Opposition — Berger v. Personal Products, Inc.

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No. 90-1305 tw, OS

WAR 20 1991

gf THE CLEKK

IN THE

Supreme Court of the United

OCTOBER TERM, 1990

ERNEST BERGER, Personal Representative

of the Estate of SHEILA BERGER,

Petitioner,

—_—V.—

PERSONAL PRODUCTS, INC., et al.,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE WASHINGTON STATE SUPREME COURT

BRIEF IN OPPOSITION

DAVID F. DOBBINS

30 Rockefeller Plaza

Of Counsel: New York, New York 10112

PATTERSON, BELKNAP, (212) 698-2500

WEBB & TYLER Counsel of Record for

Lisa C. Cohen Respondents

30 Rockefeller Plaza

New York, New York 10112

(212) 698-2500

ARTER & HADDEN

George Gore

Victoria L. Vance

Irene Keyse-Walker

1100 Huntington Building

Cleveland, Ohio 44115

(216) 696-1100

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QUESTION PRESENTED

Respondents reformulate the question presented as follows:

Does federal law preempt a state tort action based on

the claims of inadequate warnings and instructions

about the risk of contracting toxic shock syndrome asso-

ciated with tampon use when the product complies with

federal labelling requirements?

PARTIES

Petitioner is Ernest Berger as Personal Representative of

the Estate of Sheila Berger.

Respondents are Johnson & Johnson (misnamed in Wash-

ington Supreme Court opinion as ‘‘Johnson and Johnson,

Inc.’’), Personal Products Company (misnamed in Washing-

ton Supreme Court opinion as ‘‘Personal Products, Inc.’’),

and Johnson & Johnson Medical, Inc., f/d/b/a Johnson &

Johnson Products, Inc. Johnson & Johnson is a corporation

organized and existing under the laws of New Jersey with its

principal place of business in New Brunswick, New Jersey. It

is a publicly held corporation. Johnson & Johnson has no

parent corporation and has no subsidiaries or affiliates other

than wholly-owned subsidiaries. Personal Products Company,

a division of McNeil-PPC, Ing., and Johnson & Johnson

Medical, Inc. are wholly-owned subsidiaries of Johnson &

Johnson.

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TABLE OF CONTENTS

PAGE

Sg gy i

EEN OS ee ee eee il

ME A POMPEU EE oc cece ciscesvsccssocee Vv

ee es) 3

REASONS FOR DENYING THE WRIT............ 4

I. The Berger Decision Does Not Raise a Significant

Issue Concerning the Supremacy Clause and a

State’s Right to Provide Tort Claims ............ 4

A. Under the Constitution’s Supremacy Clause,

Federal Law May Explicitly or Implicitly Pre-

empt State Law, Including State Tort Claims. 4

B. The Federal Regulatory Scheme at Issue Pre-

empts Differing or Additional State Law

Requirements Concerning the Adequacy of

anc a pklskcewes vee seeess 6

1. Congress and the FDA Intended to Pre-

empt State Law Where the FDA Promul-

gates Specific Device Requirements....... 6

2. The FDA Promulgated Regulations Con-

taining Specific Requirements Concerning

Tampon Warnings, Thereby Preempting

REESE a 9

C. The Federal Regulatory Scheme Expressly Pre-

empts Competing Requirements Established by

State Product Liability Law Concerning Tam-

SE EO 10

II. There is No Conflict Between Berger and any Other

Decision Warranting this Court’s Review.........

A. There is No Conflict Among the Appellate

Courts that Have Considered the Preemptive

Effect of the FDA’s Tampon Regulations....

B. Other Cites that Petitioner Relies Upon Fail to

Create a Conflict with the Berger Decision...

SOUEY C84 Sake nnesn ous Rbk veebehenesdecees

APPENDICES

Appendix A—Courts Finding Preemption of State Law

Claims Regarding Tampon Warnings..............

Appendix B—Food, Drug, and Cosmetic Act, 21

AE EE Ve owe ENG UG 6 ieee nese eeceeeends

Appendix C—Food and Drugs, 21 CFR Ch. 1 § 898.1

Appendix D—Food and Drugs, 21 CFR Ch. 1

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Appendix E—Food and Drugs, 21 CFR Ch. 1

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Appendix F—Food and Drugs, 21 CFR Ch. 1

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Appendix G—Letter from Thomas Scarlett, Chief

Counsel, Food and Drug Administration to Stephen

M. McNamara, Esq., Hyman, Phelps & McNamara,

pee fe ee a ree

PAGE

TABLE OF AUTHORITIES

Cases PAGE

Berger v. Johnson & Johnson Products, Inc., No. 86-2-

01249-3 (Sup. Ct. Yakima Co. Wash. March 14,

1989) (Memorandum Opinion), aff’d, 115 Wash. 2d

\ yee ie Ee Fes a, 4%, 3a, 44

Berger v. Personal Products, Inc., 115 Wash. 2d 267,

ie ©). |) eae re 3, 4, M4, 13, 35-17

Bowden v. Tambrands, Inc., No. 85L 21095 (Cir. Ct.

eo ek 8 Pee er eT ere 14

California Coastal Comm’n v. Granite Rock Co., 480

Sa es Ts . : Ber ry een erat 4

Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691 (1984) 5

Chicago & N.W. Trans. Co. v. Kalo Brick & Tile Co..,

Re errr rere re ee 6, 8

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

Cir.), cert. denied, 469 U.S. 1062 (1984) .......... 12

Fidelity Fed. Sav. and Loan Ass’n v. De La Cuesta,

ee Pere eee ere 5

Florida Lime & Avocado Growers, Inc. v. Paul, 373

DS, SB Ge os eek odin escsuns 340th erakeueees 5

Forsyth v. Hammond, 166 U.S. 506 (1897).......... 14

Gibbons v. Ogden, 9 Wheat. 1 (1824)............... 4

Hillsborough County v. Automated Medical Laborato-

tien, Sac... SIi Was FOG Cees ho xs ee etreien 4, 5, 11-12

Hines v. Davidowitz, 312 U.S. 52 (1941) ............ 5

Ignace v. International Playtex, Inc., No. 86-C-480C,

CWT. Win. Ame. 06, BOGFP osc ce cusvweenstencnves’s 13-14

PAGE

International Paper Co. v. Ouellette, 479 U.S. 481 (1987) 6, 8

Jones v. Rath Packing Co., 430 U.S. 519 (1977)..... 5

Kerns v. International Playtex, Inc., No. C-1-86-297

ees Gee HAE, 00, Be op kn ndcecccecsenescasas 14

Lavetter v. International Playtex, 706 F. Supp. 722 (D.

Shr bce bomen daen cede ctee sence evens es 13-15

Louisiana Pub. Serv. Comm’n v. F.C.C., 476 U.S. 355

| _ BERRRa ReR BPeo ag Oy PEN Same NM OVERS L eycin R ag ek tes, 5

Mishlove v. Herman, M.D., No. 009-450 (Cir. Ct. Mil-

wees Co. Wi. IOV. 2, FORD 6c cccccccccasssss 14

Moore v. Kimberly-Clark Corp., 867 F.2d 243 (Sth Cir.

ss kab Ks S45 RO aha eee aian eee 6, 13, 35

Muzatko v. International Playtex, Inc., No. 85-C 1540

Ges Se Ss EE Gc Sabet uae tuwee ees 13-14

New Jersey Guild of Hearing Aid Dispensers v. Long,

Fa Wicd, SRG, Fee CAs PO GROTON kao ceskdckekes 15

O’Gilvie v. International Playtex, Inc., 821 F.2d 1428

(10th Cir. 1987), cert. denied, 486 U.S. 1032 (1988).13, 15

Papas v. The Upjohn Company, No. 89-3752, 1991

U.S. App. LEXIS 3277 (11th Cir. Feb. 28, 1991) .. 12

Poloney v. Tambrands, Inc., 399 S.E.2d 208 (Ga.

SEDs 65 00056 uneechenesscekss cohen Coe 13

Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947) 5

San Diego Bidg. Trades Council v. Garmon, 359 U.S.

ee err eer rr re fer eee re 6, 8

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

EN s:6 6s, a rweng debra esensh uae ee keel 4, 6, 8, 16-17

Smith v. Pingree, 651 F.2d 1021 (Sth Cir. 1981) ..... 15

Stewart v.

