Amicus Curiae Brief — Wyeth v. Levine

4a) AUG 14 2008

aZ OFFICE OF THE CLEFK

FILED

INTHE .

Supreme Court of the Hnited States

WYETH,

Petitioner,

Respondent.

On Writ of Certiorari to the

Vermont Supreme Court

BRIEF FOR THE AMERICAN ASSOCIATION

FOR JUSTICE AS AMICUS CURIAE

SUPPORTING RESPONDENT

Les Weisbrod Louis M. Bograd*

777 6th Street NW Francine A. Hochberg

Suite 200 CENTER FOR CONSTITUTIONAL

Washington, D.C. 20001 LITIGATION, P.C.

(202) 965-3500 777 6th Street NW

President, American Suite 520

Association for Justice Washington, D.C. 20001

(202) 944-2803

Counsel for Amicus Curiae

*Counsel of Record

TABLE OF CONTENTS

ee I iitirin ccistsniencinesncesecesccvnnniasstee i

TERME OE RAF TRIE BEI ccc ccvesccccossescececovessrevenes 1

INTEREST OF AMICUS CURIAE..................:cceeee 1

SUMMARY OF ARGUMENT .............. eee eeteeeeees 1

EA SC ee 3

I. Federal Regulation of Prescription Drugs

and State Tort Liability for Inadequate

Warnings Have Coexisted Compatibly For

Oh I ciGinatlatdindetiniieadenitntiindacidntabittihiatnateeinapanse 3

A. A Common Law Cause of Action for

Failure to Warn of the Risks Posed

by Drugs is Long-Standing and

Widely Recognized. ...........0.ccccccssesseseeee 3

B. Congress and, Until Recently, the

FDA Regarded State Tort Liability

and Federal Regulation As

Ee 8

a Congress Has Shown No

Intention To Preempt

Common Law Tort Claims

Concerning Prescription

EE 8

2. The FDA, Prior to this

Decade, Regarded State Tort

Liability and Federal

Regulation As

Complementary. ..................... 13

al

C. State Tort Liability Supports

Federal Regulation in Advancing

Congress's Goal of Safe and Effective

Pharmaceuticals. .............................<. 16 |

II. State Tort Law Has Always Taken

Compliance with Federal Regulatory

Standards Into Account In Determining

III scliecsikpnssciansitbakeebcudibididediailiitadpinnisicncets 19

A. Under the Traditional Common Law

Rule, Compliance with Federal

Regulations is Evidence of Non-

Negligence, But Not Dispositive....... 19

B. Virtually Every State, and the

Congress, Have Declined to Treat

Regulatory Compliance as

Conclusive of Non-Negligence........... 27

C. An FDA Complhiance Defense Would

Pose Many Probleme. ........................ 30

III. Because State Tort Law Takes Appropriate

Account of Compliance with FDA Labeling

Requirements, There Can Be No “Direct

and Positive Conflict” Between State and

Federal Law That Would Justify

IIS: sstinccnsciduipishivapsipinsioiabdaupassnselntinabiadusainesicianiiin 34

ee rercsnniccnesanssunssueuitiatianiitiniensciipntient 35

bee

ry

TABLE OF AUTHORITIES

CASES

Abbot by Abbot v. American Cyanamid Co., 844

Fe EY TIED sicdicicesesiccncssnsepbiiioctmnseses 7

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

I iiid tii siaitiactieths latch scislietusibialibhinpaebniaaniantiidile 3, 18, 19

Blood Balm Co. v. Cooper, 83 Ga. 457, 10 S.E. 118

I a ieeeall 3

Boyd v. Coca Cola Bottling Works, 177 S.W. 80

RAE NEE Pena a ce ene eo 5

Bristol-Myers Co. v. Gonzales, 561 S.W.2d 801

a 23, 25

Brochu v. Ortho Pharmaceutical Corp. 642 F.2d

I i sbinliines 26

Buckman Co. v. Plaintiff's Legal Committee, 531

SG ER ON SS ST 28

Caraker v. Sandoz Pharmaceuticals Corp., 172 F.

Supp. 2d 1018 (S.D. Ill. 2001)........... 8

Catani v. Swift & Co., 95 A. 931 (Pa. 1915)........... 22

Chambers v. G.D. Searle & Co., 441 F. Supp. 377

as STI cis cibisnseinstihsdinniisiiicinepneibictieidtinsumpibiabtaninsd 25

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

Ty en Ee ont ae Aen We ma [Ee 11

CSX Transportation, Inc. v. Easterwood, 507 U.S.

i hadith ct ie ital aiaticinead allel acelin 18

iv

DeSiano v. Warner-Lambert & Co., 467 F.3d 85 | .

I I svnncoccoseccmncsoonsemnemenvintarenensiatenestapers 28

Feldman v. Lederle Laborato: .es, 479 A.2d 374, . |

Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961

at i ae cd lnliigdddiig 28

Grand Trunk Railway Co. v. Ives, 144 U.S. 408

EOL ME ARERR ON ee Oren pO 21, 22

Hilisborough County v. Automated Medical

Laboratories, Inc., 471 U.S. 707 (1982) ............34

Hoffman v. Sterling, 485 F.2d 132 (3d Cir. 1973)..26

Hruska v. Parke, Davis & Co., 6 F.2d 536 (8th

EEE TE ae Raper ey eles SL TRC ot eee Da 5

In re Tetracycline Cases, 747 F. Supp. 543 (W.D.

ERECT SREP ata ane De NE Rae 7

In re Vioxx Products Liability Litigation, 501 F.

Supp. 2d 776 (E.D. La. 2007) ...........0............0. 8

In re Zyprexa Products Liability Litigation, 489 F.

Supp. 2d. 230 (E.D.N.Y. 2007) .................. Sihatailineh 8

In re Zyprexa Products Liability Litigation, 493 F.

Supp. 2d. 571 (E.D.N.Y. 2007) .............00......2.0 17

Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971) ........ 26

Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293

GF Ae ene e reed lean er 8

Levine v. Wyeth, 944 A.2d 179 (Vt. 2006)............... 12

Love v. Wolf, 226 Cal. App. 2d 378 (Cal. Ct. App.

MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65

AEP RRO ESS LRN me ner a Some o 23

Marcus v. Specific Pharmaceuticals, Inc., 82

N.Y.S.2d 194 (N.Y. Sup. Ct. 1948)... 6

Marigny v. Dejoie, 172 So. 808 (La. Ct. App. 1937).5

Mazetti v. Armour & Co., 135 P. 633 (Wash. 1913).5

McClanahan v. California Spray-Chemical Corp.,

Fee A 6 ie COs BID pencccscoccnsenssnlecnibtenmnsasinien 5

McDermott v. Wisconsin, 228 U.S. 115 (1913).....4, 5

McEwen v. Ortho Pharmaceutical Corp., 528 P.2d

Ee GD. BPO verccccscscccncsstanssonsintsmnaiesuninbtiaaumines 23

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)......... 10

Merrell Dow Pharmaceuticals, Inc. v. Oxendine,

GOB A.3d BBE OD.C. 1BDE).......ccccccccccccccccccscoscecess 1]

New State Ice Co. v. Liebmann, 285 U.S. 262

ITI sctasinitenepsntinianatattianigasoneiienbiadaediatneidiibiiilticialnds 34

Norton v. Sewall, 106 Mass. 143, 1870 WL 3529

I, TO 3

O’Gilvie v. International Playtex, Inc., 821 F.2d

ee ee She ee iccimcsnintdnanintdticnnnsmiinenieiiitiats 23

vi

Osburn v. Anchor Laboratories, Inc., 825 F.2d 908

Ee eee 8

Perry v. Novartis Pharmaceutical Corp., 456 F.

Supp. 2d 678 (E.D. Pa. 2006) ...............ccccccceeseeees 8

Peters v. Johnson, 50 W. Va. 644, 41 S.E. 190 (W.

ERE EE ee eae ee ee ae 3

Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993) 25

Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th

EE ST Pe ane eR 6

Riegel: Medtronic, __ U.S. ___, 128 S.Ct. 999

Ee ae eee ee 6, 7,9

Salmon v. Parke, Davis & Co., 520 F.2d 1359 (4th

ESTER A es a 23, 26

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

a sisiiciie 10, 18

Smith v. Maine Central Railroad Co., 32 A. 967

STE oe a ee 22

Stevens v. Parke, Davis & Co., 507 P.2d 653 (Cal.

