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| [1] | UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT |
| [2] | No. 20995 |
| [3] | 1968.C09.38 <http://www.versuslaw.com>,
399 F.2d 121 |
| [4] | January 22, 1968 |
| [5] | GLYNN RICHARD DAVIS AND FLORENCE DAVIS, HUSBAND AND WIFE, APPELLANTS, v. WYETH LABORATORIES, INC., A NEW YORK CORPORATION, AND AMERICAN HOME PRODUCTS CORPORATION, A DELAWARE CORPORATION, APPELLEES |
| [6] | Hamlin, Merrill and Duniway, Circuit Judges. Hamlin, Circuit Judge, dissenting. |
| [7] | The opinion of the court was delivered by: Merrill |
| [8] | MERRILL, Circuit Judge: |
| [9] | This case presents the question whether appellee Wyeth Laboratories, Inc.,
a manufacturer of Sabin polio vaccine, should be held to strict tort liability
to one who took the drug and contracted polio as a result. |
| [10] | Appellant Glynn Richard Davis took appellee's Type III polio vaccine at
a mass immunization clinic conducted in West Yellowstone, Montana, in March,
1963. At that time he was thirty-nine years old, in good health, and engaged
in the lumber business. Within thirty days he evidenced paralysis and other
symptoms of polio, and has remained paralyzed from the waist down ever since.
He brought suit in the District Court for the District of Idaho asserting
jurisdiction founded on diversity of citizenship and here appeals from judgment
for appellee following jury trial. |
| [11] | I. THE BACKGROUND |
| [12] | A. The Vaccine |
| [13] | The vaccine involved is Sabin oral polio vaccine, as developed by Dr.
Albert Sabin after many years of research. There are three separate types
of Sabin vaccine: Type I, Type II and Type III. Each is designed to immunize
the person taking the vaccine from contracting paralytic poliomyelitis from
a corresponding type of polio virus. Differing from the earlier Salk vaccine,
administered by injection, the Sabin vaccine utilizes live virus. |
| [14] | The use of a live virus polio vaccine which could be taken orally had
been under study throughout the world for a number of years. In the United
States it has been determined that the Sabin vaccine strains should be licensed.
Licensing was handled by The Division of Biologic Standards of the National
Institutes of Health, a part of the United States Department of Health,
Education and Welfare. Ultimately the United States licensed three manufacturers
of the vaccine, including appellee Wyeth Laboratories. Appellee was licensed
to sell Type III vaccine on May 17, 1962. |
| [15] | Licensing in the United States was preceded by worldwide clinical testing
on between 700,000 and 1,000,000 people. |
| [16] | The vaccine is licensed for sale only as a prescription drug. It is usually
manufactured in what the producers call "lots." Each lot of the
vaccine is manufactured under extremely complex and technical standards
devised by The Division of Biologic Standards. The virus used in the vaccine,
without regard to who manufactures it, comes from a common source. Appellee
obtained from Dr. Sabin a so-called "seed" virus and this original
seed, still maintained, is the parent of each separate lot of vaccine manufactured
by appellee. Each individual lot is, in turn, run through a number of tests
in the manufacturing laboratory. |
| [17] | Following manufacture and satisfactory testing within the laboratory,
the lot involved in this case was sent to The Division of Biologic Standards
where it was again subjected to rigorous testing. The Government, being
satisfied with the result of the test, granted authorization for the release
of this lot on January 31, 1963. |
| [18] | B. The Mass Immunization Clinics |
| [19] | In the fall of 1960 an advisory committee was established by the Surgeon
General of the United States to review all phases of polio prevention. In
February, 1962, the Communicable Disease Center of the Public Health Service,
Department of Health, Education and Welfare, issued recommendations and
reports of this committee. It was stated: |
| [20] | "With the licensing of type III monovalent vaccine, which is anticipated
in the near future, the complete oral polio virus vaccine will become available.
