Opposition — Haste v. American Home Products Corp.

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IN THE SUPREME COURT OF THE uNrreD SrATES

October Term, 1978 \EL R@DAK, JR., CLE

No. 78-429

WILLIAM and MAXINE HASTE, Petitioners

Ve

AMERICAN HOME PRODUCTS CORPORATION,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS FOR THE

TENTH CIRCUIT

BRIEF FOR THE RESPONDENTS IN OPPOSITION

GLENN PARKER

HIRST & APPLEGATE

200 BOYD BUILDING

CHEYENNE, WYOMING 82001

COUNSEL FOR RESPONDENT

BYRON HIRST,

JAMES L. APPLEGATE,

and THOMAS N. LONG

200 Boyd Building

Cheyenne, Wyoming 82001

and

LEWIS PERKISS

685 3rd Avenue

New York, New York 10017

OF COUNSEL

f FILED

INDEX

Opinion Below .... .-

Statement of the Case .

Summary of Argument . .

Argument . . « »« »« « «

1. The Tenth Circuit Did

Not Make A Finding Of Fact

Unproven In The Record... 4

2. The Tenth Circuit Decision

Is Not In Conflict With

Decisions Of Other Circuits

Or 21 U.S.C. §353(b)(2).

3. There Is No Conflict

Among The Tenth Circuit

» did

Decision And The Decisions

Of Other Circuits And State

Courts In Evaluating The

Duty To Warn Where

Advertising Is Involved.

CONGLUBAOGR «4 1 6 ss *

Appendix . « « « « « e

Reply Brief of Appellant and

Cross-Appellee ...

(1)

s 83

- 29

-App.

-App.

1

1

AUTHORITIES CITED

CASES:

Beauharnais v. Illinois, 343

U.S. 250, 96 L.Ed. 919, 72 S. Ct.

725, (1951), reh. den. 343 U.S.

988, 96 L.Ed. 1375, 72 S. Ct.

1070 (1952) e o . . . ° e . e ° 6

California v. Taylor, 353 U.S.

553, o07 (1957). ° ° ° ° . ° ° ° |

Colorado Serum Co. v. Arp, 504

P.24 801 (Wyo. 1972) . . ++ + + 13

Davis v. Wyeth Labortories,

Inc., 399 F.2d 121, 130 (9th Cir.

1968) .« « «© «© «eo © w © © © co © «61617,

18,19,

20,22

Desper v. Starved Rock Ferry Co.,

342 U.S. 187, 96 L.Ed. 205, 72

S. Ct. 216 (1951), reh. den. 342

U.S. 934, 96 L.Ed. 695, 72 S. Ct.

S76 (i9SS)< + we he ee eh

First National Bank v. Ford,

216 P. 691, 30 Wyo. 110 (1933) . 15

Gravis v. Parke-Davis & Co.,

502 S.W.2d 863 (Tex. App. 1973) . 21,22,

Haste v. American Home Products

Corp., 577 F.2d 1122, 1124, 1125

(10th Cir. 1978). . * e e ° ° e ° 1,10,

11,14

22,28

Heirs of Fruge v. Blood Services,

365 F.Supp. 1344, 1350 (W.D.La.

SUTel* 6 4 4° O93 Se sO a a Oe

(ii)

Helvering v. Fuller, 310 U.S. 69,

84 L.Ed. 1082, 60 S. Ct. 784

(1939) e eo ° . 7 . e . . . eo . . 6

Helvering v. Tex-Penn Oil Co.,

300 U.S. 481, 81 L.Ed. 755, 57

S. ce. 569 (1936) . . ° e ° . . . 6

Incollingo v. Ewing, 444 Pa. 263,

aus Meee Gee CAPTAls + s « 4 « «© 36,26

Kay v. United States, 303 U.S.

1, 82 L.Ed. 607, 58 S. Ct. 568

(1937) ° . ° . . ° . ° ° ° ° ° ° 6

Lanasa Fruit S.S. & Importing Co.

v. Universal Ins. Co., 302 U.S.

556, 82 L.Ed. 422, 58 S. Ct. 371

Bes ys ee ee ey ee ee

Lawn v. U.S., 355 U.S. 339,

362-363 (1957) ° ° . ° . . . . e 5

Love v. Wolf, 249 Cal. App. 2d

822, 58 Cal. Rptr. 42 (3rd

Dist. Cl. App. 1967) « «= 2 es «+ 26,35

Love v. Wolf, 266 Cal. App. 2d

378, 38 Cal. Rptr. 183 (3rd D.C.

MPs £906). «© «6 oe © tt el ee st hl el| 6S 2

Maxted v. Pacific Car & Foundry

Co., 527 P.2d 832 (Wyo. 1974). . 13

Michel v. Louisiana, 350 U.S.

91, 100 L.Ed. 83, 76 S. Ct. 158

(1955), reh. den. 350 U.S. 955,

100 L.Ed. 831, 76-S. Ct. 340

6) Be ee ae ae ee ee

(iii)

Reyes v. Wyeth Laboratories, Inc.

498 F.2d 1264 (5th Cir. 1974). . 17,18

20,22

Ruhlin v. New York Life Ins.

Co., 304 U.S. 202, 58 S. Ct. 860,

ge OE eS | re be

Singer v. Sterling Drug, Inc.,

461 F.2d 288 (7th Cir. 1972) .. 16

Sonzinsky v. United States, °

300 U.S. 506, 81 L.Ed. 772, 57

Se Ct. 554 (1936) . ~. «© «© «© «© « «© 6

Sterling Drug, Inc. v. Cornish,

370 F.2d 82, 85 (8th Cir. 1966). 20

Sterling Drug v. Yarrow, 408 F.2d

976 (Gth Cir. 1969). « « « © « «© 24,27

Stevens v. Parke Davis & Co.,

107 Cal. Rptr. 45, 507 P.2d 653

(1973) . . . . . . . . . . . . . 24,27

Youakim v. Miller, 96 S. Ct. 1399

(1976) . . . . . . . . . . . . . 5

MISCELLANEOUS:

21 U.S.C. §352(n) . 8 6 6 6 ae

a. Saweme Memeekt@ls « « 2:8 « « 2

2l Fe § 353 >. .* . . . . >. >. 2

Be Weteee Baoeeemitay « « « « « « 12,34

32 Am. Jur. 2d Federal Practice

6 Proceagure S297. <2 « «© «© ee 8

4 C.J.S. Appeal and Error §228 .

uw

Dixon, Drug Product Liability

§9.02[2] . . . . . . . . . . 20

(iv)

IN THE SUPREME COURT OF THE UNITED STATES

October Term, 1978

No. 78-429

WILLIAM and MAXINE HASTE, Petitioners

Ve

. AMERICAN HOME PRODUCTS CORPORATION,

Respondent.

BRIEF IN OPPOSITION TO PETITION FOR A WRIT

OF CERTIORARI TO THE UNITED STATES COURT

OF APPEALS FOR THE TENTH CIRCUIT

OPINION BELOW

The Court of Appeals' Opinion has

now been published and is7~ reported,

Haste v. American Home Products Corp.,

577 F.2d 1122 (10th Cir. 1978).

STATEMENT OF THE CASE

Petitioners' statement of the case

is Slanted, argumentative and omits

important circumstances established by

the evidence, necessitating a statement

by Respondent, which can probably be best

done by quoting from Respondent's Appeal

ale

and Reply Brief, which were not

challenged in the Court of Appeals:

"In 1970 Mr. and Mrs. William

Haste, Meeteetse, Wyoming, ranchers,

running some 250 head of Santa Ger-

trudis type cattle, had a problem

when some of their cows became af-

flicted with what their veterinarian,

Dr. Humphreys, diagnosed as anaplas-

mosis. They talked to him about

vaccinating with Anaplaz, a vaccine

dispensed by Defendant, if they had

more trouble in the future. He

advised of the possibility of

Neonatal Isoerythrolysis in calves

from the use of the vaccine and they

did nothing about vaccinating at that

time. In May of 1971 Hastes had Dr.

Humphreys vaccinate two of their

bulls with Anaplaz. Later that year

they bought 45 head of Angus cows

from an area infested with

anaplasmosis and after they had lost

28 cows from that disease, they

secured Anaplaz vaccine from Dr.

Roberts, another of their ‘regular

veterinarians', who also explained to

them the possibility of the side

effects of NI in calves of the

vaccinated cows. They vaccinated

cows themselves, after reading the

warning and directions on and in the

containers, each package bearing on

the outside a prominent caution sign

reading "Caution; See Enclosed

Leaflet Concerning Possible Risk In

Vaccinating Breeding Females.' (Ex.

