Amicus Curiae Brief — Cipollone v. Liggett Group, Inc.

Supreme Court brief1992

Ask Donna

What actually matters in this document.

Text

AMICUS CURIAE

BRIEF

Ris 4 Sis

f IN THE

5 Supreme Court of the United States

t , OCTOBER TERM, 1991

e THOMAS CIPOLLONE,

Ue Petitioner,

4 v.

LIGGETT GROUP, INC., et al.,

Respondents.

ON WRIT OF CERTIORARI TO THE UNITED STATES

COURT OF APPEALS FOR THE THIRD CIRCUIT

a, ne,

BRIEF OF THE NATIONAL ASSOCIATION

OF MANUFACTURERS AS AMICUS

CURIAE IN SUPPORT OF RESPONDENTS

| Of Counsel: Diane L. Zimmerman

Jan S. Amundson Counsel of Record

General Counsel Gary E. Crawford

Quentin Riegel SKADDEN, ARPS, SLATE,

Deputy General Counsel MEAGHER & FLOM

National Association of 919 Third Avenue

Manufacturers New York, New York 100220

1331 Pennsylvania Avenue, N.W. (212) 735-3000

Suite 1500 — North Lobby Counsel for Amicus Curiae

Washington, D.C. 20004-1703

(202) 637-3058

Date: July 10, 1991

BEST AVAILABLE COPY.

TABLE OF CONTENTS

pe Fr

INTEREST OF THE AMICUS CURIAE ..........

SUMMARY OF THE ARGUMENT .............

ARGUMENT

CONGRESS HAS PREEMPTED STATE COMMON

LAW CLAIMS RELATING TO HEALTH WARNINGS

Pg ae ee

A. The Cigarette Act Expressly Preempts Any

State Action That Results In A Requirement

Relating To Smoking And Health ......

State Tort Remedies Based On Failure

To Warn Have A Regulatory Effect And

Are, Therefore, A Form Of Prohibited

ST TT eT eee

Congress Followed The Cigarette Act

Model In Drafting A Later Preemption

Provision And Did So With Full Knowl-

edge Of The Preemptive Effect Given

That Language By The Federal Circuits

B. Preemption Is Implied From A Direct, Ac-

tual Conflict Between The Purposes Of Con-

gress And The Effect Of State Tort Actions

FOP Fe OP HD bebe eee ecaees

An Intent To Preempt Common Law

Tort Remedies Is Implied By The Pur-

pose, Structure And Language Of The

The Arguments Against Implied Pre-

emption Are Not Persuasive .......

a. Preemption Should Not Be Denied

Simply Because Congress Has Pro-

vided No Alternative Remedy .. .

b. Congress Struck A Balance Between

Economic And Health Goals In

Drafting The Cigarette Act, And

The States Are Not Free To “‘Im-

prove’’ Upon That Balance Through

CE se 20

c. State Tort Remedies Based On Fail-

ure To Warn Actually And Directly

Conflict With The Operation Of The

Cigarette Act... ccc cc ccnee 21

II. REVERSING THE THIRD CIRCUIT USING THE

ANALYTICAL FRAMEWORK SUGGESTED By PE-

TITIONER WOULD RESULT IN FORECLOSING

PREEMPTION CLAIMS UNDER NUMEROUS

OTR STATUTES 2... ccc cc ccccccee 25

eo eer ee 30

STATUTORY APPENDIX .......-----e2eeee A-1

TABLE OF AUTHORITIES

Page

Cases

Allen v. G.D. Searle & Co., 708 F. Supp.

See Ge BED cc cccccccccecs 29

Banzhaf v. Federal Communications Com-

mission, 405 F.2d 1082 (D.C. Cir.

1968), cert. denied, 396 U.S. 842 (1969) 21,25

Berger v. Personal Products, Inc., 115

Wash. 2d 267, 797 P.2d 1148 (1990),

cert. denied, 111 S.Ct. 1584 (1991) ... 5,28,29

Bickram v. Case I.H., 712 F. Supp. 18

De see eeeeeeeccecec 24

Blanchette v. Connecticut General Insur-

ance Corps., 419 U.S. 102 (1974) .... 13

California Coastal Commission v. Granite

Rock Co., 480 U.S. 572 (1987) ..... 16

California Federal Savings & Loan Ass@ci-

ation v. Guerra, 479 U.S. 272 (1987) . 16,17

Carlisle v. Philip Morris, Inc. , 805 S.W.2d

498 (Tex. Ct. App. 1991) ......... 2,20,21

Chicago & North Western Transportation

Co. v. Kalo Brick & Tile Co., 450 U.S.

(jj @in ioe o6 66 666 6 6.6 « 9,10

Cipollone v. Liggett Group, Inc. , 789 F.2d

181 (3d Cir. 1986), cert. denied, 479

je cactesnessececs 5,6,8,10,13,20

Cax v. Velsicol Chemical Corp., 704 F.

Supp. 85 (E.D. Pa. 1989) ......... 28

Dewey v. R.J. Reynolds Tobacco Co., 121

N.J. 69, 577 A.2d 1239 (1990)...... 2,20,21

English v. General Electric Co., 110 S. Ct.

(jj (ce ekeeseeeeeteece 17,26

Erie R. Co. v. Tompkins, 304 U.S. 64

(in enhe6eeeeeeeeee co « « 11

Feldman v. Lederle Laboratories, 234 N.J.

Super. 559, 561 A.2d 288 (App. Div.

1989), cert. granted, 122 N.J. 348 (1990) 24

ili

Ferebee v. Chevron Chemical Co. , 736 F.2d

1529 (D.C. Cir.), cert. denied, 469 U.S.

Rs sees etawaeee teesae

Fisher v. Che>s m Chemical Co., 716 F.

Supp. 1283 (w.D. Mo. 1989) ......

Fitzgerald v. Mallinckrodt, Inc., 681 F.

Supp. 404 (E.D. Mich. 1987).......

Garcia v. United States, 469 U.S. 70 (1984)

Gordon v. Niagara Machine & Tool Works,

574 F.2d 1182 (Sth Cir. 1978) ......

Greenman v. Yuba Power Products, Inc. , 59

Cal.2d 57, 377 P.2d 897, 27 Cal. Rptr.

ey Ge. weseeetresbaececees

Griggs v. Firestone Tire and Rubber Co.,

513 F.2d 851 (8th Cir.), cert. denied, 423

ae SE TE oe eccecesteececes

Illinois v. City of Milwaukee, 406 U.S. 91

UE acenéeonbécseentvasees

llosky v. Michelin Tire Corp., 307 S.E.2d

2. 5 S&S Peerrrrrrrere

Ingersoll-Rand Co. v. McLendon, 111 S. Ct.

Ge wb e026.606 60.6066 66208

International Paper Co. v. OQuelette, 479

Gee GE ED choos ccbicewecs

Jones v. Rath Packing Co., 430 U.S. 519

OG 6460066 606006 8466 6 oa8

Jackson v. Johns-Manville Sales Corp. , 781

F.2d 394 (Sth Cir.), cert. denied, 478

Wu DE cu caneceeesee.

Lavetier v. International Playtex, 706 F.

Supp. 722 (D. Ariz. 1988) ........

Lindquist v. Tambrands, Inc., 721 F. Supp.

See Ge SE BD ccccccccces

Lukaszewicz v. Ortho Pharmaceutical Corp. ,

510 F. Supp. 961, modified, 532 F. Supp.

Bae GED. We. BOGE) ccccccccsecs

MacDonald v. Ortho Pharmaceutical Corp. ,

394 Mass. 131, 475 N.E.2d 65, cert. de-

nied, 474 U.S. 920 (1985).........

Moore v. Kimberly-Clark Corp., 867 F.2d

ep Gs BE Bc bcececccoces

New York Times Co. v. Sullivan, 376 U.S.

SOG Ghee esceseesiccecs

Norfolk & W.R. Co. v. Train Dispatchers,

BBS G&. Ge. BERS GRSUED cc cc cccces:

Palmer v. A.H. Robbins Co., 684 P.2d 187

Dh PE sedceteddeeneconess

Palmer v. Liggett Group, Inc. , 825 F.2d 620

SG ED ebeeceeeecocecoces

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

Supp. 1171 (D. Mass. 1986), rev'd, 825

F.2d 620 (1st Cir. 1987) ..........

Papas v. Upjohn Co., 926 F.2d 1019 (11th

Cir. 1991), petition for cert. filed, 59

U.S.L.W. 3825 (U.S. May 29, 1991)

PPP

Pell v. Victor J. Andrew High School, 123

Ill. App. 3d 423, 78 Ill. Dec. 739, 462

PG CEEEED cocccesccocess

Piper v. Chris-Craft Industries, Inc., 430

i et SerrrrerrTrerrrrTrre

Pittstown Coal Group v. Sebben, 488 U.S.

DEP GEEEED Gcecocceceseccececs

Rinehart v. International Playtex, Inc. , 688

F. Supp. 475 (S.D. Ind. 1988) ......

Roberts v. Dow Chemical Co. , 702 F. Supp.

Pe Ge ED cecccccceces

Roysdon v. R.J. Reynolds Tobacco Co. , 849

F.2d 230 (6th Cir. 1988) ..........

San Diego Building Trades Council v.

Garmon, 359 U.S. 236 (1959) ...... .

