Scott Germaine v. HHS - Rotavirus, intussusception after third RotaTeq dose; off-Table causation denied (2021)

On June 6, 2018, Scott Germaine filed a petition under the National Childhood Vaccine Injury Compensation Program on behalf of his minor grandson, C.G., alleging that the third dose of the RotaTeq rotavirus vaccine caused C.G. to develop intussusception. C.G. was born on March 7, 2016.

He received the first two doses of a rotavirus vaccine at his two-month and four-month well-baby visits, respectively, and was assessed as normal at both visits. On August 9, 2016, C.G. was diagnosed with acute bronchiolitis.

By his six-month well-baby visit on September 7, 2016, C.G.'s symptoms had resolved, and he was assessed as normal. He received the third dose of a rotavirus vaccine, which the parties inferred to be RotaTeq, along with other scheduled immunizations.

Eighteen days later, on September 25, 2016, C.G. began vomiting and experiencing diarrhea. His diarrhea became bloody, prompting a visit to the emergency department.

At the emergency department, C.G. was diagnosed with vomiting, diarrhea, dehydration, and bloody diarrhea. A gastrointestinal panel was positive for C. difficile toxin and norovirus, and negative for adenovirus and E. coli.

C.G. was transferred to a hospital for higher-level care, where an ultrasound confirmed intussusception. Attempts at catheter reduction were unsuccessful, and surgery was performed on September 26, 2016, to remove a section of bowel and perform an incidental appendectomy.

C.G. was discharged on September 29, 2016, and by an October 18, 2016 follow-up, he was recovering well. Mr.

Germaine alleged an off-Table causation-in-fact claim, arguing that the third dose of RotaTeq caused C.G.'s intussusception, proposing an inflammatory mechanism and citing epidemiologic literature. Petitioner's expert, Dr.

John Santoro, opined that while the precise mechanism was unknown, epidemiological evidence supported a connection and suggested vaccine virus replication could cause an inflammatory response. Respondent's expert, Dr.

Chris Liacouras, challenged Dr. Santoro's interpretation and argued that C.G.'s norovirus infection was a more likely cause.

Dr. Santoro died before an expert hearing could be held, and Mr.

Germaine elected to proceed on the written record. Special Master Christian J.

Moran denied compensation, finding that petitioner had not established a persuasive medical theory connecting the third dose of RotaTeq to intussusception. The Special Master noted that the proposed inflammatory mechanism was too general and that the cited epidemiological studies (Weintraub, Yih, Haber, and Koch) did not demonstrate a significant increased risk of intussusception after the third dose of RotaTeq.

Because the first prong of the Althen test failed, the Special Master made no finding on the respondent's alternative causation argument regarding norovirus. Mr.

Germaine sought review in the Court of Federal Claims. Judge Stephen S.

Schwartz sustained the Special Master's decision on June 29, 2021, finding that the rejection of the inflammatory mechanism was not arbitrary or capricious, as the theory was not specific to the third dose and lacked evidence of C.G. experiencing inflammation. Judge Schwartz also found that the Special Master correctly interpreted the epidemiological studies, noting that Haber showed a negative excess risk for the third dose and Koch's findings for the third dose were statistically insignificant.

The motion for review was denied, and judgment was entered for the respondent. Petitioner was represented by Sean F.

Greenwood of Greenwood Law Firm. Respondent was represented by Ryan D.

Pyles of the U.S. Department of Justice.