Opposition Brief — Buckman Co. v. Plaintiffs' Legal Comm.

In the Supreme Court of the Ani

PLAINTIFFS’ LEGAL COMMITTEE,

On Petition for a Writ of Certiorari to

the United States Court of Appeals for the Third Circuit

BRIEF IN OPPOSITION TO

PETITION FOR A WRIT OF CERTIORARI

JOHN J. CUMMINGS, III ARNOLD LEVIN

Cummings Cummings

& Dudenhefer

416 Gravier Street

New Orlcans, LA 70130 MICHAEL S. TARRINGER

(504) 586-0000

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{>

No. 98-1768

OCTOBER TERM, 1998

THE BUCKMAN COMPANY,

Petitioner,

Vv.

Respondent.

MICHAEL D. FISHBEIN*

* Counsel of Record

SANDRA L. DUGGAN

Levin Fishbein Sedran & Berman

510 Walnut Street, Suite 500

Philadelphia, PA 19106

(215) 592-1500

Counsel for Respondent

RULE 29.6 STATEMENT

Pursuant to Supreme Court Rule 29.6, Respondent states

that it has no parent companies or non-wholly owned subsidiaries.

TABLE OF CONTENTS Page

RULE 29.6 STATEMENT ...... 2. eee eee eee eens i

TABLE OF AUTHORITIES ..........---++eeeeee8: ili

INTRODUCTION ... ccc ccccccesscces eu eee ee ]

THE PACTS ......ccccccesesee eu eu eee a 2

A. The Regulatory Background .......---++++e555 2

B. Buckman’s Fraud ....... 60.2 ccceceseessescs 6

C. The Proceedings Below .......-.0 05s ee eres 10

REASONS TO DENY THE WRIT ..........-.+--- vee 12

A. The Question Presented by Petitioner is Not an Issue

in this Case ... csc ccccvcsesst ene ene eee 12

B. The Court of Appeals Decision Represents a

Straightforward Application of a Recent, Unanimous

Ruling by this Court... 2.6... eee eee ees 13

C. There is No Substantial Appellate Conflict Concerning

Whether “Fraud-on-the-FDA” Claims are Preempted 21

D. This Case Does Not Present an Appropriate Vehicle to

Resolve Any Conflict Regarding the Issue of Whether

an FDA Marketing Approval Can Preempt State Laws

of General Applicability ............020e eee: 24

CONCLUSION .. ccc cccccvessesueeeeen eee eee 26

iii

TABLE OF AUTHORITIES

Federal Cases Page(s)

Chambers v. Osteonics Corp., 109 F.3d 1243 (7th Cir. 1997) ... 21

Church of Scientology of California v. Richardson,

EEE 3

Cipollone v. Liggett Group, Inc., 50S U.S. 504 (1992) ....... 20

Committee of Dental Amalgam Manufacturers and Distributors

v. Stratton, 92 F.3d 807 (9th Cir. 1996),

cert. denied, 519 U.S. 1084 (1997) .................. 21

Duvall v. Bristol-Myers-Squibb Co.,

er 21, 25

English v. Mentor Corp., 67 F.3d 477 (3d Cir. 1995),

vacated, $18 U.S. 1030 (1996) .................. 14, 15

Florida Lime + Avocado Growers, Inc. v. Paul,

EEE 19, 20

Freightliner Corp. v. Myrick, 514 U.S. 280 (1995) ....... 19, 20

Gile v. Optical Radiation Corp., 22 F.3d 540 (3d Cir.),

cert. denied, 513 U.S. 965 (1994) ................ 14, 15

Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999) ... 21

Hall v. Beals, 396 U.S. 45 (1969) .........0.000002.... 13, 25

Hawkins v. Upjohn Co., 890 F. Supp. 609 (E.D. Tex. 1994) ... 10

iv

Federal Cases (Cont.) Page(s)

Hines v. Davidowitz, 312 U.S. 52 (1941) ...........4.. 19, 20

Ingalls Shipbuilding, Inc. v. Director, Office of

Workers’ Compensation Programs, Dept. of Labor,

SID UD. BOB CITOAD nn cccccccscccccescsesccceces 13

King v. Collagen Corp., 983 F.2d 1130 (Ist Cir.),

cert. denied, 510 U.S. 824 (1993) ..........25455:. 14, 15

Kuiper v. American Cyanamid Co., 131 F.3d 656 (7th Cir. 1997),

cert. denied, 118 S. Ct. 1839 (1998) ..........005055e 22

Lake v. U.S. Food & Drug Administration,

1989 WL 71554 (E.D. Pa. June 27, 1989) .............. 3

Learjet Corp. v. Spenlinhauer, 901 F.2d 198 (ist Cir. 1990) ... 10

Lewis v. Brunswick Corp., 107 F.3d 1494 (11th Cir. 1997),

cert. dism’d, 118 S. Ct. 1793 (1998) ...... 2.6025 e eee 22

Liles v. Oregon, 425 U.S. 963 (1976) «2... ee eee l

Lohr v. Medtronic, Inc., 56 F.3d 1335 (11th Cir. 1995),

aff'd in part, rev'd in part, 518 U.S. 470 (1996) ...... 14, 15

Martin v. American Medical Systems, Inc.,

| ja | f fo @ ., BPrrrrrrrrrirr 21

Martin v. Telectronics Pacing Systems, Inc.,

105 F.3d 1090 (6th Cir. 1997),

cert. denied, 118 S. Ct. 850 (1998) ...........0002 eee 25

v

Federa, Cases (Cont.) Page(s)

McDermott v. State of Wisconsin, 228 U.S. 115 (1913) ....... 19

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

Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.),

cert. denied, 516 U.S. 815 (1995),

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

overruled by, In re Orthopedic Bone Screw Products

Liability Litigation, 159 F.3d 817 (3rd Cir. 1998) .. 14, 15, 23

Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995),

vacated, $18 U.S. 1030 (1996) .................. 14, 15

Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997),

cert. denied, 118 S. Ct. 1300 (1998) ............ 1, 22, 23

Moore v. Kimberly-Clark Corp., 867 F.2d 243 (Sth Cir. 1989) .. 19

National Bank of Commerce of El Dorado

v. Kimberly-Clark Corp., 38 F.3d 988 (8th Cir. 1994) ..... 15

Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997) ... 21, 24

In re Orthopedic Bone Screw Products Liability Litigation,

oa ara CM cavnadwevactecudess tees 22

Papike v. Tambrands Inc., 107 F.3d 737 (9th Cir.),

cert. denied, 118 S. Ct. 166 (1997) .................. 24

Princeton University v. Schmid, 455 U.S. 100 (1982) ..... 13, 25

vi

Federal Cases (Cont.) Page(s)

