Appendix — Wyeth Laboratories v. Reyes

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APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

October Term, 1972

No. 72-2251

D. C. Docket No. CA-70-B-115

Epiranio Reyes, Individually and as next Friend of

Anita Reyes, a minor, Plaintiff-Appellee,

versus

' Wyvern Lasoratorigs, a Division of American Home

Products Corporation, a Delaware Corporation,

Defendant-Appellant.

Appeal from the United States District Court for the

Southern District of Texas

Before Brown, Chief Judge, and Wispom and

Arnswortn, Circuit Judges.

JUDGMENT

This cause came on to be heard on the transeript of the

record from the United Stafes District Court for the

Southern District of Texas, and was argued by counsel:

Ox Consiperation Wiitrtor, It is now here ordered and

adjudged by this Court that the judgment of the said

District Court in this cause be, and the same is hereby,

affirmed ;

It is further ordered that defendant-appellant pay to

plaintiff-appellee, the costs on appeal to be taxed by the

Clerk of this Court.

July, 31, 1974

Issued as Mandate

OPINION

[498 F.2d 1264 (5th Cir. 1974),]

Diversity action against defendant which marketed

trivalent oral polio vaccine. The United States District

Court for the Southern District of Texas, Reynaldo G.

Garza, J., entered judgment for plaintiff, and defendant

appealed. The Court of Appeals, Wisdom, Cireuit Judge,

held that where defendant which marketed unavoidably

unsafe trivalent oral polio vaccine failed to provide par-

ents of infant with either warning of risk of individualized

medical judgment that treatment was necessary ‘and de-

sirablg for infant, defendant was liable for failing to

market its unavoidably unsafe product in such a way as

to warrant [sic] parents of unreasonably dangerous

condition. é

Affirmed.

Loyd E. Bingham, Jr., San Antonio, Tex., Eberle, Berlin,

Kading, Turnbow & Gillespie, R. B. Kading, Jr., William

J. MeKlveen, Boise, Idaho, for defendant-appellant.

Daniel R. Murray, Chicago, IL, for American Academy

of Pediatries, amicus curiae,

William J. Curran, Boston, Mass., for Conference of

State and Territorial Epidemiologists, amicus curiae.

Rafael H, Flores, J. Perry Jones, MeAllen, Tex., for

plaintiff-appellee,

Before Brown, Chief Judge, and Wispom and

Arnswortn, Circuit Judges,

Wispom, Circuit Judge: |

This produets liability case raises Significant questions

concerning the seope of a drug manufacturer’s duty to

warn ultimate consumers of dangers inherent in his pro-

duct,

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In May 1970, slightly more than two weeks after she had

received a dose of Wyeth Laboratories’ oral polio vaccine,

eight-month-old Anita Reyes was diagnosed as having

paralytic poliomyelitis. Epifanio Reyes, Anita’s father,

filed suit against Wyeth Laboratories, alleging that the

live polio virus in the vaccine had caused Anita’s polio and

that Wyeth was liable for her injuries because it had failed

to warn her parents of this danger. Wyeth contends that

it is not liable for Anita Reyes’s injuries under the prod-

ucts liability law of Texas. In addition, Wyeth raises

numerous procedural and evidentiary questions. The case

was tried to a jury. The jury answered special interroga-

tories (see Appendix A) and returned a verdict in favor

of Reyes against Wyeth for the sum of $200,000.

Twenty or thirty years ago poliomyelitis was a dread

disease that especially attacked the very young. In 1952

alone, there were 57,879 reported cases of polio in the

United States; 21,269 of these resulted in crippling

paralysis to the victims. By 1970, when Anita Reyes

contracted polio, the number of those stricken by polio

had diminished dramatically; she was one of just 33 in-

dividuals to be afflicted during that year.’ Credit for this

precipitous decline must go primarily to the medical re-

searchers who discovered the viral nature of the disease,

and were able to isolate and reproduce the virus in an

inactivated or an attenuated form. See Appendix B. But

credit for this remarkable achievement must also be given

to such laboratories as Wyeth, which processed the polio

vaccine, and to massive federal-state publie health pro-

grams for the administration of the vaccine.

' These statistics are drawn from official reports of the United

States Publie Health Service. See Morbidity and Mortality,

Weekly Reports, Vol. 10, No. 53, Table 2, Page 4. (October 1962) :

Morbidity and Mortality, Weekly Reports, Vol. 19, No. 3, Table

2, Page 4 (August 1971).

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On May 8, 1970, Anita Reyes was fed two drops of

Sabin oral polio vaceine by eye-dropper at the Hidalgo

County Department of Health clinie in Mission, Texas.

The vaccine was administered to Anita by a registered

nurse; there were no doctors present. Mrs, Reyes testified

that she was not warned of any possible danger involved

in Anita’s taking the vaccine. Mrs, Reyes has a seventh

grade education, but her primary language is Spanish.

She signed a form releasing the State of Texas from

‘fall liability in connection with immunization’’, The form

contained no warning of any sort, and it is apparent from

her testimony that she cither did not read the form or

lacked the linguistic ability to understand its significance.

About fourteen days after the vaccine was administered,

Anita Reyes became ill. On May 23, 1970, she was admitted

to the MeAllen (Texas) General ITospital, where her

disease was diagnosed as Type I paralytic poliomyelitis,

See Appendix B, foonote 59. As a result of the polio, at

the time of trial Anita was completely paralyzed from the

waist down, her left arm had become atrophied, and she

was unable to control her bladder or bowel movements,

The vaccine given Anita Reyes in the Mission clinie on

May &, 1970 was part of a ‘‘lot’’, No, 15509, prepared by

Wyeth? Lot No. 15509 was trivalent oral polio vaccine

that Wyeth had titered (mixed) from Types I, Il, and IIT

monovalent vaccine provided by Pfizer, Ltd. In response

to an order placed by the Texas State Department of

Health on December 23, 1969, Wyeth shipped 3500 vials

of Lot No. 15509 vaecine to the State Health Department

which in turn transferred 400 vials to the Hidalgo County

* The actual titering was performed by Wyeth Laboratories, Ine.,

a separately incorporated subsidiary of American Home Products,

Ine. After this mixing process was complete the vaccine was

shipped to American Home Products’ unincorporated Wyeth Labo-

ratories Division for distribution, Since both the division and

the subst iary are affiliates of appellant American Home Products,

Ine. they are referred to interchangeably as ‘* Wyeth” in the text.

Health Department. The jury found that vaccine from one

of these vials was given to Anita Reyes. Included with

every vial, each of which contained ten doses of vaccine,

was a ‘‘package cireular’’ provided by Wyeti which was

intended to warn doctors, hospitals, or other purchasers

of potential dangers in ingesting the vaccine. Mrs. Lenore

Wiley, the public health nurse who administered the

vaceine to Anita Reyes, testified that she had read the

directions on this package insert, but that it was not the

practice of the nurses at the Mission Health Clinie to pass

on the warnings to the vaccinees or to their guardians,

She testified that she gave Mrs. Reyes no warning before

she administered the vaccine to Anita.

On October 7, 1970, Epifanio Reyes, individually and as

next friend of his minor daughter, brought this action on

theories of strict products liability, breach of warranty,

and negligence. In his complaint he alleged that his

daughter had contracted polio from the live virus in

Wyeth’s vaecine, and that Wyeth’s failure to warn him

or his wife that this might occur rendered it liable for

Anita’s injuries. Wyeth’s main line of defense was that,

Anita’s polio was not vaccine-induced at all. Wyeth pro-

duced experts who characterized virus isolated from a

specimen of stool taken from Anita on the day after she

was admitted to the hospital as ‘*probably wild’’, This

probability was increased, according to epidemiological tes-

timony adduced on Wyeth’s behalf,* by the fact that there

was a polio ‘epidemic’? in Hidalgo County at the time

Anita fell ill. In effect, the jury rejected these theories

in rendering a verdict for Reyes.

4 Epidemiology’, the field of expertise of a number of Wyeth’s

experts, was defined in the defendant's trial brief as a *‘specialized

field of medicine dealing with public health’’, which is ‘‘based on

the observation of the occurrence of disease and thereafter, by

statistical methods trying to arrive at a conclusion as to the pos-

wible source of the disease’’.

Wyeth asserts more than a score of separate grounds

for reversal, each accompanied by extensive argument and

citation. We have considered all of these contentions, but

in this opinion we shall address only those challenges which

we regard as raising substantial questions.

II.

We turn first to the substantive issues raised by this

appeal. Our inquiry is bounded by the jury’s finding that

Wyeth’s vaccine was the producing cause of Anita Reyes’s

polio, and by those principles of products liability law we

conclude would be applied by the courts of Texas. Krie

R.R. Co. v. Thompkins, 1938, 304 U.S, 64, 58 S.Ct. 817,

82 L.Ed. 1188,

The jury’s finding that the Wyeth vaccine was respon-

sible for Anita Reyes’s polio is less a conclusion than a

starting point. Texas courts may hold manufacturers of

products which harm consumers liable for the injuries, but,

of course, manufacturers are not insurers.’ Texas courts

recognize both tort and warranty theories of products lia-

bility.’ This case was tried, briefed, and argued on appeal

entirely on the tort theory of strict liability. Thus the

differences between the two approaches,® and whatever

* Gravis v. Parke-Davis & Co., Tex.Civ.App. 1973. 502 S.W.2d

863, 868-869; Cudmore vy. Richardson-Merrell, Ine. Tex.Civ.App.

1965, 398 S.W.2d 640, 644, writ ref. n. r. e., cert. denied, 1967,

389 U.S. 1003, 87 S.Ct. 705, 17 L.Ed.2d 542.

* See Borel vy. Fibreboard Paper Products Corporation, 5 Cir.

1973, 493 F.2d 1076; reh. denied, 1973.

* Strict liability is ‘‘hardly more’’ than warranty stripped of

its contractual trappings, Greeno v. Clark Equipment Co., N.D.

Ind. 1965, 237 F.Supp. 427, 429. But if strict liability has swp-

planted warranty as the dominant doctrine, Grinnell vy. Charles

Pfizer & Co., Cal.Ct.App.1969, 274 Cal. App.2d 424, 79 Cal. Rptr.

369, 373, the outcome of produet liability actions, especially where

drugs are involved, does not appear to be a result of which

theory is relied upon by the parties. See Davis v. Wyeth Labora-

tories, 9 Cir. 1968, 399 F.2d 121, 126; Merrill, Compensation for

Prescription Drug Injuries, 59 Va.L.Rev. 1, 31 (1973).

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contractual trappings of warranty have not been destroyed

with the crumbling of the citadel of privity,’ need not

detain us. Rather, we turn to the theory of strict products

liability as embodied in Section 402A of the Restatement

(Second) of Torts (1965),* and approved by the Supreme

Court of Texas in McKisson v. Sales Affiliates, Tex.Sup.Ct.

1967, 416 S.W.2d 787.°

7 See Prosser, The Assault Upon the Citadel (Strict Liability to

the Consumer), 69 Yale L.J. 1099, (1960) ; Prosser, The Fall of the

Citadel (Strict Liability to the Consumer) 50 Minn.L.Rey. 791

(1966).

*$ 402A. Special Liability of Seller of Product for Physical

Harm to User or Consumer

(1) One who sells any product in a defective condition unrea-

sonably dangerous to the user or consumer or to his property

is subject to liability for physical harm thereby caused to the

ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a

product, and

(b) it is expected to and does reach the user or consumer

without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the prepa-

ration and sale of his product, and

(b) the user or consumer has not bought the product from

or entered into any contractual relation with the seller.

*The principle that sellers of food and drink for human con-

sumption should be held to a high level of responsibility for any

*‘corruption’’ in their wares is of inedieval origin. Restatement

of Torts, (Second) Section 402A, comment b: Prosser, The Assault

Upon the Citadel (Strict Liability to the Consumer), 69 Yale L.J.

1099, 1103, (1960). There is no point in rehashing the history

of the products liability doctrine. See, e.g., Professor Prosser’s

articles cited in Note 7, supra; Ray, Wade, P. Keeton, Noel, R.

Keeton, and Whitmore, Products Liability—A Symposium, 19

Sw.LJ. 1 (1965); Traynor, note 11, infra; Greenman v. Yuba

Power Products, Inc., Cal. Sup.1963, 59 Cal.2d 57, 27 Cal.Revtr.

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Basically, Section 402A subjects to liability the seller or

manufacturer of a product sold ‘tin: a defective condition

unreasonably dangerous’? to an ultimate user or consumer

Whose person or property is physically harmed by the

product."” Moreover, one who places defective goods in

the stream of commerce will be liable ‘to the user or con-

sumer even though he has exercised all possible eare in

the preparation and sale of the product’’, Restatement

(Second) of Torts, Section 402A, comment a. Yet imposi-

tion of liability is by no means automatic; the elements

tacit or explicit in Section 402.A*s mandate must be demon-

strated to the trial court's satisfaction before the burden

of the consumer’s loss will be imposed on the seller of

the product:

The plaintiff is faced with an arduous burden of proof,

He must prove that: 1) the produet in question was

defective; 2) the defeet existed at the time tie prod-

ucts left the hands of the defendant; 3) that because

of the defect the product was unreasonably dangerous

to the user or consumer (plaintiff); 4) that the con-

sumer was injured or suffered damages; 2) and that

the defect (if proved) was the proximate cause of the

injuries suffered.

(iravis v. Parke-Davis & Co., Tex.Civ. App.1973, 002 S.W.2d

863, 868. Although we do not embrace Gravis as the

all-inclusive embodiment of Texas products liability law,

697, 377 P.2d 897; Escola v. Coca Cola Bottling Co., Cal. Sup.1944,

24 Cal.2d 453, 150 P.2d 436, 440 (Traynor, J., concurring). For

recent articles on the Texas law of products liability, see Holford,

The Limits of Strict Liability for Product and Manufacture, 52?

Tex.L.Rev. 81 (1973); Freedman, The Texas Politics of Today's

Products Liability, 5 St.Mary's LJ. 1 (1973); Schattman. A Cause

of Action for the Allergie Consumer, 8 Hou.L.Rey. 827 (1971).

Although the Restatement speaks in terms of “sellers’’, man-

ufacturers of defective products are also swept within its ambit.

even where, as here, another party performs the actual transfer

of the offending product. See Section 402A, Comment f.

the framework it provides suggests a useful analysis for the

issue of Wyeth’s liability here.

