# Amicus Curiae Brief — Riegel v. Medtronic, Inc.

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2008
- **Citation:** 552 U.S. 312

## Text

\94 ©

40 No. 06-179

IN THE
Supreme Court of the United States

DONNA S. RIEGEL, INDIVIDUALLY AND AS ADMINISTRATOR OF
THE ESTATE OF CHARLES R. RIEGEL,
Petitioner,
Vv.

MEDTRONIC, INC.,
Respondent.

On Writ of Certiorari
to the United States Court of Appeals
for the Second Circuit

BRIEF OF THE ADVANCED MEDICAL
TECHNOLOGY ASSOCIATION (ADVAMED), DRI,
MEDMARC, AND THE MEDICAL DEVICE
MANUFACTURERS ASSOCIATION (MDMA)
AS AMICI CURIAE IN SUPPORT OF RESPONDENT

MICHAEL W. DAVIS CARTER G. PHILLIPS
SIDLEY AUSTIN LLP DANIEL E. TROY*
One South Dearborn Street REBECCA K. Woop
Chicago, Illinois 60603 EAMON P. JOYCE
(312) 853-7000 SIDLEY AUSTIN LLP

1501 K Street, N.W.
Washington, D.C. 20005
(202) 736-8000

Counsel for Amici Curiae AdvaMed and DRI
{ Additional Counsel Listed on Inside Cover]

October 19, 2007 * Counsel of Record

AALS A A TS TT
WILSON-EPES PRINTING Co., INC. — (202) 789-0096 ~— WASHINGTON, D. C. 20002

CHRISTOPHER L. WHITE

ADVANCED MEDICAL

TECHNOLOGY ASSOCIATION

701 Pennsylvania Ave.,
N.W.

Suite 800

Washington, D.C. 20004

(202) 783-8700

Counsel for Amicus Curiae
AdvaMed

PAUL J. MALONEY
WILLIAM J. CARTER
CARR MALONEY P.C.
1615 L Street, N.W.
Suite 500

Washington, D.C. 20036
(202) 310-5500

Counsel for Amicus Curiae
Medmarc

TABLE OF CONTENTS
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TABLE OF AUTHORITIES ........cccssscssssessssecssesseseseseeeees
INTERESTS OF AMICI CURIAE .cssccssssssssessseesssecesseeeee
SUMMARY OF ARGUMENT. .......csscssssesssseessesssecesseceees
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II.

ENHANCED STATE-LAW LIABILITY
WOULD INTERFERE WITH FDA’S
EXTENSIVE PRE- AND POST-MARKETING
OVERSIGHT OF MEDICAL DEVICES, NOT
FILL A REGULATORY “GAP?” .......... pialtabcoreces

A.FDA_ Exercises Substantial Pre-Maiaeting
Oversight Of Medical Devices ..................:...:00+

B. FDA Exercises Substantial Post-Marketing
Oversight Of Medical Devices ..............:..cscee0e+

EXTENDING STATE-LAW _ LIABILITY
WOULD UNDERMINE THE BALANCE OF
PUBLIC HEALTH OBJECTIVES REFLECTED

Be RD Ge Rntnasccencnencsnsencenctunpeniosnisesatensesasansabeccoose |

A. Siate Tort Liability Stifles Innovation Of
Important And Life-Saving Medical Devices ....

B. State Tort Liability Threatens The Availability
Of Significant Medical Treatments ....................

C. State Tort Liability Increases Price And
Undermines The Affordability Of Medical
TIED isinchisliccsenscsnsetninenientindanctcdnnnnnvnnniiteitaiinsis

D. State Tort Liability Encourages Defensive
Labeling And Overwarning That Undermine
Rational Prescribing By Physicians....................

a Piiiiscnicitentdiisnianiscunineiatainennennnnitinnnatedenessii

ii
TABLE OF AUTHORITIES
CASES Page
Brooks v. Howmedica, Inc., 273 F.3d 785 (8th
Sr Se scictiniteidctanensiuanatantoennnisanninniieenttintes 7
Browning Ferris Indus. of Vt., Inc. v. Kelco
Disposal, Inc., 492 U.S. 257 (1989) .......ccceeeceeee 21
Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir.),
cert. denied, 546 U.S. 935 (2005).................00008 7
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th
EG, IIIT oiiiehleesieivcteesicslenstndaeibindaminneiaenratabienineceimmnnit 7
Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.
ITT srdehsissieteontsenieiniteaeniiianbaicbsinasibiainsaniiniieeaneennians 7,9, 10
Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir
Ire icicchasebaenibniusictialnsdetncacieatapeianaiiiidsedceiaiiaidtiaaiainian 9
Martin v. Medtronic, Inc., 254 F.3d 573 (Sth Cir
SariTisstchidincheshiteebieieteeiieacamneshidiaianbidubeciniibebieaininiines 7
Martin v. Telectronics Pacing Sys., Inc., 105 F.3d
NEI: I cticniscnitcncinssciavassnisinpesiaitaniatansiees 8
McMullen v. Medtronic, Inc., 421 F.3d 482 (7th
Cir. 2005), cert. denied, 547 U.S. 1003 (2006) ... 7

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).... 4, 6, 15,

18, 20
Rattay v. Medtronic, Inc., 482 F. ead 2d 746
Ne Se stnreiiicieniiieneinsiniaitiiaasdtaeitantnisianniien 9
Steele v. Dep«, Irthopaedics, Inc., 295 F. Supp.
eels SIU weiitieeiciinsiicsnisitniaiiccnsiteiniiaaaiienia 9
STATUTES AND REGULATIONS
Safe Medical Devices Act of 1990, Pub. L. No.
SI GE TIED: SEIT nscsenccecmcnienescvenseoninetennsnemnes 18
Se a a cicctsstinciicctndanyuonienstcbecinaines 5
Ir cies hintaan siciolanninhaeicnapinnesiocniaialonsnatediel 13
i Sa eh iscisesiaiiiinpasindicietalnesiananidasonsieiaidiiininlaite 13
i a stiiciidsiiieidemeeeimeseesieieeenie 8, 10, 16, 19, 20
a III ccscensiesncnssiscaeitssnssiniobinialisitnibinis 5
NEE Ep ere irene 10

ill
TABLE OF AUTHORITIES—continued

Page

| ee 8, 10, 11, 13, 16
aT iiseshetiniaisipdasndanentasecesinnninhnninniniceiin 11,12

aE tinrissssnsdnsienpdanesoneconinenbenininmnnenaiiines 11, 12

El isditiacdighionaienitanaisseemsnmenieincenends 7, 11, 12, 17

er otek iieninniiieibiisivicieanienninieieiiiann 17
a cininstiactienideperpaniinipdiodiniccumneagnnbiinde 18

Oe eee ae Se terhintaitcosicciccnnnenianianniniionsiiinbesiiones 12
iii Nichi iiciidsdicaiibdaividcsimsnciindiivisiasinidaniointnionsnets 10
NEA icvsiscenepuineiienndenandinnineabenten 8

| __SEREEEn OeNNUET 13

TT Nisiicisecsinininicinsuedesondstieveonnitnitacaddiiaititil 13
EE IED aidaichicscssbiecesisinnnciidniiiaeins 7

SUIT icteiticiesteindiiciatniasheninninnesnepiimesenminaionnnin 8
SNE iiicacusisciiinnscactavsieninneinnennianionints 8
I ecinicteeniniinrseenlegsianiteih 8
TT ittsceneisnisienaniicshienimanianieites 8

TE icciioneipinnteiaseninndenionidneenniieetinnitiiin 8

SD iciticiuiesideaieieslindiiitinieninicinicesinianianee 8

SET icidvkiteidiinneniciondeisesntnenedummemaneinenees 11

IT isnsihcenssanstniioninsansonpiidinnmiinieitiedin 10

SIT dois icnascsiaveicinndtitincenbulncnpineennitith 10, 11

is tinsideaisapnieinindtetinenidcinasasininnide 11
____|__—LETe e eEE 13

SIT dihhicecriptntenennsiideasnsimiiapinpaimidessiniin 11

Sint clisiatscttecheiccistitgebbdeseiaainiiennsialeinine 1]

STITT icnnchiimnsppinienneenentaientgincenmtanieeein ll

SEIN chesiudisitubinineibanniebinenentinnbininenenneiein 16

a N cctsiicneniensseinrnenienneienansinennn 8
62 Fed. Reg. 51112 (Sept. 30, 1997)... 20

Dep’t of Health & Human Servs., FDA, Deter-
mination That Bendectin Was Not Withdrawn
From Sale for Reasons of Safety or Effective-
ness, 64 Fed. Reg. 43190 (Aug. 9, 1999)............. 23
71 Fed. Reg. 3922 (Jan. 24, 2006)...............:ccceceeees 27

iV
TABLE OF AUTHORITIES—continued
LEGISLATIVE HISTORY Page
Hearings on H.R. 5545, H.R. 974 & S. 510 Before

the Subcomm. on Health & the Environment of
the H. Comm. on Interstate & Foreign Com-

