# Opposition Brief — Baker v. St. Jude Medical Medical S.C.C., Inc. (No. 06-1262)

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2006

## Text

(® FILED
No. 06-1262 senddenad

IN THE

Supreme Court of the Gnited States

KEITH BAKER, Individually, and
IAN BAKER, Individually and as Independent Executor of the
Estate of Jean Baker, Deceased,
Petitioners,
Y.

St. JUDE MEDICAL, S.C., INC., and ST. JUDE MEDICAL, INC.,
Respondents.

On Petition for a Writ of Certiorari to the
Court of Appeals of Texas, First District, Houston

BRIEF IN OPPOSITION

JAMES C. MARTIN *
STEVEN M. KOHN
LISA M. BAIRD
REED SMITH LLP
355 South Grand Avenue, Suite 2900
Los Angeles, CA 90071-1514
* Counsel of Record (213) 457-8000

Counsel for Respondents

WILSON-EPES PRINTING Co., Inc. — (202) 789-0086 - WasnincTton, 0.C. 20002

QUESTION PRESENTED

Whether, consistent with Worthy v. Collagen Corp., 967
S.W.2d 360 (Tex.), cert. denied 524 U.S. 954 (1998), the
Texas court of appeals correctly held that 21 U.S.C. § 360k(a)
preempts petitioners’ state law damages claims involving St
Jude Medical, Inc.’s Class III medical device?

1
CORPORATE DISCLOSURE STATEMENT

Respondent St. Jude Medical, Inc. is a publicly traded
corporation and has no corporate parent. No other publicly
held company owns ten percent or more of this respondent's
stock.

Respondent St. Jude Medical, S.C., Inc. is a wholly owned
subsidiary of St. Jude Medical, Inc. No other publicly held
company owns ten percent or more of this respondent’s stock.

TABLE OF CONTENTS

QUESTION PRESENTED.......... aavoclomelaaseradaereataaiah
CORPORATE DISCLOSURE STATEMENT..............
BPMs CE BAF ETI EG er ccserorecersnrecesrcosesteavasonstnces

The Regulatory Bases For Federal Preemption As
Applied To Class III Medical Devices .............00..0....

REASONS FOR DENYING THE PETITION .............

A. The Petition Incorrectly Represents The Record
Regarding The Status Of FDA Approval For
The Medical Device In Question..........0000.........

B. There Is No Split Of Authority Regarding
Preemption Involving Medical Devices
That Allegedly Lost FDA Approval After
Implantation............ hacidesnvaadsadervacaiad lasted intestate

GAPE RINE cocatcotanncnsisecssciasteeiuscracseeseactotcatic:

APPENDIX A—April 29, 2002 Order Sustaining
Objections to Summary Judgment Evidence, Estate
of Jean Baker, Deceased, \n the Probate Court
Number One (1) of Harris County, Texas, Case No.
Pa titanate cotticnsaue maces

APPENDIX B—April 29, 2002 Order, Estate of Jean
Baker, Deceased, in the Probate Court Number One
(1) of Harris County, Texas, Case No. 312543-402..

APPENDIX C—June 30, 2005 Opinion, Court of
Appeals of Texas, Houston (Ist Dist.), Jn re Heart
Valve Litigation, 2005 WL 1541059 (Tex.App.-
Se ER SS, ARMOR ean MCR Rare RCIA herd ie to Se

1]

1]

15

3a

9a

TABLE OF CONTENTS—Continued
Page

APPENDIX D—February 8, 2006 Notice of Order un
Motion, Jan Baker, et al. v. St. Jude Medical, S.C.,
Inc., et al., Court of Appeals for the First District of
Texas at Houston, Case No. 01-02-00802-CV .......... 25a

APPENDIX E—May 2007 Brief for the United States
as Amicus Cunae, Charles R. Riegel, et al. v.
Medtronic, Inc., U.S. Supreme Court, Case No.
8 FW vad vs cgarsamientnress, EOL Me RIS aay ONE Dect 27a

Vv

TABLE OF AUTHORITIES

CASES Page
Bates v. Dow AgroSciences LLC, 544 U.S. 431
SSPE iiciiulewhinesecnisekesvaseedsrues ckdndpainadieibnntinesceeebeans 14,15
Brooks v. Howmedica, Inc., 535 U.S. 1056 (2002). 2
Brooks v. Howmedica, Inc., 273 F.3d 785 (8th
RS ECAR AEN nese a DE Lee 13,14
Buckman Co. v. Plaintiffs’ Legal Comm., 531
SE ITE © cv encgsseadascicnschaccsosntnievcartnanieoinn 5
Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir.
SU nciislutcasscmuenisesdauninavspieasavbenieinesiuaeaatuseontes 13,14
Fry v. Allergan Med. Optics, 695 A.2d 511 (R.I.
LS SE SANSA RTE Sa RET Re OD 13,14
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th
eee IIT ca iaiiadnat ccsapetdccormadentaapeneructioncsaceeiins 13, 14
Green v. Dolsky, 685 A.2d 110 (Pa. 1996)............ 13,14
Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.
SN ilaiisls shat uda dvcianilesnadi acd cerastidneseesvieouesanes tie 13,14
In re Heart Valve Litigation, 2005 WL 1541059
PRO. AD. FUEIE FU, ZIG) oevesvcevesesessvesvecnssvesennes 9,10

In re St. Jude Medical, Inc., Silzone Heart Valves
Prods. Liab. Lit., 2004 U.S. Dist. LEXIS 148
(D. Minn. Jan. 5, 2004) (MDL No. 01-1396)... 13

Kemp v. Medtronic, Inc., 534 U.S. 818 (2001)...... 3
Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir.

Knisley v. Medtronic, Inc., 126 S. Ct. 420 (2005). 2
Martin v. Medtronic, Inc., 534 U.S. 1078 (2002).. 2

Martin v. Medtronic, Inc., 254 F.3d 573 (Sth Cir.

Se FC See nn Eales Ree eo 13,14
McMullen v. Medtronic, Inc., 126 S. Ct. 1464

RARE Ar ad aS SR ae eee ee 2
McMullen v. Medtronic, Inc., 421 F.3d 482 (7th

6 So, ME ane ACL a ae a ee ae 13,14

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

vil

TABLE OF AUTHORITIES—Continued

Page
Mitchell v. Collagen Corp., 126 F.3d 902 (7th
Ee, Ea ie vnscactosecisicisicslesseebbausisancieenteaiesestnapomatnatonns 5,13, 14
Papike v. Tambrands Inc., 107 F.3d 737 (9th
Sas IE Bsnkeiiascctntasenesredseiaroeonieaaiadaensciaes 14
Riegel v. Medtronic Corp., 451 F.3d 104 (2d Cir.
ID iccsctslichsdncctaceedaieedlacucbaevelumiabalentimncalatebouate 13

Worthy v. Collagen Corp., 524 U.S. 954 (1998)... 3
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex.
SPIED scdscieisuitcsdscntnittapendbaictataccenitaidncladdicedatas passim

STATUTES, RULES, AND REGULATIONS

Federal Food, Drug, and Cosmetic Act (FDCA),
Be Ri ee ee I ircinctrccernscosnasinnivrnnensss

Medical Device Amendments (MDA),
BE le ee ee OE I vertcncremssvesinnvsnnnsciacnwens 3
PE ee OE EE socccccnccceietnresincmeennetens 4
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PE CF, © BUG Moc ccerecocccsencccccesacrsserres 2,8, 10, 1

Tex. Bus. & Commerce Code 88 | 17 01 et seq. . 9
Be Res SRN? Biissocdntnnsioncantaionideniapensdtncibenenitncamanse 12, 13
in wiictsnuvetnotinetenimncntnnanaasnenees 2,12

MISCELLANEOUS

Brief for the United States as Amicus Cuniae,
Horn v. Thoratec, 2004 WL 11437205 (3d Cir.
May 14, 2007) (No. 02-4597).........ccceccecceeeeeees 14, 15

Vil

FABLE OF AUTHORITIES—Continued

Page

Bnef for the United States as Amicus Curiae

Riegel v. Medtronic, Inc., No. 06-179 (S. Ct

May 2007)... . ; | 5 1]
H.R Rep. No. 94-853 (1976) ;

IN THE

Supreme Court of the Anited States

No. 06-1262

KEITH BAKER, Individually, and
IAN BAKER, Individually and as Independent Executor of the
Estate of Jean Baker, Deceased,
Petitioners,
V.
ST. JUDE MEDICAL, S.C., INC., and ST. JUDE MEDICAL, INC.,
Respondents.