All five elements, however, which constitute the Gravis

requirements need not be discussed here. There can be

no question that Anita Reyes was injured, so the fourth

element is not in issue. Nor is the second, since the defect

alleged, failure to warn by the manufacturer, is by definition

the manufacturer’s dereliction. Moreover, to find that the

plaintiff proved the first clement is to conclude that he

proved the third, for properly understood, ‘defective con-

dition’? has no meaning independent of ‘unreasonably

dangerous’’; the two terms are essentially synonymous.”

Thus if a product is unreasonably dangerous as marketed,

the manufacturer may be held liable for injuries proxi-

mately caused by what he has produced, whether or not

it was manufactured exactly as intended, that is without

a production “defect’’."= We do not understand this ap-

proach to dispense with the principle that to prompt lia-

bility a product must reach the consuming publie in a

“defective condition’. Rather, by rephrasing the de-

fectiveness requirement in terms of ‘‘unreasonable dan-

ger’’, it becomes clear that the circumstances of marketing

themselves can amount to a defect; the defect can be ex-

trinsic to the product. All that we need determine here,

1 Borel v. Fibreboard Paper Products Corp.. 5 Cir. 1973, 493

F.2d 1076, 1087: Wade, Stries Tort Liability of Manufecturers, 19

Sw LJ. 5. 14-15 (1965): Keeton Produet Liabiliiy and the Mean-

ing of Defect, 5 St.Mary's LJ. 36. 32 (1973). Justice Traynor

goes still further. He has conclided that there is ne single satis-

factory definition of ‘defect’ whieh wil bear universal applica-

tion. See Traynor, The Ways and Meanings of Defective Products

end Striet Liability. 32 Tenn Rey, 363. 357 (1965).

12 See, e.g. Alman Bros. Faris and Feed Mitl, Ine. v. Diamond

Laboratories, Inc.. 5 Cir. 1971. 437 F.2d 1295, 1302: Ross v. Up-

Richt. Inc.. 35 Cir. 1968, 402 F.2d 043, 946: Helene Curtis Indus-

tries, Ine. ve Pruitt. 5 Cir. 167, 385 Ftd S41. 805, cert. denied,

1968, 391 ULS. 913, 88 S.Ct. 1806, 20 L.Ed. 2d 652.

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then, is first, whether the vaccine was unreasonably dan-

gerous, and second, whether the showing of proximat +

causation was sufficient under Texas law.

a) Unreasonable Danger and the Duty to Warn

We begin the inquiry by asking whether the vaccine

was unreasonably dangerous, that is, in a defective con-

dition when Anita Reyes received it. It is clear, of course

that the vaccine was not itself defective, Wyeth Vaccine

Lot No. 15509 was exactly what its makers * and the Texas

publie health authorities intended it to be: trivalent live-

virus Sabin oral polio vaccine. The live virus which the

jury concluded caused Anita's poliomyelitis was not. in-

advertently included in the mixture." Indeed, it is the

presence of the living but attenuated Type I, I, and II]

viruses which makes the Sabin vaccine so effective [See

Appendix B].

Although the living virus in the vaccine does not make

the vaccine defective, it does make it what the Restatement

calls an *‘unavoidably unsafe product’’, one which cannot

be made ‘‘safe’’ no matter how carefully it is manufac-

tured. Such products are not necessarily ‘unreasonably

dangerous”’, for as this Court has long recognized in

wrestling with product liability questions, many goods

In a strict sense, Wyeth did not *‘make’’ or manufacture the

vaecine which caused Anita Reyes’s polio. The lot of trivalent

Vaccine was “‘titered’’ or mixed from separate strains of Type I,

Type II. and Type IIL monovalent vaecines manufactured by

Pfizer, Ltd. In the context of this case, however, we do not be-

lieve. nor did Wyeth argue, that this fact in any way affects its

liability.

% Thus this action « es not involve *‘defective’’ vaccine in the

sane sense as did Gotisdanker v. Cutter Laboratories. CaLApp.

160, 182 Cal App.2d 602, 6 Cal. Rptr. 320, an action in which the

producer of Salk ‘killed virus’’ vaccine was held liable for the

plaintiff's poliomyelitis caused by live virus inadvertently present

in its vaec ine,

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possess both utility and danger. See, e.g., Ross v. Up-

Right, Inc., 5 Cir. 1968, 402 F.2d 943, 946; Helene Curtis

Industries, Ine. v. Pruitt, 5 Cir. 1967, 385 F.2d 841, 850,

cert. denied, 1968, 391 U.S. 913, 88 S.Ct. 1806, 20 L.Ed.2d

602. -Rather, in evaluating the possible liability of a

manufacturer for injuries caused by his inevitably hazard-

ous products, a two-step analysis is required to determine

first, whether the product is so unsafe that marketing it

at all is ‘‘unreasonably dangerous per se’’, and, if not,

whether the product has been introduced into the stream

of commerce without sufficient safeguards and is thereby

*‘unreasonably dangerous as marketed.’’ In either ease,

the applicable standard, as formulated in the Restatement,

is as follows: In terms of the user’s interests, a product

is ‘unreasonably dangerous*’ only when it is ‘‘dangerous

to an extent beyond that contemplated by the ordinary

consumer’’;?® or, to phrase it in terms of the seller’s re-

<ponsibility, ‘‘so dangerous that a reasonable man would

not sell the product if he knew the risk involved’’, See

Borel v. Fibreboard Paper Products Corp., 5 Cir. 1975,

493 F.2d 1076, 1088; Helene Curtis Industries, Ine. v.

Pruitt, 585 F.2d at 850; Wade, Strict Tort Liability of

Manufacturers, 19 Sw.L.J. 5, 15 (1965).

This ‘*per se as marketed”’ distinction has been suggested by

Dean Keeton. See e.g., Keeton, Products Liability—Inadequacy

of Information, 48 Tex.L.Rev. 399, 406 (1970); Keeton, Products

Liability and Meaning of Defect, 5 St. Mary's LJ. 39, 38 (1973).

1® Comment i to Section 402A elaborates:

I. Unrcasonably dangcrous. The rule stated in this Section

applies only where the defective condition of the product makes

it unreasonably dangerous to the user or consumer. Many

products cannot possibly be made entirely safe for all consump-

tion, and any food or drug necessarily involves some risk of

harm, if only from over-consumption. ... The article sold

must be dangerous to an extent beyond that which would be

contemplated by the ordinary consumer who purchases it, with

the ordinary knowledge common to the community as to its

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In determining whether placing a commodity on the mar-

ket is ‘‘unreasonably dangerous per se’’, the reasonable

man standard of the Restatement becomes the fulerum for

a balancing process in which the utility of the product prop-

erly used is weighed against whatever dangers of harm

inhere in its introduction into commerce. Obviously, use

of an unavoidably unsafe product always presents at least

a minimal danger of harm, but only if the potential harm-

ful effects of the product—both qualitative and quanti-

tative—outweigh the legitimate public interest in its avail-

ability will it be declared unreasonably dangerous per se

and the person placing it on the market held liable." Ap-

plying this standard here, the scales must tip in favor of

availability. The evil to be prevexuted—poliomyelitis and

its accompanying paralysis—is great. Although the dan-

ger that vaccinees may contract polio is qualitatively dev-

astating, it is -statistically miniscule. On balance then,

marketing the vaccine is justified despite the danger.

Since Sabin oral polio vaccine is not ‘‘unreasonably dan-

gerous per se’’, we move to the second step of our analysis

to determine whether it is ‘‘unreasonably dangerous as

marketed’’, for to conclude that the maker of an unavoid-

Professor Wade suggests a rather more complex caleulus, with

no fewer than seven variables:

Factors involved in making this determination include,

among others, the following: (1) the usefulness and desira-

bility of the product, (2) the availability of other and

safer products to meet the same need, (3) the likelihood of

injury and its probable seriousness, (4) the obviousness of

the danger. (5) common knowledge and normal publie ex-

pectation of the danger (particularly for established prod-

ucts), (6) the avoidability of injury by care in use of the

product (including the effect of instructions or warnings),

and (7) the ability to eliminate the danger without seriously

impairing the usefulness of the product or making it unduly

expensive.

19 Sw.L.J. at 17. Without elaborating. we believe that however

scrutinized, the oral polio vaccine was not ‘‘unreasonably danger-

ous per se’’, for the reasons marshaled in the text

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ably unsafe product did not act unreasonably in placing it

on the market is not to relieve him of the responsibility to

market it in such a way as to prevent unreasonable danger.

In the case of a product such as Sabin oral polio vaccine,

this translates into a duty to provide proper warnings in

selling the product. As comment k to Section 402A in-

structs, an unavoidably unsafe product is neither defective

nor unreasonably dangerous if such a product is ‘‘ properly

prepared, and is accompanied by proper directions and

warning’’.’* Consequently, the Restatement requires a

seller who has reason to believe that danger may result

from a particular use of his product to provide adequate

warning of the danger in order that the product’s potential

18 Comment k provides:

k. Unavoidably unsafe products. There are some products

which, in the present state of human knowledge, are quite in-

capable of being made safe for their ogy and ordinary

use. These are especially common in the field of drugs. An

outstanding example is the vaccine for the Pasteur treatment

of rabies, which not. uncommonly leads to very serious and

damaging consequences when it is injected. Since the disease

itself invariably leads to a dreadful death, both the marketing

and the use of the vaccine are fully justified, notwithstanding

the unavoidable high degree of risk which they involve. Such

a product, properly prepared, and accompanied\by proper di-

rections and warning, is not defective. nor is it\wurcasonably

dangerous. The same is true of many other drugs, vaccines,

and the like, many of which for this very reason cannot legally

be sold except to physicians, or under the prescription of a

physician. It is also true in particular of many néw or es,-eri-

mental drugs as to which, because of lack of time and op-

portunity for sufficient medical experience, there can be no

assurance of safety, or perhans even of purity of ingredients,

but such experience as there is justifies the marketing and use

of the drug notwithstanding a medically recognizable risk.

The seller of such products, again with the qualification that

they are properly prepared and marketed. and praper warn-

ing is given, where the situation calls for it. is not to he held

to strict liability for unfortunate consequences attending

their use, merely vecause he has undertaken to supply the

public with an apparently useful and desirable product, at-

tended with a known but apparently reasonable risk.

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for harm may be reduced. Failure to give such a warning

when it is required will itself present a ‘‘defect’’ in the

product and will, without more, cause the product to be

“unreasonably dangerous as marketed’’,®

Issue is joined then, on the question whether Wyeth was

under a duty to warn the parents of Anita Reyes that

there was a possibility, however remote, that she might

contract polio from the drug designed to immunize her.

See Ford Motor Co. y. Russell & Smith Ford Co., Tex.

Civ.App.1971, 474 S.W.2d 549, no writ hist.; see also, Rum-

sey v. Freeway Motor Minimax, Tex.Civ.App.1968, 423 S.W.2d

387, 393, no writ hist. Restatement (Second) of Torts, Section

402A, Comments h and j ( 1965).

Comment h provides in pertinent part:

h. A product is not in a defective condition when it is safe

for normal handling and consumption. If the injury results

from abnormal handling, as where a_ bottled beverage is

knocked against a radiator to remove the cap, or from abnor-

mal preparation for use, as where too much salt is added to

food, or from abnormal consumption, as where a child eats

too much candy and is made ill, the seller is not liable. Where,

however, he has reason to anticipate that danger may result

from a particular use. as where a drug is sold which is safe

only in limited doses, he may be required to give adequate

warning of the danger (see Comment j), and a product sold

without such warning is in a defective condition. :

Comment j provides:

j. Directions or warning. In order to prevent the product

from being unreasonab?y dangerous, the seller may be required

to give directions or warning, on the container, as to its use.

The seller may reasonably assume that those with common

allergies, as for example to eggs or strawberries, will be aware

of them, and he is not required to warn against them. Where,

however, the product contains an ingredient to which a sub-

stantial number of the population are allergic, and the in-

gredient is one whose danger is not generally known, or if

known is one which the consumer would reasonably not expect

to find in the product, the seller is required to give warning

against it. if he has knowledge, or by the application of rea-

sonable, developed human skill and foresight should have

knowledge, of the presence of the ingredient and the danger.

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If such a duty existed, the vaccine was ‘‘defective’’ and

unreasonably dangerous as marketed, for such cautions as

Wyeth advanced did not, and were not intended to, reach

the Reyes family. See Davis v. Wyeth Laboratories, Inc.,

9 Cir. 1968, 399 F.2d 121, 129.

Wyeth does not deny that iis vaccine is ‘‘unavoidably

unsafe’’, or contend that it was unaware of the danger.

Rather, the appellant contends that if it had a duty to warn

at all, that duty was discharged by the warning contained

on the package insert which accompanied the vials of vac-

cine sold to the Texas State Department of Health. This

is so, Wyeth asserts, because the Sabin trivalent oral polio

vaccine in issue here is a ‘prescription drug’’, and those

who prepare such drugs are not required to warn the ulti-

mate consumer. If the warning to the dispensing physician

or authorities (here the Texas and Hidalgo County Public

Health Departments) was adequate, Wyeth is not liable

for any harm caused by the vaccine. Resolution of these

contentions is crucial; Wyeth concedes in its brief that

‘<Tslinee it is undisputed that Wyeth did not warn Reyes,

but only the Texas State Department of Health, a finding

that the vaccine was not a prescription drug establishes as

a matter of law the defectiveness of the vaccine for pur-

poses of a prima facie case in strict products liability.’’

We cannot quarrel with the general proposition that

where prescription drugs are concerned, the manufactur-

er’s duty to warn is limited to an obligation to advise the

prescribing physician of any potential dangers that may

result from the drug’s use.*” This special standard for

prescription drugs is an understandable exception to the

Restatement’s general rule that one who markets goods

” See, e.g., Basko v. Sterling Drug, Inc., 2 Cir. 1969, 416 F.2d

417, 426; Davis v. Wyeth Laboratories, 9 Cir. 1968, 399 F.2d 121,

130; Merrill, Compensating for Prescription Drug Injuries, supra

note 6, at 91. This approach has been adopted by at least one

Texas court. See, Gravis v. Parke-Davis, Inc., Tex.Civ.App.1973,

502 S.W.2d 863, 870.

Pel ands

whee

l6a

must warn foreseeable ultimate users of dangers inherent

in his products. See Restatement (Second) of Torts, See-

tion 388 (1965). Prescription drugs are likely to be com-

plex medicines, esoteric in formula and varied in effect.

As a medical expert, the prescribing physician can take

into account the propensities of the drug, as well as the

susceptibilities of his patient. His is the task of weighing

the benefits of any medication against its potential dangers.

The choice he makes is an informed one, an individualized

medical judgment bottomed on a knowledge of both patient

and palliative. Pharmaceutical companies then, who must

warn ultimate purchasers of dangers inherent in patent

drugs sold over the counter, in selling prescription drugs

are required to warn only the prescribing physician, who

acts as a “‘learned intermediary’’ between manufacturer

and consumer.*!