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

MEE de éedecvecsscavis

23,24,29

4,28

13,17,21,22

25,26

10,18,19

Stephen v. American Brands, Inc. , 825 F.2d

Stewart v. International Playtex, Inc. , 672

F. Supp. 907 (D.S.C. 1967) .......

Sturm, Ruger & Co., v. Day, 594 P.2d 38

(Alaska 1979), modified, 615 P.2d 621

(1980), cert. denied, 454 U.S. 894 (1981)

Tetuan v. A.H. Robbins Co. , 241 Kan. 441,

Se PD thee bes wees

United States v. O’Brien, 391 U.S. 367

Dt sbécenateeeedecéoteecec

Statutes

Price Anderson Act, Pub. L. 85-256, 71

DMP ceceseceenses se

Federal Insecticide, Fungicide and Rodenti-

cide Act

Pee Ue ceecéeneceeacese

Federal Cigarette Labeling and Advertising

Act

Pp ae) UE ee Ge cee oeeees

PP Sis +seeeeseeeees

EP Ws © BPP ce ccccceseseces

National Traffic and Motor Vehicle Safety

Act

ED We © BREED cc cc cccccccse

Consumer Product Safety Act

BP es © Oe co ccceececccces

Comprehensive Smokeless Tobacco Health

Education Act

a KA

BD Wee © SURED ccc ccc cccces

BS UBS. § CORR 2c cc ccc ccs

Medical Device Amendments of 1976

BO Weties © BUD ccc cccccsecs

21,28

2,11,17

11,18

4,12,18

Alcoholic Beverage Labeling Act

ARE et ® re ee

Be Wes © BEEN cc ccc cecesese

Be Us OD cc cc cccecceccs

Retirement Income Security Act

29 U.S.C. §1144(c)(1) ......-----

Atomic Energy Act

42 U.S.C. §§ 2011, et seq. ........

Legislative and Regulatory Materials

134 Cong. Rec. $8821 (daily ed. June 29,

1988) (statement of Sen. Harkin)... ..

134 Cong. Rec. $17301 (daily ed. Oct. 21,

1988) (statement of Sen. Ford) ......

134 Cong. Rec. H11250 (daily ed. Oct. 21,

1988) (statement of Rep. Coehlo) ....

134 Cong. Rec. H11249 (daily ed. Oct. 21,

1988) (statement of Rep. Coehlo) ..

134 Cong. Rec. E3764 (daily ed. Nov. 10,

1988) (statement of Rep. Conyers)... .

134 Cong. Rec. E3729 (daily ed. Nov. 10,

1988) (statement of Rep. Waxman) ...

53 Fed. Reg. 29841 (1988) ..........

H.R. Rep. No. 449, 89th Cong., 1st Sess.,

reprinted in 1965 U.S. Code Cong. &

AG, FAD TD ccc ccc cccccce

S. Rep. No. 99-209, 99th Cong., 2nd Sess.

4, reprinted in 1986 U.S. Code Cong. &

GEE T oseececeeseesccoes

S. Rep. No. 100-596, 100th Cong., 2d Sess.

Dit «tes 6s 6e0eeeh6 bees

S. 2047(g), reprinted in Alcohol Warning

Labels: Hearing Before the Subcommittee

on the Consumer of the Sen. Comm. on

Commerce, Science, and Transportation,

100th Cong., 2nd Sess. 4, 10 (1988) ..

Page

10,11,15

11,12,13

12,15

6,14,15

14,15

11,12

Other Authorities

Reducing the Health Consequences of Smok-

ing: 25 Years of Progress, A Report of the

Surgeon General (DHHS Pub. No. (CDC)

Se PC. sch eek oéueee se

Restatement (Second) of Torts § 402A

Dt ss deb uk 6404. oe 6 bho bess

Ross, Legal and Practical Considerations

for the Creation of Warning Labels and

Instruction Books, Prac. Law Inst. Litiga-

tion and Admin. Prac. Course Handbook

No. 379: Litigation 103 (1989) ......

Schwartz & Driver, Warnings in the Work-

place: The Need for a Synthesis of Law

and Communication Theory, 52 U. Cin.

id so. db eebeesce

Twerski, Weinstein, Donaher & Piehler, The

Use and Abuse of Warnings in Products

Liability— Design Defect Litigation Comes

of Age, 61 Cornell L. Rev. 495 (1976) .

W. Keeton, D. Dobbs, R. Keeton, & D.

Owen, Prosser and Keeton on Torts (Sth

Ge Gb eS ee bbetKdeecees

Viii

24,25

No. 90-1038

IN THE

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1991

THOMAS CIPOLLONE,

Petitioner,

LIGGETT GROUP, INC., ef al.,

Respondents.

ON WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

BRIEF OF THE NATIONAL ASSOCIATION

OF MANUFACTURERS AS AMICUS

CURIAE IN SUPPORT OF RESPONDENTS

INTEREST OF THE AMICUS CURIAE

The National Association of Manufacturers of the United

States of America (“‘NAM”’’) is a voluntary business association of

approximately 12,500 companies and subsidiaries, employing

eighty-five percent of all manufacturing workers and producing

over eighty percent of the nation’s manufactured goods. More than

158,000 additional businesses are affiliated with NAM through its

Associations Council and National Industrial Council. NAM and

these councils are vitally interested in a balanced and proper inter-

pretation of the scope of preemption language in federal statutes.

Letters of consent from the parties permitting the filing of this brief

have been filed with the Clerk of the Court.

SUMMARY OF THE ARGUMENT

The Third Circuit correctly held that the Federal Cigarette

Labeling and Advertising Act (“‘Cigarette Act’’), 15 U.S.C.

§§ 1331 et seq., preempts common law duty to warn claims,! but it

erred in finding preemption merely to be implied. The express pre-

emption provision of the Act unambiguously removes all state

authority to require that statements relating to smoking and health,

other than those prescribed by Congress, appear on cigarette

packaging. Because state common law tort actions have a clear

regulatory effect on the conduct of manufacturers with regard to

warnings, such actions fall squarely within the scope of the express

preemption provision of the Cigarette Act.

Even if this Court were not to find express preemption, it

should affirm the Third Circuit on the ground that preemption is im-

plied. A direct, actual conflict exists between the federal purpose

underlying the Act and the effect of state tort actions for failure to

wam. Congress intended the uniform warnings required by the Act

to facilitate interstate commerce and protect against diverse

warnings. Common law actions in state courts would inevitably im-

pose a hodgepodge of additional warning requirements. If manufac-

turers attempt, as they must, to respond by changing their warning

labels, or by disseminating additional information through other

means, Congress’ stated goal of ensuring nonconfusing and nation-

ally uniform warnings would be defeated.

1 The interest of amicus in this case largely concerns the mistaken views on the

law of preemption that have been adopted by the Petitioner and his amici and the

courts in Dewey v. RJ. Reynolds Tobacco Co., 121 N.J. 69, 577 A.2d 1239

(1990) and Carlisle v. Ph.tip Morris, Inc., 805 S.W.2d 498 (Tex. Ct. App. 1991).

We believe that the error of these views can be demonstrated through analysis of

the Cigarette Act’s preemptive effect on failure to warn claims. There is, therefore,

no need to discuss separately the issues concerning preemption cf claims based

upon the propriety of Respondents’ advertising. We note, however, our full agrec-

ment with Respondents’ interpretation of the Cigaretse Act with regard to the pre-

emption of such claims. By clearly providing that n> requirements or prohibjtions

relating to smoking and health may be imposed by the states with respect to the

labeling, advertising, or promotion of cigarettes, the statutc preempts not merely

actions for the things that cigarette manufacturers have not said about smoking and

health (i.¢., claims alleging failure to warn) but also suits for what they have

communicated (¢.g., claims alleging misrepresentation).

Finally, this Court should reject Petitioner’s invitation to adopt

a broad and inflexible rule that preemption cannot occur unless ei-

ther Congress expresses its intent ‘‘with drastic clarity”’ or there is

no sense, however farfetched, in which state and federal law can co-

exist. Such a rigid approach would require the Court to abandon its

long-established and highly appropriate practice of deciding pre-

emption questions by fact-specific inquiries into the purpose, struc-

ture, and language of particular pieces of legislation and particular

conflicts between state and federal law.

ARGUMENT

I. CONGRESS HAS PREEMPTED STATE COMMON LAW

CLAIMS RELATING TO HEALTH WARNINGS

A. The Cigarette Act Expressly Preempts Any State Action

That Results In A Warning Requirement Relating To Smok-

ing And Health.

The Third Circuit correctly found that the Cigarette Act pre-

empts state tort actions for failure to warn. The amicus differs with

the Third Circuit on this point in only one respect: we believe, in

contrast to the court below, that the statute should be found to pre-

empt such actions expressly. This does not mean that the courts that

have found implied preemption were incorrect in discerning an ac-

tual conflict between state tort actions based on the alleged inad-

equacy of the health information provided by the cigarette

manufacturers and the federal purposes underlying the Cigarette

Act—but merely that tort requirements with respect to warnings

also fall within the scope of the express preemption provision. We

urge this Court to find that Congress expressed its expectation di-

rectly in the language it chose for the preemption clause: a tort rem-

edy is preempted because it is a form of prohibited requirement.

The court below confused the analysis of this question because

it assumed that Congress, if it wished to preempt state tort remedies

directly, would have done so using specific rather than general

terms —that is, by actually specifying that states could not use tort

actions as a method of frustrating the purpose of the Act. But the

express preemption in this statute was accomplished in a different

way. Congress, rather, chose to address preemption comprehen-

sively, prohibiting other warning requirements relating to smoking

and health regardless of how or by whom such requirements might

be imposed. 15 U.S.C. § 1334(a).2 Because Congress made ab-

solutely clear that it wished to preempt state-imposed warning

requirements, the only question this Court must decide, to deter-

mine this aspect of the case, is whether tort remedies based on fail-

ure to warn are a form of requirement. If they are, and we argue that

this point is incontrovertible, then it is respectfully submitted that

the Court must find express preemption in this case.

A presumption against preemption was used by the court below

as a reason to demand specific language addressing tort remedies in

order to find express preemption. This reasoning was incorrect. The

presumption against preemption supports the interests of federalism

by providing a rule of decision for cases where it is a close question

whether or not Congress intended to displace state authority. It is

not an arbitrary stricture meant to disfavor particular means for

evincing that intent. The lower court’s approach imposes on Con-

gress an unjustifiably rigid standard for the drafting of statutes. If

that analysis is upheld, Congress will be able to achieve express pre-

emption in only one way —by spelling out in great detail every spe-

cific act that is prohibited—whereas it can impliedly preempt

exactly the same activity simply by the general way in which an act

is structured. Such a rule erects unjustified and artificial barriers to

permitting the express intent of Congress to be credited by the

courts. It should be rejected.3

2 The text of this section is set out in the Statutory Appendix (Stat. App.) at

A-1.

