Petition for Writ of Certiorari — McNeil-P.P.C., Inc. v. Valdes

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Supreme Court, U.S.

FILED

No. 10-(/29 NY 30 2010

in THE OFFICE OF THE CLERK

Supreme Court of the United States

ae ie

McNEIL—P.P.C., INC.,

Petitioner,

ARMANDO VALDES, III, incapacitated, by and through his

legal guardians, ARMANDO VALDES, JR. and VIOLETTA VALDES,

and ARMANDO VALDES, JR. and VIOLETTA VALDES, individually,

Respondents.

ON PETITION FOR WRIT OF CERTIORARE TO ‘THE DISTRICT COURT

OF APPEAL OF FLORIDA, THIRD DISTRICT

PETITION FOR WRIT OF CERTIORARI

BARRY L. DAVIS

Counsel of Record

KATHLEEN M. O’CONNOR

HOLLY S. HARVEY

THORNTON, DAVIS & FEIN, P.A.

Brickell BayView Centre,

Suite 2900

80 S.W. 8th Street

Miami, Florida 33130

(305) 446-2646

davis@tdflaw.com

Attorneys for Petitioner

QUESTION PRESENTED

Over-the-counter (“OTC”) drug products that

comply with all mandatory conditions described in

a “inal Monograph” are recognized as “safe and

effective and not misbranded.” 21 C.F.R § 330.1.

The specific warnings for all OTC Final Mono

yraph drugs are authored by the Food and Drug

Administration (“FDA”), and codified into law. /d.

Warnings “shall be in the exact language” estab-

lished in an applicable OTC Final Monograph. 21

C.FLR. § 3830.1(c)(2). The Federal Food, Drug, and

Cosmetic Act “FDCA”) section entitled “National]

Uniformity for Nonprescription Drugs” provides

that no state may establish any requirement that

is “different from or in addition to, or that 1s oth-

erwise not identical with,” a requirement of the

FDCA. 21 U.S.C. § 379r.

The question presented is whether federal law,

which imposes a strict set of labeling require-

ments on manufacturers of Final Monograph OTC

drugs, including mandatory product warnings

authored by the FDA, pre-empts state-law product

liability actions premised on theories of failure to

Warn.

LIST OF ALL PARTIES

Appellants in the Court Below

Armando Valdes. III, Incapacitated, by and

through his legal guardians, Armando Valdes,

Jr, and Violetta Valdes:

Armando Valdes, Individually

Violetta Valdes. Individually

Appellee in the Court Below

McNeil P.P.C. Ine.

CORPORATE DISCLOSURE STATEMENT

MeNeil—P.P.C., Ine. is a wholly owned sub

sidiary of Johnson & Johnson

TABLE OF CONTENTS

QUESTION PRESENTED ..

LIST OF ALL PARTIES....

CORPORATE DISCLOSURE

STATEMENT

TABLE OF CONTENTS..

TABLE OF APPENDICES

TABLE OF CITED AUTHORITIES

OPINIONS BELOW ...

JURISDICTION

PERTINENT CONSTITUTIONAL,

STATUTORY, AND REGULATORY

POET CRP OO Se i cies vip eneek eke vues

INTRODUCTION ....

STATEMENT OF THE CASE .....

A Factual Background

1. FDA Regulatory Regime for

rea eee. so Saws eanaededeeeies

PAGE

2. FDA’s Final Monograph

Regulation of OTC Nasal

Decongestants.......... ae 14

3. The Operative FDA Warning

SS) Ps 0 ae bance eae Lb

B. Proceedings Below............ e 17

] The Trial Court Proceedings. 17

2. The Appeal to the Third

District Court of Appeal of

UII cs pee eceee eas ew eee ; 19

3. The Appeal to the Supreme

Court of Florida............ ” 23

REASONS FOR GRANTING THE

Le gt, , Se are renner rere 22

!. The Court.Should Grant Review to

Correct Florida’s Rejection of

Impossibility Conflict Preemption in

a Case Where, Unlike the NDA

Regulatory Scheme, the OTC Final

Monograph Regulatory Regime Does

Not Contain a Provision that Would

Allow a Product Manufacturer to

Unilaterally Change its Product

Labeling by Adding Warnings that

Were Not Approved by the FDA....

Il. The Court Should Grant Review to

Resolve the Issue of Whether State

failure-to-Warn Claims Against

OTC Final Monograph Drug

Manufacturers Stand as an

Obstacle to National Uniformity 25

[11. The Court Should Grant Review to

Clarify the Confusion Stemming

from Overbroad Applications of

Vyeth v. Levine by Lower Courts 3]

CONCLUSION... | 33

TABLE OF APPENDICES

PAGE

Appendix A—Opinion of the

Third District Court of Appeal,

Filed December 30, 2009 ............. la

Appendix B—Decision of the Third District

Court of Appeal Denying Rehearing,

Filed February 23, 2010............. 6a

Appendix C—Decision of the Supreme

Court of Florida Denying Review,

PinOG Muwist BZ, BOL: ss i sce ec cendeses 8a

Appendix D—Order of the Circuit Court of

the Kleventh Judicial Circuit Granting

McNeil-P.P.C., Inc.’s Motion for Final

Summary Judgment, Filed

oR ee 10a

Appendix E—Final Summary Judgment of

the Circuit Court of the Eleventh

Judicial Circuit in Favor of

McNeil-P.P.C., Inc.,

Pir@a dune ©, QOGS . ooo ca decdecvess l4a

Appendix F—Complaint, Valdes v. Optimist

of Suniland, et al.,

Case No. 0309855 CA 20, in the

Circuit Court of the Eleventh Judicial

Circuit in and for Miami-Dade County,

Florida, Filed April 23, 2003............ 17a

Appendix G—Constitutional Provision

Involved, United States Constitution,

Article VI. Clause &.. oo... ccs ccuccccccas 52a

Appendix H—Statutory and Regulatory

Provisions

1 C.F.R. § 330.10

21 C.F.R. § 330.1

21 U.S.C. § 379r

Appendix I—Food and Drug Administration

Modernization and Accountability Act

of 1997, Senate Report No. 105-43

CRT) COROT IG) 66 eves ceca sesncecn’s

Appendix J—Tylenol Cold and Tylenol

NS Pee Tere Terre eT Eyer

Appendix K—Consumer Healthcare

Products Association, OTC Facts

ry a hl, ) ae

Appendix L—Drug InfoNet, Listing of Over

the-Counter/Consumer Drug

Fe eg a | 7 a a se ee

Appendix M—FDA, Drug Applications for

Over-the-Counter Drugs (last updated

Dg ge |) I ae

Appendix N—State of Indiana, Criminal]

Justice Institute, Pseudoephedrine

PROGUCE List .. ccs esis: SPs oke A AM

PAGE

TABLE OF AUTHORITIES

Cases: PAGE

Demahy v. Actavis,

593 F.3d 428 (5th Cir. 2010)..... 3]

Dowhal v. SmithKline Beecham Consumer

Healthcare,

88 P.3d 1 (Gal. Bea... css 20. 24

Florida Avocado Growers v. Pault.

373 U.S. 132 (1963) Ce, 4 22

Geter v. American Honda Motor Co..

529 U.S. S6B (20e)........-..:: Za. 2a

INS v. Natl Center for Immigrants

Rights, Inc.,

502 U.S. 168 (i eeecssssse ae 26

Mason v. SmithKline Beecham Corp.,

596 F.3d 387 (7th Cir. 2010).. - 3

Medtronic v. Lohr,

518 U.S. 470 (1966).........

Mills v. Warner-Lambert Co..,

581 F. Supp. 2d 772 (E.D. Tex. 2008) . 8.9

Robinson v. McNeil Consumer Healthcare,

615 F.3d S635 teem ae eere...........0, 7, 31

Valdes v. Optimist Club of Suniland, Inc.,

27 So. 3d 689 (Fla. 3d DCA 2009) ..... passim

Weinberger v. Bentex Pharmaceuticals, Inc.,

412 U.S. Ga ee cs eae acsess. 9, 20

Wyeth v. Levine,

129 8. Ct. 1187 (2009).................. passim

PAGE

Federal Statutes

21 U.S.C. § 301 3, 26

21 U.S.C. § 332 1, 12, 24

21 U.S.C. § 333 4,12, 24

21 U.S.C. § 334 112,24

21 U.S.C. § 353

21 U.S.C. § 355 , 4, 28

21 U.S.C. § 3791 », 13, 23, 26

21 U.S.C. § 393 26

28 U.S.C. § 1257.

Federal Regulations

21 C.F.R. § 201.80... | 29

21 C.F.R. § 314.125 28

11 C.F.R. § 314.70 », 29

11 C.F.R. § 330.1 i. &. 23

21 C.F.R. § 330.10.. ..passim

21 C.F.R. § 330.5.. 6, 20, 27

23 C.F. 6 S6i. 76 oe. <ci. | 17

21 C.F.R. § 341.80..... .passim

21 C.F.R. § 343.50 . 17

PAGE

Cold, Cough, Allergy, Bronchodilator and

Antiasthmatic Products for Over-the

Counter Human Use; Proposed

Amendment of Tentative Final

Monograph for Over-the-Counter

Nasal Decongestant Drug Products,

57 Fed. Reg. 27658 (1992)........... 16

Cold, Cough, Allergy, Bronchodilator and

Antiasthmatic Products for Over-the-

Counter Human Use; Tentative Final

Monograph for Over-the-Counter Nasal

Decongestant Drug Products,

50 Fed. Reg. 2220 (1985).......... ee 5

Cold, Cough, Allergy, Bronchodilator, and

Antiasthmatic Drug Products for Over-

the-Counter Human Use; Final]

Monograph for OTC Nasal Decongestant

Drug Products (“Final Monograph”),

59 Fed. Reg. 43386 (1994) ..........15, 16, 2!

Establishment of a Monograph for OTC

Cold, Cough, Allergy, Bronchodilator

and Antiasthmatic Products,

41 Fed. Reg. 38312 (1976).......... hes 15

Over-The-Counter Cold, Cough, Allergy,

Bronchodilator, and Antiasthmatic

Drug Products,

S7 FOG. Rem. 1GOZO (LO7TZ) ... 0. cccceces bOy OT

Procedures for Classification of Over-the-

Counter Drugs,

37 Fed. Reg. 9464 (1972) ........ , 54,37

Legislative Materials

S. Rep. No. 105-43 (1997)

—

State Rules

Fla. R. App. P. 9.030

Miscellaneous

Consumer Healthcare Products Association,

OTC Facts & Figures (The Nielsen

Company, 2009),

http://www.chpa-info.org/pressroom/

OTC_FactsFigures.aspx

Drug InfoNet, Pharmaceutical

Manufacturer Information, Over the

Counter/Consumer Drug Manufacturers

(visited Oct. 22, 2010),

http://www.druginfonet.com/

manufacturers.htm.......

KDA, Drug Applications for Quer-the

Counter Drugs (last updated

April 26, 2010),

http://www.fda.gov/Drugs/Development

ApprovalProcess/How DrugsareDeveloped

andApproved/ApprovalApplications/

Over-the-CounterDrugs/default.htm..

State of Indiana, Criminal Justice Institute

Pseudoephedrine Product List

(visited Oct. 21, 2010),

http://www.in.gov/cji/files/Product

List.pdf ..

OPINIONS BELOW

The decision of the Third District Court of

Appeal of Florida is reported at 27 So. 3d 689 (Fla.

3d DCA 2009) and reprinted in the Appendix

(“App.”) at la-5a. The trial court’s decision grant-

ing Petitioner’s Motion for Final Summary Judg

ment is reprinted at App. 10a-18a.

JURISDICTION

The Third District Court of Appeal issued

Valdes v. Optimist Club of Suniland, Inc., 27 So.

3d 689 (Fla. 3d DCA 2009), on December 30, 2009,

App. la-5a, and denied a motion for rehearing on

February 23, 2010, App. 6a. The Supreme Court of

Florida denied McNeil-P.P.C’s Petition for Dis-

cretionary Review on August 2, 2010, App. 8a. On

October 22, 2010, Justice Thomas granted an

extension until December 1, 2010 for the filing of

this Petition.

This Court has jurisdiction pursuant to 28

U.S.C. § 1257(a).

PERTINENT CONSTITUTIONAL,

STATUTORY, AND REGULATORY

PROVISIONS

The pertinent constitutional, statutory and reg-

ulatory provisions are set forth in the Appendix,

52a-100a.

INTRODUCTION

In Valdes v. Optimist Club of Suniland, 27

So. 3d 689 (Fla. 38d DCA 2009), Florida’s Third

District Court of Appeal held that state law fail

ure to warn claims against the manufacturer of an

over-the-counter (“OTC”) drug product were not

pre-empted by federal law set forth in a federal

regulation known as a Final Monograph, which

requires the manufacturer to use the warnings

authored by the Food and Drug Administration

(“FDA”). The Florida appellate court determined

that it was constrained by Wyeth v. Levine, 129 8.

Ct. 1187 (2009), in which this Court rejected

Wyeth’s broad claim that state-law failure-to-warn

claims against it were categorically pre-empted by

IDA approval of the warnings for its prescription

product, Phenergan. Among other things, this

Court rejected a claim of implied conflict pre-emp-

tion based on Wyeth’s assertion that it was impos-

sible to strengthen its product warnings without

prior approval of the FDA.

In rejecting Wyeth’s imphed conflict pre-emp-

tion argument, this Court relied on specific

statutes and regulations applicable to manufac-

turers of brand-name prescription drugs, which

allow the manufacturer to strengthen product

warnings without prior FDA approval, pursuant to

a “changes being effected” (“CBE”) procedure. The

appellate court in Valdes ignored the fact that

prescription and OTC drugs are subject to differ-

ent federal regulatory regimes. The appellate

court failed to recognize that federal laws appli-

cable to manufacturers of OTC products do not

provide a mechanism similar to the CBE proce-

dure that would permit a manufacturer to un)-

laterally change the warnings on product labeling

crafted by the FDA. Because the Valdes court did

not appreciate this crucial distinction, the court

erred in concluding that state-law failure-to-warn

claims were not pre-empted by specific federal

regulations that apply to OTC product manufac-

turers.

The Federal Food, Drug and Cosmetic Act, 21

U.S.C. § 301 et seq. (the “FDCA”), and its imple

menting regulations, provide distinct regulatory

regimes for different drug products such as brand-

name prescription drugs, generic prescription

drugs, and over-the-counter (or nonprescription)

drugs. Each regulatory scheme presents a unique

set of laws, unique Congressional purposes, and a

unique set of mechanisms that affect the safety,

cost and efficacy of drugs in our public health sys-

tem.

For purposes of the FDCA, a prescription drug

includes any drug that “because of its toxicity or

other potentiality for harmful effect ... is not

safe for use except under the supervision of a

practitioner licensed by law to administer such a

drug.” 21 U.S.C. § 353 (b)(1)(A). Prescription drugs

fall into two broad categories for regulatory pur-

poses: brand-name and generic. A manufacturer

seeking to market a new brand-name prescription

drug must submit a new drug application (“NDA”)

to the FDA for approval. The NDA must include

scientific information, a list of the drug’s compo-

nents, and samples of the proposed labeling for

the drug. 21 U.S.C. § 355 (b)(1). The FDA will

approve the NDA if it determines the drug is “safe

for use.” 21 U.S.C. § 355 (d)Q1) and (5).

After approval of an NDA, any manufacturer

may request approval for a generic version by sub-

mitting an abbreviated new drug application

(“ANDA”). 21 U.S.C. § 355G). Rather than sub-

mitting independent evidence of safety and effi-

cacy, the manufacturer must show that the

generic drug has the same listed ingredients as

the “reference listed drug” (the brand-name drug

and that the “labeling proposed for the [generic]

drug is the same as the labeling approved for” the

brand-name drug. 21 U.S.C. § 355())(2)(A) (11), Gav)

and (v).

OTC drugs are drugs that do not mect the statu-

tory definition of “prescription” drugs and, thus,

do not require a physician’s supervision for their

use by aconsumer. OTC drugs that have not pre-

viously been approved by the FDA pursuant to the

NDA or ANDA process can be marketed without

prior approval of the FDA if they comply with reg-

ulations applicable to categories of products and

set forth in an FDA Final Monograph. 21 C.F-.R.

§ 330.1. Broad categories of OTC products for

which Final Monographs exist include antacids,

contraceptives, and cold and cough remedies.

Under the Final Monograph system, no manu-

facturer may sell an OTC drug unless its label

strictly complies with categorical, mandatory

labeling language, which is written by the FDA

after formal notice-and-comment rulemaking and

codified into law as a Final Monograph. See 21

U.S.C. § 332 Gnjunction proceedings), 333 (penal-

ties), 334 (seizure); 21 C.F.R. § 330.10(b) (sub-

jecting “[a]ny product which fails to conform to an

applicable monograph” to regulatory action). This

process differs significantly from the NDA system,

under which the manufacturer—not the FDA—is

responsible for the contents of the label on its pre-

scription drug. Further, under the NDA process,

the manufacturer—not the FDA—must ensure

that its warnings remain adequate throughout the

marketing life of the drug, and the manufacturer

has the ability—through “changes being effected”

(CBE) regulations, which do not exist for OTC

products—to change its drug label to “add or

strengthen” warnings or instructions to increase

the safe use of its drug without first obtaining

FDA approval. 21 C.F.R. § 314.70(c)(6)(i1)(A), (C).

This Court’s decision in Wyeth has been applied

in some cases by lower courts to regulatory

regimes outside the context of brand-name pre-

scription drugs. Within a matter of months after

the Florida court’s decision in Valdes, the Seventh

Circuit Court of Appeals cited Wyeth for the

proposition that courts are free to hold “that state

law requires warnings on the label of an over-the-

counter drug beyond what the FDA has required.”

