In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
*********************
SAVANNAH SMITHSON, *
* No. 13-735V
Petitioner, * Special Master Christian J. Moran
*
v. *
* Filed: April 9, 2019
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
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Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for petitioner;
Lara A. Englund, United States Dep’t of Justice, Washington, DC, for respondent.
DECISION DISMISSING PETITION1
Ms. Smithson filed her claim for compensation on September 25, 2013.2
Ms. Smithson claimed that HPV vaccines she received on November 5, 2012, and
February 4, 2013, caused her to develop adrenal deficiency and dysautonomia,
which presented as postural orthostatic tachycardia syndrome (POTS). In the years
since 2013, Ms. Smithson has had the opportunity to present reports from
numerous experts and treating physicians in support of her claim of compensation.
However, the reports submitted have continued to struggle to provide preponderate
1
Because this ruling contains a reasoned explanation for the action in this case, the undersigned
is required to post it on the United States Court of Federal Claims' website in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services). This means the ruling will be available to
anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioners have 14
days to identify and move to redact medical or other information, the disclosure of which would
constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the
identified material fits within this definition, the undersigned will redact such material before
posting the ruling.
2
Savannah Smithson’s claim was initially filed by her parents, Chuck and Rhonda Smithson.
Savannah was substituted as petitioner after reaching the age of majority in Arizona. See order,
issued April 26, 2017.
evidence of an association between Ms. Smithson’s vaccinations and the injuries
she alleged. On April 2, 2019, Ms. Smithson moved to dismiss her petition, citing
her conclusion that “she will likely be unable to meet her burden of proof and
establish that she is entitled to compensation in the Vaccine Program.” Because
the undersigned finds that Ms. Smithson has been provided a full and fair
opportunity to present her claim of compensation and agrees with her conclusion
that she cannot prevail on her petition based on the evidence in the record, Ms.
Smithson’s motion is GRANTED and her petition is DISMISSED for insufficient
proof.
Brief Factual and Procedural History
Petitioner filed her statement of completion on October 21, 2013. Shortly
thereafter, respondent filed a status report identifying records that remained
outstanding. Resp’t’s Status Rep., filed Nov. 19, 2013, at 1-3. Petitioner filed the
outstanding records by February 14, 2014.
Once the record was sufficiently complete, the Secretary opposed Ms.
Smithson’s eligibility for compensation under the Vaccine Act. See Resp’t’s Rep.,
filed April 9, 2014, at 10-17. The Secretary argued that the evidence did not
support the conclusion that Ms. Smithson had the condition she alleged and,
furthermore, even if she did, it could not be and was not caused by her HPV
vaccines. Id.
Petitioner filed a brief expert report from Dr. Ramesh Adiraju, a
cardiologist, in support of her claim for compensation on July 11, 2014. Exhibit
14. Dr. Adiraju’s report was incomplete and not persuasive. See order, issued July
25, 2013, at 1. Petitioner filed a supplemental report from Dr. Adiraju on August
15, 2014. Exhibit 16. Dr. Adriraju’s supplemental report was also deficient and,
furthermore, highlighted the need for an immunologist to supplement Dr. Adiraju’s
conclusions. See order, issued Sept. 8, 2014, at 1.
Petitioner filed an expert report from Dr. David Axelrod, an immunologist,
and a second supplemental report from Dr. Adiraju, on October 13, 2014 and
October 21, 2014, respectively. Exhibit 22; exhibit 31. Respondent requested and
was granted the opportunity to submit responsive reports. Order, issued Nov. 5,
2014.
Respondent filed expert reports from Dr. Kenneth Mack, a pediatric
neurologist, and Dr. Arnold Levinson, an immunologist, on February 9, 2015.
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Exhibit A; exhibit C. Perhaps most saliently, both experts noted that there was a
gold-standard test for POTS, a tilt-table test, and that Ms. Smithson had not been
diagnosed using that procedure. Exhibit A at 3; exhibit C at 5. The undersigned
suggested that the parties contact Ms. Smithson’s treating physicians to elicit their
opinions on the correct diagnosis. See order, issued Feb. 12, 2015. The parties
were amenable to this approach and agreed to draft a joint letter. Id.
