Co., 985 F.2d 516 (11th Cir.),
  cert. denied, 510 U.S. 913 (1993)........................ 40

Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.),
  cert. denied, 522 U.S. 862 (1997)........................ 26

Patterson v. McLean Credit Union, 491 U.S.
  164 (1989) .............................................. 46

Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41 (1987)......... 49

San Diego Bldg. Trades Council v. Garmon,
  359 U.S. 236 (1959) ..................................... 49
  


viii

TABLE OF AUTHORITIES -- Continued
                                                          Page

Schneidewind v. ANR Pipeline Co., 485 U.S. 293
  (1988) .................................................. 39

United States ex rel. Touhy v. Ragen, 340 U.S.
  462 (1951) .............................................. 43

United States v. Locke, 120 S. Ct. 1135 (2000) ............ 31

Weinberger v. Hynson, Westcott & Dunning, Inc.,
  412 U.S. 609 (1973) ..................................... 35

Welchert v. American Cyanamid, Inc., 59 F.3d 69
  (8th Cir. 1995) ...................................... 39-40

Wilson v. Bradlees of New England, Inc., 96 F.3d 552
  (1st Cir. 1996), cert. denied, 519 U.S. 1149 (1997)...... 46

Constitutional Provision, Statutes,
Regulations, and Rules:

U.S. CONST. art. VI, cl. 2.................................  1

7 U.S.C. § 136v(b) ........................................ 39

15 U.S.C. § 1203(a) ....................................... 39

15 U.S.C. § 1261 note (b)(1)(A) ........................... 39

15 U.S.C. § 1392(d) ....................................... 39

15 U.S.C. § 1476(a) ....................................... 39

15 U.S.C. § 1075(a) ....................................... 39



ix

TABLE OF AUTHORITIES -- Continued
                                                          Page

18 U.S.C. § 1001 .......................................... 28

21 U.S.C. § 331(a)......................................... 20

21 U.S.C. § 336............................................ 35

21 U.S.C. § 337(a)......................................... 35

21 U.S.C. § 337(b) ........................................ 36

21 U.S.C. § 355(d)(1) ..................................... 22

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

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

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

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

21 U.S.C. § 360c(a)(2)(B).................................. 22

21 U.S.C. § 360c(f)(1).....................................  3

21 U.S.C. § 360c(f)(1)(B) .................................  3

21 U.S.C. § 360c(i)(1)(A) .............................. 3, 23

21 U.S.C. § 360c(i)(1)(D) ................................. 42

21 U.S.C. § 360c(i)(1)(E)(i)............................... 21

21 U.S.C. § 360e ..........................................  3



x

TABLE OF AUTHORITIES -- Continued
                                                          Page


21 U.S.C. § 360e(a)......................................... 3

21 U.S.C. § 360e(b)(1)(B)............................... 3, 19

21 U.S.C. § 360i........................................... 41

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

21 U.S.C. § 360k(b).................................... 17, 47

21 U.S.C. § 360l........................................... 41

21 U.S.C. § 360ll.......................................... 41

21 U.S.C. § 360nn.......................................... 41

21 U.S.C. § 360ss ......................................... 39

21 U.S.C. § 371(a)......................................... 35

21 U.S.C. § 371(h) ........................................ 35

21 U.S.C. § 393............................................ 35

21 U.S.C. § 396..................................... 4, 20, 42

28 U.S.C. § 1254(1)......................................... 1

46 U.S.C. § 4306........................................... 39

49 U.S.C. App. § 1305(a)(1) ............................... 49

21 CAL. HEALTH & SAFETY CODE § 26463(m)
  (1984) .................................................. 47



xi

TABLE OF AUTHORITIES -- Continued
                                                          Page

21 C.F.R. § 10.25(a) ...................................... 36

21 C.F.R. § 10.25(b) ...................................... 35

21 C.F.R. § 10.30(e) ...................................... 36

21 C.F.R. § 20.1 .......................................... 43

21 C.F.R. § 20.2 .......................................... 43

21 C.F.R. § 801.4 ..................................... 23, 24

21 C.F.R. Part 803 ........................................ 41

21 C.F.R. Part 804 ........................................ 41

21 C.F.R. Part 806 ........................................ 41

21 C.F.R. § 807.87 (1986)................................ 3, 7

21 C.F.R. § 807.87 (1999)............................... 3, 23

21 C.F.R. § 807.87(e) (1986, 1989)..................... 25, 29

21 C.F.R. § 807.87(h) (1986)........................ 3, 27, 29

21 C.F.R. § 807.87(j)...................................... 28

21 C.F.R. § 807.87(l)....................................... 3

21 C.F.R. § 807.100(b)(1).................................. 23

21 C.F.R. § 808.1(d) .......................... 17, 25, 29, 48



xii

TABLE OF AUTHORITIES -- Continued
                                                          Page

21 C.F.R. § 808.1(d)(1).................................... 27

21 C.F.R. § 808.1(d)(2).................................... 19

21 C.F.R. § 808.55(b)(1)................................... 47

21 C.F.R. § 808.55(b)(2)................................... 47

21 C.F.R. Part 820 Subpart M ...............................41

21 C.F.R. Part 821 .........................................41

FED. R. CIV. P. 9(b) .......................................26

FED. R. CIV. P. 54(b) ......................................10

Miscellaneous:

