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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2001
- **Citation:** 531 U.S. 341

## Text

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

~\
{>

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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x

Federal Statutes, Regulations, Rules

and Legislative Materials (Cont.) Page(s)
ee er ED "0d o6dedesdcceci ne tesbesdtdeauea 3
39 Fed. Reg. S5GZ0 (Nov. 16, 1906) 2... cc ccccccccvsceces 3
Se EE 6. ob 9.4.64 4005000840 80s0RERD 9
ee EE SNAKE ed centeeeeerenneeKEsCadceweds l
. § §: 3 0 eer Terre eer ere eT erry re TS 10
1976 U.S. Code Cong. & Admin. News, 1070, 1075 ......... 2
ss % F % fs Serre eo Te ee 2
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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385014_0276%3A03. Public record. Not legal advice.