W.C. v. Secretary of Health & Human Services
100 Fed. Cl. 440
| Fed. Cl. | 2011Background
- W.C. received the December 13, 2004 flu vaccine at age 34.
- December 24, 2004: numbness in left arm/hand and left face; initial expression of neurological problem.
- December 30, 2004 MRI showed non-enhancing, small T2 lesions suggesting MS risk; no acute enhancement.
- Subsequent course included relapses and MRIs; by mid-2005 MS diagnoses were contemplated; later MRIs showed evolving demyelinating disease.
- Experts disagreed: Tornatore linked vaccine to MS via molecular mimicry; Venkatesan argued no causal link and that lesions predated vaccination.
- Special master denied entitlement and redaction; court later affirmed denial of entitlement but granted redaction, remanding for redactions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Direct causation under Althen | C. proffers plausible Althen theory of causation. | Secretary challenged plausibility and timing. | Entitlement denied on direct-causation claim. |
| Preexisting subclinical MS as dispositive | C. contends MS predated vaccine; wrong focus | Special master properly found subclinical MS predated vaccination | Findings upheld; preexisting condition undermines direct causation. |
| Significant aggravation off-table claim | Loving framework applies; theory plausibly connects aggravation to vaccine | No reliable medical theory linking aggravation to vaccine | Loving framework applied; decision upheld denying substantial aggravation. |
| Redaction standard under Vaccine Act | Redaction necessary to protect privacy without undermining public interest | Redaction not required; public interest in decision disclosure | Redaction granted for name; medical-condition redaction balanced against public interest. |
Key Cases Cited
- Althen v. Secretary of Health & Human Servs., 418 F.3d 1274 (Fed.Cir.2005) (three-prong test for off-table causation; preponderance standard)
- Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317 (Fed.Cir.2006) (medical-pvidence sufficiency; no requirement for epidemiology)
- Moberly v. Secretary of Health & Human Servs., 592 F.3d 1315 (Fed.Cir.2010) (preponderant evidence standard; use of medical opinions)
- Andreu v. Secretary of Health & Human Servs., 569 F.3d 1367 (Fed.Cir.2009) (injury diagnosis not required to be exact if causation linked)
- Broekelschen v. Secretary of Health & Human Servs., 618 F.3d 1339 (Fed.Cir.2010) (identify injury before applying Althen analysis)
- Loving v. Secretary of Health & Human Servs., 86 Fed.Cl. 135 (2009) (six-prong test for significant aggravation off-table claims)
- Whitecotton v. Secretary of Health & Human Servs., 81 F.3d 1099 (Fed.Cir.1996) (four-part test guiding significant aggravation analyses)
- Knudsen v. Secretary of Health & Human Servs., 35 F.3d 543 (Fed.Cir.1994) (causation proof may be circumstantial; not require full biology)
- Rotoli v. Secretary of Health & Human Servs., 89 Fed.Cl. 71 (2009) (causation can be found where medical theory plausible despite limited evidence)
- Ray v. United States Dep’t of State, 502 U.S. 164 (1991) (privacy balancing framework under Exemption 6 of FOIA)