AES A ee ee 22, 24, 26

Thomas v. Winchester, 6 N.Y. 397, 1852 WL 4748

EE 3,4

Thrall v. Wolfe, 503 F.24 313 (7th Cir. 1974)........ 11

Tobin v. Astra Pharmaceutical Products, Inc., 993

I suleuuaanee 8

Toole v. Richardson-Merrell, Inc., 251 Cal. App.

2d GBY (Cal. App. 1967) ........cc.cccsecsecsesseseesseeeeee 26

vil

Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168

Webb v. Sandoz Chemical Works, Inc., 69 S.E.2d

Rs is I i aati cael cncanbeiel 6

Wells uv. Ortho Pharmaceutical Corp., 788 F.2d

ESRC AE Sa ee nee 23

Whitley v. Cubberly, 210 S.E.2d 289 (N.C. App.

Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95 (App.

RIE anal -= ees 4.09, Tat er 25

Yarrow v. Sterling Drug, Inc., 263 F.Supp. 159

(D.S.D. 1967), aff'd, 408 F.2d 978 (8th Cir.

A tele retest bse iaisliniane alii a ltadintiaiiiaiin 23

STATUTES

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

8 EE 11, 12

Food and Drug Administration Amendments Act,

Pub. L. No. 110-85, 121 Stat. 823 (2007), to be

codified at 21 U.S.C. § 355 (0)(4).............cccceeees 12

Food and Drug Administration Modernization Act

8 8 ee 12

Federal Food and Drugs Act of 1906, 21 U.S.C. §§

BD GD creseeneseusnsecncnsennecesreessenenvensnensssenseqnansnanens 4,8

Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

I al ll passim

Medical Device Amendments, 21 U.S.C. § 360 k

STITT icnuasntroviorapcennianeiciteteagaiitiesiatatiatabiitaalaiataaias 10, 12

vill

Ariz. Rev. Stat. Ann. § 12-701 ................00-ceseeseeseees 29

Colo. Rev. Stat. § 13-21-403................sscccssssreessessers 29

Colo. Rev. Stat. § 13-64-302.5............eccceeccereeeneees 29

BO RS 8 S$ eee 29

Kan. Stat. Ann. § 60-3304 sacesescesnserscconensscnsssessonsecse 29

Ky. Rev. Stat. Ann. § 411.310.....................cccsssereees 29

Mich. Comp. Laws Ann. § 600.2946(5)................... 28

Ff eS Soares 29

Ps GE, GRUNIEL, Se IEIMD cei ccicesccocnounescnccnistiniecaienhe 29

Ohio Rev. Code Ann. § 2307.80 ...................0.0020000+- 29

Bs ee i ttiniicinernsitennnnidipnnenniieantiaantide 29

Tenn. Code Ann. § 29-28-1004 .0..........cccceceeeeee senses 29

Tex. Civ. Prac. & Rem. Code Ann. § 82.007........... 29

Utah Code Ann. § 78B-6-703 .................c:ceceeeeeeeeeees 29

Utah Code Ann. § 78B-8-203 ..0..........ccccccesssnceeeeeeees 29

REGULATIONS

IT irs tnntimnegnaenesemendennecnmsnnanianiieniitien 12

SL eres 12

LEGISLATIVE MATERIALS

108 Cong. Rec. 21,083 (1962)................ eeeeeeeee ees ll

ix

153 Cong. Rec. $11833 (Sept. 20, 2007) ............... 13

Federal Food, Drug, and Cosmetic Act: A

Statement of its Legislative Record 24 (Charles

Wesley Dunn, ed. 1938)...............cccccccceceseeereeeeeees 9

H.R. 956, 104th Cong., lst Sess. § 201(f) (as

passed by House, Mar. 10, 1995)...................... 30

H.R. 5626, 96th, Ist Sess. (1979)..............000..cceeeees 30

H.R. 6300, 95th Cong., Ist Sess. § 8 (1977) ........... 30

H.R. 7284, 97th Cong., lst Sess. (1982)................. 30

Hearings on S. 1944 before a Subcomm. of the S.

Comm. on Commerce, 73d Congress, 2d

REESE SNE REE REAP eee 9

S. 403, 95th Cong., Ist Sess. § 601 (1977).............. 30 ©

S. 640, 102d Cong., Ist Sess. § 303 (1991)............. 30

S. 687, 103d Cong., Ist Sess. § 203 (1993) ............. 30

S. 1944, 73d Cong., Ist Sess. (1933).....................000- g

S. 1999, 99th Cong., 1st Sess. § 306 (1985)............ 30

S. 2760, 99th Cong., 2d Sess. § 303 (1986)............. 30

M RATIVE TER

44 Fed. Reg. 37,434 (Jun. 26, 1979) ...............00 14

48 Fed. Reg. 26,720 (June 9, 1983) ........................ 32

59 Fed. Reg. 3944 (Jan. 27, 1994) «0.0.2.0... ceceeeeeeeee 13

63 Fed. Reg. 66,378 (Dec. 1, 1998) ................cecc00es 15

65 Fed. Reg. 81,082 (Dec. 22, 2000) ...............sc00000 14

The Chief of the Bureau of Chemistry, Annual

Report 1917............. SO EAROESL EPA SOO a NONON TE E 9

FDA Subcommittee on Science & Technology,

FDA Science & Mission at Risk 1 (Nov. 2007)17, 33

GAO, FDA Drug Review: Post-Approval Risks

I aii asciinesiicsiiialiaiateainladiaiataatiatesiimsdineditls 32

Institute of Medicine, Committee on the

Assessment of the U.S. Drug Safety System,

The Future of Drug Safety: Promoting and

Protecting the Health of the Public, 152 (Alina

Baciu, et al. eds. 2007)...............0.000 10, 16, 17, 33

Secretary of Agriculture, Annual Report for the

Fiscal Year ended June 30, 1933.1 ...ccccccccccceeeces 9

OTHER AUTHORITIES

Richard C. Ausness, The Case for a "Strong”

Regulatory Compliance Defense, 55 Md. L.

Ns i a ae 30

Buckman Co. v. Plaintiff's Legal Committee, Oral

Arg. Official Trans., No.98-1768, 2000 WL

1801621 (Dec. 4, 2000) ...0...00...c ce ccccecccceeeeeeeceees 14

Steven P. Croley & Jon D. Hanson, Rescuing the

Revolution: The Revived Case for Enterprise

Liability, 91 Mich. L. Rev. 683 (1993) .............. 18

Richard A. Epstein, Legal Liability for Medical

Innovation, 8 Cardozo L.Rev. 1139 (1987)........ 28

xi

Michael D. Green, Statutory Compliance and Tort

Liability: Examining the Strongest Case, 30 U.

Mich. J.L. Ref. 461 (1997) ................2008 31, 32, 33

Peter Huber, Safety and the Second Best: The

Hazards of Public Risk Management in the

Courts, 85 Colum.L.Rev. 277 (1985) ................. 28

Aaron S. Kesselheim & Jerry Avorn, The Role of

Litigation in Defining Drug Risks, 297 JAMA

| EE Serene 17, 18

David A. Kessler, M.D. & David C. Viadeck, A

Critical Examination of the FDA’s Efforts to

Preempt Failure-to-Warn Claims, 96 Geo. L.J.

| EN EAA RA ae 16, 18

Karen E. Lasser, et al., Timing of New Black Box

Warnings & Withdrawals for Prescription

Medications, 287 JAMA 2215 (2002)................ 18

Margaret J. Porter, The Lohr Decision: FDA

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

TPT icstulipsinahinbabesdeaneninctdesnntddinbiabidiateininncenien 14, 16

Robert L. Rabin, Reassessing Regulatory

Compliance, 88 Geo. L.J. 2049 (2000)...31, 33, 34

Restatement (Second) of Torts § 288C (1965)..20, 24

Restatement (Third) of Torts: Products Liability,

IER EEE vvsee eae nT ero mOr an 21

Restatement (Third) of Torts: Products Liability §

a 7

Teresa Moran Schwartz, Regulatory Standards

and Products Liability: Striking the Right

eae

Balance Between the Two, 30 U. Mich. J.L.

as 31, 33

Teresa Moran Schwartz, The Role of Federal

Safety Regulations In Products Liability

Actions, 41 Vand. L. Rev. 1121 (1988).............. 32

Kaspar J. Stoffelmayr, Products Liability and

“Off-Label” Uses of Prescription Drugs, 63 U.

Chi. L. Rev. 276 (1906) ......ccccccccoccscccccosesscccccccees 32

W. Kip Viscusi, Reforming Products Liability 66

ESI scicendeclinasiealecnaelitiiaaieincciateseiniieminiaiaimaunsignietineiagseaee 17

John W. Wade, On the Nature of Strict Tort

Liability for Products, 44 Miss. L.J. 825 (1973)17

INTEREST OF AMICUS CURIAE

The American Association for Justice (“AAJ”),

formerly the Association of Trial Lawyers of

America, respectfully submits this brief as amicus

curiae in support of Respondent. This brief is filed

with consent of all parties.!

