United States Court of Appeals for the Federal Circuit ______________________

VICTORIA LEMING, KEVIN LEMING, PARENTS AND NATURAL GUARDIANS OF A.L., A MINOR, Petitioners-Appellants

v.

SECRETARY OF HEALTH AND HUMAN SER- VICES, Respondent-Appellee ______________________

2023-1032 ______________________

Appeal from the United States Court of Federal Claims in No. 1:18-vv-00232-EDK, Chief Judge Elaine Kaplan. ______________________

Decided: April 15, 2024 ______________________

ROBERT JOEL KRAKOW, I, Law Office of Robert J. Kra- kow, New York, NY, argued for petitioners-appellants.

JULIA COLLISON, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent-appellee. Also represented by ALEXIS B. BAB- COCK, BRIAN M. BOYNTON, C. SALVATORE D'ALESSIO, HEATHER LYNN PEARLMAN. ______________________ Case: 23-1032 Document: 45 Page: 2 Filed: 04/15/2024

2 LEMING v. HHS

Before MOORE, Chief Judge, STOLL, Circuit Judge, and BENCIVENGO, District Judge. 1 BENCIVENGO, District Judge A.L., the daughter of Petitioners-Appellants Victoria and Kevin Leming, experienced immune thrombocytopenic purpura after receiving the DTaP, Hib, and MMR vaccines. As a result of her vaccine injury, she was hospitalized for two weeks and underwent a bone marrow aspiration and biopsy. The Court of Federal Claims held that the Lemings could not establish by a preponderance of the evidence that A.L. satisfied the “surgical intervention” severity require- ment of 42 U.S.C. § 300aa-11(c)(1)(D)(iii). Because the court below relied upon a legally erroneous construction of “surgical intervention,” we reverse and remand. BACKGROUND A In 1986, the National Childhood Vaccine Injury Act (the “Vaccine Act”) was enacted to provide compensation to vaccine recipients who suffered from injury or death caused by a vaccine. See Pub. L. No. 99-660, § 311, 100 Stat. 3743, 3755-84 (codified as amended at 42 U.S.C. §§ 300aa-1 to - 34). The Vaccine Act initially restricted recovery to only those recipients who: (i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 1 year after the administration of the vaccine, (ii) incurred unreimbursable expenses due in whole or in part to such illness, disability, injury, or

1 Honorable Cathy Ann Bencivengo, District Judge, United States District Court for the Southern District of California, sitting by designation. Case: 23-1032 Document: 45 Page: 3 Filed: 04/15/2024

LEMING v. HHS 3

condition in an amount greater than $1,000, or (iii) died from the administration of the vaccine[.] Id. § 311, 100 Stat. at 3761. In 2000, however, this “severity requirement” was amended by the Children’s Health Act, Pub. L. No. 106- 310, 114 Stat. 1101, to require Vaccine Act petitioners prove that the recipient: (i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the admin- istration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suf- fered such illness, disability, injury, or con- dition from the vaccine which resulted in inpatient hospitalization and surgical inter- vention[.] 42 U.S.C. § 300aa-11(c)(1)(D) (emphasis added). The burden is on a petitioner to prove that one of these re- quirements is met by a preponderance