Recommendations as to planning and policies which will assure its maximally
effective use are now essential for the guidance of the medical profession
and official health authorities." |
| [21] | The goal of this campaign to disseminate the oral vaccine was stated as
"the complete elimination of paralytic poliomyelitis from the United
States." Community mass immunization centers were recommended and guidelines
were given for setting them up. The following month the Surgeon General,
on behalf of the Public Health Service, issued recommendations for the use
of the vaccine in the 1962 season, giving further guidance for the conduct
of community programs. |
| [22] | That month, March, 1962, representatives of the Public Health Service
held a meeting with Idaho public health officials and medical association
officers at which a joint release was issued recommending the holding of
community clinics. The holding of such clinics in Eastern Idaho was later
officially authorized by the Idaho Falls Medical Society and its Public
Health Committee, who then selected appellee's product as the vaccine to
be administered. At a subsequent meeting it was decided to include West
Yellowstone, Montana, in the Eastern Idaho program since there were no doctors
there and the residents relied on medical facilities in Ashton, Idaho. In
the absence of a doctor the administration of the vaccine for the West Yellowstone
clinic was delegated to a pharmacist. |
| [23] | The clinics in Eastern Idaho were originally scheduled for the fall of
1962. On September 14, 1962, a statement was issued by the Association of
State and Territorial Health Officers through the subcommittee on epidemic
intelligence of its committee on infectious diseases. It stated: |
| [24] | "The Sub-committee * * * has reviewed data showing a temporal association
between the incidence of paralytic poliomyelitis and the administration
of Type 3 oral poliomyelitis vaccine. The Sub-committee believes that the
data indicate a causal relationship and show that a small but definite risk
attends the use of presently available Type 3 oral polio vaccines. The data
further suggest that the risk is almost exclusively limited to adult populations.
While the Subcommittee acknowledges the presence of a small risk, it recognizes
the tremendous value of oral poliomyelitis vaccines and the detrimental
effect the unqualified withdrawal at this time would have on their future
use. In view of the very small magnitude of the risk and the enormous potential
value of oral vaccines, the Sub-committee therefore recommends that the
Surgeon General issue a statement which will: |
| [25] | 1. Apprise the public of the nature of the risk. |
| [26] | 2. Recommend that the non-epidemic use of Type 3 oral vaccine be restricted
to preschool and school age children. |
| [27] | 3. Recommend that the vaccine continue to be available for epidemic use. |
| [28] | 4. Reaffirm the desirability of restricting mass application to the late
Fall, Winter and Spring." |
| [29] | The following day a statement was issued by the Surgeon General respecting
his own special advisory committee's review of occurrences of polio cases
associated with the administration of the vaccine. It stated: |
| [30] | "The level of this risk can only be approximated but clearly is within
range of less than 1 case per million doses. Since the cases have been concentrated
among adults the risk to this group is greater; whereas, the risk to children
is exceedingly slight or practically nonexistent. |
| [31] | The Committee therefore recommends that the use of Type III vaccine in
mass campaigns be limited to preschool and school age children. Plans for
mass programs using Type I and II vaccines in all age groups should continue.
Furthermore, Type III vaccine is still indicated for use among adults in
high risk groups, which include tourists to hyperendemic areas and persons
residing in epidemic areas. |
| [32] | A special report is being prepared and will be sent to the members of
the medical and public health profession within the next few days and will
be made public." |
| [33] | The special report followed on September 21, 1962. It stated: |
| [34] | "Present data indicate that for 1962, the paralytic poliomyelitis
rate for those under 20 will be approximately 7.6 per million; for those
over 20, about 0.9 per million. These rates will represent a record low
for the 52 year period since the reporting began." |
| [35] | It reiterated the recommendation earlier made in the Surgeon General's
statement: |
| [36] | "With the incidence of poliomyelitis at a low level in this country,
the Committee therefore recommended that the Type III vaccine be restricted
to preschool and school age children and to those adults in high risk groups,
such as those travelling to hyperendemic areas or in areas where a Type
III epidemic is present or impending. |
| [37] | Since the vast majority of poliomyelitis cases occur among young children
and since children are the principal disseminators of the virus, continued
intensive immunization programs among this group are clearly indicated.
