Petition for a Writ of Certiorari — Wyeth Laboratories v. Reyes

“* acme CuUUis te .

IN THE os

Supreme Court of the United States

OctTosprer TERM, 1974

No@4-501'

WyerruH LABORATORIES, a division of American Home

Products Corporation, a Delaware corporation,

Petitioner,

v.

Errranio Reyss, individually and as next friend of

Anita Reyes, a minor,

Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

~

CLark M. CLIFFORD

_ Tuomas D. FINNEY, JR.

THomaAs RICHARD SPRADLIN

CLIFFORD, WARNKE, GLASS,

McILwaIn & FINNEY

815 Connecticut Avenue, N.W.

Washington, D. C. 20006

R. B. Kapine, JR.

WILLIAM J. MCKLVEEN

EBERLE, BERLIN, KapiInG, TURN-

Bow & GILLESPIE, CHARTERED

300 North Sixth Street

Post Office Box 1368

Boise, Idaho 83701

Counsel for Petitioner

October 29, 1974

Press or Byron S. ADAMS PRINTING, INC., WASHINGTON, D. C. —

TEE LED LI PLT ELE ELE AIOE EE SE SOEY GLY MEY

INDEX

Page

Petition For A Writ oF CERTIORARI TO THE UNITED

States Court oF APPEALS FOR THE I‘reTH CrrcuiT.. 1

BE OT TCT E RT TCOEETET ETT ETT ET 1

NS eddy ca kniwks ons aed ein an% 6b 0645465 2

QUESTIONS PRESENTED 2.0.02 cccccescccnccesesccaces 2

ConsTITUTIONAL, STATUTORY, AND FEDERAL REGULATIONS

EE cd ha prkabha sade e eke W ane eb ated eacde i 3

STATEMENT OF THE CASE ............ rr eee ee oe 6

REASONS FOR GRANTING THE WRIT ............20e000- 8

A. Congress Has So Pre-empted the Field of Law

Applicable to Labelirg of Prescription Biologi-

eal Drug Products That It Was Error for the

Courts Below To Dispose of this Case Solely

on the Basis of Local Tort Law ............. 8

B. The Decision of the Court of Appeals is in

Conflict with Applicable Texas Law and Public

Policy on the Important Question of Whether

the Manufacturer of a Prescription Drug has a

Duty to Warn the Ultimate Consumer of Pos-

sible Risks Involved in Taking the Drug...... 15

SIE a 5s 0a ba chad eNO CKO FRE WN OREN e . 5055 26

Appenpix A—Reyes v. Wyeth Laboratories, 498 F.2d

a Pe sh ek haan nat oek bane ean e eens la

Appenpbix B—Vernon’s Education Code of Texas, § 2.09 60a

Apprenpix C—Presidential Proclamation 4329, Jimmuni-

zation Action Week, 1974, October 21, 1974 [39

Fed.Reg. 37629 (Oct. 23, 1974)] ................ 62a

ii Index Continued

AUTHORITIES

C'AsEs: Page \

Algoma Plywood & Veneer Co. v. Wisconsin Employ-

ment Relations Board, 336 U.S. 301 (1949) ...... 12

Davies Warehouse Co. v. Bowles, 321 U.S. 144 (1944) 11

Davis v. Wyeth, 399 F.2d 121 (9th Cir. Eee 22, 23

Garner v. Teamsters Union, 346 U.S, 485 (1953) ...... 12

Gravis v. Parke-Davis & Co. 502 S.W.2d 863 (Tex.Civ.

App.—Corpus Christi, 1973) ............... 19, 20, 25

Karp v. Cooley, 493 F.2d 408 (Sth Cir. 1974) ... .20, 21, 25

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

Northern Pacific Ry. Co. v. Washington, 222 U.S. 370

CEE Suen hae Voda tes cuidate ou eielacete ls 12

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

Rane na ached kuna ies ceed bak tee 1, 2, 7, 14, 16, 17,

18, 19, 21, 22

Savage v. Jones, 225 U.S. 501 (1912) ................ 2

Second Employers’ Liability Cases, 223 U.S. 1 (1912) 12

Southern Ry. Co. v. Reid, 222 U.S. 424 (1912) ........ 12

Texas & Pacific Ry. Co. v. Abilene Cotton Oil Co., 204

Ses SED oi Svat ta teed ater pc, ol, 12

Wilson v. Scott, 412 S.W.2d 299 (Tex. BTS Avi esess 20

STATUTES AND REGULATIONS:

Oe SIMA FIED 4 kin a he vn eck Set rene eke 2

Federal Food, Drug, and Cosmetie Act of 1938, 52 Stat.

1040 (1938) as amended, 21 U.S.C. §§ 301, et seq.

GUOOEs ca chdes we ea We der ehenh concceueucueeuc: 2, 8, 11

ck. SEP RE I ar ia nl O 10

cogs lh. EE PETE EOL FO et Dea 3, 4, 8,9

cyte cea gs Eee Par eT En ee a sna a tls 4,8

Public Health Service Act, 58 Stat. 702 (1944) as

amended, 42 U.S.C. §§ 262 et seq. (1970) ........ 2,9

See. 351 iG SURES SEEN AD SEND SSE vie od esc s co sepene

Vernon’s Educational Code of Texas $2.09 .......... 6, 16

Be ee oo 8 vo Se a a a ba eae ECE ba wh van 5, 10

Be re BO oo sks oh eae 6 is eas a heb whe ek 4,8

Presidential Proclamation 4329, Immunization Action

Week, 1974, October 21, 1974 [39 Fed.Reg. 37629

[Ams My OUR E 565s ee adaet acs co chkues uk 17, 62a

i LEE EL EOL Met AF PLR L YALE COLI ELLA LENT TORY BY DS ° Pie ee Eg Ss, see recesrsgyse ae:

