Davis v. Wyeth Laboratories, Inc.
Decision Date | 10 September 1968 |
Docket Number | No. 20995.,20995. |
Citation | 399 F.2d 121 |
Parties | 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. |
Court | U.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.
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.
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.
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:
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 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 special report followed on September 21, 1962. It stated:
It reiterated the recommendation earlier made in the Surgeon General's statement:
In December, 1962, a further report was issued. It stated:
To continue reading
Request your trial-
Vitanza v. Upjohn Co.
...as an exception to the general duty of manufacturers to warn ultimate consumers in products liability cases"); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 130 (9th Cir. 1968) ("[o]rdinarily in the case of prescription drugs warning to the prescribing physician is Although Connecticut h......
-
In re Norplant Contraceptive Products Liab. Lit.
... ... OPINION AND ORDER (1) GRANTING IN PART AND DENYING IN PART WYETH'S MOTION FOR PARTIAL SUMMARY JUDGMENT RE THE LEARNED INTERMEDIARY ... Defendants American Home Products Corporation, Wyeth-Ayerst Laboratories, Inc., and Wyeth Laboratories, Inc. (collectively "Defendants"), on May ... (23) Minnesota Mulder v. Parke Davis & Co., 181 N.W.2d 882 (Minn.1970); ... Kociemba ... ...
-
Larkin v. Pfizer, Inc., No. 2002-SC-0746-CL.
...the A.L.I. added subsection (d)(2) to Section 6. The most often recognized exception is for mass immunizations. Davis v. Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir.1968) (recognizing exception for a mass immunization for polio because the immunization was "dispensed to all comers at mass......
-
Wooderson v. Ortho Pharmaceutical Corp.
...(2d Cir.1969); Love v. Wolf, supra 226 Cal.App.2d 378 ; Krug v. Sterling Drug, Inc., supra 416 S.W.2d 143; cf. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir.1968). See also Wright v. Carter Products, Inc., 244 F.2d 53 (2d Cir.1957); Hungerholt v. Land O'Lakes Creameries, Inc., 20......
-
Current Applications & Limitations on the Learned Intermediary Rule
...intermediary doctrine and continue to require the manufacturer to warn the ultimate consumer. In Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968), a manufacturer supplied its vaccine to a mass immunization clinic where the vaccine was dispensed to everyone who came in, withou......
-
Products liability and commercial sales
...Stevens v. Parke, Davis & Co . (1973) 9 Cal. 3d 51, 65, 107 Cal. Rptr. 45; but see Davis v. Wyeth Laboratories (9th Cir. 1968) 399 F.2d 121, 131, as cited in Carlin v. Superior Court (1996) 56 Cal. Rptr. 2d 1104, 1118, 56 Cal. Rptr. 2d 162, 170 (a duty to warn the public itself may exist if......
-
Renewed look at the duty to warn and affirmative defenses.
...U.S. 920 (1985); Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096 (1974). See also Davis v. Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir. 1968) (drug manufacturer held liable for marketing prescription polio vaccine without warning consumers because it knew drug ......
-
Effective communication of warnings in the workplace: avoiding injuries in working with industrial materials.
...The Need for a Synthesis of Law and Communication Theory, 52 U. CIN. L. REV. 38, 39 (1983). (4.) See, e.g., Davis v. Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir. 1968) (holding that the bulk manufacturer of polio vaccine had a responsibility to see that warnings reached the customer "eith......
-
CHAPTER § 9.02 Common Defenses
...230 (D.S.D. 1983), aff'd without op., 739 F.2d 340 (8th Cir. 1984) (applying South Dakota law). Ninth Circuit: Davis v. Wyeth Labs., Inc., 399 F.2d 121, 129 (9th Cir. 1968) (applying Montana law). Tenth Circuit: Jacobs v. Dista Prods. Co., 693 F. Supp. 1029, 1031 (D. Wyo. 1988). State Court......