AAd is a voluntary national bar association whose

trial lawyer members primarily represent individual

plaintiffs in personal injury cases and other civil

actions, including product liability cases.

Throughout its history, AAJ has advocated in courts,

in Congress, and in state legislatures to preserve the

protections for ordinary citizens afforded by the

common law and to ensure that state tort claims,

such as product liability claims, provide injured

persons with effective legal recourse and remedies

for wrongful injuries. By bringing such claims on

behalf of people injured by drug products and by

testifying before Congress about drug safety and the

FDCA, AAd’s members have helped to ensure that

the nation’s consumers have access to safe and

effective pharmaceuticals.

SUMMARY OF ARGUMENT

A common law cause of action against drug

manufacturers for failure to provide adequate

warnings has been recognized for over 150 years and

has coexisted with federal regulation for a century.

! Letters of consent from both parties have been filed with the

Clerk of Court. Pursuant to Rule 37.6, amicus states that no

counsel for a party authored any part of this brief, nor did any

person or entity other than amicus, its members, or its counsel

make a monetary contribution to its preparation or submiss.on.

bebe

Congress, through multiple revisions of the Food,

Drug, and Cosmetic Act, has consistently declined to

preempt such state tort litigation. For good reasons

Congress and, until recently, the FDA viewed state

tort liability as an important complement to federal

regulation in ensuring safe and effective drugs.

State tort law has always taken a drug company’s

compliance with FDA requirements into account as

evidence that the company was not negligent. Once

a defendant demonstrates such compliance, the

plaintiff must come forward with evidence that a

reasonable company would have done more under

the circumstances, as Diana Levine did in this case.

This focus on the special circumstances of the case

ensures that a finding of liability will not pose a

“direct and positive conflict” with FDA regulatory

decisions.

Virtually every state and Congress has declined

to elevate compliance with FDA requirements into a

dispositive defense. They recognize that such a

defense would be difficult to apply, place excessive

reliance on the FDA, undermine incentives for drug

companies to strengthen their warnings, and leave

injured persons remediless. This Court must not

now create a national FDA compliance affirmative

defense under the guise of implied conflict

preemption.

ARGUMENT

I. Federal Regulation of Prescription Drugs

and State Tort Liability for Inadequate

Warnings Have Coexisted Compatibly For a

Century.

A. A Common Law Cause of Action for

Failure to Warn of the Risks Posed by

Drugs is Long-Standing and Widely

Recognized.

A common law cause of action for negligence with

respect to the manufacture, sale, and administration

of medicines and related products predates federal

regulation of pharmaceuticals and is_ widely

recognized and accepted. See Thomas v. Winchester,

6 N.Y. 397, 1852 WL 4748 (N.Y. 1852) (holding a

drug manufacturer who carelessly labeled a poison

as a harmless medicine and sold the mislabeled

medicine liable for a patient’s resultant injury).

Where, as here, there has been a “long history of tort

litigation” in the area of state common law at issue,

the presumption against preemption has “add[ed]

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

449 (2005).

State courts have held drug manufacturers liable

for injuries resulting from failures to adequately

warn of the risks and potential side-effects

associated with their products since at least the mid-

nineteenth century. See, e.g. Norton v. Sewall, 106

Mass. 143, 1870 WL 3529 (Mass. Nov. 1870); Blood

Balm Co. v. Cooper, 83 Ga. 457, 10 S.E. 118 (Ga.

1889); Peters v. Johnson, 50 W. Va. 644, 41 S.E. 190

(W. Va. 1902). In Thomas v. Winchester, for

example, the court held that, although the drug

manufacturer's “sale of the poisonous article was

made to a dealer in drugs, and not to a consumer,”

the manufacturer had a duty to the ultimate

consumer to warn of possible risks attendant to the

drug and to adequately label the drug:

The defendant's duty [to the consumer]

arose out of the nature of his business

and the danger to others incident to its

mismanagement. Nothing but mischief

like that which actually happened could

have been expected from sending the

poison falsely labeled into the market;

and the defendant is justly responsible

for the probable consequences of the act.

1852 WL 4748, at *9.

Congress first regulated food and drugs in the

Federal Food and Drugs Act of 1906, 21 U.S.C. §§ 1,

et seq. The 1906 act was intended to “prevent the

misuse of the facilities of interstate commerce in

conveying to and placing before the consumer

misbranded and adulterated articles of medicine or

food ....” McDermott v. Wisconsin, 228 U.S. 115,

131 (1913). Congress did not address state tort

liability in the 1906 act, implicitly indicating that it

did not intend to restrict such well-established

causes of action, which furthered the purposes of the

act by providing remedies for persons who wrongly

suffered drug-related injuries. As this Court

explained only a few years after the statute was

enacted, “it by no means follows that the state is not

permitted to make regulations, with a view to the

protection of its people against fraud or imposition by

impure food or drugs.” Jd.

After the 1906 act was enacted, common law

failure to warn litigation continued unconstrained.

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

(8th Cir. 1925) (holding that a manufacturer's

negligence in preparing or selling a pharmaceutical

product is actionable by a consumer or third party

who suffers from the negligence); Marigny v. Dejoie,

172 So. 808 (La. Ct. App. 1937) (holding pharmacist

liable for plaintiffs injuries resulting from ingestion

of mislabeled drug); Boyd v. Coca Cola Bottling

Works, 177 S.W. 80, 81 (Tenn. 1915) (holding that

drug, food, and beverage manufacturers owe a duty

to those who consume their products and that “[a]

tort is committed, a legal right invaded, by practices

which prejudice another’s health”); see also Mazetti v.

Armour & Co., 135 P. 633 (Wash. 1913) (holding that

restauranteur could bring action against food

manufacturer when restaurant patron was injured

by manufacturer's product, which was regulated by,

and violated, the 1906 act). During this period,

various states also enacted complementary laws to

“provide the particular consumer and the general

public with a higher and surer degree of protection

than is afforded by exclusive recourse to common-law

remedies.” McClanahan v. California Spray-Chem.

Corp., 75 S.E.2d 712, 717-18 (Va. 1953) (discussing

1906 act and subsequently enacted state laws).

Congress revisited, and strengthened, federal

regulation of food and drugs in 1938, when it enacted

the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§§ 301-392 (“FDCA”). Congress did not attempt to

limit the state tort liability of pharmaceutical

manufacturers in the FDCA, or in any of its

subsequent amendments, as discussed below. See

infra at 5-6.

Moreover, even after the enactment of the FDCA,

persons injured by prescription drugs continued to .

sue drug companies for inadequate warnings. See

Riegel v. Medtronic, __ U.S. ___, 128 S.Ct. 999, 1017

(2008) (Ginsburg, J., dissenting) (from passage of

FDCA through 1976 Medical Device Amendments,

“state common-law claims for drug labeling and

design defects had continued unabated”); ‘see, e.g.,

Marcus v. Specific Pharms., Inc., 82 N.Y.S.2d 194,

194 (N.Y. Sup. Ct. 1948) (denying drug company’s

motion to dismiss failure-to-warn claims, because

“foJne who manufactures and distributes an article

which, if improperly used, is dangerous to human life

is under a duty to apprise the purchasing public by

labels or otherwise of the manner in which the

article may be safely used”); Webb v. Sandoz Chem.

Works, Inc., 69 S.E.2d 689, 692 (Ga. Ct. App. 1952)

(holding that plaintiff stated a cause of action for

failure-to-warn sufficient to withstand motion to

dismiss, but that evidence proffered later showed

that defendant had provided adequate warning);

Love v. Wolf, 249 Cal. App. 2d 822, 832 (Cal. Ct. App.

1967) (finding drug manufacturer liable for plaintiff's

injuries based on both inadequate warning on the

drug’s label and overpromotion); Reyes v. Wyeth

Labs., 498 F.2d 1264 (5th Cir. 1974) (affirming

holding that manufacturer could be hable for failure

to warn consumer of adverse events and

unreasonably dangerous conditions related to drug).

And this failure-to-warn cause of action was

expressly preserved in the most recent restatement:

“A manufacturer of a prescription drug . . . is subject

to hability for harm to persons caused by... [al

prescription drug . . . [that] is not reasonably safe

due to inadequate instructions or warnings.”

