Cloer v. Secretary of Health and Human Services

United States Court of Appeals
for the Federal Circuit
__________________________

MELISSA CLOER, M.D.,
Petitioner-Appellant,

v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________

2009-5052
__________________________

Appeal from the United States Court of Federal
Claims in 05-VV-1002, Judge Lawrence J. Block.
___________________________

Decided: August 5, 2011
___________________________

ROBERT T. FISHMAN, of Denver, Colorado, argued for
petitioner-appellant on rehearing en banc. With him on
the brief was MARI C. BUSH, Kaye and Bush, LLC, of
Denver Colorado. Of counsel on the brief was ROBERT T.
MOXLEY, Robert T. Moxley, P.C., of Cheyenne, Wyoming.

ANISHA S. DASGUPTA, Attorney, Appellate Staff, Civil
Division, United States Department of Justice, of Wash-
ington, DC, argued for respondent-appellee on rehearing
en banc. With her on the brief were TONY WEST, Assis-
CLOER v. HHS 2

tant Attorney General, TIMOTHY P. GARREN, Director,
MARK W. ROGERS, Deputy Director, GABRIELLE M.
FIELDING, Assistant Director. Of counsel on the brief were
THOMAS M. BONDY, Attorney, and LYNN E. RICCIARDELLA,
Trial Attorney.

MARTIN JAMES MARTINEZ, Martinez Law Office, of
Napa, California, amicus curiae on rehearing en banc.

THOMAS NEVILLE, Ogborn Summerlin & Ogborn, LLC,
of Denver, Colorado, for amicus curiae Colorado Trial
Lawyers Association on rehearing en banc.

CLIFFORD J. SHOEMAKER, Shoemaker & Associates, of
Vienna, Virginia, for amicus curiae National Vaccine
Information Center on rehearing en banc.

KEVIN P. CONWAY, Conway, Homer & Chin-Caplan,
P.C., of Boston, Massachusetts for amici curiae the Vac-
cine Injured Petitioners’ Bar Association, et al. on rehear-
ing en banc.
__________________________

Before RADER, Chief Judge, NEWMAN, LOURIE,
CLEVENGER, BRYSON, GAJARSA, ∗ LINN, DYK, PROST,
MOORE, O’MALLEY, and REYNA, Circuit Judges.
Opinion for the court filed by Circuit Judge CLEVENGER,
in which Chief Judge RADER and Circuit Judges LOURIE,
BRYSON, GAJARSA, PROST, MOORE, and O’MALLEY join.
Dissenting opinion filed by Circuit Judge DYK, in which
Circuit Judges NEWMAN, LINN, and REYNA join.

∗
Judge Gajarsa assumed senior status on July 31,
2011.
3 CLOER v. HHS

CLEVENGER, Circuit Judge.

This case involves the interpretation and application
of the statute of limitations in the National Childhood
Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34
(“Vaccine Act”). The statute of limitations provides that if
a vaccine-related injury occurred as a result of the ad-
ministration of a vaccine, “no petition may be filed for
compensation under the Program for [a vaccine-related]
injury after the expiration of 36 months after the date of
the occurrence of the first symptom or manifestation of
onset . . . of such [vaccine-related] injury.” 42 U.S.C.
§ 300aa-16(a)(2).

Dr. Melissa Cloer received three Hepatitis-B (“Hep-
B”) vaccinations in 1996 and 1997. Years later, in 2005,
Dr. Cloer filed a claim under the National Vaccine Injury
Compensation Program (“Vaccine Program”), established
by the Vaccine Act, seeking compensation for a multiple
sclerosis (“MS”) injury she alleged was caused by the
administration of the vaccine. The Chief Special Master
and Court of Federal Claims dismissed Dr. Cloer’s claim
as untimely because it was filed more then 36 months
after her first symptom of MS occurred in 1997. Cloer v.
Sec’y of Health & Human Servs., 85 Fed. Cl. 141 (2008).
Dr. Cloer appealed the decision and a panel of this court
reversed, ruling in her favor. Cloer v. Sec’y of Health &
Human Servs., 603 F.3d 1341 (Fed. Cir. 2010), vacated,
399 Fed. App’x 577 (Fed. Cir. Oct 25, 2010). Subse-
quently, we granted the petition of respondent and appel-
lee Secretary of Health and Human Services (“the
government”) to rehear the case en banc, vacated the
panel opinion, Cloer, 399 Fed. App’x at 577, and requested
additional briefs from the parties.
CLOER v. HHS 4

Consistent with the plain meaning of the statute, we
hold that the statute of limitations of the Vaccine Act
begins to run on the calendar date of the occurrence of the
first medically recognized symptom or manifestation of
onset of the injury claimed by the petitioner. Because Dr.
Cloer’s first symptom of MS, recognized as such at the
time she suffered the symptom, occurred more than 36
months before the filing of her petition for compensation,
her claim is time-barred. We today also reverse our
previous holding in Brice v. Secretary of Health & Human
Services, 240 F.3d 1367 (Fed. Cir. 2001) (“Brice”), which
precluded application of the doctrine of equitable tolling
in Vaccine Act cases, but reject the ground upon which
Dr. Cloer seeks the benefit of equitable tolling in this
case. We thus affirm the judgment of the Court of Fed-
eral Claims dismissing Dr. Cloer’s claim as untimely.

In Part I below, we briefly address the background
against which Congress enacted the Vaccine Act and in
particular the statute of limitations chosen by Congress.
Part II sets forth the essential facts of the case. In Part
III, we discuss the proceedings before the Chief Special
Master and the Court of Federal Claims. Part IV states
our standard of review. In Part V, we set forth and re-
spond to the three arguments Dr. Cloer presented to the
court in her initial briefs and at the initial panel hearing
of the case. In Part VI, we address and answer the three
specific questions on which we requested additional
briefing to the en banc court. Our en banc hearing fo-
cused on these questions.

I

In 1986, Congress established the Vaccine Program to
provide compensation for vaccine-related injuries and
deaths. See 42 U.S.C. § 300aa-10. The Vaccine Act
5 CLOER v. HHS

creates a “no-fault” Federal program for compensating
injuries that are either presumed or proven to be causally
connected to vaccines. The Vaccine Act arose because
“the Nation’s efforts to protect its children by preventing
disease have been [] a success,” but “[w]hile most of the
Nation’s children enjoy greater benefit from immunization
programs, a small but significant number have been
gravely injured.” H.R. Rep. No. 99-908, at 4 (1986),
reprinted in 1986 U.S.C.C.A.N. 6344, 6345. However, “at
least in part as a result of [the] increase in litigation, the
prices of vaccines [] jumped enormously.” Id. Congress
created the Vaccine Program to balance these two pri-
mary concerns that the tort system was failing to ade-
quately compensate persons injured from vaccinations
that were undergone for the public good and that exces-
sive tort liability was unsustainably raising prices and
discouraging vaccine manufacturers from remaining in
the market. See id. at 3–7, reprinted in 1986
U.S.C.C.A.N. at 6344–48.

Congress noted “for the relatively few who are injured
by vaccines — through no fault of their own — the oppor-
tunities for redress and restitution [were] limited, time-
consuming, expensive, and often unanswered.” Id. at 6,
reprinted in 1986 U.S.C.C.A.N. at 6347. In response,
Congress created the Vaccine Program to be “simple, and
easy to administer” while also being “expeditious and
fair.” Id. at 7, 12, reprinted in 1986 U.S.C.C.A.N. at 6348,
6353. To compensate injured persons quickly and fairly,
the Vaccine Act exempted petitioners from the tort re-
quirements of demonstrating that a manufacturer was
negligent or that a vaccine was defective. Id. at 12–13,
reprinted in 1986 U.S.C.C.A.N. at 6353–54. For some
injuries which the medical profession at large recognized
as especially likely to be caused by vaccine administra-
tion, Congress exempted petitioners from the burden of
CLOER v. HHS 6

proving causation. Id. In sum, while the Vaccine Act
does not prohibit a petitioner from going to state court
after completion or unfair delay of the compensation
proceedings, the Vaccine Program was intended to “lessen
the number of lawsuits against manufacturers” and
“provide[] relative certainty and generosity” of compensa-
tion awards in order to satisfy petitioners in a fair, expe-
ditious, and generous manner. 1 Id.

The legislative history shows that Congress consid-
ered alternative statutes of limitation for claims filed in
the Vaccine Program. The House of Representatives
version, H.R. 1780, introduced on March 27, 1985, pro-
vided that “any claim under this title that is filed more
than two years after the first manifestation of a vaccine-
related injury shall be barred.” National Childhood
Vaccine-Injury Compensation Act of 1985, H.R. 1780,
99th Congress § 2112(a) (1985). A subsequent Senate bill,
S. 827, introduced on April 2, 1985, took a different ap-
proach. Unlike H.R. 1780, S. 827 did not trigger the
statute of limitations upon the occurrence of the first
manifestation of an injury. Instead, it provided that
actions for compensation “shall be barred if the petitioner
fails to file the action . . . within 5 years after the occur-
rence of the compensable complication or residual effect of
the illness, disability [or] injury.” National Childhood
Vaccine Injury Compensation Act of 1985, S. 827, 99th
Congress § 2106(a) (1985). In addition, the 5 year statute
did not apply at all if a petitioner could demonstrate that
she either (a) did not receive the parent information about
vaccines required under the bill, or (b) did not know the

1 The Supreme Court has held that the Vaccine
Act preempts state law vaccine design defect claims. See
Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068, 1075 (Feb. 22,
2011).
7 CLOER v. HHS

complication or effect of her injury was compensable
under the program. Id. § 2106(b). S. 827 set forth a
Vaccine Table, listing specific vaccines, specific injuries,
and specific time periods for the first symptom or mani-
festation of onset of a listed injury after administration of
a vaccine. Compensation was required if a petitioner
could meet the specified time periods for a listed vaccine
and injury. But if a petitioner could not meet the time
period requirements, the petitioner could still prevail if
“the petitioner demonstrates on the basis of credible
evidence” that the injury “suffered by petitioner was
caused by a vaccine listed in the Vaccine Injury Table.”
Id. § 2105(a)(2). The Senate bill thus incorporated both
strict liability and causation in fact liability.

Ultimately, Congress settled on the former of the two
approaches. H.R. 5546 (September 18, 1986) followed the
approach of H.R. 1780, and provided that if a vaccine-
related injury occurred as a result of the administration of
a vaccine listed on the Vaccine Injury Table, “no petition
may be filed for compensation under the Program after
the expiration of 36 months after the date of the occur-
rence of the first symptom or manifestation of onset . . . of
such injury.” National Childhood Vaccine Injury Act of
1986, H.R. 5546, 99th Congress § 2116(a)(1)(B) (1986).
Both the House and Senate passed H.R. 5546, as incorpo-
rated into S. 1744, and the statute of limitations was
signed into law on November 14, 1986 as part of the
National Childhood Vaccine Injury Act of 1986. Pub. L.
No. 99-660, 100 Stat. 3743 (1986).

The legislative record is thus clear that Congress
chose to trigger the statute of limitations from the date of
the occurrence of the first symptom or manifestation of
onset of an injury, not from the date of the injury itself.
Further, Congress was alerted to the consequences of its
CLOER v. HHS 8

choice. For example, at a July 18, 1985 Senate Hearing
before the Committee on Labor and Human Resources,
the president of Dissatisfied Parents Together (“DPT”)
submitted testimony comparing the different pending
House and Senate bills. See To amend the Public Health
Service Act to provide for the compensation of children and
others who have sustained vaccine-related injuries, and for
other purposes: Hearing on S. 827 before the S. Comm. on
Labor and Human Res., 99th Cong. 41 (1985) (statement
of Jeffrey H. Schwartz, President of DPT). The testimony
noted that under the Senate proposal, S. 827, a claim
“must be filed within five years of occurrence of injury”
but “[t]his limitation does not apply if claimant did not
receive the required parent information packet or did not
know the injury was compensable.” Id. at 56. The testi-
mony sharply contrasted this with the pending House
proposal, H.R. 1780, under which a claim “must be filed
within 2 years after first manifestation of injury” and
“[t]his limit applies regardless of when claimant discov-
ered the causal link between the injury and the vaccine.”
Id.

From the above, we note that the Vaccine Act, as en-
acted, reflects a specific decision by Congress that the
Act’s statute of limitations would begin to run not on the
date of injury (as is sometimes seen in other contexts), but
on the date that injury first became symptomatic or
manifested.

II

The essential facts of this case are undisputed. Peti-
tioner Melissa Cloer is a physician with MS. 2 Prior to

2 MS is “a disease in which there are foci of demye-
lination of various sizes throughout the white matter of
9 CLOER v. HHS

receiving her Hep-B immunizations in 1996 and 1997, Dr.
Cloer had no significant medical issues and enjoyed
generally good health. Dr. Cloer received her first two
doses of Hep-B vaccine without major incident and re-
ceived her third and final vaccination on April 3, 1997.
Approximately one month thereafter she began to experi-
ence numbness in her left forearm and hand. She also
began to experience what she described as an “electric
shock sensation” with “electric like sensations going down
the center of her back to both feet with forward head
flexion.” This sensation is known as Lhermitte sign, long
recognized by the medical profession as a common symp-
tom of MS. See Dorland’s Illustrated Medical Dictionary
1700 (30th ed. 2003) (defining Lhermitte sign as the
development of sudden, transient, electric-like shocks
spreading down the body when the patient flexes the head
forward; seen mainly in multiple sclerosis but also in
compression and other disorders of the cervical cord).

