Amicus Curiae Brief — Wyeth v. Levine

\o\

(33) FILED

IN THE

Supreme Court of the Hnited States

WYETH,

Petitioner,

Vv.

DIANA LEVINE,

Respondent.

On Writ of Certiorari to the

Supreme Court of Vermont

BRIEF FOR CONSUMERS UNION OF

UNITED STATES, INC., AS AMICUS CURIAE

IN SUPPORT OF RESPONDENT

MARK SAVAGE *

CONSUMERS UNION OF

UNITED STATES, INC.

1535 Mission Street

San Francisco, CA 94103

(415) 431-6747

* Counsel of Record Attorney for

Consumers Union of

United States, Inc.

re ere YS SAT

VALSON-EPES PRINTING CO., INC. — (202) 789-0086 — WASHINGTON, D. C. 20002

QUESTION PRESENTED

Whether Congress intended the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.,

setting forth duties between drug manufacturers and

regulator, to pre-empt drug manufacturers’ indepen-

dent duty of care and duty to warn consumers under

state law.

(i)

TABLE OF CONTENTS

QUESTION PRESENTED ...............cccccscsssssesereees

TABLE OF AUTHORITIEG......................:sce0s000

INTEREST OF AMICUS CURIAE..............0:00008+

SUMMARY OF ARGUMENT ...............cccccceesseees

IT cet vinitintencienseniilanictinimnnipmionmeneenninnces

I.

IT.

DRUG MANUFACTURERS’ PRE-

MARKET DUTIES TO THE FOOD

AND DRUG ADMINISTRATION ARE

SEPARATE AND DISTINCT FROM

THEIR POST-MARKET DUTY OF

CARE AND DUTY TO WARN THEIR

INDIVIDUAL CONSUMERB....................

THE FEDERAL FOOD, DRUG, AND

COSMETIC COSMETIC ACT REGU-

LATES DUTIES BETWEEN DRUG

MANUFACTURER AND REGULATOR,

AND DOES NOT PRE-EMPT DRUG

MANUFACTURERS’ INDEPENDENT

DUTIES TO CONSUMERS UNDER

LONG-ESTABLISHED STATE POLICE

A. Federal Food and Drugs Act of 1906 ..

B. Federal Food, Drug, and Cosmetic

I iinceicdnnitnbnecaibidactnineiinsteiosees

C. Drug Amendments of 1962 .................

D. Medical Device Amendments of 1976.

(iii)

iv

TABLE OF CONTENTS—Continued

Page

Ill. THE FEDERAL FOOD, DRUG, AND

COSMETIC ACT SETS MINIMUM

STANDARDS FOR INTRODUCTION

OF NEW DRUGS INTO INTERSTATE

COMMERCE, AND S.'ATE LAWS RE-

QUIRING ADDITIONAL WARNINGS

TO STATE CONSUMERS DO NOT

CONFLICT WITH THE ACT.........0.0000.... 17

CID cicscnciicswtnncpessubitinvandaniniinesioensetwennas 22

v

TABLE OF AUTHORITIES

CASES Page

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

Fe a eitctcincechtntavinctiesndiitedibighiiiidumintans 4,5

Buckman Co. v. Plaintiffs’ Legal Commit-

tee, 531 U.S. 341 (2001) .........ccccccrrrreeeee 9, 16, 17

California Fed. Sav. & Loan Ass’n uv.

Guerra, 479 U.S. 272 (1987).............cc0c0ee 9

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

Be ee isniiccdcsiitdampendiaialitensniaptaginieinaiuiidl 8, 9, 16

Geier v. American Honda Motor Co., Inc.,

GFE CS Ge Ci Rccccccncessesnsostcdsnvtadiinncenss 17

Hillsborough County v. Automated Medi-

cal Laboratories, Inc., 471 U.S. 707

1} ESS Pe ERT REIN CF Ua eka 5,9

Johnson v. Fankell, 520 U.S. 911 (1997)..... 10

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

(EIIIITT Er cecicuihsessspnicnscnesnisiesbsiedieslisenciiedidamssisaaaaaianainidsi 9

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

Giriicicpsccncscenedcesndeciantidieaipaumainaiainaliieinaniia’ 2,3,9

Rice v. Santa Fe Elevator Corp., 331 U.S.

ici deciccicistahitimicscnatiiiendiaineiaied 5,9, 10

Riegel v. Medtronic, Inc., 552 U.S. __, 128

hs a, Se ee ccscnchtcioniinceideutdiintindsiieda 3, 8,9, 15

Savage v. Jones, 225 U.S. 501 (1912).......... 11

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

ee iaivicctiteitnsientncanieienienslandeebaibuiiiaiaataliaiicaa 10

Warner-Lambert Co., LLC v. Kent, 552

U.S. __, 128 S. Ct. 1168 (2008), affg

by equally divided Court Desiano uv.

Warner-Lambert & Co., 467 F.3d 85 (2d

Ss Rene ee 5

Weigle v. Curtice Brothers Co., 248 U.S.

, BIE Cit cnnctnsnsieionsicasiiiomeaaan 11

vi

TABLE OF AUTHORITIES—Continued

OTHER CASES Page

Abbott Laboratories v. Lapp, 78 F.2d 170

ee 12

Arata v. Tonegato, 152 Cal. App. 2d 837

i TD ncsscesemnensgssovarssceessscsses 12

Berry v. American Cyanamid Co., 341 F.2d

itis cncieretnattnnnctnentnteenene 13

Bine v. Sterling Drug, Inc., 422 S.W.2d 623

a 13

Braun v. Roux Distributing Co., Inc., 312

S.W.2d 758 (Mo. 1958)............cccccesesseeeseees 12

Brochu v. Ortho Pharmaceutical Corp.,

642 F.2d 652 (1st Cir. 1981)..................... 18

Caraker v. Sandoz Pharmaceuticals Corp.,

172 F. Supp. 2d 1018 (S.D. Ill. 2001) ....... 19

Coca Cola Bottling Works v. Selvidge, 4

Tenr. App. 558 (Tenn. Ct. App. 1927) ..... 11

Colacicco v. Apotex, Inc., 521 F.3d 253 (3d

DT iiiteiiccncianensninmcnsannsiatscseneaeese 19

Collins v. Eli Lilly Co., 116 Wis. 2d 166

i nicsicsindincennteepennentncseusnenees 22

Crocker v. Winthrop Laboratories, Div. of

Sterling Drug, Inc., 514 S.W.2d 429

EE 14

Croft v. York, 244 So.2d 161 (Fla. Ct. App.