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

cert. denied, 515 U.S. 1104 (1995) .............4.. 14, 15

Reeves v. AcroMed Corp., 103 F.3d 442 (Sth Cir. 1997) ...... 21

Rivers v. Roadway Express, Inc., 511 U.S. 298 (1994) ....... 13

Seminole Tribe of Florida v. Florida, 517 U.S. 44 (1996) ..... 13

Stanton by Brooks v. Astra Pharmaceutical Products, Inc.,

Fe ES GED 60 occ ceeecs tueseweweser 10

Symens v. SmithKline Beecham Corp.,

1S2 F.3d 1050 (8th Cir. 1998) 2... 1. eee eee 21

Talbott v. C.R. Bard, Inc., 63 F.3d 25 (ist Cir. 1995),

cert. dism'd, 517 U.S. 1230 (1996) ..............0006:- 15

United States v. 250 Jars, etc., 344 F.2d 288 (6th Cir. 1965) .... 3

United States v. An Article ... Consisting of 216 Cartoned

Bottles More or Less, 409 F.2d 734 (2d Cir. 1969) ........ 3

United States v. An Article of Device... Diapulse,

Fae CG GEE ce eddocsecveccdetocsees 2

United States v. Rutherford, 442 U.S. 544 (1979) ............ 4

Washington Legal Foundation v. Friedman,

13 F. Supp.2d 51, 56 (D.D.C. 1998),

order amended by 36 F. Supp.2d 16 (D.D.C.),

amended by 36 F. Supp.2d 418 (D.D.C. 1999) ........... 4

vii

Federal Cases (Cont.) Page(s)

Weinberger v. Hynson Westcott & Dunning, Inc.,

DTD cont peacneesssevsdedadsys cides 4

State Cases

Armstrong v. Optical Radiation Corp.,

57 Cal.Rptr.2d 763 (Cal. App. 1996) ................. 21

Baird v. American Medical Optics, 713 A.2d 1019 (N.J. 1998) . 22

Connely v. lolab Corp., 927 S.W.2d 848 (Mo. 1996),

cert. dism’d, 520 U.S. 1260 (1997) .............. 19,21,22

Dutton v. AcroMed Corp., 691 N.E.2d 738 (Ohio App. 1997) .. 22

Green v. Dolsky, 546 Pa. 400, 685 A.2d 110 (1996),

cert. denied, 520 U.S. 1168, 1212 (1997) ....... 16,19,21,22

Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997),

cert. denied, 118 S. Ct. 1187 (1998) ...........52045. 21

Steele v. Collagen Corp., 63 Cal. Rptr. 2d 879 (Cal. App. 1997) . 21

Walker v. Johnson & Johnson Vision Products Inc.,

217 Mich. App. 705, 552 N.W.2d 679 (Mich. App. 1996) .. 21

Federal Statutes, Regulations, Rules

and Legislative Materials

I, Sein. sine pa crnusende s demeeian 6, 18

ERE EO eT aE ns DY passim

viii

Federal Statutes, Regulations, Rules

and Legislative Materials (Cont.) Page(s)

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BO WE. BD oc cccccccsensddecescssvtossens 5, 24

Be Da ED ccc ccccescssccessdevesterdsine passim

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ix

Federal Statutes, Regulations, Rules

and Legislative Materials (Cont.) Page(s)

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21 CFR. § 807.100(b)(1) ocean 3

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21 CFR. § 814.20(b)(3)ii) oe eee eee 3

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Federal Statutes, Regulations, Rules

and Legislative Materials (Cont.) Page(s)

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39 Fed. Reg. S5GZ0 (Nov. 16, 1906) 2... cc ccccccccvsceces 3

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ee EE SNAKE ed centeeeeerenneeKEsCadceweds l

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1976 U.S. Code Cong. & Admin. News, 1070, 1075 ......... 2

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Je § FS Pere ere eee eee 3

BRIEF IN OPPOSITION TO

PETITION FOR A WRIT OF CERTIORARI

INTRODUCTION

This Court repeatedly has articulated a policy of substantial

restraint in the exercise of its review powers. See Supreme Court

Rule 10. Plainly, this policy is not served by granting a writ of

certiorari to review an appellate decision which involves the

straightforward application of legal principles recently and

unanimously announced by this Court. Liles v. Oregon, 425 U.S.

963, 964 (1976) (Stevens, J., concurring in the denial of certiorari).

However, that is precisely what the instant Petition asks this Court

to do.

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

unanimously ruled that there is no preemption of state-law tort

claims which are based on conduct that violates the requirements

of federal medical device law. Lohr, 518 U.S. at 495-97 (majority

opinion) & 518 U.S. at 513 (O’Connor, J., concurring in part).

Applying that principle in the instant matter, the United States

Court of Appeals for the Third Circuit ruled that federal law does

not preempt plaintiffs’ claims to recover damages under state law

for the injuries wich they suffered as a result of defendants’

misrepresentations to the FDA. See Appendix of Petitioner

Buckman Company to Petition for a Writ of Certigrari (“App.”),

la-25a. Since that decision represents a direct application of the

principle recently and unanimously announced by this Court in

Lohr, it should not reasonably be subject to question, let alone

certiorari review. While it is true that in a prior decision the

United States Court of Appeals for the Seventh Circuit held

otherwise, it did .o only in passing, in reliance on a pre-Lohr Third

Circuit opinion which was overruled here, and without articulating

any reasons for its holding. See Mitchell v. Collagen Corp., 126

F.3d 902, 914 (7th Cir. 1997), cert. denied, 118 S. Ct. 1300 (1998)

(“Mitchell IT’). All of the other appellate courts that have

2

considered the issue have ruled, consistent with the decision of the

Third Circuit here, that state-law claims predicated upon fraud on

the FDA are not preempted. Therefore, any technical division of

appellate authority on this issue is not sufficiently substantial or

mature to warrant intervention by the Court at this time.

THE FACTS

A. The Regulatory Background

At issue in this multidistrict litigation are medical devices

which are subject to regulation by the United States Food and Drug

Administration (“FDA”) pursuant to the Food, Drug and Cosmetic

Act (“FDCA”), 21 U.S.C. § 301, et. seqg., and the Medical Device

Amendments to that Act (*“MDAs”), 21 U.S.C. § 360, et seq. The

purpose of the FDCA and the MDAs is to protect members of the

unsuspecting public from drugs and devices “which pose serious

risk if inadequately tested or improperly designed or used.”!

One of the central tenets of the legislation is that the existence

and character of a drug or device is ultimately determined by the

“intended use” of the article, not by its physical characteristics or

' §. Rep. No. 33, 94th Cong., 2d Sess. 5, reprinted in 1976 U.S.

Code Cong. & Admin. News, 1070, 1075. See also, e.g., 21 U.S.C.

