G.J.C. v. HHS - Rotavirus, intussusception (2017)

On March 6, 2014, Kyle and Shannon Carda filed a petition on behalf of their minor child, G.J.C., alleging that two doses of the RotaTeq rotavirus vaccine, administered on January 23, 2013, and March 26, 2013, caused G.J.C. to develop intussusception. Initially, the claim was dismissed as a Table injury due to the onset of symptoms occurring more than 21 days after the second vaccine dose.

The case proceeded as an off-Table claim. Petitioners argued that the vaccine caused a series of transient, subclinical intussusceptions that culminated in an acute event requiring surgical intervention on May 22, 2013, 57 days after the second dose.

They presented expert testimony from a gastroenterologist, Dr. John Santoro, and an immunologist, Dr.

Yehuda Shoenfeld, to support their theory. Respondent presented expert testimony from two pediatric gastroenterologists, Dr.

Neal Halsey and Dr. Chris Liacouras, who opined that the RotaTeq vaccine can cause acute intussusception, but typically within 21 days of vaccination, and that the petitioner's symptoms were more consistent with gastroesophageal reflux disease (GERD) and unrelated to the vaccine.

The public decision does not describe the specific onset of symptoms, the exact nature of the transient intussusceptions, or the specific mechanism by which the vaccine was alleged to cause the chronic condition. The court found that Petitioners failed to establish a medically acceptable temporal relationship between the vaccination and the intussusception, and that their theory of a chronic or transient vaccine-induced intussusception was not supported by reliable evidence.

The court gave greater weight to the testimony of Respondent's experts, particularly Dr. Liacouras, who had more specialized experience in pediatric gastroenterology.

Ultimately, entitlement was denied because Petitioners did not carry their burden of proof under the Althen standard for off-Table claims. The decision was issued by Special Master Brian H.

Corcoran on November 16, 2017.