EE 14

Davis v. Wyeth Laboratories, Inc., 399 F.2d

a 13, 14

Desiano v. Warner-Lambert & Co., 467

F.3d 85 (2d Cir. 2006), affd by equally

divided Court sub nom. Warner-Lambert

Co., LLC v. Kent, 552 U.S. __, 128 S.

a 5

vii

TABLE OF AUTHORITIES—Continued

E.I. DuPont de Nemours & Co. ~. Ladner,

221 Miss. 378 (Miss. 1954) .......................

Eli Lilly & Co. v. Home Ins. Co., 653 F.

OO SS ee

Feldman v. Lederle Laboratories, 125 N.J.

117 (N.J. 1991), cert. denied, 505 U.S.

eT cnintnisentuecisininnnenlaninenmtiaciatieiiins

Fielding v. Superior Ct. (Westwood Phar-

maceutical Corp.), 111 Cal. App. 2d 490

SS ee

Fritz v. Parke Davis & Co., 277 Minn. 210

EE ener eee

Grinnell v. Charles Pfizer & Co., 274 Cal.

App. 2d 424 (Cal. Ct. App. 1969)..............

Henry v. Richardson-Merrell, Inc., 508

ef fF en

Hill v. Searle Laboratories, 884 F.2d 1064

Eee Serer ene

Hoffman v. Sterling Drug, Inc., 374 F.

Supp. 850 (M.D. Pa. 1974)...................004.

Hornung v. Richardson-Merrill, Inc., 317

F. Supp. 183 (D. Mont. 1970) ...................

Hruska v. Parke, Davis & Co., 6 F.2d 536

lice ininnsiniecitialiniaeaiiiam

Hurley v. Lederle Laboratories, 863 F.2d

ee

Kelly v. John R. Daily Co., 56 Mont. 63

rs iti ice lillian

Kershaw v. Sterling Drug, Inc., 415 F.2d

Ee

Kociemba v. G.D. Searle & Co., 680 F.

Supp. 1293 (D. Minn. 1988)..................0+.

Page

12 .

22

19

12

13

14

14

18

14

14

11

18

11

14

19

TABLE OF AUTHORITIES—Continued

Page

Krug v. Sterling Drug, Inc., 416 S.W.2d

ti inrncrepincnenintinninnioasinneeses 13

Love v. Wolf, 249 Cal. App. 2d 822 (Cal. Ct.

I titintinteeeninmningnainmmeuens 13

Machlitt v. Myers, 23 Ohio App. 160 (Ohio

Fe Fe wetiticinidermtevemnsvensapimaisinpenpetenapenn 11

Martin v. Bengue, Inc., 25 N.J. 359 (N.J.

REE HET Fr ov en 12

Mazetti v. Armour & Co., 75 Wash. 622

Es AI ti entninteinenmmnesineibneiienes 11

McEwen v. Ortho Pharmaceutical Corp.,

SEE 14

Moehlenbrock v. Parke, Davis & Co., 141

Minn. 154 (Minn. 1918).................0cceeeeeees 11

Motus v. Pfizer Inc., 127 F. Supp. 2d 1085

5 Teena 18, 19

Oresman v. G.D. Searle & Co., 388 F.

Supp. 1175 (D.R.1. 1975).......ccc0c0cesseeeee0ee 14

Parke-Davis & Co. v. Stromsodt, 411 F.2d

EE 14

Portage Markets Co. v. George, 111 Ohio

Be ED iccrtnidciensctutennmetnnnnee 11

Redfield v. Mead, Johnson & Co., 266 Or.

eT 14

Reyes v. Wyeth Laboratories, 498 F.2d

I GIT aiiniisinenenconsceneennamennnence 14

Ritchie v. Sheffield Farms Co., 222 N.Y.S.

of 8 Se 8 11, 12

Salmon v. Parke, Davis & Co., 520 F.2d

TT a 14, 18

Schenebeck v. Sterling Drug, Inc., 423 F.2d

eee 14

ix

TABLE OF AUTHORITIES—Continued

Schering Corp. v. Home Ins. Co., 712 F.2d

SE Be iictisnciicssicnirecidesninietiipzennne

Sindell v. Abott Laboratories, 26 Cal. 3d

ie iierainieatitiemnertinrniiatensens

Singer v. Sterling Drug, Inc., 461 F.2d 288

a

Spychala v. G.D. Searle & Co., 705 F.

Supp. 1024 (D.N.J. 1988)..................cc0ee0es

Sterling Drug, Inc. v. Cornish, 370 F.2d 82

I iinninicrnenicieninitaadieeatmtenens

Sterling Drug, Inc. v. Yarrow, 408 F.2d

Is BT eiiitiinnmenranmadupinnsans

Stevens v. Parke, Davis & Co., 9 Cal. 3d 51

EE ee a

Tinnerholm v. Parke, Davis & Co., 411

go ee

Toole v. Richardson-Merrell Inc., 251 Call.

App. 2d 689 (Cal. Ct. App. 1967)..............

Wechsler v. Hoffman-La Roche, Inc., 99

N.Y.S.2d 588 (N.Y. Sup. 1950) .................

Wells v. Ortho Pharmaceutical Corp., 788

F.2d 741 (11th Cir.), cert. denied, 479

SE eye

Wennerholm v. Stanford Univ. Sch. of

Med., 20 Cal.2d 713 (Cal. 1942)...............

Whitley v. Cubberly, 24 N.C. App. 204

en

Williams v. Vick Chemical Co., 279 F.

Supp. 833 (S.D. lowa 1967) .....................

FEDERAL STATUTES

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

SC Se

x

TABLE OF AUTHORITIES—Continued

Page

Federal Cigarette Labeling and Advertis-

ing Act of 1965, Pub. L. 89-92, 79 Stat.

i ccandidddsstenenenmnesiacdiguamenprabiianneamzenes 16

Federal Food and Drugs Act of 1906, Pub.

