Marilyn Davis v. HHS - Influenza, neuromyelitis optica (2010)

Marilyn Davis, born in 1948, received an influenza vaccine on December 4, 2006. Three weeks later, she developed back and flank pain, followed by bowel discomfort, constipation, and eventually paralysis and incontinence.

An MRI revealed enhancement in her spinal cord, and she was diagnosed with neuromyelitis optica (NMO), a rare autoimmune demyelinating disease. Ms.

Davis filed a petition for vaccine injury compensation, alleging the influenza vaccine caused her NMO. This was an off-Table claim, requiring proof of causation in fact.

Her expert, Dr. J.

Griffith Steel, proposed a 'two-hit hypothesis' where the vaccine damages endothelial cells, exposing aquaporin-4 protein to the NMO antibody, leading to demyelination. The government's expert, Dr.

Arthur Safran, argued against this theory, citing the lack of treating physician association, no supporting literature, and alternative causes, such as Ms. Davis's prior breast cancer.

The special master denied compensation, finding Dr. Steel's theory unreliable, particularly the assertion that the influenza vaccine can damage endothelial cells.

The special master also improperly relied on an external study not in the record, but this was deemed harmless error as other evidence supported the denial. The court affirmed the special master's decision, concluding that while Dr.

Steel's hypothesis might be scientifically valid in the future, it was not established by a preponderance of the evidence at the time of the decision. The petition for review was denied.