D.B. v. HHS - Hepatitis B, Evans syndrome (2019)

On August 11, 2011, Tia Bucci and Nicholas Bucci, as parents of their minor son D.B., filed a petition alleging that a Hepatitis B vaccination administered on March 4, 2009, caused D.B. to develop Evans syndrome. Evans syndrome is a rare autoimmune disorder characterized by low platelet counts and hemolytic anemia.

The petitioners presented expert testimony from Dr. Edwin Forman and Dr.

Vera Byers, who suggested that the Hepatitis B vaccine could have triggered D.B.'s condition through mechanisms such as bystander activation or epitope spreading, and that the onset of symptoms approximately eight days after vaccination was temporally appropriate. Dr.

Forman, a pediatric hematologist, opined that while D.B. had some benign post-vaccination reactions, the subsequent onset of bruising and petechiae eight days after vaccination was more likely than not caused by the vaccine. Dr.

Byers, an immunologist, focused on bystander activation, suggesting that the vaccine could activate dormant autoreactive T and B cells, leading to an attack on both red blood cells and platelets. Petitioners' counsel was Lawrence R.

Cohan. The respondent, the Secretary of Health and Human Services, argued that Evans syndrome is primarily caused by an inherent defect in the immune regulatory system, not external triggers like vaccines.

Respondent's experts, Dr. Hayley Gans (pediatric infectious disease specialist and immunologist) and Dr.

Joan Cox Gill (pediatric hematologist-oncologist), contended that the medical literature does not strongly support a link between vaccines and Evans syndrome. They proposed that the condition is more consistent with underlying immune dysregulation, specifically involving the Fas-Fas ligand pathway, which would manifest regardless of vaccination.

Dr. Gans suggested that D.B.'s symptoms might have predated the vaccination, potentially indicating an underlying immune deficiency.

Dr. Gill agreed that the pathophysiology of Evans syndrome is not fully understood but emphasized that the predominant scientific thinking focuses on immune regulatory failure rather than external triggers.

Respondent's counsel was Robert P. Coleman.

Special Master Thomas L. Gowen presided over the case.

The Special Master found that while the pathophysiology of Evans syndrome is not fully understood, the predominant scientific thinking focuses on immune regulatory failure rather than external triggers like bystander activation. The court also noted that case reports linking Hepatitis B vaccines to Evans syndrome involved patients who responded to initial treatments, unlike D.B.'s chronic condition.

Ultimately, the Special Master concluded that the petitioners had not met their burden of proving by a preponderance of the evidence that the Hepatitis B vaccine caused D.B.'s Evans syndrome, and therefore, the claim was denied. The decision was issued on March 27, 2019.