Callahan, The Process of FDA Approval of a Spinal
  Implant: Governmental Perspective, 2 J. SPINAL
  DISORDERS 288 (1989) .................................... 22

Center 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>) ............................................. 22

Comments by Plaintiffs' Legal Committee in In re
  Orthopedic Bone Screw Prods. Liab. Litig., FDA
  Dkt. No. 95N-0176 (filed March 1, 1996) ................. 12



xiii

TABLE OF AUTHORITIES -- Continued
                                                          Page

FDA Oversight: Medical Devices: Hearing before
  the Subcomm. on Oversight and Investigations
  of House Comm. on Energy & Commerce,
  97th Cong., 2d Sess. (1982) ............................. 34


FOOD & DRUG ADMIN., REPORT OF THE
  HALCION TASK FORCE (1996) ............................... 39

FOOD & DRUG ADMIN., UPDATE ON PEDICLE SCREWS
  (1993) ................................................ 4, 6

H.R. REP. NO. 94-853 (1976)............................ passim

More Information for Better Patient Care: Hearings
  on S. 1477 Before the Senate Comm. on Labor
  and Human Resources, 104th Cong. (1996) ................. 42

Nightingale, Unlabeled Uses of Approved Drugs,
  26 DRUG INFO. J. 141 (1992) ...................... 4, 20, 23

Pedicle Screws, 24 FED. MED. BULL. 10 (May 1994) .......... 20

Sherman, Use of Federal Statutes in State Negligence
  Per Se Actions, 13 WHITTIER L. REV. 831 (1992)........... 36

S. REP. NO. 105-43 (1997).................................. 21

U.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



xiv

TABLE OF AUTHORITIES -- Continued
                                                          Page

Use of Approved Drugs for Unlabeled Indications,
  12 FDA DRUG BULL. 4 (April 1982) ......................... 4

26A C. WRIGHT & K. GRAHAM, FEDERAL PRACTICE &
  PROCEDURE (1992) ........................................ 43

37 Fed. Reg. 16503 (1972) ................................. 20

41 Fed. Reg. 37457 (1976) ................................. 35

42 Fed. Reg. 30383 (1977) ................................. 48

43 Fed. Reg. 18661 (1978).............................. 30, 48

44 Fed. Reg. 19440 (1979) ................................. 47

45 Fed. Reg. 67321 (1980).......................... 30, 47, 48

55 Fed. Reg. 52323 (1990) ................................. 35

56 Fed. Reg. 46191 (1991) ................................. 35

57 Fed. Reg. 18062 (1992) ................................. 22

60 Fed. Reg. 51946 (1995) .............................. 6, 12

63 Fed. Reg. 40025 (1998) ................................. 12

63 Fed. Reg. 64556 (1998) ................................. 22

65 Fed. Reg. 44540 (2000) ................................. 42

BRIEF FOR PETITIONER

-----------------------

The relevant provision of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360k(a), is reproduced at Pet. App. 59a.

STATEMENT

2

A. The Regulatory Structure Of The Medical Device Amendments

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

The MDA divides medical devices into three classifications based on the possible risks of harm. Devices such as tongue depressors, which present little likelihood of illness or injury, are designated as Class I and subjected only to minimal regulation, or "general controls." 21 U.S.C. § 360c(a)(1)(A). Potentially more dangerous 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 that either (1) are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in 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 "substantially equivalent" to a pre-1976 device initially are automatically consid-

3

Except for certain exempt devices, manufacturers must obtain permission to market post-1976 devices in one of two ways. First, for certain Class III devices, the FDA may grant approval after a thorough premarket approval (PMA) process, in which the manufacturer 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 took effect, the FDA may permit marketing of a new device if the manufacturer submits a "premarket notification" showing that the device is "substantially equivalent" to a pre-1976 device. Id. §§ 360e(b)(1)(B), 360(k), 360c(f)(1)(B). The "premarket notification" route is often referred to as the "510(k)" process, after the section number in the original Act. See Medtronic, 518 U.S. at 478.

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, and advertisement sufficient to describe the device, its intended use, and the directions for its use"; supporting information; comparisons with currently distributed devices; and data showing the effect on safety 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 the Commissioner that is necessary * * * to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution." 21 C.F.R. § 807.87(l); id. § 807.87(h) (1986). Substantial equivalence under Section 510(k) requires that a device "ha[ve] the same intended use as the predicate device." 21 U.S.C. § 360c(i)(1)(A).

Once a device has been cleared for marketing under Section 510(k), the manufacturer may not market or promote it for uses

4

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

Petitioner The Buckman Company (Buckman) is a regulatory consultant for medical device manufacturers, helping them navigate FDA procedures, plan regulatory strategy, and monitor clinical investigations. In 1984, AcroMed Corporation hired Buckman as its liaison with the FDA in an effort to obtain marketing clearance for its devices. Pet. App. 4a-5a. Buckman assisted AcroMed in obtaining clearance for the components of two orthopedic bone screw systems: (1) the Variable Screw Placement Spinal Plate Fixation System (VSP), and (2) the ISOLA Spine Fixation System (ISOLA).