Wee S8, PUB CORE, CHITS) nccerrovcesevevevercessescecossosees 17
he Sa BRR, Gere cccscencncessncesensenensonsssnsennscsen 17
SD, Tea. BRR. SGC ED CID ecvccsccsrcesscscevecensessecscsneee 18
FLL. Raw. No. POSS (IF TE) .ncccccorovesesccescesseescosesee 17

136 Cong. Rec. $12476 (daily ed. Aug. 4, 1990)... 18
$15205 (daily ed. Oct. 12,1990).. 18
S17456 (daily ed. Oct. 27,1990)... 18

RULE
Sup. Ct. R. 48.3 (2007)....ccccccccsscccesscsssseccscssnsecescenee

SCHOLARLY AUTHORITIES

Am. Med. Ass’n, Reporting Adverse Drug &
Medical Device Events: Report of the AMA's
Council on Ethical & Judicial Affairs, 49 Food
rena 12

Anna Biernbaum, Note, Shielding the Masses:

How Litigation Changed the Faith of Birth
Control, 10 S. Cal. Rev. L. & Women’s Stud.
OE Gite Pecseccsssrcesstencenvncitininniapminainmsigtitinbtiabintias 26

David Dial et al., Tort Excess 2005: The
Necessity for Reform from a Policy, Legal and
Risk Management Perspective (2005) .........:000+++ 21

William W. George, Medical Technology and
Competitiveness in the World Market: Rein-
venting the Environment for Innovation, 50
Food & Drug L.J. 477 (1995) ......cccceceeseseeeteeeees 20

Scott Gottlieb, Latest Trends in FDA Practice,

BPS Fee Be CI cerectcsccesssnransoteemensemmenatnn 12

Vv

TABLE OF AUTHORITIES—continued
Page
Scott E. Harrington, Tort Liablity, Insurance
Rates, and the Insurance Cycle, in Brookings-
Wharton Papers on Financial Services (2004)..... 21
Reid Hastie & W. Kip Viscusi, What Juries Can't
Do Well: The Jury’s Performance As a Risk
Manager, 40 Ariz. L. Rev. 901 (1998)................ 16
Marvin E. Jaffe, Regulation, Litigation and
Innovation in the Pharmaceutical Industry: An
Equation for Safety, in Product Liability and
Innovation: Managing Risk in an Uncertain
Environment 120 (J.R. Hunziker & T.O. Jones

Liability on New Drug Developments, in The

Liablity Maze 334 (P.W. Huber & R.E. Litan

a isi ssitiiiatesinntcientnimecmnnmnencasecses 22, 23, 24, 27
Sylvia A. Law, Sex Discrimination & Insurance

for Contraception, 73 Wash. L. Rev. 363

Richard L.. Manning, Changing Rules in Tort Law
and the Market for Childhood Vaccines, 37 J.
TT nice citctesnnsentdecenescees 26
Neal I. Muni et al., Challenges in Regulating
Breakthrough Medical Devices, 60 Food &
A ee 9, 12, 13,14
C. Ineke Neutel, Variation In Rates of Hospitali-
zation for Excessive Vomiting In Pregnancy By
Bendectin/Diclectin Use in Canada, available
at http://www.nvp-volumes.org/p1_9.htm........... 14
Lars Noah, The Imperative to Warn: Disen-
tangling the “Right to Know” From the “Need
to Know” About Consumer Product Hazards,
11 Yale J. on Reg. 293 (1994) ce eeceeceeeeeseeee 28
Michael E. Porter, The Competitive Advantage of
Ee 22

vi

TABLE OF AUTHORITIES—continued

Daniel G. Schultz, M.D., Director, FDA Center
for Devices and Radiological Health, Medical
Device Safety, FDA’s Postmarket Transfor-
mation Initiative, 62 Food & Drug L.J. 593

Page

ad 4,13, 14

Lawrence Tancredi & Dorothy Nelkin, Medical
Malpractice and Its Effect on Innovation, in
The Liablity Maze 251 (P.W. Huber & R.E.
RE Tre itrtarreermresnscnitintasanennineaitcnmven

Albert George Thomas Jr. & Stephanie M.
LeMelle, The Norplant System: Where Are We
in 1995, 40 J. Fam. Prac. 125 (1995)...................

W. Kip Viscusi, Corporate Risk Analysis: A
Reckless Act?, 52 Stan. L. Rev. 547 (2000).........

W. Kip Viscusi, /ndividual Rationality, Hazard
Warnings, and the Foundations of Tort Law, 48
Rutgers L. Rev. 625 (1996) .........cccccccossccserseseees

W. Kip Viscusi, Jurors, Judges, and the Mis-
treatment of Risk By the Courts, 30 J. Legal
ee Be I vicccscnanonsinennsetnnsesmnteniainianspnitaesiii

W. Kip Viscusi et al., A Statistical Profile of
Pharmaceutical Industry Liability, 1976-1989,
24 Seton Hall L. Rev. 1418 (1994)...

W. Kip Viscusi & Michael J. Moore, An
Industrial Profile of the Links Between Product
Liability & Innovation, in The Liablity Maze 81
(P.W. Huber & R.E. Litan eds., 1991).................

OTHER AUTHORITIES

Contraceptive Maker Wins Woman's Suit Over
Side Effects, N.Y. Times, Sept. 5, 1998...............

vii
TABLE OF AUTHORITIES—continued
Page
GAO-06-62, Medicare Durable Medical Equip-

ment: Class Ill Devices Do Not Warrant a
Distinct Annual Payment Update (Mar. 1,

Am. Med. Ass’n Bd. of Trs., Jmpact of Product
Liability on the Development of New Medical
PIT vcisccniinintiticinitamticnmtndpennies 21, 22

Maria Cheng, New Study: Drug-Coated Stents
Not So Bad, Associated Press Online, Sept. 2,

SITET siisisceeiiieniesieciisdiediial aeuidaarhiamalianididiniiaaiaisaes 28

FDA, FDA’s Mission Statement, http://fda.gov/
opcaom/morechoices/mission.html (last viewed

SR, Sa cnteerenrernnennctenentatinattininicnionmnes 16
FDA, FDA Statement on Coronary Drug-Eluting
es Bi A rcetennnccnenanininininnnmne 28

FDA, Guidance for Industry and FDA Staff -
Procedures for Handling Post-Approval
Studies Imposed by PMA Order (Aug. 1, 2007).. 13

FDA, Innovation or Stagnation: Challenge and
Opportunity on the Critical Path to New Medi-
cal Products (Mar. 2004), available at http://
fda.gov/oc/initiative/criticalpath/whitepaper.
icesiisusiicentahecitueisseaidciegaaiicaiiiinaaiiiatanasibaasia 10, 20, 22, 23

FDA, The Least Burdensome Provisions of the
FDA Modernization Act of 1977: Concepts and
Principals; Final Guidance for FDA and
Industry (Oct. 4, 2002), available at http://

www. fida.gov/cdrh/ode/guidance/1332.html........ 1g
FDA, FDA Recall Policies (June 2002), available
at http://www.cfsan.fda.gov/~Ird/recall2.html .... 12

FDA, Ctr. for Devices & Radsological Health,
Recognition and Use of Consensus Standards;
Final Guidance for Industry and FDA Staff
(June 20, 2001), available at http://www.fda.
gov/cdrh/ost/guidance/321 .html .............0ceeeeees 10

Vill
TABLE OF AUTHORITIES—continued
Page
FDA, Ctr. for Devices & Radiological Health,
Review Process (June 11, 2003), http://www.
fda.gov/cdrh/devadvice/pma/review_process.
ITT sisisssietiniincindetecnaiiticnhiaainmiiinianaaadiinitibaiestiinil 9,10, 11
FDA, Ctr. for Devices & Radiological Health, FY
2006 Highlights (2006)............:cccccsescsesscssereeeeeees 12, 14
FDA/NIH Conference, Clinical Pharmacology
During Pregnancy Addressing Clinical Needs
Through Science (Dec. 4, 2000), available at
http://www.fda.gov/cder/present/clinpharm
ND ciiccnsencccanieszientsnnieeiieiemneren 24
Peter Huber, Junk Science in the Courtroom,
es SD etnteereencteenscniennsinvianntnnianuenes 28
Linda A. Johnson, Wyeth Won't Resume Norplant
Sales, Associated Press Online, July 26, 2002 .. 25, 26
Gina Kolata, Will the Lawyers Kill Off Norplant?,

N.Y. Times, May 28, 19995. ...............ccccccosseseesees 25, 26
Barbara Marsh, The Product Liability Morass,
FD 8 RR eee 26

MedSun, About MedSun, https://www.medsun.
net/about2.asp (last viewed Oct. 18, 2007).....5, 13, 14

David J. Morrow, Maker of Norplant Offers a
Settlement in Suit Over Effects, N.Y. Times,

INTERESTS OF AMICI CURIAE'

Amici, whose members are active participants in the
medical device regulatory, insurance and litigation process,
are uniquely situated to alert the Court to two practical issues
of significance to its decision here.

