The opinion of the court was delivered by: TROUTMAN
This civil action was originally filed on November 20, 1980, under the Federal Tort Claims Act, 28 U.S.C. § 1346(b) and § 2671 et seq., as incorporated by the National Swine Flu Immunization Program. Act of 1976, 42 U.S.C. § 247(b). As required by 18 U.S.C. § 2402, the case has been submitted to the Court for trial without a jury.
Historically, the case was transferred to the Judicial Panel on Multidistrict Litigation for coordinated and consolidated pre-trial proceedings and has now been remanded to this Court for further proceedings and trial. Under the Final Pre-trial Order of the transferee court, where, as here, the United States concedes that the decedent contracted Guillain-Barre Syndrome (GBS) after receiving a Swine Flu vaccination, the only issue to be decided is one of causal relationship between the Swine Flu vaccination and the GBS. No theory of liability need be established by the plaintiff to recover damages. Thus, the plaintiff need not prove negligence or other fault to recover damages.
By agreement of counsel and with the approval of the Court testimony was taken and evidence submitted on the causation issue only. If the plaintiff prevails testimony will then be taken on the issue of damages.
The first witness called by the plaintiff was Barton E. Croll, a son of the decedent, who testified as to the decedent's date of birth, date of marriage, community activities, religious activities, etc. He testified that she received the inoculation on October 8, 1976, at the age of 67 years, that she later complained of tingling of the hands, weakness and headaches. These symptoms first appear in the medical records when the decedent was admitted to the St. Joseph's Hospital on February 20, 1977, and complained of weakness and numbness of the fingers and toes, commencing February 18, 1977. The nurses' notes suggest a history of head pains commencing February 15, 1977. Importantly, the testimony of the son was expressly not offered to prove post-vaccination symptoms or complaints, but for historical purposes only. He testified as to the decedent's hospitalization from January 18, to January 27, 1977, the implantation of radium for cancer of the uterus, the existence of high blood pressure over the years, the occurrence of phlebitis and other conditions.
The plaintiff's decedent was diagnosed, with a reasonable degree of medical certainty, as having GBS and the defendant so concedes. Although the exact cause of GBS is unknown, epidemiological studies have established a causal relationship between the Swine Flu vaccine and GBS. GBS is also known to occur in persons who have never received the Swine Flu vaccine. Thus, plaintiff's burden on the issue of causation was to establish, through epidemiological evidence and other evidence, that the GBS from which decedent suffered and which manifested itself seventeen to nineteen weeks after she received the Swine Flu vaccination was more probably or more likely than not caused by the vaccination.
The basic data employed by both the plaintiff's and defendant's experts was data gathered by the Center for Disease Control (CDC) at the time of the Swine Flu immunization program in 1976 and thereafter. The program, which began on October 1, 1976, was terminated on December 16, 1976, due to concern about a disproportionate incidence of GBS in those who received vaccinations. Major studies by the CDC followed. As a result of CDC studies, the Government agreed and stipulated to liability in those cases whose GBS occurred within ten weeks of the Swine Flu inoculation. However, the plaintiff's medical expert, Dr. Goldfield, takes sincere and outspoken exception to the methods followed by Dr. Schonberger and others who participated in the CDC program. He ultimately obtained access to the CDC data base and made his own studies and findings. In response, the Government commissioned a panel of experts, including Dr. Nathanson, also a witness in this case, called by the defendant, to reevaluate the CDC data and studies. The differences in result involve the evaluation of data, the completeness and accuracy of that data, including the reporting or under-reporting of GBS cases with regard to the triggering event, varying degrees of under-reporting as between vaccinated and unvaccinated cases, as between early-onset cases and late-onset cases, as between mild and severe cases, as between various geographical areas and other factors, such as the effect of the termination of the program, possible confusion of GBS with other neurological disorders and other considerations. These problems and resultant considerations lead directly to the talents and expertise of an epidemiologist whose function is to develop, from available data, the most accurate comparison of GBS rates in vaccinated and unvaccinated populations, giving due consideration to other medical information and other disciplines. As stated, against this background, the plaintiff called Dr. Goldfield and the defendant called Dr. Nathanson, both experts in the field of epidemiology.
The defendant also called Dr. Elliott Mancall, a neurologist, who detailed his findings as a result of a complete review of the decedent's medical history and records. Upon a finding that the decedent, a known hypertensive and diabetic at the time of her vaccination on October 8, 1976, did indeed suffer GBS, that significant neurological symptoms thereof did not develop until February 18, 1977, approximately nineteen weeks following inoculation, he concluded that there was, in his opinion, no causal relationship between the immunization and the GBS. He based his opinion upon the absence of neurological abnormalities during said period of time and attributed the GBS to a "D&C followed by implantation of radium for treatment of carcinoma of the uterus" on January 19, 1977, pointing out that GBS "is sometimes encountered after non-specific and often minor surgical procedures" such as were here performed one month prior to the development of the symptoms.
