Amicus Curiae Brief — Wyeth v. Levine

Supreme Court brief2009

Ask Donna

What actually matters in this document.

Text

\0\

a) FILED

| AUG 1

No. 06-1249 me Is 2008

$ret ies CLERK

YRT, U.S.

IN THE

Supreme Court of the Anited States

WYETH,

Petitioner,

DIANA LEVINE,

Respondent.

ON WRIT OF CERTIORARI

TO THE SUPREME COURT OF VERMONT

BRIEF OF AMICI CURIAE MEMBERS OF

CONGRESS IN SUPPORT OF RESPONDENT

JONATHAN S. MASSEY

JONATHAN S. MASSEY, PC

7504 Oldchester Road

Bethesda, MD 20817

(301) 915-0990

August 2008

rr tee.

BATEMAN & SLADE, (NC LoS OUN, MASSACHIL SETTS

TABLE OF CONTENTS

pe a Ee

INTEREST OF AMICI CURIAE ...........:ccccescsseeeeseees 1

SUMMARY OF ARGUMENT ..................ccceeeeceeeeeeees 3

IIT - ichicdenicientodelisasnitndsintpennmseunccssieingeaninnenesontie 6

A. The History of the FDCA

Confirms That It Does Not

Preempt Failure-to-Warn Claims. ...... 7

B. Congress Confirmed Its

Understanding In a Series of

Amendments To The FDCA. ............. 10

C. The FDA’s Longstanding Position

Was Consistent With Congress’

eis 19

D. This Court Should Not Upset

Congress’ Settled Expectations. ........ 27

E. Preemption Would Disrupt The

Congressional Drug Safety

IIIT “Socehahniciasdeneadetsbaieannanwdnnihadinanicsicta 29

TITTY ‘cchicdcstcptin'cnsiccains eikelcigtbiekitaiikicbaniseneseeibailaieinali 36

TABLE OF AUTHORITIES

FEDERAL CASES:

Adams Fruit v. Barrett,

ee I oc ccsccnscncmnccnsenens

Adesina v. Aladan Corp.,

438 F.Supp.2d 329 (S.D.N.Y.2006).......

Alexander v. Sandoval,

Se i OUD GOD iticncincencnciniacsosmcentnns

Alman Bros. Farm & Feed Mill, Inc. v.

Diamond Laboratories, Inc.,

437 F.2d 1295 (5th Cir.1971) ......0000.....

Bates v. Dow Agrosciences LLC,

Ua Ce I seccssiseciniasiccécccsmtasentii

Brochu v. Ortho Pharm. Corp.,

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

Caraker v. Sandoz Pharm. Corp.,

172 F.Supp.2d 1018 (S.D.I1.2001).......

CBOCS West, Inc. v. Humphries,

ee SI dclisnisovesictnensncseues

Cipollone v. Liggett Group, Inc.,

Be ey GH IIE seks chceisnncssintccenicsbinaione

CSX Transp., Inc. v. Easterwood,

ee I SI cscicsiowipecnconsininsseinssie

sisdnmannte 3, 28

iil

Desiano v. Warner-Lambert Co.,

467 F.3d 85 (2d Cir.2006)

ST, Be ee, Be CD vc iccvcccssccosecssccsscsosccss 16

English v. General Elec. Co.,

NE me 3

Gonzales v. Oregon,

SE SIE, etsivropacesencsnesersnesannsmmnisnt 26, 27

Good Samaritan Hosp. v. Shalala,

ARE RE PCa a Oe 25

Hill v. Searle Labs.,

884 F.2d 1064 (8th Cir.1989) ............................. 16

Hillsborough County v. Automated Medical

Laboratories, Inc.,

I aelaeminnaie 34

Hohn v. United States,

I ll 28

In re Vioxx Prods. Liab. Litig.,

501 F. Supp. 2d 776 (E.D. La. 2007).............. 7, 24

In re Zyprexa Prods. Liab. Litig.,

489 F.Supp.2d 230 (E.D.N.Y. 2007)............. 15, 24

Jones by Jones v. Lederle Labs.,

695 F.Supp. 700 (E.D.N.Y.1988)..................00.... 16

Long Island Care at Home, Ltd. v. Coke,

a smnsaseibcnaniien 26

Martin v. Occupational Safety and Health Review

Comm’n, 499 U.S. 144 (1991)...............ccceceeeeeeees 26

McDermott v. Wisconsin,

SEATS OT 8

Medtronic, Inc. v. Lohr,

Be es MP ED ocidsicccscccccccsossons 2, 6, 23, 24, 28

Merrell Dow Pharmaceuticals, Inc. v. Thompson,

cic cssicchsneneieniesiesianieceasiionnion 13, 15

Motus v. Pfizer, Inc.,

127 F.Supp.2d 1085 (C.D.Cal.2000)................... 16

Neal v. United States,

I eee 28

Norfolk Southern Ry. Co. v. Shanklin,

ie cauuniel 25

Perry v. Novartis Pharm. Corp.,

456 F.Supp.2d 678 (E.D.Pa.2006)..................00. 16

Quill Corp. v. North Dakota,

EE REESE eo OmNCr Cao an FEE 29

Riegel v. Medtronic, Inc.,

i oc cclciebudies 12, 25

Salmon v. Parke, Davis & Co.,

520 F.2d 1359 (4th Cir. 1975)........................006 15

Shalala v. Guernsey Memorial Hospital,

514 U.S. 87 (1995) ............... 8s VE A SRR REM eet L 26

Silkwood v. Kerr-McGee Corp.,

I a, Fe I eiceetiedscinccc.ntesnnissnsrnitenasnammadiiin’ 10

Smiley v. Citibank,

Be tk, HEINE sion issisivesssiecieconismboneepsencaupeneaniac 24

Sprietsma v. Mercury Marine,

gE EERE pee D DCE SEE were 5

Stephens v. G.D. Searle & Co.,

602 F.Supp. 379 (E.D.Mich.1985)...................... 16

Stromsodt v. Parke-Davis & Co.,

257 F.Supp. 991 (D.N.D. 1966),

affd, 411 F.2d 1390 (8th Cir. 1969) ................... 15

Tobin v. Astra Pharm. Prods., Inc.,

993 F.2d 528 (6th Cir.1993) ..........eeceeeeeeees ee ees 16

United States v. Dotterweich,

I er 8

United States v. Mead Corp.,

— § 8 ERRESERRSErEaR ree eS 26, 27

Wells v. Ortho Pharm. Corp.,

788 F.2d 741 (11th Cir. 1986) .....00.......ccccceceeee eee 16

Witczak v. Pfizer, Inc.,

377 F.Supp.2d 726 (D.Minn.2005)..................... 16

Yarrow v. Sterling Drug, Inc.,

263 F.Supp. 159 (D.S.D. 1967),

STATE CASES:

Blood Balm Co. v. Cooper,

63 Ga. 457, 10 S.B. 118 (1666)............................. 7

Boyd v. Coca Cola Bottling Works,

I sn cccccnsccscessoveseosocesessncses 7

Consumer Fed'n of Am. v. Upjohn,

i rn, [TED «os cssscscseesecsonsoncnes 9

Edwards v. Basel Pharm.,

STD 16

Fleet v. Hollenkemp,

52 Ky. (1 B. Mon.) 219 (1852).............. cc ccceceeee eee 7

MacDonald v. Ortho Pharm. Corp.,

394 Mass. 131, 475 N.E.2d 65 (1985) ................ 16

McEwen v. Ortho Pharmaceutical Corp.,

| 16

Merrell Dow Pharms., Inc. v. Oxendine,

rr, SD. sesuescneessdoossens 12

Savina v. Sterling Drug, Inc.,

Sn I IE, TIED... ... .ccccoconccccenccescosececes 16

Seley v. G. D. Searle & Co.,

EE nnn 16

Stevens v. Parke, Davis & Co.,

9 Cal.3d 51, 107 Cal. Rptr. 45,

507 P.2d 653 (1973) ..........0..... ee ica 15

Vii

‘Thomas v. Winchester,

I i a 7

Willson v. Faxon, Williams & Faxon,

208 N.Y. 108, 101 N.E. 799 (1913)...................005. 7

Wooderson v. Ortho Pharmaceutical Corp.,

681 P.2d 1038 (Kan.), cert. denied,

I ORT IES SESARSRERaR OD one 16

FEDERAL STATUTES:

AD TNT TE 12

I a saeeertintnligncinpneiiiell 12

IID ons. inniicinsensqusnetetisiateiiaiemnteaiiiine 7

SETI esti hsniecnentedeonnegneniencoeseonetneumenianeniaiiniin 1

TET TENET a me Ft. 7

CS TT AARC ATER 5 * 12

i cial eens eeedadceceteniameomineniainninnnnell 12

ETE TTS eee nea N Caran seen eS: 12

acl lactameaeisidel 13

i sa aisiacncieniniananeeunibadamesiensiinnnil 12

I ll 12

TEE TSEC naNe mse BRR Se 13

anne =e 14

a ID inne ds meisieenminaiila 10

EET aE Men EE aeneaneme ee! 17

EE 9 tain paninianigianonminiedihie 14

42 U.S.C. § 300aa-214a) oo... ccceccceeseceesesescescceeceseees 14

42 U.S.C. §§ 300aa-10 to 300aa°34.........................08.. 9

a ad aibisineiemnennilinns 9

49 U.S.C. § 40101 (Supp. 2004)......................... eee. )

Vill

Pub. L. No. 110-85, 121 Stat. 823 (2007) ............. 2,17

Pub. L. No. 59-384, 34 Stat. 768 (1906) ..................... 7

Pub. L. No. 76°77, GB Stat. 1060 .........ccc.ccccccccesssceees 7

Pub. L. No. 87-781, § 202, 76 Stat. 780 (1962) ........ 11

153 Cong.Rec. $11833-35 (Sept. 20, 2007)......... 18, 33

153 Cong.Rec. H10596 (Sept. 19, 2007) ................... 18

H.R. Rep. No. 73-6110, pt. 1, § 25 (1933).........0......... 9

5 fA eS 12

S. Rep. No. 87-1744, 87th Cong.,

eit 10

S. 1082, 110th Cong., lst Sess. § 208-18................. 18

SSE nee Senora eco 12

Rp SSL SO EE eee ee ena 19

FEDERAL REGULATIONS:

SEG EE ee seal 26

SEAS 35

I steels 34

eS SS eae 18, 35

ERE ee AES Ae Oe 19, 34

TERE AE Se ene ee ee re 14, 18

39 Fed. Reg. 44629 (Dec. 24, 1974) o..cccccccccccsesseseeeee. 20

ee, CD cients ccctcnicsccensckicscennecs 20, 35

Oe Bs Be GEO ccrccceiictcscesktecctseeeinsmeniectenns 35

_ <2 eee 21

65 Fed. Reg. 81082, 81103 (2000) ...................... 23, 25

71 Fed. Reg. 3922, 3934, 3935 (2006)....................... 23

OTHER AUTHORITIES:

Robert S. Adler & Richard A. Mann,

Preemption and Medical Devices: The

Courts Run Amok, 59 Mo. L. Rev. 895, 924

SN TET ineaicictasioticditcehcipoiniupnanibipnimeninnsesiseses

Richard M. Cooper, Drug Labeling & Products

Liability: The Role of the Food and Drug

Administration, 41 Food Drug & Cosm.

es SNE INE ccisttinsisceciitsilintnintcenseapcsseoeee

Dennis R. Johnson, The History of the 1906

Pure Food and Drugs Act and the Meat

Inspection Act, 37 Food Drug Cosm. L.J. 5,

EE eiiiicieicestniiepiiiciTiuiaiidiiiaiaiitaisjeinnianitiitesnnenenets

David A. Kessler & David C. Vladeck, A

Critical Examination of the FDA’s Efforts

to Preempt Failure-to-Warn Claims, 96

a eats ey Ce Ne itiestieninintcccriennccnceszcseses

Richard Curtis Litman & Donald Saunders

Litman, Protection of the American

Consumer: The Muckrakers and the

Enactment of the First Federal Food and

Drug Law in the United States, 36 Food

Drug Cosm. L.J. 647, 648-51 (1981) ...............

Margaret Jane Porter, The Lohr Decision: FDA

Perspective and Position, 52 Food & Drug

ea. Wp i OT fetctcorieencerenneninienniaiinnimanbendninininn

Bruce M. Psaty & David Korn, Congress

Responds to the IOM Drug Safety Report -

In Full, 298 JAMA 2185, 2187 (Nov. 14,

Associated Press, “FDA’s Review Process

Under Investigation,” Mar. 4, 2008

(available at

http://ahrp.blogspot.com/2008/03/gao-to-

investigate-fda-review-process.htm)) .................. 6

Executive Order No. 13132 ..................ccccscsccscccesceees 24

FDA's Drug Approval Process: Up to the

Challenge?: Hearing Before the Senate

Comm. on Health, Educ., Labor and

Pensions, 109th Cong. (2005)................ccccceee eee 31

FDA Medwatch, The Clinical Impact of

Adverse Event Reporting (Oct. 1996).

http://www.fda.gov/medwatch/articles/

medcont/postrep.htm#una ...................0..ccee cence 31

FDA, Merck and Vioxx: Putting Patient Safety

First?: Hearing Before the Senate Comm.

on Finance, 108th Cong. (2004) .............000....00ee. 31

FDA Subcommittee on Science & Technology,

FDA Science & Mission at Risk 2-3 (Nov.

2007) (“FDA Science & Mission at Risk’)............ 6

Hearing on S. 1944 Before a Subcomm. of the

Comm. on Commerce, 73d Cong., 2d Sess.

400, 403 (1933). See also Consumer Fed'n

of Am. v. Upjohn, 346 A.2d 725, 731 (D.C.

Institute of Medicine, The Future of Drug

Safety: Promoting and Protecting the

Health of the Public 22, 152 (Alina Baciu,

Kathleen Stratton & Shelia P. Burke, eds.

Se TT occ ccniciinssdudtbedentareuncenta

Regulatory Preemption: Are Federal Agencies

Usurping Congressional and State

Authority? Hearing Before the Senate

Committee on the Judiciary, 110th Cong.

5 4 SEE eee

Risk and Responsibility’ The Roles of the FDA

and Pharmaceutical Companies in

Ensuring Safety of Approved Drugs, Like

Vioxx: Hearing Before the House Comm. on

Government Reform, 109th Cong. (2005)........

Should FDA Drug and Medica/ Device

Regulation Bar State Liability Claims?

Hearing Before the House Committee on

Oversight and Government Reform, 110th

Cong. 2d Sess. (May 14, 2008) ...................0008

U.S. Gov’T ACCOUNTABILITY OFFICE, DRUG

SAFETY: IMPROVEMENT NEEDED IN FDA’S

POSTMARKET DECISION-MAKING AND

OVERSIGHT PROCESS 10, available at

www.gao.gov/cgi-bin/getrpt?GAO-06-402........

BRIEF OF AMICI CURIAE MEMBERS OF

CONGRESS IN SUPPORT OF RESPONDENT

INTEREST OF AMICI CURIAE

The question presented in this case is whether to

discard the well-settled understanding of Congress,

courts around the country, and (until quite recently)

the federal Food and Drug Administration (“FDA”)

that the Food, Drug, and Cosmetic Act of 1938

(“FDCA”), 21 U.S.C. § 301, et seg. does not preempt

state-law failure-to-warn claims.

This brief is submitted on behalf of Senators

Patrick J. Leahy, Edward M. Kennedy, Sheldon

Whitehouse, Tom Harkin, Dianne Feinstein, Richard

J. Durbin, Bernard Sanders, Russell D. Feingold,

Representatives Henry A. Waxman, John Conyers,

Jr., John D. Dingell, Frank Pallone, Jr., Bart Stupak,

Zoe Lofgren, Linda Sanchez, Debbie Wasserman

Schultz, Maxine Waters, and Peter Welch.

Amici curiae are Members of Congress with an

important interest in this issue.!' Amuc/ include the

Chairmen of the United States Senate and House

Committees on the Judiciary, the Chairman of the

Senate Committee on Health, Education Labor, and

Pensions, the Chairman of the House Committee on

Energy and Commerce, the Chairmen of the

Subcommittee on Health and the Subcommittee on

Oversight and Investigations of the House Committee

! This brief has been filed with the written consent of the

parties, which is on file with the Clerk of Court. No counsel for

a party authored this brief in whole or in part, nor did any

person or entity, other than amici or their counsel, make a

monetary contribution to the preparation or submission of this

brief.

on Energy and Commerce, and the Chairman of the

House Committee on Oversight and Government

Reform, as well as Members of these Committees.