L. 59-384, ch. 3915, 34 Stat. 768

(repealed by Federal Food, Drug, and

Cosmetic Act of 1938, Pub. L. No. 75-

717, ch. 675, § 902(a), 52 Stat. 1040,

Sut idnicidnsecinitniclbaiitaddndetiinbinieuciuimiitpigedienes 3, 10

Federal Food, Drug, and Cosmetic Act of

1938, Pub. L. No. 75-717, ch. 675, 52

Stat. 1040 (codified as amended at 21

U.S.C. § 301 et seq.) .........:scccererereeees 3, 10, 12, 13

ee 3,4

Be I ic cccccnsccsnasenctastonsesnecntiel 3, 6, 12

TI 3,6

TTT TTI eee ee 6

| TTT aCe aT 6

| eae een 6

Medical Device Amendments of 1976, Pub.

L. No. 94-295, 90 Stat. 539....................... 15

FE Cars ND cccrrtncsnccsccssecneconsenscsceces 15

Public Health Cigarette Smoking Act of

1969, Pub. L. 91-222, 84 Stat. 87............. 16

FEDERAL REGULATIONS

iin nncterrrttennnnatiatniiilil 20, 21

RULES OF COURT

als ciccsiclttcicienetsancnnntedeasieaniai 1

Sa bitrinnisstensiretennienscsinscsciandinetiacuentl 1

IN THE

Supreme Court of the United States

No. 06-1249

WYETH,

Petitioner,

Vv.

DIANA LEVINE,

Respondent.

On Writ of Certiorari to the

Supreme Court of Vermont

BRIEF FOR CONSUMERS UNION OF

UNITED STATES, INC., AS AMICUS CURIAE

IN SUPPORT OF RESPONDENT

INTEREST OF AMICUS CURIAE'

Consumers Union of United States, Inc., publisher

of Consumer Reports, is a nonprofit membership

organization chartered in 1936 to provide consumers

' Pursuant to Rule 37.3(a) of the Rules of the Supreme Court

of the United States, petitioner and respondent have lodged

letters with the Court consenting generally to the filing of briefs

amicus curiae, and accordingly, petitioner and respondent have

consented to the filing of this brief. No counsel for a party in

Wyeth v. Levine, Case No. 06-1249, authored this brief in whole

or in part, and no person or entity other than Amicus Curiae

Consumers Union, its members, or its counsel, made a monetary

contribution to the preparation or submission of this brief. See

Sup. Ct. R. 37.6.

2

with information, education, and counsel about

goods, services, health and personal finance. Con-

sumers Union’s publications have a combined paid

circulation of approximately 8.5 million. These

publications regularly carry articles on Consumers

Union’s own product testing; on health, product

safety, and marketplace economics; and on leg-

islative, judicial, and regulatory actions that affect

consumer welfare. Consumers Union’s income is

solely derived from the sale of Consumer Reports, its

other publications and services, and noncommercial

contributions, grants, and fees. Consumers Union’s

publications and services carry no outside advertising

and receive no commercial support.

Consumers Union’s mission is “to work for a fair,

just, and safe marketplace for all consumers and to

empower consumers to protect themselves.” In line

with that mission and our assessment of priorities,

Consumers Union has actively worked for a fair and

just marketplace for consumers in critical areas

implicated by this case, including prescription drugs,

drug advertising, health care, and patient safety.

Consumers Union has filed actions in both state and

federal courts in order to protect consumers, and has

actively participated in a variety of proceedings

before both state and federal regulatory agencies.

For example, Consumers Union played an active role

in securing the passage of the Federal Food, Drug,

and Cosmetic Act of 1938 and the 1962 amendments

to the Act. It has been extremely active in the area of

testing, evaluating, and rating of prescription drugs

and health services, in order to inform consumers

and to advocate for consumers before Congress, state

legislatures, and regulatory agencies. Consumers

Union filed amicus briefs on pre-emption in Med-

3

tronic, Inc. v. Lohr, 518 U.S. 470 (1996), and in Riegel

v. Medtronic, Inc., 552 U.S. ___, 128 S. Ct. 999 (2008).

SUMMARY OF ARGUMENT

Petitioner Wyeth manufactured and sold Phen-

ergan, a drug for the treatment of nausea. The drug

manufacturer filed an application under the Federal

Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(b), to

sell the new drug in interstate commerce. After pre-

market review, the Food and Drug Administration

approved the application in 1955. Jt. App., at 266-

267; see also Pet. Br., at 11. The agency concluded

that Wyeth’s new drug met the minimum standards

of safety for introduction into interstate commerce.

21 U.S.C. § 355(a).* Neither the Act nor the Food and

Drug Administration’s specific review and approval

purported to repeal or pre-empt Wyeth’s independent

duties to its consumers under state tort law, namely

its duty of care and its duty to warn.

In post-market experience, Phenergan has caused

gangrene, resulting in amputation, when adminis-

tered by certain intravenous injection. The pre-

market tests, application, review and approval did

not disclose this grave danger, but it became

apparent after post-market sales to consumers. See,

e.g., Jt. App., at 268-269 (report of adverse reaction

in 1965); id., at 237, 240 (decision on motion for

judgment, finding knowledge of danger “[slince at

least 1976 ”).

* In 1955, section 355 required pre-market review and ap-

proval to assess general safety. Federal Food, Drug, and Cos-

metic Act of 1938, Pub. L. No. 75-717, § 505, 52 Stat. 1040,

1052. In 1962, Congress added the requirement to assess

general effectiveness. Drug Amendments of 1962, Pub. L. No.

87-781, § 102, 76 Stat. 780, 781.

a

4

After an intravenous injection of Phenergan in

2000, Diane Levine, a guitarist and pianist, de-

veloped gangrene in her right hand, requiring

amputation of her right arm at the elbow. Jt. App.,

at 237-238. Levine filed suit to recover damages for

her loss. Her complaint invoked the basic duty of

care and duty to warn between drug manufacturer

and consumer, not the regulatory duties between

drug manufacturer and Food and Drug Admini-

stration. She alleged that the drug information failed

to instruct the clinician to dilute the drug and to

administer the drug through a “running IV”; that the

information failed to provide adequate warnings that

intra-arterial injection or extravasation could cause

irreversible gangrene and loss of limb; and that

Phenergan was not reasonably safe due to inade-

quate warnings and instructions regarding fore-

seeable risks of harm. Complaint 7{ 5-6, Jt. App. 14,

14-15. She alleged that the drug manufacturer had

known that its warnings were inadequate and unsafe

in this regard since 1987. Id., {4 10-16, Jt. App., at

15-17. She concluded that Wyeth’s “conduct . . . was

negligent” and this “negligence and/or gross negli-

gence was the proximate cause of plaintiffs injuries,”

and she prayed for “appropriate damages for her

loss.” Id:, {J 19-20, Jt. App., at 17.