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PAGE

International Playtex, Inc., 672 F. Supp.

eT is Seas hb bada heed sd urges ncaeesehs % &

Stucker v.

International Playtex, Inc., No. C87-0440-

RA, CW.ke. BY. POD. BB, BOGE)... 2. es ccncccccass 14

Legislative History

H.R. Rep.

No. 853, 94th Cong., 2d sess., at 45 (1976) 12

S. Rep. No. 33, 94th Cong., Ist sess. (1975), reprinted

in 1976 U.S. Code Cong. & Admin. News 1070, 1071 6

Regulations

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Re Se 5605 ch as cceuks concn deucsece 8, 10, 11

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21 C.F.R. §§ 884.5460 and 884.5470 ................ 9

Rules

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Statutes

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Other Authorities

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IN THE

Supreme Court of the United States

OCTOBER TERM, 1990

No. 90-1305

>_>

ERNEST BERGER, Personal Representative

of the Estate of SHEILA BERGER,

Petitioner,

—_—V.—

PERSONAL PRODUCTS, INC., et al.,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE WASHINGTON STATE SUPREME COURT

_>—

BRIEF IN OPPOSITION

To: The Honorable Chief Justice and Associate Justices of

the Supreme Court of the United States:

Respondents Johnson & Johnson, Personal Products Com-

pany, and Johnson & Johnson Medical, Inc. (collectively,

‘*Personal Products Co.’’) respectfuily submit that certiorari

should not be granted in this case. In a unanimous en banc

decision, the Washington State Supreme Court held that a

state tort action based on the claims of inadequate warnings

and instructions concerning the risk of contracting toxic

shock syndrome (‘‘TSS’’) associated with tampon use are pre-

empted by federal law when the product complies with fed-

eral labelling requirements. That decision is consistent with

precedent from this Court mandating preemption of state law

where Congress or a federal regulatory agency has expressed

an intent to preempt. The decision is also in accord with the

decisions of every other appellate court—both state and

federal—that has considered this precise question.’

Petitioner’s argument against preemption—and for this

Court’s review—depends upon an oversimplified and miscon-

ceived version of the law. in the Medical Devices Amend-

ments (‘‘*MDA’’) of 1976 to the Food, Drug and Cosmetics

Act (‘‘FDCA’’), 21 U.S.C. § 301 et seq., and the regulations

promulgated thereunder, 21 CFR Part 800 er seq., Congress

and the Food and Drug Administration (‘‘FDA’’) have

expressed an intent to preempt state law where a manufac-

turer has complied with specific regulations concerning a

medical device. There is no question that the FDA’s regula-

tions concerning tampon warnings and instructions are spe-

cific requirements concerning tampons and that tampons are

classified as medical devices. In addition, there is no question

that respondents complied with the federal regulations gov-

erning tampon warnings and instructions. Thus the Washing-

ton Supreme Court decision is plainly correct in finding in

favor of preemption.

Because the decision of the Washington Supreme Court

correctly applies this Court’s precedents, and because its

holding is consistent with every other appellate decision

addressing the issue, there is no reason for this Court to

grant certiorari.

1 A list of the decisions that are consistent with the Washington

Supreme Court’s decision is contained in Appendix A.

STATEMENT OF THE CASE

The petition requests review of the Washington Supreme

Court’s unanimous en banc affirmance of the trial court’s

grant of partial summary judgment. Berger v. Personal Proa-

ucts, Inc., 115 Wash. 2d 267, 797 P.2d 1148 (1990). In grant-

ing partial summary judgment, the trial court dismissed that

portion of petitioner’s product liability claim that was based

on the alleged failure of Personal Products Co. to adequately

warn its tampon users of the rick of TSS. Following a host of

prior decisions directly on point, the Yakima County Supe-

rior Court ruled that federal law—21 U.S.C. § 360k(a) and

the relevant regulations promulgated by the FDA—preempts

state tort claims for inadequate TSS warnings and instruc-

tions where a manufacturer has complied with federal regula-

tory standards. Berger v. Johnson & Johnson Products, Inc.,

No. 86-2-01249-3 (Sup. Ct. Yakima Co. Wash. March 14,

1989).

This decision was then reviewed and unanimously affirmed

by the Washington Supreme Court. The Court’s decision is

consistent with the decisions of thirty-five other courts that

have considered this precise issue.

In seeking a writ of certiorari, petitioner attempts to erect

and defeat a straw man. Petitioner misreads the Berger deci-

sion as holding that the MDA preempts ai// state law claims.

After positing this fictional ‘‘holding,’’ petitioner then

attacks it by relying on cases that do not involve the FDA’s

regulations concerning tampons or TSS and by relying on

cases that do not involve interpretation of the MDA. These

cases are not on point.

The Washington Supreme Court’s decision does not

broadly displace all state tort law. It does not hold that tort

claims based on an alleged failure to comply with federal reg-

ulations concerning tampon warnings are preempted, and it

does not suggest that tort claims based on design defect are

displaced. In fact, petitioner had asserted a design defect

claim before the trial court and then voluntarily dismissed

that claim.

What the Berger decision, and every other reasoned deci-

sion on this issue, asserts is consistent with what the FDA has

determined in its regulations, ij.e., that state requirements are

preempted ‘‘only when the Food-and Drug Administration

has established specific counterpart regulations or there are

other specific requirements applicable to a particular device

under the act ... .’’ Berger v. Personal Products, Inc.,

supra, 115 Wash. 2d at 273, 797 P.2d at 1151, quoting

Moore v. Kimberly-Clark Corp., 867 F.2d 243, 244-45 (Sth

Cir. 1989). Because the decisions on the preemption of state

law claims concerning tampon warnings are consistent, clear,

and correct, there is no reason for this Court to grant certio-

rari to review this case.

REASONS FOR DENYING THE WRIT

I. The Berger Decision Does Not Raise a Significant Issue

Concerning the Supremacy Clause and a State’s Right to

Provide Tort Claims

A. Under the Constitution’s Supremacy Clause, Federal

Law May Explicitly or Implicitly Preempt State Law,

Including State Tort Claims

It is a ‘‘familiar and well-established principle that the

Supremacy Clause, U.S. Const., art. VI, cl. 2, invalidates

state laws that ‘interfere with, or are contrary to,’ federal

law.’’ Hillsborough County v. Automated Medical Laborato-

ries, Inc., 471 U.S. 707, 712 (1985), quoting Gibbons vy.

Ogden, 9 Wheat. 1, 211 (1824). This Court has repeatedly

recognized a variety of ways in which federal law may dis-

place state law. See generally California Coastal Comm’n vy.

Granite Rock Co., 480 U.S. 572, 581 (1987); Silkwood v.

Kerr-McGee Corp., 464 U.S. 238, 248 (1984). ‘‘Preemption

may be either express or implied, and ‘is compelled whether

Congress’ command is explicitly stated in the statute’s lan-

guage or implicitly contained in its structure and purpose.’ ”’

Fidelity Fed. Sav. and Loan Ass’n v. De La Cuesta, 458 U.S.

141, 152-53 (1982), quoting Jones v. Rath Packing Co., 430

U.S. 519, 525 (1977).

Although the case involves express preemption, Congress’

intent to displace state law may be implied because the fed-

eral regulatory scheme is-so pervasive as to make reasonable

the inference that Congress left no room for the states to

supplement it or because the federal regulation touches a

field in which the federal interest is so dominant that the fed-

eral system will be assumed to preclude enforcement of state

laws on the same subject or because the object sought to be

obtained by federal law and the character of obligations

imposed by it may reveal the same purpose. Jones v. Rath

Packing Co., supra, 430 U.S. at 525; Rice v. Santa Fe Eleva-

tor Corp., 331 U.S. 218, 230 (1947). Moreover, state law can

be preempted by federal regulations as well as by federal stat-

utes. See Louisiana Pub. Serv. Comm’n v. F.C.C., 476 U.S.

355, 369 (1986); Hillsborough County v. Automated Medical

Laboratories, Inc., supra, 471 U.S. at 713; Capital Cities

Cable, Inc. v. Crisp, 467 U.S. 691, 699 (1984); Fidelity Fed.

