Amicus Curiae Brief — Riegel v. Medtronic, Inc.

IN THE

Supreme Court of the United States

CHARLES R. RIEGEL AND DONNA S. RIEGEL.

Petitioners,

v.

MEDTRONIC, INC.,

Respondent.

On Writ of Certiorari to the United States

Court of Appeals for the Second Circuit

BRIEF OF SENATOR EDWARD M. KENNEDY

AND REPRESENTATIVE HENRY A. WAXMAN,

AS AMICI CURIAE IN SUPPORT OF PETITIONERS

MICHAEL D. GREEN WILLIAM B. SCHULTZ

SCHOOL OF LAW Counsel of Record

WAKE FOREST UNIVERSITY LISA L. BARCLAY

BOX 7206 REYNOLDA SIN. ZUCKERMAN SPAEDER LLP

WINSTON-SALEM, NC 27106 1800 M STREET, NW

(336) 758-4842 WASHINGTON, DC 20036

(202) 778-1800

Attorneys for Amici Curiae

August 2007

| A RT I A IE LED

WiLSON-EPES PRINTING Co., INC. - (202) 789-0096 — WasHinGTON, D.C. 20002

TABLE OF CONTENTS

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HISTORY OF THE MEDICAL DEVICE AMENDMENTS

OF 1976 AND ITS PREEMPTION PROVISION. ...... 2

A. The Federal Food, Drug, and Cosmetic Act........... 2

B. The 1976 Medical Device Amendments. ............... 4

C. The MDA’s Preemption Provision. .................000++ 6

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ES TIER NAN TOT ET RT TE MORE OE ETO )

THE LANGUAGE OF THE MDA AND ITS

LEGISLATIVE HISTORY DEMONSTRATE THAT

~ CONGRESS DID NOT INTEND TO PREEMPT

STATE COMMON LAW TORT SUITS................0.. 2008 9

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TABLE OF AUTHORITIES

Page(s)

Cases:

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

ITE siciiecinsiissinitiicendiannidindadeaiaseanadeniiuiaiecnmubeniiiediats 10, 15, 19

Chisom v. Roemer, 501 U.S. 380 (1991) ........ cc eceeeeee eee ee 16

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

SESE aTaT siaciesitioceilinicnipecstpimaidbcitehindincindbabdeniiniistamniiiguans 7,9, 10, 18

Commissioner v. Lundy, 516 U.S. 235 (1996)..........0.0..20605 14

Edmondson v. International Playtex, Inc., 678 F. Supp.

eT itdcnincvadeddinnicdsdapidadbinumniomieain 17

English v. General Electric Co., 496 U.S. 72 (1990)............ 9

Gustafson v. Alloyd Co., Inc., 513 U.S. 561 (1995)............ 15

Ignace v. International Playtex, Inc., No. 86-C-480-C,

1987 WL 93996 (W.D. Wis. Aug. 14, 1987)............000. 16

Medtronic, Inc. v. Lohr, 518 U.S. 470

SU hci acapiiaalaie ii aa ate alah tabi ciinlal passim

Muzatko v. International Playtex, Inc..

No. 85-C-1540. 1987 U.S. Dist. LEXIS

14281 (E.D. Wis. May 14, 1987) 00... cette eens 17

Palmer v. Liggett Group, Inc., 633 F. Supp. 1171

I a a 17

Roysdon v. R.J. Reynolds Tobacco Co., 623 F. Supp. 1189

I ee 17

Shaw v. Delta Air Lines, Inc.. 463 U.S. 85 (1983)...........0... i)

Sullivan v. Stroop. 496 U.S. 478 (1990) 0.0... ccceecc eee eeee 15

United States Department of Treasury v. Fahe, 508

Se ee I nisscckichsinnsinniscniiiatiatineintaiapiiatdianieaiialihal 14

Statutes and Bills:

Animal Drug Amendments of 1968. Pub. L. No.

90-399, 82 Stat. 343 (codified as amended at

RTA ETE NNND

Color Additive Amendments of 1960, Pub. L. No.

86-618, 74 Stat. 399 (codified as amended at

i ENG Ut Msc cunbchbnhadpanscddpineasdessecoscsesens

Drug Amendments of 1962, Pub. L. No. 87-781,

76 Stat. 780 (codified as amended at 21 U.S.C.

i all La iis dened Glas nce eae ode on dn eaed OOD

SE a a 5

Food Additives Amendment of 1958, Pub. L. No.

85-929, 72 Stat. 1785 (codified as amended at 21

TE id idan ini caininnanduisnnadenadnctsiseetones 10

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

94-295. 90 Stat. 539 (codified as amended al

Se acs cnddnsbaanndnsbddeseoonees 1,4

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BO CIBA.. 6 Femi sccosccnncnicccsecsapssaumasaeeaeee 18

Public Health Cigarette Smoking Act of 1969,

Pub. L. No. 91-222, 84 Stat. 87 (codified as amended

US WBA, Be ERG es OF BND sescsssiccsiinistiniiinnssstaiaiiiuai 7,14

BS UT... © Fare nctcvnscstcossccssnsttniupetensibanegatadaaae 15

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Pure Food and Drugs Act of 1906, Pub. L. No.

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Regulations and Federal Register Notices:

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21 CER. © OPO SOOO. csicsccncnsnceecncovenesccniuaneneeunana 5

42 Fed. Reg. 30383 (June 14, 1977).......... 0.00... cc ceee eee, 16

43 Fed Reg. 18661 (May 2, 1978).................cc cece cece ees 16

Legislative Materials:

121 Cong. Rec. $6140 (Apr. 17, 1975) ...... cece ccececeeeeee es 5

I I, I ID vc cccccscosescnsssscosesecssescecoess passim

Hearing on H.R. 5545 Before the House

Subcommittee on Health and the Environment

of the Committee on Interstate and Foreign

Commerce, 94th Cong. 1 (1975).............ccccccccccccsesseereeeees 5

EE 4

Miscellaneous:

Adler, Robert S. & Richard A. Mann, Preemption and

Medical Devices: The Courts Run Amok, 59 Mo.