Amici have extensive experience in _ federal

pharmaceutical regulation and federal preemption

issues under the FDCA. Amici have participated in

numerous legislative proceedings concerning FDCA

preemption, most recently in the context of the Food

& Drug Administration Amendments Act of 2007

(“FDAAA”), Pub. L. No. 110-85, 121 Stat. 823 (2007).

Amici have conducted public hearings on the

preemption issue, such as Regulatory Preemption:

Are Federal Agencies Usurping Congressional and

State Authority? Hearing Before the Senate

Committee on the Judiciary, 110th Cong. lst Sess.

(Sept. 12, 2007) (hereafter “Senate Regulatory

Preemption Hearing’), and Should FDA Drug and

Medical Device Regulation Bar State Liability

Claims? Hearing Before the House Committee on

Oversight and Government Reform, 110th Cong. 2d

Sess. (May 14, 2008) (hereafter “House FDA

Preemption Hearing’).

At bottom, this case presents a question of

congressional intent. This Court has explained that

“(tlhe purpose of Congress is the ultimate touchstone

in every pre-emption case.” Medtronic, Inc. v. Lohr,

518 U.S. 470, 485 (1996) (citation and internal

quotation marks omitted); see also Cipollone v.

Liggett Group, Inc., 505 U.S. 504, 516 (1992) (same).

Amici are uniquely situated to address the question

of congressional intent at the center of this case.

Although amici submit this brief in their individual

capacities, not on behalf of Congress itself, their

views are informed by their experiences as Members

of Congress.

SUMMARY OF ARGUMENT

At its core, “[p]re-emption fundamentally is a

question of congressional intent.” ELnglish v. General

Elec. Co., 496 U.S. 72, 78 (1990). Petitioner Wyeth

ascribes to Congress a considered judgment to

displace state tort remedies and strip consumers of

their right to receive compensation for injuries

caused by inadequate warnings on the part of drug

manufacturers. But Congress has made no such

judgment.

To the contrary: when Congress enacted the

FDCA 70 years ago, it deliberately preserved state-

law damages claims. Since that time, Congress has

consistently understood that federal law does not

preempt state-law failure-to-warn claims with respect

to drugs approved by the FDA. This understanding

has been fortified by settled practice under the

statute. For decades, innumerable state-law actions

involving FDA-approved pharmaceuticals have been

prosecuted to final judgment or settlement. The

courts and (until recently) the FDA have shared

Congress’ view that federal labeling rules create only

minimum requirements and do not immunize drug

companies from liability under state law. The

widespread practice of permitting state-law claims,

coupled with a common understanding of the

statute’s meaning among the courts, Congress, and

the FDA, has created precisely the kind of “well-

embedded [statutory] interpretation” that this Court

has held is entitled to respect. CBOCS West, Inc. v.

Humphries, 128 S.Ct. 1951, 1958 (2008).

In this case, the FDA has advanced a radical new

legal position regarding the preemptive effect of the

FDCA that represents a sharp break from the

practice of the past 70 years. The FDA now asserts

that the Act displaces state failure-to-warn claims for

federally approved drugs. This revolutionary change

would bar the kind of traditional state-law actions

that have been brought for decades under the FDCA.

Moreover, the agency’s changed view represents a

usurpation of authority properly belonging to

Congress, the States, and the courts. The FDA would

arrogate to itself the power to decide the preemptive

force of the federal statute, which is a matter of

congressional (and not administrative) intent.

Whatever the FDA’s view of its labeling regulation,

Congress never intended to allow the FDA to adopt

regulations that would preempt failure-to-warn

lawsuits under state law. It is congressiona/ intent,

not FDA intent. that governs the preemption inquiry.

An agency cannot supplant Congress. As Justice

Scalia has noted, “[a]gencies may play the sorcerer’s

apprentice but ..ot the sorcerer himself.” A/exander

v. Sandoval, 532 U.S. 275, 291 (2001). The FDA’s

attempt to expand the preemptive scope of the

regulatory scheme is nothing short of an illegitimate

power grab. The FDA’s position poses a threat not

merely to injured consumers and the States, but also

to the separation of powers and the constitutionally

assigned role of Congress in our system of

government.

Altering the construction of the FDCA at this late

date would also frustrate congressional intent and

impair the statutory system of federal prescription

drug regulation. Far from standing “as an obstacle to

the accomplishment and execution of the full

purposes and objectives of Congress,” state-law

claims against pharmaceutical manufacturers

“necessarily perform an important remedial role in

compensating” injured individuals and _ in

encouraging drug safety. Sprietsma v. Mercury

Marine, 537 U.S. 51, 64 (2002) (internal citations

omitted). State tort law complements federal drug

regulation by not only compensating those injured by

misconduct but also by deterring future harm.

There are important reasons for holding that

FDA approval of a drug label does not preempt state-

law failure-to-warn claims. Manufacturers should be

given the incentive to supply the FDA with the most

current evidence so that labels reflect the best

scientific information. Congress understands that

state tort law is an indispensable partner to federal

safety regulation.

As Senator Specter has commented,

If state law is preempted and lawsuits or

claims are dismissed, public safety and health

may be affected. In the past, some tort cases

have unearthed industry secrets and safety

shortcuts that manufacturers have taken.

Information obtained in tort suits has turned

out to be very useful to regulators seeking to

protect the public. In addition, the

unearthing of this information has caused

manufacturers to improve the safety of their

products, or make other changes that protect

the public.

Senate Regulatory Preemption Hearing at 133-34.

In addition, the FDA lacks the administrative

resources to safeguard drug safety without the

assistance of state-court lawsuits. The agency has

suffered from politicization and a bias favoring

approval of new pharmaceuticals rather than

ensuring the safety of the 11,000 drugs already on

the market. As Senator Grassley has observed:

“There’s enough of a pattern of problematic drugs to

ask for an independent review of how the FDA

follows up on the effects of medicines that it’s

approved.”2 One of FDA’s own scientific advisory

committees has concluded that the agency has

“serious scientific deficiencies and is not positioned to

meet current or emerging regulatory responsibilities.”

FDA Subcommittee on Science & Technology, FDA

Science & Mission at Risk 2-3 (Nov. 2007) (“FDA

Science & Mission at Risk’).

For all these reasons, this Court should hold that

the FDCA does not preempt state-law failure-to-warn

claims.

ARGUMENT

This Court has instructed that preemption

analysis must begin with a healthy presumption

against displacement of state law: “In all pre-emption

cases, and particularly in those in which Congress

has legislated in a field which the States have

traditionally occupied, we start with the assumption

that the historic police powers of the States were not

to be superseded by the Federal Act unless that was

the clear and manifest purpose of Congress.” Lohr,

518 U.S. at 485 (citation, internal quotation marks,

and alterations omitted). That starting assumption

is fortified in this case by well-settled expectations

regarding the impact of the FDCA on state law.

2 Associated Press, “FDA's Review Process Under

Investigation,” Mar. 4, 2008 (available at

http-//ahrp blogspot.com/2008/03/gao-to-investigate -fda-review-

process. htm]).

Since the FDCA was enacted in 1938, Congress, the

courts, and the FDA have operated with a shared

understanding that FDA approval of a drug label

does not preempt state-law failure-to-warn claims.

A. The History of the FCA Confirms That

It Does Not Preempt Failure-to-Warn

Claims.

Federal drug labeling regulation began with the

Pure Food and Drug Act of 1906, Pub. L. No. 59-384,

34 Stat. 768 (1906), codified at 21 U.S.C. §§ 1-15

(1934) (repealed in 1938 by 21 U.S.C. § 329(a)). Prior

to 1906, “the States provided the primary and

possibly the exclusive source of regulatory control

over the labeling of foods and drugs.” Jn re Vioxx

Prods. Liab. Litig., 501 F. Supp. 2d 776, 782 (E.D. La.

2007). State courts recognized common-law causes of

action for negligence with respect to medicines and

related products.

Nothing in the Pure Food and Drug Act of 1906

displaced traditional state-law tort remedies. The

Act was part of the progressive agenda of the trust-

bustii.g reformer, Theodore Roosevelt,4 and it was

intended solely to protect consumers — not to deny

3 See, e.g., Boyd v. Coca Cola Bottling Works, 177 S.W. 80,

81 (Tenn.1915); Willson v. Faxon, Williams & Faxon, 208 N.Y.

108, 112, 101 N_E. 799, 801 (1913): Blood Balm Co. v. Cooper, 83

Ga. 457, 10 S.E. 118, 119 (1889); Thomas v. Winchester, 2 Seld.