Although there is no question that Sabin oral vaccine is

licensed for sale only as a prescription drug,” the district

court, in its charge to the jury, noted that the vaccine was

not administered as a prescription drug at the Mission

Clinie. The court charged: ‘if you [the jury] find that

a warning should have been given, the warning had to be

given to Anita and her parents, not to Mrs. Wiley, that

Public Health nurse, somebody else... The ultimate con-

sumer is the one that had to be warned.’’ The district

court apparently based this instruction on the leading fed-

eral case in the area, Davis v. Wyeth Laboratories, 9 Cir.

1968, 399 F.2d 121. In Davis, the plaintiff had allegedly

contracted polio from Wyeth oral vaccine distributed at a

public clinic. The Ninth Circuit held that where no indi-

*1 See, Schenebeck v. Sterling Drug, ‘Ine., 8 Cir. 1970, 423 F.2d

919, 922; Davis v. Wyeth, supra note 20, 399 F.2d at 136; Sterling

Drug, Ine. v. Cornish, 8 Cir. 1966, 370 F.2d 82. 85; Gravis v. Parke-

Davis & Co., supra, note 20, 502 S.W.24d at 870, 56 Geo.L.J. 1016,

1018 (1968).

2 See, Title 42 U.S.C. § 262(a); 42 CFR. §$ 73.200-73.240,

73.1020-73.1028.

RR hay

5 Ra dnt 3. pee?

17a

vidualized medical judgment intervenes between the manu-

faciurer of a prescription drug and the ultimate consumer,

‘‘it is the responsibility of the manufacturer to see that

warnings reach the consumer, either by giving warning

itself or by obligating the purchaser to give warning.’’

399 F.2d at 131. Where there is no physician to make an

‘‘individualized balancing . . . of the risks’’, the Court

reasoned, the very justification for the prescription drug

exception evaporates. Thus, as in the case of patent drugs

sold over the counter without prescription, the manufac-

turer of a prescription drug who knows or has reason to

know that it will not be dispensed as such a drug must pro-

vide the consumer with adequate information so that he can

balance the risks and benefits of a given medication him-

self. Moreover, just as the manufacturer cannot make this

choice for its ultimate consumers, it cannot allow its imme-

diate purchaser to choose for them. In sum, then, the

manufacturer is required to warn the ultimate consumer,

or to see that he is warned. 399 F.2d at 131.

Wyeth does noi resist the Ninth Cireuit’s holding in

Davis, but asserts that the instant case can be distinguished

on four grounds. First, the appellant argues, Davis re-

ceived his vaccine during a mass immunization program,

whereas Anita Reyes ingested her vaccine at her parents’

request. Second, Wyeth stresses the fact that Davis re-

ceived his vaccine from a pharmacist, but Reyes’ was ad-

ministered by a public health nurse. Third, Wyeth’s ae-

tive participation in the mass immunization program in-

volved in the Daris case is contrasted to its relatively pas-

sive role here. Finally, Wyeth urges that unlike the situa-

tion in Daris, here it had no knowledge that the vaccine

would not be administered as a preseription drug.

None of these asserted grounds for distinguishing Daris

justifies a different result here. The first two arguments

are admittedly distinctions between Daris and the instant

fcomtroversy, but they have no bearing on the rationale of

the Davis opinion. Whether vaccine was received during

]

;

’

;

18a

a mass immunization or an on-going program, whether it

was administered by nurse or pharmacist, it was, in both

these cases, dispensed without the sort of individualized

medical balancing of the risks to the vaccinee that is con-

templated by the prescription drug exception. The third

and fourth asserted bases for distinguishing Davis from

this case are essentially the same: Wyeth took no active

part in the vaccination process here, and did not know that

its vaccine would be dispensed without procedures appro-

priate for distribution of prescription drugs.

Were we to conclude that Wyeth neither knew nor had

reason to know that its vaccine would be dispensed without

prescription drug safeguards, we might be required to hold

that the rationale in Davis is inapplicable here. But Wyeth

had ample reason to foresee the way in which its vaccine

would be distributed. A drug manufacturer is held to the

skill of an expert in his field, and is presumed to possess

an expert’s knowledge of the arts, materials, and processes

of the pharmaceutical business.%? Included in such exper-

tise must be a familiarity with practices and knowledge

common in the drug industry as to distribution and admin-

istration of pharmaceutical products,

Neal Nathanson, Professor of Epidemiology at the Johns

Hopkins University School of Public Health and a witness

for Wyeth testified that it was common knowledge in the

drug industry that ‘‘a great majority’’ of vaccinees receive

their Sabin vaccine in mass administrations or county

clinics manned at least in part by volunteers. Moreover,

Dr. Nathanson agreed that it was well known that such

clinies were stocked primarily by sale of vaccine to state

health departments. These clinies, as Wyeth must be pre-

sumed to know, dispense Sabin vaccine to all comers in an

*3 See, e.g., Wright v. Carter Products, Ine., 2 Cir. 1957, 244

F.2d 53; Johnston v. Upjohn Co., Mo.Ct.App.1969, 442 S.W.2d 93,

96: Bine v. Sterling Drug Co.. Mo.Sup.Ct.1968, 422 S.W.2d 623,

628; 2 F. Harper & F. James, The Law of Torts § 28.4 (1956): 5

San Diego L.Rev. 422, 427, n. 18 (1968).

19a

‘‘assembly line’’ fashion; there is often neither time nor

personnel to make an ‘‘individualized medical judgment”?

of the vaccinee’s needs or susceptibilities. See Davis v.

Wyeth, supra, 399 F.2d at 131; 56 Geo.L.J. 1016, 1017

(1968); 5 San Diego L.Rev. 422, 428 (1968).

Viewed in this light, the present controversy, however

it differs from Davis factually, invites application of the

Davis principles, and the conclusion that Wyeth was under

a duty to warn Anita Reyes’s parents of the danger inher-

ent in its vaccine. Wyeth knew or had reason to know that

the vaccine would not be administered as a prescription

drug, and therefore was required to warn foreseeable

users, or see that the Texas Department of Health warned

them. See Davis v. Wyeth, supra, 399 F.2d at 131; ef.

Helene Curtis Industries v. Pruitt, supra, 385 F.2d at 861.

Wyeth’s failure to warn was a breach of its duty and made

the vaceine ‘‘defective’’—hence ‘‘unreasonably dangerous”?

—as marketed.

Before moving to a consideration of causation, we pause

to analyze two possible arguments, one raised by Wyeth

and one not, which appear to add further conceptual prob-

lems in the ‘‘duty to warn’’ area.

The first may be disposed of quickly. Wyeth contends

that whatever its duty to warn, Mrs. Reyes assumed the

risk that her daughter might contract polio, or effectively

released Wyeth, by signing a ‘‘release’’? purporting to

excuse the State of Texas from liability. Wyeth does not

explain how signing a form releasing the State could excuse

Wyeth from performing a duty to warn imposed on it by

law, other than to cite the ‘‘unity of release’’ rule, appar-

ently under the assumption that the State of Texas was its

agent. Since we decline to adopt the district court’s con-

clusion that Texas was the agent of Wyeth in administering

the vaecine, we need not consider Wyeth’s contention that

the release signed by Mrs. Reyes also applied to it. More-

over, although we agree that assumption of risk is a proper

20a

defense to a product liability action in Texas (see Borel v.

Fibreboard Paper Products Corp.) one cannot assume a

risk of which he is unaware. Shamrock Fuel & Oil Sales

Co. v. Tunks, Tex.Sup.1967, 416 S.W.2d 779, 786 and n. 8.

Since Mrs. Reyes was not cognizant of the danger inherent

in the vaccine, she could not have assumed the risk of its

use.

Somewhat more troubling is a line of Texas cases involv-

ing unusual allergic reactions to potentially dangerous

products sold without a warning. These decisions may be

read for the proposition that only if the product, properly

prepared, will harm a substantial number of people will

the manufacturer be held liable for his failure to warn. See

(. A. Hoover & Son v. O. M. Franklin Serum Co., Tex.Sup.

1969, 444 S.W.2d 596, 598; Alberto-Culver Co., v. Morgan,

Tex.Civ.App.1969, 444 S.W.2d 770, 776-777, writ ref. n.

r. e.; Cudmore v. Richardson-Merrell, Inc., Tex.Civ.App.

1966, 398 S.W.2d 640, 644, writ ref. n. r. e., cert. denied,

1967, 385 U.S. 1003, 87 S.Ct. 705, 17 L.Ed.2d 542.

Essentially these are foreseeability cases; the element

they would require to invoke strict liability doctrines is

foreseeability. In these cases, the manufacturer not only

marketed the unavoidably unsafe product without adequate

warning and with the knowledge that it was inherently dan-

gerous, but the danger to any individual consumer was

sufficiently significant and knowable that (1) the manufac-

turer was cognizant of a need to warn so as to prevent

injury and (2) the consumer might or could have altered

his conduct in such a way as to lessen or avoid the danger.

This ancipital coin of foreseeability is the currency of

these Texas cases. What they seek to avoid is the imposi-

** There is considerable and respectable authority at variance

with the Texas position that immunizes a drug manufacturer from

liability to an idiosyneratie consumer. See, e.g., Davis v. Wyeth

Laboratories, supra note 20, 399 F.2d at 129; Sterling Drug, Ine.

v. Cornish, supra note 21, 370 F.2d at 85.

{ER

Shee ow

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Pat

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RRS

2la

tion of liability for ‘‘abreactions’’, hypersensitive aller-

gic reactions so unique that the class of persons exposed to

the risk is miniscule. See Cudmore v. Richardson-Merrell,

Inc., 398 S.W.2d at 644. In such cases, warnings would be

meaningless, since the manufacturer can convey nothing

meaningful to the allergic consumer unless the latter knows

he has the allergy. Without such knowledge, the consumer

is apt to assume that he is not a member of the minute sus-

ceptible class and to disregard the warning. See Alberto-

Culver Co. v. Morgan, 444 S.W.2d at 777. Thus with the

utility of warning limited and the susceptible class minute,

the manufacturer is not required to foresee that anyone

will suffer an allergic reaction to his product, and is not

held liable.

To the instant analysis, these principles present no

dilemma, for the effect of the Sabin oral vaccine upon those

who contract polio from it cannot fairly be styled an

‘‘abreaction’’. Although the danger of vaccine-induced

polio to any one individual is small, the risk appears to be

distributed evenly among that substantial 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 vaccinee. Thus, if an

individual is a member of the significant susceptible class,

and his case should be one of those rare instances in which

the vaccine strain reverts to virulence, he may contract

polio. This is not a case like Cudmore, then, where the

‘appellant belongs to a class of people not appreciable in

number who are allergic to the drug,’’ and in which a warn-

ing would have been futile. 398 S.W.2d at 644. Rather,

“3 For a more detailed discussion of various types of allergic

reactions, and their legal significance, see, Merrill, Compensating

for Prescription Drug Injuries, 59 Va.L.Rev. 1 (1973); Schatt-

man, A Cause of Action for the Allergie Consumer, 8 Houston

L.Rev. 827 (1971); Rheingold, Products Liability—The Ethical

Drug Manufacturer's Liability, 18 Rutgers L.Rev. 947 (1964).

POR &

22a

proper warnings here would be addressed to a sizeable

group and would be designed to alert each of its members

that although the incidence of vaccine-induced polio is

minute, he does belong to a substantial class, an unpre-

dictible few of which could contract polio from the vaccine.

In light of such factors, the Texas ‘‘abreaction”’ cases can-

not dilute Wyeth’s duty to warn here. This view coincides

with the objective of Section 402A to protect the consumer

by his standards of reasonableness in determining the man-

ufacturer’s duty.

b) Proximate Cause

Having concluded that Wyeth had a duty to warn Anita

Reyes, and that, dispensed without a warning, the vaccine

was unreasonably dangerous, we now turn to Wyeth’s ob-

jections to the trial court’s not instructing the jury and

not submitting an interrogatory on the issue of ‘*proxi-

mate cause’’,

As Wyeth correctly contends, there are two causution is-

sues in most product liability cases. The first is that of

‘producing cause’: Was the defendant’s product the

cause-in-fact of the plaintiff’s injuries? More specifie is

the question posed under the rubrie of proximate causa-

tion: Did the plaintiff’s injuries result from the alleged

‘‘defect’’ in the defendant’s product?) Unless the jury is

given an opportunity to pass upon both issues, Wyeth

urges, the plaintiff has not made out a prima facie case of

product liability. If Wyeth is correct, reversal is required,

for the trial judge made it clear that he did not believe

proximate cause to be an issue in this controversy, and

neither instructed the jury nor submitted an interrogatory

on the question. We cannot concur in Wycth’s premise,

*5 4 colloquy on requested instructions between two attorneys for

Wyeth and the court make the court's position on the need to

prove proximate cause clear:

Mr. Kapinc: Then we believe that there should be an in-

terrogatory between number five and number six which makes

23a

however. The submission of interrogatories accompany-

ing a general verdict is within the discretion of the trial

court.” Moreover, although an instruction on proximate

cause is appropriate in most products liability cases, a jury

finding on the question was not required here.

As a general proposition, both Texas Courts and this

Court have required that the plaintiff in a product liability

suit prove not only that his injuries were caused by the

defendant’s product, but that they resulted from an alleged

defect in the product. Leading commentators have con-

this a matter of proximate cause. In other words, to the effect

asking the jury to find whether or not the failure to warn was

proximate cause of the consequences to this child in view of

the fact that even with warning they may have proceeded

with immunization, and in fact did so even after immuniza-

tion here. And I suppose for the purposes of the record T

ought to ask the court to in effect resubmit interrogatories

that we submitted to the court before.

Mr. McKuiveen: And I think as to interrogatory number

two dealing with producing cause rather than cansal eause

the jury should be instructed that they should find—have to

find first—the product was not fit for the purpose for which

it was intended in order to get into proximate cause rather

than producing cause.

Tue Court: Well, T have already stated at the beginning

what my feelings are in this case. that if there was a risk. if

she did get it from the vaccine, and you all failed to warn

them about the risk so that they could make a choice, that you

are liable regardless. And T think T have enough answers

here.

Mr. Fiores: We have no objections.

Tie Cover: T wouldn’t mind giving the question of proxi-

mate cause but T don’t think it is necessary and you all tell

me that vou don’t want it in there.

27 The submission of interrogatories accompanying a verdict is

sanctioned by Fed.R.Civ.P. 49(b).