EEE 16

Brief of the United States as Amicus Curiae

Lohr v. Medtronics, Inc., 518 U.S. 470 (1996) .000000000.... 19

Cook. Walter W., Substance” and “Procedure” in the

Conflict of Laws, 42 Yale L.J. 333 (1933) .......ccccccccccceees 8

General Accounting Office. FDA Drug Review:

Postapproval Risks 1976-85, GAO/PEMD-90-15

as iinet einhantindensnennssenezenceecnese 19

Hursh, R.D. Annotation. Liability of Manufacturer

or Seller For Injury Caused By Medical and

Health Supplies, Appliances. and Equipment, 79

ae 16

Institute of Medicine, Safe Medical Devices for

EE 19

vi

Institute of Medicine, The Future of Drug Safety:

Promoting and Protecting the Health of

ELAR ae a eS STO 19

Lyndon, Mary, Tort Law and Technology, |2 Yale J.

SD, Birr er eee icccinnctcssnetantantaieitinviamenimitnmenai 20

Porter, Margaret J.. The Lohr Decision: FDA

Perspective and Position, 52 Food & Drug

ca cite liana ictal iain aeaiaale 21

Restatement (Third) of Torts: Products Liability § 2(b)

EES cea RENEE ee ee ee Kin EI rn 19

Rheingold, Paul D., The MER/29 Story—An Instance of

Successful Mass Disaster Litigation, 56 Cal. L.

I, Pe ieckieiniiscinsitaiasensesinniateesiinnintiniaiindubiatiniiuainiabiitaaias 10

Swartz, Edward M., Products Liability: Manufacturer's

Responsibility for Defective or Negligently Designed

Medical and Surgical Instruments, 18 DePaul L.

ee, Fee rccciniindatpanincnnicarninnhcdintiaasiaiititaiainiieasiatit 16

Vladeck, David A., Preemption and Regulatory

Failure. 33 Pepp. L. Rev. 95 (2005)...............sscccseecseeees 21

INTEREST OF AMICI CURIAE'

Edward M. Kennedy has been a member of the United

States Senate representing the State of Massachusetts since

1962. Senator Kennedy currently serves as Chairman of the

Senate Committee on Health, Education, Labor and Pensions.

In 1974-76, as the Chairman of the Subcommittee on Health,

Labor and Public Welfare, Senator Kennedy held hearings on

legislation to strengthen FDA’s authority over medical de-

vices and was the sole sponsor of the Senate bill (S. 510) that

resulted in the passage of the Medical Device Amendments

of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified as

amended at 21 U.S.C. § 360c, ef seg.) (“MDA”) to the Fed-

eral Food, Drug and Cosmetic Act (“FFDCA”), 21 U.S.C.

§ 301, et seq.

Representative Henry A. Waxman has been a member of

the United States House of Representatives representing the

30th Congressional District of the State of California since

1974. Representative Waxman currently serves as Chairman

of the House Government Reform and Oversight Committee,

which has investigative authority over all government agen-

cies and areas of federal policy. In 1976, Congressman Waa-

man served on the House Committee on Interstate and For-

eign Commerce, which reported out the MDA legislation.

Congressman Waxman supported the MDA and actively par-

ticipated in the debates on the legislation.

Senator Kennedy and Congressman Waxman have dedi-

cated their careers to working on public health issues, and

over the past 30 years have sponsored numerous bills related

to the Food and Drug Administration (“FDA”) that have been

' Petitioners and respondent have filed letters with the Clerk of the

Court consenting to the submission of amicus curiae briefs in this action.

Pursuant to Rule 37.6, amici state that no counsel for a party authored this

brief in whole or in part. No person or entity other than amici and their

counsel made a monetary contribution to the preparation or submission of

the brief.

enacted into law. They seek leave to file this brief because

they believe that the decision of the United States Court of

Appeals for the Second Circuit is contrary to the legislative

purpose and intent of the MDA, and that it stands as a sig-

nificant obstacle to the fulfillment of the importani policy

objectives that underscored the passage of that law.

HISTORY OF THE MEDICAL DEVICE

AMENDMENTS OF 1976 AND ITS PREEMPTION

PROVISION.

A. The Federal Food, Drug, and Cosmetic Act.

For over a century, the FDA has been responsible for pro-

tection of the public health with regard to the use of a wide

range of medical and other consumer products. Its authoriz-

ing statute, the Federal Food, Drug and Cosmetic Act, 21

U.S.C. § 301, et seq., has been frequently amended as emerg-

ing science and new technology have created a need for

greater or evolving protections. Often, Congress has enacted

these amendments in the wake of a public health crisis.