397, 1852 WL 4748 (N.Y.1852): Fleet v. Hollenkemp, 52 Ky. (

B. Mon.) 219, 220 (1852).

4 See Federal Food and Drugs Act of 1906, Pub. L. No. 59-

384, § 3, 34 Stat. 768, 768-69, repealed by Federal Food, Drug,

and Cosmetic Act of 1938, Pub. L. No. 75-717, § 201(d), 52 Stat.

1040, 1040 (codified in scattered sections of 21 U.S.C.).

state tort remedies to victims of defective drugs.5 For

example, in 1913, this Court considered the effect of a

1907 Wisconsin statute providing that mixtures or

syrups offered for sale “shall have upon them no

designation or brand ... other than that required by

the state law.” McDermott v. Wisconsin, 228 U.S.

115, 127 (1913). Although this Court held that

Wisconsin could not require that federally approved

labels “shall be removed from the packages,” the

Court also “[clonced[ed] to the state the authority to

make regulations consistent with the Federal law for

the further protection of its citizens against impure

and misbranded food and drugs.” Jd. at 133.

In 1938, after the deaths of more than 100 people

from elixir of sulfanilamide, Congress enacted the

FDCA, which prohibited false therapeutic claims and

for the first time required FDA premarket

notification for drugs. As this Court has long

recognized, the purpose of the statute was to increase

consumer protection. See United States v.

Dotterweich, 320 U.S. 277, 280, 282 (1943) (“The

purposes of this legislation thus touch phases of the

lives and health of people which, in the circumstances

of modern industrialism, are largely beyond self-

protection”).

Congress considered including in the Act a

private federal cause of action for damages caused by

faulty or unsafe products. See H.R. Rep. No. 73-6110,

5 Dennis R. Johnson, Jhe History of the 1906 Pure Food

and Drugs Act and the Meat Inspection Act, 37 FOOD DRUG

Cosm. LJ. 5, 8-9 (1982); Richard Curtis Litman & Donald

Saunders Litman, Protection of the American Consumer: The

Muckrakers and the Enactment of the First Federal Food and

Drug Law in the United States, 36 FOOD DRUG CosmM. L.J. 647,

648-51 (1981).

pt. 1, § 25 (1933) (“Liability for Personal Injuries - a

right of action for damages shall accrue to any person

for injury or death proximately caused by a violation

of this Act.”). Notably, the Senate deleted this

proposed private cause of action from the bill on the

ground that it was unnecessary because “[a] common-

law right of action exists” under state law. Hearing

on S. 1944 Before a Subcomm. of the Comm. on

Commerce, 73d Cong., 2d Sess. 400, 403 (1933). See

also Consumer Fed’n of Am. v. Upjohn, 346 A.2d 725,

731 (D.C. 1975) (explaining that private right of

action was omitted from bill because “it would create

an unnecessary federal action duplicative of state

remedies’ and concluding that Congress “resected [)

setting up a nationally uniform law for such” actions)

(emphasis added); Robert S. Adler & Richard A.

Mann, Preemption and Medical Devices: The Courts

Run Amok, 59 Mo. L. REV. 895, 924 & n.130 (1994)

(“Congress rejected a provision in a draft of the

original FD&C Act providing a federal cause of action

for damages [for injuries caused by prescription

drugs] because ‘a common law right of action

[already] exists.””).

Congress’ assumption that state-law causes of

action would remain under the FDCA — coupled with

its decision not to provide a federal remedy —- is

strong evidence that it did not mean to displace

traditional state tort actions. Where Congress

displaces state law, it typically provides an

alternative federal remedy. As the Court has

§ See, e.g, 42 U.S.C. § 2210 (Price-Anderson Act); 42 U S.C

§§ 300aa-10 to 300aa-34 (National Vaccine Injury Compensation

Program): 49 U.S.C. § 40101 (Supp. 2004) (Air Transportation

Safety and System Stabilization Act of 2001, also known as the

acknowledged, “[ilf Congress had intended to deprive

injured parties of a long available form of

compensation, it surely would have expressed that

intent more clearly.” Bates v. Dow Agrosciences LLC,

544 U.S. 431, 449 (2005). See also Silkwood v. Kerr-

McGee Corp., 464 U.S. 238, 251 (1984) (“This silence

lof Congress in enacting and amending the Atomic

Energy Act] 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 means of judicial recourse for those

injured by illegal conduct.”).

B. Congress Confirmed Its Understanding

In a Series of Amendments To The

FDCA.

Congress continued to assume the availability of

state-law causes of action in revisiting the FDCA in a

series of amendments over the past half-century.

Congress enacted the landmark Kefauver-Harris

amendments to the FDCA in 1962, which

strengthened pharmaceutical regulation and added

further protections for consumers. The purpose of the

legislation was “to strengthen and broaden existing

laws in the drug field so as to bring about better,

safer, medicine and to establish a more effective

system of enforcement of the drug laws.” S. Rep. No.

87-1744, 87th Cong., 2d Sess. 1 (1962). The catalyst

of the reforms was the thalidomide tragedy in Europe

in the late 1950s and early 1960s, in which thousands

of children were born with birth defects. Institute of

September 11th Victim Compensation Fund): 29 USC. § 1144

(Employee Retirement Income Security Act of 1974).

Medicine, The Future of Drug Safety: Promoting and

Protecting the Health of the Public 22, 152 (Alina

Baciu, Kathleen Stratton & Shelia P. Burke, eds.

2007) (““IOM Report”).

The 1962 Amendments “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.” IOM Report, supra, at 152

(citation omitted). Even with these reforms, the

“FDA's ability to form judgments about the safety

and efficacy of drugs depends upon the submission of

data, usually from drug company sponsors, rather

than on the use of data developed independently or

on its own initiative.” Jd.

The 1962 Amendments also clarified the FDCA’s

effect on state law. Congress included language

limiting the potential preemptive effect of the FDCA

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.” Pub.

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

(emphasis added). The plain language of this

provision makes clear that the Amendments do not

preempt state law in the absence of such a “direct

and positive” conflict.

In contrast, when Congress has wished to

preempt state law in the FDCA, it has done so

clearly. For example, Congress has enacted an

express preemption provision for medical devices.

Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008)

(considering the effect of the express preemption

provision of the Medical Device Amendments of 1976,

21 U.S.C. § 360(k)(a)). Although many Members of

Congress do not agree with the construction of the

Medical Device Amendments adopted by the Court in

Riegel,’ that decision does not govern this case

because there is no express preemption for drugs in

the FDCA.

Further confirming the absence of preemption in

this case are the express antrpreemption provisions

for nonprescription or “over-the-counter” (“OTC”)

drugs, FDCA Section 751, 21 U.S.C. § 379r, and for

the labeling and packaging of cosmetics, FDCA

Section 752, 21 U.S.C. § 379s. These provisions

prohibit any State or political subdivision from

establishing or continuing “any requirement” relating

to the regulation of an OTC drug or the labeling or

packaging of a cosmetic that is “different from or in

addition to, or that is otherwise not identical with,” a

requirement under the FDCA, the Poison Prevention

Packaging Act of 1970, 15 U.S.C. § 1471 et seg., or

the Fair Packaging and Labeling Act, 15 U.S.C. §

1451 et seq. See 21 U.S.C. §§ 379r(a), 379s(a).

However, the OTC and cosmetic anti-preemption

provisions expressly exempt state product liability

actions from federal displacement: “Nothing in this

section shall be construed to modify or otherwise

affect any action or the liability of any person under

the product liability law of any State.” 21 USC. §§

7 Legislation to reverse the WRiege/ decision has been

introduced in both the House and the Senate. See S. 3398,

110th Cong.: H_R. 6381, 110th Cong.

379r(e), 379s(e). Thus, although Congress has

provided for some degree of preemption for state

requirements regarding OTC drugs and cosmetics

labeling, it has specifically preserved state-law

products liability actions.

The statutory framework demonstrates Congress’

clear understanding of the potential for state-law

products liability actions against manufacturers of

medical devices, OTC drugs, and cosmetics. The

absence of any analogous express preemption

provision for prescription drugs is significant: “[ilf

Congress wants to take the extraordinary step of

giving drug manufacturers immunity from personal

tort actions, it would expressly state such intentions

whether by statute or legislative history.” Merrell

Dow Pharms., Inc. v. Oxendine, 649 A.2d 825, 829

(D.C. 1994) (quoting Kociemba v. G.D. Searle & Co.,

680 F. Supp. 1293, 1299-1300 (D. Minn.1988) (ruling

that FDCA did not preempt state tort law actions

against manufacturers of prescription drugs)).

