Cristal Bello v. HHS - HPV, premature ovarian failure (2023)
Case summary [AI summaries can sometimes make mistakes]
On May 22, 2013, Cristal Bello filed a petition alleging that the Human Papillomavirus (HPV) vaccine, Gardasil, administered on June 4, 2010, caused her to develop premature ovarian failure (POF). Her case was consolidated with other petitioners alleging the HPV vaccine caused POF.
Special Master Herbrina Sanders issued a decision on February 23, 2023, dismissing Bello's claim. Special Master Sanders found that Bello failed to establish by a preponderant standard that her POF was autoimmune in nature, thus failing Althen prong two.
She also found that the onset of Bello's POF was not consistent with the proposed molecular mimicry mechanism, failing Althen prong three, as the onset of symptoms did not occur within the expected acute-onset window following vaccination. The Court of Federal Claims, in an opinion issued September 12, 2023, denied Bello's motion for review, finding the Special Master's ultimate decision was not arbitrary and capricious, despite identifying some errors in the Special Master's reasoning regarding the timing of Bello's symptoms and the interpretation of her medical records.
Petitioner was represented by Mark T. Sadaka, and Respondent was represented by Kimberly Davey.
An earlier decision on November 24, 2015, by Special Master Lisa Hamilton-Fieldman, awarded Petitioner $1,015.47 for costs incurred personally, based on a stipulation between the parties. Petitioner was represented by Mark L.
Krueger in this matter.
Theory of causation
Cristal Bello received the HPV (Gardasil) vaccine on June 4, 2010, and subsequently developed premature ovarian failure (POF). Her claim was consolidated with other petitioners alleging the HPV vaccine caused POF. Special Master Sanders denied entitlement, finding that Petitioner failed to prove by a preponderant standard that her POI was autoimmune in nature (Althen prong two) and that the onset of her POI was inconsistent with the proposed molecular mimicry mechanism (Althen prong three), as the symptoms did not manifest within the expected acute-onset window following vaccination. The Court of Federal Claims denied review, finding the Special Master's decision was not arbitrary and capricious. Petitioner was represented by Mark T. Sadaka and Respondent by Kimberly Davey. An earlier stipulation awarded Petitioner $1,015.47 in costs, with counsel Mark L. Krueger involved. The public decision does not describe the specific mechanism of molecular mimicry or name specific experts for the respondent in the final decision, though multiple experts testified for both sides regarding autoimmunity and onset timing.
Source PDFs
USCOURTS-cofc-1_13-vv-00349