Robinson v. McNeil Consumer Healthcare, 615

F.3d 861, 869 (7th Cir. 2010). These courts have

misapplied Wyeth by giving it an overly broad

application. These decisions would allow state

court juries to override the federal Final Mono-

graph regulatory regime put into place by the

FDA for OTC products, which has no relationship

to the NDA process governing prescription drugs.

The confusion created by the overly-broad appli

cation of Wyeth outside the context of brand-name

prescription drugs has placed the entire OTC drug

industry at risk in the United States. This issue

affects more than “300,000 marketed OTC drug

products ... and the labeling of over 80 thera-

peutic classes of drugs”! classified into 26 Final

See FDA, Drug Applications for Over-the-Counter

Drugs (last updated April 26, 2010)

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/How-

DrugsareDevelopedandApproved/ApprovalA pplications/Over-the-

CounterDrugs/default.htm, App. 137a-140a.

Monograph categories’ and marketed by at least

26 manufacturers® in an annual market that

exceeds $16 billion.’ The OTC drugs at issue in

this case, Tylenol Cold and Tylenol Flu, are only

two of over 700 products on the market governed

by a single FDA OTC Final Monograph for nasal]

decongestants containing the active ingredients

+4)

pseudoephedrine and ephedrine.’

Granting this petition would enable the Court to

resolve the overbroad and conflicting misapplica-

tion of Wyeth to a regulatory regime in which the

intent of Congress and the goal of the FDA was to

develop across-the-board drug labeling containing

a specific set of cautions and instructions applying

to categories of drugs in a process designed to per-

mit relatively easy access to the OTC market

and ensure low-cost, prescription-free consumer

access to safe, time-tested, and properly-labeled

medicines. This is in contrast to the NDA process,

which apphes only to individual prescription

drugs, each of whose warnings are developed by

the manufacturer and approved by the FDA.

See 21 C.F.R. § 330.5.

See Drug InfoNet, Pharmaceutical Manufacturer

Information, Over the Counter/Consumer Drug Manufac-

turers (visited Oct. 22, 2010) <http://www.druginfonet.com/man

ufacturers.him>, App. 132a-136a.

4 See Consumer Healthcare Products Association, OTC

Facts & Figures (The Nielsen Company, 2009)

<http://www.chpa-info.org/pressroom/OTC FactsFigures.aspx>,

App. 1380a-13la.

See State of Indiana, Criminal Justice Institute,

Pseudoephedrine and Ephedrine Product List (visited Oct.

21, 2010) http://www.in.gov/cji/files/Product List.pdf, App. 141a-

169a.

Both Congress and the FDA have recognized

that uniformity is essential to ensure safety in the

OTC drug market. Congress's stated purpose in

amending the Federal Food, Drug, and Cosmetic

Act in 1997 was to ensure “national uniformity” in

the laws governing nonprescription drug products.

21 U.S.C. § 379r. But the Florida court in Valdes

and the Seventh Circuit in Robinson did not

address Congressional purpose regarding OTC

drugs. Recognition of the distinct Congressional]

purposes with regard to OTC drugs is essential in

considering whether’ pre-emption applies.

Medtronic v. Lohr, 518 U.S. 470, 485 (1966). Over-

broad misapplication of Wyeth to the OTC Final

Monograph regulatory regime defeats the funda-

mental Congressional purpose of national] unifor-

mity, renders compliance by OTC manufacturers

with federal regulations impossible, and threatens

to eviscerate the concept of federal pre-emption in

all drug cases, regardless of statutory regime or

Congressional intent.

In Wyeth, this Court commented that “we have

no occasion in this case to consider the pre-emp-

tive effect of a specific agency regulation bearing

the force of law.” 129 S. Ct. at 1203. In a concur-

ring opinion, Justice Breyer emphasized that com-

ment. Justice Breyer noted it is “possible that

state tort law will sometimes interfere with the

FDA’s desire to create a drug label containing a

specific set of cautions and instructions” and “it is

possible that such determinations would have pre-

emptive effect.” 129 S. Ct. at 1204 (Breyer, J.,

concurring). The OTC Final Monograph at issue

here is “a specific agency regulation bearing the

force of law,” and it contains “a specific set of cau-

tions and instructions” authored by the FDA. See

ra)

21 C.F.R. § 341.80 (“Labeling of nasal deconges

tant products”).

Granting MeNeil’s Petition would give this

Court the opportunity to rule on a significant pre-

emption issue specifically left open by Wyeth. The

Court would be able to clarify the pre-emptive

effect of FDA regulations bearing the force of law

that require OTC products to use a specific set of

warnings in order to be considered “safe” and “not

misbranded.” 21 C.F.R. § 330.1. At the same time,

this Court could clarify the confusion stemming

from overbroad application of Wyeth by lower

courts.

STATEMENT OF THE CASE

A. Factual Background

1. FDA Regulatory Regime for OTC

Drugs.

The Federal Food, Drug and Cosmetic Act

(“FFDCA”) together with implementing regulations

of the Food and Drug Administration (“FDA”), pro-

vide a comprehensive scheme of drug regulation.

Since its enactment in 1938, the FDCA has been

amended on a number of occasions. Amendments

enacted in 1962 added requirements that drugs

must be not just safe, but effective as well, and

that the labeling of a drug cannot be false or mis-

leading. See Mills v. Warner-Lambert Co., 581 F.

Supp. 2d 772, 783 (E.D. Tex. 2008). The 1962

amendments required the FDA to examine all

marketed drugs for their effectiveness, whether or

not they had been appreved previously.

The FDA recognized that it could not possibly

evaluate each of the prescription and OTC drugs

already on the market without assistance. Id.; see

Weinberger v. Bentex Pharmaceuticals, Inc., 412

U.S. 645, 650 (1973) (recognizing that in 1973

there were between 100.000 and 500,000 OTC

drugs on the market, most of which had not been

previously approved by the FDA). Accordingly, the

FDA enlisted the National Academy of Sciences—

National Research Council to create panels of

experts to evaluate categories of OTC drugs. Mills,

581 I. Supp. 2d at 783. The Academy established

seventeen advisory panels of outside experts to

review twenty-six categories of OTC drugs, which

were grouped by their intended effect (i.e.

antacids, cold remedies). This approach was

deemed prudent because although there are hun-

dreds of thousands of OTC products, the drugs

contain a relatively small number of active ingre-

dients. Jd. at 784.

The purpose of the review of OTC products was

to ensure that the products were safe and not mis-

branded. This is known as the “monograph pro-

cess.” Id.*° The detailed four-step procedure for

classifying OTC drugs as “generally recognized

among qualified experts as safe and effective for

use and not misbranded” is set forth in 21 C.F.R.

§ 330.10. In the first step, the FDA Commissioner

appoints an advisory review panel of qualified,

independent experts for each designated OTC

drug category to evaluate the safety and effec-

. As the Mills court noted, a “monograph” is defined by

Webster’s Third New International Dictionary (1986) as “a

learned detailed thoroughly documented treatise covering

exhaustively a small area of a field of learning.” Mills, 581

F. Supp. 2d at 784, n.9.

tiveness of OTC drugs, to review OTC drug label-

ing, and to advise on the promulgation of mono-

graphs. 21 C.F.R. § 330.10(a)(1). The panel then

reports its conclusions and recommendations to

the FDA “with respect to the safety and effec-

tiveness of the drugs” in the designated OTC cat-

egory. ld.

In the second step, the FDA reviews the expert

panel’s findings and then publishes a notice in the

Federal Register requesting interested persons to

submit for review and evaluation by the advisory

panel “published and unpublished data and infor-

mation pertinent to a designated category of OTC

drugs.” Jd. at (a)(2). The advisory panel meets “as

often and for as long as is appropriate” to review

the data submitted to it and to prepare a report

“with respect to the safety and effectiveness of the

drugs in a designated category of OTC drugs.” Jd.

at (a)(3). The panel may consult any individual or

group; interested persons may request permission

to present oral views to the panel. /d.

After the FDA Commissioner reviews the expert

panel's conciusions and recommendations, the

Commissioner is required to publish in the Fed-

eral Register a proposed order containing, among

other things, a monograph establishing conditions

under which a category of OTC drugs is “generally

recognized as safe and effective and not mis-

branded.” 21 C.F.R. § 330.10(a)(6)(i). The publi-

cation must contain the full report of the panel,

and interested persons are allowed to file com-

ments and documents. /d. at (a)(6)(iv). After

reviewing all comments and any new data and

information, the Commissioner is required to pub-

lish in the Federal Register a tentative order con-

taining a monograph establishing conditions

under which a category of OTC drugs 1s “generally

recognized as safe and effective and not mis-

branded.” 21 C.F.R. § 330.10(a)(7)(i). Again, inter-

ested persons are permitted to file written

comments or objections. /d. The FDA then con

siders any comments regarding the monograph

and conducts an oral hearing if there are

“reasonable grounds” for doing so. 21 C.F.R.

§ 330.10(a)(8).

In the fourth and final phase, the FDA, “[a]fter

reviewing [any] objections, the entire adminis-

trative record including all new data and infor-

mation and comments, and considering the

arguments at any oral hearing,” publishes in the

Federal Register “a final order containing a mono-

graph establishing conditions under which a cat-

egory of OTC drugs... is generally recognized as

safe and effective and not misbranded.” 21 C.F.R.

§ 330.10(a)(9).

The Final Monograph for a class of OTC drugs

includes labeling requirements. The manufacturer

of an OTC product must use the exact warning

language authored by the FDA. The Code of Fed-

eral Regulations provides that “labeling under

this subchapter and subchapter C et seq. of this

chapter shall be stated in the exact language

where exact language has been established

and identified by quotation marks in an

applicable OTC drug monograph or by regu-

lation|.]” 21 C.F.R. § 330.1(c)(2) (emphasis added).

The FDA’s labeling requirements are designed to

provide warnings reflecting known risks based

on reliable scientific evidence. See generally 21

C.F.R. § 330.10(a) (procedure for establishing OTC

monograph); § 341.80 (labeling of nasal decon-

gestant drug products). Adequate warnings are

those that, in the judgment of the FDA, are “clear

and truthful in all respects, not misleading in any

particular,’ and that accurately communicate the

benefit to risk ratio and the proper use of'the

product in terms “likely to be read and understood

by the ordinary individual.” 21 C.F.R. § 330.10(a)(4)(v).

Compliance with the Final Monograph by the

OTC drug manufacturer is mandatory. “Any prod

uct which fails to conform to an applicable mono-

graph after its effective date is hable to regulatory

action.” 21 C.F.R. § 330.10(b). Therefore, once a

Final Monograph goes into effect, it is illegal to

sell a drug described therein unless it conforms to

the monograph. See generally 21 U.S.C. §§ 332

334. If a drug is marketed without prior FDA

approval or without complying with an applicable

monograph, the United States may bring an

enforcement action under the FDCA. /d. Enforce-

ment measures include seizure of the drug prod-

uct, civil injunction against its sale and criminal

penalties against the violator. Jd.

Another significant amendment to the FDCA, a

pertinent to OTC products, was the 1997 Food and

Drug Modernization Act (“Modernization Act’)

which expressly states Congress’s fundamental

purpose of national uniformity in the regulation

and labeling of nonprescription drugs. 21 U.S.C.

§ 379r. Section 379r, entitled “National Uniformity

for Nonprescription Drugs,” provides in relevant

part:

(a) In general

Except as provided in subsection (b), (c)(1),

(d), (e), or (f) of this section, no State or

political subdivision of a State may estab-

lish or continue in effect any requirement

* *&

(2) that is different from or in addition to,

or that is otherwise not identical with, a

requirement under this chapter.

Id. (emphasis added).

As demonstrated by the legislative history of the

Modernization Act, “|djifferent or additional

requirements at the State or local level can work

against our national marketplace, confuse con-

sumers, raise prices, undermine public confidence

in our regulatory system and in products impor-

tant to public health, and result in divergent pub

lic -health protection throughout the country.”

S. Rep. No. 105-43, at 64 (1997), App. 101la-127a.

Accordingly, Congress specifically expressed its

intent to achieve national] uniformity in connec-

tion with OTC drug labeling:

Section 808 of the legislation therefore estab

lished a new section 761 of the Federal Food,

Drug, and Cosmetic Act that adopts, as a gen-

eral rule, the requirement of national! unifor-

mity in the regulation of nonprescription

drugs and cosmetics and their constituents.

No State or local government is permitted to

impose different or additional requirements

that relate to the subject matter covered by

the three Federal laws as they apply to non-

prescription drugs and cosmetics. These

include requirements imposed on product

manufacture or composition, labeling, adver

tising, or any other form of public notification

or communication.

The Modernization Act also reinforces the well-

recognized role of the FDA with regard to non

prescription drugs:

Nonprescription drugs are subject to careful

and comprehensive regulation by the FDA

The conditions under which nonprescription

drugs are considered safe and effective, for

use by the lay consumer, are specified by the

KDA in nonprescription drug monographs or

by new drug and antibiotic drug applications.

The FDA also ensures that the labeling of

nonprescription drugs provides adequate

directions for use, and adequate warnings

against unsafe use, through these monographs

and drug marketing applications, as well as

through a number of general and specific

labeling regulations.

FDA’s Final Monograph Regula-

tion of OTC Nasal Decongestants

The 1994 approval of the Final Monograph for

OTC nasal decongestants (including those con-

taining pseudoephedrine products) was the result

of a 22-year-long process. ‘The process began in

1972, when the FDA Commissioner signed the

final regulations providing for OTC drug review

and published in the Federal Register a specific

request for data and information on all cold,

cough, allergy, bronchodilator and antiasthmatic

(CCABA) active ingredients.’ A notice of a pro

Procedures for Classification of Over-the-Counter

Drugs, 37 Fed. Reg. 9464 (1972): Over-The-Counter Cold,

posed monograph was published in the Federal

monograph was the result of the evaluation of

data by the Advisory Review Panel on OTC Cold,

Cough, Allergy, Bronchodilator, and Antiasth-

matic Drug Products.°

After review and evaluation of comments sub-

mitted, the advisory panel issued a tentative Final

Monograph for OTC nasal decongestant products

on January 15, 1985, which was published in the

Federal Register.'® Interested persons were

invited to file written comments, objections, or

requests for oral hearing before the Commissioner

of the FDA regarding the proposed monograph.

At all times during the process, the FDA and the

expert advisory pane]! considered any data rele-

vant to the tentative Final Monograph and pub-

lished corrections or changes to the monograph

based upon the safety and effectiveness of the

products subject to the monograph. For example,

in 1992, the FDA published a notice to amend the

tentative Final Monograph for OTC nasal decon-

Cough, Allergy, Bronchodilator, and Antiasthmatic Drug

Products, 37 Fed. Reg. 16029 (1972) .

Establishment of a Monograph for OTC Cold, Cough,

Allergy, Bronchodilator and Antiasthmatic Products, 41 Fed.

Reg. $8312 (1976).

See Cold, Cough, Allergy, Bronchodilator, and Anti-

asthmatic Drug Products for Over-the-Counter Human Use;

Final Monograph for OTC Nasal Decongestant Drug Prod

ucts (“Final Monograph”), 59 Fed. Reg. 43386 (1994).

Cold, Cough, Allergy, Bronchodilator and Antiasth

matic Products for Over-the-Counter Human Use; Tentative

Final Monograph for Over-the-Counter Nasal Decongestant

Drug Products, 50 Fed. Reg. 2220°(1985).

sestant drug products to modify the drug inter-

action precaution statement to warn against tak-

ing such products if a consumer was also taking a

prescription drug containing a monoamine oxidase

inhibitor (MAOI) without first consulting a physi-

cian.''

On August 23, 1994, the FDA issued its Final

Monograph establishing the conditions under

which OTC nasal decongestant products are gen-

erally recognized as safe and effective and not

misbranded. See Final Monograph, 59 Fed. Reg.

43386 (codified at 21 C.F.R. pt. 341). This Final

Monograph included precise labeling requirements

Gncluding warnings) for OTC nasal decongestants

containing pseudoephedrine (and other active

ingredients). 21 C.F.R. § 341.80.

3. The Operative FDA Warning

Label

The FDA-authored mandatory warnings for

OTC nasal decongestants containing pseu-

doephedrine are set forth in 21 C.F.R. § 341.80(c),

App. 54a-68a. The labels on McNeil’s Tylenol Cold

and Tylenol Flu use the language required by the

regulation, App. 128a-129a.

Tylenol Cold and Tylenol Flu are both muiti-

symptom products containing permitted combi-

nations of active ingredients in addition to

pseudoephedrine. McNeil’s product labeling sets

forth warnings required for those other active

Cold, Cough, Allergy, Bronchodilator and Antiasth-

matic Products for Over-the-Counter Human Use; Proposed

Amendment of Tentative Final Monograph for Over-the-

Counter Nasal Decongestant Drug Products, 57 Fed. Reg.

27658 (1992).

ingredients, such as acetaminophen (for pain and

fever) and dextromethorphan hydrobromide (a

cough suppressant and antitussive). See, e.g., 21

C.F.R. § 341.74(c)(1) (the regulation containing the

final Monograph for antitussive drug products).'”

It is undisputed that McNeil’s labeling fully com.

plied with all applicable federal regulations.

B. Proceedings Below

1. The Trial Court Proceedings

While playing roller hockey, 16-year-old

Armando Valdes allegedly suffered heatstroke and

cardiorespiratory arrest. Respondents brought

alternative state law lability claims against

Defendants Optimist Club of Suniland, Optimist

International, the Sports Authority, Inc., JOFA

AB, KHF Sports OY, The Hockey Company, and

McNeil—P.P.C.'* Respondents based their claim

de Pursuant to other FDA regulations and guidelines,

one of these warnings, set forth in 21 C.F.R.