On Petition for a Writ of Certiorari to the
Court of Appeals of Texas, First District, Houston

BRIEF FOR THE RESPONDENTS IN OPPOSITION

Petitioners contend this case presents a good vehicle for
the Court to clarify Medtronic, Inc. v. Lohr, 518 U.S. 470
(1996), and address two questions: whether, under 21 U.S.C.
§ 360k(a), FDA premarket approval (PMA) of a Class III
medical device preempts conflicting state law claims arising
from the device’s design, manufacture, and labeling, and
whether preemption still holds if that approval is subse-
quently “lost.”

But the reasons for denying certiorari in this case are
significant. The primary question presented in the petition is
whether medical devices that have lost their FDA approval
give rise to preemption. Yet that issue depends on an

4,
oe

assertion—that FDA approval was lost—lacking any support
in the record. Throughout this case, petitioners have argued
that statements in two documents (the “Dee letter” and the
“Fitzgerald memo”) conclusively establish that the FDA
withdrew approval for the medical device in question. But
the Texas probate court excluded those statements, and the
Texas court of appeals did not disturb that ruling. Opp’n
App. la-2a, 8a; Pet. App. la, 5a-6a & n.4, lla n.5 (Baker
v. St. Jude Medical §.C., Inc., 178 S.W.3d 127, 132 & n.4,
134 n.5 (Tex. App. 2005)). Instead, as the court of appeals
expressly recognized, pursuant to 21 C.F.R. § 814.46, the
FDA must follow a formal process to withdraw premarket
approval, and it was undisputed “that the FDA never formally
withdrew its PMA approval of the valve, and the valve had
FDA approval on the date it was implanted.” Pet. App. 6a.
This discrete and correct evidentiary ruling does not warrant
this Court’s review, and petitioners’ failure to inform this
Court of it alone is sufficient reason to deny the petition
under Rule 14.4 (“The failure of a petitioner to present with
accuracy, brevity, and clarity whatever is essential to ready
and adequate understanding of the points requiring considera-
tion is sufficient reason for the Court to deny a petition.”’).

Moreover, petitioners’ assertions of a “conflict” in the rele-
vant preemption authority do not withstand analysis either. In
Texas state courts there is no such split. The controlling
preemption analysis, set forth in Worthy v. Collagen Corp.,
967 S.W.2d 360 (Tex.), cert. denied 524 U.S. 954 (1998),
was followed by the courts below. More broadly, the
overwhelming majority of federal and state cases follow
Worthy’s analysis. Accordingly, this Court previously has
declined to review cases appiying preemption principles to
Class III medical devices, ' and there is no reason, as the

' See, e.g., McMullen v. Medtronic, Inc., 126 S. Ct. 1464 (2006);
Knisley v. Medtronic, Inc., 126 S. Ct. 420 (2005); Brooks v. Howmedica,
535 U.S. 1056 (2002); Martin v. Medtronic, Inc., 534 U.S. 1078 (2002);

3

Solicitor General recently has noted, to depart from that
position now. See Opp’n App. 34a-35a (Brief for the United
States as Amicus Curiae at 2-3, Riegel v. Medtronic, Inc., No.
06-179 (S. Ct. May 2007)).

In sum, the petition presents a unique fact-bound issue that
is, in essence, nothing more than a dispute with the probate
court’s correct evidentiary ruling. Even if one gets beyond
the discrete nature of the dispute, the controlling preemption
principles are well settled, and there is no material conflict in
the law. The asserted bases for this Court’s review are not
present and the petition should be denied.

STATEMENT OF THE CASE

The Regulatory Bases For Federal Preemption As
Applied To Class III Medical Devices

This case involves a question of federal preemption as
applied to a Class II] medical device. These devices are the
most highly regulated and invoke express preemption princi-
ples by virtue of the controlling federal regulatory scheme.

In 1976, Congress enacted the Medical Device Amend-
ments (MDA), 21 U.S.C. §§ 360c et seq., to the Federal Food,
Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 ef seq.,
which vastly expanded the authority of the FDA to regulate
medical devices. At the same time it established a coOmpre-
hensive regulatory regime at the federal level ‘Congress
sought to protect innovations in device technology from-being
“stifled by unnecessary restrictions.” H.R. REP. No. 94-853,
at 12 (1976). Specifically, Congress attempted tp shield
medical devices from the “undufe] burden[]}” imposed by
differing state regulation by including in the MDA a “general
prohibition on non-Federal regulation.” /d. at 45. That

Kemp v. Medtronic, Inc., 534 U.S. 818 (2001); Worthy v. Collagen Corp.,
524 U.S. 954 (1998).

4

general prohibition, which also safeguards the umformity of
the federal regulatory scheme, broadly provides that no State
msy #npose “any requirement” relating to the safety or
effectiveness of a medical device that “is different from, or in
addition to, any requirement applicable ... to the device”
under federal law. 21 U.S.C. § 360k(a).

To obtain premarket approval, manufacturers must provide
the FDA with research results and other data supporting the
intended use of the device, a sample of the device, and other
information, including the proposed device composition and
proposed product labeling. Clerk’s Record (CR) 3055-56;
see also 21 U.S.C. § 360c(a)(1)(C); 21 C.F.R. § 814.20(b)).
Among other information, a PMA application must include:

* all known reports pertaining to the device’s safety and
efficacy, § 360e(c)(1)(A);

* a full statement of the components, ingredients, and
properties and of the principle or principles of opera-
tion of such device, § 360e(c)(1)(B);

* a full description of the methods used in, and the
facilities and controls used for, the manufacture, proc-
essing, and, when relevant, packing and installation
of, such device, § 360e(c)(1)(C);

* samples of the device when practical, § 360e(c)(1)(E);
and

* specimens of the labeling proposed to be used for the
device, § 360e(c)(1)(F).

CR 3055-56.

Device innovations also receive this same scrutiny. Thus,
if a PMA medical device is subsequently modified, the manu-
facturer must seek approval for the modification through
the “PMA supplement” process. CR 3056; see also 21 U.S.C.
§ 360e(d)(6)(A)(i); 21 C.F.R. § 814.39. All the procedures
and actions applicable to a PMA application apply to a PMA

5

supplement. CR 2791-92 (citing Worthy, 967 S.W.2d at 364-
65 (describing the PMA supplement process) and Kemp v.
Medtronic, Inc., 231 F.3d 216, 222 (6th Cir. 2000) (same)).
In a PMA supplement, the manufacturer must provide the
same information required by a PMA application to support
approval of the proposed modifications. CR 3056-57; see
also 21 C.F.R. § 814.39(c).

