VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00382
Package ID: USCOURTS-cofc-1_13-vv-00382
Petitioner: Karen G. Schmidt
Filed: 2015-03-11
Decided: 2015-08-20
Vaccine: influenza
Vaccination date: 2010-10-07
Condition: Guillain-Barré Syndrome
Outcome: compensated
Award amount USD: 20469

AI-assisted case summary:
Karen G. Schmidt filed a petition on March 11, 2015, alleging that she developed Guillain-Barré Syndrome (GBS) in January 2011 after receiving an influenza vaccine on October 7, 2010. The initial decision on March 11, 2015, dismissed the case for insufficient proof of causation. The court found that Ms. Schmidt did not present evidence of a Table injury, nor did she provide expert medical opinions or other persuasive evidence to establish that the flu vaccine caused her GBS. The decision noted that the approximately three-month gap between vaccination and symptom onset was not considered a medically acceptable timeframe, and that a viral gastrointestinal illness occurring two weeks prior to GBS onset was a more likely cause. However, a subsequent stipulation on July 30, 2015, led to a decision awarding attorney's fees and costs. The parties jointly proposed, and the court approved, a lump sum of $20,469.00 payable to Petitioner and her counsel. No reimbursable costs were incurred by Petitioner. The case was then dismissed based on the terms of the stipulation.

Theory of causation field:
unclear

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_13-vv-00382-0
Date issued/filed: 2015-03-11
Pages: 3
Docket text: PUBLIC DECISION (Originally filed: 02/13/2015) regarding 30 DECISION of Special Master Signed by Special Master Brian H. Corcoran. (ag) Copy to parties.
--------------------------------------------------------------------------------
Case 1:13-vv-00382-UNJ Document 31 Filed 03/11/15 Page 1 of 3
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-382V
(Not to be Published)
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
*
KAREN G. SCHMIDT, * Filed: February 13, 2015
*
Petitioner, *
* Special Master Corcoran
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES , * Decision on the Record;
* Insufficient Proof of
Respondent. * Causation; Denial of
* Entitlement; Influenza (“flu”)
* Vaccine; Guillain-Barré
* Syndrome (“GBS”)
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Diana Sedar, Maglio Christopher & Toale, Sarasota, FL, for Petitioner
Justine Walters, U.S. Department of Justice, Washington, DC, for Respondent
DECISION DISMISSING CASE FOR INSUFFICIENT PROOF1
On June 7, 2013, Karen Schmidt filed a petition in the National Vaccine Injury
Compensation Program2 alleging that she developed Guillain-Barré Syndrome (“GBS”) in
1 Because this decision contains a reasoned explanation for my actions in this case, I will post it on the United States
Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205,
116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). 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. (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.A. ' 300aa-10-' 300aa-34
(West 1991 & Supp. 2002). All citations in this decision to individual sections of the Vaccine Act are to 42
U.S.C.A. ' 300aa.
1