Enacted in 1938, the FFDCA itself was passed in the

wake of the elixir sulfanilamide disaster.’ Elixir sulfanila-

mide was an untested sulfa drug that caused the deaths of

nearly 100 people. many of them children. The statute for

the first time required pre-marketing approval for drugs,

mandating that drug manufacturers demonstrate safety before

a new drug could be marketed to the public. Congress. how-

ever. did not enact a corresponding pre-market approval re-

quirement for medical devices.

a

In some instances where Congress has amended the

FFDCA to address a public health crisis, product liability

> The Pure Food and Drugs Act of 1906, Pub. L. No. 59-384. 34

Stat. 768, was the first federal statute regulating pharmaceuticals. It did

not require pre-market approval of drugs and focused on preventing the

sale of misbranded and adulterated products.

lawsuits brought by the victims of defective products helped

bring the problem to the attention of Congress, as was true

when Congress adopted the MDA. Despite repeated refer-

ences to such lawsuits in legislative history, however, Con-

gress never has expressed any intention to preempt such Iiti-

gation in any of the amendments to the Act. In fact, the

MDA is the first time that Congress included a specific pre-

emption provision in the FFDCA, and, as amici explain be-

low, that provision was included to address a specific state

legislative scheme for regulating medical devices and not to

preempt product liability lawsuits against device manufactur-

ers. At the time the MDA was enacted in 1976, the terminol-

ogy used in the preemption provision was understood by

Congress not to encompass product liability litigation.

While FDA had focused earlier on protecting the public

from fraudulent claims made for bogus devices, around 1960

FDA began focusing on health hazards created by legitimate

medical devices. H.R. Rep. No. 94-853 (“House Report”) at

7. Emerging technology drove this effort: the creation of

heart pacemakers, kidney dialysis machines. defibrillators,

cardiac and renal catheters, surgical implants and other com-

plicated diagnostic and therapeutic devices heightened the

potential harm for consumers. /d. In 1969, the Secretary of

Health. Education and Welfare convened a medical device

study group, chaired by Theodore Cooper, M.D., then-

director of the National Heart and Lung Institute (“the Coo-

per Committee”). /d. at 9.

The Cooper Committee held meetings with representa-

tives of the medical profession, industry, consumers and gov-

ernment agencies. and it conducted an extensive literature

search that identified 10.000 injuries from medical devices

over a 10-year period. of which 751] resulted in death. /d.

The Committee recommended that new legislation be tar-

geted specificaily to the device industry, because devices

presented entirely different issues from drugs. It also sug-

gested that different classifications for medical devices be

created, which would tailor the regulatory controls to the

risks involved.

B. The 1976 Medical Device Amendments.

While the Cooper Committee’s recommendations were

being debated in Congress during 1972 and 1973, pacemaker

failures became widely reported. Between 1972 and 1976,

there were 34 voluntary recalls of pacemakers involving

23.000 units. /d. at 8. In 1975, Congress held hearings to

investigate problems that had been reported with the Dalkon

Shield intrauterine device.

As the House Report on the bill noted, the FFDCA’s “in-

adequacy has become a matter of acute concern because of

the rapid technological advances in the medical device field.”

Id. at 11. The Report also found that “[{a]bsent clear, statu-

tory authority to regulate medical devices, the FDA cannot

safeguard the health of the American public by assuring the

safety and effectiveness of such products.” /d. at 12

The tragedy of the Dalkon Shield. which caused sponta-

neous abortions, uterine infections, and many deaths, played

an important role in the events that led to the MDA of 1976

and is repeatedly cited in the legislative history. /d. at 8 (not-

ing that there were over 500 lawsuits seeking damages at the

time of the Report); S. Rep. 94-33. at 1 (1975) (“Senate Re-

port”) (submitted by Senator Kennedy). In light of the

Dalkon Shield tragedy and other information received in

hearings on the bill, the focus of the legislation was protect-

ing consumers from unsafe products.

The MDA was designed “to provide for the safety and ef-

fectiveness of medical devices intended for human use, and

for other purposes.” Pub. L. No. 94-295. 90 Stat. 539 (1976):

see also House Report at 12 (MDA intended “to assure that

the public is protected from unsafe and ineffective medical

devices, that health professionals have more confidence in

the devices they use or prescribe, and that innovations in

medical device technology are not stifled by unnecessary re-

strictions.”). Throughout the legislative history of the Act are

expressions of concern about “faulty devices” and their toll

on Americans. £.g., Hearing on H.R. 5545 Before the House

Subcommittee on Health and the Environment of the Com-

mittee on Interstate and Foreign Commerce, 94th Cong. |

(1975) (statement of Rep. Paul Rogers, Chairman oi the

House Subcommittee on Health and the Environment). As

one of the amici declared on the floor of the Senate during

debate on the bill: “The legislation is written so that the

benefit of the doubt is always given to the consumer.” 121

Cong. Rec. $6140 (Apr. 17, 1975) (Statement of Sen. Ken-

nedy). Thus, recognizing that many of the harms caused by

medical devices were preventable, Congress enacted the

MDA.

Under the MDA, the term “device” includes a vast array

of products, including tongue depressors, band-aids, tam-

pons, bone screws, hip replacements, artificial heart valves,

and pacemakers. See 21 U.S.C. § 321(h). Each medical de-

vice falls into one of three classes. Class | devices, for ex-

ample tongue depressors, are those for which the MDA's

“general cuntrols” applicable to all devices, such as record-

keeping and good manufacturing guidelines, are sufficient to

provide reasonable assurance of safety and effectiveness.

See 21 U.S.C. §§ 360i(a), 360;(f). Class II devices. for ex-

ample tampons, are those for which special controls are nec-

essary to protect the public health. Special controls include

performance standards. special labeling requirements, and

post-market surveillance. 21 U.S.C. § 360c(ay1)B): 21

C.F.R. § 874.3300(b)(2).

Finally, Class II] devices operate to sustain human life.

are important in preventing impairment of human health. or

pose potentially unreasonable risks to patients. 21 U.S.C. §

360c(ay1(C); see 21 C.F.R. § 860.3(c)(3). Class III devices

must undergo pre-market approval by the FDA, see 21

U.S.C. §§ 360e(b)(1); 360e(c)(1), unless the device qualifies

for one of the statute’s exceptions. The balloon catheter in-

volved in this case is an example of a Class III device that

underwent pre-market approval.