PMA and PMA supplement submissions are voluminous,
and the FDA’s experts evaluate them fully. On average, the
FDA spends 1200 hours reviewing a PMA. CR 3056; see
generally Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.
341, 344-45 (2001) (describing the PMA process); Mitchell v.
Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997) (same).
When the medical device at issue is a heart valve, the FDA
employs a staff of experts in that specific area, and uses
standards contained in an FDA document entitled “Replace-
ment Heart Valve Guidance” (Guidance Document).? CR
3059.

The medical device at issue in this case was reviewed
through these processes. In December 1982, following two
years of regulatory review, the FDA approved St. Jude
Medical’s initial PMA application for a mechanical heart
valve, called the “Bi-Leaflet Center Opening Pyrolytic Carbon
Cardiac Valve.” CR 3161-62. In the years following approval,
St. Jude Medical provided the FDA with a tremendous
amount of additional data regarding the safety and efficacy of
the valves, in a series of PMA supplements. /d.

* The Guidance Document sets forth the type of testing that must be
conducted, and the test data that must be submitted, to adequately demon-
Strate heart valve safety and efficacy in any PMA or PMA supplement
application for that type of device. See CR 3059. If the manufacturer
deviates from the recommended tests and other recommendations, it must
demonstrate the equivalency or superiority of its choice of alternative to
the satisfaction of the FDA or the FDA will refuse approval. /d

6

This standard mechanical heart valve achieved wide accep-
tance. As medical research continued to evolve, however, St.
Jude Medical developed innovative new technologies for
physicians and their patients, including modifying its heart
valve to incorporate a rotating sewing cuff that eliminated the
need for surgeons to position the valve prior to suturing. CR
3162. The PMA supplement for this modification, known
as the Masters Series valve, was supported by extensive
documentation, including proposed labels, design specifica-
tions, and manufacturing standards, and the FDA approved it.
CR 3162-63.

Over time, it became clear that an additional new technol-
Ogy was needed to address a well-known risk associated
with artificial heart valves: endocarditis. CR 3156. Even
with aggressive treatment, endocarditis can be life-threaten-
ing, causing death in 25% to 60% of cases. Jd.

Silver, in various forms, has been used as an antimicrobial
agent for many years, including as an infection-resistant
coating for other medical devices. CR 3157, 3222, 3237.
Spire Corporation had developed a patented technology to
coat biomaterials with a silver coating several microns thick,
subjected the coating to numerous safety and efficacy in
vitro (laboratory) and in vivo (patient or animal) tests, and
successfully used it on several medical devices. CR 3285-86.
Thus, in December 1995, St. Jude Medical preliminarily
notified the FDA of its plan to modify its Masters Series
valve to incorporate Spire’s infection-resistant, sterile silver
coating on the sewing cuff. CR 3148, 3163-64, 3285.

The FDA advised St. Jude Medical that its proposed plan
required numerous modifications—based in part on the heart
valve Guidance Document—including performance of spe-
cific tests and submission of additional data and information.
CR 3164-65. Almost a year and a half later, in May 1997,
after it had compiled the data the FDA specified, St. Jude
Medical formally submitted its PMA supplement to add the

7

silver coating (under the name Silzone®) to the sewing cuff
on its Masters Series mechanical heart valve. CR 3165-67.”

The FDA’s review of the formal PMA supplement took
more than 10 months to complete, in addition to the many
months the FDA already had spent reviewing St. Jude
Medical’s preliminary proposal. CR 3167. During this review
process, the FDA demanded further testing and data, label
changes, and manufacturing changes. CR 3167-70.

In March 1998, the FDA finally approved the PMA supple-
ment, concluding there was sufficient evidence that the
Masters Series heart valve with a Silzone®-coated sewing
ring was reasonably safe and effective for its intended use.
CR 3170-72. Through its approval, the FDA required St
Jude Medical to use the exact design, labeling, and manu-
facturing process it had approved. /d. The FDA also prohib-
ited St. Jude Medical from making claims regarding efficacy
of the Silzone® coating in preventing endocarditis pending
the completion of further testing. /d.

St. Jude Medical thereafter manufactured and marketed the
Silzone® valve in conformity with the established require-
ments. CR 3152, 3173. Petitioners have never adduced any
evidence that the specific valve at issue in this case deviated
from the FDA-required design, label, or manufacturing
process.

* This application provided important safety and efficacy data regard-
ing the proposed silver coating material, design specifications, a sample
package label for the new valve, and details regarding the manufacturing
process that would be employed. See CR 3165-67. It also included a
peer-reviewed report on a human clinical trial of the Silzone® valve. CR
3173-74, 3236. In addition, Spire had submitted to the FDA its own
Master File in support of its patented silver coating with additional infor-
mation on the coating process, quality contro! procedures, and the results
of its own tests, and St. Jude Medical’s PMA supplement relied on these
materials as well. CR 3166, 3286

8

Concomitantly with the marketing of the valve, St. Jude
Medical continued to study its efficacy. The largest and most
comprehensive of these studies was the Artificial Valve
Endocarditis Reduction Tnal (AVERT). CR 3176. An inde-
pendent data safety and monitoring board (DSMB) periodi-
cally reviewed data generated by the AVERT. CR 3176. On
January 21, 2000, the DSMi concluded the preliminary data
from AVERT indicated that a very small percentage of the
patients with the Silzone® valve had an equally small, but
Statistically significant, increased incidence of explant due
to paravalvular leak. CR 3177-78. That same day, St. Jude
Medical began a voluntary world-wide recall of all unim-
planted Silzone® products.* /d.

Following St. Jude Medical’s voluntary recall, the FDA
audited the company but never recommended any change to
the company’s voluntary recall plan or took formal regulatory
action. CR 535-40 (“Current inspection was prompted by a
voluntary recall of all unimplanted heart valves with silver
ion (silzone) impregnated sewing cuffs.... No FDA 483
was issued to this firm. It appears that St. Jude responded
quickly to the outcomes of the [redacted] study”); CR 3178.
The FDA also never took any of the steps needed to formally
revoke approval for the Silzone® valve described in 21 C.F.R.
§ 814.46. Two FDA officials wrote statements, referred to in
this case as the “Dee letter” and “Fitzgerald memo,” indicat-
ing the company’s action met “the formal definition of a
‘Recall’” and was in tieuw of FDA “legal action to remove the
defective products from the market.” Pet. App. 38a; see also
Pet. App. 5a-6a. Aé the same time, the FDA’s position on

“In connection with this voluntary recall effort, St. Jude Medical
alerted the FDA and also sent overnight alert letters to those cardiac sur-
geons and other physicians known to use its products. CR 3177-78; see
also CR 1334-43. Those letters asked the recipients to stop using the
Silzone® valve and to return any unimplanted Silzone® products. CR
3177-78; see also CR 1334-43

9

already-implanted valves was that normal monitoring was
sufficient to detect the relatively low-risk occurrence reporied
in the AVERT study. CR 604, 619-23.

Petitioners Keith Baker and lan Baker filed a lawsuit in
Probate Court Number One of Harris County, Texas claiming
that their mother’s death resulted from negligent care pro-
vided by her physicians. CR 925. They also alleged several
common law product liability theories and a statutory decep-
tive trade practices claim (Tex. Bus. & Com. Code Ann.
§ 17.01 et seg. (Vernon 2002 & Supp. 2006)) against St. Jude
Medical. CR 946-48. Each of petitioners’ claims alleged the
heart valve is “an unreasonably dangerous and defective”
medical device that should have been manufactured and
marketed with a design and label different from the one the
FDA approved and required St. Jude Medical to use. See CR
947.

