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Andrew Varga sues the United States of America for damages by reason of a swine flu immunization he received on October 31, Plaintiff Varga claims that the swine flu immunization caused him to contract Guillain-Barre syndrome on February Plaintiff Varga's case is one of the personal injury and wrongful death actions with a genesis in the National Influenza Immunization Program of Andrew Varga and presumably all of the swine flu vaccine product liability claimants rely on 42 U. This subsection provides that the United States shall be liable with respect to claims submitted after September 30.
Plaintiff states and defendant United States of America admits that he filed an administrative claim with the U. The government denied the claim on January 31, Pursuant to 28 U. In its trial brief the defendant United States of America hereafter United States, government, or defendant states:. Plaintiff agrees that in this bifurcated trial, the Goldfield IA sex dating liability issue is whether the swine flu inoculation vaccination Andrew Varga received on October 31, caused him to contract Guillain-Barre syndrome on or about February 16 or 17, He testified that the first illness he experienced after receiving the swine flu shot occurred on about December 15, He said the only way that he could describe it was that it was a cold accompanied by a severe cough.
He said he had "pains in both legs of unknown origin. He did not have a fever. Another cold started a week before February 16, as he put it. At the beginning there was a severe cough, a slight fever, and congestion in his chest that continued through the weekend. He was in bed from Friday evening until Monday morning. Although he felt better on Tuesday, on Wednesday, February 16, he felt a slight tingling in the tips of his toes. Between February 16 and February 28 the tingling, combined with numbness, traveled upward bilaterally.
By February 23 he could not get out of bed. He could not close his right eye. His speech was slurred.
He could not eat or drink. His doctor, who had earlier prescribed vitamins, made a house call and prescribed cortisone. With his legs completely paralyzed, he consulted a second doctor. After examination the doctor arranged for the immediate transfer of Mr. Varga to Lutheran Medical Center. He remained there until March 16 when he was transferred to Highland View Hospital for rehabilitation. At Lutheran Medical Center, Dr. Nakhle called in Dr. Charles C.
Brausch, M. Their t diagnosis was that Mr. Varga was suffering from Guillain-Barre syndrome. A lumbar puncture showed elevated protein of milligrams in his spinal fluid. Areflexia loss of tendon reflexes was also observed. The facial palsy was still present on March 11 according to the doctor's notes. At Highland View Hospital the diagnosis was Guillain-Barre syndrome with residual right central facial weakness and loss of power on the right side. Some of his reflexes were still decreased.
Subsidiary conditions were gout, uremia, and hypertension. He was discharged from Highland View Hospital on May 27, Plaintiff and the United States have stipulated as "true and not at issue" that the United States' investigation of GBS cases among swine flu vaccinees began at least as early as December 2, On or about December 6,New Jersey began an investigation after receiving a report of a single case of GBS in a vaccinated individual.
It stated that fifty-four cases in ten states had thus far been reported. Of these fifty-four, thirty had received the inoculation anywhere from one to thirty days before the onset of Goldfield IA sex dating symptoms. After additional data from four states was reviewed, a conference call was held on December 16, CDC Goldfield IA sex dating and outside experts participated. It was unanimously agreed that a moratorium on the administration of the swine influenza vaccine should be declared for about one month so that additional data could be obtained and evaluated.
A moratorium on the swine flu program was called on December 16, It is further stipulated that "the decision to stop the program in December was based on the finding of Guillain-Barre syndrome associated with the swine flu vaccination. Martin Goldfield, who testified for the plaintiff, and Dr.
Alexander Langmuir, who testified for the United States, are medical doctors whose specialty is epidemiology. Goldfield, in a letter of July 2, to counsel for plaintiff Varga, Scott E. Stewart, Esq. Among other things, he noticed a change in the s of GBS cases "between preparation of Langmuir's and of Schonberger's papers. Later in the letter he listed 24 pieces of information concerning the line listing of vaccinated GBS cases that counsel requested.