§ 341.80(c)(1)()(B) (If symptoms do not improve within 7

days or are accompanied by fever, consult a doctor.”), is

slightly modified to take into account the required warning

for acetaminophen. The warning for acetaminophen con-

taining products must state “Do not take this product for

pain for more than 10 days or for fever for more than 3 days

unless directed by a doctor.” 21 C.F.R. § 343.50(c)(1). As

required by the FDA, these warnings were consolidated in

the most restrictive manner and are set forth in the subject

label as “Do not take for pain for more than 7 days or for

fever for more than 3 days unless directed by a doctor.”

” Respondents alleged that the Optimist Club defen

dants acted negligently when they allowed Armando to play

hockey 1n extreme heat and without safe protocols; that the

Sports Authority was negligent for selling improper

equipment without sufficient ventilation for’ roller

hockey; and that JOFA, KHF and The Hockey Company, the

against McNeil solely upon an alleged failure to

warn. Respondents alleged that Armando Valdes

took either Tylenol Cold or Tylenol Flu, and had

at least one caffeinated beverage prior to playing

roller hockey. According to the Respondents,

Tylenol Cold and/or Tylenol Flu, which contains

pseudoephedrine, “increased the risk of heat-

related illness and heart-related risks when

ingested with caffeinated products and coupled

with strenuous or athletic events in a hot envi-

ronment like that of South Florida.” Valdes, 27 So.

3d at 690. Respondents alleged that McNeil’s “fail-

ure to warn of these risks on the labels of the

Tylenol Cold/Flu packaging breached Florida state

law requirements.” Jd. McNeil asserted its affir-

mative defenses, including federal pre-emption.

The trial court granted McNeil’s motion for final

summary judgment on federal pre-emption

grounds. Among other things, the trial court

specifically found that implied conflict pre-emp-

tion applied because it would have been impossi-

ble for McNeil to comply with federal regulations

that mandate the exact warnings for labels of

all OTC pseudoephedrine-containing products

(including those sold by McNeil) while also meet-

ing state common law jury determinations of

whether the FDA-crafted warnings were adequate.

The trial court also concluded that permitting

Florida to enforce a common law duty to warn

would defeat the fundamental federal objective of

national uniformity in the labeling of OTC Final

Monograph drugs, App. 10a-13a. The trial court

manufacturers of the helmet and gloves used by Armando,

were negligent and strictly liable for having sold products

that were defective, App. 17a-5la.

entered judgment tn accordance with its ruling,

App. 14a-16a.

2. The Appeal to the Third District

Court of Appeal of Florida

Respondents appealed to the Third District

Court of Appeal of Florida. After their initial brief

was filed, this Court issued its decision in Wyeth

v. Levine, which rejected a brand-name prescrip-

tion drug manufacturer’s argument that FDA

approval of its product’s warnings pre-empted

state law failure to warn claims. This Court found

thatit was not impossible for Wyeth to strengthen

its product warnings because Wyeth could take

advantage of a “changes being effected” provision,

applicable to prescription drugs approved under

the:NDA procedure, and change its labeling with-

out. first seeking FDA approval. This Court also

concluded that imposing hability on Wyeth for the

alleged inadequacy of its warning would not stand

as an obstacle to the accomplishment of federal

regulatory requirements and purposes. Wyeth, 129

5. Ct. at 1204.

Florida’s appellate court reversed the final sum-

mary judgment for McNe1l, finding that “the facts

in Wyeth are similar to the ones here, and the

arguments made by the prescription drug manu-

facturer are practically identical to those

advanced by McNeil.” Valdes, App. 4a. The Florida

court addressed no case other than Wyeth, and the

federal regulations applicable to McNeil’s prod-

ucts were not cited in the opinion.

The appellate court did not address McNeil’s

argument that Wyeth involved an entirely

4 : )

distinguishable regulatory regime. Regulations

governing an NDA allow the manufacturer to

change its warning without prior approval from

the FDA. Conversely, the OTC Final Monograph

regulations do not contain a “changes being

effected” (CBE) provision. Rather, all manufac-

turers of OTC nasal decongestant products con-

taining pseudoephedrine are required to use the

identical labeling language set forth in the Final

Monograph codified into law. See 21 C.F.R.

§ 330.10(b)

The appellate court did not address McNeil’s

claim that principles of implied pre-emption

appled because it was impossible for McNeil to

comply with the applicable Final Monograph as

well as state law, which, according to the Respon-

dents, would require additional warnings that did

not conform to the monograph. In addition, the

appellate court failed to address McNeil’s argu-

ment that permitting Florida to enforce its tradi-

tional common law duty to warn would stand as

an obstacle to the accomplishment of the funda-

mental Congressional objective of national uni-

formity in the labeling of nonprescription drugs.

The appellate court failed to recognize how its

decision would impact the actions of the other

OTC product manufacturers using the identical

KDA warnings on their pseudoephedrine products.

Nor did it address how the decision would affect

the conduct of manufacturers of OTC Final Mono-

graph products in other categories of drugs. All

manufacturers of OTC Final Monograph drugs are

required to use the identical FDA-crafted warn-

ings as codified in the Final Monographs govern-

ing over 26 OTC drug categories. See 21 C.F.R.

§ 330.5.

—

The appellate court never contemplated whether

its ruling would require every manufacturer to

acquire an equivalent knowledge base which

would need to be continually updated, or whether

the cost of doing so would be reflected in the

prices of the OTC drugs approved by the Final

Monograph process. Such a requirement would

surely diminish the ability of manufacturers of

Final Monograph OTC drugs to continue to sell

their products pursuant to the mandatory provi-

sions of the monograph, as Congress intended.

3. The Appeal to the Supreme Court

of Florida

On March 26, 2010, McNeil sought discretionary

review by the Supreme Court of Florida because

the. Third District’s decision had the effect of

construing the Supremacy Clause of the

United States Constitution. See Fla. R. App. P.

9.030(a)(2)(A)(Gi) (providing for discretionary juris-

diction to review decisions of district courts of

appeal that construe a provision of the state or

federal constitution). On August 2, 1010, the

Supreme Court of Florida denied McNeil’s Petition

for Discretionary Review, App. 8a.

REASONS FOR GRANTING THE PETITION

The Court Should Grant Review to

Correct Florida’s Rejection of Impos-

sibility Conflict Pre-emption in a

Case Where, Unlike the NDA Regula-

tory Scheme, the OTC Final Mono-

graph Regulatory Regime Does Not

Contain a Provision that Would Allow

a Product Manufacturer to Unilater-

ally Change its Product Labeling by

Adding Warnings that Were Not

Approved by the FDA.

The doctrine of conflict pre-emption is triggered

when compliance with both state and federal law

is impossible because one requires what the other

prohibits. Florida Avocado Growers v. Pault, 373

U.S. 1382, 142-143 (1963). In other words, “a case

of impossibility” conflict pre-emption 1s one in

which “state Jaw penalizes what federal law

requires.” Geter v. American Honda Motor Co., 529

U.S. 861, 873 (2000). Here, federal law requiring

McNeil’s product labeling to use the exact warn-

ings set forth in a Final Monograph irreconcilably

conflicts with state law that, according to Respon-

dents, would require McNeil to unilaterally pro-

vide additional warnings.

The FDA’s Final Monograph establishing the

conditions under which nasal decongestants con-

taining pseudoephedrine are generally recognized

as “safe and effective and not misbranded” is pub-

lished at 59 Fed. Reg. 43386 and the warning

label requirements are set forth in 21 C.F.R.

§ 341.80(c)(1). The federal regulation established

by the FDA sets forth the mandatory labeling

requirement for all manufacturers of all products

encompassed by the Final Monograph, App. 54a-

68a. It is undisputed that McNeil complied. The

additional warnings proposed by Respondents are

illegal because they are not in compliance with the

mandatory labeling language codified in section

341.80(c).

Moreover, the additional warnings urged by

Respondents are “different from, in addition to

and are not otherwise identical to” those set forth

in the applicable Final Monograph. 21 U.S.C.

§ 379r (providing for national uniformity for non-

prescription drugs). In Wyeth, the Court noted

that product hability actions against an OTC man-

ufacturer are not expressly pre-empted by section

379r, due to the savings clause contained in sec-

tion 379r(e). See Wyeth, 129 S. Ct. at 1200 n.8.

That does not, however, foreclose application of

the doctrine of implied conflict pre-emption. See

Geter, 529 U.S. at 896-97 (recognizing that an

express pre-emption provision coupled with a sav-

ings clause does not bar the ordinary working of

conflict pre-emption principles).

This point was made in Dowhal v. SmithKline

Beecham Consumer Healthcare, 88 P.3d 1 (Cal.

2004). In Dowhal, a citizen filed an action against

various drug companies to challenge their failure

to place health warnings mandated by California’s

Proposition 65 on nicotine replacement therapy

(NRT) products. In enacting section 379r,

Congress included a specific savings clause to pre-

serve Proposition 65 from the express pre-emptive

effect of the statute. See 21 U.S.C. § 379r(d)(2)

(“This section shall not apply to a State require-

ment adopted by a State public initiative or ref-

erendum enacted prior to September 1, 1997”).

The savings clause was designed to preserve

Proposition 65, the only state enactment that fell

within its terms. See Dowhal, 88 P.3d at 4.

The California Supreme Court held that

although the section 379r savings clause pre-

cluded express pre-emption of Proposition 65, it

did not preclude application of implied conflict

pre-emption. /d. at 9. “The language of the Mod-

ernization Act’s savings clause does not express

an intention to preclude all conflict pre-emption.”

Id. The court recognized that principles of conflict

pre-emption would apply if there was a direct con-

flict between state and federal law or if the state

law stood as an obstacle to the accomplishment

and execution of the full purposes and objectives

of Congress. Id. at 11.

In this case, the Florida court read Wyeth so

broadly as to preclude the assertion of implied

conflict pre-emption based on impossibility under

any circumstances. This case presents a classic

example of impossibility. Federal regulations pro-

vide for specific warnings and further provide that

“any product which fails to conform to an appli-

cable monograph after its effective date is liable to

regulatory action.” Once a monograph goes into

effect, it is illegal to sell a drug described therein

unless it conforms to the monograph. See also 21

C.F.R. § 330.10(a)(9), 21 U.S.C. §§ 332-334 (pro-

viding remedies and penalties for failure to con-

form). If an OTC product does not comply with a

controlling Final Monograph, the United States

may bring an enforcement action under FDCA. See

id. Therefore, it is impossible for McNeil to comply

with federal law and also provide the additional

warnings the Respondents are now asking a stat

court jury in Florida to impose.

In Wyeth this Court specifically held that impos-

sibility pre-emption was not available to Wyeth

because “the CBE regulation permitted Wyeth to

unilaterally strengthen its warning and the mere

fact that the FDA approved Phenergan’s label

does not establish that it would have prohibited

such a change.” 129 S. Ct. at 1199. Here, by con-

trast, neither Congress nor the FDA allowed a

manufacturer of an OTC product to unilaterally

change product warnings that are required to

appear verbatim on labeling provided by a manu.

facturer of a specific category of OTC Final Mono-

graph products.

Without pre-emption, OTC drug manufacturers

would be deprived of the ability to rely on FDA’s

directives as to matters that Congress delegated

to the Agency and that fall within the Agency’s

unique regulatory and scientific expertise. With

out pre-emption, McNeil, and all other OTC drug

manufacturers, would be deprived of the ability to

comply simultaneously with their federal and

state obligations or even to ascertain what those

obligations are without resort to litigation.

II. The Court Should Grant Review to

Resolve the Issue of Whether State

Failure-to-Warn Claims Against OTC

Final Monograph Drug Manufactur-

ers Stand as an Obstacle to National

Uniformity.

This Court has held that “the purpose of

Congress is the ultimate touchstone in every pre-

emption case.” Wyeth, 1295S. Ct. at 1187. The his-

torical purpose of the Federal Food, Drug & Cos-

metic Act (“FDCA”) was to establish a compre-

hensive scheme of drug regulation to ensure that

drugs are safe and effective for their intended use.

See 21 U.S.C. § 301 et seq. The FDA was estab-

lished as the sole federal agency commissioned

both to “protect the public health” by ensuring

that drugs are safe and effective and to “promote

the public health” by ensuring prompt public

access to drugs it has found to be safe and effec-

tive. 21 U.S.C. § 393(b). The mechanisms Congress

put in place to accomplish the goals of safety and

efficacy for nonprescription drugs further illus-

trate how Congress went about achieving national

uniformity.

The FDA Modernization Act of 1997 is codified

at 21 U.S.C. section 379r, entitled “National Uni-

formity for Nonprescription Drugs.” The title of

the section leaves no doubt that Congress sought

uniformity in the regulation of nonprescription

drugs. See, e.g., INS v. Nat'l Center for Immi

grant’s Rights, Inc., 502 U.S. 1838, 189 (1991) (a

section's title can aid in its interpretation).

The legislative history of the Modernization Act

further demonstrates Congress’s fundamental

purpose of achieving national uniformity by rec-

ognizing that “[d]ifferent or additional require-

ments at the state or local level can work against

our national marketplace, confuse consumers,

raise prices, undermine confidence in our regula-

tory system and in products important to public

health and result in different public health pro-

tection throughout the country.” S. Rep. No. 105-

43, at 64 (1997).

The goal of national uniformity 1s apparent from

the various statutes and implementing regula-

tions that govern the categories of OTC products,

which must have identical labeling regardless of

manufacturer. Unlike the NDA regulatory scheme,

which focuses on a single drug by a single manu

facturer, the Final Monograph regime provides for

grouping OTC medications by class or therapeutic

category. See 21 C.F.R § 330.5 (OTC drug cate-

gories). The FDA studies and approves the cate

gory or class of drug, rather than a specific brand

or a’single drug, as with an NDA. The FDA rec

ognized that hundreds of thousands of OTC prod-

ucts were on the market and would continue to be

marketed. Thus, the FDA determined that OTC

products using the same active ingredient(s)

should have the same labeling requirements.

The regulations that apply to OTC products

stand in stark contrast to the regulations appli-

cable to brand-name drugs. First, the NDA pro-

cess begins when a single manufacturer submits

its application for approval to the FDA for its

unique drug. Conversely, the Final Monograph

process begins with notice-and-comment rule-

making. Here, the FDA Commissioner published a

request in the Federal Register seeking data and

information on all cold, cough, allergy, bron-

chodilator and antiasthmatic active ingredients.

Procedures for Classification of Over-the-Counter

Drugs, 37 Fed. Reg. 9464 (1972); Over-the-

Counter Cold, Allergy, Bronchodilator and Anti-

asthmatic Drug Products, 37 Fed. Reg. 16029.

Second, under the NDA regime, the manufac-

turer of a single unique product has the burden of

proving that its drug is “safe for use under the

conditions prescribed, recommended or suggested

in the proposed labeling before it may distribute

the drug.” 21 U.S.C. § 355; 21 C.F.R. § 314.125. By

contrast, the OTC Final Monograph regime does

not place this burden on the manufacturers. The

FDA appoints an advisory review panel of quall-

fied experts to evaluate the safety and effective

ness of a “designated category of drugs.” 21 C.F.R.

§ 330.10(a)(1); see also Weinberger, 412 U.S. at

650. The panel then investigates the drug cate.

gory, “reviews all available data” and reports its

“conclusions and recommendations to the FDA”

with respect to the safety and effectiveness of the

drugs in the category. 21 C.F.R. § 330.10(a)(3).

Third, under the NDA regime the manufacturer

of a single unique product has the burden of pro

viding substantial evidence that its drug will hav

the effect it is represented to have under the cc

ditions of use prescribed, recommended or sug-

gested in the manufacturer's proposed labeling

See 21 U.S.C. § 355; 21 C.F.R. § 314.125. By con

trast, manufacturers of OTC Final Monograph

drugs are not required to introduce evidence prov

ing safety, effectiveness, or conditions of use.

Manufacturers of OTC Final Monograph drugs are

not required to test, study, investigate or partic

ipate in the regulatory process. The only require-

ment placed on manufacturers of an FDA OTC

Final Monograph product is to follow the Final

Monograph.

The OTC Final Monograph regime charges the

KDA with preparing a proposed monograph “pre-

scribing drug composition, labeling, and manu

facturing controls,” publishing it in the Federal

tional data that is submitted before publishing a

tentative Final Monograph in the Federal Regis-

ter. 21 C.F.R. § 330.10(a)(6),(7). After publication

of the tentative Final Monograph, the FDA again

considers comments and conducts an oral hearing

if there are “reasonable grounds” for doing so. 21

C.F.R. § 330.10(a)(8). Then, “after reviewing [any]

objections, the entire administrative record

including all new data and information and com-

ments, and considering the arguments made at

any oral hearing,” the FDA publishes in the Fed-

eral Register a Final Monograph “establishing

conditions under which a category of OTC drugs is

generally recognized as safe and effective and not

misbranded.” 21 C.F.R. § 330.10(a)(9). In this case,

the FDA Final Monograph applicable to Cold,

Cough, Allergy, Bronchodilator, and Antiasth-

matic Drug Products for Over-the-Counter Human

use 1s codified at 21 C.F.R. Part 341.

Fourth, under the NDA regime the manufac-

turer is specifically charged with drafting an ade-

quate label and ensuring that its warnings remain

adequate as long as its drug is on the market. See

21 C.F.R. § 201.80(e). Under this regime, the FDA

promulgated a “changes being effected” (CBE) reg-

ulation. 21 C.F.R. § 314.70(c)(6)Gii). The CBE reg-

ulation provides that if a manufacturer changes

its label to “add or strengthen a contraindication,

warning, precaution, or adverse reaction” or to

“add or strengthen an instruction about dosage

and administration that is intended to increase

the safe use of the drug product,” it may make the

labeling change upon filing a supplemental appli-

cation with the FDA; it need not wait for FDA

approval. § 314.70 (c)(6)(111)(A), (C). The Wyeth

Court found that this provision made it possible

for an NDA manufacturer to change the warning

on its label without violating federal law. Wyeth,

129 S. Ct. at 1196-1199.

The omission of a CBE regulation in the OTC

Final Monograph regulatory regime serves

national uniformity. No manufacturer is permit-

ted to change the warning because the warning is

not “its” warning for “its” unique product. The

FDA’s codified warnings apply to entire categories

of products produced by many different manufac-

turers. Allowing unilateral changes to the warning

language required by a Final Monograph would

destroy national uniformity and undermine public

safety.

