McKeage v. Secretary of Health and Human Services

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 24-1752V UNPUBLISHED

ADRIANNA MCKEAGE, Chief Special Master Corcoran Petitioner,

v. Filed: June 18, 2025

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

Bijan Esfandiari, Wisner Baum LLP, Los Angeles, CA, for Petitioner. Heather L. Pearlman, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION1

On October 25, 2024, Adrianna McKeage filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa—10 through 34 (the “Vaccine Act”). Petitioner alleges that she suffered various injuries from human papillomavirus (“HPV”) vaccinations she received on July 25, 2011, October 4, 2011, and April 3, 2018. 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 HPV vaccinations on July 25, 2011, October 4, 2011, and April 3, 2018. ECF No. 1 at 2. Within ten weeks of the October 4, 2011 vaccination, Petitioner experienced rapid heart rate, chest pains,

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.

dizziness, headaches, lightheadedness, and intolerance to heat. ECF No. 1 ¶ 5. Petitioner was later diagnosed with dysautonomia. Id. ¶ 6.

Facially, Petitioner’s claim herein was filed nearly six years after the most recent HPV dose, which was administered in April 2018, and over twelve years from the time she began manifesting symptoms around the beginning of 2012. But Petitioner maintains her delay is excusable. Petitioner stated at the time these vaccinations occurred, no one discussed the possible adverse side effects of the HPV vaccine, no Vaccine Information Statement (VIS) was provided, and no information was relayed about the Vaccine Program. Exhibit 1 ¶ 4. Petitioner stated that she only learned about the Vaccine Program in April 2023. Exhibit 3 ¶ 8.

Relevant Procedural History

On December 3, 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. 7. 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 January 2, 2025, Petitioner filed a response. ECF No. 8. Petitioner did not dispute the onset of symptoms in 2012, 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. 8 at 19. Relatedly, Petitioner argued that the failure of a healthcare professional to provide her 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

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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”).

In K.G., 951 F.3d at 1380–82 (Fed. Cir. 2020), the Circuit more explicitly endorsed the proposition that an individual’s demonstrated mental incapacity could be a basis for equitable tolling in the Program. For a mentally incapacitated individual, the Circuit instructed that the details of the individual’s relationship with her legal guardian would affect whether there was reasonable diligence or extraordinary circumstances. K.G., 951 F.3d at 1382 (Fed. Cir. 2020). More recently, the Circuit concluded that a parent acting as a legal guardian did not have extraordinary circumstances preventing the filing of a petition where the parent: (1) routinely made medical decisions on behalf of the legally incapacitated individual during the relevant time period, (2) had no documented strained relationship with the individual, and (3) had no conflicts of interest dissuading the parent from filing a petition. W.J. v. Sec'y of Health & Hum. Servs., 93 F.4th 1228, 1241 (Fed. Cir. 2024).

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.

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A) Diligent pursuit

Petitioner was fourteen years old when she received the first two HPV vaccinations in 2011 and was twenty years old when she received the third HPV vaccination in 2018. Petitioner argues that she was impeded by the failure of the vaccine administrators to provide her with a VIS or any other information about the Vaccine Program at the vaccination appointments. Petitioner admits that she only learned of the Vaccine Program in April 2023 and then began to diligently pursue her vaccine claim.

The argument about the vaccine administrators’ failure to provide a VIS or any other information about the Vaccine Program is 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. 8 at 19. 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.3 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

3 The HPV vaccine was first added to the Table in 2007. 42 C.F.R. § 100.3 (Vaccine Injury Table);

National Vaccine Injury Compensation Program: Addition of Meningococcal and Human Papillomavirus (HPV) Vaccines to the Vaccine Injury Table, 72 Fed. Reg. 19937 (Apr. 20, 2007).

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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 2011 or 2018, 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.

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

4 As noted above, Petitioner has not filed any medical records, let alone the vaccination records, that would

permit a factual evaluation of whether a VIS was provided to Petitioner at any of the vaccination appointments.

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.”