Sav. & Loan Ass’n v. De La Cuesta, supra, 458 U.S. 141.

Even where federal regulations have not completely dis-

placed state regulation in a specific area, state law is sup-

planted to the extent that @ actually conflicts with federal

law—that is, where ‘‘compliance with both federal and state

regulations is a physical impossibility,’’ Florida Lime & Avo-

cado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963), or

where state law ‘‘stands as an obstacle to the accomplishment

and execution of the full purposes and objectives of Con-

gress,’’ Hines v. Davidowitz, 312 U.S. 52, 67 (1941). In this

case, because Congress and the FDA expressed an intent to

preempt state law, there is no need to consider these issues of

implied preemption.

Petitioner is plainly wrong in suggesting that common law

claims brought in state court can never be preempted. As this

Court has stated,

{[RJegulation can be as effectively exerted through an

award of damages as through some form of preventive

relief. The obligation to pay compensation can be,

indeed is designed to be, a potent method of governing

conduct and controlling policy. Even the States’ salutary

effort to redress private wrongs or grant compensation

for past harm cannot be exerted to regulate activities

that are potentially subject to the exclusive federal regu-

latory scheme.

San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236,

247 (1959). See International Paper Co. v. Ouellette, 479

U.S. 481 (1987) (holding that, in the circumstances presented,

a claim for damages and injunctive relief under Vermont’s

common law of nuisance was preempted by the Clean Water

Act). Chicago & N.W. Trans. Co. v. Kalo Brick & Tile Co..,

450 U.S. 311, 326-27 (1981). See also Silkwood v. Kerr-

McGee Corp., supra, 464 U.S. at 256.

B. The Federal Regulatory Scheme at Issue Preempts Dif-

fering or Additional State Law Requirements Concern-

ing the Adequacy of Tampon Warnings

1. Congress and the FDA Intended to Preempt State

Law Where the FDA Promulgates Specific Device

Requirements

In this case, the preemption analysis begins with the 1976

Medical Device Ainendments to the FDCA, 21 U.S.C. § 30!

et seq. According to the Senate Committee Report that

reviewed it, the MDA’s purpose was to encourage the

research and development of increasingly sophisticated and

critically important medical devices, as well as to ensure that

‘‘the FDA has the proper authority to regulate that process

so that Americans are not put at risk from the use of unsafe

and ineffective medical devices.’’ S. Rep. No. 33, 94th

Cong., Ist Sess. (1975), reprinted in 1976 U.S. Code Cong. &

Admin. News 1070, 1071. Congress also sought to ensure

that, once the FDA had addressed an issue of safety or effi-

cacy, a state could not create an undue burden by imposing

other requirements:

The Committee recognizes that if a substantial number

of differing requirements applicable to a medical device

are imposed by jurisdictions other than the Federal gov-

ernment, interstate commerce would be unduly bur-

dened.

H.R. Rep. No. 853, 94th Cong., 2d Sess., at 45 (1976). As

one court stated, Congress intended ‘‘to prohibit, by the doc-

trine of express preemption, the proliferation of multiple,

diverse, state by state requirements.’’ Stewart v. International

Playtex, Inc., 672 F. Supp. 907, 909 (D.S.C. 1987).

Under the MDA, the FDA is authorized to classify medical

devices in three categories, depending upon the sufficiency of

information concerning their safety and efficacy. 21 U.S.C.

§ 360. The MDA delegated to the FDA the power to establish

‘*performance standards’’ with regard to all devices catego-

rized in Class I]. 21 U.S.C. § 360d(a)(1).

The preemptive effect of the FDA performance standards

is established in § 360k(a) of the MDA:

(a) General Rule

Except as provided in subsection (b) of this section, no

State or political subdivision cf a State may establish or

continue in effect with respect to a device intended for

human use any requirement—

(1) which is different froni, or in addition to, any

requirement applicable under this chapter to the

device, and

(2) which relates to the safety or effectiveness of the

device or to any other matter included in a require-

ment applicable to the device under this chapter.

(See Appendix B). A state, or a political subdivision, may

avoid preemption by applying for an exemption pursuant to

§ 360k(b), but that provision is not at issue here because

Washington State has not applied for an exemption as to

state law remedies regarding tampon labelling.

Pursuant to the MDA, the FDA promulgated specific regu-

lations addressing preemption. 21 C.F.R. Part 808. The FDA

regulations provide that

[s]tate or local requirements are preempted only when

the Food and Drug Administration has established spe-

cific counterpart regulations or there are other specific

requirements applicable to a particular device under the

act, thereby making any existing divergent State or local

requirements applicable to the device different from, or

in addition to, the specific Food and Drug Administra-

tion requirements. .. .

21 C.F.R. § 808.1(d) (emphasis added) (See Appendix C).

To the extent that the FDA’s regulations preempt state

law, there is no question that the preemption includes court

decisions. First, as noted above, it is well established that the

preemption doctrine applies to supersede common law claims

brought in state court. San Diego Bldg. Trades Council v.

Garmon, supra, 359 U.S. at 247; International Paper Co. v.

Ouellette, supra, 479 U.S. 481; Chicago & N.W. Trans. Co.

v. Kalo Brick & Tile Co., supra, 450 U.S. at 326-27; Silk-

wood v. Kerr-McGee Corp., supra, 464 U.S. at 256. Second,

the FDA explicitly included court decisions in the ambit of

state requirements that would be preempted by its regula-

tions. 21 C.F.R. § 808.1(b) (Appendix C). In relevant part,

that regulation provides that after the effective date of the

MDA,

no State or political subdivision of a State may establish

Or continue in effect any requirement with respect to a

medical device intended for human use having the force

and effect of law (whether established by statute, ordi-

nance, regulation, or court decision), which is different

from, or in addition to, any requirement applicable to

such device under any provision of the act and which

relates to the safety or effectiveness of the device or to

any other matter included in a requirement applicable to

the device under the act.

(Emphasis added.)

There can be no clearer statement by Congress or the FDA

of an intent to preempt state law—including state tort

claims—with regard to any medical device for which the FDA

establishes specific requirements.

2. The FDA Promulgated Regulations Containing Spe-

cific Requirements Concerning Tampon Warnings,

Thereby Preempting State Law

In February 1980, the FDA classified tampons as Class II

medical devices. 21 C.F.R. §§ 884.5460 and 884.5470 (See

Appendix D). Subsequently, on June 22, 1982, the FDA

promulgated a regulation setting forth specific and manda-

tory labelling requirements regarding the risk of TSS associ-

ated with tampon use. 21 C.F.R. § 801.430 (See Appendix

E). That regulation requires that specific language be

included both in and on every package of tampons, and it

mandates that such warning shall appear prominently and

legibly on the package label.”

2 At the time relevant to this action, that regulation stated in pertinent

part as follows:

be included as a package insert, the following alert statement

Shall appear prominently and legibly on the package label:

Attention: Tampons are associated with Toxic Shock Syn-

drome (TSS). TSS is a rare but serious disease that may cause

death. Read and save the enclosed information.

(d) The consumer information required by this section shail appear

prominently and legibly, in a package insert on the package, in

terms understandable by the layperson and shall/ include state-

ments concerning:

(1)i) Warning signs to TSS, e.g., sudden fever (usually 102° or

more) and vomiting, diarrhea, fainting or near fainting

when standing up, dizziness, or a rash that looks like a

sunburn;

(ii) What to do if these or other signs of TSS appear, includ-

ing the need to remove the tampon at once and seek med-

ical attention immediately;

(2) The risk of TSS to all women using tampons during their

menstrual period, especially the reported higher risks to

There is no question that the FDA’s regulation of tampon

wamings is a ‘‘requirement’’ within the meaning of 21

C.F.R. § 808.1(b) and (d), quoted supra, which provide for

preemption of state or local requirements relating to tampon

labelling. Accordingly, all state law requirements regarding

the adequacy of tampon labelling with respect to TSS warn-

ings, including court decisions, are preempted where the man-

ufacturer has complied with the FDA’s regulations. 21

U.S.C. § 360k(a); 21 C.F.R. § 808.1(b).