Restatement (Third) of Torts: Prods. Liab. § 6 (1998)

As evidence that no one perceived that state tort

litigation conflicted with federal drug regulation,

pharmaceutical defendants in these suits generally

did not even raise the defense of federal preemption.

See Riegel, 128 S.Ct. at 1017 n.11 (Ginsburg, J.,

dissenting) (“Most defendants, it appears, raised no

preemption defense to state tort suits involving FDA-

approved drugs.”) (collecting cases); see also cases

cited supra 7 (in none of the afore-referenced cases

did defendants raise a preemption defense).

Only since the late 1980s have drug company

defendants regularly argued for preemption. See,

e.g., In re Tetracycline Cases, 747 F. Supp. 543 (W.D.

Mo. 1989) (rejecting defendant drug manufacturer's

argument that the federal regulation of drug labels

and package inserts preempted plaintiffs’ claims).

And, with few exceptions, courts have consistently

rejected the defense of preemption in cases in which

it was raised. See Riegel, 128 S.Ct. at 1018-19 &

n.16 (Ginsburg, J., dissenting) (“Courts that have

considered the question have overwhelmingly held

that FDA approva! of a new drug application does

not preempt state tort suits.”) (collecting cases);

Abbot by Abbot v. Am. Cyanamid Co., 844 F.2d 1108,

1112 n.l (4th Cir. 1988) (“The overwhelming

majority of courts considering federal preemption of

state law as regards vaccines have found no

preemption.”) (collecting cases); see, e.g., id. at 1111

(holding that in the FDCA “Congress did not intend,

either expressly or impliedly, to preempt state law”);

Caraker v. Sandoz Pharms. Corp., 172 F. Supp. 2d

1018 (S.D. Ill. 2001); Tobin v. Astra Pharm. Prods.,

Inc., 993 F.2d 528 (6th Cir. 1993); Osburn v. Anchor

Labs., Inc., 825 F.2d 908, 913 (5th Cir. 1987);

‘Feldman v. Lederle Labs., 479 A.2d 374 (N.J. 1984);

Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293,

1299 (D. Minn. 1988) (“The mere fact that the Cu-7

received FDA approval does not, by itself, indicate

that Congress impliedly intended to preclude state

tort actions against prescription drug

manufacturers.”). Even after the FDA, in the

current administration, began to assert that state

tort liability and federal regulation conflict, most

courts continue to reject the preemption defense.

See, e.g., In re Vioxx Prods. Liab. Litig., 501 F. Supp.

2d 776, 785 (E.D. La. 2007); In re Zyprexa Prods.

Liab. Litig., 489 F. Supp. 2d. 230, 273-74 (E.D.NLY.

2007); Perry v. Novartis Pharm. Corp., 456 F. Supp.

2d 678 (E.D. Pa. 2006).

B. Congress and, Until Recently, the FDA

Regarded State Tort Liability and

Federal Regulation As Complementary.

1. Congress Has Shown No Intentjon

To Preempt Common Law Tort

Claims Concerning Prescription

Drugs.

Congress enacted the FDCA in 1938 to remedy

defects in the 1906 Act. Among other things, the

earlier law had “failfed] to take cognizance of

fraudulent statements covering food or drugs which

are not in or upon the food or drug package.”

Secretary of Agriculture, Annual Report for the

Fiscal Year ended June 30, 1933, 1, 13-14 (citing The

Chief of the Bureau of Chemistry, Annual Report

1917), quoted in Federal Food, Drug, and Cosmetic

Act: A Statement of its Legislative Record 24-25

(Charles Wesley Dunn, ed. 1938).

The revised Food and Drugs Act was first

introduced in the Senate in 1933 as S. 1944. S. 1944

contained a provision titled Liability for Personal

Injury, which stated: “A right of action for damages

shall accrue to any person for injury or death

proximately caused by a violation of this Act.” Jd. at

49 (citing S. 1944, as introduced in the 73d Congress,

lst Session, June 6, 1933). This provision, however,

was not included in future versions of the act.

Apparently, Congress decided not to create a federal

cause of action for damages because, as witnesses

testified, it was unnecessary: “[a] common law right

of action [already] exists.” Hearings on S. 1944

Before a Subcomm. of the S. Comm. on Commerce,

73d Cong., 2d Sess. 400 (1933) (statement of W.A.

Hines); id. at 403 (statement of J.A. Ladds) (“This act

should not attempt to modify or restate the common

law with respect to personal injuries.”); see also

Riegel, 128 S.Ct. at 1017 n.10 (Ginsburg, J.,

dissenting) (quoting same). A key way to accomplish

the FDCA’s purpose of protecting the public was by

retaining common law tort liability for personal

injuries.

By passing the FDCA without a private right of

action, Congress affirmed its intent that state tort

actions would remain available to provide “judicial

recourse for those injured.” As this Court has

observed in similar contexts:

[Congress’} silence [regarding state law

remedies for persons injured by

radiation from a nuclear plant] takes on

added significance in light of Congress’

failure to provide any federal remedy

for persons injured by such conduct. It

is difficult to believe that Congress

would, without comment, remove all

10

means of judicial recourse for those

injured by illegal] conduct.

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

(1984); see also Medtronic, Inc. v. Lohr, 518 U.S. 470,

487 (1996) (citing same in construing 21 U.S.C. §

360k(a) of the Medical Device Amendments).

Congress revisited federal food and drug

regulation in the 1962 Drug Amendments, which

“shifted the burden of proof from FDA (which

previously had to prove harm to keep a drug from

being marketed) to manufacturers, who now were

required to demonstrate both safety and efficacy

prior to receipt of marketing approval.” Institute of

Medicine, Committee on the Assessment of the US.

Drug Safety System, The Future of Drug Safety:

Promoting and Protecting the Health of the Public,

152 (Alina Baciu, et al. eds. 2007) (“IOM Report”)

(citation omitted).

The 1962 amendments clarified the FDCA’s

intended relationship to state law. Congress

included language explicitly restricting the potential

preemptive effect of federal law to cases of “direct

and positive conflict”:

Nothing in the amendments made by

this Act 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.

1]

Pub. L. No. 87-781, § 202, 76 Stat. 780, 793 (1962)

(emphasis added). When Congress’s express words

provide “a ‘reliable indicium of congressional intent

with respect to state authority, there is no need to

infer congressional intent to pre-empt state laws.”

Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517

(1992) (citation omitted).

Congress inserted the “direct and _ positive

conflict” language in the 1962 Drug Amendments to

limit claims of preemption. See Thrall v. Wolfe, 503

F.2d 313, 317 (7th Cir. 1974) (interpreting statute

with identical “direct and positive conflict” language

and concluding: “The section was doubtless inserted

for the purpose of avoiding a claim of preemption”).

“[D]ebates on the adoption of this provision expressly

noted that the provision was consistent with the

intention that federal law should not preempt in

those fields where state food and drug laws are

stronger.” Merrell Dow Pharms., Inc. v. Oxendine,

649 A.2d 825, 828 n.3 (D.C. 1994) (citing 108 Cong.

Rec. 21,083 (1962)). As the court below correctly

concluded, the “plain language of the [FDCA]

indicates that Congress did not intend to interfere

with state prerogatives except where doing so is

absolutely necessary, . . . and the plain language of

the regulation [at issuc] makes such interference

unnecessary here.” See Levine v. Wyeth, 944 A.2d

179, 191 (Vt. 2006).

Congress knows how to write an express

preemption provision when it wants to: in

subsequent amendments to the FDCA, Congress

enacted express statutory preemption provisions

applicable to medical devices, over-the-counter (OTC)

drugs, and cosmetics. 21 U.S.C. § 360k(a) (1976); 21

a

12

U.S.C. § 379r (1997); 21 U.S.C. § 379s (1997).2 But

Congress never adopted any comparable preemptive

language concerning prescription drugs, thereby

further evidencing its intent not to preempt state

law.

Most recently, in 2007, Congress enacted the

Food and Drug Administration Amendments Act of

2007, Pub. L. No. 110-85, 121 Stat. 823. That act

bolsters the FDA’s authority to require a

manufacturer to change a drug label if the agency

becomes aware of information it believes should be

included. 121 Stat. at 924 (to be codified at 21 U.S.C.

§355 (0)(4)). To defuse claims that this expanded

agency authority would lead to preemption, Congress

included a “rule of construction” to make clear that

the act did not “affect the responsibility of’ a drug

company “to maintain its label in accordance with

existing requirements,” including 21 C.F.R. §§ 201.80

(e) and 314.70(c). 121 Stat. at 925-26 (to be codified

at 21 U.S.C. § 355(0)(4)(I)). These are the regulatory

provisions invoked by many courts, including the

court below, as grounds for rejecting drug company

assertions of imphied conflict preemption. Thus, here

again, Congress indicated its intention not to

preempt state tort law. See 153 Cong. Rec. $11833

(daily ed. Sept. 20, 2007) (statement of Sen.