§§ 360e(c) & 365(d); 21 C.F.R. §§ 814.20 & 130.12; Medtronic,

Inc. v. Lohr, 518 U.S. 470, 475-78 (1996); Weinberger v. Hynson

Westcott & Dunning, Inc., 412 U.S. 609, 617-20 (1973); United

States v. An Article of Device...Diapulse, 768 F.2d 826, 832 (7th

Cir. 1985).

3

physiological effects.* Thus, for example, a screw which is

intended for use in constructing a car is obviously not a medical

“device” subject to any regulation by the FDA. The same screw,

if intended for use in constructing crutches, would be a “Class I”

medical device subject to minimal regulation. See 21 C.F.R. §

890.3150. If the same screw was intended for use in the spine, it

> See, e.g., 21 U.S.C. § 321(h) (device defined as any article

“which is -- ...intended for use in the diagnosis of disease or other

conditions, or in the cure, mitigation or prevention of disease, in

man or other animals....”); 21 U.S.C. § 321(h) (“drug” similarly

defined); Church of Scientology of California v. Richardson, 437

F.2d 214, 216 (9th Cir. 1971); United States v. An Article ...

Consisting of 216 Cartoned Bottles More or Less, 409 F.2d 734,

739 (2d Cir. 1969) (a cosmetic, such as shampoo, can be a drug,

regardless of its actual physical effects, depending on its intended

use); United States v. 250 Jars, etc., 344 F.2d 288, 289 (6th Cir.

1965) (honey classified as a drug when it is sold for therapeutic

purposes); H.R.Rep. No. 853, 94th Cong., 2d Sess. at 14-15 (“It is

the Committees’ intention that each use...be treated as constituting

a different device for purposes of classification and regulation”);

Lake v. U.S. Food & Drug Administration, 1989 WL 71554 at *5

(E.D. Pa. June 27, 1989) (“different uses pose different risks and

require new proof of safety and effectiveness”); Requests for

Comments in Regard to Citizen Petition Regarding the Food and

Drug Administration’s Policy on Promotion of Unapproved Uses

of Approved Drugs and Devices, 59 Fed.Reg. 59820 (Nov. 18,

1994).

Accordingly, the intended use of a device specified by the

person submitting a request to the FDA for marketing clearance

delineates the scope of the FDA’s review. See 21 C.F.R. §§ 801.4,

801.5, 807.87(e), 807.100(b)(1) & 814.20(b)(3)(ii).

4

would be a “Class III” medical device subject to extensive FDA

regulation. See 21 C.F.R. § 888.3070.

Another key concept at the heart of the federal regulatory

scheme arises from the legislative conviction that the safety and

efficacy of drugs and devices must be demonstrated in well-

controlled clinical trials and cannot be determined based on the

anecdotal experience of physicians. E.g., Weinberger v. Hynson

Westcott & Dunning, Inc., 412 U.S. 609, 619 (1973) (the “strict

and demanding standards [of the FDCA\], barring anecdotal

evidence indicating that doctors ‘believe’ in the efficacy of a drug

are amply justified by the legislative history [which shows] a

marked concern that impressions or beliefs of physicians, no matter

how fervently held, are treacherous”); see also United States v.

Rutherford, 442 U.S. 544, 557-58 (1979) (rejecting arguments that

FDA approval requirements for new intended uses could be

overcome, even when terminally ill patients were to receive the

treatments).’ Accordingly, the MDAs generally provide that a

medical device may not be introduced into commerce unless i

* The danger of using drugs or devices based on the clinical

theories or anecdotal experience of physicians rather than results of

well-conducted clinical trials was vividly illustrated in the 1980's

when physicians began to prescribe the drug Flecainide, off label,

to treat arrhythmias in patients who recently had heart attacks. The

drugs were very effective in controlling arrhythmias. However,

when well-controlled trials were finally conducted with respect to

this “off-label treatment,” it appeared that those who took the drug

had a two and one-half fold increase in mortality and that 3,000 to

10,000 patients per year had died as a consequence of this

“treatment.” See Washington Legal Foundation v. Friedman, 13 F.

Supp.2d 51, 56 (D.D.C. 1998), order amended by 36 F. Supp.2d 16

(D.D.C.), amended by 36 F. Supp.2d 418 (D.D.C. 1999).

5

receives “premarket approval” from the FDA based on the outcome

of well-controlled clinical trials and extensive FDA review.’ See

21 U.S.C. §§ 360c(a)(1)(C) & 360e; Medtronic, Inc. v. Lohr, 518

U.S. 470, 477 (1996).

The principal exception to the premarket approval requirement

derives from a congressional concern that manufacturers of devices

which were in commerce prior to enactment of the MDAs should

not receive a competitive advantage. Lohr, 518 U.S. at 477-79 &

493-94. This exception permits the marketing of a Class III device

without premarket approval if the FDA determines that the device

is “substantially equivalent” to a “predicate device.” See 21 U.S.C.

§§ 360(k), 360c(f) & (i); 21 C.F.R. § 807.100. A predicate device

is one which was commercially distributed prior to May 28, 1976

or which was introduced thereafter and which was reclassified into

regulatory Class 1 or II. /d. A device is “substantially equivalent”

to a predicate device only if “the device has the same intended use

as a predicate device.” 21 U.S.C. § 360c(i)(1)(A); 21 CFR §

807.100(b)(1).

Substantial equivalence, as defined by the statute, is claimed

and either accepted or rejected through a premarket notification

* If a manufacturer wishes to generate the scientific data

necessary to obtain premarket approval, it may do so under the

investigational device exemption provisions of the FDCA. 21

U.S.C. § 360j(g); 21 C.F.R. § 813, et seq. These provisions

authorize the FDA to grant an exemption permitting experimental

devices to be used without premarket approval under stringent

conditions established and actively supervised by the agency. /d.

Under FDA regulations, an investigational device may not be

promoted for commercial! distribution or test marketed outside of

the approved IDE. See 21 C.F.R. § 812.7(a).

6

submitted under Section 510(k) of the Act, 21 U.S.C. § 360(k). By

virtue of both federal statutes and FDA regulations, all statements

made in connection with a premarket notification must be truthful.

See 18 USC. § 1001, 21 CFR. § 807.87(j). In addition, a

premarket notification must include “proposed labels, labeling and

advertisements sufficient to describe the device, its intended use,

and the directions for its use” and “a statement indicating that the

device is similar to and/or different from other products of

comparable type in commercial distribution, accompanied by data

to support the statement.” See 21 C.F.R. § 807.87(e) & (f). If the

FDA determines in response to a 510(k) notification that the device

is not substantially equivalent to a lawfully-marketed predicate

device, the device may not be marketed unless it receives

premarket approval. Marketing of the device without premarket

approval would constitute adulteration in violation of the statute.

