Althen v. HHS - tetanus toxoid, optic neuritis and subsequent demyelinating illness (2003)

Petitioner, a college graduate and Public Health Administrator, received a tetanus toxoid vaccination on March 28, 1997. Prior to vaccination, she was in good health, though she had hypothyroidism and Duane's syndrome.

Approximately 18 days after vaccination, she developed blurred vision that progressed to complete loss of sight in her right eye, accompanied by headache, discomfort, pain with eye movements, and queasiness. She was diagnosed with probable right optic neuritis.

Over the following months, her condition worsened, with further vision loss, tingling, numbness, and neurological symptoms including fever, confusion, neck stiffness, and gait instability. Multiple MRIs revealed abnormalities, and diagnoses included encephalitis, questionable acute disseminated encephalomyelitis (ADEM), and central nervous system (CNS) vasculitis.

Petitioner's expert, Dr. Derek R.

Smith, testified that the tetanus toxoid vaccine likely caused her demyelinating disorder through molecular mimicry and epitope spreading. The government's experts, Dr.

Arthur P. Safran and Dr.

Roland M.G. Martin, rejected a causal link, favoring diagnoses like CNS vasculitis or meningitis, though Dr.

Martin acknowledged the theoretical possibility of a vaccine link. The Chief Special Master denied the claim, applying a five-prong 'Stevens analytical framework' and finding only the first prong (medical plausibility) met.

The court, however, reversed this decision, finding the Stevens framework contrary to law and concluding that petitioner met the statutory burden of proving causation in fact by a preponderance of the evidence. The court found a strong temporal relationship, a logical sequence of cause and effect supported by expert opinion and medical literature, and no evidence of alternative causes.

The case was remanded for an award of compensation, attorneys' fees, and costs.