3 By contrast, a very different treatment has been accorded similar language in

another statute. The Medical Device Amendments of 1976, 21 U.S.C. §§ 360c er

seq., Contain a preemption provision worded much like that in the Cigarette Act.

See 21 U.S.C. § 360k(a) (text set out in Stat. App. at A-1). The preemptive effect

of this statute has been widely tested in the courts below, largely in cases of toxic

shock attributed to tampon use. The Act has almost always becn held to preempt

tort actions for failure to warn, and in several instances, the courts have found that

intent to have been directly expressed by Congress in § 360k(a). See, e.g., Moore

v. Kimberly-Clark Corp., 867 F.2d 243, 247 (Sth Cir. 1989); Rinehart v. Inter-

While it is true that, in certain circumstances, Congress has

used both preemption and savings clauses that identify specific ac-

tors or types of actions,‘ there is certainly no rule that Congress can

only draft statutes in one way. Congress is entirely free to adopt any

form of words it chooses to accomplish its purposes, including

drafting a preemption provision, as it has here, that identifies a re-

sult, rather than a specific form of action, it wishes to prevent.

The advantage of identifying the desired result is obvious: it

allows Congress to achieve its objective without having to predict in

advance every possible circumstance under which an exercise of

state authority could defeat or distort its aims. That this was the path

Congress took in the Cigarette Act has been implicitly acknowl-

edged by the courts below. It is quite evident that the very presence

of the broadly couched preemption clause here at issue is a major

reason preemption of state tort actions by the Cigarette Act has been

so widely recognized by both state and federal courts. See, e.g.,

Cipollone v. Liggett Group, Inc. , 789 F.2d 181, 186 (3d Cir. 1986)

(broad language of preemption clause one piece of evidence relied

upon to find implied preemption), cert. denied, 479 U.S. 1043

(1987).

A reason why it is advantageous to allow Congress to target a

result rather than specific means is that Congress cannot always pre-

dict how the law will develop. This fact is demonstrated by the

historical context of the Act. The Cigarette Act was first passed at a

time of great ferment. State and local authorities as well as federal

administrative agencies had been galvanized by the 1964 Surgeon

General’s Report on Smoking and Health into looking for ways to

national Playtex, Inc., 688 F. Supp. 475, 477 (S.D. Ind. 1988); Stewart v. Inter-

national Playtex, Inc., 672 F. Supp. 907, 909 (D.S.C. 1987); Berger v. Personal

Prods., Inc., 115 Wash. 2d 267, 275, 797 P.2d 1148, 1152 (1990), cert. denied,

111 S. Ca. 1584 (1991). Nothing in the opinions reveals a reason to find express

preemption in this language and not to find it in the similar “‘requirement”’ lan-

guage of the Cigarette Act.

4 For example, the Consumer Product Safety Act of 1972 requires nationwide

compliance with federal safety standards but specifies that such compliance is not a

defense to liability under state statutory or common law. 15 U.S.C. § 2074. Simi-

larly, Congress included a savings provision for tort liability arising under either

State statutes or common law in the Comprehensive Smokeless Tobacco Health

Education Act of 1986. 15 U.S.C. § 4406(c). See pp.13—15, infra.

regulate the tobacco industry and educate consumers on the risks of

smoking. See H.R. REP. NO. 449, 89th Cong., Ist Sess., reprinted

in 1965 U.S. Code Cong. & Admin. News 2350, 2351-53. State

tort law was also in a period of change. The first important decision

applying the doctrine of strict tort liability to a personal injury action

arising from a defective product had been handed down only two

years before. Greenman v. Yuba Power Prods., Inc. , 59 Cal.2d 57,

377 P.2d 897, 27 Cal. Rptr. 697 (1963). Section 402A of the

Restatement (Second) of Torts, a strict liability formulation sub-

sequently adopted by most states for analyzing product liability

claims, was working its way through the process of adoption by the

American Law Institute in the period immediately preceding the

passage in 1965 of the original version of the Cigarette Act.

In the face of so much and such varied activity, it is little won-

der that Congress did not feel compelled (or perhaps able) either in

1965, when it wrote the preemption provision, or in 1969, when it

amended it, to predict every specific sort of activity that conflicts

with its objectives.5 Nor should it be required to do so. Rather it

chose to speak in terms of preempting state requirements. With re-

spect to tort judgments based on failure to warn, the relevant ques-

5 Petitioner cites to certain colloquies that occurred during consideration of the

1965 Cigarette Act and the 1969 amendments to support his claim that Congress

did not intend tort actions to be within the reach of the preemption provision. See

Brief for Petitioner at 33-36, nn. 41, 42. The most that can be said for these bits of

debate is that they suggest that some members of Congress believed that at least

some tort claims for personal injury would survive the passage of the Act. A de-

cision by this Court to affirm Cipollone, which finds preemption as to some but not

all of Petitioner’s claims, would in no way be inconsistent with that understanding.

The discussions do not suggest that those members of Congress had thought very

deeply about the possible impacts of tort law on its legislative scheme, but they

certainly do not evince a willingness to have the objective of a uniform national

system of warnings undercut by diverse judge- or jury-made rules. Because leg-

islative history must be used cautiously, see Piper v. Chris-Craft Industries, Inc.,

430 U.S. 1, 26 (1977), and because colloquies like these are among the least reli-

able forms of legislative history, see Garcia v. United States, 469 U.S. 70, 76

(1984); United States v. O’Brien, 391 U.S. 367, 385 (1968), this Court should not

give undue weight to these passages as evidence which contradicts the express lan-

guage, purpose and structure of the Act. The text itself provides the clearest, most

reliable evidence of what Congress intended to achieve.

tion, therefore, is simply whether such judgments are a form of

requirement. If so, then they have been expressly preempted.

1. State Tort Remedies Based On Failure To Warn Have A

Regulatory Effect And Are, Therefore, A Form Of Prohib-

ited Requirement.

Petitioner and his amici say that there is no express preemption

under the Cigarette Act because tort judgments are not a form of

requirement. Their argument is naive, and ultimately self-contradic-

tory. They attempt to downplay the regulatory nature of tort verdicts

for failure to warn by claiming that tort actions primarily com-

pensate victims and affect the future behavior of defendants at most

indirectly, and often not at all. They suggest that a verdict in favor

of a plaintiff cannot be a requirement because such a verdict lacks

the compulsory effect of a state statute or regulation. The defendant,

according to this argument, can decide not to change its behavior

but can instead simply opt to pay. This argument is wrongheaded

for many reasons, © but in particular because it ignores altogether the

peculiar nature of failure to warn claims involving mass-produced

products.

Although some might argue that tort actions for ordinary neg-

ligent injury are primarily compensatory and only incidentally regu-

latory, the same could not be said for failure to warn claims in

product cases. A traffic accident may occur in hundreds of ways,

and — fortunately for all of us—it will be a rare driver who causes

6 The argument that tort judgments do not regulate because the defendant has a

choice simply to pay money is no more convincing than the same argument would

be if applied to a criminal fine. In those cases, too, the defendant need not change

his behavior, but can simply pay. That fact alone does not mean that criminal law ts

not regulatory. Nor can it be argued that criminal fines are different because, if the

wrongdoer persists in his misconduct, the penalty will be increased. The same is

true in the tort system. A manufacturer who pays a failure-to-warn judgment with-

out modifying its subsequent behavior exposes itself to punitive damages in later

cases; a refusal to change its behavior becomes evidence of willful and wanton mis-

conduct or reckless disregard of safety that justifies exemplary damages. See, e.g.,

Sturm, Ruger & Co. v. Day, 594 P.2d 38, 47 (Alaska 1979) (punitive damages a

way to insure that manufacturer cannot opt merely to pay), modified, 615 P.2d 621

(1980), cert. denied, 454 U.S. 894 (1981). This fact is conveniently ignored by

Petitioner and his amici in making their argument that tort remedies are not

compulsory.

them repeatedly and each time in precisely the same fashion. Thus,

a successful suit against a careless driver will be quite fact-specific,

and although it will hopefuily encourage that person to take greater

care in the future, it could be argued that the primary function of the

verdict is to provide a particular victim with compensation.

In contrast to the defendant whose momentary carelessness

causes an isolated accident, a product manufacturer or distributor

who breaches its duty to warn exposes every consumer of the prod-

uct to a similar potential risk; the manufacturer’s course of conduct

that leads to Consumer A’s injury is indistinguishable from that

which injures Consumers B and C. At least as important as the

compensation of the victim, therefore, is the impetus provided by

the threat of repeated damage awards against a manufacturer or a

seller of consumer goods with the capacity to inflict similar harm on

numerous users.

An even more extreme manifestation of the regulatory objec-

tive of products liability litigation is found in the availability of pu-

nitive damages for failure to warn. See, e.g., Jackson v. Johns-

Manville Sales Corp., 781 F.2d 394, 399-407 (Sth Cir.), cert.

denied, 478 U.S. 1022 (1986) (punitive damages available for fail-

ure to war); Tetuan v. A.H. Robins Co. , 241 Kan. 441, 738 P.2d

1210 (1987) (same); Palmer v. A.H. Robins Co., 684 P.2d 187

(Colo. 1984) (same). Awards of punitive damages are well rec-

ognized to be for the purpose of “‘teaching the defendant not to do it

again, and of deterring others from following the defendant’s exam-

ple.”” W. KEETON, D. DoBBS, R. KEETON, & D. OWEN, PROSSER

AND KEETON ON TORTS 9 (Sth ed. 1984).