The trial judge’s decision to submit the issues to the jury pur-

suant to Rule 49(b) is within his diseretion, and will be reversed

only upen a clear showing of abuse. See Abernathy v. Southern

Pacifie Co., 5 Cir. 1970, 426 F.2d 512.

*E.g.. Technical Chemical Co. v. Jacobs, Tex.Sup.1972, 480

S.W.2d 602, 605; Kritser v. Beech Corp., 5 Cir. 1973, 479 F.2d

1089, 1091.

24a

eurred.” Yet the rule in Texas that proximate cause must

be specifically proved in products liability cases is not im-

mutable. In some circumstances, proximate cause may be

inferred as a matter of law or as a matter of fact. Procter

& Gamble Mfg. Co. v. Langley, Tex.Civ.App.1967, 422

S.W.2d 773, writ dismissed, want of jurisdiction. In other

cases, an instruction on producing cause which omits a con-

sideration of proximate cause may be sufficient. C. A.

Hoover and Son vy. 0. M. Franklin Serum Co., Tex.Sup.

1969, 444 S.W.2d 596, 598. We believe, in light of the hold-

ing in Hoover and crucial dicta in Technical Chemical Co.

v. Jacobs, Tex.Sup.1972, 480 S.W.2d 602, that to have

omitted a specifie proximate cause instruction here was not

reversible error.

Hoover was an action against a serum manufacturer by

the owners of 25 Hereford calves which had become des-

perately ill after having been innoculated with the defend-

ant’s antibiotie. The trial resulted in a verdict and judg-

ment for the plaintiffs, which was reversed and remanded

by the court of civil appeals because the trial court had

submitted a special issue on ‘* producing cause”’ rather than

‘*proximate cause’, ‘‘and had thus failed to require the

element of foreseeability’’. The Supreme Court of Texas

reversed the court of a; peals, and held that where, as here,

the injury’s foreseeability was not in issue, the ‘*produe-

ing cause’’ instruction was sufficient. Much of the Supreme

Court’s brief opinion is spent in distinguishing the issue

presented in Hoorer from that considered in Cudmore v.

Richardson-Merrell, Ine. Cudmore required that the jury

consider whether the defendant’s product was the ‘‘ proxi-

mate ecause’’ of the plaintiff's injuries rather than merely

whether it was the ‘‘ producing cause’’, since the latter in-

quiry ‘‘omits entirely the element of foreseeability. .. .”’

* E.g.. Keeton, Products Liability —Inadequacy of Information,

~ 48 Tex.L.Rev. 398, 413 (1970); Wade. Strict Tort Liability of

«= Manufacturers, 19 Sw.L.J. 5, 22. 25 (1965).

SS OS SEE ae |

Sara

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25a

The Hoover court distinguished Cudmore on the ground

that it involved an ‘‘abreaction’’ to a ‘‘pure drug’’ and

thus foreseeability was a crucial issue. In such a case, a

‘proximate cause’’ instruction is required. In Hoover,

however, all twenty-five innoculated cattle fell ill or died.

The jury found that the cause of this widespread illness

was not an unforeseeable abreaction. Thus, concluded the

Texas Supreme Court, foresceability was not in issue, and

no proximate cause instruction was required,

The Hoover rationale is applicable to the instant contro-

versy. Although this is, in a sense, a ‘‘pure drug’? case

like Cudmore, as we have pointed out above, it involves no

‘‘abreaction’’. As we have also concluded earlier, foresee-

ability—both as to the possibility of injuries and the man-

ner of dispensing the drug—is not really in issue. In

Hoover, **foreseeability’? was found by the jury; here it

was established as a matter of law. Hoorer was not, of

corse, a **failure to warn’’ case, The defect involved was

intrinsie to the serum which felled the plaintiff’s cattle, a

fact which may differentiate Hoorer from extrinsic defect

cases where the product and defect are separable. See

Keeton, Products Liability—Problems Pertaining to Proof

of Negligence, 19 Sw.L.J. 26, 33 (1965). Yet language in

Technical Chemieal Co, v. Jacobs, the recent Texas Supreme

Court examination of failure to warn, convinces us that

even in this area, a producing cause instruction will suffice

in the circumstances of this case.

Technical Chemical involved a suit against the manufac-

turer of a can of freon which exploded in the plaintiff's

hand as he attempted to put its contents into the air ¢on-

ditioning unit of his automobile. It was apparent from tes-

timony adduced at trial that Jacobs, the plaintiff, inadvert-

ently and mistakenly attached a hose from the ‘‘high’’ pres-

sure side of his air conditioning compresser to the can of

freon, rather than joining a hose from the ‘‘low’’ pressure

side, which was the proper procedure. The can exploded, a

possible result which the directions on the can’s label did

Dial ite 0 she ats ans

See ee ee ee

26a

uot mention. Jacobs admitted, however, that he had not

read the directions on the can’s label. In light of this fact,

the jury refused to find that Technical Chemical’s failure to

warn was a cause of Jacobs’ injuries.

In afiirming the trial verdict, the Supreme Court of Texas

held that it was ‘‘incumbent upon the plaintiff to secure a

jury finding that the faulty labeling was a cause of the in-

jury’’. This he had not done. 480 S.W.2d at 605. More-

over, a plaintiff who had not read such directions as were

provided could hardly expect the court to conclude that the

manufacturer’s failure to provide further warnings caused

his injury as a matter of law.

Although much of the Technical Chemical opinion speaks

in absolute terms of requiring proof that the defect caused

the plaintiff's injuries, it also recognizes how ‘‘speculative”’

testimony in this type of case is likely to be and suggests an

alternative approach, a legal ‘‘presumption that an ade-

quate warning would have been read’’. 480 S.W.2d at 606.

See Restatement (Second) of Torts, § 402A, comment j. As

the court explained:

Such a presumption works in favor of the mann-

facturer when an adequate warning is present. Where

there is no warning, as in chis case, however, the pre-

sumption that the user would have read an adequate

warning works in favor of the plaintiff user. In other

words, the presumption is that Jacobs would have read

an adequate warning. The presumption, may, how-

ever, be rebutted if the manufacturer comes forward

with contrary evidence that the presumed fact did not

exist.

480 S.W.2d at 606.

Read together, Moores and Technical Chemical suggest

a test for cases such as the one now before the Court:

Where a consumer, whose injury the manufacturer should

have reasonably foreseen, is injured by a product sold with-

out a required warning, a rebuttable presumption will arise

that the consumer would have read any warning provided by

27a

the manufacturer, and acted so as to minimize the risks. In

the absence of evidence rebutting the presumption, a jury

finding that the defendant’s product was the producing

cause of the plaintiff’s injury would be sufficient to hold him

liable.

Such a test makes sense in this case. The jury found that

the defendant’s polio vaccine caused Anita Reyes’s polio.

Testimony by her mother as to what she would have done,

had proper warnings been provided, would have been both

speculative and self-serving. Thus we turn to the Technical

Chemical presumption that a warning, had it been given,

would have been heeded. Buttressing the presumption that

Mrs, Reyes might have taken preventive steps is the testi-

mony of Reyes’ expert, Dr. Ramiro Casso, that some pedi-

atricians in Hidalgo County, at least by the time of trial,

had begun administering killed-virus vaccine to infants in

order to build up their level of antibodies before feeding

them the live-virus drug. Tending to rebut the presumption

that Mrs. Reyes would have behaved differently had she

heen warned was the fact that she twice returned to the Mis-

sion Clinie for further doses of vaccine, even after Anita

contracted polio. Yet it is patient from her testimony that

Mrs. Reyes had not, even then, been informed of the danger

of the polio vaccine, and did not in fact understand what

medication Anita was to receive.” The legal presumption

# On cross-examination, Mrs. Reyes was asked about a card she

had signed at the eclinie which indicated that she had returned

after the onset of Anita’s illness:

Q. And did you read that before you signed it?

A. No, I didn’t read it. I just signed it.

Q. I notice some other entries. Have you taken Anita back

for further immunization since the date of—

A. Yes.

(. What has she been immunized for or vaccinated for since

May 8, 1970?

A. I don’t know. They just put it on there.

Q. You just take her and they do it?

A. Yeah. They are the ones that know what they are going

to put next.

—w.sa.s

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28a

suggested by the Technical Chemical opinion thus operates

here to provide the final element necessary to hold Wyeth

Laboratories liable for Anita Reyes’ poliomyelitis. Aware

of its unavoidable dangers and cognizant that it foreseeably

would not be dispensed as a prescription drug, Wyeth none-

theless f2i).d to warn Mrs. Reyes that its vaccine could

cause polio in some few of the millions receiving the medi-

eation. Administered without a warning, the vaccine was

**defective’’, hence unreasonably dangerous. According to

the test we have distilled above, we must assume in the

absence of evidence to the contrary that Anita’s parents

wouid have acted on the warning, had it been given. Per-

haps this would have prevented her polio. It unquestion-

ably would have avoided Wyeth’s liability.

III.

Having concluded that Wreth was properly held liable

under substantive law, we turn to procedural matters,

specifically to Wyeth’s objections to the admission or

exclusion of various testimony and exhibits, and to its

assertion that the evidence was insufficient to support the

verdict for the plaintiffs.

(a) The Impeachment of Dr. Fox

Among the medical experts called to testify in Wyeth’s

behalf was Dr. John D. Fox, Associate Dean and Professor

of Epidemiology at the University of Washington School

of Public Health. On cross-examination, after Dr. Fox

had testified that Type III polio vaccine was less stable

than either Type I or Type II, counsel for the plaintiffs

attempted to impeach his testimony by reference to an

uncertified transcript of an earlier trial in which Dr. Fox

had been called as a witness in Wyeth’s behalf. There

Dr. Fox had testified that Type I polio vaccine was

‘“‘unstable’’, with reference to its ‘‘antigenie character”’,

and Reyes’s counsel attempted to show that this earlier

testimony contradicted Dr. Fox’s testimony as to Type I’s

stability here. Upon further inquiry, however, Dr. Fox

29a

was apparently successful in explaining that his previous

statement as to Type I’s instability dealt only with its

‘‘antigenie instability,’’ that is, its tendency to become an

‘‘-mvaccine-like’’ strain, whereas his comments on the

instability of the Type III virus related to its propensity

to cause polio in monkeys or man. On appeal, Wyeth

contends that this line of questioning was improper and

requires reversal, both because the testimony of an expert

cannot be impeached through the use of prior incon-

sistent statements and because no proper foundation was

laid.

We concur in Wyeth’s conclusion that the law of Texas

governs the conduct of this type of impeachment. See

Wright, Law of federal Courts, § 94 at 412-15." We can-

not, however, read the cases cited by the appellant as pro-

hibiting cross-examination of expert witnesses through the

use of prior inconsistent testimony. Texas does not bar

impeachment of a lay witness through the use of testimony

given by him at a former trial.”

31 Professor Charles A. Wright suggests that it may be neces-

sary to look beyond the stark dictates of F.R.Civ.P. 43(a) to de-

termine whether federal or state evidentiary standards ought to

be invoked in a given situation. Three types of evidentiary rules

exist, he postulates, and the choice between federal and state tests

ought be made on the basis of which type of rule a given bit of

evidence invokes. First are those rules which are of a merely

‘*housekeeping’’ nature; here federal standards can be applied with-

out hesitation. Next are rules that not merely regulate eviden«<,

but are closely intertwined with the substantive rights of the par-

ties. Here state standards should be honored. Finally, come state evi-

dentiary rules specifically designed to effectuate an extrinsic state

policy. So long as the rules are successful in achieving that end,

they should be honored. The impeachment of an expert witness

challenged here, was, we conclude, so tied to Wyeth’s attempt to

prove its theory of the case that substantive rights are at stake

and Texas impeachment standards must govern. See, C. Wright,

Law of Federal Courts, § 94 at 412-415. .

%2 Gabel v. Blackburn Operating Corp., Tex.Civ.App.1969, 442

$.W.2d 818, 819, no writ hist.; Flowers v. Central Power and

Light Co.; Tex.Civ.App.1958, 314 S.W.2d 373, writ ref. n. r. e.

hia la til AN a

30a

It is difficult to understand why this impeachment tech-

nique ought not be available when the witness is an expert

rather than a layman. Indeed, it might be argued that

prior. inconsistency is a particularly appropriate weapon

for attacking expert testimony, since demonstration of the

inconsistency is designed not to show that the expert has

erred, but that he is ccpable of error. See Cirilo v. Cook

Paint and Varnish Co., Tex.Civ.App.1972, 476 S.W.2d 742,

748, writ ref. n.r.e. Not surprisingly, then, Texas courts

endorse far-ranging cross-examination generally, and have

permitted particularly wide latitude in the interrogation of

an adversary’s expert. See Daviilson v. County of Harris,

Tex.Civ.App.1970, 454 S.W.2d 830, 852, writ ref. n. r. e.

Thus in Hutson y, State, Tex.Cr.App.1956, 164 Tex.Cr.R. 24,

296 S.W.2d 245, 247-248, the prosecution was permitted to

impeach the testimony of a county sheriff as to the defend-

ant’s intoxication, by introducing a tape recording (made

shortly after the defendant’s arrest) in which the sheriff

voiced an opinion contrary to that offered at trial. Also

permitted in cross-examination of real estate experts has

been reference to edrlier inconsistent appraisals of land,

the value of which is in issue.% '

A similar standard should apply to expert medical testi-

mony. Wyeth concedes that'a cross-examiner may prop-

_ erly inquire whether a medical expert has previously testi-

fied on behalf of the party for whom he offers testimony.

But, Wyeth urges, any further foray into prior testimonial

assertions is forbidden by Texas law. We do not so read

the Texas cases, To be sure, no inquiry into the correct-

ness of opinions expressed at earlier trials is proper ;* but

33 See City of Garland vy. Stevener, Tex.Civ.App.1970, 462 S.W.

2d 67, 69, writ ref. n. r. e.: City of Dallas v. Holcomb, Tex.Civ.

App.1964, 381 S.W.2d 347, 350, writ ref. n. r. ¢.

** Horton v. Houston. & T. . Ry. Co., 1907, 46 Tex.Civ. App.

' 639, 103 S.W. 467, 469, writ ref.: Traders & General Ins, Co. y.

tobinson, Tex.Civ.App.1949, 222 SW 2d 266, 269, writ ref,

3la

an inconsistency, if there is one, may be demonstrated, As

we noted earlier, the purpose of such impeachment is not

to demonstrate that the expert has erred, but that he is

capable of error. An expert in medicine is not exempt

from the use cf prior testimony to prove his fallibility.