In 1998, about a year after her final vaccination, Dr.
Cloer sought treatment from Dr. Michael Andrew Meyer,
an expert in the field of neurology with a specialty in MS.
After an MRI examination, Dr. Meyer noted “probable
early inactive non-progressive CNS [central nervous
system] demyelination/MS,” although he explained that
her situation did not meet “formal diagnostic criteria for

the central nervous system, sometimes extending into the
gray matter. Typically, the symptoms of lesions of the
white matter are weakness, incoordination, paresthesias,
speech disturbances, and visual complaints. The course of
the disease is usually prolonged, so that the term multiple
also refers to remissions and relapses that occur over a
period of many years.” Borrero v. Sec’y of the Dep’t of
Health & Human Servs., No. 01-417V, 2008 WL 4527837,
at *1 n.4 (Fed. Cl. Sp. Mstr. Sept. 24, 2008) (quoting
Dorland’s Illustrated Medical Dictionary (30th ed. 2003)
at 1669).
CLOER v. HHS 10

clinically definite MS.” Cloer, 85 Fed. Cl. at 144. Even so,
because the MRI revealed lesions on the white matter of
her central nervous system, Dr. Meyer concluded that Dr.
Cloer could have MS, Singular Sclerosis, Lyme Disease,
and/or acute disseminating encephalomyelitis, along with
other demyelinating processes. Id. at 143. Before the
Chief Special Master, Dr. Meyer testified that Dr. Cloer
suffered from MS in 1998 because “the first MS related
symptom was the [Lhermitte’s] phenomenon that she had
in 1997.” Cloer v. Sec’y of the Dep’t of Health & Human
Servs., No. 05-1002V, 2008 WL 2275574, at *6 (Fed. Cl.
Sp. Mstr. 2008) (“Special Master Opinion”), aff’d, 85 Fed.
Cl. 141 (2008).

On May 6, 1999, Dr. Cloer received a neurological ex-
amination from Dr. Ted Colapinto. Cloer, 85 Fed. Cl. at
144. Dr. Colapinto noted Dr. Cloer’s medical history and
recorded her complaints of numbness in her face, arms
and legs, and her difficulty in walking. Id. He concluded
that Dr. Cloer’s symptoms likely represented a demyeli-
nating disease, commenting that “[Dr. Cloer] is having
waxing and waning neurological symptoms in multiple
areas of her body. I fear that this may likely represent
demyelinating disease.” Sp. Mstr. Op., 2008 WL 2275574,
at *6. Dr. Cloer continued to suffer from numerous, but
somewhat fleeting, symptoms. In May 2004, Dr. Cloer
applied for and was awarded monthly Social Security
disability benefits. Dr. James P. Metcalf conducted a
comprehensive medical examination at the time and
noted that appellant “first beg[a]n to have some symp-
toms consistent with MS in 1997,” although her “symp-
toms waxed and waned until the fall of 2003 when she
beg[a]n to have manifestations of the full blown disease.”
Id. at *2.
11 CLOER v. HHS

Dr. Cloer claims that even in 2003 upon receiving a
diagnosis of MS she remained unaware of any causal
association between the Hep-B vaccine and MS. Dr. Cloer
testified that she first became aware of the possible link
when she read an editorial and prospective French study
in the September 2004 issue of Neurology. Cloer Aff., J.
App’x 270–71; see also Robert T. Naismith, M.D. & Anne
H. Cross, M.D., Does the hepatitis B vaccine cause multi-
ple sclerosis?, 63 Neurology 772 (Sept. 2004); and Miguel
A. Hernán, M.D. et al., Recombinant hepatitis B vaccine
and the risk of multiple sclerosis, 63 Neurology 838 (Sept.
2004). On October 11, 2004, Dr. Cloer reported to the
Vaccine Adverse Event Reporting System that she had
experienced numbness and tingling after her first two
Hep-B vaccinations, followed by “Lhermitte’s” approxi-
mately one month after her third vaccination. Sp. Mstr.
Op., 2008 WL 2275574, at *1–2. Dr. Cloer subsequently
filed her petition for compensation for a vaccine injury on
September 16, 2005. Cloer, 85 Fed. Cl. at 144.

III

Before the Chief Special Master, Dr. Cloer did not
challenge the evidence that she had suffered symptoms of
MS, and likely the manifestation of onset of MS, more
than three years before the filing of her petition, thus
time-barring her petition. Instead, Dr. Cloer’s primary
argument to the Chief Special Master was that the stat-
ute of limitations did not begin to run against her until
after receipt of a “clinically definite” diagnosis of MS. Dr.
Meyer, Dr. Cloer’s treating physician, explained that
because Dr. Cloer’s symptoms did not amount to a clini-
cally definite diagnosis of MS until November 2003, Dr.
Cloer was unaware of her injury until this time, and thus
also could not have been aware that the Hep-B vaccine
caused her injury. Since Dr. Cloer’s petition was filed in
CLOER v. HHS 12

September 2005, she argued it was filed within the 3 year
statute of limitations of when she was first diagnosed
with MS. Essentially, Dr. Cloer asked the Chief Special
Master to read the phrase “symptom or manifestation of
onset” as only triggering upon a symptom or manifesta-
tion that is clinically diagnosed as the disease itself.

Relying on precedent of this court, the Chief Special
Master rejected Dr. Cloer’s theory and held that the
statute of limitations begins to run on the occurrence of
the first symptom or manifestation of onset of the injury
that the petitioner alleges has resulted from the vaccina-
tion. The Chief Special Master discussed at length our
decision in Markovich v. Secretary of Health & Human
Services, 477 F.3d 1353 (Fed. Cir. 2007), quoting that “the
terms of the Vaccine Act demonstrate that Congress
intended the limitation period to commence to run prior to
the time a petitioner has actual knowledge that the
vaccine recipient suffered from an injury that could result
in a viable cause of action under the Vaccine Act.” Sp.
Mstr. Op., 2008 WL 2275574, at *5 (quoting Markovich,
477 F.3d at 1358). The Chief Special Master expressly
dismissed Dr. Cloer’s argument that a “clinically definite”
diagnosis is required by Markovich:

Petitioner misreads Markovich. The Court’s hold-
ing was that for purposes of § 300aa-16(a)(2), “the
first symptom or manifestation of onset” is the
“first event objectively recognizable as a sign of a
vaccine injury by the medical profession at large.”
Markovich, 477 F.3d at 1360. There is no re-
quirement that the vaccine injury be diagnosed.

Id. at *9.
13 CLOER v. HHS

Just as she did before the Chief Special Master, Dr.
Cloer focused her argument at the Court of Federal
Claims on her failure to receive a “clinically definite”
diagnosis of MS until 2003, elaborating that “because the
first set of symptoms may be premature for a definitive
diagnosis of a disease, it cannot itself constitute a ‘vaccine
injury.’” She also pointed to 42 U.S.C. § 300aa-
11(c)(1)(D)(i), which contains a petition content require-
ment stating that “a petition for compensation . . . for a
vaccine-related injury . . . shall contain . . . an affidavit,
and supporting documentation, demonstrating that the
person . . . suffered the residual effects or complications of
such illness, disability, injury, or condition for more than
6 months after administration of the vaccine . . . .” Be-
cause of this requirement, she argued that the statute of
limitations does not begin to run until a petitioner has
suffered the residual effects or complications for more
than 6 months after administration of the vaccine. She
alleged as a matter of fact that she did not meet this
requirement until late in 2003, which if true, would bring
her 2005 petition within the statute of limitations. Fi-
nally, she asked for relief by way of equitable tolling,
notwithstanding our opinion in Brice that equitable
tolling is not available under the Vaccine Act. She sought
relief under equitable tolling because she was not diag-
nosed with MS until 2003 and there was no reason for her
to suspect a vaccine link to MS until 2004. Cloer, 85 Fed.
Cl. at 145, 149.

The Court of Federal Claims rejected Dr. Cloer’s ar-
guments. The court understood Dr. Cloer’s primary
argument to be that a “vaccine-related” injury could not
occur based on the first occurrence of a symptom of the
injury, but instead would arise from “a physician’s ulti-
mate diagnosis” that the “vaccine caused the complained-
of specific injury.” Id. at 149. The court held her argu-
CLOER v. HHS 14

ment “contrary to Markovich, which held that the limita-
tions period begins to run at the first occurrence of a
symptom even though an exact diagnosis may be impossi-
ble until some future date when more symptoms or medi-
cal data are forthcoming.” Id. Referring to the trigger for
the statute of limitations, the court quoted from Mark-
ovich: “Congress intended the limitations period to com-
mence to run prior to the time a petitioner has actual
knowledge that the vaccine recipient suffered from an
injury that could result in a viable cause of action under
the Vaccine Act.” Id. (quoting Markovich, 477 F.3d at
1358). The court also relied on the observation in Brice
that the statute begins to run “upon the first symptom or
manifestation of the onset of injury, even if the petitioner
would not have known at that time that the vaccine had
caused an injury.” Brice, 240 F.3d at 1373.

The court held that the Lhermitte sign in 1997 was
the first symptom of Dr. Cloer’s MS and triggered the
statute of limitations, Cloer, 85 Fed. Cl. at 147–49,
which the court held is unaffected by the 6 month re-
quirement in 42 U.S.C. § 300aa-11(c)(1)(D)(i). The court
found Dr. Cloer’s petition is time barred and affirmed the
Chief Special Master. The court also noted that Brice
bars Dr. Cloer’s request for relief by way of equitable
tolling of the statute of limitations. Id. at 149, 152.

IV

We review the Special Master’s decision under the
same arbitrary and capricious standard as did the Court
of Federal Claims. 42 U.S.C. § 300a-129(e)(2)(B); Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278
(Fed. Cir. 2005). We owe no deference on questions of
law, Whitecotton ex rel. Whitecotton v. Sec’y of Health &
Human Servs., 81 F.3d 1099, 1106 (Fed. Cir. 1996), but
15 CLOER v. HHS

review factual findings for clear error, Hines ex rel. Sevier
v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1523
(Fed. Cir. 1991). In this case we are concerned with
issues of statutory interpretation: what constitutes a
“vaccine-related injury” and what event triggers the
running of the Vaccine Act’s statute of limitations.

V

In her initial appeal briefs, Dr. Cloer abandons her
argument that no vaccine-related injury can occur before
a clinically definite diagnosis is made. Instead, she
argues that a “vaccine-related injury” for purposes of the
Vaccine Act and its statute of limitations cannot occur
until the medical community at large understands and
recognizes the causal relationship between the claimed
injury and the administration of a vaccine. Dr. Cloer
alleges that because an injury cannot be alleged as “vac-
cine-related” until after this recognition, any other inter-
pretation of the statute of limitations would be unfair.
Dr. Cloer also argues that the statute of limitations
should not trigger until after a petitioner has suffered
from six months of consistent, clinically-related symp-
toms, citing 42 U.S.C. § 300aa-11(c)(1)(D)(i). Otherwise,
because a petitioner is required to attest, as a petition
requirement, to residual effects or complications lasting
“more than 6 months after the administration of the
vaccine,” Dr. Cloer argues the statute of limitations would
be unfairly reduced to less than 36 months. Finally, Dr.
Cloer requests that this court reconsider the holding in
Brice that equitable tolling is not available under the
Vaccine Act.

As noted above, the panel opinion ruled in Dr. Cloer’s
favor, accepting her argument that the statute of limita-
tions begins to run upon formation of a consensus in the
CLOER v. HHS 16

medical community that a vaccine causes the injury
claimed. The panel did not reach Dr. Cloer’s other argu-
ments. Because the panel opinion is vacated, we respond
to her original arguments in subparts A, B, and C below.

A

We first address Dr. Cloer’s primary argument on ap-
peal that a “vaccine-related” injury only arises upon a
medically established causal link between an injury and
the vaccine in question. Our analysis must begin with the
plain language of the statute. The Vaccine Act states that
“if a vaccine-related injury or death occurred as a result of
the administration of such vaccine, no petition may be
filed for compensation under the Program for such injury
after the expiration of 36 months after the date of the
occurrence of the first symptom or manifestation of onset”
of injury. 42 U.S.C. § 300aa-16(a)(2). The plain language
of the Vaccine Act thus requires injured parties to file
Vaccine Program petitions within 36 months of the date of
the first symptom or manifestation of onset of the “vac-
cine-related injury.”

The Act defines “vaccine-related injury or death” as:

[A]n illness, injury, condition, or death associated
with one or more of the vaccines set forth in the
Vaccine Injury Table, except that the term does
not include an illness, injury, condition, or death
associated with an adulterant or contaminant in-
tentionally added to such a vaccine.