This reality clearly explains the argument against preemption

made in the amicus brief submitted on behalf of twelve states,

which contradicts Petitioner’s claim that tort damage judgments do

not regulate. These states urge that Cipollone be reversed precisely

because products liability tort actions in fact do regulate. They ar-

gue that the states should be permitted to retain authority to promu!-

gate tort rules in this area because such rules act as a prophylactic

against future harm. As the states recognize, tort actions

[encourage] manufacturers to produce a safer product and de-

sign better consumer warnings regarding the dangers of ciga-

rette smoking . . . . Thus, state common law is an additional

tool, complementary to statutory enactments, to minimize the

harmful health effects of cigarette smoking on their citizens.

Brief Amici Curiae of the State of Minnesota, et al., in Support of

Petitioner at 6.

We believe that the states are clearly correct in their evaluation

of the effect of tort rules. Where we part company with them, how-

ever, is on the conclusion they draw from their observation. In their

brief, the states express a desire for authority to regulate in the area

of warnings through operation of their tort rules. This is just the

authority that Congress has denied them. The fact that the states dis-

agree with this decision does not change the fact that Congress was

entitled to make it, and did.

That tort actions can have the effect of a regulatory require-

ment has been well-recognized by this Court, a fact which could not

have been entirely beyond the ken of Congress when it drafted the

earliest version of the Act in 1965. Six years before, in San Diego

Building Trades Council v. Garmon, 359 U.S. 236 (1959), this

Court had found state tort actions to be a preempted form of regula-

tion. The opinion stated clearly that ‘‘[R]egulation can be as effec-

tively exerted through an award of damages as through some form

of preventive relief. The obligation to pay compensation can be, in-

deed is designed to be, a potent method of governing conduct and

controlling policy’’. Jd. at 247. And in 1964 in the landmark

defamation case, New York Times Co. v. Sullivan, this Court ob-

served that, ‘“The fear of damage awards . . . may be markedly

more inhibiting than the fear of prosecution under a criminal stat-

ute.”” 376 U.S. 254, 277 (1964).

Later decisions have also acknowledged that common law

rules can regulate in ways that conflict with federal statutes and

regulations. See, e.g., International Paper Co. v. Ouellette, 479

U.S. 481, 494-95 (1987) (state common law nuisance actions are a

form of conflicting regulation and preempted to the extent that they

contravene the federal water pollution control scheme); Chicago &

North Western Transp. Co. v. Kalo Brick & Tile Co., 450 U.S.

311, 323-27 (1981) (state actions for common law negligence and

interference with contractual relations a form of regulation pre-

empted by the Interstate Commerce Act).

Although the decision in Silkwood v. Kerr-McGee Corp. , 464

U.S. 238 (1984), is heavily relied upon by the Petitioner, as well as

by the District Court in the first Cipollone ruling, to support a find-

ing that common law remedies are not preempted by the Cigarette

Act, Silkwood does not in any sense stand for the proposition that a

requirement imposed by common law is not a “‘real’’ requirement

for preemption purposes. In fact, this Court specifically acknow!-

edged in Silkwood that liability for damages is a form of regulation.

Id. at 256.

2. Congress Followed The Cigarette Act Model In Drafting A

Later Preemption Provision And Did So With Full Knowl-

edge Of The Preemptive Effect Given That Language By The

Federal Circuits.

An additional source of insight into the meaning of the Ciga-

rette Act’s preemption clause can be gained by an examination of

what Congress did in drafting subsequent legislation. As this Court

has acknowledged elsewhere, other legislation containing similar

provisions can sometimes shed light on Congress’ intent with regard

to preemption. See, e.g. , Ingersoll-Rand Co. v. McLendon, 111 S.

Ct. 478, 485-86 (1990) (finding parallels between ERISA and the

Labor Management Relations Act with regard to preemption). In

this case, two statutes, both involving warnings and both passed at a

time when Congress was clearly aware that, courts were beginning to

examine whether tort actions were preempted by a variety of federal

Statutory schemes, provide support for the argument that the pre-

emption Clause in the Cigarette Act covers tort actions rooted in fail-

ure to warn. Those statutes are the Alcoholic Beverage Labeling Act

of 1988 (“Alcohol Act”’), 27 U.S.C. §§ 213 et seg., and the Com-

prehensive Smokeless Tobacco Health Education Act of 1986

(““Smokeless Tobacco Act”’), 15 U.S.C. §§ 4401 et seg.

The Alcohol Act is instructive because it parallels the Cigarette

Act in important regards.” Like the Cigarette Act, it starts with a

statement of purpose and policy. 27 U.S.C. § 213.8 Although some-

what more detailed than the equivalent provision in the Cigarette

Act, 15 U.S.C. § 1331, it states a similar intent to strike a balance

between the public’s need for information about health risks and the

need to protect “‘commerce and the national economy.”’ In both

statutes, Congress itself dictates the contents of the required

warnings.9 The Alcohol Act, like the Cigarette Act, also contains a

broadly-worded preemption provision. 27 U.S.C. § 216. Using lan-

guage very similar to that in the Cigarette Act, the Alcohol Act pro-

vides that “‘[nJo statement relating to alcoholic beverages and

health, other than the statement required by [this Act], shall be re-

quired under State law’’ on any container or box or other packaging

of alcoholic beverages. 10

There is strong evidence that use in the Alcohol Act of the

same kind of preemption provision used in the Cigarette Act was

thought by its drafters also to preclude state tort actions for failure to

warn. In the original version of S. 2047, the bill that ultimately be-

came the Alcohol Act, a savings clause had been inserted which

said that:

Nothing in this section shall be construed to relieve any

person from any liability under Federal or State law to any

other person.

7 The most significant difference is that the Alcohol Act is limited to warnings

on beverage containers and packaging; the Act does not address advertising.

8 Section 213 is set out in Stat. App. at A-1.

9 Compare 15 U.S.C. § 1333 with 27 U.S.C. § 215(a).

10 The Alcohol Act defines “‘state law” to include “‘statutes, regulations, and

principles and rules having the force of law.” 27 U.S.C. § 214 (11). This definition

is consistent with the numerous court opinions that have held that the terms ‘‘law’’

or **state law”’ include common law rules, see, ¢.g., Norfolk & W. R. Co. v. Train

Dispatchers, 111 S. Ct. 1156, 1163 (1991); Iilinois v. City of Milwaukee, 406 U.S.

91, 100 (1972); Erie R. Co. v. Tompkins, 304 U.S. 64, 71, 79 (1938), and with the

definition of “‘state law’ in other federal statutes. See, ¢.g., 29 U.S.C. §

1144(c)(1) (ERISA) (defining “‘state law” to include “‘laws, decisions, rules,

regulations, or other State action having the effect of law’’). There is no reason to

S. 2047(g), reprinted in Alcohol Warning Labels: Hearing Before

the Subcommittee on the Consumer of the Sen. Comm. on Com-

merce, Science, and Transportation, 100th Cong., 2d Sess. 4, 10

(1988). The bill was subsequently amended to replace a lengthy se-

ries of findings on the health consequences of alcohol use and abuse

with the current Declaration of Policy and Purpose, focusing (as

does the equivalent provision of the Cigarette Act) on balancing

economic and health goals. In addition, the savings clause was

eliminated and, in its place, the broad preemption provision noted

above was added.

This history suggests that, as the purpose of the legislation

changed from a purely public health measure to an accommodation

between economic and health concerns, Congress dropped the sav-

ings clause for the express purpose of precluding those state tort ac-

tions that endanger the accommodation.!! It would seem odd indeed

for Congress to use virtually the same language in the Alcohol Act

that it did in the Cigarette Act while anticipating that one provision

would be interpreted to preempt all inconsistent state actions includ-

ing tort remedies and that the other would not.

believe Congress meant the term “‘state law”’ in the Cigarette Act, 15 U.S.C. §

1334(b), where it is undefined, to have any different meaning.

11 Although comments during floor debate should be used cautiously in

determining congressional intent, the discussion of preemption prior to enactment

of the Alcohol Act lends further credence to the view that Congress intended the

Act to displace state tort actions. In describing the legislation to the Senate immedi-

ately prior to its passage, Senator Ford stated:

One of the most difficult provisions to reach agreement on in this measure was

the preemption language of section 205 [27 U.S.C. § 216]. This section was

critical to the success of the negotiations and to my support of it. * * * In an

attempt to minimize the burden on what is a legitimate and responsible in-

dustry, the preemption provisions of this act avoid what could otherwise be a

multitude of inconsistent statutes, regulations, and common law rules. . . . \t

is my understanding that this section is to be [read] and administered so as to

preclude any State or local authority, through legislation, regulation, or ju-

dicial interpretation, from requiring a different warning [label] on beverage

alcohol containers. We intend that Congress exclusively reserve the power to

consider whether, due to future developments or other considerations, any

additional or differential warnings will be required on beverage alcohol

containers.

134 CONG. REC. $17301 (daily ed. Oct. 21, 1988) (emphasis added). Similarly,

just prior to House passage of the Act, Representative Coehlo told his colleagues:

Furthermore, Congress followed the Cigarette Act model in the

face of a consensus of court decisions finding the Cigarette Act to

preempt duty to warn actions. At the time the Alcohol Act was

passed late in 1988, every federal Court of Appeals that had consid-

ered the issue had found state tort law to be preempted by the Ciga-

rette Act. See Roysdon v. R.J. Reynolds Tobacco Co. , 849 F.2d 230

(6th Cir. 1988); Palmer v. Liggett Group, Inc., 825 F.2d 620 (ist

Cir. 1987); Stephen v. American Brands, Inc. , 825 F.2d 312 (11th

Cir. 1987); Cipollone v. Liggett Group, Inc. , 789 F.2d 181 (3d Cir.