St. Jude Medical moved for summary judgment arguing
that both express and implied preemption barred the common
law and statutory claims. CR 2788-2812. Because the record
established the requisite PMA and PMA supplement approval
of the Silzone®-coated sewing cuff (CR 1019-1048), the
probate court granted summary judgment (Pet. App. 21a). It
also upheld several of St. Jude Medical’s evidentiary objec-
tions and excluded the salient portions of the Dee letter (Pet.
App. 37a-41a), and the Fitzgerald memo (Pet. App. 33a-36a).
Opp’n App. la-2a, 8a. The probate court later denied peti-
tioners’ new trial motion and renewed evidentiary arguments.
CR 4362.

Afterward, St. Jude Medical also successfully moved for
summary judgment on the claims of an additional 69 plain-
tiffs in a coordinated state court proceeding in Harris County,
Texas involving the same Silzone® heart valve. See Opp’n
App. 9a, 2la-24a (Jn re Heart Valve Litigation, 2005 WL
1541059 (Tex. App. June 30, 2005)).

10

Petitioners in this case then appealed (CR 4363), and the
69 plaintiffs in the coordinated Texas proceeding filed a
companion appeal. The court of appeals affirmed summary
judgment both in this case and in the companion appeal, and
published its decision in this case. Pet. App. la-20a; Opp’n
App. 9a-24a. It did not disturb the probate court’s exclusion
of the Dee letter (Pet. App. 37a-41a), or the Fitzgerald memo
(Pet. App. 33a-36a) excerpts. See Pet. App. Sa-6a & n.4.
It also affirmed on both express and implied preemption
grounds. See id. at 16a-17a (affirming judgment for St. Jude
Medical on negligence, product liability and Texas Deceptive
Trade Practices Act claims on express preemption grounds);
id. at 17a-20a (affirming judgment for St. Jude Medical on
fraud claim on implied preemption grounds).

In affirming, the court of appeals expressly recognized that,
pursuant to 2! C.F.R. § 814.46, the FDA must follow a for-
mal process to withdraw premarket approval, and that it was
undisputed “that the FDA never formally withdrew its PMA
approval of the valve, and the valve had FDA approval on the
date 11 was implanted in Baker.” Pet. App. at 6a.

The court of appeals denied petitioners’ motion for rehear-
ing on February 8, 2006. Opp’n App. 25a-26a. Petitioners
here then sought discretionary review by the Texas Supreme
Court, although the 69 plaintiffs in /n re Heart Valve Litiga-
tion did not. After the parties filed merits briefs, the Texas
Supreme Court denied review in this case on December 15,
2006. Pet. App. 22a.°

In one place, the petition states that “(t]hese issues were appealed
directly by the petitioners to the Texas Supreme Court.” Pet. 5. But in
fact the Texas Supreme Court denied petitioners’ discretionary petition for
review after full merits briefing on issues such as whether the court of
appeals’ opinion in this case was a faithful application of the Texas
Supreme Court’s precedent, Worthy, 967 S.W.2d 360. See Pet. App. 22a,
110a-1 12a.

1]
REASONS FOR DENYING THE PETITION

A. The Petition Incorrectly Represents The Record
Regarding The Status Of FDA Approval For The
Medical Device In Question

The federal regulations provide one avenue by which the
FDA may withdraw premarket approval: ii must issue formal
notice to the medical device manufacturer, hold a hearing,
and offer an appea! process. See 21 C.F.R. § 814.46. The
Texas court of appeals recognized no such steps were taken
for the Silzone® device, and thus it was undisputed “that the
FDA never formally withdrew its PMA approval of the valve,
and the valve had FDA approval on the date it was implanted
in Baker.” Pet. App. 6a; cf Opp’n App. 44a (Solicitor Gen-
eral’s amicus brief in Riegel, describing statutory require-
ments for FDA to withdraw premarket approval and stating
“{w]here the FDA has not taken such action, its approval
of the PMA — and the ‘requirements’ that result from that
approval — remain in effect.”).

At best, the petition mischaracterizes the appellate court’s
Statement that it was undisputed the FDA never formally
withdrew approval. It represents in one place that the Texas
court of appeals merely “implied that the Silzone-coated
valves must still be FDA-approved” and suggests it was
“clearly . . . incorrect” in reaching that conclusion. Pet. 10.

More often, however, the petition represents this case as
unequivocally involving the opposite circumstance — that the
Silzone® valve undisputedly lost approval — without any
acknowledgement of the probate court’s contrary evidentiary
finding. See Pet. 1 (“suppose a particular device is no longer
FDA-approved?”); 12 (“Preemption When the Product is No
Longer FDA-Approved” and “this product is no longer
approved by the FDA”’); 13 (“the product no longer has FDA
approval”).

12

To make these assertions, petitioners construct an argument
based upon the Dee letter and Fitzgerald memo (Pet. 9-11),
yet never once acknowledge that those documents were
excluded by the probate court, or that their exclusion was left
undisturbed by the Texas court of appeals (Pet. App. Sa-6a &
n.4, 1la n.5). This omission is not a minor one, given that
half the petition is premised on the Dee letter and Fitzgerald
memo and results in petitioners’ argument that certiorari is
warranted because the lower courts upheld preemption for a
device that was not FDA-approved.

There is no reason for this Court to grant certiorari to
address a putative legal issue not supported by the record in
this case. See S. Ct. R. 14.4 (“The failure of a petitioner to
present with accuracy, brevity, and clarity whatever is
essential to ready and adequate understanding of the points
requiring consideration is sufficient reason for the Court to
deny a petition.”). There also is no reason for this Court to
grant certiorari to address the propriety of the probate court’s
evidentiary ruling. See S. Ct. R. 10 (“A petition for a writ of
certiorari is rarely granted when the asserted error consists of
erroneous factual findings.’’).

B. There Is No Split Of Authority Regarding
Preemption Involving Medical Devices That
Allegedly Lost FDA Approval After Implantation

Even without petitioners’ fundamental record problem,
the grounds for denying certiorari are ample. According to
petitioners, the “opinion of the Texas Court of Appeals is the
only published appellate opinion in this country in which a
court has directly addressed” the issue of whether preemption
applies when a “product is no longer approved by the FDA.”
Pet. 12. On its face, this question presents no split in
authority that can traditionally provide a “compelling reason”
under Rule 10 for review.

13

The vast majority of courts—and ai/ recent appellate
decisions—have found that premarket approval and the
resultant bar on changes to an FDA-approved device create
specific federal requirements that preempt conflicting state
common law damages actions. See, e.g., Pet. App. 11a-16a;
Riegel v. Medtronic Corp., 451 F.3d 104 (2d Cir. 2006);
McMullen v. Medtronic, Inc., 421 F.3d 482, 487-88 (7th Cir.
2005); Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.
2005); Horn v. Thoratec Corp., 376 F.3d 163, 171-73 (3d
Cir. 2004); Brooks v. Howmedica, Inc., 273 F.3d 785, 799
(8th Cir. 2001) (en banc); Martin v. Medtronic, Inc., 254 F.3d
573, 585 (Sth Cir. 2001); Kemp, 231 F.3d at 226-27 (6th
Cir.); Mitchell, 126 F.3d at 911 (7th Cir.); Worthy, 967
S.W.2d at 376 (Tex.); Fry v. Allergan Med. Optics, 695 A.2d
S11, 516 (R.I. 1997); Green v. Doalsky, 685 A.2d 110, 117
(Pa. 1996).