If this group can be adequately immunized, the spread of the poliomyelitis
viruses will be sharply restricted, if not essentially eradicated." |
| [38] | In December, 1962, a further report was issued. It stated: |
| [39] | "It is therefore recommended: (1) that community plans for immunization
be encouraged, using all three types; and (2) that immunization be emphasized
for children in whom the danger of naturally occurring poliomyelitis is
greatest and who serve as the natural source of poliomyelitis infection
in the community. Because the need for immunization diminishes with advancing
age and because potential risks of vaccine are believed by some to exist
in adults, especially above the age of 30, vaccination should be used for
adults only with the full recognition of its very small risk. Vaccination
is especially recommended for those adults who are at higher risk of naturally
occurring disease; for example, parents of young children, *fn1
pregnant women, persons in epidemic situations and those planning foreign
travel. |
| [40] | Of greatest importance is the continuing vaccination of oncoming generations." |
| [41] | With these recommendations before them the East Idaho officials postponed
their clinics scheduled for the fall of 1962, but determined to proceed
in the spring of 1963. Adults were included in their immunization program. |
| [42] | C. Appellee's Participation |
| [43] | When Eastern Idaho chose appellee's vaccine for its clinics, Mr. John
Franklin, one of appellee's salesmen, was assigned to handle the sales and
assist in setting up the clinics. He was sent by appellee to Nevada to receive
special training in setting up and conducting such clinics. Thereafter he
managed the campaign for the Idaho Falls Medical Society. He furnished books
to those in charge of clinics, setting forth schedules and procedures to
be followed and details of the physical manner in which the clinics were
to be set up and also showing sample promotional letters and advertising
matter. He arranged for delivery of the vaccine from headquarters at Idaho
Falls to the various clinics, including that at West Yellowstone, by the
Idaho Falls Jeep Patrol. He arranged for the printing of forms and immunization
cards and posters urging "KO Polio" and took charge of sending
them to West Yellowstone. He organized meetings and conferred with those
in charge of the separate clinics as to the procedures to be followed. For
expenses incurred by him in connection with these activities he was reimbursed
by the medical society. |
| [44] | Each person who received the vaccine was charged 25 cents (although it
was given free of charge if the recipient so requested). Appellant paid
this amount for his dosage. Funds collected from the clinics were used to
pay the medical society's bill from Wyeth for the vaccine, with the remainder
retained by the society. |
| [45] | D. Warnings |
| [46] | The Surgeon General's March statement was the subject of a news story
in a Pocatello, Idaho, newspaper and was read by Franklin. It was his first
information respecting the subject and he promptly informed the medical
society of the release. The society confirmed the information by a telephone
call to the office of the Surgeon General. |
| [47] | The drug when sold to the medical society had a printed insert with each
bottle containing 100 doses. This insert contained directions for use and
pertinent excerpts from the Surgeon General's report. |
| [48] | A fact sheet put out by appellee and contained in the book it supplied
to clinics was published prior to the Surgeon General's report and represented
the vaccine as completely safe for all ages. A collection of news clippings
from Idaho newspapers introduced in evidence by appellant shows not only
a complete lack of warning but assurances that the vaccine was safe for
all. |
| [49] | No effort was made by Franklin or the medical society to inform the West
Yellowstone pharmacist of the existence of risk. The latter did not read
the package insert, nor did appellant. The advertising posters made no disclosure
of risk and none was made directly to those who took the drug in West Yellowstone.
Appellant testified that he had no knowledge of the risk, relied on the
posters and was convinced by the campaign's advertising that it was his
civic duty to participate. |
| [50] | II. THE ISSUES AS PRESENTED |
| [51] | Appellant stated claims founded on (1) negligent manufacture, (2) failure
to warn of known dangers, (3) strict liability in tort and (4) breach of
an implied warranty of fitness. The District Court dismissed all save that
of breach of warranty. |
| [52] | We agree with the District Court that there was nothing in the record
to create a jury issue as to negligence in manufacture. On the contrary,
the record shows scrupulous attention in the matter of preparation and testing.