L, R. Vol. VII, Ex. App. p. 122).

The Hastes also read the cautionary

ae

Statement on the inside of the

package.

"Thereafter they lost no cows

from anaplasmosis, but after two

booster shots of vaccine, the last of

which was secured in 1973 from

another of their ‘regular

veterinarians', Dr. Lester, a number

(39) of their calves died of a

disease which was diagnosed as NI. .

"Plaintiffs had a marginal opera-

tion of crossbreed cattle (Santa

Gertrudis), which were particularly

susceptible to anaplasmosis."

"Anaplaz, a vaccine against

anaplasmosis could be procured only

from veterinarians all of whom had

been advised by American Home that

the vaccine might cause NI in calves

of vaccinated animals. .. ."

"The vaccine which Plaintiffs

purchased had a prominent red warning

on the outside and also had a clear

understandable warning on the inside

that detailed the risk to one using

the product. The Hastes admitted

that they read and understood such

warning.”

SUMMARY OF ARGUMENT

l. Petitioners' "finding of fact

unproven" argument was not raised below

and is specious. The Tenth Circuit

adopted the Trial Court's supported

finding that Anaplaz, procurable only

-3-

through veterinarians, should be governed

by the “prescription drug" doctrine.

2. The Tenth Circuit decision by

extending the "prescription drug" doc-

trine to Anaplaz, because it is dispensed

in a manner similar to the sale of pre-

scriptions, is not in conflict with deci-

Sions of other circuits or with federal

Statutes regarding "prescription drugs."

No circuit has held that the "prescrip-

tion drug" doctrine applies only to those

products defined in 21 U.S.C. §353.

3. There is no conflict among the

decisions of the circuit courts regarding

the effect of advertising on the duty to

warn. Also this argument was not raised

by Petitioners below. No circuit has

imposed a duty to warn the public on a

drug manufacturer when all physicians

have been adequately warned.

1. THE TENTH CIRCUIT DID NOT MAKE A

FINDING OF FACT UNPROVEN IN THE

RECORD.

Petitioners criticize the Court of

Appeals for "making a finding of fact

unproven in the record", saying “at the

trial no substantial evidence of any sort

-4-

waS presented to prove that Anaplaz was

considered a prescription drug."

Such a criticism is unwarranted and

provides no basis for a consideration of

the matter by this Court for. several

reasons:

(a) Respondent on page 10 of its

brief to the Court of Appeals. said,

"Judge Winner in his opinion has agreed

with Defendant that Anaplaz is to _ be

considered a prescription drug." (R.

Vol. IV, p. 1352, App. p.32) Petitioners

did not challenge this as being unsuppor-

ted by the evidence, in either’ their

briefs or oral argument to the Court of

Appeals. (Their original Brief relates

only to damages. For their Reply Brief

see Appendix pages 1-35). They cannot

raise the question now.

It is well established that this

Court will refuse to consider claims not

made below. 32 Am. Jur. 2d Federal

Practice & Procedure §297; 4 C.J.S.

Appeal and Error §228; Youakim v. Miller,

96 S. Ct. 1399 (1976); California v.

Taylor, 353 U.S. 553, 557 (1957); Lawn v.

-5-

U.S., 355 U.S. 339, 362-363 (1957);

Michel v. Louisiana, 350 U.S. 91, 100

L.Ed. 83, 76 S. Ct. 158 (1955), reh. den.

350 U.S. 955, 100 L.Ed. 831, 76 S. Ct.

340 (1956); Beauharnais v. Illinois, 343

U.S. 250, 96 L.Ed. 919, 72 S.Ct. 725

(1951), reh. den. 343 U.S. 988, 96 L.Ed.

1375, 72 S. Ct. 1070 (1952); Desper v.

Starved Rock Ferry Co., 342 U.S. 187, 96

L.Ed. 205, 72 S. Ct. 216 (1951), reh.

den. 342 U.S. 934, 96 L.Ed. 695, 72 S.

Ct. 374 (1952); Helvering v. Fuller, 310

U.S. 69, 84 L.Ed. 1082, 60 S. Ct. 784

(1939); Kay v. United States, 303 U.S. l,

82 L.Ed. 607, 58 S. Ct. 568 (1937); Lanasa

Fruit S. S. & Importing Co. v. Universal

Ins. Co., 302 U.S. 556, 82 L.Ed. 422, 58

S. Ct. 371 (1937); Sonzinsky v. United

States, 300 U.S. 506, 81 L.Ed. 772, 57S.

Ct. 554 (1936); Helvering v. Tex-Penn Oil

Co., 300 U.S. 481, 81 L.Ed. 755, 57 S.

Ct. 569 (1936).

(b) The statement of Judge Winner

"Moreover, for the purposes of

resolution of this case, I accept

Defendants' arguments that Anaplaz

and its sale should be treated as

-6-

the sale of a prescription drug,

albeit the record is. short a few

elements of proof of a true

prescription drug." [Emphasis sup-

plied] (Petitioner's App. p.42)

is, in reality a finding of fact, based

on evidence that Anaplaz is sold under

circumstances which are sufficient to

invoke the "prescription drug" doctrines.

The Tenth Circuit did no more than repeat

this finding.

Petitioners have failed to consult

the record when they say,

"At the trial no_- substantial

evidence of any sort was

presented to prove that Anaplaz

was considered a_ prescription

drug."

Dr. Roberts when asked by Judge Winner,

"Did you write a prescription for it?"

answered, "No. It is not required to

write a prescription for it." (R. Vol.

X, p.- 40), and at another point said, "I

don't feel that I have to write a pre-

scripton to sell this product" (R. Vol.

X, p. 41). However, at another time he

conceded that the Hastes could not pur-

chase the vaccine themselves from Fort

-7-

Dodge, as he said, "because this is sold

to veterinarians only." (R. Vol. X, DP.

45).

Dr. Lester, another of the Hastes'

"regular veterinarians", when asked,

"Dr., what kind of a drug is Anaplaz,

what kind of a vaccine is Anaplaz

according to your knowledge or informa-

tion?" answered “It is a prescription

drug." [Emphasis supplied] (R. Vol. X, p.

105) Dr. Searl, a veterinarian employed by

Defendant, when asked about the restric-

tions with respect to Anaplaz answered,

"Anaplaz is a veterinary prescription

biological product." When counsel

queried, ". . . at least that is what you

think it is", Dr. Searl responded, "That's

what I know it is, and it is sold only to

licensed veterinarians and to no one else,

including M.D.'sS. And as with a

prescription biological, there are

requirements and obligations when he gets

it as to what he does with it." (R. Vol.

XIII, pp. 182, 183).

The Anaplaz carton and package

insert clearly stated:

@8-=

"Warning: Restricted by the

U.S. Department of Agriculture to

use by or on the order of a licensed

veterinarian." (Ex. L, R. Vol. VII;

Ex. 24, R. Vol. VI)

As indicated on the package and insert,

the Department of Agriculture restricts

the use of Anaplaz to veterinarians in

much the same way that the Food and Drug

Administration restricts use of human

prescription drugs to physicians. In

both cases it is clear that the purpose

of the restrictions is to prevent the

public at large from having direct access

to those medical products which are too

complex for lay use and for which the

layman does not have the training or

knowledge to know when, where and how to

use or not use the product.

Thus, there was before the trial

Court substantial evidence that Anaplaz

waS a prescription type drug sold only on

the order of a veterinarian, and the

Statement of Judge Winner, when fairly

interpreted, was a fully supported

finding of fact that ". . . Anaplaz and

its sale should be treated as the sale of

-9-

a prescription drug." (Petitioners' App.

p.42)

(c) If the sentences of the Circuit

Court opinion are not isolated in the

analysis, they fairly reflect the trial

Court's finding:

"The trial Judge acknowledged

that the drug was a ‘prescription

drug.' The Anaplaz vaccine was only

available from veterinarians, and

Plaintiffs obtained the dosages

here concerned from their veterinar-

ians. In this aspect of the case,

it makes no difference whether the

drug was compounded by the defendant

or by a pharmacist. Since it is a

prescription drug, the doctrines

applicable thereto must be applied,

and the trial Court was in error in

not doing so." Haste v. American

Home Products Corp., 577 F.2d 1122,

1124, (10th Cir. 1978).

"The records shows the typical

‘prescription drug' sequence of

events: The Hastes had livestock

exposed to anaplasmosis from new

stock they had brought into the

herd; they became interested in

Anaplaz from the ads in the live-

stock magazines; they consulted

their ‘regular' veterinarians (two

of them) before making a decision as

to what to do; they received typical

medical advice; they balanced the

risks; they decided to have the

alGie

Anaplaz ordered by Dr. Roberts (a

veterinarian was the only source);

they received it from him; they read

and understood the leaflets, and

used it. Their veterinarians were

knowledgeable on the problem, and

were well advised by defendant as to

the risks. In this chain or se-

quence of events, the defendant

discharged its duty to plaintiffs by

the warnings to the veterinarians."

