F.R.K. v. HHS - Hepatitis B, uveitis (2023)
Case summary [AI summaries can sometimes make mistakes]
Mette and Soren Rose Kjaer, parents and natural guardians of F.R.K., a minor, filed a petition on April 12, 2016, alleging that a series of Hepatitis B vaccinations administered on April 13, May 16, and August 12, 2013, caused their child to develop uveitis. The Secretary of Health and Human Services recommended denial, stating that the petitioners had not provided a medical theory to support causation and that the onset of symptoms occurred more than a year after the third vaccine.
The parties engaged in extensive litigation, including retaining and submitting expert reports from both sides. Petitioners filed an expert report by Dr.
Frederick W. Fraunfelder on October 28, 2018.
The Secretary filed a responsive report from Dr. Jennifer E.
Thorne on July 3, 2019. The petitioners submitted a responsive report on April 10, 2020.
The Secretary filed another report on August 21, 2020. The petitioners faced challenges in obtaining medical records from Denmark and in providing an affidavit regarding genetic testing.
The petitioners, who were living in Denmark and caring for their other child, M.R.K., moved to dismiss their petition on October 6, 2023, understanding that this dismissal would result in a judgment against them and terminate their rights in the National Vaccine Injury Compensation Program. The Special Master granted the motion, dismissing the case with prejudice for insufficient proof, as the petitioners had not established a reliable medical theory under the Althen prongs for causation.
No compensation was awarded. The decision was issued by Special Master Christian J.
Moran.
Theory of causation
Petitioners alleged that Hepatitis B vaccinations administered on April 13, May 16, and August 12, 2013, caused F.R.K. to develop uveitis. The public decision does not describe the specific onset of symptoms or provide details of the medical records, expert reports, or the proposed mechanism of causation beyond stating the petitioners advanced a theory that the vaccines led to the creation of immune complexes and relied on case reports/series, papers using scoring systems of unknown reliability, and articles that did not explain causation. The Secretary argued that the first uveitis symptoms were not noted until more than a year after the third vaccine, and petitioners had not established an appropriate temporal relationship. Petitioners' experts included Dr. Frederick W. Fraunfelder, and respondent's expert was Dr. Jennifer E. Thorne. The Special Master, Christian J. Moran, granted the petitioners' motion to dismiss with prejudice for insufficient proof, finding that the petitioners had not submitted a reliable medical theory under the Althen prongs for causation, specifically failing to establish one prong, which is sufficient for denial. The case was dismissed on November 3, 2023, with no compensation awarded. Attorneys for petitioners were Robert Joel Krakow, and for respondent was Ronalda Elnetta Kosh. The theory was considered off-Table.
Source PDFs
USCOURTS-cofc-1_16-vv-00465