First, notwithstanding petitioner and her amici’s view that
current federal oversight is lean and in need of all-
encompassing state-law augmentation, in actuality—as amici
here are well-aware and illustrate in detail below—the United
States Food and Drug Administration (“FDA”)
comprehensively regulates medical devices, both before and
after their launch on the United States market through the
Premarket Approval (“PMA”) process.

Second, amici are well-acquainted with numerous harmful
effects of state-law liability risks in this sensitive context, in
which Congress has charged an expert federal agency, FDA,
with striking a careful balance of public health objectives.
These harmful effects include: (i) forgoing innovation,
discouraging device development, and exacerbating a
growing “pipeline problem”; (ii) decreasing the availability of
potentially beneficial medical treatments in the United States,
particularly those relating to women’s health; (iii) increasing
medical costs; and (iv) encouraging “defensive labeling” that
interferes with rational prescribing decisions by physicians. '

The Advanced Medical Technology Association
(“AdvaMed”), formerly known as the Health Industry
Manufacturers Association, is the largest medical technology

' Petitioner and respondent have consented to the filing of this amicus
brief in letters on file with the Clerk’s office. Pursuant to Rule 37.6, amici
state that no counsel for a party authored any part of this brief, and no
person or entity other than amici and their counsel made a monetary
contribution to its preparation or submission. This brief is filed in
compliance with the Court’s May 2, 2005 rules. See Sup. Ct. R. 48.3
(2007).

2

association in the world. It represents more than 1,200
medical device, diagnostic, and health information system
manufacturers. AdvaMed’s members manufacture 90 percent
of the $75 billion of health care technology purchased
annually in the United States and more than 50 percent of the
$175 billion purchased around the world annually.

AdvaMed’s members are innovators of technologies that
save lives and increase the quality of life for hundreds of
thousands of patients every year. For example, technological
breakthroughs such as coronary stents, implantable
defibrillators, and minimally invasive bypass surgery have
helped reduce the death rate from heart disease by 40 percent
since 1980. AdvaMed’s members spend an enormous amount

——~ of money—troughly $9 billion annually—on the research and
development of these innovations. On a percentage of sales
basis, this investment constitutes more than four times the
average spent on research and development by non-
pharmaceutical manufacturers in other industries.

One of the inevitable consequences of innovation in health
care technology is that a small percentage of patients suffer
injuries that they allege were caused by these highly
specialized products. AdvaMed and its members therefore
have a significant interest in the outcome of this litigation.
Nearly all of AdvaMed’s members do now or will in the
future face the prospect of tort litigation concerning the
medical devices they manufacture, and related costs in the
form of self-insurance or insurance premiums to cover the
potential risks of alleged device-related injury.

DRI is an international organization that includes more than
22,000 attorneys involved in the defense of civil litigation.
DRI is committed to enhancing the skills, effectiveness, and
professionalism of defense attorneys. Because of this
commitment, DRI seeks to address issues germane to defense
attorneys and the civil justice system, to promote the role of
the defense attorney, and to improve the civil justice system.
DRI has long been a voice in the ongoing effort to make the

3

civil justice system more fair, efficient, and—where national
issues are involved—consistent. To promote these objectives,
DRI participates as amicus curiae in cases that raise issues of
importance to its membership and to the judicial system.

Here, to extend unbounded state tort liability to companies
that have successfully brought to market the most cutting-
edge medical devices pursuant to the PMA process, as
petitioner urges, would threaten the efficient and fair
administration of justice. Allowing states to serve as
secondary regulatory bodies able to impose different or
additional requirements on device manufacturers despite the
express preemption provision implicated here would override
Congress’s intentions with respect to the PMA process and
obstruct FDA from fulfilling its regulatory charge. Not only
would device manufacturers be subjected to costly and
uncertain litigation nationwide, but the overall economy and
public health would suffer as a result of the decreased
innovation triggered by the threat of liability.

The issues in this case are, accordingly, of substantial
concern to DRI. Because DRI’s members have first-hand
experience with medical device litigation and FDA’s
regulatory role, DRI is well-suited to address the grave
consequences of the unpredictable patchwork of state liability
that petitioner’s position would create.

Medmarc Insurance Group (Medmarc) is a specialty
insurer, owned by the life science industry, which provides
product liability coverage for medical device and life science
manufacturers. Owned and controlled by its member
policyholders in the life science industry, Medmarc was
founded in 1979 by that industry in response to volatile
conditions in the commercial insurance market for product
liability protection. Medmarc’s membership includes
approximately 700 manufacturers and distributors of medical
devices, biotech, generic pharmaceutical, and diagnostic
products.

4

The Medical Device Manufacturers Association (MDMA) is
a national trade association representing innovative and
entrepreneurial medical device designers and manufacturers.
Its membership includes over 150 makers of medical devices,
diagnostic products, and health care information systems.
MDMA seeks to improve the quality of patient care by
encouraging the development of new medical technology and
fostering the availability of innovative products in the
marketplace.

SUMMARY OF ARGUMENT

Amici will not repeat the legal arguments that are well
developed by respondent and other amici. Instead, amici
focus the Court’s aitention on two key issues.

First, in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the
Court observed that the § 510(k)-clearance process described
in that case was “by no means comparable” to the more
“rigorous” PMA process. /d. at 477-79. Yet petitioner and
her amici understate the robust, device-specific pre- and post-
marketing review FDA exercises in the PMA context. If
anyihing, this oversight has increased since Lohr. For
example, FDA has recently further enhanced its “long history
of effective medical device safety as a result of both its
premarket review process and its postmarket surveillance and
enforcement activities” with new initiatives to enhance efforts
to “identify safety signals at any point in a product’s lifecycle
and take timely action.” Daniel G. Schultz, M.D., Director,
FDA Center for Devices and Radiological Health (“CDRH”),
Medical Device Safety, FDA’s Postmarket Transformation
Initiative, 62 Food & Drug L.J. 593, 593 (2007). One such
initiative is the Medical Device Safety Network or
“MedSun.” MedSun, which has been in effect for
approximately five years, supplements FDA’s existing,
mandatory post-marketing surveillance mechanisms with
additional “valuable data on how devices are used in the real
world of clinical practice,” id at 594, such as identifying

5

“close calls” and engaging in other “proactive prevention”
collaboratively with clinicians and manufacturers. MedSun,
About MedSun, www.medsun.net/about2.asp.

Second, the state tort liability urged by petitioner and her
amici threatens to undermine the balance of safety,
effectiveness, and innovation Congress has charged FDA with
calibrating and would threaten numerous harmful effects. By
enacting the Medical Device Amendments (“MDA”), 21
U.S.C. §§ 360c ef seg., to the Federal Food, Drug and
Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 ef seq., and
creating the PMA process, Congress charged FDA with
striking a sensitive balance between important, and often
competing, public health objectives. On the one hand,
Congress sought to ensure that cutting-edge and oftentimes
high-risk medical devices would offer, in the agency’s expert
judgment, a reasonable assurance of safety and effectiveness
based on valid scientific evidence before reaching the United
States market. On the other hand, Congress focused on
fostering a regulatory and legal environment that promotes
device innovation that is imperative to preserving and
advancing important and life-saving patient treatments.

Enhanced state-law liability poses a challenge to this
balance and threatens to, among other things: (i) harm the
device development and innovation that Congress and FDA
have endeavored to foster; (ii) undermine the availability of
medically beneficial devices already on the market; (iii) raise
prices for important and life-saving medical devices; and
(iv) fuel the proliferation of defensive “over-warning” that
undermines rational prescribing decisions, based on risks the
expert agency determines to be scientifically justified, and
discourages use of beneficial therapies.

6
ARGUMENT

I. ENHANCED STATE-LAW LIABILITY WOULD
INTERFERE WITH FDA’S EXTENSIVE PRE- AND
POST-MARKETING OVERSIGHT OF MEDICAL
DEVICES, NOT FILL A REGULATORY “GAP.”

In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court
held that state-law claims were not preempted by the MDA’s
different Section 510(k) “substantial equivalence” process
which—unlike the comprehensive PMA process at issue
here—‘“requires little information, rarely elicits a negative
response from the FDA, and gets processed very quickly,” in
an average of only 20 hours. /d. at 477-79 (internal quotation
omitted). The Lohr opinion observed that “the 510(k) process
is focused on equivalence [to another approved product], not
safety” and “[ajs a _ result, substantial equivalence
determinations provide little protection to the public.” /d. at
493 (internal quotation omitted).

In contrast, the Court juxtaposed the “rigorous” PMA
process in which FDA spends “an average of 1,200 hours on
each submission.” /d. at 477. The Court underscored that
“{tlhe §510(k) notification process is by no means
comparable to the PMA process,” id. at 478-79, and

quite unlike a case in which the Federal Government has
weighed the competing interests relevant to the particular
requirement in question, reached an wnambiguous
conclusion about how those competing considerations
should be resolved in a particular case or set of cases, and
implemented that conclusion via a specific mandate on
manufacturers or producers. [/d. at 50! (emphasis added). }

In keeping with this analysis, nearly every Circuit to have
considered the issue (including the Second Circuit below) has

7

concluded that most state-law claims with respect to PMA-
approved medical devices are preempted.’