Then followed the videotaped deposition of Dr. Neal Nathanson who concluded with "a reasonable degree of medical epidemiological certainty" that there was no causal relationship between the immunization and the development of GBS. He described the panel upon which he served which included Dr. Langmuir, an epidemiologist, Dr. Kurland, an epidemiologist, Dr. Victor, a neurologist, and Mr. Bregman, a statistician and computer expert. Assuming the development of GBS seventeen to nineteen weeks following the vaccination, he too concluded with a "reasonable degree of medical and scientific certainty" and as an expression of an "epidemiologic opinion" that the GBS from which decedent suffered "was not casually associated with the prior administration of swine flu vaccine." He expressed this opinion with "a reasonable degree of epidemiological certainty". Like the plaintiff's witness, Dr. Goldfield, he went to the blackboard to illustrate the bases for his opinion.
We are thus faced with a substantial and sometimes a verbally "violent" difference of opinion as between Dr. Goldfield and Dr. Nathansom. The record reveals that there is room for responsible epidemiologists to differ not only in their conclusions and opinions but also in assumptions and choices required in arriving at a conclusion and opinion as to causal relationship. This fact has led to the use of unusually strong terms, particularly on cross-examination, such as "bias", "prejudice", "artifact" etc.
In weighing and considering the conflicting opinions and conclusions of Dr. Goldfield and Dr. Nathanson, both qualified, we face a difficult task. In weighing Dr. Goldfield's testimony we note that he has tended to be very selective in choosing his alternatives and in the selection of figures, statistics and assumptions upon which to base a conclusion. He has accused those who differ in their conclusions with bias when, however, his own testimony clearly demonstrates that such selections of alternatives is one of wide choice on which epidemiologists may reasonably and honestly differ. However, even his testimony, however strongly and emphatically stated, does not establish that his choices or assumptions were the only logical or reasonable assumptions or choices which a qualified epidemiologist could or would make under the circumstances.
On the contrary, Dr. Nathanson was far less definitive and arbitrary in defending his choice of alternatives, conceding always the existence of reasonable grounds for other choices and assumptions but logically defending the choices selected by him. Additionally, his opinions and conclusions are supported by other epidemiologists, including Dr. Langmuir and Dr. Kurland. His conclusions are also supported by Dr. Victor, a neurologist. It is argued that Dr. Nathanson's conclusion enjoys more biological support than that of Dr. Goldfield. We do not disagree. After considerable study and reflection, we do accept the opinion of Dr. Nathanson as opposed to that of Dr. Goldfield.
Finally, there is of record the testimony of Dr. Mark Jeffrey Brown, an impartial expert appointed by the Court. Dr. Brown specializes in the field of neurology and has outstanding qualifications. A mere reference to his curriculum vitae discloses exceptional accomplishments in his speciality. Importantly, he was retained by neither party. Rather he was appointed to express an impartial opinion to aid the Court in determining the issue involved. After studying and examining all relevant and pertinent data concerning the decedent's medical condition, including hospital records, histories, medical tests and studies, examinations and the results thereof, laboratory studies and the results thereof, and autopsy findings, he concluded that the decedent's death on March 19, 1977, was unrelated to the Swine Flu vaccination on October 8, 1976. As one who has specialized and enjoys special and unique expertise in the diagnosis and treatment of human peripheral nerve diseases, his opinion is entitled to great weight. Moreover, his impartial approach, with allegiance, loyalty and obligation to neither party, lends additional weight to his opinion and conclusions.
Accordingly, the following constitute our findings of fact and conclusions of law, as required by F.R.C.P. 52(a).
1. Verna V. Croll, plaintiff's decedent, received a Swine Flu vaccination on October 8, 1976.
2. Decedent was 67 years of age at the time she received her Swine Flu vaccination.
3. Previous to her vaccination, decedent had a history of hypertension of fifteen years duration and had received intermittent treatment for hypertensive vascular disease and acute phlebitis.
4. After receiving the Swine Flu vaccination, decedent made a visit to her family physician, Dr. J. P. Slovak, on December 1, 1976. Dr. Slovak measured decedent's blood pressure, pulse and respiration and continued her prescription for Lasix, a diuretic.
5. On December 1, 1976, decedent reported to Dr. Slovak that "she had vaginal bleeding one day", for which he referred her to a gynecologist, Dr. George Scheers.
6. On January 13, 1977, decedent made an office visit to Dr. Scheers, who did not mention the existence of any neurological signs, symptoms, or complaints in his notes of examination.
7. On January 18, 1977, decedent was admitted to St. Joseph's Hospital in Hazleton, Pennsylvania, "because of a single episode of vaginal bleeding which occurred on November 27, 1976, and lasted for only 1 day."
8. Upon physical examination on admission to St. Joseph's Hospital on January 18, 1977, it was reported with reference to decedent's musculo-skeletal system: "None contributory".
9. Decedent's nervous system was described: "No past history of paralysis or convulsion".
10. Decedent's extremities were said to be: "Normal; reflexes are physiological".
11. On January 19, 1977, decedent was taken to the operating room where a pelvic examination under anesthesis was done, a dilatation and curettage was performed and an endocervical polypectomy was completed.
12. The pathology report from the January 19, 1977, surgery confirmed an adenocarcinoma of the endometrium.
13. On January 20, 1977, it was reported that "Patient has no complaints and is ambulatory, afebrile and is doing well".
14. On January 21, 1977, decedent was returned to the operating room where she was again placed under general anesthesia and an "intra-uterine ...