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

5

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 as in 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 each substantially similar to pre-1976 devices and cleared the products for marketing in February 1986. Pet. App. 5a; J.A. 59-62.¹

2. The ISOLA System. AcroMed subsequently developed the ISOLA 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 to initiate clinical trials relating to use of the ISOLA in spinal applications (as it had done with the VSP, see note 1, supra). J.A. 18. Three months later, in September 1988, Buckman submitted three separate 510(k) notifications for the screws, rods, and hooks that made up the ISOLA System. Ibid. These submissions specified that the devices, like their pre-1976 equivalents, had an intended use in locations other than the pedicles of the spine. Ibid. In April and May 1989, the FDA determined that the rods, hooks, and screws were substantially equivalent to pre-1976 devices and cleared them for marketing. Id. at 19.

6

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

C. The Proceedings In The District Court

After a national television program ran a story on alleged harm caused by use of bone screws as spinal fixation devices, thousands of 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 civil cases involving 5,041 plaintiffs and 334 defendants -- were consolidated in this multidistrict litigation. Pet. App. 55a.

1. Plaintiffs' "Fraud On The FDA" Allegations. Plaintiffs did not contend that, in applying for 510(k) clearances, Buckman or AcroMed had misrepresented any objective fact, such as the size, shape, or technical characteristics of the screws, plates, rods or hooks, or their equivalence to pre-1976 devices. Rather, plaintiffs

7

In addition to the statements concerning "intended use" in the 510(k) submissions, plaintiffs premised their "fraud on the FDA" claim on a follow-up letter relating to the VSP bone plates that Buckman sent in January 1986. J.A. 15-16. The letter was submit- ted in response to a telephone call from an FDA official indicating that there was a "need for a more definitive statement covering the intended '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 information requested, stating (J.A. 58):

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

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

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

8

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

With the meeting at a stalemate I pointed out the FDA's long standing policy of evaluating (for not only substantial equiva- lence but safety and effectiveness) a device based on the labeling submitted for the device and the agreement between the labeling and the device's physical abilities to perform as the labeling claimed. I also pointed out that because of the physical and mechanical similarities between the plates and (the original design) screws of the system to ordinary bone plates and screws these devices, when labeled, indicated and promoted as simple bone screws and plates would, in fact, be substantially equivalent to pre-Amendment[] devices and could be shipped in interstate commerce. * * * I pointed to the oft stated FDA policy of not regulating the practice of medicine by individual physicians. I said that if individual practitioners, on their own without guidance from labeling or promotion by the manufac-

9

turer, chose to use the plates and screws for spinal fixation that would fall under the practice of medicine and outside FDA's authority.

J.A. 136.

In addition, Buckman explained that there was no possibility that the FDA had been misled about AcroMed's subjective hopes or desires that the screws, plates, rods, and hooks in the VSP and ISOLA Systems would be used by physicians in spinal applications. With regard to the VSP System, AcroMed had twice sought FDA clearance for spinal use; spinal applications had been discussed again at the December 1985 meeting; and shortly before the component plates and screws of the VSP gained 510(k) authorization, the company had asked the FDA for permission to begin clinical trials on the VSP System for spinal application. J.A. 13-16, 135-137. As for the ISOLA System, AcroMed had requested FDA approval to begin clinical trials concerning spinal use even before filing 510(k) notifications for individual components of the System. J.A. 17-18. In clearing the iliac screw component, the FDA had specifically directed the company to warn that it had "NOT BEEN APPROVED FOR PEDICULAR APPLICATION." J.A. 19.

2. The District Court's Decisions. In March 1995, the district court granted judgment on the pleadings on the "fraud on the agency" claim, holding that it was preempted both expressly by the MDA and impliedly by the federal scheme. Pet. App. 46a-53a. The district court explained that the MDA's express preemption provision "does not permit courts to 'perform the same functions initially 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 proper authority to regulate this field, courts are prohibited from conducting 'a searching state inquiry into the inner workings of FDA procedures.'" Ibid. (quoting Michael, 46 F.3d at 1329); see also Pet. App. 50a (reasoning that, "given the FDA's central role in

10

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

In March 1997, the district court reaffirmed its ruling that plaintiffs' "fraud on the agency" claim was preempted. Pet. App. 33a-44a. The court agreed that Medtronic had undercut portions of its previous analysis but held that the claim was still precluded because it was inconsistent with Congress's decision not to include a private right of action under federal law. Id. at 36a-37a. The court added that plaintiffs' claim was "not interchangeable" with the claims at issue in Medtronic, which involved no allegation of fraudulent procurement of agency clearance and therefore did not amount 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 for failure 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) of the Federal Rules of Civil Procedure. Pet. App. 54a-56a.

11

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 Michael that state "fraud on the FDA" claims are expressly and impliedly preempted. Id. at 13a-17a & n.5.

The court of appeals' reasons for rejecting express preemption were set forth in a single paragraph. According to the majority, the MDA did not expressly preempt "fraud on the FDA" claims because 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 broadly declared that plaintiffs' common law fraud claim does not impose any "state 'requirement' 'with respect to' that device." Ibid. Finally, the majority reasoned that the state requirements plaintiffs sought to enforce do not "impose any obligation on Buckman [that is] inconsistent with federal law," because federal law prohibits making fraudulent statements to the FDA. Ibid.