@ ~

Index Continued iii :

Page

\ MISCcRLLANEOUS:

Be, WOR Ds Os Oe Saeko cc beeen denivndns 16

Center for Disease Control, Annual Poliomyelitis Sum-

mary—1970, at 1-4 (September 30, 1971) ...... .6, 24

Center for Disease Control, Morbidity and Mortality

Weekly Reports—1963-1970 ................206. 17

New York Times, October 10, 1974 at 10, col. 3 ....... 25

Report of the Surgeon General’s Special Advisory

Committee on Oral Poliomyelitis Vaccines, 190

AMA Journal ai 49-51 (Oct. 1964) .............. 16

wre dues

5

evi tem nenecrsmcer ton LEMS DERE L ELAINE LEELA LEELES LILES ENGEL EAE AE ES AE LCL la

BER ARE "IMS

POEL TA LGA INCAS

aaa ee

-

‘

ert

IN THE

Supreme Court of the United States

OcToBER TERM, 1974.

No. —

\

Wyernu LABORATORIES, a division of American Ifome

Products Corporation, a Delaware corporation,

Petitioner,

v.

Errranio Reyes, individually and as next friend cf

Anita Reyes, a minor, :

Respondent.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

The petitioner, WYETH LaBorATORIES, prays that a

writ of certiorari issue to review the opinion and ©

judgment of the United States Court of Appeals for

the Fifth Circuit rendered in these proceedings on

July 31, 1974.

OPINION BELOW

The opinion of the Court of Appeals is reported as

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

1974), and appears at Appendix A, infra, at pp. 2a, et

I

2

seq. The case was tried to a jury in the United States

District Court for the Southern District of Texas, |

Brownsville Division, and that court did not render an

opinion.

JURISDICTION

The judgment of the Court of Appeals was entered

on July 31, 1974, Appendix A, infra, at p. la. This

petition for certiorari was filed less than 90 days from

the date aforesaid. The jurisdiction of this Court is

invoked -ulider 28 U.S.C. § 1254(1).

QUESTIONS PRESENTED

1. Whether, by enactment of the Federal Food, Drug,

and Cosmetie Act of 1938, 52 Stat. 1040 (1938), as

amended, 21 U.S.C. §§ 301, ct seq. (1970), and the

Public Health Service Act, 58 Stat. 702 ¢ 1944), as

amended, 42 U.S.C. §§ 262, et seq. (1970), Congress

has so pre-empted the field of law applicable to the

labeling of prescription biological drug products that

it was error for the courts below to dispose of this case

solely on the basis of local tort law.

2. Whether the Court of Appeals contravened the

public health policy of the State of Texas and of the

United States and erred in its application of Texas law

by holding, in the face of statutorily expressed public

policy of Texas to the contrary and in disregard of the

holding in the only Texas case in point, that under

Texas law a manufacturer of a prescription drug, used

to immunize large segments of the population against

paralytic polio. is required to warn the ultimate con-

sumer of the dangers of vaccination, even though ad-

mittedly adequate warnings hove been given to the

physician-administrators of the state public health

facility dispensing the drug.

3

CONSTITUTIONAL, STATUTORY, AND FEDERAL

REGULATIONS INVOLVED

The Public Health Service Act provides:

See. 351.

(b) No person shall falsely label or mark any

package or container of any virus, serum, toxin,

antitoxin, vaccine, blood, blood component or de-

rivative, allergenic product, or other product

aforesaid; nor alter any label or mark on any

package or container of any virus, serum, toxin,

antitoxin, vaccine, blood, blood component or

derivative, allergenie product, or other product

aforesaid so as to falsify such label or mark.

* * *

(g) Nothing contained in this chapter shall be

construed as in any way affecting, modifying, re-

pealing, or superseding the provisions of the

Federal Food, Drug, and Cosmetic Act.’ [42

U.S.C. § 262(b), (g) (1970).]

The Federal Food, Drug, and Cosmetic Act provides

at Sections 502 and 503:

‘See, 502. Misbranded drugs and devices.

A drug or device shall be deemed to he mis-

branded—

(a) If its labeling is false or misleading in any

particular.

* * *

(f) Unless its labeling bears (1) adequate direc-

tions for use; and (2) such adequate warnings

against use in those pathological conditions or by

children where its use may be dangerous to health,

or against unsafe dosage or methods or duration

of administration or application, in such manner

4

and form, as are necessary for the protection of

users: Provided, That where any requirement of

clause (1) of this paragraph, as applied to any

drug or device, is not necessary for the protection

of the public health, the Secretary shall promul-

gate regulations exempting such drug or device

from such requirement.” [21 U.S.C. § 352( a),(f)

(1970).]

* * *

“Sec. 503. Exemptions in ease of drugs and devices,

* * *

(b)(2) Any drug dispensed by filling or refill-

ing a written or oral prescription of a practitioner

licensed by law to administer such drug shall be

exempt from the requirements of section 502,

except paragraphs (a), (i) (2) and (3), (k),

and (1), and the packaging requirements of para- -

graphs (g), (h), and (p), if the drug bears a label

containing the name and address of the dispenser,

the serial number and date of the prescription or

of its filling, the name of the prescriber, and, if

stated in the prescription, the name of the patient,

and the directions for use and cautionary state-

ments, if any, contained in such prescription. This

exemption shall not apply to any drug dispensed

in the course of the conduct of a business of dis-

pensing drugs pursuant to diagnosis by mail, or to

a drug dispensed in violation of paragraph (1) of

this subsection.”’ [21 U.S.C. § 353 (b) (1970).]

The provisions of 21 C.F.R. § 1.106 are in pertinent

part as follows:

“$ 1.106 Drugs and devices; directions for use.

