Shapiro v. Secretary of Health & Human Services
105 Fed. Cl. 353
| Fed. Cl. | 2012Background
- Petitioner Elizabeth Shapiro seeks Vaccine Act compensation for thyroid disease and SLE allegedly caused by hepatitis-B vaccines received in 1992.
- Special Master Moran previously denied both claims; Shapiro I remanded thyroid issue and SLE timing in Shapiro II.
- On remand, the Special Master again denied thyroid causation and found no proximate temporal relationship for SLE; no compensation awarded.
- Shapiro challenged the rulings in a proceeding for review and reconsideration, arguing errors in causation theories and timing.
- The court conducted de novo and preserved review under the Vaccine Act, ultimately denying both motions.
- Key factual context includes onset of hypothyroidism around Oct. 1992 and SLE symptoms appearing later, with conflicting contemporaneous records.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether thyroid causation theory supports relief | Shapiro asserts a reliable theory connects vaccine to thyroid disease. | Ward disproves the four theories; onset timing is too early for causation. | thyroid causation fails; no preponderance of evidence |
| Whether temporal relation for SLE satisfies Althen prong 3 | SLE onset occurred within a medically acceptable window after vaccination. | Onset occurred outside the accepted window; evidence insufficient. | SLE lacks proximate temporal relationship; no compensation |
| Whether the court should reconsider SLE ruling | Reconsideration would show manifest injustice and new rationale. | No manifest injustice; arguments previously considered and rejected. | Reconsideration denied |
| Whether the standard for causation aligns with Althen and Simanski | Preponderance allows less-than-conclusive but credible theories. | Causation theories require reliable, plausible mechanisms; minimal support. | Court upheld the standard; theories insufficient |
Key Cases Cited
- Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes the three-part causation framework for Vaccine Act claims)
- Simanski v. Sec’y of Health and Human Servs., 671 F.3d 1368 (Fed. Cir. 2012) (requires a sound and reliable medical theory showing causal relation, not necessarily a detailed mechanism)
- Porter v. Sec’y of Health and Human Servs., 663 F.3d 1242 (Fed. Cir. 2011) (preponderance standard favoring claimants in close causation questions)
- Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994) (causation may be established without a conclusive mechanism)
- Moberly v. Sec’y of Health And Human Servs., 592 F.3d 1315 (Fed. Cir. 2010) (recognizes Vaccine Act causation may be proven by a preponderance despite gaps in literature)
- de Bazan v. Sec’y of Health and Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (temporal causation must be medically plausible within the onset window)