Kennedy) (“Congress has stated very clearly in the

legislation that we do not intend the new authority

being given to the FDA to preempt common law

liability for a drug company’s failure to warn its

customers of health risks”).

2 The preemption provisions applicable to OTC drugs and

cosmetics include savings clauses that expressly exempt state

product liability claims from preemption. 21 U.S.C. § 379r(e);

21 U.S.C. § 3798(d).

13

Congress has had numerous opportunities over

the past seventy years to limit common law remedies

for drug-related injuries, but has repeatedly declined

to do so. Congress, instead, has emphasized that

state law should not be preempted, except in cases

where a “direct and positive conflict” exists.

2. The FDA, Prior to this Decade,

Regarded State Tort Liability

and Federal Regulation As

Complementary.

The FDA itself also has recognized the utility of

state products liability claims, and historically has

not contended that such claims are preempted. In

1994, for example, when the FDA acted to prevent

disclosure of the identities of patients and other

persons involved with adverse event reports, the

agency took pains to make clear that the action was

“not intended to frustrate or impede tort litigation in

this area. Indeed, FDA recognizes that product

liability plays an important role in consumer

protection.” 59 Fed. Reg. 3944, 3948 (Jan. 27, 1994).

That same year, the Chief Counsel of the FDA,

Margaret Jane Porter, wrote to explain the agency’s

anti-preemption position in Medtronic, Inc. v. Lohr:

“FDA product approval and state tort liability

usually operate independently, each providing a

significant, yet distinct, layer of consumer

protection.” Margaret J. Porter, The Lohr Decision:

FDA Perspective and Position, 52 Food & Drug. LJ.

7, 11 (1997).

On at least two occasions, the FDA has explicitly

stated that its labeling regulations do not have

preemptive effect. In a 2000 Notice of Proposed

Rulemaking to revise those requirements, the agency

14

asserted that the proposed amendments “do[} not

contain policies that have federalism implications or

that preempt State law.” 65 Fed. Reg. 81,082, 81,103

(Dec. 22, 2000) (emphasis added). Similarly, at oral

argument in Buckman Co. v. Plaintiff's Legal

Committee, Oral Arg. Official Trans., No.98-1768,

2000 WL 1801621 (Dec. 4, 2000), the Solicitor

General’s office, on behalf of the FDA, distinguished

the fraud-on-the-FDA claim at issue in that case

from traditional common law tort claims: “The fraud

claim is preempted, but if there is negligent design,

negligent manufacturing, failure to warn, common

law malpractice, all of those claims are available”

and are not preempted. Buckman Oral Arg. Official

Trans., 2000 WL 1801621, at *21.

On yet other occasions, the FDA has expressed its

view that state tort litigation does not conflict with

or pose an obstacle to the agency’s mission. In 1979,

when the agency issued its final rule regarding

prescription drug labeling, the rulemaking notice

affirmed: “It is not the intent of the FDA to influence

the civil tort liability of the manufacturer... .” 44

Fed. Reg. 37,434, 37,437 (Jun. 26, 1979). More

explicitly, the rulemaking notice accompanying a

1998 final regulation on Patient Medication Guides

stated that:

FDA does not believe that the evolution

of state tort law will cause the

development of standards that would be

at odds with the agency's regulations.

FDA’s regulations’ establish the

minimal standards necessary, but were

not intended to preclude the states from

imposing additional labeling

requirements. States may authorize

15

additional labeling but they cannot

reduce, alter, or eliminate FDA-

required labeling.

63 Fed. Reg. 66,378, 66,384 (Dec. 1, 1998).

The FDA recognized that its regulatory efforts

benefited from and were supplemented by state

product liability litigation, such as that brought by

Respondent here. As former FDA Commissioner

David Kessler has written, it was

the FDA’s view that its regulatory

efforts could comfortably coexist with

state-law damages claims by consumers

injured by drugs. As the agency saw it,

state-law failure-to-warn litigation did

not interfere with the agency’s

regulatory efforts. ... State damages

litigation helps uncover and assess risks

that are not apparent to the agency

during a drug’s approval process. Until

recently, in the FDA's view, this

“feedback loop” enabled the agency to

better do its job. The agency also

wanted to avoid the “harsh

implications” of eliminating “judicial

recourse for consumers injured by

defective” drugs.

David A. Kessler, M.D. & David C. Vladeck, A

Critical Examination of the FDA’s Efforts to Preempt

Failure-to-Warn Claims, 96 Geo. L.J. 461, 463 (2008)

(emphasis added) (quoting Margaret J. Porter, The

Lohr Decision: FDA Perspective and Position, 52

Food & Drug L.J. at 9).

16

Of course, in the past several years, the FDA’s

position has undergone a “seismic shift”; “[t}he

agency now maintains that state law failure-to-warn

cases threaten its ability to protect the public

health.” Jd. But this Court should not ignore the

agency’ historic understanding that state tort

litigation complemented the federal regulatory

scheme.

Cc. State Tort Liability Supports Federal

Regulation in Advancing Congress’s

Goal of Safe and Effective

Pharmaceuticals.

Litigation is crucial to ensure the safety and

effectiveness of drugs because, as Congress

recognized, and the Institute of Medicine recently

confirmed, FDA approval is not a guarantee of safety

or efficacy and the FDA historically has lacked the

tools to fully and adequately regulate drugs after

they are on the market. See IOM Report, supra, 151-

76. The FDA’s reach is enormous, regulating

“approximately $1 trillion in consumer products or

25 cents of every consumer dollar expended in this

country annually.” FDA Subcommittee on Science &

Technology, FDA Science & Mission at Risk 1 (Nov.

2007) (“Mission at Risk“). Yet, as the FDA itself has

concluded, the agency has “serious scientific

deficiencies and is not positioned to meet current or

emerging regulatory responsibilities.” Jd. at 2-3.

The FDA is underfunded and overburdened, and

needs “substantially increased resources in both

funds and personne!]” if it is to carry out the tasks

assigned to it. LOM Report, supra, 197-98.

State common law provides an_ important

supplement to this overtaxed regulatory system. See

17

In re Zyprexa Prods. Liab. Litig., 493 F. Supp. 2d.

571, 575 (E.D.N.Y. 2007) (“[Llawyers and their

clients often find themselves serving as drug safety

researchers of last resort.”) (quotation omitted).

Private tort litigation has “helped the medical

community reassess drugs by bringing to light new

information about adverse effects” and, “[i]n both the

premarketing and postmarketing stages, lawsuits

have helped uncover important and previously

unavailable data about major adverse events.”

Aaron S. Kesselheim & Jerry Avorn, The Role of

Litigation in Defining Drug Risks, 297 JAMA 308

(Jan. 17, 2007).

Product liability claims, such as those brought by

Respondent, work in concert with federal regulation,

allowing the marketplace to provide an added

financial incentive for manufacturers to make their

products safe and effective as mandated by the

FDCA. See John W. Wade, On the Nature of Strict

Tort Liability for Products, 44 Miss. L.J. 825, 826

(1973); see also W. Kip Viscusi, Reforming Products

Liability 66 (1991) (“The purpose of products liability

is to fill the gaps left by market imperfections and to

replicate the incentives that would have been

generated had markets been functioning perfectly.”).

Moreover, by assessing risk retrospectively, product

liability helps to compensate consumers for imperfect

information. Steven P. Croley & Jon D. Hanson,

Rescuing the Revolution: The Revived Case for

Enterprise Liability, 91 Mich. L. Rev. 683, 707-08

(1993); State tort claims fulfill these roles directly,

by providing remedies to people who suffer injuries

from drugs, and also indirectly, by creating financial

incentives for drug companies to update the

warnings on their products’ labels to reflect current

knowledge about the dangers those products pose.

18

In addition, “tort law often informs regulatory

decisions, and the FDA has often acted in response to

information that has come to light in state damages

litigation.” Kessler & Viadeck, 96 Geo. L.J. at 477

(citing Bates, 544 U.S. at 451; see also Karen E.

Lasser, et al., Timing of New Black Box Warnings &

Withdrawals for Prescription Medications, 287 JAMA

2215, 2218 (2002). The “legal system [has] played an

important role in spurring change in regulatory or

corporate procedures, as well as_ extending

knowledge about drug risks by adding to the

evidence available for evaluation by physicians,

patients, and regulators.” Kesselhcim & Avorn,

supra, at 310.