The Wyeth majority specifically recognized that

“some state-law. claims might well frustrate the

achievement of congresstonal objectives.” Jd. at

1204. Justice Breyer noted in his concurring opin-

ion that there were circumstances where a plain-

tiffs inadequate warnings claim under “state tort

law” would “interfere with the FDA’s desire to cre

ate a drug label containing a specific set of cau

tions and instructions.” /d. at 1204 (Breyer, J.,

‘oneurring). Accordingly, this Court should take

the opportunity to clanfy whether state-law

requirements for additional warnings on OTC

products subject to a Final Monograph would

stand as an obstacle to accomplishing the goal of

national uniformity.

The Court Should Grant Review to

Clarify the Confusion Stemming

from Overbroad Applications of

Wyeth v. Levine by Lower Courts.

Some lower courts have given an overly-broad

ipplication to Wyeth by applying the decision to

egulatory schemes other than the NDA process

or brand-name drugs. The decisions have used

sweeping language stating that the Wyeth decision

applies to all OTC drugs. That is what the Florida

court did in this case. Another example ts the Sev-

enth Circuit's decision in Robinson v. McNeil Con-

sumer Healthcare, 615 F.3d 861 (7th Cir. 2010).

Robinson relied on Wyeth v. Levine for the propo-

sition that a court is not barred “from holding that

state law requires warnings on the label of an

over-the-counter drug beyond what the FDA has

required.” /d. at 869.

The Robinson court relied upon decisions involv

ing prescription drugs. See Mason vu. SmithKline

Beecham Corp., 596 F.3d 387 (7th Cir. 2010)

(involving the brand-name drug Paxil for treat-

ment of depression); Demahy v. Actavis, 593 F.3d

428 (5th Cir. 2010) (involving a generic drug used

for the treatment of heartburn). The decisions did

not involve OTC drugs subject to Final Mono-

graphs.

This Court’s decision in Wyeth left open the

question of pre-emption with regard to drugs, such

as the OTC drugs at issue here, which are subject

to specific federal labeling regulations. As the

Court stated in Wyeth, “we have no occasion in

this case to consider the pre-emptive effect of a

specific agency regulation bearing the force of

law.” 129 S. Ct. at 1203. By contrast, this case

presents just such an occasion. McNeil’s products

and their labeling had to comply with specific FDA

regulations bearing the force of law and mandat-

ing the exact language to be used on the products’

labeling.

In Wyeth, Justice Breyer concurred to empha-

size the Court’s statement that “we have no occa-

sion in this case to consider the pre-emptive effect

of a specific agency regulation bearing the force of

law.” Id. at 1204 (Breyer, J. concurring). As Jus-

tice Breyer recognized, it is “possible that state

tort law will sometimes interfere with the FDA’s

desire to create a drug label containing a specific

set of cautions and instructions.” /d. That is

exactly the situation presented by the conflict

between Respondent's state-law failure-to-warn

claims and the Final Monograph regime which

required McNeil to place a specific set of cautions

and instructions on its product.

Accepting review will allow this Court to answer

the important pre-emption question left open by

Wyeth by determining whether specific FDA reg-

ulations that require OTC drug manufactures to

comply with the labeling requirements of Final

Monographs pre-empt state law failure-to-warn

claims. Accepting review would provide an oppor-

tunity for this Court to resolve the confusion cre-

ated by lower courts that have given an

overly-broad application to Wyeth.

CONCLUSION

For the foregoing reasons, this Court should

grant the petition for a writ of certiorar}.

Respectfully submitted,

BARRY L. DAVIS

Counsel of Record

KATHLEEN M. O’CONNOR

HOLLY S. HARVEY

a THORNTON, DAVIS & FEIN, P.A.

7 Brickell BayView Centre,

; Suite 2900

80 S.W. 8th Street

Miami, Florida 33130

(305) 446-2646

Attorneys for Petitioner

Dated: November 30. 2010

APPENDIX

THIRD DISTRICT COURT OF APPEAL

STATE OF FLORIDA, JULY TERM, A.D. 2009

Opinion filed December 30, 2009.

Not final until disposition of timely filed

motion for rehearing.

No. 3D08-1563

Lower Tribunal No. 038-9855

ARMANDO VALDES. II]. ETC. ET AL..

Appellants,

OPTIMIST CLUB OF SUNILAND, INC... ET AL..

Appellees.

An Appeal from the Circuit .Court for Miami

Dade County, Daryl W. Trawick, Judge.

Hersch & Talisman and Patrice A. Talisman;

Donna B. Michelson, and Phillip D. Parrish, for

appellants.

Thornton, Davis & Fein and Barry L. Davis and

Michael D. Bon, for appellees.

Before RAMIREZ, C.J., and ROTHENBERG, and

LAGOA, JJ.

RAMIREZ, C.d.

Amando Valdes, III and his parents, appeal the

trial court’s entry of final summary judgment in

favor of the defendants below, McNeil-P.P.C., Inc.

Because we believe the United States Supreme

Court’s decision in Wyeth v. Levine, 129 S.Ct. 1187

(2009), controls the issue of federal preemption

presented in this case, we reverse the trial court’s

determination.

On April 24, 1999, Armando Valdes, III col-

lapsed during a roller hockey game. He had to be

resuscitated at the scene and was then taken toa

hospital. Doctors diagnosed him with having suf-

fered a heat stroke and cardio-respiratory arrest

which resulted in a brain injury, hypoxic ischemic

encephalopathy, and left him completely disabled.

On the morning of his collapse, Armando took

Tylenol Cold, an over-the-counter medication, for

his head cold along with soda. Armando and his

parents filed a negligence and products liability

suit against McNeil, the manufacturer of Tylenol

Cold, as well as the hockey club and equipment

vendor, for Armando’s injuries.

The Valdeses settled with all the defendants

except for defendant McNeil for strict liability and

negligent failure to warn. The Valdeses contended

that the Tylenol Cold medication, which contains

pseudoephedrine, increased the risk of heat-

related illness and heart-related risks when

ingested with caffeinated products and coupled

with strenuous or athletic events in a hot envi-

ronment like that of South Florida. They asserted

that McNeil’s failure to warn of these risks on the

labels of the Tylenol Cold packaging breached

Florida state law requirements.

McNeil filed several affirmative defenses in its

response to the Valdeses’ complaint including fed-

eral preemption. After discovery, McNeil moved for

final summary judgment arguing that federal law,

which governs over-the-counter and non-pre-

scription drugs, and the FDA’s labeling require-

ments, which did not require McNeil to include the

risk of heat-related illness on the label, preempted

the state law claims in the Valdeses’ complaint, 21

U.S.C. § 379r. The lower court agreed and granted

final summary judgment in favor of McNeil. The

Valdeses appealed the decision to this Court.

Because this is an appeal from an order of sum-

mary judgment and calls for a review of an issue

of law, our standard of review is de novo, State v.

Coney, 845 So. 2d 120, 137 (Fla. 2008).

McNeil argues that federal law that governs the

labeling of medication preempts state law require-

ments and bars state law claims from being

brought against it since its label contained the

FDA-approved language. The federal statute in

question states that no State or political subdivi-

sion thereof may establish regulations for drugs

different from those required by that chapter of

the statute unless one of the listed statutory

exceptions applhies, 21 U.S.C. § 379r(b). The excep-

tion at issue, subsection (e), states: “[n]othing in

this section shall be constituted to modify or oth-

erwise affect any action or the liability of any per-

son under the product liability law of any State.”

21 U.S.C. § 379r(e). McNeil concedes that express

preemption does not apply, but argues that

implied preemption is applicable here because

compliance with both state law and federal law is

impossible and, even if not impossible, would frus-

trate the Congressional purposes and objectives

behind the enactment of the statute.

The Court recently decided Wyeth, and the rul-

ing in that case controls our decision here. See

Wyeth v. Levine, 129 S.Ct. 1187 (2009). The facts

in Wyeth are similar to the ones here, and the

arguments made by the prescription drug manu-

facturer are practically identical to those

advanced by McNeil. In Wyeth, the Court found

that:

If Congress thought state-law suits posed

an obstacle to its objectives, it surely

would have enacted an express pre-emp-

tion provision at some point during the

FDCA’s 70-year history. But despite its

1976 enactment of an express pre-emption

provision for medical devices ;

Congress has not enacted such a provision

for prescription drugs ... Its silence on

the issue, coupled with its certain aware-

ness of the prevalence of state tort ltiga-

tion, is powerful evidence that Congress

did not intend FDA oversight to be the

exclusive means of ensuring drug safety

and effectiveness.

Id. at 1200.

McNeil argues that Wyeth is distinguishable

because it dealt with prescription drugs and not

over-the-counter medication like those at issue

here. We disagree with McNeil that the distinction

carries the weight to allow it to circumvent the

reasoning of the Court in Wyeth. After extensively

detailing the historical background of the FDCA

and amendments to the act, the Court found that

the failure of Congress to expressly preempt the

field in light of the long history since enacting the

FDA leads to the conclusion that state actions like

those here “lend force to the FDCA’s premise that

manufacturers, not the FDA, bear primary respon-

sibility for their drug labeling at all times. Thus,

the FDA long maintained that state law offers an

additional, and important, layer of consumer pro

tections that complements the FDA regulation.”

Id. at 1202-03. Additionally, the Court, citing to

the very statutory exception at issue here, stated

in a footnote that the 1997 amendment to the

statute “pre-empted certain state requirements

concerning over-the-counter medications and cos-

metics but expressly preserved product liability

actions. See 21 U.S.C. §§ 379r(e), 379s(d).” Id. at

1200 n.8. This further weakens McNeil’s attempts

to distinguish Wyeth from the facts of this case.

Based on the Court’s holding in Wyeth, we con-

clude that the trial court’s entry of final summary

judgment in McNeil’s favor was in error and

therefore reverse. The federal law that regulates

the labels of over-the-counter medication at issue

here expressly saves this type of state law causes

of action, and there is no implied federal pre.

emption that would keep the Valdeses from going

forward with their suit against McNeil. |

Reversed.

IN THE DISTRICT COURT OF APPEAL

OF FLORIDA

THIRD DISTRICT

JANUARY TERM, A.D. 2010

FEBRUARY 23, 2010

Case No.: 3D08-1563

Lower Tribunal No. 03-9855

ARMANDO VALDES, III, ETC, ET AL.,

Appellant(s)/Petitioner(s),

OPTIMIST CLUB OF SUNILAND. INC... ET AL..

Appellee(s)/ Respondent(s)

Upon consideration, appellee McNeil-P.P.C..,

Inc.’s motion for rehearing and clarification is

hereby denied. RAMIREZ, C.J., and ROTHENBERG

and LAGOA, JJ., concur. Appellee McNeil-P.P.C..,

Inc.'s motion for rehearing en banc is hereby

denied.

[SEAL]

ks oie

David Rutherford

Kdward F. Gagain, III

Donna B. Michelson

Philip D. Parrish

Stephen W. Bazins!}

Barry L. Davis

This cause having heretofore been submitted to

the Court on jurisdictional briefs and portions of

the record deemed necessary to reflect jurisdiction

under Article V, Section 3(b), Florida Constitu

tion, and the Court having determined that it

should decline to accept jurisdiction, it is ordered

that the petition for review is denied

No motion for rehearing will be entertained b\

the Court. See Fla. R. App. P. 9.330(d)(2)

PARIENTE, QUINCE, PO

ael concul

A True Copy

Test:

ls/ THOMAS D. HALL

Thomas D. Hall [SEAL]

Clerk, Supreme Court

Served:

BARRY L. DAVIS

PHILIP DIXON PARRISH

DONNA B. MICHELSON

HON. HARVEY RUVIN, CLERK

HON. MARY CAY BLANKS, CLERK

HON. DARYL E. TRAWICK, JUDGE

1Oa

IN THE CIRCUIT COURT OF THE

11TH JUDICIAL CIRCUIT IN AND FOR

MIAMI-DADE COUNTY, FLORIDA

GENERAL JURISDICTION DIVISION

Case No. 0383-09855 CA 20

ARMANDO VALDES, III, incapacitated, by and

through his legal guardians, ARMANDO VALDES,

JR. and VIOLETTA VALDES, and ARMANDO

VALDES, JR. and VIOLETTA VALDES, individually,

Plaintiffs,

OPTIMIST CLUB OF SUNILAND, INC., OPTIMIST

INTERNATIONAL, MCNEIL-P:P.C., THE SPORTS

AUTHORITY, INC., JOFA AB, KHF Sports OY,

and THE HOCKEY COMPANY

Defendant(s).

ORDER GRANTING DEFENDANT,

MCNEIL-P.P.C., INC."S MOTION FOR

FINAL SUMMARY JUDGMENT

THIS' CAUSE came on to be heard on April 28,

2008 on Defendant, McNei!-P.P.C., Inc.’s Motion

for Final Summary Judgment, and the Court hav

ing heard argument of counsel, having reviewed

lla

the motion and memoranda submitted by the par-

ties, and being otherwise duly advised in the

premises, it is hereupon

ORDERED and ADJUDGED that said Motion is

hereby GRANTED. This Court finds that there are

no genuine issues of material fact in dispute and

that McNeil-P.P.C., Inc. (“McNeil”) is entitled to

judgment as a matter of law. Plaintiffs’ claim

against McNeil—both of which are based upon

failure-to-warn/inadequate warnings—are pre

empted by federal law. The Plaintiffs’ claims are

expressly preempted by 21 U.S.C. § 379r (entitled,

‘National Uniformity for Nonprescription Drugs)

which specifically prohibits states, through a jury

verdict or otherwise, from establishing or contin-

uing in effect any warning requirement for a final

monograph over-the-counter drug that is “differ-

ent from or in addition to, or that is otherwise not

identical with” those required under federal law.

Although 21 U.S.C. § 379r(e) contains a savings

clause, reading the savings clause herein to

exclude the preemption of lawsuits premised on

inadequate labeling or failure-to-warn (as Plain-

tiffs suggest) would make the express preemption

provisions of 21 U.S.C. § 397r(a) a nullity and

would presume that Congress included superflu-

ous provisions or otherwise engaged in an idle act

when it enacted this statute. The United States

Supreme Court has determined that it 1s a fun-

damental] principle that a savings clause should

not be interpreted in such a way as to undercut or

dilute an express preemption clause. See American

Tel. and Tel. Co. v. Central Office Telephone, Inc.,

524 U.S. 214, 228, 118 S.Ct. 1956, 141 L.Ed.2d

12a

222 (1998). “In other words, the act cannot be held

to destroy itself.” Id. quoting Texas & Pacific R

Co. v. Abilene Cotton Oil Co., 204 U.S. 426, 446,

27 5.Ct. 350, 358, 51 L.Ed. 553 (1907).

Additionally, as also stated by the United States

Supreme Court, an express preemption provision

coupled with a savings clause does not, by “nega-

tive implication” or otherwise, “bar the ordinary

working of conflict preemption principles.” Geier

v. American Honda Motor Co., 529 U.S. 861, 869,

120 $.Ct. 1913, 146 L.Ed.2d 914 (2000). As the

non-prescription drug product at issue here is one

that is governed by specific mandatory warnings

set forth in a Final Monograph, both forms of

implied conflict preemption apply: (a) impossi-

bility and (b) frustration-of-purpose: Accordingly,

final summary judgment in favor of McNeil and

against Plaintiffs is warranted under each of

these preemption doctrines.

DONE AND ORDERED in Chambers, at Miami,

Miami-Dade County, Florida, this 14th day

of May, 2008.

ls|/ HON. DARYL E. TRAWICK

HON. DARYL E. TRAWICK

Circuit Court Judge

Copies furnished to all parties listed on the

attached service list

l3a

SERVICE LIST

Donna B. Michelson, Esq.

Donna B. Michelson, P.A.

Counsel for Plaintiffs

2937 S.W. 27th Avenue, Suite 206

Coconut Grove, Florida 33133

Patrice A. Talisman, Esq.

Co-counsel for Plaintiffs

Hersch & Talisman, P.A.

2937 SW 27th Avenue, Suite 206

Coconut Grove, FL 33131

Edward F. Gagain, III Esq.

Marshall, Dennehey, Warner, Coleman & Goggin

Counsel for The Hockey Club, JOFA AB,

KHF Sports Oy and The Sports Authority, Inc.

201: East Kennedy Boulevard, Suite 1100

Tampa, Florida 33602

David S. Rutherford, Esq.

Jennifer H. Pymm, Esq.

Rutherford & Christie, LLP

Co-Counsel for The Hockey Club, JOFA AB,

KHF Sports Oy and The Sports Authority, Inc.

300 East 42nd Street, 18th Floor

New York, New York 10017

Barry L. Davis, Esq.

Michael D. Bon, Esq.

Thornton, Davis & Fein, P.A.

Counsel for McNeil-P.P.C., Ine.

Brickell BayView Centre, Suite 2900

80 Southwest 8th Street

Miam1, Florida 33130

L4a

IN THE CIRCUIT COURT OF THE

11TH JUDICIAL CIRCUIT IN AND FOR

MIAMI-DADE COUNTY, FLORIDA

GENERAL JURISDICTION DIVISION

Case No. 0383-09855 CA 20

ARMANDO VALDES, III, incapacitated, by and

through his legal guardians, ARMANDO VALDES,

JR. and VIOLETTA VALDES, and ARMANDO

VALDES, JR. and VIOLETTA VALDES, individually,

Plaintiffs,

OPTIMIST CLUB OF SUNILAND, INC., OPTIMIST

INTERNATIONAL, MCNEIL-P.P.C., THE SPORTS

AUTHORITY, INC., JOFA AB, KHF Sports OY,

and THE HOCKEY COMPANY,

Defendant(s).

