Record and brief — Davis v. United States
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FILED
81-644 AUG 25 1981
No,
ALEXANDER L STEVAS.
a = ed
IN THE
SUPREME COURT OF THE UNITED STATES
October Term, 1981
GLYNN RICHARD DAVIS,
Petitioner,
vs.
UNITED STATES OF AMERICA,
Respondent,
PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
Robert M, Tyler, Jr. (Counsel of Record)
Blaine F, Evans
ELAM, BURKE, EVANS, BOYD & KOONTZ
P.O. Box 1559
Boise, ID 83701
Telephone: (208) 343-5454
ADLER, BARISH, LEVIN & CRESKOFF
Rohm & Haas Building
8th Floor, Lafayette Building
6th & Market Streets
Philadelphia, PA 19106
Telephone: (215) 923-8900
Attorneys for Petitiener
1, Where the federal government has
unique knowledge of potential risks to the
health of citizens who participate in gov-
ernment programs, what is the nature and
scope of the government's duty to inform
the public of those risks?
2. Whether accrual of a cause of ac-
tion within the meaning of 28 U.S.C.
§ 2401(b) is deferred where plaintiff's
failure to discover the cause of his in-
jury within two years of incurring it re-
sults from the government's acts in con-
cealing information essential to his cause
of action?
3. Whether the concealment doctrine
tolls the statute of limitations, 28 U.S.C.
§ 2401(b), where plaintiff's failure to
sue within two years of incurring an injury
results solely from the government's mis-
representations to the public and failure
to produce decuments sought by a subpoena
served on the government?
4. Whether the principles of equity
applicable to statutes of limitations pre-
clude the government from asserting a lim-
itations defense where the government has
concealed from the plaintiff information
necessary to predicate his claim against
the government?
ii
TABLE OF CONTENTS
QUESTIONS PRESENTED .
OPINIONS BELOW.
JURISDICTION,
STATUTES AND REGULATIONS.
STATEMENT OF THE CASE .
JURISDICTION IN THE COURT
OF FIRST INSTANCE .
REASONS FOR GRANTING THE WRIT .
I.
Il.
ITl.
In the context of the statute
of limitations to the Federal
Tort Claims Act, this case pre-
sents an important question of
federal law concerning the na-
ture and scope of the govern-
ment's duty to inform the pub-
lic of risks associated with
government programs which en-
courage mass citizen participa-
tion. are ae
The decision below conflicts
with this Court's decision of
United States v. Kubrick, 100
$.Ct. 352 (1979). *
The decision below conflicts
with settled federal law which
tolls statutes of limitations
where the government conceals
from a plaintiff evidence which
is crucial to his cause of
hs + ee o> 6 oe 6 6 IN
iii
17
18
49
25
35
CONCLUSION. . . 2. 2 6 ee © © © 8 42
APPENDICES
Appendix A. A-1
Appendix B. A-19
Appendix C. A-21
Appendix D. A-22
Appendix E. A-25
Appendix F. A-27
Appendix G. A-51
Appendix H. A-56
Appendix I. A-59
Appendix J. A-62
Appendix kK. A-82
Appendix L. A-98
Appendix M. A-113
Appendix N. A-124
Appendix Oo. A-129
iv
TABLE OF AUTHORITIES
Cases:
Camire v. United States, 535 F.2d
749 (2a C Cir. 1976). ' ave
Davis v. Wyeth Laboratories, Inc.,
399 F.2d 121, 123 (9th Cir. 1968)
Gicas v. United States, 508 F.Supp.
217 (E.D.Wis. 1981)
United States v. Kubrick,
100 S.Ct. 352 (1979).
Marshall v. Kimberly-Clark Corp.,
625 F.2d 1300 (5th Cir. 1980)
Public Service of New Mexico v.
General Electric Co., 315 F.2d
_ oh gs ie gelatine
Rahn v. United States, 222 F. SupP
775 (S.D.Ga. 1961). . Bie
Spevack v. United States,
390 F.2d 977 (Ct.Cl. 1968).
Toal v. United States,
438 F.2d 222 (2d Cir. 1971)
Pages
25,
24,
37
38
Pages
Statutes:
Federal Tort Claims Act, 28 U.S.C.
|S: Se Beare ; . 17
Federal Tort Claims Act, 28 U.S.C.
ie oS a ’ gttccie ee ae
National Swine Flu Act of 1976,
a ce omeeee. ar EEn sé 6-60 et we 8 22
Regulations:
42 C.F.R. § 73.114(b)(1)(iii) .. . 6, 7
vi
No.
IN THE
SUPREME COURT OF THE UNITED STATES
October Term, 1981
GLYNN RICHARD DAVIS,
Petitioner,
vs.
UNITED STATES OF AMERICA,
Respondent.
PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
OPINIONS BELOW
The Opinion of the Ninth Circuit
Court of Appeals was entered on April 20,
1981, and has been reported at 642 F.2d
328 (9th Cir. 1981). (Appendix A.) The
district court's order on defendant's
motion for Summary Judgment was entered
on March 29, 1977 (Appendix D), and is
not reported. The district court's judg-
ment granting the government summary
judgment was entered on the same day.
(Appendix E. )
JURISDICTION
The judgment of the Ninth Circuit
Court of Appeals was entered on June 22,
i981. (Appendix C.) The order of the
Ninth Circuit denying a timely petition
for rehearing and rejecting the sugges-
tion for rehearing en banc was entered on
May 28, 1981. (Appendix B.)
The jurisdiction of this Court is
invoked under Title 28, United States
Code, Section 1254(1).
STATUTES AND REGULATIONS
The federal tort claims act, 28
U.S.C. § 2401(b) which provides:
A tort claim against the United
States shall be forever barred
unless it is presented in writ-
ing to the appropriate Federal
agency within two years after
such claim accrues or unless
action is begun within six
months after the date of mail-
ing, by certified or registered
mail, of notice of final denial
-2-.=
of the claim by the agency to
which it was presented.
The Federal Tort Claims Act, 28 U.S.C.
§ 1346(b) which provides:
Subject to the provisions of
chapter 171 of this title, the
district courts, together with
the United States District Court
for the District of the Canal
Zone and the District Court of
the Virgin Islands, shall have
exclusive jurisdiction of the
civil actions on claims against
the United States, for money
damages, accruing on and after
January 1, 1945, for injury or
loss of property, or personal
injury or death caused by the
negligent or wrongful act or
omission of any employee of the
Government while acting within
the scope of his office or em-
ployment, under circumstances
where the United States, if a
private person, would be liable
to the claimant in accordance
with the law of the place where
the act or omission occurred.
42 C.F.R. 73.114(b)(1)(iii). (Appendix
0.)
STATEMENT OF THE CASE
Participating in the federal govern-
ment's campaign to eliminate paralytic
poliomyelitis, petitioner Davis took Type
III oral polio vaccine at a mass immuniza-
tion clinic conducted in West Yellowstone,
Montana in March, 1963. Within four
weeks of ingesting the vaccine he was
paralyzed from the waist down and has
continuously remained in that condition.
(Appendix F, p. A-28.)
The mass immunization plan was con-
ceived by an advisory committee estab-
lished in 1960 by the Surgeon General.
‘The committee formulated a plan to create
mass immunization centers throughout the
country, and in March, 1962, the Surgeon
General, acting on behalf of the Public
Health Service, issued recommendations
for the use of the Sabin oral vaccine.
As part of the program, representatives
of the Public Health Service held meet-
ings with local public health officials
and medical personnel in communities
throughout the United States. Davis vy.
Wyeth Laboratories, Inc., 399 F.2d 121,
123 (9th Cir. 1968).
The vaccine involved was Sabin oral
vaccine which consisted of three separate
types: Types I, II, and III. Each type
was designed to immunize the person inocu-
lated from contrac’ ng polio from a cor-
responding type of polio virus. Id. at
122. Unlike the predecessor Salk vaccine,
the Sabin vaccine utilized live virus.
In addition to creating the immuni-
zation clinics, the federal government
controlled the licensing and testing of
the vaccine through the Division of Bio-
logics Standards (DBS) of the National
Institutes of Health, an arm of the United
States Department of Health, Education
and Welfare. The government licensed
three companies to manufacture the vac-
cine, including Wyeth Laboratories, Inc.,
which produced Lot 35, from which Davis
was vaccinated.’
‘In 1964 Davis sued Wyeth on the basis of
diversity jurisdiction. The trial court
ceoere ca ae against “3 and the Ninth
ircuit rever . Davis yeth, °
That case was settl w chéut a sec ~
trial. .
Government regulations required each
manufacturer, after producing a let, to
perform prescribed tests on it and submit
the test results, together with a sample
from the lot, to the DBS, where the gov-
ernment performed additional tests to
determine its safety, potency, ane purity.
If the lot satisfied government standards,
the DBS authorized its dissemination te
the public. |
Dr. Ruth Kirschstein was the DBS
pathologist responsible for supervising
the government testing. Her deposition
was taken on October 21-22, 1965 in the
Davis v. Wyeth litigation, and on May 12,
1975, in the instant litigation. (The
former deposition is hereinafter referred
to as Kirschstein Dep. I and the latter,
as Kirschstein Dep. II.)
The critical test which DBS per-
formed on each iot was the neurovirulence
test, in which a sample from a vaccine
let was injected into the brain or spinal
eolumn ef a test animal. After destruc-
tion of the animal following an observa-
tien peried, a section of tissue was
removed from the brain or spine and sub-
jected to a histelogic examination to
determine the number and severity of
lesions, or deviations from the norm.
Lesions were graded on an increasing
scale of severity from 1 to 4. (Kirsch-
stein Dep. I, p. 103.) The occurrence of
lesions in the test lot was then compared
te a reference strain of vaccine main=
tained by the DBS pursuant toe 42 C.F.R.
§ 73.114(b)(1) (iii), which provided that
a test lot was satisfactory for manufac-
ture only if “a comparative analysis of
the test results demonstrates that the
neurevirulence of the test virus pool
dees not exceed that of the NIH Reference
Attenuated Polio Virus."
Wyeth's Lot 35 was subjected te two
tests. Prior te Dr. Kirschstein's depo-
sition in October, 1965, she was served
= 7.
. with a subpoena directing the DBS to
produce all its records pertaining to Lot
35. Yet at this deposition she failed to
preduce the results of a second neurevi-
the lot. (Kirschstein Dep. II, pp. 21-25,
30, 33-34.) The results ef the second
test, included as Appendix I hereto,
that the lot never should have been re-
leased. (Appendix G.) Indeed, the re=-
sults ef this second test on Lot 35 showed
the first grade 4 lesion recorded by the
DBS testing (Appendix G), which was the
most severe on the DBS range of severity.
Because the government failed to
preduce the results of the second test at
Dr. Kirsehstein's deposition in 1965, it
was only fertuiteusly that Davis was
informed ef these facts in 1973 by an
attorney representing another person who
had contracted polio from taking the
vaccine. (Appendix F, p. A-31.) When
Davis obtained this crucial information,
he promptly filed suit against the govern-
ment alleging negligent release of Lot
35. (Appendix F, pp. A-31-32.)
He had earlier sued Wyeth on the
theory of strict liability for failure to
warn of the risk that a person could
centract polio from ingesting the Sabin
vaccine. In that case, Davis had no
evidence of any defect in Lot 35 because
ef the government's concealment of the
results of the second test, and was able
te effer only epidemiclogical proof that
the vaccine had caused his disease.
(Appendix F, p. A=42.) Indeed, the Ninth
Cireuit Court ef Appeals, which ruled in
Davis's favor in the Wyeth litigation,
believed that the Lot satisfied government
standards. Davis v. Wyeth, supra, 399
F.2d at 123. Of course, the court like
Davis had access to only the first test
preduced at Dr. Kirschstein's deposition
in 1965.
| The record is replete with evidence
that Davis aggressively sought to deter-
mine the cause of his paralysis, yet he
was repeatedly told that it was impos-
sible to prove that a particular case of
polio was caused by the vaccine and that
cases which showed a possible epidemiolog-
ical link with the vaccine were not asso-
ciated with any particular lots. (Appen-
dix F.)
Davis's affidavit attached as Appen-
dix F describes in detail his efforts to
learn the cause of his injury. Only
three months after contracting the disease
he began to write letters to epidemiolo-
gists and other scientists and to review
literature on polio contained both in
medical journals and government publica-
tions. (Appendix F.) He wrote to the
«10
Director of the Food and Drug Administra-
tion and the Public Health Service. He
corresponded with the Administrator of
National Health and Welfare in Canada and
in the summer of 1964, wrote to Dr. Sabin
himself, who responded that there was
absolutely no way that he could have
contracted polio from the vaccine. (Ap-
pendix F, pp. A-38-39.) In July, 1964,
Davis's attorneys consulted with Dr.
Salk, developer of the predecessor vac-
cine, and he too, was unable to state
that there was any association of partic-
ular vaccine lots with inducement of the
disease. (Appendix F, p. A-39.) Ina
letter to the Washington State Department
of Health which Davis wrote in October,
1963, he stated that not one of nearly 20
doctors who had examined him would ac-
knowledge that his paralysis could have
been caused by the vaccine. (Appendix A,
p. A-16.)
= ll -
Davis's conscientious review of the
literature proved no more fruitful. A
June, 1963 article by Dr. Gelfand, Chief
of the Enterovirus Unit of the Communica-
ble Disease Center, stated that "it re-
mained impossible to decide whether or
the oral vaccine. ..." (Emphasis ad-
ded.) (Appendix M, p. A-121.) The same
article stated that "[Njo evidence has
composed of these strains, had ever
prevent." (Emphasis added.) (Appendix
F, p. A=35.)
In addition to medical journals,
Davis, beginning only a few months after
the onset of his disease, thoroughly read
the documents which the government dis-
tributed concerning the issue of possible
asteciation ef polio with ingestion of
the oral vaccine.
s 12 «
Sometime in 1962 the Surgeon General,
Dr. Luther Terry, formed a Special Oral
Poliomyelitis Vaccine Advisory Committee
(Committee) comprised of some of the
world's foremost experts on epidemiology
and virology. The Committee included
scientists working both within and with-
out the federal government. Some of the
members were Dr. Ernest Ager, an epidemi-
clogist employed by the Washington Depart-
ment of Health; Dr. Albert Sabin, the
creator of the oral vaccine; and Dr.
Roderick Murray, director of the DBS.
(Appendix L, pp. A-106-108. )
The findings of the Committee's
meetings, held from August, 1962 through
July, 1964, were published in the Commit-
tee's reports, as well as reports and
press releases issued by the Surgeon
General. The meeting of September 15,
1962 was described in the September 20,
1962 technical report authored by the
Surgeon General. (Appendix J.) This was
one of several reports that the Committee
published after September 3, 1962, the
date of completion of the second neurovi-
rulence test on Lot 35.
The September 20 report related that
the Committee had reviewed data concern-
ing the occurrence of polio cases after
administration of the oral vaccine and
had examined those cases which it consid-
ered not inconsistent with a vaccine
relationship. The report noted that the
vaccine administered to those cases was
from several lots not produced by a single
manufacturer. The Committee was able to
conclude only that the reported cases
were “clinically consistent with paralytic
poliomyelitis and with laboratory findings
which could not exclude a possible rela-
tionship to the administration of oral
vaccine." Thus, this Committee, composed
of some of the world's most eminent ex-
perts on polio, could do no more than
acknowledge its inability to exclude a
»14<
possible relationship between ingestion
of vaccine and contraction of polio.
In its next report, issued in Decem-
ber, 1962, it firmly stated that it "does
not consider that an individual case can
be proved to be caused by the vaccine and
no laboratory test has thus far provided
a definitive answer." (Emphasis added. )
(Appendix K, p. A-87.) The public was in
effect being informed that there existed
no possible cause of action against a
drug manufacturer or any other party
predicated on a defect in a particular
lot of vaccine.
With respect to those cases consid-
ered to be "compatible" with the possi-
bility of having been induced by the
vaccine (Appendix K, p. A-87), the pre-
vailing scientific thinking was that the
vaccine relationship to disease was a
general property of the vaccine rather
than defects in manufacture. This view
was re-emphasized in a September, 1964
ah® «
press release of the Surgeon General.
(Appendix L, p. A-102.)
On September 30, 1964, the Surgeon
General released a document listing re-
ported cases of polio which the Committee
considered compatible with the possibil-
ity of having been induced by the vaccine.
Davis's case is contained in that list.
(Appendix L, p. A-11l.) Davis read this
report almost immediately upon its publi-
cation.
Noct until he learned the results of
the second test did Davis have any reason
to believe that the cause of his paraly-
sis was a defect in Lot 35. The results
of this second test constituted the sole
evidence that the cause of his disease
was a peculiar property of Lot 35 rather
than a generic characteristic of Type III
vaccine. Prior to learning of the second
test, he had relied on the government's
representations that it was impossible to
@16«
prove that the disease could be caused by
a specific lot of vaccine.
In none of its reports did the Com-
mittee ever state that any lot had failed
to meet government standards. Indeed,
the affidavit of Ernest Ager, a Committee
member, revea.s that Dr. Murray represen-
ted to the Committee at its July, 1964
meeting; that all lots of Type itt vac-
cine which had been tested up to that
time had satisfied government standards.
(Appendix H, p. A-56.) Dr. Murray's
representation was made despite the re-
sults of the second neurovirulence test
on Lot 35, conducted more than a year and
a@ half earlier, which showed that that
lot violated the applicable regulation.
JURISDICTION IN THE COURT
OF FIRST INSTANCE
The basis for federal jurisdiction
in the district court was the Federal
Tort Claims Act, 28 U.S.C. § 1346(b).
REASONS FOR GRANTING THE WRIT
Ze
IN THE CONTEXT OF THE STATUTE OF
LIMITATIONS TO THE FEDERAL TORT
CLAIMS ACT, THIS CASE PRESENTS AN
IMPORTANT QUESTION OF FEDERAL LAW
CONCERNING THE NATURE AND SCOPE OF
THE GOVERNMENT'S DUTY TO INFORM THE
PUBLIC OF RISKS ASSOCIATED WITH
GOVERNMENT PROGRAMS WHICH ENCOURAGE
MASS CITIZEN PARTICIPATION.
This case presents very important
questions of construction of 28 U.S.C.
§ 2401(b) in the context of far-reaching
government programs designed to affect
the lives of millions of American citi-
zens. The effect of the polio vaccine
program on some citizens, like petitioner,
was permanent paralysis. The government
knew as early as 1962 that some cases of
polio were associated with ingestion of
the Sabin vaccine, yet through the Sur-
geon General and his advisory Committee,
the government repeatedly informed the
public that there was no possible way to
prove that the vaccine caused a particular
@ 16
case of polio and that there was no demon-
strable associa*ion of a case of polio
with any particular lot.