In the following months, petitioner filed responsive letters from two of Ms.
Smithson’s treating physicians: Dr. Michael Gerber and Dr. Stewart Tatem.
Exhibit 32; exhibit 34. Dr. Gerber’s letter stated that Ms. Smithson was diagnosed
with POTS, though did not reference the diagnostic criteria used, and Dr. Tatem’s
letter indicated that Ms. Smithson had had signs consistent with POTS (i.e.,
elevated heart rate) but did not provide a first-hand account of having diagnosed
her with the condition. Id. Petitioner requested, and was granted, leave to proceed
with responsive reports from her expert witnesses. Order, issued June 30, 2015, at
4. The petitioner’s experts were provided with detailed instructions for how to
address the elements of Ms. Smithson’s case. Id. at 1-4.
Petitioner did not proceed with reports from her original two experts, Dr.
Adiraju and Dr. Axelrod, but instead provided a report from Dr. Patrick
Nemechek, an internal medicine specialist. Exhibit 39. The undersigned raised
several concerns about deficiencies in Dr. Nemechek’s report and granted
petitioner leave to have Dr. Nemechek prepare a supplemental report to address
these concerns. Order, issued Sept. 16, 2015, at 1-3. Dr. Nemechek was especially
encouraged to address Ms. Smithson’s pre-vaccination state, the lack of tilt-table
testing with regards to her diagnosis, and the appropriate timing between the
vaccine and the onset of dysautonomia under her proposed theory of causation. Id.
The undersigned also ordered petitioner to supplement Dr. Adiraju and Dr.
Axelrod’s reports to address the previously-identified deficiencies in the case that
petitioner intended to rely on either of their reports at a hearing. Id.
In a status report filed on December 2, 2015, petitioner stated that she
intended to proceed with Dr. Nemechek as her only witness and would not rely on
the reports submitted by Dr. Adiraju and Dr. Axelrod. On December 2, 2015,
petitioner filed the supplemental report from Dr. Nemechek. Exhibit 110. During
a status conference on January 19, 2016, the undersigned communicated various
concerns about the contents of Dr. Nemechek’s reports and his failure to address
various elements of petitioner’s claim for compensation. See order, issued Jan. 27,
2016.
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After multiple enlargements of time were requested and granted, respondent
filed responsive reports from both Dr. Mack and Dr. Levinson on August 22, 2016.
Exhibit E; exhibit G. Both reports were, persuasively, critical of Dr. Nemechek’s
most recent report, noting numerous instances where Dr. Nemechek made
conclusions based on facts not in the record and relied on inferences that were not
scientifically plausible. See id.
Following the submission of respondent’s expert reports in August 2016,
efforts were undertaken by petitioner and her expert, Dr. Nemechek, to perform
diagnostic testing on Ms. Smithson that would be able to show that she suffered
from dysautonomia. See order, issued Sept. 15, 2016. Petitioner filed the results
of this testing on January 10, 2017. Exhibit 125. This testing, which was
performed by Dr. Nemechek, alleged showing that Ms. Smithson suffered from
“substantial parasympathetic damage” and “inadequate sympathetic function.” Id.
While the results of the autonomic testing were potentially relevant and helpful, it
was noted during the February 7, 2017 status conference that Dr. Nemechek’s
report had failed to address the concerns raised by respondent’s expert in his most
recent report. Order, issued Feb. 7, 2017. Petitioner was offered an opportunity to
supplement Dr. Nemechek’s expert report. Id. In a status report filed on April 3,
2017, petitioner stated that she had “conferred with Dr. Nemechek and determined
that no additional report from Dr. Nemechek is needed or will be forthcoming.”
