Ruzicka v. Secretary of Health and Human Services
17-0109V
Fed. Cl.Dec 1, 2023Background
- Petitioner Frances Ruzicka filed a Vaccine Act claim alleging the July 29, 2014 Tdap shot caused fibromyalgia and a "post‑vaccination syndrome"; petition filed Jan. 24, 2017.
- Onset: flu‑like symptoms and a severe local reaction within days; treating PCP noted ongoing diffuse pain and diagnosed a "post‑vaccination reaction;" rheumatologist Dr. Denio diagnosed fibromyalgia on Jan. 20, 2015 and opined it was triggered by the Tdap.
- Petitioner’s experts (Dr. Toni Bark and Dr. James Neuenschwander) advanced theories involving aluminum‑induced endoplasmic reticulum (ER) hyperstress, immune overactivation, and small fiber neuropathy (SFN).
- Respondent’s experts (Drs. Aaron Levinson, Carlos Rose, and Lan Zhou) agreed petitioner has fibromyalgia but rejected the causal link to Tdap, found petitioner did not meet criteria for ME/CFS or SFN, and emphasized untreated hypothyroidism and pre‑existing symptoms as alternative explanations.
- Procedural history: extensive expert briefing; respondent recommended denial; Special Master Katherine E. Oler concluded petitioner failed to prove causation and dismissed the petition (Decision dated Nov. 13, 2023).
Issues
| Issue | Ruzicka's Argument | Respondent's Argument | Held |
|---|---|---|---|
| Whether petitioner has established diagnoses (ME/CFS, SFN, fibromyalgia, or "post‑vaccination syndrome") | Ruzicka: doctors and experts diagnosed fibromyalgia; experts also posited ME/CFS and SFN as diagnoses or mechanisms | Respondent: treating records and testing do not support ME/CFS or SFN; fibromyalgia is supported but may predate vaccine; "post‑vaccination syndrome" is undefined | Held: Fibromyalgia is established; ME/CFS and SFN are not proven; "post‑vaccination syndrome" is not a defined, cognizable injury here |
| Althen prong 1 — whether a reliable medical theory links Tdap (or its aluminum adjuvant) to fibromyalgia | Ruzicka: aluminum in Tdap caused ER hyperstress/immune overactivation leading to chronic symptoms (Bark, Neuenschwander) | Respondent: proposed mechanisms are vague, unsupported by literature, implausible for a single low‑dose vaccine exposure; fibromyalgia is not generally autoimmune | Held: Petitioner failed to provide a sound, reliable medical theory establishing that Tdap caused fibromyalgia |
| Althen prong 2 — logical sequence of cause and effect (vaccine → injury) | Ruzicka: temporal proximity plus experts’ opinions that vaccine precipitated immune dysregulation link vaccine to condition | Respondent: treating records, labs (normal ESR/negative ANA), and pre‑existing symptoms undermine a persuasive causal chain; treating physicians’ conclusory notes lack adequate rationale | Held: The record does not preponderantly establish a logical, persuasive causal chain from Tdap to petitioner’s fibromyalgia |
| Althen prong 3 — medically‑acceptable temporal relationship | Ruzicka: symptoms began within 48 hours; experts assert temporality supports causation | Respondent: pathogenesis of fibromyalgia and central sensitization takes longer; petitioner’s prior/ongoing symptoms and untreated hypothyroidism better explain timing | Held: Petitioner failed to show the onset was in a medically acceptable timeframe consistent with her causation theory |
Key Cases Cited
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (articulates three‑prong test for off‑Table vaccine causation)
- Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (expert theory must be sound and reliable)
- Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (medical records and treating physician views are important in Althen prong two analysis)
- Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (petitioner may meet Althen prong one without extensive literature but expert reliability is required)
- Boatmon v. Sec'y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (special masters may require indicia of reliability for expert assertions)
- Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (identifying the injury is a prerequisite to Althen causation analysis)
- Lombardi v. Sec'y of Health & Human Servs., 656 F.3d 1343 (Fed. Cir. 2011) (special master should determine the injury supported by the record before Althen)
- Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are given substantial weight)
- LaLonde v. Sec'y of Health & Human Servs., 110 Fed. Cl. 184 (Ct. Cl. 2013) (possible explanations for inconsistencies between records and later testimony)