1986), cert. denied, 479 U.S. 1043 (1987). Congress’ use of al-

most identical statutory language in the face of these highly publi-

cized judicial interpretations arguably evinces agreement with the

result reached by the courts.12

The Smokeless Tobacco Act, 15 U.S.C. § 4401 ef seq.,

presents a telling contrast. Like the Cigarette and Alcohol Acts, the

Smokeless Tobacco Act also sets out the text of the required warn-

ing, id. § 4402. The statute has a preemption provision that prohib-

To avoid a crazy quilt of inconsistent statutes, regulations and common law

rules that would subject alcoholic beveragcs to intolerable burdens, section

205 [27 U.S.C. § 216] makes clear that under the act the power to regulate the

labeling of alcoholic beverages to achieve public health objectives rests exclu-

sively with the Congress.

134 Conc. REC. H11250 (daily ed. Oct. 21, 1988) (emphasis added). Contrary

statements, denying an intent to preempt tort law, were inserted into the record by

two Congressmen after the statute was enacted, see 134 CONG. REC. E3764 (daily

ed. Nov. 10, 1988) (statement of Rep. Conyers); id. at E3729 (statement of Rep.

Waxman). Post-enactment statements such as these, however, have little, if any,

interpretive value because they were not before Congress at the time it decided

whether, and in what form, to pass the legislation. See, ¢.g., Pittstown Coal Group

v. Sebben, 488 U.S. 105, 118-119 (1988); Blanchette v. Connecticut Gen. Ins.

, 419 U.S. 102, 132 (1974).

12 While the decisions in question found implied rather than express pre-

emption, that distinction was unlikely to have affected Congress’ thinking. The

main point is that Congress could not have had any significant doubt that its new

initiative would be interpreted by the courts as preempting inconsistent tort require-

mers. For example, during consideration of the Alcohol Act, Senator Harkin in-

seried an article from The New Republic into the Congressional Record. That article

discussed the fact that the Cigarette Act had been held in Cipollone to prevent

recovery for failure to warn and suggested that the pending alcohol labeling Icgisia-

tion would benefit alcoholic beverage manufacturers by similarly protecting them

from such suits. 134 Conc. Rec. $8821-22 (daily ed. June 29, 1988).

its the requirement of any other statement by “‘any State or local

Statute or regulation.”’ id. § 4406(b). Unlike the Cigarette and Al-

cohol Acts, it provides that, ‘‘Nothing in this chapter shall relieve

any person from liability at common law or under State statutory

law to any other person.”’ Jd. § 4406(c).13

This important difference between the Smokeless Tobacco Act

and the Cigarette and Alcohol Acts is attributable to the different

purposes of the respective sets of laws. The Smokeless Tobacco Act

is wholly a public health measure; nowhere on the face of the statute

‘is one word said about balancing health concerns against the

competing claims of interstate commerce and the national economy.

Indeed, the legislative history of the Act makes abundantly clear

that Congress did not have balancing in mind.

The reason is that the economic and health aspects of the equa-

tion were, in Congress’ view, quite different in the case of smoke-

less tobacco. First, compared with the cigarette and alcoholic

beverage industries, the impact of smokeless tobacco on the na-

tional economy was minor. Cigarettes and alcoholic beverages are

much larger industries, with spillover effects on many other sectors

of the economy. Thus, their fiscal ‘‘health’’ was a legitimate con-

cern of Congress. The House Report on the original Cigarette Act

noted that the effects of regulation of health warnings could be felt

by “‘the entire tobacco raising and manufacturing industry, and the

numerous businesses which market tobacco products,’’ including

“‘the television, radio, and publishing industries.”” H.R. REP. No.

449, 89th Cong., 1st Sess., reprinted in 1965 U.S. CODE CONG. &

ADMIN. NEWS 2350, 2352. The Senate Report on the Alcohol Act

stresses that the choice of a single warning for all beer, wine and

spirits is intended ‘‘to avoid misleading information and minimize

burdens on interstate commerce.”’ S. REP. NO. 100-596, 100th

Cong., 2d Sess. 5 (1988). Without reasonable, uniform directions

on how to accommodate their business practices to the public need

for health information, the cigarette and alcohol industries and asso-

ciated businesses could suffer considerable financial harm in the

form of a tangle of inconsistent local statutes and regulations as well

as from the potential for unpredictable and significant tort claims.

13 This is the same language that appeared in the original Senate version of the

Furthermore, because Congress could count on a considerable

reservoir of already-existing public knowledge about both alcoholic

beverages!4 and cigarettes!5 — which did not, in Congress’ view,

exist in the case of smokeless tobacco!® — it was able, responsibly,

to balance its desire to provide consumers with clear, non-confusing

information on risks, while at the same time preserving for the ciga-

rette and alcohol industries freedom from ‘‘a multiplicity of State

and local regulations’ and ‘‘chaotic marketing conditions.’’!7 It

would have made no sense, given the factual circumstances and

Congress’ dual goals, either for Congress to have included a savings

14 Congress recognized when it enacted the Alcohol Act that the public was

already very well-informed about risks associated with alcohol consumption and

abuse. Comments about the high degree of public awareness of the major health

effects of alcoholic beverage abuse appear throughout the legislative history of the

Alcohol Act, often supported by references to national polling data. See, e.g. , 134

CONG. REC. H11249 (daily ed. Ort 21, 1988) (statement of Rep. Coehlo) (aware-

ness is “nearly universal’); id. at $17301 (statement of Sen. Ford) (awareness is

“‘widespread’’). As a result, Congress characterized its purpose in requiring the

statutory warning as providing a “‘reminder’’. 27 U.S.C. § 213.

15 As a result of the enormous publicity surrounding the 1964 Surgeon Gen-

eral’s Report on Smoking and Health and the vigorous public education campaign it

generated, the House Committee on Interstate and Foreign Commerce observed in

1965 that “‘many persons . . . already are aware of the smoking and health issuc.””

H.R. REP. No. 449, supra, 1965 U.S. Cope Conc. & ADMIN. News at 2352. The

House Report notes that, largely as a result of this publicity, one out of four adult

male smokers had given up cigarettes in the previous year. /d. In 1964, the year

before the passage of the Cigarette Act, 81% of adults agreed that smoking is harm-

ful to health. Reducing the Health Consequences of Smoking: 25 Years of Progress,

A ro gen of the Surgeon General at 179 (DHHS Pub. No. (CDC) 89-8411, 1989).

16 The 1964 Surgeon General’s Report launched a national effort to educate the

public on the risks associated with cigarette smoking. Congress concluded, how-

ever, that an unanticipated outcome of this campaign was to send some consumers

in search of a ‘‘safe”’ substitute for cigarettes. Many apparently turned to smoke-

less tobacco products. According to Congress, the sales of products like snuff and

chewing tobacco burgeoned because some were ‘‘under the mistaken impression

that the use of smokeless tobacco carries no significant risk to health,”’ and was “‘a

safe and healthful alternative to cigarettes.’ S. REP. NO. 99-209, 99th Cong., 2nd

Sess. 4, reprinted in 1986 U.S. Cope Conc. & ADMIN. NEws 7, 10. The exclusive

purpose of the smokeless tobacco legislation, therefore, was to close this perceived

information gap.

17 H.R. REP. NO. 449, supra, 1965 U.S. Cope Conc. & ADMIN. NEWS at

2352 (Cigarette Act). See also, S. REP. NO. 100-596, 100th Cong., 2d Sess. 5

(1988) (Alcohol Act).

clause in this legislation, or to have chosen to tolerate any form of

inconsistent state or local regulation of warnings, including that im-

posed by virtue of tort law.

When all these considerations are taken into account, the

conclusion that the preemption language in the Cigarette Act

reaches all state requirements relating to warnings is difficult to

avoid. Because tort law judgments plainly impose requirements,

they fall within the scope of the express preemption clause of the

Act.

It is obvious from reading the amicus briefs on behalf of Pe-

titioner that, in the case of cigarettes, many fervently disagree with

the policy choice made by Congress to compromise between eco-

nomic and health interests, and that they would like this Court to

shift that balance. These sentiments may be widely shared. We

respectfully submit, however, that this case is not a referendum on

whether cigarettes should continue to be sold, or on whether Con-

gress has found the right balance between health and economic con-

cerns. Those policy questions are for Congress. The only question

here is what Congress meant by the express language it used, and

we submit that the answer to that question is clear.

B. Preemption Is Implied From A Direct, Actual Conflict

Between The Purposes of Congress And The Effect Of State

Tort Actions For Failure To Warn.

Even if this Court were to conclude that tort actions do not fall

within the proscriptive ambit of the express preemption provision,

the inquiry is not complete.18 As this Court has said when deciding

preemption questions, the “‘sole task is to ascertain the intent of

Congress.”’ California Fed. Savings & Loan Ass’n v. Guerra, 479

18 Petitioner and certain amici for Petitioner argue that if the preemption pro-

vision in a statute does not expressly cover a particular form of state activity, this

Court should end its inquiry. The cases cited for this proposition do not support the

simplistic analysis urged by Petitioner. In both California Fed. Savings & Loan

Ass'n v. Guerra, 479 U.S. 272 (1987), and in California Coastal Comm’n v. Gran-

ite Rock Co., 480 U.S. 572 (1987), which are cited for this proposition, the Court

in fact engaged in a searching examination of the evidence of Congress’ intent be-

fore deciding the preemption question. The Court looked at a variety of matters,

including the history of the statutes, at other provisions of the acts, and at the

U.S. 272, 280 (1987). If the preemption provision alone supplies

insufficient evidence of that intent or if no preemption provision ex-

ists, this Court’s uniform practice has been to ask whether pre-

emption can be implied from a combination of other indicia of

intent. See, e.g., International Paper Co. v. Ouellette, 479 U.S.

481, 494-97 (1987) (Court finds partial preemption, despite savings

clause, by examining congressional objectives under Clean Water

Act).

One reason to find implied preemption is that state law “‘regu-

lates conduct in a field that Congress intended the Federal Govern-

ment to occupy exclusively.”’ English v. General Electric Co. , 110

S.Ct. 2270, 2275 (1990). Another is that state law ‘‘actually con-

flicts with federal law.”’ Jd. These categories are not entirely dis-

crete, often making it possible to think of the same problem either as

one of field preemption or of actual conflict. Palmer v. Liggett

Group, Inc. , 825 F.2d 620, 624-26 (1st Cir. 1987). Most courts to

date have analyzed the Cigarette Act as posing a question of actual

conflict. What is most important, however, is that the overwhelm-

ing majority of them have found an implied intent to preempt failure

to warn actions by examining the face of the Act. The reasons for

this will quickly be discerned by the Court.