42 U.S.C. § 300aa-33(5). As both Dr. Cloer and the gov-
ernment recognize, this definition does not provide defini-
tive guidance for us on the specific argument put forward
by Dr. Cloer. However, “[a]s a rule, a definition which
17 CLOER v. HHS

declares what a term ‘means’ . . . excludes any meaning
that is not stated.” Burgess v. United States, 553 U.S.
124, 130 (2008) (quoting Colautti v. Franklin, 439 U.S.
379, 392–93 n.10 (1979)). Thus, we begin with a hesita-
tion to read a causal link requirement into the term when
no such link is included in the explicit statutory defini-
tion. Moreover, “[a] term appearing in several places in
a statutory text is generally read the same way each time
it appears.” Ratzlaf v. United States, 510 U.S. 135, 143
(1994). As the term “vaccine-related injury” appears
throughout the Vaccine Act, we must analyze the effects
of adopting Dr. Cloer’s contention that the term always
requires recognition in the medical community of a causal
link between the vaccine and the injury.

The Vaccine Act provides a Vaccine Injury Table of
vaccines and the injuries commonly associated with the
use of each vaccine. See 42 U.S.C. § 300aa-14; see also 42
C.F.R. § 100.3(a) (containing updated Table). For injuries
listed in the Table, generally referred to as “Table inju-
ries,” a petitioner need only prove that the first symptom
or manifestation of onset occurred within the time period
after vaccine administration set forth in the Vaccine
Injury Table in order to receive compensation, see 42
U.S.C. § 300aa-11(c)(1)(C)(i), unless the government can
prove that a factor unrelated to the vaccination actually
caused the illness, disability, or condition. See Pafford v.
Sec’y of Health & Human Servs., 451 F.3d 1352, 1355
(Fed. Cir. 2006) (citing 42 U.S.C. § 300aa-13(a)(1)(A),(B)).
For these injuries recognized by the medical community
as linked to vaccine administration, Congress eliminated
the petitioner’s burdensome proof requirement. For “non-
Table injuries,” a petitioner must prove the injury was
caused by the vaccine. See 42 U.S.C. § 300aa-
11(c)(1)(C)(ii).
CLOER v. HHS 18

A “vaccine-related injury” is the subject of the petition
for compensation in both Table and non-Table cases. For
Table injury cases, the statute specifically defines for each
vaccine the “vaccine-related” injuries for which compensa-
tion is assured. For example, a petitioner who suffers
from a symptom of an anaphylactic shock injury within
four hours of receiving a DTaP vaccine is presumed to
have been injured by the vaccine. See 42 C.F.R.
§ 100.3(a). But for non-Table injuries, a petitioner must
file an affidavit and supporting documentation demon-
strating that the “vaccine-related injury” for which com-
pensation is sought was caused by a vaccine. 3

3 We note that a petitioner’s pleading burden is,
of course, lower than the preponderance burden that must
be met in order to receive compensation. See 42 U.S.C.
§ 300aa-13(a)(1) (“Compensation shall be awarded to a
petitioner if the special master or court finds . . . (A) that
the petitioner has demonstrated by a preponderance of
the evidence the matters required in the petition.”). To
meet the preponderance standard, a petitioner must show
that the vaccination brought about her injury by provid-
ing: “(1) a medical theory causally connecting the vaccina-
tion and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal rela-
tionship between vaccination and injury.” Althen, 418
F.3d at 1278. A petitioner only needs to “provide a repu-
table medical or scientific explanation that pertains
specifically to the petitioner’s case” and “the explanation
need only be legally probable, not medically or scientifi-
cally certain.” Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)
(quotation marks omitted).
Congress clearly contemplated that petitioners
might not be able to meet the burden to demonstrate
causation-in-fact by preponderance at the time the peti-
tion is filed. This is easily seen in the statute as a Vac-
cine Act petitioner, even if ultimately unsuccessful, can
19 CLOER v. HHS

The statute of limitations for the Act uses the same
“vaccine-related injury” terminology.

In the case of . . . a vaccine set forth in the Vaccine
Injury Table which is administered after October
1, 1988, if a vaccine-related injury occurred as a
result of the administration of such vaccine, no
petition may be filed for compensation under the
Program for such injury after the expiration of 36
months after the date of the occurrence of the first
symptom or manifestation of onset or of the sig-
nificant aggravation of such injury . . . .

42 U.S.C. § 300aa-16(a)(2) (emphasis added).

Dr. Cloer would read “vaccine-related injury”
throughout the Vaccine Act to require that the alleged
injury must be objectively recognized by the medical
community as related to the vaccine before it can be
deemed a “vaccine-related injury.” Accordingly, the
statute of limitations would not begin to run on prospec-
tive petitioners until after this recognition is established.
However, the statute is clear that only “[a] person who
has sustained a vaccine-related injury . . . may, if the
person meets the requirements of subsection (c)(1) of this
section [listing the required elements of a petition], file a
petition for compensation under the Program.” 42 U.S.C.
§ 300aa-11(b)(1)(A) (emphasis added). Under Dr. Cloer’s
view that no vaccine-related injury exists until there is
consensus in the medical community of a causal link
between an injury and a vaccine, the key element of the

still receive compensation to cover reasonable attorneys’
fees and other costs incurred in the proceeding “if the
special master or court determines that the petition was
brought in good faith and there was a reasonable basis for
the claim.” 42 U.S.C. § 300aa-15(e)(1).
CLOER v. HHS 20

petition for compensation — the vaccine injury — does not
arise until the requisite medical consensus exists. For
example, in this case, it is agreed that even now there is
not medical consensus of a causal link between the Hep-B
vaccine and MS. Thus, under Dr. Cloer’s definition of
vaccine-related injury, she, like the great majority of non-
Table injury petitioners, would lack standing to file a
petition until the requisite medical consensus arises. Any
construction that would result in a party suffering from a
non-Table injury to be unable to file a petition because the
alleged injury is not recognized by the medical community
at large cannot be what Congress intended. 4

4 The first time an injury is causally linked with a
vaccine often occurs as a result of a successful non-Table
petition. Over time, as injuries occur throughout the
population and are linked to a vaccine, the medical com-
munity begins to recognize a link between the vaccine and
the injury. This can occur through studies published in
medical journals or as a result of government research.
Often, however, before the link is sufficiently established
to become generally recognized by the medical commu-
nity, petitioners are able to muster enough evidence to
receive compensation from the Vaccine Program. See,
e.g., Andreu ex rel. Andreu v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (“[R]equiring
‘objective confirmation’ in the medical literature prevents
‘the use of circumstantial evidence . . . and negates the
system created by Congress’ through the Vaccine Act.”)
(quoting Althen, supra note 4, 418 F.3d at 1279–80)
(omission in original); Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1325 (Fed. Cir. 2006)
(“[R]equiring either epidemiologic studies, rechallenge,
the presence of pathological markers or genetic disposi-
tion, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and
effect is contrary to [precedent].”) (emphasis added).
Finally, because a successful “causation in fact” petition
can be the first established link between a vaccine and a
non-Table injury, it must be allowed to be filed before an
21 CLOER v. HHS

Further, settled law establishes a firm default rule
that a cause of action arises at the same time the statute
of limitations begins to run on the cause. See Graham
Cnty. Soil & Water Conservation Dist. v. United States ex
rel. Wilson, 545 U.S. 409, 418 (2005) (“Congress generally
drafts statutes of limitations to begin when the cause of

objective recognition is understood by the medical com-
munity at large.
As noted above, Althen sets forth the three pleading
requirements for a non-Table injury petition. These
requirements have not been insurmountable for petition-
ers seeking compensation for MS caused by the Hep-B
vaccine. At least 35 petitions alleging MS caused by the
Hep-B vaccine have resulted in public opinions to date,
and at least 14 of those petitioners have been successful.
Many of the successful petitioners filed their petitions in
1999. See, e.g., Fisher v. Sec’y of the Dep’t of Health &
Human Servs., No. 99-432V, 2009 WL 2365459 (Fed. Cl.
Sp. Mstr. Jul. 13, 2009) (petition filed Jul. 2, 1999); Adler
v. Sec’y of the Dep’t of Health & Human Servs., No. 99-
608V, 2008 WL 5068931 (Fed. Cl. Sp. Mstr. Nov. 18, 2008)
(petition filed Aug. 4, 1999); Doe/23 v. Sec’y of the Dep’t of
Health & Human Servs., 2008 WL 4865974 (Fed. Cl. Sp.
Mstr. Oct. 16, 2008) (petition filed May 17, 1999); Baril-
laro v. Sec’y of the Dep’t of Health & Human Servs., No.
99-408V, 2008 WL 2465794 (Fed. Cl. Sp. Mstr. May 28,
2008) (petition filed June 28, 1999); Doe/13 v. Sec’y of the
Dep’t of Health & Human Servs., 2008 WL 926930 (Fed.
Cl. Sp. Mstr. Mar. 31, 2008) (petition filed May 14, 1999);
Doe/07 v. Sec’y of the Dep’t of Health & Human Servs.,
2007 WL 3306493 (Fed. Cl. Sp. Mstr. Nov. 2, 2007) (peti-
tion filed Jul. 16, 1999); Augustynski v. Sec’y of the Dep’t
of Health & Human Servs., No. 99-611V, 2007 WL
3033614 (Fed. Cl. Sp. Mstr. Sep. 28, 2007) (petition filed
Aug. 4, 1999); Phippen v. Sec’y of the Dep’t of Health &
Human Servs., No. 99-435V, 2006 WL 5631725 (Fed. Cl.
Sp. Mstr. Dec. 5, 2006) (petition filed Jul. 2, 1999);
Werderitsh v. Sec’y of the Dep’t of Health & Human Servs.,
No. 99-310V, 2006 WL 1672884 (Fed. Cl. Sp. Mstr. May
26, 2006) (petition filed May 18, 1999).
CLOER v. HHS 22

action accrues.”). The Supreme Court has recognized that
Congress is free to provide the “odd result” of a cause of
action that arises at a time different from the beginning of
a statute of limitations, see Reiter v. Cooper, 507 U.S. 258,
267 (1993), but only by explicitly rejecting the default
rule. See Dodd v. United States, 545 U.S. 353, 359–60
(2005). Under Dr. Cloer’s interpretation of a vaccine-
related injury, her claim for compensation would accrue
(thus letting her petition go forward) before medical
consensus as to causation exists. To succeed, she must
show that Congress meant to divorce the date of accrual
of her cause of action from the date that the statute of
limitations begins to run. She faces the heavy burden of
proving that Congress intended the odd result of breach-
ing the firm default rule. Nothing in the text of the
Vaccine Act demonstrates that Congress made a deliber-
ate choice to allow a cause of action for a vaccine-related
injury to accrue before the Vaccine Act’s statute of limita-
tions begins to run. 5

5 The foregoing discussion responds to arguments
made by Dr. Cloer in her initial briefs and at oral argu-
ment before the panel concerning the meaning of “vaccine-
related injury.” In the en banc proceedings, she preserved
the consensus argument from her initial briefs, but re-
treated somewhat from her initial stance, arguing that
the statute of limitations runs and her cause of action
arises instead upon “recognition” by the medical commu-
nity of a causal link between an injury and a vaccine. Her
“recognition” trigger requires less proof than consensus in
the medical community. Her rephrasing thus keys ac-
crual of her claim not to medical agreement as to cause,
but to whether there is reason to know that a vaccine may
have caused her injury. As rephrased, her argument
depends upon a discovery rule being found in the Vaccine
Act statute of limitations. We address that question in
part VI.A below.
23 CLOER v. HHS

In addition, we note an unintended result that would
occur were we to accept Dr. Cloer’s argument that the
statute of limitations for a non-Table injury does not
begin to run until the medical community at large recog-
nizes a causal link between a vaccine and a claimed
injury. Congress recognized that the Vaccine Injury Table
could be revised such that a person not previously eligible
for compensation might become eligible to seek compensa-
tion for the newly-recognized Table Injury. In such in-
stances, Congress wrote a special statute of limitations
that permits a claim for compensation under the revised
Vaccine Injury Table if a vaccine-related death or injury
occurred less than 8 years before the revision of the
Vaccine Injury Table and the claim is filed within 2 years
after the effective date of the revision. See 42 U.S.C.
§ 300aa-16(b). If Dr. Cloer’s trigger for the statute of
limitations for a non-Table injury were accepted, she and
those similarly situated would enjoy a more generous
statute of limitations than Congress provided for Table
Injury petitioners, for whom causation is presumed. We
do not think Congress would have intended such a result.

The correct interpretation of the term “vaccine-related
injury” is plain from the language of the statutory provi-
sions that set forth the statute of limitations and the
requirements for a petition. For Table injury cases where
causation is presumed, the vaccine-related injury is the
injury specified in the Vaccine Injury Table for which a
petitioner seeks compensation. For non-Table injury
cases where the petitioner must establish causation, the
vaccine-related injury is the injury which the petitioner
avers is caused by the vaccine. The statute of limitations
on its face requires a petition for compensation to be filed
within 36 months after the date of occurrence of the first
symptom or manifestation of onset of vaccine-related
injury. The statutory language, however, begs the ques-
CLOER v. HHS 24

tion of the test for recognition of the existence of a symp-
tom or manifestation of onset of an injury. In short, who
decides if a symptom or manifestation of an injury has
occurred? We were faced with, and decided, that question
in Markovich. 477 F.3d at 1360.

