A.R. v. HHS - Hepatitis A, nephrotic syndrome (2016)

On September 25, 2012, Grzegorz and Agnieszka Rus, as parents and natural guardians of A.R., filed a petition under the National Vaccine Injury Compensation Program alleging that their minor child, A.R., developed nephrotic syndrome as a result of receiving the Hepatitis A vaccine on October 30, 2009. The respondent, the Secretary of Health and Human Services, recommended against awarding compensation.

A.R. was born on August 31, 2006, and was approximately three years old at the time of vaccination. Prior to October 30, 2009, A.R. was described as healthy and developing normally.

On October 30, 2009, she received a Hepatitis A vaccine during a well-child visit. The following day, October 31, 2009, A.R. was taken to the emergency room due to lethargy and fever.

She experienced an episode described as shaking with her eyes rolled back, lasting about a minute, which was suspected to be a febrile seizure secondary to the vaccination. Laboratory results on November 1, 2009, showed normal albumin, slightly decreased total blood protein, and elevated urine protein.

On November 4, 2009, A.R. was noted to have a swollen face, and lab work revealed decreased albumin, markedly decreased total blood protein, high triglycerides, and high cholesterol. A diagnosis of nephrotic syndrome was made, and A.R. was started on prednisone.

A renal biopsy was not performed, and genetic testing for certain renal disease genes was negative. A.R. has since experienced multiple relapses of her nephrotic syndrome.

Petitioners alleged an "off-Table" injury, meaning they had to prove causation-in-fact under the Althen standard. Petitioners presented the expert report of Dr.

Jan T. Kielstein, a nephrologist, who opined that the Hepatitis A vaccine caused A.R.'s nephrotic syndrome through two proposed mechanisms: a specific T-cell response leading to a circulating glomerular permeability factor, or an inflammatory cytokine response altering angiopoietin-like 4 (ANGPTL4) production.

Dr. Kielstein cited anecdotal reports and case studies linking various vaccines to nephrotic syndrome, though he acknowledged the low quality of the database and admitted he was unaware of specific case reports linking Hepatitis A vaccines to nephrotic syndrome.

Respondent presented the expert report of Dr. Bernard S.

Kaplan, a pediatric nephrologist, who disagreed that the Hepatitis A vaccine caused A.R.'s condition. Dr.

Kaplan acknowledged the unknown pathogenesis of nephrotic syndrome and the existence of case reports suggesting temporal relationships with vaccines, but found them to be few in number and not involving the Hepatitis A vaccine. He stated there was no reliable medical theory linking vaccines, particularly Hepatitis A, to nephrotic syndrome.

The Special Master considered the three prongs of the Althen standard: a reliable medical theory, a logical sequence of cause and effect, and a proximate temporal relationship. The Special Master found that the timing of A.R.'s symptoms post-vaccination was suggestive and that the disease progression was rapid, potentially consistent with the ANGPTL4 theory.

However, the Special Master found that the proposed medical theories, particularly the T-cell response and the ANGPTL4 mechanism, were too uncertain and lacked sufficient supporting evidence to establish a causal link by a preponderance of the evidence. The T-cell theory was deemed problematic due to the timing, and the ANGPTL4 theory was considered too speculative and not sufficiently supported by current medical knowledge linking it to vaccine causation.

The Special Master concluded that petitioners failed to prove by a preponderance of the evidence that the Hepatitis A vaccine caused A.R.'s nephrotic syndrome and denied compensation. The decision was issued by Special Master Thomas L.

Gowen on July 27, 2016. Petitioners were represented by Kate G.

Westad of Larkin Hoffman, et al., Ltd., and respondent was represented by Amy P. Kokot of the United States Department of Justice.