McCollum v. Secretary of Health and Human Services
14-790
Fed. Cl.Jan 5, 2018Background
- Petitioner Michael McCollum filed a Vaccine Act claim alleging that an influenza (H1N1) vaccination in fall 2011 caused narcolepsy with cataplexy; Special Master denied compensation for lack of causation.
- McCollum had multiple preexisting conditions and prior sleep-related events (including obstructive sleep apnea, obesity, diabetes, prior episodes of falling asleep and an event in 2010 evaluated as possible TIA).
- Direct medical records of the 2011 vaccination were not produced; petitioner relied on circumstantial evidence (wife’s advice, Walgreens practices, a bank purchase) to show vaccination and later testified he received another flu shot in October 2012.
- Neurologic and sleep evaluations between Jan 2012 and 2013 culminated in sleep studies at Stanford showing hypersomnia, OSA, HLA positivity, and a diagnosis including narcolepsy with cataplexy; treatment improved his functioning by May 2013.
- Petitioner proffered Dr. Marcel Kinsbourne; Respondent proffered Dr. Maryanne Deak. Special Master found petitioner failed Althen prong one (a credible, reputable medical theory linking the U.S. unadjuvanted H1N1 vaccine to narcolepsy) and thus denied entitlement.
- Petitioner’s Motion for Review argued (1) the Special Master ignored a challenge–rechallenge theory and (2) the Special Master improperly heightened the Althen prong-one standard; the Court denied review, upholding the Special Master’s rationale.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a challenge–rechallenge supports causation | McCollum: symptoms worsened after a later flu shot (challenge–rechallenge) and that proves causation | HHS: no direct record of either shot; challenge–rechallenge was not argued below and is waived; records do not show a meaningful post-shot worsening | Court: Waived and unsupported; Special Master not required to consider an unraised theory; no remand warranted |
| Whether petitioner satisfied Althen prong one (medically-reliable theory) | McCollum: cites studies linking H1N1/Pandemrix and seasonal increases in narcolepsy; contends established researchers accept a causal link | HHS: U.S. vaccine was unadjuvanted and different from Pandemrix; some studies show no association; epidemiology in U.S. found no link; Special Master permissibly discounted applicability | Court: Special Master reasonably required indicia of reliability; no legal error in applying Althen/Moberly standards; Althen prong one not met |
| Whether Special Master applied an unlawfully stringent standard | McCollum: argues Special Master elevated burden beyond Althen (advocates for Contreras’ less stringent view) | HHS: Special Master applied Federal Circuit precedent requiring indicia of reliability (Moberly, Andreu) | Court: Bound by Federal Circuit precedent; Special Master did not err or elevate burden |
| Whether new literature (post-decision) justified reconsideration/remand | McCollum: submitted retrospective pediatric review suggesting seasonal increase post-2009 H1N1 | HHS: abstract insufficient and does not change balance; prior studies and epidemiology remain unpersuasive for U.S. vaccine | Court: Special Master appropriately rejected the abstract as inadequate to alter the decision |
Key Cases Cited
- Munn v. Secretary of Health & Human Services, 970 F.2d 863 (Fed. Cir.) (arbitrary-and-capricious standard for fact/discretionary review; de novo for legal conclusions)
- Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir.) (three-part test for causation-in-fact in Vaccine Program)
- Capizzano v. Secretary of Health & Human Services, 440 F.3d 1317 (Fed. Cir.) (explains challenge–rechallenge concept)
- Moberly v. Secretary of Health & Human Services, 592 F.3d 1315 (Fed. Cir.) (experts must provide indicia of reliability; special master may require reliable support)
- Porter v. Secretary of Health & Human Services, 663 F.3d 1242 (Fed. Cir.) (special master’s reasoned findings entitled to deference)
- Hines v. Secretary of Health & Human Services, 940 F.2d 1518 (Fed. Cir.) (deference to special master where decision considers evidence and articulates rational basis)
- Lombardi v. Secretary of Health & Human Services, 656 F.3d 1343 (Fed. Cir.) (discusses evaluation of expert proof in vaccine claims)