Monzon v. Secretary of Health and Human Services
17-1055
| Fed. Cl. | Jul 1, 2021Background
- Petitioner Rosa Monzon received a Tdap vaccine on April 12, 2016 and developed acute fatigue, arm/neck pain and a deltoid hematoma within days; she sought urgent care within 10 days.
- Initial rheumatology impressions included myalgia and polymyalgia rheumatica (PMR); later (after anti-CCP testing) her treating rheumatologist amended the diagnosis to rheumatoid arthritis (RA).
- Laboratory testing showed elevated inflammatory markers and a high‑titer anti‑CCP antibody (a serologic marker strongly associated with RA); treatment included prednisone and later methotrexate, with eventual remission and discontinuation of RA meds.
- Petitioner filed a Vaccine Program petition alleging Tdap caused her RA; entitlement hearing was held; petitioner’s expert was Dr. Daniel Wallace (rheumatology), respondent’s expert was Dr. Chester Oddis (rheumatology).
- Disputed factual/medical points: whether petitioner had true clinical RA versus preclinical RA/fibromyalgia, whether Tdap can cause RA (mechanism/epidemiology), and whether the 2‑day onset is a medically acceptable temporal link.
- Chief Special Master Corcoran denied entitlement: he found the record more consistent with preclinical RA (not classic RA), and held petitioner failed to prove that Tdap can cause RA or that it did so in this case.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper diagnosis: Did Petitioner develop clinical RA (vs preclinical RA)? | Monzon/Wallace: positive anti‑CCP + post‑vaccine symptoms support RA diagnosis; treating rheumatologist ultimately diagnosed RA. | Gov/Oddis: records lack objective RA signs (no synovitis/swelling, lack of progression); course fits preclinical RA or fibromyalgia. | Held for Defendant: record preponderates for preclinical RA, not classic RA. |
| Althen prong 1 — Can Tdap cause RA? (theory) | Wallace: vaccines can trigger autoimmune disease via molecular mimicry, adjuvant effects, or anamnestic responses; cited meta‑analysis and case reports. | Oddis: literature does not show a reliable Tdap→RA causal link; epidemiology does not support causation; molecular mimicry/ASIA theories are speculative. | Held for Defendant: petitioner failed to preponderantly establish a reliable mechanism tying Tdap to RA. |
| Althen prong 2 — Did Tdap cause this petitioner’s RA? (logical sequence) | Wallace: temporal proximity and inflammatory response after vaccination plausibly converted preexisting seropositivity into symptomatic RA. | Oddis: lack of objective RA progression, treatment‑responsive course, and alternative diagnosis (fibromyalgia/preclinical RA) undercut causation. | Held for Defendant: logical causal chain not shown; vaccine at most explains transient, nonspecific post‑vaccine reaction. |
| Althen prong 3 — Temporal relationship (onset within 2 days) medically acceptable? | Wallace: rapid immune activation can produce symptoms within days; temporal proximity supports causation. | Oddis: RA is typically insidious; development of antibody‑mediated RA within 48 hours is not medically plausible. | Held for Defendant: 2‑day onset insufficiently explained by the proposed theory; temporality not satisfied for vaccine‑caused RA. |
Key Cases Cited
- Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for causation in Vaccine Program cases)
- Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (preponderance standard and substantial‑factor causation requirement)
- de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (temporal relationship must be medically acceptable and consistent with theory)
- Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328 (Fed. Cir. 2010) (use of Daubert factors to evaluate expert reliability in Vaccine Act cases)
- Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367 (Fed. Cir. 2009) (treatment of scientific evidence and burden for Althen prong one)
- Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351 (Fed. Cir. 2019) (plausibility alone is insufficient to satisfy causation)
- Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339 (Fed. Cir. 2010) (credibility and persuasiveness of competing experts may decide cases)
- Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317 (Fed. Cir. 2006) (application of Althen framework)