No. 94-372

In the Supreme Court of the United States

OCTOBER TERM, 1994

DONNA E. SHALALA, SECRETARY OF HEALTH
AND HUMAN SERVICES, PETITIONER

v.

MARGARET WHITECOTTON, ET AL.

ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

BRIEF FOR THE PETITIONER

DREW S. DAYS, III
Solicitor General

FRANK W. HUNGER
Assistant Attorney General

EDWIN S. KNEEDLER
Deputy Solicitor General

IRVING L. GORNSTEIN
Assistant to the Solicitor General

BARBARA C. BIDDLE
RICHARD A. OLDERMAN
KAREN P. HEWITT
Attorneys

Department of Justice
Washington, D.C. 20530
(202)514-2217
      
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QUESTIONS PRESENTED

1. Whether, under the National Childhood Vaccine
Injury Act of 1986, 42 U.S.C. 300aa-11(c)(1)( C)(i), a
presumption that a vaccine has caused an injury can be
established by evidence that a symptom of the injury
occurred shortly after administration of the vaccine,
when that injury had already manifested itself prior to
administration of the vaccine and the injury did not
markedly worsen afterwards.
2. If so, whether the presumption of causation can be
rebutted by a showing that an identifiable preexisting
condition caused the injury, when the specific cause of
that condition is unknown.

(I)

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II

PARTIES TO THE PROCEEDING

Petitioner is Donna E. Shalala, the Secretary of
Health and Human Services. Respondents are Margaret,
Kay and Michael Whitecotton.

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TABLE OF CONTENTS

Page

Opinions below . . . . 1
Jurisdiction . . . . 1
Statutory provisions involved . . . . 2
Statement . . . . 6
Summary of argument . . . . 17
Argument:
The court of appeals erred in holding that the Vaccine
Act authorizes compensation when the child's injury
first manifested itself prior to administration of the
vaccine . . . . 20
A. Proof that a symptom of a condition occurred
within the Table period after administration of
a vaccine does not create a presumption that the
vaccine caused the condition when the condition
had already manifested itself prior to adminis-
tration of the vaccine . . . . 21
B. The Secretary may rebut a prima facie case of
causation by proving that an identified preexisting
condition caused the injury, even though the
specific cause of that condition is itself unknown . . . . 29
Conclusion . . . . 35

TABLE OF AUTHORITIES

Cases:

Brown v. Gardner, No. 93-1128 (Dec. 12, 1994) . . . . 32
Cepeda v. Secretary of Dep't of HHS, No. 90-2664V
(Fed. Cl. July 12, 1994) . . . . 24
Church of the Holy Trinity v. United States,
143 U.S. 457 (1892) . . . . 34
Connecticut Nat'1 Bank v. Germain, 112 S. Ct. 1146
(1992) . . . . 23
Department of Revenue Of Oregon v. ACF Industries,
inc., 114 S. Ct. 843 (1994) . . . . 23
          
(III)

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IV

Cases-Continued:

Page

Grant v. Secretary of Dep't of HHS, 956 F.2d 1144
(Fed. Cir. 1992) . . . . 31
Haggar Co. v. Helveri, 308 U.S. 389(1940) . . . . 34
Hodges v. Secretary of Dep't of HHS, 9 F.3d 958
(Fed. Cir. 1993) . . . . 31
International Bhd. of Teamsters v. United States,
431 U.S. 324 (1977) . . . . 25
Knudsen v. Secretary of Dep't of HHS, No. 93-5107
(Fed. Cir. Sept. 9, 1994) . . . . 28
Koston v. Secretary, Dep't of HHS, 974 F.2d 157
(Fed. Cir. 1992) . . . . 16, 33, 34
NLRB v. Baptist Hosp., Inc., 442 U.S. 773 (1979) . . . . 25
Price Waterhouse v. Hopkins, 490 U.S. 228 (1989) . . . . 25
Public Citizen v. United States Dep't of Justice,
491 U.S. 440 (1989) . . . . . 34
Richardson v. Richardson-Merrell, Inc., 857 F.2d 823
(D.C. Cir. 1988), cert. denied, 493 U.S. 882 (1989) . . . . 31
Schafer v. American Cyanamid Co., 20 F.3d 1
(lst Cir. 1994) . . . . 7

Statutes:

National Childhood Vaccine Injury Act of 1986, 42 U.S.C.
300aa-1 et seq. (1988 & Supp. IV 1992) . . . . 2, 6, 20 
Pt. 1 . . . . 6 
42 U.S.C. 300aa-10 to 300aa-6 (1988 & Supp. IV
1992) . . . . 6-7 
42 U.S.C. 300aa-1 . . . . 6 
Pt. 2 . . . . 7
42 U.S.C. 300aa-1 O to 300aa-34 (1988 & Supp. IV
1992) . . . . 7 
42 U.S.C. 300aa-10(a) . . . . 7
42 U.S.C. 300aa-10(b) . . . . 8
42 U.S.C. 300aa-10(c) (Supp. IV 1992) . . . . 8

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V

Statutes-Continued:                

Page
  
42 U.S.C. 300aa-11 (1988 & Supp. IV 1992) . . . . 2, 10
42 U.S.C. 300aa-11(a)(1) (Supp. IV 1992) . . . . 8
42 U.S.C. 300aa-11(a)(2) (Supp. IV 1992) . . . . 7
42 U.S.C. 300aa-11(c)(1) (C)(i) . . . . passim
42 U.S.C. 300aa-11(c)(1) (C)(ii) . . . . 9
42 U.S.C. 300aa-12 (1988 & Supp. IV 1992) . . . . 7
42 U.S.C. 300aa-12(d)(3) (Supp. IV 1992) . . . . 9
42 U.S.C. 300aa-12(e)(2)(B) (Supp. IV 1992) . . . . 9
42 U.S.C. 300aa-12(f) (Supp. IV 1992) . . . . 10
42 U.S.C. 300aa-13 (1988 & Supp. IV 1992)  . . . . 3,26
42 U.S.C. 300aa-13(a)(1)(A) (1988 & Supp. IV
1992) . . . . 3, 9, 21, 29
42 U.S.C. 300aa-13(a)(1)(B) (1988 & Supp. IV
1992) . . . . 3, 9, 20, 28, 29
42 U.S.C. 300aa-13(a)(2)(A) . . . . 3, 9, 30
42 U.S.C. 300aa-13(a)(2) (B) . . . . 3, 28
42 U.S.C. 300aa-14 (1988 & Supp. IV 1992) . . . . 4
42 U.S.C. 300aa-14(a) (Supp. IV 1992) . . . . . 4, 8, 12, 16, 18, 26
42 U.S.C. 300aa-14(b) (1988 & Supp. IV 1992) . . . . 
42 U.S.C. 300aa-14(b)(2) . . . . 27 
42 U.S.C. 300aa-14(b)(3)(A) . . . . 5, 12 
42 U.S.C. 300aa-14(c) . . . . 8 
42 U.S.C. 300aa-15 . . . . 7
42 U.S.C. 300aa-15(i)(1) . . . . 7 
42 U.S.C. 300aa-15(i)(2) . . . . 7
42 U.S.C. 300aa-16 (1988 & Supp. IV 1992) . . . . 7 
42 U.S.C. 300aa-21(a) (1988 & Supp. IV 1992) . . . . 7, 10 
42 U.S.C. 300aa-22 . . . . 10 
42 U.S.C. 300aa-23 (1988 & Supp. IV 1992) . . . . 10 
42 U.S.C. 300aa-33(4) . . . . 6, 23 
National Childhood Vaccine Injury Act of 1986, Pub. L.
No. 99-660, Tit. III, 100 Stat. 3755 . . . . 6 
26 U.S.C. 4131 . . . . 7 
26 U.S.C. 9510 (1988 & Supp. V 1993) . . . . 7 