Petitioner and her amici seek to undermine the force of this
analysis by suggesting that PMA devices actually receive
little oversight by FDA. See, e.g., Pet. Br. 4-6, 24-31; Br.
Amici Curiae Am. Ass’n for Justice et al. 22-27. They then
advance the position that state law can properly serve as “a
complement” to the PMA process and is “congenial to”
Congress’s charge and FDA’s regulation of PMA devices.
Br. Amicus Curiae Consumers Union 11. Their view is
mistaken.

As recognized in the Lohr decision, the PMA process
involves robust federal regulation affecting every stage of the
development and marketing of a medical device, both before
and after FDA permits it to reach the United States market. If
anything, this review—and the case for preemption—has
become even stronger since the time of Lohr.

A. FDA Exercises Substantial Pre-Marketing Over-
sight Of Medical Devices.

Even before the PMA process begins, manufacturers
typically must satisfy extensive FDA requirements to gain a
so-called Investigational Device Exemption (“IDE”) to
authorize clinical investigations involving human subjects.
To obtain an IDE, the manufacturer must make detailed
submissions to FDA regarding every aspect of the device and
clinical investigation. See 21 U.S.C. § 360j(g); 21 C.F.R.
§§ 812.1-812.150 (regulations applicable to IDEs). During
the IDE process, FDA reviews voluminous materials and

? See, e.g., Pet. App. 2a; McMullen v. Medtronic, Inc., 421 F.3d 482
(7th Cir. 2005), cert. denied, 547 U.S. 1003 (2006); Cupek v. Medtronic,
Inc., 405 F.3d 421 (6th Cir.), cert. denied, 546 U.S. 935 (2005); Horn v.
Thoratec Corp., 376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica, Inc.,
273 F.3d 785 (8th Cir. 2001) (en banc); Martin v. Medtronic, Inc., 254
F.3d 573 (Sth Cir. 2001); but see Goodlin v. Medtronic, Inc., 167 F.3d
1367 (11th Cir. 1999).

8

evaluates whether “the anticipated benefits to the subjects and
the importance of the knowledge to be gained” from such
trials outweighs the estimated “risks to the subjects,” and
further ensures that the informed consent provisions are
adequate, the investigation is scientifically sound, and there is
no reason to believe the device will be ineffective. 21 C.F.R.
§ 812.30; see Martin v. Telectronics Pacing Sys., Inc., 105
F.3d 1090, 1095-96 (6th Cir. 1997) (describing IDE process
and related preemption issues). Clinical investigations
generally require prior approval from an Institutional Review
Board (“IRB”)}—an independent scientific reviewing body
acting under the auspices of the National Institutes of Health.
See 21 C.F.R. §§ 56.101-56.124 (IRB regulations); 45 C.F.R.
§§ 46, et seg. (Health and Human Services regulations
regarding protection of human subjects and pertaining to
IRBs); see also, e.g., 21 C.F.R. §§ 812.35(b), 812.40-812.47,
812.60-812.66, 812.150(a)-(b) (imposing IDE-specific IRB
requirements).

Before FDA can determine that a device is safe and
effective through the PMA process, 21 U.S.C.
§§ 360c(a)(1)(C)(i), 360e(d)(2), it reviews exhaustive
submissions. A PMA application must include: (1) full
reports of all safety and efficacy investigations; (2) a full
statement of the device’s components, ingredients, properties,
and principles of operation; (3) a complete description of the
methods used in, and the facilities and controls used for, the
manufacture, processing, and packing or installation of the
device; (4) information demonstrating compliance with
statutory performance standards; (5) samples of the device, if
requested by the FDA; (6) specimens of proposed labeling;
and (7) any other information FDA requires. See 21 U.S.C.
§ 360e(c)(1); id. § 360e(f)(3); 21 C.F.R. § 814.20 (requiring
statements of indications for use, device description,
alternative practices and procedures, marketing history,
summary of studies, and study conclusions).

9

These submissions typicaily include “‘thousands of pages
of documentation’” to which FDA must apply its expert
analysis to determine whether there is a reasonable assurance
of safety and efficacy. Horn v. Thoratec Corp., 376 F.3d
163, 172 (3d Cir. 2004) (quoting amicus curiae brief of the
United States); see Rattay v. Medtronic, Inc., 482 F. Supp. 2d
746, 748 (N.D.W. Va. 2007) (PMA application exceeded
1,700 pages); Steele v. DePuy Orthopaedics, Inc., 295 F.
Supp. 2d 439, 444 (D.N.J. 2003) (PMA application 2,000
pages before supplements).

During this review, FDA informs the manufacturer if there
are any “major” or “minor” deficiencies that must be
satisfactorily addressed before the PMA application can move
forward. See generally FDA, CDRH, Review Process June
11, 2003), www.fda.gov/cdrh/devadvice/pma/review_process.
html. For example, “[o]ne of the most important aspects of
the device approval process is the development of a
meaningful and accurate product label” and the agency
“works closely with the manufacturer to create this label.” I.
Muni et al., Challenges in Regulating Breakthrough Medical
Devices, 60 Food & Drug L.J. 137, 138 (2005). If FDA
determines that the application is deficient in any respect
(e.g., labeling, manufacturing, design specifications), it may
take a manufacturer months, if not years, to cure the
deficiency. See, e.g., Horn, 376 F.3d at 169-70 (PMA
process began in 1975, PMA application submitted to FDA in
1992, and device approved in 1994); Kemp v. Medtronic, Inc.,
231 F.3d 216, 219 (6th Cir. 2000) (four years between IDE
approval and PMA approval).”

During this process, the agency draws on its unique vantage
point. Indeed, FDA “holds the only broad, cross-cutting
knowledge” and “experience with the totality of other

> Such back-and-forth would not be necessary, of course, if FDA
determines the PMA application fully answers its questions in the first
instance and no remaining issues need to be addressed.

10

applications,” and also utilizes its knowledge of “the latest
science.” FDA, Jnnovation or Stagnation: Challenge and
Opportunity on the Critical Path to New Medical Products 13
(Mar. 2004), available at www.fda.gov/oc/initiatives/critical
path/whitepaper.html. To the extent an application does not
meet FDA’s standards or the agency has questions, there may
need to be substantial back-and-forth between the
manufacturer and agency. In Horn, for example, after the
manufacturer submitted its PMA application to FDA it
“supplemented it in the ensuing three years with a substantial
amount of amendments and responses to FDA questions.”
Horn, 376 F.3d at 170.

Even after a manufacturer satisfies any deficiencies flagged
by FDA, the agency generally refers the application to an
independent committee of experts, which holds a public
meeting to review the device and prepares a report and
recommendation to FDA on whether a device is safe and
effective. See 21 U.S.C. § 360e(c)(2); 21 C.F.R. pt. 14; id
§§ 814.42, 814.44; FDA, Review Process, supra. After the
committee issues its recommendation,-FDA considers that
information along with the other submissions to determine
whether the device’s “safety and effectiveness” has been
demonstrated through “valid scientific evidence.” 21 C.F.R.
§ 860.7; FDA, Review Process, supra (recognizing that even
after a committee recommendation, FDA may require
additional submissions from the manufacturer).*

* Since Lohr, FDA also has increased its scrutiny of a limited set of
§ 510(k) devices. In FDAMA, Congress augmented the § 510(k) process
by allowing manufacturers an option of gaining clearance by utilizing
conformance with FDA recognized standards to demonstrate safety and
efficacy equivalent to a predicate device. See 21 U.S.C. § 360d(c)(1); id
§ 360c(i1(A)ii); FDA, CDRH, Recognition and Use of Consensus
Standards; Final Guidance for Industry and FDA Staff (June 20, 2001),
available at www.fda.gov/cdrh/ost/guidance/321.html (“In the case of
510(k)s, information on conformance with recognized consensus
standards may help establish the substantial equivalence” and “can be

1]

If FDA determines that a manufacturer has provided
reasonable assurance that the device is safe and effective for
its intended use, the agency then issues a letter order
incorporating by reference the submissions pertaining to this
regulatory process and permitting the manufacturer to market
the device in the United States. It does so after a
manufacturer demonsiraies that the manufacturing and
processing methods and facilities conform to FDA
requirements, and that the proposed labeling is not false or
misleading. See 21 U.S.C. § 360e(d)(2); 21 C.F.R. § 814.45.
Thereafter, as described below, the manufacturer may not
alter design, labeling, or manufacturing process in any way
that would affect the safety or effectiveness of the device or
“is inconsistent with any conditions to approval specified in
the PMA approval order for the device” without FDA
approval. /d. § 814.80.

