L.I. v. HHS - Hepatitis A, inflammatory bowel disease (2025)
Case summary [AI summaries can sometimes make mistakes]
Rivka and Mordechie Iliovits, parents and natural guardians of L.I., a minor, filed a petition on August 18, 2021, alleging that a hepatitis A vaccine L.I. received on August 22, 2018, caused her to develop inflammatory bowel disease (IBD) within 19 days. The petitioners submitted medical records and affidavits.
On January 21, 2025, they filed an expert report from Dr. Wanda Phipatanakul, a board-certified allergist/immunologist, who opined that the hepatitis A vaccine led to L.I.'s IBD through potential mechanisms such as molecular mimicry, immune response dysregulation, or epitope mimicry, and that 19 days was an acceptable timeframe for IBD onset.
On February 10, 2025, they filed an expert report from Dr. W.
Michael McDonnell, a gastroenterologist, who opined that L.I.'s diagnosis was IBD. The Secretary of Health and Human Services filed a report on August 23, 2024, contesting entitlement and arguing that the petitioners had not provided preponderant evidence of causation satisfying the Althen prongs, nor sufficient medical evidence or an expert report supporting causation.
On April 10, 2025, the respondent filed expert reports from Dr. Andrew J.
MacGinnitie, a board-certified allergist/immunologist, and Dr. Subra Kugathasan, a board-certified pediatric gastroenterologist.
Dr. MacGinnitie opined that the petitioners provided no support for how the proposed mechanisms of the hepatitis A vaccination could cause IBD and disputed the timing of IBD onset.
Dr. Kugathasan opined that L.I.'s IBD diagnosis was not related to her vaccination.
The petitioners did not submit any supplemental expert reports. On June 27, 2025, the petitioners moved for a decision dismissing their petition.
Special Master Christian J. Moran granted the motion, finding that the petitioners had failed to meet their burden of proof by a preponderance of the evidence to show a medical theory connecting the vaccine to the injury, a logical sequence of cause and effect, and a proximate temporal relationship, as required by Althen v.
Sec’y of Health & Hum. Servs.
The case was dismissed with prejudice for insufficient proof.
Theory of causation
Petitioners alleged that the hepatitis A vaccine administered on August 22, 2018, caused L.I. to develop inflammatory bowel disease (IBD) within 19 days. Petitioners' experts, Dr. Wanda Phipatanakul and Dr. W. Michael McDonnell, opined that the vaccine caused IBD through mechanisms including molecular mimicry, immune dysregulation, or epitope mimicry, and that the 19-day onset was acceptable. Respondent's experts, Dr. Andrew J. MacGinnitie and Dr. Subra Kugathasan, disputed the proposed mechanisms, the timing of onset, and the causal link between the vaccine and the IBD diagnosis. The Special Master found that petitioners failed to provide preponderant evidence of a medical theory connecting the vaccine and injury, a logical sequence of cause and effect, or a proximate temporal relationship, as required by Althen. Petitioners subsequently moved to dismiss their own case. The case was dismissed with prejudice for insufficient proof. Attorneys for petitioner were Robert Joel Krakow, Law Office of Robert J. Krakow, P.C. Attorneys for respondent were Julianna Rose Kober, United States Dep’t of Justice. Special Master was Christian J. Moran. Decision date was July 31, 2025. The theory of causation was off-Table.
Source PDFs
USCOURTS-cofc-1_21-vv-01727