In all of these ways state tort claims complement

federal regulation and further the purposes of the

FDCA. Cf. CSX Transp., Inc. v. Easterwood, 507

U.S. 658, 668 (1993) (“In fact, the scheme of [state]

negligence liability could just as easily complement

[federal] regulations”); Silkwood, 464 U.S. at 264

(Blackmun, ! . dissenting) (stating that tort damages

“complement the federal regulatory standards, and

are an implicit part of the federal regulatory

scheme”). As this Court said in Bates v. Dow

Agrosciences LLC about a similar statutory scheme:

“Private remedies .. . would seem to aid, rather than

hinder, the functioning of FIFRA .... FIFRA

contemplates that pesticide labels will evolve over

time, as manufacturers gain more information about

their products’ performance in diverse settings... .

[TJort suits can serve as a catalyst in this process.”

544 US. at 451.

Petitioners and the FDA’s arguments that

Respondent’s claims are preempted ignore the long

coexistence of state tort law and federal regulation

19

and the structural complementarity between the two.

This Court should reject these arguments and,

instead, reaffirm that state tort claims advance the

FDCA’s goal of consumer protection and the

regulatory objective of prompt and effective warnings

of serious health risks.

Il. State Tort Law Has Always’ Taken

Compliance with Federal Regulatory

Standards Into Account In Determining

Liability.

How is it possible that, for nearly a century,

neither courts nor legislators nor federal regulators

perceived any significant conflict between state tort

hhability for failure to warn and federal regulation of

prescription drugs? One principal reason is that

state tort law has always taken federal standards

into account, permitting pharmaceutical companies

to introduce their compliance with federal] labeling

requirements as evidence of non-negligence. But, at

the same time, every state recognized that this

evidence could be overcome by other evidence of

negligence or willful wrongdoing. Such an approach

ensures that there will be no “direct and positive

conflict” between state tort liability standards and

federal regulation.

A. Under the Traditional Common Law

Rule, Compliance with Federal

Regulations is Evidence of Non-

Negligence, But Not Dispositive.

The traditional rule has been set forth clearly in

both the second and third restatements of tort law.

Section 288C of the Second Restatement provides:

“Compliance with a legislative enactment or an

20

administrative regulation does not prevent a finding

of negligence where a reasonable man would take

additional precautions.” Restatement (Second) of

Torts § 288C (1965). The Third Restatement

reiterates this principle in the context of products

liability claims, while clarifying that regulatory

compliance is relevant and admissible evidence to be

considered:

In connection with liability for defective

design or inadequate instructions or

warnings: ... (b) a product’s comphance

with an applicable product safety

statute or administrative regulation is

properly considered in determining

whether the product is defective with

respect to the risks sought to be reduced

by the statute or regulation, but such

compliance does not preclude as a

matter of law a finding of product

defect.

Restatement (Third) of Torts: Prods. Liab., § 4

(1998) (emphasis added).

3 In a comment, the Restatement draws a sharp distinction

between regulatory compliance and federal) preemption.

Section 4(b) of the Restatement:

addresses the question of whether and to what

extent, as a matter of state tort law, compliance

with product safety statutes or administrative

regulations affects liability for product

defectiveness. . . .The safety statute or

regulation may be a federal provision, but the

decision to give it determinative effect is a state-

law determination. In contrast, in federal

preemption, the court decides as a matter of

federal law that the relevant federal statute or

21

This treatment of regulatory compliance is a

longstanding rule of common law. The principle was

first prominently discussed by this Court in a case

involving an accident at a railroad crossing, Grand

Trunk Railway Co. v. Ives, 144 U.S. 408 (1892). As

this Court observed:

It is also held in many of the states (in

fact the rule is well-nigh, if not quite,

universal) that a railroad company,

under certain circumstances, will not be

held free from negligence, even though

it may have complied literally with the

terms of a statute prescribing certain

signals to be given, and _ other

precautions to be taken by it, for the

safety of the traveling public at

crossings.

Id. at 420-21; see also Smith v. Maine Cent. R.R. Co.,

32 A. 967, 970-71 (Me. 1895) (“[T]Jhe statutes

prescribing these special duties .. . do not constitute

the sole measure of duty. The common law still

requires the exercise of care and prudence

commensurate with the degree of danger incurred.

The statutes .. . do not release the company from the

obligations to take such additional] precautions as

the peculiar circumstances of the case may

demand.”); Catani v. Swift & Co., 95 A. 931, 933 (Pa.

1915) (“federal statutes providing for meat

regulation reflects, expressly or impliedly, the

intent of Congress to displace state law,

including state tort law, with the federal statute

or regulation. .. . [T)he issue of defectiveness

under state law is never reached.

Id., Comment e (emphasis added).

22

inspection by government officers do not relieve the

packer from liability for damages [for breach of

“common-law duty to sell only wholesome food”]

where he has made no inspection nor taken any

steps to ascertain for himself whether the meat sold

by him is fit for food”).

The rule has been applied repeatedly in failure-

to-warn suits against pharmaceutical companies.

See, e.g., Stevens v. Parke, Davis & Co., 507 P.2d

653, 661 (Cal. 1973) (“mere compliance with

regulations or directives as to warnings, such as

those issued by the [FDA] here, may not be sufficient

to immunize the manufacturer or supplier of the

drug from liability...[WJhen the manufacturer or

supplier knows of, or has reason to know of, greater

dangers not included in the warning, its duty to

warn may not be fulfilled.”); McEwen v. Ortho

Pharm. Corp., 528 P.2d 522, 534 (Or. 1974) (“We

hold that the warnings given by an cthical drug

manufacturer may be found inadequate, ‘[a}lthough

all of the government regulations and requirements

have been satisfactorily met in the production and

marketing of [the drug], and in the changes made in

the literature”) (quoting Yarrow v. Sterling Drug,

Inc., 263 F. Supp. 159, 162 (D.S.D. 1967), aff'd, 408

F.2d 978 (8th Cir. 1969)); Salmon vu. 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.”); Bristol-Myers Co. v. Gonzales, 561 S.W.2d

801, 804 (Tex. 1978) (“fact that the package insert ...

had been approved by the FDA did not relieve

Bristol-Myers of its obligation to communicate an

adequate warning to the users of this dangerous

drug”); MacDonald v. Ortho Pharm. Corp., 475

23

N.E.2d 65 (Mass. 1985) (“in instances where a trier

of fact could reasonably conclude that a

manufacturer's compliance with FDA labeling

requirements or guidelines did not adequately

apprise oral contraceptive users of inherent risks,

the manufacturer should not be shielded from

liability by such compliance.”); Wells vu. Ortho

Pharm. Corp., 788 F.2d 741, 746 (11th Cir. 1986)

(“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”);

OGilvie v. Int'l Playtex, Inc., 821 F.2d 1438, 1443

(10th Cir. 1987).

Indeed, an instruction based on this rule was

given to the jury in this case:

You may consider evidence of

compliance by Wyeth with FDA

requirements in obtaining approval for

the Phenergan warning. Compliance

with FDA requirements does not by

itself establish that the warning was

adequate for purposes of this case. You

must decide whether the instructions

and warnings were adequate based

upon all the evidence presented in this

trial including evidence about the FDA

process.

See Jury Instructions, Printed Case, vol. II, at 348.

Wyeth did not object to this instruction. Jd.

Many courts have explained the rule on the

grounds that most product safety statutes and

regulations set only minimum safety standards. See,

e.g., Stevens, 507 P.2d at 661 (“The warnings

24

required by such agencies may be only minimal in

nature”). But it would perhaps be more precise to

say that such regulations set a proper, legally

sufficient standard only in the absence of any special

circumstances. Restatement (Second) of Torts, §

288C, Comm. a. (“Where there are no such special

circumstances, the minimum standard prescribed by

the legislation or regulation may be accepted by the

triers of fact, or by the court as a matter of law, as

sufficient for the occasion; but if for any reason a

reasonable man would take additional precautions,

the provision does not preclude a finding that the

actor should do so.”) (emphasis added). Thus, once a

defendant has demonstrated that its conduct

conformed to all regulatory requirements, it becomes

incumbent on the plaintiff to come forward with

evidence to support the proposition that, under the

circumstances, more should have been done.

Numerous pharmaceutical cases demonstrate the

application of this rule. Where no_ special

circumstances existed, courts have granted judgment

as a matter of law to defendants that complied with

FDA labeling requirements. See, e.g., Chambers v.

G.D. Searle & Co., 441 F. Supp. 377, 384 (D. Md.