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

12

E. The FDA's Reclassification Proceeding

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

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

13

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

II. Plaintiffs' "fraud on the FDA" claim is also impliedly preempted. Unlike the traditional state tort requirements involved in Medtronic, the gravamen of plaintiffs' claim is that petitioner Buckman defrauded a federal agency. That claim amounts to a collateral attack on the FDA's decision to clear the relevant devices for marketing. To prevail on their state-law claim, plaintiffs would have to show that the AcroMed devices should not have been on the market. But, from the perspective of the federal government, these devices were properly on the market. It is difficult to imagine a 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 that was not disclosed, and (4) what the FDA would have done if

14

Plaintiffs' "fraud on the FDA" claim also would conflict with the 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 the uniformity of federal law. And it would interfere substantially with federal government operations, by subjecting agency personnel to intrusive discovery, creating serious distortions in the FDA's regulatory 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 reexamine Medtronic's conclusion that the MDA's express preemption clause encompasses only "specific requirements" imposed by state and federal law. The concept of "specificity" is contrary to the plain language of Section 360k(a); is inherently ambiguous; has spawned enormous confusion and conflict in the lower courts; and has led to uncertainty and serious practical difficulties for device manufacturers. It is also based on an erroneous view of the FDA's past regulatory practice. The Court should eliminate this "utterly irrational loophole" (Morales v. Trans World Airlines, Inc., 504 U.S. 374, 386 (1992)) from the law of MDA preemption.

ARGUMENT

15

This case is entirely different. The gravamen of plaintiffs' state- law claim is that certain participants in a federal regulatory process defrauded the federal agency. According to the plaintiffs, petitioner should have made certain disclosures and statements (and should not have made others) to the Food and Drug Administration in the course of seeking regulatory clearance to market certain medical devices. But it is hardly a traditional role of state law to police whether parties to a federal regulatory process comply with disclosure requirements imposed by a federal agency. Although state law generally includes protections against fraud, plaintiffs do not claim that they were defrauded; they claim that the FDA was defrauded.

This case accordingly bears no resemblance to the product liability suit in Medtronic, which involved routine state-law claims of design and manufacturing defects. This case also differs from Medtronic because preempting plaintiffs' claim here would not have "the perverse effect of granting complete immunity from design defect liability to an entire industry." 518 U.S. at 487. To the contrary, plaintiffs would still be able to bring product liability suits against 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 plaintiffs would have had under state law if the MDA had not been enacted. Indeed, plaintiffs' claim could not exist if there were no federal regulatory process in place; it is entirely dependent upon, and derivative of, a federal regulatory proceeding.

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

16

For all of these reasons, plaintiffs' unorthodox claim is expressly as well as impliedly preempted by federal law. Plaintiffs' claim is expressly preempted because it imposes disclosure requirements with respect to medical devices that are plainly "different from, or in addition to" the disclosure requirements imposed by federal law. 21 U.S.C. § 360k(a). Plaintiffs' claim is impliedly preempted because it is a collateral attack on the marketing clearance decisions of expert federal regulators; it conflicts with Congress's decision to delegate to the FDA exclusive regulatory authority over the MDA (and Congress's corresponding decision not to create a private right of action under the MDA); it threatens the uniformity of federal law; and it creates distortions in the federal regulatory process, in the flow of information relating to off-label uses of devices, and in the agency's allocation of its own resources.

17

In enacting the MDA, Congress sought to preserve the unifor- mity of the federal regulatory scheme and to protect innovations in device 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" was expressed in a broadly worded preemption clause:

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

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

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

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

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

18

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 of Section 360k(a) adopted by the FDA in setting forth the agency's procedures for considering exemptions from preemption. See 21 C.F.R. § 808.1(d). The Court also instructed that any inquiry into express preemption requires "a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre- empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations." 518 U.S. at 500. We accordingly explain, first, why the federal and state disclosure "requirements" involved in this case are different and, second, why those requirements fit within the ambit of Section 360k(a) as construed in Medtronic.

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

1. As an initial matter, we note that plaintiffs have never disputed that, at the time of the conduct giving rise to their claim, federal law imposed "requirements" on Buckman to make certain disclosures to the FDA in the 510(k) process involving the AcroMed devices. Indeed, plaintiffs have consistently maintained that Buckman violated the agency's disclosure requirements -- an allegation that would make no sense if disclosure of the information specified in the agency regulations were optional. Although the parties vehemently disagree about what disclosures federal law

19

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 duties imposed through the common law constitute "requirements"within the 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 (opinion of Breyer, J.). Indeed, Justice Breyer even gave as an example of a claim that would be preempted by the MDA "a state law tort action that premises liability upon the defendant manufacturer's failure to use 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 law in Justice Breyer's hypothetical.

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

20

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

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

21

a. The statutory text strongly confirms our understanding of the scope of the federal disclosure requirement. In its current form, the MDA expressly provides that the "intended use" of a device in the 510(k) context is the use designated by the manufacturer in its submission to the FDA. The statute provides that "[a]ny determina- tion by the Secretary of the intended use of a device," for purposes of determining whether the device is "substantially equivalent" to a pre-1976 device, "shall be based upon the proposed labeling" in the 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 warning statement on the device's label against foreseeable uses that are potentially harmful -- just as it did here, in requiring the statement "WARNING -- THIS DEVICE HAS NOT BEEN APPROVED FOR PEDICULAR APPLICATION" to be included on labeling of the 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 its 510(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 the FDA have made clear that it corresponds to the original intent of Congress about how Section 510(k) should be applied. The committee report accompanying the clarifying amendment explains that 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 listed in proposed labeling "is not different from the manner in which 510(k)s have traditionally been reviewed." U.S. Dep't of Health &