FINAL SUMMARY JUDGMENT FOR

DEFENDANT MCNEIL-P.P.C., INC.

THIS CAUSE having come before the Court on

Defendant, McNeil-P.P.C., Inc.’s Motion for Entry

of Fina! Summary Judgment following this Court’s

entry of the May 14, 2008 Order Granting Defen-

ld5a

dant, McNeil-P.P.C., Inc.’s Motion for Final Sum-

mary Judgment and this Court, having reviewed

the motion and being otherwise fully advised in

the premises, it is hereupon

ORDERED and ADJUDGED that Final Summary

Judgment is hereby entered in favor of Defendant

McNeil-P.P.C., Inc. and against Plaintiffs. Plain-

tiffs, ARMANDO VALDES, II1, by and through his

legal guardians, ARMANDO VALDES, JR. and V1O-

LETTA VALDES, and ARMANDO VALDES, JR. and

VIOLETTA VALDES, individually, take nothing by

this action and that Defendant, McNeil-P.P.C.,

Inc.,-shall go hence without day.

DONE AND ORDERED in Chambers, at Miami,

Miami-Dade County, Florida, this 9th day of June,

2008

[si HON. DARYL E. TRAWICK

HON. DARYL E. TRAWICK

Circuit Court Judge

Copies furnished to all parties listed on the

attached service list

l6a

SERVICE LIST

Donna B. Michelson, Esq.

Donna B. Michelson, P.A.

Counsel for Plaintiffs

2937 S.W. 27th Avenue, Suite 206

Coconut Grove, Florida 33133

Patrice A. Talisman, Esq.

Co-counsel for Plaintiffs

Hersch & Talisman, P.A.

2937 SW 27th Avenue, Suite 206

Coconut Grove, FL 33131

Edward F. Gagain, III, Esq.

Marshall, Dennebey, Warner, Coleman & Goggin

Counsel for The Hockey Club, JOFA AB,

KHF Sports Oy and The Sports Authority, Inc.

201 East Kennedy Boulevard, Suite 1100

Tampa, Florida 33602

David S. Rutherford, Esq.

Jennifer H. Pymm, Esq.

Rutherford & Christie, LLP

Co-Counsel for The Hockey Club, JOFA AB,

KHF Sports Oy and The Sports Authority, Inc.

300 East 42nd Street, 18th Floor

New York, New York 10017

Barry L. Davis, Esq.

Michael D. Bon, Esq.

Thornton, Davis & Fein, P.A.

Counsel for McNeil-P.P.C., Inc.

Brickell BayView Centre, Suite 2900

80 Southwest 8th Street

Miami, Florida 33130

lva

IN THE CIRCUIT COURT OF THE

11TH JUDICIAL CIRCUIT IN AND

FOR DADE COUNTY, FLORIDA

GENERAL JURISDICTION DIVISION

Case No. 03-09855 CA 20

Filed April 23, 20038

ARMANDO VALDES, III, incapacitated, by and

through his legal guardians, ARMANDO VALDES,

JR. and VIOLETTA VALDES, and ARMANDO

, VALDES, JR. and VIOLETTA VALDES, individually,

Plaintiffs,

OPTIMIST CLUB OF SUNILAND, INC., OPTIMIST

INTERNATIONAL, MCNEIL-P.P.C., THE SPORTS

AUTHORITY, INC., JOFA AB, KHF Sports OY,

anc THE HOCKEY COMPANY,

Defendants.

lda

COMPLAINT

Plaintiffs, ARMANDO VALDES, III, incapacitated,

by and through his legal guardians, ARMANDO

VALDES, JR. and VIOLETT* VALDES, and

ARMANDO VALDES, JR. and VIOLETTA VALDES,

individually, sue Defendants, OPTIMIST CLUB OF

SUNILAND, INC. OPTIMIST INTERNATIONAL,

McNEIL-P.P.C., INc., THE SPORTS AUTHORITY,

INc., JOFA AB, KHF SPporTsS Oy, and THE

HOCKEY COMPANY, and allege:

1. This is a cause of action for damages in excess

of $15,000.00 exclusive of interest and costs.

2. As a result of the incident which forms the

basis of this lawsuit, Plaintiff, ARMANDO VALDES,

III, a resident of Miami-Dade County, Florida,

whose date of birth is March 15, 1983, is legally

incapacitated.

3. At all times material, Plaintiffs, ARMANDO

VALDES, JR. and VIOLETTA VALDES, were and are

the natural parents and legal guardians of

ARMANDO VALDES, III, incapacitated; residents of

Miami-Dade County, Florida; over the age of 18

years; and otherwise sul juris.

4. At all times material, Defendant, OPTIMIST

CLUB OF SUNILAND, INC. (hereinafter “SUNILAND

OPTIMISTS”), now dissolved, was a Florida non-

profit corporation with its principal place of busi-

ness in Miami-Dade County, Florida. Among other

things, said Defendant was regularly engaged in

the business of operating, controlling and con-

ducting athletic events and sports leagues, includ-

ing a roller hockey league. Said Defendant was

lYa

chartered as a member Club of Defendant, OPTI-

MIST INTERNATIONAL.

5. At all times material, Defendant, OPTIMIST

INTERNATIONAL, a foreign non-profit corporation

with its principal place of business in St. Louis,

Missouri, was in the business of affiliating Clubs

to, among other things, sponsor, operate, control

and conduct athletic events and sports leagues.

Said Defendant was regularly engaged in said

business in the State of Florida through its

agents, its chartered member Clubs, including

Defendant, SUNILAND OPTIMISTS, as it directed

the programs and established the policies for its

member Clubs and required them to comply with

its directives and policies. As a result, said Defen-

dant was operating, conducting, engaging in and

Carrying on business in the State of Florida and it

was that activity which gave rise to Plaintiff,

ARMANDO VALDES, III's, injury.

6. Defendant, MCNEIL-P.P.C., INC. (hereinafter

“MCNEIL”), was a foreign corporation transacting

business within the State of Florida for profit and

the cause of action which is hereinafter alleged

arose from that business or business venture

being carried on by said Defendant. More specifi-

cally, at all times material, Defendant MCNEIL,

did manufacture Tylenol products, including

Tylenol Cold and Tylenol Flu, outside of the State

of Florida that were sold into the stream of com-

merce with the intent and knowledge that such

products would ultimately be utilized in the State

of Florida, wherein any defects or hazards or

breaches of warranties regarding such products

20a

would or might result in injuries, claims and dam-

ages.

7. At all times material, Defendant, THE

SPORTS AUTHORITY, INC. (hereinafter “SPORTS

AUTHORITY”), was a foreign corporation registered

to and, in fact doing business in the State of

Florida with its principal place of business located

at 3383 N. State Road 7, Ft. Lauderdale, Florida.

Said Defendant was in the business of marketing

and selling sports equipment to the general pub-

lic and did have numerous stores in the State of

Florida, including several in Miami-Dade County,

Florida.

8. Defendant, JOFA AB (hereinafter “JOFA”),

was a foreign corporation transacting business

within the State of Florida for profit and the cause

of action, which is hereinafter alleged, arose from

that business or business venture being carried on

by said Defendant. At all times material, Defen-

dant, JOFA, did manufacture and or distribute

hockey gear, including helmets, outside of the

State of Florida that was sold into the stream of

commerce with the intent and knowledge that

such goods would ultimately be utilized in the

State of Florida, wherein any defects or hazards or

breaches of warranties regarding such goods

would or might result in injuries, claims and dam-

ages. More specifically, prior to April 24, 1999,

Defendant, JOFA, did design, manufacture and or

distribute JOFA brand helmets for ice hockey,

which were then distributed and or sold by said

Defendant to Defendant, SPORTS AUTHORITY, for

retail sale to the public for use in both ice hockey

Zla

and roller hockey and Plaintiffs purchased one of

those helmets.

9. Defendant, KHF Sports OY (hereinafter

“KHF SPORTS”), was a foreign corporation trans-

acting business within the State of Florida for

profit and the cause of action, which is hereinafter

alleged, arose from that business or business ven-

ture being carried on by said Defendant. At all

times material, Defendant, KHF Sports, did

manufacture and/or distribute hockey gear,

including gloves, outside of the State of Florida

that was sold into the stream of commerce with

the intent and knowledge that such goods would

ultimately be utilized in the State of Florida,

wherein any defects or hazards of breaches of war-

ranties regarding such goods would or might

result in injuries, claims and damages. More

specifically, prior April 24, 1999, Defendant, KHF

SPORTS, did design, manufacture and/or distribute

KOHO brand gloves for ice hockey, which were

then distributed and/or sold by said Defendant to

Defendant, SPORTS AUTHORITY, for retail sale to

the public for use in both ice hockey and roller

hockey and Plaintiffs purchased one of those pairs

of gloves.

10. Defendant, THE HOCKEY COMPANY, was a

foreign corporation transacting business within

the State of Florida for profit and the cause of

action, which is hereinafter alleged, arose from

that business or business venture being carried on

by said Defendant. At all times material, Defen-

dant, THE HOCKEY COMPANY, did manufacture

and/or distribute hockey gear, including helmets

and gloves, outside of the State of Florida that

was sold into the stream of commerce with the

intent and knowledge that such goods would ult-

mately be utilized in the State of Florida, wherein

any defects or hazards or breaches of warranties

regarding such goods would or might result in

injuries, claims and damages. More specifically,

prior to April 24, 1999, Defendant, THE HOCKEY

COMPANY, did design and manufacture helmets

and gloves for ice hockey. Said Defendant did then

distribute said helmets and gloves to Defendants,

JOFA and KHF Sports, respectively, for mar-

keting and sale to retailers and the public for use

in both ice hockey and roller hockey. Alterna-

tively, Defendants, JOFA and KHF SPortms,

respectively, designed and manufactured helmets

and gloves and Defendant, THE HOCKEY Com.

PANY, acted as their agent with respect to sales

and distribution of said products within the

United States, including within Florida. Said he]

mets and gloves were sold to Defendant, SPORTS

AUTHORITY, who in turn sold one of the JOFA

brand helmets and one of the KOHO brand pairs

of gloves to the Plaintiffs.

11. Prior to April 24, 1999, Plaintiffs, ARMANDO

VALDES, JR. and VIOLETTA VALDES, did, without

joining SUNILAND OPTIMISTS, sign up their son,

ARMANDO VALDES, II], then a minor, as a partic-

ipant in the SUNILAND OPTIMIS'S’ Youth Roller

Hockey League. They paid the non-club member

fee for their son's participation in the league.

12. Prior to April 24, 1999, Plaintiff, ARMANDO

VALDES, III, accompanied by one or both of his

parents, did go to Sports Authority stores owned

by Defendant, SPORTS AUTHORITY, to shop for and

purchase equipment and gear for his use in the

SUNILAND OPTIMISTS’ Roller Hockey League. On

one or more of those occasions, said Plaintiffs,

upon entering the store, asked for roller hockey

equipment and gear and were directed by Defen-

dant, SPORTS AUTHORITY’s, employees to the area

of the store designated for Hockey. Unappreciated

by the Plaintiffs was the fact that, the hockey gear

in that area was actually designed for ice hockey

use and not for roller hockey use. Plaintiffs result-

ingly purchased a JOFA brand helmet and KOHO

brand gloves from Defendant’s stores, which sub-

jected Plaintiff, ARMANDO VALDES, III, to a

greater risk of heat stroke because the insulation

prevented his body’s normal heat dissipation

through the head and hands.

13: Prior to April 24, 1999, Defendant, SUNI-

LAND OPTIMIST, through its employees and/or

agents, did schedule a game for Plaintiff,

ARMANDO VALDES, III's, youth roller hockey team

for April 24, 1999, at approximately i:00 p.m. at

the Palmetto Golf Course Roller Hockey Rink

where there were no adequate shaded areas for

the participants.

14. On the morning of April 24, 1999, Plaintiff,

ARMANDO VALDES, II], was feeling symptoms of a

head cold or flu and decided to take a cold or flu

medication prior to the game. Plaintiff took

Tylenol Cold or Tylenol Flu medication manufac-

tured by Defendant, MCNEIL, containing pseu-

doephedrine, which Plaintiff, VIOLETTA VALDES,

had previously purchased for the family’s use. It is

also likely that Plaintiff drank a caffeinated soda

that day prior to the game as well.

24a

15. On April 24, 1999, Plaintiff, ARMANDO

VALDES, III] attended and participated in his

team’s roller hockey game at the Palmetto Golf

Course Roller hockey rink. Said game took place

at approximately noon or 1:00 p.m. with the tem-

perature in the 80’s (degrees Fahrenheit). At said

time and place, Plaintiff wore his uniform as well

as required gear including his helmet and gloves.

16. At said time and place, because the team

was shorthanded, Plaintiff, ARMANDO VALDES,

Ill, played most of the game.

17. At said time and place, as the game was

nearing completion, Plaintiff, ARMANDO VALDES,

III, collapsed while on the rink due to heat stroke.

Plaintiff, ARMANDO VALDES, III, suffered a car-

diorespiratory arrest which left him permanently

and significantly brain damaged.

COUNT I—NEGLIGENCE OF DEFENDANT,

SUNILAND OPTIMISTS

Plaintiffs repeat and adopt paragraphs 1]

through 17 above and further allege:

18. At all times material, Defendant, SUNILAND

OPTIMISTS, as sponsor and operator of a youth

roller hockey league, through its employees and/or

agents, had the obligation to operate, control and

conduct said league in a non-negligent way and to

take reasonable precautions to prevent heat ill-

ness 1n its youth athletic participants.

19. Notwithstanding the above, Defendant,

SUNILAND OPTIMISTS, acting through its employ-

25a

ees and/or agents, was negligent in the commis-

sion or omission of the following acts:

a. chose a facility at which'to play its

roller hockey games that was without

adequate shaded areas;

b. scheduled Plaintiff's team’s game for

the heat of the day in April, a month

that is both hot and humid in South

Florida;

c. failed to have in effect and/or to

enforce reasonable policies and pro-

cedures for heat illness prevention

such as, among other ways, limiting

the participants’ playing time, requir-

ing the participants to remove gear

during rest periods to allow for heat

dissipation, providing shaded areas

for appropriate rest periods, schedul-

ing games at cooler times of day and

providing adequate hydration sources;

d. failed to recommend and/or provide

roller hockey gear suitably colored,

ventilated and otherwise appropriate

to be used in the heat and humidity of

South Florida;

e. failed to have a properly trained Com-

missioner and/or Coaches on the sub-

ject of heat illness prevention;

f. failed to warn the league participants

of the risk of heat illness and, partic-

ularly, heat stroke and to instruct

said participants on how to minimize

the risks: and

26a

g. other acts that will be learned of

through discovery.

20. As a direct and proximate result of the

above-described negligence, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

21. As a further direct and proximate result.

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT II—NEGLIGENCE OF OPTIMIST

INTERNATIONAL

Plaintiffs repeat and adopt paragraphs 1

through 17 above and further allege:

22. At all times material, Defendant, OPTIMIST

INTERNATIONAL, through its agents, its affiliated

member Clubs, did sponsor, conduct and operate

athletic events and sports leagues. Said Defendant

did provide directives and policies to its member

Clubs, including Defendant, SUNILAND OPTI-

ws)

—~]

MISTS, concerning the manner and methods of

sponsoring, conducting and operating athietic

events and sports leagues.

23. At all times material, Defendant, OPTIMISTS

INTERNATIONAL, had an obligation, to use rea-

sonable care in overseeing the activities of its

member Clubs and to assure that they took rea-

sonable precautions to prevent heat illness at

their events and league games, particularly the

children and youth leagues.

24. Notwithstanding the above, Defendant,

OPTIMIST INTERNATIONAL, acting through its

employees and/or agents, was negligent in the

commission or omission of the following acts

regarding the operation of its roller hockey

leagues:

a. failed to have in effect and to enforce

reasonable policies and procedures for

heat illness prevention such 4s,

among other ways, limiting the par-

ticipants’ playing time, requiring the

participants to remove gear during

rest periods to allow for heat dissipa-

tion, providing shaded areas for

appropriate rest periods, scheduling

games at cooler times of day and pro-

viding adequate hydration sources:

b. failed to reccommend and/cy provide

roller hockey gear suitably colored,

ventilated and otherwise appropriate

to be used in hot and humid climates;

c. failed to establish heat illness pre-

vention guidelines for use by its mem-

28a

ber clubs to train and instruct the

club’s Commissioners and/or Coaches:

and

other acts that will be learned of

through discovery.

25. As a direct and proximate result of the

above-descrived negligence. Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat strote

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

tne expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

26. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of hospitalization, medical and nursing care and

treatment and have suffered the loss of their son’s

companionship, society, love, affection, and solace

as well as loss of ordinary day-to-day services he

would have rendered. Plaintiffs will suffer these

losses 1n the Future.

COUNT III—STRICT LIABILITY OF MCNEIL

Plaintiffs repeat and adopt paragraphs

through 17 above and further allege:

27. Prior to April 24, 1999, Plaintiff, VIOLETTA

VALDES, purchased Tylenol Cold and Tylenol Flu

for the family’s use when needed. Unappreciated

29a

by the Piaintiffs, Defendant, MCNEIL’s products,

Tylenol Cold and Tylenol Flu, contain the

decongestant, pseudoephedrine, an ephedrine

alkaloid which can produce effects similar to

amphetamines. When pseudoephedrine is used in

combination with caffeine, stimulant effects are

multiplied. Mor sver, because one of the effects of

pseudoephedrine is to constrict blood vessels,

which impairs the body’s ability to dissipate heat,

this in turn increases the risk of heat illness espe-

cially in those participating in athletic events,

such as the Plaintiff, ARMANDO VALDES, III.

