Amicus Curiae Brief — Riegel v. Medtronic, Inc.

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No. 06-179

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IN THE

Supreme Court of the Anited States

CHARLES R. RIEGEL AND DONNA S. RIEGEL,

Petitioners,

Vv.

MEDTRONIC, INC.,

Respondent.

On Writ of Certiorari

to the United States Court of Appeals

for the Second Circuit

BRIEF OF AARP,

NATIONAL WOMEN’S HEALTH NETWORK,

U.S. PUBLIC INTEREST RESEARCH GROUP, AND

NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES

AS AMICI CURIAE IN SUPPORT OF PETITIONERS

DAVID C. FREDERICK

Counsel of Record

BRENDAN J. CRIMMINS

KELLOGG, HUBER, HANSEN,

TODD, EVANS & FIGEL, P.L.L.C.

1615 M Street, N.W.

Suite 400

Washington, D.C. 20036

(202) 326-7900

Counsel for Amici AARP, National Women’s Health Network,

U.S. Public Interest Research Group, and

National Research Center for Women & Families

August 27, 2007

OO — ——

QUESTION PRESENTED

Whether the express preemption provision of the

Medical Device Amendments of 1976, which amended the

Food. Drug, and Cosmetic Act, 21 U.S.C. § 360k(a),

preempts state-law claims seeking damages for injuries

caused by medical devices that received premarket

approval from the Food and Drug Administration.

QUESTION PRESENTED

TABLE OF CONTENTS

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INTEREST OF AMICI CURIAE

BACKGROUND

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gk _______, SE RN UR MN TEE E ETE 5

ARGUMENT

II.

PREMARKET APPROVAL PROVIDES A

LIMITED SCREENING OF MEDICAL

DEVICES THAT IS INADEQUATE AND

NOT INTENDED TO REPLACE STATE

ee tttrinisuiniinsitenistnbisiinineniabiseneaiiniaianieasens

A. Premarket Approval Applies A Ge-

neric Safety Standard Based On

Limited Device Testing Reviewed By

Burdened Regulators................c.ccccceseeeeees

B. Premarket Approval Provides Negli-

gible Continuing Oversight And Per-

mits Design. Manufacture. And Label

Changes With Either Expedited FDA

Review Or No Review At All ...........0........

THE TORT SYSTEM PROVIDES REM-

EDIES AND INCENTIVES NECES.-

SARY TO PROTECT THE PUBLIC

AND TO COMPENSATE PATIENTS

INJURED BY DEFECTIVE MEDICAL

DEVICES THAT RECEIVED PREMAR-

ne eT acanstinniiicinininnapinuatinecemninetsiocese

A. By Uncovering Information About

Defective Medical Devices, Litigation

Spurs Improvements In The Medical

Device Industry And The FDA.................

OCP ee eee eee eee eee eee ee eee ee eee eee ee eee eee eee ee eee eee eee)

iene 18

B. Litigation Compensates Victims Of

Defective Medical Devices .........................00000 26

ID eiacipbanbcisnteccnncicinibsndencibitekdatmicimanbusebestnhintaniidetiins 30

TABLE OF AUTHORITIES

Page

CASES

Bates v. Dow AgroSciences LLC, 544 U.S. 431

pret teviscnsccdisensccdeiassindesisiandiemeiseadtiiaidiamaaiias 9, 17, 18, 21

Cipollone v. Liggett Group, Inc., 505 U.S. 504

Ti icccseniessiiahennalacdiadadiiabimenidipinttedade omnia 17, 26, 27

Ferebee v. Chevron Chem. Co., 736 F.2d 1529

Cs GE BI ercsintecstnnnnciediieimiaaekele aces 18

Guidant Corp. Implantable Defibrillators Prod.

Liab. Litig., In re. MDL No. 05-1708

(DWF/AJB), Civil No. 06-25 (DWF/AJB), 2007

WL 1725289 (D. Minn. June 12, 2007)........... 20, 22, 23

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ............ 2, 3, 4.

o, 6, 11, 21

Medtronic, Inc. Implantable Defibrillators Litig.,

In re, 465 F. Supp. 2d 886 (D. Minn.

ee cvicisieveuimnsnalinibinisnienminitiniissineeiiigeaniiaeain 20-21, 25, 26

OGilvie v. International Playtex, Inc., 821 F.2d

SE CI GA Be icicisttesscicsitcsntentimaaiionaiae 27

Silkwood v. Kerr-McGee Corp., 464 U.S. 238

CII ncccwssitncsincssnsciiaciciiipiaieassiesetaniaaieeeeianasnia anna 27

Sprietsma v. Mercury Marine, 537 U.S. 51 (2002)........... 26

St. Jude Med., Inc. Silzone Heart Valves Prod.

Liab. Litig.. In re, No. MDL 01-1396

JRTFLN, 2004 WL 45503 (D. Minn. Jan. 5,

SID vecsssnesnsonnsenniinnsiconiiudandblamunimadeaniiaaaate 21. 24, 25

Sulzer Hip Prosthesis & Knee Prosthesis Liab.

Litig.. In re:

268 F. Supp. 2d 907 (N.D. Ohio 2003) .................. 29, 30

455 F. Supp. 2d 709 (N.D. Ohio 2006).................. 20, 28

STATUTES, REGULATIONS, AND RULES

Federal Insecticide. Fungicide, and Rodenticide

, censinnnmonnnnoncoaoens i)

Food and Drug Administration Modernization

Act of 1997, Pub. L. No. 105-115, 111 Stat.

a cerns nemsnsnnsonnnnonentons 12

Medical Device Amendments of 1976, Pub. L. No.

ssa a errnenansssannunnencnnees 2

I I i sctcnetensimenosienenneniennnes 21, 27

css ec ctecscemisnseinnnimnenti 3

TTT 3

sai id aenatinatibonnnenengns 3

a rtercacnncencnecagicnnnovenwneoesanes 3

nc crnrntninneunneionues 2

os ncescnensnsandnnooadepeeneuceosense 4

I sa nrnneriasons 7,8

a cain cretrnonaoninicnnnevenaioneess 8

ee To cericcececeerecsenenoesoooneeneceonousenscces 12

Ecce ccsesencootecsovnnoovenectoesccses 9

I crrrnaicnrrmncnebipersonosonnccennie y

21 U.S.C. § F6Ded GHANA) ........:ccccsesreeeeereeeesesneen 16,17

21 U.S.C. § 36MC(AM EMAIL o...cccccccecceccccesescescseeeeeeeeeees 16

ee Co | | ae 27

a _coolpniusubdaiioossovsonsinest 4

I a aieaniailanes 4

Medica! Device User Fee and Modernization Act

of 2002. Pub. L. No. 107-250, 116 Stat. 1588............. 13

§ 102, 116 Stat. 1589 (codified at 21 U.S.C.

a Be er 13

21 C.F.R.:

I iil ial seeadaadlienedalem 3

RANA SEU E COTTIER 4

LILO LTR AT IE 4

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ERE SEO ITLL leancnesouinsiealciasa mene 16

REL AM TEIN. 4,7

OS sadesceciadbiiinisaneiaicaiiien 16

atl le ae 17

OS EALERTS SM Ferrera eT. 17

Se EEA SERIE ee ee eT 10

AMINA I SE 10

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i IS iiss icsiiiieaiianiiliadiadaanbaaimamada 11

ERR RRM A eT AT 1]

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ELATED ITT eT 10

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DIET ..sncinsssnonsasistntieiconaiestisesisiadiiiel tuieaiiinid aan 9

iI nssanpnesmroticneahiiniasibapaiinnleniaialiesi dalam cena 11

I I... snsesisninnsiiirimpeieisiionnsneisbiieitacsletadeigaataananmnan 11

EO ..._...::ssniniiciisensiihitaiabuaiembiiietiaicsial mana 4

BU DE FR BG Boe eccencccesnssscrcnccnsnensnensseriietinemanninmmanstacmniantiiins 1

vil

LEGISLATIVE MATERIALS

H.R. Conf. Rep. No. 94-1090 (1976). reprinted in

a ei sth intenrtelataracinii 27

S. Rep. No. 94-33 (1975), reprinted in 1976

REPRE Se cede ee ee Oe 2

Statement of Franklin A. Curtis, Associate

Director, Human Resources Division. United

States General Accounting Office, Before the

House Committee on Energy and Commerce,

Subcommittee on Health and the Environ-

ment, on the Federal Regulation of Medical

Devices, 98th Cong. (Feb. 24. 1984), available

at http://archive.gao.gov/d40t 12/123484.pdf .............. 14

ADMINISTRATIVE MATERIALS

Center for Devices and Radiological Health, Food

and Drug Admin.:

Ensuring the Safety of Marketed Medicai

Devices (2006), available at http://www-fda.

gov/cdrh/postmarket/mdpi-report.pdf eee... 15

Office of Device Evaluation and Office of

InVitro Diagnostic Device Evaluation and

Safety Annual Report (2003), available at

http://www.fda.gov/edrh/annual/fv2003/ode/

STITT scastinsiiatsthedtessdalianiidiidieddlagdaiaadidisiemansindsbidibiainidcleiidacibamiesleds 17

Food and Drug Administration:

Enforcement Report, http://www.fda.gov/bbs/

topics/entorce/2005/EN FOOR91. html] (Mar. 16.

