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GRIFFIN v. UNITED STATES

November 7, 1972

Richard J. GRIFFIN and Mary Jane Griffin, His Wife
v.
UNITED STATES of America


Newcomer, District Judge.


The opinion of the court was delivered by: NEWCOMER

NEWCOMER, District Judge.

 On October 27, 1963, plaintiff, Mary Jane Griffin, participated in a mass campaign to eradicate the dreaded disease of poliomyelitis sponsored by the Montgomery County Medical Society, by swallowing a dose of Sabin live virus oral polio vaccine. Just over a month later, Mary Jane Griffin lay near death in a coma at Lankenau Hospital in Philadelphia. She emerged from that coma a permanent quadriplegic. In this suit, it is urged that the United States is liable to Mrs. Griffin and her husband, Richard Griffin, for her tragic condition under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671 et seq.

 This action was commenced on October 26, 1965. It was tried to the Court without jury from July 10 to July 27, 1972. In accordance with rule 52(a) of the Federal Rules of Civil Procedure, this Court makes the following findings of fact and conclusions of law:

 FINDINGS OF FACT -- LIABILITY

 1. Plaintiffs, Mary Jane Griffin and her husband, Richard J. Griffin, are both citizens of the Commonwealth of Pennsylvania.

 2. At all times pertinent to this action, both plaintiffs have lived together at 317 Conshohocken State Road, Gladwyne, Montgomery County, Pennsylvania.

 3. At the time of trial, plaintiff Mary Jane Griffin was 50 years old.

 4. At the time of trial, plaintiff Richard J. Griffin was 54 years old.

 6. Gladwyne, Pennsylvania is an upper socio-economic suburb of the City of Philadelphia, Pennsylvania.

 7. In the year 1963, Mary Jane Griffin was primarily a housewife taking care of her husband and two children.

 8. In the summer of 1963, Mary Jane Griffin and her two daughters visited with her parents in Longport, New Jersey until after Labor Day when they returned to their home in Gladwyne, Pennsylvania.

 9. In addition to her duties as wife and mother in the year 1963, Mary Jane Griffin was employed by the Atlantic City Race Track of Atlantic City, New Jersey, in a part-time capacity to do public relations work for the Race Track involving the staging of fashion shows on Tuesdays during its summer meeting.

 10. Mrs. Griffin's duties at the Atlantic City Race Track were concluded by the end of September, 1963.

 11. Mrs. Griffin did not leave the Gladwyne area between September 1963 and the onset of her symptoms in November of 1963.

 12. Beginning June 1, 1963, cases of poliomyelitis, Type I, began to appear in certain sections of the City of Chester and the City of Philadelphia.

 13. The Montgomery County Medical Society, spurred by the appearance of these cases, decided to sponsor a mass campaign of immunization against all three known types of polio, using the Sabin live-virus oral polio vaccine.

 14. The campaign was to be conducted, and ultimately was conducted in Montgomery County, Philadelphia County, Delaware County and Bucks County, Pennsylvania, and Camden, New Jersey.

 15. The contract to supply the campaign with live-oral polio vaccine went to Charles Pfizer Company, the American distributor of Sabin live-oral polio vaccine manufactured by Pfizer, Ltd. of Sandwich, England, a subsidiary of the American Corporation. (Both entities are hereinafter referred to simply as "Pfizer").

 16. The contract called for Pfizer to supply the campaign with 500,000 dosages of each of the three types of Sabin vaccine, Type I, Type II and Type III.

 17. Mary Jane Griffin, participating in the mass campaign, took Sabin Type I vaccine at the Gladwyne School on September 22, 1963, along with the other members of her family.

 18. Mary Jane Griffin, participating in the mass campaign, took Sabin Type III vaccine at the Gladwyne School on October 27, 1963, along with the other members of her family.

 19. The vaccine used in the October 27 feeding at Gladwyne School was taken from an undetermined number of doses of Pfizer Lot 71 Type III vaccine and an undetermined number of doses of Pfizer Lot 56 Type III vaccine provided to Montgomery County by Pfizer for use in the campaign.

 20. As a result of taking this vaccine, Mary Jane Griffin developed Type III poliomyelitis, which is responsible for her present paralysis.

 21. Mary Jane Griffin ingested a dose of Pfizer Lot 56 oral polio vaccine.

 22. Pfizer Lot 56 was approved and released for sale and human consumption by the Division of Biologic Standards of the National Institutes of Health, a part of the Department of Health, Education and Welfare, hereinafter referred to as D.B.S., in Bethesda, Maryland by letter of July 9, 1962.

 23. The testing and evaluation which led to the release of Lot 56 was done by D.B.S. in Bethesda, Maryland.

 24. The regulation governing the evaluation of monkey neurovirulence testing at all times pertinent to this action was 42 CFR 73.114(b)(1)(iii) promulgated March 25, 1961, which reads as follows:

 
Determination of neurovirulence.
 