Miscellaneous:

Dorland's Illustrated Medical Dictionary (27th ed.
1988) . . . . 30

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VI

Miscellaneous-Continued:

Page

H.R. Rep. No. 908, 99th Cong., 2d Sess. Pt. 1 (1986) . . . . 24, 33
International Dictionary of Medicine and Biology
(1976) . . . . 30
Stedman's Medical Dictionary (25th ed. 1990) . . . . 30
The American Medical Association Encyclopedia of
Medicine (1989) . . . . 30
The Oxford English Dictionary (2d ed. 1989):
Vol. 5 . . . . 22
Vol. 10 . . . . 22
The Random House Dictionary of the English Language
(2d ed. 1987) . . . . 22
Webster's Third New International Dictionary (1986) . . . . 22

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In the Supreme Court of the United States

OCTOBER TERM, 1994

No. 94-372

DONNA E. SHALALA, SECRETARY OF HEALTH
AND  HUMAN SERVICES, PETITIONER

v.

MARGARET WHITECOTTON, ET AL.

ON WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT

BRIEF FOR THE PETITIONER

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-9a) is
reported at 17 F.3d 374. The opinion of the United States
Claims Court (now the Court of Federal Claims) (Pet.
App. 10a-23a) and the decision of the Special Master (Pet.
App. 24a-43a) are unreported.
        
JURISDICTION

The judgment of the court of appeals was entered on
February 15, 1994. A petition for rehearing was denied
on April 29, 1994. Pet. App. 44a-45a. On July 19, 1994, the
Chief Justice extended the time within which to file a
petition for a writ of certiorari to and including August
27, 1994 (a Saturday). The petition for a writ of

(1)

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2

certiorari was filed on August 29, 1994, and was granted
on October 31, 1994. The jurisdiction of this Court rests
on 28 U.S.C. 1254(1).

STATUTORY PROVISIONS INVOLVED

The National Childhood Vaccine Injury Act of 1986,
42 U.S.C. 300aa-1 et seq. (1988 & Supp. IV 1992), provides,
in pertinent part:

300aa-11. Petitions for compensation

* * * * *

(c) Petition content

A petition for compensation under the Program
for a vaccine-related injury or death shall contain-

(1) except as provided in paragraph (3), an
affidavit, and supporting documentation, demon-
strating that the person who suffered such injury or
who died -

* * * * *

(C)(i) sustained, or had significantly aggra-
vated, any illness, disability, injury, or condition
set forth in the Vaccine Injury Table in
association with the vaccine referred to in
subparagraph (A) or died from the administration
of such vaccine, and the first symptom or
manifestation of the onset or of the significant
aggravation of any such illness, disability, injury,
or condition or the death occurred within the time    
period after vaccine administration set forth in
the Vaccine Injury Table[.] * * *
                                                      
* * * * *

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3

300aa-13. Determination of eligibility
and compensation

(a) General rule

(1) Compensation shall be awarded under the
Program to a petitioner if the special master or court
finds on the record as a whole-

(A) that the petitioner has demonstrated by a
preponderance of the evidence the matters
required in the petition by section 300aa-11(c)(1)
of this title, and

(B) that there is not a preponderance of the
evidence that the illness, disability, injury,
condition, or death described in the petition is due
to factors unrelated to the administration of the
vaccine described in the petition.

The special master or court may not make such a
finding based on the claims of a petitioner alone,
unsubstantiated by medical records or by medical
opinion.

(2) For purposes of paragraph (1), the term
"factors unrelated to the administration of the
vaccine"-

(A) does not include any idiopathic, unex-
plained, unknown, hypothetical, or undocu-
mentable cause, factor, injury, illness, or
condition; and

(B) may, as documented by the petitioner's
evidence or other material in the record, include
infection, toxins, trauma (including birth trauma

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4

and related anoxia), or metabolic disturbances
which have no known relation to the vaccine
involved, but which in the particular case are
shown to have been the agent or agents
principally responsible for causing the peti-
tioner's illness, disability, injury, condition, or
death.     

* * * * *

300aa-14. Vaccine Injury Table

(a) Initial table

The following is a table of vaccines, the injuries,
disabilities, illnesses, conditions, and deaths resulting
from the administration of such vaccines, and the time
period in which the first symptom or manifestation of
onset or of the significant aggravation of such
injuries, disabilities, illnesses, conditions, and deaths
is to occur after vaccine administration for purposes of
receiving compensation under the Program:

VACCINE INJURY TABLE

I. DPT * * *

Illness, disability,
injury, or condition
covered:

Time period for first
symptom or manifestation
of onset or of significant 
aggravation after vaccine 
administration:

* * * * *

B. Encephalopathy (or encephalitis) . . . . 3 days

*  * * * *

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5

(b) Qualifications and aids to interpretation

* * * * *

The following qualifications and aids to
interpretation shall apply to the Vaccine Injury Table
in subsection (a) of this section:

(3) (A) The term "encephalopathy" means any
significant acquired abnormality of, or injury to, or
impairment of function of the brain. Among the
frequent manifestations of encephalopathy are focal
and diffuse necrologic signs, increased intracranial
pressure, or changes lasting at least 6 hours in level of
consciousness, with or without convulsions. The
neurological signs and symptoms of encephalopathy
may be temporary with complete recovery, or may
result in various degrees of permanent impairment.
Signs and symptoms such as high pitched and unusual
screaming, persistent inconsolable crying, and
bulging fontanel are compatible with an encephalo-
pathy, but in and of themselves are not conclusive
evidence of encephalopathy. Encephalopathy usually
can be documented by slow wave activity on an
electroencephalogram.

(B) If in a proceeding on a petition it is shown by
a preponderance of the evidence that an encephalo-
pathy was caused by infection, toxins, trauma, or
metabolic disturbances the encephalopathy shall not
be considered to be a condition set forth in the table. If
at the time a judgment is entered on a petition filed
under section 300aa-11 of this title for a vaccine-

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6

related injury or death it is not possible to determine
the cause, by a preponderance of the evidence, of an
encephalopathy, the encephalopathy shall be con-
sidered to be a condition set forth in the table. In
determining whether or not an encephalopathy is a
condition set forth in the table, the court shall
consider the entire medical record.

* * * * *

300aa-33. Definitions

For purposes of this part:

* * * * *

(4) The term "significant aggravation" means
any change for the worse in a preexisting condition
which results in markedly greater disability, pain, or
illness accompanied by substantial deterioration of
health.