See 21 USC. §S§ 351(f, 352(0), 360c(a)(1 KC), 360c(N(1) &

360e(a); 21 C.F.R. § 807.100(a)(2).

B. Buckman’s Fraud

Petitioner, Buckman Company, is a regulatory consultant who

was retained by AcroMed Corporation to assist it in obtaining

marketing clearance for the Variable Screw Placement (“VSP”)

Spinal Plate Fixation System. App., 4a. The system was designed

as an adjunct to spinal fusion surgery and consisted of plates which

were to be attached to the posterior portion of the lumbar spine

with screws inserted into the spinal pedicles, the bony archways

which flank the spinal cord. See Appendix to Plaintiffs’ Brief in

the District Court, MDL 1014, Docket Item No. 858 (hereinafter

“D.Ct.App.”), Ex. # | at 312-14.

On September 4, 1984 and again on September 20, 1985,

Buckman filed premarket notifications for the VSP device,

truthfully representing that it was intended for use as a pedicle

7

screw fixation construct in spinal fusion surgery. App., 4a-Sa. In

response to each notification, the FDA expressly determined that

the VSP Spinal Plate Fixation System was not substantially

equivalent to any device marketed in commerce prior to May 28,

1976, and that it posed potential risks not exhibited by other spinal

fixation systems including “greater chance of neurological deficit.”

Id. Therefore, the agency advised AcroMed and Buckman that the

VSP system could not be commercially distributed without

premarket approval. /d.

Determined to sell the VSP system as a pedicle screw fixation

device, AcroMed and Buckman concocted an unlawful scheme to

bring the VSP device components to market without premarket

approval. App., Sa. Pursuant to this plan, AcroMed changed the

name of the VSP device from a “spinal plate fixation system” to

“nested bone plates” and “cancellous bone screws.” /d. Then, in

late December, 1985, Buckman submitted separate premarket

notifications for the plates and screws in which Buckman

fraudulently omitted all reference to the use of the device in the

spine. App., 6a. Instead, these 510(k) notifications falsely

represented to the FDA that the device components were

substantially equivalent to preamendment Class II devices used to

repair fractures of the arms and legs. /d. Consistent with this,

each 510(k) notification expressly represented to the agency that

there was “no new application, indication, material, device

configuration or specification presented by” the device components,

even though Buckman was aware that AcroMed’s intention was to

market the device components solely as a spinal fixation construct

which the FDA had already decided was a “new application,

indication and device configuration” for which 510(k) marketing

clearance was not appropriate. D.Ct.App., Ex. #s 7 & 8.

Noting that the nested bone plates and cancellous bone screws

were identical to the components of the VSP Spinal Plate Fixation

System which the FDA had previously refused to clear, the FDA

sought clarification concerning the intended use of the plates and

screws. D.Ct.App., Ex. # 1 at 92-93 & 127; Ex. #9. On January

10, 1986, Buckman responded to this request, affirmatively

representing to the FDA that: “The AcroMed plates are intended

for use in appropriate fractures of long bones of both the upper and

lower extremity....”. App., Sa-6a (citing Third Circuit Appendix at

A-58); D.Ct.App., Ex. # 9.

There is no question that the representations made by Buckman

to the FDA concerning the intended use of AcroMed’s plates and

screws were fraudulent. Indeed, contemporaneous with the

Buckman-AcroMed 510(k) submission to the FDA, AcroMed’s

President wrote a letter in which he admitted that the submission

was “a labeling slight-of-hand that satisfies the agency’s

regulations but in no way changes the intended use of the plates

and screws.” D.Ct.App., Ex. # 12; Third Circuit Appendix, No.

97-1783 at A-58. In addition, in an interview with FDA

enforcement officials, AcroMed’s former Vice President of

Operations directly admitted that “the device was always intended

for use in the spine.” D.Ct.App., Ex. # 14. Finally, AcroMed’s

President and Chief Counsel admitted, under oath, that AcroMed’s

plates and screws were designed solely for use in the spine. Third

Circuit App. at 58; D.Ct.App., Ex. # 13 at 17.

In reliance on Buckman’s misrepresentations, the FDA

determined that AcroMed’s nested bone plates and cancellous bone

screws were substantially equivalent to devices marketed in

interstate commerce prior to May 28, 1976. App., 6a. This

allowed the plate and screw components to be introduced into the

marketplace without being seized by the FDA. Then, in conformity

with the fraudulent scheme developed by AcroMed and Buckman,

AcroMed marketed the plates and screws solely for use in the spine

as a pedicle screw fixation construct. /d. This marketing was done

9

on a massive scale, largely through the promotional efforts of

physicians retained by AcroMed pursuant to agreements which

afforded these virtual commissioned sales agents the right to

participate in the financial growth of AcroMed through very

substantial stock options.’ D.Ct.App., Ex. #s 30, 34, 35, 36 & 37.

Other manufacturers adopted the Buckman-AcroMed scheme.

* Such unlawful marketing resulted in FDA sanctions including

withdrawal of FDA approval to conduct clinical trials regarding use

of the VSP device, the issuance of numerous warning letters, and

the convening of a grand jury investigation. D.Ct.App., Ex. #s 71

& 72. See also 63 Fed.Reg. at 40037-38. Notwithstanding these

enforcement efforts, the marketing scheme adopted by AcroMed

and other manufacturers was so successful that pedicle screw

fixation gained a foothold among a segment of spine surgeons.

Beginning in 1994, the FDA launched an investigation to determine

whether to reclassify pedicle screw fixation devices. Despite the

fact that the devices had been the subject of at least 14 different

clinical trials to assess their safety and efficacy and widespread

“off-label” use, the FDA concluded in 1998 that there was

insufficient evidence that devices were sufficiently safe or effective

to justify their reclassification for treatment of all but a handful of

spinal maladies. Even for such indications, however, the agency

mandated that the devices would be subject to special controls in

regard to labeling, design, material composition, and

biocompatibility. See “Orthopedic Devices: Classification &

Reclassification of Pedicle Screw Spinal Systems.” 63 Fed. Reg.

40025 (1998). Accordingly, the regulation cannot be viewed as an

endorsement with regard to the safety and effectiveness of pedicle

screw fixation devices generally or as a ratification of past illegal

conduct which brought these devices into the hands of physicians

for use in spinal surgery. See 63 Fed. Reg. at 40037-38.

