VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01554
Package ID: USCOURTS-cofc-1_16-vv-01554
Petitioner: Lisa Baker
Filed: 2016-11-11
Decided: 2018-05-11
Vaccine: shingles
Vaccination date: 2014-12-30
Condition: cutaneous T cell lymphoma
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Lisa Baker filed a petition on November 11, 2016, alleging that she developed cutaneous T cell lymphoma (CTCL) as a result of receiving the Hepatitis B and shingles vaccines on December 30, 2014. The shingles vaccine, Zostavax, is not covered by the National Vaccine Injury Compensation Program because it is not listed on the Vaccine Injury Table and is administered only to adults. Therefore, Baker's petition was limited to proving actual causation for the Hepatitis B vaccine. On May 10, 2018, Baker filed a motion to dismiss her own petition, stating that an investigation of the facts and science demonstrated she would be unable to prove entitlement to compensation and that further proceedings would be unreasonable and a waste of resources. She acknowledged that a dismissal would result in a judgment against her, ending her rights in the Program. The public decision does not describe the onset of symptoms, specific medical records, or treatments. The court found that the medical records did not establish causation. Petitioner's experts, Drs. Judy Mikovits and Francis Ruscetti, submitted reports with theories that were found unpersuasive, relied on inapplicable theories, and contained misleading references to medical literature and non-existent factual situations. The court noted that the expert theories were similar to those previously disproven in other cases and did not establish the necessary Althen prongs for off-Table claims. Because Baker failed to demonstrate either a Table injury or actual causation, her case was dismissed for insufficient proof by Chief Special Master Nora Beth Dorsey. Petitioner's counsel was Renee J. Gentry, and respondent's counsel was Althea W. Davis. No award amount was granted as the case was dismissed.

Theory of causation field:
Petitioner Lisa Baker alleged that she developed cutaneous T cell lymphoma (CTCL) as a result of receiving the Hepatitis B and shingles (Zostavax) vaccines on December 30, 2014. The shingles vaccine is not covered by the National Vaccine Injury Compensation Program (NVICP) as it is not on the Vaccine Injury Table. Petitioner's case was therefore limited to proving actual causation for the Hepatitis B vaccine. Petitioner later moved to dismiss her own petition, stating she could not prove entitlement to compensation. The Special Master found that the medical records did not establish causation. Petitioner's experts, Drs. Judy Mikovits and Francis Ruscetti, submitted reports with theories deemed unpersuasive, relying on inapplicable theories and misleading references. The Special Master noted the theories were similar to those disproven in prior cases and failed to meet the Althen prongs for off-Table claims. The case was dismissed for insufficient proof by Chief Special Master Nora Beth Dorsey on May 11, 2018. Petitioner's counsel was Renee J. Gentry; respondent's counsel was Althea W. Davis. No award was made.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-01554-0
Date issued/filed: 2018-06-06
Pages: 3
Docket text: PUBLIC DECISION (Originally filed: 05/11/2018) regarding 36 DECISION of Special Master Signed by Chief Special Master Nora Beth Dorsey. (tlf) Service on parties made.
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Case 1:16-vv-01554-UNJ Document 37 Filed 06/06/18 Page 1 of 3
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
(Filed: May 11, 2018)
* * * * * * * * * * * * * * * UNPUBLISHED
LISA BARKER, *
* No. 16-1554V
Petitioner, *
*
v. * Chief Special Master Dorsey
*
SECRETARY OF HEALTH * Petitioner’s Motion for Dismissal;
AND HUMAN SERVICES, * Insufficient Proof of Causation;
* Hepatitis B; Shingles;
Respondent. * Cutaneous T Cell Lymphoma.
*
* * * * * * * * * * * * * * *
Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School,
Washington, DC, for petitioners.
Althea W. Davis, United States Department of Justice, Washington, DC, for respondent.
DISMISSAL DECISION1
On November 11, 2016, Lisa Baker (“petitioner”) filed a petition pursuant to the National
Vaccine Injury Compensation Program.2 On March 8, 2017, petitioner filed an amended petition
alleging that she developed cutaneous T cell lymphoma (“CTCL”) as a result of the Hepatitis B
(“Hep B”) and shingles vaccines she received on December 30, 2014. Amended Petition, dated
March 8, 2017, at ¶ 12. The information in the record, however, does not show entitlement to an
award under the Program.
1 This decision will be posted on the website of the United States Court of Federal Claims’
website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This
means the Decision will be available to anyone with access to the internet. As provided by
42 U.S.C. § 300aa-12(d)(4)B), however, the parties may object to the published Decision’s
inclusion of certain kinds of confidential information. Specifically, Under Vaccine Rule 18(b),
each party has 14 days within which to request redaction “of any information furnished by that
party: (1) that is a trade secret or commercial or financial in substance and is privileged or
confidential; or (2) that includes medical files or similar files, the disclosure of which would
constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole decision will be available to the public in its current form. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-1 to -34 (2012) (“Vaccine Act” or “the Act”). All citations in this decision
to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa.