* * * * *

STATEMENT

1. In 1986, Congress enacted the National Childhood
Vaccine Injury Act (Vaccine Act), Pub. L. No. 99-660,
Tit. III, 100 Stat, 3755, codified as amended at 42 U.S.C.
300aa-1 et seq. (1988 & Supp. IV 1992). Part 1 of the Act
directs the Secretary of Health and Human Services
(Secretary) to establish a National Vaccine Program
designed "to achieve optimal prevention of human
infectious diseases through immunization and to achieve
optimal prevention against adverse reactions to
vaccines." 42 U.S.C. 300aa-1; see 42 U.S.C. 300aa-1 to

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7

300aa-6 (1988 & Supp. IV 1992). Part 2 of the Act, at
issue here, establishes a National Vaccine Injury
Compensation Program (compensation program), ad-
ministered by the Secretary, "under which compensation
may be paid for a vaccine-related injury or death."
42 U.S.C. 300aa-10(a); see 42 U.S.C. 300aa-10 to 300aa-34
(1988 & Supp. IV 1992).
a. Under the compensation program, compensation
for injury or death related to administration of a vaccine
prior to the effective date of the Act in 1986 is paid out of
appropriations by Congress. 42 U.S.C. 300aa-15(i)(1).
Compensation in connection with administration of a
vaccine after that date is paid out of the Vaccine Injury
Compensation Trust Fund established in the Treasury
by 26 U.S.C. 9510 (1988 & Supp. V 1993) and funded by a
tax imposed by 26 U.S.C. 4131 on the manufacture of
vaccines. See 42 U.S.C. 300aa-15(i)(2); see also 42 U.S.C.
300aa-15 (setting forth elements of compensation
available under the program).
The compensation program is designed to afford a fair,
informal, and expeditious alternative to tort suits
against vaccine manufacturers as a way of securing a
monetary recovery on behalf of persons who are alleged
to have been injured by the administration of a vaccine.
Schafer v. American Cyanamid Co., 20 F. 3d 1, 2-3 (1st
Cir. 1994); see, e.g., 42 U.S.C. 300aa-12 (1988 & Supp. IV
1992) (describing procedures). Accordingly, in the case
of a vaccine administered after the effective date of the
Act, no civil action seeking more than $1000 in damages
may be brought unless and until the claimant has
exhausted the procedures under the Act. 42 U.S. C.
300aa-11(a)(2) (Supp. IV 1992); see also 42 U.S.C. 300aa-16
(1988 & Supp. IV 1992) (limitations of actions); 42 U.S.C.
300aa-21(a) (1988 & Supp. IV 1992) (election by claimant
after procedures exhausted). The Act also provides

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8

measures to encourage invocation of the compensation
program in connection with claims based on
administration of vaccines prior to the effective date of
the Act. See, e.g., 42 U.S.C. 300aa-10(b) (declaring it to
be ethical obligation of attorney who is consulted about
vaccine-related injury to advise individual that
compensation may be available under the program); 42
U.S.C. 300aa-10(c) (Supp. IV 1992) (Secretary shall
undertake reasonable efforts to inform the public of the
availability of the program).
b. A proceeding under the compensation program is
initiated by the filing of a petition in the Court of
Federal Claims. 42 U.S.C. 300aa-11(a)(1) (Supp. IV 1992).
A claimant may establish an entitlement to compen-
sation by relying on the Vaccine Injury Table, which in
effect provides for a rebuttable presumption of causation
in certain circumstances. See 42 U.S.C. 300aa-14(a)
(Supp. IV 1992). The Table identifies vaccines covered by
the Act and lists particular injuries, disabilities,
illnesses, and conditions after each vaccine. The Table
then specifies for each injury, disability, illness, or
condition a "[t]ime period for first symptom or
manifestation of onset or of significant aggravation after
vaccine administration." 42 U.S.C. 300aa-14(a) (Supp. IV
1992). 1. See p. 4, supra. The claimant is entitled to a
rebuttable presumption of causation if the special master
or court finds on the record as a whole that the claimant
has shown by a preponderance of the evidence that a child
"sustained, or had significantly aggravated, any illness,
disability, injury, or condition set forth in the Vaccine
Injury Table in association with the vaccine [the child
received] * * *, and the first symptom or manifestation

___________________(footnotes)

1 The Secretary has authority to promulgate regulations to
modify the Vaccine Injury Table. See 42 U.S.C. 300aa-14(c).

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9

of the onset or of the significant aggravation of any such
illness, disability, injury, or condition * * * occurred
within the time period after vaccine administration set
forth in the Vaccine Injury Table." 42 U.S.C. 300aa-
11(c)(1)(C)(i); see 42 U.S.C. 300aa-13(a)(1) (A) (1988 &
Supp. IV 1992).
The Secretary may rebut the presumption of causation
and defeat the claim for compensation if she shows by a
preponderance of the evidence that the illness, disability,
injury, or condition "is due to factors unrelated to the
administration of the vaccine described in the petition."
42 U.S.C. 300aa-13(a)(1)(B) (1988 & Supp. IV 1992). The
term "factors unrelated to the administration of the
vaccine" does not, however, include "any idiopathic,
unexplained, unknown, hypothetical, or undocumentable
cause, factor, injury, illness, or condition." 42 U.S.C.
300aa-13(a)(2)(A).
If a child suffers from an injury that is not listed in the
Table-or if the child suffers from an injury listed in the
Table, but the first symptom or manifestation of the
injury did not occur within the Table's time limits-
recovery is not altogether precluded. Rather, in those
circumstances, the claimant must prove that the vaccine
caused the child's condition without the benefit of a
rebuttable presumption. 42 U.S.C. 300aa-11(c)(1)(C)(ii).
c. Cases under the compensation program are
adjudicated, in the first instance, by a special master.
42 U.S.C. 300aa-12(d)(3) (Supp. IV 1992). On motion by a
party, the Court of Federal Claims will review the
special master's decision. The court may either uphold
the decision, or "set aside any findings of fact or
conclusion of law * * * found to be arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact
and conclusions of law." 42 U.S.C. 300aa-12(e)(2)(B)

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10

(Supp. IV 1992). The decision of the Court of Federal
Claims is subject to review in the United States Court of
Appeals for the Federal Circuit. 42 U.S.C. 300aa-12(f)
(Supp. IV 1992).
After judgment is entered by the Court of Federal
Claims (or, if an appeal is taken, after the appellate
court's mandate is issued), the petitioner who filed the
petition under Section 300aa-11 must, within 90 days, file
an election in writing with the clerk of the Court of
Federal Claims to accept the judgment awarding or
denying compensation, or to file a civil action for
damages for the injury or death. If an election is not
filed within 90 days, the petitioner is deemed to have
accepted the judgment. 42 U.S.C. 300aa-21(a) (1988 &
Supp. IV 1992). 2.
2. Respondent Margaret (Maggie) Whitecotton was
born on April 22, 1975, with a head size in the second
percentile, more than two standard deviations below the
norm for a child of the same sex and age. Pet. App. 32a-
33a. Maggie's head size remained at the second
percentile through her first three months of age, but
then fell below the second percentile. Id. at 33a-34a. The
head size of a child is "indicative of the size of the brain."
Id. at 33a. Children with particularly small heads have a
condition known as microcephaly, which is most
commonly defined as a head size two standard deviations
below the norm for a child of the same sex and age. Id. at
32a.

___________________(footnotes)
             
2 The Act also prescribes standards of responsibility for
manufacturers in any civil action filed with respect to adminis-
tration of a vaccine after the effective date of the Act, 42 U.S.C.    
300aa-22, and prescribes stages for the conduct of the trial in such a    
civil action and limitations on the availability of punitive
damages, 42 U.S.C. 300aa-23 (1988 & Supp. IV 1992).

