VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00465
Package ID: USCOURTS-cofc-1_16-vv-00465
Petitioner: F.R.K.
Filed: 2016-04-12
Decided: 2023-11-03
Vaccine: Hepatitis B
Vaccination date: 
Condition: uveitis
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
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 field:
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.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-00465-0
Date issued/filed: 2023-11-03
Pages: 4
Docket text: PUBLIC DECISION (Originally filed: 10/12/23) regarding 188 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made.
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Case 1:16-vv-00465-UNJ Document 189 Filed 11/03/23 Page 1 of 4
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
* * * * * * * * * * * * * * * * * * * * * * * * *
METTE ROSE and SOREN ROSE KJAER, *
parents and natural guardians of F.R.K., a * No. 16-465V
minor, *
*
Petitioners, * Special Master Christian J. Moran
*
v. *
* Filed: October 12, 2023
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Robert Joel Krakow, Law Office of Robert J. Krakow, P.C., New York, NY for petitioners;
Ronalda Elnetta Kosh, United States Dep’t of Justice, Washington, D.C., for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Mette Rose and Soren Rose Kjaer (“the Roses”) alleged that a series of Hepatitis B
vaccinations on April 13, May 16, and August 12, 2013 caused their child F.R.K. to develop
uveitis. Pet., filed Apr. 12, 2016 at 3. On October 6, 2023, the Roses moved for a decision
dismissing their petition.
I. Procedural History
The Roses filed their petition on behalf of F.R.K. on April 12, 2016. They also filed
relevant medical records and affidavits. Around the same time, the Roses also filed a petition on
behalf of their other child, M.R.K., for alleged uveitis caused by the Hepatitis B vaccine. Case
No. 16-466V. The cases were litigated simultaneously.
The Secretary filed his Rule 4(c) Report on February 28, 2017, recommending that
compensation be denied. The Secretary stated that petitioners had not provided an expert report
or medical theory to support their claim that one or more Hepatitis B vaccines caused F.R.K
injury. Resp’t’s Rep. at 11. The Secretary further noted that F.R.K.’s first uveitis symptoms
1
Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This
means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b),
the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. Any changes will appear in the document posted on the website.

Case 1:16-vv-00465-UNJ Document 189 Filed 11/03/23 Page 2 of 4
were not noted until more than a year after her third vaccine, and argued that petitioners had not
established that this was an appropriate temporal relationship to injury causation. Id.
A status conference was held on March 17, 2017, to discuss the next steps in the case.
The Roses decided to retain an expert. See Order, issued Mar. 20, 2017. The Roses were also
ordered to file their VAERS report; any results of genetic testing; any records from a genetic
counselor; and any additional records as they became available. Id. The parties discussed the
possible existence of videotapes to help determine the onset of F.R.K.’s vision issues. Id.
After eleven extensions, the Roses filed an expert report by Dr. Frederick W. Fraunfelder
on October 28, 2018. Exhibit 26. The Secretary’s expert had since retired, and so additional
time was necessary to retain a new expert. See Order, issued Nov. 20, 2018. After two
extensions, the Secretary filed a responsive report from Dr. Jennifer E. Thorne on July 3, 2019.
Exhibit A. The Roses submitted a responsive report on April 10, 2020 after eight extensions.
Exhibit 51. The Secretary filed another report on August 21, 2020, and the Roses decided not to
submit any additional expert reports. Exhibit C; Pet’rs’ Status Rep., filed Oct. 23, 2020.
The undersigned issued an order for briefs on November 24, 2020. The Roses were
ordered to file additional medical records by January 25, and their brief and prehearing materials
by March 2, 2021. The Roses were granted additional time to file their brief and records, many
of which were from providers in Denmark. Order, issued April 7, 2021. The Roses submitted
their brief on June 30, 2021 and continued to work towards obtaining their outstanding records.
They submitted records for M.R.K. in their other case, but never filed updated records for F.R.K.
The Secretary filed his brief on November 12, 2021, and petitioners replied on January 12, 2022.