At the conclusion of the observation period comparative histopathological examinations shall be made of the lumbar cord, cervical cord, lower medulla, upper medulla and mesencaphalon of each monkey in the groups injected with virus under test and those injected with the NIH Reference Attenuated poliovirus, except that for animals dying during the test period, these examinations shall be made immediately after death. The animals shall be examined to ascertain whether the distribution and histological nature of the lesions are characteristic of poliovirus infection. A comparative evaluation shall be made of the evidence of neurovirulence of the virus under test and the NIH Reference Attenuated Poliovirus with respect to (a) the number of animals showing lesions characteristic of poliovirus infection, (b) the number of animals showing lesions other than those characteristic of poliovirus infection, (c) the severity of the lesions, (d) the degree of dissemination of the lesions, and (e) the rate of occurrence of paralysis not attributable to the mechanical injury resulting from inoculation trauma. The virus pool under test is satisfactory for poliovirus vaccine manufacture only if at least 80 percent of the animals in each group survive the observation period and if a comparative analysis of the test results demonstrate that the neurovirulence of the test virus pool does not exceed that of the NIH Reference Attenuated Poliovirus." (Emphasis added)

 25. The reference strain for monkey neurovirulence testing was a Type I strain called NA-2.

 26. The reason for monkey neurovirulence testing of a live oral polio vaccine lot was to attempt to insure that the lot was safe to those who ingested vaccine from the lot.

 27. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence tests knew that Sabin Type III vaccine virus was more genetically unstable than NA-2 on in vivo passage and might be genetically unstable on in vitro passage.

 28. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence tests knew that the neurovirulence characteristics of Sabin Type III virus had changed in a way suggestive of possible danger after the removal of Simian virus 40 from the original seed pools, that is, that Sabin Type III then produced more severe lesions in the intrathalamic test.

 29. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence tests had accepted the proposition that the intrathalamic test was the most important and critical test of monkey neurovirulence.

 30. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence tests knew that the test results of the manufacturing laboratories submitting protocols of their own monkey neurovirulence testing were unreliable and could not be given weight in the decision to approve and release a given vaccine lot.

 31. At the time the protocol for Pfizer Production Lot 56 was submitted to D.B.S. for approval, the cumulative experience of D.B.S. for NA-2 concerning lesion scores as a result of intrathalamic inoculation was based on 305 monkeys. From the standpoint of severity, which is the average lesion score of the site closest to inoculation, only one monkey with an average Grade 3 lesion had been observed; from the standpoint of spread, which is the average lesion score of the sight furthest from the inoculation, only one monkey with an average Grade 3 lesion had been observed. All other lesions were either Grade 1 or Grade 2 lesions. No monkeys showed paralysis by clinical observation.

 33. The minimal lesion, a Grade 1 lesion, is where there is destruction of one or two anterior horn cells on one side of the spinal cord in one horn. A mild lesion, a Grade 2 lesion, is where there is destruction of more than two but less than five anterior horn cells on one side or destruction of one or two anterior horn cells on both sides. A moderately severe lesion or a Grade 3 lesion, is where only one or two anterior horn cells remain undamaged on both sides. A Grade 4 lesion, or a severe lesion, is where all anterior horn cells on both sides are totally destroyed.

 34. Production Lot 56, when tested by D.B.S. for monkey neurovirulence by inoculation of thirty monkeys, demonstrated that four monkeys showed lesions. As to severity of lesions, two monkeys showed average Grade 4 lesions. One monkey showed average Grade 3 lesions. One monkey showed average Grade 2 lesions. For spread, three monkeys showed average Grade 3 lesions and one monkey showed average Grade 2 lesions. One of the monkeys showing Grade 4 lesions also demonstrated paralysis not related to the trauma of inoculation by clinical observation.

 35. At the time that D.B.S. completed their monkey neurovirulence testing, the cumulative experience of lesion scores as a result of D.B.S.'s intrathalamic inoculations of 305 monkeys with reference strain NA-2 demonstrated that there had never been a paralyzed monkey and that there had never been any monkeys with average Grade 4 lesions either as to severity or spread.

 36. Out of the 305 monkeys intrathalamically inoculated by D.B.S., 24 monkeys showed lesions regardless of Grade. On an average basis per 30 monkeys this would be the equivalent of 2.36 lesions per 30 monkeys inoculated. Of the 24 monkeys showing lesions, 13 monkeys showed only minimal lesions which by definition were lesions affecting only one or two horn cells.

 37. Production Lot 56 showed four monkeys with lesions, all of which exceeded minimal grade scores.

 38. D.B.S. experience with NA-2 showed that NA-2 viewed in terms of 30 monkey lots produced four lesions of any kind in only about 1/4 of the cases (4 of 15 test groups by defense exhibit 98).

 39. Lot 56 fell into the upper range of experience with NA-2 as to incidence of lesions both viewed in terms of the average experience with NA-2 and the experience with NA-2 in 30 monkey lots.

 40. A comparative analysis of the test results obtained in testing Lot 56 for monkey neurovirulence and the NA-2 experience did not demonstrate that Lot 56 did not exceed the reference in neurovirulence.

 41. A comparison of the test results obtained in testing Lot 56 for monkey neurovirulence and the NA-2 experience demonstrated that Lot 56 probably exceeded the reference in neurovirulence.

 42. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence test knew or should have known that Lot 56 probably exceeded the reference in neurovirulence.

 43. On July 9, 1962, the personnel of D.B.S. charged with evaluating the results of the monkey neurovirulence test definitely knew or should have known that a comparison of the test results to the cumulative experience with NA-2 did not demonstrate that Lot 56 did not exceed NA-2 in neurovirulence.

 44. All information received by D.B.S. between July 9, 1962 and October 22, 1963 indicated that Lot 56 did in fact exceed the reference strain in neurovirulence.

 45. D.B.S. could have recalled Lot 56 at all times between July 9, 1962 and October 22, 1963.

 46. D.B.S. did not recall Lot 56 between July 9, 1962 and ...


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