C. The MDA’s Preemption Provision.

When it considered the MDA, Congress was aware of

various state programs requiring pre-market approval of

medical devices, and the House Report specifically noted that

in 1970 California had adopted the Sherman Food, Drug, and

Cosmetic Law. which the Committee described as “compre-

hensive” in its regulation of medical devices. House Report

at 45. Although it adopted a comprehensive federal regula-

tory system, Congress gave FDA the authority to preserve

more stringent state provisions where they existed. finding

them to be “a useful supplement to Federal regulation.” /d.

In 21 U.S.C. § 360k(a), the MDA provided that States

may not “establish or continue in effect with respect to a de-

vice .. . any requirement” that is “different from. or in addi-

tion to” certain federal device “requirement{s]” imposed un-

der the MDA. 21 U.S.C. § 360k(a). However, Congress au-

thorized FDA to grant state and local governments exemp-

tions from preemption for their medical device laws in cer-

tain circumstances. including when the requirement is more

stringent than the federal requirement. See 21 U.S.C. §

360k(b); House Report at 4. Congress noted that the more

stringent program established by the state of California was

an example of a program that should be allowed to continue

to operate even after passage of federal legislation. House

Report at 46. Since passage of the MDA, FDA has granted

several such exemptions to States that have passed more

stringent regulations regarding hearing aids. See. e.g.. 21

C.F.R. §§ 808.53: 808.55: 808.69. Thus, consistent with the

focus on public safety in the MDA, Congress favored patient

protection over nationwide uniformity.

D. The Lohr Decision.

In 1996. this Court considered the scope of preemption in

section 360k(a) in Medtronic, Inc. v. Lohr, 518 U.S. 470

(1996). In Lohr, the Court held that a state product liability

lawsuit was not preempted with respect to a medical device

that had not undergone pre-market approval. Nevertheless,

some members of the Court discussed the issue of whether

section 360k(a) preempts any tort suits.

In the plurality opinion by Justice Stevens, four members

of this Court found no preemption in the Lohr case, but left

open the issue of whether there could ever be preemption.

Four members of the Court joined an opinion by Justice

O’Connor that concluded that section 360k(a) did preempt

product liability cases and that the product liability lawsuit in

Lohr was preempted. Justice O'Connor relied heavily on the

Court’s interpretation of the Public Health Cigarette Smoking

Act of 1969°s preemption provision that the Court construed

in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992).

Justice Breyer, in a separate opinion, agreed with Justice Ste-

vens that there was no preemption in the Lohr case, but he

also stated that “[o|]ne can reasonably read the word ‘re-

quirement’ as including the legal requirements that grow out

of the application, in particular circumstances, of a State's

tort law.” Lohr, 518 U.S. at $04.’

That “requirement” in the Public Health Cigarette Smok-

ing Act of 1969, Pub. L. No. 91-222. 84 Stat. 87 (codified at

15 U.S.C. § 1331, et seg.) (°;PHCSA”), as amended and codi-

fied. 15 U.S.C. §§ 1331-40. may include common law tort

In his opinion, Justice Breyer discussed the tension between an

FDA regulation that hearing aids be designed with a two-inch wire and a

product liability lawsuit alleging the manufacturer should have used a

safer, one-inch wire. As explained below, in enacting the express pre-

emption provision contained in section 360k(a), Congress did not intend

to preempt state product liability actions. Nevertheless, conflicts between

state and federal law may be addressed under principles of implied con-

flict preemption. In this brief. amici do not address the complex issue of

whether a state court verdict might be subject to implied conflict preemp-

tion, which was neither raised in nor decided by the court of appeals.

claims does not mandate a conclusion that use of the same

term in a very different statute with different goals means the

same thing. Amici explain below that use of the term “re-

quirement” in the MDA, the structure of the MDA, the moti-

vation of Congress in enacting the MDA, and other legisla-

tive history demonstrate that the term “requirement” in the

MDA does not encompass state tort action. As Professor

Walter Wheeler Cook cautioned some 75 years ago, although

the tendency to assume that the same word means the same

thing in different contexts “has all the tenacity of original

sin,” it “must constantly be guarded against.” Walter W.

Cook, “Substance” and “Procedure” in the Conflict of

Laws, 42 Yale L.J. 333. 337 (1933).

SUMMARY OF ARGUMENT

The language of section 360k and its legislative history

demonstrate that Congress did not intend to preempt state tort

suits. The legislative history demonstrates that Congress in-

cluded section 360k in the MDA for one specific reason--to

reconcile the new federal regulatory scheme with device

regulatory schemes that states had adopted in the absence of

federal regulation. There is no suggestion anywhere in the

legislative history to suggest that Congress even considered

preempting state tort suits, much less that it intended to pre-

empt such suits.

Congress amended the FFDCA numerous times between

1938, when it enacted the FFDCA, and 1976, when it enacted

the MDA. to increase the authority of the FDA, yet it never

included a provision expressly preempting state positive law

or state tort suits. Because there were no parallel state regu-

latory schemes, Congress had no occasion to preempt state

positive law. A preemption provision would have been nec-

essary had Congress been concerned about state tort actions

against the manufacturers that it was regulating. It was not.

Section 360k(a) prohibits States from establishing a “re-

quirement” that is different from a federal “requirement” ap-

plicable to a medical device. Thus, in order to trigger pre-

emption, there must be both a federal and a state requirement.

Federal requirements are established by the statute, agency

regulations, and in some cases by an order applicable to a

specific product. For example, FDA is authorized to prom-

ulgate performance standards applicable to medical devices.

