McCollum v. Secretary of Health and Human Services, 14-790

Background

Michael McCollum filed a Vaccine Program petition alleging he developed narcolepsy with cataplexy after an influenza (H1N1-containing) vaccination in fall 2011; no contemporaneous vaccination record existed.
Circumstantial evidence (wife’s affidavit, a Walgreens charge on Oct 18, 2011) led the special master to find it more likely than not McCollum received an unadjuvanted injectable H1N1-containing seasonal flu shot in October 2011.
McCollum was ultimately diagnosed with narcolepsy/cataplexy in early 2012 based on clinical presentation and sleep testing (MSLT, later evaluation at Stanford); he was HLA-DQB1*06:02 positive but had no CSF hypocretin testing.
Petitioner’s expert (Dr. Kinsbourne) relied on molecular mimicry literature linking Pandemrix (an adjuvanted European H1N1 vaccine) to narcolepsy and argued NP (nucleoprotein) content could make U.S. vaccines causal; respondent’s expert (Dr. Deak) disputed the diagnosis reliability and the applicability of Pandemrix-focused science to unadjuvanted U.S. vaccines.
The parties submitted competing epidemiologic studies: European Pandemrix-associated studies supporting an association, and Duffy et al. (cohort study of U.S. H1N1 vaccines) finding no increased narcolepsy risk after U.S. vaccines.
After an entitlement hearing, the special master denied compensation, concluding Petitioner failed Althen prong one — insufficient reliable evidence that the unadjuvanted U.S. H1N1 vaccine can cause narcolepsy.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Did Petitioner prove he received the flu vaccine in Oct 2011?	McCollum/ wife testified he was vaccinated at Walgreens shortly after wife’s Sept 2011 hospitalization; bank charge supports timing.	Respondent emphasized lack of contemporaneous vaccination record at Walgreens.	Held: Preponderance met — likely received an unadjuvanted injected H1N1 vaccine on Oct 18, 2011.
Did Petitioner prove a reliable medical theory that the U.S. vaccine caused narcolepsy (Althen prong 1)?	Kinsbourne: molecular mimicry — NP antibodies from H1N1 antigen can cross-react with hypocretin receptor; Pandemrix studies and NP-level comparisons support plausibility for some U.S. formulations.	Deak: Pandemrix/adjuvant context is materially different; U.S. unadjuvanted vaccines lack persuasive evidence; epidemiology (Duffy) shows no U.S. association.	Held: Not satisfied — theory is insufficiently supported for unadjuvanted U.S. vaccine; Althen prong one fails.
Did petitioner establish a logical sequence of cause and effect (Althen prong 2)?	McCollum pointed to temporal onset of symptoms post-vaccination, genotype (HLA-DQB1*06:02), and clinical course consistent with immune-mediated hypocretin loss.	Respondent argued prior sleep complaints and comorbidities (OSA, meds, prior TIA-like event) undermine causation and chronology.	Held: On balance, some factual findings favored petitioner (vaccine receipt, post-vaccine onset), but overall causation-in-fact not established because prong one failed.
Was timing between vaccination and symptom onset medically acceptable (Althen prong 3)?	Petitioner: onset within ~4–6 weeks, consistent with literature on Pandemrix-associated cases.	Respondent: timeframe alone cannot establish causation; prong 3 depends on valid mechanism tying vaccine to disease.	Held: Although timing was plausible, without a reliable causal theory timing alone insufficient; Althen prong three not dispositive.

Key Cases Cited

Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance standard and substantial-factor causation requirement)
Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (expert theory need not be supported by literature but must be reliable)
Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three-pronged test for vaccine causation: theory, logical sequence, temporal relationship)
Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (evaluation of scientific evidence under Vaccine Act standard)
Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867 (Fed. Cir.) (medical certainty not required)
Pafford v. Sec'y of Health & Human Servs., 451 F.3d 1352 (Fed. Cir.) (substantial-factor causation discussion)
Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir.) (Althen prong one requires a sound and reliable medical or scientific explanation)
Cedillo v. Sec'y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir.) (use of Daubert factors in weighing expert evidence)
Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (credibility of experts and relative persuasiveness may determine outcome)
Lampe v. Sec'y of Health & Human Servs., 219 F.3d 1357 (Fed. Cir.) (expert testimony requirement and its evaluation)