SII iisieidaiciiendeiesitenieinetaahenecnieeadabielephiaeciiaitiadieaanendaitaiaadaiiniennledisaneadinnal 26

Learn About Medical Device Recalls.

http://www.fda.gov/cdrh/recalls/learn. html

I N,N caninsaneiion 16

vill

Medical Device Exemptions 510(k) and GMP

Requirements, http://www.accessdata.fda.gov/

scripts/cdrh/cfdocs/cfped/315.cfm (last visited

Aug. 23, 2007) ......c..c.cesceccececcecossessessecessecsesseesesceseece:

General Accounting Office, Comptroller General's

Report to Congress, Federal Regulation of

Medical Devices: Problems Still to Be Over-

come (GAO/HRD-83-53, 1983). .........0c. cece eeeeeeeeeee wees

Elizabeth D. Jacobson, AdvaMed’s Written Tes-

timony on The Critical Path White Paper at

Science Board to the Food and Drug Admini-

ys SE actentiecitiacnnndanasemecnininnteinaiines

Office of Device Evaluation, Center for Devices

and Radiological Health, Food and Drug

Admin.:

Annual Report Fiscal Year 1996 ..................2....0000-+.

Annual Report Fiscal Year 2000 .....................2..0000+

Annual Report Fiscal Year 2004 ..0.........0..000..0...0000

Annual Report Fiscal Year 2005 .................0...0000000

OTHER MATERIALS

Robert S. Adler & Richard A. Mann, Preemption

and Medical Devices: The Courts Run Amok.

ek ic: SY I cctserersinctnaticnsicnnnnnienemnniamioniness

Marcia Angell & Arnold S. Relman, Op-Ed,

Prescription for Profit. Wash. Post. June 20,

2001, at A27 dneetatantidibididinadinaaenaien sideband

Mark Carlson et al.. Recommendations from the

Heart Rhythm Society Task Force on Device

Performance Policies and Guidelines (2006) ..........

Paul D. Carrington. Recent Efforts to Change

Discovery Rules: Advice for Draftsmen of

Rules for State Courts. 9 Kan. J.L. & Pub.

ARRAS NE mre NSC AV errs

sone 3

—

wei 8

Robert Cohen & J. Scott Orr:

A Glitch Can Kill, But Pacemaker Users Will

Take That Chance, Star-Ledger (Newark,

I I a saianiaiinaiae

Often the Patient Is the Last to Know, Star-

Ledger (Newark, N.J.), Aug. 11, 2002, at 1.... 12, 24,

Victoria Colliver, Surgical Manufacturer Under

Fire; ‘Recycled’ Hip Implants Spell More Suf-

fering; Some Defective Devices Replaced with

Ones Previously Recalled, S.¥. Chron., June

i, Sas OD I cetevececintsenepntntincneceseemnetemmsnsnsnnveensssnnens

Price Colman, Telectronics Defends Efforts With

Defective Wire, Rocky Mountain News, Mar.

ai Se UE SUI dierietinienhcciennnnnsiatunenonnieineninsnniibretneenmests

Richard A. Deyo, Gaps, Tensions, and Conflicts

in the FDA Approval Process: Implications

for Clinical Practice, 17 J. Am. Board Fam.

I 6, 7-

Five Implants Later, Local Woman's Hip Still

Not Right; She Says the Defective Hip

Implant Caused Complications that Linger,

Grand Rapid Press, Aug. 25, 2002. at C1...............

Steven Garber, Product Liability and _ the

Economics of Pharmaceuticals and Medical

FEE sae eee

Mark Geistfeld. Negligence, Compensation, and

the Coherence of Tort Law, 91 Geo. Lid. 585

eee bheniniciicicetntnesidlsdciiandiseiinenbiadesdnenaninnnhiatitneness

Michael D. Green & William B. Shultz. Tort

Law Deference to FDA Regulation of Medical

Devices. 88 Geo. L.J. 2119 (2000).............0..cc eee

Ben Harder. Heart Device Recall: For Patients

with Suspect Models, Tough Choices, Wash.

—_

ones OO

Institute of Medicine, Safe Medical Devices for

Children (Marilyn J. Field & Hugh Tilson

SERRE si iiaheebiiliiiiaa ainainataialnatitiae 15, 16

Mark Jewell, Guidant’s Warning Letter on Defi-

brillators Never Sent, Assoc. Press, Aug. 6,

Jon Kamp, Guidant Discloses Lawsuit Tally,

Savs Many More Possible. Market Watch,

I TI alasiscichiichicetinceiieciciniinienicilenidiaianiitianpitiabaniiatienbidi 23

Mare Kaufman, More Heart Devices Malfunction;

As Sophistication Has Grown, So Have Fail-

ures, FDA Reports, Wash. Post, Sept. 17,

SI IIT IIIT sis ihubieieihaie tied iceaioasei a beeentinbipnisd aiid tididintaniaseenaegunns 23

Aaron S. Kesselheim & Jerry Avorn, The Role of

Litigation in Defining Drug Risks, 297 J. Am.

EE nN TEN 18, 20

Peter Lurie et al., Financial Conflict of Interest

Disclosure and Voting Patterns at Food and

Drug Administration Drug Advisory Commit-

tee Meetings, 295 J. Am. Med. Ass'n 1921

REEDED vo ae tee ae 13

William H. Maisel, Safety Issues Involving Medi-

cal Devices; Implications of Recent Implant-

able Cardioverter-Defibrillator Malfunctions,

294 J. Am. Med. Ass'n 955 (2005) ...00..... cece cece eeeneee 22

Barry Meier:

F.D.A. Expanding Inquiry into Heart-Device

Company, N.Y. Times, Aug. 25. 2005, at C8 .............. 22

Guidant Debated Device Peril, N.Y. Times,

i Ie: I ME TET incidicunteeidianstiiniuiaiieisseiaadieneabiiibinaiinauenes 23

Heart Device Makers Plan Enhanced Safety

Reviews, N.Y. Times, May 16, 2006, at C3................. 24

Inquiry Arranged by Guidant May Aid Law-

suits and Critics, N.Y. Times, Mar. 22, 2006.

Morton Mintz, Questions Arose Early on Contra-

ceptive’s Safety, Wash. Post, Apr. 7, 1985, at

Siri iscsaaseheicieshsincileesichibaclteatedeunsiienaiisieintehibenitddiadiniateiieia inated datceeeatiine Kea 2

Oral Arg. Tr., Bates v. Dow AgroSciences LLC,

No. 03-388, 2005 WL 148903 (Jan. 10, 2005)............... ]

J. Scott Orr & Robert Cohen, Messy Plant Made

Faulty Hip Joints; Late Federal Inspections,

Denial Blamed in Class-action Lawsuit.”

Times-Picayune, Aug. 13, 2002, at 1 ........ 27, 28, 29, 30

Margaret Jane Porter. The Lohr Decision: FDA

Perspective and Position, 52 Food & Drug L..J.

a Trt hiccsnceieeniiciotunhainathiciaceinacii aha heiterininnmtatiabiiiiiadiednmaeeat 9, 27

Robert L. Rabin, Keynote Paper: Reassessing

Regulatory Compliance, 88 Geo. L.J. 2049

iI aici dhiaetidasieebdaieaiaahibeiniadidapeenpiidinguaalnibitaintinintiobisiahiness 19, 28

Scott D. Ramsey et al.. The Limited State of

Technology Assessment for Medical Devices:

Facing the Issues, 4 Am. J. Managed Care

IRE Troeee eee eee eee ne a 7

Jonathan D. Rockoff, FDA Seeks to Limit Con-

flicts of Interest; Rules Would Restrict Outside

Advisors with Industry Ties, Baltimore Sun,

I sens 13

Teresa Moran Schwartz, Prescription Products

and the Proposed Restatement (Third). 61

a 7.8

Catherine T. Struve. The FDA and the Tort

System: Postmarketing Surveillance, Compen-

sation, and the Role of Litigation, 5 Yale J.

Health Pol'y. L. & Ethics 587 (2005) «0.0... 19

Jeff Swiatek, Doctors Seek Device-Flaw Data-

hase; Guidant’s Belated Revelation of Defect

in its Prizm 2 Defibrillator Spurs Call for

Changes, Indianapolis Star, May 31, 2008, at

| EET SEE Lap Oe FOE een Re ION NOSE TE aE 4

Union of Concerned Scientists, Voices of Scien-

tists at FDA: Protecting Public Heath

Depends on Independent Science (2006),

available at http://www.ucsusa.org/scientific_

integritv/interference/fda-scientists-survey-

IE ecrtricsentonigntucncnaccenipnenntsinsintanestiineiase

U.S. Amicus Br.:

Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.

ee ne Se ccdecnccnicctisemsasvivemntennncisinnstennies

Smiths Indus. Med. Svs., Inc. v. Kernats,

No. 96-1405, cert. denied, 522 U.S. 1044

Fee ccininivnsunicninensstanesatsssnsdesepineammnnetentataieieenunies

David C. Vladeck, Presumption and Regula:ory

Failure. 33 Pepp. L. Rev. 95 (2005) .....................

Wendy Wagner, When All Else Fails: Regulating

Risky Products Through Tort Litigation, 95

OE an eT Lem?

Elizabeth A. Weeks, Beyond Compensation:

Using Torts to Promote Public Health, 10 J.

Health Care & Pol'y 27 (2007) .................0cc eee ee

sonsoee 12

smneiiane 9

veonetons be)

eneoeen 20

INTEREST OF AMICI CURIAE '

AARP is a non-profit, non-partisan organization with

more than 39 million members, dedicated to addressing

the needs and interests of people aged 50 and older. It

promotes independence, dignity. and purpose for older

persons; sponsors research on aging; provides educational

programs, publications, and member benefits: and repre-

sents the concerns of older persons before government

bodies. As the largest membership organization repre-

senting the interests of older persons, AARP has long sup-

ported laws and public policies designed to protect its

members’ rights and to preserve the availability of legal

redress when they are harmed in the marketplace.