(a) Adequate directions for use. ‘Adequate

directions for use’? means directions under which

the layman can use a drug or device safely and

for the purposes for which it is intended. Di-

5

rections for use may be inadequate because (among

other reasons) of omission, in whole or in part,

or incorrect specification of:

(1) Statements of all conditions, purposes, or

uses for which such drug or device is intended,

including conditions, purposes, or uses for which

it is prescribed, recommended, or suggested in its

oral, written, printed, or graphic advertising, and

conditions, purposes, or uses for which the drug

or device is commonly used; except that such

statements shall not refer to conditions, uses, or

purposes for which the drug or device can_ be

safely used only under the supervision of a

practitioner licensed by law and for which it is

advertised solely to such practitioner.

(b) Eremption for prescription drugs. A drug

subject to the requirements of section 503(b) (1)

of the act shall be exempt from section 502(f) (1)

if all the following conditions are met:

* * *

(4) Any labeling, as defined in section 201(m)

of the act, whether or not it is on « ¢ within a pack-

age from which the drug is to be dispensed, .. .

contains: (i) Adequate information .. . under

which practitioners licensed by law to administer

the drug can use the drug safely and for the pur-

poses for which it is intended... .”’

The language of 21 C.F.R. § 1.2 is as follows:

**§ 1.2 Labeling; label; definitions.

(a) Labeling includes all written, printed, or

graphic matter accompanying an article at any

time while such article is in interstate commerce

or held for sale after shipment or delivery in inter-

state commerce.

(b) ‘Label? means* any display of written,

printed, or graphic matter on the immediate con-

— es |

ROE ae OH

a

6

tainer of any article, or any such matter affixed to

‘any consumer commodity or affixed to or appearing

upon a package containing any consumer com.

modity.”’

The relevant statute of the State is Vernon’s Eduea-

tion Code of Texas, Section 2.09, which provides in

part as follows:

‘““No person may be admitted to any elementary

or secondary school or institution of higher eduea-

tion unless he has been immunized against .. .

poliomyelitis... . except as provided in Sub-

section (¢).”

The complete text of § 2.09 is reproduced in full at

Appendix B, infra, at pp. 60a-61a.

STATEMENT OF THE CASE

On May 8, 1970, Anita Reyes, an 8-mouth-old infant,

received a dose of trivalent ora] polio vaccine at a State

of Texas County Health Department Clinie in Hidalgo

County, Mission, Texas. The vaccine was administered

in the course of an epidemie as declared by the United

States Government through the Center for Disease

Control as a part of an epidemic control program

conducted pursuant to the recommended policy of the

Center for Disease Control in Atlanta, Georgia. Of

the 33 cases of polio reported throughout the Nation

during the year 1970, 22 occurred in Texas. All but

one of these eases occurred in the Rio Grande

Valley, where Anita Reyes resides, an area of concen-

trated Mexican-American population; and 1 out of

every 3 of the Texas cases were in ] lidalgo County.

Center for Disease Control, Annual Poliom yelitis

Summary—1907, at 1-4 (Sept. 30, 1971).

7

The vaccine Anita received was part of 400 vials

manufactured and shipped by Petitioner in interstate

commerce in accordance with Federal law and regula-

tions. It was shipped by the Texas Department of

Health in Austin, Texas, to the Hidalgo County Health

Department, and had been purchased by the Texas

Health Department under a competitive bid from Peti-

tioner, Wyeth Laboratories. Wyeth Laboratories is a

division of American Home Products Corporation

and is the distribution outlet for Wyeth Laboratories,

Ine., a wholly owned subsidiary of American Home

Products.

Each vial of this vaccine contained a “package cir-

eular’’ detailing the dangers associated with taking

the vaccine. The registered public health nurse at the

Mission Health Clinie of the Hidalgo County Health

Department had read the package insert. No warning

of the inherent danger, characterized by the Court of

Appeals as “statistically miniscule’? (498 F.2d at 1274),

was given by the public health nurse to Anita’s mother.

Approximately twenty days after she received the

vaccine, it was determined that Anita had contracted

Type I paralytic polio.

Respondent, Epifanio Reyes, filed suit individually,

and as next friend of his minor daughter, Anita Reyes,

against Petitioner is the Federal District Court for

the Southern District of Texas, Brownsville Division,

with jurisdiction based on diversity of citizenship.

The jury concluded that Petitioner’s vaccine was the

cause of Anita’s polio and rendered a verdict against

Petitioner. On appeal, the United States Court of

Appeals for the Fifth Circuit held Petitioner liable

under Texas products liability law for failing to warn

Anita’s parents of the danger inherent in the vaccine.

‘ 5 n fi aa

Ree ese hint. Sante et. on

Peet ne eee

‘ ; ee

Bitiswcsssesernss NS See a ear

8

REASONS FOR GRANTING THE WRIT

A. Congress Has So Pre-empted the Field of Law Applicable to

This case involves an important question of Federal

Supremacy which has never before been specifically

considered by this Court. The manner in which this

question is resolved will have a profound impact on

publie health care throughout our Nation, particularly

on national programs of disease prevention.

Section 502(a) of the Federal Food, Drug, and

Cosmetic Act provides that a drug shall be deemed to

be misbranded if its labeling is false or misleading

in any particular, 21 U.S.C. §352(a). A drug will

also be deemed misbranded according to Section 502( f)

if its labeling does not bear ‘**(1) adequate directions

for use; and (2) such adequate warnings against use

in those pathological conditions or by children where

its use may be dangerous to health ... .”? 21 U.S.C.

§ 352(f).