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On August 18, 1975, when Maggie was nearly four
months old, she received her third DPT vaccination.
After administration of the vaccine, Maggie suffered a
series of brief seizures. Pet. App. 27a. She was
hospitalized, but subsequently discharged after a
neurological examination indicated that her condition
was normal and that she had suffered no apparent ill
effects from the seizures. Id. at 40a. Her treating
physicians also decided not to administer any anticon-
vulsive medication. Id. at 30a. The discharge summary
diagnosed Maggie as having microcephaly and as having
experienced postimmunization encephalopathy with
seizures. ibid. The discharge summary also noted the
opinion of one treating physician that "children with
microcephaly and some brain damage [are] unusually
susceptible to this vaccine." Ibid.
There was no dramatic change in Maggie's condition
following her release. Symptoms of neurological damage
gradually appeared, however. Pet. App. 41a-42a.
Currently, Maggie is "severely disabled both mentally
and physically." Id. at 37a. She has cerebral palsy, hip
and joint problems, and cannot communicate verbally.
Ibid. She is, "for all practical purposes, totally depen-
dent on others for her needs," Ibid. Maggie had several
seizures in the five years following her third DPT
vaccination, but has not had any seizures in recent
years. Id. at 28a-30a.
3. On August 2, 1990, Maggie's parents, who are also
respondents, applied for compensation under the Vaccine
Act. Pet. App. 2a. They alleged that Maggie had suffered
an "encephalopathy" as a result of her third DPT
vaccination. Ibid. As noted above, an encephalopathy is
one of the injuries listed in the Table in connection with
the DPT vaccine. "Encephalopathy" is defined as "any
significant acquired abnormality of, or injury to, or

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12

impairment of function of the brain." 42 U.S.C. 300aa-
14(b)(3)(A). To trigger the presumption of causation
under the Table, the first symptom or manifestation of
the onset or significant aggravation of an encephalo-
pathy must occur within three days of the adminis-
tration of the vaccine. 42 U.S.C. 300aa-14(a) (Supp. IV
1992). Maggie's parents alleged that Maggie's post-
vaccination seizures were such a manifestation.
a. A special master denied compensation. Pet. App.
24a-43a. The special master adopted the most commonly
accepted definition of microcephaly, namely a head size
smaller than two standard deviations below the mean for
a child of the same sex and age. By that definition, the
special master concluded, a child whose head size is at
the second percentile is microcephalic, "since the cutoff
for two standard deviations is above the second percen-
tile." Pet. App. 32a; see also id. at 20a (Claims Court
decision). In this case, the special master noted that
Maggie's head size was at the second percentile at birth
and remained on the second percentile curve through
three months of age, but had dropped below that curve by
August 20, when she was examined in the hospital after
the vaccine was administered. Id. at 33a. Based on that
evidence, the special master found "that Maggie was at
least borderline microcephalic at birth and that she was
clearly microcephalic by the time she received her third
DPT shot on August 18, 1975." 1d. at 32a-33a.
The special master was persuaded by the evidence
concerning Maggie's head size and the testimony of
neurologists that "Maggie had suffered an encephalo-
pathy sometime prior to the administration of the DPT
vaccine on August 18, 1975." Pet. App. 33a. He cited the
testimony of the government's expert, who believed that
Maggie's head size indicated that she suffered brain
injury prior to birth. Id. at 34a. The special master also

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13

relied on respondents' expert, who testified that
"[something was clearly happening to the child before
[the DPT vaccination]" (id. at 33a), and who stated in his
report that the growth of Maggie's head had fallen below
the normal curve, which "implie[d] a post-partum injury
to the brain, at or near three months of age" (id. at 34a).
on that record, the special master found that "[w]hether
the injury occurred prior to birth or thereafter, the
preponderance of evidence indicates that Maggie was
already encephalopathic prior to August 18, 1975." Ibid.
The special master therefore concluded that Maggie's
"original encephalopathy was not a Table injury which
followed the August 18 DPT shot." ibid.
The special master also determined that the seizures
that had occurred within the three-day statutory period
after administration of the vaccine did not significantly
aggravate Maggie's preexisting encephalopathy. Pet.
App. 34a-43a. The special master found that in Maggie's
early months, there were only hints, apart from her
small head size, that she might have suffered brain
damage. Id. at 36a. She rolled over from her stomach to
her back at two weeks of age, which could be a sign of
spasticity, and she had difficulty swallowing from birth,
which could be a sign of mental retardation and cerebral
palsy. Id. at 36a-37a. The special master found, however,
that the absence of obvious symptoms of neurological
damage in the early months of life was not atypical for a
child with microcephaly. He noted that neurological
problems often do not become obvious until a child
matures to the point where developmental milestones
(such as walking or talking) are missed or delayed. Id. at
37a. For example, cerebral palsy typically becomes
evident between six months and one year of age. Id. at
38a. Mental retardation may not become evident until
much later. Ibid. The special master determined that

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14

there was more than a 90% likelihood that Maggie would
have been mentally retarded based on her microcephaly
alone. Ibid.
The special master further found that the DPT
vaccination "may have caused a temporary encephalo-
pathy evidenced by transient seizure activity, but the
seizures did not continue and there was no dramatic turn
for the worse in [Maggie's] condition indicating a
permanent aggravation of her brain disorder." Pet. App.
42a. Rather, the special master explained, as Maggie
"matured neurologically, the complications of whatever
caused her microcephaly gradually manifested them-
selves, just as they do in a typical case involving
congenital brain damage." Ibid. Accordingly, the special
master found "no basis for implicating the vaccine as the
cause of any aspect of [Maggie's] present condition." Id.
at 42a-43a.
The special master issued formal findings of fact that
were consistent with his analysis of the record evidence.
Thus, the special master found that Maggie "was born
* * * with a brain disorder evidenced by microcephaly
which became more pronounced by the age of four
months," that she "suffered transient seizure activity
within three days following the administration of the
DPT vaccine," that she "did not suffer a permanent
encephalopathy within three days following the said
administration of DPT vaccine," and that "[n]o
significant aggravation of Maggie's underlying brain
disorder was manifested within three days following the
said administration of the DPT vaccine." Pet. App. 43a. 3.

___________________(footnotes)

3 Although respondents' petition for compensation alleged that
Maggie suffered from an encephalopathy, respondents asserted at
the hearing that Maggie also suffered from a residual seizure
disorder. Pet. App. 26a n.2. The special master found that

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15

b. The United States Claims Court (now the Court of
Federal Claims) overruled respondents' objections to the
special master's decision and entered judgment for the
Secretary. Pet. App. 10a-23a. The court concluded that
there was sufficient evidence to support the special
master's finding that Maggie was microcephalic before
she received her third DPT vaccination, id. at 19a-21a,
noting that "Maggie's preexisting injury precluded the
vaccination from being the cause of the encephalopathy,"
id. at 21a. The court also found sufficient evidence to
support the special master's finding that the seizures
that had occurred within the three-day statutory period
after administration of the vaccine were not an indi-
cation that the preexisting encephalopathy had been
significantly aggravated by the vaccine. Id. at 23a. The
court pointed out that "[t]here is simply no evidence that
these transient seizures were a sign of permanent brain
damage." Ibid. The court also cited evidence indicating
that Maggie's "entire clinical history is typical for a
person with a condition similar to [Maggie's] who did not
have vaccine complications." Ibid.
c. The court of appeals reversed the judgment of the
Claims Court and remanded for an award of compen-
sation. Pet. App. 1a-9a. The court of appeals held that
respondents' showing that Maggie had suffered seizures
within three days following administration of the vaccine
was sufficient to establish a presumption that the
vaccine had caused the onset of an encephalopathy. Id. at
5a-7a. The court recognized that 42 U.S.C. 300aa-
11(c)(1)(C)(i) requires a claimant to show that the first
manifestation  of any  injury  occurred after

___________________(footnotes)

Maggie did not suffer from such a disorder, id. at 27a-30a, 42a, and
the Claims Court sustained that finding, id. at 16a-19a. The court
of appeals did not address that issue, and it is not involved here.

