Nicole Girardi v. HHS - HPV, optic neuritis (2025)

On February 7, 2017, Nicole Girardi, then 15 years old, filed a petition under the National Vaccine Injury Compensation Program. She alleged that her third dose of the Cervarix human papillomavirus (HPV) vaccine, received on March 20, 2014, caused her to develop optic neuritis and related symptoms, or alternatively, significantly aggravated her existing optic neuritis.

The public decision does not describe the petitioner's counsel or respondent's counsel by name. Special Master Mindy Michaels Roth issued the ruling on entitlement on October 24, 2024.

Petitioner Girardi received her third dose of the bivalent HPV vaccine, Cervarix, on March 20, 2014. Approximately 38 days later, she began experiencing severe headaches, followed by blurred vision and pain behind her right eye.

She was diagnosed with optic neuritis, an inflammation of the optic nerve. The Special Master reviewed the record, expert reports, and associated literature, and heard testimony.

The Special Master found that petitioner preponderantly established that the Cervarix vaccine triggered her optic neuritis within a medically relevant timeframe. The decision details the nature of HPV infection and the Cervarix vaccine, as well as the medical condition of optic neuritis, noting its association with white matter lesions and potential early signs of multiple sclerosis.

The procedural history outlines the filing of the petition, amended petition, expert reports from Dr. Lawrence Steinman for the petitioner and Drs.

Timothy Lotze and J. Lindsay Whitton for the respondent, and subsequent filings and hearings.

Petitioner's medical history prior to vaccination indicated she was a healthy 15-year-old with no prior history of relevant conditions. Following the vaccination, she experienced headaches, sinusitis symptoms, and eye pain, leading to a diagnosis of optic neuritis on May 21, 2014.

She was treated with pulsed steroids, which significantly improved her vision, and was discharged on oral steroids. Subsequent follow-ups showed continued improvement, with no brain lesions noted on MRI.

Petitioner testified that the optic neuritis resulted in underlying damage to her peripheral vision and eye strain. The case involved competing expert opinions.

Petitioner's expert, Dr. Lawrence Steinman, a neuroimmunologist, theorized that molecular mimicry between components of the Cervarix vaccine and myelin antigens (MOG, PLP, MBP) in the optic nerve could trigger an autoimmune response leading to optic neuritis.

He relied on bioinformatic searches (BLAST) and literature demonstrating similarities between vaccine components and myelin proteins, and animal studies showing that even short homologous sequences could induce neuroinflammation. Respondent's experts, Dr.

Timothy Lotze (neurologist) and Dr. J.

Lindsay Whitton (Ph.D. in immunology), argued against causation. Dr.

Lotze contended that petitioner's symptoms began more than 30 days after vaccination, outside the timeframe suggested by the vaccine's package insert for headaches, and that large-scale epidemiological studies showed no association between HPV vaccines and optic neuritis. Dr.

Whitton criticized Dr. Steinman's methodology, particularly the use of BLAST searches, arguing that mere sequence homology does not prove an immune response or disease causation, and that Dr.

Steinman's findings were based on chance similarities and lacked biological significance. He emphasized that extensive studies have found no convincing evidence linking HPV vaccines to optic neuritis.

The Special Master applied the three-pronged Althen test for off-Table claims. For the first prong (medical theory), the Special Master found Dr.

Steinman's theory of molecular mimicry to be sound and reliable, noting that the Vaccine Program has accepted this mechanism in other cases. For the second prong (logical sequence of cause and effect), the Special Master found a logical sequence supported by petitioner's medical records, the absence of other identified causes, and her response to treatment, concluding that the vaccine was a substantial factor.

For the third prong (proximate temporal relationship), the Special Master found the onset of symptoms within a medically acceptable timeframe, citing precedent for similar injuries and mechanisms. The Special Master concluded that petitioner proved by a preponderance of the evidence that the Cervarix vaccination caused or triggered her optic neuritis.

The case was ruled entitled to compensation, and it proceeded to determine the damages award.