By Federal regulation, 21 C.F.R. § 1.106(a), the

term ‘adequate directions for use” as used in Section

O02(f) of the Act means ‘directions under which the

layman can use a drug or device safely and for the

purposes for which it is intended.” These require-

ments, however, are not applicable to prescription

drugs beeause of the provisions of Section 503 of the

Act. That section exempts from the ‘‘directions for

use’’ requirements of Section 902(f) any drug which

is dispensed on the order of 4 practitioner licensed by

law to administer such drug. This exemption of pre-

scription drugs is further reflected in 21 C.F.R. § 1.106

(a) (1), which states that the ‘directions for use’? re

9

quirements shall not apply ‘‘to conditions, uses, or pur-

poses for which the drug or device can be safely used *,

only under the supervision of a practitioner licensed by -

law and for which it is advertised solely to such prac-

titioner.”” The provisions of Section 502(a) pro-

hibiting false or misleading labeling remain applicable

to prescription drugs.

The foregoing provisions are not the only Federal

laws regulating the labeling of biological drug products.

The Public Health Service Act, 58 Stat. 702 (1944),

as amended, 42 U.S.C. §§ 262, et seq., contains detailed

requirements on the licensing, labeling, and marketing

of any virus, serum, toxin, antitoxin, vaccine, or similar

biological product in interstate commerce, Section

351 (g) provides explicitly, however, that: ‘Nothing

contained in this Act shall be construed as in any way

affecting, modifying, repealing, or superseding the pro-

visions of the Federal Food, Drug, and Cosmetic Act.”’

42 U.S.C. § 262(g).

It has not been and cannot be alleged that the labeling

which Petitioner provided with its trivalent polio vac-

cine in this case was in any way false or misleading. It

was the standard labeling developed with approval of

Federal officials through long experience, and it was

properly shipped in interstate commerce to the public

health officials in charge of the immunization program

out of which this case arose. That labeling, as required

by Federal law, was directed to health professionals

and contained all necessary directions and warnings.

Because of the scientific and medical complexities sur-

rounding this vaccine, as with any prescription drug

product, adequate labeling could have been directed

only to health professionals and not to the ultimate lay

consumer.

10

The courts below would have the manufacturer at-

tempt to provide some form of written information to

the lay consumer regarding the use of this vaccine.

Without question any such statement would amount to

“labeling” under Federal law and regulations. That

term is defined at Section 201(m) of the Act as meaning

“‘all labels and other written, printed, or graphie

matter (1) upon any article or any of its containers or

wrappers, or (2) accompanying such article,”

The term is further explained by Federal regulation

at 21 C.F.R. § 1.2:

“$1.2 Labeling; label; definitions.

(a) Labeling includes all written, printed, or

graphic matter accompanying an article at any

time while such article is in interstate commerce

or held for sale after shipment or delivery in inter-

state commerce.

(b) ‘Label’ means any display of written,

printed, or graphic matter on the immediate con-

tainer of any article, or any such matter affixed

to any consumer commodity or affixed to or ap-

pearing upon a_ package containing any con-

sumer commodity.”’

The court below has committed a fundamental error

which, if not corrected, will have a profoundly adverse

impact upon public health immunization programs in

the future. In its attempt to equate the situation in

this case with the sale of over-the-counter drugs, and

draw therefrom a duty on the part of the manufacturer

to provide labeling providing laymen with ‘adequate

directions for use’’ of trivalent oral polio vaccine, the

Court of Appeals’ decision threatens to wreak havoe

with our Nation’s health care delivery system.

ee hee TOLLS LOL ALLEL Oe

q

11

Erroneously, and contrary to Federal law, the Court

of Appeals has assumed that the manufacturer, or

anyone other than trained an@ licensed health pro-

fessionals dealing directly with their patients, can

provide ‘‘adequate directions for use”’ for prescription

drug products which are meaningful to laymen, many

of whom may be of limited educational background.

This case does not involve the purchase of a common

analgesic or an antacid at a local drug store. It in-

volves the administration by public health authorities in

an epidemic situation of a potent and, complex vac-

cine properly manufactured and shipped in inter-

state commerce pursuant to Federal law.

The decision to conduct mass immunization in this

ease was made by public health authorities. The pro-

fessional labeling accompanying the vaccine in ques-

tion was made available by Petitioner to those authori-

ties. The inherent risk involved in administering the

vaecine was known to them. No representative of Peti-

tioner was present during administration of the vac-

cine, and it would stretch the bounds of credibility to

suggest that it should be otherwise.

The entire context of the Federal Food, Drug, and

Cosmetic Act, as it concerns the labeling of prescrip-

tion drug products, shows without question that Con-

gress intended to pre-empt this area of interstate

commerce. While the extension of Federal control

into traditionally local matters is always a delicate

exercise of legislative authority and requires aeccom-

modation between the needs of central control and the

maintenance of local institutions, where the intent of

Congress is clearty to pre-empt the field in matters re-

garding interft:te commerce that intention must

prevail. Davies! Warehouse Co. v. Bowles, 321 US.

12 ’

144 (1944). No one will question that where State and

Federal laws do not overlap, a State’s jurisdiction is

unimpaired. Id.; Algoma Plywood & Veneer Co. v.

Wisconsin Employment Relations Board, 336 U.S. 301

(1949). But as this Court has als» noted in a related

context involving the predecessor of the Federal Food,

Drug, and Cosmetic Act:

“*... [I]t is equally well settled that the State may

not, under the guise of exercising its police power

or otherwise, impose burdens upon or discriminate

against interstate commerce, nor may it enact

legislation in conflict with the statutes of Congress

passed for the regulation of the subject, and if

it does, to the extent that the state law interferes

with or frustrates the operation of the acts of

Congress, its provisions must yield to the superior

Federal power given to Congress by the Consti-

tution. Texas & Pacific Ry. Co. v. Abilene Cotton

Oil Co., 204 U.S. 426; Northern Pacific Ry. Co. vy.