In that case, the parents of a child sought compensa-
tion for seizure disorders suffered by the child after
administration of a vaccine. On the day of administration
of the vaccine, July 10, 2000, the child began to rapidly
blink her eyes. The eye-blinking episodes continued for
more than a month and culminated in a grand mal sei-
zure. Id. at 1354–55. Under recognized standards of the
medical profession at large, the eye-blinking episodes
were symptoms of the seizure activity for which compen-
sation was sought. The government argued that the first
of such symptoms, on July 10, 2000, triggered the statute
of limitations and required dismissal of the petition,
which had been filed more than three years from the July
10 date. The petitioners argued for a subjective test to
determine when the first symptom occurs. Accordingly,
they argued that the symptom of the injury had to be
understood as such by the parents. Because they thought
the first blinking episodes were simply everyday events
meaning the child was tired, they argued that the statute
of limitations did not begin to run until August 30, 2010,
when they became aware that their child had an injury.
Under their view of how a symptom should be deter-
mined, their petition was timely. Id. at 1356–57.

Markovich thus resolved the dispute:

A subjective standard that focuses on the parent’s
view would result in an uneven and perhaps
overly broad application of the statute of limita-
tions dependent entirely on the subjective percep-
25 CLOER v. HHS

tions of lay persons having widely varying degrees
of medical awareness or training. On the other
hand, an objective standard that focuses on the
recognized standards of the medical profession at
large treats petitioners equally, without regard to
their individual medical awareness. An objective
standard is consistent with the statutory re-
quirement that the first symptom or manifesta-
tion of onset of the injury begins the running of
the statute of limitations, as well as the cases . . .
that have consistently construed the Vaccine Act
to include subtle symptoms that would be recog-
nizable to the medical profession at large but not
necessarily to the parent.

477 F.3d. at 1360.

We thus held that the first symptom or manifestation
of onset of a vaccine-related injury is “the first event
objectively recognizable as a sign of a vaccine injury by
the medical profession at large.” Id. The analysis and
conclusion in Markovich is correct. The statute of limita-
tions in the Vaccine Act begins to run on the date of
occurrence of the first symptom or manifestation of onset
of the vaccine-related injury for which compensation is
sought, and the symptom or manifestation of onset must
be recognized as such by the medical profession at large.

B

In order to file a petition, a claimant must attest, inter
alia, that she has “suffered the residual effects or compli-
cations of such illness, disability, injury, or condition for
more than 6 months after the administration of the
vaccine.” 42 U.S.C. § 300aa-11(c)(1)(D)(i). Dr. Cloer
argues that because her symptoms were fleeting, she
CLOER v. HHS 26

could never have met this requirement until late 2003
when her symptoms were continuous and related enough
to be deemed “residual effects or complications” of her
Hep-B vaccinations. The government responds that the
petition requirements are wholly separate from the stat-
ute of limitations and should not be read to extend the
filing date of the petition beyond 36 months.

We agree with the government that the 6 month re-
quirement is a condition precedent to filing a petition for
compensation, not a limitation on the 3 year statute of
limitations. The 6 month provision is a petition content
requirement to which no reference is made in the statute
of limitations. Had Congress intended to adjust the
statute of limitations in light of the petition content
requirement, we think it would have done so in the stat-
ute of limitations. We thus agree with the Court of Fed-
eral Claims that there is no support for Dr. Cloer’s
argument in the text of the Act, nor any in the case law.
Congress included the 6 month petition requirement “to
limit the availability of the compensation system to those
individuals who are seriously injured from taking a
vaccine.” H.R. Rep. No. 100-391(I), at 699 (1987), re-
printed in 1987 U.S.C.C.A.N. 2313-1, -373. Thus, this
provision, along with the other petition requirements, is
intended to restrict eligibility to the compensation pro-
gram, not to act as a statutory tolling mechanism for the
statute of limitations.

C

Finally, Dr. Cloer requested in her initial briefs that
equitable tolling be made available and applied to the
facts of her case, in spite of the binding precedent of Brice.
Although the argument was rejected by the Chief Special
Master and the Court of Federal Claims, and not ad-
27 CLOER v. HHS

dressed by the panel which initially heard the case, the en
banc court decided to reconsider Brice through the lens of
specific questions that were put to the parties. Equitable
tolling is considered below, in parts VI.B and C.

VI

In an October 25, 2010 order, the court vacated its
May 6, 2010 opinion and reinstated the appeal. We
requested the parties to file new briefs addressing the
following questions:

(a) Should the discovery rule, used for example in
medical malpractice cases, see United States v.
Kubrick, 444 U.S. 111, 120 (1979) and TRW, Inc.
v. Andrews, 534 U.S. 19, 27–28 (2001), apply to 42
U.S.C. § 300aa-16(a)(2) so that the statute of limi-
tations does not begin to run until the claimant
has knowledge or reason to know of the cause of
her injury?

(b) Should Brice v. Secretary of Health & Human Ser-
vices, 240 F.3d 1367 (Fed. Cir. 2001) be overruled
to permit equitable tolling of 42 U.S.C. § 300aa-
16(a)(2)?

(c) If equitable tolling is permitted, do the circum-
stances of this case support equitable tolling?

Upon reviewing the briefs of the parties the court heard
argument on May 10, 2011. We now address each ques-
tion put to the parties.

A

Whether to incorporate a discovery rule in the Vaccine
Act’s statute of limitations requires us to decide when the
CLOER v. HHS 28

statute of limitations is triggered. Absent a discovery
rule, the plain words of the statute trigger the statute of
limitations on the date of the first symptom or manifesta-
tion of onset of the injury claimed. If, instead, the statute
of limitations does not begin to run until a petitioner
knows or has reason to know a vaccine has caused her
vaccine-related injury, the plain words of the statute must
be adjusted. Whether or not to incorporate a discovery
rule boils down to a matter of interpretation of the statute
of limitations. 6

As previously stated, the statute of limitations con-
tained in the Vaccine Act reads:

In the case of—

...

(2) a vaccine set forth in the Vaccine Injury Table
which is administered after October 1, 1988, if a
vaccine-related injury occurred as a result of the
administration of such vaccine, no petition may be
filed for compensation under the Program for such
injury after the expiration of 36 months after the
date of the occurrence of the first symptom or

6 As a matter of caution, we must recognize and re-
spect that a “statute of limitations is a condition on the
waiver of sovereign immunity by the United States” and
courts should be “careful not to interpret [a waiver] in a
manner that would extend the waiver beyond what Con-
gress intended.” Stone Container Corp. v. United States,
229 F.3d 1345, 1352 (Fed. Cir. 2000) (quoting Block v.
North Dakota ex rel. Bd. of Univ. & Sch. Lands, 461 U.S.
273, 287 (1983) (internal quotation omitted)). We have
consistently followed this admonition when interpreting
the Vaccine Act’s statute of limitations. See, e.g., Mark-
ovich, 477 F.3d at 1360; Brice, 240 F.3d at 1370.
29 CLOER v. HHS

manifestation of onset or of the significant aggra-
vation of such injury[.]

42 U.S.C. § 300aa-(16)(a). Dr. Cloer makes two argu-
ments for why a discovery rule should be read into the
Vaccine Act. First, she argues that the text of the statute
of limitations amounts to a discovery accrual rule requir-
ing a claimant to know both the fact and the cause of her
injury. Second, she argues that the language of the
Vaccine Act is compatible with an implied discovery
accrual rule. See TRW, 534 U.S. at 27 (“[L]ower federal
courts generally apply a discovery accrual rule when a
statute is silent on the issue.”) (quotation marks omitted);
see also Rotella v. Wood, 528 U.S. 549, 555 (2000) (“Fed-
eral courts, to be sure, generally apply a discovery accrual
rule when a statute is silent on the issue.”).

For the reasons that follow, we conclude that the Vac-
cine Act does not itself contain a discovery rule, and,
applying the relevant analytic tools provided by the
Supreme Court, conclude also that a discovery rule cannot
be read by implication into the Vaccine Act’s statute of
limitations. We first address Dr. Cloer’s argument that
the Act contains its own discovery rule.

Dr. Cloer specifically highlights the phrase “if a vac-
cine-related injury occurred as a result of the administra-
tion of [the] vaccine” in the statute of limitations. Dr.
Cloer argues that the inclusion of this phrase in the
statute means that a non-Table injury claim does not
accrue until the claimant has knowledge that the injury
“occurred as a result of the administration of [the] vac-
cine.” Otherwise, Dr. Cloer posits, the phrase would be
superfluous. The government counters that the phrase is
essential to breathe meaning into the term “vaccine-
related injury” as used in the statute of limitations. The
CLOER v. HHS 30

government reads the accrual of a non-Table injury (and
thus the beginning of the statute of limitations) to arise
on the “date of occurrence of the first symptom or mani-
festation of onset” of the injury the claimant alleges to be
“vaccine-related” for having “occurred as a result of the
administration of [the] vaccine.”

As an initial matter, Dr. Cloer is correct that “we con-
strue statutes, where possible, so as to avoid rendering
superfluous any parts thereof.” Astoria Fed. Sav. & Loan
Ass’n v. Solimino, 501 U.S. 104, 112 (1991). However,
the clearly dominant language in the statute of limita-
tions is “the date of occurrence of the first symptom or
manifestation of onset.” As the Supreme Court has
noted, the date of the occurrence of the first symptom is
forceful — “[t]here cannot be two first symptoms or onsets
of the same injury” — and the first symptom “signal[s] the
injury’s onset.” Shalala v. Whitecotton, 514 U.S. 268, 274
(1995). We do not think that dominant phrase can be
overcome by inferring a discovery requirement from the
phrase “occurred as a result of the administration of [the]
vaccine.” We therefore reject Dr. Cloer’s argument that
the statute of limitations already contains a discovery
rule that would key the accrual of a non-Table injury
claim and the beginning of the statute of limitations to a
claimant’s discovery that the vaccine caused her injury. 7

7 We note that Congress knows how to legislate an
explicit discovery rule. For example, when providing a
cause of action to quiet title of property in which the
United States claims an interest, Congress mandated that
“[a]ny civil action under this section . . . shall be barred
unless it is commenced within twelve years of the date
upon which it accrued. Such action shall be deemed to
have accrued on the date the plaintiff or his predecessor
in interest knew or should have known of the claim of the
United States.” 28 U.S.C. § 2409(g); see also TRW, 534
31 CLOER v. HHS

We now turn to whether the Vaccine Act statute of
limitations is susceptible to an implied discovery rule. As
a preliminary matter, we note that the Supreme Court
has left open the question of whether a presumption
exists that “all federal statutes of limitations, regardless
of context, incorporate a general discovery rule unless
Congress has expressly legislated otherwise.” TRW, 534
U.S. at 27. Nonetheless, the Supreme Court noted in
TRW, id., that it had held in Holmberg v. Armbrecht, 327
U.S. 392 (1946), that “where a plaintiff has been injured
by fraud and remains in ignorance of it without any fault
or want of diligence or care on his part, the bar of the
statute of limitations does not begin to run until the fraud
is discovered.” 534 U.S. at 27 (quoting Holmberg, 327 U.S.
at 397). The Supreme Court proceeded to note in TRW
that “[t]he only other cases in which we have recognized a
prevailing discovery rule, morever, were decided in two
contexts, latent disease and medical malpractice, ‘where
the cry for [such a] rule is loudest.’” Id. (quoting Rotella,
528 U.S. at 555) (second alteration in original). As the
guide for deciding whether to read a discovery rule into a
federal statute of limitations, the Supreme Court held in
TRW that Congress can “convey its refusal to adopt a
discovery rule . . . by implication from the structure or
text of the particular statute.” Id. at 27–28.

The question we must decide is whether, in the con-
text of a no-fault vaccine-injury remedy statute Congress,
in the text of the Vaccine Act and considering its overall
structure, conveyed its refusal to permit an implied

U.S. at 38 (Scalia, J., concurring) (discussing three addi-
tional examples of explicit discovery rules enacted by
Congress).
CLOER v. HHS 32

discovery rule. We have already held that Congress did
not write an explicit discovery rule into the statute.

Congress enacted the Vaccine Act statute of limita-
tions against the backdrop of state law providing reme-
dies for physical injuries. Indeed, Dr. Cloer points to that
body of state law, noting that virtually all of the state
laws on the subject incorporate discovery rules into their
statutes of limitations. Those discovery rules look to the
knowledge of a plaintiff to determine the date upon which
the statute of limitations begins to run. From this body
of state law, Dr. Cloer argues that Congress must have
meant for the Vaccine Act statute of limitations to incor-
porate a discovery rule.