Moreover, the relationship between OTC and

prescription drugs makes the lack of an express

preemption provision for prescription drugs even

more significant. Some OTC drugs are initially

approved as prescription drugs under the FDCA and

are “switched over” to OTC status after several years

of marketing, as in the cases of Claritin and Zyrtec.

Thus, a drug initially receiving FDA approval may

later become an OTC drug governed by Section 751,

which explicitly contemplates products liability

claims under state law. It is implausible to suggest

that Congress silently created immunity through

federal preemption for prescription-drug-related

claims but then affirmatively negated that immunity

when the same drug became OTC. Rather, it is plain

that Congress has always assumed that the fact of

FDA approval would not preclude state-law product

liability actions.

Other provisions of the FDCA also acknowledge

Congress’ understanding of drug company failure-to-

warn liability. For example, Section 756 of the FDCA

provides that certain safety reports to FDA may not

be considered admissions for liability purposes. 21

U.S.C. § 379v (manufacturer’s submission of a safety

or adverse event report is not “an admission that the

product involved malfunctioned, caused or

contributed to an adverse experience, or otherwise

caused or contributed to a death, serious injury, or

serious illness”). This provision indicates a

congressional recognition of the potential for state

tort suits, because its evident purpose is to prohibit

the use of safety reports in product liability litigation.

In addition, in the National Vaccine Injury

Compensation Program (“VICP”), Congress provided

an administrative remedy for vaccine related injuries

as an alternative to state tort liability, with the

possibility of an opt-out to state court if the injured

person wishes to pursue a state-law products liability

remedy. 42 U.S.C. § 300aa-21(a). Vaccines are

approved under the Public Health Service Act, 42

U.S.C. § 300aa-1 to -6, but otherwise regulated as

drugs. £g., 21 C.F.R. § 600 et seg. VICP quite

clearly confirms Congress’ understanding that FDA

regulation of a drug does not preempt state-law tort

liability.

Given the statutory structure, “[clourts have

generally rejected the argument that the FDA

labeling approval process somehow preempts state

law adequacy of warning claims.” Jn re Zyprexa

Prods. Liab. Litig., 489 F.Supp.2d 230, 273 (E.D.N-Y.

2007). Innumerable cases have proceeded to final

judgment or _ settlement on the widespread

understanding that FDA approval does not bar state

failure-to-warn claims. The traditional view is that

“approval by the FDA of the language involved is aot

necessarily conclusive on the question of the

adequacy of the warnings.” Brochu v. Ortho Pharm.

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

original; citation omitted). “[CJompliance with

federal laws and regulations concerning a drug,

though pertinent, does not in itself absolve a

manufacturer of liability.” Salmon v. Parke, Davis &

Co., 520 F.2d 1359, 1362 (4th Cir. 1975). In Merrell

Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S.

804, 815-16 & n.13 (1986), this Court encountered a

state-law negligence per se claim premised on a

violation of the FDCA. See also Yarrow v. Sterling

Drug, Inc., 263 F.Supp. 159, 162 (D.S.D. 1967), affd,

408 F.2d 978 (8th Cir. 1969) (imposing liability

“lallthough 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”); Stromsodt v. Parke-

Davis & Co., 257 F.Supp. 991, 997 (D.N.D. 1966),

affd, 411 F.2d 1390 (8th Cir. 1969) (“Although all of

the Government regulations and requirements had

been satisfactorily met in the production and

marketing of Quadrigen, the standards promulgated

were minimal. The Defendant still owes a duty to

warn of dangers of which it knew or should have

known in the exercise of reasonable care.”); Stevens v.

Parke, Davis & Co., 9 Cal.3d 51, 65, 107 Cal.Rptr. 45,

53, 507 P.2d 653, 661 (1973) (“The warnings required

by such [regulatory] agencies may be only minimal in

nature and when 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.”); Wooderson v. Ortho Pharmaceutical

Corp., 681 P.2d 1038 (Kan.), cert. denied, 469 U.S.

965 (1984) (imposing liability for compensatory and

punitive damages based on failure to make a

disclosure even though FDA expressly rejected a

similar disclosure, proposed by a manufacturer of a

competing version of same product); McEwen v.

Ortho Pharmaceutical Corp., 528 P.2d 522, 534 (Ore.

1974) (“We hold that the warnings given by an ethical

drug manufacturer may be found inadequate,”

despite FDA approval).§

As a former Commissioner of the Food and Drug

Administration has written:

8 See also Desiano v. Warner-Lambert Co., 467 F.3d 85, 97

& n.9 (2d Cir.2006). aff'd, 128 S.Ct. 1168 (2008); Tobin v. Astra

Pharm. Prods., Inc., 993 F.2d 528, 537-38 (6th Cir.1993); Ai// v.

Searle Labs., 884 F.2d 1064, 1068 (8th Cir.1989); Wells v. Ortho

Pharm. Corp., 788 F.2d 741, 745-46 (11th Cir.1986); A/man

Bros. Farm & Feed Mill, Inc. v. Diamond Laboratories, Inc., 437

F.2d 1295 (5th Cir.1971); Perry v. Novartis Pharm. Corp., 456

F.Supp.2d 678, 685 (E.D.Pa.2006); Adesina v. Aladan Corp., 438

F.Supp.2d 329, 337-38 (S.D.N.Y.2006); Witczak v. Pfizer, Inc.,

377 F.Supp.2d 726, 731-32 (D.Minn.2005): Caraker v. Sandoz

Pharm. Corp., 172 F Supp.2d 1018, 1033 (S.D 111.2001); Motus v.

Pfizer, Inc., 127 F.Supp.2d 1085 (C.D.Cal.2000); Jones by Jones

v. Lederle Labs., 695 F.Supp. 700, 709-11 (E.D.N.Y.1988);

Stephens v. G.D. Scarle & Co. 602 F.Supp. 379, 382

(E.D.Mich.1985); Savina v. Sterling Drug, Inc., 795 P.2d 915,

931 (Kan.1990); MacDonald v. Ortho Pharm. Corp., 394 Mass.

131, 475 N.E.2d 65, 70°71 (1985); Seley v. G. D. Searle & Co.,

423 N.E.2d 831, 837 (Oh.1981); Edwards v. Base] Pharm., 933

P 2d 298, 302 (Okla.1997).

Nothing in the statutes the FDA administers

suggests that they oust state damages actions

for pharmaceutical products. No appellate

court, before or after the advent of the FDA,

has held that a state-law failure-to-warn

claim for a prescription drug is preempted by

federal law. And Congress has not acted to

preempt or limit state damage actions, even

though it has long been aware of tort

litigation over drug products....

David A. Kessler & David C. Vladeck, A Critical

Examination of the FDA’s Efforts to Preempt Failure-

to-Warn Claims, 96 GEO. L.J. 461, 462 (2008).

The same view of non-preemption is reflected in

the recently enacted Food & Drug Administration

Amendments Act of 2007 (“FDAAA”), Pub. L. No.

110-85, 121 Stat. 823 (2007). The Act does not

contain any express preemption provision barring

state-law damages claims. The sole preemption

language included in the FDAAA precludes states

and their political subdivisions from “establishling] or

continuling] in effect any requirement for the

registration of clinical trials or for the inclusion of

information relating to the results of clinical trials in

a database,” 42 U.S.C. § 282(d), a provision that is

not relevant to the instant case.

In enacting the FDAAA, Congress, for the first

time, gave FDA the authority to require certain

labeling changes. In so doing, however, Congress

rejected a Senate proposal sought by pharmaceutical

companies that would have required FDA to pre-

approve all changes to drug labels — a proposal that

might have given drug companies an argument

against state tort suits alleging that they wrongly

failed to issue voluntary warnings.? Instead of such a

provision, Congress adopted a “Rule of Construction”

providing that FDA’s new labeling change authority

“shall not be construed to affect the responsibility” of

the manufacturer “to maintain its label in accordance

with existing responsibilities, including subpart B of

part 201 and sections 314.70 and 601.12 of title 21,

Code of Federal Regulations (or any successor

regulations).” The cited regulations establish a

mechanism for drug manufacturers to provide up-to-

date safety information to physicians and patients,

even without prior FDA approval. Members of

Congress made clear that, in giving FDA the power to

order a labeling change, the FDAAA did not alter a

manufacturer’s longstanding responsibility promptly

to update product labels with safety information at

the earliest possible moment — without waiting for

FDA to approve the change.!® The statements also

° S. 1082, 110th Cong., Ist Sess. § 208 (proposing new §

506D to FDCA).