The Surgeon General and the Commit-
tee made these representations despite
the existence of evidence, as early as
September, 1962, that at least one lot of
vaccine, Lot 35, exceeded the govern-
ment's permissible level of neuroviru-
lence and thus did not meet the govern-
ment's safety criteria. During all its
meetings between 1962 and 1964, the Com-
mittee knew that the DBS's purpose in
conducting neurovirulence tests on each
lot of vaccine was to determine whether
it exceeded the neurovirulence of the
DBS's reference strain of vaccine, i.e.,
te ascertain whether or not # particular
lot was safe for public use. In Davis's
case the government's misrepresentations
were compounded by concealment of the
results of the second DBS test on Lot 35,
» 419 «
which constitutes the very heart of his
claim.
This is the setting in which § 2401(b)
must be construed in this case. The
government created and administered a
nationwide program designed to impact the
lives of virtually all American citizens
in the most important conceivable matter
--life itself. The government initiated
the campaign, supervised establishment of
immunization clinics, and strictly regu-
lated the testing and licensing of vaccine.
The polio immunization program is an
example of the extensive role of guardian
or watchdog for the public which the
government has increasingly assumed in
recent decades. The government's under-
taking such an active involvement in the
lives of its citizens raises the vital
question of the corresponding duties the
government incurs to provide citizens
with accurate information about govern-
ment programs, including full disclosure
#- 20 «
ef potential risks asseciated with par-
ticipation in then.
In the polio immunization program,
the government's knowledge of the field
was vastly superier to that of the aver=
age citizen. The government had almost
exclusive contrel ever the resources and
personnel necessary to carry out the
preject. Because eof its superior knowl-
edge and centreol, the government was in
effect the public's guardian and only
safeguard in this highly technical area.
The government eccupied a position of
trust and enormous influence vis-a-vis
the public. In its role of guardian the
government assumed the duty te all mem=
bers ef the public te deal with them at
arm's length and to imform them fully of
all aspects of that program which could
potentially affect their lives.
The evidence in this case is over=
whelming that the government did not
discharge its duty. The Surgeon General's
= 21 =
reports represented to Davis and others
in hie position that there was no way to
preve that the vaccine caused a particular
ease of polio. Further, by failing to
produce the results of the critical test
en Let 35, the DBS concealed from him,
whether through negligence or otherwise,
the crucial piece of evidence in his case
which established that his polic was
indeed caused by the vaccine.
As the government continues to play
a pervasive role in the regulation of
myriad technical matters affecting the
public health, it is very /ikely that
there will arise other cases which pre-
sent similar issues involving construction
ef § 2401(b). One illustration of the
type ef program likely to produce limita-
tions issues similar to this one is the
swine flu immunization program created by
the National Swine Flu Act of 1976, 42
U.3.C. § 247(b). The federal govern=
ment's objective under the Act was to
inoculate the entire adult population of
the United States against threat of a
swine flu epidemic. It was the largest
immunization program in the nation's
history, and over 45 million Americans
were vaccinated. Gicas v. United States,
508 F.Supp. 217 («.D.Wis. 1981).*
In executing programs like the police
immunization campaign in which the public
justifiably places great reliance on the
government's expertise and good faith,
the government should not be permitted to
make misrepresentations to the public,
conceal vital information and then employ
its misrepresentations and concealments
by invoking the statute of limitations to
*Under the Act the United States assumed
liability for damages sustained as a re-
sult of the inoculation. One reason that
the government assumed this responsibility
was the collapse of the commercial liabil-
ity insurance market for vaccine manufac-
turers occasioned by petitioner's earlier
munis, Soh Paige ae eS.
e¢ that Davis remains uncompensated
by the government for injuries he in-
curred more than 18 years ago.
= 23 =
deprive a citizen of a legitimate claim
under the Federal Tort Claims Act. To
sanction such a result would enable a
defendant to profit from his own wrong
and thus violate the most fundamental of
equitable precepts. Rahn v. United States,
222 F.Supp. 775 ($.D.Ga. 1963).
Statutes of limitation themselves
are an equitable device designed to in-
sulate potential defendants from dilatory
tactics. Conversely, the discovery rule
used in the construction of § 2401(b) and
the concealment doctrine are equitable
concepts intended to protect plaintiffs
from harsh application of statutes of
limitations in circumstances where plain-
tiffs, despite the exercise of reasonable
diligence, cannot discover causes of
action because of the acts of prospective
defendants.
The discovery rule and the conceal-
ment doctrine both apply to this case.
e 24 <
Those rules must be analyzed in the con-
text of the government's duty to inform
the public when the government undertakes
to create and police a national plan
affecting the public health.
II.
THE DECISION BELOW CONFLICTS WITH
THIS COURT'S DECISION OF UNITED
Ce KUBRICK, 100 S.CT. 352
The majority of the court below
correctly observed that while the present
case does not involve medical malpractice,
it is in many ways similar to such an
action, and it is therefore here appro-
priate to apply the “discovery rule"
under which a cause of action does not
accrue until the plaintiff discovers, or
in the exercise of reasonable diligence
should have discovered, both his injury
and its cause. (Appendix A, pp. A-5-6.)
As Judge Tang perceived in his dissent,
while the majority may have correctly
stated the rule of Kubrick, supra, it
= 3S <
clearly erred in its purported applica-
tion of Kubrick to the facts of this
case.
As Judge Tang observed, there are
vital distinctions between this case and
Kubrick which require reversal of the
decision below affirming the summary
judgment. The record contains undisputed
facts which as a matter of law establish
that Davis's cause of action did not
accrue until 1973 when he learned of the
results of the second neurovirulence test
on Lot 35. At a bare minimum this evi-
dence created a genuine issue of material
fact of the point in time at which he
knew (1) of his injury and (2) its cause.
These are the key differences between
the facts of Kubrick and this case:
(1) there was no evidence in Kubrick that
the government had failed to disclose to
the plaintiff any documents relevant to
his case; (2) long before two years had
elapsed from the occurrence of his injury,
—
Kubrick had been informed by a physician
that it was “highly possible” that his
deafness had been caused by administra-
tion of the drug neomycin, whereas Davis
was on numerous occasions informed by
various sources that it was impossible to
prove that his polio was caused by the
vaccine and that there was no known asso-
ciation of polio cases with particular
lots of vaccine; (3) unlike Davis, Kubrick
had available to him alternative sources
ef information concerning the cause of
his injury; (4) Kubrick failed to make
diligent inquiry concerning the cause of
his injury, whereas Davis doggedly pursued
the truth about his paralysis; and (5) in
Kubrick there was no showing that the
government had made any public represen-
tations concerning the drug neomycin.
Nine months after the surgery in
which he was treated with neomycin Kub-
rick was informed by a doctor that it was
"highly possible" that his hearing loss
resulted from administration of this
drug. It was common knowledge in the
medical community at that time that this
application of neomycin was improper
because it could cause precisely this
consequence.
By contrast, Davis did not learn
until 1973 of the cause of his injury--a
defect in Lot 35. As opposed to Kubrick's
being informed by a physician of a high
possibility that neomycin caused his
deafness, at most Davis may have suspected
that the vaccine caused his disease.
Knowledge of cause and a mere suspicion
cannot be equated for purposes of apply-
ing Kubrick. Most important, the govern-.
ment never revealed to Davis the critical
evidence on causation--the second test on
Lot 35.
As Judge Tang stated, far from sug-
gesting a high possibility that his paral-
ysis and the vaccine were causally linked,
mumerous reputed authorities informed
- 28 -
Davis that the vaccine could not be proved
to cause the disease. In 1964 Dr. Sabin
himself, still a member of the Surgeon
General's Committee, told Davis that
there was absolutely no way that he could
have contracted polio from taking the
vaccine. The medical journals and govern-
ment documents which Davis reviewed uni-
formly represented that it was impossible
to prove that the vaccine caused an indi-
vidual polio case.
When Davis was discharged from the
Veterans Hospital on October 25, 1963,
his case was diagnosed as polio, due to
undetermined cause. (Appendix F, p.
A-29.) In a June 26, 1964 letter to the
Communicable Disease Center, the Director
of Idaho's Preventive Medicine Division
stated with respect to the cause of
Davis's paralysis:
The etiology of this case of
paralysis has not been deter-
mined and a large number of
virus diseases are to be consid-
ered. The present diagnosis of
« 29
lower neuron disease with paral-
y8is--etiology unknown --is the
(Emphasis added.) (Appendix N, pp. A-126-
127.) Davis's case was never officially
reported as polio by the Idaho Department
of Health. (Appendix F, p. A-38.) Only
thirteen months before Dr. Kirschstein's
first deposition, the Surgeon General's
Committee released the last of a series
of reports in which it consistently rep-
resented that it was not possible to
prove an individual case was caused by
the vaccine. (Appendix A, p. A-17.)
The foregoing evidence clearly was
sufficient to create an issue of fact
whether Davis knew, prior to Dr. Kirsch-
stein's deposition in October, 1965, the
cause of his paralysis. If he did not
know the cause at that time, then there
can be no doubt that his cause of action
did not accrue under § 2401(b) until 1973
when he learned of the existence and
«: 90 -
results of the second test on Lot 35.
Judge Tang correctly read the record to
suggest that "Davis was still struggling
to determine the cause of his injury by
the critical date in October, 1963, and
well beyond.” (Emphasis added.) (Appen-
dix A, p. A-17.)
If the cause of action did not accrue
prior to the Kirschstein deposition, then
it could not have accrued prior to 1973,
because Dr. Kirschstein in her first
depositon failed to produce the crucial
piece of evidence on which Davis's claim
rests. Without evidence of a defect in
the particular lot from which he was
vaccinated Davis had no cause of action
against the government, because the Com-
mittee’s reports had indicated the possi-
bility of vaccine-induced polio, although
the government continuously represented
that this fact could not be proven ina
given case. Thus to recover against the
© 31
government Davis had to show that a de-
fect in Lot 35 rather than a generic
property of Type III vaccine was the
cause of his injury. Of course, without
the results of the second test on Lot 35
Davis lacked the critical evidence needed
(1) to prove a defect in that lot and
(2) to refute the government's assertions
that it was not possible to prove that a
particular polio case was vaccine-induced.
An important point in this Court's
decision in Kubrick was the ready avail-
ability outside government channels of
information pertaining to the cause of
plaintif{£'s injury:
That he has been injured in
fact may be unknown or unknow-
able until the injury manifests
itself; and
caus
te
. Pg prospect is not so
. for a eal in Lf
rgd of
ee ne longer at etieee mercy 2%
whe an ta ein ie hae Deen
- 32 «
(Emphasis added.) 100 S.Ct. at 359.
Kubrick and this case are at opposite
ends of the spectrum of available alterna-
tive sources of information. For Kubrick
it was a simple matter of consulting
physicians in his community. For Davis
it was totally different. The government
continuously had exclusive control of the
critical evidence on causation and never
voluntarily disclosed that information to
Davis. Moreover, unlike Kubrick, a Com-
mittee formed by the government told
Davis there was no way to prove that his
injury was caused by the drug involved.
Davis simply had no alternative source of
information about the cause of his injury.
The Surgeon General's Committee was
made up of some scientists who worked for
the government and others who did not.
Unlike the medical procedure involved in
Kubrick, which was common knowledge both
within and without government circles,
only the Surgeon General, the Committee
« 33 -
and the DBS had access to the critical
data concerning the polio immunization
program.
In Kubrick the Court questioned
plaintiff's diligence, stating, "Kubrick
need only have made inquiry among doctors
with average training and experience. . .
to have discovered that he probably had a
good cause of action. The difficulty is
that it does not appear that Kubrick ever
made any inguiry. .. ." (Emphasis ad-
ded.) 100 S.Ct. at 360. By contrast,
the record in this case discloses that
Davis exercised diligence of the highest
order in attempting to determine the
cause of his paralysis.
It is well established that a dis-
pute over the facts regarding the date on
which a statute of limitations commences
to run precludes summary judgment for
defendant. Marshall v. Kimberly-Clark
Corp., 625 ¥.24 1300 (Sth Cir. 1980);
Camire v. United States, 535 F.2d 749 (24
« 34
Cir. 1976). On this record Davis is
entitled at a minimum to trial on the
question when he knew of both his injury
and its cause within the meaning of Kub-
rick. We think the record shows that as
a matter of law his cause of action did
net acerue until 1973, that his action
was timely filed in April of 1974, and
that he is entitled te remand for a full
trial en the merits. This Court should
accept review of this case because of the
government's immense superiority in knowl-
edge and resources in this field and the
fundamental implications of fairness
whieh these considerations entail, both
in this case and others likely to follow.
Itt.
THE DECISION BELOW CONFLICTS WITH
SETTLED FEDERAL LAW WHICH TOLLS
GOVERNMENT CONCEALS FROM "A. PLAIN=
HIS CAUSE OF ACTION.
Under the concealment doctrine a
statute of limitations is tolled where
the defendant conceals facts essential to
= 35 =
plaintiff's cause of action. Rahn v.
United States, 222 F.Supp. 775 (8.D.Ga.
1963). The concealment doctrine is read
inte every federal statute of limitations.
Public Service of New Mexico v. General
Blectric Co., 315 F.2d 306 (10th Cir.),
cert. denied, $3 $.Ct. 1695 (1963). The
doctrine has been applied specifically te
the Federal Tort Claims Act. E.g., Rahn,
supre .
In this case the government con-
cealed from Davis both (1) the results of
the second test on Lot 35 and (2) the
faet that one could prove, through evi-
dence of neurevirulence test results,
that a polio case was caused by a defect
in a particular vaccine lot. The results
ef the second test constituted the crucial
evidence on the elements of both causation
and the government's breach of duty.
Without this evidence Davis could not
prove that hie injury was caused by this
= 36 =
particular lot and thereby establish
liability of the government.
The facts of Rahn, supra, are analo-
gous to the circumstances of this case.
In Rahn plaintiff suffered disfigurement
ef her arm because of the negligence of
government doctors. She sought the gov-
ernment's medical records regarding her
ease, but was not furnished them until
more than two years had passed from the
time of her injury. These records com-
prised the only evidence of negligence,
and the court held that the statute of
limitations did not commence to run until
she obtained the critical documents.
Likewise, in this case the federal
government had exclusive possession of
the relevant information so that the
government's concealment made it impos-
sible for Davis to pursue an action
against the United States. Accord, Spe-
vack v. United States, 390 F.2d 977 (Ct.Cl.
1968) (statute of limitations tolled
e $7 «
where Atomic Energy Commission concealed
from plaintiff fact that Commission used
his invention). See also Toal v. United
States, 438 F.2d 222 (2d Cir. 1971) (sta-
tute of limitations tolled where govern-
ment doctor failed to note in medical
records that he did not remove from plain-
tiff's body a chemical contrast medium
used to perform surgery).
It is clear that the government
concealed the results of the second test
@uring the 1965 deposition of Dr. Kirsch-
atein, but the majority below rejected
this position, asserting that the two-year
period had elapsed prior to the deposition.
The majority's position ignored entirely
the substantial evidence in the record,
recited by Judge Tang in his dissent and
summarized in this petition, which shows
that on several occasions in 1964, less
Shan two years before the firet Kirsch-
atein deposition, Davis was still attempt-
ing to determine the cause of his injury.
= 38 <
As late as September 30, 1964, only thir-
teen months prior to the deposition, the
government once again stated that it was
not possible to prove that an individual
case was caused by the vaccine. It is
clear that the cause of action had not
accrued at the time Dr. Kirschstein's
deposition was taken in October, 1965.
Addressing the concealment doctrine,
the majority below also stated:
It may well be that the govern-
ment was negligent in maintain-
ing and publishing records.
However, failure of the govern-
ment to ascertain and publish
the fact of its negligence is
hardly sufficient to constitute
fraudulent concealment.
(Appendix A, p. A-12.) The majority would
equate the Surgeon General's Committee
with the ordinary civil lawsuit where
defendant does not acknowledge his own
negligence. This view completely ignores
the compelling social significance of
this case--the government's role as guard-
ian in the administration of a nationwide
program affecting millions of citizens.
- 39 -«
Without question the government did have
the duty to disclose to the public that
it was possible to prove that a particular
lot of vaccine, as distinguished from a
uniform property of the generic Type III
strain, could cause the disease. Further,
the government had the obligation to
provide to individual participants all
information relating to injuries received
by then.
The main purpose of the neuroviru-
lence testing was to insure safety of the
vaccine and thus to protect people from
contracting the disease from the vaccine.
The regulations prohibited the release of
a lot whose neurovirulence exceeded that
of the reference virus. Yet the Committee
consistently represented that there was
no possible way to prove a causal connec-
tion between ingestion of a particular
let and the onset of polio. The exis-
tence of and reasons for government stan-
dards for neurovirulence, as well as the
results of the second test on Lot 35,
were acutely material to the question
considered by the Committee whether a
causal connection could be proved between
a case of polio and ingestion of vaccine.
The silence of the government's
reports, in combination with non-disclo-
sure of the second test, concealed from
‘Davis an essential element of his cause
of action--that a defect could exist ina
particular lot and that such a defect
could be proved to have caused the con-
traction of polio. Thus at the time he
filed his lawsuit against Wyeth in July,
1964 plaintiff could not have known that
there was a provable defect in Lot 35 and
a causal connection between his injury
and that defect.
In view of the government's complete
control over the polio immunization pro-
gram, to permit the government to invoke
the statute of limitations in this case
would set a precedent inconsistent with
Kubrick and existing federal law on the
concealment doctrine and violative of
fundamental fairness and the public's
right to rely on the government's good
faith. |
CONCLUSION
This Court should review this case
in light of the important questions it
presents concerning the government's
duties to the public in the administra-
tion of nationwide programs affecting the
public health. The majority's decision
incorrectly applies Kubrick, and, if al-
lowed to stand, could cause serious con-
fusion among the federal courts in the
construction of the statute of limita-
tions in future cases. To let stand the
Ninth Circuit's judgment would effective-
ly sanction an abuse of the government's
great power over the lives of individual
citizens and would constitute a dangerous
precedent inimical to the spirit of indi-
vidual rights.
For all of the foregoing reasons,
this Court should grant the Petition for
Certiorari. |
Dated: mes... 1981.
RESPECTFULLY SUBMITTED,
Mh LY. ge,
Robert M. Tyler, Jw
(Counsel of Record)
ELAM, BURKE, EVANS, BOYD &
KOONTZ
P.O. Box 1559
Boise, ID 83701
Attorneys for Petitioner
» 43 <
ADLER, BARISH, LEVIN &
CRESKOFF
Rohm & Haas Building
Sth Floor, Lafayette Bldg.