Case 1:13-vv-00382-UNJ Document 31 Filed 03/11/15 Page 2 of 3
January of 2011 after receiving the influenza (“flu”) vaccine on October 7, 2010. See Petitioner’s
Motion for Decision on the Record at 1-2 (ECF No. 28).
After gathering and then filing the relevant medical records, Petitioner filed a Statement
of Completion on March 4, 2014. (ECF No. 23). Subsequently, Respondent filed her Rule 4(c)
Report on May 5, 2014. (ECF No. 24). In it, she asserted that an award of compensation was not
appropriate in this matter, because (a) Petitioner did not offer a reputable medical or scientific
theory to causally connect her flu vaccination to the onset of her GBS, and (b) Petitioner had not
shown that the twelve-week time gap between her receipt of the flu vaccine and onset of
Petitioner’s GBS symptoms was a medically accepted temporal relation. ECF No. 24 at 8-9.
After the filing of the Rule 4 Report, the parties participated in a status conference on
May 15, 2014, at which time a deadline of August 13, 2014 was set for the filing of Petitioner’s
expert report. (ECF No. 25). Petitioner subsequently requested an extension of that deadline to
November 12, 2014 (ECF No. 26) which I permitted. On November 12, 2014, Petitioner filed
another motion for extension of time to file the expert report to January 12, 2015, which I also
permitted. (ECF No. 27) Instead of filing an expert report, however, Ms. Schmidt filed a motion
on January 12, 2015 (ECF No. 28) seeking a decision on the record under Vaccine Rule 8(d).
Respondent filed a pleading in response (ECF No. 29). Petitioner did not file a reply, and the
matter is now ripe for resolution.
To receive compensation under the Program, Ms. Schmidt must prove either 1) that she
suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table – corresponding
to one of her vaccinations, or 2) that she suffered an injury that was actually caused by a vaccine.
See §§13(a)(1)(A) and 11(c)(1). An examination of the record, however, did not uncover any
evidence that Ms. Schmidt suffered a “Table Injury.” Further, the record does not contain a
medical expert’s opinion or any other persuasive evidence supporting the conclusion that
Petitioner’s alleged injuries were vaccine-caused. Petitioner has in particular failed to offer
expert or other scientific or medical testimony that the flu vaccine caused Petitioner’s GBS as
opposed to her viral gastrointestinal illness approximately two weeks prior to onset of her
symptoms. There is no evidence in the filed record of any of Petitioner’s treating physicians
linking her GBS to her receipt of the flu vaccination. And the record evidence does not support
the conclusion that the onset of Petitioner’s GBS symptoms, approximately three months after
she received the flu vaccine, occurred in a medically-acceptable timeframe after she received the
flu vaccine.
Under the Vaccine Act, a petitioner is not entitled to a Program award based solely on his
claims alone. Rather, her petition must be supported by either medical records or by the opinion
of a competent physician. §13(a)(1). In this case, there is insufficient evidence in the record for
2

Case 1:13-vv-00382-UNJ Document 31 Filed 03/11/15 Page 3 of 3
Ms. Schmidt to meet her burden of proof. Petitioner’s claim therefore cannot succeed and must
be dismissed. §11(c)(1)(A).
Thus, this case is dismissed for insufficient proof. The Clerk shall enter judgment
accordingly.
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master
3

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DOCUMENT 2: USCOURTS-cofc-1_13-vv-00382-1
Date issued/filed: 2015-08-20
Pages: 2
Docket text: PUBLIC DECISION (Originally filed: 7/30/2015) regarding 36 DECISION Fees Stipulation. Signed by Special Master Brian H. Corcoran. (ag) Copy to parties.
--------------------------------------------------------------------------------
Case 1:13-vv-00382-UNJ Document 39 Filed 08/20/15 Page 1 of 2
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-382V
(Not to be published)
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
*
KAREN G. SCHMIDT, *
* Filed: July 30, 2015
Petitioner, *
* Decision by Stipulation; Attorney’s
v. * Fees & Costs
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Diana L. Stadelnikas Sedar, Maglio Christopher and Toale, PA, Sarasota, FL, for Petitioner
Justine Walters, U.S. Dep’t of Washington, DC, for Respondent
ATTORNEY’S FEES AND COSTS DECISION1
On June 7, 2013, Karen Schmidt filed a petition seeking compensation under the National
Vaccine Injury Compensation Program. On January 12, 2015, Petitioner’s counsel moved for a
decision on the record. On January 28, 2015, Respondent responded, arguing that the case be
dismissed. I then issued a decision dismissing the case for insufficient proof on March 11, 2015.
The parties have now filed a stipulation on July 30, 2015, in which they jointly propose
that Petitioner’s counsel receive a lump sum of $20,469.00, in the form of a check payable to
Petitioner and Petitioner’s counsel. In addition, and in compliance with General Order No. 9,
Petitioner has represented that she did incur any reimbursable costs in proceeding on this petition.
1 Because this decision contains a reasoned explanation for my actions in this case, I will post it on the United States
Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, § 205, 116
Stat. 2899, 2913 (Dec. 17, 2002) (current version at 44 U.S.C. § 3501 (2014)). 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 fourteen 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. Id.

Case 1:13-vv-00382-UNJ Document 39 Filed 08/20/15 Page 2 of 2
I approve the requested amount for attorney’s fees and costs as reasonable. Accordingly,
an award should be made in the form of a check in the amount of $20,469.00 payable jointly to
Petitioner and Petitioner’s counsel, Diana L. Stadelnikas Sedar, Esq. In the absence of a motion
for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER
JUDGMENT in accordance with the terms of the parties’ stipulation.2
IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master
2 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.