B. FDA Exercises Substantial Post-Marketing Over-
sight Of Medical Devices.

After a PMA application is approved, FDA’s compre-
hensive oversight continues—and has been enhanced further
in recent years. See, e.g., 21 C.F.R. § 814.44; FDA, Review
Process, supra. For instance, the manufacturer may have to
satisfy further conditions of approval for the device to remain
on the market. 21] C.F.R. §814.82(a). As noted, a
manufacturer may not change the approved product design,
labeling, or manufacturing process in any manner that would
affect the safety or effectiveness of the device without FDA
approval. /d § 814.80; id § 814.39 (requiring prior FDA
approval for most modifications). The manufacturer is
subject to audit and inspection by FDA. See 21 U.S.C.
§§ 360h, 360i, 360); 21 C.F.R. §§ 814.80, 814.82, 814.84.

FDA’s oversight of safety issues continues post-marketing,
as the device moves from the realm of clinical study to

used to show that the new device is as safe and effective as the predicate
in the areas covered by the standards.”).

12

broader, real-world clinical use. As the FDA Deputy
Commissioner has explained, “even for a product that is
rigorously tested preapproval, some risks will become
apparent only after approval, when the product is used in tens
of thousands or even millions of patients in the general
population.” Scott Gottlieb, Latest Trends in FDA Practice,
878 PLI/Pat 525, 536 (2006). This can occur, for example,
with respect to rare side effects. See Muni, supra, at 138-39.

As the American Medical Association has long recognized,
FDA’s “post marketing surveillance outside of formal studies
constitutes a vital activity in ensuring the safety of drugs and
devices.” Am. Med. Ass’n, Reporting Adverse Drug and
Medical Device Events: Report of the AMA’s Council on
Ethical and Judicial Affairs, 49 Food & Drug L.J. 359, 360
(1994). Of course, if Congress instead had enacted a different
regulatory system that effectively “forbid marketing of a
[device] until all long-term consequences and interactions are
identified through formal research{, it] would impose
unacceptable costs in the form of untreated or inadequately
treated illness.” /d.

FDA has a continuing role in notifying healthcare
professionals (and affected individuals) of risks presented by
medical devices, see 21 U.S.C. § 360h(a), requiring
manufacturers to repair or replace defective devices, id.
§ 360h(b), instituting recall campaigns, id § 360h(e),°
overseeing required recordkeeping and reports of adverse
reactions and injuries associated with devices, id. § 360i, and
requiring post-market surveillance of devices, id § 360j. In

* FDA has different classes of “recall,” most of which do not involve a
product’s removal from the market, and which range from addressing
potentially serious issues (Class |) to simply correcting matters that “are
unlikely to cause any adverse health reaction” (Class Ill). FDA, FDA
Recall Policies (June 2002) available at www.cfsan.fda.gov/~ird/
recall2.html; accord FDA, CDRH, FY 2006 Highlights 30 (2006); see 21
C.F.R. § 7.3(g)-(h); Muni, supra, at 141 (stating there are approximately
1,000 “recalis” per year yet only 10-20 per year are designated as Class I).

13

addition, FDA may revoke PMA approval if it subsequently
determines, inter alia, that a device is no longer safe and
effective or that the manufacturer has not satisfied
postapproval requirements. See id § 360e(e); 21 C.F.R.
§ 814.46. Furthermore, FDA can invoke injunctive relief,
seizure, criminal, and civil monetary penalty options for non-
compliance. See 21 U.S.C. §§ 332, 333.

Moreover, since Lohr was decided, FDA has enhanced
post-approval oversight. See generally Daniel G. Schultz,
M.D., Director of FDA’s CDRH, Medical Device Safety:
FDA’s Postmarket Transformation Initiative, 62 Food &
Drug L.J. 593, 593 (2007) (“[W]e have instituted significant
changes over the past few years in our approach to postmarket
medical device issues.”); id. at 595 (stating that the measures
rely on “expertfise]” in all aspects of medical device
development and regulation to “manage device-related public
health issues” including “comprehensive review of medical
device performance through a product’s lifecycle”); Muni,
supra, at 139 (discussing enhancements since 2002).

Among other initiatives, FDA has (i)issued guidance
regarding how post-approval studies are to be conducted, see,
e.g., FDA, Guidance for Industry and FDA Staff - Procedures
for Handling Post-Approval Studies Imposed by PMA Order
(Aug. 1, 2007); (ii) utilized Public Health Notifications and
the “FDA Patient Safety News” program to disseminate
information about device-related risk, see Muni, supra, at
141; and (iii) supplemented the existing post-marketing
Medical Device Reporting (“MDR”) system, 21 C.F.R.
§§ 803.30, 803.50, with the Medical Device Safety Network
or “MedSun.” Schultz, supra, at 594; Muni, supra, at 139.

Launched in 2002, MedSun draws on active reporting from
practitioners in healthcare facilities across the United States
“of problems like close calls or the rejection of a device over
safety concerns.” MedSun; About MedSun, www.medsun.
net/about2.asp. As an interactive surveillance and compli-
ance program, when an issue is raised, “MedSun researchers

14.

work with each facility’s representatives to clarify the

situation and fully understand the problem. Reports are later

shared without facility identification so that clinicians can
take necessary preventative actions.” /d.

FDA has been ‘active in responding to potential “safety
signals” emitted by the reporting systems, as well as engaging
in compliance and enforcement where appropriate. See
Schultz, supra, at 593 (“over the past five years, we have seen
an increase in the number of adverse event reports received”).
For instance, FDA recently reported that in the last quarter of
fiscal year 2006 alone its “safety analysts identified over 100
new and ongoing medical device safety issues” and
“responded to over 100 consult requests related to
information in the reports database.” FDA, CDRH, FY 2006
Highlights 28 (2006); see also id. at 29 (discussing fiscal year
2006 actions including ordering postmarket surveillance
studies, continuing ongoing surveillance, and issuing warning
letters for postmarket surveillance violations). During 2006,
CDRH took at least 55S enforcement actions, including four
seizures and an injunction, and initiated hundreds of
correction actions. /d. at 30.

During this process, collaboration between the agency and
the manufacturer is integral to ensuring patient safety:

[T]his cooperation between FDA and its regulated
industries has been demonstrated to be the quickest and
most reliable method to remove potentially dangerous
products from the market. This method has been
successful because it is in the interest of industry, as well
as FDA, to get unsafe and defective products out of the
hands of clinicians and patients as soon as possible.
{[Muni, supra, at 140.}

Furthermore, FDA has the expert perspective necessary to
ensure that the correct measure of oversight is employed. See
id. at 141 (noting that, in some cases, inspections may be

15

necessary whereas, in others, spot checks alone might be
sufficient to cure the identified problem).

* *+ © *

Given FDA’s continuing pre-approval scrutiny of PMA
devices, see Lohr, 518 U.S. at 477, and the increase in post-
approval! oversight, the potential for siaie-law interference has
grown since this Court last considered the MDA in Lohr. In
this light, the case for preemption in the PMA context is even
stronger than this Court previously suggested. Cf. id. at 478-
79 (contrasting § 510(k) review with PMA).

State-law tort actions, in contrast, cannot promise the
swiftness with which FDA can act; fail to account for the
safety-efficacy-innovation balance both Congress and FDA
have sought to strike; and lack the expert perspective central
to fulfilling the multiple objectives of Congress. Expansive
state tort liability not only provides a form of additional
regulation, but would “regulate” in a manner completely
‘untethered to the designs of the MDA and PMA process such
that it undoes their purposes.® Moreover, lay juries are not
institutionally well-equipped to make the kinds of nuanced
risk-benefit calculations and scientific judgments Congress

° Petitioner’s amici, including the American Association for Justice and
Public Justice, admit that tort liability functions as a form of regulation.
Br. Amici Curiae Am. Ass'n for Justice et al. 18-19. Although they posit
that the enhanced state-law liability they seek “promot{es] optimal
deterrence,” they do not (and cannot) reconcile their position with the
deterrence balance already reached by FDA, which is charged by
Congress with balancing considerations of safety, efficacy, and
innovation. /d at 18 (internal quotation omitted). To have state tort
liability promote “optimal deterrence” that hinges on “minimiz[ing] the
sum of accident costs” would necessarily unravel the PMA regime, which
purposely allows—and encourages—devices with the greatest degree of
risk to come to market under the expert agency's close oversight. In the
end, petitioner and her amici seek to have state law second-guess and
supplant the public health balance struck by Congress and the individual
balancing determinations reached by FDA as to particular devices.

16

has charged FDA—as the expert federal agency—with
making. For example, mock jury studies explain that lay
jurors tend to overestimate the level of risk of low probability
events, overreact to risks posed by new technology, and
punish defendants for undertaking risk-benefit analyses. See
Reid Hastie & W. Kip Viscusi, What Juries Can’t Do Well:
The Jury’s Performance As a Risk Manager, 40 Ariz. L. Rev.
901, 909-11 (1998).’

Il. EXTENDING STATE-LAW LIABILITY WOULD
UNDERMINE THE BALANCE OF PUBLIC
HEALTH OBJECTIVES REFLECTED IN THE MDA.