10 As Rep. Waxman explained, “in giving FDA this labeling

change authority, Congress is making it clear that we do not

intend to impact a drug company’s responsibility to promptly

update its label with safety information on its own accord.” 153

Cong.Rec. H10596 (Sept. 19, 2007) (statement of Rep. Waxman).

Accord, 153 Cong.Rec. $11833 (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 FDA to preempt common law lability for a drug company’s

failure to warn its customers of health msks.”); 7d. at S11834

(statement of Sen. Leahy) (“The legislation we are set to pass

today contains a rule of construction making clear that Congress

has again decided that we are not preempting State law

regarding the responsibility of drug manufacturers to

immediately notify consumers of dangers without waiting for

the FDA to act.”); sd. at S11835 (statement of Sen. Durbin) (“The

drug labeling provisions in today's legislation include a rule of

confirm Congress’ intention that, when a

manufacturer fails to uphold this responsibility, it

should be held accountable under the state tort

system, consistent with longstanding practice.

C. The FDA’s Longstanding Position Was

Consistent With Congress’ Under-

standing.

Until recently, the FDA shared Congress’

understanding of the preemptive scope of the FDCA.

The FDA has traditionally taken the view that its

approval of a drug label does not preempt state laws

except in very limited circumstances.

In 1974, for example, FDA adopted a regulation

providing for confidential treatment of any

identifying information relating to physicians (and

other health care professionals) included in adverse

drug reaction reports (ADRs) submitted by the

manufacturer to the FDA. 21 C.F.R. § 314.80(h).

FDA adopted this regulation precisely because it

recognized that federal law permits products liability

lawsuits in which plaintiffs’ counsel would seek such

identifying data:

construction that makes clear that Congress does not intend to

preempt state requirements regarding drug companies’

responsibilities. Rather, this legislation recognizes that State

liability laws, including lability laws for improper drug labeling,

play an essential role in ensuring that drug products remain

safe and effective for all Americans.”). Even those who did not

agree with Congress’ approach recognized that the FDAAA

undermined any argument of preemption. Jd. at S11837

(statement of Sen. Allard) (expressing disappointment in the

Senate's acquiescence to the House language, contained in the

Rule of Construction, and warning that it will “open the

floodgates” to litigation and is “a definite boon to trial lawyers”).

Large numbers of requests are received from

plaintiffs attorneys in product liability

lawsuits, requesting records relating to any

other injuries caused by the product that is

the subject of the lawsuit.

39 Fed. Reg. 44629 (Dec. 24, 1974).

In a 1979 preamble accompanying a drug rule,

the agency explained that state tort law does not

interfere with federal regulation: “It is not the intent

of the FDA to influence the civil tort liability of the

manufacturer.” 44 Fed. Reg. at 37437 (1979).

Similarly, in a 1998 Final Rule relating to

labeling provided directly to patients for certain

prescription drugs and other biological products, the

FDA indicated that its regulations do not preempt

state failure-to-warn claims:

Some comments contended that the

provision of patient labeling would adversely

affect the legal liability of manufacturers,

physicians, pharmacists, and other

prescribers or dispensers of prescription drug

products by abrogating the “learned

intermediary doctrine.” Some comments

urged that FDA provide for Federal

preemption of State regulation with respect to

civil tort liability claims and other labeling

requirements. The comment claimed that

without preemption, FDA would encourage

“failure to warn” claims and challenges to

patient labeling, especially compared _ to

professional labeling.

Tort liability cannot be a= major

consideration for FDA which must be guided

by the basic principles and requirements of

the act in its regulatory activities.

Nevertheless, FDA does not believe this rule

would adversely affect civil tort liability....

x**k

FDA does not believe that the evolution of

state tort law will cause the developments of

standards thai would be at odds with the

agency’s regulations.

63 Fed. Reg. 66378, 66384 (1998). FDA added that

its regulation providing for FDA approval of patient

labeling for a limited number of products was “not

intended to preclude the states from imposing

additional labeling requirements.” Jd.

In 1986, a former chief counsel of the FDA

explained the agency’s view that federal approval did

not bar state failure-to-warn claims:

In a number of cases, state and federal courts

have held that package inserts approved by

FDA have contained inadequate disclosure of

risks. ... Is not such review under state law a

violation of the supremacy of federal law?

Are not manufacturers being held liable for

inserts controlled not by them but by FDA, so

that juries are imposing on manufacturers

disclosure obligations inconsistent with the

regulation of inserts by FDA? The answer

currently is no. In some situations, FDA has

not, at the relevant time, considered the

precise question of whether the insert it had

previously approved should be changed in

light of subsequent information. Where that

is the case, there would seem to be no

relevant federal decision entitled to

supremacy. Nor does the Food, Drug, and

Cosmetic Act reflect a congressional intent to

preempt in all circumstances common law

review of drug labeling.

Richard M. Cooper, Drug Labeling & Products

Liability: The Role of the Food and Drug

Administration, 41 FooD DruG & CosoM. L.J. 233, 234-

35 (1986).

Another chief counsel of the FDA explained that

this Court’s no-preemption ruling in JLoAr was

consistent with the FDA’s “longstanding

presumption against preemption.” Margaret Jane

Porter, The Lohr Decision: FDA Perspective and

Position, 52 Foop & DruG L.J. 7, 10 (1997). She

added that:

Given the harsh implications of foreclosing

all judicial recourse for consumers injured by

defective medical devices, FDA does not

believe that Congress intended to effect so

sweeping change without even a comment.

Rather, the agency believes that Congress

intended to restrict preemption to positive

enactments (for example, legislation or

regulations) that apply to the marketing of

medical devices within a state, and did not

“tend to preempt state tort remedies for

injury to individual consumers.

Id. at 9. Although the article concerned medical

devices specifically rather than pharmaceuticals, its

explanation of FDA’s longstanding view of limited

preemption applies a fortior! with respect to drugs.

After all, the FDCA contains no express preemption

provision for drugs, in contrast to the Medical Device

Act amendments interpreted in Medtronic.

In December 2000, the FDA proposed a new

regulation to address the form and content of drug

labeling, the principal purpose of which was to

require a “Highlights” section on drug labels. At that

time, the agency explained that “this proposed rule

does not preempt state law,” and “FDA ‘has

determined that this proposed rule does not contain

policies that have federalism implications or that

preempt State law.” 65 Fed. Reg. 81082, 81103

(2000).

In 2006, in finalizing these labeling rules, the

agency took a different view with respect to the very

same regulation, claiming that the federal approval of

drug labeling may preempt a state tort claim based

on a failure to warn:

FDA believes that under existing preemption

principles, FDA approval of labeling under

the act, whether it be in the old or new

format, preempts conflicting or contrary State

law.

71 Fed. Reg. 3922, 3934 (2006). FDA added:

State law actions also threaten FDA's

statutorily prescribed role as the expert

Federal agency responsible for evaluating and

regulating drugs.

Id. at 3935.

The preemption preamble is an improper FDA

power grab that seeks to seize authority belonging to

Congress, the States, and the courts. The FDA did an

inexplicable about-face and attempted to achieve

federal preemption “through the back door.” Zyprexa,

489 F Supp.2d at 275-76. “Until January 24, 2006,

the FDA itself had consistently recognized that state-

law claims could coexist with federal regulation of

prescription drugs: Indeed, the FDA’s current

position on preemption represents a _ significant

departure from well-settled administrative and

judicial views on the issue, and ultimately is both

unpersuasive and untenable... .” Jn re Vioxx Prods.

Liab. Litig., 501 F. Supp. 2d 776, 788 (E.D. La. 2007).

The 2006 preemption preamble is_ also

inconsistent with Executive Order No. 13132, which

requires federal agencies to consult with state and

local officials whenever a proposed rule contains

preemption provisions. The FDA failed to follow the

prescribed procedures in 2006. See Senate

Regulatory Preemption Hearing at 6-7 (statement of

Hon. Donna Stone, Del. State Rep. and President,

National Conference of State Legislatures).

Accordingly, the Conference of State Chief Justices

adopted a resolution in January 2008 stating that

“recent actions by federal agencies have led to a

growing concern by the Conference of Chief Justices

about federal regulatory agency efforts to preempt

federal and state statutes and common law through

the promulgation of proposed rules.”!!