C. The Federal Regulatory Scheme Expressly Preempts

Competing Requirements Established by State Product

Liability Law Concerning Tampon Warnings

Petitioner argues that the MDA does not expressly preempt

all state product liability law and hence state tort actions

based on inadequate tampon warnings claims are not pre-

empted. Respondents agree that the MDA does not automati-

cally displace all state tort law. What the MDA does is

women under 30 years of age and teenage girls, the esti-

mated incidence of TSS of 6 to 17 per 100,000 menstruating

women and girls per year, and the risk of death from con-

tracting TSS;

(3) The advisability of using tampons with the minimum absor-

bency needed to control menstrual flow;

(4) Avoiding the risk of getting tampon-associated TSS by not

using tampons, and possibly reducing the risk of getting

TSS by alternating tampon use with sanitary napkin use

during menstrual periods; and

(5) The need to seek medical attention before again using tam-

pons if TSS warning signs have occurred in the past, or if

women have any questions about TSS or tampon use.

(f) Any menstrual tampon that is not labeled as required by this

section and that is initially introduced or initially delivered for

introduction into commerce after December 20, 1982, is mis-

branded pursuant to sections 502(a) and 201(n) of the act.

(Emphasis added.) The FDA has subsequently amended this regula-

tion. A copy of the 1990 amended regulation is produced at Appendix

provide the framework requiring preemption when the FDA

promulgates specific requirements for medical devices. Peti-

tioner’s argument simply ignores the FDA’s specific regula-

tions that do expressly preempt state law claims for tampon

warnings that comply with FDA regulations. It is those regu-

lations, promulgated with proper authority, that mandate

preemption in this case.

Petitioner also ignores the substantial body of law that uni-

formly interprets those precise regulations as preempting state

product liability claims based on the adequacy of tampon

warnings. As the Washington Supreme Court and many other

courts have determined, those regulations reflect the ‘‘expres-

sion of intent to preempt state law.’’ Berger v. Personal

Products, Inc., supra, 115 Wash. 2d at 271, 797 P.2d at

1150. (See also decisions listed in Appendix A.)

Petitioner cannot find support for its position in the lan-

guage or history of either the MDA or the regulations

promulgated thereunder. Unable to find support in the one

statute that governs this case, petitioner turns to other stat-

utes that are not controlling here. Thus petitioner argues that

the legislative history of the 1938 FDCA does not show an

intent to preempt state law. That argument is misplaced. The

relevant statute is the MDA, not the FDCA of 1938. The

FDCA history was superseded in 1976 when Congress enacted

the MDA, which explicitly preempts state law where such law

is inconsistent with FDA regulations. 21 U.S.C. § 360k(a)

(Appendix B). Pursuant to authority conferred by the MDA,

the FDA determined to preempt all competing state regula-

tion, including court decision, by promulgating specific

requirements for medical devices. 21 C.F.R. § 808.1(b)

(Appendix C). The FDA has, in fact, promulgated a detailed

requirement on tampon warnings and instructions. 21 C.F.R.

§ 801.430 (Appendix E). The history of the 1938 FDCA that

petitioner cites has no bearing on the preemptive effect of

regulations promulgated under authority granted by a later

Congress, and this Court should not grant review based on

irrelevant legislative history. See Hillsborough County v.

Automated Medical Laboratories, Inc., supra, 471 U.S. at

714 (suggesting that subsequent history revealing a change in

Congress’ or the FDA’s position supersedes previous history).

Turning even further afield, petitioner also attempts to rely

on the Federal Insecticide, Fungicide and Rodenticide Act

(‘‘FIFRA’’) and a case decided under FIFRA. Ferebee v.

Chevron Chem. Co., 736 F.2d 1529 (D.C. Cir.), cert. denied,

469 U.S. 1062 (1984). That reliance is equally misplaced.

FIFRA established minimum requirements for labeling claims

and it did not preempt a state’s right to set higher standards.

Moreover, FIFRA has its own regulatory and legislative his-

tory, and it is absurd to suggest that the FDA—and this

Court—should be bound by the interpretations of this

entirely different statute. Lastly, a recent Eleventh Circuit

decision expressly rejected Ferebee and held that FIFRA had

implicitly preempted state tort claims based on labelling.

Papas v. The Upjohn Company, No. 89-3752, 1991 U.S.

App. LEXIS 3277 (11th Cir. Feb. 28, 1991). Thus, Ferebee is

not only not on point, but it is also of questionable preceden-

tial value.

In contrast to regulations promulgated under FIFRA,

which set only minimum requirements, the FDA’s regulations

concerning warning requirements on tampon packaging for

TSS are detailed, exacting and exclusive. See, e.g., Stewart v.

International Playtex, Inc., supra, 672 F. Supp. at 910 (dis-

tinguishing Ferebee because of the differences between the

regulatory scheme promulgated under the MDA and regula-

tions dealing with pesticide labelling). Those requirements

dictate the exact language and content of the TSS warnings

which must appear on and in all boxes of tampons. The

Berger decision was correct in finding that competing state

standards cannot stand without imposing an undue burden

on commerce. See H.R. Rep. No. 853, 94th Cong., 2d Sess.,

at 45 (1976) (Congress sought to prevent ‘‘a substantial num-

ber of differing requirements applicable to a medical device

. imposed by jurisdictions other than the Federal govern-

ment’’).

II. There is No Conflict Between Berger and any Other Deci-

sion Warranting this Court’s Review

A. There is No Conflict Among the Appellate Courts

that Have Considered the Preemptive Effect of the

FDA’s Tampon Regulations

The Washington Supreme Court’s decision in Berger is

consistent with the only federal Court of Appeals that has

examined this precise issue. Moore v. Kimberly-Clark Corp..,

supra, 867 F.2d 243. The Berger decision is also consistent

with the only state court of last resort that has considered

this issue. Poloney v. Tambrands, Inc., 399 S.E.2d 208 (Ga.

1991). Both Moore and Poloney hold that where a manufac-

turer complies with federal regulations concerning warnings

for TSS on tampon packaging, state law for inadequate

warnings is preempted by federal law. Thus, there is no con-

flict between the Berger decision and any decision from a

federal Court of Appeals or a state court of last resort war-

ranting this Court’s review.

In addition, thirty-five other federal district courts and

lower state courts have also considered this issue; thirty-three

have found that the federal regulations preempt state law

concerning the adequacy of the TSS warnings on tampon

packages. (See decisions listed in Appendix A.)

Of the thirty-eight decisions that have addressed the issue,

only two lower court decisions, both unpublished, have held

that the federal scheme does not preempt state law regarding

tampon warnings. Neither decision is well-reasoned.’ More-

3 One of those cases, Muzatko v. International Playtex, Inc., No. 85-

C 1540 (E.D. Wis. May 14, 1987), relied on O’Gilvie v. International

Playtex, Inc., 821 F.2d 1428 (10th Cir. 1987), cert. denied, 486 U.S.

1032 (1988), which did not even address this issue. See infra p. 15.

Thus, it is utterly unpersuasive. See Berger v. Personal Products, Inc.,

supra, 115 Wash. 2d at 274-75, 797 P.2d at 1151-52; Jgnace v. Interna-

tional Playtex, Inc., No. 86-C-480C, slip op. at 13, n.S (W.D. Wis.

Aug. 14, 1987); Lavetter v. International Playtex, 706 F. Supp. 722,

over, these two aberrational decisions cannot be considered a

conflict in the face of thirty-six consistent decisions.‘ It is

thus easy to understand why petitioner did not address either

decision.

B. Other Cites that Petitioner Relies Upon Fail to Create a

Conflict with the Berger Decision

Petitioner ignores the consistent body of cases that have

considered FDA regulations covering tampons and TSS, and

instead attempts to invoke this Court’s discretionary review

723 (D. Ariz. 1988); Stucker v. International Playtex, Inc., No. C87-

0440-L(B), slip op. at 5-6 (W.D. Ky. Feb. 26, 1988). In addition,

Muzatko has not been followed by any subsequent court, including

two sitting in the same state. See Ignace v. International Playtex, Inc.,

supra, No. 86-C-480C; Mishlove v. Herman, M.D., No. 009-450 (Cir.

Ct. Milwaukee Co. Wis. Nov. 29, 1989). See also Bowden v. Tam-

brands, Inc., No. 85L 21095 (Cir. Ct. Cook Co. Ill. July 9, 1990)

(declining to follow Muzatko).