6th & Market Streets
Philadelphia, PA 19106
Attorneys for Petitioner
APPENDIX A
IN THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
Glynn Richard Davis
Plaintiff-Appellant,
Vv.
UNITED STATES of America
Defendant-Appellee.
OPINION
No. 77-1942
(Argued and Submitted Dec. 12, 1979)
(Decided April 20, 1981)
Appeal from the United States District
Court for the District of Idaho
Before: MERRILL, TANG and SCHROEDER,
Circuit Judges
Background
The Sabin Type III oral polio vaccine
Was administered to appellant Davis as
part of a nationwide campaign initiated
by the government of the United States to
eradicate paralytic poliomyelitis (polio)
in this country. Mass immunization cen-
ters were established in cooperation with
with state and local medical authorities,
A-1
and the campaign was widely publicized.’
The Division of Biologic Standards (DBS)
of the National Institutes of Health, a
part of the United States Department of
Health, Education and Welfare, was charged
with testing and licensing manufacture of
‘the vaccine; pursuant to 42 C.F.R. § 73.110
et seq.
The vaccine was administered to appel-
lant Davis at one of these centers in
March, 1963. Within thirty days, appel-
lant was paralyzed from the waist down and
exhibited other symptoms of polio. Davis
brought suit against the manufacturer of
the drug, Wyeth Laboratories, Inc., in
1964.
In the course of that litigation, in
October, 1965, defendant Wyeth Laborato-
‘This mass immunization program is described in
pave < myeth Laboratories, Inc., 339 ¥.24 121,
123- r. » & prev action brought
by this plaintiff against the manufacturer of the
vaccine he ingested. The district court initially
gave judgment for the manufacturer; this court
reversed and remanded. The parties settled out of
court before the case went to trial 4 second time.
A-2
ries, Inc., noticed the deposition of Dr.
Ruth Kirschstein, the chief of the path-
Ology section of the laboratory of Viral
Immunology, DBS, accompanied by a subpoena
duces tecum ordering her to bring to the
deposition, inter alia, all records of
DBS relating to lot No. 03503 of the
Sabin Type I1I oral polio vaccine. The
vaccine inge.ted by Davis was from this
lot. Appellant's attorney was present at
this deposition. Dr. Kirschstein brought
with her records documenting the results
of a single neurovirulence test;* the
results fell within acceptable limits.’
Each lot of vaccine was subjected to various
tests by DBS. The so-called newrovirulence test,
at issue here, involved administering the vaccine
to thirty monkeys. After 4 seventeen-to-twenty-
day observation period, the monkeys were destroyed
and the brain or spinal cord of each monkey, de-
pending on which had been injected with the vac-
cine, was removed and the tissue examined undsr 4
microscope for lesions. Lesions were graded on 4
scale of severity from one to four; if the number
of monkeys developing lesions and the severity of
the lesions fell within DBS standards, the lot was
deemed to have satisfied the newrovirulence test.
‘The test results revealed by Dr. Kirschstein at
the October, 1965, deposition indicated that one
monkey had developed lesions classified “one” and
A-3
Appellant alleges that not until 1973
Gid he learn from an attorney representing
a plaintiff in another suit’ that DBS
had conducted another neurovirulence test
on lot No. 03503, and that the results of
that test did not fall within the accept-
able range.’ In April, 1973, appel-
lant filed a notice of claim under the
Federal Tort Claims Act (FTCA) 28 U.S.C.
§ 1346 et seg., and in April, 1974,
brought the instant action in the court
below.
The district court granted summary judg-
ment for the United States, holding that
Davis’ suit was barred by the two-year
statute of limitations which applied to
all actions brought under the FTCA. 28
another monkey had developed lesions classified
“three”; these results were within the acceptable
range under the DBS standards.
[tit inv, United States, 351 F.Supp. 10 (£.0.Pa.
1972), aff'd ‘ (34 Cir. 1974).
SOne monkey developed lesions classified “four;
appellant contends that this was not within the
acceptable range under the DBS standards.
A-4
U.S.C. § 2401(b).
Davis appeals, contending that either:
(1) the cause of action did net accrue
until he learned, in 1973, of the facts
indicating the government's responsibility
for his paralysis; or (2) the statute was
tolled by the government's fraudulent
concealment of the results of the second
test.
We affirm the district court's grant of
summary judgment.
A two-year statute of limitations ap=«
plies to all suits brought under the FICA.
28 U.S.C. § 2401 (b).* Appellant con=
tends, however, that under the so-called
“discovery rule” applied in medical mal=
"The statute was amended in 1970 to provide that
@ tort claim against the United States shall be
barred unless written notice is provided to the
date federal agency within two years oF
es6 @ suit is instituted within six poaths of
the mailing of notice of final agency action.
Previously, the statute had simply required that
aa action be begua within two years of the time
when it acerued. As will be apparent, the result
in the present case is the same under either form
of the statute.
A=5
malpractice cases, the cause of action
did not accrue and the statute did not
begin to run until he learned, in 1973,
ef the results of the second neuroviru=
lence test. United States v. Kubrick,
444 U.S. 111, 100 S.Ct. 352, 62 L.Bd.2d
239 (1979), is cited in suppert of the
proposition that the action accrues when
the plaintiff learns, or, in the exercise
ef reasonable diligence should have
learned, of his injury and of the actions
that caused it. 444 U.S. at 123=24, 100
$.Ct. at 360-61. While the present case
is not technically one involving medical
malpractice, it is in many ways similar
to such an action,’ and we will assume,
arguendo, that it should be assimilated to
the category of medical malpractice for
statute of limitations purposes. Nonethe«
less, we conclude that appellant's claim
is barred by the statute.
= oe
hee vw. United States, 388 F.Supp. 928,
932 4 * % s s
A=6
The general rule in tort law is that
the claim accrues at the time of the
Plaintiff's injury. In the area of
medical malpractice this has been felt to
be unduly harsh in those cases where the
fact of injury remains undisclosed. The
rule accordingly has widely been modified
to provide that a claim does not accrue
until the injury has manifested itself.
Urie vs. Thompson, 337 U.S. 163, 69 $.Cct.
1018, 93 L.Bd.2d 1282 (1949). The Re-
statement (Second) of Torts § 899, Com-
ment e, quoted in United States v. Kubrick,
supra 444 U.S. at 120 n.7, 100 S.Ct. at
3388 n.7?, reflects this change:
“In a wave of recent decisions
{it has been held) that the
statute must be construed as not
intended to start to run until
the plaintiff has in fact dis-
covered the fact that he has
suffered injury or by the exer-
cise of reasonable diligence
should have discovered it.”
In Kubrick, the Court assumed that the
discovery rule should be further modified
to provide that accrual does not occur, and
A=?
thus that the statute of limitations does
not commence to run, until the plaintiff
has discovered, or, in the exercise of
reasonable diligence should have discov-
ered, both his injury and its cause.*
The Court noted that “the United States
was prepared to concede as much for
present purposes,” id. at 120-21, 100
$.Ct. at 358-59.) The question presented
was whether the rule should be still
further extended to defer accrual until
the plaintiff had, or, in the exercise of
reasonable diligence should have had,
knowledge of the defendant's negligence.
The Court approached this question as one
involving the construction of § 2401(b).
It stated:
*This rule is followed in this and most other cir-
cuits. rford v. United Stat 307 F.2d 99,
102 (9th Cir. 1962). Accord, Exnicious v. United
States, 563 F.2d 418 (10th Cir. 1977); Bridgford
vy. United States, 550 F.2d 978 (4th Ge he 1977);
Jordan v. United States, 503 F.2d 620 (6th Cir.
1974); Toal vw. United States, 438 F.2d 222 (2d
Cir. 1971).
A-8
"[We} are not free to ccn-
strue it so as to defeat its
ebvious purpose, which is to
encourage the prompt presenta-
tion of claims. [Citations
omitted]. We should regard the
plea of limitations as a ‘meri-
terious defense, in itself
serving a public interest.'
[Citations omitted) ."
The Court then made it plain that it
was not prepared to go further than the
government concession. It refused to
defer accrual until fault as well as
injury and cause had been discovered; it
would not hold that “the statute is not
to rum until the plaintiff is led to
suspect negligence.” Id. at 124, 100
S.Ct. at 124.
{2} With knowledge of the fact of
injury and its cause the malpractice
Plaintiff is on the same footing as any
negligence plaintiff. The burden is then
em plaintiff to ascertain the existence
and source of fault within the statutory
period. It follows that diligence or
lack of diligence in these efforts is
A-?
irrelevant. In the absence of fraudulent
concealment it is plaintiff's burden,
within the statutory period, to determine
whether and whom to sue. Kubrick makes
this plain. Once a plaintiff knows that
harm has been done to him, he must, the
Court states, “determine within the
period of limitations whether to sue or
not, which is precisely the judgment that
other tort claimants must make. If he
fails to bring suit because he is incom-
petently or mistakenly told that he does
not have a case, we discern no sound
reason for visiting the consequences of
such error on the defendant by delaying
the accrual the claim until the plaintiff
is otherwise informed or himself deter-
mines to bring suit, even though more
than two years have passed from the
plaintiff's discovery of the relevant
facts about injury." Id.
A-10
{2} Im the present case, appellant was
aware in April, 1963, that he had been
injured and that the Sabin vaccine was
the likely cause of his injury.*
With knowledge of the fact of injury and
its cause, appellant was at the time of
his injury placed on the same footing as
other negligence plaintiffs. The claim,
then, accrued at the time of injury and
the statute started to run. It was up to
him to “determine within the period of
limitations whether to sue or not." Id.
We conclude that i- the absence of
fraudulent concealment, appellant's claim
against the United States was barred by
limitations.
Fraudulent Concealment
{3} Appellamt contends that even if
the cause of action accrued prior to
1973, the statute was tolled by the
*at the very latest, he was certainly aware that
the vaccine was the cause in 1964, when he brought
suit against Wyeth Laboratories alleging that such
was the case.
A-11
government's fraudulent concealment of
the results of the second test during the
October, 1975, deposition of Dr. Kirsch-
stein. This argument fails, since the
two-year period had already elapsed.
Appellant also argues that certain
press releases and reports by the govern-
‘ment indicating that there was no probable
link between the taking of the vaccine
and subsequent polio cases amounted to
fraudulent concealment. This contention
is meritless.** It may well be that
the government was negligent in maintain-
ing and publishing records. However,
failure of the government to ascertain
and publish the fact of its negligence is
hardly sufficient to constitute fraudulent
concealment. See Rutledge v. Boston
**These press releases and reports might have
served also as additional notice to appellant of
the government's involvement in his claim.
A-12
250 (9th Cir. 1978).
We conclude that appellant's action was
barred by the applicable statute of lim-
itations. The decision of the district
court granting summary judgment is af-
firmed.
TANG, Circuit Judge, dissenting.
I respectfully dissent. Quite simply,
the record fails to support the majority's
assertion that “appellant was aware in
April 1963, that the Sabin vaccine was
the likely cause of Davis’ injury."
First, although Davis contacted polio in
April 1963, he was hospitalized until
October 25, 1963, and it is unclear when
he had sufficiently recovered to be aware
of anything. At best, the record indi-
cates that Davis was functioning again in
"approximately June, 1963" when he began
to write letters inquiring about his
A-13
disease. Clerk's Transcript Vol. IA, at
243. ,
More importantly, although Davis may
have wondered in the summer of 1962 if
the vaccine had induced his disease,
"“guestioning” and a “knowing” causation
cannot be equated. The Kubrick court
plainly held that the statute begins to
run only when a plaintiff is "armed with
the facts about the harm donetohim.. ."
444 U.S. at 123, 100 S.Ct. at 360. In
other words, the plaintiff must be in
"possession of the critical facts that he
has been hurt and who has inflicted the
injury" because “the facts about causation
may be in the control of the putative
defendant, unavailable to the plaintiff
or at least very difficult to obtain."
Id. at 122, 100 S.Ct. at 359 (emphasis
added). In Kubrick, the plaintiff had
surgery in April and developed a hearing
loss in mid-June. In succeeding months,
he consulted several specialists who
A-14
diagnosed his malady as "bilateral nerve
disease." Finally, in January (some 7
months after injury), a doctor told
Kubrick that it was “highly possible"
that a treatment administered after
surgery caused his deafness. At that
point, the court held, Kubrick knew of
his injury and its cause and the statute
began to run. .
Here, Davis may have suspected that the
vaccine caused his disease (just as
Kubrick may have suspected his recent
surgery was in some way connected), but
apparently no one, much less a doctor,
would even suggest a "high possibility”
that the two events were causally linked.
To the contrary, all authorities consulted
apparently assured Davis that oral Sabin
vaccine could not be proved to cause the
disease. For example, sometime in October,
1963, still searching for the cause of
his disease, Davis wrote to the Washington
A-15
State Department of Health. In recounting
his story, he stated:
During the last six months I
have had around 20 Drs. check
me and everyone of them have
said I was paralyzed, which I
was just a little bit aware of.
Not one of them would say a
damn thing or admit it could
have been due to the cube that
was the cause of my ill-
ness .. . {sic]
Clerk's Transcript, Vol. IA, at 286.
Consistent with this description, on
October 25, 1963, Davis was discharged
with a diagnosis of paralytic poliomyeli-
tis “due to undetermined cause". Id. at
241. Interestingly, in fact, the Idaho
State epidemiologist refused to report
Davis’ case as poliomyelitis, and, in the
Fall 1964, was stiil diagnosing Davis’
disease as “lower neuron disease with
paralysis--etiology unknown". Id. at
245.
Moreover, the scientists to whom
Davis wrote, and the articles he read,
failed to suggest a causal connection
A-16
between the vaccine and the paralysis.
For example, a1) HEW doctor stated in an
article published in June 1963 that “no
evidence has been adduced to show that
this vaccine, composed of these strains,
had ever caused the disease it was de-
signed to prevent.” Id. at 244. Simi-
larly, in the summer of 1964, Dr. Sabin
informed Davis “that there was absolutely
no way” that he could have contracted
polio from taking the vaccine. Id. at
246. See also id. (U.S. government
committee report of September 30, 1964,
stating that “it is not possible to prove
that any individual case was caused by
the vaccine and that no laboratory tests
available can provide a definitive
answer. )
The record available to me, then,
suggests that Davis was still struggling
to determine the cause of his injury by
the critical date in October 1963, and
well beyond. In any event, at the least
A-17
the question when Davis knew (1) of his
injury (paralysis) and (2) its cause (the
vaccine) should be a factual determination
for the jury, and I would reverse the
premature grant of stmmary judgment ‘
Such a result is justified since the |
Government, as the moving party, has
failed to carry its burden of demornstrat-
ing the absence of a genuine issue of
material fact. See also Marshall v.
Kimberly-Clark Corp., 625 F.2d 1300, 1302
(Sth Cir. 1980) ("A dispute over the
facts surrounding the date the statute of
limitations began ‘would alone warrant
Genial of the motion for summary judg-
_ment.‘'"); see generally Yazzi v. Olney,
Levy, Kaplan & Tenner, 593 F.24 100, 103
(9th Cir. 1979).
In sum, I agree that the majority
properly states the Kubrick rule. On
this record, however, I fail to see how
it can affirm the summary judgment.
A-18
APPENDIX B
IN THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
GLYNN RICHARD DAVIS,
)
ee.) ) No, 77-1942
Plaintiff-Appellant, )
» B.C. Neo.
ve. ) Civil
) 1-74-68
UNITED STATES OF AMERICA, )
) ORDER
Defendant-Appellee. eens
Before: MERRILL, TANG and SCHROEDER,
Circuit Judges
With regard to the petition for re-
hearing in the above matter, the panel
has voted as follows: Judges Merrill and
Schroeder to deny the petition for re-
hearing, while Judge Tang would grant
panel rehearing; and Judges Tang and
Sehreeder have voted to reject the sug=-
gestion for rehearing in bane and Judge
Merrill has recommended such rejection.
The full court has been advised of the
suggestion for an in bane hearing, and no
judge of the court has requested a vote
A-19
om the suggestion for rehearing in banc.
Fed.R.App.P. 35(b) .
The petition for rehearing is denied
and the suggestion for a rehearing in
bane is rejected.
A-20
wemorxc |S ainct on
Tithe ail ae
eS US Se Se ee ee :
SERB CLAPP, Crmte
Quited States Court of Appeals"
FOR The Nintee Concust
-—--—-——e—eoo
GLYN RECHARD, VAWES..
Phaimt {£f-Apperhaunt,,
WSs ee ae Se
UNETED STATES, OF AMERICA, RE CY 1-74-08 A
Defendant -Appelhee.
4
THIS. CAUSE came on to be heard on the Tranactiph of the Becord from the United States
PO EE SE Ey
“me eee tee ee enn enn 9 Ee
ON CONSIDERATION WHEREOR, It in nom hare ordered and adjudged by thin Court, that the
Y Rhee ___ judgment of te saith Dintrick Court im thin Cannan, andi becedy: in, 2° 8. Mn
“—
“h Dy ne
Clark pp Sun
Bint and etanee PER 7D, AW Crees
-m °° a ee -
APPENDIX D
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO
GLYNN RICHARD DAVIS, ) Civil Ne.
) 1+74-68
Plaintiff, )
) ORDER ON
Vv. ) DEFENDANT'S
) MOTION FOR
UNITED STATES OF ) SUMMARY
AMERICA, ) JUDGMENT
)
Defendant . )
)
This matter was duly brought on for
hearing om March 15, 1977, om the Motion
of the United States to Dismiss or in the
Alternative for Summary Judgment. The
Court concludes that matters outside the
pleadings, that is, requests for admis-
sions, interrogatories, amd responses
thereto, together with certain deposi-
tions, affidavits and attachments thereto
and the record om file in Davis v. Wyeth
Laboratories, Civil No. 3973, in this
Court having been submitted and consid-
ered as a part of the record for purposes
A-22
ef disposition of the government's motion
and including in part the Affidavits of
the Plaintiff Glynn Richard Davis, dated
February 16, 1977, March 3, 1977, and
March 22, 1977, together with attachments
to those affidavits, the affidavit of
Dector Ernest A. Ager, dated February 25,
1977, and the affidavit of Blaine F.