Washington, 222 U.S. 370; Southern Ry. Co. vy.

Reid, 222 U.S. 424; Second Employers’ Liability

Cases, 223 U.S. 1; Savage v. Jones, supra, 533.’’

McDermott vy. Wisconsin, 228 U.S. 115, 131-132

(1913).

Therefore, where Congress has taken jurisdiction of

a particular matter or type of controversy affecting

interstate commerce, the States, through their courts,

may be precluded from adjudging the controversy and

extending their own forms of relief. Garner v. Team-

sters Union, 346 U.S. 485 (1953).

In the situation now at hand the purpose of Congress

is clear and manifest. The labeling of prescription

drug products shipped in interstate commerce is subject

entirely to Federal law and regulation, and the States

are without power to impose contrary restraints in this

area. When the manufacturer of a prescription drug

22a NORIO ALA alate it UB

OT ts we or Ge RR ns Powe fk

13

product has complied fully with the provisions of Fed-

eral law regarding the Jabeling of that product, he has

completed his obligation to the public. Indeed, he

should have no other obligation to the public with re-

gard to prescription drug labeling than to comply. with

Federal law, whether that obligation be asserted in the

form of criminal sanctions or civil or tort liability.

Moreover, throughout the Federal statutes and regula-

tions on this subject there is an inherent recognition of

the sanctity to be accorded the doctor-patient relation-

ship. No drug manufacturer is required or even

allowed under Federal law to interpuse himself be-

tween doctor and patient.

The decision of the Court of Appeals below, if left

standing, would not only violate Federal policy as

promulgated by Congress and the Secretary of Health,

Education, and Welfare but weuld also inevitably

breed a new form of liability suit brought by individ-

uals against drug manufacturers based on unavoidable

injuries due to inherent risks in taking prescription

medication on the advice of health professionals. Such

a result would alter in a fundamental way the health

eare delivery system in this Nation. Manufacturers,

not health professionals, would be ultimately respon-

sible for the administration of prescription drugs to

individual patients.

The effect of the Court of Appeals’ decision would

be to remove the public health physician in particular

from the relationship between the patients of a public

health clinic and the manufacturers whose drugs are

used to further the goals of such an institution. To

the class of persons dependent upon the services pro-

vided by a publie health clinic, the lower court's de-

cision would have a devastating impact. These per-

14

sons would be faced with a choice which they are un-

prepared to make and which would be made for them if

they had the financial resources to. seek health care

from a private physicia&. This is true because, as

Petitioner has repeatedly emphasized, in the adminis-

tration of polio vaccine there is no basis for the in- ;

dividualized medical judgment on which the court be- |

low rests its decision. This fact was either ignored

or never understood by the Court of Appeals.

For the Nation as a whole, but particularly for large

agricultural states such as Texas with a significant num-

ber of poorly educated migrant laborers among whom

the incidence of communicable diseases such as polio

is tragically high, the lower court’s conclusion that

DS a ee

public health authorities cannot play a meaningful role

in administering prescription drugs used in immuniza- ;

tion programs will have serious repercussions because i

of the increased likelihood of communicable disease

epidemics. This is especially true should manufac-

turers of polio vaccine be forced to discontinue its sale

to public health institutions because of the problem of

insuring that adequate warnings are given. The Court

of Appeals’ reference to cost-benefit analysis cuts both

ways. Also, the lower court’s suggestion that the

manufacturer’s loss ‘‘be passed on to the public in the

form of price increases to [its] customers,” 498 F.2d

at 1294, is an unrealistic assessment. Public health

institutions are by far the largest-volume purchasers

of Petitioner’s vaccine, and they are finaneed by State

and Federal governments which have neither the inten-

tion nor the authority to become the manufacturer’s

insurers.

The assumption of necessary and unavoidable risk in

the case of administration of any potent prescription

EOL LOLI ELL ERED LOLS POSE LLL EEL II Yn Bs PME LEI IM LOL IER IO GENS SIO LE LE RON DOB

er eee

ee ee ee eS

15

drug is a medical judgment to be made by the health

professional in dealing with his patient. To place that

risk at the door of drug manufacturers will, among

other things, have a chilling effect on their ability to

cooperate with public health officials in epidemic sit-

uations such as that in this case. It is Federal policy

to leave the decision on administration of drugs similar

to the vaccine here to individual health professionals in

the context of their own relationships with their pa-

tients—even in public health situations. That policy

' is clearly seen in the Federal statutes and regulations.

It is a policy which the decisions below would destroy.

B. The Decision of the Court of Appeals Is in Conflict with

Applicable Texas Law and Federal and State Public Policy

on the Important Question of Whether the Manufacturer

of a Prescription Drug Has a Duty to Warn the Ultimate

Consumer of Possible Risks Involved in Taking the Drug.

This case merits review because of the significant

public health ramifications which will flow from the

lower court’s holding that the manufacturer of a pre-

scription drug, administered in the course of a Fed-

erally approved State program designed to immunize

segments of the population against a highly communi-

cable disease, is required to warn the ultimate consumer

of the danger inherent in the drug, even though an

adequate warning has already been given to the

physicians in charge of the public health facility which

dispenses the drug. The importance of this issue can-

not be overstressed, since it is certain that the impact

on future operations and decisions of public ‘health

authorities—both State and Federal— will be disrup-

tive not only with respect to the administration of polio

vaccine, but also with respect to other drugs adminis-

tered in public health clinies or in the course of publicly

sponsored mass immunization programs.

e ee eee

Tile tee gi

SEO NA te SRT NE

a Ce en

16

The Court of Appeals failed to follow applicable

Texas law, and ignored the very strong public policy

of the State of Texas in preventing the spread of com-

municable disease. Review by this Court is needed ty

correct this misapplication of State law, and to avoid

the serious adverse effects which it is certain to

produce,

There can be no doubt that Texas has a strong

interest in preventing the spread of communicable

diseases. In order to implement this policy, Texas

law requires that students be immunized against cer-

tain communicable diseases, including poliomyelitis.

