H.L. v. Hhs
715 Fed. App'x 990
| Fed. Cir. | 2017Background
- A.I., a six-year-old with undiagnosed but later-confirmed preexisting Leigh disease (a mitochondrial disorder), received the live attenuated FluMist® vaccine while experiencing an upper respiratory infection; she developed neurological symptoms days later and died weeks thereafter.
- Petitioner H.L., A.I.’s mother, filed a Vaccine Act petition alleging FluMist, together with the respiratory infection, significantly aggravated A.I.’s Leigh disease leading to metabolic decompensation and death.
- The special master held an evidentiary hearing, found the petitioner’s expert (Dr. Kendall) unpersuasive, and denied compensation under the Althen causation-in-fact framework.
- The Court of Federal Claims affirmed the special master; the petitioner appealed. The Federal Circuit reviewed de novo legal issues and applied the arbitrary-and-capricious standard to the special master’s factual findings.
- The Federal Circuit affirmed: it held the special master’s factual credibility assessments, reliance on the government expert, rejection of post‑marketing insert statements and the cited articles, and temporal-analysis were not arbitrary or capricious, and petitioner failed to prove causation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner proved causation-in-fact under Althen (medical theory and logical sequence) | FluMist plus contemporaneous respiratory infection produced oxidative stress that significantly aggravated Leigh disease and caused decompensation | Medical literature and gov’t expert show decompensation in Leigh is unpredictable, often without identifiable trigger; petitioner’s theory speculative and unsupported by record | Held for defendant: petitioner failed Althen prongs 1–2; special master’s credibility findings not arbitrary or capricious |
| Whether the temporal relationship supported causation (Althen prong 3) | Onset (staring spells hours after vaccination, collapses 11 days later) consistent with vaccine contribution when combined with infection | Symptoms occurred hours (staring spells) to days after vaccination but while infection was resolving; literature supports onset days after infection, making vaccine an unlikely cause | Held for defendant: timing makes vaccination an unlikely explanation; special master’s temporal analysis permissible and not contrary to Paluck |
| Whether post‑marketing vaccine insert and case‑report literature prove causation | Insert and cited articles (e.g., Poling) indicate vaccines can exacerbate mitochondrial conditions and support causation | Insert contains unspecific post‑marketing reports; cited articles discuss different disorders or wild virus effects and do not establish mechanism for attenuated vaccine | Held for defendant: special master reasonably discounted these sources as non‑probative or inapposite |
| Standard of review for factual findings | (Preservation) urged de novo review of facts | Court applies Milik: deferential arbitrary-and-capricious review to special master’s factual findings | Held for defendant: arbitrary-and-capricious standard applies; petitioner cannot overcome deference |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (establishing three‑prong causation‑in‑fact test for off‑table vaccine injuries)
- Milik v. Sec’y of Health & Human Servs., 822 F.3d 1367 (Fed. Cir.) (applying arbitrary‑and‑capricious review to special master factual findings)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (petitioner must show injury was caused by vaccine)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir.) (upholding special master findings so long as not wholly implausible)
- Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir.) (temporal relationship required under Althen prong 3)
- Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir.) (cautioning against rigid temporal cutoffs in mitochondrial disorder cases)
- Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir.) (but‑for causation and contribution standards)
- De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir.) (timing too soon after vaccination can defeat causation)
- Whitecotton v. Sec’y of Health & Human Servs., 81 F.3d 1099 (Fed. Cir.) (Vaccine Act covers significant aggravation of preexisting conditions)