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16

administration of the vaccine. Id. at 5a. The court
reasoned, however, that "the Table language [in 42
U.S.C. 300aa-14(a)] is that the first symptom after
vaccine administration must occur within Table time,
not, as the Secretary argues, that the first of all
manifestations must so occur." Id. at 5a.
The court then held that the Secretary could not rely
on Maggie's preexisting microcephaly to show that her
current condition was caused by a "factor unrelated" to
the vaccine. Pet. App. 7a-8a. The court did not disturb
the special master's findings that Maggie "was
microcephalic before she received the suspect vaccine,"
and that her "microcephaly marked [her] as a child likely
to experience developmental problems," Id. at 8a. And
the court acknowledged that, "[l]ogically, these findings
point to some preexisting condition, and not the vaccine,
as the source of Maggie's injury." Ibid. Nonetheless,
the court held that Maggie's microcephaly was not a
"factor unrelated" to administration of the vaccine
within the meaning of the Vaccine Act. Id. at 6a.
Relying on its decision in Koston v. Secretary, Dep't of
HHS, 974 F.2d 157, 160-161 (Fed, Cir. 1992), the court
concluded that Maggie's microcephaly was "idiopathic"
because, although it was preexisting, its specific cause
could not be identified. Pet. App. 7a-8a. 4.

___________________(footnotes)

4 The court of appeals denied the Secretary's petition for
rehearing and suggestion for rehearing en bane. Pet. App. 44a-
45a.

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17

SUMMARY OF ARGUMENT

The court of appeals has interpreted the Vaccine Act
to require compensation in circumstances in which a
child's condition logically could not have been caused by
a vaccine. The court arrived at that result by misinter-
preting two provisions of the Act.
A. First, the court erred in its construction of 42
U.S.C. 300aa-11(c)(1)(C)(i), which creates a presumption
of causation when a claimant can show that "the first
symptom or manifestation of the onset or of the
significant aggravation" of the child's condition occurred
within the time period after administration of the
vaccine set forth in the Act. The court held that the
phrase "first symptom or manifestation of the onset"
means that a claimant is entitled to a presumption of
causation as long as any symptom or manifestation of an
underlying injury or condition occurred within the
statutory period. In the court's view, the claimant does
not have to show that there was no preexisting symptom
or manifestation of that condition.
That construction is at odds with the plain meaning of
the statutory text. When an injury or condition has
manifested itself prior to administration of the vaccine, a
manifestation after administration cannot be the "first."
And when an injury or condition had its start prior to
administration of the vaccine, any manifestation that
occurs after that time cannot be a manifestation of the
"onset."
The court of appeals' interpretation also renders
superfluous the statutory text creating a presumption of
causation when the first symptom or manifestation of a
"significant aggravation" of a preexisting condition
occurs within the statutory period after administration
of the vaccine. If a presumption of causation arises

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18

whenever any symptom happens to occur within the
Table period, there would never be a need for a claimant
to establish a significant aggravation of a preexisting
condition. Implicit in Congress's decision to authorize
significant aggravation as a separate ground for re-
covery is that there cannot be a presumption of causation
when a condition that manifested itself prior to adminis-
tration of the vaccine did not get markedly worse
afterwards.
This interpretation of the statutory scheme also is the
most logical. Presumptions are generally created when
there is at least some likelihood that the presumption is
in fact accurate. When a condition for which a claimant
seeks recovery had already manifested itself prior to
administration of the vaccine and the condition did not
markedly worsen afterwards, there is no realistic
possibility that the vaccine caused the condition.
The court of appeals, while recognizing that the
language in Section 300aa-11(c)(1)(C)(i) did not support
its interpretation of the Act, held that the language in
the heading to the Table in 42 U.S.C. 300aa-14(a) (Supp.
IV 1992) did. There is, however, no relevant distinction
between the two Sections. Both provide that the
symptom or manifestation in the statutory period must
be "the first symptom or manifestation of the onset or of
the significant aggravation" of the condition (emphasis
added). Moreover, if there were a difference between the
two, Section 300aa-11(c)(1)(C)(i) would take precedence,
since that Section formally sets forth the elements that
a claimant must establish. The language in Section
300aa-14(a) relied upon by the court of appeals is simply a
heading that summarizes the requirements for a
presumption in shorthand form. The other statutory
provisions relied upon by the court of appeals merely
articulate the details of the statutory scheme or fashion

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19

special standards for its application in particular
circumstances; they do not undermine the clear import
of Section 300aa-11(c)(1)(C)(i).
B. The court of appeals also erred in holding that the
Secretary could not rely on Maggie's microcephaly to
rebut a prima facie case of causation because her
microcephaly is, in the court's view, "idiopathic."
Although the Act excludes "idiopathic" factors from the
"factors unrelated to the administration of the vaccine"
that may rebut a prima facie case, the Secretary did not
rely on such a factor here.
Idiopathic means "of unknown cause." Accordingly, in
order to rebut the presumption, the Secretary cannot
rely exclusively on medical evidence showing that there
is no known cause of the child's injury or on evidence
showing that there is no established relationship be-
tween the vaccine and the child's injury. The Secretary
must be able to point to an identifiable condition as an
explanation for the claimant's injury. Here, the Secre-
tary did point to a specific, preexisting condition-
microcephaly-to explain Maggie's current condition.
Because microcephaly is sufficiently well-defined, and
because it logically eliminates the vaccine as the cause
of Maggie's injuries, it is non-idiopathic within the
meaning of the Vaccine Act.
The court of appeals held that the Secretary was
relying on an "idiopathic" factor because the Secretary
could not in turn identify the specific cause of Maggie's
microcephaly. It is true that the cause of Maggie's
preexisting condition is not fully understood. But that is
almost always true in medicine. Congress could not have
intended the term "idiopathic" to be applied at that level
of generality, since to do so might effectively preclude
the Secretary from ever rebutting a prima facie case.
Thus, as the legislative history confirms, the court of

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20

appeals took the requirement that an unrelated factor
must be non-idiopathic one step further back than
Congress intended.
The court of appeals' interpretation also would lead to
consequences that Congress could not have intended.
For example, under the court of appeals' interpretation,
if the Secretary could prove that a child had only a
partial brain at birth and that such a condition inevitably
results in the kinds of injuries that the child suffers, a
prima facie case could not be rebutted unless the
Secretary could also establish what had caused the child
to have a partial brain. Since Congress could not have
intended to permit compensation in circumstances in
which the evidence shows that a preexisting condition
and not the vaccine caused the child's injuries, the court
of appeals' interpretation of the term "idiopathic" should
be rejected.

ARGUMENT

THE COURT OF APPEALS ERRED IN HOLDING THAT
THE VACCINE ACT AUTHORIZES COMPENSATION
WHEN THE CHILD'S INJURY FIRST MANIFESTED
ITSELF PRIOR TO ADMINISTRATION OF THE VACCINE

The court of appeals has interpreted the National
Childhood Vaccine Injury Act of 1986 (Vaccine Act) to
require compensation in circumstances in which logic
dictates that a child's condition was not caused by the
vaccine.  The court arrived at that result by
misinterpreting two provisions of the Act. Specifically,
the court improperly construed 42 U.S.C. 300aa-
11(c)(1)(C)(i), which sets forth the elements that a
claimant must. prove to establish a presumption that the
vaccine has caused his or her condition, and 42 U.S.C.
300aa-13(a)(1)(B) (1988 & Supp. IV 1992), which sets forth
what the Secretary must show to rebut that statutory

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21

presumption. Each of those errors independently
requires reversal of the judgment below.