22

b. Prior FDA pronouncements and applications of the statute are consistent with the principle that the intended use of a device for 510(k) purposes is determined by labeling claims rather than by the manufacturer's subjective intent. Thus, an FDA official explained in 1989 that determining whether the "intended use" of a device is substantially equivalent to that of a predicate device is established by asking whether the new device has the "Same Indication Statements" as the pre-1976 device. Callahan, The Process of FDA Approval of a Spinal Implant: Governmental Perspective, 2 J. SPINAL DISORDERS 288, 289 (1989); accord Center 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 agency official noted, "it does so on a device-by-device basis for specific intended uses and not in general terms, e.g., pedicle spinal fixation systems." Callahan, 2 J. SPINAL DISORDERS at 290 (emphasis added); see also, e.g., 57 Fed. Reg. 18062, 18063 (1992) ("[i]n determining whether the new device has the same intended use as a predicate device" under Section 510(k), FDA assesses "any differences in indications for use in terms of the safety and effectivenessquestions they may raise" (emphasis added)); 63 Fed. Reg. 64556, 64560 (1998) (noting that new "intended use" is created when device previouslymarketed for general use is labeled for use on specific body part).

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

23

c. Determining substantial equivalence under 510(k) by reference to a manufacturer's subjective intent is also difficult to reconcile with the nature of the 510(k) process itself. The substan- tial equivalence inquiry under 510(k) is necessarilycomparative in nature: the 510(k) device must "ha[ve] the same intended use as the predicate 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 how the manufacturer of a predicate device subjectively intended for it to be used prior to 1976 (or for that matter what the manufacturer's subjective intent is today, because the FDA does not require manufacturers to seek clearance of new off-label uses for devices that are already on the market).⁴ Accordingly, the intended use of the predicate device must necessarily be judged by its labeling claims. Under plaintiffs' theory, the FDA would have to apply one standard of "intended use" to the predicate device and another,

⁴ The FDA's longstanding position has been that "the decision about whether or not, and when" to apply for approval of off-label uses is the manufacturer's alone to make. Nightingale, 26 DRUG. INFO. J. at 142.

24

d. Plaintiffs' subjective standard also undermines the basic purpose underlying Section 510(k), which is to ensure that pre- 1976 devices are not insulated from competition by later market entrants. Plaintiffs' definition of intended use would mandate rejection of new devices based on vague notions of subjective intent. That, in turn, would have the effect of impeding competition even where the proposed 510(k) device has the same labeling claim as a predicate, pre-1976 device to which the proposed device is substantially equivalent. There is no reason to think that Con- gress meant to enhance competition only where manufacturers of 510(k) devices have no subjective hope, desire, or expectation that their devices, once cleared, might be used by physicians for some off-label use.

e. Finally, plaintiffs' definition of intended use would be wholly unworkable in practice. Plaintiffs have not explained, for example, whose subjective intent would have to be disclosed to the FDA. If a corporate director intended one use for a device, while the marketing director intended another, which would be subject to mandatory disclosure to the FDA and govern the substantial equivalence inquiry? Cf. 21 C.F.R. § 801.4 (defining intended use for labeling purposes as "objective intent of persons legally responsible for the labeling of devices" (emphasis added)). What if corporate officials intended primarily that the device would be used in a well-established manner, but hoped for eventual accep- tance of a now-experimental methodology? Would it make any difference if the company's subjective intent changed between the time it filed the 510(k) notification and the FDA's clearance of the device for marketing? These questions demonstrate why 510(k) disclosure requirements focus on how a device will be labeled and do not extend to a manufacturer's subjective intent or hope about how a device might be used.

25

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

The FDA, however, has taken the position that Section 360k(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 to endorse 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 mention of a requirement of specificity, and there is no sound basis for determining that such a restriction on 'any requirement' exists."). Whether Medtronic's actual holding turned on the absence of specificity in the state requirements involved in that case is not altogether 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 that requirements under Section 360k(a) are preempted or preemptive only if they are "specific."

26

In any event, the state requirements underlying plaintiffs' claim satisfy any "specificity" gloss that might apply. In sharp contrast to Medtronic, where "the precise contours of [plaintiffs'] theory of recovery" had "not yet been defined" (518 U.S. at 495), plaintiffs' "fraud on the agency" claim has been set forth in minute detail in their complaint (see J.A. 13-21), as required by Fed. R. Civ. P. 9(b). Plaintiffs allege that Buckman and AcroMed should have made specific disclosures to the FDA in connection with the 510(k) submissions they made for the components of the VSP device and ISOLA Systems. In particular, plaintiffs claim that Buckman was required to state precisely that AcroMed had a subjective desire or intent that each of these devices would be used by physicians in spinal applications. That claim is just as "specific" as Justice Breyer's example of a claim based on the manufacturer's failure to use 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 Mitchell v. Collagen Corp., 126 F.3d 902, 912 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1998).

27

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

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

The federal disclosure requirements at issue in this case are derived from FDA regulations in effect at the time Buckman submitted 510(k) notifications for the devices comprising the VSP and ISOLA Systems. Those regulations, which remain in force today, mandated the disclosure for proposed 510(k) devices of "the following information: * * * (e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use." 21 C.F.R. § 807.87(e) (1986, 1989) (emphasis added). The FDA's regulations also required regulated entities to supply "[a]ny additional information regarding the device requested by the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution." 21 C.F.R. § 807.87(h) (1986, 1989).