Haste v. American Home Products

COfG., St! sae Lh88, 4445 [itn

Cir. 2078).

It is submitted that the West head-

note 2 well summarizes the Court of

Appeals holding:

"Products Liability. Where

cattle vaccine in question was only

available from veterinarians, and

cattle breeders obtained dosages for

their herd from their veterinarians,

vaccine was "prescription drug,"

regardless of whether it was

compounded by manufacturer or by

pharmacist, and prescription drug

doctrines were applicable in prod-

ucts liability action arising out of

use of vaccine." Haste v. American

Home Products Corp., 577 F.2d 1122

(lOth Cir. 1978)

Petitioner's did not raise the point

before the Court of Appeals, so that the

sufficiency of the evidence to support

Judge Winner's acceptance could there

-ll-

have been determined. They cannot now

avoid the fact that both the trial Court

and the Court of Appeals have held that

the vaccine, because it could be procured

Only through doctors, should be governed

by the doctrines applicable to

prescription drugs.

2. THE TENTH CIRCUIT DECISION

IS NOT IN CONFLICT WITH

DECISIONS OF OTHER CIRCUITS OR

21 U.S.C. §353(b) (2).

It should be noted initially that

Petitioners base their second and third

grounds for review upon a purported con-

flict of opinions among the Circuit

Courts of Appeal. However, all cases

mentioned by Petitioners were brought as

diversity actions involving application

of the law of California, Illinois,

Montana, Pennsylvania, South Dakota or

Texas. In this action, the Tenth Circuit

acknowledged that Wyoming law is control-

ling and that the matter must_ be

=} 2e

———

considered in light of such Wyoming

decisions as Maxted v. Pacific Car &

Foundry Co., 527 P.2d 832 (Wyo. 1974) and

Colorado Serum Co. v. Arp, 504 P.2d 801

(Wyo. 1972). Petitioners have not cited

a conflict between the Tenth Circuit

Opinion and other reported cases involving

Wyoming law. The decision of the Tenth

Circuit is Supportable as a matter of

Wyoming state law, as Respondent herein

contends, and thus any "conflict" (which

Respondent denies in the argument below)

may be the result of differing state laws

and does not warrant the extraordinary

relief sought by Petitioners, Ruhlin v.

New York Life Ins. Co., 304 U.S. 202, 58

S. Ct. 860, 82 L.Ed. 1290 (1938).

Furthermore, Petitioners do not_~ raise

important questions of federal law nor any

issues of constitutional dimension.

Petitioners have cited no conflict between

the Tenth Circuit Opinion and any

decisions of this Court. Petitioners

merely seek review to obtain a reversal of

the Tenth Circuit Opinion for their own

private benefit.

-]13-

The Court of Appeals actually adopted

the finding of Judge Winner that, "Anaplaz

and its sale should be treated as the sale

of a prescription drug" (Petitioners' App.

p. 42) [Emphasis supplied] and stated as

its reason the fact that "The Anaplaz

vaccine was only available from

veterinarians, and Plaintiffs obtained the

dosages here concerned from their

veterinarians." Haste v. American Home

Products Corp., 577 F.2d 1122, 1124 (10th

Cir. 1978).

Neither Court, by fair analysis, said

that Anaplaz was a prescription drug

within the meaning of 21 U.S.C. §353(b),

nor could they have properly done. so,

Since that statute specifically limits the

"prescription by physician" to "the drug

intended for use by man .. ." [Emphasis

supplied]. Certainly Congress adopting 21

U.S.C. §353(b6)(2) did not intend it to

apply to animals.

A fair reading of Judge Winner's

Opinion and that of the Court of Appeals

indicates that neither meant to say that

Anaplaz was in fact a prescription drug

-14-

but rather that it bore the characteris-

tics of a prescription drug, which cir-

cumstance justified its being treated as

One, Since it could be procured only from

a doctor, familiar with diseases, their

prevention or cure, and familiar with the

circumstances of his patients who may

have need of the drug.

It must also be be cne in mind that

Dr. Roberts was not the only veterinarian

who testified concerning Anaplaz as a

prescription drug and that Dr. Lester

Said unequivocally, "It is a prescription

drug."

Also, aS waS pointed out at page 6 of

Respondent's Court of Appeals Reply Brief,

which was unchallenged by Petitioners, Dr.

Searl testified that the "Dear Doctor"

warning letters were sent to all veterina-

rians (R. XIII, p. 180). There is a pre-

Sumption that they were received, First

National Bank v. Ford, 216 P. 691, 30 Wyo.

110 (1933), and the District Court adopted

this presumption (Petitioners' App. p.

42). That presumption is unrebutted here.

=} 5=

Further, Dr. Humphreys discussed the "Dear

Doctor" letters in his testimony (R. Vol.

X, p. 23) and indicated that he had seen

these as_ well as like publications

containing warnings. The District Court

found that these letters to veterinarians

", . « recognized the risk of N.I.,.. ."

(Petitioners' App. p. 36).

In this light, discussion of the

cases cited by Petitioners in this sec-

tion is relevant and desirable.

Singer _v. Sterling Drug, Inc., 461

F.2d 288 (7th Cir. 1972) was a case where

the drug manufacturer failed to give

notice of the danger to the doctor, who

gave an oral prescription to pharmacists,

ana where there was no evidence of a

warning to the user, except that she stay

out of the sun. Here there was positive

evidence that the veterinarians were

warned, that they relayed the warnings to

the Hastes and additionally the Hastes

read the written warnings on and in the

vaccine packaging.

Davis v. Wyeth Laboratories, Inc.,

399 F.2d 121 (9th Cir. CA 1968) dealt

with a human vaccine for polio, dispensed

-l16-

in mass clinics where individual consul-

tations between patient and doctor were

non-existent. The Court held that under

such a situation there was no sufficient

warning to a customer who had no contact

with a physician who had received the

warning. However, that Opinion contained

a statement at page 131 which is signifi-

cant in the present case:

"When drugs are sold over the

counter to all comers’ warnings

normally can be given by proper

labeling."

The Hastes admitted the reading of the

warnings on the outside of the Anaplaz

package as well as that contained in the

inserts. (R. Vol. XI, pp. 50, 51)

In Reyes v. Wyeth Laboratories Inc.,

498 F.zd 1264 (5th Cir. 1974), a case

which also dealt with oral polio vaccine,

the Court affirmed a judgment for the

Plaintiff citing Davis v. Wyeth Labora-

tories of the 9th Cir., supra, holding

that where the laboratory marketed

unavoidably unsafe trivalent oral polio

vaccine and failed to provide parents of

infants with either warning of risk or

-l17-

individualized medical judgment it was

liable for failing to warn. Both of the

Wyeth cases are consistent with the hold-

ing of the Court of Appeals in Hastes.

Petitioners' conclude that, on the

Strength of the Davis case, "if the drug

is not dispensed by filling and refilling

a prescription, warning must be given to

the consumer directly by the most

reasonable means available to adequately

inform the user of the risks." The Court

of Appeals decision, as already pointed

out, noted the Hastes read and understood

the written warnings which the vaccine

package contained, and as to that from

the veterinarians stated succinctly:

"The trial Judge considered

and evaluated the warnings’ given

Plaintiffs by the veterinarians, and

found them minimal. However, the

record shows that the veterinarians

were well aware of the risks. They

had adequate advice as to the risks

from Defendant. These were- the

‘warnings’ which are significant for

prescription drugs, and thus- con-

trolling here. There were no fact

questions as to these warnings."

-18-

Certainly the Haste decision followed,

rather than departed from the holding in

Davis v. Wyeth.

The line of cases which reflect the

"prescription drug" doctrine do not focus

on whether the product is in fact a "pre-

scription drug" within the meaning of the

federal statutes and regulations, nor on

whether the sale of the drug is adminis-

tered strictly through doctor's prescrip-

tion and subsequent purchase from a phar-

macist. The key factor cited by the

courts is the contact between the consu-

mer and a licensed practitioner who has

received warnings from the manufacturer

and who is’ familiar with the circum-

Stances of his patients. The one-to-one

contact permits the licensed practitioner

to give sound advice to the consumer

regarding a decision within his field of

practice.

"Ordinarily in the case of prescrip-

tion drugs warning to the prescrib-

ing physician is sufficient. In

such cases the choice involved is

essentially a medical one involving

an assessment of medical risks in

~19—

light of the physician's knowledge

of his patient's needs and

susceptibilities." Davis v. Wyeth

Laboratories, Inc., 399 F.2d 121,

t ir. ).

