Carolynne Olson v. HHS - HPV, rheumatoid arthritis (2017)

Carolynne Olson, a 52-year-old woman, received the HPV Gardasil vaccine on July 1, 2010, for the treatment of warts, an off-label use. She alleged that the vaccine caused her to develop rheumatoid arthritis (RA).

Her medical history at the time of vaccination was significant for hypothyroidism, vitamin D deficiency, asthma, and chronic sinusitis. Olson claimed to experience burning in her hands within two weeks of vaccination, with knuckle enlargement and pain developing about three months later.

She was diagnosed with probable seronegative rheumatoid arthritis by Dr. Gregory Middleton in September 2013, who attributed it to an immune system overreaction from the vaccine.

Olson's theory of causation posited that alum, an adjuvant in the vaccine, could trigger RA in individuals with pre-existing inflammatory lung conditions by activating inflammasomes and subsequently cytokines. She presented expert testimony from Dr.

Middleton and Dr. Lawrence Mayer.

Respondent argued that Olson could not establish causation. The Special Master denied entitlement, finding that Olson failed to prove by a preponderance of the evidence that the HPV vaccine caused her RA.

The Special Master concluded that her theory lacked reliable scientific support, particularly regarding the role of alum and cytokine upregulation as a trigger for RA, and that the evidence did not establish a logical sequence of cause and effect. The Court of Federal Claims affirmed the Special Master's decision, finding it was not arbitrary, capricious, or contrary to law.

The case was denied compensation.