In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 24-1138V UNPUBLISHED
ARIELLE LEWIS, Chief Special Master Corcoran Petitioner, v. Filed: March 12, 2025 SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent.
Bijan Esfandiari, Wisner Baum LLP, Los Angeles, CA, for Petitioner. Julia M. Collison, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION1
On July 25, 2024, Arielle Lewis filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa—10 through 34 (the “Vaccine Act”). Petitioner alleged that she suffered various injuries from human papillomavirus (“HPV”) vaccinations she received on March 17, 2019, May 13, 2019, and October 15, 2019. ECF No. 1 at 2.
Because the petition was untimely filed, and Petitioner has failed to establish a basis for equitable tolling, Respondent’s motion to dismiss is GRANTED and this case is DISMISSED.
Relevant Factual Background
As alleged in the petition2, Petitioner stated that she received the first HPV vaccination on March 17, 2019, and that she experienced increased heart rate and shortness of breath within days of the vaccination. ECF No. 1 ¶¶ 2, 5. Petitioner then received the second HPV vaccination on May 13, 2019, and the third vaccination on 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 Petitioner has not filed any medical records to establish the vaccinations or her injuries. I will assume
the accuracy of the facts in the petition to resolve the motion to dismiss. October 15, 2019. Petitioner stated she received a diagnosis of inappropriate sinus node tachycardia in December 2020 and later received various diagnoses including dysautonomia, small fiber neuropathy, Sjogren’s disease, and postural orthostatic tachycardia syndrome. Id. ¶ 6.
Facially, Petitioner’s claim herein was filed over five years after the first HPV vaccination, which was administered on March 17, 2019, and over five years after she began manifesting symptoms days later. But Petitioner maintains her delay is excusable. Thus, in an affidavit dated August 2, 2024, Petitioner has attested that, at the time these vaccinations occurred, no Vaccine Information Statements (VIS) were provided, and no information was relayed about the Vaccine Program. Exhibit 1 ¶ 4. Petitioner only became aware of the Vaccine Program in August 2023. ECF No. 7, attachment #1, ¶ 8.
Relevant Procedural History
On July 30, 2024, Respondent filed a motion to dismiss arguing that the claim had been filed outside the Vaccine Act’s 36-month statute of limitations, Sec. 16(a)(2). ECF No. 6. Respondent maintained that Petitioner had not diligently pursued her rights before filing a vaccine claim in 2024. 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 the statute of limitations.
On August 12, 2024, Petitioner filed a response. ECF No. 7. Petitioner did not dispute the onset of symptoms in 2019, or that her petition was filed in 2024 (beyond the statute of limitations deadline), 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. 7 at 20. Relatedly, Petitioner argued that the failure of a healthcare professional to provide him with a Vaccine Information Statement at the time 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.
Respondent did not file a reply to Petitioner’s response.
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
2 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”).
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 the first HPV vaccination.
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In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 24-1138V UNPUBLISHED
ARIELLE LEWIS, Chief Special Master Corcoran Petitioner, v. Filed: March 12, 2025 SECRETARY OF HEALTH AND HUMAN SERVICES,
Respondent.
Bijan Esfandiari, Wisner Baum LLP, Los Angeles, CA, for Petitioner. Julia M. Collison, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION1
On July 25, 2024, Arielle Lewis filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa—10 through 34 (the “Vaccine Act”). Petitioner alleged that she suffered various injuries from human papillomavirus (“HPV”) vaccinations she received on March 17, 2019, May 13, 2019, and October 15, 2019. ECF No. 1 at 2.
Because the petition was untimely filed, and Petitioner has failed to establish a basis for equitable tolling, Respondent’s motion to dismiss is GRANTED and this case is DISMISSED.
Relevant Factual Background
As alleged in the petition2, Petitioner stated that she received the first HPV vaccination on March 17, 2019, and that she experienced increased heart rate and shortness of breath within days of the vaccination. ECF No. 1 ¶¶ 2, 5. Petitioner then received the second HPV vaccination on May 13, 2019, and the third vaccination on 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 Petitioner has not filed any medical records to establish the vaccinations or her injuries. I will assume
the accuracy of the facts in the petition to resolve the motion to dismiss. October 15, 2019. Petitioner stated she received a diagnosis of inappropriate sinus node tachycardia in December 2020 and later received various diagnoses including dysautonomia, small fiber neuropathy, Sjogren’s disease, and postural orthostatic tachycardia syndrome. Id. ¶ 6.
Facially, Petitioner’s claim herein was filed over five years after the first HPV vaccination, which was administered on March 17, 2019, and over five years after she began manifesting symptoms days later. But Petitioner maintains her delay is excusable. Thus, in an affidavit dated August 2, 2024, Petitioner has attested that, at the time these vaccinations occurred, no Vaccine Information Statements (VIS) were provided, and no information was relayed about the Vaccine Program. Exhibit 1 ¶ 4. Petitioner only became aware of the Vaccine Program in August 2023. ECF No. 7, attachment #1, ¶ 8.
Relevant Procedural History
On July 30, 2024, Respondent filed a motion to dismiss arguing that the claim had been filed outside the Vaccine Act’s 36-month statute of limitations, Sec. 16(a)(2). ECF No. 6. Respondent maintained that Petitioner had not diligently pursued her rights before filing a vaccine claim in 2024. 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 the statute of limitations.
On August 12, 2024, Petitioner filed a response. ECF No. 7. Petitioner did not dispute the onset of symptoms in 2019, or that her petition was filed in 2024 (beyond the statute of limitations deadline), 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. 7 at 20. Relatedly, Petitioner argued that the failure of a healthcare professional to provide him with a Vaccine Information Statement at the time 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.
Respondent did not file a reply to Petitioner’s response.
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
2 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”).
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 the first HPV vaccination. 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 in August 2023 that she had a legal remedy for potential adverse effects of the HPV vaccine.
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
3 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. 7 at 20. 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, him personally could rise to the level of the kind of “fraud” that might excuse 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 2019, is an extraordinary circumstance. Even assuming the factual accuracy of that allegation, 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.
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.3
IT IS SO ORDERED. s/Brian H. Corcoran
3 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.”
4 Brian H. Corcoran Chief Special Master