"In such a case the purchaser's

doctor is a learned intermediary

between the purchaser and the manu-

facturer. If the doctor is properly

warned of the possibility of a side-

effect in some patients, and is

advised of the symptoms normally

accompanying the side-effect, there

is an excellent chance that injury

to the patient can be avoided."

Sterling Drug, Inc. v. Cornish, 370

F.2d 82, 85 (8th Cir. 1966)

"The universal view is that a warn-

ing in a prescription drug should be

made to the prescribing practition-

er, because he is in the theoretical

position of being able to evaluate

and balance the dangers of the drug

against the utility from the drug."

Dixon, Drug Product Liability,

§9.02([2].

Certainly non-prescription drugs can

be dispensed under circumstances in which

a “learned intermediary" is involved, and

can therefore fall into the category of

"prescription drugs" for the purpose of

determining to whom the manufacturer's

warning should be directed. This has

=~2@=

been recognized in existing case law, and

therefore the Tenth Circuit opinion is

not in conflict with other opinions by

extending the “prescription drug" doc-

trine to products which are not prescrip-

tion drugs under federal Statutory

definitions. For example, in Heirs of

Fruge v. Blood Services, 365 F.Supp. 1344

(W.D.La. 1973), the court noted at page

1350 that blood products are ". . .

analogous to ‘prescription only' drugs .

- -" and proceeded to apply the general

rule that, in Situations where a product

can be obtained only through a physician,

only the physician need be warned.

Similarly, in Gravis v. Parke-Davis §&

Co., 502 S.W.2d 863 (Tex. App. 1973), the

court noted that the product’ involved

therein, an anesthetic, wasS available

Only upon order of a physician, and went

on to hold:

"The laws and regulations prevent

prescription type drugs from being

purchased by individuals without the

advice, guidance and consent of li-

censed physicians and pharmacists.

These professionals are in the best

position to evaluate the warnings

put out by the drug- industry."

-2li-

(Emphasis supplied) Gravis v.

Parke-Davis & Co., 502 S.W.2d 863,

870 (Tex. App. 1973).

It is equally clear that when the "“"lear-

ned intermediary" is not involved in a

sale of a drug to consumers, the mere

fact that the product involved is a pre-

scription drug within the meaning of

federal statutes will not permit’ the

product's manufacturer to invoke the

protection of the "prescription drug"

doctrine. In Davis, supra. and Reyes,

supra., the Sabin Type III oral polio

vaccine was indeed a prescription drug

within the meaning of the federal

statutes, but nevertheless a warning to

the physician was insufficient where the

physician did not fill the role of

"learned intermediary."

The Tenth Circuit Opinion likewise

focused on the presence of the ". . .

typical ‘prescription drug' sequence of

events . . .", Haste v. American Home

Products Corp., 577 F.2d 1122, 1125 (10th

Cir. 1978). The Tenth Circuit Opinion is

therefore in harmony with the other cases

-22-

which form the basis of the "prescription

drug" doctrine, and there exists no con-

flict among the circuits which would

warrant the issuance of ae writ of

certiorari.

3. THERE IS NO CONFLICT AMONG

THE TENTH CIRCUIT DECISION AND

THE DECISIONS OF OTHER CIRCUITS

AND STATE COURTS IN EVALUATING

THE DUTY TO WARN WHERE ADVER-

TISING IS INVOLVED.

Petitioner erroneously claims there

is a conflict among the circuits’ and

State courts concerning the effect of

advertising on the duty to warn.

Petitioner also cites a conflict between

the Tenth Circuit decision and federal

law.

It should again be noted that the

federal laws regarding advertising of

prescription drugs, 21 U.S.C. §352(n) and

21 C.F.R. §202.1(e), are not applicable

to Anaplaz because it is not a prescrip-

tion drug within the meaning of 21 U.S.C.

§353. Thus no actual conflict or erron-

eous ruling of law exists in this regard

which would call for review by

this Court. Furthermore, Petitioners'

-23-

argument regarding federal statutory

advertising requirements was not raised

in the Court below, being nowhere found

in the Petitioners' Tenth Circuit Reply

Brief attached hereto at Appendix pp.

1-35, and should not be considered by

this Court.

The cases cited by Petitioners for

the proposition that a seller's over-

promotion of a drug mitigates the warn-

ings otherwise given to practitioners are

not on point and are not in conflict with

the opinion of the Tenth Circuit Court of

Appeals. In all four cases (Love _ v.

Wolf, 249 Cal. App. 2d 822, 58 Cal. Rptr.

42 (Ct. App. 1967); Incollingo v. Ewing,

444 Pa. 263, 283 A.2d 206 (1971); Stevens

v. Parke Davis & Co., 107 Cal. Rptr. 45,

507 P.2d 653 (1973); and Sterling Drug v.

Yarrow, 408 F.2d 978 (8th Cir. 1969)) the

Courts were dealing with situations

involving over-promotion of a prescription

drug to a physician. The cases did not

involve advertising directed to the

public. The trial court in this action

did not find that American Home _ had

directed its advertising to the

-24-

veterinarians, but rather found that it

had directed its advertising toward

cattlemen, Petitioners' Appendix pp. 35,

42.

In Love v. Wolf, 249 Cal. App. 2d

822, 58 Cal. Rptr. 42 (Ct. App. 1967)

the Court noted at 58 Cal. Rptr. 49, 249

Cal. App. 2d 832, 833, that the doctor's

state of mind is an important factor,

particularly as it is affected by the

drug manufacturer. The Court found that

the warnings to the doctor were

inadequate and that the drug manufacturer

was aware of the inadequacy. The Court

concluded that over-promotion of the drug

to the doctor was one factor in the

inadequacy of the warnings. In this

case, the District Court did not find

that American Home gave inadequate

warnings to the veterinarians, nor did it

find that there was any over-promotion of

the drug to the veterinarians, nor did it

find that American Home was aware of any

inadequacy in the warnings given. to

veterinarians. It should further be

noted that in an earlier case involving

the same parties and facts, Love v. Wolf,

-25-

266 Cal. App. 2d 378, 38 Cal. Rptr. 183,

Ct. App. 1964), the Court had held that

the drug manufacturer only had a duty to

warn the doctor:

"Parke-Davis has no contact with the

ultimate consumer of this drug, the

patient. The duty, therefore,

whatever its extent may be, must be

a duty to warn the doctor’ who

prescribes the drug. This would be

the only effective means by which

warning could help the patient."

Love v. Wolf, 38 Cal. Rptr. 183,

—-——_-

192, 266 Cal. App. 2d 378 (Ct. App.

1964).

In Incollingo v. Ewing, 444 Pa. 263,

283 A.2d 206 (1971), again there was

Over-promotion of the drug to the doctor,

but there was no advertising to’ the

public. The court held that ". . . the

warning required is not to the general

public or to the patient, but to the pre-

scribing doctor." The Court went on to

find that the warnings given doctors were

inadequate in light of the manufacturer's

knowledge and were further nullified by

the representations of "detail men" which

amounted to over-promotion of the drug.

Again, distinquishing the present case

_

from Incollingo are the absence of a

finding that advertising was directed to

the physician, and the absence of a

finding that warnings actually given to

the veterinarians were inadequate.

In Stevens v. Parke-Davis & Co., 107

Cal. Rptr. 45, 507 P.2d 653 (1973) the

Court found that warnings to doctors were

inadequate because they had been "watered

down" by over-promotion of the drug to

the doctors. Again, no duty to warn the

public was involved, but rather a finding

that a duty to warn the doctors had not

been fulfilled. In the present case, the

District Court did not find that American

Home had failed to adequately warn the

veterinarians.

In Sterling Drug v. Yarrow, 408 F.2d

978 (8th Cir. 1969) the Court repeated

the standard "prescription drug” doctrine

that a warning need only be given to

doctors. However, again the drug manu-

facturer's "detail men" failed to point

out the side effects of the drug, and the

Court found that such failure amounted to

a failure to give adequate warning to the

-27-

doctors of the possible side effects.

Again, no advertising was directed to the

public and no duty to warn the public was

established.

The District Court held here that

there is a duty to warn the consumer

directly when advertising is aimed at the

consumer:

"I think that the direct sales

effort (even though the product was

channeled through veterinarians)

imposed on Defendant a duty to warn

the ultimate consumer’ before he

spent his money on the purchase."

(Petitioners' App. 43, 44.)

