The opinion of the court was delivered by: OBERDORFER
FINDINGS OF FACT AND CONCLUSIONS OF LAW
I. Findings of Fact
2. In 1972 Mr. Hitchcock was assigned to the United States Consulate in Buenos Aires, Argentina by the Department as Deputy Chief of Mission. Mrs. Hitchcock planned to accompany him to Buenos Aires and to perform the public functions expected of a Foreign Service Officer's wife by the Department. At the time, the wives of Foreign Service Officers were expected to contribute to their husbands' careers.
(Testimony of Mr. and Mrs. Hitchcock.)
3. In May and June, 1972, Mr. and Mrs. Hitchcock reported to the Foreign Service Institute in Rosslyn, Virginia, to receive a series of inoculations required or recommended by the Department for Foreign Service personnel assigned to Buenos Aires, Argentina. The Foreign Service Institute is a facility operated for and by the Department.
4. In May and June, 1972, the Department routinely administered duck embryo-derived antirabies vaccine ("DEV") as pre-exposure prophylaxis for Foreign Service personnel assigned to Buenos Aires, Argentina, and to other particular stations. The DEV was routinely administered by a nurse, with no physician present.
(Testimony of Mr. and Mrs. Hitchcock and Dr. Martin Wolfe, Department of State Office of Medical Services.)
5. The DEV pre-exposure prophylaxis administered at the Foreign Service Institute to Mr. and Mrs. Hitchcock consisted of two injections of DEV (one cc. per injection) with an interval of approximately one month between injections. A third injection or "booster" was to be given six or seven months later. This fact was noted on Mrs. Hitchcock's immunization record (Plaintiffs' exhibit 13).
Mrs. Hitchcock received the first injection of DEV on May 17, 1972; she received the second injection of DEV on June 13, 1972. Mrs. Hitchcock did not receive a third "booster" injection.
Mrs. Hitchcock was not tested shortly after her vaccination to determine whether the DEV in her system had been effective in producing rabies antibody. Such a test is called an "antibody titer." Mrs. Hitchcock's first antibody titer was taken in 1975 by a private physician. See pp. 73-73, Infra.
(Testimony of Mr. and Mrs. Hitchcock; Plaintiffs' exhibits 13 and 59(c); Defendant's exhibit 8.)
There was also no evidence that personnel administering the DEV to Mr. and Mrs. Hitchcock disclosed that the manufacturer of DEV recommended that each inoculee obtain an antibody titer soon after vaccination to determine the effectiveness of the vaccination. See pp. 72-73, Infra. Defendant adduced no evidence to establish that the Department itself provided for the taking of rabies antibody titers.
(Testimony of Mr. and Mrs. Hitchcock and Nurse Martha Richioppi).
7. After the first injection with DEV in May, 1972, Mrs. Hitchcock noted a "tiredness" and "heaviness" in her legs. After the second injection with DEV in June, 1972, she again noticed that her legs felt tired and heavy; she also noticed that she was having difficulty getting up and down stairs. Mrs. Hitchcock began experiencing numbness in her hands in February, 1973; by May, 1973, her legs and waist were numb; the feelings of tiredness progressed. By December, 1974, Mrs. Hitchcock could walk only slowly and with some difficulty. In an undated report of her medical history through February, 1974, she wrote that without special padding in her shoes, "I feel as if my bones are coming through my feet." Defendants' exhibit 8. Mrs. Hitchcock's symptoms progressed, and by May, 1978, she was confined to a wheelchair. At present, Mrs. Hitchcock can stand for about five minutes and only with assistance. She is no longer able to perform the functions of a Foreign Service Officer's wife. She suffers from a progressive demyelinating disease,
which has caused paralysis, pain, numbness, limitation of physical movement, mental anguish, inability to work or to do housework, and loss of enjoyment of life. She is permanently and totally disabled.
Mr. Hitchcock suffered no similar effects after the DEV injections.
(Testimony of Mr. and Mrs. Hitchcock and Dr. Ernesto Herskovits, an expert neurologist and Mrs. Hitchcock's treating physician since 1974; Plaintiff's exhibits 3 and 4; Defendant's exhibits 8, 9, 35 and 36.)
8. Prior to the DEV injections in May and June, 1972, Mrs. Hitchcock was a relatively healthy, fifty-one year old woman. (Testimony of Margaret Hitchcock; Defendants' exhibits 5, 6, 7 and 8.)
9. On November 2, 1954, Mrs. Hitchcock was examined by an opthalmologist for a complaint of blurred vision in her right eye. Examination at that time revealed central serous retinitis. The blur later cleared slightly but vision was not as bright in the right eye as in the left eye. (Defendant's exhibit 32.)