28

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

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

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

29

This case presents an especially strong one for preemption because of the active role played by the FDA in requiring Buckman to make disclosures about the "intended use" of the AcroMed devices. It is undisputed that the FDA met with Buckman and AcroMed in December 1985 specifically to discuss the "intended use" of the VSP System. It is also undisputed that after Buckman submitted the 510(k) notifications for the VSP, the FDA reviewed those submissions and requested a more detailed disclosure, which was 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 combined into a single 510(k) submission. J.A. 18. Plaintiffs also allege that the FDA, in authorizing the marketing of the iliac screw, imposed a specific warning requirement that plainly indicated an awareness of the possibility that some physicians might use the screw in pedicle applications. J.A. 19.

30

a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved * * *, and implemented that conclusion via a specific mandate on [the] manufacturer[].

518 U.S. at 501.⁶

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

31

The only basis for plaintiffs' claim against Buckman is that the FDA should not have cleared AcroMed's devices for sale under Section 510(k). Plaintiffs do not contend that Buckman is liable because the devices were defectivelydesigned or manufactured; as a 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 the devices were marketed for an unapproved use, undoubtedly because Buckman had no involvement in marketing. Plaintiffs assert, instead, that Buckman fraudulently misrepresented the intended use of AcroMed's devices in its submissions and state- ments to the FDA and that, but for this fraud, "the FDA would not have issued 510(k) clearances for AcroMed's pedicle screw fixation devices for any purpose, the devices would not have been introduced 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 allow AcroMed's devices to be marketed; that is the sole error they challenge here.

Plaintiffs' attack on the FDA's decisional process intrudes on an area "so 'intimately blended and intertwined with responsibilities of the national government' that its nature alone raises 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 also United States v. Locke, 120 S. Ct. 1135, 1147 (2000); Boyle v. United Technologies Corp., 487 U.S. 500, 507 (1988). The basic premise of plaintiffs' claim is that the States must oversee (and occasionally override) federal agencies'decisions to ensure faithful execution of the agencies' duties. Yet the relationship between a federal agency and the entities it regulates is a matter solely of

32

Predictably, then, state "fraud on the agency" claims would have substantial adverse effects on federal law and policy. If permitted, plaintiffs' claim would undermine the validity and finality of agency decisions and threaten the interests that underlie those decisions; conflict with Congress's intent that the MDA be administered exclusively by the FDA and with the FDA's own claim of primary jurisdiction over regulated matters;contravene the FDA's decision to permit AcroMed to market its devices notwithstanding plaintiffs' allegations of fraud; and interfere substantially with FDA operations by encouraging regulated entities to flood the agency with unwanted information and by embroiling the agency and its employees in private litigation. Thus, regardless of whether plaintiffs' "fraud on the agency" claim is expressly preempted, it is impliedly preempted because it would "actually conflict" with federal law (Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982)) and would "stand[]"

33

A. "Fraud On The Agency" Claims Conflict With Federal Agencies' Interest In Valid, Final, And Correct Decisionmaking

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

"Fraud on the agency" claims contravene this basic principle. To prevail on their claim, plaintiffs must obtain a determination under state law that AcroMed's devices are illegallyon the market, even though the FDA has conclusively determined, under federal law, that they should be on the market. States lack this "virtual power of review" over federal agency decisions. Leslie Miller, Inc. v. Arkansas, 352 U.S. 187, 190 (1956); see Bethlehem Steel, 330 U.S. at 775-776. It is difficult to imagine a greater conflict between state 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 and similarly situated litigants were permitted to pursue "fraud on the agency" claims, "federal regulatory decisions that Congress intended to be dispositive would merely be the first round of decision making, with later more important rounds to be played out in the various state courts." Lewis v. Brunswick Corp., 107 F.3d 1494, 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.

34

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

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

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

35

The FDA is expresslycharged with determining when and how to 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 "issues within its statutory mandate," including the decision "whether a device that is marketed for the first time after May 28, 1976, is substantially equivalent to a previously marketed device." 21 C.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 previous decisions that "the agency conclude[s] should be reconsidered." 21 C.F.R. § 10.25(b).

The FDA's enforcement authority is marked by "complete discretion" 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 FDCA where it "believes that the public interest will be adequatelyserved by a suitable written notice or warning"). Although the FDA typicallywithdraws clearance of a device upon learning that it was obtained through fraud or misrepresentation, the agency may choose not to overturn its prior decision if, in its view, public health or other considerations support another course of action. See 56 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 other federal regulatory schemes, there is no express or implied private right of action under the FDCA. See Medtronic, 518 U.S. at 487. To the contrary, "all * * * proceedings for the enforcement, or to restrain violations, of [Title 21, Chapter 9] shall be by and in the name of the United States." 21 U.S.C. § 337(a). Although States

36

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

By infringing on the FDA's exclusive authority to decide whether a device is substantially equivalent to a pre-1976 device and to respond to fraud or misrepresentation in the clearance process, and by asking a court to nullify an FDA decision under state law, plaintiffs' claim "interferes with the methods by which the [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 not permit a court applying state law to "usurp[] a function that Congress 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 right of action under the FDCA, but held that, under Medtronic, this