The Tenth Circuit held that it was error

to ignore the warnings given to veteri-

narians and to impose such a duty:

"The Trial Court was in error in

holding that the contents of the

advertisements of Anaplaz in the

various livestock publications are

controlling on the warnina issue,

and thus override the practical

considerations which arise from the

requirement that the consumer

purchase the vaccine only from

veterinarians, and override the

established "prescription drug'

doctrines." Haste v. American Home

Products Corp., 577 F.2d 1122, 1125

(1lOth Cir. 1978).

-28<

American Home in its Appeal Brief stated

that the duty imposed by the District

Court iS unsupported in the law. In the

Tenth Circuit, Petitioner was unable to

point out any law in support of such a

duty. The cases now cited by Petitioner

can only stand for the proposition that

advertising directed to physicians must

be considered in determining the adequacy

of warnings given to the physician, and

they cannot be considered as support for

the proposition that there is an absolute

duty to warn consumers in advertising

directed to the consumer when adequate

warnings have been given to physicians.

Here all of the advertising directed to

the consumers advised them to first

consult their veterinarian; the veteri-

narians were warned by American Home and

these warnings were also relayed to the

Petitioners when they consulted with

their “regular veterinarians" regarding

vaccinating with Anaplaz.

CONCLUSION

The Tenth Circuit Court of Appeals

did not make a "finding of fact unproven

in the record," nor is its decision in

=-29<

conflict with the decisions of other cir-

cuits or with federal law. The Petition-

ers have raised spurious arguments in

order to obtain review by this Court of

their private grievance which involves no

questions of federal or constitutional

import. The Petition for a Writ of

Certiorari should be denied.

Respectfully Submitted,

SLENN PARKER

HIRST & APPLEGATE

200 Boyd Building

Cheyenne, Wyoming 82001

BYRON HIRST,

JAMES L. APPLEGATE,

and THOMAS N. LONG

200 Boyd Building

Cheyenne, Wyoming 82001

and

LEWIS PERKISS

685 3rd Avenue

New York, New York 10017

OF COUNSEL

b October 1978

«3@0

UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

Nos. 76-2015 and 76-2016

WILLIAM HASTE and

MAXINE HASTE,

Plaintiff-Appellant

and Cross-Appellee,

VS.

AMERICAN HOME PRODUCTS

CORPORATION,

Defendant-Appellee

and Cross-Appellant.

)

)

)

)

)

)

)

)

)

)

)

)

)

REPLY BRIEF OF APPELLANT AND CROSS-APPELLEE

BADER & DUFTY

Pamela N. Hultin

600 Boston Building

828 - 17th Street

Denver, Colorado 80202

ATTORNEY FOR PLAINTIFF-

APPELLANTS

August 10, 1977

App. p. l

TABLE OF CONTENTS

Brief (App.)

Page Page

ISSUES PRESENTED .. . « « «© «© « ef (5)

STATEMENT OF THE CASE ....e. 2 (6)

ARGUMENT . . «© © © © ew ew ee ow oe eG (8)

I. Computation of cows was in

CCfOE« « 2 + s+ ss + we « 2 6 (8)

II. Upgrading program damages. .5 (9)

Itz. Oxhibite 91 and 92. « « » of (12)

IV. Increased Feed Costs ... .8 (13)

7, Gaesatiowh s » + a i « « o » wf (13)

VI. Waerning®S . . «© «6 » «© © «© « ohh (18)

VII. Contributory Negligence and

Assumption of the Risk. . .16 (25)

VIII. Limitation of Implied

Warranty. «© « « s «6 « « « «40 (32)

IX. Unusual Susceptibility ... (33)

CONCLUSION ° ° . ° ° ° . . ° ° . 022 (34)

App. p.2

TABLE OF CASES CITED

Brief(App.)

Page Page

Elder v. Crawley Book Machine Co,

441 F.20 771 (3rd Cir. 1971). . .18 (27)

Ferraro vs. Ford Motor Co.,

423 Pa. 324, 223 A.2d 746 (1966) .18 (29)

Love vs. Wolf,

226 Cal. App. 2d 378, 38 Cal.Rptr.15 .(24)

Ralston’ vs. Illinois Power Co.,

299 @U.W. 24 497 (Ill. 1973) « « « 19 (36)

Stevens vs. Parke Davis and Co.,

507 P.2d 653 (Calif. 1973) « « « 83 €23)

Vernon vs. Lake Motors,

466 P.26 362 (Utah. i971) « « « « @ (31)

OTHER AUTHORITIES

STATUTES

Wyoming Statutes

Section 34-2-316 ° ° ° *- 2°© ° 20 (32)

PUBLICATIONS

United States Department of Agriculture

release dated December 29, 1969 .14 (21)

Restatement of Torts 2d

Section 496A, Comment d.. .18 (28)

Section 496C, Comment e .. .18 (28)

Section 496D, Comment c.. .18 (28)

Section 496E, Comment a... .18 (29)

App. p. 3

UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

Nos. 76-2015 and 76-2016

WILLIAM HASTE and

MAXINE HASTE,

Plaintiff-Appellant

and Cross-Appellee,

AMERICAN HOME PRODUCTS

CORPORATION,

De fendant-Appellee

)

)

)

)

)

)

vs. )

)

)

)

)

)

and Cross-Appellant.)

REPLY BRIEF OF APPELLANT AND

CROSS-APPELLEE

This reply brief is submitted in

rebuttal on the issues presented in the

Opening brief of Appellee and Cross-

Appellant. Appellant and Cross-Appellee

responds first to the Appellee and Cross-

Appellant's rebuttal regarding the issues

of Damages and then to the issues regard-

ing Cross-Appellant's challenge of the

finding of liability in the trial ,court.

Parties will be referred to by

name or aS designated Plaintiff oor

Defendant in the trial court.

App. p.4

All citations to the Appendix

prepared in this case shall be in this

form [App. p. 366, L.2]. Citation to the

Prepared Exhibits will be in this form

[Ex. p.616]. Citation to the Record

shall be [Rec.Vol. XX p.3010, Le 2).

Citation to exhibits not in the Prepared

Exhibits shall be in this form [Rec.Vol.

VII, Ex.198].

ISSUES PRESENTED

I. The trial Court erred in its

computations regarding the number. and

value of cows sold.

Ir. The trial Court erred in

failing to award damages for loss to the

upgrading program.

III. The trial court erred in

failing to admit Exhibits 91 and 92.

IV. The trial court erred in

failing to award for increased _ feed

costs.

V. The Record discloses sub-

stantial evidence of causation;

VI. Any warnings were insubstan-

tial, inadequate and eroded by publicity

promoting the product.

VIII. Actual and implied warran-

ties were given by Defendant in

App. p. 5

promotional literature.

STATEMENT OF THE CASE

The Hastes would incorporate the

Statement of the case presented in the

opening brief as if fully set out here-

in.

The statement of the case as

presented in the Defendant's brief is

objectionable in that it represents

"facts" as "proven" where obvious) and

continuing conflict existed in the

exhibits and testimony. A reading of the

entire record, particularly the tran-

Script of trial testimony, discloses that

the plaintiffs and the veterinarians

called by Defendant gave continually

conflicting testimony regarding the

conversations between them and the

particulars of those conversations.

The record discloses that none

of the veterinarians called by the

Defendant testified to having received

any of the "Dear Doctor" letters apparen-

tly sent by the Defendant. Furthermore,

the testing of Anaplaz performed by

Outside experts has continually shown

that Anaplaz causes Neonatal Isoerythro -

lysis (N.I.). Plaintiffs did not seek to

App. p. 6

© RELI NEE DD

show that Anaplaz is the only cause, but

that it was the cause in this case.

Defendant states in its Statement of the

Case that:

"To this date, it is the

opinion of veterinarians’ and

scientists who have participated

in the investigations that there

is not enough scientific proof

to establish a cause and effect

relationship between Anaplaz and

N.I." (Brief of Appellee and

Cross-Appellant P.7).

This totally mistates the status of the

present scientific investigation and

ignores the evidence presented at this

trial from scientists such as Dr.

Stormont and Dr. Young, the veterinarians

called by the Defendant, and the United

States Government as well as the Defen-

dant itself who saw fit to include a

warning in the insert indicating that

there are indications that N.I. may

result. Certainly at the time of trial

in this matter substantial testing had

been performed as testified to by Dr.

Stormont and indicated by the articles of

Dr. Stormont and Dr. Young. Plaintiffs

invite the Court to read the record of

the liability trial, specifically the

App. p. 7

testimony of Dr. Stormont, for evidence

presented on the relationship of Anaplaz

to N.I. It is evident that the Defendant

is hiding its corporate head in the sand

to ignore and discount the overwhelming

evidence that Anaplaz has a direct rela-

tionship to the occurrence of N.I.