’ Vernon’s Education Code of Texas § 2.09 (1971), [See

Appendix B, infra, pp. 60a-61a.]

The success of such programs of immunization in

virtually eliminating epidemics of poliomyelitis is well

known. As the Court of Appeals recognized, much of

the credit for the elimination of polio from the United

States is due to the combined efforts of Federal and

State public health authorities and the manufacturers

of polio vaccine. 498 F.2d at 1270. Substantial par-

ticipation in such immunization programs by the Fed-

eral Government indicates the national importance of

these efforts.’ The current poliey of the Federal Goy-

For the past 10 years, the United Staies Publie Health Service,

an agency of ine Department of Health, Education, and Welfare,

has advocated the use of oral polio vaccines to combat the threat of

poliomyelitis and has played a substantial role in encouraging mass

immunization programs. See Report of the Surgeon General's

Special Advisory Committee on Oral Poliomyelitis Vaccines, 190

A.M.A. Journal at 49-5] (October 1964). This policy has been

frequently reiterated. See, eg. 16 A.M.A. Journal (Angust

1967); 18 A.M.A. Journal (October 1969); 2] ALA. Journal

(June 1972). In line with this Federal poliey the United States

Public Health Service through the Center for Disease Control jn

Atlanta, Georgia, has been an active participan‘ in watching for

PVE TAO ee ee pi a lll ie tae

_e

Ce

7

3

f

2

eee ee ere et

17

*

ernment is manifested by a recent proclamation in

which the President of the United States urged ‘‘all

parents, educators, and medical personnel to exert re-

newed efforts during this week and throughout the year

to immunize every American child against diseases for

which vaccines are available.’’ Presidential Procla-

mation 4329, Immunization Action Week 1974, October

21, 1974 [39 Fed. Reg. 37629 (Oct. 23, 1974) ; See Ap-

pendix C, infra, p. 62a.]

In an epidemic situation the public health physician

has only one choice to halt the spread of communicable

disease. That choice is mass immunization. Under

the Couwt of Appeals’ decision below the manufac-

turer of the prescription drug to be used in the immuni-

zation. program would be required to interfere with

that « hoice by carrying a warning to the ultimate con-

sumer, The effect of that holding would be to undermine

the ability of public health physicians to act decisively

aud effectively to control threatened epidemics, such as

the situation which existed in Hidalgo County in 1970.

The polio vaccine administered here was not defee-

tively manufactured. It was ‘*exactly what its makers

and the Texas public health authorities intended it to

be.’’ 498 F.2d at 1273. Even so, there remained the

chance—established statistically at ranges from 1 in 1

million to 1 in 16 million— that one ingesting the vac-

and in helping state and local authorities control outbreaks of

poliomyelitis. (For examples of this participation refer to the

official publication of the Center for Disease Control, Morbidity

and Mortality Weekly Report, for the following weeks: July 2s,

1963 (Pennsylvania); Angust 2. 1963 (Walker County. <Ala-

bama); April 3, 1965 (Pinal County, Arizona): May 22, 1965

(Scotts Bluff, Nebraska): June 26. 1965 (Arizona); July 2. 1966

(Texas); August 13, 1966 (Texas): February 24, 1968 (Midalvo

County, Texas); May 30, 1970, (Hidalgo County, Texas); and

September 19, 1970 (San Antonio, Texas).)

wit Oa tthe Se AR Clea ear BA ay

18

cine would contract polio.? Unlike most other pre-

scription drugs, however, it éannot be determined by a

physician on the basis of an individual’s medieal

history, physical condition, or from a medical examina-

tion whether a particular person is susceptible to con-

tracting polio from ingestion of this raceine. This is

especially true of infants and young children. Thus,

the medical judgment involved ean be made just as

intelligently on a generic basis by publie health

physicians as it ean on an individual basis by a private

physician, the patient, or tie patient’s parents. A

warning of some sort by the manufacturer to the ulti-

mate consumer would not provide for a more informed

choice, but would merely impede the efforts of public

health authorities to prevent the outbreak of an

epidemice.

Petitioner's liability is grounded on its failure to

warn Anita’s mother of the statistical probabilities in-

volved in her daughter's taking the vaccine. In the Fifth

Circuit's view, the necessity for such a warning stems

from the unavoidably unsafe nature of the vaccine and

the need when dealing with such a drug for ‘‘an indi-

vidualized medieal judgment that this treatment or

medication is necessary and desirable for this patient.’’

498 F.2d at 1295. To hold Petitioner strictly liable in

tort, the court necessarily coneluded that an individual-

ized medical judgment was necessary and that this fune-

* Generally, these statistics were compiled by epidemiologists,

Epidemiology is a specialized field of medicine dealing with publie

health, which is based on the observation of disease and thereafter,

by statistical methods, trying to arrive at a conclusion as to the

possible source of the disease. 498 F.2d at 1271 n. 3. The state-

ment in the text does not mean that one of every million persons

who takes the vaccine will contract polio; it means that within the

ranges given, it is statistically compatible with the possibility that

the vaccine caused the illness,

19

tion was not performed by the State’s public health phy-

sicians. This two-pronged conclusion is the foundation

for the court’s decision because of the rule ‘‘that where

prescription drugs are concerned, the manufacturer’s

duty to warn is limited to an obligation to advise the

prescribing physicianmyof any potential dangers that

may result from the Pie's use.”’? Id. at 1276.