The resulting product was precisely what was intended. *fn2
For this reason we also reject appellant's claim that it was error for the
District Court to refuse to give an instruction that under Montana law appellee
was held to an implied warranty that there was no "impurity" in
the vaccine. |
| [53] | We find no error in the District Court's choice to present the case to
the jury on warranty rather than on strict liability in tort. The law as
emerging is tending toward the latter treatment *fn3
but under either approach the elements remain the same. The difference is
largely one of terminology. *fn4 |
| [54] | We do find reversible error, however, in the manner in which the breach
of warranty claim was given to the jury in the light of the court's dismissal
of the claim for breach of a duty to warn. |
| [55] | Appellant contends that the District Court erred in instructing, on warranty,
that the test is whether the drug was "reasonably fit and reasonably
safe for use by the public as a whole." *fn5
He contends that the warranty was that the drug was fit and safe as to him. |
| [56] | As a general proposition we would question the correctness of appellant's
contention. It would, if generally applied, be equivalent to an imposition
of absolute enterprise liability whereby all those who suffer unanticipated
harm from the use of drugs are compensated out of profits from the sale
of such products as a cost of doing business to the manufacturer. Although
there are those who regard such a result as just, *fn6
it has so far been found inappropriate for the courts to impose such a farreaching
change in the law of products liability. |
| [57] | Under the circumstances of this case, however, we conclude that strict
liability does attach to sale of the drug to appellant and that the jury
should have been so instructed, either by such an instruction as that requested
by appellant or otherwise. Our conclusion in this respect is based upon
our determination that a duty to warn existed, as to which none of appellant's
requested instructions was given. |
| [58] | While appellant alleged negligent breach of a duty to warn as an independent
claim, we regard failure to warn, where the circumstances of sale imposed
that duty, as exposing the vendor to trict liability in tort *fn7
(or to liability for breach of warranty if that approach is used). |
| [59] | It was stipulated below that Montana law governed this case. We can find
no Montana decision in point on the issue of a drug manufacturer's duty
to warn of dangers inherent in its product. Privity of contract between
buyer and seller as a prerequisite to recovery in an implied warranty action
has long been abolished in that state in cases involving food, and strict
liability has been imposed on those who sold it. *fn8
It would seem that the same approach would be adopted by the Montana Supreme
Court in cases involving drugs meant for internal use. Faced with the absence
of controlling state precedent, we choose to assume that Montana would follow
the majority of other states in finding that liability can attach to the
sale of drugs, in either tort or warranty, despite lack of privity, and
would adopt the views set forth below on the manufacturer's duty to warn
of dangers in "nondefective" but potentially harmful products.
*fn9 |
| [60] | III. THE LAW OF STRICT LIABILITY AS APPLICABLE HERE |
| [61] | The clearest statement of the law as it exists today is in our view that
set forth in the Restatement (Second) of Torts (1965). Relevant to our case
are § 402A and comments j and k. They are set forth in the margin. *fn10 |
| [62] | The general proposition as there stated (subject to certain exceptions)
is that strict liability shall attach to one who sells a product "in
a defective condition, unreasonably dangerous" to the consumer. |
| [63] | At the outset we reject appellee's contention that the rule applies only
where unreasonable danger results because of an ascertainable "defect"
or "impurity" in the product, and that since this product was
precisely what it was intended to be there was no such defect. The true
test in a case of this kind is whether the product was unreasonably dangerous.
*fn11 |
| [64] | Comment j recognizes that to prevent a product from being unreasonably
dangerous, direction or warnings as to its use must be given in appropriate
cases. |
| [65] | Comment k deals with the unavoidably unsafe product. Here the fact that
a product is dangerous does not result in strict liability if, on balance,
public interest demands that it be made available notwithstanding its dangerous
characteristics. This situation, as the comment notes, is especially common
in the field of drugs, and, in particular, new and experimental drugs. We
agree with appellee that the Sabin vaccine qualifies for such treatment.
As the comment stresses, however, strict liability is avoided in these situations
only where sale is accompanied by proper directions and proper warnings.
*fn12 Thus we are returned to
the problem of the duty to warn. |
| [66] | The duty seems clear where the drug's danger is directed to a foreseeable
and ascertainable class of persons, such as those prone to certain allergies.
*fn13 Such a warning constitutes
a caution that certain persons should not take the drug; that as to certain
persons it is not "fit." |
| [67] | There are many cases, however, particularly in the area of new drugs,
where the risk, although known to exist, cannot be so narrowly limited and
where knowledge does not yet explain the reason for the risk or specify
those to whom it applies. It thus applies in some degree to all, or at least
a significant portion, of those who take the drug. This is our case; there
seems to be no certain method of isolating those adults who may be affected
adversely by taking Type III Sabin vaccine. *fn14 |
| [68] | In such cases, then, the drug is fit and its danger is reasonable only
if the balance is struck in favor of its use. Where the risk is otherwise
known to the consumer, no problem is presented, since choice is available.