A. Proof That A Symptom Of A Condition Occurred
Within The Table Period After Administration Of
A Vaccine Does Not Create A Presumption That
The Vaccine Caused The Condition When The
Condition Had Already Manifested Itself Prior To
Administration Of The Vaccine

The Vaccine Act provides that a rebuttable pre-
sumption of causation exists when a claimant shows by a
preponderance of the evidence that a child

sustained, or had significantly aggravated, any
illness, disability, injury, or condition set forth in the
Vaccine Injury Table in association with [a specified]
vaccine * * *, and the first symptom or
manifestation of the onset of or the significant
aggravation of any such illness, disability, injury, or
condition * * * occurred within the time period
after vaccine administration set for in the Vaccine
Injury Table.

42 U.S.C. 300aa-11(c)(1)(C)(i); see 42 U.S.C. 300aa-13(a)(1)
(A) (1988 & Supp. IV 1992). That statutory language
creates a presumption of causation in two kinds of cases:
those in which the claimant shows that the child first
began to suffer from an injury or condition after
administration of the vaccine, and those in which the
claimant shows that the child suffered from a Table
injury or condition prior to administration of the
vaccine, but that it markedly worsened thereafter.
In this case, the special master carefully examined
each of those possibilities. The special master found that
Maggie's head size indicated that she had already
suffered an encephalopathy before she received her third
DPT vaccination. Pet. App. 30a-34a. The special master

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22

also found that the seizures that Maggie experienced
after administration of her third DPT vaccine did not
significantly aggravate that preexisting condition. Id. at
34a-43a.  The special master therefore properly
concluded that respondents could not rely on the pre-
sumption of causation established by Section 300aa-
11(c)(1)(C)(i).
The court of appeals did not disturb the special
master's findings that Maggie suffered from an
encephalopathy before she received her third adminis-
tration of the DPT vaccine and that her condition did not
markedly deteriorate afterwards. The court nonetheless
held that there was a presumption that the DPT vaccine
caused Maggie's current condition. It reasoned that the
statutory phrase "first symptom or manifestation of the
onset" means that a claimant is entitled to a presumption
of causation as long as any symptom or manifestation of
an underlying injury or condition happened to occur
within the Table period. Pet. App. 5a-7a. That holding is
incorrect for several reasons.
1. First, the court's interpretation cannot be re-
conciled with the plain meaning of the statutory text.
The term "first" means "before all others," and the term
"onset" means "a beginning or start." The Random
House Dictionary of the English Language 723, 1354 (2d
ed. 1987); see also Webster's Third New International
Dictionary 856, 1577 (1986) (defining "first" as "being
number one in a countable series," and "onset" as
"beginning, commencement, start"); 5 The Oxford
English Dictionary 957 (2d ed. 1989) (defining "first" as
"[p]rior to all others in occurrence"); 10 The Oxford
English Dictionary, supra, at 821 (defining "onset" as
"beginning, commencement, start"). When an injury or
condition has manifested itself prior to administration of
a vaccine, a manifestation that occurs after adminis-

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23

tration cannot be the "first." And when an injury or
condition had its start prior to administration of a
vaccine, any manifestation that occurs after adminis-
tration cannot he a manifestation of the "onset." Simply
put, the phrase "first symptom or manifestation of the
onset" cannot mean a further symptom of a preexisting
injury.
In interpreting the meaning of legislation, "courts
must presume that a legislature says in a statute what it
means and means in a statute what it says." Connecticut
Nat'1 Bank v. Germain, 112 S. Ct. 1146, 1149 (1992).
Because the court of appeals' interpretation is at odds
with the statutory text, it must be rejected.
2. The court of appeals' interpretation also violates
the principle that "a statute should be interpreted so as
not to render one part inoperative," Department of
Revenue of Oregon v. ACF Industries, Inc., 114 S. Ct.
843,848 (1994), because it fails to give any meaning to the
statutory text creating a presumption of causation when
the first symptom or manifestation of a "significant
aggravation" of an injury or condition occurs within the
statutory period after the administration of a vaccine. 42
U.S.C. 300aa-11(c)(1)(C)(i). Under the Act, "significant
aggravation" means "any change for the worse in a
preexisting condition which results in markedly
greater disability, pain, or illness accompanied by sub-
stantial deterioration of health." 42 U.S.C. 300aa-33(4)
(emphasis added). If, as the court of appeals concluded, a
presumption of causation arises whenever any symptom
occurs within the statutory period, there would never be
a need for a claimant to establish a significant aggra-
vation of a preexisting condition. As one special master
has recently explained, under the court of appeals'
interpretation, significant aggravation "need no longer
be referenced in the resolution of any Table cases."

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24

Cepeda v. Secretary of the Dep't of HHS, No. 90-2664V
(Fed. Cl. July 12, 1994), slip op. 2.
Congress could not have intended for the significant
aggravation presumption to be superfluous. Rather, as
the definition of "significant aggravation" makes clear,
that presumption must have been designed to cover the
cases in which a Table condition was "preexisting" and
had manifested itself prior to administration of the
vaccine. Implicit in Congress's decision to authorize
significant aggravation as a separate ground for
recovery is that there cannot be a presumption of
causation or an award of compensation where, as here, a
condition that manifested itself prior to administration
of the vaccine did not get markedly worse afterwards.
The legislative history to the Vaccine Act confirms
that natural reading of the statutory text. As explained
in the House Report, the Act "does not include
compensation for conditions which might legitimately be
described as pre-existing (e.g., a child with monthly
seizures who, after vaccination, has seizures every three
and a half weeks), but is meant to encompass serious
deterioration (e.g. a child with monthly seizures who,
after vaccination, has seizures on a daily basis)." H.R.
Rep. No. 908, 99th Cong., 2d Sess. Pt. 1, at 14-16 (1986).
The court of appeals' decision fails to give effect to that
congressional intent.
3. Had Congress intended to create a presumption
like the one imposed by the court of appeals, it surely
would have done so in far simpler terms. Instead of
providing that a claimant must show that the first
symptom or manifestation of the onset or significant
aggravation of the condition occurred within the
statutory period, Congress could simply have provided
that the claimant must show that "a symptom or
manifestation of the condition occurred within the time

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25

period after vaccine administration set forth in the
Vaccine Injury Table." The language Congress chose
shows that it decided to create a presumption where the
claimant could show not only that a symptom of the
condition occurred in the statutory period, but also
either that there was no symptom or manifestation of the
condition prior to administration of the vaccine, or, if
there was, that there was a marked deterioration in that
preexisting condition after administration of the vaccine.
That choice by Congress is a logical one. When a
claimant can show that the first symptom of onset or
significant aggravation of a condition occurred within a
short time after administration of a vaccine, there is at
least a substantial likelihood that the vaccine might have
caused that condition. Creating a presumption of
causation in such circumstances is therefore consistent
with the manner in which presumptions are recognized
as a general matter. See NLRB v. Baptist Hosp., Inc.,
442 U.S. 773, 787 (1979) (presumption appropriate where
there is "a sound factual connection between the proved
and inferred facts"); International Bhd. of Teamsters v.
United Slates, 431 U.S. 324, 359 n.45 (1977) (proof that
employer has engaged in a policy of discrimination
creates sufficient likelihood that employer has engaged
in discrimination in an individual case to shift the burden
of proof); Price Waterhouse v. Hopkins, 490 U.S. 228,
262-266 (1989) (O'Connor, J., concurring in the judgment)
(proof that discrimination is a substantial factor in a
decision creates sufficient likelihood that discrimination
is the but-for cause to shift burden of proof). When a
condition for which a claimant seeks recovery has
already manifested itself prior to administration of the
vaccine and the condition did not markedly worsen
afterwards, however, there is no realistic possibility that
the vaccine caused the condition. The creation of a