Wyeth also urges that even if permitting the impeach-

ment was proper, counsel for Reyes failed to lay the proper

foundation for the impeachment and that therefore the

court erred in allowing the cross-examination to proceed.

Texas courts and this Cireuit have held that to impeach a

witness by showing a prior inconsistent statement, ‘‘a

foundation must first be laid by asking the witness whether

he mace the statement, giving him an opportunity to admit

or deny the statement, to correct his testimony, and to ex-

plain the apparent contradiction’.

Yet it is Reyes’s attempt to lay precisely such a founda-

tion to which Wyeth takes exception here. Dr. Fox’s at-

tention was drawn to his testimony in Davis v. Wyeth Lab-

oratories, Ine., 9 Cir. 1968, 399 F.2d 121, and he was given

an opportunity to examine the uncertified transcript relied

upon by Reyes, out of the sight of the jury and during a

luncheon recess. When court reconvened, under question-

ing by counsel for Reyes, Dr. Fox testified that the tran-

script, although ‘‘somewhat inaccurate’? did contain the

substance of his prior testimony. He then explained at

length why his former statements were in no way incon-

sistent with his testimony on direct examination here.

Wyeth continually objected to this attempt to lay a founda-

tion on the ground that no foundation had been laid. Over-

ruling such objections cannot constitute reversible error.

* Ray v. Gage, Tex.Civ.App.1954, 269 S.W.2d 411, 419. writ

ref.; Robertson v. M/S Sanyo Maru, 5 Cir. 1967, 374 F.2d 463.

465, cert. denied, 1970, 400 US. 854, 91 S.Ct. 59, 27 L.Ed.2d 91:

jurton v. United States, 5 Cir. 1949, 175 F.2d 960, 965, cert. de-

nied, 338 U.S. 909, 70 S.Ct. 347, 94 L.Ed. 560.

| ae ae ee

32a

b) The Exclusion of Dr. Nakano’s Opinion

Dr. James Nakano, a virologist and the Chief of the

Poliovirus Strain Characterization Laboratory in Atlanta,

Georgia, was allowed to testify that, based on his analysis

of Anita’s stool specimens, he had concluded that the etio-

logical agent causing her paralysis was probably a ‘‘wild

strain’’. The trial court, however, refused to allow Dr.

Nakano, who is not a physician, to advance his opinion as

to ‘‘the probable cause of Anita Reyes’s paralysis’’. As-

serting that this ruling constitutes reversible error, Wyeth

points out that another of its experts who is also not a

practicing physician was permitted to render an opinion

as to the cause of Anita’s condition, as were several other

experts who based their conclusions on Dr. Nakano’s lab-

oratory findings. Aside from indicating that any error in

the exclusion of Dr. Nakano’s testimony was probably

harmless, such arguments have little foree, .As we con-

cluded in another Texas diversity action:

Generally, the admission of .. . tendered expert testi-

mony is a matter within the sound discretion of the

trial court, and the action of the trial court in admit-

ting or excluding such evidence will be sustained un-

less clearly and manifestly erroneous.

Scott v. Fancher, 5 Cir. 1966, 369 F.2d 842, 844. It is at

least arguable that the effect of a disease virus on a par-

ticular human being whom he had not examined was out-

side of the scope of Dr. Nakano’s expertise. In any event,

in light of all of the testimony on the issue, the exclusion

of his testimony was not so ‘‘clearly and manifestly erro-

neous’’ as to constitute reversible error.

ce) The Admission of Exhibit 13

Wyeth vigorously excepts to the admission into evidence

of Plaintiff’s Exhibit Number 13, a document purporting

to detail the suspected and confirmed cases of polio which

occurred in Hidalgo County during 1970, on the ground

that counsel for Reyes failed to lay the proper foundation

33a

for admission of the document under the ‘‘business rec-

ords’’ exception to the hearsay rule.

Exhibit 13 was first referred to during the cross-exam-

ination of Mrs. Ruth McDonald, Director of Nursing for

the Hidalgo County Health Department. On direct exam-

ination, Mrs. McDonald testified that the County Health

Department kept statistics and records on communicable

diseases and immunization of the population in Hidalgo

County and there her ‘‘employer’’ was Dr. Copenhaver,

director of the Public Health Unit in Hidalgo and

Cameron Counties. On cross-examination she was shown

the challenged exhibit, and testified that she had seen the

report previously ‘‘when it was made up’’. Mrs. McDonald

also identified certain writing on the exhibit as Dr. Copen-

haver’s handwriting. This tended to link Wyeth with the

vaceine given Anita Reyes. The Exhibit was marked

‘*Plaintiff’s 13’’ for identification, but was not offered in

evidence.

The following day, Oscar Garza, another defense witness,

who is a Health Programs Specialist for the Texas State

Department of Health, was confronted with Plaintiff’s

Exhibit 13 on cross-examination. Exhibit 13 appeared to

bear a strong similarity to a list prepared by Mr. Garza,

although Mr. Garza’s list evidently did not show all of the

same entries, and exhibited none of the handwriting

previously identified as Dr. Copenhaver’s. Mr. Garza

demonstrated a general familiarity with the information

contained in Exhibit 13, but under interrogation by counsel

for Wyeth, he testified that the list was not a record pre-

pared or retained in the regular course of business of his

office. Exhibit 13 was then offered in evidence by Reyes’s

counsel, and Wyeth objected on the ground that a proper

foundation had not been laid. After a colloquy which

revealed that the challenged exhibit had been appended to

Dr. Copenhaver’s deposition in accordance with a request

that he submit all relevant records, the trial court decided

34a

that the record had been sufficiently authenticated to justify

admission.

The considerable Texas authority Wyeth marshals to

support its position is of little aid, for its assumption that

Texas law con‘ vols our review of the trial court’s decision

is erroneous. While state standards may be found to

apply to evidentiary issués in federal courts, such ques-

tions are governed by federal standards in general, and by

Fed.R.Civ.P. 43(a) in particular. Bailey v. Kawasaki-

Kisen, K. K., 5 Cir. 1972, 455 F.2d 392, 397. Rule 43(a)

provides:

(a) Form and Admissibility.

In all trials the testimony of witnesses shall be taken

orally in open court, unless otherwise provided by these

rules. All evidence shall be admitted which is ad-

missible under the statutes of the United States, or

under the rules of evidence heretofore applied in the

courts of the United States on the hearing of suits in

equity, or under the rules of evidence applied in the

courts of general jurisdiction of the state in which the

United States court is held. In any case, the statute

or rule which favors the reception of the evidence

governs and the evidence shall be presented according

to the most convenient method prescribed in any of

the statutes or rules to which reference is herein made.

The competency of a witness to testify shall be

determined in like manner.

We are less sanguine than the appellants in assuming

that Texas courts would not admit this exhibit as a busness

record.” We are aware also that it is at least arguably

% The Texas policy on the admission of business records is em-

bodied in Article 3737e, Vernon's Ann. Texas Civil Statutes (Supp.

1974).

The statute is not specific as to the proof necessary to support a

judicial finding that its strictures have been met but at least one

decision of the Texas Supreme Court sugges's that if the testimony

of a ‘*quatified witness’’ supports an implied finding by the trial

judge that the records in dispute were made in the regular course

35a

admissible under the Federal Business Records Act.”

Yet neither a protracted statutory analysis nor the

of business and were made at or reasonably near the time of the

recorded act or event, the statutory strictures will have been

bridged. See University Savings & Loan Assoc. v. Security Lum-

ber Co., Tex.Sup.Ct.1967, 423 S.W.2d 287, 290.

Here, the testimony of Nurse McDonald supported the court’s

finding that Exhibit 14 was a business record prepared in the regu-

lar course of the business of the Hidalgo County Health Depart-

ment at or near the time in question. This is particularly true,

in that Exhibit 13 was appended by Dr. Copenhaver to his depo-

sition pursuant to a request that he submit copies of all of his

records relevant to Anita Reyes’s case. In light of the considerable

latitude Texas affords the trial judge in admitting evidence, it is

by no means clear to us that a Texas appellate court would find

the admission of Exhibit 13 to have been erroneous.

*% The business records exception to the hearsay rule is also ad-

dressed by federal statute. Title 28, United States Code, Section

1732(a) in pertinent part provides:

(a) In any court of the United States and in any court es-

tabiished by Act of Congress, any writing or record, whether

in the form of an entry in a book or otherwise, made as a

memorandum or record of any act, transaction, occurrence, or

event, shall be admissible as evidence of such act, transaction,

occurrence, or event, if made in regular course of any bus-

iness, and if it was the reguler -ourse of such business to make

such memorandwin or record at the time of such act, transac-

tion, oecurrence, or event or within a reasonable time there-

after.

All other circumstances of the making of such writing or

record, including lack of personal knowledge by the entrant

or maker, may be shown to affect its weight, but such cireum-

stances shall not affect its admissibility.

The resemblance of this federal provision to the Texas statute is

almost familial and the interpretation given it by the court reveals

a certain fraternity as well.

Generally, testimony by the custodian or another qualified witness

that the records offered were kept in the regular course of business

and that they were prepared at or near the time in issue is a predi-

cate to admission under § 1732(a). See, e.g., United States v. Middle-

brooks, 5 Cir. 1970, 431 F.2d 299, 302, cert. denied, 1971, 400 US.

1009, 91 S.Ct. 569, 27 L.Ed.2d 622. Yet nowhere does the Act

36a

precarious Erie ruminations characteristic of such close

cases is necessary to approve the admission of Exhibit 13

here. Rather, Rule 43(a), itself, perceived through -the

liberal prism of our earlier decisions, furnishes the basis

for Exhibit 13’s admission. Plainly enough, the Rule is a

standard of admission not exclusion; all doubts are to be

require that the foundation come from the individual who kept the

records or had supervision over them; all that need be established

is that the record was kept in the regular course of business. Sa-

batino v. Curtiss National Bank, 5 Cir. 1969, 415 F.2d 632, 635,

cert. denied, 1970, 396 U.S. 1057, 90 S.Ct. 750, 759, 24 L.Ed.2d

752. And, as Judge Thornberry suggests in his able analysis of

Section 1732 in Sabatino, the determination whether a record has

been kept in the regular course of business should be made in light

of the purposes of the statute :

[T|he decisions excluding offered items indicate that the

main reason for the statutory language ‘‘in regular course of

any business’’ is to provide a check on trustworthiness, in

that (1) the records must be kept pursuant to some routine

procedure designed to assure their accuracy, (2) they must

be created for motives that would tend to assure accuracy

(preparation for litigation, for example, is not such a motive),

and (3) they must not themselves be mere cumulations of

hearsay or uninformed opinion.

415 F.2d at 637.

Viewed in this way, the summary of suspected and confirmed

polio cases in HidalgoCounty submitted by Dr. Copenhaver may

well have been admissible under the Act. The nature of the report it-

self and Nurse McDonald's testimony that she had seen the report

as it was being compiled at the County Health Department indicate

that it was routinely prepared. Obviously the Health Depart-

ment’s motive for accuracy in recording data on so serious an ill-

ness would be strong, and the data itself would reflect opinion from

sources well-informed. Since the trial court here chose to admit

the report once it was satisfied that the record was kept in the

regular course of business, that determination can be altered only

upon a showing of abuse of discretion. United States v. Middle-

brooks, supra, 431 F.2d at 392. Were we required to rely upon the

Federal Business Records Act, we do not believe that such an abuse

would be found.

374

resolved in favor of admissibiljty, * and even evidence not

perceived as admissible when viewed through the receptive

trifocals of Rule 43(a), is not necessarily to be excluded. *”

This expansive standard was} conceived in Monarch In-

surance Co. v. Spach, 5 Cir. 1960, 281 F.2d 401, 411, and

born in Dallas County v. Commercial Union Assurance

Co., 5 Cir. 1961, 286 F.2d 388,) 395, decisions which point

the way to our approval of the admission of Exhibit 13

here.

In Monarch Insurance, the Court faced the difficulty of

interpreting Rule 43(a)’s sanction of evidence admissible

‘‘under the rules of evidence jheretofore applied in the

courts of the United States om the hearing of suits in

equity’. On its face, this formula might be read as

endorsing admission of only thatievidence admissible under

specific pre-1938 equity precedents. But the notion that

in order to admit such evidence the court must pore over

ancient volumes in search of pre-Federal Rules dogma was

firmly interred, so far as this} Court is concerned, by

Monarch Insurance. Judge, now Chief Judge Brown,

writing for the Court, pointed out that’ the district court

sits as a court of equity, and the trial judge is not pinioned

to pre-1938 holdings: ‘‘his chief censor is the conscience of

a Chancellor.”’ Dallas County v. Commercial Union As-

surance Co., 286 F.2d at 395.* Moreover, not only did

38 Bailey v. Kawasaki-Kisen, K.K., 5 Cir. 1972, 455 F.2d 392,

397: Household Goods Carriers’ Bureau v. Terrell, 5 Cir. 1971,

452 F.2d 152, 160 (en banc): Butler v. Southern Pacifie Co. 5

Cir. 1970, 431 F.2d 77, 79, cert. denied, 1971, 401 U.S. 975, 91

S.Ct. 1196, 28 L.Ed.2d 325.

* See, e.g. Price v. United States, 5 Cir. 1964, 335 F.2d 671,

677: Dallas County v. Commercial Union Assurance Co., 5 Cir.

1961, 286 F.2d 388, 394.

would not have sounded in equity at common law does hot prevent

the district judge from admitting Exhibit 13 under the ‘‘suits in

equity’’ provision, if equitable principles would have authorized

its admission in an equitable action. See, e.g., Treharne v. Calla-

38a

Monarch Insurance greatly expand the scope of evidence

admissible within the strictures of Rule 43(a), it also

signalled the advent of a still more liberal standard by

suggesting that the Rule ‘‘does not purport to prohibit the

admission of other relevant material probative evidence

which, in the considered exercise of judicial wisdom, is

trustworthy’? 281 F.2d at 411.

The other shoe was dropped a year later in Dallas County

v. Commercial Union Assurance Co., when we flatly held

that a federal court is not required to eram proffered

evidence into one of Rule 43(a)’s pigeonholes in order to

find it admissible. Nor must the court find that the exhibit

or testimony is within a **readily identifiable and happily

tagged’’ exeeption to the hearsay rule to admit it. 286

F.2d at 398. Rather, in the words of Dallas County, if

the exhibit is ‘necessary and trustworthy, relevant and

material’’, the trial judge is free to exercise his discretion

and admit it, so long as he keeps the hearing within reason-

able bounds. 286 F.2d at 394, 398: Price y. United States,

5 Cir. 1964, 335 F.2d 671, 677.

From our review of the transcript it is plain that reeep-

tion of Exhibit 13 posed no threat to the proper conduct of

the trial. Neither party contests the exhibit’s materiality

or relevance; indeed the damage which the appellants

allege resulted from its admission establishe< those char-

acteristics beyond any doubt. Sinee Exhibit 13 was **nee-

essary and trustworthy”’, it- was properly admitted under

the liberal Dallas County standard...