Evans, and further including in part a
memorandum dated September 19, 1962, to
Dector George A. Hottle, Chief, LVI, from
Ruth L. Kirschstein, Chief, Pathology,
and the Results o% Neurovirulence Test of
Poliovirus Vaccine in Rhesus Monkeys
dated September 19, 1962, comsisting of
four (4) pages, the matter is properly
treated as a Motion for Summary Judgment
Ppursuamt to Rules 12(b) and 56 of the
Federal Rules of Civil Procedure, and the
Court beins fully advised in the premises,
The Court finds amd comcludes that
there exists mo gemuine or substantial
issue of material fact with respect to
A-23
the Motion of the United States, and that
the United States is entitled to judgment
2s a matter of law, for the reason that
the imstant action is barred by the
applicable period of limitatioms and the
Court lacks jurisdiction of the subject
matter of the action. 28 U.S.C. § 2401(b).
IT IS, THEREFORE, ORDERED and this does
erder that the Motion of the Defendant
Umited States of America for Summary
Judgment be, and the same hereby is
granted, that the Complaint and action
herein be, and the same hereby is, dis-
missed with prejudice, and that the
Defendant recover its costs of action.
Dated this 28th day of March, 1977.
/s/ RAY McNICHOLS
United States District Judge
A-24
APPENDIX E
UNITED STATES DISTRICT COURT FOR
THE DISTRICT OF IDAHO
GLYNN RICHARD DAVIS,
Civil No.
Plaintiff, 1-74-68
UNITED STATES OF
AMERICA,
ee ee
Defendant .
This matter having come before the
Court upon the Motion of the United
States to Dismiss or in the Alternative
for Summary Judgmeni:, the Court having
heard further oral argument on March 15,
1977, by counsel for the parties, the
Court having om this day entered its
Order om said motion, and the Court
being fully advised in the premises;
IT IS HERESY ORDERED, ADJUDGER AND
DECREED that the Defendant Umited States
of America hereby does, have judgment
against the Plaintiff Glynn Richard Davis
and the complaint and action of said Plain-
tiff shall be, and the same hereby are,
dismissed with prejudice and that the
Defendant shall recover its costs in this
action.
Dated this 28th day of March, 1977.
/s/ RAY McNICHOLS
United States District Judge
A-26
APPENDIX F
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO
GLYNN RICHARD DAVIS,
Plaintiff, Civil No. 1-74-78
AFFIDAVIT OF
GLYNN RICHARD
DAVIS IN SUPPORT
AMERICA, OF MOTION TO
RECONSIDER ORDER
Defendant .- GRANTING SUMMARY
et et et et eet et et eet et et ee
GLYNN RICHARD DAVIS, being first
duly sworn under oath, deposes and says:
That I was a plaintiff-appellant in
the case of Glynn Richard Davis, and
Florence Davis v. Wyeth Laboratories,
Inc., and American Home Products
Corporation, Civil No. 3973, United
States District Court for the District of
Idaho, Appeal No. 20995 in the United
States Court of Appeals for the Ninth
Circuit. That I am the plaintiff in this
action and make this affidavit in support
AZ
of my Motion to Reconsider Order Granting
Summary Judgment.
That on or about March 17, 1963, I
ingested Sabin Type 3 oral polio virus
vaccine taken from Lot 35 manufactured by
Wyeth Laboratories.
That approximately two weeks follow-
ing ingestion of the vaccine, I contracted
oral poliomyelitis, and after being
treated in the Ashton Memorial Hospital,
I was transferred to Idaho Falls, Idaho,
where I was treated in the Idaho Falls
Hospital; thereafter I was transferred to
the Idaho Elks Rehabilitation Center, in
Boise, Idaho, on May 14, 1963, and dis-
charged on June 13, 1963, for admittance
to the Veterans Administration Hospital
of the United States government in Boise,
Idaho.
That I remained in the Veterans
Hospital until my discharge on October 25,
1963, but thereafter I returned daily for
physical therapy, which continued until
A-28
,
May 29, 1964. At the time of my discharge
from the Veterans Admiristration on
October 25, 1963, my case was diagnosed
as follows:
"Paralytic poliomyelitis, conva-
lescent stage, due to undeter-
mined cause, with paralysis of
the lower extremeties, and
paresis of the right triceps."
The history of the licensing of
Sabin oral polio vaccine and the mass
immunization clinics that were held
throughout the United States for the
purpose of innoculating as many people as
possible are graphically and correctly
described in Davis v. Wyeth Laboratories,
399 F.2d 121 (9th Cir. 1968). In Febru-
ary, 1962 the Communicable Disease Center,
(CDC) of the United States Public Health
Service, and the Department of Health,
Education and Welfare of the United
States announced that Type 3 monovalent
vaccine had been licensed and that a
complete oral polio virus vaccine was
thus available. The sgcvernment, through
A293
the CDC and HEW, announced at that time a
campaign to completely eliminate paralytic
poliomyelitis in the United States.
Idaho, pursuant to the national plan,
subsequently held clinics in the eastern
part of the state, one of which was held
at West Yellowstone, Idaho which was
attended by me. Although doctors were
supposed to be in attendance at the
clinics, there was no doctor at the
clinic in West Yellowstone, Montana, and
the administration of the vaccine was
delegated to a pharmacist.
On September 20, 1962, Luther Terry,
M.D., Surgeon General Public Health
Service, U.S. Department of Health,
Education and Welfare, issued a report of
the Surgeon General's Oral Poliomyelitis
Vaccine Advisory Committee, which had
been meeting in Washington, D.C. and
reviewing the data concerning the occur-
rence of cases of poliomyelitis after the
administration of poliomyelitis vaccine —
A-30
during the calendar year of 1962. His
report contained the following statement:
Sats Ste 'er‘Shte ane moe
SEVERAL LOTS AND WAS NOT
PRODUCED BY ANY SINCLE MANU-
FACTURER.*
Lot 35, from which was taken the vaccine
which I ingested, was not yet licensed by
the United States government for use.
However, prior to isouance of the Septen-
ber 20, 1962 report, Lot 35 had been
subjected to two tests by the federal
government. The second test made on the
vaccine revealed that it did not meet
applicable government standards required
for licensing and release of the vaccine
to the public. This information was
available to the Government on Septen-
ber 3, 1962, just two weeks before
Dr. Terry issued his press release. I
did not discover that the vaccine that I
took did not meet government standards
until approximately the time I filed my
claim with the government for damages on
A31
April 39, 1973. I was also unaware of
the Surgeon General's Report, and not
until the summer of 1963 did I discover
it and the report of the Surgeon
General's Committee issued on December 21,
1962. In the latter report the Committee
stated:
"IT SHOULD SE EMPHASIZED THAT
THE COMMITTEE DOES NOT CONSIDER
THAT AN INDIVIDUAL CASE CAN BE
PROVED TO BE CAUSED BY THE
VACCINE AND NO LABORATORY TEST
HAS THUS FAR PROVIDED A DEFINI-
TIVE ANSWER."
The Committee recommended that community
plans for immunization be encouraged,
using all three types of vaccine, that is
Types 1,2 and 3.
In January of 1963, Lot 35 manufac-
tured by Wyeth was released by the Surgeon
General for distribution despite the fact
that it did not meet government tests.
After contracting the disease of polio
and after sufficiently recovering to be
able to do so, I began an intensive
search in approximately June, 1963, to
A-32
@etermine why I was given a vaccine that
weuld give me the the disease instead of
preventing it. My wife is a registered
nurse. Im the process of my search I
discovered the Surgeon General’s Report
of September 20, 1962, and the Commit-
tee's Report eof December, 1962. In
addition, some time in the summer of
1963, I read am article published on
June 22, 1963 im the Journal of the
American Medial Association. The article
was authored by Henry Gelfand, M.D.,
Chief Enterovirus Unit, Communicable
Disease Center, (CDC), Umited States
Public Health Service, Department of
Health, Education and Welfare. It is to
be noted that it was the Communicable
Disease Center which was charged with the
responsibility ef ascertaining the cause
ef the disease and the relationship
between disease amd the cause. It was
Dr. Langmuir of the Communicable Disease
Center who first proved epidemiologically
A
that the vaccine could cause the disease.
My case against Wyeth, Civil No. 39373 in
this Court, was finally tried om the sole
issue of epidemiological proof that the
waccine had caused the disease.
There was mo evidence available to
me or to the public that the vaccine was
not manufactured im accordance with
government standards or that the waccine
with respect to amy particular lot was
defective in the sense that it would give
the recipient the disease. The proof of
causation in that trial, and the only
proof available, was through the use of
epidemiology. Im Dr. Gelfand"s article,
at page 353, he stated the following
after reviewing the various cases of
polio im the United States:.
"Until recently, there was
almost universal agreement that
living, attenuated, oral polio
virus vaccine (OPV) composed of
the Sabin strains is safe, both
t® @ primary vaccinee and to
his contacts. This tation
for safety was one of bases
ef the use of OPV in millions
of persons im the U.S. and many
Aw
ether countries. Although the
thoroughness of routine report=
ing of morbidity and of special
surveillance for possible
vaccine-induced cases of
paralytic poliomyelitis dif-
fered greatly among the
Various programs, no evidence
has been adduced to show that
this waccine, composed of
these strains, had ever caused
the disease it was designed to
prevent."
Im the same article, Dr. Gelfand
alse stated:
“IF A HARMFUL RESULT WERE A
GENERAL PROPERTY OF A VACCINE,
NO ASSOCIATION WITH MANUFACTURER
OR LOT CAN BE DEMONSTRATED WITH
EITHER THE INACTIVATED OR LIVE,
ATTENTUATED TYPES. IF, HOWEVER,
THE DEFECT WERE NOT A UNIFORM
PROPERTY, BUT A VARIABLE IN THE
MANURACTURING PROCESS, SUCH AN
ASSOCIATION MIGHT BE DEMON-
STRABLE..”
Among the “compatible” cases studied by
this special committee in 1962, no assoeci-
ation with manufacturer or lot was found.
Vaccines of all three American producers,
and many different lots, were represented
ameng these cases. And them, in Table 2
of the article, Dr. Gelfand stated that
with respect to Sabin oral vaccine no
ABD
causal connection was demonstrated between
a particular lot of vaccine and incidence
of the disease.
Im attempting to find out why I got
the disease from the vaccine, I commenced
im the early part of the summer of 1963
to write to numerous people, one of whom
was Dr. Ernest Ager, the state epidemi-
elegist for the state of Washington in
Olympia, Washingtom. Im respomse to my
letter, I received ome from Dr. Ager on
October 30, 1963, which was introduced as
plaintiff's Exhibit No. 25 at trial. Im
Dawis w. Wyeth, Civil No. 3973 Dr. Ager
referred my case to the Communicable
Disease Center im Atlanta, Georgia.
Dr. Johm Mather, the Idaho State
Spiduntelaqaet, has refused to report my
case as one of poliomyelitis.
Im 1964, the Surgeom General's
Committee again met, amd issued a new
report, the new committee had greatly
expanded its membership, and Dr. Ager was
AB
a member of that committee. This report
came out om September 30, 1964. Immedi-
ately prior to issuance of the report, in
a letter dated August 17, 1964, Dr. Pierce
Gardmer, Chief of the Poliomyelitis
Surveillamce Umit, Department of Health,
Education and Welfare, wrote Dr. Mather
and told him that the Committee had met,
and that my case was placed in the
compatible probable group. Gardner
stated that he thought that Mather would
appreciate advamce motice of the Commit-
tee"s judgment im that Mather might wish
to comsider the Committee"s opimionm in
reaching a fimal decisiom whether to
include this case as am official reported
case of poliomyelitis. This letter is
plaintiff"s Exhibit No. 17 im Davis wv.
Wyeth. Plaimtiff"s Exhibit No. 16 im
that case is Mather"= -respemse to
Dr. Gardner, im which he <«)scted the
thinking of the Surgeom Gene: al"s Commit-
tee om poliomyelitis, a committee composed
AD
ef the outstanding epidemiologists,
neurologists and doctors im the field of
poliomyelitis im the world, and stated
that:
"The present diagnosis of lower
neurom disease with paralysis--
etiology umknownm--is the con-
timuing diagmosis by this
ee ef this interesting
My case never has been officially reported
by the Idaho Department of Health.
Im conmection with this matter, I
wrote numerous people including the
tiom an} the Umited States Public Health
Service im Boise, Idaho. Attached to
this affidavit as am exhibit is a copy of
the letter which I wrote to Mr. J. W.
Montieth, Administrator of Natiomal
Health and Welfare, Ottowa, Ontario,
Canada, which is typical of the letters
that I semt out. Imcluded im the
correspondence which [I sent to many
doctors amd scientists, both im and out
ef government, was a letter toDr. Sabin
AB
himself sometime in the summer of 1964;
Dr. Sabin responded that there was abso-
Lepaly me way thet I could have contracted
polio from taking the vaccine.
I authorized my attorney, Mr. Blaine
Evans to interview Dr. Jomas Salk to see
what information could be obtaimed from
him. Om July 18, 1964, my attormey, in
company with Mr. Dale Clemoms, another
attormey im Boise, Idaho, visited Dr.
Salk. Dr. Salk was umable to furnish any
information that there was am identifica-
tiom of amy particular lot with the
vaccine induced poliomyelitis cases being
reported around the Umited States.
Im its report of September 30, 1964,
the revised poliomyelitis committee
imcluded my case, amd I was judged a
probable compatible case of having the
disease induced by the vaccine. The
Committee expressly stated im its report,
however, that mo specific case could be
proved to have beem caused by the vaccine.
The Committee specifically stated:
AD
Thereafter, im the Journal of the American
Medical Associatiom, October 5, 1964,
Dr. Alexander Langmuir, who had first
proven epidemiologically that there was
am association between the vaccine and
the disease, stated im referemce to the
Committee's findings:
"There was mo apparent associa-
tiom of cases with specific
lots of vaccine or vaccines
produced by a particular manu-
facturer."
Im other words, at mo time did the govern-
ment ever state that a lot of vaccine
that had beem released and used had mot
met government standards and im fact, the
United States stated continuously to the
contrary that mo specific lot of vaccine
was involved im causing the disease. The
A-40
scientific thinking at that time was that
the vaccine relatiomship to disease was a
general property of the vaccine and not
one resulting from improper manufacturing
of the vaccine. With numerous individuals
having been interviewed by my attorneys,
with my own letter writing, and with the
articles that I had read following my
getting the disease, it was obvious at
that time that the vaccine that had been
released had met government standards and
that the government could not have been
at fault im releasing for public use the
particular lot of vaccine from which I
was vaccinated.
As a matter of fact, it was not
umtil the Surgeom General"s Report in
September of 1964 (and read by me almost
immediately upom its publicatiom) that
there was amy comcrete evidence that my
own case could have been associated with
the vaccine. Here again, it was thought
or believed by the leading scientists and
A41
Goctors, including the very inventor of
the vaccine, that there was no evidence
that it would have made any difference as
to which lot of vaccine I had taken.
Th*« was the proof that was adduced
against Wyeth. The Circuit Court of
Appeals itself im considering my case on
appeal pointed out that the lot of vaccine
that had been used had met government
standards and that the only proof of
vaccine-induced disease was epidemi-
ological. Moreover, when the drug house
took the depositiom of Drs. Kirschstein
and Murray im October of 1965, Wyeth"s
attorneys as well as my attorneys were
assured im the depositiom that the test
administered by the Divisiom of Biologic
Standards of Lot 35 met government stan-
dards, but im fact Dr. Kirschstein failed
to disclose, although asked about it, any
other testing and kept secret the fact
that a second test was conducted on Lot
35 which revealed that Lot 35 failed to
M42
comply with government standards and
therefore never should have been released
to the public. The second test, all of
which is more fully explained in the
affidavit of Stanley Kops, which is
incorporated herein by reference, shows
that the lot of vaccine that was released
by the government and that gave me the
disease was a lot of vaccine that was too
virulent by government standards to be
released. It had not been sufficiently
tamed or in the language of the scien-
tists, attenuated to be released.
Virulence means a capability of giving
the disease to a human host. For this
reason, when I first learned of the
results of this second test, I immediately
filed a complaint against the government
Om the ground that the government was at
fault im releasing this defective lot of
vaccine and the government's release of
Lot 35 in violation of its own regulations
caused me to get the disease.
A43
Following my trial in Davis v.
Wyeth, certain exhibits were withdrawn
from the file of the court at my request.
I have examined these exhibits and they
are the same documents offered into
evidence at that time, and as a part of
this affidavit, I now list these documents
and include them in this affidavit:
Idaho Falls medical
records
Idaho Elks" Rehabilita-
tion Center Records
Veterans Administration
Hospital records
Idaho State Laboratory
Report
Chart of incidence
of polio
Press Release from
the Office of the
Surgeon General,
August 22, 1962
Surgeon General's
Press Release of
September 15, 1962.
A-44
12
14
16
17
23
28
State of Idaho, Dept.
of Health, Bureau of
Vital Statistics-
statistics on polio
Chart on Polio
Incidence in Montana
1962-1965
Letter from William F.
Cashmore, M.D. Secre-
tary of the Board of
Medical Examiners
State of Montana, to
Blaine F. Evans
Letter from John
Mather, M.D.,
Director of Prevertive
Medicine Division to
Pierce Cardner, M.D.
dated June 26, 1964
Letter from Pierce
Gardner, M.D. to
John A. Mather, M.D.
dated August 17, 1964
rr, 1963 issue
of Northwest Medicine
Form used in Sabin
vacination program
Record of plaintiff's
vaccination with
Type 1 Sabin vaccine
Letter from Ernest A.
Ager, M.D. to Glynn
R. Davis, dated
October 30, 1963
Check for $74.50
dated April 1, 1963
to Del Simpson from
Robert M. Brower
A4
32
33
34
35
36
37
38
70
Check for $79.50
dated May 7, 1963
te Del Simpson from
Robert M. Brower
Record of Wyeth
Laboratories of ship-
ment of Type 3
vaccine to Idaho Falls
Medical association
Statement of $150.20
from J.N. Franklin
Invoice to KO Polio
¢/o J. N. Franklin
dated April 30, 1963
for $32.00
K.O. Polio Expense
invoice for $68.91
signed by J.N.
Franklin
Summary of Invoices
PIE Freight Bill
dated 3/6/63 to
Bannock County Health
Unit
Menorarndum to All State
and Territorial Health
Officers frow Dr. A.L.
Gray, re: Statement
on Type 3 Oral Polio-
myelitis Vaccine,
dated September 14,
1962
Morbidity and
Mortality, Weekly
Report, by U.S.
Department of Health,
Education and Welfare,
Public Health Service,
Vol. 13, No. 54
A-46
Poliomyelitis
Surveillance Report
No. 225 dated June 16,
1961
OTHER EXHIBITS OFFERED
WITH THIS AFFIDAVIT:
The Association of
Cases of Poliomyelitis
with the use of Type
III Oral Poliomyelitis
vaccines (September 20,
1962) by Luther L.
Terry, M.D.