The enhanced state-law liability petitioner seeks would
threaten the calibrated public health balance at the heart of the
MDA. On the one hand, the MDA seeks to protect patients
by ensuring that medical devices are marketed in the United
States only after FDA determines that they meet the requisite
threshold of safety and effectiveness based on valid scientific
evidence. See, e.g., 21 U.S.C. §§ 360c(a)(1), 360e(d)(2); 21
C.F.R. § 860.7; FDA, FDA’s Mission Statement, www.
fda.gov/opacom/morechoices/mission.html (FDA’s mission
includes “protecting the public health by assuring the safety,
efficacy, and security of . . . medical devices”).

On the other hand, the MDA recognizes that device
development, innovation, and availability are essential to
improving public health. Indeed, Congress expressly sought
to foster innovation in medical device technology and “to
encourage, to the extent consistent with the protection of the
public health and safety and with ethical standards, the
discovery and development of useful devices intended for

” See, e.g., W. Kip Viscusi, Jurors, Judges, and the Mistreatment of
Risk By the Courts, 30 J. Legal Stud. 107, 111-14 (2001). (finding mock
jurors misapplied cost-benefit analyses particularly in low-probability,
large-loss cases); W. Kip Viscusi, Corporate Risk Analysis: A Reckless
Act?, 52 Stan. L. Rev. 547, 588 (2000) (jury awards and attitudes skeptical
of risk-benefit analyses).

17

human use.” 21 U.S.C. § 360j(g)(1). As the Senate
Committee Report explains:

As medicine progresses, as research makes new
breakthroughs, an increasing number of sophisticated,
critically important medical devices are being developed
and used in the United States. These devices hold the
promise of improving the health and longevity of the
American people. The Committee wants to encourage
their research and development. [S. Rep. No. 94-33, at 2
(1975).].

Such innovation leads to more effective, safer, and more
affordable treatments. See id.

The express preemption provision at issue here arose in this
context of balancing important public health objectives.*
Addressing the propriety of the express preemption provision
in light of the importance of device development, the House
Report counseled that “if a substantial number of differing
requirements applicable to a medical device are imposed by
jurisdictions other than the federal government, interstate
commerce will be unduly burdened,” and preemption will be
necessary to ensure that “innovations in medical device
technology are not stifled by unnecessary regulation.” H.R.
Rep. No. 94-853, at 12, 45 (1976); see id. at 10 (protecting
the public from unsafe devices is “counterbalanced by an
equally strong conviction that excessive or ill-conceived
Federal device regulation would stifle progress in this field”);
id. at 12 (stating that MDA “reflects the need to develop
innovative new devices”); Hearings on H.R. 5545, H.R. 974
& S. 510 Before the Subcomm. on Health & the Environment
of the H. Comm. on Interstate & Foreign Commerce, 94th

* The express preemption provision appears at 21 U.S.C. § 360k(a).
The briefs of respondent and its other amici, as well as the Second
Circuit’s decision below ably detail! the application of this provision to the
PMA context. We will not burden the Court by repeating that analysis
here.

18

Cong. 201 (1975) (Statement of Rep. Fred Rooney) (urging
passage of the MDA to replace the “piecemeal” and “after the
fact” approach typifie4 by then-existing judicial remedies).

In 1990, Congress reaffirmed that its goals included
encouraging medical device development to flourish when it
amended the MDA. See Safe Medical Devices Act of 1990,
Pub. L. No. 101-629, 104 Stat. 4511 (“SMDA”). “Simply
put, the [MDA] sought to avoid overregulation, thus
eliminating unnecessary resource costs to industry and
government, foster incentives to encourage innovation in a
relatively youthful industry and, most importantly, provide
the public reasonable assurances of safe and effective
devices.” S. Rep. No. 101-513, at 13 (1990).°

Following Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996),
Congress again sought to encourage innovation through the
Food and Drug Administration Modernization Act of 1997
(“FDAMA”). There, Congress further refined FDA’s
mission, requiring the agency, inter alia, to “promote the
public health by promptly and efficiently reviewing clinical
research and taking appropriate action on the marketing of
regulated products in a timely manner.” 21 U.S.C.
§ 393(b)(1). Indeed, “[a] central purpose of the [FDAMA] is
‘to ensure the timely availability of safe and effective new
products that will benefit the public and to ensure that our
Nation continues to lead the world in new product innovation
and development.’” FDA, The Least Burdensome Provisions
of the FDA Modernization Act of 1997: Concepts &

* Statements by a cross-section of members of Congress echo these
objectives. See, e.g., 136 Cong. Rec. $15205, S15211 (daily ed. Oct. 12,
1990) (statement of Sen. Kennedy) (objectives include “encourag[ing]}
technological innovation”); id at S12493 (daily ed. Aug. 4, 1990)
(statement of Sen. Dodd) (MDA “‘is structured to guard against excessive
governmental restrictions which might inhibit innovation in the
development and advancement of biomedical products”); id at $17459
(daily ed. Oct. 27, 1990) (statement of Sen. Hatch) (legislation “balance[s]
the need for regulation with the benefits of innovation’).

19

Principles; Final Guidance for FDA & Industry (Oct. 4,
2002) (quoting S. Rep. No. 105-43 (1997)) (“Congress’[s]
goal was to streamline the regulatory process (i.e., reduce
burden) to improve patient access to breakthrough tech-
nologics.”), available at www.fda.gov/c4rh/ode/guidance/

1332.html.

The state-law liability petitioner seeks to impose would
trigger, or exacerbate, harmful effects contrary to these
congressional purposes. These effects include discouraged
innovation, diminished availability, increased costs, and
defensive labeling—each of which would undermine public
health. '°

A. State Tort Liability Stifles Innovatior Of Impor-
tant And Life-Saving Medical Devices.

The state tort liability for which petitioner advocates would
stifle medical device innovation, thereby exacerbating an
already serious “pipeline problem” in the development of
important medical devices. Robust research and development
is the catalyst for safer devices and new devices that may
address previously untreatable or poorly controlled
conditions. Indeed, the Medtronic catheter at issue here, like
all Class III medical devices, is so-classified because it is
used “in supporting or sustaining human life.” 21 U.S.C.
§ 360c(a)(1)(C)(ii)(1). Congress subjected these devices to
the stringent federal regulatory oversight of the PMA process
because they intrinsically “present[] a potential unreasonable

'° Although not presented in this appeal, this is not to suggest that all
State tort claims with respect to a PMA-approved medical device
necessarily would be preempted. It may be the case that certain
manufacturing flaw claims—those premised not on a challenge to the
overall FDA-approved manufacturing process but on the specific device
the patient received containing a manufacturing flaw reflecting a deviation
from the FDA-approved design and manufacturing process—would
survive a preemption analysis. See, e.g., Pet. App. 3Sa (addressing
manufacturing flaw claim that otherwise failed to survive summary
judgment).

20

risk of illness and injury.” /d. § 360c(ay(1)(C)(ii)(I1); see
Lohr, 518 U.S. at 477 (juxtaposing § 510(k) review and
explaining that FDA takes, on average, 1,200 hours to review
a PMA application). Yet Congress freed such devices from
additional state regulatory requirements, thereby facilitating
continued innovation.

AdvaMed’s members alone spend roughly $9 billion
annually on research and development to facilitate device
innovations. Even a decade ago, this trajectory was evident:
In 1995, the average research and development expense
underlying a PMA-approved device was approximately $75
million, a three-fold increase from 1990. See William W.
George, Medical Technology and Competitiveness in the
World Market: Reinventing the Environment for Innovation,
50 Food & Drug L.J. 477, 480 (1995). In addition to
threshold research and development costs, the PMA
application itself imposes significant costs. The United States
Government Accountability Office found that user fees
charged by FDA for PMA review of a device averaged over
$239,000 per device in 2005. GAO-06-62, Medicare Durable
Medical Equipment: Class Ill Devices Do Not Warrant a
Distinct Annual Payment Update 3 (Mar. 1, 2006). And, over
ten years ago, FDA estimated that PMA applications and
supplements cost the industry approximately $35 million per
year. See 62 Fed. Reg. 51112, 51113 (Sept. 30, 1997).

These costs, and the length of PMA approval, contribute to
a background “pipeline problem” in bringing new and
innovative medical products to market that is further
exacerbated by state tort liability risks. See generally FDA,
Innovation or Stagnation, supra, at | (recognizing a “growing
crisis in moving basic discoveries to the market where they
can be made available to patients”); id. (noting the decrease in
the number of device applications). FDA recently expressed
its “growing concern that many of the new basic science
discoveries made in recent years may not quickly yield more
effective, more affordable, and safe medical products for

21

patients. This is because the current medical product
development path is becoming increasingly challenging,
inefficient, and costly.” /d. ‘

The American Medical Association has observed that
“{ijnnovative new products are not being developed or are
being withheld from the market because of liability concerns
or inability to obtain adequate insurance.” Am. Med. Ass’n
Bd. of Trs., Impact of Product Liability on the Development
of New Medical Technologies | (1988). It remains difficult to
properly insure against state tort risks. '!