The court in the other decision, Kerns v. International Playtex, Inc.,

No. C-1-86-297, slip op. at 2 (S.D. Ohio Apr. 15, 1988), denied partial

summary judgment on the issue of TSS warning stating that, because

other issues remained open in the case, ‘‘[t}he granting of a partial

summary judgment, in view of the ciffering judicial decisions, would

lend little to a just final determination of this dispute among the par-

ties and, as a practical matter, would not shorten the trial or lessen the

parties’ obligation to present evidence.’’ This is not a reasoned opin-

ion, and no court has followed it.

4 Even if the two district court decisions were inconsistent with the

Berger decision, they would not create a conflict so as to warrant this

Court’s discretionary jurisdiction. See Sup. Ct. R. 10.1(b) (indicating

that this Court will not generally grant jurisdiction unless a decision

from a state court of last resort on a federal question ‘‘conflicts with

the decision of another state court of last resort or of a United States

court of appeals’’). See also Forsyth v. Hammond, 166 U.S. 506, 513-

15 (1897) (per Brewer, J.) (stating that this Court’s certiorari jurisdic-

tion ‘‘is a power which will be sparingly exercised, and only when the

circumstances of the case satisfy us that the importance of the question

involved, the necessity of avoiding conflict between two or more

Courts of Appeal, or between Courts of Appeal and the courts of a

State, or some matter affecting the interests of this nation in its inter-

nal or external relations, demands such exercise’).

relying on two inapposite decisions involving hearing aid reg-

ulations. In Smith v. Pingree, 651 F.2d 1021 (Sth Cir. 1981),

and New Jersey Guild of Hearing Aid Dispensers v. Long, 75

N.J. 544, 384 A.2d 795 (1978), the courts held that state laws

governing the dispensing and fitting of hearing aids were not

preempted by FDA regulations. Neither of those decisions are

applicable here because the FDA had not promulgated spe-

cific requirements in those areas. Smith v. Pingree, supra,

651 F.2d at 1021, 1025; New Jersey Guild of Hearing Aid

Dispensers v. Long, supra, 384 A.2d at 811-12.

The Fifth Circuit in Moore v. Kimberly-Clark Corp.,

supra, 867 F.2d at 246-47, found this distinction to be critical

in a case involving the preemptive effect of the FDA’s regula-

tion concerning tampon warnings. It held that, unlike the

hearing aid regulations at issue in Smith, state law claims

based on inadequate tampon labelling and warnings concern-

ing TSS were preempted because the FDA had promulgated

specific requirements controlling tampon warnings.

Petitioner next attempts to create a conflict between Berger

and a Tenth Circuit decision that affirmed a jury verdict in a

TSS case. O’Gilvie v. International Playtex, Inc., supra, 821

F.2d 1428. However, as the Washington Supreme Court and

other courts have recognized, the issue of preemption was not

raised in that case. Berger v. Personal Products, Inc., supra,

115 Wash. 2d at 275, 797 P.2d at 1152; Stewart v. Interna-

tional Playtex, Inc., supra, 672 F. Supp. at 910; Lavetter v.

International Playtex, supra, 706 F. Supp. 722. The O’Gilvie

decision is not on point and does not conflict with the hold-

ing in Berger.

Petitioner also asserts that there is a conflict between

Berger and letters written by FDA staff members. Resort to

such communications highlights the inherent lack of merit in

the petition. According to FDA regulations, any opinion ren-

dered by a staff member of the FDA ‘‘does not uecessarily

represent the formal position of the FDA, and does not bind

or otherwise obligate or commit the agency to the views

expressed.”’ 21 C.F.R. § 10.85(k). Moreover, these letters

merely state that general tort remedies are not preempted by

the MDA. Regardless of petitioner’s attempts to stretch these

letters, they do not conflict with the Washington Supreme

Court’s decision—indeed, these letters do not even address

the preemptive effect of the specific requirements regulating

tampon warnings.

Similarly, an FDA advisory opinion offered by petitioner,

see Petitioner’s Appendix at 17a-18a, fails to create a con-

flict. That opinion merely states that state law Temedies avail-

able to those injured by Dalkon shield IUDs marketed before

the MDA was passed are not preempted by the subsequent

passage of the MDA. Rather than supporting the petitioner,

this advisory opinion aids the respondents by emphasizing

that state law requirements are preempted ‘‘when FDA has

established specific counterpart regulations or there are other

specific requirements applicable to a particular device or class

of devices under the act. . . .”? Pet. Appendix at 18a.°

Finally, contrary to petitioner’s claims, the Berger decision

is consistent with this Court’s opinion in Silkwood v. Kerr-

McGee Corp., supra, 464 U.S. 238. Ia that decision, this

Court found that Congress had not intended to preempt state

law remedies that were available to those injured by nuclear

incidents. In reaching this conclusion, this Court relied on the

legislative history of the Price-Anderson Act, in which Con-

gress specifically considered the survival of state law remedies

for those who are injured by nuclear accidents. Jd. at 252.

The Court held that the state law remedies were not pre-

empted because the possibility of conflict created by a state

decision ‘‘was something that Congress was quite willing to

accept.’’ Jd. at 256.

Unlike the legislative intent at issue in Si/kwood, both Con-

gress and the FDA have expressed a clear intent in the MDA

and in the regulations promulgated thereunder to preempt

5 In support of this clearly correct interpretation, respondents have

attached to this brief as Appendix G a letter written by the FDA’s

Chief Counsel attesting that the question of preemption depends upon

the circumstances of each particular case.

state law claims with regard to requirements established for

medical devices. Thus, there is no conflict between Si/kwood

and Berger.

” * .

The Washington State Supreme Court and thirty-five other

courts have agreed that where a manufacturer complies with

detailed federal regulations, state tort claims based on the

adequacy of tampon warnings are expressly preempted by

federal law. This uniform view is consistent with this Court’s

preemption decisions. None of the appellate courts that have

analyzed the issue have reached a contrary conclusion, nor

could a contrary conclusion be reached upon consideration of

the statutory and regulatory schemes. Accordingly, there is

no reason for this Court to grant the petition.

CONCLUSION

For all reasons set forth above, the petition for Writ of

Certiorari should be denied.

Of Counsel:

PATTERSON, BELKNAP,

WEBB & TYLER

Lisa C. Cohen

30 Rockefeller Plaza

New York, New York 10112

(212) 698-2500

ARTER & HADDEN

George Gore

Victoria L. Vance

Irene Keyse-Walker

1100 Huntington Building

Cleveland, Ohio 44115

(216) 696-1100

Respectfully submitted,

DAVID F. DOBBINS

30 Rockefeller Plaza

New York, New York 10112

(212) 698-2500

Counsel of Record for

Respondents

APPENDICES

A-l

Courts Finding Preemption of State Law Claims

Regarding Tampon Warnings

FEDERAL COURT OF APPEALS

Moore v. Kimberly-Clark Corp., 867 F.2d 243 (Sth Cir.

198°)

DISTRICT COURTS

10.

12.

Ignace v. International Playtex, Inc., No. 86-C-480C

(W.D. Wis. Aug. 14, 1987)

. Edmondson v. International Playtex, Inc., 678 F. Supp.

1571 (N.D. Ga. 1987)

. Stewart v. International Playtex, Inc., 672 F. Supp. 907

(D.S.C. 1987)

. Perrotta v. International Playtex, Inc., No. 86-8099-CIV-

KEHOE (S.D. Fla. Nov. 9, 1987)

. Moore v. Kimberly-Clark Corp., 676 F. Supp. 731 (W.D.

La. 1987), aff’d in part and rev’d in part, 867 F.2d 243

(Sth Cir. 1989)

. Lavetter v. International Playtex, Inc., 706 F. Supp. 722

(D. Ariz. 1988)

. Stucker v. International Playtex, Inc., No. C-87-0440-

L(B) (W.D. Ky. Feb. 26, 1988), rev’d on other grounds,

865 F.2d 261 (6th Cir. 1988)

. Briggs v. International Playtex, Inc., No. 86C-540-E

(N.D. Okla. Apr. 7, 1988)

Rinehart v. International Playtex, Inc., 688 F. Supp. 475

(S.D. Ind. 1988)

. Needham v. International Playtex, Inc., No. 87-152

(E.D. Ky. Oct. 25, 1988), aff’d on reconsideration, 1989

U.S. Dist. LEXIS 800 (Jan. 26, 1989)

Gilbert v. Kimberly-Clark Corp., No. 87-C-470-E {N.D.