ARGUMENT

I. Computation of cows was in

error.

Plaintiffs make no argument that

Defendant's exhibit U indicates that 40

cattle were not worth more than slaughter

value. However, the evidence discloses

that the plaintiffs gave value to the

cows and estimated a life for them as

indicated in their tax returns. Dr.

Charlesworth indicates that these cows

had no practical value as breeders. He

never saw these cows or the results of

their breeding. His opinion is’ based

upon generalities of his experience and

not supported by any actual evidence that

the particular cattle had no value as

breeders to the Hastes, There is no

evidence that these cows would fail to

produce viable, saleable calves.

App. p. 8

Furthermore, the Plaintiffs

testified that due to the N.I. propensi-

ties of their brood cows they were forced

to sell at slaughter prices. Mr. Haste

testified that he actually received

$300.00 on an average for each cow sold

for slaughter. [Mr. Haste's testimony,

App. p.94, L.1l-ll]j. The Defendant's

Exhibit U indicates that the slaughter

value according to Dr. Searl and 0Dr.

Charlesworth would be $353.00. The

forced sale at the time the Hastes had to

sell breeding cows in Wyoming, where no

other Santa Gertrudis herds’ existed,

caused at least a minimum loss. of

$2,120.00.

{I. Upgrading program damages.

Defendant states, as did the

trial Court memorandum on the issue of

damages, that the request for damages for

losses sustained by the up-grading pro-

gram was actually a request for multiple

damages since before and after value of

the cows was given. Yet neither Judge

Winner nor the Defendant indicates how

this award would be duplicitous of the

other award if the before and after value

of the cows is subtracted from the

App. p. 9

loss to the upgrading program.

Mr. Elrod testified that the

Hastes entered into the upgrading program

in February of 1972. This program had

value to the Hastes in that, at its con-

clusion the Hastes would have not only a

herd of cattle, but the reputation, good-

will and certification as breeders of

purebred Santa Gertrudis cattle. The

loss of the individual cattie at the time

of the injury and the loss of breeding

capacity cannot compensate fully for the

loss of future profit from the termina-

tion of the involvement in this program.

This is not simply a speculative

improvement of the breed but a program

determined by other breeders designed to

provide standards of quality and a rating

procedure. All testimony -indicated that

cattle given a higher’ classification

(except bulls until they were registered

pure-bred) were of increasingly greater

value. The program was scientifically

controlled by inbreeding to achieve

ultimate perfection within tthe Santa

Gertrudis' breed. There was ample

evidence that the Hastes were

following the program and actively

App. p. 10

Wa a

Ae ge See 6

attempting to increase the value of the

herd.

This loss was not easily calcu-

lable. However, the case law is clear

that simply because the damages. are

difficult of ascertainment the fact

finder is not relieved of the ~<esponsi-

bility of approximating an amount for an

award. [This issue was amply raised and

argued in the Plaintiffs' opening brief

and cases cited there will not be repeat-

ed in the interest of brevity.]

Mr. Haste's unrebutted testimony

that the upgrading program itself repre-

sented a loss of $100,000.00. As indica-

ted in the opening brief, if the award

for the lost cows and calves is subtrac-

ted from the amount representing the loss

to the upgrading program there is no

terrible danger that a duplication of

damage would occur.

The Defendant implies that the

Hastes did not pursue a course of reason-

able action in failing to purchase re-

placement cows. The testimony regarding

the plaintiffs' desparate financial

condition after the N.I. problem and due

to it, as well as the then existing cost

App. p. ll

of comparable cross-bred cattle made such

replacement impossible for the Plain-

tiffs. As the opening brief citations

indicate such replacement is not neces-

Sary in situations where the burden would

be too onerous.

III. Exhibits 91 and 92.

Counsel for Plaintiffs would

agree with counsel for Defendant that the

record of the damages trial indicates

such amount of confusion and a perplexing

lack of preparation on the part of Plain-

tiffs' trial attorneys on the issues

related to damages. However, the evi-

dence that was educed at the trial makes

it abundantly clear that some form of

demonstrative evidence would have been

useful to clarify exactly the thrust of

the Plaintiffs' damage allegations.

Exhibits 91 and 92 were such exhibits and

should have been admitted despite the

inartful manner in which they were des-

cribed and presented. The trial Court

seemed overtly antagonistic to the expert

economic testimony presented by the

Plaintiffs and continually challenged

Plaintiffs' attorneys and apparently

badgered them into withdrawing one of

App. p. 12

their claims.

The claim for damages to upgra-

ding was not withdrawn and the Exhibits

offered had a direct bearing on_ the

determination of the amount of ‘loss to

that program.

IV. Increased Feed Costs.

The increased feed costs, as

evidenced by the tax returns of the

Plaintiffs and statements of the sickly

condition of the cattle by Gene

Schreibeis are ample evidence of addi-

tional damage to the Plaintiffs. The

feed required to prepare the cattle for

Sale after the N.I. illnesses is not a

multiplication or duplication of awarded

damages.

This feed was in addition to

that normally required. It is not

reflected as part of the awarded price of

the cattle. Judge Winner was remiss in

not making some monetary award for this

loss.

V. Causation.

The Defendant asserts that since

the written records provided to Dr. Searl

by Mrs. Haste show that one calf that

died of N.I. was born of a cow for which

App. p. 13

no notation of vaccination with Anaplaz

was made that this conclusively shows

that Anaplaz did not cause the N.I. in

the Haste herd.

Maxine Haste testified that all

of the brood cows were vaccinated with

Anaplaz vaccine [Appendix p.65, Line

9-23). The records in evidence show that

the Plaintiffs vaccinated hundreds of

animals with Anaplaz as well as other

vaccines. These records were kept by

Maxine Haste during the course of the

normal ranch routine. The finding of one

mistake or omission on the part of Mrs.

Haste in her record keeping is neither

Surprising nor dispositve of the liabil-

ity issue in this case. The fact that

Mrs. Haste missed only one entry out of

several hundred cows is credit to her

bookkeeping.

The Defendant goes to _ great

lengths to argue that the testimony of

Dr. Searl is the only probative testimony

on the issue of causation. As Judge

Winner noted,

"The opinion testimony is diame-

tric as to causation. The pro-

duct is new, and perhaps further

App. p. 14

Scientific study and_ research

will prove defendant's experts

to be right, but as the trier of

fact, and based upon the expert

testimony so saying, I find that

the Anaplaz vaccinations of

Plaintiffs' herd was the proxi-

mate cause of the N.I. later

discovered in those cattle."

(3) “In so finding, I am not

unaware of evidence tending to

show that one cow diagnosed as

having N.I. was not vaccinated

with Anaplaz, but I think that

the preponderance of the evi-

dence shows to causal connection

between Anaplaz and N.I. That

connection is surely not estab-

lished beyond a reasonable

doubt, but I think that’ the

civil case test of preponderance

of the evidence is met."

Plaintiffs agree that proof can-

not be speculative, but in matters of

expert opinion it is not uncommon that

the experts differ in the interpretation

of data and the methods used. The exten-

Sive testimony of Dr. Stormont, that his

experiments proved that Anaplaz produces

the sensitization in catle causing isoan-

tibodies which ultimately cause N.I. in

calves [Appendix p.100-116] was not

controverted by comparable evidence of

App. p. 15

experiments by the Defendant’ showing

otherwise. Dr. Searl and Dr. Stormont

are at odds as to the side-effects of

Anaplaz. Judge Winner in weighing the

evidence chose, rightly, to find that by

a preponderance of the evidence Anaplaz

caused N.I. in the Haste herd.

Dr. Stormont indicates that he

has never encountered N.I. in a herd that

was not vaccinated with Anaplaz [App. p.

117 L. 17-20). He also indicated that he

knew of no published proof that N.I. had

been found in any herd that had not been

vaccinated with Anaplaz [App. p.1l7 L.

21-24] except from Australia where they

have another kind of homologous’ blood

vaccine [App. p.118 L.4-9]. Dr. Stormont

further indicated that the cows in his

test group still produced the isoanti-

bodies over a year after their last

booster injection [App. p.118 L.10-23].

This testimony clearly shows that the

witnesses had some conflicting opinions

and by the preponderance of evidence that

Anaplaz caused N.I. in the Haste herd.

Other evidence that Anaplaz

causes N.I. was produced by the Plain-

tiffs in the form of papers. The Court

App. p. 16

should read, for example, Exhibits No. 53

[Ex. p.10); Exhibit No.54 [Ex. p.15];

Exhibit No. 55 [Ex.p.19]; Exhibit No. 58

[Ex. p.20]; Exhibit No. 80, [Ex. p.29].

