G.S. v. HHS - Hepatitis B, alopecia areata (2024)
Case summary [AI summaries can sometimes make mistakes]
Jeffrey and Brittney Sears, parents of G.S., a minor, filed a petition on August 2, 2021, alleging that the hepatitis B and/or inactive polio vaccine G.S. received on August 7, 2019, caused her to develop alopecia areata the next day. The Secretary of Health and Human Services contested entitlement, arguing that the petitioners had not provided sufficient evidence of a causal connection and that none of G.S.'s treating doctors opined that the vaccines caused her condition.
The petitioners submitted an expert report from dermatologist Dr. Richard Horan, who opined that the hepatitis B vaccine caused the alopecia areata via molecular mimicry, citing supporting literature.
The Secretary's experts, dermatologist Dr. Andrew Krakowski and immunologist Dr.
Andrew MacGinnitie, critiqued this theory. Dr.
Krakowski cited an epidemiological study that did not show an increased incidence of alopecia areata after the hepatitis B vaccine and argued that the 36-hour onset time was too rapid for an immune response. Dr.
MacGinnitie also opined that the time course was too rapid for an adaptive immune response. The Special Master noted the strength of the respondent's arguments and gave the petitioners an opportunity to supplement the record with another report from Dr.
Horan, but Dr. Horan was unresponsive.
The Special Master tentatively found that the petitioners had not presented persuasive evidence of causation or an appropriate temporal interval. On June 28, 2024, the petitioners moved for a dismissal of their petition.
The Special Master granted the motion, dismissing the case with prejudice for insufficient proof, as the petitioners failed to establish a medical theory connecting the vaccination and injury, a logical sequence of cause and effect, or a proximate temporal relationship, particularly concerning the theory of molecular mimicry and the rapid onset of symptoms. The decision was issued by Special Master Christian J.
Moran.
Theory of causation
Petitioners alleged that the hepatitis B and/or inactive polio vaccine administered on August 7, 2019, caused G.S. to develop alopecia areata the next day. Petitioners' expert, Dr. Richard Horan, proposed the theory of molecular mimicry, citing literature associating the hepatitis B vaccine with alopecia areata. Respondent's experts, Dr. Andrew Krakowski and Dr. Andrew MacGinnitie, critiqued this theory, citing an epidemiological study that did not link the hepatitis B vaccine to alopecia areata and arguing that the 36-hour onset was too rapid for an immune response, specifically an adaptive immune response. The Special Master found Dr. MacGinnitie's critique persuasive and noted that molecular mimicry typically takes multiple days, at least five, to occur, which did not align with the alleged 36-hour onset. Petitioners were unable to provide a supplemental report from Dr. Horan to address the respondent's expert opinions. Ultimately, the petitioners moved for dismissal, and the Special Master granted the motion, dismissing the case with prejudice for insufficient proof, as the petitioners failed to establish a medical theory, a logical sequence of cause and effect, or a proximate temporal relationship under the Althen standard. The decision was issued by Special Master Christian J. Moran on August 7, 2024, with attorneys Ronald Craig Homer and Christina Ciampolillo representing the petitioner, and Rachelle Bishop representing the respondent. The theory of causation was deemed off-Table.
Source PDFs
USCOURTS-cofc-1_21-vv-01651