Wyeth claims pre-emption because the drug and

labeling received pre-market review and approval

from the Food and Drug Administration pursuant to

the Federal Food, Drug, and Cosmetic Act of 1938, 21

U.S.C. § 355.

Neither the Act in general nor the provisions on

pre-market review of new drugs in particular include

any term expressly pre-empting state tort remedies.

As the Court observed in Buckman Co. v. Plaintiffs’

5

Legal Committee, 531 U.S. 341 (2001), the Act

regulates “the relationship between a federal agency

and the entity it regulates.” 531 U.S., at 347 (dis-

cussing parallel provisions on pre-market review of

medical devices under the Federal Food, Drug, and

Cosmetic Act). It does not purport to regulate the

distinct relationship between the manufacturer and

the consumer. See also Desiano v. Warner-Lambert

& Co., 467 F.3d 85, 94-95 (2d Cir. 2006) (distin-

guishing claims “premised on traditional duties be-

tween a product manufacturer and . . . consumers”

and claims premised on a “duty between a manu-

facturer and a federal agency”), affd by equally

divided Court sub nom. Warner-Lambert Co., LLC v.

Kent, 552 U.S. __, 128 S. Ct. 1168 (2008) (per

curiam). Instead, that separate relationship has long

been governed by the duty of care and duty to warn

under state common law, tort, and products liability.

See Section I, post, at 6.

The legislative history of the Act, and the con-

current history of cases recognizing and enforcing

drug manufacturers’ duties to consumers under state

law, confirm the fundamental presumption against

pre-emption. See Section II, post, at 9. This does

not surprise. “(T]he regulation of health and safety

matters is primarily, and historically, a matter of

local concern.” E.g., Hillsborough County v. Auto-

mated Medical Laboratories, Inc., 471 U.S. 707, 719

(1985); Rice v. Santa Fe Elevator Corp., 331 U.S. 218,

230 (1947). As a significant majority of courts have

held, the Federal Food, Drug, and Cosmetic Act sets

minimum standards for introduction into interstate

commerce, and state laws requiring additional warn-

ings to state consumers do not conflict with the Act.

See Section III, post, at 19.

6

ARGUMENT

I. DRUG MANUFACTURERS’ PRE-MAR-

KET DUTIES TO THE FOOD AND DRUG

ADMINISTRATION ARE SEPARATE AND

DISTINCT FROM THEIR POST-MARKET

DUTY OF CARE AND DUTY TO WARN

THEIR INDIVIDUAL CONSUMERS.

Under the Federal Food, Drug, and Cosmetic Act,

drug manufacturers must file an application and

receive approval before introducing any new drug

into interstate commerce. 21 U.S.C. § 355(a).

The application shall include the drug’s compo-

sition, how it is manufactured and packaged, the

proposed labeling, reports of investigations showing

whether the drug is safe for use and effective in use,

and samples of the drug if required. ZJd., § 355(b)(1).

Within 180 days, the agency shall either approve the

application, or notify the applicant that it may elect a

hearing. Id., § 355(c)(1). The agency shall approve

the application, unless one of seven enumerated

grounds exists. IJd., § 355(d). The agency shall not

approve the application if the reported investigations

were not adequate to show, or there is insufficient

information to determine, whether the drug is safe;

or the manufacturing and packaging are inadequate;

or the agency lacks substantial evidence that the

drug will have the effect claimed; or certain patent

information is missing; or the proposed labeling is

false or misleading in any particular. Jbid. The

agency may subsequently withdraw approval to

engage in interstate commerce under enumerated

circumstances. Id., § 355(e). These are disclosures to

and duties between regulator and regulated entity, to

obtain approval for introduction of the new drug into

interstate commerce.

7

Between drug manufacturer and consumer, how-

ever, the drug manufacturer’s duties are quite dif-

ferent. The trial court below explained those duties

between drug manufacturer and consumer under

Vermont law in its instructions to the jury:

Duty of Care

The manufacturer of a product such as Wyeth

has a duty to take reasonable steps to notify

users of the product—in this case the medical

community—of the risks and dangers of the

product and to provide adequate instructions

about how to use the product safely. This

standard of conduct does not require that useful

drugs with dangerous potential be removed from

the market. Instead, the law requires that

Wyeth exercise reasonable care to warn or

protect against the risks.

... Warnings for prescription drugs are intended

for the physician and his staff whose duty it is to

balance the risks against the benefits of various

drugs and treatments and to prescribe them and

supervise their effects.

Duty to Warn

. . . The manufacturer’s duty is to warn of all

potential dangers in its prescription drugs that it

knew, or in the exercise of reasonable care,

should have known to exist... .

Strict Liability—Failure to Warn

A manufacturer of a product such as Phenergan

is responsible for harm to a person caused by a

defective product that reaches a user without

undergoing substantial change.

Jt. App., at 227, 227-231.

8

The jury may consider evidenve that the drug

manufacturer complied with the Food and Drug

Administration’s requirements, but that evidence

does not prove that the drug manufacturer’s warn-

ings met its duties to the consumer. I/d., at 227-228.

In short, the drug manufacturers’ pre-market

duties to the Food and Drug Administration in order

to secure prior approval for interstate commerce, are

separate and distinct from its subsequent, post-

market duties to actual consumers under state law.

The Federal Food, Drug, and Cosmetic Act does not

pre-empt or conflict with these independent duties

drug manufacturers have under state law.

Il. THE FEDERAL FOOD, DRUG, AND

COSMETIC ACT REGULATES DUTIES

BETWEEN DRUG MANUFACTURER AND

REGULATOR, AND DOES NOT PRE-

EMPT DRUG MANUFACTURERS’ INDE-

PENDENT DUTIES TO CONSUMERS

UNDER LONG-ESTABLISHED STATE

POLICE POWERS.

The Supreme Court of Vermont agreed with the

preponderance of courts that the Federal Food, Drug,

and Cosmetic Act does not pre-empt state failure-to-

warn claims. App. to Pet. for Cert. 15a; see, e.g.,

Riegel v. Medtronic, Inc., 552 U.S. __, _s_ & n.. 11,

_. & n. 16, 128 S. Ct. 999, 1017 & n. 11, 1018-1019

& n. 16 (2008) (Ginsburg, J., dissenting) (collecting

cases).

