DOE 93 v. SECRETARY OF HEALTH AND HUMAN SERVICES

Jane Doe 93 involves the development of transverse myelitis (“TM”) after receipt of flu vaccine.  The Special Master denied entitlement based in part on the lack of definitive literature support that flu vaccine can cause TM, the failure of epidemiological studies to demonstrate statistical significance in the onset of TM after flu vaccine, the failure to rule out all alternative causes of her TM despite lack of any clinical support for the potential diagnosis, and the lack of a definitive statement in her medical records on how the flu vaccine could cause TM.

On a Motion for Review, the Claims Court found that the special master had “imposed a far more exacting burden on Petitioner under [Althen] prong One” and in doing so, improperly elevated petitioner’s burden of proof by “requir[ing] conclusive proof in the medical literature linking the flu vaccine to TM.  In addition, the court found that requiring petitioner to exclude all potential infectious causes of her injury in the absence of any evidence that she suffered from such an infection was error.  The court further found an insufficient analysis of Althen prong 2 that was ‘tainted’ by the special master’s elevation of petitioner’s burden of proof in prong 1.  The court vacated the underlying decision and remanded for a redetermination of causation “consistent with the legal principles articulated” in the decision.

On remand, entitlement was granted.