1. An Intent To Preempt Common Law Tort Remedies Is Im-

plied By The Purpose, Structure And Language Of The

Cigarette Act.

The stated purposes of the Act, its structure, and the existence

in it of a broad preemption provision all work together to make

manifest an intent to settle the question of how cigarette manufac-

turers are to fulfill their duty to see that consumers are adequately

informed about the health hazards associated with their product.

The purpose of the Cigarette Act is set out in 15 U.S.C. §

1331. This section speaks of Congress’ intent to “‘establish a com-

possibility of an actual conflict between state and federal authority. Furthermore, in

Jones v. Rath Packing Co., 430 U.S. 519, 540-41 (1977), the Court, after failing to

find express preemption, went on to conclude that state law was nonetheless

impliedly preempted. These decisions evinced no inclination to apply some cut-

and-dried summary approach to preemption analysis, and the Court is urged to con-

tinue to examine each case rigorously, fully and on its own merits. See pp. 25 —29,

infra.

prehensive Federal program to deal with cigarette labeling and

advertising with respect to any relationship between smoking and

health’’ (emphasis supplied); it then goes on to set out as dual goals

the provision of adequate information to the public while at the

same time providing protection of “‘commerce and the national

economy”” and preventing “‘diverse, nonuniform, and confusing

regulations with respect to any relationship between smoking and

health.”’ Clearly, Congress was engaged in a balancing of interests.

In pursuit of the desired balance, Congress dictated the actual

wording of the health warning. 15 U.S.C. § 1333. It also added the

preemption provisions in § 1334(a) and (b), which prohibit the im-

position on manufacturers by the states of any additional require-

ment with regard to labeling or any prohibition or requirement with

regard to advertising or promotion of cigarettes. All of this careful

crafting was obviously intended to provide cigarette manufacturers

with the considerable business benefit of a dependable, predictable

way to fulfill their responsibilities to caution consumers.

Petitioner and his amici concede that Congress wanted to dis-

place direct regulatory activity by the states with regard to warnings

so that the manufacturers, and the nation’s economy, could enjoy

the benefits of this scheme. In effect, however, they argue that Con-

gress was perfectly willing to see its carefully crafted compromise

undone by the regulatory effect of common law tort actions impos-

ing, on an ad hoc basis, a hodgepodge of additional requirements.

This argument is absurd on its face, and it is little wonder that very

few courts have accepted it. The handful of courts that have rejected

preemption seem to have based their decisions more on a dislike for

Congress’ choice of policy than on a sound, objective preemption

analysis. We suggest that this Court need look no further than the

face of this statute—at what Congress said about its intent and

expectations —to decide that the law does indeed preempt tort ac-

tions relating to health warnings.

2. The Arguments Against Implied Preemption Are Not

Persuasive.

(a) Preemption Should Not Be Denied Simply Because Con-

gress Has Provided No Alternative Remedy.

Petitioner relies heavily on this Court’s decision in Silkwood v.

Kerr-McGee Corp. , 464 U.S. 238 (1984), for the proposition that

the presumption against preemption should be applied with special

rigor in cases where individuals would otherwise be deprived of tra-

ditional state tort remedies. Petitioner cites to language in Justice

Blackmun’s dissent that, out of context, seems to support that argu-

ment. 464 U.S. at 263-64. But the reason that state tort actions were

not found to be preempted in Si/kwood turns out upon examination

to have been on quite different grounds.

The Atomic Energy Act of 1954, 42 U.S.C. §§ 2011 et seq.,

was designed by Congress to place the safety regulation of nuclear

facilities in the hands of the federal government. The Act was, how-

ever, silent on the subject of remedies for individuals injured by

radiation from such facilities. When this Court examined all the ev-

idence surrounding the Act, however, it found clear indication that

Congress had no intention of displacing the right of injured persons

to recover under state tort law. This evidence was supplied by a sub-

sequent amendment to the Act, the 1957 Price-Anderson Act, Pub.

L. 85-256, 71 Stat. 576. The Price-Anderson Act set a ceiling on

the aggregate amount of damage awards that could be imposed on a

facility for a single nuclear incident; from this, the Court not

surprisingly inferred that Congress had iniended state tort remedies

to be unaffected when it passed the earlier Atomic Energy Act. 464

U.S. at 251-53.

Had it not been for this exceedingly unambiguous signal of

congressional understanding, the case might well have come out

differently. Justice White, writing for the majority, in fact stated

that, “‘[T]his concern over the States’ inability to formulate effec-

tive standards and the foreclosure of the States from conditioning

the operation of nuclear plants on compliance with state-imposed

safety standards arguably would disallow resort to state-law rem-

edies by those suffering injuries from radiation in a nuclear plant.”’

Id. at 250-51.

No comparable evidence of intent to allow tort actions can be

found within the provisions of the Cigarette Act. The mere fact that

some remedies which might otherwise be available to plaintiffs in

State courts are removed is not, in and of itself, sufficient to require

a rigid and inflexible application of the presumption against pre-

emption where, as in the Cigarette Act, the statute itself so clearly

evinces Congress’ legitimate aims. Furthermore, Petitioner and

amici for Petitioner exaggerate the effect of preemption to the extent

that they suggest that affirmance of Cipollone will strip consumers

of all tort remedies for physical harm attributable to cigarettes. That

is simply not so; only those claims that conflict with the objective of

a unitary federal system of regulating the labeling, advertising, and

promotion of cigarettes are preempted.

(b) Congress Struck A Balance Between Economic And Health

Goals In Drafting The Cigarette Act, And The States Are

Not Free To “‘Improve’’ Upon That Balance Through Tort

Rules.

Petitioner’s argument that tort actions further the purposes of

the Cigarette Act rests on an idiosyncratic reading of the statute that

distorts its purposes. Under this interpretation, the overriding goal

of the Cigarette Act is to inform the public adequately about the

health risks of smoking. Protection of commerce and of the national

economy was merely an incidental, secondary consideration. Tort

remedies for failure to warn, it is said, merely further Congress’

purpose. Carlisle v. Philip Morris, Inc., 805 S.W.2d 498, 510-11

(Tex. Ct. App. 1991); Dewey v. R.J. Reynolds Tobacco Co., 121

N.J. 69, 87-88, 577 A.2d 1239, 1248 (1990).

The Act does say that Congress intended that the public be in-

formed about health risks by means of labeling. But it also says that

Congress intended to protect the national economy ‘‘to the maxi-

mum extent possible consistent with [the] declared policy’’ of the

Act. Importantly, Congress itself decided how to accommodate the

informational and economic values, and it did not invite the states to

rework that balance according to their own predilections. Congress

decided that the way to achieve both the economic and informa-

tional goals was to draft the specific warning message itself and to

prohibit the states from establishing any other requirements. Thus,

the Cigarette Act was not so predominantly a public health measure

that courts are justified in jettisoning Congress’ economic goals.

Rather, the Act was a compromise over which Congress exercised

plenary control. The “‘narrow”’ approach to public health taken by

the Act, reconciling public health goals with economic ones, has

been acknowledged by courts for close to two and a half decades.

See Banzhaf v. Federal Communications Comm’n, 405 F.2d 1082,

1090-91 & n.25 (D.C. Cir. 1968), cert. denied, 396 U.S. 842

(1969).

If, as Carlisle and Dewey seem to assume, Congress had in-

tended to maximize the amount of health information cigarette

manufacturers must make available to consumers each time they

pick up a pack or look at an advertisement, the structure it adopted

for the Cigarette Act was certainly an odd way to go about it. The

only reasonable conclusion is that Congress did not have the objec-

tive that the Carlisle and Dewey courts, and Petitioner, have attrib-

uted to it.

And Directly Conflict With The Operation Of The Cigarette

Act.

Petitioner’s argument that no direct conflict exists between the

Cigarette Act and state tort remedies for failure to warn is borrowed

from Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (D.C.

Cir.), cert. denied, 469 U.S. 1062 (1984). In a case involving the

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7

U.S.C. §§ 136 et seq., the Ferebee court concluded that tort rem-

edies for failure to warn did not conflict with the federally-mandated

warnings because manufacturers could comply with both federal

and state law by simultaneously using the federally-approved label

and paying tort damages.

The Ferebee reasoning splits hairs in a fashion worthy of a

medieval scholiast. The Court of Appeals for the First Circuit made

short work of this argument in Palmer v. Liggett Group, Inc. , 825

F.2d 620 (1st Cir. 1987). Calling it ‘‘disingenuous,’’ the court

added:

This ‘choice of reaction’ seems akin to the free choice of

coming up for air after being underwater. Once a jury has

found a label inadequate under state law, and the manufacturer

liable for damages for negligently employing it, it is unthink-

able that any manufacturer would not immediately take steps

to minimize its exposure to continued liability. The most ob-

vious change it can take, of course, is to change its label.

Id. at 627-28. The exercise by cigarette manufacturers of their “‘free

choice’’ to change their labels in the face of a variety of state court

decisions would, to be sure, totally defeat Congress’ stated goal of

protecting against ‘‘diverse, nonuniform, and confusing cigarette

labeling and advertising regulations.”’

Petitioner’s amici try to avoid this obvious problem with their

argument in two ways. Some say that there need be no lack of uni-

formity because manufacturers can use in all states the version of

the warning that would satisfy the most stringent of the varying state

standards. Brief of the National League of Cities, et al. , at 26 & n.

20. Presumably, this would mean warning about every conceivable

health effect of smoking, an approach which, whether or not it

meets the test of uniformity for a given manufacturer, certainly fails

miserably under the ‘‘nonconfusing”’ standard.19 In addition, this

approach would not address the problem of nonuniformity of

warnings among manufacturers as each company tries to come up

with its own response to the threat or reality of failure-to-warn suits.