The contemporaneous existence of that body of state
law, however, cuts against Dr. Cloer. First, that body of
state law, dealing with fault liability, keys the accrual of
the cause of action to the occurrence of the injury for
which relief is sought. See, e.g., Colo. Rev. Stat. §§ 13-80-
106, 13-80-108 (enacting discovery rule for cause of action
otherwise accruing at injury). As with the Federal Tort
Claims Act, 28 U.S.C. § 2401(b), those state laws are
understood to trigger their statutes of limitations upon
the discovery of the existence and the cause of the injury.
See United States v. Kubrick, 444 U.S. 111, 120 (1979).
We may presume that Congress is generally aware of the
consequences of enacting a statute of limitations that
runs from the date of occurrence of an injury. As noted
above, Congress was presented the option of enacting a
statute of limitations that would have run from the
knowledge of the occurrence of a vaccine-related injury.
See S. 827, 99th Congress § 2106(a) (1985). Had it done
so, the parallel between state law and the Vaccine Act
sought by Dr. Cloer would have been plausible. Instead,
Congress made the deliberate choice to trigger the Vac-
33 CLOER v. HHS

cine Act statute of limitations from the date of occurrence
of the first symptom or manifestation of the injury for
which relief is sought, an event that does not depend on
the knowledge of a petitioner as to the cause of an injury.
This trigger confirms that a Vaccine Act cause of action
accrues on that same date, not at a later date when a
petitioner may have knowledge that the vaccine caused
the injury. We need not decide whether the choice of
Congress to bypass a statute of limitations comparable to
the large body of state law shows a firm intent to bar,
without more, a discovery rule in the Vaccine Act statute
of limitations. But the choice made by Congress surely
goes a long way to showing that Congress “conveyed its
refusal to adopt a discovery rule.” 8 TRW, 534 U.S. at 27.

8 The legislative history which we emphasize is not
a matter of difference of opinion among legislators about
what statutory language means, or individual statements
by legislators. See generally Garcia v. United States, 469
U.S. 70, 75 (1984) (cautioning against reliance on legisla-
tors’ “passing comments” and “casual statements” as
indicating Congressional intent). Instead, it is a matter of
pure fact that Congress had two clear and significantly
differing concepts to choose from in writing the statute of
limitations for the Vaccine Act. Compare H.R. 1780, 99th
Congress § 2112 (1985) with S. 827, 99th Congress
§ 2106(a) (1985). Less significant but not unimportant is
the additional fact that Congress was warned by Dissatis-
fied Parents Together, an interest group favoring the
approach of S. 827, that the approach ultimately selected
by Congress would trigger the statute of limitations
regardless of when the claimant discovered the causal
link between the injury and the vaccine. See To amend
the Public Health Service Act to provide for the compensa-
tion of children and others who have sustained vaccine-
related injuries, and for other purposes: Hearing on S. 827
before the S. Comm. on Labor and Human Res., 99th
Cong. 41 (1985) (statement of Jeffrey H. Schwartz, Presi-
dent of DPT).
CLOER v. HHS 34

Examination of the overall structure of the Vaccine
Act and its text buttresses our conclusion that a discovery
rule cannot be read into the Vaccine Act statute of limita-
tions. First and foremost, Congress selected a specific
textual calendar date to trigger the statute of limitations.
Nothing in that date, the first occasion of a symptom or
manifestation of onset of the injury for which compensa-
tion is sought, asks for information about how much
knowledge a petitioner had. It is a statutory date that
does not depend on when a petitioner knew or reasonably
should have known anything adverse about her condition.
We have recognized this in our previous cases. See Mark-
ovich, 477 F.3d at 1357 (rejecting the argument that eye
blinking episodes were insufficient to start the statute of
limitations because “the eye blinking symptom could not
reasonably alert the Markoviches that anything was
wrong.”); Wilkerson v. Sec’y of Dep’t of Health & Human
Servs., 593 F.3d 1343, 1345–46 (Fed. Cir. 2010) (rejecting
a subjective standard for determining when the limita-
tions period began to run based on the parent’s perception
and confirming an objective standard based on the medi-
cal profession’s recognition of the existence of a symptom
or manifestation of an injury).

The date of the first symptom or manifestation reso-
nates throughout the Vaccine Act. For example, with
regard to Table injury cases, the petitioner is supplied in
the Vaccine Injury Table with a list of symptoms or mani-
festations and a list of dates associated with the time of
occurrence of each of those symptoms or manifestations.
The Table Injury petitioner uses the same single statute
of limitations as a non-Table injury claimant, and has 36
months from the date of the first symptom or manifesta-
tion in which to file a petition for compensation.
35 CLOER v. HHS

As noted in Part I above, a significant motive for Con-
gress in enacting the Vaccine Program was to provide an
efficient, simple, and easy to administer system for proc-
essing vaccine injury claims. We think the triggering
mechanism selected by Congress for the statute of limita-
tions promotes those goals, whereas a discovery rule may
not. Once it is understood that Congress intended a
specific date, rather than a date that would vary depend-
ing on the knowledge of a petitioner, to trigger the statute
of limitations, it is easily understood that time-consuming
debates over when the statute of limitations started to
run would not likely occur in processing a petition for
compensation. When the date a symptom first occurred
might sometimes be in issue, but the more complicated
inquiry about whether petitioner knew or reasonably
should have known of a causal connection only arises
under Dr. Cloer’s view of the statute. Further, “the date
of occurrence of the first symptom or manifestation of
onset” treats all petitioners equally, whereas under a
discovery rule, the otherwise neutral 36 month time limit
will vary from petitioner to petitioner.

A discovery rule necessarily adjusts the beginning of a
statute of limitations to the circumstances of an individ-
ual case. The rule typically asks when a plaintiff knew or
reasonably should have known of enough facts to proceed
with her case. Kubrick, 444 U.S. at 120–22; see also Kach
v. Hose, 589 F.3d 626, 634–35 (3d Cir. 2009); Rakes v.
United States, 442 F.3d 7, 20 (1st Cir. 2006); Fries v.
Chicago & Nw. Transp. Co., 909 F.2d 1092, 1095 (7th Cir.
1990); 2 Calvin W. Corman, Limitation of Actions § 11.1.1
(1991). The discovery rule tethers accrual of the cause,
and with it the start of the limitations period, to the
knowledge of the plaintiff or of a reasonable actor in the
plaintiff’s position. The discovery rule is therefore an
inherently personal, plaintiff-specific one. As a matter of
CLOER v. HHS 36

both practice and design, a discovery rule treates different
plaintiffs differently based on their personal circum-
stances. Cascone v. United States, 370 F.3d 95, 104 (1st
Cir. 2004) (“The issue is whether a reasonable person
similarly situated to the plaintiff would have known the
necessary facts.”).

In our view the personal, plaintiff-oriented approach
of a discovery rule is antithetical to the simple, symptom-
keyed test expressly required by the Vaccine Act’s text.
Such a conclusion is not surprising in light of the Vaccine
Act’s structure as a simplified no-fault administrative
scheme. We note further that this conclusion is consistent
with Congress’s expressed desire that the Vaccine Act be
“simple, and easy to administer” as well as “expeditious
and fair.” See supra part I (discussing legislative history).
Under the Vaccine Act as written, two plaintiffs who
receive the same vaccine on the same day, and who ex-
perience the same medically-recognized symptom of a
vaccine-related injury shortly afterwards, also on the
same day, begin their limitations periods simultaneously.
But under the more capacious analysis of the discovery
rule, the start of the limitations period could vary widely
based on each plaintiff’s personal circumstances. We
think these two results so different as to make implication
of a discovery rule fundamentally incompatible with the
text Congress enacted.

We therefore hold that Congress “conveyed its refusal
to adopt a discovery rule . . . by implication from the text
and structure” of the Vaccine Act. TRW, 534 U.S. at 27–
28. The statute of limitations begins to run on a specific
statutory date: the date of occurrence of the first symptom
or manifestation of onset of the vaccine-related injury
recognized as such by the medical profession at large.
37 CLOER v. HHS

B
In our second question for en banc briefing, we asked
if Brice should be overruled to permit equitable tolling of
42 U.S.C. § 300aa-16(a)(2). We now answer that question
in the affirmative. We therefore overrule Brice and hold
that equitable tolling applies to the Vaccine Act. In Part
C below, we reach and decide the ground on which Dr.
Cloer seeks equitable tolling.

The Supreme Court observed in John R. Sand &
Gravel Co. v. United States, 552 U.S. 130, 133 (2008), that
“[m]ost statutes of limitations seek primarily to protect
defendants against stale or unduly delayed claims.”
Limitations statutes of that nature do not implicate the
jurisdiction of a court, and thus do not preclude relief
from time filing limits by way of equitable tolling. The
time limits in other statutes, the Supreme Court noted,
have been read in the light of the statute’s overall purpose
as “more absolute, say as requiring a court to decide a
timeliness question despite a waiver, or as forbidding a
court to consider whether certain equitable considerations
warrant extending a limitations period.” Id. at 133–34.
As examples of such more absolute statutes, the Supreme
Court mentioned statutes that “achieve a broader system-
related goal, such as facilitating the administration of
claims, see, e.g., United States v. Brockamp, 519 U.S. 347,
352–353 (1997), limiting the scope of a governmental
waiver of sovereign immunity, see, e.g., United States v.
Dalm, 494 U.S. 596, 609–10 (1990), or promoting judicial
efficiency, see, e.g., Bowles v. Russell, 551 U.S. 205, 210–
13 (2007).” John R. Sand & Gravel, 552 U.S. at 133.
Whether a particular statute of limitations is treated as
“jurisdictional” thus depends on the overall context of the
statute. The term “jurisdictional” has no notable meaning
in such contextual inquiries and is merely convenient
CLOER v. HHS 38

shorthand for statutory limits that are absolute and
require a court to consider timeliness questions without
reference to equitable considerations. Id. at 133–34. The
“jurisdictional” determination thus merges into the ques-
tion of whether Congress intended to allow equitable
tolling of the Vaccine Act’s statute of limitations. 9

9 In Martin ex rel. Martin v. Secretary of Health &
Human Services, 62 F.3d 1403 (Fed. Cir. 1995), the par-
ents of a child injured by polio vaccine sought attorneys’
fees and costs under the Vaccine Act. 42 U.S.C. § 300aa-
11(a)(6) bars a petition for compensation if the petitioner
has previously filed a civil suit for damages for the same
injury. Because the Martins had filed such a suit, their
petition was dismissed for lack of subject matter jurisdic-
tion. We thus viewed the barrier to suit in § 300aa-
11(a)(6) as jurisdictional, and consequently held that the
absence of jurisdiction over the Martins’ petition for
compensation removed jurisdiction over their application
for attorneys’ fees and costs. 62 F.3d at 1407. After we
held in Brice that equitable tolling does not lie under the
Vaccine Act, the Brices sought attorneys’ fees and costs.
The Court of Federal Claims, in the light of Martin,
treated the Brices’ failure to meet the statute of limita-
tions as jurisdictional, and thus dismissed the Brices’
attorneys’ fee and costs request for lack of jurisdiction.
On appeal, we too assumed, without analysis, that com-
pliance with the Vaccine Act’s statute of limitations is a
jurisdictional requirement, and affirmed the Court of
Federal Claims decision. Brice v. Sec’y of Health & Hu-
man Servs., 358 F.3d 865, 869–70 (Fed. Cir. 2004) (“sec-
ond Brice”).
Dr. Cloer brought Martin and the second Brice de-
cision to our attention, pointing out that the second Brice
decision merely assumed that the statute of limitations is
jurisdictional, and asking that we clarify the issue.
Notably, the government does not rely on the second Brice
decision; indeed, it does not assert that the statute is
“jurisdictional” and thus inhospitable to equitable tolling.
The only purpose of the statute of limitations in
the Vaccine Act is to protect the government from stale or
39 CLOER v. HHS

Any analysis of whether equitable tolling lies against
a federal statute of limitations begins with Irwin v. De-
partment of Veterans Affairs, 498 U.S. 89 (1990). In that
case, the Supreme Court established a presumption that
all federal statutes of limitations are amenable to equita-
ble tolling absent provision by Congress to the contrary.
Id. at 95–96. Irwin left for decision in later cases whether
when enacting specific statutes Congress rebutted the
basic presumption in favor of equitable tolling. A leading
case providing guidance on Congressional rebuttal is
United States v. Brockamp, 519 U.S. 347 (1997).
Brockamp framed the rebuttal question as “whether there
is good reason to believe that Congress did not want
equitable tolling to apply.” 519 U.S. at 350. Brockamp
detailed five factors for use in determining whether
Congress rebutted the basic Irwin presumption: the
statute’s detail, its technical language, its multiple itera-
tion of the limitations period, its explicit inclusion of
exceptions, and its underlying subject matter. See
Brockamp, 519 U.S. 350–52. These same factors were
considered by this court when it previously decided that
equitable tolling is not available. Indeed, at that time and
again in this case, the government agrees that only two of
the factors cut against equitable tolling. First, the gov-
ernment argues that the Vaccine Act includes two specific
exceptions to the basic 36 month statute of limitations.
And second, the government argues that the Vaccine Act’s
detail as a whole reveals multiple strict deadlines.

unduly delayed claims. Whether viewed from the overall
purpose perspective or, as demonstrated below, from the
perspective of whether Congress barred equitable tolling
by erecting a jurisdictional barrier, the answer is the
same. There is no barrier to equitable tolling under 42
U.S.C. § 300aa-16(a)(2), and the statute of limitations is
not jurisdictional. Previous law to the contrary is over-
ruled.
CLOER v. HHS 40

The first exception to which the government refers
provides for the situation when a petition for compensa-
tion is improperly filed as a tort claim in a state or federal
court. Because a person seeking compensation for a
vaccine-related injury must first file under the Vaccine
Program, 42 U.S.C. § 300aa-11(a)(2), previous court
filings elsewhere are improper and must be dismissed.
The date such a dismissed action was filed “shall, for
purposes of the limitations of actions prescribed by section
300aa-16 of this title [the 36 month period], be considered
the date the petition was filed if the petition was filed
within one year of the date of the dismissal of the civil
action.” 42 U.S.C. § 300aa-11(a)(2)(B). 10 This exception
was relied on in Brice as a reason to deny equitable toll-
ing.