The National Women's Health Network improves the

health of all women by influencing pclicy and supporting

informed consumer decision-making. The Network is

supported by 8,000 individual and organizational mem-

bers and accepts no financial support from pharmaceuti-

cal companies, tobacco companies, or device manufactur-

ers. Since it was founded in 1975, the Network has

worked to ensure that safe drugs, devices, and medical

procedures are available to all women. The Network be-

lieves that effective state tort law remedies are necessary

to protect women from dangerous medical devices.

U.S. Public Interest Research Group (“U.S. PIRG”), the

federation of state Public Interest Research Groups, Is a

national, non-profit advocacy group with more than one

million members around the country. Its mission is to

protect the interests of consumers and ordinary citizens

using the tools of investigative research, media reports.

grassroots organizing, legislative and public policy advo-

“vy, and litigation. The ability of States to protect the

' Pursuant to Supreme Court Rule 37.6. counsel tor amict represent

that they authored this brief and that no entity other than amici, their

counsel, or their members made a monetary contribution to its prepa-

ration or submission. All parties have consented to the filing of this

amict bret. and letters reflecting their blanket consent to the filing of

amicus bnets in this case are on file with the Clerk.

health and well-being of their residents has been a long-

standing area of concern to U.S. PIRG.

The National Research Center for Women & Families

is a non-profit, nonpartisan organization dedicated to

improving the health and safety of women, children, and

families, by using objective, research-based information to

encourage new, more effective programs and policies. The

Center gathers and analyzes information and translates it

into clearly presented facts and policy implications that

are made widely available to the public, the media, and

policy makers.

Amici have participated as an amicus curiae in numer-

ous cases opposing federal preemption of state and local

laws that provide important consumer protections.

BACKGROUND

“To provide for the safety and effectiveness of medical

devices intended for human use,” Congress enacted the

Medical Device Amendments of 1976, Pub. L. No. 94-295,

90 Stat. 539 (“MDA”). See Medtronic, Inc. v. Lohr, 518

U.S. 470, 474 (1996): id. at 491 (Stevens, J., plurality)

(“[T]he primary issue motivating the MDA’s enactment

[was] the safety of those who use medical devices.”).

Before 1976, the federal Food and Drug Administration

(“FDA”) could regulate drugs, but not medical devices. A

series of high-profile failures of medical devices, most

notably the Dalkon Shield, a defective intrauterine device

responsible for at least 18 deaths and thousands of seri-

ous injuries, led to calls for increased consumer protection

against such dangerous devices. See S. Rep. No. 94-33, at

1-2 (1975), reprinted in 1976 U.S.C.C.A.N. 1070, 1070-71."

In response, Congress passed the MDA. which provided

the FDA with limited new authority over the medical de-

vice industry. Among other provisions. the MDA created

- See also Morton Mintz. Questions Arose Early on Contraceptives

Safety. Wash. Post. Apr. 7. 1985. at Al (describing how defects in the

Dalkon Shields design caused infections m thousands of women and

birth defects in their children).

a premarket approval (“PMA”) process designed to pre-

vent dangerous medical devices from reaching the mar-

ket. See Pub. L. No. 94-295, § 2, 90 Stat. 552 (codified as

amended at 21 U.S.C. § 360e).

This PMA process ts part of a three-tiered regime that

provides general regulation of the “vast array of medical

equipment [f]rom bedpans to brainscans,” Lohr, 518 U.S.

at 476 (alteration in original: internal quotation marks

and citation omitted). The MDA requires that the FDA

classify every medical device into one of three categories.

Class I devices, like rubber gloves, are the least risky

devices and are subject to only basic requirements, such

as that the device not be misbranded or adulterated. See

21 U.S.C. § 360c(a)(1)(A). Class II devices, such as hear-

ing aids, are more likely to harm consumers, so the FDA

may pass regulations subjecting these devices to addi-

tional controls, such as requiring specific warning labels.

See id. § 360c(a)(1)(B): 21 C.F.R. § 801.430. In most cases,

manufacturers do not need to obtain approval from the

FDA before marketing Class | or Class Il medical devices

to consumers.’

A Class ITT medical device, like the balloon catheter at

issue in this case, is one that either presents “a potential

unreasonable risk of illness or injury” or is “purported or

represented to be for a use in supporting or sustaining

human life or for a use which is of substantial importance

in preventing impairment of human health.” 21 U.S.C.

§ 360c(a)(1)(C). Before manufacturers can market these

devices, they must receive permission from the FDA,

through either the premarket notification or the pre-

market approval process. The premarket notification

process requires the manufacturer to submit a form to

the FDA describing the device and explaining how it

is substantially equivalent to an FDA-approved device

that is already on the market. See id. §§ 360c(f)(1)(a).

~ See FDA. Medical Device Exemptions 510k) and GMP Require-

ments. http://www.accessdata.fda gov/scripts/edrh/ctdocs/cfped/3 15.ctm

(last visited Aug. 23, 2007).

360e(b)(1)(B); 21 C.F.R. § 807.92. If the FDA finds, on the

basis of this information, that the device is substantially

equivalent to an approved device, it can be marketed. See

Lohr, 518 U.S. at 478-79.

If no substantial equivalent exists, the device can be

sold only upon the FDA's premarket approval, which re-

quires a more detailed application from the manufacturer

and a lengthier review of that application by the FDA.

See 21 C.F.R. § 814.20. In Lohr, this Court held that

premarket notification does not preempt duties tradition-

ally enforced by state tort law. See 518 U.S. at 501-02.

This case involves the preemptive effect of the second

Class II approval process, the PMA.

The MDA includes a narrow, express preemption provi-

sion that, “with respect to a device intended for human

use, preempts a state “requirement (1) which is different

from, or in addition to, any requirement applicable under

this chapter to the device, and (2) which relates to the

safety or effectiveness of the device or to any other matter

included in a requirement applicable to the device under

this chapter.” 21 U.S.C. § 360k(a). FDA regulations im-

plementing § 360k(a) provide that an FDA requirement

has preemptive effect only when it establishes a device-

specific “counterpart” to a “divergent” state-law require-

ment that is “specific” to a particular device. 21 C.F.R.

§ 808.1(d). The MDA does not preempt requirements of

“general applicability ... to other products.” /d.

For example. FDA regulations impose specific design

requirements for certain laser devices. see id. § 886.4392.

which would preempt contrary or additional state regula-

tion. The FDA may also exempt state requirements from

the preemptive effect of a federal requirement, see 21

U.S.C. § 360k(b). and the exemptions granted reflect the

FDA’s narrow understanding of § 360k(a)'s preemptive

effect. What this Court recognized in Lohr remains true

today: “the FDA has never granted. nor. to the best of our

knowledge. even been asked to consider granting, an ex-

emption for a state law of general applicability: all 22

existing exemptions apply to excruciatingly specific state

requirements regarding the sale of hearing aids. 518

U.S. at 499-500; see 21 C.F.R. §§ 808.53-808.101.

SUMMARY OF ARGUMENT

I. Congress enacted the MDA to prevent manufacturers

from introducing new, untested, and potentially danger-

ous medical devices to doctors and patients, not to pro-

vide & comprehensive safeguard from defective products.

While it requires device makers to conduct some testing

and to provide a “reasonable assurance” of product safety,

the PMA process is based on limited information, which

restricts its depth and scope. The FDA does not routinely

require controlled clinical trials, is unable to subpoena

information from manufacturers, has no authority or re-

sources to conduct independent testing, ane cannot com-

pare the safety or efficacy of a submitted device to others

on the market. Furthermore, PMA applications enjoy a

presumption in favor of approval, if an enumerated reason

for denial does not apply, the statute and implementing

regulations require premarket approval.

This limited premarket review is a one-time licensing

scheme and involves very little continuing regulation

after a device is approved and in use by doctors and

patients. Defective devices with premarket approval typi-

cally remain on the market until the manufacturer com-

mences a voluntary recall, and the FDA neither compen-

sates victims nor sanctions device makers.

Il. The traditional state tort system provides manufac-

turers with safety incentives, the public with information

about defective devices. and victims with compensation

for their injunes. The PMA svstem. at best. can only sup-

plement—and cannot supplant—-those traditional func-

tions of state tort liabilitv. When dangerously defective

devices reccive premarket approval and injure scores of

patients, litigation reinforces the purposes of the MDA

improving the safety and effectiveness of medical devices

by uncovering flaws. encouraging compliance with FDA

standards, and compensating victims.

Premarket approval is an important process intended to

end an era in which manufacturers marketed potentially

dangerous medical devices without any meaningful test-

ing and with no assurances of safety. But, while the PMA

process provides minimum safeguards, it is insufficient to

replace the comprehensive and continuous safety incen-

tives, information disclosure, and victim compensation

that state tort law has traditionally provided.

ARGUMENT

I. PREMARKET APPROVAL PROVIDES A LIM-

ITED SCREENING OF MEDICAL DEVICES

THAT IS INADEQUATE AND NOT INTENDED

TO REPLACE STATE TORT LAW

As this Court recognized in Lohr, “the statutory frame-

work” and “the structure and purpose of the statute as a

whole.” revealed in the text and “the reviewing court’s

reasoned understanding of the way in which Congress in-

tended the statute and its surrounding regulatory scheme

to affect business, consumers, and the law,” are relevant

in interpreting the MDA’s preemption provision. 518 U.S.

at 486 (internal quotation marks and citations omitted).