Where not known, however, the drug can properly be marketed only in such
fashion as to permit the striking of the balance; that is, by full disclosure
of the existence and extent of the risk involved. |
| [69] | As comment k recognizes, human experimentation is essential with new drugs
if essential knowledge ever is to be gained. No person, however, should
be obliged to submit himself to such experimentation. If he is to submit
it must be by his voluntary and informed choice or a choice made on his
behalf by his physician. |
| [70] | In such cases, then, the drug is fit and its danger is reasonable only
if the balance is struck in favor of its use. It can properly be marketed
only in such fashion as to permit the striking of that balance; that is,
by full disclosure of the existence and extent of the risk involved. |
| [71] | When Type III Sabin vaccine was first licensed by the Government in early
1962 and first manufactured and sold by Wyeth, there was no known or foreseeable
risk involved in taking it. Thus Wyeth could not initially be expected to
warn of unknown dangers. But its responsibility did not end there. When,
after further experience, the danger became apparent a duty to warn attached.
*fn15 We do not need to fix the
precise point at which it attached. Certainly by March, 1963, when appellant
took the vaccine, six months after the Surgeon General's first report on
the subject, it was the responsibility of Wyeth to see that such warning
was given. |
| [72] | There will, of course, be cases where the personal risk, although existent
and known, is so trifling in comparison with the advantage to be gained
as to be de minimis. Appellee so characterizes this case. It would approach
the problem from a purely statistical point of view: less than one out a
million is just not unreasonable. This approach we reject. When, in a particular
case, the risk qualitatively (e.g., of death or major disability) as 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. *fn16 |
| [73] | Appellee contends that even under such a test no true choice situation
is presented here. It asserts that "common sense and knowledge of the
mainstreams of human conduct would unavoidably bring one to the conclusion"
that appellant would have chosen to take the risk. It says, "Simply
stated that proposition is this: A man has less than one in a million chance
of contracting the dreaded disease of polio if he takes the vaccine. If
he does not take the vaccine his chances of contracting polio are abundantly
increased." |
| [74] | We do not so read the record. The Surgeon General's report of September,
1962, as we have quoted it, predicted that for the 1962 season only.9 persons
over 20 years of age out of a million would contract polio from natural
sources. While appellant was the father of two young children, he resided
in an area that not only was not epidemic but whose immediate past history
of incidence was extremely low. We have no way of knowing the extent to
which either factor would affect the critical statistics. Thus appellant's
risk of contracting the disease without immunization was about as great
(or small) as his risk of contracting it from the vaccine. Under these circumstances
we cannot agree with appellee that the choice to take the vaccine was clear. |
| [75] | We may note further that where the end sought is prevention of disease
(and the likelihood of contracting the disease from natural sources is a
relevant factor) the situation is a different one from that in which the
disease has already struck and the end sought is relief or cure. Risks are
far more readily taken in the latter case. |
| [76] | We conclude that the facts of this case imposed on the manufacturer a
duty to warn the consumer (or make adequate provision for his being warned)
as to the risks involved, and that failure to meet this duty rendered the
drug unfit in the sense that it was thereby rendered unreasonably dangerous.
Strict liability, then, attached to its sale in absence of warning. |
| [77] | Appellee contends that its duty to warn was met by Franklin's disclosures
to the medical society. It points out that its only direct sale of vaccine
was to the medical society and that it was the society's judgment and not
appellee's to proceed with the clinics. |
| [78] | Ordinarily in the case of prescription drugs warning to the prescribing
physician is sufficient. *fn17
In such cases the choice involved is essentially a medical one involving
an assessment of medical risks in the light of the physician's knowledge
of his patient's needs and susceptibilities. Further it is difficult under
such circumstances for the manufacturer, by label or direct communication,
to reach the consumer with a warning. A warning to the medical profession
is in such cases the only effective means by which a warning could help
the patient. *fn18 |
| [79] | Here, however, although the drug was denominated a prescription drug it
was not dispensed as such. It was dispensed to all comers at mass clinics
without an individualized balancing by a physician of the risks involved.
