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March 2, 1982

Carlos SIMONETTI and Anna Simonetti, Plaintiffs,
UNITED STATES of America, Defendant

The opinion of the court was delivered by: PRATT


Plaintiffs brought this action to recover for injuries claimed to have been caused by a swine flu vaccine administered to plaintiff Carlos Simonetti on October 26, 1976 as part of the national swine flu immunization program. Jurisdiction is not disputed. 28 U.S.C. § 1346(b) & 42 USC § 247(b).

 Upon the consent of the parties the court ordered that the issue of causation be tried separately. To that end, evidence was presented to the court, sitting without a jury on January 25 and 26, 1982. Both of the plaintiffs testified. In addition, the direct testimony of Dr. Murray Budabin was submitted in writing. When the government indicated no desire to cross-examine Dr. Budabin, his presence at the trial became unnecessary and his written testimony was deemed part of the record. On behalf of the defendant, Dr. Bennett M. Derby testified. Defendant also submitted the deposition of plaintiff's treating physician, Dr. R. Antonio Troncoso. Reports of various other treating physicians and of Montefiore Hospital where Carlos Simonetti was confined in May, 1977, were placed in evidence.

 The court has carefully considered the live testimony, the deposition and written testimony, the exhibits submitted, and the arguments of counsel. This memorandum constitutes the court's decision and includes the court's findings and conclusions pursuant to FRCP 52(a).

 It is undisputed that plaintiff received a swine flu shot on October 26, 1976 and that she experienced no immediate reaction to it. Plaintiff testified that about the middle of December he noticed a small numb spot on the sole of his right foot. He paid little attention to it, and it went away. About a month later he noticed a small numb spot on the sole of his left foot. Later, perhaps in January, "maybe much later", his toes began to get numb and his tongue felt funny. He testified that in February he experienced an "explosion of symptoms". His toes became more numb, and he had balance problems that caused him to stumble a lot and fall down steps. Nevertheless, he continued to work.

 On March 28th he saw his family physician, Dr. Troncoso, complaining to him for the first time of his neurological symptoms, which included incoordination of both legs, numbness over his toes, and a mild fullness and heaviness sensation of the legs. On April 17th, after examining him again for a continuation of the same symptoms, Dr. Troncoso referred plaintiff to a neurologist, Dr. David Fine.

 Dr. Fine reported that plaintiff had noted numbness of his right foot and toes, which had been present to a mild degree for the past four months, but increased in severity in the past month. He also reported numbness of the other foot and both hands, difficulty in walking because of these complaints, weakness in the extremities, an occasional feeling of spasm all over his body, and "on one occasion" a weird feeling over the tip of his tongue. On neurologic examination plaintiff disclosed a generalized areflexia (absence of deep tendon reflexes). Dr. Fine's preliminary diagnosis was "a polyneuropathy with minimal degrees of weakness and some mild sensory loss".

 Under Dr. Fine's care plaintiff was treated in Montefiore Hospital from May 12 through May 27, 1977. After that treatment Dr. Fine concluded that he had "a chronic progressive polyneuropathy".

 Plaintiff was referred to Dr. Michael Swerdlow, a neurologist at Montefiore Hospital, under whose care he gradually recovered so that as of 1980 his symptoms had basically disappeared. At the time of trial plaintiff complained of occasional feelings of numbness and some weakness in one arm. The loss of sensation during sexual activities that plaintiff had experienced at the height of his disease, had disappeared some 6 to 12 months before trial.

 Relying on references in the medical records and the opinion of Dr. Murray Budabin, plaintiff claims to have suffered from Guillian-Barre Syndrome (GBS) caused by the swine flu vaccine. That diagnosis was listed by Dr. Troncoso as a possibility when he examined plaintiff on April 11, 1977. It was also listed in the discharge summary of the Montefiore Hospital record, a summary that was dictated by a resident at the hospital approximately nine months after the discharge.

 In the opinion of Dr. Budabin, plaintiff's illness represented a form of GBS. Dr. Budabin pointed out that sensory complaints began about one and one-half months after the injection, progressed to the hands and feet, eventually involved the face and later caused problems with motor performance, balance, coordination, strength and the autonomic nervous system. According to Dr. Budabin, GBS is a diverse collection of signs and symptoms that cannot be too closely delimited. Its pathology is an inflammatory condition of undetermined etiology, perhaps due to viral infection or perhaps secondary to immunological challenge.

 Dr. Budabin pointed out that although plaintiff's initial symptoms were sensory and only later evolved into symptoms affecting his motor system, nevertheless, from the time of his first motor complaint to the time of his neurologic referral to Dr. Fine, only about five weeks elapsed, a period that fits the criteria for the period determined for motor weaknesses to develop as determined by the authors of an article in the Annals of Neurology. Dr. Budabin expressed his opinion that the swine flu inoculation of October, 1976 caused plaintiff's condition, because the sensory component "followed hard upon the history of swine flu inoculation".

 When asked if plaintiff's was a typical case of GBS, Dr. Budabin acknowledged that plaintiff presented a "most extraordinary concatenation of signs and symptoms" and that plaintiff's case was "rather unusual and bizarre". Nevertheless, he did feel that "many of these characteristics still does permit it to be labeled as Guillian-Barre Syndrome".

 At the time Dr. Budabin examined plaintiff on December 27, 1981, plaintiff showed no clinical signs of having had GBS, but according to Dr. Budabin, plaintiff's recent complaints of numbness in his legs and ...

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