19 As a policy matter, furthermore, overly comprehensive warning messages

can be counterproductive. Experts agree that ‘‘overwarning”’ can lead consumers

to disregard information. See, e.g., Twerski, Weinstein, Donaher & Pichler, The

Use and Abuse of Warnings in Products Liability - Design Defect Litigation

Comes of Age, 61 Cornell L. Rev. 495, 514 (1976); Schwartz & Driver, Warnings

in the Workplace: The Need for a Synthesis of Law and Communication Theory, 52

U. Cin. L. Rev. 38, 60 (1983). This point was acknowledged recently by the

Occupational Safety and Health Administration (OSHA). The amount of warning

information on chemicals in the workplace should be minimized, said OSHA,

because:

This approach is in keeping with the Agency’s evaluation of available data on

effectiveness . . . which indicates that the more detail there is on a label, the

less likely it is that employees will read and act on the information.

53 Fed. Reg. 29841 (1988). Petitioner’s amici have not explained why product

warnings should be controlled by the state whose law is the least consistent with

sound communications theory, and the most disrcspectful of Congress’ intent to

protect national commerce.

Others blithely suggest that the manufacturers can leave their

label warnings alone and instead fulfill their common law duty to

warn by package inserts, public service announcements, warning

brochures, instruction manuals, and general educational programs.

See Brief Amicus Curiae of the American Cancer Society ef al. at

17; Brief Amicus Curiae of the Five Former Surgeons General et al.

at 10-12. This argument is spurious; indeed no support for it is

offered.

First, if state courts were free to require a variety of these alter-

native methods of warning, the goal of a uniform regulatory scheme

for cigarette manufacturers would be defeated as surely as if courts

were to require ad hoc amendments to the current federally man-

dated warnings on cigarette packs and in advertisements. Congress

decided on the warnings manufacturers must give and on the places

where they must give them. It did so to provide businesses with the

benefit of a method they could depend on to meet their responsibil-

ity to consumers in a clear, nonconfusing way.2° The suggestion of

Petitioner’s amici is no more or less than a clever attempt to accom-

plish an end run around Congress’ objectives.

This observation has special pertinence to the suggestion that

package inserts —rather than changes in the warnings on the pack-

ages — could be used to fulfill the common law requirements. Pack-

20 To understand the business significance of a uniform regulatory scheme, the

Court must take into account the uncertainties that currently attend a manufac-

turer’s efforts to meet its common law duty to warn. Tort rules are applied on an ad

hoc basis. As a result, one way businesses can respond is to change a product warn-

ing after each successful lawsuit. Not only are considerable expenses entailed in

constant revisions of this sort, but the manufacturer musi also decide what to do

with products already in the stream of commerce. Do they need to be recalicd?

Must additional warnings be communicated as to them, and, if so, how? Alter-

natively, a manufacturer could respond by trying at the outset to devise the most

comprehensive warning imaginable. This approach, however, may result, as al-

ready discussed, in an ineffective warning. Also, as a practical matter, it is virtually

impossible to craft a warning, however comprehensive, that is certain to satisfy all

courts and all juries. See, e.g., MacDonald v. Ortho Pharmaceutical Corp., 394

Mass. 131, 475 N.E.2d 65, 71-72 (up to jury to decide whether the government-

approved language chosen for the warning adequately alerted piaintiff to the risk of

strokes from use of oral contraceptives), cert. denied, 474 U.S. 920 (1985). These

are precisely the uncertainties a uniform statutory scheme avoids.

age inserts are merely another form of labeling.2! To distinguish

package inserts from what appears on the outside of the package,

therefore, is a particularly sophistical attempt to defeat Congress’

intent.

Furthermore, it is far from clear under the law of most states

that the alternatives suggested by Petitioner’s amici would in fact be

deemed adequate alternatives to warnings on the cigarette pack it-

self. Public service announcements and educational programs may

reinforce warnings on the product, but they have yet to be held to be

a substitute for them. Cigarettes are not complex equipment like a

car or a chain saw, and the suggestion that they be sold with instruc-

tion manuals or brochures is replete with so many practical prob-

lems as to be absurd on its face.

In any event, manufacturers have no assurance that state courts

will find warnings that appear in places other than on the outside of

the package a satisfactory way to meet their duty at common law. In

many states, part of the calculus for the jury in deciding the ade-

quacy of a warning is whether its placement is adequate.?2

Warnings are typically expected to be on the product itself or on its

packaging, and liability may be imposed if the cautionary informa-

tion appears solely in a booklet or is otherwise not placed cirectly on

the product or its packaging.23 For that reason, it is standard prac-

tice to advise manufacturers to place safety warnings directly on the

product or package so that the information can be seen whenever the

consumer uses it. Ross, Legal and Practical Considerations for the

21 See, e.g., Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961,

964 (package inserts referred to as labeling), modified, 532 F. Supp. 211 (E.D.

Wis. 1981); Feldman v. Lederle Laboratories, 234 N.J. Super. 559, 561 A.2d 288,

299 (App. Div. 1989) (same), cert. granted, 122 N.J. 348 (1990); MacDonald v.

Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65, 70 (same), cert. de-

nied, 494 U.S. 920 (1985).

22 See, ¢.g., Bickram v. Case I.H., 712 F. Supp. 18, 22 (E.D.N.Y. 1989)

(applying New York law); Pell v. Victor J. Andrew High School, 123 Ul. App. 3d

423, 78 Ill. Dec. 739, 462 N.E.2d 858, 863 (1984); llosky v. Michelin Tire Corp.,

307 S.E.2d 603, 611 (W. Va. 1983).

3 See, e.g., Gordon v. Niagara Machine & Tool Works, 574 F.2d 1182, 1185-

88 (Sth Cir. 1978) (Mississippi) (warning solely in product literature inadequate);

Griggs v. Firestone Tire & Rubber Co., 513 F.2d 851 (8th Cir.) (Missouri) (same),

cert. denied, 423 U.S. 865 (1975); Hosky, 307 S.E.2d at 611 (same).

Creation of Warning Labels and Instruction Books, Prac. Law Inst.

Litigation and Administrative Practice Course Handbook No. 379:

Litigation 103, 116 (1989). As a result, no one can safely predict

that the common law duty to warn can be met while leaving the

labeling on the cigarette pack itself untouched.

In summary, if this Court reverses the Third Circuit, it will in-

deed pave the way for an actual conflict, and one of a very serious

sort. Petitioner attempts to characterize this conflict merely as an

acceptable “‘tension’”’ between state and federal objectives. This is

not ““tension”’; it is an outright pitched battle in which state author-

ity, if permitted, would directly undercut the goals the Act was de-

signed to achieve.24

Duty to warn cases are a particularly vexing area of products

liability law. The difficulty in anticipating what future courts and

juries will find to be inadequate makes sensible business decisions

about product information hard to reach. With a mass-marketed

product, the potential liability for an incorrect guess, particularly in

light of the real risk of repeated punitive damage awards, could eas-

ily be crippling. Congress chose —clearly and unambiguously — to

prevent health and safety information from becoming a vehicle for,

in the words of the Banzhaf court, ‘‘compelling the cigarette compa-

nies to dig their own graves.”’ 405 F.2d at 1090. This economic cal-

culus could easily be undone by a formalistic “‘actual conflict’’

analysis that ignores the real-world implications of the industry’s

““choice of reactions.”

fl. REVERSING THE THIRD CIRCUIT USING THE

ANALYTICAL FRAMEWORK SUGGESTED BY PE-

TITIONER WOULD RESULT IN FORECLOSING PRE-

EMPTION CLAIMS UNDER NUMEROUS OTHER

STATUTES

Given the strong evidence of congressional intent outlined

above, it is scarcely surprising that, in all but two of the jurisdic-

24 As the discussion at pp. 13—16, supra, shows, the express preservation of

common law remedies in the Smokeless Tobacco Act cannot be used to argue that

the conflict between tort remedies and the goals of the Cigarette Act is a tension

that Congress intended to tolerate in tobacco health warning legislation. Judge

Mazzone’s use of the Smokeless Tobacco Act for this purpose in Palmer v. Liggett

tions that have thus far considered the question, the prevailing rule

is that duty to warn claims are indeed preempted. Petitioner urges

this Court to disregard that strong consensus among state and fed-

eral courts. Furthermore, he urges the Court to reach that result by

applying a rule that represents a serious misreading of existing law.

The Court should find, Petitioner argues, that Congress cannot dis-

place state tort remedies unless it either expresses its intent to do so

“‘with drastic clarity’’ or there is no conceivable sense, however un-

satisfactory, in which federal and state law can coexist.

This Court should clearly and firmly reject the invitation to

adopt a rule that would exclude preemption except in cases where

Congress makes its will known not only by explicitly addressing the

result it seeks to achieve, but by detailing as well the means to that

end. Certainly, that approach would not be consistent with estab-

lished precedent. For example, in International Paper Co. v.

Ouellette, a case in which a common law tort remedy was found to

be preempted despite a broad savings clause, Justice Powell, writ-

ing for the majority, said flatly, “*[I]t is not necessary for a federal

statute to provide explicitly that particular state laws are pre-

empted.”” 479 U.S. 481, 491 (1987). Instead, the Court has decided

preemption questions by highly fact-specific inquiries into each

piece of legislation and each particular alleged conflict. What the

Court has sought to discern by careful examination of the purpose,

structure, and language of the statute is whether Congress’ intent to

displace state law is made “‘clear and manifest.’’ English v. General

Electric Co., 110 S. Ct. 2270, 2279 (1990).