37

The Third Circuit's reasoning suffers from several fatal flaws. To begin with, the language quoted from Medtronic was concerned entirely with the applicability of express preemption of common law claims under 21 U.S.C. § 360k(a). This Court had no occasion in Medtronic to consider the consequences for implied preemption of Congress's decision to preclude a private right of action under the FDCA. Indeed, even the Justices who concluded that express preemption did not apply agreed that a common law claim might nonetheless be impliedly preempted because of its conflict with the federal 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 from the routine product liability claims that were then before the Court. Medtronic upheld against preemption "a traditional damages remedy for violations of common-law duties," so long as those duties "parallel federal requirements." 518 U.S. at 495. Common law claims alleging liabilityfor design defect or negligent manufac- ture -- i.e., claims like the ones in Medtronic, id. at 481 -- are within the core of the State's police power. They rest on state- imposed duties of care, derived from state standards. They do not require a state judge or jury to evaluate the wisdom of the FDA's decision to grant marketing clearance under 510(k), and a judgment

38

The claim at issue here is of a very different sort. It involves the FDA's enforcement of its requirements governing the federal regulatory process, an area of longstanding and exclusive federal authority. It seeks to impose liability for violation of a duty imposed by federal, not state, law. And the crux of the claim is a challenge to the propriety of an FDA clearance decision and the integrity of the FDA decisional process. In this sense, plaintiffs' "fraud on the agency" claim is similar to a claim challenging a device's 510(k) clearance on the grounds that the employee responsible for the decision was not hired in accord with FDA requirements. Like the FDA's compliance with its own internal hiring policies, Buckman's compliance with FDA regulatory requirements is an area of exclusively federal concern, properly policed by the agency itself and not by judges and juries applying the laws of the 50 States.

Congress's decision to centralize all FDCA enforcement authority in the FDA, and to preclude private rights of action to enforce the federal statute, might not be frustrated by allowing traditional state law claims, such as those involved in Medtronic, to proceed. But it is quite another matter to allow plaintiffs' "fraud on the agency" claim, which (while nominally based on state law) could not exist apart from the FDCA, which seeks to enforce requirements imposed by the FDCA, and which in essentially all respects is indistinguishable from a private cause of action under the FDCA.

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

39

In this case, the potential inconsistency has become actual. Plaintiffs pursue a "fraud on the FDA" claim despite the fact that the FDA has already thoroughly considered their allegations of fraud and concluded that AcroMed's devices should remain on the market. As noted above (at 11-12), plaintiffs submitted lengthy comments in recent FDA proceedings to reclassify bone screws, in which plaintiffs raised each of their allegations of fraud against Buckman; after reviewing the evidence, the FDA nonetheless decided that -- far from being removed from the market -- bone screws should be subject to less regulation and labeled for use in the spine. "It is difficult to escape the conclusion that the [state] litigation [is] * * * an attempt by a disappointed [litigant] to gain from the [state] courts the relief it was denied by the [federal agency]," 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., 485 U.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 in many other statutes,⁸ manifests Congress's intent to shield

40

Even unsuccessful claims of "fraud on the agency" impose tremendous burdens on regulated entities. Allegations of incom- plete disclosure in the MDA context, for example, can trigger burdensome, intrusive, and expensive discovery into product development files, covering multi-year periods and evolving scientific evaluations of complex formulas and patient reactions. Often, such claims can be rejected only after a full trial. And of course, companies may be charged with "fraud on the agency" not just by disgruntled consumers but also by industry competitors. Suits such as these, which represent collateral attacks on agency decisions, cannot be reconciled with Congress's decision to preempt inconsistent state laws and to centralize all enforcement authority in the FDA.

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

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

41

In some instances, federal safety requirements might reason- ably be viewed as "minimum" or "baseline" standards, to be supplemented by additional, more stringent requirements under state law. It is inconceivable, however, that Congress intended federal requirements governing interaction with a federal agency -- such as requirements about what information must be submitted in a 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 "fraud on the agency" claims, were permitted to interpret federal require- ments governing 510(k) submissions, it is inevitable that they would disagree with the FDA and each other about what those requirements entail. Rather than run the risk of liability for "de- frauding" the FDA by not submitting information that a court or jury might subsequently find material, manufacturers would seek to 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 overload of information, neither the FDA nor consumers would be able to separate wheat from chaff, thus defeating the entire point of the regulatory scheme. And the deluge of paper would not stop with 510(k) clearance, because manufacturers would approach post- clearance reporting obligations⁹ with the same incentive to flood the agency with information of uncertain and attenuated relevance.

42

The threat of state-law liability for "fraud on the FDA" would have negative effects extending beyond this immediate context. As Judge Cowen noted in dissent (Pet. App. 29a-31a), manufacturers might well be reluctant to research and develop new off-label uses, since each such use would be potential evidence of a new "intended use" that, under plaintiffs'theory, should have been disclosed to the FDA and placed on the device's labeling regardless of its safety or efficacy. Even where off-label uses were known, device manufac- turers would be loathe to disseminate information about them (by sending reprints of scientific articles in response to physician inquiries or otherwise), for fear that such communications would be taken as evidence of the manufacturer's "true" "intended use" for the device. As a result, physicians would make less informed treatment decisions or simply shy away from off-label uses. This outcome would not only impair the public health -- for, as the FDA has recognized, off-label use of devices and drugs can be beneficial to patients, see page 4, supra -- it would also thrust judges and juries into regulation of medical practice (i.e., off-label use of devices) under the guise of "protecting" the FDA, even though the FDA itself is prohibited from regulating in this area. See 21 U.S.C. § 396; More Information for Better Patient Care: Hearings on S. 1477 Before the Senate Comm. on Labor and Human Resources, 104th Cong. 82 (1996) (William B. Schultz,

43

2. As noted above (at 33), "fraud on the agency" claims require proof of an agency's regulatory requirements, the applicant's failure to satisfy those requirements, and the way in which the agency 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 the agency itself. Accordingly, if these claims were allowed to go forward, private litigants would routinely seek discovery from federal agencies and agency officials to shed light on these crucial issues.