Such a reasoned understanding reveals that the PMA

process was established as, and remains, one where “the

agency faces limitations that result from many factors,

including the agency's legal mandate, pressures from

industry, pressures from advocacy groups, funding con-

straints, and varied political pressures.” Richard A. Devo,

Gaps, Tensions, and Conflicts in the FDA Approval

Process: Implications for Clinical Practice, 17 J. Am.

Board Fam. Prac. 142, 143 (2004).

PMA is based upon partial information that is reviewed

bv a constrained and conflicted FDA. That review merely

screens new Class III medical devices and licenses for

market those that appear to meet a generic standard of

safety and efficacy. The FDA does not apply a single spe-

cific safety standard or requirement to a device before

its approval. And PMA is a one-time review, with no

reevaluation and very little FDA oversight once a device

reaches doctors and patients. Due to the limitations

inherent in the PMA process, the FDA cannot guarantee

that defective, dangerous, and deadly medical devices will

not reach consumers. The limited PMA process, which

was intended to promote consumer safety, is entirely in-

adequate to replace the long-standing safety incentives

and consumer protections provided by state tort law.

A. Premarket Approval Applies A Generic Safety

Standard Based On Limited Device Testing

Reviewed By Burdened Regulators

1. Limits on the information that manufacturers must

submit to the FDA during the PMA process restrict the

scope and depth of the FDA’s review. A manufacturer's

PMA application includes information on the device. any

investigations conducted into its safety and efficacy, and

its manufacture, processing, and labeling. See 21 U.S.C.

§ 360e(c)(1); 21 C.F.R. § 814.20. The FDA lacks authority

to subpoena additional information from the device maker

or independently to obtain safety data. See Teresa Moran

Schwartz. Prescription Products and the Proposed Restate-

ment (Third), 61 Tenn. L. Rev. 1357, 1386 (1994).

Those constraints inhibit the FDA’s review. First. the

testing of device safety reported in the PMA application

can be quite limited, and many applications are approved

despite the lack of any controlled clinical study. See Scott

D. Ramsey et al., The Limited State of Technology As-

sessment for Medical Devices: Facing the Issues. 4 Am. J.

Managed Care SP188. SP190 (1998) (“Studies do not nec-

essarily have to be randomized or have a control popula-

tion, although the FDA encourages controlled clinical in-

vestigations. In practice, most new device evaluations are

neither randomized nor controlled studies.”). Whereas

the safety of new drugs must be demonstrated by at least

two controlled clinical trials. device manufacturers need

submit only a single clinical study, and controls are not

mandatory. See Michael D. Green & William B. Shultz.

Tort Law Deference to FDA Regulation of Medical Devices.

88 Geo. L.J. 2119. 2136 (2000): see also Devo, 17 J. Am.

Board Fam. Prac. at 144 (recognizing that the FDA's ap-

proach to approving medical devices is “less stringent”

than that applied to new drug approvals).

Further, that limited clinical testing can be unreliable.

As two former editors-in-chief of the New England Jour-

nal of Medicine have observed, “companies now often in-

sist on controlling how the research is done and reported,

and whether the results will even be published at all,”

under “financial arrangements with academic medical

centers and their faculties ... that threaten the objectiv-

itv and credibility of clinical research.” Marcia Angell &

Arnold S. Relman, Op-Ed. Prescription for Profit, Wash.

Post, June 20, 2001, at A27. The FDA has no authority to

conduct or commission independent investigations into

device safety and must typically rely on study results pro-

vided in the manufacturer's application.

Second, a PMA application discloses nothing more than

the device design, manufacture, and labeling that the

manufacturer chooses to submit for approval. See 21

U.S.C. § 360e(c)(1). Thus, the manufacturer is not re-

quired to submit information about development of the

device, including any alternative designs. manufacturing

methods, and labeling possibilities that the manufacturer

considered, but rejected. Nor does the FDA have the

authority to subpoena these and other records from the

manufacturer, and, “therefore, in most instances cannot

compel the disclosure of information about product risks.”

Schwartz, 61 Tenn. L. Rev. at 1386.

2. The PMA process applies a generic safety standard:

it does not impose device specific safety requirements

demanding particular design, manufacture, or labeling.

The FDA merely evaluates whether the manufacturer has

provided a “reasonable assurance’ that its device meets

the general safety standard applicable to all medical

devices. See 21 U.S.C. § 360e(c)(3).

When the FDA determines that a manufacturer has

submitted a complete PMA application according to the

application criteria, it evaluates the application to deter-

mine whether the device maker has made “a showing of

reasonable assurance” that the device is safe and effec-

tive. Id. § 360e(d)(2)(A), (B). The factors to which the

FDA looks in determining safety apply generally to all

Class III devices, as well as to the classification decision

for any type of medical devices and to the establishment

of performance standards for any Class II device. See 21

C.F.R. § 860.7. Some consider this generic review to be

rigorous because manufacturers devote considerable time

to preparing an application and because the FDA takes

months to review the application for compliance. But, as

the government once argued to this Court, time is no sub-

stitute for specificity: the FDA does “not set out specific

requirements for the particular device” and, instead, “the

manufacturer may select any design, manufacturing, and

labeling features that will satisfy the general minimum

standards in the Act and regulations.” U.S. Amicus Br. at

16, Smiths Indus. Med. Sys., Inc. v. Kernats, No. 96-1405,

cert. denied, 522 U.S. 1044 (1998).4

* For more than 25 vears after the MDA’s enactment. the govern-

ment opposed PMA preemption. as it did in Aernats. As the FDA's

former Chief Counsel explained. “|s]ince the passage of the |[MDA\, it

has been the agency's position that the scope of preemption under sec-

tion 521 should be interpreted narrowly. with a presumption against

preemption. and that “preemption is limited to instances where there

are specific FDA requirements applicable to a particular device or class

of devices.” Margaret Jane Porter, The Lohr Decision: FDA Perspective

and Position, 52 Food & Drug LJ. 7. 7 (1997) (emphasis added).

Beginning in 2001. the government reversed course and advocated

for preemption in the lower courts. See. e.g.. US. Amicus Br.. Horn «

Thoratec Corp... 376 F.5d 163 (3d Cir, 2001) (No. 02-4597). Because

preemption analysis turns on congressional mtent. it is unpersuasive

for the current Admimistration to purport to have engaged in a 1s)-

degree reassessment of congressional intent after a quarter-century of

settled administrative practice. Cf, Bates t. Dow AgroSciences LLC.

S44 US. BBL, 449 (2005) tealling “particularly dubious” the assertion

that the Federal Insecticide. Fungicide. and Rodentiaide Act (FIFRA)

contamed a “nonambiguous command to pre-empt [certain) tort claims”

where the United States had argued to the contrary five vears carher).

see also Oral Arg. Tr. Bates i. Dow AgroSciences LLC. No. 03-38%.

2005 WL 148903. at *37-*39 Glan. 10, 2005).

Instead of specific requirements, there is a presumption

in favor of approval unless the FDA finds that a specifi-

cally enumerated cause for denial applies. See 21 C.F.R.

§ 814.44(d)(1) (FDA will issue to the applicant an order

approving a PMA if none of the reasons in § 814.45 for

denying approval to the application applies.”). If a PMA

application meets the generally applicable level of safety

and efficacy. the FDA is required by law to approve it—

even if there are safer devices on the market and the FDA

knows the device's safety is suboptimal. Indeed. the FDA

did not deny any original PMA application during fiscal

years 1993 through 2008, the last year for which annual

reporting is available. A majority of the original PMA

applications—including Medtronic’s Evergreen Balloon

Catheter—received the FDA’s generic approval letter.°

When an application “substantially’—but not fully—

meets the PMA requirements, the FDA issues an “ap-

provable letter.” 21 C.F.R. § 814.44(e). The approvable

letter informs the manufacturer that its PMA application

can be approved upon the submission of missing infor-

mation, an inspection of its manufacturing facilities, a

restriction on the sale or distribution of the device (.e..

requiring distribution by licensed professionals). or an

agreement to postapproval duties that typically involve

continued testing, reporting. and recordkeeping. See id.:

see also id. § 814.82." An approvable letter imposes no

> The FDA last denied an original PMA application in 1992. when it

issued four denials. From 1992 through 2005. the FDA made 889 over-

all “approval decisions’—ineluding 507 approvals. 248 approvable let-

ters. 130 not approvable letters. and the 4 denials in 1992. See Office

of Device Evaluation. Annual Report Fiscal Year 2005, at 36: Office

of Device Evaluation. Annual Report Fiscal Year 2004, at i1: Office

of Device Evaluation. Annual Report Fiscal Year 2000. at 35: Office

of Device Evaluation. Annual Report Fiscal Year 1996, at 17. (Office

of Device Evaluation Annual Reports are available at http://www

tda gov/cdrh/ode/odeannualreports.ht ml)

facturing. or labeling requirements (aside from requiring the promi.

nent display of the manufacturer s proposed warning). the court below

Was Wrong to assert that an “approvable letter” enables the FDA “to

device-specific requirements, however, and merely pro-

vides a means to facilitate approval where a substantially

complete PMA application falls just shy of the minimum

requirements for approval. It is a tool intended to avoid

cycles of denial and resubmission; a manufacturer is free

to decline the approvable letter’s information requests or

postapproval conditions and to resubmit an entirely new

PMA application. See id. § 814.44(e)(2)(ii), (im). Alterna-

tively, where the FDA believes that an enumerated

ground for denial may keep an application from being

approved, it may issue a “not approvable” letter that

describes the deficiency and provides the opportunity to

amend the PMA application. See id. § 814.44(f).

