Full opinion text
MEMORANDUM ORDER AND JUDGMENT BARTLETT, District Judge. Anticipating an outbreak of swine flu in 1976, the federal government undertook a massive immunization effort through the National Swine Flu Immunization Program Act of 1976, Pub.L. No. 94-380, § 2, 90 Stat. 1113 (August 12, 1976) (codified at 42 U.S.C. § 247b(j)) (repealed by Pub.L. No. 95-626, § 202, 92 Stat. 3574 (1978), 42 U.S.C. § 247b (1978)) (hereafter called the Swine Flu Act). The program was directed at the prevention of an anticipated epidemic of swine flu in the United States adult population through the vaccination of large numbers of people in nationwide immunization centers. To encourage pharmaceutical companies to supply the vaccine, Congress relieved the companies of liability for injuries resulting from its use and provided remedies against the United States under the Federal Tort Claims Act, 28 U.S.C. § 1846(b). On October 1, 1976, the swine flu immunization program began. On December 18, 1976, the Center for Disease Control declared a moratorium on swine flue vaccinations to investigate an increased incidence of Guillain-Barre Syndrome (GBS) in the adult population and an apparent association between GBS and the swine flu vaccination. Plaintiff Louis Manko received a swine flu vaccination on October 20, 1976. On January 15, 1977, plaintiff was admitted to Menorah Medical Center with paralysis in his legs and arms that was diagnosed as GBS. On November 14, 1979, plaintiff Louis Manko initiated this lawsuit by filing his complaint against defendant the United States seeking damages under the Federal Tort Claims Act and the Swine Flu Act. On January 31, 1980, this case was transferred by the Judicial Panel on Multidistrict Litigation to the United States District Court for the District of Columbia, In re: Swine Flu Immunization Products Liability Litigation, MDL 330, Misc. No. 78-0040, Civil Action No. D.C. 80-0255, for coordinated and consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407. On June 9,1980, the Judicial Panel on Multidistrict Litigation remanded this case to the United States District Court for the Western District of Missouri for further pretrial proceedings and trial. The Final Pretrial Order, paragraph IX, p. 9 issued by the United States District Court for the District of Columbia in the Multidistrict Litigation (D.D.C. November 15, 1979) stated in relevant part that: The United States and the plaintiffs disagree as to whether the injuries alleged can be caused by administration of the vaccine, except that the United States has stipulated that the Guillain-Barre Syndrome can be caused by the vaccine in certain instances. If the United States has stipulated that the plaintiff in fact developed the Guillain-Barre Syndrome at any time, it will remain to be determined whether such injuries were in fact caused by administration of the vaccine, but it will not be necessary for plaintiff to establish any theory of liability, i.e. negligence or any available theory founded on the law of the applicable jurisdiction. Thus, the only liability issue in such cases will be causation, unless the United States has also stipulated as to causation____ In defendant’s response to plaintiff’s request for admission filed January 20, 1981, defendant admitted that subsequent to receipt of the swine flu vaccine, plaintiff contracted GBS and that plaintiff need not prove negligence or any other legal theory in order to establish liability against the United States. Therefore, pursuant to the Final Pretrial Order and defendant’s January 20, 1981, admission, the sole liability issue is whether plaintiff’s swine flue vaccination caused his GBS. I. MOTIONS Motion to Strike Mayo Clinic Records On December 5, 1983, pursuant to defendant’s motion and plaintiff’s consent, this Court ordered plaintiff to submit to a medical examination at the Mayo Clinic to evaluate plaintiff’s alleged impotence. Plaintiff was examined and tested over a five day period in December, 1983. On November 27, 1984, during the hearing on damages, the Mayo Clinic records (Plaintiff’s Exhibit 409) were admitted in evidence without objection by defendant Tr. 25-96. Dr. Lichtenfield, plaintiff’s neurological expert, testified on direct examination about the Mayo Clinic records and specifically about the diagnoses of the Mayo Clinic physicians. Tr. 25-39. On cross-examination, defendant examined Dr. Lichtenfield about the tests conducted at Mayo Clinic (Tr. 25-107) and the diagnosis from Mayo Clinic. Tr. 25-121. Then the Court examined Dr. Lichtenfield about the Mayo Clinic records. Tr. 25-137 to 25-140. The Mayo Clinic records were mentioned by other witnesses, including Dr. Rhamy, Dr. Leifer and Dr. Victor. At oral argument on the issue of damages on December 14, 1984, the United States made an oral motion to limit the admissibility of the Mayo Clinic records based on Skogen v. Dow Chemical Co., 375 F.2d 692 (8th Cir.1967). Tr. 31-10. At that time the Court reserved ruling on defendant’s motion to give plaintiff an opportunity to read the case cited by defendant and brief the issue. On December 20, 1984, plaintiff filed a brief on this issue. In Skogen, the Eighth Circuit held that a doctor’s opinion of how his patient’s accident occurred is inadmissible hearsay under the business records statute, 28 U.S.C. § 1732(a). Thereafter, Congress enacted Rule 803(6), Federal Rules of Evidence, and repealed § 1732(a). The diagnoses contained in the Mayo Clinic records are admissible under the more liberal standards contained in Rule 803(6). The Advisory Committee notes to Rule 803(6) expressly state that Skogen and its interpretation of § 1732 are no longer good law. Rule 803, Federal Rules of Evidence, Notes of the Advisory Committee on Proposed Rules, note to Exception 6. Further, the defendant waived its objection by its failure to timely object. Defendant’s objection at oral argument after the evidentiary record had been closed only served to needlessly complicate the issues before the Court. Therefore, defendant’s oral motion to strike the Mayo Clinic records (Plaintiff’s Exhibit 409), is denied. Defendant’s Motion to Keep Open the Record Presentation of evidence on the issue of causation concluded on February 17, 1984. During oral argument on February 21, 1984, the United States made an oral motion to keep the record open so that Dr. Nathanson could submit a revision of Defendant’s Exhibit 273 (Dr. Nathanson’s analysis of whether there was a drop in reporting the occurrence of GBS in the immunized population after December 18, 1976). Plaintiff objected to the admission of additional evidence after the record closed and the Court suggested defendant file a written motion. On February 22, 1984, defendant filed a written motion to keep the record open. On April 16, 1984, defendant filed a renewed motion to keep the record open and attached a copy of Dr. Nathanson’s revision of Defendant’s Exhibit 273. During presentation of defendant’s case, Dr. Nathanson testified extensively on behalf of defendant. Later, Dr. Nathanson was recalled at the Court’s request and testified concurrently with Dr. Goldfield in rebuttal. Dr. Nathanson has been given an adequate opportunity to present his expert opinion and its basis. If the tendered revision of defendant’s Exhibit 273 was admitted into evi- , dence, it is fair to assume that plaintiff would request an evidentiary hearing to cross-examine Dr. Nathanson. Further delay in concluding this case is not justified. Defendant’s request to introduce a revised defendant’s Exhibit 273 is denied. Motion to Strike Dr. Goldfield’s Testimony During the trial, the United States objected to Dr. Goldfield’s expert testimony on the cohort analysis. Tr. 7-53. After the trial, both parties briefed the issues raised by this objection. Defendant first argues that Dr. Goldfield’s testimony about his cohort analysis should be stricken because it does not satisfy the standard for scientific techniques set forth in Frye v. United States, 293 F. 1013 (D.C.Cir.1923). In Frye, the Court held that testimony based on the results of a polygraph test was inadmissible because scientific recognition of the accuracy of the technique was inadequate. Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while the courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs. Id. at 1014. Apparently, the United States believes that because its experts did not use the Mantel/Haenszel cohort analysis to make their epidemiological evaluations, then the cohort analysis is not generally accepted in the epidemiological community. Although plaintiff’s experts and defendant’s experts dispute whether the underlying data is stratified, i.e., whether there was a drop in reporting after December 18, 1976, all the experts agreed that the Mantel/Haeznel approach is a recognized and generally accepted method of analyzing stratified epidemiological data. Based on the Court’s conclusion that the data was stratified, the Mantel/Haenszel analysis is the appropriate and generally recognized method of determining whether there was a statistically meaningful association between a swine flu vaccination and contracting GBS. The United States next argues that Dr. Goldfield’s testimony should be stricken under Rule 702, Federal Rules of Evidence, because it did not assist the trier of fact. Dr. Goldfield’s expertise and testimony unquestionably assisted this Court in evaluating the available epidemiological data and in deciding the causation issue. The United States next argues that Dr. Goldfield’s expert testimony should be stricken under Rule 703, Federal Rules of Evidence, because Dr. Goldfield relied on data obtained from administrative claim forms that are not of the type reasonably relied upon by experts. Rule 703 provides that: The facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to him at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence. Defendant’s argument is without merit for two reasons. First, the administrative claim forms were admitted into evidence. Second, Dr. Goldfield testified and the Court finds that the data contained in the administrative claim forms is the type reasonably relied upon by epidemiologists in forming opinions. For the reasons stated, defendant’s motion to strike Dr. Goldfield’s expert testimony is denied. II. CAUSATION A. Guillain-Barre Syndrome GBS is not a well-defined organic disorder but rather a collection of neurological symptoms and findings. It is a peripheral neuropathy characterized by an immune-mediated attack on the peripheral nervous system resulting in inflammation and demyelination of the nerves, particularly the peripheral nerves. A demyelinating illness causes destruction and loss of the myelin sheath, or the insulation surrounding the nerve fibers. Demyelinated nerve fiber will not conduct impulses from the central nervous system in a normal fashion. A typical case of GBS involves rapid onset of neurological dysfunction progressing rapidly to paralysis of the legs and/or arms. This phase of the disease, called the acute phase, typically begins with neurological symptoms such as tingling, numbness, or weakness in the toes, feet, fingers and/or hands and progresses along the limbs to the trunk. The severity of the weakness ranges from mild ataxia (failure of muscle coordination) to paralysis with maximum weakness within two months in ninety percent of the cases. The acute phase is then followed by a much longer recovery period during which most patients gradually regain use of their limbs. Although most patients make a complete recovery, approximately five percent of GBS victims suffer some residual neurological deficit. The etiology, or cause, of GBS is unknown. However, it has been associated with numerous antecedent events such as a viral infection. In 1976, an epidemiological report, the Schonberger study, was released indicating that the swine flu vaccine was an antecedent event, leading to the onset of GBS up to ten weeks after the innoculation. Schonberger, et al., Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, American Journal of Epidemiology, Vol. 110, No. 2, 105 (1979) (Defendant’s Exhibit 38). B. Applicable Law on Issue of Causation The law of the place where the tort occurred is applicable to claims against the United States under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2675. Hungate v. United States, 626 F.2d 60, 61 (8th Cir.1980). Here, it is undisputed that plaintiff received his swine flu vaccination in Kansas City, Missouri. Therefore, Missouri law applies to the issues raised by plaintiff’s claim. Under Missouri law, the burden of proof is on plaintiff to show by a preponderance of the evidence that plaintiff’s GBS was a reasonable and probable consequence of plaintiff’s swine flu vaccination. George v. Howard Const. Co., 604 S.W.2d 685, 692 (Mo.App.1980). C. Plaintiffs Causation Theories Plaintiff argues that the evidence presented at trial establishes that plaintiff’s GBS was a reasonable and probable consequence of plaintiff’s swine flu vaccination because: a) plaintiff demonstrated GBS symptons in the fall of 1976 shortly after plaintiff received the swine flu vaccination and these symptoms smoldered until early January 1977, when plaintiff became acutely ill; or b) even if the symptoms of plaintiff’s GBS were first manifested in early January 1977, there is a causal relationship between plaintiff’s GBS and the swine flu vaccination based on a proper epidemiological analysis of available data; or c) based on cases that were deemed long onset cases of GBS pursuant to discovery sanctions imposed in the Court’s November 29, 1983, Order, there is a causal relationship between plaintiff’s GBS and his swine flu vaccination regardless of whether plaintiff’s analytical approach or defendant’s analytical approach is used. D. There is a Causal Relationship Between Plaintiffs GBS and the Swine Flu Vaccination Because the Onset of Plaintiffs GBS Was Within Three Weeks of the Vaccination. Plaintiff argues that he suffered from chronic or smoldering GBS that began with neurological impairments such as tingling in the hands and feet, fatigue, light-headedness and weakness in his legs in early November, 1976. His condition progressively worsened during November, 1976, and December, 1976, and erupted into acute GBS on January 15, 1977. Defendant argues that a) GBS does not exist in the chronic or smoldering form; and b) the testimony of plaintiff, his family, friends and co-workers about plaintiffs symptoms in November-December, 1976, was not credible. 