On October 24, 2022, the undersigned issued an order stating that the case would proceed
to oral argument to determine whether testimony was necessary. The Roses were ordered to
submit an affidavit regarding genetic testing, and the Secretary was ordered to file a motion
requesting genetic testing or a status report disclaiming an interest in such. The Roses, who were
living in Denmark and busy caring for their children’s health, were granted four extensions to
file their affidavit. See Order, issued April 3, 2023. Although the Roses had not yet filed their
affidavit, the Secretary filed a status report on March 27, 2023, disclaiming any interest in
seeking additional genetic testing but requesting that a complete and certified set of records of
any previous genetic testing be provided. The Roses stated that some genetic testing had been
performed as a part of a research project, but they did not have access to the data or a report
showing the results. Pet’rs’ Status Rep. filed April 17, 2023.
Nine days later, the Roses asked their attorney informally by email to withdraw their
petition due to the pressing circumstances of illness and hospitalization of their other child,
M.R.K. Pet’rs’ Status Rep. filed April 26, 2023. Counsel requested 30 days to clarify with the
Roses that they wished to terminate their petitioner. A status conference was held on May 4 to
discuss the next steps. The undersigned noted that the case could proceed without much direct
involvement from the Roses, but that continuation would not necessarily result in an award of
compensation. Counsel requested until early June to confer with the Roses about their intent to
continue litigating the case. See Order, issued May 4, 2023.
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Case 1:16-vv-00465-UNJ Document 189 Filed 11/03/23 Page 3 of 4
Counsel made several attempts to obtained signed confirmation that the Roses wished to
withdraw their petition and that they understood that withdrawal would terminate their rights in
the Vaccine Injury Compensation Program. See Order, issued Sept. 19, 2023. After counsel
received these documents, the Roses filed a motion for a decision dismissing the petitioner on
October 6, 2023, along with a declaration confirming their intent. Exhibit 63. The Roses
simultaneously moved to dismiss the case brought on behalf of M.R.K. The Roses state that
they understand that dismissal will result in a judgment against them, which will terminate their
rights in the Program. Pet’rs’ Mot. to Dismiss at 2. The Secretary did not file a response to this
motion. This matter is now ready for adjudication.
II. Analysis
To receive compensation under the National Vaccine Injury Compensation Program
(hereinafter “the Program”), a petitioner must prove either 1) that the vaccinee suffered a “Table
Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding to one of the
vaccinations, or 2) that the vaccinee suffered an injury that was actually caused by a vaccine.
See §§ 300aa-13(a)(1)(A) and 300aa-11(c)(1). Under the Act, a petitioner may not be given a
Program award based solely on the petitioner’s claims alone. Rather, the petition must be
supported by either medical records or by the opinion of a competent physician. § 300aa-
13(a)(1).
In this case, the Roses have filed some medical records, two expert reports, and briefs in
support of their claim, but nonetheless, wish to have their claim dismissed and judgment entered
against them. Though the Roses did not cite to a specific rule when filing this motion, the
undersigned will construe this as a motion filed pursuant to 42 U.S.C. § 300aa—21(b) (regarding
involuntary dismissal), given the Roses’ intent that a judgment be issued against them. See
Pet’rs’ Mot. to Dismiss at 2.
To conform to section 12(d)(3), a decision must “include findings of fact and conclusions
of law.” Here, although the parties were in the process of presenting arguments, the evidence
weighs against a finding that F.R.K.’s uveitis was caused by the Hepatitis B vaccinations, as the
Roses have not submitted a reliable medical theory under Althen prong one. The Roses advance
the theory that the vaccines led to the creation of immune complexes, and rely heavily on case
reports/series, papers using scoring systems of unknown reliability, and articles which do not
explain causation. See Hazlehurst v. Sec'y of Health & Hum. Servs., 604 F.3d 1343, 1347, 1354
(Fed. Cir. 2010) (no error in special master’s decision to discount opinion of doctor who relied
heavily upon unreliable studies). An analysis of the other Althen prongs is not necessary. See
W.C. v. Sec'y of Health & Hum. Servs., 704 F.3d 1352, 1358 (Fed. Cir. 2013) (because a
petitioner must establish all three prongs, failure to establish one prong necessarily implies a
petitioner cannot establish causation under Althen).
Thus, the Motion for Decision is GRANTED and this case is DISMISSED WITH
PREJUDICE for insufficient proof. The Clerk shall enter judgment accordingly. See
Vaccine Rule 21(b).
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Case 1:16-vv-00465-UNJ Document 189 Filed 11/03/23 Page 4 of 4
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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