M.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 M.R.K., a minor, filed a petition on April 13, 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 petition was filed by Robert Joel Krakow.
The Secretary of Health and Human Services, represented by Ronalda Elnetta Kosh, filed a report on February 28, 2017, recommending denial of compensation. The Secretary noted the absence of a supporting expert report or medical theory from the petitioners and pointed out that the first symptoms of uveitis were observed more than a year after the third vaccination, questioning the temporal relationship for causation.
The parties engaged in extensive litigation, including the exchange of expert reports. The petitioners filed an expert report by Dr.
Frederick W. Fraunfelder on October 28, 2018.
The respondent filed a responsive report from Dr. Jennifer E.
Thorne on July 3, 2019. The petitioners submitted a responsive report on April 10, 2020, followed by another report from the Secretary on August 21, 2020.
The petitioners subsequently decided not to submit additional expert reports. The case involved numerous extensions for filing briefs and medical records, particularly those from Denmark.
The parties also discussed the possibility of genetic testing, with the petitioners stating they did not have access to data from prior testing performed as part of a research project. On October 6, 2023, the petitioners moved for a decision dismissing their petition, stating they understood this would result in a judgment against them and terminate their rights in the Vaccine Injury Compensation Program.
Special Master Christian J. Moran construed this as a motion for dismissal due to insufficient proof.
The Special Master noted that the evidence weighed against a finding of causation, as the petitioners had not submitted a reliable medical theory under the Althen standard, specifically regarding the temporal relationship between the vaccination and the alleged injury. The Special Master granted the motion to dismiss, and the case was dismissed with prejudice for insufficient proof.
The Clerk was ordered to enter judgment accordingly.
Theory of causation
Petitioners Mette and Soren Rose Kjaer alleged that Hepatitis B vaccinations administered on April 13, May 16, and August 12, 2013, caused their minor child M.R.K. to develop uveitis. The case was dismissed with prejudice for insufficient proof. The petitioners advanced a theory that the vaccines led to the creation of immune complexes, relying on case reports/series, papers using scoring systems of unknown reliability, and articles that did not explain causation. The Special Master, Christian J. Moran, found that the evidence weighed against a finding of causation, as the petitioners had not submitted a reliable medical theory under the Althen standard, particularly concerning the temporal relationship between the vaccination and the alleged injury. The Special Master noted that failure to establish one prong of the Althen test necessarily implies a petitioner cannot establish causation. The public decision does not describe the specific onset of symptoms, diagnostic tests, treatments, or the mechanism of injury beyond the immune complex theory. Expert reports were filed by Dr. Frederick W. Fraunfelder for the petitioners and Dr. Jennifer E. Thorne for the respondent. The petitioners' counsel was Robert Joel Krakow, and the respondent's counsel was Ronalda Elnetta Kosh. The decision was issued on November 3, 2023, following a motion to dismiss filed by the petitioners on October 6, 2023.
Source PDFs
USCOURTS-cofc-1_16-vv-00466