These articles as well as letters submit-

ted into evidence between Dr. Stormont

and American Home Products as well as

United States Government directives to

the Defendant submitted into evidence

more than adequately showed by a prepon-

derance that Anaplaz causes N.I.

Clearly the testing as evidenced

by the testimony of Dr. Stormont and Dr.

Young was not the subject of speculation

on their parts. Their opinions were

based on these tests and were competent

to a reasonable degree of certainty.

It is unrebutted that the

Plaintiffs' calves died of N.I. Dr.

Blessing and Dr. Stormont testified to

that. A great deal of testimony was

given by many witnesses both experts and

veterinarians that N.I. was caused by

Anaplaz. Dr. Roberts testified for the

Defendant and he indicated that he would

not recommend Anaplaz because of the

danger of N.I. caused by the vaccine.

[R.Vol. X, p.55, App. p.132].

App. p. 17

VI. Warnings.

Defendant contends that the

conversations between Dr. Roberts and Dr.

Humphreys and the Hastes were sufficient

to satisfy its duty to warn the Plain-

tiffs of the risk of N.I. As they noted,

these individuals “had no connection

whatever with American Home _ Products

coe It is unclear how the Defendant

finds that its duty to warn can be

assigned to veterinarians in Wyoming,

where these veterinarians never testified

to having received any "Dear Doctor"

letters from American Home Products

regarding the impossible danger of N.l.

from Anaplaz vaccination. Dr. Roberts

indicated that the knowledge he had about

N.I. came from published articles and not

from any information disseminated by

Defendant.

Adequate warning did not issue

to the Hastes from the Defendant. The

testimony regarding these conversations

by Dr. Humphreys and Dr. Roberts was

contradicted by the Plaintiffs' recollec-

tion of these conversations. Dr.

Humphreys minimized any warning that he

may have made. Dr. Roberts did not

App. p. 18

consider the vaccine to be a prescription

drug and therefore he had no “profession-

al duty" to do more than order’ the

vaccine which he did. Mrs. Haste testi-

fied that Dr. Roberts said only one sen-

tence that indicated he would not use

Anaplaz, without any indication as to

why:

"When we were at Dr. Roberts' we

told him we were thinking about

doing this, in fact, had almost

decided to do it. He said that

if it were he, he wouldn't do

it. We said 'Why?' and he said

"Because of the kind of vaccine

te is.* And that is all he

said. He does not explain a

lot and that is every word he

said to us." [Rec.Vol. XI

Judge Winner aptly resolved this

testimonial conflict in his memorandum

opinion:

"I accept plaintiffs' testimony

as to the extent of Dr. Roberts'

warning, and I do not think that

this warning was of a nature to

place a reasonable cattleman on

notice of realistic risk from

use Of Anaplaz." [App. p.30]

Not only was there no duty known

to the veterinarians to warn on behalf of

the Defendant and no evidence of actual

notice to them from the Defendant of N.I.

App. p. 19

danger, there was obvious conflict as to

the extent of the warnings they testified

to which was resolved by the trier of

fact in favor of the Plaintiffs. This

Court has only to read the record of the

liability trial to see that Judge Winner

had ample testimony upon which to base

his determination that any warnings from

the doctors were minimal. .That decision

Should not now be overturned by this

Court on appeal.

The Defendant challenges Judge

Winner's determination that:

"There is a duty to warn the

rancher of potential risks in

the advertising and sales

material which promote the sale

of the product." [R.Vol. IV, p.

1352, App. p.32].

The Defendant neglects to men-

tion that this product was extensively

advertised in cattlemen's magazines. The

Plaintiffs first learned of the product

from these magazines. These are included

in the Record of this case but Judge

Winner's citation of certain passages in

his brief indicates some of the represen-

tations of safety and the lack of any

warning of any potential side effect in

App. p. 20

this literature:

"Understandably, and justifi-

ably, the advertising is lauda-

tory of Anaplaz, but, in

addition to the broad commenda-

tory language, published adver-

tisements say, for example,

"So vaccinations not only

protect your cow herd, but

your profits from two calf

crops as well. With ease,

safety and economy.

"Anaplaz" is an inactivated

vaccine, incapable of prod-

ucing disease. It has been

scientifically researched,

developed and tested by

controlled procedures under

both laboratory and actual

field conditions. Exten-

Sive trials have been con-

ducted in herds on widely

separated farms and

ranches.'

The 'Dear Doctor' letters recog-

nized the risk of N.I. but the

material directed to the ulti-

mate purchaser gave no clue that

there was any risk. MThe adver-

tising literature did not men-

tion a release by the United

States Department of Agriculture

dated December 29, 1969, which

said, inter alia:

"Vaccinating brood cows

with anaplasmosis vaccine

sometimes may cause fatal

side-effects in calves, the

App. p. 21

»

U.S. Department of Agricul-

ture cautioned today

Judge Winner was stating what

may seem patently obvious to the lay

person but not apparently to counsel for

the Defendant. The representations to

the buyer were such as to induce them to

purchase. Known risks vere not merely

minimized but were ignored stating that

the drug was “incapable of producing

disease." Surely some burden should be

placed on the manufacturer of a product

with a known risk to inform potential

buyers, before purchase, of that danger.

Exhibit 23 (1) [Memorandum

Opinion App. p.29] which is a brochure

supplied by the Defendant to Dr.

Humphreys and given by him to- the

Plaintiffs when they inquired about the

Anaplaz vaccine assured them that "five

years of Anaplaz field use has_~ shown

there's no longer any reason for running

the risks of suffering the ravages of

anaplasmosis." (emphasis added). This

Same brochure described the vaccine as

"safe" and "readily available."

App. p. 22

These overt representations,

that uncontrovertedly reached the plain-

tiffs, were relied on by them in purchas-

ing the vaccine. Any understanding they

may have had about a risk as enormous as

the one existing here came from others

and wasS minimized by them.

In Stevens vs. Parke Davis and

Co., 507 P.2d 653 (Calif. 197) the ques-

tion was raised as to the adequacy of a

warning given to a physician regarding

dangers of a prescription drug for human

use. The Supreme Court of California

stated:

"Although the manufacturer or

Supplier of a prescription drug

has a duty to adequately warn

the medical profession of its

dangerous properties or of facts

which makes it likely to be

dangerous, an adequate warning

to the profession may be eroded

Or even nullified by over-promo-

tion of the drug through a vig-

Orous sales program which may

have the effect of persuading

the prescribing doctor to disre-

gard the warnings given." (id.

at p.661)

If over-promoting a drug to a

doctor can be grounds for the nullifica-

tion of any warnings given him then a

App. p. 23

fortiori the same principle should apply

to lay persons to whom the drug is

directly marketed. Another prescription

drug case raised a similar issue making

the point that if over-promoting reason-

ably induces a doctor to disregarding

warnings he has received then the warning

is withdrawn or cancelled. See Love vs.

Wolf, 226 Cal. App. 2d 378, 38 Cal. Rptr.

183.

The warnings, if any, given by

the doctors were in contradiction to the

literature read by the Plaintiffs and

Supplied by the Defendant. This litera-

ture assured safety and indicated "no

reason" for taking any risk of

anaplasmosis. The package insert sup-

plied in small print inside the container

was insufficient as a warning. The

Sales-pitch of the Defendant could not be

Overcome by a minimizing technical state-

ment inside the purchased package.

The trial Court's determination

that the warnings were inadequate is

amply supported by the record and by

available case law and should not be

overturned.

App. p. 24

VII. Contributory Negligence And

Assumption of the Risk.

The Defendant asserts that the

Plaintiffs, being fully informed of the

possibility of N.I. from Anaplaz vaccine,

assumed the risk of their cattle contrac-

ting the disease and proceeded to vacci-

nate. As discussed in the preceeding

section, the Plaintiffs were certainly

not "fully informed" and in fact were

misled by the literature published by

Defendant that they received.

Defendant indicates that’ the

vaccination of the bulls by the Plain-

tiffs shows that they were’ testing

the product for future use on the cows

evidencing a “calculated risk on their

part." It is highly unlikely that a

reasonable rancher would test out a

product on his most valuable animals.

Dr. Humphreys indicated that the reason

he vaccinated the bulls at the time he

did was because they were in Worland.

"... and when Bill brought down

these two bulls, they were his

most valuable animals, he

decided to use the vaccine on

the bulls as he had them down,

App. p. 25

he brought them down to

Worland, anyway, to have their

feet trimmed." [App. p.136

L.5-9].

Since this was the first time Dr.

Humphreys recalled mentioning the possi-

bility of N.I., it is unlikely that Mr.