In such cases (as in the case of over-the-counter sales of nonprescription
drugs *fn19) warning by the manufacturer
to its immediate purchaser will not suffice. The decision (that on balance
and in the public interest the personal risk to the individual was worth
taking) may well have been that of the medical society and not that of appellee.
But just as the responsibility for choice is not one that the manufacturer
can assume for all comers, neither is it one that he can allow his immediate
purchaser to assume. In such cases, then, 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. Here appellee knew
that warnings were not reaching the consumer. Appellee had taken an active
part in setting up the mass immunization clinic program for the society
and well knew that the program did not make any such provision, either in
advertising prior to the clinics or at the clinics themselves. On the contrary,
it attempted to assure all members of the community that they should take
the vaccine. |
| [80] | We conclude that appellee did not meet its duty to warn. |
| [81] | This duty does not impose an unreasonable burden on the manufacturer.
When drugs are sold over the counter to all comers warnings normally can
be given by proper labeling. Such method of giving warning was not available
here, since the vaccine came in bottles never seen by the consumer. But
other means of communication such as advertisements, posters, releases to
be read and signed by recipients of the vaccine, or oral warnings were clearly
available and could easily have been undertaken or prescribed by appellee. |
| [82] | For these reasons we hold that it was error to fail to instruct the jury,
either in warranty or in tort, that appellee was strictly liable if its
drug caused appellant to contract polio and if appellant's taking of the
drug was without knowledge of risk. *fn20 |
| [83] | Reversed and remanded for new trial. |
| [84] | HAMLIN, Circuit Judge (dissenting). |
| [85] | I respectfully dissent. |
| [86] | Appellee brought to the attention of the Medical Society the report of
the Surgeon General. After this, the Medical Society, which was in charge
of the mass immunization program, decided to proceed and the program was
thereafter under the direction of that organization. On each of the bottles
containing 100 doses of that vaccine which appellee sold to the Medical
Society, appellee included a printed insert containing pertinent portions
of the Surgeon General's report. Under the circumstances of this case I
cannot agree with the court's holding that there was as a matter of law
an absolute breach by appellee of its duty to warn. |
| [87] | The court's instruction to the jury that there was an implied warranty
on the part of appellee that the vaccine was reasonably fit for the particular
purpose for which it was manufactured was proper, and the jury verdict in
favor of appellee apparently found that there was no breach of that warranty. |
| [88] | I would affirm. |
|
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| Opinion Footnotes | |
|
|
|
| [89] | *fn1 Appellant fell in this class. |
| [90] | *fn2 In this respect our case
differs from Gottsdanker v. Cutter Laboratories, 182 Cal.App.2d 602, 6 Cal.Rptr.
320, 79 A.L.R.2d 290 (1960), involving the Salk vaccine. There harm resulted
because through inadequate testing procedures live virus remained in a product
from which they supposedly had been eliminated. |
| [91] | *fn3 Greenman v. Yuba Power Products,
Inc., 59 Cal.2d 57, 27 Cal.Rptr. 697, 377 P.2d 897, 13 A.L.R.3d 1049 (1963). |
| [92] | *fn4 See Prosser, The Fall of
the Citadel (Strict Liability to the Consumer), 50 Minn.L.Rev. 791, 804-05
(1966). Greeno v. Clark Equipment Co., 237 F. Supp. 427, 429 (N.D.Ind.1965),
noted that strict liability as imposed by Restatement (Second) of Torts
§ 402A (1965) is "hardly more than what exists under implied warranty
when stripped of the contract doctrines of privity, disclaimer, requirements
of notice of defect, and limitation through inconsistencies with express
warranties." |
| [93] | *fn5 "In considering the
question of breach of an implied warranty, you are instructed that the implied
warranty involved in this case is that the vaccine was reasonably fit for
the particular purpose for which it was manufactured. In other words, under
such circumstances the law imposes upon defendants a warranty that the Sabin
vaccine, which it manufactured and supplied, was reasonably fit and reasonably
safe for consumption by members of the public as a whole. This warranty
does not mean, however, that this vaccine could be used with absolute safety,
but means only that the vaccine must have been reasonably fit and reasonably
safe for use by the public as a whole." |
| [94] | *fn6 Cochran v. Brooke, 243 Ore.