“[M]edical equipment companies are increasingly reluctant
to innovate because of concern about suits with larger
numbers of claimants and extraordinary awards.” Lawrence
Tancredi & Dorothy Nelkin, Medical Malpractice and Its
Effect on Innovation 251, 260, in The Liability Maze (P.W.
Huber & R.E. Litan eds., 1991). “The threat of . . . enormous
awards has a detrimental effect on the research and
development of new products. Some manufacturers of
prescription drugs, for example, have decided that it is better
to avoid uncertain liability than to introduce a new pill or
vaccine into the market.” Browning Ferris Indus. of Vt., Inc.
v. Kelco Disposal, Inc., 492 U.S. 257, 282 (1989) (O’Connor,
J., concurring in part and dissenting in part).

'' See, e.g., David Dial et al., Tort Excess 2005: The Necessity for
Reform from a Policy, Legal and Risk Management Perspective 9-10
(2005) (“[t}he unpredictable and catastrophic nature of U.S. tort
exposures... has made insuring large-scale liability risks substantially
more challenging” in recent years, and “the scarcity of coverage” for
pharmaceuticals “has reached critical. proportions”); Scott E. Harrington,
Tort Liability, Insurance Rates, and the Insurance Cycle, Brookings-
Wharton Papers on Financial Services (2004) (“An expanding tort
liability system that entails substantial uncertainty about the cost of future
claims will inevitably lead to increasingly expensive [insurance]
coverage.”).

22

Numerous commentators have remarked on _ this
phenomenon.’? For example, Professor Michael E. Porter of
the Harvard Business School has explained that in the United
States “product liability is so extreme and uncertain as to
retard innovation” because “the legal and regulatory climate
places firms in constant jeopardy of costly and, as
importantly, lengthy product liability suits” and “goes beyond
any reasonable need to protect consumers.” Michael E.
Porter, The Competitive Advantage of Nations 649 (1990)
(emphasis added). State tort exposure’s “profound negative
impact on the development of new medical technologies,”
AMA, Bd. of Trs., supra, at 1, unfortunately reflects a
reasoned response by manufacturers to pull back in the face
of unreasonable and unpredictable liability.

Similarly, the threat of liability skews device-development
incentives in a manner that can undermine public health. For
example, FDA has recognized that rising costs create
incentives for manufacturers to focus on low risk, high profit
products. See generally FDA, /nnovation or Stagnation
(“Because of rising costs, innovators often concentrate their
efforts on products with potentially high market return.”). At
the same time, manufacturers are discouraged from

? See, e.g., Louis Lasagna, The Chilling Effect of Product Liability on
New Drug Development in The Liability Maze 34, 337, supra (“concern
about liability has led to serious delays in product development and to
increased liability insurance costs”); W. Kip Viscusi & Michael J. Moore,
An Industrial Profile of the Links Between Product Liability & Innovation
in The Liability Maze 8\, 83, 94-96, supra (recognizing that product
liability can cause lags in drug development and that losses exceeded
premiums for insurers of pharmaceutical companies throughout the
1980s); W. Kip Viscusi, et al., A Statistical Profile of Pharmaceutical
Industry Liability, 1976-1989, 24 Seton Hal! L. Rev. 1418, 1434 (1994)
(“The pharmaceutical industry, which is ‘one of the most innovative
industries in the economy, has been particularly hard hit by the surge in
liability costs.”); id at 1419 (recognizing that a National Academy of
Science panel also found that increased liability costs had discouraged
innovation in the pharmaceutical industry).

23

developing medical treatments which, despite potentially life-
saving benefits, also pose heightened risks. See id. (“For very
innovative and unproven technologies, the probability of an
individual product’s success is highly uncertain, and the risks
are perceived as extremely high.”); see also id. (“[iJnventors
of candidate artificial organs, bioengineered tissues, and other
novel devices face serious challenges and uncertainties”).

B. State Tort Liability Threatens The Availability
Of Significant Medical Treatments.

The specter of state liability threatens the availability of
important medical treatments and can have a chilling effect
on marketing treatments in the United States that are available
abroad. Historically, this phenomenon has been particularly
acute in the area of women’s health.

Bendectin, the only prescription medication approved by
FDA for treating significant morning sickness during
pregnancy, provides a classic example of this dynamic. See
Lasagna, supra, at 337-41. Extreme morning sickness can
have a devastating medical impact both on the pregnant
woman and on the developing child and requires medical
treatment. Although no scientifically reliable study ever
found a causal relationship between the medication and birth
defects, and FDA repeatedly found the product to be safe and
effective, the manufacturer faced nearly 2,000 tort suits
seeking to recover for alleged birth defects. See generally
Dep’t of Health & Human Servs., FDA, Determination That
Bendectin Was Not Withdrawn From Sale For Reasons Of
Safety Or Effectiveness, 64 Fed. Reg. 43190 (Aug. 9, 1999).
And even though its manufacturer was successful in
defending the litigation on the merits, Bendectin was
withdrawn from the market in 1983, in light of $18 million
per year insurance and legal costs, as compared to only $20
million in annual sales. See, eg., Marvin E. Jaffe,
Regulation, Litigation and Innovation in the Pharmaceutical
Industry: An Equation for Safety, in Product Liability &
Innovation: Managing Risk in an Uncertain Environment

24

120, 126 (J.R. Hunziker & T.O. Jones eds., 1994); Lasagna,
supra, at 338 (“[Bendectin’s] doom was traceable to the flood
of legal actions that followed assertions in the scientific
literature that Bendectin could produce congenital defects in
- both animals and humans.”).

This experience has had a ripple effect in discouraging the
future development of morning sickness treatments in the
United States. See Lasagna, supra, at 341 (stating that after
the Bendectin experience “[i]t seems safe to predict” that no
manufacturer will seek FDA approval for a morning sickness
drug). In the absence of a viable treatment such as Bendectin,
“treatment for severe nausea during pregnancy” accounted for
“nearly $40 million of the nation’s annual hospital bill” in
1994 alone, and “[ijt is unlikely that any new drug will be
developed to close this therapeutic gap.” Jaffe, supra, at 126.
Moreover, since the withdrawal of Bendectin from the United
States market, hospitalizations due to severe morning sickness
have increased three-fold in the United States, while such
hospitalizations have declined, for example, in Canada, where
the drug has remained available under the name “Diclectin.”
FDA/NIH Conference, Clinical Pharmacology During
Pregnancy Addressing Clinical Needs Through Science (Dec.
4, 2000), available at www.fda.gov/cder/present/
clinpharm2000/1204preg.txt; see C. Ineke Neutel, Variation
In Rates of Hospitalization for Excessive Vomiting In
Pregnancy By Bendectin/Diclectin Use in Canada, available
at www.nvp-volumes.org/p1_9.htm (“What is then the impact
of the withdrawal of Bendectin? The increase of
hospitalization for [excessive vomiting in pregnancy] for
thousands of women for more than a decade led to increased
cost and hardship to the women and their families, as well as
to the healthcare system.”).

The withdrawal of Norplant from the United States market
also illustrates the point. Norplant, a set of implanted rods
that release a hormone to inhibit ovulation, was acclaimed
upon introduction to the market in 1991 and had

25

approximately one million users by 1995. See Linda A.
Johnson, Wyeth Won't Resume Norplant Sales, Associated
Press Online, July 26, 2002; Albert George Thomas Jr. &
Stephanie M. LeMelle, The Norplant System: Where Are We
in 1995, 40 J. Fam. Prac. 125, 125 (1995). FDA repeatediy
found Norplant to be an effective method of birth control.
See, e.g., Johnson, supra; Syivia A. Law, Sex Discrimination
& Insurance for Contraception, 73 Wash. L. Rev. 363, 371
(1998) (“Norplant has been subject to extensive testing and
appears to be highly effective and safe.”). Yet Norplant was
withdrawn from the United States market in August 2000,
amidst allegations that certain individual lots might not be
effective. See Johnson, supra.

Despite positive public health findings by FDA, the World
Health Organization, and the American Society of
Reproductive Medicine, commentators have observed that
Norplant was “killed off,’” as lawsuits based on “untru{ths]”
and “misperceptions” hurt sales, and Norplant’s manufacturer
made a “business decision” to no longer market the product.
Johnson, supra; Gina Kolata, Will the Lawyers Kill Off
Norplant?, N.Y. Times, May 28, 1995, at C1.'° Even the
company’s “‘legal success has come at a steep price because
lawsuits are time consuming, expensive and have a chilling
effect on research.’” Morrow, supra (quoting manufacturer’s
North American President).