1. Smoldering Guillain-Barre Syndrome Two neurologists testified on behalf of plaintiff. Dr. Peter Lichtenfield is a neurologist in private practice in Long Island, New York, with teaching appointments at the Cornell University Medical College and the State University of New York. Dr. Lichtenfield is the former head of the Division of Neurology at the Roger Williams General Hospital. Dr. Milton Alter is the Chairman of the Department of Neurology at Temple University Hospital. Dr. Lichtenfield and Dr. Alter both had extensive experience in the diagnosis and treatment of GBS. Based on the credible testimony of Dr. Lichtenfield and Dr. Alter, the Court is convinced that the symptoms of GBS can be manifested either suddenly (acute GBS) or or over a period of time (smoldering or chronic GBS). According to Dr. Alter, GBS is technically defined as being both chronic inflammatory polyneuritis and acute inflammatory polyneuritis. Both neuropathies involve the same immune mediated process. The distinction is the length of time it takes symptoms to develop. The chronic or smoldering form of GBS is characterized by a slow progressive period of onset with gradually worsening neurological impairments such as tingling in the hands and feet, fatigue, light-headedness and weakness in his legs. Defendant’s neurologists, Dr. Barry Arnason, Chairman of the Department of Neurology at the University of Chicago and a noted expert in the field of neuroimmunology, and Dr. Maurice Victor, Professor of Neurology at Case Western Reserve University School of Medicine and Chairman of the Department of Neurology at Cleveland Metropolitan General Hospital, testified that GBS exists in a single form characterized by rapid onset of weakness, with the acute phase reaching its zenith in approximately one to four weeks, followed by stabilization of the neurologic process and then a lengthy recovery. Although Dr. Arnason and Dr. Victor have excellent credentials, the Court was not persuaded by their insistence that GBS occurs only in the acute form. The first edition of a textbook titled “Peripheral Neuropathy” authored by Peter Dyck, Peter Thomas and Ed Lambert, which Dr. Arnason testified was the standard textbook for peripheral neuropathy, states that the acute form and chronic form of GBS are variants of the same disease and that “the majority of slowly progressing sporadic cases of chronic neuropathy represents variants of acute inflammatory polyradiculoneuropathy....” Tr. 13-134; Plaintiff’s Exhibit 2. Recently, Dr. Arnason co-authored Chapter 91 of the second edition to reflect the author’s view that the chronic and acute neuropathies are separate and distinct entities. The coincidence of the involvement of Dr. Arnason in the nationwide GBS litigation, the changing of his opinion about the existence of chronic GBS and the rewriting of the textbook to reflect his new opinion, casts a shadow over the change in opinion. In short, the Court was not persuaded that absent the GBS litigation, this change in opinion would have occurred. In a 1981 textbook authored by Dr. Victor, he states “[cjases with steady or stepwise progression over weeks or months, some of which show asymmetries of involvement, with recovery in some parts and worsening in others, are other variants. A relapsing form is also known and was noted in approximately 10 percent of the cases.” Tr. 14-30. Dr. Victor now believes that “I no longer would phrase that statement in the same way based on a sharpening of my knowledge and further experience with these diseases. Instead of calling it a variant, I would now refer to it as a distinctive clinical entity, separable on a variety of clinical grounds from acute Guillain-Barre Syndrome. I wouldn’t refer to it as a variant.” Tr. 14-30 to 14-31. Dr. Victor plans to change this chapter in the next edition to reflect his view that chronic and acute inflammatory neuropathies are distinct entities. On cross-examination, Dr. Victor conceded that the most important factor in bringing about this distinction is the swine flu litigation and that all of the neurologists advocating a single form of GBS have been involved in the swine flu litigation. Tr. 14-33. 2. Plaintiff Suffered From Smoldering Guillain-Barre Syndrome In October 1976, plaintiff was a vibrant, outgoing, physically active man. He had a firm handshake and a brisk steady walk. He was and had been employed for 37 years by K & M Kaufman, a clothing wholesaler. His position as regional sales manager involved supervising sales people. He attended the major markets in his region to supervise and assist his sales staff. At these markets, plaintiff was on his feet eight to twelve hours a day and then socialized in the evenings. Plaintiffs co-workers described him as a man with incredible vitality who never got tired, “a horse” and “strong as an ox.” Plaintiff was not one to complain about his physical condition. When he was not traveling on business, he and his wife, Sylvia, enjoyed entertaining in their home or attending parties given by others. Plaintiff enjoyed dancing, playing golf, attending sporting events and the theatre. At least once a year, usually in December, plaintiff and his wife vacationed in a warm climate. On October 20, 1976, plaintiff received a swine flue vaccination in Kansas City, Missouri. On October 23, 1976, plaintiff went to a market in Dallas, Texas, for five days. He was on his feet continuously from approximately 8:00 a.m. to 10:00 p.m. On October 30, 1976, plaintiff went to a market in St. Louis, Missouri. At the St. Louis market, plaintiff felt unusually fatigued, lethargic and was unable to stay on his feet all day. He suffered muscle soreness in his left leg, intermittent headaches and light-headedness. On November 7, 1976, plaintiff went to the Chicago, Illinois, market. Plaintiff had constant headaches, felt light-headed and suffered from muscle spasms and soreness in his legs. Plaintiff had difficulty standing for prolonged periods of time. A business associate, Ed Tannebaum, observed plaintiff sitting more than usual and walking like an old man. When Tannebaum asked plaintiff to go out for dinner, plaintiff told him that he was having problems with his legs and that he was tired. Plaintiff complained of charley horses and muscle spasms in his legs. Tannebaum stated that this was very uncharacteristic of plaintiff who he described as “an absolute bull.” On November 14, 1976, plaintiff went to the Minneapolis, Minnesota, market. There, plaintiffs physical problems worsened. He sat constantly. He suffered from dizziness, light-headedness, increased instability on his feet and loss of equilibrium. From mid-November to mid-December, plaintiff worked in his office in Kansas City. Because of fatigue and light-headedness, plaintiff could not work his normal long hours. He was not able to call on the accounts he usually called on at this time of year. The soreness in plaintiff’s left leg increased. He began having soreness, tingling and numbness in his right leg and left hand. Plaintiff suffered from lethargy, headaches and light-headedness; he was unusually irritable. Plaintiff’s son, David Goodman, noticed that plaintiff’s grip was weak when they shook hands. During this period of time Florence Gottlieb, a long-time friend of plaintiff’s wife, went to plaintiff’s home to play bridge with his wife. While there, she observed that plaintiff did not walk with his usual springy gait. Plaintiff walked slowly and seemed to shuffle along rather than pick up his feet. She testified that plaintiff appeared tired and sluggish. Maxine