10

C. The Proceedings Below

Many people were injured as a result of the spinal application

of AcroMed’s hardware for pedicle screw fixation. In the product

liability litigation which resulted, some of these plaintiffs named

Buckman as a defendant based on the theory that Buckman’s fraud

on the FDA gave rise to actionable injuries under state law.°

The District Court, sitting as the MDL transferee forum for all

federal pedicle screw cases, dismissed these “fraud-on-the-FDA”

claims under Fed. R.Civ.P. 12(b)(6). In doing so, it explicitly

recognized that such fraud claims were not preempted, particularly

in light of this Court's decision in Medtronic, Inc. v. Lohr, 518

U.S. 470 (1996). However, the District Court decided that

allowing a fraud-on-the-FDA claim would essentially create a

private right of action for violation of the FDCA and that, “in view

of the FDA's exclusive prosecutorial discretion...any grant of an

* While the issue has not been widely decided, state law appears

to recognize a cause of action where a fraudulent misrepresentation

induces a regulatory agency charged with the protection of the

public to issue an authorization in the form of a permit, clearance,

license or the like and the activity conducted pursuant to the

regulatory authorization produces physical harm. See, e.g., Learjet

Corp. v. Spenlinhauer, 901 F.2d 198, 202-03 (Ist Cir. 1990)

(allowing aircraft purchaser's claim against manufacturer based on

misrepresentations to the Federal Aviation Administration); Stanton

by Brooks v. Astra Pharmaceutical Products, Inc., 718 F.2d 553,

568-69 (3d Cir. 1983) (allowing patients’ claims against drug

manufacturer based on misleading statements made to the FDA),

Hawkins v. Upjohn Co., 890 F. Supp. 609, 612 (E.D. Tex. 1994)

(same).

implied private right of action would be contrary to the letter and

spirit of the statute.” App., 37a.

On appeal, Buckman sought to justify the District Court's

opinion on its own terms and never asserted that state-law claims

based on agency fraud were preempted, either expressly or

impliedly. However, Sofamor Danek Group, a manufacturer of

various pedicle screw fixation devices, appeared in the Court of

Appeals as amicus curiae. Sofamor Danek argued that plaintiffs’

fraud-on-the-FDA claims were impliedly preempted. No one

argued for express preemption under 21 U.S.C. § 360k.

The Court of Appeals reversed, holding that no principle of

federal law prevented plaintiffs from proceeding with state-law

claims which were predicated upon Buckman’s alleged

misrepresentations to the FDA. The reasoning in support of this

holding was straightforward.

First, the Court of Appeals held that “[a]bsent preemption by

federal law...a district court cannot decline to enforce liability

imposed by the relevant state common law.” App., I4a. Second,

it recognized that preemption is a matter of legislative intent and

that “where Congress has expressed itself on preemption in a

statute,” Congress’ preemptive intent is primarily “discerned from

the language of the preemption statute and the ‘statutory

framework’ surrounding it.” App., ISa. Third, the Court

recognized that the MDAs contain an express preemption provision,

21 U.S.C. § 360k, which was definitively construed by this Court

in Lohr as manifesting a congressional intent to allow states to

provide “a traditional damages remedy for violations of common

law duties when those duties parallel federal requirements.” App.,

l6a, citing Lohr, 518 U.S. at 495. Because plaintiffs’ claims were

based on a common-law duty to refrain from making

misrepresentations which is identical to the duty imposed by federal

12

law to refrain from making misrepresentations to the FDA, the

Court concluded that “the state common law relied upon does not

impose any obligation on Buckman inconsistent with federal law”

and accordingly was not preempted.’ App., 13a.

REASONS TO DENY THE WRIT

A. The Question Presented by Petitioner

is Not an Issue in This Case ___

The principal question which Buckman seeks to present to the

Court by its Petition for Certiorari is “Whether a state tort claim

collaterally attacking a decision of the Food and Drug

Administration to permit the marketing of a medical device on the

ground that the approval was obtained through a ‘fraud on the

agency’ is expressly and impliedly preempted by the Medical

Device Amendments to the Food, Drug and Cosmetic Act.” This

“question” has nothing whatsoever to do with this case. The

plaintiffs here did not seek, and the Court of Appeals did not

authorize, any “attack” on any decision by the FDA, collateral or

otherwise. Rather, plaintiffs simply contended, and the Court of

’ The Court of Appeals also observed that:

We do not rule out the possibility that there may

be some areas of preemption outside the scope of

Section 360k based on clear and direct conflicts

between the requirements of state law and those of

the FDCA. The existence of Section 360k, its

relatively narrow scope and Lohr’s presumption

against preemption of areas traditionally occupied

by state law, however, counsel caution in finding

implied preemption where no express preemption

exists. App., 18a.

13

Appeals agreed, that there was nothing in federal law which

precluded plaintiffs from seeking damages for injuries proximately

caused by fraud committed on the FDA to the extent that state law

would permit such recovery. Thus, the question which Buckman

seeks to present for the Court’s review has nothing to do with the

question actually presented and decided in this case. Thus, it is

non-justiciable. Princeton University v. Schmid, 455 U.S. 100, 103

(1982) (Supreme Court does not sit to decide hypothetical issues or

to give advisory opinions); Hall v. Beals, 396 U.S. 45, 48 (1969)

(same).

B. The Court of Appeals Decision Represents

a Straightforward Application of a Recent,

Unanimous Ruling by this Court

Certainly, this Court's certiorari powers are properly exercised

to bring clarity to the resolution of important issues of federal law

where the appellate judicial dialogue has been unable to do so.

See, e.g., Ingalls Shipbuilding, Inc. v. Director, Office of Workers’

Compensation Programs Dept. of Labor, 519 U.S. 248, 254-55

(1997); Seminole Tribe of Florida v. Florida, 517 U.S. 44, 45

(1996). However, where the Court has recently exercised such

review powers to articulate guiding legal principles with respect to

the appropriate interpretation of a federal statute, it is plainly

inappropriate to invoke the re-exercise of the Court's review powers

to patro) the implementation of those principles by the lower

courts. Rivers v. Roadway Express, Inc., 511 U.S. 298, 312-13

(1994). And, it is particularly inappropriate to do so where the

decision for which certiorari review is sought involves a

straightforward application of a recent, unanimous ruling by this

Court. Yet, that is precisely what the instant Petitioner asks of this

Court.

14

The MDAs include an express preemption provision, 21 U.S.C.