The second exception to the basic limitations statute
raised by the government concerns the provision in the
Vaccine Act that deals with petitions for compensation
filed after the Vaccine Injury Table is revised. For exam-
ple, a person who was not eligible for compensation before
the Vaccine Injury Table revision may file a petition for
compensation under the revision, provided the petitioner’s
injury occurred no more than 8 years before the date of
the revision and the petition is filed not later than 2 years

10 The relief afforded to petitioners by 42 U.S.C.
§ 300aa-11(a)(2)(B) was not available to the petitioner in
Martin. See supra n.9. That case dealt with 42 U.S.C.
§ 300aa-11(a)(6), which completely barred access to the
Vaccine Program if a petition was filed after November
15, 1988, for a vaccine-related injury or death associated
with administration of a vaccine before November 15,
1988. In Martin, the vaccine was administered in 1986
and the state court suit was brought on November 15,
1989. Martin, 62 F.3d at 1404.
41 CLOER v. HHS

after the effective date of the revision. 42 U.S.C. § 300aa-
16(b). This exception was not discussed in Brice.

As for the overall structure of the Vaccine Act, the
government points to the many strict time deadlines that
regulate cases once they are started. In particular, the
government points to the need for special masters to
decide cases within 240 days after the filing of a petition,
and the bar to suspension of proceedings for more than
150 days. See 42 U.S.C. § 300aa-12(d)(3)(A)(ii),(C).

The correct analysis of the government’s “exceptions”
points is informed by the Supreme Court’s recent decision
in Holland v. Florida, 130 S. Ct. 2549 (2010), of which the
Brice court did not have the benefit. Holland answered in
the affirmative whether the one-year statute of limita-
tions on petitions for federal habeas corpus relief by state
prisoners under the Antiterrorism and Effective Death
Penalty Act of 1996 (“AEDPA”) is subject to equitable
tolling. The respondent in Holland argued that the
AEDPA should be interpreted to foreclose equitable
tolling because the statute has explicit exceptions to the
basic statute of limitations. 130 S. Ct. at 2561. The
Supreme Court “concede[d] that [the AEDPA] is silent as
to equitable tolling while containing one provision that
expressly refers to a different kind of tolling.” Id. at
2561–62 (citing the “exception” as 28 U.S.C. § 2244(d)(2),
which does not count against the one-year statute the
time a petitioner has a pending request for postconviction
relief, because the federal petition cannot be brought
before exhaustion of state remedies). The Supreme Court
held that Congress had to balance the interaction of state
and federal participation in the underlying subject mat-
ter, and the “exception” thus is a special need, and as such
negates the significance of the special exception for
Brockamp factor analysis purposes. 130 S. Ct. at 2562.
CLOER v. HHS 42

Holland teaches that exceptions to statutes of limita-
tions do not necessarily rebut the bedrock Irwin presump-
tion in favor of equitable tolling. Exceptions, instead,
must be understood in context, for, as in Holland, an
exception may signal a beneficent Congressional act, not a
rebuttal of the Irwin presumption. In the context of the
Vaccine Act, the “exception” seen in 42 U.S.C. § 300aa-
11(a)(2)(B) does not counsel against equitable tolling.

As noted above, before a tort suit can be brought for
damages, a claimant must seek relief under the Vaccine
Program. If a would-be petitioner mistakenly first files a
traditional tort suit, the tort suit must be dismissed. 42
U.S.C. § 300aa-11(a)(2)(B). Recognizing that the result of
a rule requiring dismissal of premature suits could leave
a petitioner nonsuited due to different statutes of limita-
tions for state torts and the Vaccine Act, Congress in-
cluded a special need provision that would allow the
petitioner to benefit from the earlier state filing date
when faced with the Vaccine Act’s statute of limitations.
Similarly, Congress included a provision that tolls state
statutes of limitations during the pendency of Vaccine
Program action. See 42 U.S.C. § 300aa-16(c). Thus,
Congress created a system that provides for a petitioner
to have equal access to the Vaccine Program and to state
remedies once any filing occurs regardless of the forum.

We think it clear that Congress had a specific concern,
unrelated to equitable tolling considerations, in enacting
the “exception” in 42 U.S.C. § 300aa-11(a)(2)(B). This
provision shows Congressional response to possible confu-
sion regarding the new no-fault compensation system by
minimizing the consequence of certain errors. This “ex-
ception” is driven by a special need, as was the case in
Holland, and does not show a desire by Congress to bar
equitable tolling.
43 CLOER v. HHS

We turn now to the statutory provision that permits a
petition for compensation to be filed upon revisions to the
Vaccine Injury Table. We reject the government’s argu-
ment that this “exception” bars equitable tolling of the
statute of limitations. This statutory provision is aimed
at scientific advances in medicine that enable the estab-
lishment of new Table Injuries, for which causation will
be presumed. Individual factual circumstances, the grist
of equitable tolling claims, played no role in enactment of
this provision. We think equitable tolling concepts lie in a
different world from the opening to all vaccine recipients
of a claim due to new medical knowledge. This “excep-
tion” too is easily understood as a special need provision
to address a Vaccine Program that moves forward in time
with advances in medicine. Equitable tolling is not de-
feated by the wisdom of Congress to see into the future.

The remaining factor urged by the government to
support its view that Congress rebutted the Irwin pre-
sumption concerns the detailed time limits governing
processing of cases under the Vaccine Program. Those
factors, identified above, relate to the speed with which
the special master must move in processing cases. Such
limits are tight, to be sure, and they serve to meet the
Congressional goal of swift and efficient disposition of
claims once a petition is filed. These time limits are
designed to benefit the petitioner. If a petitioner were to
cause some delay in processing of her petition because the
government resists her request for equitable tolling, she
could not be heard to complain if the time to decide her
claim is greater than a petitioner who filed her petition
within the 36 month limit. And any delay in getting the
merits of a petition underway because of equitable tolling
is no greater, if as great, as the delay that would be
inherent in resolving disputes about whether a petitioner
reasonably should have known of a causal link between
CLOER v. HHS 44

her injury and a vaccination. Further, the 36 month
period comports with traditional tort remedy statutes of
limitations, and is not overly generous. See United States
v. Beggerly, 524 U.S. 38, 48–49 (1998) (denying equitable
tolling on an “unusually generous” 12-year statute of
limitations.)

In sum, measuring the Vaccine Act by the standards
in Irwin, Brockamp, and Holland, we see no reason to bar
equitable tolling of the statute of limitations in the Vac-
cine Act, and therefore must conclude that there is not
“good reason to believe that Congress did not want the
equitable tolling doctrine to apply.” Brockamp, 519 U.S.
at 350.

C

In the order setting this case for en banc decision, we
asked the parties to address whether, if equitable tolling
is permitted, the circumstances of this case support
equitable tolling. Dr. Cloer took advantage of our invita-
tion and argued, as she has throughout these proceedings,
that equitable tolling is appropriate in this case on the
ground that she first became aware of the causal link
between her MS and the Hep-B vaccine in 2004 when she
saw an article in a journal suggesting such a link. She
asserts that it is inequitable and unfair to hold her to the
36 month filing period when she had no reason to know,
before 2004, of the causal link between her injury and the
Hep-B vaccine. She thus posits that equitable tolling in
her case, and presumably in other future cases with
similar facts, should be a substitute for the discovery rule.

In other words, Dr. Cloer individually asks for the
same relief as a matter of equity that Congress has with-
held from all petitioners as a matter of law. But we find
45 CLOER v. HHS

no basis in equity for doing so. Dr. Cloer has put no
argument before this court that, for example, she has
been the victim of a fraud, or of duress. See, e.g., Bailey v.
Glover, 88 U.S. 342, 349–50 (1874). Instead, we under-
stand her to argue that the result reached in the analysis
above is ipso facto unfair because it threatens to deprive
her of her claim. That is not, in our view, the sort of
circumstance that might merit equitable tolling. See Pace
v. DiGuglielmo, 544 U.S. 408, 418 (2005) (noting that
equitable tolling requires a litigant to have diligently
pursued his rights, but that “some extraordinary circum-
stance stood in his way”); see also Irwin, 498 U.S. at 96
(noting that equitable tolling is to be used “sparingly” in
federal cases and has been limited to cases involving
deception or the timely filing of a procedurally defective
pleading).

While we recognize that our holding sharply limits
Dr. Cloer’s ability to be compensated under the Vaccine
Act, this outcome is the result of a policy calculation made
by Congress not to afford a discovery rule to all Vaccine
Act petitioners and Dr. Cloer’s failure to point to circum-
stances that could justify the application of equitable
tolling to forgive her untimely claim. We thus hold that
equitable tolling under the Vaccine Act due to unaware-
ness of a causal link between an injury and administra-
tion of a vaccine is unavailable. 11

11 In Irwin, the Supreme Court found for the first
time that equitable tolling is presumptively available in
all actions against the government, including the one
asserted by Mr. Irwin. 498 U.S. at 95–96. Because the
Court concluded that Mr. Irwin could not satisfy the
stringent requirements of that doctrine, however, the
Court affirmed the judgment the judgment against Mr.
Irwin. Id. We follow a similar course here.
CLOER v. HHS 46

Accordingly, the judgment below is

AFFIRMED
 United States Court of Appeals
for the Federal Circuit
__________________________

MELISSA CLOER, M.D.,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________

2009-5052
__________________________

Appeal from the United States Court of Federal
Claims in case no. 05-VV-1002, Judge Lawrence J. Block.
__________________________

DYK, Circuit Judge, dissenting, with whom Circuit Judges
NEWMAN, LINN, and REYNA join.
Contrary to the majority, I think it is quite clear that
the National Childhood Vaccine Injury Act of 1986, Pub.
L. No. 99-660, 100 Stat. 3743, 3755, Title III (1986) (codi-
fied at 42 U.S.C. § 300aa-1 to 34) [hereinafter the Vaccine
Act], incorporates a discovery rule under which the limi-
tations period does not begin to run until the claimant
knew or should have known of a connection between the
alleged injury and a vaccine. 1

1 This does not mean, of course, that a definitive di-
agnosis of the alleged injury is required to trigger the
statute of limitations, as this court made clear in Mark-
CLOER v. HHS 2

I
It is well established in both state and federal law
that a discovery rule should be presumed for limitations
purposes for claims similar to those under the Vaccine
Act. The Supreme Court has “recognized a prevailing
discovery rule . . . in [the] two context[s] of latent disease
and medical malpractice, ‘where the cry for [such a] rule
is loudest.’” TRW Inc. v. Andrews, 534 U.S. 19, 27 (2001)
(quoting Rotella v. Wood, 528 U.S. 549, 555 (2000)).
Application of a discovery rule is necessary in these
circumstances because the very fact that the plaintiff “has
been injured . . . may be unknown or unknowable until
the injury manifests itself; and the facts about causation
may be in the control of the putative defendant, unavail-
able to the plaintiff or at least very difficult to obtain.”
United States v. Kubrick, 444 U.S. 111, 122 (1979).
Where the plaintiff has knowledge of both the injury and
its cause, however, “[t]he prospect is not so bleak” because
the plaintiff is no longer at the mercy of the defendant,
who possesses specialized medical knowledge. Id. Six of
our sister circuits have similarly held that, in the case of
medical malpractice and similar actions, the limitations
period generally does not begin to run until the plaintiff
knew or should have known of both the injury and its
cause. 2 See also TRW, 534 U.S. at 27 (“[L]ower federal

ovich v. Sec’y of Health & Human Servs., 477 F.3d 1353,
1360 (Fed. Cir. 2007).
2 See, e.g., Sell v. U.S. Dep’t of Justice, 585 F.3d
407, 409 (8th Cir. 2009) (“In medical malpractice
cases . . . the cause of action accrues when the plaintiff
discovers the nature and cause of his injury.”); Hensley v.
United States, 531 F.3d 1052, 1056 (9th Cir. 2008) (noting
that, “[i]n certain circumstances, such as claims involving
medical malpractice, accrual does not occur until a plain-
tiff knows of both the existence of an injury and its
cause”); Green v. United States, 180 F. App’x 310, 313 (3d
3 CLOER v. HHS

courts generally apply a discovery accrual rule when a
statute is silent on the issue.”) (internal quotation marks
omitted); Rotella, 528 U.S. at 555 (“Federal courts, to be
sure, generally apply a discovery accrual rule when a
statute is silent on the issue . . . .”).
While the majority does not dispute that the Vaccine
Act remedy is similar to, and replaces, a medical malprac-
tice or similar remedy, it asserts that the application of a
discovery rule to petitions under the Vaccine Act is inap-
propriate because such a rule would be inconsistent with
the language and structure of the Act. Relying on the
Supreme Court decision in TRW, the majority points out
that “Congress can ‘convey its refusal to adopt a discovery
rule . . . by implication from the structure or text of the
particular statute.’” Maj. Op. at 31 (quoting TRW, 534
U.S. at 27–28). The text and the structure of the Vaccine
Act, however, do not suggest that Congress rejected a
discovery rule. To the contrary, both the text and the