Supplement to PSU
273, December 21,
1962
Oral Vaccine: Associ-
ated Paralytic Polio-
myelitis, 1962,
Journal of American
Medical Association,
by Henry M. Gelfand,
M.D. Atlanta
Oral Poliomyelitis
Vaccines, Report of
Special Advisory
Committee on Oral
Poliomyelitis Vaccines
to the Surgeon General
of the PUblic Health
Service, Vol. 190,
No. 1 submitted by
Dr. Alexander D.
Langmuir
Letter dated 9/4/64
from Glynn R. Davis
to Jay W. Monteith
Poliomyelitis Surveil-
lance, Report No. 285
September 30, 1964
A-47
Although the Surgeon General's
Committee was emphatic in issuing state-
ments that no particular lot of vaccine
was involved as a lot that induced the
disease in the human host and that the
disease producing characteristic oi the
vaccine manufactured, I do know, and I
have been informed by Dr. Ernest Ager,
and assert the fact that he, as well as
the other members of the 1964 Surgeon
General's Committee, was told by Dr.
Roderick Murray, a member of the Commit-
tee and Dr. Kirschstein's superior at the
Division of Biologics Standards, that all
cf the lots that had been released by the
United States government for use by the
public had met government standards. In
fact, of course, as Dr. Murray well knew,
or should have known, Lot 35 did not.
/s/ GLYNN RICHARD DAVIS
A-48
SUBSCRIBED AND SWORN to before me
this day of February, 1977.
Notary Public for Idaho
Residing at Boise, Idaho
A-49
APPENDIX G
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO
GLYNN RICHARD DAVIS,
Plaintiff, Civil No.
1-74-68
Vv.
AFFIDAVIT OF
STANLEY P.
KOPS
UNITED STATES OF
AMERICA,
Defendant.
me ee ee ee ee ee ee ee ee ee ee”
A-50
COMMONWEALTH OF PENNSYLVANIA:
COUNTY OF PHILADELPHIA:
Stanley Pau] Kops, Esquire, being duly
sworn according to law deposes and says
that he is a member of the law firm of
Freedman, Browosky and Lorry, who were
counsel for the plaintiffs in the case of
Griffin v. United States of America, 351
F.Supp. 10, -F.2d- CA3,
1974, and that in the trial of Griffin v.
United States of America, documents were
introduced into evidence which showed
that Lot 35 of Wyeth Type III did not
comply with the Code of Federal Regula-
tions relating to Sabin Polio Vaccine;
that the five licensing lots of Wyeth
were lots 1€. 19, 20, 23 and 24, that as
of September 1, 1963, Wyeth Lots 23 and
24 would not have been released and in
fact their release was in violation of
the Code of Federal Regulations; that Lot
35 according to documents introduced in
the Griffin trial was tested on two
A-51
occasions by the U.S. Government, once
beginning June l, 1962 and then sonia
beginning August 17, 1962; that at the
depositions of Dr. Roderick Murray and
Dr. Ruth Kirschstein, in the case of
Davis v. Wyeth, the U.S. Government
employees only testified in regard to one
test and only one test was marked as an
exhibit. The test of August 17, 1962
which had a grade 4 monkey which had
never been seen in regard to NA2 by the
use of the intrathalamic test in the
hands of the U.S. Government was never
disclosed to plaintiff or plaintiff's
counsel. According to the regulations
this lot did exceed the NA2 standard. In
addition in a meeting held on October l,
1962 a comparison. of the Wyeth Type III
Vaccine with NA2 indicated that Wyeth
Vaccine far exceed NA2 in regard to the
number of grade 3 lesions and grade 4
lesions and the number of monkeys showing
any grade whatsoever. Attached to this
A-52
affidavit is a letter from Paul Fehnel,
Esq. indicating in paragraph nine that
Wyeth Lots 23, 24, and 31 would not have
been accepted for release as of August 12,
1963. Lots 23, 24 and 31 were among the
four preceding lots to lot 35. Attached
to this affidavit is a copy of the meet-
ing of January 30, 1963 in where there is
a discussion of Wyeth Type III Polio
Vaccine testing in regard to Lots 35, 36
and 40. Lots 36 and 40 were the lots
which followed Lot 35.
Attached to this affidavit is a copy of
the minutes of the meeting of October l,
1962 which indicates on page two of the
said document that Wyeth Type III Vaccine
far exceeded NA2. At no time did the
U.S. Govenrment disclose to plaintiff or
to plaintiff's counsel in the case of
Davis vs. Wyeth the fact of the second
test in regard to Lot 35; the fact that
the four preceding lots did not qualify
under the Code of Federal Regulations;
A-53
the fact that the five licensing lots did
not comply with the Code of Federal
Regulations. The attached documents are
among the records furnished plaintiff's
counsel by the U.S. Government in the
matter of Griffin vs. U.S. of America.
Stanley Paul Kops, Esquire further
deposes and states that the facts set
forth above are true and correct to the
best of his knowledge, information and
belief and based on the review of the
records of Griffin vs. U.S. of America
and the depositions of Dr. Murray and Dr.
Kirschstein in the case of Davis vs.
Wyeth.
/s/ STANLEY PAUL KOPS
A-54
APPENDIX H
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO
GLYNN RICHARD DAVIS, Civil No.
1-74-68
Plaintiff,
AFFIDAVIT OF
ERNEST AGER IN
SUPPORT OF MOTION
TO RECONSIDER
ORDER GRANTING
SUMMARY JUDGMENT
TO THE UNITED
STATES
vs.
UNITED STATES OF
AMERICA,
Defendant.
eee Oe eae
STATE OF WASHINGTON )
County of King 106:
ERNEST AGER, being first duly sworn,
deposes and says:
That some time in the summer of 1964,
he was appointed by the Surgeon General
of the United States to the Surgeon Gen-
eral's Special Advisory Committee on Oral
Poliomyelitis Vaccine and that this Com-
mittee met some time in July, 1964.
That one of the members of this Com-
mittee was Dr. Roderick Murray, who at the
time of the Committee's meeting in July,
“4-55
1964, was Director of the Division of Bi-
Ologics Standards of the Nationai Institutes
of Health.
That the subject of the Committee's
study was the possible relationship be-
tween ingestion of Sabin vacine to inci-
dence of the disease of polio.
That during the Committee's meeting in
July, 1964, Dr. Murray represented to the
Committee that all Type 3 Lots of the
oral vaccine which had been tested by the
Division of Biologics Standards up to the
time of the July 1964 meeting had satis-
fied the government's neurovirulence
standards.
/s/ ERNEST AGER
SUBSCRIBED AND SWORN to before me this
25th day of February, 1977.
/s/JOY E. McCORMICK
Notary Public for Washington
Residing at Lynnwood
A-56
CERTIFICATE OF DELIVERY
I hereby certify that on the 14th day
of March, 1977, I hereby served a copy
of the above and foregoing Affidavit of
Ernest Ager in Support of Motion to Re-
consider Order Granting Summary Judgment
to the United States by delivering a
true and correct copy of same to United
States Attorney for the District of Idaho,
Paul L. Westberg, 550 W. Fort Street,
Boise, Idaho.
/s/ ROBERT M. TYLER, JR.
A-57
8S-WV
‘ Result of dewrovireien coat vs Pelsevitet Vaccine in eur Honkeys
wyetl Let He. PO 35-11t by _Iatrathalestc teceutation titer-log 107:? | RED.
est perflorned at ops by pes Test scored at__ 08S Se .
olume of inoculum/monkey .
wvber of rry 4 inocu s y -... (2) Date of inoeviation £/17/%7
ee ee Date of secrifice — 9/32
il. iT Histologic Lesions of Poliomyelitis a
ri Monkey | faralyets | ~~ Cuaber | Cervical ~“fedul ie Score wf Foli+
noc. | Wo. —
fa 2 Li2]3/ 4] 5] 6] av | tover|vpper| midbrain |] Severity®|Sprera”
19h} 13046 we Olololojolo] o Folololololol o inline 0 ——
2 15047 af O1O;O;O0;0;0) Oo O;O;O;O;o0;08 0 0 0 0 0 6
L5048 " O}Ololololo] o fololjolojojof o | o 0 0 0 0
» | is049 " ololojololo] o | ololololojof o fo | o | om fo ‘| J
- 1.5050 e (EERE olol eo oie 27.0.9 .0 | 02 | sm = ae ee 5
aS Ulla Glojolojolo] o f ojojojojojof o | o 0 O- t) i
" 1.5052 nd O1O0;0;0;/0; 0) 0 O10; 0/0/;0); 05 0 ie) 0 0 0 Lo
S 15053 ws O1}O;O7O, 0; 048 0 010 4 ojo; 0 tC) QO i) AS Ah eee
° L5054 Mh 3} 3}2/3)2)38 3 83,313) 3, 2,25 3 . a 3 4 Le
« | 15055 ° OL O;Olo; oO; oO] © Fojojolojojo} © Ff o ) 0 ee 2 OE
Total ne. with polio/tetal ac. ef @onkeys - Tetsl Ratio Seesnext pace/
* + non-specific lestons Av. = erithectic average of lusber or cervical icsion score
' « mo lestons @ -s average lesion score in arcas of or close ‘o inoculation
score key for lesions of poliompelitic & = average Lesion score in ares most dist..nt from
1 + winioal ivoculation site :
2 + wfld © -« Tetel ratie; total lesion scere over aueber: of mon! cys
3 - moderately severe uP - no pacelysic
4 + severe
a, Me enessaw - au
6S~-W
220
Reowlt of ticwrovirulonce test of foliovirus Vaccine tn Mheeua Monkeys
kyeth tet He, PO -IS-tF by __Introthalomic Luocutat Lon ‘gheer-tog 10? a
wee Fe eee
perforned at “DNS by — * . Test scored ot aes by mre.
“2 of wnat ~ homer
vc of ot ah! nyo "5,000,000 AY (2) Date of incculation 8/17/62
(4) Date of sacrifice oir?
a a Wistologié Lesions of Poliomyelitis
Neukey | Pavalyete jiabne evizar tedulla Yc ¢ ot toile
tie,
j tl2ialalsis S[a[afe [a] a] ae | tore [onper|auencate ty" lsngend®
| 13056 ud OOOO; O; 0] Oo olololololol o i) °o » © =a = ee
ise] Jolololololol Holelololelolo fo | o| 0 °
_ 15059 ° OfOlOlololo] o Hololojojo ol 0 0 t) t) i = Ss
Ro OOOO lO/ Ol oO VOlolioiolololo fo jo 9 = -_
12000} WOLOTO 10/01 oO Hololaialolof o fo | 0 | 9 8 a
_| ©5061 bed OOO ;0;0;01 Oo O;O;O;O;o;oF o t) ) ) - © 0
_|_ 15062 ” Ojo jo jolojolo Holololojololo ojo] oe { 0 wa Re
[5063 " OfOsolelojof o folololjojolof o Fo C) () | t)
_.| 15066 ” 0 )0/0jo/0/0} © Tolololojojoj o o | 0 0 0 0
Lnsons. J ojolojojojoj o sjojololofo f_o J o-| « Jo 0.
Total no, with polic/totel we. of soukeys = Total Rate Seq wext patsy
non-speelCle Lesions dv. = arithectic average of lusber or cecvien! Irelon sence
no icstons & + average lesion score in areas of oc close to inoculation
> bey fow Lestous of polfowyel itis b + average Lesion scove in ates most distant ices
t+ elatest inoculation site
2 + mild c * Total wath: totel leston score ever .ourber of ecal.cys
Fe eadewstole eeusee ws. weet sole
09-V
rlovecd
ok neculur/
se
ef
—
Resuit of teursvirulence ‘tose of Pelluvives Vacelne tn Mhecus Konkeyy ft
yeth_—4t We. __ pa 2s3tt_. by jntrathelante _tneculagion — tlter-teg 10 aS ee
rage
by pes Test deored o¢__ pw byt
—_---
eris/6>
Auceulated/monkey 32.009,,090_.._ (3) _ __(2) Dace of inoculation <j
ees ji
(3) (4) 7. fe
'* a | — Wletologic estene pe Lh 7
L213 5 Liza 6 ff Lover luppce'
15066) tw FOL OG lololo} o fojololojojoro fe 0
15057 . olojolololo] o foicto 218 eo o ho. to
_ 15068 | ¥ clololololo}] oF ololojojojoj o fF o je
13069 ye Jolololololo ) ololololalo o §_° je
_1s070|__" _ folelolelololo tele olofo | o |e
1.5071 ° olololololol o Fololjejojojo§ o ojo
3072 e Ololololo/ol o Fololol;oio/o8 o o;}o
. ° olololololo} o Fojololelaios o oj ¢
i ABABA Ojojojojojoy o fF of 2)
5075 “ ajojo ojo ejojeloloji o iaaeaee
he Totel no. with polie/tetct no. of monkeys = 2/30.
oe 0 sts tnt test mee ane fo arto
key Cov lesions of pollesyelitis b = average Leslon scoce in eres mest distant fre.
wild
wintwrl
wodevately severe
severe
inoculation site
= Total ratio: total lesion score over ausber of soukeys
a? «+ no paralysis
APPENDIX J
THE ASSOCIATION
OF
CASES OF POLIOMYELITIS
With the Use of Type III
Oral Poliomyelitis Vaccines
A TECHNICAL REPORT
by
Luther L. Terry, M.D.
Surgeon General, Public Health Service
U.S. DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE
September 20, 1962
. The data in this report have been compiled
by the Poliomyelitis Surveillance Unit, Communi-
cable Disease Center, Public Health Service, U.S.
Department of Health, Education, and Welfare. The
information is based on routine morbidity and spe-
cial poliomyelitis surveillance reports, indivi-
dual case investigations and a wide variety of
laboratory and field studies, all of which repre-
sent the work of several hundred practicing physi-
cians, local, state and federal health officials,
epidemiologists, and laboratory scientists. Their
contribution is gratefully acknowledged.
A-61
On September 15, 1962, the Surgeon
General's Oral Poliomyelitis Vaccine Ad-
visory Committee met in Washington, D.C.,
and reviewed the data concerning the oc-
currence of cases of poliomyelitis after
the administration of oral poliomyelitis
vaccines during the current calendar year.
After a full discussion of the problem
the Committee unanimously recommended
that the use of Type III vaccine be limi-
ted to preschool and school age children
and to adults at high risk, i.e. those
traveling to hyperendemic areas and those
living in areas where Type III epidemics
were present or impending. They advised
that mass programs using Types I and II
oral vaccines be continued for all age
*
Groups.
“The members of the Special Oral Poliomyelitis
Vaccine Advisory Committee who approved the recom-
mendations are: Drs. David Bodian, John P. Fox,
Archie L. Gray, William McD. Hammon, Hugh H.
Hussey, Alexander D. Langmuir, Roderick Murray,
John R. Paul, Edward B. Shaw, Joseph E. Smadel.
Dr. Albert B. Sabin, also a member of the Commit-
tee, participated in its first two meetings on
A-62
The present report summarizes the
information which was reviewed by the
committee and upon which its recommenda-
tions were based. Included are: (1) a
brief review of the use of poliomyelitis
vaccines in the United States, particular-
ly the use of recently licensed oral
poliomyelitis vaccines; (2) an appraisal
of the present poliomyelitis problem; and
(3) a listing, in detail, of the cases of
poliomyelitis that have occurred in
association with the use of oral poliomye-
litis vaccines. This information is
being made broadly available to the
medical and health professions at this
time in order that they may have the
opportunity for a full understanding of
the basis for the recommendations.
Use of Poliomyelitis Vaccines:
The Type I oral vaccine was licensed
for distribution in interstate commerce
August 9 and 16, 1962. He was out of the country
on September 15 and was thus unable to be present
at the meeting on that date. The Surgeon General
served as Chairman of the Committee.
A-63
on August 17, 1961; Type II vaccine on
October 10, 1961; and Type III on March
27, 1962. Prior to these dates, experi-
mental lots of the respective vaccines
were employed in a number of small scale
and some large scale community programs.
Since vaccine licensure, a great
many community-wide vaccination programs
have been carried out. The programs have
ranged in size from those involving
Single small towns, to those which in-
clude metropolitan areas in several
continguous counties, ‘to an essentially
statewide program in Massachusetts. The
oral vaccines have also been employed for
smaller programs among selected popula-
tion groups and for routine use in pri-
vate practice and health department
immunization clinics.
In epidemic control, Type I vaccine
was used immediately following release in
the Syracuse, New York, area and, in
1962, in many counties of Texas; in
A-64
Mobile, Alabama; Pasadena, California;
and several rural counties in Kentucky
and Pennsylvania to abort existent or
impending epidemics. Experimental lots
of Type III vaccine were used in 1961 in
outbreaks in Atlanta, Georgia, and in
Newberry County, South Carolina. Commer-_
cial Type III vaccine was used in Wash-
ington County, Virginia, in 1962.
The estimated use of oral vaccines
in the United States is summarized in
table 1. Utilization of both experimen-
tal lots and the licensed product is
shown. Since it was recommended that
Type 1 vaccine be fed first and because
many programs did not start until late
spring, the estimates show a much greater
use of this type of vaccine than Types II
and III. Estimated use in community
programs of the three types of vaccine by
mouth is shown in figure 1.
In most areas the vaccine was of-
fered to persons of all ages and found
A-65
wide acceptance among adults as well as
children. In a few areas, as in Massa-
chusetts, use of the oral vaccines in
public programs was largely limited to
children.
During the past 12 months, the
inactivated (Salk) poliomyelitis vaccines
(IPV) have continued to be used although
iess widely. Since April 1955, a total
of 537 million doses of IPV has been
distributed. A random sample survey of
the population in September 1961 indica-
ted that slightly more than 50 million
persons in the population had received 4
or more doses of the inactivated vaccine.
Incidence of Poliomyelitis:
The annual’ incidence of reported
cases of poliomyelitis by paralytic
status from 1955 through 1961 is shown in
table 2. The marked decline in paralytic
cases can be attributed largely to the
widespread use of the inactivated polio
vaccine. During the first 9 months of
A-66
1962, the incidence of poliomyelitis has
further declined as shown in table 3.
Present data indicate that for 1962,
the paralytic poliomyelitis rate for
those under 20 will be approximately 7.6
per million; for those over 20, about 0.9
per million. These rates will represent
a record low for the 52-year period since
the reporting began.
. The further decline in the incidence
of poliomyelitis in 1962 may be attribu-
ted to the steadily improved immunization
status of the population resulting both
from the continued use of inactivated
polio vaccine and the wide use of oral
vaccines.
