Alyssa Salerno v. HHS - Influenza, chronic migraine (2020)

Alyssa Salerno, born in 1998, filed a petition on October 6, 2016, alleging that she sustained an off-table injury from influenza and human papillomavirus (HPV) vaccinations administered on November 12, 2013. She claimed the vaccinations caused her to develop a chronic migraine lasting approximately nine months, or alternatively, significantly aggravated her pre-existing headaches.

The Secretary of Health and Human Services disputed these claims. Ms.

Salerno's primary medical theory, advanced by her expert neurologist Dr. Hal Gutstein, was Autoimmune Syndrome Induced by Adjuvants (ASIA).

Dr. Gutstein posited that the aluminum adjuvant in the vaccines led to increased Calcitonin Gene-related Peptide (CGRP) production, resulting in migraines.

The Secretary's expert, pediatric neurologist Dr. Peter M.

Bingham, opined that the vaccinations did not cause or exacerbate Ms. Salerno's headaches and suggested alternative contributing factors such as obesity, seasonal changes, polycystic ovarian syndrome, intercurrent infection, and low vitamin D levels.

The Special Master, Christian J. Moran, reviewed the medical records and expert reports.

The public decision does not describe Ms. Salerno's specific symptoms, diagnostic tests, or treatments beyond what is detailed in the medical history section.

The Special Master found that the ASIA theory of causation has been consistently rejected by special masters as unreliable and unsupported by persuasive evidence. Furthermore, Ms.

Salerno failed to establish a reliable medical theory connecting the vaccinations to her chronic migraine, including the proposed mechanism involving CGRP. The court also noted that Dr.

Gutstein was unaware of epidemiological studies supporting the ASIA theory and that a study cited by the petitioner regarding HPV vaccination and migraine found no statistically significant association. The Special Master also considered Ms.

Salerno's alternative claim of significant aggravation of pre-existing headaches. While acknowledging that Ms.

Salerno's post-vaccination condition involved daily headaches requiring hospitalizations and new symptoms like photophobia, the Special Master found the evidence for significant aggravation to be mixed. The medical records indicated that some pre-vaccination headaches were also severe and involved whole-head pain, and that Ms.

Salerno's post-vaccination symptoms showed improvement with various treatments, including a nerve block. Crucially, Ms.

Salerno's treating neurologist, Dr. Robert Fryer, described the etiology of her headache as multifactorial, making it difficult to attribute solely to the vaccinations.

The Special Master concluded that Ms. Salerno did not meet her burden of proof on causation, as she failed to establish a persuasive medical theory linking the vaccinations to her chronic migraine or its significant aggravation.

A hearing was deemed unnecessary as the outcome would not change based on the presented evidence and legal precedent. The petition was denied.

Petitioner's counsel was Michael London, Virginia Anello, and Douglas & London, P.C. Respondent's counsel was Robert Coleman, III.

The decision was issued on June 24, 2020.