C.A. v. Secretary of Health and Human Services
17-1033
| Fed. Cl. | Dec 5, 2017Background
- Petitioners (parents Teresa and David Audino) filed a vaccine-injury petition alleging their daughter C.A. developed dysautonomia/POTS beginning two days after an HPV (Gardasil) vaccination on August 14, 2014.
- Contemporaneous medical records do not support onset two days post-vaccination; records show relevant symptoms beginning months later (spring–summer 2015) and many exams were normal.
- No medical doctor diagnosed C.A. with dysautonomia or POTS; the sole diagnosing provider was a chiropractor (George Michalopoulos) who lacks a medical degree and whose opinion the Special Master declined to credit.
- Petitioners submitted later affidavits with histories inconsistent with contemporaneous medical records; the Special Master emphasized the reliability of contemporaneous records over later statements.
- Petitioners conceded they could not meet their burden of proof and filed a motion to dismiss; the Special Master granted the motion and dismissed the petition.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether C.A. suffered dysautonomia/POTS caused by HPV vaccine | HPV vaccine caused C.A.’s dysautonomia/POTS with onset shortly after vaccination | Medical records and lack of qualified medical diagnosis refute vaccine causation | Dismissed: petitioners failed to prove C.A. has dysautonomia or that vaccine caused it |
| Credibility of non‑medical provider diagnosis | Chiropractor Michalopoulos’s diagnosis should be treated as evidentiary support | A chiropractor lacks a medical degree/training to diagnose dysautonomia; his opinion is insufficient | Held: chiropractor’s diagnosis not accepted as a medical diagnosis |
| Reliability of later affidavits vs contemporaneous records | Affidavits provide accurate symptom history and timing | Contemporaneous medical records are more reliable and conflict with affidavits | Held: contemporaneous records preferred; affidavits inconsistent and unpersuasive |
| Burden of proof under Althen/Grant (causation) | Temporal association and exclusion of other causes support causation | Need for a medical theory, reliable expert support, and proximate temporal relationship; petitioners presented none | Held: petitioners did not satisfy Althen — dismissal granted |
Key Cases Cited
- United States v. United States Gypsum Co., 333 U.S. 364 (U.S. 1948) (contemporaneous records generally reliable)
- Burns v. Secretary, HHS, 3 F.3d 415 (Fed. Cir. 1993) (records vs later testimony credibility)
- Cucuras v. Secretary, HHS, 993 F.2d 1525 (Fed. Cir. 1993) (trustworthiness of medical records)
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (three‑part test for causation in Vaccine Program)
- Grant v. Secretary of Health and Human Services, 956 F.2d 1144 (Fed. Cir. 1992) (temporal association alone insufficient; need medical theory or expert support)
- Shyface v. Sec’y of HHS, 165 F.3d 1344 (Fed. Cir. 1999) (but‑for and substantial factor causation principles)