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26

presumption of causation in those circumstances
therefore would make no sense.
4. The court of appeals appeared to recognize that the
phrase "first symptom or manifestation of the onset" in
Section 300aa-11(c)(1)(C)(i) requires a showing that the
first of all symptoms of the condition occurred after
administration of the vaccine. Pet. App. 5a. The court
concluded, however, that the language in Section 300aa-
14(a) that serves as a heading for the statutory time
periods for Table injuries dictates a different conclusion.
Pet. App. 5a. That heading reads: "Time period for first
symptom or manifestation of onset or of significant
aggravation after vaccine administration." 42 U.S.C.
300aa-14(a) (Supp. IV 1992). According to the court of
appeals, Section 300aa-14(a), unlike Section 300aa-11(c)(1)
(C)(i), provides that "the first symptom after vaccine
administration must occur within Table time, not, as
the Secretary argues, that the first of all mani-
festations must so occur." Pet. App. 5a.
There is, however, no relevant distinction between
Section 300aa-11(c)(1)(C)(i) and Section 300aa-14(a). Both
provide that the symptom or manifestation in the Table
period must be "the first symptom or manifestation of
the onset or of the significant aggravation" of the
condition (emphasis added), not simply "a" or "any"
symptom or manifestation of the condition. If there were
a difference between the two Sections, however, Section
300aa-11(c)(1)(C)(i) should take precedence over Section
300aa-14(a), not the other way around. The language in
Section 300aa-14(a) cited by the court of appeals is simply
a heading that summarizes the rule in shorthand form.
In contrast, Section 300aa-11(c)(1)(C)(i) formally sets
forth the elements that a claimant must establish to
trigger the statutory presumption of causation. See 42
U.S.C. 300aa-13 (1988 & Supp. IV 1992).

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The court of appeals also purported to find support for
its interpretation in the manner in which residual
seizure disorders are addressed in the "Qualification and
aids to interpretation," which appears in subsection (b) of
Section 300aa-14, following the Table. There, the Act
provides that a residual seizure disorder may be found if
the claimant "did not suffer a seizure or convulsion
unaccompanied by fever or accompanied by a fever of less
than 102 degrees Fahrenheit before the first seizure or
convulsion after the administration of the vaccine
involved." 42 U.S.C. 300aa-14(b)(2). The court of appeals
reasoned that, because the Act places no such limitation
with respect to encephalopathies, Congress must not
have intended to require claimants to show that there
was no preexisting symptom of that injury or condition.
Pet. App. 5a-6a. The special provision on seizure
disorders was necessary, however, because seizures
accompanied by high fevers may not be symptomatic of a
seizure disorder. To avoid any uncertainty about
whether the existence of pre-vaccination seizures
accompanied by high fevers would preclude a showing of
post-vaccination onset, Congress made clear that they
would not. Thus, the provision does not demonstrate
that Congress intended to require claimants to show the
absence of prior symptoms or manifestations in residual
seizure disorder cases, but not in others. Instead, it
clarifies how the general statutory requirement-that a
claimant must show that a manifestation that occurred
within the statutory period was the first such
manifestation-should be applied in the special circum-
stances of alleged residual seizure disorders.
Finally, the court of appeals attributed significance to
the provision in the Act that permits a prima facie case
to be defeated upon proof by a preponderance of the
evidence that the injury or condition was due to "factors

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28

unrelated to the administration of the vaccine," 42
U.S.C. 300aa-13(a)(1)(B) (1988 & Supp. IV 1992), a term
that may include "infection, toxins, trauma (including
birth trauma and related anoxia), or metabolic distur-
bances," 42 U.S.C. 300aa-13(a)(2)(B). According to the
court, "[i]t would make no sense to allow proof by the
Secretary of birth trauma as a factor unrelated if the
petitioner were required to prove that no such
preexisting injury occurred as an element of the Table
case." Pet. App. 6a. That reasoning is flawed.
There may well be cases in which a child has a
preexisting condition, but no signs of that condition
appeared prior to administration of the vaccine. There
may also be cases in which signs of the condition
appeared, but they were unobserved or unrecorded. In
such circumstances, the claimant may establish a prima
facie case of causation by showing that the first
symptom or manifestation of the condition occurred
within the Table period. The "factors unrelated" pro-
vision serves the distinct purpose of permitting the
Secretary to rebut that prima facie case by showing that,
even though the record does not establish that there was
a prior symptom or manifestation of the injury or
condition, it nonetheless is due to an unrelated factor,
such as birth trauma. See Knudsen v. Secretary of
Dep't of HHS, No. 93-5107 (Fed. Cir. Sept. 9, 1994), slip
op. 6-7. The "factors unrelated" provision is therefore
entirely compatible with the requirement that the
claimant must show that a symptom or manifestation
that occurred within the Table period was the "first"
such symptom or manifestation of the "onset" of the
injury or condition.
5. In sum, in order to establish a presumption of
causation, it is not enough for a claimant to show that a
symptom or manifestation of a Table condition happened

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29

to occur in the statutory period. The claimant must also
establish either that there was no previous symptom or
manifestation of that condition, or that the preexisting
condition markedly worsened after administration of the
vaccine.

B. The Secretary May Rebut A Prima Facie Case Of
Causation By Proving That An Identified
Preexisting Condition Caused The Injury, Even
Though The Specific Cause Of That Condition Is
Itself Unknown

The court of appeals likewise erred in holding that the
Secretary could not rely on Maggie's preexisting
microcephaly to rebut a prima face case of causation.
The Act expressly provides that compensation shall be
awarded if the special master or court finds that the
petitioner has demonstrated by a preponderance of the
evidence the matters necessary to recover (including the
predicate circumstances for invoking the rebuttable
presumption created by the Table), and "that there is not
a preponderance of the evidence that the illness,
disability, injury, condition, or death described in the
petition is due to factors unrelated to the administration
of the vaccine." 42 U.S.C. 300-13(a)(1)(A) and (B) (1988 &
Supp. IV 1992). The latter clause sets out the basis for
the Secretary to rebut the presumption of causation.
The special master found that Maggie's microcephaly
was unrelated to administration of the vaccine and that it
marked her as a child likely to experience the very
developmental problems that she ultimately encountered
as she matured. Pet. App. 42a-43a. In particular, the
special master found that "there was a greater than 90%
likelihood that Maggie would have been mentally
retarded based on her microcephaly alone." Id. at 38a.
Those findings were sufficient to support the conclusion