1975) (where defendant had “no other information . .

. indicating greater risks or dangers” than was

available to FDA team that had developed package

insert for oral contraceptive, it was reasonable for

defendant to “rely on warnings approved by the

entire group”); Wolfgruber v. Upjohn Co., 423

N.Y.S.2d 95, 97-98 (App. Div. 1979) (summary

judgment appropriate where “[t]he warning given

was adequate by any standard and the plaintiff as a

doctor knew the risks of taking this particular drug

whose side effects were those specifically warned

against as fully as defendant was able.”); Ramirez v.

25

Plough, Inc., 863 P.2d 167, 175 (Cal. 1993)

(Manufacturer of aspirin was not negligent as a

matter of law for failing to include warnings in

Spanish, where “FDA’s regulations abundantly

demonstrate its sensitivity to the issue of foreign-

language labeling, and yet the FDA regulations do

not require it”).

In many other cases, where plaintiffs presented

evidence that a reasonable drug company should

have done more to warn of the dangers posed by its

product, courts have concluded that the issue of

negligence was for the jury. Bristol-Myers Co. v.

Gonzales presents what may be the paradigmatic

case: there officials at the defendant drug company

knew “that the approved insert did not adequately

warn of potential dangers . . . long before the

inadequacy became known to the government.” 561

S.W.2d at 804. But such plaintiffs’ evidence has

taken numerous other forms. In Salmon, for

example, there was evidence that the defendant had

resisted an FDA suggestion to strengthen the

warning on an antibiotic, despite knowledge that

physicians were ignoring the existing warning and

using the drug carelessly to treat minor infections.

520 F.2d at 1363. In Brochu v. Ortho Pharm. Corp.,

the court of appeals affirmed a jury verdict against a

manufacturer of oral contraceptives that used the

same label warnings on all of its products, even

though it knew that the risk of stroke was far greater

with its high-estrogen-dose pills. 642 F.2d 652, 657-

59 (1st Cir. 1981). In Hoffman v. Sterling Drug, Inc.,

the defendant drug company promoted the use of its

drug for the treatment of lupus, an indication that

had not been approved by the FDA. 485 F.2d 132,

138 (3d Cir. 1973). In Toole v. Richardson-Merrell,

Inc., the drug company’s submission of false and

26

misleading reports to the FDA gave rise to a

“presumption of negligence”. 251 Cal.App. 2d 689,

702-04 (Cal. App. 1967). And, in a number of cases,

courts have held that overpromotion of a drug by the

manufacturer may have undermined the

effectiveness of its label warnings and created a

triable issue regarding negligence. See, e.g., Whitley

v. Cubberly, 210 S.E.2d 289, 291-92 (N.C. App. 1974);

Stevens v. Parke, Davis & Co., 507 P.2d at 662;

Incollingo v. Ewing, 282 A.2d 206, 220 (Pa. 1971);

Love uv. Wolf, 226 Cal. App. 2d 378, 396 (Cal. Ct. App.

1964).

Respondent Diana Levine offered comparable

evidence at trial. She introduced evidence that,

although the FDA was concerned about the greater

dangers of inadvertent arterial exposure associated

with intravenous (IV) administration of Phenergan,

as opposed to intramuscular administration, the

agency never directly considered or addressed the

relative merits of IV push versus IV drip as methods

of IV administration. See Pet. App. 167a-168a

(Phenergan label); Resp. Br. at 10-14. In addition,

plaintiff presented expert testimony at trial] that

Pfizer, the manufacturer of Vistaril, a product posing

risks similar to Phenergan when administered

intravenously, voluntarily modified its label around

1970 to permit only intramuscular administration

and to prohibit IV use. Trial Tr., Mar. 8, 2004, Vol. I,

at pp. 232-33 (testimony of Dr. Harold Green). This

was more than sufficient evidence for a jury to decide

that Wyeth should have “take{n] additional

precautions.”

Thus, since long before there was any federal

regulation of prescription drugs, the legal principle

has been well established that compliance with

27

regulatory requirements does not preclude a finding

of negligence. And that has remained the

predominant common law rule, through each

revision of federal food and drug law, without

objection from Congress or, until recently, the FDA.

B. Virtually Every State, and_ the

Congress, Have Declined to Treat

Regulatory Compliance as Conclusive

of Non-Negligence.

As the administrative state—including the

federal regulation of prescription drugs—has grown

more comprehensive and complex, some have

asserted that this traditional common law treatment

of regulatory compliance was insufficient and have

argued for a strengthened regulatory compliance

defense that would, under certain circumstances,

preclude a finding of Jiability. See, e.g., Peter Huber,

Safety and the Second Best: The Hazards of Public

Risk Management in the Courts, 85 Colum. L. Rev.

277 (1985); Richard A. Epstein, Legal Liability for

Medical Innovation, 8 Cardozo L.Rev. 1139 (1987).

Despite this advocacy, virtually every state, as well

as the Congress, has declined to make regulatory

compliance a dispositive affirmative defense.

Many state legislatures have considered whether

to adopt a regulatory compliance affirmative defense,

but only one—the state of Michigan—has actually

done so.‘ A handful of states have passed laws that

‘ Michigan, alone among the states, has determined that

compliance with FDA labeling requirements should bar

virtually any liability for failure to warn. Mich. Comp. Laws

Ann. § 600.2946(5) provides that a drug “is not defective or

unreasonably dangerous, and the manufacturer or seller is not

liable, if the drug was approved for safety and efficacy by the

™

28

create a presumption that a defendant who satisfies

regulatory requirements is not negligent, but make

that presumption rebuttable.5 Such statutes do not

depart much, if at all, from the common law rule: a

plaintiff may still rebut the presumption by

presenting evidence that, under the circumstances, a

reasonable defendant would have gone further.

A smaller number of states have decided that

compliance with FDA requirements should be a bar

to punitive damages, absent a showing that the

defendant defrauded or withheld information from

the agency. These statutes, however, do not limit a

[FDA], and the drug and its labeling were in compliance with

the [FDA's] approval at the time the drug left the control of the

manufacturer or seller.” The statute does leave open the

possibility that a drug company may be liable if it withheld or

misrepresented information that it was required to submit to

the FDA, id. § 600.2946(5)(a), though courts have divided about

whether this so-called “fraud” exception is preempted under

this Court's decision in Buckman Co. v. Plaintiffs Legal

Committee, 531 U.S. 341 (2001). Compare Garcia v. Wyeih-

Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), with 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, 128 S.Ct. 1168 (2008).

5 See Colo. Rev. Stat. § 13-21-403 (1)(b); Ind. Code Ann. § 34-20-

5-1; Kan. Stat. Ann. § 60-3304; Ky. Rev. Stat. Ann. § 411.310(2);

Tenn. Code Ann. § 29-28-104; Utah Code Ann. § 78B-6-703(2).

New Jersey and Texas also create such a_ rebuttable

presumption specifically for FDA-approved warnings. See NJ.

Stat. Ann. § 2A:58C-4; Tex. Civ. Prac. & Rem. Code Ann. §

82.007.

§ See Ariz. Rev. Stat. Ann. § 12-701; N.J. Stat. Ann. § 2A:58C-

5(c); Ohio Rev. Code Ann. § 2307.80(C)(1); Or. Rev. Stat. §

30.927; Utah Code Ann. § 78B-8-203; cf. Colo. Rev. Stat. § 13-

64-302.5(5)(a) (limiting protection against punitive damages to

health care professionals).

29

drug company defendant's exposure to compensatory

damages if a jury finds fault with its conduct.

Thus, even after careful legislative consideration,

forty-nine of the fifty states have rejected a

regulatory compliance affirmative defense to liability

for failure to warn of the dangers posed by

prescription drugs.

Congress has been even less willing to treat

federal regulatory compliance as a barrier to state

tort lability. In 1977, legislation was proposed in

the Senate that would have given manufacturers a

defense to damage claims if they complied with

federal product safety standards, S. 403, 95th Cong.,

Ist Sess. § 601 (1977), but no action was taken on it.

That same year, a bill introduced in the House would

have created a rebuttable presumption that a

product that complied with applicable standards was

not negligently or defectively designed, H.R. 6300,

95th Cong., lst Sess. § 8(a)(3), but no action was

taken. Similar bills, H.R. 5626 and H.R. 7284,

introduced in 1979 and 1982 respectively, met the

same fate.

In the 1980s and early 1990s, a number of bills

were introduced that would have established a

regulatory compliance defense to punitive damages,

sometimes limited to drug and device companies and

airplane manufacturers, but which would not have

affected compensatory damage claims. See, e.g., S.