Although Petitioner’s vaccine was conceded to be a

prescription drug, the court avoided the prescription

drug rule by reasoning, in essence, that it would not ap-

ply unless there was a face-to-face meeting of patient

and physician, Absent such a meeting the principles ap-

plicable to the sale of over-the-counter drugs, which re-

quire a warning to the ultimate consumer, govern the

manufacturer’s discharge of its duty. Jd. at 1276.

Considered against the backdrop of public health

policy, the Fifth Circuit’s all-or-nothing approach not

only threatens the effectiveness of the State’s program

to prevent the spread of communicable disease but also

represents an egregious misapplication of Texas prod-

ucts liability law.

The Circuit Court’s misapplication of Texas law is

highlighted by its improper treatment of the only

Texas case in point on the issue whether Petitioner's

warning to the public health authorities was sufficient

to discharge its duty. In Gravis v. Parke-Davis & Co.,

502 S.W.2d 863 (Tex.Civ. App.—Corpus Christi, 1973),

the court was concerned with a prescription drug man-

ufacturer’s duty to warn the ultimate consumer of the

dangers of a particular drug.

**We hold that it is unreasonable to demand that

the manufacturer of drugs specifically warn each

and every patient that receives drugs prescribed

by the physician or other authorized persons. The

20

entire system of drug distribution in America is

set up so as to place the responsibility for distri-

bution and use upon professional people. The laws

and regulations prevent prescription type drugs

from being purchased by individuals without the

advice, guidance and consent of licensed physicians

and pharmacists. These professionals are in the

best position to evaluate the warnings put out by

the drug industry.’’ 502 S.W.2d at 870. (Emphasis

added.)

Obviously, the approach taken by the court below is

directly contrary to the holding in Gravis. The Gravis

court rejected the approach taken by the Fifth

Cireuit by explicitly recognizing that the central

question is whether a ‘‘physician or other authorized

[person]’’ has made the decision that a partieular drug

should be used. A Texas court faced with the cireum-

stances of this case would have held as a matter of law,

based on Gravis, that the warning to the public health

physicians discharged Petitioner’s duty to warn any-

one else.

A different panel of the Fifth Circuit, applying

Texas law, recently held that a Texas physician is not

required to inform his patient cf all the risks involved

in the treatment offered. He must only act as would

a reasonable medical practitioner in the same cir-

cumstances. Karp v. Cooley, 493 F.2d 408 (5th Cir.

1974. See also, Wilson v. Scott, 412 S.AV.2d 299, 301

(Tex. 1967); Gravis v. Parke-Davis & Co., supra, 502

S.W.2d at 870.

The underlying rationale of Karp is contrary to the.

approach taken by the Fifth Circuit in this ease. Pe-

titioner provided a complete and adequate warning to

the appropriate public health officials. These officials,

:

PEND Res wa

oF CRA

21

having determined that a polio epidemic was in pro-

gress in the Rio Grande Valley, and acting in accord-

ance with Federal and State policy, determined that

every effort should be made to immunize all persons.

There can be no doubt that their action complied with

the standard outlined in Karp as measured by the local

and nationwide practices of public health physicians.

The lower court’s attempt to distinguish the vaccine

involved in this case from other prescription drugs

which require no warning to the ultimate consumer is

based on the absence of a ‘‘prescribing physician, who

acts as a ‘learned intermediary’ between manufacturer

and consumer.’ 498 F.2d 1276. The assessment of

risk by publie health physicians, and their decision

not to warn each recipient is in accord with the stand-

ards set in Karp, and represents the same type of

judgment that a prescribing physician would make.

Furthermore, the court below conceded that an indi-

vidual! prescribing physician would be unable to do any

more than the State authorities have done in treating a

particular patient, since, as the court noted, “*. . . the

risk appears to be distributed evenly among that sub-

stantial segment of the population that is not naturally

immune to polio. This is so because the behavior of

polio virus in those who contract the disease seems to

suggest more a reversion to virulence by the virus than

a sensitivity in the vaccine.”’ Id. at 1279. Accord-

ingly, an individualized examination of each patient

would in no way lessen the risk involved.

Thus, Petitioner, by providing an adequate warning

to Texas public health authorities, fully discharged

any duty it had under Texas law, as well as Federal

law, since the State’s authorities could and did fune-

ee |

wh

{en Patemekd t

Sete ic, Spd Sy

La

22

tion as a ‘‘learned intermediary’’ whose judgment re-

lieved the manufacturer of a duty to warn the ultimate

consumer directly.

In reaching its decision, the Court of Appeals relied

almost exclusively thronghout its opinion on the rea-

soning of Davis v. Wyeth, 399 F.2d 121 (9th Cir. 1968),

which also involved a plaintiff who allegedly contracted

polio from Petitioner’s vaccine. On the facts of this

‘ase, the court’s reliance on Davis, which involved an

application of Montana Law, cannot be reconciled with

the applicable Texas authorities, or with the strong

public policy of Texas in favor of immunizing all the

children of the State against polio.

In Davis the vaccine was given in 1963 to a 39-year-

old man in a nonepidemie environment in the course of

a mass immunization program conducted by the local

medical society with Petitioner’s cooperation. Because

of unusual circumstances the vaccine was administered

by a pharmacist, rather than by a registered public

health nurse or physician. The Davis eourt character-

ized the vaccine as ‘‘new and experimental,’’ as indeed

it may have been in 1963, and also observed :

“A fact sheet put out by [Wyeth] and contained

in the book it supplied to clinies was published

prior to the Surgeon General’s Report and repre-

sented the vaccine as completely safe for all ages,

A collection of news clippings from Idaho news-

papers introduced in evidence by [Davis] shows

not only a complete lack of warning but assurances

that the vaccine was safe for all.’ 399 F.2d at 125.