The Occurrence of Cases Following Oral
Vaccine:
With the licensing of Type I oral
vaccine in August 1961, the poliomyelitis
surveillance program of the Communicable
Disease Center placed particular stress
on the evaluation of reported cases of
A-67
poliomyelitis developing after vaccine
use. It was recognized that when mil-
iions of persons participate in an immun-
ization program, any of a variety of
subsequent events might occur coinciden-
tally but be attributed erroneously to
the vaccine. This could be particularly
true of an intercurrent disease such as
aseptic meningitis that might simulate
poliomyelitis and even poliomyelitis due
to infection with wild polioviruses that
had been acquired prior to the vaccina-
tion. The problem is compounded during
the summer and early fall when many
enteroviruses are actively circulating.
In epidemic control a number of
cases of disease among vaccinees can be
expected in the days immediately follow-
ing an immunization program before there
has been opportunity for immunity to
develop. In nonepidemic areas, the
frequency of coincidental cases should be
lower, although not necessarily zero. If
A-68
vaccine is related in a causal way to the
cases, the intervals between immunization
and onset of disease should group with
the expected 7- to 30-day incubation
period of the disease.
Since August 17, 1961, when Type I
oral vaccine became commercially avail-
able, there have been 62 cases of polio-
myelitis officially reported to the
Public Health Service in which oral polio
vaccine had been administered within 30
days prior to the onset of symptoms.
During the epidemic in New York
State in 1961, a total of 32 "under
30-day vaccinated cases" was reported.
Most of these developed soon after admin-
istration of the vaccine, in fact, 15
within 6 days. The early appearance of
these cases indicates a coincidental
rather than a causal relationship to
vaccination. Similarly, in South Caro-
lina, Georgia, and Texas, a total of 17
"under 30-day vaccinated cases" was
A-69
reported. Again, most appeared soon
after vaccination, 11 within 6 days, and
do not suggest a causal relationship.
In the nonepidemic areas, a total of
16 “under 30-day vaccinated cases" has
been reported. These have come from
seven States. Two followed Type I vac-
cine, 1 followed Type iI vaccine, and 13
followed Type III vaccine. Eleven of the
16 occurred between the 15th and 29th
days. This finding warranted further
consideration of the possibility of a
causal relationship to the vaccine,
particularly to the Type III vaccine.
The Advisory Committee directed
special attention to these 16 under
30-day cases reported from nonepidemic
areas. All available clinical, epidemio-
logical, and laboratory information was
reviewed. Each case was considered
individually, and excluded or not exclu-
ded by group decision from further consi-
deration as to the possibility of its
A-70
being vaccine induced. No case was
excluded except by unanimous agreement of
the committee members. Included for
consideration were those cases clinically
compatible with poliomyelitis which
demonstrated any significant paralysis
and in which laboratory findings to date
were not inconsistent with a vaccine
relationship. Descriptive data regarding
these cases are summarized in table IV.
Of the two cases of poliomyelitis
reported following Type I vaccine admin-
istration, only one (case 2) was thought
by the Committee to be entirely compati-
ble clinically with poliomyelitis. Of
recent onset, the virologic studies on
this patient are still in process. The
clinical history of the other case (case
1) indicated it to be exceedingly mild
and atypical. The patient experienced no
known febrile illness, he was not hospi-
talized, and no cerebrospinal fluid
A-71
studies were performed. He recovered
with no residual paralysis.
The single case reported following
immunization with Type II vaccine was
found to have a Type III virus in his
stool. Since Type III vaccine had not
been fed, it can be concluded that the
infection was due to a wild virus.
Eleven of the 13 cases following
Type III oral polio vaccine were consi-
dered by the Committee as possibly vac-
cine related. Of the two cases excluded,
one (case 14) had an illness atypical for
poliomyelitis with no functional impair-
ment after 30 days. Both Type I and
Type III polioviruses were recovered from
the stool, 55 and 27 days respectively
after Types I and III vaccines had been
fed to the child. The Type I virus which
was recovered was characterized as "wild-
like" according to the results obtained
by the modified Wecker and McBride tests.
These tests are used to demonstrate
A-72
slight antigenic differences between
poliovirus strains of the same type.
Since the virus strains may, after a
period of intestinal multiplication, show
such a shift in the antigenic character-
istics of the viruses, no definitive
interpretation of this finding was possi-
ble. The second case (case 16) which was
excluded from further consideration had
an insignificant paralytic residual and
no detectable Type III antibody in either
acute or convalescent serum specimens.
From 6 of the 11 cases, Type III
poliovirus was recovered from. stool
specimens. Five of the six were charac-
terized as "vaccine-like" by the modified
Wecker and McBride Tests. Although this
finding was of interest, it unfortunately
provided little help in determining
whether the vaccine played a causal role.
Each of these considered had been fed
Oral vaccine and, hence, might be expec-
ted to be excreting the Type III vaccine
A-73
virus which might appear by the modified
Wecker and McBride tests to be, as noted
above, either "wild-like” or "vaccine-
like." Further, it is possible that the
Oral vaccine strain may have displaced a
"wild" enterovirus which was, in fact,
the etiological agent responsible for the
paralytic illness. In summary, isolation
of a Type III virus from the stool and
demonstration of Type III antibodies in
the patient's sera served to indicate
only that the paralytic disease would not
be incompatible with Type III vaccine-in-
duced disease.
The 11 cases considered as possibly
related to Type III vaccine feeding are
between 16 and 52 years of age, with all
but 3 of the cases over 30. The vaccine
administered to this group of cases was
from severai lots and was not produced by
any single manufacturer. Of the 11
cases, 3 occured in Oregon, 3 in Nebras-
ka, 2 in Michigan, 2 in Ohio, and 1 in
A-74
New York State. The clinical illnesses
in these patients range from significant
to ‘severe. No deaths occurred. Among
the 11 cases, the entire spectrum of
nonfatal paralytic illness characteristic
of poliomyelitis was evident.
Discussion Summary:
Of the reported cases to date, 1
following Type I vaccine and 11 following
Type III vaccine were considered by the
Committee to be clinically consistent
with paralytic poliomyelitis and with
laboratory findings which could not
exclude a possible relationship to the
administration of oral vaccine.
As noted, a single case occurred
within 30 days of Type I vaccine adminis-
tration during a period of almost 9
months when approximately 20 million
persons were fed Type I vaccine. This is
wholly compatible with coincidental
origin.
A-75
The 11 cases following Type III
_ vaccine cannot all be assumed to be
coincidental. The adult age distribution
ranging from 16 to 52 years with eight of
the cases over 30 years of age, and the
clustering of the intervals from vaccine
feeding to onset in the 2-3 week period
suggest a vaccine relationship. For
these reasons the Committee concluded
_that "there is sufficient epidemiological
evidence to indicate that at least some
of these cases have been caused by the
Type III vaccines."
The incidence, assuming all cases to
have been vaccine induced, is but ll
cases among more than 13 million fed.
This is less than one case per million
loses given. When the risk is related to
age it is apparent that adults are ex-
posed to a greater hazard than are child-
ren. Inadequate information on the age
specific vaccine acceptance rate, however,
makes it impossible to calculate a more
A-76
precise estimate of the risk at this
time.
With the incidence of poliomyelitis
at a low level in this country, the
Committee therefore recommended that the
Type III vaccine be restricted to pre-
school and school age children and to
those adults in high risk groups, such as
those traveling to hyperendemic areas or
in areas where a Type III epidemic is
present or impending.
Since the vast majority of poliomye-
litis cases occur among young children
and since chiidren are the principal
disseminators of the virus, continued
intensive immunization programs among
this group are clearly indicated. If
this group can be adequately immunized,
the spread of the poliomyelitis viruses
will be sharply restricted, if not essen-
tially eradicated.
A-77
—
Taste I.—Estimated Use of Oral Poliomyelitig Vaccine (Sabin strains) in the
United States
Type of vaccine (in 1,000’s of doses)
I Il Il Total
Experimental vaccines:
Community prophylactic programs... .. *693 *612 *621 *1, 926
| an Sees ee ee Pe 322 322
Licensed vaccines:
Community prophylactic programs... 12,392 | 3,622 | 0,492; 25, 506
Epidemic control. ................... 3, 064 |........ 2 3, 066
Other programs, routine immunization
clinies and private practice.......... 5,000 | 3,000; 4,000/| 12,000
Wi idbtnitisecdsetbtcccencesed 21,149 | 7,234) 14,437 | 42, 820
“Including trivalent vaccine.
Taste If.—Annwal Incidence of Reported Cases of Poliomyelitis by Paralytic
Status in the United States 1955-G1
Number of reported cases
Year ,
Paralytic Nonparalytic Unspecified Total
Si tencédensbeced 13, 850 12, 453 2, 682 28, 985
Bees wedsdeontoccac 7,911 6, 555 674 15, 140
) ae 2, 499 2, 826 160 5, 485
Sb secccocucdécdud 3, 697 1, 041 149 5, 787
Sree 6, 289 * 2,045 91 8, 425
Se 2, 525 626 39 3, 190
Ee 988 305 19 1,312
Taste III.—/ncidence of Poliomyelitis by Paralytic Statue in the United Statca
a through 36th Week—1962 and Comparable Periods in Previous
eare
Paralytic status 1962 1961 1960 1959
eae 393 454 1, 200 3, 122
Nonparalytic...............-.- 78 151 368 1, 304
Vnapesiied. .... crcecccccccce 29 77 167 440
Witah. cicwcccccedsttvece 500 682 1, 735 4, 956
Number cf Persons (1000's)
Figure 1
During Known Moss Community Oro! Polo Voccineten Programs
6.4
a Es
Catimete of the Number of Persons Pod
by Month from Dote of Licensure, United Stotes
o
a 2
ale uP Oot wiv Ol [ain iB MAR ADR MAY UN Am UO
8,000 LICENSED.
v
1200
° ’ u ' ’ ul a” ae ; ‘ ’ . a
ar
gue SEP OCT NOV OFC | vam PEO WAR APR MAY HUN 4%
A-79
TasLe 1V.—Caacs of Reported Pavalytic Poliomyelitia Occurring Within 36 Daya of the Administration of Oral Poliomyclitia Vaccines
in Nonepidemic Arcas January I to Scptember 15, 1962
Type I Vaccine .
Onset Interval ~~ OPV Virus isolates Anti-
a Age | Race | Sex — first | Clinical a body | Committee ‘
0. mptom| severity T T Tesponse, apprainal
| Pt) Type) Wie | Type | Character PY
SE” 3} wi M 2| 5/29 | ae} es ee ¢ | Wid like......... | 1 | Bxetuded.
SATS 25; W M 1 8/30 3 iP Rabies icondne (**) | (9%)... wneneeeeel (**) | Compatible.
Type Il Vaccine
Sie 2|wtlr 2| 223 3 jOver 90) j= lll ie — | Excluded
Type Ill Vaccine ps
ee HD 23| WiM 4] 716 —! ay RRs 17 | III | Wild like......... ul Compatible.
need 36| W b 0 7/20 4} eae ae 22 | Ill | Vaccine like......| Il | Compatible.
Seeing is| W F 5 "1 te > == if SF . saaratsetes (**) =| Compatible.
, Rbraren 51; W | M o| 7/16 lie | Seese 22 _ (**) | Compatible.
BP 37| wi M 0; 7/23 {a of omer 16}; — a= — | Compatible.
Lanes 49| W | M o| «eis 4} +90 |...... 26| O _ Il & IIT} Compatible.
10...--- i) WM | Ol lye) 8] as [ccc is} — - — | Compatible.
OS a sca 36' WiM 0| 715 | Pte eee 21| Oo - T& Il |
eRe: 48| W F 0 ait Oa: Be eed 7 | III | Vaccine like...... 111 | Compatible.
a 39; W M 0 1 4 4 aa 23} IIl | Vaccine like......) — Compatible
a 6; Wi] M 0 Ph. Mea el 27 Wild like......... on Exeluded
15 52| W | M 0} 6/26 4| 52 19| Hi | Vaccine like222.2-) if | Compatible
Mi 610! & 4| 6/12 Are {ewe oe ay eeeenenee Tee ee
**In process. we
Key fer severity : a — Key for CRegative test, outtboty les :
2=Miuor involvement. ba yt
4= Gieability. Virus chargcter. wie Ly by the modified Weeker and
i= dixabled ( wheelchair, extensive bracing). tests.
Con-idered me} toy accine-induyed disease cases clinically tndistinguisbaple f lomselitis with some significant residue!
partigels and tobscarian eausine bot tasemeteenes Cite the pasate ct cattine selatani 94 lt
nn ne £6 2¢. 68 S66@.0¢8 sees
APPENDIX K
SUPPLEMENT TO PSU 273
December 21, 1962
Statement Released from the Office
of the Surgeon General, December 19,
1962.
Report of the Special Advisory Com-
mitee on Oral Poliomyelitis Vaccine
to the Surgeon General. December 18,
1962
Line Listing of Cases Considered by
the Committee.
Reprinted with Permission of
Surveillance Section
Epidemiology Branch
Communicable Disease Center
U.S.P.H.S.
A-81
A. Statement Released to the Press by
the Office of the Surgeon General
Communities planning immunization
campaigns against poliomyelitis are urged
to move ahead, using all three types of
Sabin oral vaccine with particular em-
phasis on children and young adults,
Surgeon General Luther L. Terry of the
Public Health Service announced today.
Dr. Terry said that this is the re-
gommendation of the Surgeon General's
Special Advisory Committee on Oral Po-
liomyelitis Vaccine which concluded its
fifth meeting this year on December 18,
and that he has accepted the Committee's
recommendations.
The Committee stressed that special
attention be given to children because
they comprise the population group "in
whom the danger of naturally occurring
poliomyelitis is greatest and who serve
A-82
as the natural source of poliomyelitis
infection in the community."
"The Committee feels and I whole-
heartedly agree that of greatest im-
portance is planning for the continuing
vaccination of oncoming generations,"
the Surgeon General said. "This is the
only way we will succeed in eradicating
polio permanently."
The Surgeon General quoted the re-
commendation of the Committee with respect
to vaccinations among adults:
"Because the need for immunization
diminishes with advancing age and be-
cause potential risks of vaccine are be-
lieved by some to exist in adults,
especially above the age of 30, vaccina-
tion should be used for adult only with
the full recognition of its very small
risk. Vaccination is especially re-
commended for those adults who are at
higher risk of naturally occurring disease;
A-83
for example, parents of young children,
pregnant ‘iin persons in arn sit-
uations and those planning foreign travel."
Dr. Terry presided at the two-day meet-
ing at which committee members reviewed
all cases of suspected polio-like illness
currently known to have been associated
with the administration of oral polio
virus vaccine of all three types in non-
epidemic areas.
"In the oral and the Salk vaccines we
have two established weapons against polio
and we can, I believe, look forward to the
day when polio is finally eliminated in this
country," the Surgeon General stated. "With
a total of around 650 cases reported this
year, compared to almost 58,000 a decade ago,
it is clear we are well on our way."
In commenting on the work of his Advisory
Committee, Dr. Terry said: “The meticulous
care with which members of this committee--
all experts in the scientific disciplines
A-84
involved in the use of vaccines--have
watched and evaluated developments in the
widespread use of oral poliomyelitis
vaccines is exemplary." They are render-
ing an invaluable service in advising
us.
Members of the Surgeon General's Com-
mittee are: Dr. David Bodian, The Johns
Hopkins School of Medicine; Dr. John Fox,
Public Health Research Institute of the
City of New York; Dr. Archie L. Gray,
Secretary and Executive Officer, Mississippi
State Board of Health; Dr. William MCD.
Hammon, University of Pittsburgh; Dr. Hugh
Hussey, Dean, School of Medicine, George-
town University; Dr. Alexander Langmuir,
Public Health Service, Communicable
Disease Center, Atlanta, Georgia; Dr.
Roderick Murray, Public Health Service,
National Institutes of Health, Bethesda,
MD; Dr. John Paul, Yale University School
of Medicine; Dr. Albert Sabin, University
A-85
of Cincinnati; Dr. Edward D. Shaw, Uni-
versity of California School of Medicine;
and Dr. Joseph E. Smadel, Public Health
Service, National Institutes of Health,
Bethesda, Md.
The report of the committee's find-
ings and recommendations is attached.
B. Report of the Special Advisory
Committee on Oral Poliomyelitis
Vaccine to the Surgeon General,
PHS. December 18, 1962
The Committee met to review all cases
of suspect polio-like illness currently
known to have been associated with the
administration of oral poliovirus vaccine
of all three types in non-epidemic areas.
These included, in addition to cases pre-
viously considered, 25 cases newly dis-
covered among persons fed vaccine and four
cases among individuals in contact with
vaccinated persons. Some of the cases pre-
viousiy accepted as “compatible” have been
dropped from this category because of
A-86
additional clinical and laboratory evi-
dence that has become available. New
cases have been added to the “compatible”
group where careful review has justified
such action.
It should be emphasized that the com-
mittee does not consider that an individual
case can be proved to be caused by the vac-
cine and no laboratory test has thus far
provided a definitive answer. However, it
has attempted to decide for each case
whether or not it is *oenpetibie" with
the possibility of having been induced by
the vaccine. Cases have been judged as
“compatible” when three criteria were met:
(1) onsent within a period (4-30 days after
feeding) consistent with a reasonable in-
cubation period; (2) an illness clinically
consistent with paralytic polio; and (3)
laboratory findings which do not exclude
a vaccine relationship.
On the basis of data now available the
total number of cases associated in time
A-87
with the direct administration of Type
III vaccine and considered by a committee
majority as “compatible” is now ll, of
which 8 are over 30 years of age. Four
cases were excluded as clearly unrelated
to Type III vaccination; and seven cases
were considered inconclusive as to a
possible vaccine relationship.
The total number of cases associated
with the administration of Type I vaccine
and considered as “compatible” is seven,
of which 4 are over 30 years of age. Ten
cases were excluded; six were considered
inconclusive. None of the three Type II
associated cases was judged to be
“compatible”.
It should be noted that the total
number of doses of oral vaccine given in
non-epidemic areas during 1962 is approxi-
mately 31 million Type I, 19 million Type
II and 15 million Type III. Hence, the
maximum potential risk for Types I and
A-88
III is of the order of one per million or
less Overall, but higher for those over 30
years of age. For Type II there is still
no indication of risk.
Consideration of the four cases in
unvaccinated persons in household con-
tact with vaccinees resulted in two being
judged “compatible” and two "excluded".
One additional “compatible” case occurred
in a nonhousehold contact. Considering
the large amount of vaccine administered
and the known frequency of vaccine virus
spread from vaccinated to unvaccinated
persons, particularly within homes, it
is concluded that contact spread has
posed no significant hazard.