§ 300k. Section 360k states:

[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 applic. ble under this chapter to the

device...

a

Before this Court's decision in Lohr, most of the Courts of

Appeals held that the available FDA marketing clearances or

approvals (.¢., investigational device exemptions, 510k clearances

and premarket approvals) as well as general FDA labeling and

manufacturing regulations, constituted preempting “federal

requirements” under Section 360k which totally displaced the

availability of common-law tort remedies which were construed as

preempted “state-law requirements.”* As a necessary consequence

of this view, they ruled that under section 360k, “states have no

authority to police [a manufacturer's] compliance with the FDA’s

* Eg, Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995),

vacated, S18 U.S. 1030 (1996); English v. Mentor Corp., 67 F.3d 477

(3d Cir. 1995), vacated, 518 U.S. 1030 (1996); Lohr v. Medtronic,

Inc., 56 F.3d 1335 (11th Cir. 1995), aff'd in part, rev'd in part, 518

U.S. 470 (1996); Michael v. Shiley Inc., 46 F.3d 1316 (3d Cir.), cert.

denied, 516 U.S. 815 (1995), rejected by Medtronic, Inc. v. Lohr, 518

U.S. 470 (1996), overruled by In re Orthopedic Bone Screw Products

Liability Litigation, 1589 F.3d 817 (3rd Cir. 1998); Reeves v. AcroMed

Corp., 44 F.3d 300 (Sth Cir.), cert. denied, 515 U.S. 1104 (1995),

Gile v. Optical Radiation Corp., 22 F.3d 540 (3d Cir.), cert. denied,

513 U.S. 965 (1994); King v. Collagen Corp., 983 F.2d 1130 (Ist

Cir.), cert. denied, 510 U.S. 824 (1993).

15

procedures.” E.g., Michael, 46 F.3d at 1329.° This view was

buttressed by the observation that the FDCA did not expressly or

impliedly afford a private damage.”'® Thus, these courts ruled that

state-law claims based on violations of FDA regulations, including

fraud on the FDA, were preempted by Section 360k."'

The decision of this Court in Lohr completely rejected both the

rulings and the underlying reasoning of this body of federal

appellate law. Lohr involved claims of preemption with respect to

a medical device which, like the devices at issue here, had been

cleared for commercial distribution pursuant to the 510k premarket

notification process. Lohr, 518 U.S. at 470. Although the

Petitioner characterizes Lohr as a “fractured four-one-four” opinion,

the decision of the Court was unanimous in two important respects.

* — See also Talbott v. C.R. Bard, Inc., 63 F.3d 25, 28-29 (ist Cir.

1995), cert. dism’d, 517 U.S. 1230 (1996); English, 67 F.3d at 482-

83; Mitchell 1, 67 F.3d at 1283; Lohr, 56 F.3d at 1343; Reeves, 44

F.3d at 306; Gile, 22 F.3d at 544; King, 983 F.2d at 1140.

'° Lohr, 56 F.3d at 1343; Michael, 46 F.3d at 1329; Reeves, 44

F.3d at 307; National Bank of Commerce of El Dorado vy.

Kimberly-Clark Corp., 38 F.3d 988, 992 n.2 (8th Cir. 1994); Gile,

22 F.3d at 544; King, 983 F.2d at 1140.

'! Mitchell 1, 67 F.3d at 1283; Talbot, 63 F.3d at 28-29; Lohr, 56

F.3d at 1343; Michael, 46 F.3d at 1329; Reeves, 44 F.3d at 306;

Gile, 22 F.3d at 544. Contrary to Petitioner’s assertion, all of these

cases were based on express preemption under Section 360k, not

on any principle of implied preemption.

16

First, all of the members of the Court agreed that while the

FDA is required to examine 510k notifications with a concern for

safety and effectiveness, nothing in the statute requires it to make

a determination that the device at issue is safe or effective. Lohr,

518 U.S. at 493-94 (majority) & 513 (O'Connor, J., concurring in

part). Therefore, all of the members of the Court agreed that a

$10k clearance determination by the FDA does not represent a

“requirement” sufficient to displace state law. /d.

The consequences of this aspect of Lohr for the present case

are clear. Just as there is nothing in the statute or regulations

regarding the 510k notification process which requires the FDA to

come to a specific conclusion regarding device safety in terms of

the design, labeling or manufacture of devices, there is nothing in

the statute or regulations which requires the agency to evaluate the

truthfulness of a 510k submission with respect to intended use or

any other matter. See 21 U.S.C. §§ 360c(f)(1), 360c(i)(1)(A); 21

C.F.R. § 807.100. Thus, while the FDA may consider questions of

truthfulness just as it may consider questions of design safety or

labeling adequacy in evaluating a 510k notification, it is not

compelled to do so. Therefore, an FDA clearance determination no

more represents a preempting “requirement” with respect to the

representations made in connection with a 510k notification than it

represents a preempting requirement with regard to the design or

labeling of a device under Lohr, and a liability determination based

on such representations under state law would no more represent

an impermissible “collateral attack” on the FDA’s 510k

determination than it did in Lohr.”

2 See, e.g., Green v. Dolsky, 546 Pa. 400, 685 A.2d 110, 118-19

(1996) (holding that while premarket approval is a specific

requirement which determines adequacy of device design and

labeling and therefore preempts state-law design and labeling

(continued...)

17

The second area of unanimity in Lohr which is significant here

was the Court's treatment of the issue of whether Section 360k

preempts state-law claims based on conduct which violates the

requirements of Federal Medical Device Law. With respect to this

issue, the Court explicitly recognized that there is no private right

to relief for violations of the FDCA. Lohr, 518 U.S. at 487.

Notwithstanding this, it unanimously rejected the rationale of those

cases which held that Section 360k deprived the states of any

authority to “police a defendant's compliance” with FDA

regulations. Rather, the Court found that because the MDAs

preempt only state-law requirements which are “different from or

in addition to” federal requirements and because allowing a remedy

for unlawful conduct does not amount to the imposition of a

“requirement,” the MDAs, by their express terms, do not preempt

state-law claims to the extent that they seek damages for alleged

violations of federal requirements. Lohr, 518 U.S. at 495-97

(majority opinion) and 518 U.S. at 513 (O’Connor, J., concurring

in part).'* In fact, the Court observed, the statutory language of

= (...continued)

claims, premarket approval does not adjudicate the truthfulness of

the information supplied to the FDA and, therefore, does not

preempt claims that the manufacturer provided the FDA with false,

fraudulent or incomplete information), cert. denied, 520 U.S. 1168,

1212 (1997).

'* In this regard, Justice O'Connor's Opinion states:

1 also agree that the Lohrs’ claims are not

preempted by § 360k to the extent that they seek

damages for Medtronics’ alleged violation of

federal requirements. Where a state cause of

action seeks to enforce an FDCA requirement, that

claim does not impose a requirement that is

(continued. .)

18

Section 360k may manifest an intent to foster state-law claims for

violations of FDCA requirements in order to “provide[ } another

reason for manufacturers to comply with ... existing ‘requirements’

under federal law.” /d. at 495. See also id. at 513 (O'Connor, J.,

concurring in part) (“to be sure, the threat of a damages remedy

will give manufacturers an additional cause to comply [with federal

requirements]”).

This unanimous ruling literally compelled the conclusion

reached by the Court of Appeals here. Federal statutory law

expressly prohibits the making of fraudulent statements and

representations to federal agencies. See 18 U.S.C. § 1001.