Mooney, a friend of the Mankos for over forty years, testified that they socialized frequently. During the latter part of November, she noted that plaintiff seemed irritable and lacked energy. She though plaintiff had had a slight stroke. On December 21, 1976, plaintiff went to a regional sales meeting in Chicago at which he was offered the position of national sales manager for R & M Kaufman. Ed Tannebaum testified that plaintiff appeared very sluggish and was walking like an old man. Donald Smith, a regional sales manager with R & M Kaufman who has known plaintiff since 1959, noticed that plaintiff walked slowly and had trouble keeping up with people. He testified that plaintiff complained that his legs did not feel good and that he was having cramps in his legs. During late December and early January, plaintiff’s condition worsened. He had increased difficulty walking. Several friends noted that plaintiff acted strangely at parties. For instance, Rita Gershon, a close personal friend of the Mankos, testified that she observed plaintiff at a New Year's Eve party at the Oakwood Country Club. She testified that plaintiff, who normally danced at such parties, would not dance because he said that his legs were bothering him. At a party on the following day, plaintiff sat apart from his friends. He got out of the chair “like an old man” pushing himself out of the chair with his arms. He was unsteady on his feet. Maxine Mooney also saw plaintiff at the New Year’s Eve party at the Oakwood Country Club. Plaintiff was unusually quiet and did not dance. Helen Rae Cerier, plaintiff’s sister-in-law, saw plaintiff around December 23, 1976. She observed plaintiff use his arms to push himself out of a chair and walk very slowly with an old man’s shuffle. Between approximately January 4, and January 9, 1977, plaintiff had a flu-like illness. On January 11, 1977, plaintiff flew to Chicago, Illinois, to commence work as national sales manager. His wife accompanied him because she was concerned about his health. On January 12, 1977, plaintiff drove to R & M Kaufman’s office in Aurora, Illinois. He did not feel well but worked all day in his new job as national sales manager. Plaintiff drove back to the hotel in Chicago, Illinois. Plaintiff’s difficulty in walking had increased; he had to stop and rest during the three block walk between his hotel and the parking garage. When he got to the hotel, he had to pull himself up the stairs of the hotel by grabbing the handrail. When he reached his apartment, he began to cry because he was so weak and ill. On Thursday, January 13, 1977, plaintiff got up and drove to work. During the day he suffered leg cramps in his legs. After working all day, plaintiff drove back to the apartment in Chicago. In the evening, plaintiff fell several times while walking three blocks from the parking garage to the hotel. The Mankos decided to return to Kansas City on Saturday so plaintiff could see his regular physician. On January 14, 1977, plaintiff went to work. At 10:00 a.m. he got up from his desk to go to a meeting and could not walk. He could move only by shuffling his feet. Plaintiff became very frightened at his increasing weakness and immediately made arrangements to return to Kansas City to see his regular physician. Plaintiff drove back to his apartment and parked his car directly in front of the hotel. Again, plaintiff had to pull himself up the stairs into the hotel lobby. Plaintiff could not lift his suitcase. Plaintiff drove to the airport and as he got out of the rental car, he fell because his legs buckled. He fell again getting into the bus. He required assistance getting up the bus steps. The bus driver had to assist plaintiff off the bus when it arrived at the airport. Plaintiff’s wife helped him into the airplane. While waiting for his luggage in the Kansas City airport, plaintiff collapsed again. Two strangers picked him up, drove the Mankos home in their limousine and carried plaintiff into his house. As plaintiff attempted to get out of the limousine, he fell and cut his leg. Early the following morning, plaintiff got out of bed, completely collapsed and was unable to push himself up with his arms or legs. He became hysterical and had to crawl into the bathroom. Plaintiff's wife called plaintiffs doctor and was told to transport plaintiff by ambulance to Menorah Medical Center. When plaintiff was admitted to the hospital, he could not move his arms or legs. Dr. Gustave Eisemann, the member of the Statland Clinic on call on January 15, 1977, was plaintiff’s admitting physician in the emergency room at Menorah Medical Center. Dr. Eisemann spent approximately ten minutes taking the following medical history from plaintiff and his wife: The patient was apparently in good health until Thursday except for a mild upper respiratory illness. Thursday evening he noticed some weakness and fatigue and felt that this was possibly associated with a prolonged drive from Aurora, Illinois to Chicago where he has an apartment and also as a result of tension and anxieties of the last few weeks. Yesterday morning the patient had more weakness, feeling of numbness and tingling sensation in his lower extremities. He was able to complete his work in Chicago yesterday, however, when he arrived at the airport in Kansas City he was unable to lift his baggage because of marked weakness. He was unable to walk without assistance because of the persistent weakness. He continued to have progressive muscular weakness during the evening when trying to get out of bed at night to urinate and had to crawl to the bathroom. This morning he was unable to sit up or to walk and because of this he was brought to the hospital by ambulance. No history of chills or fever. No history of other underlying illness recently. The patient had a Swine flu shot in this office on 10-20-76 without complication. He was scheduled to have a regular check-up in the office in a couple of days. He has had no unusual illnesses in the recent past. Defendant’s Exhibit 59, p. 5. Dr. Mario Kafeng Sia Yu, a neurologist, was called in by Dr. Eisemann to verify the diagnosis of GBS. On January 15, 1977, Dr. Yu did a complete neurological examination. The history recorded by Dr. Yu states: The patient had a bad flu on January 4, 1977, with fever, chills and diarrhea. This lasted about one week. Four days ago he went back to work and had to travel a lot. Two days ago he developed cramping of the right lower extremity that he has had in the past. Yesterday morning, his lower extremities became progressively weaker to the point of having to drag his legs when walking. By yesterday afternoon his upper extremities became weak and he could not carry the luggage. Last night he fell to the ground because his legs buckled on him. Last night he had crawled to the bathroom. He felt his weakness is worse today compared to last night. He denies difficulty in breathing or swallowing. There is no paresthesia. There is no bladder or bowel dysfunction. He had no recent vaccination although he had a swine flu shot in October of 1976. Defendant’s Exhibit 59, p. 7. Dr. Elliott Frank, the resident physician on duty at Menorah Hospital on January 15, 1977, recorded the following history: [Year old white male] last 2 days has noted increasing weakness of arms and legs. So bad today he had to crawl to bathroom. Has had minor pain [left] leg 