Shapiro v. Secretary of Health & Human Services
101 Fed. Cl. 532
| Fed. Cl. | 2011Background
- Petitioner Elizabeth Shapiro seeks Vaccine Act compensation for hypothyroidism and SLE allegedly caused by hepatitis-B vaccines.
- Special Master Moran denied compensation, ruling illnesses not caused by the vaccine.
- petitioner had no pre-vaccination contemporaneous medical records showing those illnesses.
- First hepatitis-B dose on April 13, 1992; hypothyroidism onset appears October 1992; Synthroid started October 21, 1992.
- Second and third hepatitis-B doses occurred September 21, 1992 and February 8, 1993; SLE symptoms emerged in July 1993.
- Court later remanded the hypothyroidism issue while affirming the denial of SLE, and vacated/remanded for further proceedings consistent with the opinion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the Master erred in concluding hypothyroidism predated the first vaccine. | Shapiro contends Ginsberg letter is misread; contemporaneous records support later onset post-vaccination. | Master relied on Ginsberg letter showing October 1991 onset, which predates vaccine; legitimate weight given. | Remand for reconsideration of hypothyroidism in light of full record. |
| Whether the Master erred by privileging a non-contemporaneous letter over other contemporaneous evidence. | Shapiro argues contemporaneous records and later histories support post-vaccination onset. | Secretary argues contemporaneous record not clearly superior; decision within discretion. | Remand required to reassess the Ginsberg letter and related records. |
| Whether the SLE claim was properly denied under the proximate temporal relationship standard. | SLE onset within medically acceptable timeframe after vaccination; causation theory supported by experts. | Onset occurred outside the medically acceptable interval; evidence insufficient. | SLE claim upheld as not meeting proximate temporal relationship; denial affirmed. |
Key Cases Cited
- Cucuras v. Sec’y of Health and Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous records favored over later recollections in vaccine cases)
- Burns by Burns v. Sec’y of Health and Human Servs., 3 F.3d 415 (Fed. Cir. 1993) (contemporaneous documents given weight in medical causation analysis)
- Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (establishes three-part framework for Althen causation analysis)
- de Bazan v. Sec’y of Health and Human Servs., 539 F.3d 1347 (Fed. Cir. 2008) (timing framework for causation based on etiology)
- Hines v. Sec’y of Health and Human Servs., 940 F.2d 1518 (Fed. Cir. 1991) (emphasizes consider all relevant evidence; avoid arbitrary reliance on timing)
- Lampe v. Sec’y of Health and Human Servs., 219 F.3d 1353 (Fed. Cir. 2000) (weighs evidence within the record; not purely mechanical)