Moreover, FDA regulations expressly require that premarket

notifications submitted pursuant to Section 510k contain truthful

information. See 21 C.F.R. § 807.87(j). The basis for plaintiffs’

fraud claim is that Buckman and others defrauded the FDA by

making false statements to the agency concerning an issue of

paramount regulatory concern -- the intended use of AcroMed

orthopedic plates and screws. Thus, plaintiffs seek recovery for

conduct which violates federal law. If Lohr was clear about

anything, it was clear that such claims are not preempted. Thus, -

the decision of the Court of Appeals here reflected a conclusion

13

(...continued)

“different from, or in addition to” requirements

under federal law. To be sure, the threat of a

damages remedy will give manufacturers an

additional cause to comply, but the requirements

imposed on them under state and federal law do

not differ. Section 360k does not preclude states

from imposing different or additional remedies, but

only different or additional requirements.

518 U.S. at 513.

19

which inevitably followed from recent, unanimous precedent by

this Court for which certiorari review is particularly inappropriate.

Perhaps sensing this weakness in its position, Petitioner invokes

the principle of implied preemption to attract the Court's attention

to the issue of whether plaintiffs may bring a state-law claim for

injuries caused by fraud on the FDA. However, the principles of

implied preemption are just as clear as the rules of express

preemption and equally unavailing to Petitioner here.

Implied preemption is a well-defined, narrowly-construed

doctrine that provides for preemption in only two specific, discrete

circumstances.

The first circumstance requires a demonstration that it would

be impossible to comply with both state and federal law at the

same time. See, e.g., Lohr, 518 U.S. at 507 (Breyer, J.,

concurring); Freightliner Corp. v. Myrick, 514 U.S. 280, 287

(1995); Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S.

132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

A good example of a case warranting this type of implied conflict

preemption is where state law would impose liability on a

manufacturer for using a label required by federal law. See, e.g.,

McDermott v. State of Wisconsin, 228 U.S. 115, 133-34 (1913);

Moore v. Kimberly-Clark Corp., 867 F.2d 243, 245-47 (Sth Cir.

1989). Plainly, federal law does not permit or require fraudulent

statements or prohibit truthful disclosure of information such that

state common-law fraud claims would come into actual conflict

with specific federal regulatory requirements. See Connely v. lolab

Corp., 927 S.W.2d 848, 853-55 (Mo. 1996), cert. dism'd, 520 U.S.

1260 (1997); Green, 685 A.2d at 118. Under such circumstances,

the assertion of implied “conflict” preemption would be specious.

20

For the same reason, Petitioner cannot demonstrate the second

circumstance which warrants implied preemption -- that “state-law

stands as an obstacle to the accomplishment and execution of the

full purposes and objectives of Congress.” See, e.g., Lohr, 518

U.S. at 507 (Breyer, J., concurring); Freightliner, 514 U.S. at 287-

88; Florida Lime, 373 U.S. at 142-43; Hines v. Davidowitz, 312

U.S. at 67. As Lohr observed, permitting state-law claims for

conduct in violation of federal requirements, such as perpetrating

a fraud on the FDA, serves to secure compliance with federal law.

See Lohr, 518 U.S. at 495 (majority) & 518 U.S. at 513 (O'Connor,

J., concurring in part). Thus, permitting a state-law claim for fraud

on the FDA serves the objectives of federal law. It does not stand

as an obstacle to the accomplishment of those objectives. This

conclusion is all the more compelling considering that Congress

expressly considered the extent to which FDA actions should

displace state law in Section 360k and made an express

determination not to preempt state-law claims of the type presented

here. See, e.g., Freightliner Corp. v. Myrick, 514 U.S. 280, 288

(1995); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517 (1992).

Accordingly, this type of implied preemption is also unavailable

here.

For all of these reasons, it is clear that the Court of Appeals

decision in the present case represents a straightforward application

of clear principles of law which have been firmly established by

this Court and does not engender the kind of legal uncertainty

which requires resolution by the exercise of this Court's certiorari

powers.

21

C. There is No Substantial Appellate Conflict

Concerning Whether “Fraud-on-the-FDA”

Claims are Preempted _

Every appellate court which has considered the issue after Lohr

has ruled that state-law claims based on a violation of the MDAs

are not preempted as “collaterally attacking” or otherwise usurping

the FDA's function.'* Consistent with this, virtually every appellate

court which has considered the question after Lohr has ruled that

state-law claims arising from fraud on the FDA are not

'* See, ¢.g., Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1381-82

(11th Cir. 1999); Martin v. American Medical Systems, Inc., 116

F.3d 102, 104 (4th Cir. 1997); Duvall v. Bristol-Myers-Squibb Co.,

103 F.3d 324, 330 (4th Cir. 1996); Reeves v. AcroMed Corp., 103

F.3d 442, 447 (Sth Cir. 1997); Chambers v. Osteonics Corp., 109

F.3d 1243, 1248-49 (7th Cir. 1997); Symens v. SmithKline Beecham

Corp., 152 F.3d 1050, 1055 (8th Cir. 1998); Committee of Dental

Amalgam Manufacturers and Distributors v. Stratton, 92 F.3d 807,

812-13 (9th Cir. 1996), cert. denied, 519 U.S. 1084 (1997); Oja v.

Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1977); Niehoff v.

Surgidev Corp., 950 S.W.2d 816, 822 (Ky. 1997), cert. denied, 118

S. Ct. 1187 (1998); Green v. Dolsky, 546 Pa. 400, 685 A.2d 110

(1996), cert. denied, 520 U.S. 1168 (1997); Armstrong v. Optical

Radiation Corp., 57 Cal.Rptr.2d 763. 768, 772 (Cal. App. 1996);

Connelly v. lolab Corp., 927 S.W.2d 848 (Mo. 1996), cert. dism’d,

520 U.S. 1260 (1997); Walker v. Johnson & Johnson Vision

Products Inc., 217 Mich.App. 705, 719, 552 N.W.2d 679, 686

(Mich.App. 1996); Steele v. Collagen Corp., 63 Cal.Rptr2d 879

(Cal.App. 1997).

22

preempted.'* Thus, the status quo does not present the kind of

judicial conflict which suggests a need for certiorari review.

Nevertheless, Buckman posits that there is a serious division in the

Courts of Appeals over whether fraud-on-the-FDA claims are

undone by federal law. Plainly, this is not the case.