It is therefore recommended: (1)
that community plans for immunization
be encouraged, using all three types;
wie (2) that immunization be emphasized
for children in whom the danger of natur-
ally occurring poliomyelitis is greatest
A-89
and who serve as the natural source of
poliomyelitis infection in the community.
Because the need for immunization dimin-
ishes with advancing age and because po-
tential risks of vaccine are believed by
some to exist in adults, especially above
the age of 30, vaccination should be used
for adults only with the full recognition
of its very small risk. Vaccination is
especially recommended for those adults
who are at higher risk of naturally occur-
ring disease; for example, parents of
young children, pregnant women, persons in
epidemic situations and those planning
foreign travel.
Of greatest importance is the continu-
ing vaccination of oncoming generations.
C. Cases Considered by the Special
Advisory Committee
As stated in the report of the Advisory
Committee, all known cases of suspect polio-
like illness associated in time with the
A-90
administration of the three types of oral
polio vaccines outside of epidemic areas
were reviewed. The line listings which
appear below categorize the cases for
consideration as occurring after the ad-
ministration of Type I, Type II or Type
III vaccine. Thus any case with onset
more than 30 days after one type of
vaccine administration but within 30
days of a second type received 2 reviews.
Two cases, as indicated in the listing,
were considered both as primary vaccinees
and as contacts of vaccinees.
All cases considered have been listed
in previous P.S.U. reports except for ten
cases from California which have not yet
been officially reported. These were
considered from a special report prepared
and submitted to the Committee by the
California State Department of Public
Health. The Committee appraisal on each
individual case is indicated, based on
the criteria listed in their report.
A-91
76-V
Cases of Polio-lixe Illness Following Oral Polio Vaccines
Occurring Outside of Epidemic Arcas in 1962 - Reviewed ty the
Surgeon General's Advisory Committee on Policnyelitis Vace.nes
I. Cases Follcwing Type I Vacci-e
Strate
calif.
Calif. (sR)
Calif. (XR)
calif.
Calif.
Ceiif.
Calif. (Na)
Calif.
Calif.(NR)
Calif.(@m)
Caiif. (NR)
Calizt. (NWR)
Caliz.(sR)
Calif.(wR)
Calif. (ur)
Til.
lowe
Mess.
Mass.
Ace
8
ll
32
42
ZRSCLKRMIERAKEKMe KK rx .
zum
> ee poe of tn hg
~O@MOF“wUYUOaUNCONOOrS
euu
mr frow Feeding o
~_ ak a
27)
2(4)
(14)
8(11)
18(19)
25(26)
740)
22(25)
~2(12)
14(23)
~4(8)
~8(E)
$(13)
(97) a 48
9(11)
4(6)
(9)
(27)
16(30)
No Specizen
0 No Isolate Obtained
te In Process
Isolate
Character
ue
site 32%
Non-Vacc. like
(3 Specimens)
Vaccine-like
(1 Specicen)
Vaccine-like
Antibody
Response
I
Inconclesive
T
1
I
Inconciusive
**
Incenclusive
Iaconclusive
Inconclusive
Inconclusive
Inconclusive
mee
we
I
I, i
Vaccine-like Inconclusive
Cocnittee
Cxcluded
Incenclusive
Corpat-dle
Cocpatable
Ceapacible
Cozpativle?
Excluded
Inconclusive
Excluccd
Excluded
Excluded
Excluded
Inconclusive
Excluded
Coapacible
Compatible
Compatible
Excluded
Incenclusive
£6-W
- Wo Specicen
I. Cases Following type 1 Vaccine (Continued) © Ho Isolate Obrained
** In Process
Days from Feeding of orv
Doses to Illness Virus Isolate Antibody Committee
Szste Age Sex IPV I Ill. ‘Type Character Response Appraisa}
sy.ay 3 «(8 (23) I Non-Vace.Like 1 Excluded
Ohio 1% #86© ce) 28(43) 1415) - I"t Incoaclusive
Zena. (2) 1 4(11) I WNon-Vecc.Like I, Il, III. Incoxclusive
wash.6 6 Ms 4 (37) (5) I Vaccine-Like I Excluded
1. The number in parenthesis indicates interval from feeding to onset of paralysis.
2. (8K) California cases not yet officially reported but consicered from s special
teport submitted by the California State Departaent of Public Health.
3. Considered a “compatible” case if laboratory work in process is not
inconsistent with a vaccine relationship.
4. Wumber in parenthesis following State-designation corresponds with the number
of the case in the technical report of the Surgeon General - Septexber 20, 1962.
5S. Specizen taken two days after patient received Type II vaccine.
6. Also considered (and listed) with relation to Type III vaccine.
v6-V
=- Ne Specimen
© No Isolate Obtained
*#* In Process
State Ags Sex _IPv I — —-
Neb “2% | 4 90
Ohie{3) a 2 a , — Ge pol
Ohi 67M 0 (64 (8) (36) 0
1 Also considered and listed with relation to Type III vaccine
Antibody
Response
Incon.
Incon.
Comittce
Appraisal
Inconclusive
Excluded
Inconclusive
S6-V
} ~ aresate Obeained
ITI. Cases Following Ives ZI Vaccine em In Frecees
frou of OFV
Days Peeding
State Ase Sex PV. t Response
Mess. 4 Ms 4 $4(64) 26(36 0 -
Mass. sa C=~<*‘ ) 22(24) 40 a
Mich.(4) 23 M 2or4 76(80) 16(20 III intermediate Incen,
to non-vaccine
like
Mich.(S) 36 F 0 22(28 III Vaccine-like III
Neb. (6) 1s 6C6F S 34(42) 7015 III Vaccine-like Incen.
Nob. (7) a Oo 51(S4 22(25 0 Incen.
Ned. (8) 37 «OM Oo 43(48 15/20) - Incen.
Heb. so. 6F 4 61(69) 19{27) ° I, Il, III
Keb. s7 iM 0 49(S7 12(20) o I
Neb. 6 Ms 3 49(56 7(14) Il Ince.
ised. s. Fv 3 41(44) 16(19) III Vaccine-like Incon.
Neb. -: = 0 46(52) 10(16) - Incon.
xx(9) 49 «OM ) (>$0) 26(29) C) 1, I!, U1
Chico 67 += 0 64 (8) 36) 0 Incon,
Ohic(io? 16 M OO 28(43 1(15) - Ill
onieQll)* 33 Nu O 21(25) 0 I, lit
Oregor.(12) 43 F 0 34(38) 7(11) III Vaccine-like I, II, III
Oregon(13) 39 M&M o 8 s50(sl 23(24) III Yaccine-like Incon.
Orcson(l4) 6 4M 0 (54 (27) I —— Incon.
III Vaccinc-like
ae S38 “(3 19(20) III Vaccine-like Incon.
-— & IiI Vaccine-like Incon.
Wash.(16)> 6 M 4 (37 (s) I Vaceine-like I
1 Type II vaccine fed 8 days before specimen
collected
- aoe par soe = paveer with relation to Type II vaccine
Alse consider 3 isted) th relation to T vacc
4+ Also cozpatible with Type I houschold eenesee weed wt
Cormittce
Apgrsisah
Excluded
Inconciusive
Compatidic
Compatidle
Coxpatible
Co-patitle
Cozpatitle
patible
Incorclusive
laconclusive
Compe tible
Incen-:lusive
Inconcl uscive
Ircorclusive
Inconclusive
Corps itle
Compattole
Comyatitle
Excluded
Cenpatible
Exdl uded
Excluded
96-WV
Cesce Aueng Movadheld Contents of Yacein
Age Sex _1PY_
21 M 0
42 F 4
is/iz ™M 0
29 M 0
6/fi2 & 0
Doses to Onset of IlInexs
t iL wu
! (26
‘ss (25
” Qs)
(55 (25)
(69 (33)
1 Contact in adjacent apartzent
- No Specizer
0 io Isolate Crcaionl
#* In Mrecess
Virug Trolate Antitedy
Type Character Resrons>
I We I
I Intermediate I
to non-vaccine
like
II Vaccine-like II
III Vaccine-lixe -
Cormnittee
Aprreis2
Excluded
Excluded
Corpatible
Corpatible
Cenpatibiec
APPENDIX L
SUPPLEMENT TO POLIOMYELITIS
SURVEILLANCE REPORT
NO. 285
September 30, 1964
ASSOCIATION OF PARALYTIC DISEASE
II.*
III.*
Iv.*
WITH ORAL POLIO VACCINES
Press Release
Report of a Special Advisory
Committee on Oral Poliomyelitis
Vaccine to the Surgeon General
of the Public Health Service
Comments on the Report of the
Special Advisory Committee By
Albert B. Sabin
Paralytic Disease Associated with
Oral Polis Vaccines, By D. A.
Henderson, J. J. Witte, L. Morris,
and A. D. Langmuir
Listing of Reported Cases of Para-
lytic Poliomyelitis Occurring
A-97
Within 30 Days After Receiving the
Oral Poliomyelitis Vaccines, 1961-
1964
Appearing in The Journal of the
American Medical Association
dated October 5, 1964.
A-98
HUNTFER--WO 2-2125
U. S. DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE
Public Health Service
Washington 25, D. C.
FOR IMMEDIATE RELEASE HEW-C60
Wednesday, September 23, 1964
A special advisory committee to the
Surgeon General of the Public Health
Service, Department of Health, Educa-
tion, and Welfare, urged today renewed
drives by local communities during the
fall and winter to vaccinate the younger
age group against poliomyelitis.
The report was prepared by a special
advisory committee on oral poliomyelitis
vaccine and was made public today by
Surgeon General Luther L. Terry.
A-99
The committee's report said that the
age groups to be immunized and the vaccine
chosen for use should be determined lo-
cally. The committee said, however, that
in its view the oral vaccination of persons
over 18 should "generally be recommended
only in those situations in which unusual
exposure to poliomyelitis might be anti-
cipated, such as epidemics, entry into
military service, and travel to other
countries."
The committee recommended strongly
the immunization of infants during their
first year of life and the routine im-
munization of all children on entering
school.
Dr. Terry, in releasing the report,
said that the Public Health Service was
accepting the committee's recommendations.
He pointed out that the shift in emphasis
away from adults toward the younger age
groups was forecast in a committee report
A-100
of December 1962. The advisory committee
at that time emphasized the importance
of concentrating on the immunization of
the younger age groups and noted a “very
small risk" incident to the use of oral
vaccine in persons 30 years of age and
over.
The current committee report also re-
commends alteration in the sequence of
administering monovalent vaccines, with
Type II the first to be given. The newly-
recommended order is Type II, I, and III.
Dr. Albert Sabin, developer of the oral
vaccine and a member of the committee,
filed a report dissenting from the commit-
tee’s recommendations and calling for the
continued immunization of all age groups.
The Service is making available the full
text of both reports to State Health Of-
ficers, professional organizations, and
other interested agencies, Dr. Terry said.
A-101
The committee's recommendations were
based on an exhaustive analysis of 87
reported cases of "“polio-like illness
associated with the administration of
oral vaccines" which have occurred in
non-epidemic areas since December 1961.
These cases were considered by the
committee on the basis of whether or not
they were "compatible with the possibility
of having been induced by the vaccine."
I concluded that it is not possible
to prove that any individual case was
caused by the vaccines and that no labo-
ratory tests available can provide a
definitive answer. Nevertheless, the
committee said, “Considering the epi-
demiological evidence developed with
respect to the total group of ‘compati-
ble' causes, the committee believes that
at least some of these cases were caused
by the vaccine."
A-102
The committee's recommendations were
based on an exhaustive analysis of 87
reported cases of "polio-like illness
associated with the administration of
oral vaccines" which have occurred in
non-epidemic areas since December 1961.
These cases were considered by the
committee on the basis of whether or not
they were "compatible with the possi-
bility of having been induced by the
vaccine."
It concluded that it is net rersible
to prove that any individual case was
caused by the vaccines and that no labo-
ratory tests available can provide a
definitive answer. Nevertheless, the
committee said, "Considering the epi-
demiological evidence developed with
respect to the total group of ‘compati-
bie’ causes, the committee believes that
at least some of these cases were caused
by the vaccine."
A-103
The extent of the “risk factor", ac-
cording to the report, is, for Type III,
only 1 case in 2.5 million doses adminis-
tered; for Type I, only 1 in 6 million;
and for Type II, only 1 in 50 million.
With respect to the very minimal risk,
‘Dr. Terry emphasized that there should be
no apprenhension whatsoever among those who
have already taken the oral vaccine.
In its analysis of the 87 cases, the
committee found 57 which they considered
“compatible.”
The “compatible” cases, the report said,
occurred largely among adults. Most were
widely scattered throughout the country.
The onset of illness fell between 4 and 28
days following vaccine administration.
"There was no soparest association of
cases with specific lots of vaccine or
vaccines produced by a particular manu-
facturer," the report added.
A-104
In urging a renewed effort to vaccinate
those still susceptible, most of them
poorly-immunized children in economically-
depressed population groups, the commit-
tee cited the spectacular decline of polio
during recent years.
The decline has been from an annual rate
of 14.6 cases per 100,000 during 1950-54
to a rate of 1.8 for 1957-61. This repre-
sents a decrease of 88 percent.
"On the basis of reports to date, less
than 150 cases of paralytic poliomyelitis
may be anticipated for the entire year
(of 1964)," the report added.
In commenting on this phase of the
report, Surgeon General Terry said:
"When you compare this year's record
low with the 54,000 cases of polio re-
ported in 1952, the triumph against polio
is an historic achievement in preventive
medicine. This great victory has been
made possible by the work of two
A-105
extraordinarily dedicated scientists--
Dr. Jonas Salk and Dr. Albert Sabin--and
it has come to pass through the devoted
efforts of hundreds of organizations and
thousands of individuals,” Dr. Terry said.
The Surgeon General added: "I heartily
and enthusiastically endorse the committee's
primary recommendation that every effort
be made for the continuing vaccination of
infants and younger age groups. Only
through this means can we achieve total
victory over polio."
Dr. Terry praised the committee for a
“painstaking, conscientious and thorough
report in the public interest."
Members of the Committee were:
Dr. Ernest A. Ager, State Department
of Health, Olympia, Washington
Dr. David Bodian, The John Hopkins
University, Baltimore, Maryland
Dr. Gordon C. Brown, University of
Michigan School of Public Health,
Ann Arbor
Dr. Alice D. Chenoweth, Childrens
Bureau, Washington, D.C.
A-106
Dr. Geoffrey Edsall, Massachusetts
Department of Public Health, Boston
Dr. John P. Fox, Public Health Re-
search Institute of New York, New
York
Dr. James L. Goddard, Communicable
. Disease Center, Public Health Service,
Atlanta, Georgia
Dr. A. L. Gray, Mississippi State
Board of Health, Jackson
Dr. William McD. Hammon, University
of Pittsburgh, Pa.
Dr. Donald A. Henderson, Communicable
Disease Center, Public Health Service,
Atlanta, Georgia
‘Dr. David T. Karzon, Childrens Hospital,
University of Buffalo, New York, (unable
to attend)
Dr. Alexander D. Langmuir, Communicable
Disease Center, Public Health Service,
Atlanta, Georgia
Dr. Theodore A. Montgomery, California
State Department of Public Health,
Berkeley
Dr. Roderick Murray, National Institutes
of Health, Public Health Service,
Betheada, Maryland
Dr. Albert Sabin, The Childrens Hospital
Research Foundation, Cincinnati, Ohio
Dr. Edward B. Shaw, University of Cali-
fornia School of Medicine, San Francisco
A-107
Dr. Paul F. Wehrle, University of
Southern California School of Medicine,
Los Angeles
A-108
Number of Cases
Figure V
PARALYTIC POLIOMYELITIS
OCCURRING WITHIN 30 DAYS OF OPV
INTERVAL BETWEEN VACCINATION AND ONSET
December |, 196! through June 27, 1964
1 5
12° EPIDEMIC AREAS RECEIVED
Type |
10 Type tl
Type tll
8 Trivolent
6
4
2
0
NON- EPIDEMIC AREAS *
12 -
10 -
WRARGA
: SK :
mit Bom ew eS ear
Intervals by 3-Day Periods
*coses considered compatible by committee
A-109
OTT-W
Paralytic Poliomyelitis Cases (Non-Epidemic Areas)
With Onsets Less than 30 Days After Receiving OPV
I. Cases Adjudged “Compatible” by Special Advisory Committee
A. Cases Following Type I
State
1961
SP
NK. Ve
1962
Calif.
Calif.
Calif.
Calif.
Calif.
Calif.
Tl.
lowa
B. Cases Following Type II
1962
Ariz.
1964
Se Cc.
County
Chautauqua
Chautauqua
Santa Clara
Alameda
San Francisco
Santa Clera
San Mateo
San Diego
Stephenson
Story
Gibson
Yakina
Chippewa
Bartow
Pr. Georges
Maricopa
Lenoir
49
zz EM EFEMNEETMNEVNEEZT ET
Doses
PV
Type
Fed
6-14
et et et et et ee ee —
Interval (Days)
OPV to Onset
12
28
Isol.
60-Day*
Status
a
ee wn VeuvuUn wuu &
TItt-wv
C. Cases Following Type II!
State County
1962
Mich. Branch
Mich. Midland
Neb. Dougias
Ned. Douglas
Neb. Dodge
Keb. Lancaster
Neb. Cherry
Neb. Phelps
Neb. Lincoln
Neb. Keya Paha
Ohio Portage
Ohio Cuyahoga
Okia. Logen
Oreg. Washington
Oreg. Benton
1963
Calif. Sacramento
Calif. Los Angeles
Calif. Napa
Calif. Shasta
Calif. Los Angeles
Mass. Middlesex
Mass. Middlesex
Minn, hennepin
Pa. Schuykill
Pa. Del aware
Pa. Delaware
Ss. Cc. Spartanburg
Tenn. Mont gomery
Texas Bexar
Idaho(NOR)
Utah(NOR) Sevier
EREEEEEEECEEEEEE EVES TEMEEEKTME
Doses Type Interval (Days)
Onset Mad Fed CPV to Onset
7-1S 4 (2) If! 16
7-20 t) Il 22
7-1 5 Ill 7
7-16 0 Ill 22
7-23 0 Il 1s
8-S cr 8-12 53 II 7 or 14
8-15 0 Ir 10
8-16 4 Il 19
8-24 0 Il 19
9-3 3 Ill 16
6-& 0 lll 15
7-18 0 Ill 24
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APPENDIX M
ORAL VACCINE:
ASSOCIATED PARALYTIC POLIOMYELITIS, 1962
Henry M. Gelfand, MD, Atlanta
UNTIL RECENTLY, there was .almost |
universal agreement that living attenua-
ted, oral poliovirus vaccine (OPV) com-
posed of the Sabin strains is safe, both
to the primary vaccinee and to his con-
tacts. This reputation for safety was
won on the basis of the use of OPV in
millions of persons in the US and many
other countries. Although the thorough-
ness of routine reporting of morbidity
and of special surveillance for possible
vaccine-induced cases of paralytic polio-
myelitis differed greatly among the
various programs, no evidence had been
adduced to show that this vaccine, com-
posed of these strains, had ever caused
the disease it was designed to prevent.
