Davis v. Wyeth Laboratories, Inc.

399 F.2d 121
CourtCourt of Appeals for the Ninth Circuit
DecidedJanuary 22, 1968
DocketNo. 20995
StatusPublished
Cited by165 cases

This text of 399 F.2d 121 (Davis v. Wyeth Laboratories, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968).

Opinions

MERRILL, Circuit Judge:

This ease presents the question wheth-. er 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.

I. THE BACKGROUND

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 man[123]*123ufactured 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 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 [124]*124value 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.

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399 F.2d 121, Counsel Stack Legal Research, https://law.counselstack.com/opinion/davis-v-wyeth-laboratories-inc-ca9-1968.