2-3 days ago, but not now. [Patient] had swine flu shot 6 weeks ago. Had GI [gastrointestinal] flu w/nausea, vomiting, diarrhea, temperature two weeks ago. Has been commuting from here to Chicago in a new job. Physical examination: alert, oriented, NAD [not acute distress] Defendant’s Exhibit 59, p. 17. Defendant argues that the testimony of plaintiff, his family, friends and business associates about their observations of plaintiff in November, December and early January is not credible and should be rejected because plaintiff did not tell the doctors on January 15, 1977, about the problems he had been having since early November. When these medical histories were taken and recorded, the doctors’ primary concern was to make an immediate diagnosis and to initiate the appropriate treatment. The doctors were not interested in investigating past events beyond what was necessary to make the proper diagnosis. Dr. Eisemann testified that he focused primarily on the twenty-four to forty-eight hours immediately preceding admission because this period was most important in making the diagnosis. When he ascertained that the severe symptoms had developed rapidly, it was not. necessary to inquire carefully about plaintiff’s physical condition in November-December, 1976. Although the doctors probably did ask plaintiff how long he had been experiencing problems with his legs, his failure to respond to such a question with a recitation of the problems he had been having since November 1976, is understandable. At the time plaintiff was admitted to the emergency room, he was almost completely paralyzed. Undoubtedly, when asked when his symptoms began, plaintiff focused on the rapidly progressing and severe symptoms he had experienced in the past two days. Plaintiff’s inclination to focus on the immediate past was encouraged by the doctors’ interest in the immediate past. Recollection of the problems plaintiff had been having since November 1976, and realization of their possible significance would come only after the crisis had passed. Defendant also argues that the testimony of plaintiff’s witnesses should be rejected as incredible because plaintiff failed to consult his physician about these symptoms from November to early January. Defendant asserts that an analysis of plaintiff’s past medical history shows plaintiff did not hesitate to bring minor physical ailments to the attention of his physician. Defendant prepared a chart purporting to demonstrate that plaintiff consulted his physician ninety-two times in twenty years, or approximately four times per year. Plaintiff’s Exhibit 92. Plaintiff’s medical history does not suggest that he was a chronic complainer or that he regularly called his doctor for minor complaints. To the extent the medical records show minor complaints, most of them were made when plaintiff was in the doctor’s office for some other purpose. During this twenty year period, plaintiff had conditions that required him to see his physician frequently and regularly. For instance, there was a period of time during which plaintiff saw his physician regularly to check high blood pressure. Also, plaintiff had regular physicals. Further, plaintiff, his wife and others who knew him well testified that he did not go to the doctor easily. For instance, his wife frequently had to call the doctor for plaintiff because he would not. Plaintiff’s conduct around the time he was admitted to the hospital is consistent with this testimony. As plaintiff’s symptoms worsened in Chicago, he did not call a doctor either in Chicago or Kansas City even though his Kansas City doctor was a personal friend. Plaintiff continued to work until his condition became so debilitating that he had to return to Kansas City. Even after returning to Kansas City, neither plaintiff nor his wife called his doctor until he completely collapsed early in the morning on January 15, 1977. Therefore, based on the credible testimony of plaintiff, plaintiff’s family, friends and co-workers, plaintiff began having neurological symptoms in early November. Neurological symptoms continued until early January 1977 when they suddenly accelerated in severity. These gradually worsening neurological impairments were symptoms of smoldering GBS. The acute phase was triggered by the flu plaintiff suffered in early January 1977. Defendant’s neurologists offered no credible explanation other than GBS for the neurological symptoms plaintiff suffered in November 1976 through December 1976. For instance, Dr. Victor testified that plaintiff’s symptoms were signs of depression not GBS. On the other hand, Dr. Amason had no explanation for plaintiff’s symptoms but concluded that the symptoms were not symptoms of depression. Defendant concedes that if the onset of plaintiff’s GBS was approximately three weeks after the swine flu vaccination, there was a causal relationship between the vaccination and the GBS. Therefore, plaintiff has established that his GBS was caused by the swine flu vaccination he received in October, 1976. E. Even if the Onset of Plaintiffs GBS Was in Early January, 1977, the Swine Flu Vaccination Caused Plaintiffs GBS. Plaintiff’s second causation theory is based on an epidemiological analysis to determine the effect of swine flu vaccinations on the rate of incidence of GBS. Plaintiff argues that a proper analysis of the epidemiological data demonstrates that the swine flu vaccinations caused a statistically significant enhanced risk of contracting GBS for a period extending beyond thirteen weeks after vaccination. (Plaintiff received a swine flu vaccination on October 20, 1976, and entered the hospital on January 15, 1977, some 13 weeks later.) Defendant argues that a swine flu vaccination only increased the relative risk of contracting GBS to a statistically significant level for six weeks after the vaccination. Epidemiology is the study of the available data to determine whether a causal relationship exists between an event and the outbreak of a disease. The first step in analyzing whether there is a causal relationship between an event and the outbreak of a disease is to determine whether the causal relationship is biologically possible. Both plaintiffs experts and defendant’s experts agree that it is biologically possible for the swine flu vaccination to cause GBS. Because a causal relationship between the swine flu vaccination and GBS is biologically possible, the next inquiry is whether there is a statistically significant association between the vaccination and the outbreak of the disease. This association is determined by a mathematical computation that produces a ratio for the relative risk of contracting the disease. The relative risk ratio is computed by dividing the observed number of cases of a particular disease for a particular time period (numerator data) by the expected number of cases of that disease for the same time period based on historical information not influenced by the event in question (denominator data). A relative risk of “1” is the expected rate of contracting a disease in a population not influenced by the event under investigation. A relative risk of “2” means that the disease occurs among the population subject to the event under investigation twice as frequently as the disease occurs among the population not subject to the event under investigation. Phrased another way, a relative risk of “2” means that, on the average, there is a fifty percent likelihood that a particular case of the disease was caused by the event under investigation and a fifty percent likelihood that the disease was caused by chance alone. A relative risk greater than “2” means that the disease more likely than not was caused by the event. In the context of this case, the epidemiologists testifying for both plaintiff and defendant agree that if the relative risk of contracting GBS among the population receiving the swine flu immunization exceeds “2”, it is more likely than not that the swine flu immunization caused the GBS. 1. The Cohort Analysis is the Appropriate Means to Evaluate the Relationship Between the Swine Flu Vaccine and the Incidence of GBS The parties disagree about the best approach to analyze whether receiving a swine flu vaccination significantly enhanced the relative risk of contracting GBS. Defendant’s epidemiologists analyzed the cumulative data for all GBS cases among the immunized population without regard to the date of vaccination. This analysis resulted in a log normal distribution showing a rapidly increasing rate of incidence among the immunized population peaking in the second or third week after receipt of the swine flu vaccination. Thereafter, the rate of incidence dropped until the sixth week when the rate of incidence of GBS reached a plateau consistent with the rate of incidence of GBS among the unimmunized population. The Langmuir panel report (Defendant’s Exhibit 26) relied on by the United States, assumed there was no significant decline in reporting cases of GBS after December 18, 1976 (the date the swine flu vaccination program was halted). Plaintiffs epidemiologist and statistician primarily relied on the Mantel/Haenszel procedure (cohort analysis), the recognized and accepted method of statistical analysis for determining relative risk in stratified populations. A stratified population is any population in which an independent factor, such as age, distinguishes two otherwise comparable populations. The available data is stratified or broken into sub-groups or cohorts, and the relative risk for each cohort is analyzed independently. The relative risk for each group is then combined to arrive at a cumulative relative risk. Defendant’s epidemiologists concede that the cohort analysis and not the analytical approach followed by the Langmuir panel should be used if there was a significant drop in reporting GBS after December 18, 1976. Because the Court is convinced that there was a substantial drop in reporting after December 18, 1976, the cohort analysis is the most appropriate method for analyzing relative risk. See Plaintiff’s Exhibit 183, Tables 20, 8, 9; Plaintiff’s Exhibit 285, Tables 6, 7; Schoenberger report, Defendant’s Exhibit 38, p. 109. 2. Application of the Cohort Analysis to the Available Epidemiological Data To apply the cohort analysis to this case, the vacinees are separated into cohorts based on the calendar week of vaccination. The relative risk of getting GBS for each weekly cohort is then computed for any given incubation period. The relative risk of contracting GBS for each incubation period is then taken from each cohort and accumulated to arrive at a cumulative relative risk for any given incubation period. To determine the relative risk of getting GBS 13 weeks after receiving a swine flu vaccination, the first step is to determine the observed number of GBS cases with onset of GBS occurring 11-16 weeks after the receipt of the swine flu vaccination (long onset cases). The parties disagree about the number of long onset GBS cases that occurred between October 1, 1976, and January 31, 1977. The Court is not persuaded by the panel’s approach to determining the number of long onset cases. The Justice Department restricted the panel to single sheet computer printouts containing information about GBS cases reported by state health departments. In addition, the panel had a computer listing of 1,098 GBS cases with onset between October 1, 1976, and January 31, 1977. The Justice Department did not permit the panel to verify records, check apparent inconsistencies or investigate apparent typographical errors. As a result, the panel excluded 121 cases. See Langmuir panel report, Defendant’s Exhibit 26, Table 1, p. 41; Nathanson’s report, Defendant’s Exhibit 36, Table 1; Defendant’s Exhibit 191. Defendant’s experts conceded that the restrictions placed on the panel by the Justice Department were contrary to their best judgment as epidemiologists. In addition, the panel excluded 122 cases (Category E) (including a significant number of long onset cases) because the recorded data was insufficient to classify by extent of paralysis. See Langmuir panel report, Defendant’s Exhibit 26, Table 2, p. 42; Nathanson’s report, Defendant’s Exhibit 36, Table 2; Defendant’s Exhibit 192. Furthermore, the panel’s method of classifying GBS cases by severity and excluding from consideration milder cases of GBS artifically reduced the relative risk for long onset cases. See Langmuir panel report, Defendant’s Exhibit 26, Table 6, p. 46; Defendant’s Exhibit 196. Plaintiff’s epidemiologist relied on a more complete data base. Consequently, he identified 31 cases of long onset GBS that were ignored by defendant’s experts. Defendant’s Exhibit 180. During cross-examination, Dr. Goldfield conceded that Case No. 1212 and Case No. 2237 are the same case and only one of them should be included as a long onset case. Tr. 8-67. Also, Case No. 2465 must be dropped because it was Manko’s case. Although the United States challenges other cases in this group, the Court is convinced that these 29 cases were cases of GBS with onset occurring 11-16 weeks after immunization. The total expected number of GBS cases occurring among the immunized population 11-16 weeks after vaccination, assuming no enhanced risk from the immunization, is 7.449 (the denominator component of the relative risk computation). See Plaintiff’s Exhibit 285, Table 4. Therefore, the relative risk of contracting GBS 11-16 weeks after vaccination is 3.89. Because a viral illness can cause GBS and because plaintiff had a viral illness in early January 1977, this relative risk must be adjusted to accommodate the possibility that plaintiff’s antecedent illness caused his GBS. Based on the mathematical computations of plaintiff’s experts Dr. Goldfield and Dr. Mantel, assuming plaintiff had a viral illness in January 1977, the relative risk of contracting GBS 11-16 weeks after vaccination is 3.396. See Plaintiff’s Exhibit 332. Because the relative risk of contracting GBS during the period 11-16 weeks after vaccination is greater than 2, it is more likely than not that plaintiff’s swine flu vaccination caused his GBS. F. Facts Resulting from Imposition of Discovery Sanctions Establish Beyond Dispute a Causal Connection Between Plaintiff’s Vaccination and His GBS Based on evidence presented in this case and on defendant’s conduct throughout this case, the Court has con-eluded that the defendant’s litigation posture has prevented a complete and thorough scientific analysis of why the swine flu immunization program caused an epidemic of GBS. For instance, one of defendant’s epidemiologists, Dr. Kurland, agreed there is a cloud hanging over any future large scale immunization program as a result of the government’s failure to