In contrast to these decisions, petitioners identify (at
Pet. 1) — but never discuss — an outdated federal court of
appeals decision that did not find premarket approval to be
preemptive—Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th
Cir. 1999). The decision in Goodlin, which arises on facts
different from those presented here, is not reflective of the
current state of law and is no threat to the stability of the
prevailing authority in the Texas state courts or elsewhere.°

* Petitioners also identify one unpublished interlocutory district court
order that involved the same medical device as this case and did not find
the PMA and PMA supplement process preemptive, /n re St. Jude
Medical, Inc., Silzone Heart Valves Prods. Liab. Lit., 2004 U.S. Dist.
LEXIS 148 (D. Minn. Jan. 5, 2004) (MDL No. 01-1396). (Pet. App. 42a,
77a). But they do not contend that this order is of any significance in
terms of a split of authority (Pet. 7-10), nor could they given the ordez’s
interlocutory nature and the fact it is only a trial court order that has not
yet received appellate review. See S. Ct. R. 10 (identifying other compel-
ling circumstances where review is warranted).

14

In the eight years since Goodlin was decided, no other
court of appeals and no other state supreme court has joined
the Eleventh Circuit. Given the legal and administrative
developments in the meantime, there is reason to believe that
the Eleventh Circuit will correct itself. See Opp’n App. Sla-
52a.

The appellate court’s decision in this case also does not
conflict with this Court’s precedent Bates v. Dow AgroSciences
LLC, 544 U.S. 431 (2005). Petitioners argue that “it is not
entirely clear” after Bates “when requirements might be
deemed imposed by state court suits so as to run afoul of
preemption provisions.” Pet. 25. But once again, the vast
majority of lower courts, and a// courts to have considered
the issue recently, have held that, under the MDA, state tort
claims can be preempted. See, e.g., Pet. App. 7a-Ila;
McMullen, 421 F.3d at 487; Cupek, 405 F.3d at 424; Horn,
376 F.3d at 173-77; Brooks, 273 F.3d at 799; Martin, 254
F.3d at 584; Kemp, 231 F.3d at 224; Mitchell, 126 F.3d at
913-14; Papike v. Tambrands Inc., 107 F.3d 737, 741 (9th
Cir. 1997); Worthy, 967 S.W.2d at 376-77; Fry, 695 A.2d at
517; Green, 685 A.2d at 117-18.

Similarly, petitioners contend that “Bates made one point
abundantly clear: even if a jury verdict in a damages claim
were to be based on a finding that would conflict with an
agency finding, the verdict would never support application
of the preemption doctrine.” Pet. 25. But in Bates, this Court
held that the term “requirements” in the identically-worded
Federal Insecticide, Fungicide, and Rodenticide Act includes
common law claims. Bates, 544,U.S. at 443. This issue thus

is also well settled.? See Opp’tApp. 44a-45a (Solicitor

\
\

” As the FDA explained through the Solicitor Osneral, during the PMA
process it conducts “a thorough review of a substanWal scientific record”
(Brief for the United States as Amicus Curiae, Horn vs Thoratec, 2004
WL 1143720, at *16 (3d Cir. May 14, 2007) (No. 02-4597))and performs
a “careful balancing” of the benefits and risks associated ———-

aN

15

General acknowledging that this Court has consistently held
state common law actions can create state “requirements”).

Whatever petitioners’ confusion about the state require-
ment side of the preemption analysis, it is not reflected in any
recent circuit or state high court decision. There also is no
conflict between the appellate court’s position and this Court’s
Bates decision. The result reached below likewise comports
with the prevailing administrative construction of the perti-
nent regulatory scheme. Finally, as the FDA has emphasized,
“very strong public policy considerations” support application
of preemption principles to state common law claims involv-
ing Class II] medical devices. Brief for the United States as
Amicus Curiae, Horn v. Thoratec, 2004 WL 1143720, at *25
(3d Cir. May 14, 2007) (No. 02-4597). According to the
FDA—the agency charged with implementing the MDA—
“the accomplishment of its regulatory goals would be under-
mined if lay judges or juries were permitted to second-guess
the scientific judgments it makes in approving a PMA
application.” Opp’n App. 45a.

CONCLUSION

The petition at bottom asks this Court to revive and resolve
a state law evidentiary dispute that does not present a reason
to grant certiorari and was not preserved for appeal. Beyond
that, it asks this Court to set a Texas court on its proper
course without any showing that the preemption principles
applied are in need of correction. Even as to the result
reached, an examination of the recent and controlling case

device (id. at *29). State tort actions, however, usurp “the central role of
{the] FDA” by requiring “lay judges and juries to second-guess the
balancing of benefits and risks of a specific device.” /d. at *25. Because
such second-guessing “may disrupt the careful balancing performed by
the FDA in the PMA process” (id. at *29), state common law claims such
as those asserted in Horn—and here—"“are preempted under federal law.”
Id. at *31.

16

law reveals no material conflict in the application of estab-
lished preemption principles to this unique set of facts. For
each of these reasons, the petition should be denied.

Respectfully submitted

AMES C. MART
EVEN M. KOHN
LISA M. BAIRD
REED SMITH LLP
55 South Grand Avenue, Suite 2900

A noala f OV ! S1A
os Angeles, CA 90071 14

4

4) 457-8000

J )
Pte
r —_

.

ee ee
The court of appeals “agree[d] with the district court’s conclusion that
[petitioners’] negligent manufacturing claim was not preempted, to the
extent that it rested on the allegation that the particular Evergreen Balloon
Catheter that was deployed during Mr. Riegel’s angioplasty had not been
manufactured in accordance with the PMA-approved standards.” Pet.
App. 35a. The court explained that “[a] jury verdict in [petitioners’] favor
on this claim would not have imposed state requirements that differed
from, or added to, the PMA-approved standards for this device, but would
instead have simply sought recovery for {respondent’s] alleged deviation
from those standards.” /d. at 35a-36a. The court of appeals affirmed the
district court’s grant of summary judgment to respondent on the merits of
the negligent-manufacturing claim, however, see id. at 38a-43a, and peti-
tioners do not challenge that ruling in this Court.

40a

38a—that the FDA’s premarket approval of a Class III
medical device imposes federal “requirements” that preclude
the imposition of state-law tort liability based on respondent’s
alleged failure to satisfy inconsistent or additional state-law
requirements. The Second Circuit’s decision in this case
accords with the large majority of federal and state appellate
rulings on the question presented here. Although one federal
court of appeals and one state supreme court have held that
comparable tort claims were not preempted, those decisions
predate most of the other cases addressing the question, and
they were issued without the benefit of FDA’s current judg-
ment that premarket approval of a Class III device imposes
federal “requirements” that should be given preemptive
effect. In light of those intervening developments, the courts
that have previously rejected preemption defenses in this
context may reconsider their position in an appropriate case.
This case, moreover, would not be an appropriate vehicle in
which to address the preemption of state tort suits concerning
Class III devices that have received PMA approval. See pp.
14- 15, infra. Review by this Court therefore is not warranted.

A. The Decision Of The Court Of Appeals Is Correct

Petitioners contend (Pet. 19-22) that the court of appeals’
ruling in this case is inconsistent with this Court’s decision in
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Lokr, however,
does not govern this case.

1. In Lohr, this Court considered the application of the
MDA’s express preemption provision, 21 U.S.C. 360k, to a
tort suit involving a medical device for which the FDA had
made a substantial-equivalence determination. See 518 U.S.
at 480-481. In rejecting the manufacturer’s claim that the suit
was preempted, the Court explained that the process by which
substantial-equivalence findings are made “is by no means
comparable to the PMA process,” involving an average of

20 hours of review time in contrast to the 1200 hours spent
on the average PMA review. /d. at 478-479. The Court

4la

also noted the FDA’s own admonition that its substantial-
equivalence determination “should not be construed as an
endorsement of the [device]’s safety.” Jd. at 480.

