Olson v. Secretary of Health and Human Services
13-439
| Fed. Cl. | Jan 5, 2018Background
- Petitioner Carolynne Olson received the HPV (Gardasil) vaccine on July 1, 2010 and alleges it caused her to develop seronegative rheumatoid arthritis (RA).
- Petitioner reported joint symptoms months after vaccination and was evaluated by rheumatologists; laboratory testing was repeatedly negative for rheumatoid factor and anti-citrullinated protein antibodies (ACPAs).
- Petitioner’s experts (a treating rheumatologist and an epidemiologist) advanced a theory that alum adjuvant in the vaccine triggered inflammasome-mediated cytokine activity in a patient with chronic lung inflammation, initiating a citrullination-related pathway to RA.
- The Special Master denied compensation under the Vaccine Act, finding Petitioner failed to prove Althen prongs: (1) a reliable medical theory specific to this case, (2) a logical sequence linking vaccine to injury, and (3) appropriate temporal relationship.
- The Court of Federal Claims reviewed the Special Master’s decision under the deferential "arbitrary, capricious, abuse of discretion, or otherwise not in accordance with law" standard and denied Petitioner’s motion for review, upholding the Special Master.
Issues
| Issue | Olson's Argument | Secretary's Argument | Held |
|---|---|---|---|
| Whether Petitioner established a medically reliable theory (Althen prong 1) | Alum in Gardasil can trigger inflammasomes → cytokine activation → citrullination/lung-driven RA in a susceptible patient | Petitioner did not present persuasive, reliable, case-specific evidence that alum can cause RA | Court upheld Special Master: theory speculative and insufficiently supported by reliable evidence |
| Whether there is a logical sequence of cause and effect (Althen prong 2) | Temporal proximity plus biological theory is sufficient to link vaccine to RA | Medical records and negative biomarkers (ACPAs, RF) undercut the alleged causal sequence; alternative causes not excluded | Court upheld Special Master: record lacked corroborating signs/tests showing the proposed process occurred in petitioner |
| Whether Special Master raised petitioner’s burden or mischaracterized theory | Special Master misconstrued theory, required improper evidence, and gave undue weight to expert credentials | Special Master properly weighed evidence, noted limits of petitioner’s experts, and articulated reasons for rejecting the theory | Court found no misapprehension or burden-shifting; Special Master’s credibility and evidentiary assessments were permissible and deferentially reviewed |
| Whether timing of symptom onset supports causation (Althen prong 3) | Onset within 1–2 weeks supports causation under petitioner’s trigger theory | Even if temporally consistent, timing cannot salvage an otherwise unpersuasive biological theory | Court affirmed Special Master: timing alone insufficient once prong 1 failed |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (three-prong test for causation in Vaccine Act non‑table cases)
- Moberly ex rel. Moberly v. Sec’y of HHS, 592 F.3d 1315 (Fed. Cir. 2010) (special master may require indicia of reliability for asserted biological mechanisms)
- Hodges v. Sec’y of HHS, 9 F.3d 958 (Fed. Cir. 1993) (deferential standard of review for special masters’ factual findings)
- Porter v. Sec’y of HHS, 663 F.3d 1242 (Fed. Cir. 2011) (credibility determinations of experts are virtually unreviewable)
- Pafford v. Sec’y of HHS, 451 F.3d 1352 (Fed. Cir. 2006) (petitioners must present a reputable medical theory)
- Hines v. Sec’y of HHS, 940 F.2d 1518 (Fed. Cir. 1991) (special master must consider relevant evidence and articulate rational basis for decision)
- Paluck v. Sec’y of HHS, 786 F.3d 1373 (Fed. Cir. 2015) (misapprehension of petitioner’s theory by special master requires reversal)
- Terran v. Sec’y of HHS, 195 F.3d 1302 (Fed. Cir. 1999) (standard for reliability of expert assertions)
- Grant v. Sec'y of HHS, 956 F.2d 1144 (Fed. Cir. 1992) (temporal proximity alone insufficient to establish causation)
- Perreira v. Sec’y of HHS, 33 F.3d 1375 (Fed. Cir. 1994) (weight of treating physician’s opinion depends on underlying rationale)