Regardless of the precise path a device takes to pre-

market approval, the device will never need to meet a

device-specific requirement. The manufacturer always

has the freedom to choose any design, manufacturing

method, or labeling, so long as it meets the generic mini-

mum safety standard. Thus, in this case, the FDA “did

not ‘require’ Medtronic’'s [catheter] to take any particular

form for any particular reason.” Lohr, 518 U.S. at 493.

3. The FDA conducts the PMA process with minimal

resources and suffers from conflicts of interest. The FDA

receives limited funding from Congress and depends

increasingly on both industry funding and advisory panel

members with financial and professional interests in the

require the device to take a particular form in order to be approved as

sate and effective.” Pet. App. 26a. In any event. the FDA did not issue

an approvable letter in this case. See id. at 27a. Moreover, the court

below conflated the limited “conditions of approval” that are included

in an approvable letter with the FDA's power to condition PMA on a

manufacturer meeting device-specitic performance standards promul-

gated through notwe-and-comment rulemaking (see 21 C_FLR. §§ 861.1.

861.20). See Pet. App. 26a-28a. No device-specific performance stan-

dards applied to Medtroniw’s Evergreen Balloon Catheter. and thus its

PMA was not conditioned on meeting such a standard. The court

below wrongly suggested that the mere authority to issue device-

specific performance standards after notice-and-comment rulemaking

preempts state tort law even where no such performance standards

have been promulgated. See id. at 27a-28a.

device industry. As Judge Pooler recognized in dissent

below, “the FDA may not have adequate resources to

genuinely ensure that devices are safe or to properly

and effectively reevaluate approvals as new information

becomes available.” Pet. App. 48a. The FDA is under

enormous pressure and, as Dr. David Feigal, the former

head of the FDA’s Center for Devices and Radiological

Health, has admitted, “|the FDA has] to make choices

about which things to work on because of shrinking

resources.” Robert J. Cohen & Scott Orr. Often the

Patient Is the Last to Know, Star-Ledger (Newark, N.J.),

Aug. 11. 2002, at 1. Congress nonetheless has reinforced

its intent that the FDA license devices as quickly as pos-

sible, stating in the Food and Drug Administration Mod-

ernization Act of 1997, Pub. L. No. 105-114, 111 Stat.

2296, that the FDA should approve or deny a PMA appli-

cation “[a]s promptly as possible,” generally no later than

“one hundred and eighty days after the receipt of an

application.” 21 U.S.C. § 360e(d)(1)(A).

Because the FDA has limited resources from congres-

sional appropriations, it is perhaps unsurprising that the

agency turns to individuals with interests in the regulated

industry and, more recently. to industry financing of the

regulatory process to fill the gaps in its drug and device-

approval processes. In a recent survey, FDA scientists

“reported significant interference with the FDA‘s scientific

work.” Union of Concerned Scientists. Voices of Scientists

at FDA: Protecting Public Heath Depends on Independent

Science at 1 (2006), available at http://www.ucsusa.

org/scientific integritv/interference/fda-scientists-survey-

summarv.html. Sixty percent of the scientists surveved

knew of cases where commercial interests inappropriately

influenced FDA approvals or other decisions. See id.

at 2. One-fifth reported being “asked explicitly by FDA

decision makers to provide incomplete. inaccurate or

misleading information to the public. regulated industry.

media. or elected/senior government officials.” /d.

The FDA's use of panels of “outside scientists” to advise

the agency on whether to approve new medical devices

and drugs is especially plagued by conflicts of interest. A

recent study of drug advisory committees found that

almost one-third of the scientists on these panels “had

financial interests greater than $50,000" in the company

whose products they were responsible for evaluating.

Jonathan D. Rockoff, FDA Seeks to Limit Conflicts of In-

terest; Rules Would Restrict Outside Advisors with Indus-

try Ties, Baltimore Sun, Mar. 22. 2007, at 1A. For more

than one-fifth of these panels, a majority of the scientists

reportedly had a conflict of interest. See Peter Lurie et

al., Financial Conflict of Interest Disclosure and Voting

Patterns at Food and Drug Administration Drug Advisory

Committee Meetings, 295 J. Am. Med. Ass'n 1921, 1924

(2006). On nearly three-quarters of the panels, at least

one of the scientists was reported to have a conflict of in-

terest. See id. A scientist who has served on FDA panels

reported that those with conflicts of interest sometimes

influence the panel’s advice, remarking “they can be very

persuasive.” Rockoff, FDA Seeks to Limit Conflicts of

Interest (internal quotation marks omitted).

The recent enactment of “user fees,” through which the

regulated industry now funds a significant portion of the

regulatory process, has only exacerbated these conflicts of

interest. See Medical Device User Fee and Modernization

Act of 2002, Pub. L. No. 107-250, § 102, 116 Stat. 1588,

1589 (codified at 21 U.S.C. § 379i). Critics argue that

the user fees create an obvious conflict of interest.

So much of the FDA budget now comes from the in-

dustry it regulates that the agency must be careful

not to alienate its corporate “sponsors.” FDA offi-

cials believe they remain careful but concede that

user fees have imposed pressures that make review

more difficult|.]

Deyo, 17 J. Am. Board Fam. Prac. at 146 (footnote omit-

ted). In permitting the regulated industry to exercise

such influence over PMA decisions, Congress could not

have intended the FDA to act as the final arbiter of device

safety. foreclosing recovery by consumers subsequently

injured by that industry's defective medical devices.

B. Premarket Approval Provides Negligible Con-

tinuing Oversight And Permits Design, Manu-

facture, And Label Changes With Either Ex-

pedited FDA Review Or No Review At All

1. Congress intended premarket approval to be a one-

time licensing scheme, and therefore provided the FDA

with little authority to monitor and regulate devices that

have received PMA. Today, the FDA’s postmarket moni-

toring programs are deeply flawed and rely almost exclu-

sively on a self-reporting honor system among manufac-

turers. As the leading industry group has stated, device

manufacture is “a continuous, iterative process,” where

“actual use of devices by practitioners in the clinical set-

ting typically spurs additional refinements and improve-

ments.” Elizabeth D. Jacobson, AdvaMed’s Written Tes-

timony on The Critical Path White Paper at Science Board

to the Food and Drug Adménistration 3 (Apr. 22, 2004).

But, once a device is approved for marketing, the FDA ex-

ercises minimal oversight.

The near-total lack of post-PMA device regulation pro-

vided for by the original MDA demonstrates that Con-

gress did not establish a comprehensive. continuous re-

view process for Class IIIT medical devices. Under the

original MDA, which included the preemption provision at

issue here, “device manufacturers [were] not required to

notify FDA when they [became] aware of a death, injury.

or hazard caused by a medical device. Statement of

Franklin A. Curtis. Associate Director. Human Resources

Division, United States General Accounting Office, Before

the House Committee on Energy and Commerce. Sub-

committee on Health and the Environment, on the

Federal Regulation of Medical Devices. 98th Cong., at 5

(Feb. 24. 1984). available at http://archive.gao.gov/

d40t12/123484.pdf. A report to Congress indicated that.

while “|t]he effectiveness of FDA's regulation of medical

devices depends largely on the quality of its information.”

once devices received approval there were “major deficien-

cies that hinder the development of a useful medical de-

vice database” to monitor for dangerous product defects.

General Accounting Office, Comptroller General's Report

to Congress; Federal Regulation of Medical Devices: Prob-

lems Still To Be Overcome at 11 (GAO/HRD-85-53, 1983).

Nor do the modest improvements to the FDA's post-

market surveillance provide sufficient protection for con-

sumers.‘ Current postmarket surveillance relies, almost

entirely, on an honor system under which manufacturers

are expected to forward defect and injury reports to the

FDA. The FDA has admitted that the “passive nature of

these systems” results in “severe underreporting.” Center

for Devices and Radiological Health, Ensuring the Safety

of Marxeted Medical Devices 22 (2006). available at

http://www.fda.gov/cdrh/postmarket/mdpi-report. pdf.

When adverse events are reported, there are “no specific

rules” requiring further investigation, and “judgments

about appropriate FDA responses have a considerable

subjective component.” Safe Medical Devices for Children

at 125. Resource constraints “limit the agency’s ability to

investigate [adverse-event| reports that do not involve

deaths and other high-profile events.” /d. at 125-26.

Manufacturers may report information in annual reports

that are limited to a “summary and bibliography” of

— —— — --——————

* Amendments to the MDA, which incorporate limited postmarket

survetllance, indicate further congressional recognition that PMA pro-

vides only a screening function. As the Institute of Medicine reported:

The statutory provisions for postmarket studies reflect Congres:

sional awareness that the data and assessments associated with

the approval or clearance of a complex medical device may leave

meaningtul unanswered questions about uncommon adverse

events, effects in groups not studied ... and long-term ettects

To the extent that FDA encourages and accepts smaller. faster.

and otherwise more limited studies to promote earher consid:

eration of a device for approval and reduce burdens on sponsors.

more questions may remain for the postmarket period,

Institute of Medicine. Sufe Medical Devices for Children 184 (Marilyn

J. Field & Hugh Tilson eds... 2005).

information not included in the PMA application. 21

C.F.R. § 814.84(b)(2). Even where manufacturers must

provide postmarket data pursuant to their PMA approval,

the Institute of Medicine discovered a “disappointing

picture of the agency's performance in monitoring study

commitments for medical devices.” Safe Medical Devices

for Children at 192.