Even assuming that it would be proper for a court

to defer to an agency on the issue of a statute’s

preemptive effect — an issue which this Court has not

resolved!? — the FDA's new-found position does not

'! Available at http://ccj.ncsc.dmi.us/FederalismResolutions/

rcsoll Respect PrinciplesOfF ederalism htm}.

12 Smiley v. Citibank, 517 US. 745, 744 (1996); see also

Medtronic, Inc. v. Lohr, 518 U.S. 470, 512 (1996) (O'Connor, J..,

deserve judicial deference. In fact, in Riegel v.

Medtronic, Inc., 128 S. Ct. 999 (2008), this Court did

not rely upon the agency’s view of the preemptive

effect of the Medical Device Amendments. Instead,

this Court opined that “the degree of deference might

be reduced by the fact that the agency’s earlier

position was different.” Jd. at 1009. This Court has

repeatedly held that an agency’s change of position is

not entitled to deference. See, e.g., Bates v. Dow

Agrosciences LLC, 544 U.S. 431, 449 (2005); Norfolk

Southern Ry. Co. v. Shanklin, 529 U.S. 344, 356

(2000); Good Samaritan Hosp. v. Shalala, 508 US.

402, 418 (1993) (citing JNS v. Cardoza-Fonseca, 480

U.S. 421, 446, n.30 (1987)).

Further features of the 2006 preemption

preamble preclude Chevron deference. Because the

proposed rule had stated that no preemption would

arise from the labeling requirement, the public

received no notice or opportunity to comment against

preemption. The 2000 preamble had addressed

preemption not as a subject for comment, but as part

of the analysis of the labeling rule itself and whether

it ought to be changed because of liability concerns.

The 2000 preamble, in other words, presupposed the

potential for liability under state law and did not

even hint that federal preemption was on the horizon.

See Content and Format of Labeling for Human

Prescription Drugs and Biologics, 65 Fed. Reg. at

81103 (2000). The drafters of the 2006 preamble

proceeded from precisely the opposite premise,

denying fair notice and an opportunity for interested

parties to comment. The absence of public comment

concurring in part and dissenting in part, joined by Rehnquist,

C.J., and Scaha and Thomas. JJ).

precludes any claim of deference. See United States

v. Mead Corp., 533 U.S. 218, 231 (2001) (denying

deference because, among other reasons, the agency

ruling was “far removed .. . from notice-and-comment

process”).

Next, the 2006 preemption statement arose in the

context of a regulatory preamble. Under FDA

regulations, a preamble to a proposed or final

regulation is merely “an advisory opinion,” rather

than part of the rule itself. 21 C.F.R. § 10.85(d)(1).

“An advisory opinion may be amended or revoked at

any time after it has been issued,” without notice or

comment. Jd. at § 10.85(g). “An advisory opinion

may be used in administrative or court proceedings to

illustrate acceptable and unacceptable procedures or

standards, but not as a legal requirement.” Jd. at

§ 10.85G). If an advisory option is not binding in

administrative or court proceedings, it cannot be

entitled to Chevron deference. See Long Island Care

at Home, Ltd. v. Coke, 127 S.Ct. 2339, 2349 (2007)

(agency guideline entitled to only “persualsive]”

rather than “bindling]” weight); Gonzales v. Oregon,

546 U.S. 243, 256-57 (2006) (interpretive rule not

entitled to deference); Mead, 533 U.S. at 232

(“interpretive rules ... enjoy no Chevron status as a

class’); Martin v. Occupational Safety and Health

Review Comm'n, 499 U.S. 144, 157 (1991)

(interpretive rules are “not entitled to the same

deference as norms that derive from the exercise of

the Secretary’s delegated Jawmaking powers”). See

also Shalala v. Guernsey Memorial Hospital, 514 U.S.

87, 99 (1995) (interpretive rule” “doles] not require

notice and comment”).

In sum, the FDA’s 2006 change of position

provides no basis for upsetting Congress’

longstanding understanding of the preemptive effect

of the FDCA. The FDA’s abrupt change in view

should be rejected.

D. This Court Should Not Upset Congress’

Settled Expectations.

Congress, the FDA, and the courts have long

assumed the availability of state-law damages actions

for failure-to-warn and inadequate warning claims,

notwithstanding FDA approval of a drug label. To

find preemption in this context would eliminate all

compensation for often devastating injuries — lost

wages, medical costs, and other traditional forms of

damages — without providing any federal remedy as a

substitute. It would effectively bestow an immunity

on drug manufacturers that Congress has refused to

grant.

Moreover, a holding of preemption would also

have serious implications for institutional principles

arising from the separation of powers. Agencies, as

creatures of their organic statutes, do not have the

power to regulate with the force of law unless

Congress has delegated that power to them. See

Gonzales, 546 U.S. at 255-56. Deference is warranted

only “when it appears that Congress delegated

authority to the agency generally to make rules

carrying the force of law, and that the agency

interpretation claiming deference was promulgated in

the exercise of that authority.” Mead, 533 U.S. at

226-27.

Congress has not authorized the FDA to imbue

the 2006 preamble with preemptive force. To defer to

the FDA's preemption preamble would turn the

proper inquiry upside down. Preemption is

ultimately a question of congressional intent, not

agency intent. Medtronic, 518 U.S. at 485. An

agency may not expand the preemptive reach of a

statutory scheme outside the congressional mandate.

See Adams Fruit v. Barrett, 494 U.S. 638, 650 (1990)

(declining to defer to agency’s view regarding

preemptive reach of federal statute’s right of action,

and noting that, despite agency’s authority to issue

relevant safety standards, "an agency may not

bootstrap itself into an area in which it has no

jurisdiction.”) (quoting Federal Maritime Comm'n v.

Seatrain Lines, Inc., 411 U.S. 726, 745 (1973)).

In addition, important issues of repose and

settled statutory meaning counsel strongly against

overturning decades of practice under the FDCA.

Where Congress, the FDA and the courts have all

operated on the basis of a common, longstanding view

regarding the construction of a statutory scheme,

there are powerful reasons not to disrupt their shared

interpretation. The expectations regarding the

preemptive effect of the FDCA reflect precisely the

kind of “well-embedded interpretation” of a statute

that this Court has held is entitled to judicial respect.

CBOCS West, 128 S.Ct. at 1958.

The value of repose in this context is akin to the

principle of statutory stare decisis. This Court has

explained that it “givels] great weight to stare decisis

in the area of statutory construction,” in part because

of “institutional concerns about the relationship of

the Judiciary to Congress.” Neal v. United States,

516 U.S. 284, 295 (1996) (Kennedy, J.). See also

Hohn v. United States, 524 U.S. 236, 251 (1998)

(“Considerations of stare decisis have special force in

the area of statutory interpretation ... .”) (quoting

Patterson v. McLean Federal Credit Union, 491 U.S.

164, 172-73 (1989)); Quill Corp. v. North Dakota, 504

U.S. 298, 320 (1992) (Scalia, J., concurring in part

and in the judgment) (stressing importance of stare

decisis in dormant Commerce Clause context, where

Congress “has the final say over regulation of

interstate commerce”).

For more than 70 years, Congress has operated

against the background understanding that FDA

approval of a drug label does not bar state-law

failure-to-warn claims. If that rule of law is to be

altered, it should be changed directly by Congress.

This Court should not nullify more than 70 years of

practice under the FDCA by bestowing an immunity

that Congress has thus far declined to grant, nor

should it permit the FDA to accomplish such a result

indirectly through an unauthorized expansion of its

regulatory power.

E. Preemption Would Disrupt The

Congressional Drug Safety Scheme

The congressionally designed scheme for drug

safety contemplates a meaningful role for state-law

tort actions. When a drug is approved, the available

information is not sufficient to guarantee its safety

over time. FDA typically approves drugs on the basis

of relatively small clinical trials, which may involve

healthy volunteers and other subjects far different

from the patients for whom doctors usually write

prescriptions. The Institute of Medicine of the

National Academies reports that drugs are generally

tested on no more than 600 to 3,000 patients prior to

approval. See lOM Report, supra, at 36. At the time

of approval the label contains only the information

that can be definitively established by the trials.