The Davis court based its decision, then, on the

theory that no adequate warning was given to anyone,

This is crucial because there was some evidence that an

23

adult of that plaintiff’s age stood a statistically higher

risk of contracting polio than would a child. On these

facts, the Ninth Circuit reversed a jury verdict for the

defendant, holding that the District Court erred in

failing to instruct the jury on the warning issue.

Petitioner does not contend that it has no duty to

warn. Rather, it asserts now, as it has continuously (see

498 F.2d at 1275), that its duty was fulfilled. The

warning present with each vial of vaccine contains cau-

tionary language regarding administration of the vac-

cine and no contention has been made that this warn-

ing is inadequate. Moreover, the warning in this case

was given to physicians in charge of a State’s public

health program—physicians eminently familiar with

the needs of those the program would serve, and to the

public health nurse who administered the vaccine. Fi-

nally, the vaccine here was given to an 8-month-old

child, in an epidemic environment, with the undisputed

fact being that children of tender years are most sus-

ceptible to polio. These are not distinctions without

differences, for they thoroughly undermine the lower

court’s mechanistic reliance on Davis. Petitioner sub-

mits that a Texas court would not have regarded Davis

as controlling on the basis of these factual differences

and in view of the State’s stroug public policy in favor

of universal immunization for its children.

That the Court of Appeals erred, to a degree war-

ranting review by this Court, in relying so heavily on

Davis and in failing to aecord any weight to the appli-

eable decisions interpreting Texas law is apparent

when the factual context in which the vaccine was

administered here is considered,

The court either failed to consider or attached too

little significance to the type of health institution at

24

which Anita Reyes received the polio vaccine. The

Mission Health Clinie in Mission, Texas, is run by the

Hidalgo County Health Department, which in turn is

an arm of the Texas State Department of Health. It is

one of many such institutions operating throughout the

State of Texas and across the Nation. The clinic is

staffed by two registered public health nurses, there

being no physician there on a fulltime basis. The eru-

cial decisions are made by medical doctors at the local,

county and State level. One of the primary functions

of these local public health clinies is to provide health

care for those who cannot afford a private physician.

Large segments of the population receive communi-

cable disease vaccines, including polio vaccine, free of

charge to the recipient at these clinics, As a practical

matter, these innoculations against the more common

communicable diseases may well be the ouly health care

received by a significant portion of the population.

The need for such services in Texas is obvious, As

we have previously mentioned, of the 33 cases of polio

reported nationwide in 1970, 22 oceurred in Texas, with

all but 1 of the cases occurring in an area of concen-

trated Mexican-American population and the yast

majority in the Rio Grande Valley area where Anita

Reyes resides. In fact, 7 of the 22 Texas cases were

from Hidalgo County. Center for Disease Control,

Annual Poliomyelitis Sum mar y—1970, at 1-4 ( Sept. 30,

1971). We need Say no more to illustrate that the

problem is not hypothetical or a matter of conjecture—

it is an ever-present concern of public health authori-

ties.’

* On September 30, 1974, while counsel for Wyeth was preparing

this petition, an Associated Press article appeared on the front

page of the Idaho Statesman in which the Center for Disease Con-

25

In summary, Petitioner submits that had the issue

been submitted to the Texas courts, the State’s public

policy in favor of polio immunization combined with

the admittedly adequate warning to the appropriate

State public health authorities would have produced a

holding that the manufacturer of this prescription drug

was not required, to provide the ultimate consumer with

some form of ‘‘labeling’’ about the drug which would

include information on the statistical danger of con-

tracting polio by ingesting the vaccine. ‘‘[I]t is un-

reasonable to demand that the manufacturer of drugs

specifically warn each and every patient that receives

drugs prescribed by the physician or other authorized

persons.”’ Gravis v. Parke-Davis & Co., supra, 502

S.W.2d at 870; see Karp v. Cooley, supra, 493 F.2d at

420. Texas, by enacting its statute mandating immuni-

zation of children against poliomyelitis, has made a

policy judgment which the Court of Appeals ignored.

A Texas court would have recognized this policy, would

have examined the circumstances in which the vaccine

was administered, and then would have held as a matter

of law that the warning to the public health physicians

discharged Petitioner’s duty.

It is apparent that the Court of Appeals failed in its

duty to construe, interpret, and apply Texas law as

would a Texas court. This error can only be corrected

if this Court grants Petitioner’s writ of certiorari.

trol in Atlanta, Georgia, a division of the Department of Health,

Education, and Welfare, warned that nationwide epidemics of child-

hood diseases could still erupt. Figures released by the CDC indi-

cated that immunization levels for polio for 1-4 year-old children

dropped in 1973 to a low of 60.4 percent, compared to 84.0 percent

in 1963. See also, New York Times, Oct. 10, 1974, at 10, col. 3.

|

Pict seer seon: rane.’

26

CONCLUSION

For the reasons stated, a writ of certiorari should be

granted to review the judgment and opinion of the

United States Court of Appeals for the Fifth Circuit.

Respectfully submitted,

Ciark M. Ciirrorp

Tuomas D. Fixney, Jr.

THoMAS RICHARD SPRADLIN

CLIFFORD, WARNKE, GLAss,

McILWwatn & FINNEY

815 Connecticut Avenue, N.W.

Washington, D. C. 20006

R. B. Kapina, Jr.

WituaM J. McKiveen

EBERLE, Bertin, Kapine, Turn-

Bow & GILLESPIE, CHARTERED

300 North Sixth Street

Post Office Box 1368

Boise, Idaho 83701

Counsel for Petitioner

October 29, 1974