10. The symptoms of serous retinitis are identical to those of optic neuritis. It has only been in recent years, with the invention of the indirect opthalmoscope and fluorescein angiography, that the two conditions can be distinguished. Those techniques were not available in 1954 and were not performed on Mrs. Hitchcock at that time. Optic neuritis is a very common early symptom of multiple sclerosis. (Defendant's exhibits 32 and 35; Plaintiffs' exhibit 4.)
11. A visual evoked response test was administered to Mrs. Hitchcock in 1979. The findings of this test are highly suggestive of an optic nerve dysfunction of the demyelinating type. A localized retina problem, such as central serous retinopathy, should not affect the visual evoked response. Although multiple sclerosis frequently involves the optic nerve, a demyelinating disease that is not multiple sclerosis could also involve dysfunction of the optic nerve. (Testimony of Drs. Herskovits and Schulein; Defendant's exhibit 34.)
12. Mrs. Hitchcock's symptoms closely resemble multiple sclerosis.
Several doctors have diagnosed her disease as multiple sclerosis. Multiple sclerosis is a demyelinating disease for which there is no known cause or cure. (Testimony of Drs. Herskovits and Schulein.)
13. DEV is an antirabies vaccine introduced in 1955 and licensed for use in the United States in 1957. DEV was developed by Eli Lily and Company as an alternative to older nervous tissue vaccine ("NTV"). Serious post-vaccinal neurologic reactions to NTV, including paralysis and death, are not uncommon and make its use hazardous." (Plaintiff's exhibit 15, at 643.) For example, the rate of death for persons immunized with NTV has been estimated at 1 to 35,000. DEV is a suspension of 10% Duck embryo tissue infected with a fixed virus and then inactivated. DEV is thought to contain little or none of the "paralytic factor" that causes paralysis and death after treatment with NTV. The identity of the "paralytic factor," however, is not known with certainty. DEV has been described as "markedly reducing" the hazard of post-vaccinal neurologic complications and as "relatively safe". Nevertheless, because DEV contains duck embryo protein, it is capable of causing neurologic reactions similar to NTV.
(Plaintiffs' exhibits 15, 22, and 59(c); Defendant's exhibits 26 and 27; deposition of Dr. Stanley Plotkin, an expert on rabies and rabies vaccine, May 10, 1979 at 23-24.)
14. Defendant's Duty to Inform: Risk. In May and June, 1972, defendant United States and its agents knew, or should have known, that there existed some risk of serious neurologic reaction in a patient treated with multiple injections of DEV as pre-rabies exposure prophylaxis.
This finding is based on testimony offered at trial and on information contained in the following materials of which defendant and its agents knew, or should have known, in May and June, 1972:
A. The DEV product information sheet dated April 5, 1972, prepared by Eli Lily and Company, the manufacturer of DEV, and distributed with the vaccine does not state that there is no risk of paralysis or other serious neurologic reaction to DEV, but rather ambiguously advises that DEV
"contain(s) little or none of the "paralytic factor' . . . ."
The product information sheet does not unconditionally recommend a post- exposure DEV prophylaxis, notwithstanding the fact that if rabies develops it will almost certainly be fatal:
Postexposure Immunization Indications for and against giving rabies vaccine are difficult to define. In favor of giving it is the fact that, if rabies develops, it will almost certainly have fatal results. Against giving it is the danger of development of severe side-effects involving the central nervous system when the vaccine contains brain tissue . . . the incidence of neurological side-effects has been low with the use of duck embryo vaccine.
The product information sheet describes certain reported cases of adverse reaction to the post-exposure series of DEV:
In connection with the administration of about 90,000 fourteen-dose (post-exposure) courses of duck-embryo vaccine there have been reports of two patients with symptoms suggesting encephalitis and two with transverse myelitis. All four patients recovered completely. If symptoms appear that indicate central-nervous system involvement, vaccine injections should be discontinued.
(Plaintiffs' exhibit 59(c).)
(Plaintiffs' exhibits 71 and 59(c).)
C. The "Recommendation of the Public Health Service Advisory Committee on Immunization Practices" (October, 1969), advises, in part, that:
The problem of whether or not to immunize those bitten or scratched by animals suspected of being rabid is a perplexing one for physicians. All available methods of systemic treatment are complicated by numerous instances of adverse reactions, a few of which have resulted in death or permanent disability
The Relatively low frequency of reactions to DEV has made it more practical to offer pre-exposure immunization to persons in high-risk groups . . . . (Emphasis added.)
(Defendant's exhibit 26.)