The manufacturer in Lohr argued that the FDA’s prom-
ulgation of general standards for labeling and manufacturing
of medical devices “pre-empts any and all common-law
claims brought by an injured plaintiff against a manufacturer
of medical devices.” 518 U.S. at 486 (plurality opinion). All
Members of this Court agreed that the statute does not impose
that blanket prohibition on the imposition of state-law tort
liability. See id. at 487 (plurality opinion); id. at 50S (Breyer,
J., concurring in part and concurring in the judgment); id. at
513 (O’Connor, J., concurring in part and dissenting in part).
The manufacturer also argued, inter alia, that the FDA’s
clearance of a device based on a substantial-equivalence
determination preempted suits alleging that the device was
defectively designed. See id. at 492 (opinion of the Court). In
rejecting that contention, the Court explained that “[t}he com-
pany’s defense exaggerates the importance of the [substan-
tial-equivalence] process,” ibid., and that the device at issue
had “never been formally reviewed [by the FDA] under the
MDA for safety or efficacy,” id. at 493. Accerd id. at 513
(O’Connor, J., concurring in part and dissenting in part).

A four-Justice plurality of the Lohr Court predicted that
any common-law suits preempted by Section 360k would be
“few” and “rare.” 518 U.S. at 502. In his concurring opinion,
however, Justice Breyer stated that “ordinarily, insofar as the
MDA preempts a state requirement embodied in a state stat-
ute, rule, regulation, or other administrative action, it would
also pre-empt a similar requirement that takes the form of a
standard of care imposed by a state-law tort action.” /d. at
504-505. Justice Breyer further stated that he was “not con-
vinced that future incidents of MDA pre-emption of common-
law claims will be ‘few’ or ‘rare.” /d. at 508. The remaining
four Justices “conclude[d] that state common-law damages

42a

actions do impose ‘requirements’ and are therefore pre-
empted where such requirements would differ from those
imposed by the [FDCA].” Jd. at 509 (O’Connor, J., con-
curring in part and dissenting in part). Those Justices also
expressed disagreement with the plurality’s forecast that
instances of such preemption would be “rare.” Jbid. Thus,
five Members of the Court in Lohr agreed that state tort suits
are preempted on essentially the same terms as state pre-
scriptive requirements.

The Court in Lohr also noted the significant role of the
FDA in defining the MDA’s preemptive scope. The Court
explained:

Because the FDA is the federal agency to which Con-
gress has delegated its authority to implement the provi-
sions of the Act, the agency is uniquely qualified to
determine whether a particular form of state law “stands
as an obstacle to the accomplishment and execution of
the full purposes and objectives of Congress,” Hines v.
Davidowitz, 312 U.S. 52, 67 (1941), and, therefore,
whether it should be pre-empted.

518 U.S. at 496 (footnote omitted). The Court concluded that,
with respect to the construction of the FDCA’s express pre-
emption provision, “[t]he ambiguity in the statute—and the
congressional grant of authority to the agency on the matter
contained within 1t—provide a sound basis for giving sub-
stantial weight to the agency’s view of the statute.” /bid.
(citation and internal quotation marks omitted).

2. In the instant case, the court of appeals held that the
FDA’s premarket approval of the Evergreen Balloon Catheter
imposed specific federal “requirements” that preempted in-
consistent duties sought to be imposed through application of
state tort law. See Pet. App. 25a-29a. That holding is correct
and is consistent with this Court’s decision in Lohr.

43a

The FDA’s premarket approval for the Evergreen Balloon
Catheter was premised on the agency’s finding that there was
reasonable assurance that the device was safe and effective
under the conditions of use prescribed, recommended, or
suggested in the labeling of the device and that the labeling
was neither false nor misleading. 21 U.S.C. 360c(a)(2)(B),
360e(d)(1)(A) and (2)(A)-(E); see Pet. App. 25a, 27a-28a.
Once the device was approved, moreover, respondent could
not lawfully implement any changes that would affect the
safety or efficacy of the device without submitting a supple-
mental application to the FDA (and, in most instances,
receiving prior FDA approval). See id. at 26a; p. 3 and note 2,
supra. Because the specifications contained in respondent’s
application were binding on the manufacturer once the
application had been approved, and because the FDA’s PMA
approval reflected the agency’s considered judgment as to the
product’s safety and efficacy, the court of appeals correctly
held that those specifications constitute federal “require-
ment[s]” within the meaning of Section 360k(a)(1).

Moreover, in determining the safety and effectiveness of a
device, the FDA must “weigh{] any probable benefit to health
from the use of the device against any probable risk of injury
or illness from such use.” 21 U.S.C. 360c(a)(2)(C). The court
of appeals’ ruling thus is fully consistent with Lohr, in which
the Court distinguished the facts before it from a case, such as
this one, “in which the Federal Government has weighed the
competing interests relevant to the particular requirement in
question, reached an unambiguous conclusion about how
those competing considerations should be resolved in a par-
ticular case or set of cases, and implemented that conclusion
via a specific mandate on manufacturers.” 518 U.S. at 501.

As the court of appeals explained, if the FDA had deter-
mined that the device as described in respondent’s application
was not safe and effective, the agency could have conditioned
its grant of premarket approval on respondent’s agreement to

44a

undertake specified modifications. Pet. App. 27a-28a. A
product specification devised by the FDA and imposed as a
condition of authority to market a medical device would con-
stitute a federal “requirement” that would preempt state ef-
forts to impose inconsistent or additional common-law duties.
The court of appeals correctly recognized that respondent
should not be subject to greater potential tort liability simply
because the FDA had “deemed the PMA application for the
Evergreen Balloon Catheter acceptable in its present form”

and therefore had declined to impose additional conditions.
Id. at 28a.

The FDCA also specifically addresses the possibility that
new information might come to light that would call into
question whether a previously approved device meets the
Act’s requirements for PMA approval. Once again, however,
the FDCA vests responsibility for taking action in the FDA,
based on its evaluation of the information and weighing of the
relevant considerations. The Act thus authorizes the FDA to
withdraw its PMA approval of a device if the agency finds
that the device is unsafe or ineffective, or if the agency finds,
on the basis of new information evaluated together with
information available to it when it approved the application,
that the requisite showing of reasonable assurance that the
device is safe and effective is lacking, or that the labeling is
false or misleading in any particular and was not corrected
within a reasonable time after receipt from the FDA of no-
tice of that fact. See 21 U.S.C. 360e(e)(1)(A), (B) and (F).
Where the FDA has not taken such action, its approval of the
PMA—and the “requirements” that result from that ap-
proval—remain in effect.

The court of appeals also correctly held that petitioners’
tort suit seeks to impose state “requirement[s],” within the
meaning of Section 360k(a), that relate to safety or efficacy
and are different from the federal requirements that apply to
the Evergreen Balloon Catheter. See Pet. App. 30a-35a. As

45a

the court of appeals recognized, this Court in construing
similarly worded federal preemption provisions “has held
firm to the view that state ‘requirements’ can be created by
state common law actions.” /d. at 3la; see, e.g., Bates v. Dow
Agroscis. LLC, 544 U.S. 431, 443 (2005); see also Lohr, 518
U.S. at 503-504 (Breyer, J., concurring in part and concurring
in the judgment); id. at 510-512 (O’Connor, J., concurring in
part and dissenting in part). The claims that the court of
appeals held to be preempted do not rest on the premise that
the particular catheter used during Mr. Riegel’s angioplasty
deviated from the specifications in the approved PMA
application. Rather, they all rest on the allegation that the
Evergreen Balloon Catheter, in the form approved by the
FDA, “is in some way defective and therefore requires modi-
fication.” Pet. App. 32a. A verdict in petitioners’ favor would
necessarily reflect a finding that respondent could comply
with applicable state-law duties of care only by altering the
product specifications or labeling that had been reviewed and
approved by the FDA. Imposition of tort liability on the basis
of such a finding would entail the application of state-law
requirements that are “different from, or in addition, to,” 21
U.S.C. 360k(a)(1), the federal requirements applicable to the
device, and that “relate[] to the safety or effectiveness of the
device,” 21 U.S.C. 360k(a)(2).