In analyzing whether the Federal Food, Drug, and

Cosmetic Act pre-empts a drug manufacturer’s duty

of care and duty to warn consumers under state

laws, Congressional intent is the touchstone. E.g.,

Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516

9

(1992); California Fed. Sav. & Loan Ass’n v. Guerra,

479 U.S. 272, 280 (1987) (in deciding whether federal

law pre-empts state law, “our sole task is to ascertain

the intent of Congress”); Rice, 331 U.S., at 230 (“the

historic police powers of the States [are] not to be

superseded by . . . Federal Act unless that [is] the

clear and manifest purpose of Congress.”); see also

Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)

(same).

The statute itself is the first indicia of intent.

When Congress enacted the Federal Food, Drug, and

Cosmetic Act in 1938, it included no provision to pre-

empt state law. Jones v. Rath Packing Co., 430 U.S.

519, 538 (1977) (“The FDCA contains no pre-emptive

language.”); see also Riegel, 552 U.S., at __, 128 S.

Ct., at 1016 (Ginsburg, J., dissenting).

Where a statute—such as the Federal Food, Drug,

and Cosmetic Act—expresses no intent or purpose to

pre-empt state laws, the Court presumes that

Congress did not intend to pre-empt states laws.

E.g., Lohr, 518 U.S., at 485 (“[B]ecause the States are

independent sovereigns in our federal system, we

have long presumed that Congress does not cava-

lierly pre-empt_ state-law causes of action.”);

Hillsborough County, 471 U.S., at 715 (“presumption

that state or local regulation of matters related to

health and safety is not invalidated under the

Supremacy Clause”); Rice, 331 U.S., at 230 (“the

historic police powers of the States [are] not to be

supersede. by . . . Federal Act unless that [is]

the clear and manifest purpose of Congress.”). A

long history of state tort remedies—as here—against

manufacturers in the area at issue “adds force to the

basic presumption against pre-emption.” Bates v.

Dow AgroSciences LLC, 544 U.S. 431, 449 (2005); ef.

10

Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251-256

(1984) (Congress assumed that existing state tort

remedies would be available). Wyeth faces a “heavy

burden of persuasion” to demonstrate the requisite

“clear and manifest purpose of Congress” that alone

can overcome that presumption. Johnson v. Fankell,

520 U.S. 911, 917 (1997); Rice, 331 U.S., at 230.

The legislative history of the Act, and the con-

current history of cases recognizing and enforcing

drug manufacturers’ independent duties to con-

sumers under state law, confirm this fundamental

presumption against pre-emption.

A. Federal Food and Drugs Act of 1906

The basic structure of the Food, Drug, and Cos-

metic Act and the argument against pre-emption date

back over 100 years, to the Federal Food and Drugs

Act of 1906, Pub. L. 59-384, ch. 3915, 34 Stat. 768,

the predecessor to the Food, Drug, and Cosmetic Act

of 1938.

The Federal Food and Drugs Act of 1906 prohibited

manufacture of and interstate commerce in adul-

terated or misbranded foods and drugs, as defined in

the act. Id., §§ 1-2, 7-8, 34 Stat. at 768, 769-770

(repealed by Federal Food, Drug, and Cosmetic Act of

1938, Pub. L. No. 75-717, § 002(a), 52 Stat. 1040,

1059). The act did not purport to pre-empt the

manufacturer's duty of care and duty to warn its

consumers, nor the traditional state laws enforcing

those duties. For example, a state law in Wisconsin

generally prohibited selling food that contains the

preservative benzoate of soda. A federal regulation

under the Federal Food and Drugs Act of 1906

provided that addition of the preservative benzoate of

soda was not injurious to health and was not

11

objectionable under the federal act. When a food

shipper argued that the federal regulation pre-

empted the state law, even as applied to local retail

sales, this Court disagreed:

When objects of commerce get within the sphere

of state legislation the State may exercise its

independent judgment and prohibit what Con-

gress did not see fit to forbid. ... The Food and

Drugs Act does not interfere with state regu-

lation of selling at retail. [Citations omitted.|

Such regulation is not an attempt to supplement

the action of Congress in interstate commerce

but the exercise of an authority outside of

that commerce that always has remained in the

states.

Weigle v. Curtice Brothers Co., 248 U.S. 285, 288

(1919); see also Savage v. Jones, 225 U.S. 501, 539

(1912) (Federal Food and Drugs Act of 1906 does

not pre-empt state statute requiring disclosure of

additional matters, viz. the product’s ingredients, in

order to protect against deception and ensure that

purchasers are informed about what they are buying

by certificate and label requirements).

Accordingly, state-based tort claims proceeded

without pre-emption under the predecessor Federal!

Food and Drugs Act of 1906. See, eg., Mazetti

v. Armour & Co., 75 Wash. 622 (Wash. 1913);

Moehlenbrock v. Parke, Davis & Co., 141 Minn. 154

(Minn. 1918); Kelly v. John R. Daily Co., 56 Mont. 63

(Mont. 1919); Hruska v. Parke, Davis & Co., 6 F.2d

536 (8th Cir. 1925); Portage Markets Co. v. George,

111 Ohio St. 775 (Ohio 1924); Machlitt v. Myers, 23

Ohio App. 160 (Ohio App. 1926); Coca Cola Bottling

Works v. Selvidge, 4 Tenn. App. 558 (Tenn. Ct. App.

1927); Ritchie v. Sheffield Farms Co., 222 N.Y.S. 724

12

(N.Y. Mun. Ct. 1927); Abbott Laboratories v. Lapp, 78

F.2d 170 (7th Cir. 1935).

B. Federal Food, Drug, and Cosmetic Act

of 1938

In 1938, Congress augmented and stiffened the

requirements for new drugs by providing for pre-

market review to assess safety. Federal Food, Drug,

and Cosmetic Act of 1938, Pub. L. No. 75-717, ch.

675, § 505, 52 Stat. 1040, 1052. The act mandated

that “[nJo person shall introduce or deliver for

introduction into interstate commerce any new drug,

unless an application filed pursuant to subsection (b)

is effective with respect to such drug.” Ibid. (codified

as amended at 21 U.S.C. § 355(a) [“No person shall

introduce or deliver for introduction into interstate

commerce any new drug, unless an approval of an

application filed pursuant to subsection (b) or (j) is

effective with respect to such drug.”)).