“Clear and manifest’’ does not mean beyond a reasonable

doubt. It does not mean that Congress must express its intent with

absolute precision and in elaborate detail. The presumption against

preemption, as historically applied, serves to accommodate the con-

cerns of federalism while at the same time facilitating the operation

of the Supremacy Clause. By suggesting that preemption should be

found only where Congress speaks with “drastic clarity’’ or where

no alternatives, however far-fetched, would allow state and federal

Group, Inc., 633 F. Supp. 1171, 1179 (D. Mass. 1986), rev'd, 825 F.2d 620 (1st

Cir. 1987) altogether ignores the crucial differences between the two statutes that

explain why tort remedies frustrate the purpose of one act but not the other.

law to coexist, Petitioner seeks to shift the underlying nature of that

accommodation.

The reason for doing so in this case is far from clear. This is

not, after all, a matter which implicates state sovereignty under the

Eleventh Amendment; there a drastic clarity standard serves an

intelligible structural purpose, rooted in the shape and language of

the Constitution. This is a case solely implicating the exercise of

power by Congress under the Commerce Clause. That an exercise

of this power can displace state law should not be treated as a

lamentable result to be avoided whenever possible, but rather the

unremarkable outcome of the original constitutional decision to

cede authority over interstate commerce to a federal legislative body

and to back that authority with the weight of the Supremacy Clause.

Were the Court to pursue the path suggested by the Petitioner,

it would work a structural change in this criginal agreement. The

presumption against preemption would be elevated into an affir-

mative barrier, a stumbling block thrust by the judiciary onto the

path Congress takes to effectuate its legitimate legislative goals.

This would tip the balance in federal-state relations as sharply out of

equilibrium as would a broad presumption in favor of preemption.

This Court’s traditional practice of highly particularized treat-

ment of preemption cases under the Commerce Clause recommends

itself on pragmatic as well as theoretical grounds. As noted in an

earlier section of this brief, Congress will rarely be able to foresee

with unerring accuracy every development in state law that could

result in a defeat or distortion of the goals of a federal law. The

Cigarette Act, for example, was passed at a time when the law of

products liability was in its infancy. Few would have predicted, we

think, the complexities that now attach in various states to the com-

mon law duty to warn. It would be unrealistic and obstructive to

require that Congress accommodate the unpredictable future by

amending legislation to adapt to every relevant new tort rule.

A further benefit of the Court’s careful, individualized analysis

of preemption claims is that it avoids the inadvertent disposition of

other cases. Should the Court, as we urge, affirm the Third Circuit

in its usual fact-specific way, preemption claims arising under other

Statutory structures will not be prematurely decided. But if the Court

were to reverse the Third Circuit using the analytical scheme urged

by Petitioner and his amici, the effect would be to automatically

foreclose preemption claims by a wide range of manufacturers un-

der numerous other statutes.

Untimely preclusion, of course, is precisely the result that Pe-

titioner is urging. In his view, a sweeping ‘“‘drastic clarity’’ rule

would be a good thing, an effective way to put out what he charac-

terizes perjoratively as a “‘prairie fire’’ of preemption. By this, he

refers to litigation arising under a wide variety of statutes and affect-

ing a broad range of American industry. These statutes have in com-

mon a goal of achieving a degree of nationwide uniformity in

matters such as safety standards and product information. In addi-

tion to the Alcohol Act, discussed above, examples of statutes with

preemption provisions are FIFRA, 7 U.S.C. § 136v; the Medical

Device Amendments to the Food, Drug, and Cosmetic Act, 21

U.S.C. § 360k(a); and the National Traffic and Motor Vehicle

Safety Act, 15 U.S.C. § 1392(d). Other statutory schemes lack pre-

emption provisions but have nevertheless presented questions of

whether or not it is appropriate for states to regulate in the same area

by means of their tort law. Requirements by the Food and Drug

Administration for warning information on drugs are an example.

In some areas, for example FIFRA, the lower courts have di-

vided on the preemption question.25 In others, for example cases

covered by the Medical Device Amendments, support for a finding

of preemption has beeu essentially uniform, much as in the cigarette

litigation.26 In still other instances, for example those relating to

25 See, ¢.g., Papas v. Upjohn Co., 926 F.2d 1019 (11th Cir. 1991) (state tor

claims pre-empted), petition for cert. filed, 59 U.S.L.W. 3825 (U.S. May 29,

1991) (No. 90-1837); Fisher v. Chevron Chem. Co., 716 F. Supp. 1283 (W.D.

Mo. 1989) (same); Fitzgerald v. Mallinckrodt, Inc., 681 F. Supp. 404 (E.D.

Mich. 1987) (same); but see Ferebee v. Chevron Chem. Co., 736 F.2d 1529

(D.C. Cir.) (no preemption), cert. denied, 469 U.S. 1062 (1984); Cax v. Velsicol

Chem. Corp., 704 F. Supp. 85 (E.D. Pa. 1989) (same); Roberts v. Dow Chem.

Co., 702 F. Supp. 195 (N.D. Ill. 1988) (same).

26 See, ¢.g., Moore v. Kimberly-Clark Corp., 867 F.2d 243 (Sth Cir. 1989);

Lindquist v. Tambrands, Inc., 721 F. Supp. 1058 (D. Minn. 1989); Rinehart v.

International Playtex, Inc.,

; F.

regulation under the Food and Drug Act, claims have thus far been

largely unsuccessful.27.

We do not take a position on the merits of any of these pre-

emption questions or on the validity of the existing precedent

concerning these questions. They are not before the Court. Rather,

we would like simply to point out that manufacturers, when they

invoke a preemption defense under these federal statutes, are not

behaving deviously or distorting the ‘‘benign’’ intentions of the

law. Indeed, it would seem a quite reasonable quid pro quo for

compliance with a national regulatory scheme that the regulated in-

dustry have the benefit of a set of instructions which, if followed,

satisfy an industry’s affirmative duties in the regulated area. It is not

beyond belief that Congress could, in some if not all of the exam-

ples invoked by the Petitioner in his “‘parade of horribles,’’ have

intended just such a result. A rule of “‘drastic clarity’’ or a require-

ment of absolute conflict, either of which would deprive the Court

of the ability to examine all the relevant evidence and make a rea-

soned judgment, could effectively decide the outcome of all these

cases without regard to the purposes of Congress or its economic

judgments. We urge the Court to avoid this draconian and un-

necessary outcome.

Inc., 115 Wash. 2d 267, 797 P.2d 1148 (1990), cert. denied, 111 S. Ct. 1584

(1991).

27 See, ¢.g., Allen v. G.D. Searle & Co., 708 F. Supp. 1142 (D. Or. 1989)

(state tort actions not pre-empted by federal regulation of intrauterine contra-

ceptives); MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475

N.E.2d 65, cert. denied, 474 U.S. 920 (1985) (tort action for duty to warn not

preempted by federal labeling requirements).

CONCLUSION

For the reasons stated above, the judgment of the Court of Ap-

peals should be affirmed.

Respectfully submitted,

Of Counsel: DIANE L. ZIMMERMAN

JAN S. AMUNDSON Counsel of Record

General Counsel GARY E. CRAWFORD

QUENTIN RIEGEL SKADDEN, ARPS, SLATE,

Deputy General Counsel MEAGHER & FLOM

National Association of 919 Third Avenue

Manufacturers New York, New York 10022

1331 Pennsylvania Avenue, N.W. (212) 735-3000

Suite 1500 — North Lobby Counsel for Amicus Curiae

Washington, D.C. 20004-1703

(202) 637-3058

Date: July 10, 1991

STATUTORY APPENDIX

Federal Cigarette Labeling and Advertising Act: 15

U.S.C. § 1334

(a) No statement relating to smoking and health, other

than the statement required by section 1333 of this title, shall

be required on any cigarette package.

(b) No requirement or prohibition based on smoking and

health shall be imposed under State law with respect to the

advertising or promotion of any cigarettes the packages of

which are labeled in conformity with the provisions of this

chapter.

Medical Device Amendments of 1976: 21 U.S.C. § 360k(a)

[N]o State or political subdivision of a State may estab-

lish 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 chapter to the device, and

(2) which relates to the safety or effectiveness of the de-

vice or to any other matter included in a requirement ap-

plicable to the device under this chapter.

Alcoholic Beverage Labeling Act of 1988: 27 U.S.C. § 216

No statement relating to alcoholic beverages and health,

other than the statement required by section 215 of this title,

shall be required under State law to be placed on any container

of an alcoholic beverage, or on any box, carton, or other pack-

age, irrespective of the material from which made, that con-

tains such a container.

Alcoholic Beverage Labeling Act of 1988: 27 U.S.C. § 213

The Congress finds that the American public should be

informed about the health hazards that may result from the

consumption or abuse of alcoholic beverages, and has deter-

mined that it would be beneficial to provide a clear,

A-1

nonconfusing reminder of such hazards, and that there is a

need for national uniformity in such reminders in order to

avoid the promulgation of incorrect or misleading information

and to minimize burdens on interstate commerce. The Con-

gress finds that requiring such reminders on all containers of

alcoholic beverages is appropriate and necessary in view of the

substantial role of the Federal Government in promoting the

health and safety of the Nation’s population. It is therefore the

policy of the Congress, and the purpose of this subchapter, to

exercise the full reach of the Federal Government’s constitu-

tional powers in order to establish a comprehensive Federal

program, in connection with the manufacture and sale of alco-

holic beverages in or affecting interstate commerce, to deal

with the provision of warning or other information with re-

spect to any relationship between the consumption or abuse of

alcoholic beverages and health, so that —

(1) the public may be adequately reminded about any

health hazards that may be associated with the consumption or

abuse of alcoholic beverages through a nationally uniform,

nonconfusing warning notice on each container of such bev-

erages; and

(2) commerce and the national economy may be —

(A) protected to the maximum extent consistent with this

declared policy,

(B) not impeded by diverse, nonuniform, and confusing

requirements for warnings or other information on alcoholic

beverage containers with respect to any relationship between

the consumption or abuse of alcoholic beverages and health,

and

from a noncomprehensive program covering alcoholic bev-

erage containers sold in interstate commerce, but not alcoholic

beverage containers manufactured and sold within a single

State.

A-2

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.