D. A letter dated September 25, 1970, from Dr. Michael Hattwick, a rabies expert for the Center for Disease Control located in Atlanta, Georgia, addressed to Dr. Martin Wolfe, Department of State, advises, among other things, that while serious reactions to DEV pre-exposure prophylaxis have been observed to occur less frequently than serious reactions to DEV post-exposure prophylaxis, such reactions, although not common, do occur:
Reactions to duck embryo vaccine are of several types most conveniently minor reactions, neurological reactions, and true allergic reactions . . . . Neuroparalytic reactions have been described only after the post-exposure treatment of rabies. There does not seem to be any significant risk of neuroparalytic reactions to the pre-exposure prophylaxis schedule . . . .
It must be stressed that serious reactions to rabies pre-exposure prophylaxis are not common. In areas where the potential exposure to rabies is high as it apparently is in the Karachi (Pakistan) area, the unlikely possibility of allergic reactions should not prevent vaccination of persons at high risk.
(Defendant's exhibit 17.)
E. Prussin & Katabi, "Dorsolumbar myelitis following antirabies vaccination with duck embryo vaccine", Annals of Internal Medicine, 60: 114-116 (1964), reporting a case of transverse myelitis after injection with DEV in a post-exposure series. (Reference at Plaintiff's exhibit 15, n. 14.)
F. Harrington & Olin, "Incomplete transverse myelitis following rabies duck embryo vaccination", Journal of the American Medical Association, 216: 2137-2138 (1971), reporting a case of transverse myelitis after treatment with DEV during a post-exposure series. The article also notes that:
The Public Health Service has reported that neurologic complications with rabies duck embryo vaccine occurred in 1 per 25,000 cases, with one death in 225,000 persons immunized.
Neurologic side-effects of DEV in 1 per 25,000 cases may be compared with the estimate of deaths resulting from NTV vaccination in 1 per 35,000 cases. NTV has been described as "hazardous." See p. 68, Supra (Plaintiffs' exhibit 22.)
G. Shiraki, Hirotsugu, "The Comparative Study of Rabies Postvaccinal Encephalomyelitis and Demyelinating Encephalomyelitides of Unknown Origin, with Special Reference to the Japanese Cases" (1968).
This paper states, among other things, that there were 41 cerebral encephalomyelitic reactions to post-exposure series of NTV in Japan from 1947 to 1959. In 48 examples of the spinal form there were 5 fatalities, 19 incomplete recoveries and 24 complete recoveries. Among the 41 cases of the cerebral form there were 8 fatalities, 27 incomplete recoveries and 6 complete recoveries. It appears that no report of the more severe cerebral form of the disease had appeared in the Western literature, at least at the time this earlier article was written.
It is clear that the morphologic characteristics of both (spinal and cerebral) forms of rabies post-vaccinal encephalomyelitis have Important similarities to features of acute multiple sclerosis. (at 177) (Emphasis added.)
These features include involvement of the cerebral hemispheres, the optic nerve, brain stem and spinal cord.
(Plaintiffs' exhibit 53.)
H. Rubin, Hattwick, Jones, Gregg and Schwartz, "Adverse Reactions to Duck Embryo Rabies Vaccine" (1973).
This article compiles and comments upon retrospective reports of side-effects resulting from DEV vaccination during the period 1958 to 1971 and prospective studies of DEV side-effects begun in 1969 and conducted by the Center for Disease Control in Atlanta, Georgia. The research of the Center for Disease Control revealed that, although the incidence of serious reactions, including neuroparalytic reactions, to DEV is significantly less than similar reactions to NTV, DEV is only "relatively safe." The relatively low risk of serious reactions to DEV has made it possible to introduce a pre-exposure prophylaxis for individuals such as veterinarians and animal handlers, who are "significantly at risk of being exposed to rabies."
Serious reactions to (DEV) are relatively rare; only four neurologic complications and one death were reported in the first 50,000 treated individuals . . . . (The) relative safety (of DEV) has made possible the introduction of preexposure prophylaxis for such individuals as veterinarians and animal handlers, who are significantly at risk of being exposed to rabies. (at 643.)
Approximately 424,000 persons in the United States received DEV between 1958 and 1971. Minor neurologic reactions to DEV were reported in one hundred thirty-seven cases; symptoms included listlessness, increased fatiguability or sleepiness. Major neurologic reactions, defined as "major neurologic dysfunction lasting more than 4 days, beginning within 6 weeks of vaccination and with no clear causative agent known", were reported in thirteen cases. All of the reported cases had onsets between 3 and 16 days after initiation of the vaccine series. Four cases of transverse myelitis were reported after use of DEV in patients 20 to 56 years of age; symptoms were similar in all patients: "painless, flaccid ...