Megan L. Godfrey v. HHS - HPV, juvenile ankylosing spondylitis (2016)

Megan L. Godfrey, who was 18 years old at the time of vaccination, received a single dose of the Gardasil HPV vaccine and a meningococcal conjugate vaccine on August 22, 2007.

Approximately four months later, she began experiencing hip pain, which was diagnosed as juvenile ankylosing spondylitis (JAS). Petitioner alleged that the HPV vaccine caused her JAS.

The case proceeded as an off-Table claim, requiring proof of causation. Petitioner's expert, Dr.

Michael McCabe, proposed a theory that the HPV vaccine could trigger JAS in genetically predisposed individuals by causing a release of pro-inflammatory cytokines. Respondent's experts, Dr.

Carlos Rose and Dr. Burton Zweiman, argued that the vaccine's effect on cytokine levels would be transient and insufficient to trigger JAS, and that petitioner's condition was likely due to her genetic predisposition and possibly other environmental factors like her cheerleading activities.

The initial decision denied compensation, finding that petitioner failed to establish causation. This decision was reviewed by the court, which remanded the case for reconsideration in light of the Federal Circuit's decision in Koehn v.

Secretary of Health and Human Services. On remand, a special master again denied entitlement, finding that the differences between this case and Koehn, particularly the nature of the disease (JAS vs.

SJIA) and the lack of specific evidence linking the HPV vaccine to JAS, meant that Dr. McCabe's theory was not sufficiently established.

The court affirmed this decision, concluding that petitioner failed to prove a legally probable medical theory of causation. The case was later resolved with an award of interim attorney fees and costs totaling $141,851.84, indicating a potential settlement or stipulation for damages after the entitlement decisions.