Donahue v. Secretary of Health and Human Services

CourtUnited States Court of Federal Claims
DecidedNovember 12, 2025
Docket21-2144V
StatusUnpublished

This text of Donahue v. Secretary of Health and Human Services (Donahue v. Secretary of Health and Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Donahue v. Secretary of Health and Human Services, (uscfc 2025).

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 21-2144V

KAREN DONAHUE, as executor of ESTATE OF MARY LOU HILVERS, Chief Special Master Corcoran

Petitioner, Filed: October 6, 2025 v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

Konrad Kircher, Kircher Law, Maineville, OH, for Petitioner.

Elizabeth Andray, U.S. Department of Justice, Washington, DC, for Respondent.

DECISION DISMISSING CASE1

On November 8, 2021, Mary Lou Hilvers filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). She alleged that she suffered a left shoulder injury related to vaccine administration (“SIRVA”), a defined Table Injury, which was caused by the influenza (“flu”) vaccine she received on September 17, 2020. Petition at 1, ¶ 2, 25. Additionally, she asserted that she “suffered residual pain and complications from injuries suffered as a result of the negligent administration of the [v]accination for more than six (6) months.” Id. at ¶ 23. On September 8, 2025, Karen Donahue,3 Ms. Hilver’s daughter and executor of

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 section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2018).

3 Any reference to “Petitioner” in this Decision will mean Ms. Donahue. her estate, was substituted as Petitioner after Ms. Hilvers sadly passed away from a condition unrelated to her alleged SIRVA injury. ECF Nos. 33-34.

For the reasons set forth below, I hereby DENY entitlement. Petitioner has provided insufficient proof of severity of injury – a requirement for all Vaccine Act claims. See Section 11(c)(1)(D)(i).4 Accordingly, no version of the claim can succeed, and the matter is appropriately dismissed.

I. Relevant Procedural History

Along with the Petition, Ms. Hilvers filed the affidavit and some of the medical records required under the Vaccine Act. Exs. 1-5, 7-13, ECF No. 1; see Section 11(c). She also filed supporting affidavits from her son and daughter and a statement and curriculum vitae from her orthopedist (Dr. Gallagher). Exs. 5-6, 14 ECF No. 1. Over the subsequent five-month period, Ms. Hilvers filed her remaining medical records and a supplemental affidavit (addressing the basic requirements of Section 11(c)). Exs. 16-19, ECF Nos. 9, 12. On April 25, 2022, the case was activated and assigned to the “Special Processing Unit” (OSM’s adjudicatory system for resolution of cases deemed likely to settle). ECF No. 14.

During the initial July 2022 status telephonic conference, the parties discussed potentially-outstanding medical records and two possible factual issues - related to onset and severity - needing further development while awaiting Respondent’s medical review. Order, issued July 25, 2022, ECF No. 19. On December 2, 2022, Ms. Hilvers provided briefing and additional medical records. Brief of Petitioner (“Brief”), ECF No. 21; Exs. 20- 22, ECF No. 21. On May 25, 2023, Respondent responded, requesting that I dismiss the claim. Response to Petitioner’s Fact Briefing and Respondent’s Rule 4(c) Report (“Opp.”), ECF No. 23.5

On April 5, 2024, I issued an order instructing Ms. Hilvers to provide the preponderant evidence needed to show six-months sequelae to avoid dismissal of the claim. Order to Show Cause at 10-11, ECF No. 42. On December 3, 2024, she filed a response, along with outstanding medical records from treatment in 2020-21 and an updated medical record from a visit in April 2023. Brief in Response to Show Cause Order

4 Petitioner does not allege, nor would the evidence support, either alternative for establishing the severity

requirement: that the alleged injury resulted in death, or “inpatient hospitalization and surgical intervention.” Section 11(c)(1)(D)(ii), (iii). Rather, this case turns on Petitioner’s inability to prove six months of post-onset sequelae.

5 Respondent filed the same document twice, using both the Rule 4(c) Report and Response CM/ECF

events. See ECF Nos. 22-23. I will reference the document filed last, using the CM/ECF event for a response.

2 (“Show Cause Response”), ECF No. 32; Exs. 23-26, ECF No. 31. The matter is now ripe for adjudication.

II. Applicable Legal Standards

Petitioners carry the burden of establishing the matters required in the petition by a preponderance of the evidence. Section 13(a)(1)(A). One such requirement is “documentation demonstrating that [the petitioner]6 ... suffered the residual effects or complications of such [vaccine-related] illness, disability, injury, or condition for more than 6 months after the administration of the vaccine.” Section 11(c)(1)(D)(i); see also Black v. Sec’y of Health & Hum. Servs., 33 Fed. Cl. 546, 550 (1995) (reasoning that the “potential petitioner” must not only make a prima facie case, but clear a jurisdictional threshold, by “submitting supporting documentation which reasonably demonstrates that a special master has jurisdiction to hear the merits of the case”), aff’d, 93 F.3d 781 (Fed. Cir. 1996) (internal citations omitted).

As stated by Congress when amending the Vaccine Act in 1987, the six-month severity requirement was designed “to limit the availability of the compensation system to those individuals who are seriously injured from taking a vaccine.” H.R. REP. 100-391(I), at 699 (1987), reprinted in 1987 U.S.C.C.A.N. 2313–1, 2313–373. The only exception is the alternative added in 2000, a showing that the vaccine injury required inpatient hospitalization and surgical intervention. Children’s Health Act of 2000, Pub. L. No. 106– 310, § 1701, 114 Stat. 1101, 1151 (2000) (codified as amended at 42 U.S.C. § 300aa– 11(c)(1)(D)(iii)). This exception was added to allow compensation in intussusception cases which often required surgical intervention but then resolved in less than six months. Id.

The Act prohibits finding a petition requirement “based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Section 13(a)(1). Medical records must be considered, see Section 13(b)(1), and are generally afforded substantial weight. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Murphy v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 74931, *4 (Fed. Cl. Spec. Mstr.

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