evaluate the swine flu immunization program accurately. Consequently, many people will die who would have been saved by some of the remarkably effective vaccines available today. Tr. 16-207 to 16-209. Defendant’s attitude was graphically demonstrated by its refusal to comply with discovery orders intended to make available to plaintiff’s experts crucial medical information. Specifically, the defendant refused to comply with the Court’s Order to produce administrative claim forms with accompanying medical information filed under the Swine Flu Act. The medical information filed with the claim forms could provide valuable information about whether the claimants actually had GBS and, if so, when the GBS began in relation to the date of vaccination. Rather than comply with the production order, the United States requested that the Court impose sanctions on it. Therefore, on November 29, 1983, the Court entered its Order granting defendant’s request to impose sanctions. The following sanctions were imposed: [T]he defendant is precluded from contesting that if the administrative claim forms designated by plaintiff had been produced as ordered on July 8, 1983, and November 18, 1983, the following information would have been reflected therein: 1) Any claimant who alleged that he or she developed GBS peripheral neuropathy, polyneuropathy, polyneuritis, Landry Strohl Guillain-Barre Syndrome polyradiculoneuropathy, paralysis of more than one limb, weakness of more than one limb, and any claimant whose injury is not indicated on the administrative claim form, in fact, had GBS. 2) A claimant’s statement on the administrative claim form produced for plaintiff that he or she was immunized with the Swine Flu vaccine will be presumed correct. 3) Any claimant who denies having been immunized on the claim form produced for plaintiff’s inspection or who states facts on the claim form produced indicating that the claimant was not immunized, in fact, was not immunized. However, if the information on the claim form produced for plaintiff is unclear or nonexistent, such a claimant will be assumed to have stated that he or she was immunized. 4) A claimant’s statement that he or she was immunized on a certain date will be presumed correct. If no date is set forth then defendant agrees not to contest a date of immunization which is consistent with other relevant factual information stated on the copy of the claim furnished to plaintiff. If no information is furnished on the claim form from which to make a reasonable inference of the immunization date, then defendant is precluded from contesting the immunization date assigned by plaintiff. 5) A claimant’s statement on the administrative claim form produced for plaintiff’s inspection that his or her GBS had its onset on a certain date will be presumed correct. If no onset date is indicated on a claim form then defendant will not contest a date of onset which is consistent with any other relevant factual information stated on the copy of the claim furnished to plaintiff. If no information is furnished on the claim form from which to make a reasonable inference about the onset date, then defendant is precluded from contesting the onset date assigned by plaintiff. As a result of these sanctions, both plaintiff and defendant agree that a sufficient number of long onset cases are identified to cause the relative risk of contracting GBS thirteen weeks after receiving a swine flu vaccination to far exceed 2. Therefore, plaintiff’s GBS contracted in January 1977, was caused by the October 1976, swine flu vaccination. III. DAMAGES Missouri law governs the determination of damages recoverable under the Federal Tort Claims Act because plaintiff received his swine flu vaccination in Missouri. Overton v. United States, 619 F.2d 1299, 1305 n. 5 (8th Cir.1980); Pretre v. United States, 531 F.Supp. 931, 934 (E.D.Mo.1981). Under Missouri law plaintiff should be awarded an amount of money that will reasonably compensate him for his injuries. Rickard v. Pratt, 459 S.W.2d 13, 16 (Mo.App.1970). Plaintiff's age, the nature and extent of the injuries and losses, diminished working and earnings capacity, changing economic factors, the degree of injury or disability, the amount of pain and suffering, plaintiff’s educational level and awards in cases involving similar injuries should be considered in determining plaintiff’s damages. Koehler v. Burlington Northern, Inc., 573 S.W.2d 938, 945 (Mo.App.1978). A. Pain and Suffering An element of plaintiff’s damages is the pain, suffering and misery plaintiff has endured and is likely to endure in the future as a direct result of his GBS. Mullendore v. Gentry, 377 S.W.2d 494, 497-98 (Mo.App.1964). When plaintiff was hospitalized at Menorah Medical Center on January 15, 1977, both of his legs and his left arm were paralyzed. By the third day of hospitalization, plaintiff was totally paralyzed except he could move his head from side to side approximately two inches. For approximately four weeks plaintiff suffered from severe paralysis. During this period of time, plaintiff had intermittent headaches, severe cramps in his legs and soreness in his shoulders due to the rapid deterioration of his muscles. Plaintiff’s treatment during this period consisted of constant monitoring and painful passive therapy during which a physical therapist moved his limbs for him to prevent further deterioration. In addition, plaintiff endured painful medical procedures such as spinal taps. By the end of January, 1977, plaintiff was able to sit up in bed for twelve minutes with the assistance of two people. On February 9, 1977, plaintiff got out of bed for the first time when he was taken to the physical therapy department on a hospital cart. By February 15,1977, plaintiff could sit in a wheelchair for an hour. On February 21, 1977, plaintiff could roll from side to side in his bed with assistance. On March 11, 1985, plaintiff could move the toes of his left foot. On March 23, 1985, plaintiff stood between two parallel bars and took three steps with the assistance of three people. On April 4, 1977, plaintiff walked 250 feet between parallel bars with the assistance of two persons. On April 11, 1977, plaintiff walked 300 feet between parallel bars with the assistance of two persons. On April 18, 1977, plaintiff walked 350 feet between parallel bars with the assistance of two persons. On April 25,1985, plaintiff stood from a sitting position with the assistance of two people. On April 26, 1977, plaintiff sat up from a lying position with the assistance of two persons. On May 3,1977, plaintiff walked on crutches 230 feet with the assistance of two persons. On May 9,1977, plaintiff walked 400 feet on crutches with the assistance of two people. On May 16, 1977, plaintiff raised himself to a sitting position from a side lying position without assistance and walked on crutches with the assistance of only one person. On June 9,1977, plaintiff crawled eight to ten feet without assistance. On June 14, 1977, plaintiff stepped up a single step with the assistance of a therapist and parallel bars. On June 17, 1977, plaintiff was discharged from the hospital. Physical pain and discomfort were present throughout plaintiff’s five months in the hospital. In addition, he endured emotional pain and suffering including fear that he would not survive the illness, that he would be permanently