These standards may establish specific requirements for a

device. A state regulation that imposed a different require-

ment would be preempted by section 360k(a). However, the

structure of the MDA makes clear that the use of the word

“requirement” in the context of federal action does not ex-

tend to a lawsuit. The logical and most plausible inference is

that the reference to a state “requirement” in the same sub-

section of the MDA does not encompass state lawsuits.

Any doubt about the meaning of section 360k(a) is re-

solved by section 360k(b), which permits states to obtain an

exemption from section 360k(a) for a state “requirement.”

Once again, the structure of the MDA reveals that Congress

could not have intended “requirement” to encompass a law-

suit: there is no practical way for a state to seek an exemp-

tion for a lawsuit, cither before or after a jury verdict. Since

“requirement” in subsection (b) docs not include tort law-

suits. the term “requirement” in subsection (a) also does not

include such lawsuits.

ARGUMENT

THE LANGUAGE OF THE MDA AND ITS LEG-

ISLATIVE HISTORY DEMONSTRATE THAT

CONGRESS DID NOT INTEND TO PREEMPT

STATE COMMON LAW TORT SUITS.

This Court repeatedly has stated that the touchstone for

express preemption is the intent of Congress. English v.

General Electric Co., 496 U.S. 72, 78-79 (1990); Shaw: vy.

Delta Air Lines, Inc., 463 U.S. 85, 95 (1983). The relevant

intent must be discerned from the language of the statute, its

structure, purpose, and subject matter. Cipollone, 505 U.S. at

10

545 (Scalia. J.. concurring in the judgment in part and dis-

senting in part). In addition, there is a presumption against

Congress's displacing state law. especially in an area of tradi-

tional state authority, such as tort law. See id. at 516; see

also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449

(2005).

Since 1938, when Congress adopted the FFDCA. which

required pre-market approval of “new drugs.” it has amended

the Act numerous times, in 1958 to require pre-market ap-

proval of food additives, in 1960 to require pre-market ap-

proval of color additives, in 1962 to require that human drugs

be proven to be effective in the pre-market approval process,

and in 1968 to require pre-market approval of new animal

drugs.

At the time that it adopted each of these provisions, inso-

far as amici are aware, there were no competing state regula-

tory schemes covering any of these product categories, and in

each case Congress did not include a preemption provision in

any of these laws. Insofar as amici are aware, there was no

interest in Congress in preempting state product liability law-

suits. although such suits. especially involving pharmaceuti-

cals. were an ever-present backdrop. See, e.g, Paul D.

Rheingold. The MER 29 Story - An Instance of Successful

Mass Disaster Litigation, 56 Cal. L. Rev. 116 (1968) (de-

scribing MER/29 litigation, the first drug-related mass tort

suse, which was emerging as Congress was considering the

1962 Amendments).

* Food Additives Amendment of 1958. Pub. L. No. 85-829. 72 Stat.

1785 (1958) (codified as amended at 2! U.S.C. § 348): Color Additive

Amendments of 1960, Pub. L. No. 86-618. 74 Stat. 399 (1960) (codified

as amended at 21 U.S.C. § 376), Drug Amendments of 1962, Pub. L. No.

87-781, 76 Stat. 780 (1962) (codified as amended at 21 U.S.C. § 321. ef

seq.). Animal Drug Amendments of 1968, Pub. L. No. 90-399, 82 Stat.

343 (1968) (codified as amended at 21 U.S.C. § 382).

As noted above, in 1976, when Congress enacted the

MDA, the state of California had adopted a comprehensive

regulatory system applicable to medical devices. This led

Congress to include for the first time in the FFDCA a provi-

sion providing for preemption of certain state device regula-

tory requirements. The provision, section 521(a) of the

FFDCA, added by the MDA, provides as follows:

Except as provided in subsection (b), no State or politi-

cal subdivision of a State may establish or continue in

effect with respect to a device intended for human use

any requirement —

(1) which is different from, or in addition to, any

requirement applicable under this Act 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 Act.

21 U.S.C. § 360k(a) (emphasis supplied).

The purpose of section 360k(a) is clear on its face. First,

preemption applies only when there is a “requirement appli-

cable to the device under this Act.” 21 U.S.C. § 360k(a)(1).

For example, under section 360d, FDA may issue perform-

ance standards, which are mandatory requirements applicable

to specific devices. See, e.g., 21 C.F.R. § 801.410 (providing

specific requirements for impact-resistant lenses in eye-

glasses and sunglasses). Thus, if FDA mandates that eye-

glass lenses must pass a specific test prior to being labeled as

impact-resistant. then section 360k(a) would bar a state from

adopting a standard that is “different from, or in addition to”

the FDA requirement.

Similarly, under section 360j(e). FDA. by regulation,

may restrict the sale, distribution or use of devices. For ex-

ample, FDA can mandate that a device be used only by phy-

sicians with specific training relevant to a product's use.

12

Such a regulation also could preempt a state requirement ap-

plicable to the same device that addressed the same subject

matter as the regulation. The statute gives FDA other author-

ity to impose requirements. See, e.g., 21 U.S.C. § 360i (au-

thorizing FDA to require records and reports). Every re-

quirement imposed on a medical device manufacturer by

FDA is imposed by the statute, by regulation or by an order

applicable to a specific device.” None is issued by a court or

any other body. In other words, “requirement.” the second

and third time it is used in section 360k(a), means a require-

ment imposed by federal positive law.

Section 360k(a) applies to a state “requirement” that is

“different from or in addition to™ the federal “requirement.”

