VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_23-vv-01494
Package ID: USCOURTS-cofc-1_23-vv-01494
Petitioner: Andrea Mae Warren
Filed: 2024-04-24
Decided: 2024-05-21
Vaccine: HPV
Vaccination date: 2008-05-28
Condition: postural orthostatic tachycardia syndrome (POTS)
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Andrea Mae Warren filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging she suffered injuries due to an HPV vaccine received on May 28, 2008. She was twenty-four years old at the time of vaccination. The petition was filed on April 24, 2024, over fifteen years after the vaccination and several years after her symptoms began to progress. Petitioner stated her injuries progressed in the years following the vaccination, and she was diagnosed with postural orthostatic tachycardia syndrome (POTS) in June 2020, describing her symptoms as chronic by September 2020. The court noted a significant gap in medical records between the 2008 vaccination and a January 2019 appointment. The primary issue was the timeliness of the filing, as the petition was filed outside the 36-month statute of limitations. Petitioner argued for equitable tolling, claiming she did not receive a Vaccine Information Statement (VIS) at the time of vaccination and only learned of potential adverse effects and the Vaccine Program in September 2020. The court found these arguments unpersuasive, stating that the statute of limitations accrues upon symptom onset, not upon discovery of a potential claim, and that failure to provide a VIS does not support equitable tolling. Petitioner's arguments regarding manufacturer misconduct were also dismissed as speculative and irrelevant to the causation standards of the Vaccine Act. The court concluded that Petitioner failed to establish both diligent pursuit of her rights and extraordinary circumstances necessary for equitable tolling. Consequently, the case was dismissed as untimely filed.

Theory of causation field:
unclear

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_23-vv-01494-0
Date issued/filed: 2024-05-21
Pages: 6
Docket text: PUBLIC DECISION (Originally filed: 4/24/2024) regarding 16 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (abs) Service on parties made.
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Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 1 of 6
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 23-1494V
UNPUBLISHED
ANDREA MAE WARREN,
Chief Special Master Corcoran
Petitioner,
v.
Filed: April 24, 2024
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Robert M. Hatch, Bronster Fujichaku Robbins, Honolulu, HI, for Petitioner.
Julia M. Collison, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION1
On August 29, 2023, Andrea Mae Warren filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa—10 through 342
(the “Vaccine Act”). Petitioner alleges that she suffered various injuries due to a human
papillomavirus (“HPV”) vaccine she received on May 28, 2008. ECF No. 1 at 2.
Because the petition was untimely filed, and Petitioner has failed to establish a
basis for equitable tolling, this case is DISMISSED.
Relevant Factual Background
Petitioner stated she received an HPV vaccination on May 28, 2008, when she
was twenty-four years old. ECF No. 1. Petitioner has not submitted the administration
records to establish this vaccination or even a vaccination history. The oldest medical
1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made
publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or
at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government
Services). This means the Decision will be available to anyone with access to the internet. In
accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other
information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I
agree that the identified material fits within this definition, I will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “Sec.” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 2 of 6
records submitted by Petitioner is a January 14, 2019 appointment, an almost eleven
year gap in Petitioner’s medical history. Exhibit 1 at 22.
Petitioner stated that her (unspecified) injuries “progressed in the subsequent
years.” ECF No. 1 ¶ 5. Petitioner appears to have been diagnosed by her cardiologist
with postural orthostatic tachycardia syndrome (“POTS”) in June 2020 but has not filed
the cardiology records. Exhibit 2 at 31, 39. In September 2020, Petitioner described her
POTS symptoms as chronic. ECF No. 1 ¶ 7.
Petitioner alleged the preceding medical history in the petition and repeated the
history in her response to the order to show cause. Facially, Petitioner’s claim herein was
filed over fifteen years after her last HPV dose, which was administered in 2008, and
several years after she began manifesting symptoms.3 But Petitioner maintains her delay
is excusable. Thus, in an affidavit dated November 2023, Petitioner has attested that, at
the time this vaccination occurred, no Vaccine Information Statement (VIS) was provided
and no information was relayed about the Vaccine Program. ECF No. 11 at 21, ¶ 4.
Petitioner only learned that the HPV vaccine might be capable of causing adverse effects
in September 2020. Id. at 22, ¶ 6.
Relevant Procedural History
Given that the timeliness of the claim was legitimately called into question merely
by the face of the actual Petition, while the case was still in the initial “pre-assignment
review” (a process utilized by the Office of Special Masters to assess whether a claim’s
primary evidentiary documentation has been filed), I ordered Petitioner to show cause
why the claim had not been filed outside the Act’s 36-month statute of limitations. Sec.
16(a)(2); ECF No. 7.
On November 20, 2023, Petitioner filed a response. ECF No. 11. Petitioner did not
dispute that the onset of symptoms occurred more than three years before the petition
was filed in 2023, but instead argued that the limitations period should be equitably tolled.
Petitioner asserted that she had diligently pursued her rights once she realized the
connection between her injuries and the HPV vaccine and became aware of the Vaccine
Program. Petitioner also made allegations not relevant to a Vaccine Act claim, about the
perfidious conduct of the vaccine manufacturer in fraudulently concealing the HPV
vaccine’s harmful character from the public. ECF No. 11 at 17. Relatedly, Petitioner
argued that the failure of a healthcare professional to provide her with a VIS at the time
3 As noted in the order to show cause, ECF No. 7, because Petitioner described her symptoms as
“chronic” by September 2020 and that her symptoms had progressed over years, I understand the onset
of these symptoms to have occurred years before 2020. Petitioner did not contradict this understanding in
her response to the order to show cause and did provide any further detail about the onset of her
symptoms. ECF No. 11.
2

Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 3 of 6
of vaccination can be attributed to the Department of Health and Human Services’ failure
to systematically ensure that VIS are provided and explained to all vaccine recipients. Id.
at 3.
On January 10, 2024, Respondent submitted a responsive brief of his own, arguing
for dismissal due to untimeliness. ECF No. 13. Respondent maintained that Petitioner in
fact had not diligently pursued her rights before filing a vaccine claim in 2023. Respondent
also disputed the veracity of contentions about the manufacturer’s conduct, and whether
it could in any event constitute an extraordinary circumstance that would serve as a basis
for tolling of the statute.
On January 24, 2024, Petitioner filed a reply to Respondent’s arguments. ECF No.
15. The reply generally reiterates Petitioner’s prior arguments.
Legal Standards
The Vaccine Act's statute of limitations is thirty-six months. Sec. 16(a)(2). The
statute begins to run from the manifestation of the first objectively cognizable symptom,
whether or not that symptom is sufficient for diagnosis (or even recognized by a claimant
as significant). Id.; Carson v. Sec'y of Health & Hum. Servs., 727 F.3d 1365, 1369 (Fed.
Cir. 2013).
The Federal Circuit has held that the doctrine of equitable tolling can apply to
Vaccine Act’s statute of limitations. See Cloer v. Sec'y of Health & Hum. Servs., 654 F.3d
1322, 1340-41 (Fed. Cir. 2011). However, in keeping with applicable U.S. Supreme Court
precedent, equitable tolling of a limitations period is to be permitted “sparingly.” Irwin v.
Dep't of Veterans Affairs, 498 U.S. 89, 96, (1990). The appropriateness of equitable tolling
is ultimately to be determined on a case-by-case basis, without rigid application of any
relevant overarching guidelines. Holland v. Florida, 560 U.S. 631, 649–50 (2010); accord
Arctic Slope Native Ass'n v. Sebelius, 699 F.3d 1289, 1295 (Fed. Cir. 2012).
Petitioners must prove two elements to establish equitable tolling: (1) that
petitioner diligently pursued her rights, and (2) an extraordinary circumstance prevented
her from timely filing the claim. K.G. v. Sec'y of Health & Hum. Servs., 951 F.3d 1374,
1379 (Fed. Cir. 2020) (citing Menominee Indian Tribe v. United States, 577 U.S. 250, 255
(2016)). When first articulating this limited exception to equitable tolling, the Federal
Circuit primarily enumerated fraud and duress—but not, for example, lack of awareness
on a petitioner's part that she might have an actionable claim. Cloer, 654 F.3d at 1344–
45 (noting that tolling of the Vaccine Act's statute of limitations period is not triggered “due
to unawareness of a causal link between an injury and administration of a vaccine”).
3

Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 4 of 6
Analysis
The untimeliness of this filing is acknowledged by Petitioner, so the only question
to be resolved is whether equitable tolling should save the claim. But Petitioner has failed
to establish both elements of equitable tolling – diligent pursuit and extraordinary
circumstances.
A) Diligent pursuit
Petitioner was twenty-four years old when she received an HPV vaccination in
2008. Petitioner argues that she was impeded by the failure of the vaccine administrator
to provide her with a VIS or any other information about the Vaccine Program. Petitioner
only began to diligently pursue a vaccine claim after she learned that the HPV vaccine
had potential adverse effects in September 2020.
These arguments are wholly unpersuasive. It is beyond question that claims
asserted in the Vaccine Program are not subject to a “discovery rule,” accruing only when
a claimant learns he or she might possess a cause of action. Rather, the statute of
limitations period is triggered by the onset of Petitioner’s symptoms – whether or not onset
was understood to be the start of the claimed injurious illness or condition. Cloer v. Sec'y
of Health & Hum. Servs., 654 F.3d 1322, 1340 (Fed. Cir. 2011) (en banc). And the failure
to be advised of the Vaccine Program or the Act does not support equitable tolling of the
statute of limitations period for an otherwise-untimely filed petition. Speights v. Sec'y of
Health & Hum. Servs., No. 03-2619V, 2013 WL 5944084, at *13 (Fed. Cl. Spec. Mstr.
Oct. 17, 2013). Thus, a petitioner cannot generally shield an untimely claim from dismissal
by asserting, even in good faith, that she literally was unaware of her Vaccine Act “rights.”
B) Extraordinary Circumstances
Petitioner’s arguments about the purported fraudulent conduct of the vaccine’s
manufacturer, in hiding proof of the vaccine’s dangers, deserve even less consideration.
ECF No. 11 at 17. As a threshold matter, these contentions are speculative and not
evidentiarily-supported. And regardless of their actual truth, the fact remains that the
Government has approved the HPV vaccine for administration to minors, rendering it
“covered” under the Act. The only issue to be resolved in a Program case is whether
(assuming, as here, the claim is not a Table claim) the claim meets the standards for
causation – and those standards have nothing to do with a manufacturer’s alleged
misconduct in preparation or promotion of the underlying vaccine.
These allegations also are not a basis for tolling under the circumstances.
Petitioner simply has not shown that contentions of corporate misconduct not specific to,
or directed at, her personally could rise to the level of the kind of “fraud” that might excuse
4

Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 5 of 6
failing to file a Program claim in a timely manner. Nor has she persuasively established
that the vaccine administrator’s “failure to warn,” or provide a VIS in 2008, is an
extraordinary circumstance. Even assuming the factual accuracy of that allegation,4 it
remains the case (as the Circuit recognized in Cloer) that vaccine claims accrue upon
onset – and that the failure to be advised of the Vaccine Program does not support
equitable tolling. Cloer, 654 F.3d at 1340; see also Speights, 2013 WL 5944084, at *13.
And arguments about governmental agency knowledge of a failure to warn reflect
overheated, almost-conspiratorial allegations that do not come close to excusing the
claim’s untimely nature.
Finally, Petitioner also asserts that the safety of the HPV vaccine is “in dispute
[and] the Court should not simply accept the assertions of the Respondent over those of
the Petitioner without further proceedings including expert testimony on the subject.” No.
15 at 2. But this argument willfully ignores the extent to which I have personally ruled in
numerous prior cases that medical science does not preponderantly support the
contention that the HPV vaccine can cause POTS or other autonomic issues. See, e.g.,
J.S. v. Sec'y of Health & Hum. Servs., No. 16-1083V, 2022 WL 20213038, at *20 (Fed.
Cl. Spec. Mstr. July 15, 2022), mot. for review denied, 164 Fed. Cl. 314 (2023), appeal
docketed, No. 23-1644 (Fed. Cir. Mar. 22, 2023); Hughes v. Sec'y of Health & Hum.
Servs., No. 16-930V, 2021 WL 839092, at *31 (Fed. Cl. Spec. Mstr. Jan. 4, 2021), mot.
for review denied, 154 Fed. Cl. 640 (2021); E.S. v. Sec'y of Health & Hum. Servs., No.
17-480V, 2020 WL 9076620, at *40, 43 (Fed. Cl. Spec. Mstr. Nov. 13, 2020), mot. for
review denied, 154 Fed. Cl. 149 (2021); McKown v. Sec'y of Health & Hum. Servs., No.
15-1451V, 2019 WL 4072113, at *44–45 (Fed. Cl. Spec. Mstr. July 15, 2019). The Act
does not require that the same theory rejected so many times before must be relitigated
by the Program ad infinitum (especially in the absence of new compelling evidence).
Rather, special masters are expressly empowered to rely on their expertise, earned in
adjudicating Program cases, in subsequent similar matters. To suggest that they should
ignore what they have learned in that process reveals a complete miscomprehension of
the Program’s underlying goals and purposes.
4 Vaccine administration records typically state whether VIS are provided to patients and/or whether
patients have been counseled about the vaccine. As noted above, Petitioner has not submitted a vaccine
administration record or vaccination history to establish the HPV vaccination. Thus, Petitioner has not
submitted any contemporaneous medical records of the vaccination to determine whether a VIS was
provided to her. Petitioner’s only evidence that no VIS or information about the Vaccine Program was
provided is her affidavit dated November 2023, in which she attested about events that occurred over fifteen
years earlier. ECF No. 11 at 21, ¶ 4.
5

Case 1:23-vv-01494-UNJ Document 17 Filed 05/21/24 Page 6 of 6
Conclusion
Thus, Petitioner has failed to establish equitable tolling. This case is dismissed
for being untimely filed. The Clerk of Court shall enter judgment accordingly.5
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
5 If Petitioner wishes to bring a civil action, she must file a notice of election rejecting the judgment pursuant
to § 21(a) “not later than 90 days after the date of the court’s final judgment.”
6