paralyzed or crippled, that he would always be dependent on others for his basic daily needs, and that he would be unable to return to his job. Plaintiff often cried at night because he was frustrated, dependent and depressed. When plaintiff was dismissed from the hospital on June 17, 1977, he could climb a step with the assistance of two people, crawl 45 feet although he needed assistance to raise his hips to a crawling position, slide from a wheelchair to a commode, and walk with crutches on a carpeted surface with the assistance of one person. Plaintiff needed assistance to shave, use the bathroom, feed himself, get out of bed and dress himself. After plaintiff arrived home and realized that he would no longer have the constant care he was used to, he became hysterical and wanted to return to the hospital. Although plaintiff adjusted quickly to being at home, the first six months at home were physically and emotionally draining. Plaintiff could only move around in a wheelchair or a commode chair. He had to be pulled or lifted from his bed to the chair. He was unable to dress unless someone put his pants on, buttoned his shirt, tied his ties and put on his socks and shoes. Plaintiff constantly dropped things because of the weakness and tremors in his hands. In order to bathe, someone had to pull plaintiff across a slide board from his wheelchair to a high shower stool. Then plaintiff needed assistance in washing himself. During this period of time, an attendant spent five to six hours a day assisting plaintiff. The rest of the time, plaintiff was assisted by his wife, his stepson and occasionally by a maid. On June 20, 1977, plaintiff began physical therapy on an out-patient basis at Menorah Medical Center. When plaintiff began physical therapy as an out-patient, he had poor to fair muscle strength in his lower extremities, required maximum assistance to come to a standing position and could get in and out of a chair with assistance and a sliding board. According to the director of the rehabilitation institute, plaintiff always pushed himself resulting in many falls. As plaintiffs physical condition gradually improved, he began walking with crutches and with the help of an attendant. The attendant walked behind plaintiff holding onto a belt strapped around plaintiffs waist. Nevertheless, plaintiff fell many times. In January, 1978, plaintiff went to Palm Springs for three months. Plaintiff continued physical therapy at Eisenhower Medical Center. Plaintiff still used the wheelchair but he practiced walking with crutches. Plaintiff continued to fall frequently. Substantial improvement occurred during that winter in Palm Springs. For instance, by the time he left Palm Springs, he could dress himself except for his shoes and socks and he no longer used the wheelchair. In July, 1978, plaintiff had to use the arms of a chair to lift himself; he could walk up and down three steps using one cane and the railing and he could walk with two canes for limited distances. When plaintiff walked, his knees would snap back because of weakness in the knee muscle. By the end of July, plaintiff could lift twenty pounds. By the end of August, plaintiff could walk up and down ten stair steps and he could tolerate the exercise session with rest periods in between the various exercises. By September, plaintiff could stand without assistance if there was no external force such as the jostling of a crowd. However, plaintiff had footdrop and a step-page gait due to weak muscles in his ankles causing him to lift his foot up high for each step so his foot could clear the floor. By December, 1978, plaintiffs standing balance had improved but he still could not maintain his balance if jostled by someone in a crowd. Plaintiff was discharged from outpatient physical therapy in January, 1979. At that time plaintiff needed two canes to walk; his knees still snapped back when he walked; and he could only walk up and down ten stair steps. In January, 1979, plaintiff returned to Palm Springs. By this time he could get in and out of chairs and completely dress himself. However, he continued to need a cane to walk. Physical therapy continued at the Eisenhower Institute. After plaintiffs return to Kansas City, physical therapy resumed at the Menorah Rehabilitation Institute. Plaintiff still had footdrop, slapfoot gait and balance problems. His endurance had improved so that he could complete the therapy session without rest periods between each exercise. Plaintiff gradually improved until he was released in January, 1980. If plaintiff missed a therapy session his strength and endurance decreased. During the period from June 1977, to early 1980, plaintiff suffered continuous pain particularly when he exercised and during the physical therapy sessions. As a result of plaintiffs neurological impairments, he will always have pain and cramping in his legs. Plaintiffs impaired sensation causes his legs to tingle and burn constantly similar to the sensation one feels when a foot starts to come back after it has fallen asleep. Furthermore, plaintiff suffered and continues to suffer emotional distress as a result of his condition. Plaintiff has had to adjust to the reality that he would not be able to do many of the things he enjoyed doing before he had GBS. For instance, plaintiff started playing golf when he was nine years old and was an avid golfer in 1976. In 1981, plaintiff attempted to play golf with his wife holding him for balance. However, he fell every time he swung the club. Plaintiff now plays a limited golf game with assistance. When plaintiff and his wife go to social events, they usually must return early because he gets tired. He avoids crowded places, e.g., restaurants, sporting events, and the theatre because he has been jostled and knocked down on numerous occasions. Plaintiff can no longer dance. The onset of plaintiffs GBS occurred over nine years ago and plaintiffs life expectancy is nine years from his present age. The Court finds that the sum of $250,000 is an appropriate amount to compensate plaintiff for living eighteen years with the pain and suffering, mental anguish and loss of enjoyment of life directly caused by the GBS. B. Permanent Disability The nature, character and extent of the effects of GBS on plaintiff is an element of damage independent of pain and suffering. Slusher v. United Electric Coal Companies, 456 S.W.2d 339, 341 (Mo.1970). Plaintiff has a residual neurological deficit as a direct result of his GBS. As a result, plaintiffs gait is obviously impaired requiring the use of a cane. Plaintiffs awkardness is caused by the lack of muscle power in his legs and by the impaired sensation in his feet and ankles. Plaintiff cannot stand on his toes, stand on his heels, tap his feet or arise from a squat position without using his hands for balance. Plaintiff must use his arms to push himself out of a chair. Plaintiffs ankles are frequently swollen. Plaintiff has no deep tendon reflex in the lower extremities. As a result of these physical limitations, plaintiff must sit on a shower stool to bathe because he could slip and fall if he attempted to take a shower while standing. He can only walk for a block before his legs start cramping. Occasionally painful leg cramps keep him awake at night. He must use one cane when he walks. He must use his cane and the guardrail to climb stairs. Plaintiff