Goldfield's inquiries, brought to the attention of Judge Gerhard Gesell by plaintiff's counsel, led to the judge reopening discovery in the multi-district litigation. Pursuant to the reopening order, three of documents were produced by the CDC and made available to each party. In transmitting the documents on November 20, to counsel for the plaintiff, counsel for the Department of Justice first identified "a one- table of the denominator data taken from the Schonberger study.
Goldfield, supra. This one- table contains two columns of s under the date of October 3  and a single column of s under the dates October 10 through December Each horizontal row of s vaccination totals is identified by a code and an abbreviation for each of the 50 states and the District of Columbia. This printout contains a line listing for each of the 1, GBS cases reviewed in the Schonberger study, supra at 9. The line listings provide information under column abbreviations.
Left to right, these columns provide: the GBS caseidentificationstate, age, sex, onset date, immunization status, vaccination date, and whether or not diagnosed by a neurologist or whether the origin of diagnosis is unknown. The remaining 15 columns characterize the illness e. Finally, the parties received pursuant to Judge Gesell's rediscovery order approximately 1, computer printout sheets.
Each included the illness information just described and additional data, e. While these back-up records include the 1, cases analyzed in the Schonberger study, these records also include military GBS cases and GBS cases occurring prior to October 1, Some printouts are duplicates, contributing to the excess of over 1, case printouts. The rediscovery material was turned over to Dr. Martin Goldfield. It forms the basis of his calculations, tables and testimony.
The Department of Justice in the fall of assembled a panel to examine and evaluate the rediscovery material. The panel includes Dr. Langmuir as coordinator, Dr. Leonard T. Langmuir's opinions and conclusions grow out of his examination of the rediscovery material in serving as coordinator of the panel. Goldfield prepared a of tables 1 through 4 and 6 through 12all of which utilized This was reported by Dr. These tables, table 5 all hereafter referred to as Dr. Goldfield's original tables and tables were received in evidence as plaintiff's exhibit No. Post-trial, Dr. Goldfield submitted, and the court received in evidence as plaintiff's exhibit No.
Goldfield's revised tables.
The revised tables have the same components as the original tables, except they represent new calculations based on CDC's estimate of Goldfield also prepared other tables which relate to tables and graphs prepared by Dr. Langmuir, and these are also considered. Goldfield agrees that table 12 of his set of tables is at the "heart of his analysis" of this case. The first column of the table identifies weeks after immunization with a separate line listing for weeks 1 through 5. Thereafter appear weeks, and The relative risks observed of GBS cases divided by expected of GBS cases  shown in columns 1 and 4 are juxtaposed below:.
In contrast, epidemiologist Alexander Langmuir, M. Langmuir explained that the panel has met four times. It has not yet issued a final report. The conclusions and opinions which he expresses are his own and the tables and graphic figures offered by the government and received in evidence are prepared by him. In the continuation of part I, the focus is on epidemiological evidence. Part II first dwells on the neurological evidence, especially the testimony of the neurologists, and then reviews the impact of the immunological evidence in this case. In part III, the court reaches its final conclusion.
In reaching his conclusion that there is a relative risk of 3. Goldfield principally relies on his revised tables and table 1. In revised table 6, Dr. He obtains this percentage drop by first comparing his calculated GBS rate for each of weeks two Goldfield IA sex dating nine after December 18 with his calculated GBS rate for weeks two through nine before December In original table 1, Dr. Goldfield computed the attack rate among the unimmunized population for October 1 December 18 as. He computed the rate for the period of December 18 January 29 as.
Goldfield declared that even prior to December 18, the GBS cases among the unimmunized population which were reported produced an "observed rate," but "not necessarily the true rate.
Goldfield agreed with defendant counsel's statement that if ". Asked if his computed relative risk hinged upon the "observed rate figure as calculated by you of. Goldfield answered:. However, concerning these rates, he stated that "there is no way to prove whether they represent the true rate [of occurrence of Guillain-Barre Syndrome] and they probably are underestimates.
They are reported rates. Short of a d nationwide surveillance of GBS cases among the unimmunized population that is shown to be exhaustive, there is probably no way to ascertain a true national rate of incidence of GBS among the unimmunized population.Goldfield IA sex dating
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