Okla. Nov. 4, 1988)

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

A-2

Meyer v. International Playtex, Inc., 724 F. Supp. 288

(D.N.J. 1988)

Jones v. Tambrands, Inc., No. C87-0102 (N.D. lowa

Dec. 2, 1988)

Cornelison v. Tambrands, Inc., 710 F. Supp. 706 (D.

Minn. 1989)

Bejarano v. International Piaytex, Inc., 750 F. Supp. 443

(D. Idaho 1989)

Parrott v. International Playtex, Inc., No. SA CV 88-491

JSL (RWRx) (C.D. Cal. May 15, 1989)

Lindquist v. Tambrands, Inc., 721 F. Supp. 1058 (D.

Minn. 1989)

Rockett v. International Playtex, Inc., No. 87-2870

(W.D. La. Oct. 2, 1989)

Chapman v. Playtex FP, Inc., No. 89-0718-LC (W.D.

La. Nov. 17, 1989)

Krause v. Kimberly-Clark Corp., 749 F. Supp. 164

(W.D. Mich. 1990)

Northrip v. International Playtex, Inc., 750 F. Supp. 402

(W.D. Mo. 1990)

STATE COURTS

23.

24.

25.

26.

27.

Berger v. Personal Products, Inc., 115 Wash. 2d 267, 797

P.2d 1148 (Wash. 1990)

Poloney v. Tambrands, Inc., 399 S.E.2d 208 (Ga. 1991)

Craig v. Kimberly-Clark Corp., No. 86-2-14780-2 (Sup.

Ct. King Co. Wash. Sept. 15, 1988)

Eason v. Tambrands, Inc., No. 87-11677-A (Dist. Ct.

Dallas Co. Tex. Nov. 29, 1988)

Laughlin v. Kimberly-Clark Corp., No. 17715 T.D.-1

(Cir. Ct. Memphis, Tenn. Dec. 7, 1988)

28.

29.

30.

ai.

32.

33.

34.

35.

36.

37.

38.

A-3

Case v. International Playtex, Inc., No. C 607960 (Sup.

Ct. Maricopa Co. Ariz. Jan. 23, 1989)

Berry v. Tambrands, Inc., Nos. 193692, 193724 (Sup. Ct.

Kern Co. Cal. Feb. 27, 1989)

Berger v. Personal Products, Inc., No. 86-2-01249-3

(Sup. Ct. Yakima Co. Wash. Mar. 14, 1989) (Memoran-

dum Opinion), aff’d, 115 Wash. 2d 267, 797 P.2d 1148

(1990)

Remer v. Tampax, Inc., No. 578755 (Sup. Ct. San Diego

Co. Cal. May 10, 1989)

Aase v. Tambrands, Inc., No. 68108 (Dist. Ct. Kootenai

Co. Idaho Aug. 24, 1989)

Mishlove v. Herman, M.D., No. 009-450 (Cir. Ct. Mil-

waukee Co. Wis. Nov. 29, 1989)

Poloney v. Tambrands, Inc., No. 88-1-1084-10 (Sup. Ct.

Cobb Co. Ga. Apr. 16, 1990), aff’d, 399 S.E.2d 208 (Ga.

1991)

Bowden v. Tambrands, Inc., No. 85 L 21095 (Cir. Ct.

Cook Co. Ill. July 9, 1990)

Byrne v. International Playtex, Inc., No. 86309 (Nine-

teenth Jud. Cir. Va. July 24, 1990) (Letter Ruling)

Joliff-Smith v. Tambrands, Inc., No. 165928 (Sup. Ct.

Sonoma Co. Cal. Nov. 7, 1990)

Platts v. Tambrands, Inc., No. 901712 (Sup. Ct. San

Francisco Co. Cal. Jan. 16, 1991)

B-1

FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C.

§ 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no

State or political subdivision of a State may establish or con-

tinue in effect with respect to a device intended for human

use any requirement—

(1) which is different from, or in addition to, any

requirement applicable under this chapter to the device,

and

(2) which relates to the safety or effectiveness of the

device or to any other matter included in a requirement

applicable to the device under this chapter.

(b) Exempt requirements

Upon application of a State or a political subdivision

thereof, the Secretary may, by regulation promulgated after

notice and opportunity for.an oral hearing, exempt from sub-

section (a) of this section, under such conditions as may be

prescribed in such regulation, a requirement of such State or

political subdivision applicable to a device intended for

human use if—

(1) the requirement is more stringent than a require-

ment under this chapter which would be applicable to

the device if an exempiion were not in effect under this

subsection; or

(2) the requirement —

(A) is required by compelling local conditions,

and

(B) compliance with the requirement would not

cause the device to be in violation of any applica-

ble requirement under this chapter.

(June 25, 1938, c. 675, § 521, as added May 28, 1976, Pub.L.

94-295, § 2, 90 Stat. 574.)

C-1

FOOD AND DRUGS, 21 CFR Ch. 1

PART 808—EXEMPTIONS FROM FEDERAL PRE-

EMPTION OF STATE AND LOCAL MEDICAL DEVICE

REQUIREMENTS

* * *

Subpart A—General Provisions

§ 808.1 Scope

(a) This part prescribes procedures for the submission,

review, and approval of applications for exemption from

Federal preemption of State and local requirements applica-

ble to medical devices under section 521 of the act.

(b) Section $21(a) of the act contains special provisions

governing the regulation of devices by States and localities.

That section prescribes a general rule that after May 28,

1976, no State or political subdivision of a State may estab-

lish or continue in effect any requirement with respect to a

medical device intended for human use having the force and

effect of law (whether estab)’shed by statute, ordinance, regu-

lation, or court decision), which is different from, or in addi-

tion to, any requirement applicable to such device under any

provision of the act and which relates to the safety or effec-

tiveness of the device or to any other matter included in a

requirement applicable to the device under the act.

the Commissioner of Food and Drugs may, upon application

by a State or political subdivision, allow imposition of a

requirement which is different from, or in addition to, any

requirement applicable under the act to the device (and which

is thereby preempted) by promulgating a regulation in

accordance with this part exempting the State or local

requirement from preemption. The granting of an exemption

does not affect the applicability to the device of any require-

ments under the act. The Commissioner may promulgate an

C-2

exemption regulation for the preempted requirement if he

makes either of the following findings:

(1) That the requirement is more stringent than a require-

ment under the act applicable to the device; or

(2) That the requirement is required by compelling local

conditions and compliance with the requirement would not

cause the device to be in violation of any applicable require-

ment under the act.

(d) State or local requirements are preempted only when

the Food and Drug Administration has established specific

counterpart regulations or there are other specific require-

ments applicable to a particular device under the act, thereby

making any existing divergent State or local requirements

applicable to the device different from, or in addition to, the

specific Food and Drug Administration requirements. There

are other State or local requirements that affect devices that

are not preempted by section 521(a) of the act because they

are not ‘‘requirements applicable to a device’’ within the

meaning of section 521(a) of the act. The following are exam-

ples of State or local requirements that are not regarded as

preempted by section 521 of the act:

(1) Section 521(a) does not preempt State or local require-

ments of general applicability where the purpose of the

requirement relates either to other products in addition to

devices (e.g., requirements such as general electrical codes,

and the Uniform Commercial Code (warranty of fitness)), or

to’unfair trade practices in which the requirements are not

limited to devices.

(2) Section 521(a) does not preempt State or local require-

ments that are equal to, or substantially identical to, require-

ments imposed by or under the act.

(3) Section 521(a) does not preempt State or local permits,

licensing, registration, certification, or other requirements

relating to the approval or sanction of the practice of medi-

cine, dentistry, optometry, pharmacy, nursing, podiatry, or

any other of the healing arts or allied medical sciences or

C-3

related professions or occupations that administer, dispense,

or sell devices. However, regulations issued under section

520{e) or (g) of the act may impose restrictions on the sale,

distribution, or use of a device beyond those prescribed in

State or local requirements. If there is a conflict between

such restrictions and State or local requirements, the Federal

regulations shall prevail.

