J.R. v. HHS - Rotavirus, intussusception (2021)

Rebecca and Timothy Reske, parents and natural guardians of J.R., a minor, filed a petition on January 28, 2019, seeking compensation under the National Childhood Vaccine Injury Compensation Act. They alleged that the third dose of the RotaTeq vaccine administered to J.R. caused her to develop intussusception.

J.R. was born in 2016 and received two doses of a rotavirus vaccine prior to her six-month well-baby appointment. At that appointment, she received a third dose of RotaTeq.

Fourteen days later, J.R. began experiencing fussiness and vomiting. The following day, she was taken to an emergency department with abdominal pain and bloody diarrhea.

An ultrasound confirmed intussusception, which was surgically repaired. Medical records from August 2018 indicated J.R. was developmentally normal.

The petitioners argued that the third dose of RotaTeq caused J.R.'s intussusception, proposing a theory that the vaccine induced an immune response leading to hyperplasia of lymph nodes near the bowel, which then triggered the intussusception. The respondent, the Secretary of Health and Human Services, argued that the Vaccine Injury Table only associates intussusception with the first two doses of the rotavirus vaccine and that the petitioners failed to establish causation for an off-Table claim.

The Special Master reviewed numerous epidemiological studies presented by both parties. The studies relied upon by the petitioners included Murphy, Parashar, Escolano, and Kassim.

The studies presented by the respondent included Yih, Koch, Haber, Lu, and Soares-Weiser. The Special Master found that the weight of the epidemiological evidence did not support a link between the third dose of RotaTeq and intussusception.

Specifically, studies involving the older RotaShield vaccine were deemed less relevant. The Escolano study suggested a small increase in risk after the third dose, but this was not found to be statistically significant in other studies like Yih, Haber, and Koch.

The Special Master also found Dr. Sferra's medical theory unpersuasive, noting it was overly general and lacked empirical support, essentially stating the vaccine caused the cause of intussusception without explaining how.

The Special Master further found that the temporal relationship was not clearly established, as the primary risk window for intussusception following rotavirus vaccination is within the first week after the first dose, and the petitioners did not establish that a 13-day interval after the third dose was appropriate given the lack of a coherent medical theory. The Special Master concluded that the petitioners failed to meet their burden of proof for entitlement to compensation on all three Althen prongs and denied the claim.

The decision was made on the record without an evidentiary hearing. Special Master Christian J.

Moran issued the decision on September 20, 2021.