Supporting this conclusion are several post-Dallas County

decisions by this Court. In Butler y. Southern Pacifie Co.,

5 Cir. 1970, 431 F.2d 77, 80, cert. denied, 1970, 401 U.S.

975, 91 S.Ct. 1196, 28 L.Ed.2d 325, a proffered report was

held to be necessary beeause information in it went ‘*to the

han, 3 Cir. 1970, 426 F.2d 5s, 62-63; Hope v. Hearst Consolidated

Publications, Ine.. 2 Cir. 1961, 294 F.2d 631, 688-690, cert. de-

nied, 1902, 368 U.S. 956 82 S.Ct. 399, 7 L.Ed 2d 388; 9 (. Wright

& A. Miller, Federal Practicé and Procedure, § 2403 at 317 n. 39.

POET EGA LPO ETE ED Paes - ~\

39a

heart of the case’’ and it was trustworthy because it was

in the ‘‘direct financial interest’’ of the maker of the report

to prepare it accurately. In the other instance, Sabatino

vy. Curtiss National Bank, 5 Cir. 1969, 415 F.2d 632, 636,

cert. denied, 1970, 396 U.S. 1057, 90 S.Ct. 750, 759, 24

L.Ed.2d 752, trustworthiness was revealed both by the

financial interest of the keeper of the record in its accuracy,

aud the fact that it ‘‘was kept according to a regular

procedure of entries made contemporancously with the

events it reeorded’’. There was no question of necessity ;

the sponsoring witness was dead.

So analyzed, the report at issue here was properly ad-

mitted. The report of suspected and confirmed polio cases,

inseribed with the word ‘‘Wyeth,’’ was crucial in linking

Wyeth to the vaccine which allegedly caused Anita Reyes’s

polio. Although it does not appear from the record why

Dr. Copenhaver did not testify at trial, we do not believe

that Reyes was required to demonstrate his unavailability

in order to meet the necessity test. Cf. Butler v.

Southern Pacific Co., 431 F.2d at 80. There were also

sufficient indicia of trustworthiness to justify admission.

Nurse McDonald testified that she had witnessed the re-

port’s preparation, and that it was laden with Dr. Copen-

haver’s handwriting. The motivation for accuravy in a

record prepared by a public health official concerning out-

breaks of serious disease within an arta committed to his

charge is obvious. <A brand of expertise sufficient to insure

accuracy may be assumed; there can be no suggestion that

in analyzing poliomyelitis cases Hidalgo County Public

Health officials were amateurish or careless. The notation

as to the origin of the lot number of the vaccine ingested

by Anita Reyes shares this reasonable presumption of

aceuracy. /ixhibit 13, necessary and trustworthy, met this

Court’s -trietures for admission.

(a) The Sufficiency of the Evidence

Finaily, we confront the appellant’s contentions that the

trial court erred in denying its motions for a directed ver-

40a

dict, for judgment notwithstanding the verdict, and for a

new trial. One argument urged by Wyeth in support of

this conclusion—that there was no evidence that Wyeth

had a duty to warn Anita Reyes—we discussed in dealing

with the substantive law. Thus here we need consider only

the contentions that the evidence was insufficient to support

the verdict and judgment, that the verdict was the result

of passion and prejudice, and that it was against the clear

weight of the evidence.

The yardstick against which such motions must be

measured is a federal one:

On motions for directed verdict and for judgment

notwithstanding the verdict the Court should consider

all of the evidence—not just that evidence that sup-

ports the non-mover’s cas —but in the light and with

all reasonable inferences most favorable to the party

opposed to the motion. If the facts and inferences

point so strongly and overwhelmingly in favor of one

party that the Court believes that reasonable men could

not arrive at a contrary verdict, granting of the

motions is proper. On the other hand, if there is

substantial evidence opposed to the motions, that is,

evidence of such quality and weight that reasonable

and fair-minded men in the exercise of impartial

judgment might reach different conclusions, the

motions should be denied. and the case submitted to

the jury.

Boeing Co. v. Shipman, 5 Cir. 1969, 411 F.2d 365, 374. As

an appellate court, our sole function is to ascertain whether

there is a rational basis in the record for the jury’s verdict ;

we are forbidden to usurp the function of the jury by

weighing the conflicting evidence and inferences and then

reaching our own conclusion. *

There was conflicting testimony as to the cause of Anita

Reyes’s polio. In answer to a special interrogatory, the

*! Borel v. Fibreboard Paper (o., supra note 5, 493 F.2d at 1092:

Helene Curtis Industries, Inc. v. Pruitt, supra note 12, 385 F.2d

at 850.

4la

jury found, despite the testimony of Wyeth’s expert

witnesses to the contrary, that Anita’s polio was vaccine-

induced. Essentially Wyeth complains that the jury

credited the testimony of the physician who treated Anita

Reyes rather than evidence offered by its parade of experts.

Presented with conflicting credible evidence, such a deter-

mination was within the jury’s prerogative; expert wit-

nesses appear to assist in the court’s decision-making proc-

ess, not to control it. Houston Natural Gas Corp. v. Pearce,

Tex.Civ.App.1958, 311 S.W.2d 899, 909, writ ref. n. r. e.; see

Steakley, Expert Medical Testimony in Texas, 1 St. Mary’s

L.J. 161-162 (1969). The rule is the same in the Fifth

Cireuit. See Alman Brothers Farm & Seed Mill, Ine. v.

Diamond Laboratories, Ine., 5 Cir. 1971, 437 F.2d 1295,

1298. The evidence for Wyeth was somewhat persuasive ;

there is no doubt about it. The evidence for Reyes was

substantial and at least as persuasive, looking at the

record coldly. Consequently, the trial court was guilty of

no error in denying Wyeth’s motions for a directed verdict

and judgment n. o. v. Denial of a motion for a new trial will

be reversed only upon showing of clear abuse of discretion

by the trial court, Davis v. Yellow Cab Co., 5 Cir. 1995,

290 F.2d 790, 791. In light of the conflicting evidence, the

denial of the motion reveals no abuse here.

IV.

Finally, we come to a series of contentions under the

general heading of challenges to comments, instructions,

and charges by the trial judge. Some of these have

already been considered. Remaining are Wyeth’s ob-

jections to specific instructions by the trial court, par-

ticularly: (1) its definition of the term ‘*epidemic,’’ (2)

its failure to define ‘‘medieally cognizable risk,’’? and (3)

its failure to instruct the jury as to the issue of ‘relative

risk’’.

42a &

Federal courts apply their own rules ” in the manner

and method of charging the jury. Where state rights are

involved, state law must, of course, be looked to for the

substance of the instructions, but the form of the charges

and the language employed to convey the substance are

procedural, hence federal, concerns. See 9 C. Wright & A.

Miller, federal Practice and Procedure, § 2255 at 651

(1971). Where as here, the issues are submitted upon a

general verdict to be accompanied by answers to specifie

interrogatories, the Federal Rules provide simply that,

**[t}he court shall give such explanation or instruction as

may be necessary to enable the jury to make answers to the

interrogations and to render a general verdict. . . .”? Not

varprisingly, then, while a litigant is entitled to have

the trial judge advise the jury of his theories and claims

(to the extent they are supported by the evidence adduced

at trial), the actual form of the instructions is within the

trial court’s diseretion. Counsel cannot, therefore, require

that an instruction be rendered in the categorical language

that he fancies would be most beneficial to his cause.

To requests for use of specific verbal formulae, defini-

‘ions, or synonyms a rule of reason should apply.

Unadorned language comprehensible to the average juror,

; not legal jargon, should characterize the instructions.

Words familiar to persons of average intelligence do not

require definition.** In reviewing the linguistie choices

‘ = >

** Barrett v. Virginian Ry. Co., 1919, 250 U.S. 473, 39 S.Ct. 540,

63 L.Ed. 1092; Nudd v. Burrows, 1875, 91 U.S. 426, 23 L.Ed. 286.

See note 27 supra.

* Delancey v. Motichek Towing Service, Inc., 5 Cir. 1970, 427

F.2d 897, 902; Kayo Oil Co. v. Sammons, 5 Cir. 1963, 321 F.2d°

729, 730.

* See McClendon vy. Reynolds Electrical & Engin ring, 5 Cir.

1976, 432 F.2d 320, 323: Government Employees’ Insurance Co.

¥. Davis, 5 Cir, 1959, 266 F.2d 760, 765; 9 C. Wright & A. Miller,

supra, © 2556 at 657-58.

, ean eh ee | Seam

43a

made by the trial court, the charge must be read as a

whole. An ambiguous phrase or inaccurate clause does not

necessarily destroy an entire instruction. Delancey v.

Motichek Towing Service, Inc., 5 Cir. 1970, 427 F.2d 897,

901. Rather, the test is whether the charge, viewed as a

whole, was sufficiently clear and accurate to be understood

by jurors of ordinary intelligence, and to be applied by

them to the evidence so as to reach a proper conclusion.

Wyeth’s objections to the instructions here do not present

serious difficulties. The appellant first contends that the

issue whether there was a polio epidemic in the Rio Grande

Valley at the time Anita Reyes con.racted the disease

should never have been presented to the jury, and, al-

ternatively, that the trial judge’s definition of the term

‘‘epidemic’’ was erroneous. It ix manifest that both argu-

ments center on the definitional dispute. Wyeth produced

eight expert medical and epidemiological witnesses, each

of whom testified that in his opinion a polio epidemic existed

in Hidalgo County, Texas in May 1970. To arrive at this

conclusion, Wyeth’s experts employed an ‘‘epidemiological

definition’ of epidemic, according to which two cases within

a given city, county, or metropolitan area in a four week

period may constitute a polio epidemic. ‘7 Dr. Ramiro R.

Casso, the Hidalgo County general practitioner who testi-

fied as Reyes’s medical expert, referred to a medical dic-

tionary to define ‘‘epidemic’’ as ‘‘ [disease] attacking many

* Rivers v. Angf. A/B Tirfing, 5 Cir. 1971, 450 F.2d 12, 15;

McGuire v. Davis, 5 Cir. 1971, 437 F.2d 570, 574.

This definition, which appeared as part of the 1969 Recom-

mendations of the United States Public Health Service's Advisory

Committee on Immunization Practice, is as follows: ‘* An ‘epidemic’

of poliomyelitis is defined as two or inore cases caused by the same

polio virus type and oceurring within a four-week period in a

circumscribed population such as that of a city, county or metro-

politan area.””

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people in any region at the same time’’.* From a review

of its comments during the trial it is apparent thas the

court, properly, did not consider itself bound by either

definition, ” although in its instructions to the jury the

court employed a definition not unlike that read from the

medical dictionary by Dr. Casso.”

Here the question whether there was an epidemic in

Hidalgo County during the relevant period bore directly

on an ultimate issue of fact. Did Anita Reyes contract

polio from a wild virus strain or from the defendant’s vae-

* This definition was the first, of three, appearing in Dorlan’s

Illustrated Medical Dictionary, Twenty-Fourth Edition, which Dr.

Casso testified was ‘‘the most generally acceptéd dictionary by

medical people.’” :

” For example, at the precharge deliberations, the court observed :

You see, I don’t think we are bound by what these doctors

say, or the government says, or what anybody says about the

fact what an epidemic is.

But see footnote 50.

” The court instructed :

Now we are talking about epidemic and we have heard lots

of testimony here about two cases within thirty days or four

cases within thirty days, and all these doctors have testified

, to that. Some of them say for operational purposes. Well,

that’s the evidence you can take into consideration on whether

or not there was any epidemic in the area. But for our pur-

pose here I am going to tell you that under the law that the

term epidemic is a relative term. and the quest’on of how

many cases constitute an epidemic is a question . fact de-

pending upon the prevailing circumstances, Th term epi-

demie in its common and ordinary meaning apy.ies to any

disease which is widely spread or generally prevailing at a

given place and time. That is what an epidemic is. You. will

be guided by that definition.

Now if you find that there was an epidemi. and that this

girl got her paralytic polio from the wild virus as the defend-

ant would let us view the evidence, because of the report of

Dr. Nakano that there is probably a wild virus, then yon have

to say by your verdict she did not contract the paralytic polio

as a result of having taken the defendant's vaccine.

45a

cine? In light of its importance, the trial judge submitted

the ‘‘epidemic’’ issue to the jurors; they had heard the con-

flicting testimony. He defined ‘‘epidemic’’ in terms per-

tinent to determining the question of causation. He de-

clined to use Wyeth’s ‘‘ epidemiological definition’’, a defini-

tion that might have confused the jurors. He did not

abuse his diserction in doing so. The substance of the

charge was correct, and the appellants were not entitled

to an instruction in the specifie terms they desired.

Wyeth objected to the trial court’s failure to define the

term ‘‘medically cognizable risk’’ used in Interrogatories

Nos. 3 and 4 and its failure to charge the jury on the ixsue

of ‘‘ relative risk’’. Wyeth insists that a definition of ‘med.

cally cognizable, risk’’ was necessary to insure that the

jury would realize that there had to exist some danger or

risk from the vaccine in order to conclude that Wyeth had

a duty to warn.

Yet whatever the ferm of the interrogatories, the link

between ‘‘medically cognizable risk’’ and ‘‘duty to warn’’

was made clear by the court’s instructions.“ It appears

5 In explaining the interrogatories to the jury the court in-

structed:

Now if you find that she did get the polio from this vaecine

ond not from a wild virus, then | must ask you do you find

from a preponderance of the evidence that on May &, 1970,

there was a medically cognizable risk that Anita Reyes might

contract paralytic polio by taking trivalent oral vaccine. We

have to view this as of May Sth, at that time. Did Wyeth

know that this trivalent oral vaccine that they were selling to

the State of Texas to immunize children was unavoidably

dangerous—I mean unreasonably dangerous or nnavoidably

unsafe, and should they have advised the parents of Anita of

this risk? Did they know that their product was unreasonably

dangerous or unavoidably unsafe to be given in the southern

tier of states between the months of April and November or

March and November, I mean? Did they know that? And if

they knew it or should have known it, did they give them warn-

ing, to the consumer? And in that connection | tell you that

the law is that if you find that the product was unreasonably

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BPrriseaaronsrenswcwe.