Even after discovering that a device for which it pro-

vided premarket approval is defective, the FDA has few

tools at its disposal. Nearly all device recalls are volun-

tarily undertaken and directed by the manufacturer,

rather than by the FDA.“ Nor can the FDA order the re-

call of all PMA devices that no longer meet the threshold

standards of safety and efficacy: it can do so only when it

finds there is a reasonable probability that the device

would cause “serious. adverse health consequences or

death.” 21 C.F.R. § 810.10(a). Even that limited author-

ity is exercised rarely.

2. The FDA also has limited authority to regulate de-

sign, manufacturing, and labeling changes to a device af-

ter it receives premarket approval. First. a manufacturer

can make any change after premarket approval without

further FDA review if that change. in the manufacturers

judgment, does not “affect|] safety or effectiveness.” 21

U.S.C. § 360e(d)(6)(A)G). FDA regulations explain that

“the burden of determining whether a |PMA] supplement

is required is primarily on the PMA holder” 21 C.F.R.

§ 814.39(a).

Second, after premarket approval, the device maker can

make manufacturing changes to a device with minimal

FDA oversight. It need only give notice to the FDA that

describes the change. “summarizes” any supporting data

or other information, and informs the FDA that the

manufacturer is adhering to good manufacturing prac-

tices. See 2] U.S.C. § 3600e(d)(6)CA)01). Unless the FDA

~ See FDA. Learn About Medical Device Recalls. http:/www.tda.gow

edrh/recallslearn htm] (last visited Aug. 23. 2007).

objects, within 30 days of the notice, no FDA approval is

needed for the manufacturing change to the device.

Finally, even for device changes, which require FDA

approval when the manufacturer admits the change af-

fects safety or effectiveness, the FDA provides a stream-

lined version of the original PMA process called a supple-

mental PMA. See id. § 360e(d)(6)(A)(i): see also 21 C.F.R.

§ 814.39(c) (“the information required in [a supplemental

PMA application] is limited to that needed to support the

change”). Certain labeling changes or changes to “quality

controls or manufacturing process” can be implemented

while a PMA supplemental application is still pending, so

long as the manufacturer believes the changes enhance

safetv. 21 C.F.R. § 814.39(d). The FDA reviews a sup-

plemental PMA application—like that submitted and ap-

proved for the Evergreen Balloon Catheter, see Pet. App.

3a-4a—in approximately 60 percent less time than it de-

votes to an original PMA. See Center for Devices and

Radiological Health, Office of Device Evaluation and

Office of InVitro Diagnostic Device Evaluation and Safety

Annual Report (2003), available at http://www.fda.gov/

cdrh/annual/fy2003/ode/2003. pdf.

The availability of multiple methods through which

device manufacturers can update and redesign products,

manufacturing methods, and device labeling forecloses a

claim that PMA approval imposes any requirement upon

the device. Cf. Bates, 544 U.S. at 451 (‘Unlike the ciga-

rette labeling law at issue in Cipollone [v. Liggett Group,

Inc., 505 U.S. 504 (1992)], which prescribed certain immu-

table warning statements, FIFRA contemplates that pes-

ticide labels will evolve over time. as manufacturers gain

more information about their products’ performance in

diverse settings.’). The MDA provides ample opportunt-

ties for device makers to adopt different designs, manu-

facturing methods, and labeling, with hmited and stream-

lined regulatory oversight. PMA approval imposes no

immutable requirements upon a device manufacturer.

Il. THE TORT SYSTEM PROVIDES REMEDIES

AND INCENTIVES NECESSARY TO _ PRO-

TECT THE PUBLIC AND TO COMPENSATE

PATIENTS INJURED BY DEFECTIVE MEDI-

CAL DEVICES THAT RECEIVED PREMARKET

APPROVAL

Unlike the constrained premarket approval process, the

state tort system protects consumers from dangerous

medical devices. Through litigation, the public gains

information about dangerous devices and wider problems

within the medical device industry and with the FDA’s

regulatory regime. Furthermore. unlike the FDA. litiga-

tion compensates those who are injured by defective

medical devices. Recent cases involving products that

obtained premarket approval, such as defibrillators. heart

valves, and hip implants, have highlighted defects that

seriously injured consumers and demonstrated the value

of litigation in informing the public and compensating

victims.

A. By Uncovering Information About Defective

Medical Devices, Litigation Spurs Improve-

ments In The Medical Device Industry And

The FDA

1. As this Court recognized in Bates. “tort suits can

serve as a catalyst’ to improve industry and federal regu-

latory practices, by “‘aid{ing] in the exposure of new dan-

gers” and addressing their consequences. 544 U.S. at 451

(quoting Ferebee v. Chevron Chem. Co., 736 F.2d 14529.

1541-42 (D.C. Cir. 1984)). When “devices that do more

harm than good ... reach consumers.” litigation can “help

uncover previously unavailable data on adverse effects.

questionable practices by manufacturers, and flaws in...

regulatory svstems. David C. Vladeck. Preemption and

Regulatory Failure, 33 Pepp. L. Rev. 95. 122. 129 (2005):

Aaron 3S. Kesselheim & Jerry Avorn. The Role of Litiga-

tion in Defining Drug Risks. 297 J. Am. Med. Ass'n 308.

308 (2007). Thus. by “dropping inflated information costs

and sparking public understanding and debate.” litigation

“jump-starts the market and political process,” leading to

better regulatory oversight and improved compliance with

regulations. Wendy Wagner, When All Else Fails: Regu-

lating Risky Products Through Tort Litigation, 95 Geo.

L.J. 693, 710 (2007).

In line with this Nation’s long tradition of favoring

“private law enforcement” over bureaucratic regulation,

litigants have broad powers to obtain information from

device manufacturers, while, by statute, the FDA has

relatively few discovery tools, obtaining principally what

manufacturers choose to reveal (see supra Part IA). See,

e.g., Paul D. Carrington, Recent Efforts to Change Discov-

ery Rules: Advice for Draftsmen of Rules for State Courts,

9 Kan. J.L. & Pub. Pol’y 456, 457-58 (2000) (“Private liti-

gants in America thus do, and do more effectively, much

of what is in other industrial states done by .. . an admin-

istrative bureaucracy.”). Unlike the FDA, “litigants can

demand all documents and information that halve] bear-

ing on a product's health risks,” creating a much “more

complete picture of the manufacturers’ information on

product risks than narrowly drafted self-reporting re-

quirements do.” Wagner, 95 Geo. L.J. at 700. These

broad discovery and document production powers give

litigation a “singular role ... in educating the public

about unscrupulous and socially dangerous business prac-

tices detrimental to the public health.” Robert L. Rabin,

Keynote Paper: Reassessing Regulatory Compliance, 88

Geo. L.J. 2049, 2068 (2000). By “identifying and substan-

tiating problems” with particular medical devices, litiga-

tion alerts the public to potential dangers. Catherine T.

Struve. The FDA and the Tort System: Postmarketing

Survetllance, Compensation, and the Role of Litigation, 5

Yale J. Health Pol'y, L. & Ethics 587, 606 (2005).

The public is also “substantially dependent on the tort

system” to uncover problems within the medical device

industry as a whole and with the FDA itself. Rabin, 88

Geo. L.J. at 2069. In addition to highlighting problematic

industry behavior. litigation has “helped identify regu-

latory policies that can keep unsafe [products] on the

market” and has “exposed important limitations in the.

FDA information collection and dissemination proce-

dures.” Kesselheim & Avorn, 297 J. Am. Med. Ass'n at

310. For instance, the Guidant defibrillator litigation ex-

posed the deficiencies in disclosure practices in the heart

device industry, and the Sulzer hip implant litigation re-

vealed that the FDA was failing to inspect medical device

factories as frequently as the MDA requires. See Jn re

Guidant Corp. Implantable Defibrillators Prod. Liab.

Litig., MDL No. 05-1708 (DWF/AJB), Civil No. 06-25

(DWE/AJB), 2007 WL 1725289 (D. Minn. June 12. 2007);

In re Sulzer Hip Prosthesis & Knee Prosthesis Liab. Litig.,

455 F. Supp. 2d 709, 712 (N.D. Ohio 2006).

By publicizing such problems, litigation spurs the

“industry to improve safety, the FDA to implement more

stringent controls, individuals to improve health habits,

and health care providers to improve communications

with patients.” Elizabeth A. Weeks, Bevond Compensa-

tion: Using Torts to Promote Public Health, 10 J. Health

Care L. & Pol'y 27. 48 (2007). Just as the Dalkon Shield

litigation spurred the enactment of the MDA itself. recent

litigation involving defective medical devices with pre-

market approval has led the medical device industry to

improve its disclosure practices and safety standards, and

has drawn public attention to constraints on the FDA's

effectiveness. See Kesselheim & Avorn. 297 J. Am. Med.

Ass'n at 310 (crediting the tort system with “spurring

change in regulatory {and] corporate procedures, as well

as extending knowledge about ... risks by adding to the

evidence available for evaluation by physicians, patients.

and regulators ): see also Wagner. 95 Geo. L.J. at 705.

In addition to alerting the public to these dangerous de-

vices. litigation deters misconduct by manufacturers and

encourages compliance with FDA standards. The FDA's

limited ability to monitor products on the market some-

times tempts manufacturers to forgo monitoring their

own products or to hide problems when they discover

them. See, e.g.. In re Guidant, 2007 WL 1725289: In

re Medtronic, Inc. Implantable Defibrillators Litig.. 465

F. Supp. 2d 886, 889 (D. Minn. 2006). As this Court rec-

ognized in Bates, “(t]he long history of tort litigation ...

emphasizes the importance of providing an incentive to

manufacturers to use the utmost care in the business of

distributing inherently dangerous items.” 544 U.S. at

449-50. Because “failure to comply with FDA regulations

can be very damaging to the liability case of a defendant,”

the threat of “liability considerably strengthens company

incentives to comply with FDA regulations,” thereby “con-

fer{ring] substantial safety benefits” on the public. Steven

Garber, Product Liability and the Economics of Pharma-

ceuticals and Medical Devices 125 (1993); see also Bates,

544 U.S. at 451 (“|pjrivate remedies that enforce federal

. requirements would seem to aid, rather than hinder,

the functioning” of federal regulations).