A-112
From July through November, 1962, a
small number of cases which had followed
the use of oral vaccine came to light and
they have cast some doubt on the safety
of OPV in adult vaccinees. This cluster
of cases was intensively studied and
discussed in a series of meetings by a
Special Advisory Committee on Oral Polio-
‘“myelitis Vaccine to the Surgeon General,
USPHS. This Committee concluded in its
1 that "...there
report of September 20,
is sufficient epidemiological evidence to
indicate that at least some of these
cases have been caused by the type III
vaccines." After considering new case
reports accumulated during the following
few months, and additional laboratory
2
data, in its report of Dec 18, the
Committee recommended:
Chief, Enterovirus Unit, Communicable Disease
Center, USPHS, Department of HEW.
Based on a presentation at the Annual Meeting
of the Association of Teachers of Preventive
Medicine, Miami, Fla., Oct 14, 1962.
A-113
which this conclusion was based
discuss ' some
"...(1) that community plans
for immunization be encour-
aged, using all three types;
and, (2) that immunization be
emphasized for children in
whom the danger of naturally
eccurring poliomyelitis is
greatest and who serve as the
natural source of poliomyeli-
tis infection in the commun-
ity. Because the need for
immunization diminishes with
advancing age and because
potential risks of vaccine are
believed by some to exist in
adults, especially above the
age of 30, vaccination should
be used for adults only with
the full recognition of its
very small risk. Vaccination
is especially recommended for
those adults who are at higher
risk of naturally occurring
disease; for example, parents
of young children, pregnant
women, persons in epidemic
situations and those planning
foreign travel.
Of greatest importance is
the continuing vaccination of
oncoming generations."
It is the purpose of the present
communication to review the data upon
analysis and evaluation of the signifi-
A-114
and to
theoretical problems in
cance of OPV-associated paralytic polio-
myelitis. Only cases accepted as "compa-
tible with the possibility of having been
induced by the vaccine” and included in
the two reports just cited will be consi-
dered in this article. A summary of some
pertinent details relating to these cases
is presented in Table 1. Other cases of
paralytic poliomyelitis followed the use
of OPV in 1962 and were considered by the
Committee. A majority of the Committee
believed these to be clearly incompatible
with the possibility of vaccine induction
or as "inconclusive" - on clinical, epi-
demiologic, or laboratory grounds. Still
other cases which had followed the use of
OPV were not considered to be part of
this investigation, because they had
occurred in epidemic settings where
vaccine had been used as a control mea-
sure. Under those circumstances, new
cases are expected for several weeks
after vaccination.
A-115
The compilation of the data in
Table 1. was made possible by the work of
hundreds of practicing physicians and
others in the epidemiology and laboratory
divisions of the various state health
departments and of the Communicable
Disease Center of the Public Health
Service. The Surgeon General has grate-
fully acknowledged their contri-.
{[cjommunity, all three types were in ex-
tensive use at about the same time, if
the country is considered as a whole.
The pecdeniiant association of "compat-
ible" cases with Type 3 OPV is apparent.
Other Laboratory Data. - The diffi-
culties and limitations of characteriza-
tion of poliovirus strains as a tool for
the solution of problems of OPV-case
association have been discussed. All
that can be said is that those patients
from whom "vaccine-like" virus strains
were isolated were almost certainly ex-
creting the progeny of vaccine viruses.
A-116
Unfortunately, no naturally occurring
poliovirus strains of the same type were
available from the same localities for
comparative tests. However, only rarely
are “vaccine-like" strains found where
OPV has not been used. 27 In those few
instances in which monkey intracerebral
tests were performed, the results con-
firmed that the fecally excreted viruses
were attenuated. Neither antigenic nor
virulence tests added appreciably to
epidemiologic analysis.
The most useful application of
antigenic strain differentiation would be
in the testing of a virus isolate ob-
tained from tissues from a fatal case.
The recovery of a "vaccine-like" strain
from the brain or spinal cord would be
almost certain evidence for incriminating
the vaccine as the causative agent, even
if all other evidence were equivocal.
Since there have been no fatal cases in
the aggregate under investigation in
A-117
1962, no‘CNS strains have been available
for testing.
The inclusion of each case in a
problem group must be predicted on the
failure to detect concurrent infection
with another potentially paralytogenic
agent. As already mentioned, no nonpol-
iovirus infection was demonstrated, by
isolation of virus or serologic change,
in any single case included in the pre-
sent investigation. However, it must be
remembered that the finding of random
infections with other enteroviruses might
be mere coincidence in the opposite
Girection. Each instance of dual infec-
tion would have to be considered in the
light of our present incomplete know-
ledge. Greater understanding will deve-
lop with accumulating experience.
Comment and Summary
We expected and we have found that
cases of paralytic poliomyelitis occur in
A-118
temporal relationship with the widespread
use of OPV, particularly if it is used
during the summer season. It is the
responsibility of the appropriate author-
ities to establish and maintain polio-~
myelitis surveillance of a very high
standard and to examine reports of vac-
cine-associated disease critically and
objectively, making maximum use of all
available clinical, laboratory, and
epidemiologic data. .The Poliomyelitis
Surveillance Unit of the Communicable
Disease Center, with its long history of
experience in this field, performed this
task in the US in 1962 with extraordinary
skill and speed. However, it was ham-
pered in some instances by delays in
reporting by the patients themselves,
attending physicians, hospitals, and
local public health agencies.
After close examination, it was
possible to eliminate many cases from
serious consideration of a causal rela-
A-119
tion to vaccine on the basis of incorrect
or uncertain diagnosis, the recovery of a
poliovirus not fed as vaccine, too long
or too short an interval between vaccina-
tion and the disease onset, or some other
factor. There was then left a residuum
of suspicious cases.
Such a collection of cases was hard
to evaluate. They had been diagnosed
clinically as "poliomyelitis," they had
occurred after use of OPV at an interval
compatible with the incubation period,
and the only demonstrable infection was
with a poliovirus of the type fed as
vaccine. This triad of circumstances
constituted the basis for considering
them “compatible with vaccine-induced
disease." Occurring, as they did, in a
rather random and sporadic manner, they
might have remained only a suspicion and
& puzzle if the aggregation of cases had
not presented certain epidemiologic
features that appeared significant.
A-120
There were three characteristics of
this group of cases that appeared most
meaningful to the Surgeon General's
Special Advisory Committee on Oral Polio-
myelitis Vaccine: the adult age distri-
bution of "compatible" cases, the fre-
quent interval of one to four weeks
between vaccination and onset of symp-
toms, and the predominance of cases after
use of Type 3 OPV as compared with Types 1
and 2. Although it remained impossible
to decide whether or not an individual
case had been caused by the oral vaccine,
this constellation of findings suggested
that, as a group, at least some of these
cases had been causally related to OPV.
Because of the widespread interest in
possible vaccine-associated cases in the
US, in 1962, and the zealous activities
of the Poliomyelitis Surveillance Unit,
it is unlikely that any significant
number of suspicious cases went unrepor-
ted. Since it can be concluded only that
A-121
at least some of the "compatible" cases
were one case per 4.4, 0, and 1.4 million
"attack rates" express the maximum poten-
tial risk associated with the use of
these vaccines; the actual risk may be
considerably less. These rates were one
case per 4.4, 0, and 1.4 million vaccines
for OPV wr 1, 2, and 3, respectively.
Since a complete course of OPV consists
of the administration of all 3 types,
these rates must be added to produce a
"combined maximum potential risk" of one
case per 1.04 million complete immuniza-
tions.
The combined maximum potential risk,
moreover, was not felt equally by all age
groups; in 12 of the 18 "compatible"
cases the patients were more than 30
years of age. With only one "com-.
A-122
APPENDIX N
Boise, Idaho
June 26, 1964
Air Mail
Pierce Gardner, M.D.
Assistant Chief
Poliomyelitis Surveillance Unit
Communicable Disease Center
Atlanta, Georgia 30333
DAVIS, Glynn
Dear Doctor Cardner:
Mr. Glynn Davis developed a paralytic
illness within a thirty-day period follow-
ing the administration of Type III oral
poliomyelitis vaccine. He may have had
one or two injections of poliomyelitis
vaccine (Salk) in prior years. Dates of
vaccination and illness are as follows:
Oral poliomyelitis vaccine --
Type I February 3, 1963
Type III March 17, 1963
» Onset of illness April 12, 1963
Onset of paralysis April 14, 1963
A-123
Hospitalized at Ashton
Memorial Hospital April 17, 1963
Transferred to Idaho
Falls LDS Hospital April 24, 1963
Transferred to Elks
Convalescent Center,
Boise May 14, 1963
Transferred to VA
Hospital, Boise June 13, 1963
Enclosed are hospital and physician
examinations at the time of admission
of Mr. Davis to the Idaho Falls LDS
Hospital on April 24, 1963, and a con-
sultation after his transfer to Boise.
Doctors John S. McMillan and Maurice M.
Burkholder practice the specialty of
internal medicine.
Spinal fluid tests are as: follows:
During hospital-
ization at Ashton April 24, 1963
Pressure 165mm 96mm
Jugular pressure --- 254mm, rapid
fall to 136
WBC 60 78
Polys 64% 3%
A-124
Sugar -- 66 mgs %
Protein -- 40 mgs %
Pandy Pos oo
Wasserman -- Neg.
Mr. Davis was released from the
Veterans Administration Hospital in the
early fall of 1963 and has continued
with physiotherapy treatment at the
Veterans Administration Hospital on an
outpatient basis until the present time.
Physiotherapy will be discontinued during
the week of June 29, 1964, and muscle
evaluations at time of admission and
during the week of June 29, 1964, will be
obtained and forwarded. His diagnosis
at the Veterans Administration Hospital
is paralytic poliomyelitis (old defini-
tion of “inflammation of grey matter of
spinal cord") etiology undetermined.
The paralysis of the right triceps
has disappeared. The present involve-
ment is limited to below the knees with
A-125
weakness of the anterior muscle group
of the right lower leg and both an-
terior and posterior muscle groups of
the left leg. He continued to show im-
provement of muscle function and appar-
ent return of muscle use from a flaccid
paralysis state. He now walks with a
left leg brace, elastic aid to prevent
foot drop on the right, and crutches.
There are unusual circumstances con-
cerning the clinical course and the in-
conclusive laboratory findings in this
case. A flu like illness may have been
present among residents of West Yellow-
stone as noted by Mr. Davis. There were
sensory changes found by one consultant.
There has been an apparent recovery of
partial muscle function over an extended
period of time. The etiology of this case
of paralysis has not been determined and
a large number of virus deseases are to be
considered. The present diagnosis of
A-126
lower neuron disease with paralysis --
etiology unknown -- is the continuing
diagnosis by this office of this inter-
esting case.
Sincerely yours,
PREVENTIVE MEDICINE
DIVISION
John A. Mather, M.D.
Director
Enclosures
A-127
APPENDIX O
43 C.F.R. § 73.114(b) (1) (iii) provides:
(iii) 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 polio-
virus infection, (b) the number of animals
A-128
showing lesions other than those character-
istic 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 re-
sulting from inoculation trauma. The virus
pool under test is satisfactory for polio-
virus 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.
The “NIH Reference Attenuated Poliovirus"
was designated by regulation to be Type I
poliovirus. 42 C.F.R. § 73.111. It was
referred to herein as the "reference
strain."
The regulation specifically refers to
"virus pool" under test. Both the district
A-129
court and the briefs filed with this court
treat “virus pool” and “lots” interchange-
ably. We continue this treatment.
43 C.F.R. § 73.114(b) (1) (iii) is a
regulation promulgated by the Surgeon
General pursuant to the Public Health
Service Act, 43 U.S.C. § 201 et seq.;
see 43 U.S.C. § 262(d).
A-130
‘UoNISoddg
T Office - Supreme Co =
FIL urt, U.S.
ED
3 In the Supreme Court of the
OcTOBER TERM, 1981
GLYNN RICHARD DAVIS, PETITIONER
Vv.
UNITED STATES OF AMERICA
ON PETITION FOR A WRIT OF CERTIORARI TO
THE UNITED STATES COURT OF APPEALS FOR
THE NINTH CIRCUIT -
MEMORANDUM FOR THE UNITED STATES
IN OPPOSITION
Rex E. Lee
Solicitor General
Department of Justice
Washington, D.C. 20530
(202) 633-2217
STEVAS.
TABLE OF AUTHORITIES
Cases:
Rahn v. United States, 222 F.Supp. 775 ....... 6
Spevack v. United States, 390 F.2d 977 ........ 6
Toal v. United States, 438 F.2d 222 .........+. 6
United States v. Kubrick, 444 U.S.
PEE Kanddeehb cc ebsadusecoscocceeeces 2, 3-4, 5
Statute:
Federal Tort Claims Act, 28 U.S.C.
ED 60k hecdncsinkeversoccavescaseces 1,2
Inu the Supreme Court of the Hnited States
OcTOBER TERM, 1981
No. 81-644
GLYNN RICHARD DAVIS, PETITIONER
A
UNITED STATES OF AMERICA
ON PETITION FOR A WRIT OF CERTIORARI TO
THE UNITED STATES COURT OF APPEALS FOR
THE NINTH CIRCUIT
MEMORANDUM FOR THE UNITED STATES
IN OPPOSITION
1. The question presented in this case is whether peti-
tioner’s claim under the Federal Tort Claims Act is barred
by the applicable two-year statute of limitations, 28 U.S.C.
2401(b). Petitioner filed his administrative claim in 1973
seeking damages for injuries he suffered in 1963, allegedly
as a result of the government's negligence in its administra-
tion of a nationwide program for mass immunization
against poliomyelitis, using the Sabin oral vaccine (Pet.
App. A-! to A-4).
The vaccine was licensed and tested by the Division of
Biological Standards (DBS), a part of the Department of
Health, Education, and Welfare, and it was administered at
state and local immunization centers (Pet. App. A-I to
A-2). Petitioner was administered Type II] Sabin vaccine at
an immunization center in March 1963; within 30 days he
was paralyzed from the waist down and manifested other
2
symptoms of polio (id. at A-2). In 1964, petitioner brought
suit against Wyeth Laboratories, Inc., manufacturer of the
vaccine he had ingested (ibid.).'
In 1965, during the course of that litigation, Wyeth
noticed the deposition of Dr. Ruth Kirschstein, the chief of
the pathology section of Viral Immunology, DBS, accom-
panied by a subpoena duces tecum ordering her to bring to
the deposition all records relating to the DBS testing of
vaccine Lot No. 03503. The vaccine petitioner ingested was
from this lot. Dr. Kirschstein brought records document-
ing one neurovirulence test on the lot which indicated that
the results fell within acceptable limits (Pet. App. A-2 to
A-3). Petitioner alleges that not until 1973 did he learn,
from an attorney engaged in another lawsuit, that a second
neurovirulence test had been performed on Lot No. 03503
and that the results of that test exceeded acceptable limits
(id. at A-4).
Petitioner filed an administrative claim under the Tort
Claims Act in Apri! 1973 and brought this action in the
United States District Court for the District of Idaho in
April 1974 (Pet. App. A-4). The district court granted the
government’s motion for summary judgment, ruling that
the action was barred by the applicable two-year statute of
limitations, 28 U.S.C. 2401(b) (Pet. App. A-22 to A-24).
The court of appeals affirmed, with one judge dissenting
(Pet. App. A-I to A-18). The court concluded that petition-
er’s claim had accrued in April 1963 and that it therefore
was time-barred. Relying on United States v. Kubrick, 444
U.S. 111 (1979), the court reasoned (Pet. App. A-11; foot-
note omitted):
'In that action the district court ruled in favor of the manufacturer,
but the court of appeals reversed and remanded. Davis v. Wveth
Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968). The case was settied by
the parties prior to a second trial (Pet. App. A-2 n.1).
3
[ Petitioner] was aware in April, 1963, that he had been
injured and that the Sabin vaccine was the likely cause
of his injury. With knowledge of the fact of injury and
its cause, [petitioner] was at the time of his injury
placed on the same footing as other negligence
plaintiffs.
The court of appeals rejected petitioner’s contention that
the limitations period was tolled by the government's
alleged fraudulent concealment of the results of the second
neurovirulence test during the October 1965 deposition of
Dr. Kirschstein.2? The court noted (id. at A-12) that the
allegation was irrelevant because, by that time, the two-year
period for filing the tort elaim had already expired. As to
the government's conduct during that two-vear period, the
court acknow:edged that the government might have been
negligent in its publication of reports on the vaccine, but it
held that the government's failure “to ascertain and publish
the fact of its negligence” did not amount to fraudulent
concealment (ibid.).
2. The decision of the court of appeals is correct and does
not conflict with decisions of this Court or of other courts of
appeals. Both lower courts held that petitioner's claim for
injuries sustained in 1963 was barred by the statute of
limitations. Further review of this fact-bound question is
unwarranted.
a. Contrary to petitioner's contention (Pet. 25-35), the
decision below is entirely consistent with United States v.
Kubrick, supra. As the Court noted in Kubrick, the general
rule is that a claim under the Federal Tort Claims Act
“accrues at the time of the plaintiff's injury.” 444 U.S. at
?The appendix to the petition contains a typographical error: the
court of appeals referred to the October 1965 deposition. not to the
“October, 1/975, deposition™( Pet. App. A-12; emphasis added). See 642
F. 2d 328, 331.
4
120. A number of courts have held that in medical malprac-
tice cases, in which the injury may not manifest itself until
long after it has been inflicted, the claim should be deemed
to accrue only later, when the victim discovers both the
injury and its cause. /d. at 120-121 & n.7. Kubrick rejected
any extension of this “discovery” rule, however, and it thus
reversed a decision extending the accrual period until the
plaintiff became aware, not only of his injury and its cause,
but also of the fact that his injury had been negligently
inflicted. /d. at 123.
Even assuming that the “discovery” rule applies to this
case, the court of appeals correctly held that petitioner's
claim was time-barred. Petitioner contracted polio in April
1963, not long after he was given the vaccine; and according
to his own affidavit (Pet. App. A-32 to A-33; emphasis in
original), he “began an intensive search in approximately
June, 1963, to determine why I was given a vaccine that
would give me the disease instead of preventing it.” Peti-
tioner does not contend that the government’s involvement
in the vaccine program— in particul
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