# Amicus Curiae Brief — Wyeth v. Levine

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0529%3A26

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2009
- **Citation:** 555 U.S. 555

## Text

\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.

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0529%3A26. Public record. Not legal advice.