Removing this incentive would ivrationally reward mis-

conduct by immunizing device manufacturers from tort

suits when they gained or kept their premarket approval

by withholding information about defects from the FDA.

See, e.g., In re St. Jude Med., Inc. Silzone Heart Valves

Prod. Liab. Litig., No. MDL 01-1397 JRTFLN, 2004 WL

455038, at *11 n.4 (D. Minn. Jan. 5, 2004) (immunizing

manufacturers that “wrongfully withhold data from the

FDA ... cannot be what Congress had in mind when it

enacted the MDA because, in its judgment, medical device

manufacturers needed to be more strictly regulated”):

Lohr, 518 U.S. at 487 (Stevens, J.. plurality) (removing

tort liability would have the “perverse effect of granting

complete immunity from design defect liability to an en-

tire industry that, in the judgment of Congress. needed

more stringent regulation in order ‘to provide for the

safetv and effectiveness of medical devices intended for

human use’™) (quoting 90 Stat. 539 (preamble to MDA)).

Even when manufacturers comply with FDA regula-

tions and act swiftly to address problems, defective medi-

cal devices can still seriously injure patients, who depend

on the tort system to provide them with information about

the risks thev face and compensation for the harms they

suffer. See, e.g.. Robert Cohen & J. Scott Orr. A Glitch

Can Kill, But Pacemaker Users Will Take That Chance,

Star-Ledger (Newark, N.J.), Aug. 12, 2002, at 7 (describ-

ing how a defect in Telectronics’ pacemaker led to at least

18 deaths, 30 injuries, and thousands of replacement sur-

geries despite the company’s swift and thorough response

to the problem): Price Colman, Telectronics Defends Ef-

forts With Defective Wire, Rocky Mountain News, Mar. 17,

1995, at 49A.

2. The Guidant defibrillator litigation demonstrates

how litigation can reveal problems and encourage im-

provements in the medical device industry. Guidant. a

major medical device manufacturer, obtained premarket

approval for what turned out to be a seriously defective

heart device. In 2000, the FDA granted premarket ap-

proval to Guidant’s Prizm 2 defibrillator, a device meant

to restore regular heart rhythms by delivering shocks

when needed. See Ben Harder, Heart Device Recall: For

Patients with Suspect Models, Tough Choices, Wash. Post,

June 28, 2005, at Fl. In 2002. Guidant discovered that

the device had two design flaws—an ineffective insulating

material and inadequate wire spacing—that gave it a

tendency to short-circuit and fail. See In re Guidant, 2007

WL 1725289. at *2. Rather than instituting a recall.

Guidant designed its newer models to address the prob-

lem, without informing the FDA. See id. Meanwhile, it

continued to sell the older models, which it knew to be

flawed, “after it had fixed the problem in newer versions.”

Barry Meier. F.D.A. Expanding Inquiry into Heart-Device

Company. N.Y. Times. Aug. 25, 2005, at C3.

Guidant successfully hid its knowledge of the defect for

three vears. Not until 2005. when a defective Guidant

defibrillator caused the highly publicized death of a col-

lege student. did Guidant inform physicians and the FDA

of the design flaw. The defect was responsible for at least

six other deaths. See Jn re Guidant, 2007 WL 1725289. at

*3: Wilham H. Maisel. Safety Issues Involving Medical

Devices; Implications of Recent Implantable Cardioverter-

Defibrillator Malfunctions, 294 J. Am. Med. Assn 955,

955 (2005). A month after the publicity began, Guidant

met with the FDA and agreed to a recall. But, by that

point, the faulty devices had been implanted in about

24.000 people. See In re Guidant, 2007 WL 1725289, at

*3: Jon Kamp, Guidant Discloses Lawsuit Tally, Says

Many More Possible, Market Watch, Feb. 22, 2006; Marc

Kaufman, More Heart Devices Malfunction; As Sophis-

tication Has Grown, So Have Failures, FDA Reports,

Wash. Post, Sept. 17, 2005, at A7. During litigation over

Guidant’s conduct, documents revealed that company ex-

ecutives had debated warning the public about the defects

earlier and had even drafted a warning letter to doctors.

But the letter was not sent, and the company allowed doc-

tors to continue implanting patients with FDA-approved

devices it knew to be dangerously flawed. See Mark

Jewell, Guidant’s Warning Letter on Defibrillators Never

Sent, Assoc. Press, Aug. 6, 2006; Barry Meier, Inquiry

Arranged by Guidant May Aid Lawsuits and Critics, N.Y.

Times, Mar. 22, 2006, at C4; Barry Meier, Guidant De-

bated Device Peril, N.Y. Times, Jan. 20, 2006, at C1.

Litigation brought Guidant’s misconduct to the public’s

attention and encouraged improved disclosure of problems

in the heart-device industry. Under pressure from the

litigation, Guidant appointed an outside panel of doctors

to review its disclosure practices. The panel concluded

that “engineers ... were deciding medical issues without

hearing from doctors” and that Guidant failed to provide

doctors “with detailed data on defibrillator failure.” so

that the information “had never been communicated to

patients.” Meier, /nquiry Arranged by Guidant.

These revelations led physicians and patients’ groups to

call for reforms to the medical device industry. including

“greater transparency in post-market surveillance.” better

“analvsis and reporting of device performance and mal-

function information.” and more cooperation between doc-

tors, the FDA, and device manufacturers. Mark Carlson

et al.. Recommendations from the Heart Rhythm Society

Task Force on Device Performance Policies and Guidelines

1251 (2006). The criticisms led two other major heart

device manufacturers. Medtronic and St. Jude. as well as

Guidant, to “heighten their scrutiny of device safety and

reliability” by directly notifying patients of problems and

allowing greater outside review of company safety data.

Barry Meier, Heart Device Makers Plan Enhanced Safety

Reviews, N.Y. Times, May 16, 2006, at C3. The Guidant

litigation also spurred physicians to create an online

database tracking defibrillator problems, so that they

would no longer have to rely solely on information from

device manufacturers, and patients would be able “to

check on the safety and performance records” of their

heart devices. Jeff Swiatek, Doctors Seek Device-Flaw

Database; Guidant’s Belated Revelation of Defect in its

Prizm 2 Defibrillator Spurs Call for Changes, Indianapo-

lis Star, May 31, 2005, at 1A.

3. The Silzone heart valve litigation shows how litiga-

tion can identify dangerously defective products that have

received premarket approval and encourage the manufac-

turer to address the problem quickly, protecting patients.

The Silzone heart valve gained premarket approval

despite little proof of its safety or effectiveness. Artificial

heart valves are implanted to replace patients’ damaged

or diseased valves. St. Jude developed the Silzone heart

valve, featuring a silver coating, in the hope that silver’s

“anti-microbial properties” would help combat infections.

In re St. Jude, 2004 WL 45503, at *1. The FDA gave the

Silzone valve supplemental premarket approval in 1998,

even though the silver-coated valve had not undergone

clinical trials and had been tested in only “a small study

of sheep and an ‘observational study’ of 20 patients for

two months.” Cohen & Orr. Often the Patient Is the Last

to Know.

When the device proved to be dangerously defective, the

prospect of litigation eventually encouraged the company

to remove the product from the market. while the FDA

took little action. After St. Jude began selling the Silzone

valves to patients. clinical tests revealed that the silver

coating not only did not prevent infections. but also

caused the valves to leak. See id.: In re St. Jude. 2004

WL 45503, at *1. According to St. Jude. the company

“followed all the [FDA's] rules and procedures, and. . .

fully informed the FDA of [its] analysis.” Cohen & Orr,

Often the Patient Is the Last to Know (internal quotation

marks omitted). The then-head of the FDA's Center for

Devices and Radiological Health agreed that the Silzone

valve was “one of those {problems] you just don't detect

until you have a larger experience.” Z/d. (internal quota-

tion marks omitted). Nonetheless, the defect was likely

responsible for at least one death, a woman who died of

heart failure a month after her third surgery, to replace

her second defective Silzone valve, “her heart never

having fully recovered from the strain of the three opera-

tions.” Jd. And at least 36,000 defective Silzone valves

had been implanted in patients before St. Jude, in the

face of lawsuits, issued a voluntary recall. See id. In re-

sponse to St. Jude’s voluntary recall, the FDA, which had

taken no previous action, “informed St. Jude that its ac-

tions would be classified as a ‘recall’” and that it consid-

ered the valves to be “defective.” Jn re St. Jude, 2004 WL

45503, at *2.

4. Finally, the Medtronic defibrillator litigation demon-

strates that. when device manufacturers obtain pre-

market approval by conccaling information from the FDA,

litigation helps reveal and punish their misconduct, en-

couraging increased compliance with FDA standards. In

2000, Medtronic redesigned the battery for its defibrilla-

tors and received supplemental premarket approval from

the FDA for the changes. See In re Medtronic, 465 F.

Supp. 2d at 889. Early in 2003, Medtronic discovered that

the battery had a defect, which sometimes caused it to

short-circuit. See id. When a battery short-circuited, it

would deplete “within a few hours to a few days, after

which there is a complete loss of device function.” /d. at

890. Instead of informing doctors, patients, or the FDA of

this defect. Medtronic began redesigning the battery.

meanwhile obtaining FDA premarket approval for three

additional defibrillator models containing the battery

Medtronic knew to be defective. See id. at 889.