Just as the federal “requirement” must be a regulation or spe-

cific agency pronouncement under the Act, Congress in-

tended for the term state “requirement” to apply to medical

device requirements enacted by a legislature or promulgated

by an administrative agency. The straightforward meaning

of section 360k(a) is that the provision was intended to pre-

empt state laws and regulations applicable to specific devices

that are “different from. or in addition to” any federal “re-

quirement.”

The preemption of state requirements is not absolute.

Congress provided that states could apply for an exemption

as to statutes and regulations preempted by subsection (a).

Thus. in subsection (b), it provided the states an opportunity

to obtain an exemption to the general preemption rule. Sec-

tion 360k(b) states:

* For example. under section 360e(d)(1 (BX ii), in its approval deci-

sion, FDA may by order impose the same restriction that it may impose

under section 360j(e) by regulation for all devices (for example, mandat-

ing that a device be used only by physicians with specific training rele-

vant to the product's use). Such an order would be a requirement under

section 360k(a).

13

(b) Upon application of a State or a political subdivi-

sion thereof, the Secretary may, by regulation

promulgated after notice and opportunity for an

oral hearing, exempt from subsection (a), under

such conditions as may be prescribed in such

regulation, a requirement of such State or political

subdivision applicable to a device intended for

human use if —

(1) the requirement is more stringent than a re-

quirement under this Act which would be ap-

plicable to the device if an exemption were

not in effect under this subsection; or

(2) the requirement ~

(A) is required by compelling local condi-

tions, and

(B) compliance with the requirement would

not cause the device to be in violation of

any applicable requirement under this

Act.

21 U.S.C. § 360k(b) (emphasis supplied).

As discussed above. when Congress enacted section

360k(b), it was aware that California already had adopted a

regulatory scheme for medical devices.° Accordingly, in sec-

tion 360k(b)(i), Congress provided that a state could apply to

FDA for an exemption from section 360k(a) if the state re-

quirement is more stringent than the federal requirement.

Section 360k(b)(2) permits exemption from section 360k(a)

because of compelling local conditions. These exemptions

plainly contemplated that states that had laws or regulations

“different from or in addition to” FDA requirements could

obtain an exemption from FDA. It is difficult to imagine

° See 1970 Cal. Stat. 3270 (requiring new medical devices receive

pre-marketing approval before they can be sold).

Bs

™

ci

14

how such an exemption could apply to a products liability

jury verdict, either in advance of or after such a verdict.

Yet, if section 360k(a) is read to preempt certain product

liability claims, then section 360k(b) must be read to provide

an Opportunity for an exemption from such claims, since both

provisions apply only to federal and state “requirements.” As

this Court explained in Commissioner yv. Lundy, 516 U.S.

235, 249-50 (1996). there is “no reason to believe that Con-

gress meant the term . . . to mean one thing” in the first part

of section 360k(a) “but to mean something else altogether”

the next two times it appears.’ As the Court further ex-

plained, “the interrelationship and close proximity of these

provisions . . . ‘present[] a classic case for application of the

normal rule of statutory construction that identical words

used in different parts of the same act are intended to have

the same meaning.” /d. at 250 (quoting Sullivan v. Stroop,

496 U.S. 478, 484 (1990) (internal quotations and case cita-

tions omitted)); see also, e.g.. United States Department of

Treasury v. Fabe, 508 U.S. 491. 515 (1993) (Kennedy. J..

dissenting) (referring .o foregoing principle as a “basic rule

of statutory construction”). Thus, since “requirement” in sec-

tion 360k(b) must be limited to state statutes and regulations.

” Amici urge here that the word “requirement” when it appears mul-

tiple times in the same section of a statute should be understood to mean

the same thing. By contrast, amici have argued that the use of the word

“requirement” in a different statute. the PHCSA, should not be under-

stood to mean the same thing as it does in the MDA. The PHCSA was

enacted by a different Congress at a different time and had different pur-

poses than the MDA, including an explicit purpose of avoiding inconsis-

tent state requirements for the labeling on cigarette packaging and in ad-

vertising and promoting cigarettes, 1S U.S.C. § 1331 The PHCSA con-

tained specific requirements for the language to be used on cigarette

packages and in advertising and promotion, and did not contain other

usages of “requirement” in the statutory language inconsistent with a

meaning that includes state common law. Thus, the two contentions by

amici about the appropriate interpretation of “requirement” are not incon-

sistent.

15

that same term in section 360k(a) must be limited in the same

way. If Congress had meant there to be different meanings

for the same word employed in ihe same subsection, one

would have expected it to say so. Gustafson v. Alloyd Co.,

Inc., 513 U.S. 561, 573 (1995). Congress's silence on this

matter speaks loudly about its intent. There is no room in the

plain language of the statute for an interpretation that that

term could also include “requirements” imposed by product

liability tort suits.

There also is no indication in the Congressional hearings,

the Committee Reports or the debates on the House or Senate

floor that even a single member of the House or Senate be-

lieved that section 360k would bar state common law reme-

dies against manufacturers. Of course, the existence of such

remedies was at the forefront of the consideration of the

MDA, since prior to adopting the amendments, Congress had

heard extensive testimony about the Dalkon Shield tragedy.

There is no indication in the Congressional history of the

MDA that Congress intended to prevent state tort actions,

which is strong evidence that such preemption was not in-

tended.” As Justice Stevens observed in Lohr, the absence of

any hint of preempting common law claims in the entirety of

the MDA legislative history is “spectacularly odd” if such

preemption was intended by Congress. Lohr, 518 U.S. at

491; see also Bates, 544 U.S. at 449 (2005) (“The long his-

* The MDA was enacted against a backdrop of a long history of tort

suits involving medical devices. See Edward M. Swartz, Products Liabil-

itv: Manufacturer's Responsibility for Defective or Negligently Designed

Medical and Surgical Instruments, 18 DePaul L. Rev. 348, 358 (1969);

R.D. Hursh, Annotation, Liahility of Manufacturer or Seller For Injury

Caused By Medical and Health Supplies, Appliances, and Equipment, 79

A.L.R.2d 401 (1961).