1999, 99th Cong., Ist Sess. § 306(c) (1985); S. 2760,

99th Cong., 2nd Sess. § 303(c)(1) (1986); S. 640, 102d

Cong., Ist Sess. § 303(c) (1991); S. 687, 103d Cong..,

lst Sess. § 203(b)(1) (1993). While several of these

bills made it to the Senate floor, none was passed.

See generally, Richard C. Ausness, The Case for a

30

“Strong” Regulatory Compliance Defense, 55 Md. L.

Rev. 1210, 1248-51 (1996). The House of

Representatives did once adopt a _ provision

immunizing drug companies from punitive damages

for FDA-approved drugs as part of sweeping tort

reform legislation, H.R. 956, 104th Cong., lst Sess. §

201(f) (as passed by House, Mar. 10, 1995), but that

provision was dropped in conference to avoid likely

rejection in the Senate, and the bill was vetoed by

President Clinton. See Teresa Moran Schwartz,

Regulatory Standards and Products Liability:

Striking the Right Balance Between the Two, 30 U.

Mich. J.L. Ref. 431, 441 n.50 (1997) (“Striking the

Right Balance”).

Thus, despite numerous opportunities to consider

the issue, Congress has been unwilling to enact even

the more limited restrictions on state tort lhability—

the rebuttable presumption and bar to punitive

damages—that have been adopted by some states.

Congress has shown no interest whatsoever in going

further and making compliance with FDA

regulations a complete defense to liability for failure

to warn.

C. An FDA Compliance Defense Would

Pose Many Problems.

Congress and the states had good reason for

rejecting a regulatory compliance defense for

prescription drugs. Such a defense would necessarily

be narrow and difficult to apply, would place

excessive reliance on an underfinanced FDA for drug

safety, would undermine incentives for

manufacturers to apply to the FDA to strengthen

their label warnings, would—if effected by the

federal government—infringe upon state

3]

sovereignty, and would leave persons injured by

drugs with inadequate warnings without any remedy

for their injuries. See generally, Michael D. Green,

Statutory Compliance and Tort Liability: Examining

the Strongest Case, 30 U. Mich. J.L. Ref. 461 (1997);

Schwartz, supra, Striking the Right Balance, 30 U.

Mich. J.L. Ref. 431; Robert L. Rabin, Reassessing

Regulatory Compliance, 88 Geo. L.J. 2049 (2000).

Such an affirmative defense would be narrow and

difficult to apply for many reasons. First, courts

would have to determine whether the precise

question in the underlying tort litigation had been

considered and resolved by the FDA. Teresa Moran

Schwartz, The Role of Federal Safety Regulations In

Products Liability Actions, 41 Vand. L. Rev. 1121,

1130-31 (1988) (“If an agency has not addressed

specifically the matter before the court, the

argument for judicial deference fails.”). Next,

defendants would have to demonstrate not simply

that their drug and label had been approved by the

FDA, but also that they had complied with all

regulatory requirements regarding both pre-approval

testing and post-approval marketing, to ensure that

the agency had all necessary information when

rendering its judgment; this would significantly limit

the defense’s utility as a tool to simplify tort

litigation. Green, 30 U. Mich. J.L. Ref. at 481-82,

488-90. Moreover, an FDA compliance defense

would have virtually no applicability to the majority

of failure-to-warn cases, which involve risks

discovered after product approval,’ off-label] uses,® or

7 Most failure-to-warn cases involve “risks that emerged after

the drugs were approved by the FDA and made available to the

public.” Jd. at 473; see also GAO, FDA Drug Review: Post-

Approval Risks 1976-85 3 (1990) (over half of approved drugs

had serious risks not detected until after FDA approval).

32

allegations of overpromotion, all contexts in which

the FDA cannot have weighed the optimal balance

between over- and under-warning. Rabin, 88 Geo. L.

Rev. at 2077-82.

A compliance defense would also place excessive

reliance on the FDA. Even if the agency had

adequate resources, there would be problems of

regulatory obsolescence and regulatory lag, the time

it takes for the FDA to process and act upon new

information. Moreover, the agency is dependent on

drug companies for information and such companies

have substantial influence upon the drug approval

process. And, report after report in recent years has

concluded that the FDA is under-resourced and

under-staffed to ensure the currency and adequacy of

existing drug labels. See, Schwartz, Striking the

Right Balance, 30 U. Mich. J.L. Ref. at 443-46; I|OM

Report, supra, 197-98; Mission at Risk, supra, 2-3.

Third, a regulatory compliance defense would

have a negative effect on the adequacy of FDA

labeling requirements; a defense to tort lability

would give drug companies strong incentives to

resist efforts to strengthen the warnings on their

products. Schwartz, Striking the Right Balance, 30

Se

8 Estimates are that close to half of all American drug

prescriptions are written for indications that have not been

approved by the FDA. See Kaspar J. Stoffelmayr, Products

Liability and “Off-Label” Uses of Prescription Drugs, 63 U. Chi.

L. Rev. 275, 278 (1996). As the agency has observed: “Once a

drug product has been approved for marketing, a physician

may, in treating patients, prescribe the drug for uses not

included in the drug’s approved labeling. The primary legal

constraints in that situation are State 'aws on medical practice

and products liability law.” 48 Fed. Reg. 26,720, 26,733 (June

9, 1983) (emphasis added).

33

U. Mich. J.L. Ref. at 452-53; Green, 30 U. Mich. J.L.

Ref. at 501-02.

Fourth, displacement of state tort law by the

federal government would be a_é significant

infringement on state sovereignty. As this Court has

acknowledged repeatedly, “regulation of health and

safety matters is primarily, and historically, a

matter of local concern,” within the police powers of

the states. Hillsborough Cty. v. Automated Med.

Labs., Inc., 471 U.S. 707, 719 (1982). The states

have experimented with various approaches to

address the relationship between regulatory

compliance and tort law. To override the states’

ability to define that relationship in their civil justice

systems would deprive states of their autonomy and

do serious harm to our federalism. Rabin, 88 Geo. L.

Rev. at 2057, 2073-74.

Finally, and most importantly, a_ regulatory

compliance defense would leave those persons

injured by drug products, such as Diana Levine,

remediless, regardless of the negligence of the

drugmaker or the inadequacy of the warnings that

had been approved by the FDA. Id. at 2073.

Given all these problems, “it is not so surprising

that the regulatory compliance defense has never

captured the widespread assent of courts and

* In Justice Brandeis’ famous words: “It is one of the happy

incidents of the federal system that a single courageous state

may, if its citizens choose, serve as a laboratory; and try novel

social and economic experiments without risk to the rest of the

country.” New State Ice Co. v. Liebmann, 285 U.S. 262, 311

(1932) (Brandeis, J., dissenting).

34

commentators,” id. at 2084, or of state legislatures

and the Congress.

IlJl. Because State Tort Law Takes

Appropriate Account of Compliance with

FDA Labeling Requirements, There Can

Be No “Direct and Positive Conflict”

Between State and Federal Law That

Would Justify Preemption.

Wyeth and its amici, including the FDA, now

seek from this Court what they have been unable to

gain from state courts, state legislatures, and the

Congress: a broad and blunt regulatory compliance

affirmative defense under the guise of implied

conflict preemption. Forty-nine of the fifty states

have rejected the call for such a defense. They have

found state tort law and federal regulation to be

complementary systems that can comfortably co-

exist. Likewise, Congress has shown no interest in

adopting a national] compliance affirmative defense,

nor has it expressed any intention to preempt state

tort remedies against drug companies. To the

contrary, Congress has made clear its position that

there should be no preemption of state law, except in

cases of “direct and positive conflict.”

There is no such conflict here. Under the

traditional, common law treatment of regulatory

compliance, a person injured by a prescription drug

will not prevail on a failure-to-warn claim against a

drug company that complied with its FDA labeling

obligations, unless she can come forward, as Diana

Levine did, with evidence that under the

circumstances a reasonable drug company would

have done more to warn of the dangers posed by its

35

product. Where such special circumstances exist, a

determination of state tort liability against the

company cannot be said to be in “direct and positive

conflict” with FDA labeling determinations.

CONCLUSION

For the foregoing reasons, amicus curiae the

American Association for Justice urges this Court to

affirm the judgment of the Vermont Supreme Court.

Respectfully Submitted,

August 14, 2008 Louis M. Bograd

Counsel of Record

Francine A. Hochberg

CENTER FOR CONSTITUTIONAL

LITIGATION, P.C.

777 6th Street NW

Suite 520

Washington, DC 20001-3723

(202) 944-2803

Counsel for Amici Curiae