Makaylah Kelly v. HHS - HPV, Postural Orthostatic Tachycardia Syndrome (POTS) (2024)

Makaylah Kelly, who was 17 years old, filed a petition for compensation under the National Vaccine Injury Compensation Program on February 1, 2021. She alleged that she developed Postural Orthostatic Tachycardia Syndrome (POTS) as a result of receiving a human papillomavirus (HPV) vaccination on February 1, 2018.

The respondent argued that the case was not appropriate for compensation under the Act. Special Master Nora Beth Dorsey issued a decision on July 22, 2024, finding that Makaylah Kelly failed to provide preponderant evidence that the HPV vaccination caused her to develop POTS, thus failing to satisfy her burden of proof under the Althen standard.

The petition was therefore dismissed. Petitioner's medical history included anxiety and migraines, and a prior syncopal episode after receiving other vaccines at age eight.

Following the HPV vaccination, she experienced symptoms including sore throat, dizziness, rash, and body aches, leading to multiple emergency department visits and hospitalizations. She was eventually diagnosed with POTS in the spring of 2018.

Petitioner's expert, Dr. Mitchell G.

Miglis, a neurologist specializing in autonomic nervous system disorders, proposed a theory of molecular mimicry between the HPV vaccine and adrenergic receptors. However, the Special Master noted that similar theories have been rejected in prior cases, and no claim alleging the HPV vaccine causes POTS has succeeded in the Vaccine Program.

Respondent's experts, Dr. Andrew MacGinnitie, an allergist/immunologist, and Dr.

Brian Olshansky, a cardiologist specializing in autonomic disorders, opined that there was no established causal link between the HPV vaccine and POTS. They suggested Petitioner's symptoms were more likely due to viral infections, such as Epstein-Barr virus (EBV) which was diagnosed, or anxiety and deconditioning.

The Special Master agreed with the reasoning in prior cases that have denied entitlement for HPV/POTS claims, finding that Petitioner failed to establish a sound and reliable medical theory of causation, specifically failing to satisfy the first prong of the Althen standard. As a result, the petition was dismissed.

Petitioner was represented by David Charles Richards of Christensen & Jensen, P.C., and the respondent was represented by Madelyn Weeks of the U.S. Department of Justice.

The decision was issued by Special Master Nora Beth Dorsey.