46a

to us that the challenged interrogatories were neither con-

fusing nor misleading:

“‘INTERROGATORY NO. 3

‘*Do you find from a preponderance of the evidence that

on May 8, 1970, there was a medically cognizable risk

that Anita Reyes might contract paralytic polio by

taking trivalent oral vaccine?

‘*The jury will answer ‘there was a risk’ or ‘there was

not a risk’.’’

‘“‘INTERROGATORY NO. 4

‘*Do you find from a preponderance of the evidence

that there was a medically cognizable risk that Anita

Reyes might contract paralytic polio by taking the

vaccine after March 31st, and before November 1, 1970?

‘*The jury will answer ‘there was a risk’ or ‘there was

not a risk’.’’

The terms [sie] ‘‘medically cognizable risk”? is self-defining,

clear, and comprehensive to men of average intelligence ;

it need not be belabored in jury instructions. Use of these

interrogatories did not prejudice Wycth’s presentation of

its case.

dangerous or unavoidably unsafe, and that such condition

was known to the defendant, or in the exercise of reasonable

care should have been known to the defendant, the law im-

poses upon them a duty to use reasonable methods to inform

the consumer of the nature of the product so that the con-

sumer may evaluate whether or not he should use the product

and take the risk.

The court later added:

Now they say, the way I understand it from their evidence

here, that these people have failed to prove that this product

was unreasonably dangerous or unavoidably unsafe, that the

records show that the vaecine has worked in thousands and

thousands of cases. On May 8th they didn’t think there was

any risk of any kind, then they had no duty—or could not

find out if there was a risk—then they had no duty to warn

because if I don’t know of a risk how can I warn anybody?

T have to know of a risk in order to have a duty to warn. So

I either know about it or I should have known about it.

47a

Wyeth contends that the trial court should have instructed

the jury to consider the ‘‘relative risk’’ of contracting polio

from the vaccine as opposed to contraction from a natural

source. This, Wycth argues, would have presented the

question more fairly than did the charge on ‘“medically

cognizable risk’’, for the jury would “have weighed the

probabilities that Anita Reyes was paralyzed by vaccine-

induced rather than ‘‘wild’’ polio virus. Yet this is pre-

cisely the consideration invited by Interrogatories 3 and

4. The distinction, therefore, is verbalistic rather than

substantial and to have refused to charge in the words

Wyeth preferred constitutes no error.

In two lengthy sections of its brief, Wyeth attacks the

trial court’s summary of the evidence in the course of in-

structing the jury and cites as prejudicial various com-

ments advanced by the court during the trial. More spe-

cifically, Wyeth excépts to the court’s comments on the evi-

dence in explaining the first two interrogatories to the

jury, * and the court’s discussion of the preponderance of

52 Compare interrogatories 1 and 2. In his summary of evidence

relevant to the first interrogatory, the trial judge made reference

to the testimony of Dr. Louis Miller, a physician in the employ of

the United States Public Health Service whose testimony tended to

demonstrate that it was only Wyeth’s vaccine that was available at

the Mission clinie on May 8, 1970, the day Anita Reyes received her

vaccine. Wyeth urges that since specific reference was not made to

the testimony of three witnesses whose recollections cast doubt on

Dr. Miller’s conclusion, it was prejudiced by this summary. Aside

from our conclusion in the text that the trial court fairly sum-

marized the evidence and specifically left the factual decisions for

the jury, it might be observed that the testimony Wyeth relies upon

does not appear to be probative of a conclusion contrary to that

reached by Dr, Miller.

Nor is the appellant’s objection to the court’s summary of evi-

dence relevant to the second interrogatory meritorious. Essentially,

Wyeth seeks to reargue the court’s failure to employ its epidemi-

ological definition of ‘‘epidemic’’ in the charge and summary. We

have discussed that contention earlier in the opinion.

oe ee

48a

the evidence standard.” Wyeth -asserts that in each in-

stance the court’s summary of the evidence unfairly em-

phasized Reyes’s theory of the case at the expense of its

own. We disagree with Wyeth’s assertion. Federal trial

courts have a proper discretion in summarizing and com-

menting upon the evidence in an effort to expedite the

jury’s determination of factual issues, See, e. g., Trezza v.

Dame, 5 Cir. 1967, 370 F.2d 1006, 1008-1009, Indeed, explan-

atory comments are prejudicial only when the court fails to

make clear to the jurors that they alone have the burden of

decision. See Stuckey vy. Andrews, 5 Cir. 1957, 249 F.2d

$28; 11 C. Wright & A. Miller, supra, § 2886 at 292-294 and

n. 73. Here the trial court went to great lengths to impress

upon the jurors that they were the exclusive arbiters of

—_— —__——

*8 The ‘‘ preponderance of the evidence”’ instruction rendered by

the court was scarcely novel, yet Wyeth contends that it was

prejudiced by the éourt’s admonition that the jury ought not be

influenced by the number of witnesses produced by either party.

The court instructed :

Preponderance of the evidence also means that it is the evi-

dence thet you believe believable. Doesn't depend on numbers

of witnesses because ten people can sit up here and -tell you-

that the horse he saw was black, and one man ean come up

here and testify that the horse he saw was white. And if you

_ believe the man that says it was white then you can disregard

the ten that said it was black, see, if the reasons he gives for

telling you the horse is white seem more plausible to you, see,

or preponderates. So the number of witnesses has nothing to

do with this. It is the quality of the evidence and the reasons

for the evidence that count. ‘So that is another way of telling

you what preponderance of the evidence means.

This segment of the court’s charge was error, Wyeth asserts,

in that it abraded the impact of Wyeth’s extensive expert testi-

mony. To the contrary, we find that offered in the midst of a

lengthy and accurate charge explaining preponderance, such an

explanaticu is laudable to the extent that it tends to concentrate

the visicn of the jury on the preponderance of believable evidence

rather than the numerical superiority of witnesses or exhibits. It

certainly was not error.

49a

the facts, the sole judges of the witnesses’ credibility. ™*

Since we also conclude that the summaries and comments

upon the evidence were basically fair, we find no ground for

reversal here.

Finally, Wyeth contends, in an argument bolstered by

twenty-three detailed references to the trial transcript, that

the cumulative effect of the trial court’s comments on the

evidence and sympathetic references to Anita Reyes so prej-

udiced its case as to require reversal. We shall not at-

tempt to consider the challenged comments separately. We

have examined the transcript from beginning to end. We

have paid particular attention to the court’s instruction to

the jury. We hold that the court’s comments were gener-

ally designed to fulfill its responsibility to keep the trial

progressing on course and at a proper pace. A trial judge

takes no vow of silence; he vows to follows the law, to be

fair, and to serve as an arbiter in the interests of justice.

See Nordmann v. National Hotel Co., 5 Cir. 1970, 425 F.2d

1103, 1109. We consider that the trial judge conducted a

fair trial. Nevertheless, we do not approve of the trial

judge’s over-frequent references to Anita Reyes as ‘‘this

little girl’’. It was obvious to all that Anita was a little

girl. And she was the victim of a great tragedy. But

judges must steel themselves to avoid any comment that a

jury might construe as bias in favor of any ‘little girl’’, or

"4 The court admonished at the outset of its charge:

Now you are the exclusive judges of the facts and the eredi-

bility of the witnesses and the weight to be given to their testi-

mony. But the law you must take from me for it would be a

violation of your sworn duty as jurors to take any other view

of the law other than that as I give it to you.

Now during the trial of this case it has been necessary for

me to make rulings on objections. I have also asked some

Witnesses questions, and during the conducteof this trial if

-. you have gotten any ideas that I am leaning one way or

wother in this case | want you to dispel that from your mind

because that was not my intention. I am very happy to have

you decide the facets in the case and relieve me of that re-

sponsibility.

50a

any injured claimant. Here, a thorough examination of the

transcript, consideration of the trial judge’s rectitude

throughout the trial, and the trial judge’s curative instruc-

tion ® to the jury convince us that his references to Anita

as ‘‘this little girl’? were not so harmful to Wyeth’s cause

as to constitute reversible error.

In closing, we feel that we should comment on the import-

ant policy considerations raised in the briefs of the amici

curiae, the American Academy of Pediatries [AAP] and the

Conference of State and Territorial Epidemiologists

[CSTE]. Both insist that the holding we reached is ‘‘dan-

gerous’’ to the nation’s preventive medicine programs and

contravenes a strong public policy favoring large-scale par-

ticipation in immunization efforts to combat infectious dis-

ease. The crucial points of the argument are two: first,

that any effort to warn vaccinees will be futile and fright-

ening, leading only to confusion, and second, that a warning

is unnecessary once epidemiologists have reached a deliber-

ate medical judgment that universal vaccination is neces-

sary. These public health policy questions cut across the

law. We realize their importance.

Citing a recent Texas statute which requires that all

Texas schoolchildren receive polio vaccine, ® the AAP in-

sists that this renders any warnings futile. This argument

assumes, of course, that the only options available are to in-

gest the oral vaccine at the clinic or to eschew immunity.

Obviously, however, one can choose to be innoculated with

killed-virus Salk vaccine, either to provide complete immu-

nity or as a pregautionary prelude to ingesting oral vaccine.

The AAP also insists ‘hat the warnings would be so com-

plex or misleading as to confuse and frighten potential

vaccinees, This is possible. Yet we believe that a warning

55 See note 54, supra.

6 67 Tex.Stat.Rev. § 209(a) (1971).

5la

advising a patron of a public health clinie of the relative

risk of contracting polio from a ‘‘wild’’ source against the

slight chance of contracting it from the vaccine would not be

terrifying or confusing. Some would sufficiently con-

cerned to take the Salk vaccine innoculation. Others, per-

haps those who, like the plaintiff in Davis, have as great a

chance of contracting polio from the vaccine as contracting

it from a wild source, will undoubtedly be deterred from

immunization. The AAIP’s answer to this problem is to

warn no one. That is no answer.

This position raises a policy consideration scarcely less

urgent than the need for mass immunization from disease ;

the right of the individual to choose and control what risk

he will take, in the absence of an individualized medical

judgment by a physician familiar with his needs and sus-

ceptibilities. Recognition of this right counters the argu-

ment advanced in the CSTE’s brief that once an epidemio-

logical balancing of the risks of immunization has been

made, no warning is required. Clearly, the rationale excus-

ing warnings to ultimate consumers of prescription drugs

whose physicians have balanced the risk for them, cannot

be extended to a medical determination that statistical

probabilities justify universal immunization. In such

cases, the test is that outlined in Davis:

When... the risk qualitatively (e. g., death or major

disability) ax well as quantitatively, on balance with

the end sought:«to be achieved, is such as to call for a

true choice judgment, medical or personal, the warning

must be given.

399 F.2d at 129-130.. Here the qualitative risk was great,

the quantitative risk minute. The end sought to be achieved

—immunization—is important both to the individual and

society. Striking the balance in this ease is difficult, but by

adding two elements to the Davis caleulus we conelude that

a sufficient ‘‘true choice judgment’’ was involved here to

lend strong policy support to our holding. First, the risk

52a

here was foreseeable statistically, although unknowable in-

dividually. Thus, unlike the abreaction cases, here there

was a basis for rational choice. Second, a choice here, if

given, had an opportunity to be efficacious, since reasonable

alternatives to taking the oral vaccine were available.

Therefore, the choice was not so clear cut that even offering

the opportunity to choose was meaningless.

Moreover, there is a third policy factor at work here

overlooked by the amici:

Until Americans have a comprehensive scheme of social

insurance, courts must resolve by a balancing process

the head-on collison between the need for adequate re-

covery and viable enterprises. . . . This lalancing task

should be approached with a realization that the basic

consideration involves a determination of the most just

allocation of the risk of loss between the members of

the marketing chain.

Helene Curtis Industries, Ine. v. Pruitt, supra, 385 F.2d at

862. Statistically predictable as are these rare cases of

vaccine-induced polio, a strong argument can be advanced

that the loss ought not lie where it falls (on the victim), but

should be borne by the manufacturer as a foreseeable cost

of doing business, and passed on to the public in the form of

price increases to his customers.”

*? See, e. g., Calabresi & Bass, Right Approach, Wrong Implica>

tions: A Critique of MeKean on Products Liability, 38 U.Chi.L.

Rev. 74 (1970); Calabresi, Some Thoughts on Risk Distribution

and the Law of Torts, 70 Yale L.J. 499 (1961) ; Morris Enterprise

Liability and the Actuarial Process—The Insignificanee of Fore-

sight, 70 Yale L.J. 554 (1961); 46 N.Y.U.L.Rev. 403 (1971) ; see

also Escola v. Coca Cola Bottling Co., Cal. Sup.1944, 24 Cal2d

453, 150 P.2d 436, 440 (Traynor, J., coneurring). It can also be

argued, of course, that since all society benefits from universal

immunization against infectious disease, the loss should be borne

by the local, state or federal government. Unless the doctrine of

sovereign immunity is significantly altered, however, such a loss dis-

tribution scheme does not appear to be likely. See Merrill, Com-

pensation for Prescription Drug Injuries. 59 Va.L.Rev. 1, 102

(1973).

i" Ng T Se ee ee ee FRO ea . - ’ 1

53a

Contrary to the assertions of the AAP and the CSTE, we

feel strongly that our holding is in accord with public policy

considerations. We recognize both the essential role the

city health clinic and the rural county clinic play in the na-

tion’s public health scheme, and the dangers that their de-

personalized medical treatment pose.* We do not then, lay

down an absolute duty to warn all who receive medication

at public clinics. Instead, we hold that in the case of a pre-

scription drug which is unavoidably unsafe, and as to which

there is a certain, though small, risk throughout the popula-

tion, there niust be cither a warning—meaningful and com-

plete so as to be understood by the recipient—or an individ-

ualized medical judgment that this treatment or medication

is necessary and desirable for this patient. Anita’s parents

received neither. Wyeth is therefore liable for the con«e-

quence of its failure to market its unavoidably unsafe prod-

uct in such a way as to warn Anita’s parents of its unrea-

sonably dangerous condition.

The judgment is affirmed.

APPENDIX A: INTERROGATORIES

The interrogatories submitted to the jury and the jury’s

ai: swers are as follows:

INTERROGATORY NO. 1

Do you find from a preponderance of the evidence that

Anita Reyes received a polio vaccine from Defendant

Wyeth’s Lot No. 15509?

The Jury will answer ‘‘She did’’ or ‘‘She did not’’.

We, the Jury, answer: She did.

** See 56 Geo.L.J. 1016 (1968) ; 5 San Diego L.Rev. 422 (1968).

d4a

INTERROGATORY NO. 2

Do you find from a preponderance of the evidence that

Anita Reyes contracted paralytic polio as a result of having

taken Defendant’s vaccine?