Cir. 2006) (“[W]hen the fact of injury alone is insufficient
to put an injured party on notice of its cause, the Supreme
Court has indicated that the accrual of the claim is de-
layed until the injured party discovers that cause.“);
Waggoner v. United States, 95 F. App’x. 69, 71 (5th Cir.
2004) (“[A] claim under the FTCA accrues when a plaintiff
knows or reasonably should have known of ‘the existence
and the cause of his injury.’”); Mix v. Delaware & Hudson
Ry. Co., 345 F.3d 82, 86 (2d Cir. 2003) (“[A]n FELA action
accrues when the plaintiff in the exercise of reasonable
diligence knows both the existence and the cause of his
injury.”) (internal quotation marks omitted); Price v.
United States, 775 F.2d 1491, 1493-94 (11th Cir. 1985)
(“[A] medical malpractice claim under the FTCA accrues
when the plaintiff is, or in the exercise of reasonable
diligence should be, aware of both [his] injury and its
connection with some act of the defendant.”); see also
Kubrick, 444 U.S. at 120–21 (noting government conces-
sion that in medical malpractice cases plaintiff must
know of both injury and its cause).
CLOER v. HHS 4

structure of the Act confirm that Congress adopted the
prevailing discovery rule approach.
A
Section 300aa-16(a)(2) of the Vaccine Act provides:
[I]f a vaccine-related injury occurred as a result of
the administration of such vaccine, no petition
may be filed for compensation under the Program
for such injury after the expiration of 36 months
after the date of the occurrence of the first symp-
tom or manifestation of onset or of the significant
aggravation of such injury.
42 U.S.C. § 300aa-16(a)(2). Notably, the statute does not
provide that the limitations period commences on the date
of the injury. Instead, the limitations period commences
on the date of the “first symptom or manifestation” of a
“vaccine-related injury,” making clear that the statute of
limitations is triggered only where the claimant knew or
should have known of both the injury and its connection
to the vaccine. 42 U.S.C. § 300aa-16(a)(2) (emphases
added). As the majority recognizes, the terms “symptom”
and “manifestation” suggest knowledge or reason to know
on the part of the claimant. 3 Maj. Op. at 25. That knowl-
edge requirement refers not merely to the existence of a
vaccine-related injury, but to knowledge that the injury
was related to the vaccine. In other words, the limitations
period is not triggered by knowledge of the injury itself,
but by the first event which would put the claimant on
notice that a vaccine-related injury has occurred.

3 See Webster’s Third New Int’l Dictionary 1375,
2318 (1986) (defining “manifestation” as “something that
manifests or constitutes an expression of something else:
a perceptible outward, or visible expression,” and “symp-
tom” as “something that indicates the existence of some-
thing else”).
5 CLOER v. HHS

Indeed, the limitations provision makes clear that it is
not triggered merely by the first symptom of an injury—
the injury itself must be related to the vaccine (i.e., a
“vaccine-related injury”) and must occur “as a result of . . .
a vaccine.” 42 U.S.C. § 300aa-16(a)(2) (emphasis added).
The statutory definition of “vaccine-related injury” con-
firms this point, defining “vaccine-related injury” as “an
illness, injury, condition, or death associated with one or
more of the vaccines set forth in the Vaccine Injury Ta-
ble.” Id. § 300aa-33(5) (emphasis added). At the time the
Vaccine Act was passed, the word “associated” was de-
fined as “closely connected, joined, or united.” Webster’s
Third New Int’l Dictionary 132 (1986). Thus, in order for
an injury to be “associated with” a vaccine, there must be
some connection between the injury and the vaccine, and
there must be a manifestation or symptom of such an
injury, i.e., there must be knowledge or reason to know
that the injury is vaccine-related.
The majority asserts that the text of the Vaccine Act
is inconsistent with the application of a discovery rule
because “the clearly dominant language in the statute of
limitations is ‘the date of occurrence of the first symptom
or manifestation of onset.’” Maj. Op. at 30 (quoting 42
U.S.C. § 300aa-16(a)(2)). Because the majority finds this
phrase to be “dominant,” it fails to recognize that the
phrase “first symptom or manifestation of onset” means
nothing standing alone. It can be understood only by
looking to the remainder of the language in the limita-
tions provision, which links the “first symptom or mani-
festation” to “a vaccine-related injury” and requires that
such injury occur “as a result” of a vaccine. See 42 U.S.C.
§ 300aa-16(a)(2).
The majority’s novel “dominant language” approach to
statutory interpretation is plucked out of thin air and is
contrary to Supreme Court precedent, which makes clear
CLOER v. HHS 6

that when interpreting a statute, the “[i]nterpretation of a
word or phrase depends upon reading the whole statutory
text.” Dolan v. United States Postal Serv., 546 U.S. 481,
486 (2006); see also U.S. Nat’l Bank of Or. v. Indep. Ins.
Agents of Am., Inc., 508 U.S. 439, 455 (1993) (explaining
that “we must not be guided by a single sentence or
member of a sentence, but look to the provisions of the
whole law, and to its object and policy”); Astoria Fed. Sav.
& Loan Ass’n v. Solimino, 501 U.S. 104, 112 (1991) (“[W]e
construe statutes, where possible, so as to avoid rendering
superfluous any parts thereof.”); Hornback v. United
States, 601 F.3d 1382, 1385 (Fed. Cir. 2010) (quoting U.S.
Nat’l Bank of Or., 508 U.S. at 455). The majority’s rule
that the limitations period begins to run on the “date of
the occurrence of the first medically recognized symptom
or manifestation of onset of the injury claimed by the
petitioner,” Maj. Op. at 4, simply rewrites the statutory
language by leaving out the requirement that the injury
be “vaccine-related” and occur “as a result” of a vaccine.
In an effort to support its decision to ignore the statu-
tory text, the majority relies on legislative history suppos-
edly demonstrating that Congress deliberately chose to
trigger the limitations period from the date of the first
symptom or manifestation of the alleged injury, regard-
less of whether there is an objective reason to suspect a
causal connection between the alleged injury and the
vaccine. Even under the questionable assumption that
legislative history could support a reading contrary to the
text of the statute, there is no such legislative history
here. The majority cites two alternative pieces of legisla-
tion considered by Congress—H.R. 1780 and S. 827. The
House of Representatives version required, in language
similar to that finally enacted, that claims under the Act
be brought within “two years after the first manifestation
of a vaccine-related injury,” a formulation that also re-
7 CLOER v. HHS

quired the “first manifestation” be “vaccine-related.”
National Childhood Vaccine-Injury Compensation Act of
1985, H.R. 1780, 99th Cong. § 2112(a) (1985). The Senate
version required that claims be brought “within 5 years
after the occurrence of the compensable complication or
residual effect of the illness, disability, injury, or condition
listed in the Vaccine Injury Table.” National Childhood
Vaccine-Injury Compensation Act of 1985, S. 827, 99th
Cong. § 2106(a) (1985). In the Senate bill, as in the final
version of the Act, causation was presumed for injuries
listed in the Vaccine Injury Table. See 42 U.S.C. § 300aa-
11(c)(1)(C)(i). The Senate version also permitted the filing
of a petition after the time period specified if it was dem-
onstrated that the claimant “did not know that such
complication or effect was compensable under the pro-
gram,” or the claimant “was not provided the information
required by section 2143.” S. 827, § 2106(b). Section
2143(c)(9) required that persons receiving a vaccine listed
in the Vaccine Injury Table be provided certain informa-
tion, including “information on . . . the availability of the
Program.”
The majority urges that Congress’ rejection of the
limitations provision set forth in the Senate bill demon-
strates that Congress intended the limitations period to
be triggered by the first symptom or manifestation of the
alleged injury, regardless of whether there is any reason
to suspect a connection between the alleged injury and the
vaccine. But Congress’ rejection of the exception con-
tained in the Senate bill in no way demonstrates that
Congress intended to reject the application of a discovery
rule.
First, unlike the Vaccine Act, the Senate bill did not
permit a claimant to recover for an injury unless the
CLOER v. HHS 8

injury was listed in the Vaccine Injury Table. 4 The only
role of causation was to permit claimants to recover for
Table injuries even though the time requirements for
onset of the injury were not met. See S. 827,
§ 2105(a)(2). 5 The Senate bill did not, however, in this or

any other respect, provide an exception to the limitations
period based on the claimant's lack of knowledge or
reason to know that there was a causal connection be-
tween the alleged injury and the vaccine. Thus, the
rejection of the Senate bill hardly suggests a rejection of a
discovery rule requiring that the claimant know or have
reason to know of a causal connection between the alleged
injury and the vaccine.
Second, the exception to the limitations period in the
Senate bill was not a discovery rule. It did not depend on
what the claimant knew or should have known, but on
what the claimant actually knew. The exception permit-
ted the filing of a petition after the time period specified
only if it was demonstrated that (1) at the time of the

4 Section 2103 permitted the award of compensa-
tion only where “there is an adequate demonstration that
. . . the [claimant] sustained, or had significantly aggra-
vated, any of the illnesses, disabilities, injuries, or condi-
tions listed in the Vaccine Injury Table.” S. 827,
§ 2103(a)(2)(A). Additionally, the bill defined the term
“vaccine-related injury” only in terms of injuries appear-
ing in the Vaccine Injury Table, stating specifically that
“the term ‘vaccine-related injury’ means any injury . . .
listed in the Vaccine Injury Table.” Id. § 2164(20).
5 The Senate bill set forth a Vaccine Injury Table
containing specific vaccines, injuries, and time periods for
the first symptom or manifestation of onset of a listed
injury. Id. § 2105(a)(1). Where the claimant's first symp-
tom did not occur within the specified time period, the
claimant could nonetheless recover upon demonstrating
that the injury was caused by the vaccine.
9 CLOER v. HHS

vaccine, the petitioner was not provided with, among
other things, information about the Vaccine Injury Com-
pensation Program; or (2) that the petitioner did not know
that the complication or effect of the injury was com-
pensable under the Program. Id. §§ 2106(b), 2143(c)(9).
Neither of these exceptions was designed to address a
situation in which the claimant had no reason to suspect
a causal connection between the alleged injury and the
vaccine. Instead, they were designed to deal with circum-
stances in which the claimant had no knowledge of the
availability or scope of the Vaccine Injury Compensation
Program. As a result, Congress’ rejection of the Senate
limitations provision, does not suggest that Congress
rejected a discovery rule or intended the language in the
limitations provision of the Vaccine Act to be read to
mean something different than the plain language con-
veys.
B
The application of a discovery rule is compelled by
both the structure and history of the Vaccine Act, as well
as its language. If the limitations provision were inter-
preted not to incorporate a discovery rule, claimants like
Dr. Cloer would be faced with the odd result that the
limitations period would begin to run before a petition
could be filed under the Act., i.e., before the cause of
action accrued. The majority itself recognizes that “set-
tled law establishes a firm default rule that a cause of
action arises at the same time the statute of limitations
begins to run on the cause.” Maj. Op. at 21 (citing Gra-
ham Cnty. Soil & Water Conservation Dist. v. United
States ex rel. Wilson, 545 U.S. 409, 418 (2005)). Thus,
absent an indication to the contrary, the limitations
period begins when the cause of action accrues. Graham
Cnty., 545 U.S. at 418; see also Reiter v. Cooper, 507 U.S.
258, 267 (1993) (declining to permit the “odd result” that
CLOER v. HHS 10

the accrual of a federal cause of action and the start of the
limitations period arise at different times without “any
such indication in the statute”).
The Vaccine Act divides vaccine-related injuries into
two types—those which appear in the Vaccine Injury
Table (“Table injuries”) and those that do not (“non-Table
injuries”). See 42 U.S.C. § 300aa-11(c)(1)(C). The same
limitations period applies to both Table and non-Table
injuries. See id. § 300aa-16(a)(2). For Table injuries,
there is no need for the petitioner to establish causation
because causation is presumed for injuries listed in the
Table. 42 U.S.C. § 300aa-11(c)(1)(C)(i). But where, as
here, a claimant seeks compensation for a “vaccine-
related injury” not listed in the Table, the petition must
contain, among other things, “an affidavit, and supporting
documentation, demonstrating that the person who
suffered such injury . . . sustained, or had significantly
aggravated, any illness, disability, injury, or condi-
tion . . . which was caused by a vaccine.” Id. § 300aa-
11(c)(1)(C)(ii) (emphasis added). A claimant’s cause of
action does not accrue until the time at which the claim
becomes enforceable. 6 Claims under the Vaccine Act
become enforceable, or accrue, only when a claimant can
file a petition demonstrating that the alleged injury was
“caused by a vaccine.” Id. §§ 300aa-11(a), (c). The legisla-
tive history makes clear that this requirement is not
satisfied by a mere allegation that the injury was caused
by the vaccine, i.e., the usual pleading standard. Instead,
“evidence in the form of scientific studies or expert medi-
cal testimony is necessary.” H.R. Rep. No. 99-908, at 15
(1986). Thus, in order for the limitations period to com-
mence, the claimant must be able to file a petition. And