She further noted that the concerns raised by respondent’s expert would “be
addressed in pre-hearing briefing.” On May 16, 2017, Ms. Smithson’s petition was
set for a three-day hearing to be held May 21, 2018 to May 23, 2018, in
Washington, D.C.
Three months before the hearing was scheduled to occur, petitioner
requested a status conference. During the status conference, held on February 22,
2018, petitioner stated that she was no longer confident in her expert’s ability to
opine in support of her claim for compensation. Order, issued Feb. 23, 2018. As a
result, petitioner requested that the hearing be cancelled so that she could obtain an
expert report from a new expert. Id. Petitioner’s request was granted, and
petitioner was given until April 27, 2018 to file a report from a new expert witness.
Petitioner filed an expert report from her fourth, and final, expert, Dr.
Mitchell Miglis, on April 3, 2018. Exhibit 127. A status conference was held on
May 8, 2018, to discuss Dr. Miglis’ report. During the status conference,
petitioner was ordered to have Dr. Miglis supplement his initial report with
additional information on the diagnostic testing used to diagnose Ms. Smithson
with dysautonomia and furthermore to state the basis for his association of the
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HPV vaccine and dysautonomia. Order, issued May 9, 2018. Petitioner filed a
supplemental report from Dr. Miglis on July 16, 2018. Exhibit 141. During a
status conference on October 16, 2018, the undersigned emphasized that while Dr.
Miglis had provided some evidence to conclude that POTS has an autoimmune
etiology, there did not appear to be support for his conclusion that the HPV vaccine
could cause the autoimmune process that would give rise to POTS. Order, issued
Oct. 17, 2018, at 1.
Respondent filed a final set of reports from Dr. Levinson and Dr. Mack on
November 9, 2018. Exhibit H; exhibit I.
During a November 29, 2018 status conference to discuss next steps, the
undersigned communicated concerns about petitioner’s case. Most importantly,
the undersigned noted that “without evidence associating the HPV vaccination to
POTS, Ms. Smithson cannot be awarded compensation.” Order, issued Nov. 29,
2018, at 1 (citing Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355,
1365 (Fed. Cir. 2012)). The undersigned identified a recent decision by Special
Master Corcoran that evaluated claims very similar to petitioner’s and indicated
that the analysis by Special Master Corcoran appeared to be sound. Id. at 2 (citing
Johnson v. Sec'y of Health & Human Servs., No. 14-254V, 2018 WL 2051760, at
*37-41 (Fed. Cl. Spec. Mstr. Mar. 23, 2018)). Petitioner requested, and was
granted, time to consult with her attorney and consider her next steps. Id. at 2.
On April 2, 2019, petitioner filed the present motion for her petition to
dismissed.
Analysis and Conclusion
Petitioners are required to establish their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence
standard requires a “trier of fact to believe that the existence of a fact is more
probable than its nonexistence before [he] may find in favor of the party who has
the burden to persuade the judge of the fact’s existence.” Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations
omitted). In other words, Ms. Smithson must prove that, more likely than not, that
she was injured by her vaccinations.
The facts of Ms. Smithson’s case do not allow the undersigned to find that
the evidence preponderates in favor of Ms. Smithson’s claim that her vaccinations
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caused her to develop dysautonomia, POTS, or any related conditions. As noted
throughout the pendency of this proceeding, the evidence submitted by Ms.
Smithson failed to provide persuasive evidence supporting her claim that HPV
vaccinations can cause dysautonomia, POTS, or any other underlying autoimmune
disorder she may suffer from. Furthermore, the evidence failed to establish that
the vaccinations did cause the conditions she alleges she suffers from.
For these reasons, the undersigned finds that Ms. Smithson has been
provided a full and fair opportunity to present her case of a vaccine injury.
Furthermore, the undersigned finds that the evidence entered by Ms. Smithson is
not sufficient to meet her statutory burden for proving a compensable vaccine
injury. Accordingly, Ms. Smithson’s petition is DISMISSED pursuant to Vaccine
Rule 8(d).
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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