A.H. v. HHS - HPV, Evans syndrome (2019)

Lizette Stillabower, on behalf of her minor daughter A.H., filed a petition on February 23, 2017, alleging that the third dose of the human papillomavirus (HPV) vaccine, administered on March 12, 2014, caused A.H. to develop Evans syndrome. A.H. was 11 years old at the time of the vaccination and had no prior relevant health concerns.

The first two doses of the HPV vaccine were administered on August 23, 2013, and December 3, 2013. In early July 2014, Ms.

Stillabower noticed jaundice in A.H.'s skin and eyes, prompting a visit to an emergency room where A.H. was diagnosed with autoimmune hemolytic anemia and subsequently Evans syndrome. Evans syndrome is characterized by the presence of both immune thrombocytopenia and autoimmune hemolytic anemia, and its exact pathophysiology is unknown.

The petitioner's expert, Dr. Eric Gershwin, opined that the HPV vaccine caused A.H.'s Evans syndrome through molecular mimicry.

However, the Special Master found Dr. Gershwin's report insufficient.

The Secretary of Health and Human Services filed a motion for a ruling on the record, challenging the sufficiency of Dr. Gershwin's report.

The Special Master noted that Dr. Gershwin's report accepted assertions from Ms.

Stillabower's affidavit that were not supported by contemporaneous medical records and did not adequately address the timing of the alleged injury. The medical records were unclear regarding the onset of Evans syndrome.

Dr. Gershwin stated the interval from vaccination to the appearance of jaundice was "consistent from a temporal perspective," but this was deemed too vague.

The Special Master noted that if an expert could satisfy the timing prong by simply stating consistency, the element would be ineffective. Dr.

Gershwin appeared to rely on affidavits created years after the events, which the Special Master had not found to be established by a preponderance of the evidence. The Special Master also noted that if A.H. first showed symptoms on June 9, 2014, as suggested by an affiant and accepted by Dr.

Gershwin, this would be approximately 89 days after the March 12, 2014 vaccination, which exceeds the timeframe often recognized as consistent with a reaction mediated through the adaptive immune system, citing a case where a medically appropriate interval for the HPV vaccine to cause immune thrombocytopenic purpura was found to be four to six weeks. Regarding the theory of causation, Dr.

Gershwin proposed molecular mimicry but offered no evidence to substantiate it, such as showing homology between vaccine components and the body parts attacked in Evans syndrome. The Special Master cited other cases where similar theories were found unpersuasive due to a lack of empirical evidence.

The Special Master also considered the letter from A.H.'s treating physician, Dr. Mehta, who recognized a temporal sequence but did not opine on causation.

The Special Master concluded that Ms. Stillabower failed to establish the required elements for an off-Table claim under Althen: a medical theory causally connecting the vaccine to the injury, a logical sequence of cause and effect, and a proximate temporal relationship.

The Secretary's motion for a ruling on the record was granted, and entitlement to compensation was denied. The decision was issued by Special Master Christian J.

Moran on August 6, 2019. Petitioner's counsel was Sean Greenwood, and respondent's counsel was Alexis B.

Babcock.