The opinion of the court was delivered by: PRATT
Plaintiffs brought these actions to recover for injuries claimed to have been caused by a swine flu vaccine administered to plaintiff Roslyn Grill and to plaintiff Richard Healy as part of the national swine flu immunization program. Jurisdiction is not disputed. 28 USC § 1346(b) and 42 USC § 247(b).
After remand from the multidistrict litigation phase of these cases, and after local discovery, the parties agreed that the issue of causation should be tried separately and first. Because both plaintiffs claim to have contracted optic neuritis as a result of the vaccine and, because both plaintiffs are represented by the same attorney, the parties agreed to a joint trial of the causation issues. To that end evidence was presented to the court sitting without a jury in May, 1982. Each of the plaintiffs testified; treating doctors and expert witnesses also testified in person and by deposition. In addition, both parties rely on excerpts from deposition testimony taken during MDL discovery.
The court has considered carefully the live testimony, the deposition testimony, the exhibits submitted and the arguments of counsel. This memorandum constitutes the court's decision in both cases, and includes the court's findings and conclusions pursuant to FRCP 52(a).
It is undisputed that both plaintiffs developed severe eye problems within a month after receiving a swine flu shot. Plaintiffs claim the condition was optic neuritis, an inflammation of the optic nerve, which runs back from the retina of the eye into the brain. Optic neuritis has many known causes and associations, including certain drugs and chemicals such as lead and carbon tetrachloride, viral problems, an autoimmune process, and toxins. It is also associated with multiple sclerosis. Plaintiffs claim here that the swine flu vaccine caused a hypersensitive autoimmune reaction which resulted in demyelinization of the optic nerve. Plaintiffs argue that the onset of eye problems soon after the administration of the vaccine, coupled with the symptoms exhibited and the medical opinions in evidence, satisfy their burden of proving causation.
Defendant contends that the only probative evidence here is temporal, that the incidence of optic neuritis in vaccine recipients was no greater than its incidence in the general population, that there are many other possible causes of optic neuritis, and that the causes in these cases were vascular problems for Mr. Healy and a slow growing tumor on the optic nerve of Mrs. Grill.
Mrs. Grill received her swine flu vaccine on October 15, 1976 when she was 50 years of age. She had experienced no prior eye trouble, except she did use glasses for reading. Immediately after the shot, she suffered the normal post-vaccinal sensations of burning and swelling of the left arm, followed by flu-like symptoms of a mild temperature, chills and aching lungs. She testified that she also felt a slight pain during this period, in her left eyeball. Suddenly, on November 6, 1976, she could not see out of her left eye. The following Monday she went to Dr. Abraham D. Winter and told him that she had experienced pain in her left eye, and that she could not see out of her left eye, but had no vision problems in her right eye.
She visited a number of other doctors and was placed on cortisone therapy, on which she has become dependent. If the amount of cortisone is decreased, her vision deteriorates and pain recurs. When a heavier cortisone dosage is restored, the pain disappears and the vision returns to a level where she can see forms, but not details and features.
Dr. Winter's initial diagnosis was that Mrs. Grill had iridocyclitis, which is an allergic condition, in this case causing an inflammation of the iris and ciliary body. Her loss of color vision in the left eye indicated to him a possible involvement of the optic nerve, because color vision fibers are very sensitive to inflammatory changes of that nerve.
In late December of 1976, Dr. Winter diagnosed Mrs. Grill's worsened condition as an active optic neuritis. She was experiencing severe pain and could count fingers only up to six feet away. While he was not sure, Dr. Winter suspected the swine flu vaccine as a cause, because he had read in the literature that optic neuritis is a condition which sometimes follows vaccinations. His treatment of Mrs. Grill was as if she had an inflammatory condition; he gave her cortisone, varying the amount to determine the smallest amount that would keep her comfortable and keep her vision level tolerable. He found that if he reduced the dosage, her pain increased and the quality of her vision deteriorated.
Dr. Winter interpreted a CAT (computed axial tomography) scan of Mrs. Grill's optic nerve and felt strongly that the enlargement on the optic nerve was not a tumor, primarily because he felt that a tumor could not respond so dramatically to cortisone, which is a drug that reduces inflammatory reactions. A second CAT scan showed, in his opinion, no enlargement of the elongated tortuous optic nerve.
Dr. Winter's conclusion was that Mrs. Grill had suffered an allergic reaction to the swine flu vaccine and that the effects were continuing to date. Her problems followed reasonably soon after receiving the vaccine; and he could find no other etiology for her symptoms, although he conceded that her case differs from any other optic neuritis he has seen. In his opinion the CAT scans did not show a tumor. Her response to cortisone treatment was indicative that she suffers from an inflammatory condition, not a tumor.
On cross-examination Dr. Winter conceded that he had had no prior experience with eye problems caused by the swine flu vaccine. Dr. Winter conceded that a tumor was a possibility in one of the CAT scans, but he contended that if the cause of her eye trouble were a tumor, the beneficial effect of cortisone would have been limited to only a few weeks, and would not have continued for years. Dr. Winter conceded that over half of the cases of optic neuritis have no known etiology and that an ordinary virus may cause the condition.
Dr. Miles Michael Behrens' deposition was presented to the court. He had treated Mrs. Grill beginning in January 1977. In his opinion, the flu vaccine was related as one possible alternative cause of Mrs. Grill's condition. To him, however, her clear response to steroid therapy indicated something other than ordinary optic demyelinating neuritis, which to him raised "the possibility of an orbital inflammatory pseudo-tumor ...