28. Tylenol Cold and Tylenol] Flu were designed,

manufactured, assembled, tested, packaged, dis-

tributed and sold by Defendant, MCNEIL, in a

defective condition unreasonably dangerous to the

users, such as Plaintiff, ARMANDO VALDES, II], in

that:

a. said medications failed to warn or to

adequately warn users of the risks

and latent dangers inherent in the

use of them in their normal and

intended manner, particularly, when

users are also ingesting caffeinated

products and participating in athletic

or strenuous events in a hot climate;

and

b. said medications failed to instruct or

to adequately instruct users on how

and when to use them.

29. Due to the defects described in Paragraph

28, the Tylenol Cold or Tylenol Flu taken by

Plaintiff, ARMANDO VALDES, III, which was

30a

designed, manufactured, assembled, tested, pack-

aged, distributed and sold by Defendant MCNEIL,

was not reasonably fit for the purposes for which

it was intended or for the purposes reasonably

foreseeable at the time of its design, manufacture,

assembly, packaging, distribution and sale.

30. Due to the defects described in Paragraph

28, the Tylenol Cold or Tylenol Flu taken by

Plaintiff, ARMANDO VALDES, [II, which was

designed, manufactured, assembled, tested, pack-

aged, distributed and sold by Defendant, MCNEIL,

was placed on the market in a defective or inher-

ently dangerous condition.

31. Due to the defects described in Paragraph

28, the Tylenol Cold or Tylenol Flu taken by

Plaintiff, ARMANDO VALDES, III, was unreason

ably dangerous because of its design, manufac-

ture, assembly, testing, packaging, distribution

and sale in that the risk of danger to users, such

as Plaintiff, outweighed the benefits of the prod-

uct.

32. Due to the defects described in Paragraph

28, the Tylenol Cold or Tylenol Flu taken.by

Plaintiff, ARMANDO VALDES, III, was dangerous

beyond the expectation of the ordinary user when

used as intended or in a manner reasonably fore-

seeable to the Defendant, MCNEIL.

33. Plaintiffs were unaware of the defective and

unreasonably dangerous condition of the Defen-

dant’s medications.

34. Defendant, MCNEIL, knew or should have

know that its medication would be used without

inspection for defects, and by placing it on the

Sla

market represented tnat it would safely do the job

for which 1¢ was intended.

35. As a direct and proximate result of the

defects described above, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, ‘nconve-

nience, loss of capacity for the enjoymet.t of life

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

36. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES JR., III and VIO-

LETTA VALDES, individually, have incurred the

expense of their son’s hospitalization, medical and

nursing care and treatment and have suffered the

loss of their son’s companionship, society, love,

affection, and solace as well as loss of ordinary

day-to-day services he would have rendered.

Plaintiffs will suffer these losses in the future.

COUNT IV—NEGLIGENCE OF

DEFENDANT, MCNEIL

Plaintiffs repeat and adopt paragraphs 1

through 17 and 27 above and further allege:

37. At all times material hereto, Defendant,

MCNEIL, had a duty to design, manufacture,

assemble, test, package, distribute and sell its

medications and to provide warnings to be utilized

and relied on by users in a manner that would

make said medications, and in particular the med-

‘ye

32a

ication at issue in this case, reasonably safe for

use.

38. At all times material hereto, Defendant,

MCNEIL, breached said duties owing to the Plain-

tiffs by failing to exercise reasonable care in the

design, manufacture, assembly, testing, packag-

ing, distribution and sale of the subject medica-

tions for the reasons set forth in Paragraph 28.

39. At all times material hereto, Defendant,

MCNEIL, knew, or in the exercise of reasonable

care should have known, that its acts and omis-

sions with respect to the design, manufacture,

assembly, testing, packaging, distribution and

sale of the subject medication, together with its

lack of warnings, would result in injury to users,

such as the Plaintiff, ARMANDO VALDES, III.

40. As a direct and proximate result of the

above-described negligence, the subject medication

caused the Plaintiff, ARMANDO VALDES, III, to

suffer heat stroke resulting in bodily injury,

including brain damage, pain and suffering, dis-

ability, physical impairments, disfigurement, loss

of capacity for the enjoyment of life, the expenses

of hospitalization, medical and nursing care and

treatment, and loss of wage earning capacity.

These injuries are permanent in nature and the

Plaintiff will suffer these losses in the future.

41. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

oda

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT V—STRICT LIABILITY OF SPORTS

AUTHORITY

‘Plaintiffs repeat and adopt Paragraphs 1

through 17 and further allege:

42. At all times material, Defendant, SPORTS

AUTHORITY, was involved in the marketing, dis-

tribution and sale of hockey gear to the public.

Defendant, SPORTS AUTHORITY, did market, dis-

tribute and sell ice hockey gear as roller hockey

gear, including the JOFA brand helmet and

KOHO brand gloves which were purchased by the

Plaintiffs.

“43. The JOFA brand helmet and KOHO brand

gloves at issue in this case were designed, manu-

factured, tested, packaged, marketed, distributed

and sold by Defendant, SPORTS AUTHORITY, in a

defective condition unreasonably dangerous to

roller hockey users, such as Plaintiff, ARMANDO

VALDES, III, in that:

a. said gear was not adequately venti

lated, colored and otherwise appro

priate for use in roller hockey in a hot

climate;

b. said gear failed to warn or to ade

quately warn users of the risks and

latent dangers inherent in using ice

hockey gear for roller hockey in a hot

climate; and

34a

c. said gear failed to instruct or to ade-

quately instruct roller hockey users of

how and when to use the gear.

44. Due to the defects described in Paragraph

43, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, SPORTS

AUTHORITY, were not reasonably fit for the pur-

poses for which they were intended or for the pur-

poses reasonably foreseeable at the time of

marketing, distribution and sale by Defendant,

SPORTS AUTHORITY.

45. Due to the defects described in Paragraph

43, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, SPORTS

AUTHORITY, were placed on the market in a defec-

tive or inherently dangerovs condition.

16. Due to the defects described in Paragraph

43, the JOFA brand helmet and KOHO brand

gloves and sold to Plaintiff by Defendant, SPORTS

AUTHORITY, were unreasonably dangerous

because the risk of danger to users, such as Plain-

tiff, ARMANDO VALDES, III, outweighed the ben-

efits of the product.

47. Due to the defects cescribed in Paragraph

43, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, SPORTS

AUTHORITY, were dangerous beyond the expecta

tion of the ordinary user when used as intended or

in a manner reasonably foreseeable to the Defen

dant, SPORTS AUTHORITY.

48. Plaintiffs were unaware of the defective and

unreasonably dangerous condition of the JOFA

brand helmet and KOHO brand gloves at issue in

this case

19. Defendant, SPORTS AUTHORITY, knew or

should have known that its hockey gear would be

used without inspection for defects, and by placing

it on the market represented that it would safely

do the job for which it was intended

50. As a direct and proximate result of the

defects described above, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, menial anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the futur

51. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son's hospitalization, medical and nursing

care and treatment and have suffered the loss of!

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future

COUNT VI—BREACH OF WARRANTY BY

SPORTS AUTHORITY

Plaintifi repeat and adopt Paragraph

through 17, 42 and 43 and further allege

36a

52. At all times material, Defendant, SPORTS

AUTHORITY, warranted that the hockey gear it

sold was reasonably fit for its intended use for all

types of hockey, including roller hockey played

outdoors in the hot and humid climate of South

Florida.

53. Plaintiffs purchased hockey gear from

Defendant, SPORTS AUTHORITY, as more specifi-

cally described in paragraph 12.

54. Due to the defects described in Paragraph

43, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, SPORTS

AUTHORITY, were not reasonably fit for the pur

poses for which they were intended or for the pur-

poses reasonably foreseeable to Defendant at the

time of sale.

55. Due to the defects describec in Paragraph

13, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, SPORT:

AUTHORITY, were not reasonably fit for the spe-

cific purpose for which Defendant, SPORTS

AUTHORITY, knowingly sold them and for which

Plaintiff bought them in rehance on the judgment

of Defendant, SPORTS AUTHORITY.

56. As a direct and proximate result of,the

breaches described above, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair

ment, disfigurement, mental anguish, inconve

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs

ing care and treatment, and loss.of wage earning

oia

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

57. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT VII—NEGLIGENCE OF SPORTS

AUTHORITY

Plaintiffs repeat and adopt Paragraphs 1

through 17 and 42 and further allege:

~58. At all times material, Defendant, SPORTS

AUTHORITY, had a duty to market, recommend

and sell hockey gear in a reasonably safe manner

and to provide warnings to be utilized and relied

on by users in a manner that would make said

gear, and in particular the gear at issue in this

case, reasonably safe for use.

59. At all times material, Defendant, SPORTS

AUTHORITY, breached said duties owing to the

Plaintiffs by failing to exercise reasonable care in

the marketing, recommendation of and sale of the

hockey gear at issue in this case for the reasons

set forth in Paragraph 43 above.

60. At all times material, Defendant, SPORTS

AUTHORITY, Knew, or in the exercise of reasonable

care, should have known, that its acts and omis-

Ioa

sions with respect to the marketing, recommen-

dation of and sale of the hockey equipment at

issue 1n this case, together with its lack of warn-

ings and instructions, would result in tnjury to

users such as Plaintiff, ARMANDO VALDES, III.

61. As a direct and proximate result of the

above-described negligence, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

62. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT VIII—STRICT LIABILITY OF JOFA

Plaintiffs repeat and adopt Paragraphs 1

through 17 above and further allege:

63. Defendant, JOFA’s, helmet which is at issue

in this case, was designed, manufactured, assem-

bled, tested, packaged, marketed, distributed and

39a

sold by Defendant, JOFA, in a defective condition

unreasonably dangerous to roller hockey users,

such as the Plaintiff, in that:

a. it was inadequately ventilated for use

in outdoor roller hockey in_ hot

climates;

_b. it was improperly colored for use in

outdoor roller hockey in hot climates;

c. it did not contain adequate warnings

concerning its use in hot climates; and

d. it did not contain adequate instruc-

tions concerning its use in _ hot

climates.

64. Due to the defects described in Paragraph

63, the helmet designed, manufactured, assem-

bled, tested, packaged, marketed, distributed and

sold by Defendant, JOFA, was not reasonably fit

for the purposes for which it was intended or for

the purposes reasonably foreseeable at the time of

its design, manufacture, assembly, testing, pack-

aging, marketing, distribution and sale.

65. Due to the defects described in Paragraph

63, the JOFA brand helmet sold to Plaintiff by

Defendant, JOFA was not reasonably fit for the

purposes for which it was intended at the time of

marketing, distribution and sale.

66. Due to the defects described in Paragraph

63, the JOFA brand helmet sold to Plaintiff was

placed on the market in a defective or inherently

dangerous condition.

40a

67. Due to the defects described in Paragraph

63, the JOFA brand helmet sold to Plaintiff was

unreasonably dangerous because the risk of dan-

ger to users, such as Plaintiff, ARMANDO VALDES,

111, outweighed the benefits of the product.

68. Due to the defects described in Paragraph

63, the JOFA brand helmet sold to Plaintiff was

dangerous beyond the expectation of the ordinary

user when used as intended or in a manner rea-

sonably foreseeable to the Defendant, JOFA.

69. Plaintiffs were unaware of the defective and

unreasonably dangerous condition of the JOFA

brand helmet at issue in this case.

70. Defendant, JOFA, knew or should have

known that its helmet would be used without

inspection for defects, and by placing it on the

market Defendant, JOFA, represented that it

would safely do the job for which it was intended.

71. As a direct and proximate result of the

defects described above, Plaintiff, ARMANDO

VALDES, II], incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

72. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

4la

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT IX—NEGLIGENCE OF JOFA

Plaintiffs repeat and adopt Paragraphs 1

through 17 and further allege:

73. At all times material, Defendant, JOFA, had

a duty to design, manufacture, assemble, test,

package, market, distribute and sell hockey hel-

mets in a reasonably safe manner and to provide

‘warnings to be utilized and relied on by users in a

manner that would make said gear, and in par-

ticular the gear at issue in this case, reasonably

safe for use.

74. At all times material, Defendant, JOFA,

breached said duties owing to the Plaintiffs by

failing to exercise reasonable care in the design,

manufacture, assembly, testing, packaging, mar-

keting, distribution and sale of the .ockey helmet

at issue in this case for the reasons set forth in

Paragraph 63 above.

75. At all times material, Defendant, JOFA,

knew, or in the exercise.of reasonable care, should

have known, that its acts and omissions with

respect to the design, manufacturing, assembly,

testing, packaging, marketing, distribution and

sale of the hockey helmet at issue in this case,

together with its lack of warnings and instruc-

tions, would result in injury to users such as

Plaintiff, ARMANDO VALDES, III.

76. As a direct and proximate result of the

above-described negligence, Plaintiff, ARMANDO

VALDES, I!I, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

77. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their scn’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT X—STRICT LIABILITY OF KHF

SPORTS

Plaintiffs repeat and adopt Paragraphs 1

through 17 above and further allege:

78. Defendant, KHF Sportrs, KOHO brand

gloves which are at issue in this case, were

designed, manufactured, assembled, tested, pack-

aged, marketed, distributed and sold by Defen-

dant, KHF SporRrs, in a defective condition

43a

unreasonably dangerous to roller hockey users,

such as the Plaintiff, in that:

a. they were inadequately ventilated for

use in outdoor roller hockey in hot

climates;

b. they were improperly colored for use

in outdoor roller hockey in hot

climates;

c. they did not contain adequate warn-

ings concerning their use in hot

climates; and

d. ‘they did not contain adequate instruc

tions concerning their use in hot

climates;

79. Due to the defects described in Paragraph

78. the gloves designed, manufactured, assembled,

‘tested, packaged, marketed, distributed and sold

by Defendant, KHF SPORTS, were not reasonably

fit for the purposes for which they were intended

or for the purposes reasonably foreseeable at the

time of their design, manufacture, assembly, test-

ing, packaging, marketing, distribution and sale.

80. Due to the defects described in Paragraph

78, the KOHO brand gloves sold to Plaintiff by

Defendant, KHF SPORTS, were not reasonably fit

for the purposes for which they were intended at

the time of marketing, distribution and sale by

Defendant, KHF SPORTS.

81. Due to the defects described in Paragraph

78, KOHO brand gloves sold to Plaintiff by Defen-

dant, KHF SPORTS, were placed on the market in

a defective or inherently dangerous condition.

44a

82. Due to the defects described in Paragraph

78, the KOHO brand gloves sold to Plaintiff were

unreasonably dangerous because the risk of dan-

ger to users, such as Plaintiff, ARMANDO VALDES,

III, outweighed the benefits of the product.

83. Due to the defects described in Paragraph

78, the KOHO brand gloves sold to Plaintiff were

dangerous beyond the expectation of the ordinary

user when used as intended or in a manner rea-

sonably foreseeable to the Defendant, KHF

SPORTS.

84. Plaintiffs were unaware of the defective and

unreasonably dangerous condition of the KOHO

brand gloves at issue in this case.

85. Defendant, KHF SPORTS, knew or should

have known that its hockey gloves would be used

without inspection for defects, and by placing

them on the market, Defendant, KHF SPORTS,

represented that they would safely do the job for

which they were intended.

86. As a direct and proximate result of the

defects described above, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

87. As a jurther direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT XI—NEGLIGENCE OF KHF SPORTS

Plaintiffs repeat and adopt Paragraphs 1

through 17 and further allege:

88. At all times material, Detendant, KHF

SPORTS, had a duty to design, manufacture,

assemble, test, package, market, distribute and

sell: hockey gloves in a reasonably safe manner

and to provide warnings to be utilized and relied

on by users 1n a manner that would make said

gear, and in particular the gear at issue in this

case, reasonably safe for use.

89. At all times material, Defendant, KHF

SPORTS, breached said duties owing to the Plain-

tiffs by failing to exercise reasonable care in the

design, manufacturing, assembly, testing, pack-

aging, marketing, distribution and sale of the

hockey gloves at issue in this case for the reasons

set forth in Paragraph 78 above.

90. At all times material, Defendant, KHF

SPORTS, knew, or in the exercise of reasonable

care, should have known, that its acts and omis-

sions with respect to the design, manufacturing,

assembly, testing, packaging, marketing, distri-

bution and sale of the hockey gloves at issue in

this case, together with their lack of warnings and

A6a

instructions, would result in injury to users such

as Plaintiff, ARMANDO VALDES, III.

91. As a direct and proximate result of the

above-described negligence, Plaintiff, ARMANDO

VALDES, II], incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

92. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT XII—STRICT LIABILITY OF THE

HOCKEY COMPANY

Plaintiffs repeat and adopt Paragraphs 1

through 17 above and further allege:

93. Defendant, THE HOCKEY COMPANY’s, hel-

met°and gloves which are at issue in this case,

were designed, manufactured, assembled, tested,

packaged, marketed, distributed and sold by

Defendant, THE HOCKEY COMPANY, in a defective

47a

condition unreasonably dangerous to roller hockey

users, such as the Plaintiff, in that:

a. they were inadequately ventilated for

use in outdoor roller hockey in hot

climates;

b. they were improperly colored for use

in outdoor roller hockey in _ hot

climates;

c. they did not contain adequate warn

ings concerning their use in_ hot

climates; and

d. they did not contain adequate instruc

tions concerning their use in hot

weather conditions.