The FDA is the expert agency charged by Congress with
balancing the risks and benefits of medical devices under the
FDCA, and the accomplishment of its regulatory goals would
be undermined if lay judges or juries were permitted to
second-guess the scientific judgments it makes in approving a
PMA application. When the FDA has concluded that a
particular medical device is safe and effective for use and has
approved the device for marketing, it would undermine the
regulatory scheme established by Congress for a jury adjudi-
cating a state-law claim to determine that the same device is
defectively designed. Similarly, when the FDA concludes that
a particular warning label strikes an appropriate balance

46a

between properly notifying users of potential dangers and
ensuring that beneficial and possibly life-saving uses of the
device are not deterred, a jury should be precluded from
deciding that different warnings ought to have been given.

3. In Bates, this Court construed the preemption provi-
sion of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), which provides that a State “shall not impose or
continue in effect any requirements for labeling or packaging
in addition to or different from those required under this sub-
chapter.” 7 U.S.C. 136v(b) (quoted in Bates, 544 U.S. at 439).
FIFRA prohibits the sale of “misbranded” products and states
that a pesticide is misbranded if its labeling contains “false or
misleading” statements, “does not contain adequate instruc-
tions for use,” or “omits necessary warnings.” Bates, 544 U.S.
at 438. That misbranding prohibition applies to pesticides that
are registered with the Environmental Protection Agency
(EPA). /bid. The Court held in Bates that FIFRA did not
preempt the plaintiffs’ state-law damages claim alleging a
tortious failure to warn so long as the elements of the state
cause of action were substantively equivalent to FIFRA’s
prohibition on the sale of “misbranded” products. See id. at
447. The Court “emphasize[d],” however, that “a state-law
labeling requirement must in fact be equivalent to a require-
ment under FIFRA in order to survive pre-emption.” /d.
at 453.

The FDCA also prohibits the distribution of misbranded
devices, see 21 U.S.C. 331(a)-(c), and a device is deemed
misbranded 1f, inter alia, “its labeling is false or misleading in
any particular,” or the device “is dangerous to health when
used in the * * * manner, or with the frequency or duration
prescnbed, recommendec, or suggested in the labeling there-
of.” 21 U.S.C. 352(a) and (j). The misbranding prohibition
applies to products that have received PMA approval. The
federal requirements that result from the PMA process have
preemptive effect, however, and as explained below, the

47a

possibility of federal misbranding liability does not alter that
result. See pp. 15-16, infra. In any event, petitioners in their
certiorari petition do not advance the theory that their state-
law claims are preserved because the relevant state-law re-
quirements parallel the FDCA’s misbranding provisions. Cf.
note 4, infra. Indeed, petitioners do not even cite the FDCA’s
misbranding provisions. Nor did the court of appeals address
that issue; it considered oniy whether the PMA approval
process itself results in “requirement(s]” under 21 U.S.C.
360k(a), and whether state common law imposes correspond-
ing state “requirement[s].” This case therefore would not
present an occasion for the Court to consider the viability of
such a theory.

Such a theory would.be unavailing in any event. The proc-
ess of agency review under FIFRA with regard to the label
language at issue in Bates differs in important respects from
the process by which the FDA decides whether to grant pre-
market approval for particular Class III devices. The plaintiff
farmers in Bates alleged that the label of a pesticide manu-
factured by the defendant had failed to warn of the potential
for the pesticide to damage the farmers’ peanut crops. See
544 U.S. at 434-435. Under FIFRA, EPA reviews pesticides
and their labeling to determine whether the pesticide causes
unreasonable adverse effects on human health or safety or the
environment, but EPA does not evaluate the efficacy of the
product, including its potential to harm crops or cause other
property damage, and the agency does not review the accu-
racy of any statements about efficacy on the proposed label-
ing for the product. Jd. at 440. EPA therefore had not deter-
mined whether the label at issue in Bates had adequately
warned farmers of the potential for damage to their crops. See
ibid. (noting that EPA had “never passed on the accuracy of
the statement in [the pesticide’s] original label recommending
the product’s use ‘in all areas where peanuts are grown”). In
the instant case, by contrast, petitioners’ challenge to the
safety and efficacy of the Evergreen Balloon Catheter goes

48a

directly to matters as to which the FDA conducted a rigorous
agency review in the PMA process—a review that culminated
in the FDA’s finding that the Evergreen Balloon Catheter
does provide “reasonable assurance of safety and effective-
ness” and that the labeling is not “false or misleading.” See
21 U.S.C. 360e(d)(1)(A).4

Furthermore, the Court explained in Bates that FIFRA does
not have a comprehensive goal of “uniformity,” but rather
“authorizes a relatively decentralized scheme that preserves
a broad role for state regulation.” 544 U.S. at 450. Under
the FDCA, by contrast, the FDA is vested with centralized
authority in order to promote uniformity of regulation, includ-
ing the authonty under 21 U.S.C. 360k(b) to decide whether
exceptions to preemption of state law should be allowed.

4. In its amicus brief filed at the petition stage at the
Court’s invitation in Smith Industries Medical Systems, Inc. v.
Kernats, cert. denied, 522 U.S. 1044 (1998), the United States
took the position that the FDA’s grant of premarket approval
for a medical device does not itself establish federal
“requirement(s]” for the device within the meaning of Section

* As a general matter, 21 U.S.C. 360k(a) does not preempt common-
lawsuits in which the duty of care is defined by federal law and a State
simply provides additional remedies for violations of the federal standard.
See Lohr, 518 U.S. at 494-497; id. at 513 (O’Connor, J., concurring in
part and dissenting in part). Consistent with that principle, the court of ap-
peals correctly held that petitioners’ “negligent manufacturing claim was
not preempted, to the extent that it rested on the allegation that the
particular Evergreen Balloon Catheter that was deployed during Mr.
Riegel’s angioplasty had not been manufactured in accordance with the
PMA-approved standards.” Pet. App. 35a; see note 3, supra. Adjudication
of the negligent-manufacturing claim would not implicate any FDA find-
ing, since the agency has made no individualized determination whether a
particular catheter conforms to the approved product specifications. With
respect to the adequacy of the product specifications themselves, however,
the FDA found that there was reasonable assurance of safety and effec-
tiveness of the device, and that the labeling was not false or misleading,
when it approved respondent’s PMA application.

49a

360k(a). U.S. Br. at 14-17, Kernats, supra (No. 96-1405).
The position taken in the government’s brief in Kernats was
based upon the FDA’s interpretation of the MDA and the
agency’s characterizatioy of its role in the administrative
process at that time, as reflected in a proposed interpretive
rule that was appended to the brief and published shortly after
the brief was filed. See 62 Fed. Reg. 65,384, 65,387 (1997).
That proposed rule, however, was subsequently withdrawn.
See 63 Fed. Reg. 39,789 (1998).