* “A careful perusal of the entire legislative history reveals no men-

tion of preempting state common law tort claims.” Robert S. Adler &

Richard A. Mann. Preemption and Medical Devices: The Courts Run

Amok, 59 Mo. L. Rev. 895, 923-24 n.128 (1994).

16

tory of tort litigation against manufacturers . . . adds force to

the basic presumption against pre-emption. If Congress had

intended to deprive injured parties of a long available form of

compensation, it surely would have expressed that intent

more clearly.”); Chisom v. Roemer, 501 U.S. 380, 396 (1991)

(“if Congress had such an intent, Congress would have made

it explicit in the statute, or at least some of the Members

would have identified or mentioned it at some point in the

unusually extensive legislative history.”).

It is, thus, not surprising that public commentary follow-

ing the enactment of the MDA also does not even suggest the

possibility that the Medical Device Amendments could pre-

empt state common law product liability actions. See Lohr,

518 U.S. at 491 n.13 (plurality opinion). Similarly, in 1977,

when it proposed 21 C.F.R. § 808.1(b) to implement the

MDA, FDA directed applicants for an exemption to inform it

as to “whether the statute, rule, or regulation has been subject

to judicial or administrative interpretations that give it legal

meanings in the State or political subdivision that are not

readily apparent from the face of the document”). 42 Fed.

Reg. 30383. 30385 (June 14, 1977): accord 43 Fed. Reg.

18661. 18663 (May 2. 1978). It is also relevant that the

FDA’s regulations declare that a state “requirement” is not

“eligible for exemption from preemption™ unless it has been

“issued in final form.” 21 C.F.R. § 808.5(b)(2). Regulations,

ordinances and similar enactments are “issued” in “final

form.” Product liability judgments are not “issued,” and. al-

though they do become final. they are not refined into a “fi-

nal form.” FDA understood that the preemption provision

applied to a “statute, rule. or regulation.” and not to product

liability lawsuits.

Indeed, the first reported decision that amici can locate in

which preemption under section 360k(a) was employed as a

defense to a state tort suit is /gnace v. International Playtex,

17

Inc., No. 86-C-480-C, 1987 WL 93996 (W.D. Wis. Aug. 14,

1987).'° Thus, it did not occur to attorneys in the medical

device industry and the nation’s product liability attorneys,

who are paid to identify defenses to litigation against their

clients, that Congress intended in section 360k(a) to preempt

common law tort claims until more than a decade after the

statute was enacted. That they began to assert preemption is

likely the result of the emergence, in the mid-1980s, of cases

claiming preemption based on the Federal Cigarette Labeling

and Advertising Act. See, e.g., Palmer v. Liggett Group,

Inc., 633 F. Supp. 1171 (D. Mass. 1986); Roysdon v. R.J.

Reynolds Tobacco Co., 623 F. Supp. 1189 (E.D. Tenn.1985).

It was not until the decision in Cipollone in 1992 that

Congress was aware that this Court might interpret the term

“requirement” in a statutory preemption provision to include

state product liability lawsuits. At this point, Congress began

explicitly stating in statutes that the term “requirement” in

preemption provisions did not preempt product liability ac-

tions. In two amendments to the FFDCA since 1992, in

which Congress preempted state “requirements,” Congress

explicitly stated that product liability cases were nut pte-

empted. Thus, in § 751 of the FFDCA, 21 U.S.C. § 379r,

which preempted certain “requirement{s]” applicable to non-

prescription drugs, Congress added subsection (e) titled “No

effect on product liability law.” Subsection (e) states that

“[nJothing in this section shal! be construed to modify or oth-

erwise affect any action or the liability of any person under

the product liability law of any State.” If Congress had had

any indication in 1976 when it enacted the MDA that a court

’ There is also a slightly earlier, unreported case: Muzatko v. In-

ternational Playtex, Inc., No. 85-C-1540, 1987 U.S. Dist. LEXIS 14281

(E.D. Wis. May 14, 1987), cited in Edmondson v. International Playtex,

Inc., 678 F. Supp. 1571 (N.D. Ga. 1987). Notably, in all of these cases,

FDA had promulgated a regulation mandating certain information about

tampon risks to be placed on the product's labeling. See 21 C.F.R. §

801.430.

eo

18

would interpret the term “requirement” in section 360k to

include state product liability law. then it would have in-

cluded such a provision in the MDA. '!

Permitting state design defect claims also is consistent

with the Congressional purpose in enacting the MDA. Deny-

ing them is not. As noted previously, in the aftermath of the

Dalkon Shield tragedy, Congress's primary focus was ensur-

ing the safety of medical devices when it enacted the MDA.

Modern design defect litigation frequently requires a plaintiff

to identify an alternative design that would make the product

safer. See Restatement (Third) of Torts: Products Liability §

2(b) (1998) (product has defective design when a “reasonable

alternative design” would reduce the foreseeable risks of the

product). Moreover, if design defect litigation for PMA de-

vices is preempted, the incentive created by tort litigation to

identify better designs in the wake of adverse events suffered

by users of those devices will be lost. See Bates, 544 U.S. at

451 (“the specter of damage actions may provide manufac-

turers with added dynamic incentives to continue to keep

abreast of all possible injuries stemming from use of their

product so as to forestall such actions through product im-

provement”) (citation omitted). Congress might have de-

cided that preemption is appropriate if the FDA were decid-

ing the optimal design of medical devices in the PMA proc-

ess, but that is not the case.