94. Due to the defects described in Paragraph

93,*the helmet and gloves designed, manufac-

tured, assembled, tested, packaged, marketed, dis-

tributed and sold by Defendant, THE HOCKEY

COMPANY, were not reasonably fit for the pur

poses for which they were intended or for the pur-

poses reasonably foreseeable at the time of their

design, manufacture, assembly, testing, packag

ing, distribution and sale.

95. Due to the defects described in Paragraph

93, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, THE

HOCKEY COMPANY, were not reasonably fit for the

purposes for which they were intended at the time

of their design, manufacturing, assembly, testing,

packaging, marketing, distribution and sale.

96. Due to the defects described in Paragraph

93, the JOFA brand helmet and KOHO brand

48a

gloves sold to Plaintiff by Defendant, THE

HOCKEY COMPANY, were placed on the market in

a defective or inherently dangerous condition.

97. Due to the defects described in Paragraph

93, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, THE

HOCKEY COMPANY, were unreasonably dangerous

because the risk of danger to users, such as Plain-

tiff, ARMANDO VALDES, III, outweighed the ben-

efits of the products.

98. Due to the defects described in Paragraph

93, the JOFA brand helmet and KOHO brand

gloves sold to Plaintiff by Defendant, THE

HOCKEY COMPANY, were dangerous beyond the

expectation of the ordinary user when used as

intended or in a manner reasonably foreseeable to

the Defendant, THE HOCKEY COMPANY.

99. Plaintiffs were unaware of the defective and

unreasonably dangerous condition of the JOFA

brand helmet and KOHO brand gloves at issue in

this case.

100. Defendant, THE HOCKEY COMPANY, knew

or should have known that its hockey gear would

be used without inspection for defects, and by

placing it on the market represented that it would

safely do the job for which it was intended.

101. As a direct and proximate result of the

defects described above, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

49a

the expense of hospitalization, medical and nurs

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future

102. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

COUNT XIII—NEGLIGENCE OF THE

HOCKEY COMPANY

Plaintiffs repeat and adopt Paragraphs 1

through 17 and further allege:

103. At all times material, Defendant, THE

HOCKEY COMPANY, had a duty to design, manu

facture, assemble, test, package, market, dis-

tribute and sell hockey gear in a reasonably safe

manner and to provide warnings to be utilized and

relied on by users in a manner that would make

said gear, and in particular the gear at issue i!

this case, reasonably safe for use.

104. At all times material, Defendant, THE

HOCKEY COMPANY, breached said duties owing to

the Plaintiffs by failing to exercise reasonable care

in the design, manufacturing, assembly, testing,

packaging, marketing, distribution and sale of the

hockey gear at issue in this case for the reasons

set forth in Paragraph 93 above

50a

105. At all times material, Defendant, THE

HOCKEY COMPANY, knew, or in the exercise of

reasonable care, should have known, that its acts

and omissions with respect to the design, manu-

facturing, assembly, testing, marketing, distnri-

bution and sale of the hockey equipment at issue

in this case, together with its lack of warnings and

instructions, would result in injury to users such

as Plaintiff, ARMANDO VALDES, III.

106. As a direct and proximate result of the

above-described negligence, Plaintiff, ARMANDO

VALDES, III, incapacitated, suffered heat stroke

resulting in bodily injury, including brain damage,

pain and suffering, disability, physical impair-

ment, disfigurement, mental anguish, inconve-

nience, loss of capacity for the enjoyment of life,

the expense of hospitalization, medical and nurs-

ing care and treatment, and loss of wage earning

capacity. The injuries are permanent in nature

and Plaintiff will suffer these losses in the future.

107. As a further direct and proximate result,

Plaintiffs, ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, have incurred the expense

of their son’s hospitalization, medical and nursing

care and treatment and have suffered the loss of

their son’s companionship, society, love, affection,

and solace as well as loss of ordinary day-to-day

services he would have rendered. Plaintiffs will

suffer these losses in the future.

Wherefore, Plaintiffs, ARMANDO VALDES, III,

incapacitated, by and through his legal guardians,

ARMANDO VALDES, JR. and VIOLETI'A VALDES,

and ARMANDO VALDES, JR. and VIOLETTA

VALDES, individually, sue Defendants, OPTIMIST

a ©

Dla

CLUB OF SUNILAND, INC., OPTIMIST INTERNA-

TIONAL, MCNEIL-P.P.C., INC., Tike SPORTS

AUTHORITY, INC., JOFA AB, KHE Sports OY,

and Til HOCKEY COMPANY, for compensatory

damayves and demand trial by jury.

LAW OFFICES OF SHARON L. BLAKE

9200 S. Dadeland Blvd., Ste. 311

Miami, Florida 33156

(305) 670-2223: (305) 670-2234 (Fax)

AND

SILVER, GARVETT & HENKEL, PLA.

1110 Brickell Avenue

9th Floor, Penthouse One

Miami, FL 33131-3139

(305) 377-8802; (305) 377-8804 (Fax)

AND

DONNA B. MICHELSON, P.A.

1110 Brickell Avenue

9th Floor, Penthouse One

Miami, FL 33131-3139

(305) 579-5722; (3805) 377-8804 (Fax)

ls/ Donna B. Michelson

Donna B. Michelson, Esq.

Florida Bar No.: 805677

H2a

Article. V. —- Amendment

The Congress, whenever two thirds of both

Houses shall deem it necessary, shall propose

Amendments to this Constitution, or, on the

Application of the Legislatures of two thirds of the

several States, shall call a Convention for propos-

ing Amendments, which, in cither Case, shall be

valid to all Intents and Purposes, as part of this

Constitution, when ratified by the Legislatures of

three fourths of the several States, or by Con-

ventions in three fourths thereof, as the one or the

other Mode of Ratification may be proposed by the

Congress; Provided that no Amendment which

may be made prior to the Year One thousand eight

hundred and eight shallin any Manner affect the

first and fourth Clauses in the Ninth Section of

the first Article; and that no State, without its

Consent, shall be deprived of its equal Suffrage in

the Senate.

Article. VI. — Debts, Supremacy, Oaths

All Debts contracted and Engagements entered

into, before the Adoption of this Constitution,

shall be as valid against the United States under

this Constitution, as under the Confederation.

This Constitution, and the Laws of the United

States which shall be made in Pursuance thereof;

and all Treaties made, or which shall be made,

under the Authority of the United States, shall be

the supreme Law of the Land; and the Judges in

every State shall be bound thereby, any Thing in

the Constitution or Laws of any State to the Con-

trary notwithstanding.

The Senators and Representatives before men-

tioned, and the Members of the several State Ley-

58a

islatures, and all executive and judicial Officers,

both of the United States and of the several

States, shall be bound by Oath or Affirmation, to

support this Constitution; but no religious Test

shall ever be required as a Qualification to any

Office or public Trust under the United States.

Article. VII. — Ratification

The Ratification of the Conventions of nine

States, shall be sufficient for the Establishment of

this Constitution between the States so ratifying

the Same.

Done in Convention by the Unanimous Consent

of the States present the Seventeenth Day of

September in the Year of our Lord one thousand

seven hundred and Eighty seven and of the Inde-

pendence of the United States of America the

Twelfth. In Witness whereof We have hereunto

subscribed our Names.

21 C.F.R. § 341.80

§ 341.80 Labeling of nasal decongestant

drug products.

(a) Statement of identity. The labeling of the

product contains the established name of the drug,

if any, and identifies the product as a “nasal

decongestant.”

(b) Indications. The labeling of the product

states, under the heading “Indications,” the

phrase listed in paragraph (b)(1) of this section, as

appropriate, and may contain any additional

phrases listed in paragraph (b)(2) of this section.

Other truthful and nonmisleading statements,

describing only the indications for use that have

been established and listed in paragraphs (b)(1)

and (b)(2) of this section, may also be used, as pro-

vided in § 3830.1(c)(2) of this chapter, subject to the

provisions of section 502 of the Federal Food,

Drug, and Cosmetic Act (the act) relating to mis-

branding and the prohibition in section 301(d) of

the act against the introduction or delivery for

introduction into interstate commerce of unap-

proved new drugs 1n violation of section 505(a) of

the act.

(1) (Select one of the following: “For the

temporary relhef of nasal congestion” or “Tem-

porarily relieves nasal congestion”) (which

may be followed by any of the following in

paragraphs (b)(1) @), (11), and (111) of this sec-

tion):

(1) “due to” (select one of the following: “the

common cold” or “a cold”).

AR.

IVA

(11) “due to” (select one of the following: “hay

fever,” “hay fever (allergic rhinitis),” “hay

fever or other upper respiratory allergies,” or

“hay fever or other upper respiratory allergies

(allergic rhinitis)”).

(2) In addition to the information identified

in paragraph (b)(1) of this section, the labeling

of the product may contain any (one or more)

of the following statements:

Qa) (Select one of the following: “For the tem-

porary relief of or “Temporarily relieves”)

(select one of the following: “stuffy nose,”

=““stopped up nose,” “nasal stuffiness,” or

“clogged up nose.”)

(ii) (Select one of the following: “Reduces

2swelling of,” “Decongests,” or “Helps clear”)

“nasal passages; shrinks swollen membranes.”

Gil) “Temporarily restores freer breathing

through the nose.”

(iv) “Helps decongest sinus openings and

passages; temporarily relieves sinus conges-

tion and pressure.”

(v) “Promotes nasal and/or sinus drainage;

temporarily relieves sinus congestion and

pressure.”

tains the following warnings under the heading

“Warnings”

(1) Oral nasal decongestants

GQ) For products containing phenylephrine

hydrochloride, pseudoephedrine hydrochlo-

56a

ride, pseudoephedrine sulfate, or phenyle-

phrine bitartrate identified in § 341.20 (a)(1)

through (a)(4) when labeled for adults.

(A) “Do not exceed recommended dosage.

(first sentence in boldface type] Hf ner-

vousness, dizziness, or sleeplessness occur,

discontinue use and consult a doctor.”

(B) “If symptoms do not improve within 7

days or are accompanied by fever, consult a

doctor.”

heart disease, high blood pressure, thyroid

disease, diabetes, or difficulty in urination

due to enlargement of the prostate gland

unless directed by a doctor.”

(D) Drug interaction precaution. “Do not

use if you are now taking a prescription

monoamine oxidase inhibitor (MAOT) (cer-

tain drugs for depression, psychiatric, or

emotional conditions, or Parkinson's dis-

ease), or for 2 weeks after stopping the

MAOI drug. If you do not know if your pre-

scription drug contains an MAOI, ask a

doctor or pharmacist before taking this

product.”

(ii) For products containing phenylephrine

hydrochloride, pseudoephedrine hydrochlo-

ride, pseudoephedrine sulfate, or phenyle-

phrine bitartrate identified in § 841.20 (a)(1)

through (a)(4) when labeled for children under

12 years of age.

57a

(A) “Do not exceed recommended dosage.

[first sentence in boldface type] If ner-

vousness, dizziness, or sleeplessness occur,

discontinue use and consult a doctor.”

(B) “If symptoms do not improve within 7

days or are accompanied by fever, consult a

doctor.”

who has heart disease, high blood pressure,

thyroid disease, or diabetes unless directed

by a doctor.”

(D) Drug interaction precaution. “Do not

use ina child who is taking a prescription

monoamine oxidase inhibitor (MAOI) (cer-

tain drugs for depression, psychiatric, or

emotional conditions, or Parkinson’s dis-

ease), or for 2 weeks after stopping the

MAOI drug. If you do not know if your

child’s prescription drug contains an

MAOI, ask a doctor or pharmacist before

giving this product.”

(iii) For oral nasal decongestant products

labeled for both adults and children under 12

years of age. The labeling of the product con-

tains the warnings identified in paragraph

(c)(1)Q) of this section.

(2) Topical nasal decongestants—

(i) For products containing any topical nasal

decongestant identified in § 341.20(b) when

labeled for adults.

(A) “Do not exceed recommended dosage.”

[sentence 1n boldface type]

58a

(B) “This product may cause temporary

discomfort such as burning, stinging,

sneezing, or an increase in nasal dis-

charge.”

than one person may spread infection.”

(ii) For products containing levmetamfe-

tamine identified in § 341.20(b)(1) when used

in an inhalant dosage form and when labeled

for adults. “Do not use this product for more

than 7 days. Use only as directed. Frequent or

prolonged use may cause nasal congestion to

recur or worsen. If symptoms persist, ask a

doctor.”

(iii) For products containing ephedrine,

ephedrine hydrochloride, ephedrine sulfate,

naphazoline hydrochloride, oxymetazoline

hydrochloride, phenylephrine hydrochloride,

or xylometazoline hydrochioride identified in

§ 341.20(b)(2), (b)(3), (b)(4), (b)(6), (6) (7),

(b)(8), and (b)(10) when used as nasal sprays,

drops, or jelhes and when labeled for adults.

(A) “Do not use this product for more

than 3 days. Use only as directed. Frequent

or prolonged use may cause nasal conges-

tion to recur or worsen. If symptoms per-

sist, consult a doctor.”

(B) “Do not use this product if you have

heart disease, high blood pressure, thyroid

disease, diabetes, or difficulty in urination

due to enlargement of the prostate gland

unless directed by a doctor.”

59a

(iv) For products containing naphazoline

hydrochloride identified in § 341.20(b)(6) at a

concentration of 0.05 percent. “Do not use this

product in children under 12 years of age

because it may cause sedation if swallowed.”

(v) For products containing propylhexedrine

identified in § 341.20(b)(9) when used in an

inhalant dosage form and when labeled for

adults. “Do not use this product for more than

3 days. Use only as directed. Frequent or pro-

longed use may cause nasal congestion to

recur or worsen. If symptoms persist, consult

a doctor.”

(vi) For products containing any topical

nasal decongestant identified in § 341.20(b)

.When labeled for children under 12 years of

age. The labeling of the product contains the

warnings identified in paragraph (c)(2)() of

this section.

(vil) For products containing levmetamfe-

tamine identified in § 341.20(b)(1) when used

in an inhalant dosage form and when labeled

for children under 12 years of age. “Do not use

this product for more than 7 days. Use only as

directed. Frequent or prolonged use may cause

nasal congestion to recur or worsen. If symp-

toms persist, ask a doctor.”

(vill) For products containing ephedrine,

ephedrine hydrochloride, ephedrine sulfate,

naphazoline hydrochloride, oxymetazoline

hydrochloride, phenylephrine hydrochloride,

or xylometazoline hydrochloride identified in

§ 341.20(b)(Z), (b)(3), (b)(4), (b)(6), (b)(7),

(b)(8), and (b)(10) when used as nasal sprays,

60a

drops, or jellies and when labeled for children

under 12 years of age.

(A) “Do not use this product for more

than 3 days. Use only as directed. Frequent

or prolonged use may cause nasal conges-

tion to recur or worsen. If symptcms per-

sist, consult a doctor.”

(B) “Do not use this product in a child

who has heart disease, high blood pressure,

thyroid disease, or diabetes unless directed

by a doctor.”

(ix) For products containing propyl-

hexedrine identified in § 341.20¢b)(9) when

used in an inhalant dosage form and when

labeled for children under 12 years of age. “Do

not use this product for more than 3 days. Use

only as directed. Frequent or prolonged use

may cause nasal congestion to recur or

worsen. If symptoms persist, consult a doctor.”

(x) For topical nasal decongestant products

labeled for both adults and for children under

12 years of age. The labeling of the product

contains the applicable warnings identified in

paragraphs (c)(2)(1), (c)(2)(i1), (c)(2)(i11), and

(c)(2)(v) of this section.

(d) Directions. The labeling of the product con-

tains: the following information under the heading

“Directions”:

(1) Oral nasal decongestants—

(i) For products containing phenylephrine

hydrochloride identified in § 341.20(a)(1).

Adults and children 12 years of age and over:

6la

10 milligrams every 4 hours not to exceed 60

milligrams in 24 hours. Children 6 to under

12 years of age: 5 milligrams every 4 hours

not to exceed 30 milligrams in 24 hours. Chil-

dren 2 to under 6 years of age: 2.5 milligrams

every 4 hours not to exceed 15 milligrams in

24 hours. Children under 2 years of age: con-

sult a doctor.

(11) For products containing pseu-

doephedrine hydrochloride or pseu-

doephedrine sulfate identified in § 341.20

(a)(2) and (a)(3). Adults and children 12 years

of age and over: 60 milligrams every 4 to 6

hours not to exceed 240 milligrams in 24

hours. Children 6 to under 12 years of age: 30

milligrams every 4 to 6 hours not to exceed

-120 milligrams in 24 hours. Children 2 to

“under 6 years of age: 15 milligrams every 4 to

-. 6 hours not to exceed 60 milligrams in 24

hours. Children under 2 years of age: consult

a doctor.

(111) For products containing phenylephrine

bitartrate identified in § 341.20(a)(4). Include

information on the number of dosage units

and the quantity of water the dosage units are

to be dissolved in prior to administration as

shown in the following table:

Age' Dose!

Adults and children 12 years 15 6 milligrams every 4 hours not

of age and over to exceed 62 4 milligrams in 24 hours

7.8 milligrams every 4 hours not to

exceed 31 2 milligrams in 24 hours

Children 6 to 12 under of age

Children under 6 years of age Ask a doctor

' Headings are not required to appear in the product's labeling

62a

(2) ‘Lorical nasal decongestants—

Gi) For products containing levmetamfe-

tamine identified in § 341.20(b)(1) when used

in an inhalant dosage form. The product deliv-

ers in each 800 milliliters of air 0.04 to 0.150

milligrams of levmetamfetamine. Adults: 2

inhalations in each nostril not more often

than every 2 hours. Children 6 to under 12

years of age (with adult supervision): 1

inhalation in each nostril not more often than

every 2 hours. Children under 6 years of age:

ask a doctor.