Congress inserted no pre-emption clause. Drug

manufacturers remained subject to tort claims, inde-

pendent of the new provisions for pre-market review

and approval of new drugs. See, e.g., Wennerholm v.

Stanford Univ. Sch. of Med., 20 Cal.2d 713 (Cal.

1942); Wechsler v. Hoffman-La Roche, Inc., 99

N.Y.S.2d 588 (N.Y. Sup. 1950); Fielding v. Superior

Ct. (Westwood Pharmaceutical Corp.), 111 Cal. App.

2d 490 (Cal. Ct. App. 1952); E.J. DuPont de Nemours

& Co. v. Ladner, 221 Miss. 378 (Miss. 1954); Arata v.

Tonegato, 152 Cal. App. 2d 837 (Cal. Ct. App. 1957);

Martin v. Bengue, Inc., 25 N.J. 359 (N.J. 1957);

Braun v. Roux Distributing Co., Inc., 312 S.W.2d 758

(Mo. 1958).

13

C. Drug Amendments of 1962

In 1962, Congress further amended the require-

ments for new drugs by providing that pre-market

review assess effectiveness as well. Drug Amend-

ments of 1962, Pub. L. No. 87-781, § 102, 76 Stat.

780, 781. When it did so, Congress expressly stated

that “[njothing in the amendments made by this Act

{Drug Amendments of 1962] to the Federal Food,

Drug, and Cosmetic Act shall be construed as

invalidating any provision of State law which would

be valid in the absence of such amendments unless

there is a direct and positive conflict between such

amendments and such provision of State law.” Drug

Amendments of 1962, § 202, 76 Stat., at 793; see also

id., § 104, 76 Stat. at 784 (amending section 505 of

the Federal Food, Drug, and Cosmetic Act on pre-

market review of new drugs).

In other words, nothing in the amendments in-

validated the numerous provisions of state law

enforced by the cases cited above, which clearly had

already been valid in the absence of the amendments.

There was no direct and positive conflict, and drug

manufacturers remained subject to tort claims for

failure to meet their duty of care and duty to

warn state consumers. See, e.g., Berry v. American

Cyanamid Co., 341 F.2d 14 (6th Cir. 1965); Sterling

Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966);

Love v. Wolf, 249 Cal. App. 2d 822 (Cal. Ct. App.

1967); Krug v. Sterling Drug, Inc., 416 S.W.2d 143

(Mo. 1967); Toole v. Richardson-Merreill Inc., 251 Cal.

App. 2d 689 (Cal. Ct. App. 1967); Fritz v. Parke Davis

& Co., 277 Minn. 210 (Minn. 1967); Williams v. Vick

Chemical Co., 279 F. Supp. 833 (S.D. Iowa 1967);

Bine v. Sterling Drug, Inc., 422 S.W.2d 623 (Mo.

1968); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121

14

(9th Cir. 1968); Sterling Drug, Inc. v. Yarrow, 408

F.2d 978 (8th Cir. 1969); Tinnerholm v. Parke, Davis

& Co., 411 F.2d 48 (2d Cir. 1969); Parke-Davis & Co.

v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969); Grinnell

v. Charles Pfizer & Co., 274 Cal. App. 2d 424 (Cal. Ct.

App. 1969); Kershaw v. Sterling Drug, Inc., 415 F.2d

1009 (5th Cir. 1969); Schenebeck v. Sterling Drug,

Inc., 423 F.2d 919 (8th Cir. 1970); Hornung v.

Richardson-Merrill, Inc., 317 F. Supp. 183 (D. Mont.

1970); Croft v. York, 244 So.2d 161 (Fla. Ct. App.

1971); Singer v. Sterling Drug, Inc., 461 F.2d 288 (7th

Cir. 1972); Stevens v. Parke, Davis & Co., 9 Cal. 3d 51

(Cal. 1973); Redfield v. Mead, Johnson & Co., 266

Or. 273 (Or. 1973); Hoffman v. Sterling Drug, Inc.,

374 F. Supp. 850 (M.D. Pa. 1974); Reyes v. Wyeth

Laboratories, 498 F.2d 1264 (5th Cir. 1974); Crocker

v. Winthrop Laboratories, Div. of Sterling Drug, Inc.,

514 S.W.2d 429 (Tex. 1974); McEwen v. Ortho Phar-

maceutical Corp., 270 Or. 375 (Or. 1974); Whitley v.

Cubberly, 24 N.C. App. 204 (N.C. Ct. App. 1974);

Oresman v. G.D. Searle & Co., 388 F. Supp. 1175

(D.R.L. 1975); Henry v. Richardson-Merrell, Inc., 508

F.2d 28 (3d Cir. 1975); Salmon v. Parke, Davis & Co.,

520 F.2d 1359 (4th Cir. 1975).

D. Medical Device Amendments of 1976

When Congress enacted the Medical Device

Amendments of 1976, it added the only other

provision on the effect of the Federal Food, Drug, and

Cosmetic Act upon state and local law. Congress

limited the scope of that provision to medical devices

only:

SEc. 521. (a) Except as provided in subsection

(b), no State or political subdivision of a State

may establish or continue in effect with respect

15

to a device intended for human use any re-

quirement—

(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.

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

295, § 2, 90 Stat. 539, 574 (adding Section 521 to the

Federal Food, Drug, and Cosmetic Act, codified as

amended at 21.U.S.C. § 360k(a)).

Congress did not extend this pre-emption to the

rest of the Federal Food, Drug, and Cosmetic Act in

general and pre-market approval of new drugs in

particular. See Riegel, 552 U.S., at__, 128 S. Ct., at

1009 (“if, as the dissent believes, Congress wanted

the two regimes to be alikel,] Congress could have

applied the pre-emption clause to the entire FDCA.

It did not do so, but instead wrote a pre-emption

clause that applies only to medical devices.”). The

cases cited above on drug manufacturers’ inde-

pendent duties to consumers were all on the books

when Congress enacted the Medical Device Amend-

ments of 1976. If Congress had wanted to end or

restrict drug manufacturers’ independent duty of

care and duty to warn their consumers, and the

history of tort relief for injuries caused by new drugs

after the creation of pre-market review in 1938, then

Congress would not have written a pre-emption

clause limited to medical devices alone.