(4) Section 521(a) does not preempt specifications in con-

tracts entered into by States or localities for procurement of

devices.

(5) Section 521(a) does not preempt criteria for payment of

State or local obligations under Medicaid and similar Federal,

State or local health-care programs.

(6)(i) Section 521{a) does not preempt State or local

requirements respecting general enforcement, e.g., require-

ments that State inspection be permitted of factory records

concerning all devices, registration, and licensing require-

ments for manufacturers and others, and prohibition of man-

ufacture of devices in unlicensed establishments. However,

Federal regulations issued under sections 519 and 520(f) of

the act may impose requirements for records and reports and

good manufacturing practices beyond those prescribed in

State or local requirements. If there is a conflict between

such regulations and State or local requirements, the Federal

regulations shall prevail.

(ii) Generally, section 521(a) does not preempt a State or

local requirement prohibiting the manufacture of adulterated

or misbranded devices. Where, however, such a prohibition

has the effect of establishing a substantive requirement for a

specific device, e.g., a specific labeling requirement, then the

prohibition will be preempted if the requirement is different

from, or in addition to, a Federal requirement established

under the act. In determining whether such a requirement is

preempted, the determinative factor is how the requirement is

interpreted and enforced by the State or local government

and not the literal language of the statute, which may be

identical to a provision in the act.

C-4

(7) Section 521(a) does not preempt State or local provi-

sions respecting delegations of authority and related adminis-

trative matters relating to devices.

(8) Section 521(a) does not preempt a State or local

requirement whose sole purpose is raising revenue or charging

fees for services, registration, or regulatory programs.

(9) Section 521(a) does not preempt State or local require-

ments of the types that have been developed under the

Atomic Energy act of 1954 (42 U.S.C. 2011 note), as

amended, the Radiation Control for Health and Safety Act

of 1968 (Pub. L. 90-602 (42 U.S.C. 263b et seqg.)) and other

Federal statutes, until such time as the Food and Drug

Administration issues specific requirements under the Federal

Food, Drug, and Cosmetic Act applicable to these types of

devices.

(e) It is the responsibility of the Food and Drug Adminis-

tration, subject to review by Federal courts, to determine

whether a State or local requirement is equal to, or substan-

tially identical to, requirements imposed by or under the act,

or is different from, or in addition to, such requirements, in

accordance with the procedures provided by this part. How-

ever, it is the responsibility of States and political subdivi-

sions to determine initially whether to seek exemptions from

preemption. Any State or political subdivision whose require-

ments relating to devices are preempted by section 521(a) may

petition the Commissioner of Food and Drugs for exemption

from preemption, in accordance with the procedures provided

by this part.

(f) The Federal requirement with respect to a device

applies whether or not a corresponding State or local require-

ment is preempted or exempted from preemption. As a

result, if a State or local requirement that the Food and Drug

Administration has exempted from preemption is not as

broad in its application as the Federal requirement, the Fed-

eral requirement applies to all circumstances not covered by

the State or local requirement.

[43 FR 18665, May 2, 1978, as amended at 45 FR 67336,

Oct. 10, 1980]

D-1

FOOD AND DRUGS, 21 CFR Ch. 1

§ 884.5460 Scented menstrual tampon.

(a) Identification. A scented menstrual tampon is a

device that is a plug made of cellulosic or synthetic material

that is inserted into the vagina and used to absorb menstrual

or other vaginal discharge. It has scent (i.e., fragrance mate-

rials) added for aesthetic purposes. This generic type of

device does not include menstrual tampons treated with

added antimicrobial agents or other drugs.

(b) Classification. Class II] (performance standards).

§ 884.5470 Unscented menstrual tampon.

(a) Identification. An unscented menstrual tampon is a

device that is a plug made of cellulosic or synthetic material

that is inserted into the vagina and used to absorb menstrual

or other vaginal discharge. This generic type of device does

not include menstrual tampons treated with scent (i.e., fra-

grance materials) or those with added antimicrobal agents or

other drugs.

(b) Classification. Ciass I] (performance standards).

ine

A |

E-]

FOOD AND DRUGS, 21 CFR Ch. 1

§ 801.430 User labeling for menstrual tampons.

(a) This section applies to scented or scented deodorized

menstrual tampons as identified in § 884.5460 and unscented

menstrual tampons as identified in § 884.5470 of this chapter.

(b) Available data show that toxic shock syndrome (TSS),

a rare but serious and sometimes fatal disease, is associated

with the use of menstrual tampons. To protect the public and

to minimize the serious adverse effects of TSS, menstrual

tampons shall be labeled as set forth in paragraphs (c) and

(d) of this section.

section is to be included as a package insert, the following

alert statement shall appear prominently and legibly on the

package label:

Attention: Tampons are associated with Toxic Shock

Syndrome (TSS). TSS is a rare but serious disease that

may cause death. Read and save the enclosed informa-

tion.

(d) The consumer information required by this section

shall appear prominently and legibly, in a package insert or

on the package, in terms understandable by the layperson

and shall include statements concerning:

(1)(i) Warning signs of TSS, e.g., sudden fever (usually

102° or more) and vomiting, diarrhea, fainting or near faint-

ing when standing up, dizziness, or a rash that looks like a

sunburn;

(ii) What to do if these or other signs of TSS appear,

including the need to remove the tampon at once and seek

medical attention immediately;

(2) The risk of TSS to all women using tampons during

their menstrual period, especially the reported higher risks to

women under 30 years of age and teenage girls, the estimated

E-2

incidence of TSS of 6 to 17 per 100,000 menstruating women

and girls per year, and the risk of death from contracting

TSS;

(3) The advisability of using tampons with the minimum

absorbency needed to control menstrual flow;

(4) Avoiding the risk of getting tampon-associated TSS by

not using tampons, and possibly reducing the risk of getting

TSS by alternating tampon use with sanitary napkin use dur-

ing menstrual periods; and

(5) The need to seek medical attention before again using

tampons if TSS warning signs have occurred in the past, or if

women have any questions about TSS or tampon use.

(e) Any menstrual tampon dispensed by a vending machine

is exempt from the requirements of this section.

(f) Any menstrual tampon that is not labeled as required

by this section and that is initially introduced or initially

delivered for introduction into commerce after December 20,

1982, is misbranded pursuant to sections 502(a) and 20i(n) of

the act.

F-1

FOOD AND DRUGS, 21 CFR Ch. 1

§ 801.430 User labeling for menstrual tampons.

(a) This section applies to scented or scented deodorized

menstrual tampons as identified in § 884.5460 and unscented

menstrual tampons as identified in § 884.5470 of this chapter.

(b) Data show that toxic shock syndrome (TSS), a rare but

serious and sometimes fatal disease, is associated with the use

of menstrual tampons. To protect the public and to minimize

the serious adverse effects of TSS, menstrual tampons shall

be labeled as set forth in paragraphs (c), (d), and (e) of this

section and tested for absorbency as set forth in paragraph

(f) of this section.

section is to be included as a package insert, the following

alert statement shall appear prominently and legibly on the

package label:

ATTENTION: Tampons are associated with Toxic

Shock Syndrome (TSS). TSS is a rare but serious disease

that may cause death. Read and save the enclosed infor-

mation.

(d) The labeling of menstrual tampons shall contain the

following consumer information prominently and legibly, in

such terms as to render the information likely to be read and

understood by the ordinary individual under customary con-

ditions of purchase and use:

(1)(i) Warning signs of TSS, e.g., sudden fever (usually

102° or more) and vomiting, diarrhea, fainting or near faint-

ing when standing up, dizziness, or a rash that looks like a

sunburn;

(ii) What to do if these or other signs of TSS appear,

including the need to remove the tampon at once and seek

medical attention immediately;

(2) The risk of TSS to all women using tampons during

their menstrual period, especially the reported higher risks to

F-2

women under 30 years of age and teenage girls, the estimated

incidence of TSS of 1 to 17 per 100,000 menstruating women

and girls per year, and the risk of death from contracting

TSs;

(3) The advisability of using tampons with the minimum

absorbency needed to control menstrual flow in order to

reduce the risk of contracting TSS;

(4) Avoiding the risk of getting tampon-associated TSS by

not using tampons, and reducing the risk of getting TSS by

alternating tampon use with sanitary napkin use during men-

strual periods; and

(5) The need to seek medical attention before again using

tampons if TSS warning signs have occurred in the past, or if

women have any questions about TSS or tampon use.