In the end, ligation stifled a medical treatment that was
beneficial to many women, leaving in its wake a poor climate
for future development of contraceptive devices. As Dr.
Felicia Stewart, ther:-deputy assistant for population affairs at

'? Over the course of Norplant litigation, more than 50,000 plaintiffs
purportedly sued the company. See Contraceptive Maker Wins Woman's
Suit Over Side Effects, N.Y. Times, Sept. 5, 1998. No plaintiff won a jury
verdict and the manufacturer won multiple trials, numerous summary
judgment motions, and had tens of thousands of cases dismissed. David J.
Morrow, Maker of Norplant Offers a Settlement in Suit Over Effects, N.Y.
Times, Aug. 27, 1999.

26

the Department of Health and Human Servives, recognized
““fijt’s clear watching what happened with Norplant why a
company thinking about marketing a new contraceptive
product might say it isn’t worth making an investment.’”
Kolata, supra; see, e.g., Johnson, supra (noting that the
manufacturer also declined to introduce a successor device to
the United States market although it had done so abroad’;
Anna Biernbaum, Note, Shielding the Masses: How Litigation
Changed the Face of Birth Control, 10 S. Cal. Rev. L. &
Women’s Stud. 411, 412-13 (2001) (“Due to the bad publicity
Norplant received, few women are using this safe and
effective form of birth control.... [T]here is no longer an
incentive for drug companies to research and market new
birth control devices, since the threat of litigation is
something that they are keenly aware of in the wake of
Norplant.”). Under the rule for which petitioner and her
amici advocate, there is no reason to believe that the threats to
innovation will be any less severe with respect to PMA-
approved medical devices.

C. State Tort Liability Increases Price And Under-
mines The Affordability Of Medical Treatments.

State tort liability increases the price of medical therapies.
See, e.g., Barbara Marsh, The Product Liability Morass;
Complications Set In; Big Suppliers Pulling Out of Medical
Market, L.A. Times, May 6, 1995, at Al. For example,
manufacturers of certain catheters, heart valves and other
devices were forced to withdraw from the market when
silicone prices increased to $100 per pound from $6 per
pound due to product liability litigation. /d Vaccines
provide another example of the point. Between 1980 and
1989, the wholesale price of most vaccines doubled or tripled;
in contrast, the price of two vaccines with a higher perceived
liability potential increased by factors of 40 and seven in the
same period. Richard L. Manning, Changing Rules in Tort
Law and the Market for Childhood Vaccines, 37 J. L. & Econ.
247, 254-57, 273 (1994) (describing, respectively, the

27

increased price of the diphtheria, pertussism and tetanus
(DPT) vaccine and the oral polio vaccine).

In setting the price of medical therapies, not only must a
manufacturer recoup its research, development, and
production costs through device sales—a goal managers of
publicly held companies may have a fiduciary duty to
pursue—but it also must insure against litigation risks. As
described above, companies “often have to self-insure”
against the prospect of large tort awards in a climate of
“present and future risks that are almost impossible to
quantify but that may be potentially large enough to include
financial catastrophe for the manufacturer.” Lasagna, supra,
at 337. Moreover, endeavoring to comply with 50-plus
divergent state standards governing the marketing, design,
and labeling of a device—trather than a single federal
standard—would pose considerable incremental costs that
would be reflected in increased price.

D. State Tort Liability Encourages Defensive Label-
ing And Overwarning That Undermine Rational
Prescribing By Physicians.

FDA has cautioned that state common-law tort actions
which “encourage, and in fact require, lay judges and juries to
second-guess” FDA’s balancing of the benefits and risks of a
specific device, create pressures for “‘defensive labeling’ . . .
resulting in scientifically unsubstantiated warnings and
underutilization of beneficial treatments.” Br. Amicus Curiae
of the United States at *25-26, Horn, available at 2004 WL
1143720 (filed 3d Cir. May 14, 2004) (recognizing potential
harm to public health); cf. 71 Fed. Reg. 3922, 3935 (Jan. 24,
2006) (“[A]dditional [state-law] requirements for the
disclosure of risk information are not necessarily more
protective of patients. Instead, they can erode and disrupt the
careful and truthful representation of benefits and risks that
prescribers need to make appropriate judgments about drug
use.”).

28

In an attempt to avoid state liability where plaintiffs allege
they were not adequately warned of a particular risk,
manufacturers have an inappropriate incentive to disregard
FDA’s expert judgment about the proper balance of risk
information and instead warn of each and every conceivable
risk of using the product, no matter how remote. This creates
a serious danger that manufacturers include warnings with
respect to medical devices that are not scientifically
substantiated and overemphasize warnings as to marginal
risks—thereby inappropriately de-emphasizing more serious
risks.

Defensive labeling is far from benign. A _ physician’s
prescription decision is rational only when he or she has an
accurate understanding of the risks and benefits of the
prescription device under consideration and can compare
those risks and benefits to those associated with other
treatment alternatives. A fog of unmanaged warnings,
unfiltered by FDA’s expert judgment, impairs the ability of
prescribing physicians to properly assess whether the
potential benefits of the therapy for a particular patient
outweigh its potential risks. Defensive labeling may cause
physicians to prescribe a treatment that is riskier than they
realize because serious risks are obscured in a blur of low
risks, and may ultimately dissuade physicians from
prescribing (and patients from undergoing) therapies that
have more potential good than harm for a given patient
because of unsubstantiated fears. '

'* See, e.g., Horm Amicus Br., supra, at 25-26; Brooks, 273 F.3d at 797;
W. Kip Viscusi, /ndividual Rationality, Hazard Warnings, and the
Foundations of Tort Law, 48 Rutgers L. Rev. 625, 665-66 (1996)
(“Excessive wamings are not innocuous. If wamings indicate a high
relative risk when there is none, they will distort relative product
comparisons, thus compromising credibility. Similarly, if warnings are
included for inconsequential risks, they will serve to further dilute the
warnings for the real hazards that should be identified to consumers.”);
Lars Noah, The Imperative to Warn: Disentangling the “Right to Know”

29

Inappropriate incentives with respect to defensive warnings
are particularly acute given that “[t]ime and again, one sees
how an avalanche of lawsuits can be set loose by a tiny
hiccup of error in scientific research.” Peter Huber, Junk
Science in the Courtroom, Forbes, July 8, 199i, at 68. The
following example illustrates the point:

[L]awyers won a spectacular $5.1 million verdict ...
largely on the strength of a single study that had very
tentatively suggested that spermicides might cause birth
defects. Not quite two years after the verdict, however,
the several authors of that study spoke out again. One
acknowledged that their work “was not corroborated by
subsequent studies,” and that their “study’s definition of
exposure to spermicide near the time of conception was
grossly inaccurate.” Another conceded: “I believe our
article should never have been published. In our present
_ litigious environment, the reservations and qualifications
written into a published report are often ignored, and the
article is used as ‘proof of a causal relationship.” [/d.'*]

Tort risks such as these encourage “defensive labeling.”

From the “Need to Know” About Consumer Product Hazards, \\ Yale J.
on Reg. 293, 380 (1994) (discussing dangers of overwarning and
recognizing that FDA “generally frowns upon and will not approve
defensive labeling”).

'S A similar research “blip” occurred recently with respect to drug-
coated heart stents—stents with a drug coating to help minimize re-
narrowing of heart structures following surgery. Last year, researchers
presented preliminary data at academic conferences “that suggest[ed] a
small but significant increased risk of stent thrombosis [i.e., blood clots] in
patients who have drug-eluting stents” as opposed to bare-metal stents
FDA, FDA Statement on Coronary Drug-Eluting Stents (Sept. 14, 2006).
FDA concluded that the drug-coated stents remained safe and effective,
and pledged further study. See id. Soon thereafter, the same researchers
concluded (after completing an additional year of study) that there was no
Statistically significant difference in the risk posed by drug-coated stents.
See Maria Cheng, New Study: Drug-Coated Stents Not So Bad, Associated
Press Online, Sept. 2, 2007.

30

CONCLUSION

For these reasons, as well as those set forth in respondent’s
brief, the decision below should be affirmed.

MICHAEL W. DAVIS
SIDLEY AUSTIN LLP

One South Dearborn Street
Chicago, Illinois 60603
(312) 853-7000

Counsel for Amici Curiae
AdvaMed and DRI

CHRISTOPHER L. WHITE

ADVANCED MEDICAL

TECHNOLOGY ASSOCIATION

701 Pennsylvania Ave.,
N.W.

Suite 800

Washington, D.C. 20004

(202) 783-8700

Counsel for Amicus Curiae
AdvaMed

October 19, 2007

Respectfully submitted,

CARTER G. PHILLIPS
DANIEL E. TROy*
REBECCA K. Woop
EAMON P. JOYCE

SIDLEY AUSTIN LLP
1501 K Street, N.W.
Washington, D.C. 20005
(202) 736-8000

Counsel for Amici Curiae
AdvaMed and DRI

PAUL J. MALONEY
WILLIAM J. CARTER
CARR MALONEY P.C.
1615 L Street, N.W.
Suite 500

Washington, D.C. 20036
(202) 310-5500

Counsel for Amicus Curiae
Medmarc

* Counsel of Record

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0289%3A13. Public record. Not legal advice.