(ii) For products containing ephedrine,

ephedrine hydrochloride, or ephedrine sulfate

identified in § 341.20(b)(2), (3), and (4)—

(A) Nasal drops or sprays—For a 0.5-per-

cent aqueous solution. Adults and children

12 years of age and over: 2 or 3 drops or

sprays in each nostril not more often than

every 4 hours. Children 6 to under 12 years

of age (with adult supervision): 1 or 2 drops

or sprays in each nostril not more often

than every 4 hours. Children under 6 years

of age: consult a doctor.

(B) Nasal jelly—For a 0.5-percent water-

based jelly. Adults and children 6 to under

12 years of age (with adult supervision):

place a small amount in each nostril and

inhale well back into the nasal passages.

Use not more often than every 4 hours.

(i111) For products containing naphazoline

hydrochloride identified in § 341.20(b)(6)—

(A) Nasal drops or sprays—

63a

(1) For a 0.05-percent aqueous solu-

tion. Adults and children 12 years of age

and over: 1 or 2 drops or sprays in each

nostril not more often than every 6

hours. Do not give to children under 12

years of age unless directed by a doctor.

(2) For a 0.025-percent aqueous solu-

tion. Children 6 to under 12 years of age

(with adult supervision): 1 or 2 drops or

sprays in each nostril not more often

than every 6 hours. Children under 6

years of age: consult a doctor.

(B) Nasal jelly—

(1) For a 0.05-percent water-based

jelly. Adults and children 12 years of

age and over: place a small amount in

each nostril and inhale well back into

the nasal passages. Use not more often

than every 6 hours. Do not give to chil-

dren under 12 years of age unless

directed by a doctor.

(2) For a 0.025-percent water-based

jelly. Children 6 to under 12 years of

age (with adult supervision): place a

small amount in each nostril and inhale

well back into the nasal passages. Use

not more often than every 6 hours. Chil-

dren under 6 years of age: consult a doc-

tor.

(iv) For products containing oxymetazoline

hydrochloride identified in § 341.20(b)(7)—

(A) Nasal drops or sprays—

64a

(1) For a 0.05-percent aqueous solu-

tion. Adults and children 6 to under 12

years of age (with adult supervision): 2

or 3 drops or sprays in each nostril not

more often than every 10 to 12 hours.

Do not exceed 2 doses in any 24-hour

period. Children under 6 years of age:

consult a doctor.

(2) A 0.025-percent aqueous solution

in a container having either a calibrated

dropper or a metered-dose spray that

delivers no more than 0.027. milligrams

of oxymetazoline per three drops or

three sprays. Children 2 to under 6

years of age (with adult supervision): 2

or 3 drops or sprays in each nostril not

more often than every 10 to 12 hours.

Use only recommended amount. Do not

exceed 2 doses in any 24-hour period.

{previous two sentences in boldface

type] Children under 2 years of age:

consult a doctor.

(B) Nasal jelly—For a _ 0.05-percent

water-based jelly. Adults and children 6 to

under 12 years of age (with adult supervi-

sion): place a small amount in each nostril

and inhale well back into the nasal pas-

sages. Use not more often than every 10 to

12 hours. Do not exceed 2 doses in any 24-

hour period. Children under 6 years of age:

consult a doctor.

(v) For products containing phenylephrine

hydrochloride identified in § 341.20(b)(8)—

65a

(A) Nasal drops or sprays

(1) For a 1-percent aqueous solution.

Adults and children 12 years of age and

over: Z or 3 drops or sprays 1n each nos-

tril not more often than every 4 hours.

Do not give to children under 12 years

of age unless directed by a doctor.

(2) For a 0.5-percent aqueous solution.

Adults and children 12 years of age and

over: 2 or 3 drops or sprays in each nos-

tril not more often than every 4 hours.

Do not give to children under 12 years

of age unless directed by a doctor.

(3) For a 0.25-percent aqueous solu-

tion. Adults and children 6 to under 12

years of age (with adult supervision): 2

or 3 drops or sprays in each nostril not

more often than every 4 hours. Children

under 6 years of age: consult a doctor.

(4) A 0.125-percent aqueous solution

in a container having either a calibrated

drepper or a metered-dose spray that

delivers no more than 0.135 milligrams

of phenylephrine per three drops or

three sprays. Children 2 to under 6

years of age (with adult supervision): 2

or 3 drops or sprays in each nostril not

more often than every 4 hours. Use only

recommended amount. [previous sen-

tence in boldface type] Children under 2

years of age: consult a doctor.

(B) Nasal jelly

66a

(1) For a l-percent water-based jelly.

Adults and children 12 years of age and

over: place a small amount in each nos-

tril and inhale well back into the nasal

passages. Use not more often than every

4 hours. Do not give to children under

12 years of age unless directed by a doc-

tor.

(2) For a 0.5-percent water-based

jelly. Adults and children 12 years of

age and over: place a small amount in

each nostril and inhale well back into

the nasal passages. Use not more often

than every 4 hours. Do not give to chil-

dren under 12 years of age unless

directed by a doctor.

(3) For a 0.25-percent water-based

jelly. Adults and children 6 to under 12

years of age (with adult supervision):

place a small amount in each nostril

and inhale well back into the nasal pas-

sages. Use not more often than every 4

hours. Children under 6 years of age:

consult a doctor.

(vi) For products containing propyl-

hexedrine identified in § 341.20(b)(9) when

used in an inhalant dosage form. The product

delivers in each 800 milliliters of air 0.40 to

0.50 milligrams of propylhexedrine. Adults

and children 6 to under 12 years of age (with

adult supervision): 2 inhalations in each nos-

tril not more often than every 2 hours. Chil-

dren under 6 years of age: consult a doctor.

67a

(vil) For products containing xylometazoline

hydrochloride identified in § 341.20(b)(10)—

(A) Nasal drops or sprays—

(1) For a 0.1-percent aqueous solution.

Adults and children 12 years of age and

over: 2 or 3 drops or sprays in each nos-

tril not more often than every 8 to 10

hours. Do not give to children under 12

years of age unless directed by a doctor.

(2) A 0.05-percent aqueous solution in

a container having either a calibrated

dropper or a metered-dose spray that

delivers no more than 0.054 milligrams

of xylometazoline per three drops or

three sprays. Children 6 to under 12

years of age (with adult supervision): 2

or 3 drops or sprays 1n each nostril not

more often than every 8 to 10 hours.

Children 2 to under 6 years of age (with

adult supervision): 2 or 3 drops or

sprays 1n each nostril not more often

than every 8 to 10 hours. Use only rec-

ommended amount. Do not exceed 3

doses in any 24-hour period. |previous

two sentences in boldface type] Children

under 2 years of age: consult a doctor.

(B) Nasal jelly

(1) For a 0.1-percent water-based

jelly. Adults and children 12 years of

age and over: place a small amount in

each nostril and inhale well back into

the nasal passages. Use not more often

than every 8 to 10 hours. Do not give to

68a

children under 12 years of age unless

directed by a doctor.

(2) For a 0.05-percent water-based

jelly. Children 6 to under 12 years of

age (with adult supervision): place a

small amount in each nostril and inhale

well back into the nasal passages. Use

not more often than every 8 to 10 hours.

Children under 6 years of age: consult a

doctor.

(vill) Other required statements——lor prod-

ucts containing levmetamfetamine or propyl-

hexedrine identified in § 341.20(b)(1) or (b)(9)

when used in an inhalant dosage form.

(A) “This inhaler is effective for a mini-

mum of 3 months after first use.”

(B) “Keep inhaler tightly closed.”

[59 FR 43409, Aug. 23, 1994; 63 FR 40650, July

30, 1998; 64 FR 13295, March 17, 1999; 64 FR

18571, April 15, 1999; 65 FR 8, Jan. 3, 2000; 65

FR 38191, June 20, 2000; 70 FR 58977, Oct. 11,

2005; 71 FR 48362, Aug. 1, 2006]

SOURCE: 51 FR 35339, Oct. 2, 1986: 52 FR 30055.

Aug. 12, 1987; 54 FR 39636, Sept. 27, 1989; 62 FI

51516, Oct. 1, 1997, unless otherwise noted.

meaemeominy: 21 U.S.C. 321, 351, 352, 353, 355,

360, 371.

21 C. F. R. § 341.80, 21 CFR § 341.80

Current through October 14, 2010; 75 FR 63377

69a

21 C.F.R. § 330.10

§ 330.10 Procedures for classifying OTC

drugs as generally recognized as safe and

effective and not misbranded, and for

establishing monographs.

For purposes of classifying over-the-counter (OTC)

drugs as drugs generally recognized among qualified

experts as safe and effective for use and as not mis-

branded drugs, the following regulations shall apply:

(a) Procedure for establishing OTC drug mono-

yraphs—

(1) Advisory review panels. The Commissioner

shall appoint advisory review panels of qualified

experts to evaluate the safety and effectiveness

of OTC drugs, to review OTC drug labeling, and

to advise him on the promulgation of mono-

graphs establishing conditions under which OTC

drugs are generally recognized as safe and effec-

tive and not misbranded. A single advisory

review panel shall be established for each des-

ignated category of OTC drugs and every OTC

drug category will be considered by a panel. The

members of a panel shall be qualified experts

(appointed by the Commissioner) and may

include persons from lists submitted by organi-

zations representing professional, consumer, and

industry interests. The Commissioner shall des-

ignate the chairman of each panel. Summary

minutes of all meetings shal] be made.

(2) Request for data and views. The Commis-

sioner will publish a notice in the Federal Reg-

ister requesting interested persons to submit, for

T0a

review and evaluation by an advisory review

panel, published and unpublished data and

information pertinent to a designated category of

OTC drugs. Data and information submitted

pursuant to a published notice, and falling

within the confidentiality provisions of 18 U.S.C.

1905, 5 U.S.C. 552(b), or 21 U.S.C. 331Q), shall

be handled by the advisory review panel and the

Food and Drug Administration as confidential

until publication of a proposed monograph and

the full report(s) of the panel or until the Com-

missioner places the panel’s recommendations on

public display at the office of the Division of

Dockets Management. Thirty days thereafter

such data and information shall be made pub-

licly available and may be viewed at the office of

the Division of Dockets Management of the Food

and Drug Administration, except to the extent

that the person submitting it demonstrates that

it still falls within the confidentiality provisions

of one or more of those statutes. To be consid-

ered, eight copies of the data and/or views on any

marketed drug within the class must be sub-

mitted, preferably bound, indexed, and on

standard sized paper (approximately 8 1/2 x 11

inches). When requested, abbreviated submis-

sions should be sent. All submissions must be in

the following format:

OTC Drug Review Information

I. Label(s) and all labeling (preferably

mounted and filed with the other data—facsim-

ile labeling is acceptable in lieu of actual con-

tainer labeling).

dla

II. A statement setting forth the quantities of

active ingredients of the drug.

111. Animal safety data.

A. Individual active components.

1. Controlled studies.

2. Partially controlled or uncontrolled studies.

-B. Combinations of the individual active com-

ponents.

1. Controlled studies.

2. Partially controlled or uncontrolled studies.

C. Finished drug product.

1. Controlled studies.

2. Partially controlled or uncontrolled studies.

1V. Human safety data.

A. Individual active components.

1. Controlled studies.

2. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination as to the safety of each

individual active component.

5. Pertinent medical and scientific literature.

B. Combinations of the individual active com-

ponents.

1. Controlled studies.

T2a

2. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination as to the safety of com-

binations of the individual active components.

5. Pertinent medical and scientific literature.

C. Finished drug product.

1. Controlled studies.

. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination as to the safety of the

finished drug product.

5. Pertinent medical and scientific literature.

V. Efficacy data.

A. Individual active components.

1. Controlled studies.

2. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination on the efficacy of each

individual active component.

5. Pertinent medical and scientific hterature.

B. Combinations of the individual active com-

ponents.

73a

1. Controlled studies.

. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination on the efficacy of com-

binations of the individual active components.

5. Pertinent medical and scientific literature.

C. Finished drug product.

. Controlled studies.

2. Partially controlled or uncontrolled studies.

3. Documented case reports. Identify expected

or frequently reported side effects.

4. Pertinent marketing experiences that may

influence a determination on the efficacy of the

finished drug product.

5. Pertinent medical and scientific literature.

VI. Asummary of the data and views setting

forth the medical rationale and purpose (or lack

thereof) for the drug and its ingredients and the

scientific basis (or lack thereof) for the conclusion

that the drug and its ingredients have been

roven safe and effective for the intended use. If

there is an absence of controlled studies in the

material submitted, an explanation as to why

such studies are not considered necessary must

be included.

VII. An official United States Pharmacopeia

(USP)-National Formulary (NF) drug monograph

for the active ingredient(s) or botanical drug sub-

TA4a

stance(s), or a proposed standard for inclusion in

an article to be recognized in an official USP-NF

drug monograph for the active ingredient(s) or

botanical drug substance(s). Include information

showing that the official or proposed compendial

monograph for the active ingredient or botanical

drug substance is consistent with the active

ingredient or botanical drug substance used in

the studies establishing safety and effectiveness

and with the active ingredient or botanical drug

substance marketed in the OTC product(s) to a

material extent and for a material time. If dif-

ferences exist, explain why.

(3) Deliberations of an advisory review panel.

An advisory review panel will meet as often and

for as long as 1s appropriate to review the data

submitted to it and to prepare a report contain-

ing its conclusions and recommendations to the

Commissioner with respect to the safety and

effectiveness of the drugs in a designated cate-

gory of OTC drugs. A panel may consult any

individual or group. Any interested person may

request an opportunity to present oral views to

the panel; such request may be granted or denied

by the panel. Such requests for oral presenta-

tions should be in written form including a sum-

marization of the data to be presented to the

panel. Any interested person may present writ-

ten data and views which shall be considered by

the panel. This information shall be presented to

the panel in the format set forth in paragraph

(a)(2) of this section and within the time period

established for the drug category in the notice for

review by a panel.

75a

(4) Standards for safety, effectiveness, and

labeling. The advisory review panel, in reviewing

the data submitted to it and preparing its con-

clusions and recommendations, and the Com-

missioner, in reviewing the conclusions and

recommendations of the panel and the published

proposed, tentative, and the final monographs,

shall apply the following standards to determine

general recognition that a category of OTC drugs

is safe and effective and not misbranded:

(i) Safety means a low incidence of adverse

reactions or significant side effects under ade-

quate directions for use and warnings against

unsafe use as well as low potential for harm

which may result from abuse under conditions of

widespread availability. Proof of safety shall con-

sist of adequate tests by methods reasonably

+ applicable to show the drug is safe under the

prescribed, recommended, or suggested condi-

tions of use. This proof shall include results of

significant human experience during marketing.

General recognition of safety shall ordinarily be

based upon published studies which may be cor-

roborated by unpublished studies and other data.

(ii) Effectiveness means a reasonable expec-

tation that, in a significant proportion of the tar-

get population, the pharmacological effect of the

drug, when used under adequate directions for

use and warnings against unsafe use, will pro-

vide clinically significant relief of the type

claimed. Proof of effectiveness shall consist of

controlled clinical investigations as defined in

§ 314.126(b) of this chapter, unless this require-

ment is waived on the basis of a showing that it

76a

is not reasonably applicable to the drug or essen-

tial to the validity of the investigation and that

an alternative method of investigation is ade-

quate to substantiate effectiveness. Investiga-

tions may be corroborated by partially controlled

or uncontrolled studies, documented clinical

studies by qualified experts, and reports of sig-

nificant human experience during marketing.

Isolated case reports, random experience, and

reports lacking the details which permit scien-

tific evaluation will not be considered. General

recognition of effectiveness shall ordinarily be

based upon published studies which may be cor-

roborated by unpublished studies and other data.

(iii) The benefit-to-risk ratio of a drug shall be

considered in determining safety and effective-

ness.

(iv) An OTC drug may combine two or more

safe and effective active ingredients and may be

generally recognized as safe and effective when

each active ingredient makes a contribution to

the claimed effect(s); when combining of the

active ingredients does not decrease the safety or

effectiveness of any of the individual active

ingredients: and when the combination, when

used under adequate directions for use and

warnings against unsafe use, provides rational

concurrent therapy for a significant proportion of

the target population.

(v) Labeling shall be clear and truthful in all

respects and may not be false or misleading in

any particular. It shall state the intended uses

and results of the product; adequate directions

for proper use; and warnings against unsafe use,

T7a

side effects, and adverse reactions in such terms

as to render them likely to be read and under-

stood by the ordinary individual, including indi-

viduals of low comprehension, under customary

conditions of purchase and use.

(vi) A drug shall be permitted for OTC sale and

use by the laity unless, because of its toxicity or

other potential for harmful effect or because of

~the method or collateral measures necessary to

its use, it may safely be sold and used only under

the supervision of a practitioner licensed by law

to administer such drugs.

(5) Advisory review panel report to the Com-

missioner. An advisory review panel may submit

to the Commissioner a report containing its con-

clusions and recommendations with respect to

the conditions under which OTC drugs falling

“within the category covered by the panel are gen-

*® erally recognized as safe and effective and not

misbranded. Included within this report shall be:

(i) A recommended monograph or monographs

covering the category of OTC drugs and estab-

lishing conditions under which the drugs

involved are generally recognized as safe and

effective and not misbranded (Category I). This

monograph may include any conditions relating

to active ingredients, labeling indications, warn-

ings and adequate directions for use, prescription

or OTC status, and any other conditions neces-

sary and appropriate for the safety and effec-

tiveness of drugs covered by the monograph.

(ii) A statement of active ingredients, labeling

claims or other statements, or other conditions

78a

reviewed and excluded from the monograph on

the basis of the panel’s determination that they

would result in the drug’s not being generally

recognized as safe and effective or would result

in misbranding (Category II).

(iu) A statement of active ingredients, labeling

claims or other statements, or other conditions

reviewed and excluded from the monograph on

the basis of the panel’s determination tha

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