A.F. v. HHS - HPV, Postural Orthostatic Tachycardia Syndrome (POTS) (2023)
Case summary [AI summaries can sometimes make mistakes]
On March 26, 2019, A.F. filed a petition under the National Vaccine Injury Compensation Program alleging that the human papillomavirus (HPV) vaccine, received on December 30, 2017, caused her to develop Postural Orthostatic Tachycardia Syndrome (POTS). A.F., born January 14, 1993, was 24 years old at the time of vaccination.
Approximately four days after receiving the vaccine, she began experiencing symptoms including dizziness and fainting, which progressed to extreme fatigue, mental fogginess, and difficulty focusing. She was later diagnosed with POTS and hypermobile Ehlers-Danlos syndrome.
Petitioner argued that the HPV vaccine caused her POTS through an autoimmune mechanism involving molecular mimicry and autoantibodies. Petitioner's experts, Dr.
Mitchell Miglis and Dr. S.
Sohail Ahmed, presented medical literature and theories to support this claim. Respondent's expert, Dr.
Christopher Gibbons, countered that there was no reliable scientific evidence linking the HPV vaccine to POTS, that POTS has a heterogeneous etiology not primarily autoimmune, and that the autoantibodies proposed as causal were not specific or pathogenic. The Special Master reviewed extensive medical literature and expert reports.
Ultimately, the Special Master found that Petitioner failed to establish by a preponderance of the evidence that the HPV vaccine can cause POTS, citing the lack of reliable scientific support and the repeated rejection of similar claims in prior cases. The Special Master also noted that Petitioner's own test results did not conclusively support the presence of the alleged causal autoantibodies.
Therefore, entitlement was denied. Petitioner was represented by Edward Kraus of Kraus Law Group, LLC, and Respondent was represented by Mitchell Jones of the U.S.
Department of Justice. The decision was issued by Chief Special Master Brian H.
Corcoran on January 18, 2023.
Theory of causation
Petitioner A.F. alleged that the HPV vaccine administered on December 30, 2017, caused her to develop Postural Orthostatic Tachycardia Syndrome (POTS). Petitioner's experts, Dr. Miglis and Dr. Ahmed, proposed that the HPV vaccine could trigger an autoimmune response through molecular mimicry, leading to the production of autoantibodies (specifically anti-adrenergic receptor antibodies) that target autonomic nerve receptors, thereby causing POTS. They cited various studies suggesting a link between POTS and autoantibodies, and proposed that the HPV vaccine's components could mimic human proteins, initiating a cross-reaction. Respondent's expert, Dr. Gibbons, argued that there is no reliable scientific evidence to support a causal link between the HPV vaccine and POTS, that POTS has multiple etiologies and is not primarily autoimmune, and that the autoantibodies cited by Petitioner's experts are not specific or proven to be pathogenic. Dr. Gibbons also noted that Petitioner's own testing for these autoantibodies was largely negative or inconclusive, and that many studies cited by Petitioner had methodological flaws, such as small sample sizes and selection bias. The Special Master found that Petitioner failed to establish by a preponderance of the evidence that the HPV vaccine can cause POTS, noting that the scientific literature did not sufficiently support the proposed autoimmune mechanism or a causal link between the vaccine and POTS, and that Petitioner's own medical evidence was insufficient. Entitlement was denied. The theory of causation was considered "Off-Table."
Source PDFs
USCOURTS-cofc-1_19-vv-00446