Case 1:16-vv-01554-UNJ Document 37 Filed 06/06/18 Page 2 of 3
On May 10, 2018, petitioner moves for a decision dismissing her petition, stating that
“[a]n investigation of the facts and science supporting has demonstrated to the Petitioner that she
will be unable to prove that she is entitled to compensation” and that “to proceed any further
would be unreasonable and would waste the resources of the Court, the respondent, and the
Vaccine Program.” Petitioner’s Motion for Decision Dismissing Their Petition at ¶¶ 1, 2.
Petitioner states that she understands that a decision by the Chief Special Master dismissing her
petition will result in a judgment against her, and that she has been advised that such a judgment
will end all of her rights in the Vaccine Program. Id. at ¶ 3. Petitioner states that she intends to
protect her right to file a civil action. Id. at ¶ 4.
As an initial matter, the shingles vaccine, Zostavax3 does not appear in the Table and is
therefore not covered by the Program. Unlike the hepatitis B vaccine which is routinely
administered to children, Zostavax is for immunization against varicella zoster (shingles) and is
only administered to adults. Previous petitions seeking compensation for injury resulting from
the shingles vaccine have been dismissed. See, e.g., Scanlon v. Sec’y of HHS, No. 13-219V,
2013 WL 5755061 (Fed. Cl. Spec. Mstr. Sept. 27, 2013), aff’d, 114 Fed. Cl. 135 (2013); Nilsen
v. Sec’y of HHS, No. 10-110V, 2010 WL 1753471 (Fed. Cl. Spec. Mstr. Apr. 6, 2010); Doe/44
v. Sec’y of HHS, No. [redacted]V, 2009 WL 3124758 (Fed. Cl. Spec. Mstr. Sept. 25, 2009);
Doe/47 v. Sec’y of HHS, No. [redacted]V, 2009 WL 3416368 (Fed. Cl. Spec. Mstr. Sept. 10,
2009).
To receive compensation under the Program, petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury falling within the Vaccine Injury Table—corresponding
to the vaccination, or (2) that she suffered an injury that was actually caused by the vaccination.
See §§ 13(a)(1)(A) and 11(c)(1). An examination of the record did not uncover any evidence
that petitioner suffered a “Table Injury,” nor does she allege that she suffered a “Table Injury.”
Therefore, petitioner’s burden is to show actual causation, which she can do by filing medical
records or an expert medical opinion in support of her claim. The medical records in this case do
not establish causation. Petitioner also filed expert reports from Drs. Judy Mikovits and Francis
Ruscetti. However, as the undersigned explained during the Rule 5 conference, the theories
proffered by petitioner’s experts were unpersuasive because they relied upon misleading
references to medical literature and factual situations which were non-existent in the instant case.
Rule 5 Order, ECF No. 34, at 2. The undersigned also noted that the theory that “human and
animal DNA containing retroviral nucleic acids” can contribute to the development of CTCL to
be very similar to a theory put forth and disproven in the J.M. et al. omnibus cases See J.M. et
al. v. Sec’y of Health & Human Servs., 2017 WL 7409771 (Fed. Cl. Spec. Mstr. August 31,
2017). Finally, the undersigned noted that even if the expert reports did contain reliable and
scientifically accurate information, they did not provide preponderant evidence of Althen Prongs
II or III. Rule 5 Report at 2-3 (citing Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005)).
Under the Vaccine Act, a petitioner may not receive a Program award based solely on the
petitioner’s claims alone. Rather, the petition must be supported by either medical records or by
3 See Zostavax official website at www.zostavax.com (“Zostavax is a vaccine used for adults 50 years of age or
older to prevent Shingles (also known as zoster).”).
2

Case 1:16-vv-01554-UNJ Document 37 Filed 06/06/18 Page 3 of 3
the opinion of a competent physician. § 13(a)(1). In this case, there are insufficient medical
records supporting petitioner’s claim, and the medical theories espoused by Drs. Mikovits and
Ruscetti are unpersuasive and inapplicable to the instant case.
Accordingly, it is clear from the record in this case that petitioner has failed to
demonstrate either that she suffered a “Table Injury” or that the injuries were “actually caused”
by her December 30, 2014, vaccinations. Thus, this case is dismissed for insufficient proof.
The Clerk shall enter judgment accordingly.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
3