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that Maggie's current condition is due to "factors
unrelated to the administration of the vaccine."
The court of appeals did not disturb the special
master's findings, and it acknowledged that, "[logically,
these findings point to some preexisting condition, and
not the vaccine, as the source of Maggie's injuries." Pet.
App. 8a. The court nonetheless held that the Secretary
had not established a "factors unrelated" defense
because, in its view, Maggie's microcephaly was, in turn,
"idiopathic." Id. at 8a-9a. That holding is in error. The
Act provides that the term "factors unrelated to the
administration of the vaccine" " does not include any
idiopathic, unexplained, unknown, hypothetical, or
undocumentable cause, factor, injury, illness, or
condition," 42 U.S.C. 300aa-13(a)(2)(A), and it thereby
precludes the Secretary from relying on an "idiopathic"
factor to rebut a prima facie case of causation. But the
Secretary did not rely on such a factor here.
1. Medical dictionaries uniformly define "idiopathic"
as "of unknown cause." International Dictionary of
Medicine and Biology 1398 (1976); Stedman's Medical
Dictionary 762 (25th ed. 1990); Dorland's Illustrated
Medical Dictionary 815 (27th ed. 1988); The American
Medical Association Encyclopedia of Medicine 566
(1989). The core of what Congress was attempting to
preclude by ruling out reliance on "idiopathic" factors is
apparent from that definition. The Secretary could not
attempt to rebut a prima facie case by relying on a
statement from an expert such as: "I have no idea what
caused the injury, but it could not have been the
vaccine."
That statutory protection for the claimant is
important. There are medical studies that show that the
overall frequency of certain identified conditions in
children who receive the DPT vaccine is the same as it

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is in children who do not receive the vaccine. See Grant
v. Secretary of Dep't of HHS, 956 F.2d 1144, 1148-1149
(Fed. Cir. 1992). Outside the context of the Vaccine Act,
such studies have been found to be sufficient by
themselves to defeat a finding of causation. See, e.g.,
Richardson v. Richardson-Merrell, Inc., 857 F.2d 823,
830 (D.C. Cir. 1988), cert. denied, 493 U.S. 882 (1989).
Because the Vaccine Act excludes reliance on
"idiopathic" or "unknown" factors from consideration as
"factors unrelated to the administration of the vaccine,"
the Secretary could not rely on such studies alone to
rebut a prima facie case. Similarly, the Secretary could
not attempt to rebut a prima facie case by relying on a
condition that has no medical meaning or significance
other than to identify a situation in which the cause of
the injury is unknown. For example, the Secretary
could not attempt to rebut a prima facie case of a vaccine-
related death by proving that a child died from sudden
infant death syndrome (SIDS) because SIDS "is not an
illness or injury, but an idiopathic diagnosis used to
describe the otherwise unexplained death of an infant."
Hodges v. Secretary of Dep't of HHS, 9 F.3d 958, 963
(Fed. Cir. 1993) (internal quotation marks omitted).
What these examples have in common is the absence of
any identifiable condition as an explanation for the
person's injuries. When the Secretary is unable to point
to such an identifiable condition, the Act requires that
the claimant receive the benefit of the doubt on the issue
of causation, even though it is unclear whether the
vaccine actually caused the injury. Here, however, the
Secretary did identify a specific, preexisting condition-
microcephaly-to explain Maggie's brain injury. Be-
cause that condition is sufficiently well-defined, and
because it logically eliminated the vaccine as the cause

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of Maggie's current injuries, it is non-idiopathic within
the meaning of the Vaccine Act.
2. The court of appeals nonetheless concluded that the
Secretary was relying on an "idiopathic" factor because
the Secretary could not in turn identify the cause of
Maggie's preexisting microcephaly. Pet. App. 7a-8a. It
is true that the cause of Maggie's underlying condition
is not fully understood and that it could therefore be
termed "idiopathic" in that broader sense. In medicine,
however, the cause of an event is almost never fully
understood; there is almost always more to be learned.
Congress could not have intended the term "idiopathic"
to be applied at that level of generality, however, since to
do so might effectively preclude the Secretary from ever
rebutting a prima facie case.
The court of appeals lost sight of the fact that the term
"idiopathic" is used in the Act for a specific purpose: to
limit and define the term "factors unrelated to the
administration of the vaccine," which defeats a showing
of causation under the Act. The term should be
construed with that purpose in mind, and thereby with
reference to the degree of relatedness and possible
causal nexus between the child's current injury or
condition and the "factor" to which the injury or
condition is (according to the Secretary's evidence)
"due." When the term "idiopathic" is thus read in the
context of the Act as a whole, Brown v. Gardner, No. 93-
1128 (Dec. 12, 1994), slip op. 3, it is clear that the court of
appeals took the requirement that an unrelated factor
must be non-idiopathic one step further back than
Congress intended. The Act gives the claimant the
benefit of the doubt in cases in which the Secretary
cannot point to any identifiable condition that justifies
elimination of the vaccine as the cause of the injury or
condition. It does not require compensation in circum-

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stances in which the Secretary can point to a specific
condition that does logically eliminate the vaccine as the
cause of the child's current injury, simply because the
cause of that specific condition is, in turn, unknown.
The legislative history supports that reading of the
statutory text. The House Report states that "factors
unrelated to the administration of the vaccine" cannot
include "speculative or hypothetical matters or explana-
tions." H.R. Rep. No. 908, supra, at 18. It makes clear,
however, that the Secretary may prevail by relying on
"other, defined illnesses or factors." Ibid.
3. The court of appeals' broader definition of
"idiopathic" leads to consequences that Congress could
not have intended. The Federal Circuit's previous de-
cision in Koston v. Secretary, Dep't of HHS, 974 F.2d 157
(1992), is illustrative. There, the Secretary introduced
evidence that the child's condition was caused by Rett
Syndrome, a condition manifested by mental regression
and peculiar behavioral symptoms. Id. at 160-161. Even
though the Secretary could establish that this condition
is always present from birth and therefore logically
eliminated the vaccine as the cause of the child's
condition, the court held that it was idiopathic (and
therefore could not be regarded as a "factor unrelated to
the administration of the vaccine") because medical
science had not yet established the specific cause of Rett
Syndrome. Ibid.
Similarly, under the court of appeals' interpretation,
even if the Secretary could prove that a child had only a
partial brain at birth and that such a condition invariably
results in the kind of injury or disability from which the
child suffers, a prima facie case could not be rebutted
unless the Secretary were able to identify what had
caused the child to have a partial brain. It is implausible
that Congress would have intended that result.

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In seeking to justify its holding in Koston, the court of
appeals stated that it was its duty to construe the Act as
written, even if that construction would (as the
Secretary argued) produce absurd consequences. 974
F.2d at 161. Even if the text of the Act seemed unam-
biguous on the point, a court's duty is not so unyielding.
See, e.g., Public Citizen v. United States Dep't of
Justice, 491 U.S. 440, 453-454 (1989); Church of the Holy
Trinity v. United States, 143 U.S. 457, 459 (1892). In
fact, however, the term "idiopathic" is susceptible of a
far narrower construction than the one adopted by the
court of appeals. In such circumstances, the court had a
duty to avoid an interpretation of the statutory language
that would produce absurd results. Haggar Co. v.
Helvering, 308 U.S. 389, 394 (1940); see also Public
Citizen, 491 U.S. at 454-455. Because Congress could
not have intended to permit compensation in circum-
stances in which the evidence shows that a preexisting
condition, and not the vaccine, caused the child's injury
or disability, the court of appeals' construction of the
term "idiopathic" should be rejected.

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CONCLUSION

The judgment of the court of appeals should be
reversed, and the case should be remanded to the court of
appeals for review of the judgment of the Court of
Federal Claims under the proper legal standards.
Respectfully submitted.

DREW S. DAYS, III
Solicitor General

FRANK W. HUNGER
Assistant Attorney General

EDWIN S. KNEEDLER
Deputy Solicitor General

IRVING L. GORNSTEIN
Assistant to the Solicitor General

BARBARA C. BIDDLE
RICHARD A. OLDERMAN
KAREN P. HEWITT
Attorneys

DECEMBER 1994

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