A recent decision by the Court further illustrates

the point in juxtaposition.

16

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

(1992), concerned express pre-emption provisions in

two federal laws on cigarette labeling and adver-

tising. The Federal Cigarette Labeling and Ad-

vertising Act of 1965 specified the warning to be

placed on a package of cigarettes. In a section

entitled “Preemption,” the act also provided that no

other statement shall be required on any cigarette

package, and that “[nJo [other] statement related to

smoking and health shall be required in the ad-

vertising of [those] cigarettes.” See Federal Cigarette

Labeling and Advertising Act of 1965, Pub. L. 89-92,

§§ 4, 5, 79 Stat. 282, 283. The Court held that the

first pre-emption provision, of 1965, “only pre-empted

state and federal rulemaking bodies from mandating

particular cautionary statements and did not pre-

empt state-law damages actions.” Cipollone, 505

U.S., at 519-520.

The act’s successor, the Public Health Cigarette

Smoking Act of 1969, strengthened the requisite

warning’s language, and provided instead that “[nJo

[other] requirement or prohibition based on smoking

and health shall be imposed under State law with

respect to the advertising or promotion of [those]

cigarettes.” See Public Health Cigarette Smoking

Act of 1969, Pub. L. 91-222, § 2, 84 Stat. 87, 88

(amending sections 4 and 5). The Court held that the

second pre-emption provision, of 1969, did pre-empt

claims that state law required post-1969 advertising

or promotions to “include[] additional, or more clearly

stated, warnings.” Cipollone, 505 U.S., at 524-525."

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

(2005) held that a provision of the Federal Insecticide, Fun-

gicide, and Rodenticide Act—that certain States “shall not

impose or continue in effect any requirements for labeling or

17

Here, in contrast, Congress has inserted no such

pre-emption provision, of either kind, regarding

labeling approved under the Federal Food, Drug, and

Cosmetic, Act. Congress did not prohibit any other

“requirement or prohibition . . . imposed under state

law,” as in the 1969 act. Congress did not prohibit

any other statements in advertising, as in the 1965

act--which would not have pre-empted state damages

actions in any case. Diane Levine proved that ad-

ditional or more clearly stated warnings were re-

quired, and the Federal Food, Drug, and Cosmetic

Act nowhere pre-empts the drug manufacturer’s basic

duties to its consumers under state law.

lil. THE FEDERAL FOOD, DRUG, AND COS-

METIC ACT SETS MINIMUM STAN-

DARDS FOR INTRODUCTION OF NEW

DRUGS INTO INTERSTATE COMMERCE,

AND STATE LAWS REQUIRING ADDI-

TIONAL WARNINGS TO STATE CON-

SUMERS DO NOT CONFLICT WITH THE

ACT.

Courts have frequently recognized that federal

safety regulations between regulator and regulated

entity set minimum standards, and that common-law

tort claims could require stricter standards so long as

they did not conflict with the federal regulatory

scheme. E.g., Geier v. American Honda Motor Co.,

Inc., 529 U.S. 861, 867-868 (2000) (recognizing that

federal safety regulations set minimum standards

and that common-law tort claims could require

packaging in addition to or different from those required under

this subchapter”—pre-empted common-law actions. 544 US.,

at 443 (discussing 7 U.S.C. § 136v(b)).

18

stricter standards so long as they did not conflict

with the federal regulatory scheme).

Accordingly, most courts have held that the Fed-

eral Food, Drug, and Cosmetic Act’s regulation of

prescription drugs establishes minimum standards,

for the introduction of new drugs into interstate

commerce, and that a drug manufacturer’s compli-

ance with those minimum duties to the Food and

Drug Administration does not pre-empt or repeal the

drug manufacturer’s separate duty of care and duty

to warn its consumers, nor absolve the manufacturer

of tort liability for failure to meet those independent

duties. See, e.g., Brochu v. Ortho Pharmaceutical

Corp., 642 F.2d 652, 658 (1st Cir. 1981) (rejecting

argument that warnings were adequate if drafted by

the Food and Drug Administration as required

uniform labeling); Salmon v. Parke, Davis & Co., 520

F.2d 1359, 1362 (4th Cir. 1975) (“In North Carolina,

as elsewhere, compliance with federal laws and

regulations concerning a drug, though pertinent, does

not in itself absolve a manufacturer of liability.”);

Hurley v. Lederle Laboratories, 863 F.2d 1173, 1177

(5th Cir. 1988) (“FDA regulation does not generally

preempt stricter state law standards for medical

products.”); Hill v. Searle Laboratories, 884 F.2d

1064, 1068 (8th Cir. 1989) (“FDA approval is not a

shield to liability. [Citations omitted.} FDA regula-

tions are generally minimum standards of conduct

unless Congress intended to preempt common law,

which Congress has not done in this area.”); Wells v.

Ortho Pharmaceutical Corp., 788 F.2d 741, 746 (11th

Cir.) (“An FDA determination that a warning is not

necessary may be sufficient for federal regulatory

purposes but still not be sufficient for state tort law

purposes.”), cert. denied, 479 U.S. 950 (1986); Motus

v. Pfizer Inc., 127 F. Supp. 2d 1085, 1096 (C.D. Cal.

19

2000) (“Several other courts have determined that

FDA requirements are minimal standards and that

FDA approval is not a shield to liability.”); Caraker v.

Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1018,

1033 (S.D. Ill. 2001) (“The reason why many courts

find no preemption is that the FDA’s drug labeling

decisions impose only ‘minimum’ standards that are

open to supplementation by state law through a

jury’s verdict enforcing a manufacturer’s common law

duty to warn.”); Kociemba v. G.D. Searle & Co., 680

F. Supp. 1293, 1299 (D. Minn. 1988) (“widely held

view that FDA regulation of prescription drugs

establishes minimum standards, both as to design

and warning”); Spychala v. G.D. Searle & Co., 705 F.

Supp. 1024, 1030 (D.N.J. 1988) (“There is less sense

of a comprehensive regulatory scheme, however, than

there is of labeling requirements which must be met

at a minimum and certainly no suggestion that if

additional requirements were imposed by the states

any FDA regulatory scheme for IUD design and

labeling would be destroyed. Courts have held with

some consistency that while FDA regulation of

prescription drugs may establish minimum standards

for product design and warning labels, compliance

does not necessarily absolve a manufacturer of tort

liability”); Feldman v. Lederle Laboratories, 125

N.J. 117, 141 (N.J. 1991) (compliance with FDA

regulations may establish that the manufacturer met

the appropriate minimum standards of due care,

but compliance does not necessarily absolve the

manufacturer of all liability), cert. denied, 505 U.S.