6 To “accrue” in the sense of a cause of action means
“[t]o come into existence as an enforceable claim or right.”
Black’s Law Dictionary 23 (9th ed. 2009).
11 CLOER v. HHS

in order to file a petition, the claimant must demonstrate
a causal connection between the vaccine and the injury
using “scientific studies or expert medical testimony.” See
id. As a result, the limitations period cannot begin to run
until “scientific studies or expert medical testimony”
demonstrating a possible connection between the vaccine
and the injury are known or should be known to the
claimant.
The majority urges that a discovery rule would make
“the otherwise neutral 36 month time limit . . . vary from
petitioner to petitioner,” Maj. Op. at 35, and thus under-
mine this court’s decision in Markovich that the statute of
limitations begins to run at “the first event objectively
recognizable as a sign of a vaccine injury by the medical
profession at large,” 477 F.3d at 1360. Under a discovery
rule, however, the statute of limitations is triggered when
the claimant knew or should have known that an injury
was vaccine related. Though a claimant’s subjective
knowledge is certainly sufficient to trigger the statute of
limitations, Markovich makes clear that subjective
knowledge is not required.
The remedial nature of the Vaccine Act also supports
a discovery rule. The Supreme Court has long recognized
the canon of construction that remedial legislation should
be construed liberally. See, e.g., Atchison, Topeka &
Santa Fe Ry. Co. v. Buell, 480 U.S. 557, 561–62 (1987);
Peyton v. Rowe, 391 U.S. 54, 65 (1968); Cosmopolitan
Shipping Co. v. McAllister, 337 U.S. 783, 790 (1949);
Stewart v. Kahn, 78 U.S. 493, 504 (1870). The Vaccine
Act, which created “a new system for compensating indi-
viduals who have been injured by vaccines,” H.R. Rep. No.
99-908, at 3, clearly falls into the category of remedial
legislation. The Vaccine Act’s compensation program was
intended to be a “program under which awards [could] be
made to vaccine-injured persons quickly, easily, and with
CLOER v. HHS 12

certainty and generosity.” Id. (emphasis added). It was
“designed to work faster and with greater ease than the
civil tort system.” Shalala v. Whitecotton, 514 U.S. 268,
269 (1995) (citing H.R. Rep. No. 99-908, at 3–7). Thus, it
is clear from the legislative history that Congress in-
tended the Vaccine Act’s compensation program to be
more generous than the civil tort system. 7

7 Developments in the past few years have demon-
strated the importance of the right to sue for non-Table
injuries. The Secretary has revised the Vaccine Injury
Table to add only four vaccine-related injuries since the
Vaccine Act was enacted in 1986. See National Vaccine
Injury Compensation Program Revision of the Vaccine
Injury Table, 60 Fed. Reg. 7678, 7694 (Feb. 8, 1995)
(adding “Chronic arthritis” as an injury associated with
the MMR vaccine); National Vaccine Injury Compensation
Program: Revisions and Additions to the Vaccine Injury
Table—II, 62 Fed. Reg. 7685, 7688 (Feb. 20, 1997) (adding
“Brachial neuritis” as an injury associated with the DTP
vaccine, “Thrombocytopenic purpura” and “vaccine-strain
measles virus infection” as injuries associated with the
MMR vaccine, and “vaccine-strain poliovirus infection” as
an injury associated with the live poliovirus vaccine);
National Vaccine Injury Compensation Program: Revi-
sions and Additions to the Vaccine Injury Table, 67 Fed.
Reg. 48558, 48559–60 (Jul. 25, 2002) (adding “intussus-
ception” as an injury associated with the live, oral,
rhesus-based rotavirus vaccine). In each case, the Secre-
tary noted that the addition of a particular injury is
appropriate only where it “can reasonably be deter-
mined . . . to be caused . . . by certain vaccines.” 62 Fed.
Reg. at 7685; see also 67 Fed. Reg. at 48558 (stating that
the proposed revisions were “based upon the Secretary’s
determination that the [injury] can reasonably be deter-
mined in some circumstances to be caused by [a specific
vaccine]”); 60 Fed. Reg. at 7681 (declining to add certain
injuries allegedly related to the DTP vaccine because the
Secretary “could not ‘reasonably determine’ that a causal
connection exists”). Additionally, the Secretary has stated
that the addition of an injury to the Vaccine Injury Table
13 CLOER v. HHS

At the time the Vaccine Act was enacted, a large
number of states recognized a discovery rule under which
the limitations period did not begin to run until the
plaintiff knew or should have known of both the injury
and its cause. 8 Thus, in these states, the statute of limi-

is inappropriate “[w]here [the] scientific research concern-
ing the relationship between a disorder and a vaccine is
incomplete or nonexistent.” 62 Fed. Reg. at 7686.
8 See, e.g., Anson v. Am. Motors Corp., 747 P.2d
581, 584 (Ariz. Ct. App. 1987) (holding that “a cause of
action does not ‘accrue’ until a plaintiff discovers or by the
exercise of reasonable diligence should have discovered
that he or she has been injured by the defendant's negli-
gent conduct”); Yamaguchi v. Queen’s Med. Ctr., 648 P.2d
689, 693 (Haw. 1982) (same); Barnes v. A.H. Robins Co.,
476 N.E.2d 84, 87–88 (Ind. 1985) (same); Louisville Trust
Co. v. Johns-Manville Prods. Corp., 580 S.W.2d 497, 501
(Ky. 1979) (same); Penn v. Inferno Mfg. Corp., 199 So.2d
210, 219 (La. Ct. App. 1967) (same); Baysinger v. Schmid
Prods. Co., 514 A.2d 1, 3–4 (Md. 1986) (same); Olsen v.
Bell Tel. Labs., Inc., 445 N.E.2d 609, 611–12 (Mass. 1983)
(same); Cullender v. BASF Wyandotte Corp., 381 N.W.2d
737, 739 (Mich. Ct. App. 1985) (same); Ahearn v. Lafayette
Pharmacal, Inc., 729 S.W.2d 501, 503–504 (Mo. Ct. App.
1987) (same); Thompson v. Neb. Mobile Homes Corp., 647
P.2d 334, 338 (Mont. 1982) (noting that statute of limita-
tions begins to run on products liability claims when the
plaintiff knew or should have known of both the injury
and the defect); Vispisiano v. Ashland Chem. Co., 527
A.2d 66, 71–72 (N.J. 1987) (holding that the statute of
limitations begins to run when the plaintiff knew or
should have known of both the injury and its cause);
O’Stricker v. Jim Walter Corp., 447 N.E.2d 727, 732 (Ohio
1983) (same); Daugherty v. Farmers Coop. Ass’n, 689 P.2d
947, 950–51 (Okla. 1984) (same); Burnside v. Abbott
Labs., 505 A.2d 973, 987–88 (Pa. Super. Ct. 1985) (same);
Woods v. Sherwin-Williams Co., 666 S.W.2d 77, 78–79
(Tenn. Ct. App. 1983) (same); Olson v. A.H. Robins Co.,
696 P.2d 1294, 1298–99 (Wyo. 1985) (same).
CLOER v. HHS 14

tations on a vaccine-injury claim would not run until the
claimant knew or should have known that there was a
causal connection between the alleged injury and the
vaccine. Under the majority’s reading of the limitations
provision, however, the Vaccine Act may be far less gen-
erous than the remedy afforded by the civil tort system,
which generally applies a discovery rule to injuries like
the ones at issue here. A claimant who is legitimately
injured by a vaccine will nonetheless be barred from filing
a petition simply because science has not advanced
enough prior to the end of the three-year period following
his or her first symptom to furnish a reason to suspect a
connection between the injury and the vaccine. This
simply cannot be the result intended by Congress when it
set out to establish a “program under which awards
[could] be made to vaccine-injured persons . . . with cer-
tainty and generosity.” H.R. Rep. No. 99-908, at 3.
In any event, it seems quite unlikely that Congress
intended the Vaccine Act’s statute of limitations to effec-
tively bar more generous state remedies that utilize a
discovery rule, but that is also the effect of the majority’s
decision. The Vaccine Act was not intended to bar state
remedies, but to provide an additional system for vaccine
injury compensation which would “lessen the number of
lawsuits against manufacturers.” H.R. Rep. No. 99-908,
at 12 (1986). This was accomplished by “requir[ing] that
a person with an injury resulting from a vaccine . . . file a
compensation petition and go through the compensation
program before proceeding with any litigation against the
manufacturer.” Id. Congress’ intent to preserve state law
remedies is clearly expressed in § 300aa-16(c) of the
Vaccine Act, which provides for a stay of state limitations
periods when a petition for compensation is filed under
the Vaccine Injury Compensation Program. See 42 U.S.C.
§ 300aa-16(c). But in states that recognize a discovery
15 CLOER v. HHS

rule, that remedy is likely unavailable under the major-
ity’s view.
The Vaccine Act plainly requires that a claimant seek
a remedy from the Vaccine Injury Compensation Program
before attempting to pursue state law claims. See 42
U.S.C. § 300aa-11(a)(2); H.R. Rep. No. 99-908, at 14
(stating that claimants “must complete the compensation
proceeding . . . before pursuing a civil action”); see also
Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068, 1075 (2011).
Where the claimant does not do so, the Act requires that
the suit be dismissed by the state court. 42 U.S.C.
§ 300aa-11(a)(2)(B); see also H.R. Rep. No. 99-908, at 14.
But the remedies available under the Vaccine Act are
barred by the majority’s view if more than thirty-six
months have passed since the claimant’s first symptom or
manifestation of the injury. Thus, without the benefit of a
discovery rule under the Vaccine Act, the claimant will be
barred from filing a federal petition even though the state
statute of limitations incorporating a discovery rule will
not have run. The apparent result is that the state rem-
edy will be barred for failure to file a petition under the
Vaccine Act. It is incredible to think that the Vaccine Act
was intended to foreclose the very state law remedies that
it was designed to preserve and augment. 9
In the end, there is nothing in the structure or history
of the Vaccine Act that renders a discovery rule inappro-
priate. In fact, the structure and history of the Act not

9 The majority makes the strange argument that
the failure of the Vaccine Act to tie the limitations period
to “occurrence of the injury,” as do state discovery stat-
utes, somehow manifests a rejection of the discovery rule.
Maj. Op. at 32. The fact that Congress chose to be more
explicit about the discovery rule than state statutes
hardly reflects a different policy choice.
CLOER v. HHS 16

only confirm, but compel the conclusion that a discovery
rule is appropriate. 10 Failure to adopt a discovery rule
will create a situation in which a claimant will be unfairly
barred from filing a petition even if he or she never knows
or has reason to know that a claim exists. Contrary to the
majority’s assertion, a discovery rule does not result in
disparate treatment of similarly situated claimants, but
ensures equitable treatment of all claimants.
II
The injustice of the majority’s approach is amply
demonstrated by the circumstances in this case. In Dr.
Cloer’s case, there is no dispute that the first symptom or

10 The majority’s sole structural argument is based
on the fact that a discovery rule would provide claimants
like Dr. Cloer with a more generous limitations period
than that provided for claimants seeking compensation
when a new injury is added to the Vaccine Injury Table.
The majority asserts that it would be incongruous for
claimants asserting non-Table injuries to “enjoy a more
generous statute of limitations than . . . Table Injury
petitioners, for whom causation is presumed.” Maj. Op. at
23. But the different treatment of the statute of limita-
tions for Table and non-Table injuries makes eminent
sense. Claimants asserting Table injuries have construc-
tive notice of the vaccine-related nature of their injuries.
Claimants asserting non-Table injuries, however, have no
such notice. Based on the standards espoused by the
Secretary, an injury may be added to the Vaccine Injury
Table only where there is sufficient evidence to support a
determination that the injury is caused by a certain
vaccine. See supra note 7. If evidence of a causal connec-
tion has not advanced to that point, claimants will not
have the benefit of constructive notice or any presumption
of causation. In those circumstances, it is not at all
incongruous that the statute of limitations should not
begin to run until the claimant knew or should have
known that the injury is vaccine-related.
17 CLOER v. HHS

manifestation of injury occurred in May 1997 when she
experienced a Lhermitte sign, which is recognized by the
medical profession as a common symptom of MS. The
government has submitted no evidence, however, that Dr.
Cloer had reason to suspect a connection between multi-
ple sclerosis (“MS”) and the Hepatitis B vaccine before
2004. Under the majority’s reading of the Act, the limita-
tions period on Dr. Cloer’s claim began running on the
date of her first symptom of MS, which occurred more
than four years before her cause of action accrued. There
is simply no indication that Congress intended that the
limitations period begin before she had the information
necessary to file a petition.