Davis v. Wyeth Laboratories, Inc.

Decision Date10 September 1968
Docket NumberNo. 20995.,20995.
Citation399 F.2d 121
PartiesGlynn 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.
CourtU.S. Court of Appeals — Ninth Circuit

Blaine F. Evans (argued), of Elam, Burke, Jeppesen & Evans, Boise, Idaho, for appellant.

William C. Roden (argued), R. B. Kading, Jr. (argued), of Richards, Haga & Eberle, Boise, Idaho, for appellee.

Before HAMLIN, MERRILL and DUNIWAY, Circuit Judges.

MERRILL, Circuit Judge:

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.

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.

A. The Vaccine

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.

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.

Licensing in the United States was preceded by worldwide clinical testing on between 700,000 and 1,000,000 people.

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.

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.

B. The Mass Immunization Clinics

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:

"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."

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.

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.

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:

"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 Sub-committee 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:
1. Apprise the public of the nature of the risk.
2. Recommend that the non-epidemic use of Type 3 oral vaccine be restricted to preschool and school age children.
3. Recommend that the vaccine continue to be available for epidemic use.
4. Reaffirm the desirability of restricting mass application to the late Fall, Winter and Spring."

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:

"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.
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.
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."

The special report followed on September 21, 1962. It stated:

"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."

It reiterated the recommendation earlier made in the Surgeon General's statement:

"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.
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."

In December, 1962, a further report was issued. It stated:

"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,1 pregnant women, persons in epidemic

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