1219 (1992). But cf. Colacicco v. Apotex, Inc., 521

F.3d 253, 271-272 & n. 17 (3d Cir. 2008) (where the

FDA has publicly rejected the need for a warning

that plaintiffs argue state law requires, holding that,

“under the circumstances of this case, the plaintiffs’

20

failure-to-warn claims are preempted by the FDA’s

actions taken in accordance with its statutory

authority,” and expressly not deciding “whether the

FDA’s mere approval of drug labeling is sufficient to

preempt state-law claims alleging that the labeling

failed to warn of a given danger, [or] whether FDA

approval of drug labeling constitutes minimum stan-

dards in the absence of the FDA’s express rejection of

a specific warning,” and distinguishing the Supreme

Court of Vermont’s decision in Wyeth on these

grounds).

Recognizing the drug manufacturer’s independent

duties to consumers to provide adequate warning at

all times after approval, the Food and Drug Admini-

stration’s own regulations provide for immediate

label changes without prior approval to provide ade-

quate warnings:

(A) To add or strengthen a contraindication,

warning, precaution, or adverse reaction;

(B) To add or strengthen a statement about

drug abuse, dependence, psychological effect, or

overdosage;

(C) To add or strengthen an instruction about

dosage and administration that is intended to

increase the safe use of the drug product;

(D) To delete false, misleading, or unsupported

indications for use or claims for effectiveness; or

(E) Any labeling change normally requiring a

supplement submission and approval prior to

distribution of the drug product that FDA specifi-

cally requests be submitted under this provision.

21 C.F.R. § 314.70(c)\(6)iiMA)(E); accord id.,

§ 314.70(b\(2\v(A) (exempting labeling changes

21

under § 314.70(c)\(6)(iii) from the requirement of a

supplemental application and approval prior to mak-

ing the labeling change); id., § 314.70(c)(4) (exempt-

ing labeling changes under § 314.70(c)\6) from the

requirement to wait 30 days before making the

change).

The regulation confirms that neither the Federal

Food, Drug, and Cosmetic Act nor the implementing

regulations preclude additional labeling in compli-

ance with the drug manufacturer’s duty of care and

duty to warn. Again, the federal standards estab-

lished between drug manufacturer and regulator are

minimal standards for introducing the new drug into

interstate commerce; they do not pre-empt the drug

manufacturer’s separate duties to consumers under

state laws. With respect to labeling in particular,

there is no conflict between drug manufactures’

duties to consumers under state law and drug

manufacturers’ separate regulatory duties under the

Federal Food, Drug, and Cosmetic Act.

The cases are legion where new drugs that the

Food and Drug Administration has approved for

introduction into interstate commerce—duties be-

tween drug manufacturers and the Food and Drug

Administration having been met—subsequently cause

great harm or death to individual consumers because

the pharmaceutical company failed its separate duty

of care and duty to warn the individual consumer.

These cases demonstrate the importance of drug

manufacturers’ continuing and independent duties to

consumers under state law.

One illustrative example concerns the drug DES.

In the late 1940s, the Food and Drug Administration

approved drug manufacturers’ applications to sell

diethylstilbestrol (DES) in interstate commerce. See,

22

e.g., Collins v. Eli Lilly Co., 116 Wis. 2d 166, 179

(Wis. 1984). Pharmaceutical companies marketed

DES for use by pregnant women to prevent mis-

carriage. Ibid. In 1952, the Food and Drug Ad-

ministration decided that DES was no longer a “new

drug,” and drug manufacturers could sell it in

interstate commerce without prior testing and new

drug applications under 21 U.S.C. § 355(b). See id.,

at 179; Sindell v. Abott Laboratories, 26 Cal. 3d 588,

593 (Cal. 1980). DES, however, caused growths and

cancer in daughters of mothers who took DES during

pregnancy, which did not manifest until after a

minimum period of latency of 10 or 12 years. See,

e.g., Sindell, 26 Cal. 3d, at 594. Medical studies

questioned the therapeutic value of the promoted use

to prevent miscarriage. E.g., Collins, 116 Wis. 2d, at

179, n. 6 (citing medical study published in 1953). In

1971, the Food and Drug Administration ordered

drug manufacturers to cease selling DES for this use,

and to warn physicians and the public that pregnant

women should not use it. Jd., at 179. Cases such as

this illustrate the critical importance of a drug

manufacturer’s continuing and independent duties to

consumers under state law, when post-market ex-

perience subsequently proves that the new drug

should not be used as promoted and advertised.

CONCLUSION

Every day in this country, the ordinary consumer

has no choice but to trust strangers to provide them

* The DES cases also revealed that drug manufacturers

actually purchase insurance in anticipation of state tort actions.

See, e.g., Schering Corp. v. Home Ins. Co., 712 F.2d 4, 7-8 (2d

Cir. 1983); Eli Lilly & Co. v. Home Ins. Co., 653 F. Supp. 1, 3-5

(D.D.C. 1984).

23

with uncontaminated food, good medicine, honest

financial services, safe cars, and the whole host of

other products and services associated with modern

life. Every day, manufacturers’ fundamental duty of

care and duty to warn this ordinary consumer are

critical consumer remedies and protections. With the

Federal Food, Drug, and Cosmetic Act, Congress

enacted minimum standards of safety and efficacy for

sales of new drugs in interstate commerce, but it

nowhere pre-empted the drug manufacturers’ sepa-

rate duty of care and duty to warn the individual

consumer. Under the Federal Food, Drug, and

Cosmetic Act, federal pre-market regulatory review

and approval, and state common-law remedies and

duties in the marketplace, exist in concert to secure a

fair, just, and safe marketplace for all consumers.

For the reasons set forth above and in the Brief for

Respondent, the judgment of the Supreme Court of

Vermont should be affirmed.

Respectfully submitted,

MARK SAVAGE *

CONSUMERS UNION OF

UNITED STATES, INC.

1535 Mission Street

San Francisco, CA 94103

(415) 431-6747

* Counsel of Record Attorney for

Consumers Union of

United States, Inc.