89, 409 P.2d 904, 907 (Ore.1966); James, The Untoward Effects of Cigarettes
and Drugs: Some Reflections on Enterprise Liability, 54 Calif.L.Rev. 1550,
1558 (1966); Traynor, The Ways and Meanings of Defective Products and Strict
Liability, 32 Tenn.L.Rev. 353 (1965). See also Keeton, Products Liability
-- Some Observations About Allocation of Risks, 64 Mich.L.Rev. 1329, 1347-48
(1966). |
| [95] | *fn7 See Crane v. Sears, Roebuck
& Co., 218 Cal.App.2d 855, 32 Cal.Rptr. 754 (1963); Canifax v. Hercules
Powder Co., 237 Cal.App.2d 44, 46 Cal.Rptr. 552 (1965); Traynor, (supra)
note 6; 2 Frumer & Friedman, Products Liability § 16A[4] (1967). |
| [96] | *fn8 Kelley v. John R. Daily
Co., 56 Mont. 63, 181 P. 326 (1919); Bolitho v. Safeway Stores, 109 Mont.
213, 95 P.2d 443 (1938). |
| [97] | *fn9 In vicariously creating
state law in such cases, we must look to the same sources that would be
used by the state court -- Restatement of Law, treatises, law review commentary
and both state and federal decisions. Wright, Federal Courts 206 (1963);
Corbin, The Laws of the Several States, 50 Yale L.J. 762, 775-76 (1941).
We have been proven wrong before when we predicted that a state court would
refuse to follow a more enlightened rule of personal injury recovery. Compare
Summers v. Wallace Hospital, 276 F.2d 831 (9th Cir. 1960), with Owens v.
White, 342 F.2d 817 (9th Cir. 1965). |
| [98] | *fn10 "§ 402A. Special
liability of Seller of Product for Physical Harm to User or Consumer |
| [99] | (1) One who sells any product in a defective condition unreasonably 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 |
| [100] | (a) the seller is engaged in the business of selling such a product, and |
| [101] | (b) it is expected to and does reach the user or consumer without substantial
change in the condition in which it is sold. |
| [102] | (2) The rule stated in Subsection (1) applies although |
| [103] | (a) the seller has exercised all possible care in the preparation and
sale of his product, and |
| [104] | (b) the user or consumer has not bought the product from or entered into
any contractual relation with the seller. |
| [105] | j. Directions or warning. In order to prevent the product from being unreasonably
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 substantial number of the population
are allergic, and the ingredient 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 reasonable, developed human skill
and foresight should have knowledge, of the presence of the ingredient and
the danger. Likewise in the case of poisonous drugs, or those unduly dangerous
for other reasons, warning as to use may be required. |
| [106] | But a seller is not required to warn with respect to products, or ingredients
in them, which are only dangerous, or potentially so, when consumed in excessive
quantity, or over a long period of time, when the danger, or potentiality
of danger, is generally known and recognized. Again the dangers of alcoholic
beverages are an example, as are also those of foods containing such substances
as saturated fats, which may over a period of time have a deleterious effect
upon the human heart. |
| [107] | Where warning is given, the seller may reasonably assume that it will
be read and heeded; and a product bearing such a warning, which is safe
for use if it is followed, is not in defective condition, nor is it unreasonably
dangerous. |
| [108] | k. Unavoidably unsafe products. There are some products which, in the
present state of human knowledge, are quite incapable of being made safe
for their intended 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 invariabily leads to a dreadful
death, both the marketing and the use of the vaccine are fully justified,
notwithstanding the unavoidably high degree of risk which they involve.
Such a product, properly prepared, and accompanied by proper directions
and warning, is not defective, nor is it unreasonably 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 new or experimental
drugs as to which, because of lack of time and opportunity for sufficient
medical experience, there can be no assurance of safety, or perhaps 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 proper warning is given, where the situation
calls for it, is not to be held to strict liability for unfortunate consequences
attending their use merely because he has undertaken to supply the public
with an apparently useful and desirable product, attended with a known but
apparently reasonable risk." |
| [109] | *fn11 See Wade, Strict Tort
Liability of Manufacturers, 19 S.W.L.J. 5, 14-15 (1965): |
| [110] | "The more difficult problem arises with a product which was made
in the way it was intended to be made and in the condition planned and which
yet proves to be dangerous. Is such an article defective? * * * In cases
of this general type the phrase 'defective condition' has no independent
meaning, and the attempt to use it is apt to prove misleading. The only
real problem is whether the product is 'unreasonably dangerous,' because
'defective condition,' if it is to be applied at all, depends on that."