(e) The statements required by paragraph (e) of this section

shall be prominently and legibly placed on the package label

of menstrual tampons in conformance with section 502(c) of

the Federal Food, Drug, and Cosmetic Act (the act) (unless

the menstrual tampons are exempt under paragraph (g) of

this section).

(1) Menstrual tampon package labels shall bear one of the

following absorbency terms representing the absorbency of

the production run, lot, or batch as measured by the test

described in paragraph (f)(2) of this section;

Ranges of absorbency in _ Corresponding term of

grams' absorbency

6 OMG WEEE 2 Blow ccncss Junior absorbency.

PP eau ecuncinchaveaveee Regular absorbency.

cls bbs de kew wees es Super absorbency.

Cakinadwandeeaawes Super plus absorbency.

SME 634444540440600 80% None.

Es co bv yan beadi wah None.

‘These ranges are defined, respectively, as follows: less than or equal to 6 grams;

greater than 6 grams up to and including 9 grams; greater than 9 grams up to and

including 12 grams; greater than 12 grams up to and including 15 grams; greater

“than 15 grams up to and including 18 grams; and greater than 18 grams.

= F-3

(2) The package label shall include an explanation of the

ranges of absorbency and a description of how consumers

can use a range of absorbency, and its corresponding absor-

bency term, to make comparisons of absorbency of tampons

with the minimum absorbency needed to control menstrual

flow in order to reduce the risk of contracting TSS.

(f) A manufacturer shall measure the absorbency of indi-

vidual tampons using the test method specified in paragraph

(f)(2) of this section and calculate the mean absorbency of a

production run, lot, or batch by rounding to the nearest 0.1

gram.

(1) A manufacturer shall design and implement a sampling

plan that includes collection of probability samples of ade-

quate size to yield consistent tolerance intervals such that the

probability is 90 percent that at least 90 percent of the absor-

bencies of individual tampons within a brand and type are

within the range of absorbency stated on the package label.

(2) In the absorbency test, an unlubricated condom, with

tensile strength between 17 Mega Pascals (MPa) and 30 MPa,

as measured according to the procedure in the American

Society for Testing and Materials (ASTM), D 3492-83,

‘Standard Specification for Rubber Contraceptives (Con-

doms)’’’ for determining tensile strength, which is incorpo-

rated by reference in accordance with 5 U.S.C. 552(a), is

attached to the large end of a glass chamber with a rubber

band (see Figure 1) and pushed through the small end of the

chamber using a smooth, finished rod. The condom is pulled

through until all slack is removed. The tip of the condom is

cut off and the remaining end of the condom is stretched

over the end of the tube and secured with a rubber band. A

preweighed (to the nearest 0.01 gram) tampon is placed

within the condom membrane so that the center of gravity of

the tampon is at the center of the chamber. An infusion

1 Copies of the standard are available from the American Society for

Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or available

for inspection at the Office of the Federal Register, 1100 L St., N.W., Wash-

ington, DC.

F-4

needle (14 guage) is inserted through the septum created by

the condom tip until it contacts the end of the tampon. The

outer chamber is filled with water pumped from a

temperature-controlled waterbath to maintain the average

temperature at 27+1 °C. The water returns to the waterbath

as shown in Figure 2. Syngyna fluid (10 grams sodium chlo-

ride, 0.5 gram Certified Reagent Acid Fuchsin, 1,000 millili-

ters distilled water) is then pumped through the infusion

needle at a rate of 50 milliliters per hour. The test shall be

terminated when the tampon is saturated and the first drop

of fluid exits the apparatus. (The test result shall be discarded

if fluid is detected in the folds of the condom before the tam-

pon is saturated). The water is then drained and the tampon

is removed and immediately weighed to the nearest 0.01

gram. The absorbency of the tampon is determined by sub-

tracting its dry weight from this value. The condom shall be

replaced after 10 tests or at the end of the day during which

the condem is used in testing, whichever occurs first.

(3) The Food and Drug Administration may permit the use

of an absorbency test method different from the test method

specified in this section if each of the following conditons is

met:

(i) The manufacturer presents evidence, in the form of a

citizen petition submitted in accordance with the requirements

of § 10.30 of this chapter, demonstrating that the alternative

test method will yield results that are equivalent to the results

yielded by the test method specified in this section; and

(ii) FDA approves the method and has published notice of

its approval of the alternative test method in the FEDERAL

(g) Any menstrual tampon intended to be dispensed by a

vending machine is exempt from the requirements of this sec-

tion.

(h) Any menstrual tampon that is not labeled as required

by paragraphs (c), (d), and (e) of this section and that is ini-

tially introduced or initially delivered for introduction into

F-5

commerce after March 1, 1990, is misbranded under sections

201(n), 502 (a) and (f) of the act.

(Information collection requirements contained in paragraphs

(e) and (f) were approved by the Office of Management and

Budget under control number 0910-0257)

[47 FR 26989, June 22, 1982, as amended at 54 FR 43771,

Oct. 26, 1989)

[GRAPHS OMITTED]

G-]

[LETTERHEAD OF

DEPARTMENT OF HEALTH & HUMAN SERVICES]

February 20, 1987

Stephen M. McNamara, Esq.

Hyman, Phelps & McNamara, P.C.

1120 G Street, N.W.

Washington, D.C. 20009

Dear Mr. McNamara:

In a meeting today, you brought to my attention an affida-

vit from Marlys A. Marshall recounting a communication

between her and Ms. Beverly Rothstein of my office. The

affidavit has been submitted in connection with a lawsuit

entitled Edmondson v. International Playtex, Inc. You have

requested that I comment on the affidavit. After discussing

the affidavit with Ms. Rothstein, I have the following com-

ment.

Ms. Rothstein’s statements pertained to the general issue of

whether common law liability for damages for injury would

be considered to be a requirement with respect to a medical

device within the meaning of 21 U.S.C. § 360k(a) based on

prior rulings of the Food and Drug Administration in related

situations and did not state what the Food and Drug Admin-

istration would officially conclude were it to consider the

question in the context of a petition for an advisory opinion.

Ms. Rothstein supplied the March 8, 1984, letter from Mr.

Paul Hile of FDA to Mr. Robert E. Manchester of the

National Women’s Health Network to Ms. Marshall as a

statement of the agency’s position on the specific issue

addressed in that letter and conveyed the view that if asked

to respond officially on the same type of issue in the future,

the agency’s position would be consistent. Obviously, what

would be consistent would depend on the specific circum-

stances described. Moreover, although it is generally the case

that the agency’s interpretations remain uniform over time, it

is obviously not possible for a member of the Office of the

Chief Counsel to guarantee a specific outcome in a particular

case, and certainly no firm prediction would ever be made by

G-2

a member of the Office of the Chief Counsel during a casual

telephone conversation. It was specifically for that reason

that Ms. Rothstein suggested to Ms. Marshall that Ms. Mar-

shall submit a petition for an advisory opinion on the specific

issue Ms. Marshall raised.

I should also note that a sentence that includes a reference

to the ‘‘Chief Counsel’? on page 17 of a memorandum (of

which you gave me pages 16-17) is erroneous in two respects.

Ms. Rothstein was not providing an ‘‘informal opinion’’

(other than in the sense that any statement that is not about

facts is an opinion) but was providing assistance to someone

wanting information, and Ms. Rothstein was not speaking as

the Chief Counsel, but as an Associate Chief Counsel.

According to Ms. Rothstein, Ms. Marshall did not state

that Ms. Rothstein’s views would be incorporated in an affi-

davit and submitted in litigation in substitution for an official

FDA opinion: Ms. Marshall stated that she was doing

research and needed assistance.

I understand that you may use this letter in connection

with the litigation and you have my permission to do so.

Sincerely yours,

/s/ THOMAS SCARLETT

Thomas Scarlett

Chief Counsel

Food and Drug Administration

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This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.