Even if the discovery attempts were unsuccessful,¹¹ they would drain agency resources. The agency would be obliged to contest discovery requests and to litigate ensuing efforts to obtain compliance. And if the FDA ultimately were not required to provide the critical evidence, the result would be flawed decisionmaking and enormous harm to defendants charged unfairly with having defrauded the agency.

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

44

This case presents a telling example of the way in which federal agencies would be burdened by private litigants pursuing "fraud on the agency" claims. Plaintiffs sought documents from the FDA 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 to any communications regarding each of the relevant premarket notifications and any agency action thereon"; "[a]ll documents reflecting, relating or referring to each 'predicate device' for which substantial equivalence was claimed in each of the relevant premarket notifications"; and "[a]ll documents reflecting, relating or referring to the justification for any agency action taken in response 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 advisory committee that reviewed pedicle screw systems. J.A. 25-26. The federal government sought a protective order, submitting evidence that special employees would be "hesitant to serve" on advisory panels if they could be subjected to depositions in private lawsuits. J.A. 25, 33, 34-35. Nonetheless,the district court allowed discovery to go forward against all but a single government employee. See In re 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 fell subject to judicial monitoring and supervision as a result of this litigation. At the request of the district court, the FDA extended the period for filing public comments on the FDA's proposal to reclassify pedicle screws. See In re Orthopedic Bone Screw Prods. Liab. Litig., MDL 1014, slip op. at 1 (E.D. Pa. Jan. 2, 1996) (PTO 188). The FDA was ordered to turn over to plaintiffs its internal

45

The interference that this litigation has caused with FDA operations is not aberrational. If state "fraud on the agency" claims were permitted to go forward, their predictable effect would be to swamp federal agencies with information they do not want and have not requested, and generally to interfere with agencies' abilities to carry out their mandated duties. The States have no power, under the Supremacy Clause, to impose these harmful effects on the federal regulatory process.

III. THE COURT SHOULD RECONSIDER ASPECTS OF MEDTRONIC THAT ERRONEOUSLYRESTRICT THE SCOPE OF EXPRESS PREEMPTION UNDER THE MDA

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

46

Experience has proven this Court's fractured decision in Medtronic to be just such a case. As demonstrated in the petition (at 14-16, 19-25), the lower courts have had tremendous difficulty understanding what the decision means and how it should be applied. See also Wilson v. Bradlees of New England, Inc., 96 F.3d 552, 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 Medtronic dissenters 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 three separate opinions interact to dispose of the issues before the Court (although that has been difficult enough for the lower courts). See Pet. 19-25. It also lies in the hopelessly ambiguous concept of "specificity" itself, which could refer either to the content of a requirement (as in Justice Breyer's 2-inch wire, which is "specific" when compared to a more generalized duty to use care in the design of a product) or to a requirement's applicability to more than a single device, a single class of devices, or to products in addition to medical devices. As the United States acknowledged at the petition stage (U.S. Br. 10 n.4), even a requirement that is general in content or that applies broadly to products other than medical devices can (and usually does) become "specific" over the course of litigation as the plaintiff develops his precise theory of

47

2. This aspect of Medtronic should also be revisited because it rests on an erroneous premise. In adopting the "specificity" requirement as a gloss on Section 360k(a), the majority reasoned that "the FDA has never granted, nor, to the best of our knowledge, even been asked to consider granting, an exemption for a state law of general applicability." 518 U.S. at 499-500. In fact, the FDA has repeatedly treated state requirements that are not "specific" -- because they are not limited to a single medical device, class of medical devices or even to medical devices in general, or because they are general in content -- as eligible for exemption from express preemption. Perhaps the best example of the former is California's Sherman Food, Drug and Cosmetic Law, which contains numerous provisions that are couched in general terms and/or pertain to drugs as well as to medical devices -- provisions that 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 has taken the position in regulatory notices, as well as in its brief in Medtronic (Nos. 95-754 and 95-886 U.S. Br. 24-25 & nn.19-20), that the federal GMP requirements trigger express preemption and that state GMP regulations are susceptible to express preemption. Indeed, the FDA has indicated that if California -- which in passing the Sherman Law "adopt[ed] the FDA GMP regulations as its own" -- either "interprets or applies the GMP regulations in

48

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

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

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

49

Not surprisingly, this Court has repeatedly rejected invitations to 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 Act of 1978 ("ADA") that "pre-empts the States from 'enact[ing] or enforc[ing] any law, rule, regulation, standard or other provision * * * relating to rates, routes, or services of any air carrier.'" Id. at 383 (quoting 49 U.S.C. App. § 1305(a)(1)). The Court categorically rejected the argument that "only state laws specifically addressed to the airline industry are pre-empted, whereas the ADA imposes no constraints on laws of general applicability." Id. at 386.¹³ Such an interpretation, this Court noted,

50

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