The sources which Buckman uses in an attempt to generate the

appearance that there is a serious judicial debate warranting a

unifying resolution by this Court simply don’t bear the weight of

that effort. Kuiper v. American Cyanamid Co., 131 F.3d 656 (7th

Cir. 1997), cert. denied, 118 S. Ct. 1839 (1998), was a case

involving express preemption under FIFRA. It did not involve any

claim of fraud on any agency and is so obviously unrelated to the

issues here that it was not cited by Buckman in any of the

proceedings in the Court of Appeals. Lewis v. Brunswick Corp.,

107 F.3d 1494 (Lith Cir. 1997), cert. dism'd, 118 S. Ct. 1793

(1998), involved the Coast Guard's enforcement of the Federal Boat

Safety Act and is so unrelated to the issues raised here that neither

Buckman nor its amici cited the case in their briefs or at oral .

argument in the Court of Appeals. Moreover, to the extent that

Lewis found that damage claims arising from fraud on the Coast

Guard were preempted, it did so without citation to or discussion

of a single legal authority. See Lewis, 107 F.3d at 1505.

Similarly, while the Seventh Circuit ruled in Mitchell 11 that fraud-

on-the-FDA claims were preempted, it did so only in passing,

without expressing any legal reasons for this conclusion and

'S See, e.g., In re Orthopedic Bone Screw Products Liability

Litigation, 159 F.3d 817 (3d Cir. 1998); Green v. Dolsky, 546 Pa.

400, 685 A.2d 110,117-18 (1996); Connelly v. lolab Corp., 927

S.W.2d 848, 855 (Mo. 1996); Dutton v. AcroMed Corp., 691

N.E.2d 738, 811-12 (Ohio App. 1997); Baird v. American Medical

Optics, 713 A.2d 1019, 1030 (NJ. 1998).

23

without citing any authority to support it other than a pre-Lohr

decision by the Third Circuit which was subsequently found by that

Court to have been overruled in Lohr.'® See Mitchell v. Collagen

Corp., 126 F.3d 902, 914 (7th Cir. 1997), cert. denied, 118 S. Ct.

1300 (1998). Finally, although Judge Cowen’s dissent in this case

discusses policy considerations which might be raised in a

legislative debate concerning preemption, nothing in his dissenting

opinion discusses the applicable legal standards for determining

whether Congress has, in fact, manifested a legislative intent to

preempt state-law claims or attempts to explain why such standards

would require preemption in the circumstances presented here.

App., 2Sa-32a.

Thus, Buckman has failed to point to any source which

indicates that there is a genuine, reasoned, legal debate concerning

the matters at issue here which exists at the appellate level, let

alone one that has matured to the point that Supreme Court

intervention is appropriate.

‘© In reaching its conclusion, the Court in Mitchell I relied on the

Third Circuit's pre-Lohr ruling in Michael v. Shiley, 46 F.3d 1316

(3d Cir. 1995). In the instant case, one of the authors of the Third

Circuit's Michael Opinion found that it had been overruled by

Lohr. App., 16a-17a. Given this, the Seventh Circuit may well

recede from its perfunctory ruling that fraud-on-the-FDA claims are

preempted if it is given the opportunity to do so. Further, Mitchell

II involved preemption with respect to a device which reached the

market through premarket approval and not through 510k clearance.

While the preemptive implications of premarket approval may be

ambiguous, Lohr clearly established that an FDA decision to issue

a 510k clearance is not preemptive. Consequently, Mitchell 1/1 is

distinguishable on this basis.

24

D. This Case Does Not Present An Appropriate

Vehicle to Resolve Any Conflict Regarding the

Issue of Whether an FDA Marketing Approval

Can Preempt State Laws of General Applicability

It is true that the Court in Lohr did not resolve by a clear

majority the question of whether there can ever be preemption of

state tort laws of general applicability under Section 360k. 518

U.S. at 504-05 & 509 (Breyer, J., concurring in part). Moreover,

while the Court in Lohr held that a 510k clearance will not be

preemptive, it did not by a clear majority express any principle

sufficient to resolve the question of whether other FDA device

marketing “approvals” -- specifically, an investigational device

exemption or a premarket approval'’ -- qualify as preempting

federal “requirements” for purposes of Section 360k. /d. In

practical terms, this has left open the question of whether an FDA

decision to grant a premarket approval or an investigational device

exemption preempts product liability claims relating to the devices

which are subject to such approvals. And the Courts of Appeals

are, to some extent, divided as to the resolution of that question."

' Under the statute, the FDA may not grant premarket approval

unless it finds that there is “reasonable assurance that [the] device

is safe under the conditions of use prescribed, recommended or

suggested in the proposed labeling thereof.” See 21 U.S.C. §

360e(d)(2). Similarly, an IDE will only be granted where the

applicant satisfies a number of express statutory conditions relating

to the safety of the proposed experimental device use. See 21

U.S.C. § 360j(g); 21 C.F.R. § 813, et seq.

‘* Compare, e.g., Oja v. Howmedica, 111 F.3d 782, 789 (10th

Cir. 1997) (no preemption) with Papike v. Tambrands Inc., 107

F.3d 737, 742 (9th Cir.), cert. denied, 118 S. Ct. 166 (1997)

(continued...)

25

It is not clear that this division has reached the point that

Supreme Court intervention is required to clarify the law.

However, if the issue is to be decided by the Court, it should not

be resolved as an abstract proposition of law but as part of a

controversy in which its resolution will actually make a difference

to the outcome. Princeton University v. Schmid, 455 U.S. 100, 103

(1982); Hall v. Beals, 396 U.S. 45, 48 (1969). This is not such a

case.

First, this case does not present the real question engendered by

the cited intercircuit split -- whether an IDE or PMA can be

preemptive -- because this case only involves a 510k clearance.

Second, even if this Court were to conclude that generally

applicable tort law could be preempted by some federal

requirements under the MDAs, there would still be no preemption

of plaintiffs’ claims against Buckman. This is because those claims

are based on a violation of federal law and because this Court

unanimously held in Lohr that such claims are not preempted.

Thus, this case does not present a proper vehicle to resolve the

broad question of whether state laws of general applicability can be

preempted by an FDA requirement or the relevant subsidiary

question of whether an FDA decision to grant a premarket approval

or investigational device exemption is preemptive of state tort

claims arising from the use of a device which is subject to such an

exemption or approval.

* (...continued)

(preemption) ; Martin v. Telectronics Pacing Systems, Inc., 105

F.3d 1090, 1099 (6th Cir. 1997), cert. denied, 118 S. Ct. 850

(1998) (same); Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324,

330 (4th Cir. 1996) (same).

26

CONCLUSION

For the foregoing reasons, Respondent respectfully submits that

the Petition for Certiorari should be denied.

Respectfully submitted.

JOHN J, CUMMINGS, III ARNOLD LEVIN

Cummings Cummings MICHAEL D. FISHBEIN*

& Dudenhefer * Counsel of Record

416 Gravier Street SANDRA L. DUGGAN

New Orleans, LA 70130 MICHAEL S. TARRINGER

(504) 586-0000 Levin Fishbein

Sedran & Berman

510 Walnut Street, Suite 500

Philadelphia, PA 19106

(215) 592-1500