Doe 93 v. Secretary of Health & Human Services
98 Fed. Cl. 553
| Fed. Cl. | 2011Background
- Petitioner seeks Vaccine Act compensation for transverse myelitis allegedly caused by the October 8, 2004 influenza vaccination.
- Special Master denied causation, finding Petitioner failed to prove a medical theory linking the vaccine to TM because Dr. Tornatore’s theory and supporting literature were not persuasive.
- Petitioner’s experts testified that vaccination can cause TM and that flu vaccine could trigger TM via mechanisms such as molecular mimicry; Respondent’s expert disputed causation and causative plausibility.
- Record shows temporal proximity between vaccination and TM onset, substantial diagnostic workups, and exclusion of certain alternative causes, though no definitive postvaccinal TM diagnosis was made.
- Court vacates the Special Master’s decision and remands for redetermination of causation, clarifying that Althen’s Prong One requires a biologically plausible medical theory, not conclusive proof of causation.
- Petitioner’s motion to supplement the record is denied; remand proceedings must be completed within 90 days.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper Althen Prong One burden | Petitioner argues the Special Master wrongly elevated the burden beyond biological plausibility. | Respondent argues a more stringent standard requiring probable causation with literature support. | Remand to reassess Prong One under proper biological plausibility standard |
| Medical theory linking vaccine to TM | Tornatore provides a biologically plausible theory that flu vaccine can cause TM, including molecular mimicry. | Bielawski contends lack of solid causal mechanism and epidemiology undermines plausibility. | Remand to evaluate whether Petitioner’s medical theory is biologically plausible |
| Role of epidemiology and literature in Prong One | Epidemiology is not required to prove a rare causal link; case reports and literature support plausibility. | Epidemiology and cited literature must show more than speculative links; unsupported by evidence. | Remand to reweigh literature consistent with proper standard |
| Prong Two analysis adequacy | Evidence of temporal relationship and medical records supports a causal sequence. | Affidavits and treating physician notes are insufficient to establish a logical cause-effect sequence. | Remand to readdress Prong Two with fuller consideration |
| Preclusion of differential diagnosis as persuasive evidence | Differential diagnosis can contribute to causation under Althen when reasonably performed. | Differential diagnosis does not by itself prove vaccine causation and was appropriately discounted. | Remand to reevaluate differential diagnosis in light of correct legal standard |
Key Cases Cited
- Althen v. Sec’y of HHS, 418 F.3d 1274 (Fed. Cir. 2005) (three-prong test for causation under Vaccine Act)
- Andreu v. Sec’y of HHS, 569 F.3d 1367 (Fed. Cir. 2009) (biological plausibility suffices for Prong One; not require certainty)
- Walther v. Sec’y of HHS, 485 F.3d 1146 (Fed. Cir. 2007) (biologically plausible cause recognized in ADEM context)
- Pafford v. Sec’y of HHS, 451 F.3d 1352 (Fed. Cir. 2006) (epidemiological and medical evidence considered)
- Knudsen v. Sec’y of HHS, 35 F.3d 543 (Fed. Cir. 1994) (causation can be non-medical certainty; sequence is logically probable)
- Munn v. Sec’y of HHS, 970 F.2d 863 (Fed. Cir. 1992) (standard for review of factual findings under Vaccine Act)
- Broekelschen v. Sec’y of HHS, 618 F.3d 1339 (Fed. Cir. 2010) (preponderant evidence of a medical theory governing vaccine causation; context-specific)
- Doe/11 v. Sec’y of HHS, 2008 WL 649065 (Fed. Cl. Spec. Masters) (discourages 'more likely than not' standard for medical theory; allows possible link)