The FDA has since reexamined the issue and determined
that the position it announced at the time of the filing in
Kernats was erroneous. The FDA’s current position was set
forth in an amicus brief filed by the United States on May 14,
2004, in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.
2004). See Horn, 376 F.3d at 170-173 (discussing the FDA’s
position set forth in the amicus filing). The government
explained in the amicus brief in Horn that the pnor position
did not adequately reflect either the highly detailed nature of
the process by which the FDA reviews applications for pre-
market approval, or the constraints that premarket approval
places on manufacturers who subsequently wish to change a
device’s specifications. U.S. Amicus Br., Horn v. Thoratec,
supra, at 28 (No. 02-4597); see generally id. at 6-11, 15-17,
20-21, 25-27. The government’s position in Kernats is also
inconsistent with the msk-management principles that the
FDA currently follows, which recognize that over-warning
may be detrimental to the public health. See, e.g., id. at 29; 71
Fed. Reg. 3935 (2006) (explaining that additional state re-
quirements governing disclosure of drug-risk information
“can erode and disrupt the careful and truthful representation
of benefits and risks that prescribers need to make appropriate
judgments about drug use,” and that “[e]xaggeration of risk
could discourage appropriate use of a beneficial drug”). This
Court held in Lohr that the FDA’s views on preemption
questions under 21 U.S.C. 360k are entitled to “substantial
weight.” 518 U.S. at 496.

50a

B. The Decision Of The Court Of Appeals Does Not
Warrant Review

The Second Circuit’s resolution of the preemption question
raised in this case is consistent with the rulings of the great
majority of federal and state appellate courts that have
addressed the issue since Lohr. During that period, all but one
of the federal courts of appeals to decide the issue have held
that premarket approval of a medical device preempts state
tort claims challenging the safety or efficacy of a product that
was designed, manufactured, and labeled in compliance with
the terms of the premarket approval order. See Pet. App. 24a-
38a; Horn, 376 F.3d at 166-180; MeMullen v. Medtronic,
Inc., 421 F.3d 482, 486-490 (7th Cir. 2005), cert. denied, 126
S. Ct. 1464 (2006); Martin v. Medtronic, Inc., 254 F.3d 573,
575-585 (Sth Cir. 2001), cert. denied, 534 U.S. 1078 (2002);
Kemp v. Medtronic, Inc., 231 F.3d 216, 221-237 (6th Cir.
2000), cert. denied, 534 U.S. 818 (2001); see also Brooks v.
Howmedica, Inc., 273 F.3d 785, 791-799 (8th Cir. 2001) (en
bane) (finding federal preemption based on approval of
device pursuant to regulatory precursor of premarket approval
process), cert. denied, 535 U.S. 1056 (2002); but see Good- .
lin v. Medtronic, Inc., 167 F.3d 1367, 1369-1382 (11th Cir.
1999) (holding that comparable claims were not preempted).
Similarly, all but one of the state supreme courts to rule on
this issue have held that analogous suits are preempted by
federal law. See Green v. Dolsky, 685 A.2d 110, 115-118
(Pa. 1996), cert. denied, 520 U.S. 1168, and 520 U.S. 1212
(1997); Fry v. Allergan Med. Optics, 695 A.2d 511, 514-517
(R.1.), cert. denied, 522 U.S. 952 (1997); Worthy v. Collagen
Corp., 967 S.W.2d 360, 366-377 (Tex.), cert. denied, 524
U.S. 954 (1998); but see Weiland v. Telectronics Pacing Sys.,
Inc., 721 N.E.2d 1149, 1151-1154 (Ill. 1999).°

* Petitioners contend that three additional cases are in conflict with the
weight of authority holding that the FDA’s premarket approval of a medi-
cal device preempts state tort claims under Section 360k(a). See Pet. 3

Sla

Moreover, the decisions in Goodlin and Weiland, which re-
jected preemption defenses similar to that raised by re-
spondent here, were issued in 1999, when the law in this area
was relatively undeveloped and when the stated view of the
FDA, as set forth in the amicus brief filed by the United
States in Kernats (see pp. 16-17, supra), was that the PMA
approval process does not impose “requirement[s]” under 21
U.S.C. 360k(a) and that claims like petitioners’ were not
preempted. Since that time, several federal courts of appeals
and state supreme courts have sustained analogous preemp-
tion defenses, and no such court has issued a contrary ruling.
And since that time, the FDA has reassessed the issue and has
concluded that the PMA approval process does result in
“requirements” and that state tort claims challenging the
safety or efficacy of PMA-approved devices are therefore
preempted under 21 U.S.C. 360k(a). See p. 17, supra.

The courts in Goodlin and Weiland had no opportunity to
take into account the later-developing majority view among
the federal and state appellate courts. Nor did the courts in
Goodlin and Weiland have the opportunity to consider the
current position of the FDA, the expert agency charged by
Congress with administering the FDCA. In any future deci-
sion concerning Section 360k’s preemptive scope, those
courts would be required to give “substantial weight” to the
FDA’s position. Lohr, 518 U.S. at 496.

(citing Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997), and
Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997), cert. denied, 523
U.S. 1005 (1998)); Pet. 14 (citing State ex rel. Miller v. New Womyn, Inc.,
679 N.W.2d 593 (Iowa 2004)). Those cases are readily distinguishable.
None of them involved devices for which the FDA had approved a PMA
application before the conduct that was alleged to be the basis for liability.
See Oja, 111 F.3d at 787, 789; Niehoff, 950 S.W.2d at 817; New Womyn,
679 N.W.2d at 597. In Oja and Niehoff, moreover, the courts held that
liability under state tort law or other state law of general applicability
would not result in the imposition of a state “requirement,” see Oja, 111
F.3d at 789; Niehoff, 950 S.W.2d at 822—a premise that was subsequently
rejected by this Court in Bates, see 544 U.S. at 443; p. 12, supra.

S2a

In light of those intervening developments, the Eleventh
Circuit and the Illinois Supreme Court may reconsider their
earlier approach should this issue arise in future cases
litigated within those jurisdictions. Under these circum-
stances, the narrow split in authority does not warrant this
Court’s review. This Court has repeatedly denied certiorari
petitions that presented questions concerning the preemptive
effect of the FDA’s issuance of premarket approval for Class
IIi medical devices. See McMullen v. Medtronic, Inc., 126 S.
Ct. 1464 (2006); Knisley v. Medtronic, Inc., 126 S. Ct. 420
(2005); Brooks v. Howmedica, Inc., 535 U.S. 1056 (2002);
Martin v. Medtronic, Inc., 534 U.S. 1078 (2002); Kemp v.
Medtronic, Inc., 534 U.S. 818 (2001); Worthy v. Collagen
Corp., 524 U.S. 954 (1998); Fry v. Allergan Med Optics, 522
U.S. 952 (1997); Green v. Dolsky, $Z0 U.S. 1168 (1997);
Collagen Corp. v. Green, 520 U.S. | 212 (1997). There is no
reason for a different result here.

CONCLUSION
The petition for a writ of certiorari should be denied.
Respectfully submitted,

PAUL D. CLEMENT
Solicitor General
Counsel of Record
PETER D. KEISLER
Assistant Attorney General
EDWIN S. KNEEDLER
Deputy Solicitor General

DANIEL MERON MALCOLM L. STEWART
General Counsel Assistant to the Solicitor
Ceneral

SHELDON T. BRADSHAW

Associate General Counsel DOUGLAS N. LETTER

SHARON SWINGLE

Department of Health and A .
Human Services ttorneys
Rockville, MD 20857 Department of Justice

Washington, D.C. 20530-0001
May 2007 202) 514-2217

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386016_2332%3A2. Public record. Not legal advice.