Several months after it discovered the defect, Medtronic

received supplemental premarket approval for design

changes to the defective battery, finally informing the

FDA that the older model was prone to short-circuit.

See id. But neither the FDA nor Medtronic instituted

a recall of the faulty models or informed patients or physi-

cians of the problem. and Medtronic continued to sell

defibrillator models with the defective battery. See id.

at 889-90. As evidence mounted that batteries in

patients’ defibrillators had failed, raising the threat of

lawsuits, Medtronic finally warned doctors about the

defect—more than two years after the company had dis-

covered it. See id. at 890. Medtronic then initiated

a recall of more than 100,000 defective defibrillators.

See FDA, Enforcement Report, http://www.fda.gov/bbs/

topics/enforce/2005/ENF00891.htm! (Mar. 16, 2005).

B. Litigation Compensates Victims Of Defective

Medical Devices

1. A critical function of litigation is to make whole the

victims of others’ misconduct. See Mark Geistfeld, Negli-

gence, Compensation, and the Coherence of Tort Law, 91

Geo. LJ. 585, 597-602 (2003). As this Court noted in

Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), state

tort actions, “unlike most administrative and legislative

regulations{.] necessarily perform an important remedial

role in compensating accident victims.” /d. at 64: see also

Cipollone, 505 U.S. at 537 (Blackmun, J., concurring in

the judgment in part and dissenting in part) (recognizing

that “tort law has an entirely separate function—

compensating victims—-that sets it apart from direct

forms of regulation”). When defective medical devices

reach the market. whether or not the manufacturer com-

plied with FDA regulations. patients are often seriously

injured, both physically and financially. Compensation

helps shield patients from the crushing financial burdens

caused by defective devices. Those injured by defective

devices are often left temporarily unable to work or to

enjov normal lives: some never fully recover. And. in

addition to suffering physical injury. pain. and anxiety.

patients often must undergo costly and dangerous surger-

ies to replace the defective devices, devices that them-

selves may be extremely expensive. See, e.g., J. Scott Orr

& Robert Cohen, Messy Plant Made Faulty Hip Joints;

Late Federal Inspections, Denial Blamed in Class-action

Lawsuit, Times-Picayune, Aug. 13, 2002, at 1.

Tort law provides the only relief for patients injured by

defective medical devices. The MDA contains no damages

remedy; it cannot and was not intended to eompensate

victims of defective medical devices.” Congress passed the

MDA to protect consumers from dangerous medical de-

vices. See Pub. L. No. 94-295, 90 Stat. 539 (preamble); see

also H.R. Conf. Rep. No. 94-1090, at 1 (1976), reprinted in

1976 U.S.C.C.A.N. 1103, 1103; Robert S. Adler & Richard

A. Mann, Preemption and Medical Devices: The Courts

Run Amok, 59 Mo. L. Rev. 895, 922 n.126 (1994). Con-

gress could not have intended the same law to strip all

remedies from consumers when that protection fails. See

Porter, 52 Food & Drug L.J. at 9 (“Given the harsh impli-

cations of foreclosing all judicial recourse for consumers

injured by defective devices, FDA does not believe that

Congress intended to effect so sweeping a change without

even a comment.”); see also Cipollone, 505 U.S. at 54!

(Blackmun, J., concurring in the judgment in part and

dissenting in part) (noting that “[t]he Court in the past

has hesitated to find pre-emption where federal law pro-

vides no comparable remedy”); Silkwood v. Kerr-McGee

Corp.. 464 U.S. 238, 251 (1984) (Congress would |not],

without comment. remove all means of judicial recourse

for those injured by illegal conduct”).

“The MDA has a limited provision, apparently never used. allowing

the FDA to compel refunds for detective devices that present “an un-

reasonable risk of substantial harm” and were not “properly designed

or manutactured with reference to the state of the art” 21 USC.

§ 360h(bx 1). This provision does not provide a substitute for compen-

satory damages. It would have allowed, for instance. relatives of a

woman who died of toxic shock syndrome caused by a detective Playtex

tampon to receive only the cost of the tampon. See OGilvie vc. Interna-

tional Playtex, Inc., 82) F.2d 1438 (10th Cir. 1987).

It is particularly implausible that Congress intended

to leave uncompensated patients injured by defective

devices that received premarket approval, because those

devices often present the greatest dangers. See 21 U.S.C.

§ 360c(a)(1)(C) (Class II] medical devices may present “a

potential unreasonable risk of illness or injury’). Instead

of creating a regulatory mechanism for compensating

victims of defective medical devices, Congress left this

important function to the traditional forum—the state

courts. See Rabin. 88 Geo. L.J. at 2068, 2076 (“[Rlegu-

latory agencies are not designed to do ‘double duty in the

sense that tort law does: that is, compensating as well as

creating incentives to safety.”).

2. The Sulzer hip and knee implant litigation demon-

strates the need for tort law to compensate patients whose

lives are disrupted by the misconduct of device manufac-

turers. Litigation compensated patients who were injured

by a serious manufacturing defect in Sulzer’s artificial

joints. including covering the cost of replacement surger-

ies and providing a fund for patients who had suffered

further damages.

Sulzers artificial hips and knees were designed to

replace diseased joints. increasing mobility and relieving

pain. Although the FDA granted the artificial joints pre-

market approval after an assertedly “rigorous review of

the design. manufacturing methods, quality control pro-

cedures, clinical investigations, and labeling and market-

ing of the medical device.” a manufacturing defect kept

the implants from bonding properly with patients bones.

In re Sulzer, 455 F. Supp. 2d at 712: Orr & Cohen, Messy

Plant Made Faulty Hip Joints. Sulzer admitted in deposi-

tions that the defect resulted from unsanitary conditions

in its factorv. Lubricants “leaked from machinery’ left a

residue on the artificial joints. which Sulzer failed to dis-

cover because it never tested the devices “for oil or other

contaminants. Orr & Cohen. Messy Plant Made Faulty

Hip Joints. The FDA had not recently inspected the fac-

torv. Although federal law requires it to inspect plants

every two vears. “the FDA admits that manufacturers’

plants are inspected by the agency only every five years.”

Id.

For six months, Sulzer hid its knowledge of the defect

from the FDA and the public. Doctors began reporting

these problems to Sulzer in June 2000. But, instead of

informing the FDA or instituting a recall, Sulzer assigned

“marketing and sales officials” to conduct an internal in-

vestigation. Concerned about diminishing the company’s

record sales of the defective products, the officials “tried to

foist blame for the failed components on others,” including

doctors and other manufacturers. /d.

In December 2000, Sulzer finally informed the FDA and

instituted a recall of approximately 40,000 defective hip

implants. By that point, “about 26,000 had already been

implanted in patients.” Jn re Sulzer Hip Prosthesis &

Knee Prosthesis Liab. Litig., 268 F. Supp. 2d 907, 911

(N.D. Ohio 2003). With the FDA overseeing the recall,

Sulzer “took some of the unimplanted recalled shells,

cleaned them to remove the problem residue and sent

them out to be implanted by orthopedists into patients.”

Victoria Colliver, Surgical Manufacturer Under Fire;

‘Recycled’ Hip Implants Spell More Suffering; Some

Defective Devices Replaced with Ones Previously Recuiled,

S.F. Chron., June 2, 2002, at A3. About 6,000 of these

reprocessed parts were implanted. See id. Soon, these

“reprocessed” implants also began to fail, particularly in

patients whose health had been compromised by previous

defective Sulzer implants. /d.

The defective hips caused symptoms. according to Sul-

zer, of “severe groin pain and inability to bear weight on

vour leg.” Jn re Sulzer. 268 F. Supp. 2d at 912. As one

patient described his experience with a defective Sulzer

hip implant, “it was pretty painful. After a while. I could

walk, but it still hurt. I'd walk maybe 10 or 15 steps, and

it'd catch. I'd almost go down—not quite, but close.” Orr

& Cohen. Messy Plant Made Faulty Hip Joints. Other

patients lost the abilitv to walk without crutches. See id.

Many needed further surgery to replace the defective

implants. Some, who received defective “reprocessed”

hips to replace their first defective implants, required

multiple surgeries; one woman needed five hip replace-

ment surgeries to replace defective Sulzer implants. To

their dismay, patients had no choice but to continue using

Sulzer components. because the replacements needed to

fit the rest of their artificial hips. See Five Implants

Later, Local Woman's Hip Still Not Right; She Says the

Defective Hip Implant Caused Complications that Linger,

Grand Rapid Press, Aug. 25, 2002, at C1; Orr & Cohen,

Messy Plant Made Faulty Hip Joints. Other patients,

“medically ineligible for revision surgery.” must live per-

manently with the pain their defective implants cause. Jn

re Sulzer, 268 F. Supp. 2d at 912.

Litigation provided compensation to patients who suf-

fered from Sulzer’s misconduct. A settlement provided

compensation for patients who were harmed by defective

Sulzer implants. including $206,000 for each surgery a

patient needed to replace a defective implant. and a $100

million fund for patients suffering extraordinary dam-

ages. See Five Implants Later. The litigation aiso con-

vinced the ¢ nmpany to change its manufacturing prac-

tices, including instituting “a new standard for cleanliness

of products before they are sent to market.” Orr & Cohen,

Messy Plant Made Faulty Hip Joints.

CONCLUSION

The court of appeals’ judgment should be reversed.

Respectfully submitted,