Julia Balasco v. HHS - HPV, autonomic dysfunction, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, and orthostatic intolerance (OI) (2020)
Case summary [AI summaries can sometimes make mistakes]
On February 14, 2017, Julia Balasco, represented by Andrew Downing of Van Cott & Talamante, PLLC, filed a petition under the National Childhood Vaccine Injury Act. The petition alleged that two doses of the Gardasil Human Papillomavirus (HPV) vaccine, administered on August 4, 2014, and October 16, 2014, caused her to develop autonomic dysfunction, postural orthostatic tachycardia syndrome (POTS), fibromyalgia, and orthostatic intolerance (OI).
Petitioner was 13 years old at the time of the first vaccination and 14 at the time of the second. The respondent was the Secretary of Health and Human Services, represented by Alexis Babcock of the U.S.
Department of Justice. Special Master Daniel T.
Horner presided over the case. The petitioner's medical records indicated a history of headaches, dizziness, ear issues, fatigue, and joint pain, with some physicians diagnosing vestibular migraines and fibromyalgia.
Petitioner's experts, Dr. Mitchell Miglis and Dr.
Yehuda Shoenfeld, opined that the HPV vaccine caused her conditions, suggesting an autoimmune response and autonomic nervous system deregulation. Respondent's experts, Dr.
William Talman and Dr. Lindsay Whitton, contested these theories, arguing that the petitioner's symptoms were better explained by other conditions and that the evidence did not support a causal link to the vaccine.
The Special Master reviewed extensive medical records and expert reports. The court found that the evidence did not preponderate in favor of a diagnosis of POTS or OI.
While fibromyalgia was diagnosed, the court found it was not proven to be an autonomic disorder or causally linked to the vaccine. The court also determined that the petitioner did not establish a medically appropriate timeframe for causation.
Ultimately, Special Master Horner concluded that the petitioner had not met the burden of proof under the Althen test for off-Table claims and denied compensation. The petition was dismissed on March 16, 2020.
Theory of causation
Petitioner Julia Balasco, vaccinated with Gardasil HPV on August 4, 2014, and October 16, 2014, at age 13 and 14, alleged that the vaccine caused autonomic dysfunction, POTS, fibromyalgia, and OI. Petitioner's experts, Dr. Mitchell Miglis and Dr. Yehuda Shoenfeld, proposed a theory that the HPV vaccine triggered an exaggerated autoimmune response, leading to autonomic nervous system deregulation, POTS, OI, and fibromyalgia. This theory involved molecular mimicry between HPV and human proteins, a hyperimmune response to aluminum adjuvant, and the autoimmune nature of POTS, suggesting a shared etiology for these conditions. Respondent's experts, Dr. William Talman and Dr. Lindsay Whitton, disputed this theory, arguing that petitioner's symptoms were better explained by other conditions like vestibular migraines and fibromyalgia, and that there was no established link between the HPV vaccine and these alleged injuries. The Special Master found insufficient evidence to support a diagnosis of POTS or OI, and while fibromyalgia was diagnosed, it was not proven to be an autonomic disorder or vaccine-related. The court also found that a medically appropriate timeframe for causation was not established. Ultimately, the petition was denied as petitioner failed to meet the Althen test for off-Table claims, with Special Master Daniel T. Horner issuing the decision on March 16, 2020. Attorneys for petitioner were Andrew Downing and for respondent was Alexis Babcock.
Source PDFs
USCOURTS-cofc-1_17-vv-00215