Donna Ramsay v. HHS - HPV, systemic Juvenile Idiopathic Arthritis (sJIA) (2015)

On August 30, 2011, Tina Ramsay filed a petition under the National Vaccine Injury Compensation Program on behalf of her daughter, Donna Ramsay, who was 14 years old at the time of her first vaccination. The petition alleged that Donna Ramsay developed systemic Juvenile Idiopathic Arthritis (sJIA) as a result of receiving two doses of the Gardasil vaccine on March 19, 2008, and June 30, 2008.

Donna Ramsay, born June 16, 1993, had a prior medical history that included a tonsillectomy, migraine headaches, and irritable bowel syndrome, but no prior adverse reactions to vaccines. Her symptoms, including flu-like symptoms, aching, fever, rash, and joint pain, began in early November 2008, approximately seven months after the first vaccine and four months after the second.

Initial medical evaluations in November 2008 diagnosed her with allergies or a viral illness, but subsequent hospitalizations and consultations with specialists, including a pediatric rheumatologist, led to a presumptive diagnosis of sJIA, also referred to as Still's disease or juvenile rheumatoid arthritis. Tests for infectious and autoimmune diseases were negative.

Her condition improved with steroid and methotrexate treatment, which target inflammatory cytokines. The respondent initially suggested Macrophage Activation Syndrome (MAS) or a viral infection as alternative causes but ultimately conceded that Petitioner's injury was sJIA.

Petitioner argued that the Gardasil vaccine acted as an environmental trigger for her genetically predisposed condition, causing an upregulation of pro-inflammatory cytokines. The Special Master found that Petitioner successfully established a novel, yet plausible, medical theory connecting the Gardasil vaccine to sJIA, demonstrating a logical sequence of cause and effect, and a proximate temporal relationship between the vaccinations and the onset of her symptoms.

The Special Master relied on the expert testimony of Dr. Eric Gershwin and Dr.

Michael McCabe, who opined that the Gardasil vaccine can trigger sJIA in genetically susceptible individuals by inducing pro-inflammatory cytokines, and that the timing of Donna Ramsay's symptom onset was consistent with this mechanism. The respondent's expert, Dr.

Carlos Rose, disagreed, citing a lack of epidemiological evidence and arguing that the onset should have been earlier. The Special Master found the epidemiological studies cited by the respondent to be underpowered and not dispositive given the rarity of sJIA.

The Special Master concluded that Petitioner had proven by a preponderance of the evidence that her sJIA was caused by the Gardasil vaccinations and was entitled to compensation. The case was ordered to proceed to damages.

Patricia Leigh O’Dell represented the Petitioner, and Darryl Wishard represented the Respondent. Special Master Lisa Hamilton-Fieldman issued the ruling on December 18, 2015.