Olson v. Secretary of Health and Human Services
13-439
| Fed. Cl. | Aug 23, 2017Background
- Petitioner Carolynne Olson received Gardasil (HPV) vaccine on July 1, 2010 (age 52, off-label use) and reported onset of hand pain/bulging within weeks and knuckle swelling within months.
- Medical records document chronic respiratory disease (asthma, chronic sinusitis; possible bronchiectasis), intermittent prednisone use, and progressive joint symptoms from late 2010 through 2013; she was ultimately diagnosed with seronegative rheumatoid arthritis (RA).
- Petitioner’s treating rheumatologist (Dr. Middleton) opined the vaccine (specifically the alum adjuvant) triggered RA via inflammasome/cytokine upregulation; he relied heavily on temporal proximity and literature about alum and NLRP3 inflammasome activation.
- Respondent’s expert (Dr. Lightfoot) testified the RA was idiopathic, disputed causation, and emphasized absence of key biomarkers (ACPAs, rheumatoid factor), mild clinical course, and lack of evidence that alum at vaccine doses causes RA.
- Petitioner also submitted an epidemiologist (Dr. Mayer) who questioned applicability of population studies to Olson (older, off-label use) but did not provide mechanism-level support linking Gardasil to RA.
- Special Master found temporal association credible but concluded Petitioner failed Althen prongs 1 and 2 (theory and logical sequence), and therefore denied entitlement and dismissed the claim.
Issues
| Issue | Olson's Argument | HHS/Respondent's Argument | Held |
|---|---|---|---|
| Whether Gardasil (alum adjuvant) can cause RA (Althen prong 1) | Alum in vaccine activated NLRP3/inflammasome → cytokine upregulation → triggered autoimmunity in a lung‑susceptible patient | No reliable science shows alum at vaccine doses initiates RA; literature shows adjuvanticity not pathogenicity for RA | Denied — petitioner’s theory not supported by reliable, specific scientific evidence |
| Whether vaccination was the actual cause in this individual (Althen prong 2) | Temporal proximity, preexisting lung disease made Olson susceptible; treating physician supports vaccine causation | Temporal proximity alone is insufficient; lack of biomarkers (ACPAs), lack of inflammatory markers or other corroboration in records | Denied — medical record does not show the proposed pathogenic sequence occurred in Olson |
| Whether timing of onset was medically plausible (Althen prong 3) | Symptoms began within 1–2 weeks of vaccine; analogous latent responses (e.g., MMF) support plausibility | Even if temporally proximate, timing must align with a reliable mechanism—here mechanism not established | Held (timing proved) but insufficient because prongs 1–2 failed; timing alone cannot establish causation |
| Evidentiary weight of treating physician and literature | Dr. Middleton (treater) and cited articles support causation theory | Treating opinions and literature must be reliable and specific; many cited studies are inapposite or animal/other-disease studies | Held: treating opinion and literature given limited weight where mechanism and record corroboration are lacking |
Key Cases Cited
- Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (preponderance standard and substantial-factor causation requirement in Vaccine Program)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (three-prong test for causation in non-Table vaccine claims)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir.) (requirement that vaccine causation theory be a sound and reliable medical/scientific explanation)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir.) (flexible proof for Althen prong one but still subject to preponderance standard)
- Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (weighing credibility of competing experts in Vaccine Program cases)
- Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144 (Fed. Cir.) (temporal proximity alone insufficient to prove causation)