See also Rapson, Products Liability Under Parallel Doctrines: Contrasts
Between the Uniform Commercial Code and Strict Liability in Tort, 19 Rutgers
L.Rev. 692, 702 (1965). |
| [111] | *fn12 See Prosser, (supra)
note 3, at 808. In one sense, the lack of adequate warning is what renders
the product "defective." See 2 Frumer & Friedman, Products
Liability § 16A[4] (1967), and sources cited. |
| [112] | *fn13 E.g., Wright v. Carter
Products, Inc., 244 F.2d 53 (2d Cir. 1957). |
| [113] | *fn14 Such apparently was also
the case in Toole v. Richardson-Merrell, Inc., 251 Cal. App. 2d 689, 29
A.L.R.3d 988, 251 A.C.A. 785, 60 Cal.Rptr. 398 (Dist.Ct.App.1967), where
it was held that the traditional "defect" in the product was unnecessary
for recovery by a person who developed cataracts from using MER/29, a treatment
for arteriosclerosis; and that "strict liability is justified on the
ground that the product was marketed without proper warning of its known
dangerous result." Id. at 807, 60 Cal.Rptr. at 414. |
| [114] | *fn15 See Note, The Manufacturer's
Duty to Warn of Dangers Involved in Use of a Product, 1967 Wash.U.L.Q. 206,
211. |
| [115] | *fn16 The purely statistical
approach has been abandoned in many recent cases in the allergy field, and
a duty to warn a small hypersensitive group has been found where the potential
side effect of a cosmetic or drug was serious. In Wright v. Carter Products,
Inc., (supra) note 13, the court stated that, despite the fact that only
a miniscule number of users of the deodorant in question were endangered,
"duties to warn are not, in all cases, measured by quantitative standards,"
and that a manufacturer may in some circumstances have a duty to warn "those
few persons who it knows cannot apply its product without serious injury."
Id. at 56, 58. Accord, Sterling Drug Inc. v. Cornish, 370 F.2d 82 (8th Cir.
1967); Gober v. Revlon, Inc., 317 F.2d 47 (4th Cir. 1963); Braun v. Roux
Distrib. Co., 312 S.W.2d 758 (Mo.1958). |
| [116] | *fn17 Sterling Drug Inc. v.
Cornish, (supra) note 16; Magee v. Wyeth Laboratories, 214 Cal.App.2d 340,
29 Cal.Rptr. 322 (1963). |
| [117] | *fn18 Love v. Wolf, 226 Cal.App.2d
378, 394, 38 Cal.Rptr. 183, 192 (1964). In Wolf the profit from the sale
of a drug was held admissible to show motive for alleged overpromotion of
that drug to the medical profession that might be held to cancel out the
effectiveness of an insert warning. Appellant claims that the trial court
erred in refusing to allow him to gain, through interrogatories, evidence
of Wyeth's profits on the sale of Sabin vaccine. Since we find that, in
any event, the package insert did not fulfill Wyeth's obligation to warn
in this case, we need not rule on this contention. |
| [118] | *fn19 Stottlemire v. Cawood,
213 F. Supp. 897, 899 (1963). The consumer may, of course, choose to sue
the retailer rather than the manufacturer in such cases. See Crotty v. Shartenberg's-New
Haven, Inc., 147 Conn. 460, 162 A.2d 513 (1960). |
| [119] | *fn20 The Surgeon General's
Advisory Committee on Poliomyelitis Control in 1964 reviewed 87 cases in
which paralytic illness had occurred within 30 days of the taking of Sabin
vaccine, of which 57 were found "compatible" with having been
caused by the vaccine. These 57 cases were further subdivided into "probable"
and "possible" categories. Appellant's case was placed in the
"compatible-probable" group. There seems to be no method of knowing
with medical certainty whether any such attack of poliomyelitis has been
caused by external virus or by the vaccine. The issue of causation was properly
left to the jury in the trial below, but no special verdict on this issue
was returned. On remand this question remains for jury determination. |
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