Berlin Bravo v. HHS - HPV, multiple sclerosis (2023)

Berlin Bravo, born in 1999, filed a claim alleging that her third dose of the human papillomavirus (HPV) vaccine, administered on March 21, 2014, either caused her to develop multiple sclerosis (MS) or significantly aggravated a pre-existing, undiagnosed case of MS. The Secretary of Health and Human Services disputed these claims.

The case was adjudicated by Special Master Christian J. Moran.

Petitioner was represented by Sol P. Ajalat of Ajalat & Ajalat, LLP, and Respondent was represented by Colleen Hartley of the United States Department of Justice.

The Special Master issued a published decision denying entitlement on May 31, 2023. Initially, Ms.

Bravo alleged that the HPV vaccine was the cause-in-fact of her MS. However, the Special Master found that the evidence preponderated in favor of Ms.

Bravo having suffered from undiagnosed multiple sclerosis before receiving the vaccine. This finding was based on imaging from a May 2, 2014 MRI, which revealed lesions, including a "black hole" lesion in the left frontal region, that experts agreed must have predated the vaccination.

Dr. Subramaniam Sriram, a neurologist for the respondent, opined that this lesion indicated a chronic abnormality preceding the vaccination date.

Dr. David Wilson, a neuroradiologist retained by the petitioner, also agreed that a juxtacortical lesion discussed in his report predated the vaccination, although he initially maintained it was not related to MS.

Dr. Jonathan Kleefield, a neuroradiologist for the respondent, also concluded that the overwhelming majority of lesions were typical for demyelinating disease and indicated a chronic abnormality preceding the vaccination.

Due to this finding, Ms. Bravo could not prevail on a causation-in-fact theory.

The case then proceeded as a significant aggravation claim. Ms.

Bravo presented several theories for how the HPV vaccine could have significantly aggravated her MS, including molecular mimicry, the persistence of alum causing neurotoxicity, and alum leading to IL-1beta. She retained experts such as neurologist Lawrence Steinman, immunologist Yehuda Shoenfeld, pathologist Sin Hang Lee, and Ph.D. researcher Christopher Shaw.

The Secretary retained neurologist Subramaniam Sriram, immunologist Neil Romberg, and neuroradiologist Jonathan Kleefield. The Special Master found Ms.

Bravo's theories unpersuasive. Regarding molecular mimicry, the Special Master noted inconsistencies with large epidemiological studies (Scheller and Mouchet) that did not associate the HPV vaccine with an increased risk of MS.

The court also found that short amino acid sequence similarities are common and that Ms. Bravo and her experts failed to establish that any identified similarities were biologically relevant or that attacks on specific proteins like myelin basic protein or myelin oligodendrocyte-glycoprotein would worsen MS.

The Special Master also found that Ms. Bravo failed to establish a logical sequence of cause and effect linking the vaccine to her specific condition, noting the absence of affirmative statements from treating physicians, such as Dr.

Langer-Gould, who treated Ms. Bravo but did not connect her HPV vaccination to her MS in her records.

Regarding the theory of alum persistence and neurotoxicity, the Special Master cited a study (Linneberg) showing no increased risk of autoimmune diseases, including MS, in individuals receiving immunotherapy with aluminum hydroxide adjuvant. The Special Master also noted that the amount of aluminum in an HPV vaccine is significantly less than amounts used in experimental studies potentially showing harm.

For the theory of alum leading to IL-1beta, the Special Master noted that Ms. Bravo did not meaningfully advance this theory in her briefs and that caselaw trends against such theories.

The Special Master also referenced prior decisions where similar theories involving alum and cytokines were rejected. While Ms.

Bravo presented evidence of a temporal association, with optic neuritis manifesting approximately five weeks after her final HPV vaccination, the Special Master stated that temporal association alone is insufficient to establish causation. The Special Master concluded that Ms.

Bravo failed to establish by a preponderance of the evidence that the HPV vaccine caused or significantly aggravated her multiple sclerosis. Consequently, Ms.

Bravo's claim for compensation was denied. The decision was made without an evidentiary hearing, as Ms.

Bravo had a full opportunity to present her case through expert reports and briefs.