The Jury will answer ‘‘She did”’ or “‘She did not”.

We, the Jury, answer: She did.

If you answered this ‘‘She did not’’, then you need not

answer any other issue.

INTERROGATORY NO. 3

Do you find from a preponderance of the evidence that on

May 8, 1970, there was a medically cognizable risk that

Anita Reyes might contract paralytic poKo by taking Tri-

valent Oral Vaccine?

The Jury will answer ‘‘There was a risk’? or ‘*There

was not a risk’’,

We, the Jury, answer: There was a risk.

INTERROGATORY NO. 4

Do you find from a preponderance of the evidence that

there was a medically cognizable risk that Anita Reyes

might contract paralytic polio by taking the vaccine after

March 31st, and before November 1, 1970?

The Jury will answer “There was a risk”’ or ‘*There was

not a risk’’,

We, the Jury, answer: There was a risk,

If you have answered either or both interrogatories No.

3 and 4 ‘*There was a risk’’, then you will answer the fol-

lowing Interrogatory.

55a

INTERROGATORY NO. 5

Do you find from a preponderance of the evidence that

the Defendant Wyeth failed to warn the parents of Anita

Reyes of the risk that you have found so that they could

make their choice?

The Jury will answer ‘‘ They failed’’ or ‘‘They did not

fail’’.

We, the Jury, answer; They failed.

INTERROGATORY NO. 6

What sum of money, if paid now in cash, would compen-

sate Anita Reyes for the injuries sustained by her?

The Jury will answer in dollars and cents.

We, the Jury, answer : $200,000.00.

APPENDIX B: POLIOMYELITIS

It was not until about 1950 that scientists and physicians

really began to understand how poliomyelitis attacks its vie-

tims. They learned that polio is caused by an enterovirus

which grows in the intestinal tract, but that the virus is in-

troduced into the body orally, through the mouth. After

entering the body, the virus reproduces rapidly in the ali-

mentary tract, and when it reaches the lower intestinal tract

its growth causes what could be termed an ‘‘infection’’.

This does not mean that the individual ‘*infected’’ has con-

tracted polio; upwards of SO percent of the population is

naturally immune to polio virus, and only about one of every

hundred persons who experience the intestinal viral in-

fection will later manifest clinical symptoms of polio.

When disease does result, medical scientists believe, the

‘virus moves, perhaps through the bloodstream, from the

intestinal tract or alimentary tract to the spinal column,

where it attacks the anterior horn cells, the ‘‘grey matter’’

wr ee

56a

within the spinal column. Destruction of sufficient ‘‘grey

matter’? will result in ‘‘motor neuron disease’’, that is,

muscular paralysis.

The initial problem facing researchers attempting to de-

velop a vaccine—cultivation of a growth of polio virus in tis-

sue outside the body—was solved by Dr, Enders at Harvard

University in 1949. The scientists also learned that polio

Virus was of three distinct types, and that to provide effec-

tive protection, a vaccine would have to immunize the

vaccinee to all three types. The first breakthrough resulted

from the research of Dr. Jonas Salk. who perfected 2

“killed virus’? vaccine to be administered by innoculation,

To produce this vaccine, polio virus is grown ina tissue eul-

ture and clinically ‘‘killed’’, that is, rendered incapable of

causing disease, [n killing the virus, however, no chemical

alteration o¢eurs and when it is introduced ints the body in

tae vaccine, the virus acts as an antigen to prompi the pro-

duction of antibodies, Should a wild or virulent strain of

polio virus enter the bloodstream, the antibodies ge ierated

as a reaction to the vaccine will destroy it, and the vaccinee

will avoid polio,

In 1955 after extensive tests were conducted under the

auspices of The National Foundation fo* Infantile Paraly-

sis (March of Dimes) the researchers concluded that the

Salk vaccine was effective and, if the virus were killed, com-

pletely safe.” The Salk vaccine then becaine the primary

* These are commonly referred to as Type T., Type IT and Type

IIT, respectively. To the extent that*the differences among the

three types are relevant, they are referred to in the text. It js

undisputed, however, that Anita Reyes suffers from Type I polio.

When Salk vaceine which inadvertently contained some

unkilled virulent viral strains was released for use, however, as it,

the “Cutter incident”? of 1955, several cases of vaceine-induced

polioymelitis resulted. See, Gottsdanker y. Cutter Laboratories,

Cal. App.1960, 182 Cal. App.2d 602, 6 Cal. Rptr. 320.

—_

57a

weapon against polio. But the killed virus vaccine none-

theless exhibited several drawbacks. It had to be injected

by hypodermic needle, and a separate innoculation was re-

quired for each type of polio virus, as were repeated

‘‘booster’’ injections. Most importantly, perhaps, the Salk

vaccine failed to immunize the intestinal tract of the vae-

cinee. Thus, individuals themselves immunized could still

pass the virus to non-immune persons with whom they came

in contact. These limitations led to efforts to produce a

completely effective oral vaccine, the most successful of

which was that of Dr. Aibert Sabin. Developed in the

middle and late 1950’s, the Sabin oral vaccine introduced

living but attenuated polio virus into the recipient’s system.

An attenuated polio virus is one which laboratory processes

have rendered incapable of producing disease (to the extent

of attenuation), but which retains sufficient strength to

cause the production of antibodies to resist and destroy an

attacking wild or virulent polio virus in the vaccinee’s ali-

mentary tract. Three types of ‘monovalent’? vaccines were

developed, one to deal with each type of polio virus, but

through a ‘‘titering’’ or mixing process, a single ‘triva-

lent’’ oral vaccine can be produced which, upon ingestion,

will provide protection against all three types of virus.

Like its ‘‘killed virus’? predecessor, the Sabin vaccine

was extensively tested worldwide to determine whether it

was safe and effective for general nse. When favorable

results were achieved, the vaccine was licensed for mannu-

facture and sale in the United States by the Division of

Biologie Standards of the National Institute of Health

[D.B.S.], an arm of the Department of Health, Education

and Welfare. Wyeth Laboratories was among the three

original licensees who were authoyized to prepare and dis-

tribute the vaccine only as a preseription drug. Irrespee-

tive of which licensee prepares the vaccine, it is derived

from a common source: a seed virus obtained from Dr.

Sabin. The ‘seed virus’’ from which Wyeth Laboratories

38a

¥aceine is produced was obtained from Dr. Sabin by Pfizer,

Ltd., of England, and is repeatedly reproduced by them ia

a culture of monkey tissue. Reproduction is rapid, and

the virus is frequently “‘harvested”’ and the vaccine pre-

pared in separate “‘lots’’. At this point Pfizer conducts

extensive tests on each lot to ensure that it is safe and |

effective. Once satisfied by its laboratory findings, Pfizer

ships the lot of vaccine to the D.B.S., where it is again

subjected to rigorous testing." If the vaccine meets D.B.S,

_ Standards, it is released to the manufacturing laboratory,

where the vaccine is titered or mixed,

Despite careful preparation and testing, it is apparent

that live virus oral polio vaccine eannot be stripped of all

danger. As early as January 1961, a subeommittee of a

Health, Education and Welfare Department Committee on

Poliomyelitis Control expressed concern about the ‘known

potentiality of reversion to virulence of live poliovirus

vaccine.’”’ A year and one-half later, both a subcommittee

of the Association of State and Territorial Health Officers

and the Surgeon General’s own Special Advisory Commit-

tee on Oral Poliomyelitis Vaceine, concluded that, at least

where Type III oral vaccine was concerned, a causal con-

nection exists between administration of the vaccine and

the occurrence of poliomyelitis in some adults. Thus a

**small but definite risk’’ attaches in feeding Type III oral

vaccine to.adults.* By July 1964, with more data avail-

able, the Surgeon General's Special Committee found that

15 cases of polio deemed compatible with vaceine causation

had followed ingestion of Type I vaccine, 2 had followed

ingestion of Type II, and 36 had followed ingestion of

Type III. The Committee concluded that “at least some

“! A more extensive discussion of the nature and complexity of

the tests may be fuced in Griffin v. United States, E.D.P2.1972,

351 F.Supp. 10.

See Davis v. Wyeth Laboratories, 9 Cir. 1969, 399 F.2d 121,

123-125.

59a

of these,cases were caused by the vaccine’. This is not

to say that the Special Committee concluded that these

cases were produced by the vaccine; to the contrary, the

members cautioned that ‘‘no laboratory tests available ean

provide a definitive answer’, Rather, they employed a

brief datalogue of symptoms ™ which they believed would

separate those cases compatible with vaccine-causation

from ffase clearly caused by wild strains, and would far-

ther separate the **probable’’ vaccine-related cases from

those merely possibly associated with it.

* Report of the Special Advisory Committee on Oral Poliomye-

litis Vaecine to the Surgeon General, Publie Health Service, 1964

at 4. A report by the Health, Education and Welfare Depart-

ment 's Center for Disease Control indicates that for the year 1964,

20 of 56 reported cases could be associated with vaccine ingestion,

Center for Disease Control, [Department of Health, Education and

Welfare|, 1964 Surveillance Report, at 3.

* As paraphrased in Reyes’ brief, these symptoms inelude :

1, An onset of illness between 4 and 230 days following. feeding

of the specifie vaccine type in question and with!sie] an

onset of paralysis not sooner than six days after the feeding.

. Significant residual lower-noter-neuron paralysis.

4. Laboratory data not inconsistent with respect to multiplica-

tion of the vaecine virus fed.

4. No evidence of upper motor neuron disease, definite sensory

loss, or progression or recurrence of paralytic illness one

month or more after onset.

These compatible cases were further subdivided into **probable’’

and ** possible ’* cases employing the following guidelines for ** prob-

able”’ cases:

1. Evidence of fever at onset of paralysis.

2. History of svstemic iilness preceding the development of pa-

ralysis. “

3. Clinical evidence of meningeal involvement manifested either

bY? muchal rigidity or cerebrospinal fluid cell count greater

than 10 ells per enhie milliliter.

For a further discussion of the development of polio vaceine.

avd the elaborate testing procedures, see, eg. Davis vo Wyeth

Laboratories, Inc.. & Cir. 1969, 399 F.2d 121: Griffin v. United

States. E.D.Pa.1972, 351 F.Supp. 10; Stahlheber v. American

Cyanamid Co., Mo.Sup.Ct.1970, 451 S.W.2d 48. Ls

60a ~

APPENDIX B

| VERNON'S EDUCATION CODE OF TEXAS

- $2.09. Immunization |

~* (a) No person may, be admitted to any elementary or

secondary school or institution of higher education unless

he h&% been immunized against diphtheria, rubeola, rubella,

tetanus, poliomyelitis, and smallpox, except as provided in

* Subsection (e). 5, ons

(b) Subject to the provisions of Subsection ¢) the State

Board of Health may modify or delete any f the immu-

_ hizations in Subsection (a) or may require injmunizations

against additional diseases as a requirement for admission

to any elementary or secondary school or institution of

higher education. |

admission to any elementary or secondary school or insti-

tution of higher education when the person plying for

admisdion submits to the admitting official either of the

following: $1] |

.- 2

(1) an affidavit signed by a doctor who i: duly regis-

tered and licensed under the Medical Pra tice Act of

Texas, in which it is stated that, in the do¢tor’s opin-

ion, the immunization required would be injurious to

the health and well-being of the applicant or any mem-

ber of his family or household; or ont, ae

(2) an affidavit signed by the applicant or, if_a

minor, by his parent or guardian stating that the im-

munization conflicts with the tenets and practice of a

recognized church or religious denomination of which

the applicant is an adherent or member; provided,

however, that this exemption does not apply in times of

emergency or epidemic declared by the Commissioner 5

of Health. 4 t

sem

& v4

(d) The State Department of Health shall provide the

required immunizations to children in areas where no local

provision exists to provide these services,

REPENS Kec Bey, rae LEAL RGAE RO Ve Se pe by

mie ’ 7 = i =

eee 6la

(e) A person may be provisionally admitted to an ele-

mentary or secondary school or institution of higher edu-

cation if he has begun the required immunizations and if

he continues to receive the necessary immunizations as

rapidly as is medically feasible. The State Department of

Health shall promulgate rules and regulations relating to

the provisional admission of persons to an elementary or

secondary school or institution of higher education.

Amended by Aets 1971, 62nd Leg., p. 702, ch. 67,0§ 1, eff.

April 26, 1971; Subsec. (b) amended by Acts’ 1971, 62nd

“Leg., p. 1442, ch. 398, § 1, eff. May 26,1971; Subsec, (e)

added by Acts 1971, 62nd Leg., p. 1441, ch. 393, § 2, eff.

May 26, 1971.

een ge

62a

ASPENDIX C

PRESIDENTIAL DOCUMENTS

Title 3—The President

PROCLAMATION 4329

Immunization Action Week, 1974

By the President of the United States of America

A Proclamation <

This Nation has always been committed to fostering the

health of its people, and. particularly of its children. Im-

munization against disease has been an exciting chapter in

that effort. The United States can take pride in the dedi-

cated research which has produced safe afid effective vae-

eines against polio, measles, rubella, and other childhood

diseases,

~ Cooperation by the medical profession and public health

organizations in distributing these vaccines to children has

achieved dramatic reductions in diseases which can kill,

cripple, or cause birth defects, ineluding niental retarda-

tion. Because of their tragic consequences, we dare not

let down our guard against a resurgence of these diseases.

The Presideni’s Committee on Mental Retardation a

brought to my attention an alarming decline of immunity

levels among pre-school children. Last year more “than

40 percent of these children. were unprotected against

either polio, measles, rubella, diphtheria, pertussis, or

tetanus. On polio, for example, the Department of Health,

iducation, and Welfare Center for Disease Control re-

ports that immunization levels dropped from 79 percent in

1963 to 60 percent in 1973.

Our children are America’s future. Let us make that

future a healthy one, for their sake and the Nation’s sake.

, »

63a

Now, Tuererore, I, Gerauo R. Forp, President of the, ~~

United States of America, do hereby proclaim the week

beginning October 20, 1974, as ‘*Immunization Actidn

Week,”’ and call upon all parents, educators, and medical

personnel to exert renewed efforts during this week and

throughout the year to immunize every American child

against diseases for which vaceines are available.

In Witness Wurreor, | have hereunto set my hand this

- twenty-first day of October, in the year of our Lord nine-

teen hundred seventy-four, and of the Independence of the>

United States of America the one hundred ninety-ninth.

. /s/ Geran R. Forp

[FR Doe.74—24889 Filed 10-21-74;3:56 pm]

FrpreraL Recisrer, Vo. 39, No. 206—Wepnespay,

OctoBer 23, 1974

i «

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