Haste "calculated" that risk in vaccina-

ting the bulls. As the counsel _ for

Defendant appropriately noted at the

trial, the bulls weren't going to have

any calves so any mention the doctor may

have made about calves having N.I. would

not have indicated any risk as far as the

bulls were concerned. Nor would the

vaccination of the bulls resolve any

"calculation" of risk of N.I. in cows and

their calves. Clearly the reason for the

vaccination was to protect his "most

valuable" animals from anaplasmosis.

Assumption of a risk as distin-

guished from contributory negligence

requires “actual knowledge" of the danger

and not constructive knowledge. What was

in the mind of the plaintiffs when they

purchased the vaccine and vaccinated

their cattle is what is important. The

Hastes' actions and statements at trial

App. p. 26

evidence the fact that they were not

actually aware of the severe damage that

could occur to their herd. They read the

enclosed warning but, as Mr. Haste's

testimony reveals regarding the enclosed

"warning" on the instruction sheet in the

vaccine:

"A. Well, it minimized the

warning end of it to where you

wouldn't even consider it.

Q. In any event you didn't

consider it?

A. In any event I didn't

understand the language to the

point where I considered it as

any gamble between my calf crop

or my cows, because after all i

had lost the cows, the big

Siege, and from there on it was

a precautionary measure, and I

sure wouldn't have vaccinated my

cows intentionally with

something that I knew was

gambling the loss of my calf

crop on, or the ruination of my

cows later." [App. p.147

L.8-17).

In Elder vs. Crawley Book

Machine Company, 44] F.2d 771 (3rd Cir.

1971) the Court in an action for personal

injuries under strict liability

interpreted The Restatement of Torts 2d

in its definition of what we call

App. p. 27

assumption of risk as requiring actual

knowledge:

"In defining the doctrine, the

Restatement makes it clear that

the law envisions a conscious

appreciation of danger and

willingness to risk it. Thus,

comment d, Section 496A _ says:

In theory, the distinction

between the two (contributory

negligence and assumption of

risk) is that assumption of risk

rests upon the voluntary consent

of the Plaintiff to encounter

the risk and take his chances

.-. A subjective standard is

applied to assumption of the

risk, in determining whether the

Plaintiff knows, understands,

and appreciates the risk. Com-

ment e, Section 496C states:

Assumption of risk is a matter

of which Plaintiff knows, under-

stands, and is willing to

accept. Comment c, Section 496D

states: That the standards to

be applied is a subjective one

of what the particular Plaintiff

in fact sees, knows, understands

and appreciates ... . If by

reason of age or lack of infor-

mation, experience, intelligence

or judgment, the Plaintiff does

not understand the risk involved

in a known situation he will not

be taken to assume the risk."

l.. applying this subjective

standard the Court found that the

App. p.28

Plaintiff had not assumed the risk of

having her fingers severed by a machine

she worked on. Here it is clear from the

testimony that what the Plaintiffs saw,

understood, and appreciated regarding the

vaccine did not include a risk to _ the

calf crop or cows from N.I.

In Ferraro vs. Ford Motor Co.,

423 Pa. 324, 223 A.2d 746 (1966), this

case involved personal injuries received

by the Plaintiff driver of a truck where

the Plaintiff knew of the defects in the

truck and had several times tried to have

the defe@ss fixed by the Defendant, who

assured Plaintiff that the condition

would correct itself; the Pennsylvania

Supreme Court followed the Restatement of

Torts 2d, Section 496E comment (a) in

reversing a judgment notwithstanding the

verdict.

"Comment (a), however,

immediately goes on to. say:

Where, however, the Plaintiff

Surrenders his better judgment

upon an assurance of safety or a

promise of protection against

the risk, he does not assume it

unless a known danger is_ so

extreme that there can be no

reasonable reliance upon such an

assurance, or unless so- much

App. p. 29

Co.,

time has elapsed without action

that he can no longer reasonably

rely on it.

It is our conclusion that the

matrix of logic does not clearly

compel the acceptance of only

one of those opposing positions.

Rather do we believe, that,

under the circumstances, reason-

able men could honestly differ

as to what impact, if any, the

dealers assurance would or

should have had on the mind of a

reasonably prudent automobile

driver. Hence, a jury question

was presented. We will, there-

fore, reverse the entry of the

judgment notwithstanding the

verdict." (emphasis added).

In Ralston vs. Illinois Power

299 N.W. 2d 497 (Ill. 1973), it is

pointed out that contributory negligence

is not a defense to the action of strict

products liability and states in regard

to assumption of the risk:

"That tests to be resorted to in

determining whether one _ has

assumed the risk is’ fundamen-

tally a subjective test, in the

sense that it is his knowledge,

understanding, and appreciation

of the danger which must be

assessed, rather than that of a

reasonably prudent person."

App. p. 30

Once again, obviously in the

case at bar, the knowledge, understanding

and appreciation of the use of the

Anaplaz vaccine by the Plaintiffs

considering their reliance on Defendant

and its product and the - inadequate

warning was such that they could certain-

ly not be considered to have assumed the

risk in any respect as Plaintiff William

Haste stated so emphatically, he would do

nothing that would endanger his herd, and

thus, his livelihood.

In Vernon vs. Lake Motors, 488

P.2d 302 (Utah 1971) the Utah Supreme

Court stated:

ah? Plaintiff knows’ of the

defect and the danger, but

nevertheless ‘deliberately and

unreasonably' goes ahead, he

should be precluded from

recovery."

The interpretation of the words,

"deliberately" and "unreasonably" are

important. Whether the Plaintiffs knew

of the danger was also at issue in this

case.

Judge Winner rejected assumption

of the risk and contributory negligence

on the basis of a failure of evidence and

App. Pp. 3l

not because he did not feel it was a

proper defense in this case. [App. p.45

and 46]. Therefore the lengthy argument

and case cites by Defendant to the effect

that contributory negligence and assump-

tion of risk are proper defenses in cases

of this nature is not rebutted either by

the trial Courts ruling or this brief.

VIII. Limitation of Implied

Warranty

The uniform commercial code as

enacted in Wyoming indicates that for

implied warranties to be excluded the

exclusion must be in writing and

conspicuous. The proper language being

"There are no warranties which extend

beyond the description on the face

hereof." W.S. §34-2-316.

The warranties in this case were

written in the brochures and literature

of the Defendant as indicated in previous

sections of this brief. The container

itself contained no modifying language

but only a referral to enclosures.

The reason for requiring the

product to have cautionary statements and

warnings printed on the container is to

insure that sales contracts are fully

App. p. 32

informed. To give a disclaimer after the

sale has occured will not protect the

seller from his written warranties given

in advertising prior to the sale.

IX. Unusual Susceptibility

The Defendant asserts that since

the Hastes were experienced breeders of

Santa Gertrudis cattle and the warning

contained in the package of vaccine

notified them that N.I. occured in

another cross-breed, Charolais, in 75% of

the reporved cases, that they assumed the

risk of vaccinating their Santa Gertrudis

cattle (another cross-breed). Surely if

the Hastes should be held to foresee the

danger to their cattle, then the particu-

lar susceptibility of their cattle was

not unforeseeable to the manufacturer of

the product with the weight of scientific

development and experimentation behind

it.

There was no testimony presented

that the risk of N.I. was not known to

the Defendant. Indeed, Dr. Searl's test-

imony and all the literature presented as

well as the package insert indicates that

it was known to the Defendant that cer-

tain cases of N.I. had been reported

App. p. 33

after use of Anaplaz.

The extent of occurrence in the

Haste herd is not the correct gauge for

foreseeability. Which cattle will con-

tract N,.I. at one place is not required

to be foreseeable, only the occurrence

* need be foreseeable, which it

Clearly was.

CONCLUSION

The Defendant appeals the

finding of liability in this’ case

basically on a theory of a failure of

evidence. The record is full of causa-

tion evidence and evidence of warranties

of safety and evidence of reliance by the

Plaintiffs. The trial Courts' liability

decision is amply supported by relevant

testimony and exhibits and should not be

overturned by this Court,

The Damages Judgment should be

increased or remanded as set out in the

Opening brief of Plaintiffs.

App. p. 34

Respectfully submitted,

BADER & DUFTY

Pamela N. Hultin [4646]

BY:

600 Boston Building

828-17th Street

Denver, Colorado 80202

Attorney for Plaintiff

CERTIFICATE OF SERVICE

I hereby certify that a true and

correct copy of the above and foregoing

Reply Brief was served by mailing,

postage prepaid this 15th day of August,

1977, to the following:

Glenn Parker

Hirst and Applegate

200 Boyd Building

Cheyenne, Wyoming 82001

App. p. 35