With respect to devices subject to pre-market approval,

the basic determination that the FDA makes is whether the

device--designed in whatever fashion the manufacturer has

determined--is safe and effective for use. See Brief of the

United States as Amicus Curiae at 20-21, Lohr v. Medtronics,

'' In 1997, Congress also amended the FFDCA to include a provi-

sion preempting state and local requirements for the labeling or packag-

iny of cosmetics, which is codified at 21 U.S.C. § 379s(a). Congress also

included a savings clause for state product liability claims in sec-

tion 379s(d).

19

Inc., supra. \f the device meets this statutory standard, FDA

has no authority to deny approval even if an alternative de-

sign might make the device safer than the design proposed by

the applicant. In other words, the manufacturer — not the

FDA - has control over the design of the device.

Moreover, clinical trials of medical devices will not ide

tify all of the significant risks involved in the use of the de-

vice. Risks that are relatively rare but important will emerge

only when a device is released into a larger and more hetero-

geneous population. See Institute of Medicine, Safe Medical

Devices for Children 113 (2005) (explaining the importance

of adverse event reporting and monitoring of medical devices

to identify “serious problems” with devices in light of its

post-approval use “with many more patients, with different

patient populations (e.g., children), in different ways (e.g.,

involving ad hoc modifications for pediatric use). for differ-

ent purposes, in new and possibly less well-equipped set-

tings, over longer periods, and, sometimes, by less experi-

enced or skilled clinicians and care teams”); see also General

Accounting Office, FDA Drug Review: Postapproval Risks

1976-85 at 52 (1990) (finding that over 50 percent of pre-

scription drugs approved by the FDA had serious risks that

went undetected during pre-marketing clinical testing); Insti-

tute of Medicine, Zhe Future of Drug Safety: Promoting and

Protecting the Health of the Public (2007) (explaining the

difficulty of determining all drug risks during pre-market

testing).

After a device has been approved, new information about

design changes to the device that may improve safety or effi-

cacy Is largely in the control of the manufacturer. Moreover,

the FDA has limited authority to force a manufacturer to

make a design change even if it is aware that the change

would improve the device. The FDA can initiate proceedings

to withdraw the product from the market, but the agency

must establish that the product no longer meets the statute's

safety and efficacy requirements and, in any event, this can

be a time consuming process.'* In this context, design defect

litigation affords an opportunity to identify those newly

emergent risks and to consider alternatives to the design that

would further consumer safety—the focus of the MDA. See

Mary Lyndon, Tort Law and Technology, 12 Yale J. on Reg.

137, 176 (1995) (“{T]ort law's signals contain necessary ba-

sic messages that are not delivered through any other me-

. . Offer{ing] advantages that we need to account for

dium

20

before preempting tort law.”).

The Chief Counsel of the FDA, in the wake of Lohr,

trenchantly explained this concern:

i2

FDA regulation of a device cannot anticipate and

protect against all safety risks to individual con-

sumers. Even the most thorough regulation of a

product such as a critical medical device may fai!

to identify potential problems presented by the

product. Regulation cannot protect against all

possible injuries that might result from use of a

device over time. Preemption of all such claims

would result in the loss of a significant layer of

consumer protection, leaving consumers without

a remedy for injurics caused by defective medi-

cal devices. Moreover, FDA's regulation of de-

vices would have been accorded an entirely dif-

ferent weight in private tort litigation than its

counterpart regulation of drugs and biologics.

This disparity is neither justified nor appropriate,

nor does the agency believe it was intended by

Congress when section 521 was enacted.

See, e.g.. 21) U.S.C. § 360e(e)(1) (requiring notice, an opportu-

nity for an informal hearing. and, where appropriate, convening an advi-

sory committee) & 21 U.S.C. § 360e(e\(2) (providing for review of an

order withdrawing approval).

21

Margaret J. Porter, The Lohr Decision: FDA Perspective and

Position, 52 Food & Drug L.J. 7, 11 (1997); see also David

A. Vladeck, Preemption and Regulatory Failure, 33 Pepp. L

Rev.95. 97 (2005) (“Since the founding of our Republic, tort

liability has filled [regulatory gaps].”).

CONCLUSION

Congress was fully aware of widespread tort law suits

over medical devices, yet there is nothing in the legislative

history to suggest an intent preempt such suits. At the time

the MDA was enacted, Congress did not understand the term

“requirement” to include staie tort law verdicts. More recent

FDA legislation has ciarified that preemption of state re-

quirements does not include tort lawsuits. If Congress had

intended to preempt state tort law suits, it would have explic-

itly done so. Taking into account the plain language of the

MDA preemption provision, the absence of any indication in

the legislative history that Congress even considered the pos-

sibility that the provision would preempt state tort suits, the

p”esumption against preemption, and the legislative purpose

of the MDA, it is plain that the “requirements” preempted

under the statute do not include state tort law suits.

Based upon the foregoing, the amici respectfully request

that this Court reverse the decision of the Second Circuit and

remand the case for trial.

Nw

tr

Respectfully submitted,

MICHAEL D. GREEN WILLIAM B. SCHULTZ.

SCHOOL OF LAW Counsel of Record

WAKE FOREST UNIVERSITY LISA L. BARCLAY

BOX 7206 REYNOLDA SIN ZUCKERMAN SPAEDER LLP

WINSTON SALEM, NC 27106 = 1800 M. STREET, NW

(336) 758-4842 WASHINGTON, DC 20036

(202) 778-1800

Attorneys for Amici Curiae

August 2007