Thus, “FDA approval does not represent a lifetime

guarantee of safety and efficacy,” and drugs enter the

U.S. market with “incomplete safety profiles.” Jd. at

2, 37. Because of statistical limitations, latency

periods, and population sub-groups with special

characteristics, pre-approval testing cannot reveal

the safety problems that may emerge only after long-

term, large-scale use. The IOM concluded:

Preapproval trials typically are too small to

detect even significant safety problems if they

are rare. An adverse event (even a serious

one) that occurs in less than one in 1,000

patients cannot be reliably detected except in

the largest premarket trials but can pose a

serious public health problem when hundreds

of thousands or millions of people use the

drug.

1OM Report at 37-38 (citations omitted).

Many features of drug testing, production and

marketing can result in new and unexpected risks

once a drug enters widespread use, and these dangers

are often solely within a manufacturer’s knowledge.

As a matter of both resources and _ statutory

responsibility, manufacturers are in a far better

position than FDA to discover unexpected risks of

their own drugs and to make appropriate warnings to

patients. FDA oversees the safety of 12,000 drugs

made by 5,000 manufacturers around the world.

Given the agency's limited resources and information,

it is utterly unrealistic to expect that the FDA alone —

with no assistance from state tort suits — can protect

patients from the post-market risks of even a fraction

of these products.

The voluntary physician reporting system on

which FDA relies for collecting rea]-time information

on drug side effects identifies fewer than 1% of

serious side effects.'5 Moreover, FDA’s system for

collecting and analyzing those reports is severely

antiquated, underfunded, and often overwhelmed,

resulting in “incredible missed opportunities” to

detect signals of post-market drug risks. FDA

Science & Mission at Risk at 50 & App. J. A long

series of congressional hearings and reports has

documented that the FDA’s resources are not

commensurate with the agency’s enormous task.!4

One of FDA’s own advisory committees concluded

that “[iJn contrast to previous reviews that warned

crises would arise if funding issues were not

addressed, recent events and our findings indicate

that some of those crises are now realities and

American lives are at risk.” FDA Science & Mission

at Risk at 6. The committee documented a litany of

FDA shortcomings:

13 FDA Medwatch, The Clinical Impact of Adverse Event

Reporting (Oct. 1996). http://www fda.gov/medwatch/articles/

medcont/postrep htm#und

\4 See, e.g., Risk and Responsibility: The Roles of the FDA

and Pharmaceutical Companies in Ensuring Safety of Approved

Drugs, Like Vioxx: Hearing Before the House Comm. on

Government Reform, 109th Cong. (2005); FDA's Drug Approval

Process: Up to the Challenge?’ Hearing Before the Senate

Comm. on Health, Educ., Labor and Pensions, 109th Cong.

(2005); FDA, Merck and Vioxx: Putting Patient Safety First?:

Hearing Before the Senate Comm. on Finance, 108th Cong.

(2004); U.S. Gov'r ACCOUNTABILITY OFFICE, DRUG SAFETY:

IMPROVEMENT NEEDED IN FDA'S POSTMARKET DECISION-MAKING

AND OVERSIGHT PROCESS 19, available at www.gao.gov/cgi

bin/getrpt?GAO-06-402.

We found that FDA’s resource shortfalls have

resulted in a plethora of inadequacies that

threaten our society - including, but not

limited to, inadequate inspections of

manufacturers, a dearth of scientists who

understand emerging new _ technologies,

inability to speed the development of new

therapies, an import system that is badly

broken, a food supply that grows riskier each

year, and an information infrastructure that

was identified as a source of risk in every

Center and program reviewed by the

Subcommittee. We conclude that FDA can no

longer fulfill its mission without substantial

and sustained additional appropriations... .

Id. at 2.

The FDAAA of 2007 is intended to address these

deficiencies, but it is not a panacea. Even with the

enactment of the 2007 amendments, “drugs with

unrecognized toxicity will reach the market.” Bruce

M. Psaty & David Korn, Congress Responds to the

IOM Drug Safety Report - In Full, 298 JAMA 2185,

2187 (Nov. 14, 2007). Senator Kennedy, chief Senate

sponsor of the FDAAA and a leader on federal drug

regulation for decades, has explained that even a

strengthened FDA should not be expected to assume

exclusive responsibility for collecting and analyzing

post-market safety data:

Clearly, the resources of the drug industry to

collect and analyze postmarket safety data

vastly exceed the resources of the FDA, and

no matter what we do, they will always have

vastly greater resources to monitor the safety

of their products than the FDA does. It 1s

absurd to argue that the FDA, even with the

enhanced resources and authorities provided

by this legislation, commands the field when

it comes to postmarket safety. The drug

companies have the capacity to do a far more

comprehensive job .. . [and] cannot be

allowed to ignore their responsibilities and

wait for the FDA to act.

153 Cong. Rec.S11832 (daily ed. Sept. 20, 2007).

By necessity, manufacturers play a central role in

the development and dissemination of information

about their products. Accordingly, cases brought by

injured consumers under state law can help ensure

that manufacturers have the incentive to provide the

most up-to-date warning information. Gregory

Curfman, executive editor of the New England

Journal of Medicine, recently warned that

“preemption of common-law tort actions against drug

and medical device companies is ill advised and will

result in less safe medical products for the American

people.” House FDA Preemption Hearing (testimony

of Dr. Curfman). Another expert advised a House

Committee that:

Preempting lawsuits against pharmaceutical

manufacturers would remove a check on

pharmaceutical manufacturers that is

essential to prescription drug safety and the

public health. Without the, possibility of

litigation against manufacturers and their

executives, we are likely to see greater

misrepresentation of safety-related data and

more inappropriate use of potentially harmful

medications.

Id. (testimony of Aaron S. Kesselheim, Brigham &

Women’s Hospital and Harvard Medical School).

State tort cases also provide an invaluable source

of data for regulators. Time and time again,

problems with long-term use of drugs were identified

first in failure-to-warn litigation, involving such

drugs as Vioxx, Bextra, Celebrex, Avandia, Rezulin,

Baycol, Halcion, and Zomax. State court litigation

plays the same complementary role in the FDCA

context as it does in other areas. See Bates, 544 U.S.

at 451 (“Private remedies that enforce federal

misbranding requirements would seem to aid, rather

than hinder, the functioning of FIFRA.”); CSX

Transp., Inc. v. Easterwood, 507 U.S. 658, 668 (1993)

(railroad safety); Hillsborough County v. Automated

Medical Laboratories, Inc., 471 U.S. 707, 720-21

(1985) (blood plasma).

Moreover, it is clear from the brief amicus curiae

of the United States in this case (“SG Br.”) that in

fact there is no conflict between FDA approval of a

label and state-law failure-to-warn duties. The

Solicitor General explains that, under the FDA's

regulations, a manufacturer may make changes in

drug labeling by first submitting a supplemental

application to the FDA. SG Br. 3. A manufacturer is

required to submit such a supplemental application

“to include a warning about a clinically significant

hazard as soon as there is reasonable evidence of a

causal association with a _ drug.” 21 C.F.R.

§ 201.57(c)(6). FDA labeling regulations instruct that

drug “labeling shall be revised to include a warning

as soon as there is reasonable evidence of an

association of a serious hazard with a drug....” Jd. at

§§ 201.57(e), 201.80(e).

The Solicitor General adds that a manufacturer

may “change a drug’s labeling after its supplemental

application is received by FDA, without waiting for

the agency’s approval of the change, if, among other

things, the change ‘addl[s]’ or ‘strengthens’ a warning

or a statement about administration of the drug in

order to promote safety.” SG Br. 3 (emphasis added

and quoting 21 C.F.R. § 314.70(c)(6)Giii)(A) and (C)).

However, an FDA proposed rule would permit

changes without prior approval “only to address

‘newly discovered risks’ for which there is sufficient

evidence of causal association with the drug.” Jd. at

In the view of the undersigned Members of

Congress, the FDA's current regulations

appropriately require manufacturers to warn of risks

as early as possible — regardless of whether the risk

is “newly discovered” or not. In any event, even if

prior FDA approval for labeling changes to enhance

safety were required, such a requirement could not

possibly shield a manufacturer from liability (if it

could have any preemptive effect at all) when the

drug maker had never even requested the approval.

In addition, manufacturers may provide risk

information by various means besides label changes,

such as “Dear Health Care Professionals” letters. 21

C.F.R. § 200.5; 44 Fed. Reg. 37434, 37447 (1979). A

manufacturers failure to use such _ non-label

measures may serve as a basis for imposing state-law

failure-to-warn Liability.

In sum, there is no basis for reversing 70 years of

statutory interpretation and preempting traditional

state law failure-to-warn claims.

CONCLUSION

The judgment below should be affirmed.

Respectfully submitted,