          In the United States Court of Federal Claims
                                 OFFICE OF SPECIAL MASTERS
                                          No. 14-0935V
                                      Filed: April 15, 2016
                                         UNPUBLISHED

****************************
BARBARA PEREZ,                         *
                                       *
                   Petitioner,         *
                                       *       Entitlement; Motion for Decision on the
v.                                     *       Record; Decision Without a Hearing;
                                       *       Influenza (“Flu”); Guillain-Barré
SECRETARY OF HEALTH                    *       Syndrome (“GBS”); Special Processing
AND HUMAN SERVICES,                    *       Unit (“SPU”)
                                       *
                   Respondent.         *
                                       *
****************************
Diana Stadelnikas Sedar, Maglio Christopher and Toale, PA, Sarasota, FL for petitioner.
Lara Ann Englund, United States Dep’t of Justice, Washington, DC, for respondent.

                                               DECISION1

Dorsey, Chief Special Master:

I.      Introduction

       On October 3, 2014, Barbara Perez (“petitioner” or “Ms. Perez”) filed a petition
for compensation under the National Vaccine Compensation Program (“the Program” or
the “Vaccine Act”),2 alleging that she suffered Guillain-Barré syndrome (“GBS”) as a
result an influenza (“flu”) vaccine she received on October 7, 2011. See Petition (“Pet.”)
at 1. On October 30, 2015, petitioner filed a motion for a decision on the record
(“Motion for Decision”). Respondent filed her Rule 4(c) report and a response to the
Motion for Decision on November 2, 2015. After a review of all the evidence, the

1
  Because this unpublished decision contains a reasoned explanation for the action in this case, the
undersigned intends 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). In accordance with Vaccine Rule 18(b), petitioner has 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 from public access.
2
 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
undersigned finds that the medical records and information in the record do not support
a finding that petitioner is entitled to compensation under the Vaccine Act. For the
reasons discussed below, petitioner has failed to demonstrate that she is entitled to
compensation.

II.    Procedural History

       Ms. Perez filed her petition on October 3, 2014. She filed nine sets of medical
records and a Statement of Completion over the next two months. On December 17,
2015, the staff attorney assigned to this case held the initial status conference call.
During the status conference, respondent’s counsel stated that her client was still in the
process of reviewing the medical records to make an assessment of the case.
Additional time was granted for respondent to complete this process. See Order dated
Dec. 17, 2015.

        On June 29, 2015, respondent filed a status report stating that she did not wish
to discuss settlement and proposed filing her Rule 4(c) report by August 28, 2015.
Later that same day, then-Chief Special Master Vowell instead ordered petitioner to file
an expert report in support of her claim so that respondent’s Rule 4(c) report, when
filed, would be based on a review of both petitioner’s medical records and petitioner’s
expert report. See Order dated June 29, 2015. After being granted one extension of
time to file her expert report, petitioner, on October 30, 2015, instead filed a motion for a
decision on the record stating that “[a]fter further analysis of the records, science and
expert consultation, Petitioner will not be filing a medical expert opinion.” Motion for
Decision at 1, ¶5.

        On November 2, 2015, respondent filed her report pursuant to vaccine Rule 4(c)
and a response to the Motion for Decision. Respondent stated that petitioner had not
met her burden of proof under Althen v. Sec’y of Health & Human Servs., 418. F.3d
1274, 1278 (Fed. Cir. 2005), because she did not offer a plausible medical theory or
logical sequence of cause and effect linking the flu vaccination to her condition. See
Respondent’s Rule 4(c) Report and Response dated Nov. 2, 2015, at 6. In addition,
respondent noted that none of Ms. Perez’s treating physicians determined that the flu
vaccine was the likely cause of her GBS and none offered a medical theory connecting
the vaccines to the injury. Id. Finally, respondent argued that Ms. Perez had not shown
an appropriate proximate temporal relationship between the vaccine and the onset of
her GBS. Id. at 6-7. Respondent recommended that compensation be denied. Id. at 7.

       The case is now ripe for decision on the record.




                                              2
III.    Factual History3

       On October 7, 2011, Ms. Perez, who was 57 years-old at the time, received a flu
vaccine. Pet. Ex. 1 at 1. She was employed as a head cook in a nursing home. Pet.
Ex. 6. at 95. On October 26, 2011, petitioner was seen in the emergency room of a
local hospital for a first degree burn on her left forearm while she was at work. Id. at
193. Her wound was dressed, she was prescribed Bacitracin ointment and discharged
home. Id. at 195.

      On November 9, 2011, petitioner was seen in the Emergency Department of
Mercy Regional Medical Center (“Mercy”) for complaints of neck and back pain, fatigue,
soreness, a cough, achiness and an “off/on” low grade fever. Pet. Ex. 7 at 106-14. She
was diagnosed with acute bronchitis. Id. at 108. Petitioner was discharged the same
day and instructed to follow-up with her primary care physician. Id. at 111.

        On February 22, 2012, more than four months after receiving her flu vaccination,
petitioner was seen at Elyria Medical Center (“EMH”) for complaints of chest pain and
tingling in her legs that started at 2 p.m. earlier that day. Pet. Ex. 6 at 27. The
attending physician wanted to admit Ms. Perez, but petitioner decided to go home
instead. Id. Later that same day, Ms. Perez returned via ambulance to EMH for
complaints of worsened chest pain and she was admitted for further evaluation. Id. Ms.
Perez underwent a CT scan of her chest which was suggestive of underlying chronic
obstructive pulmonary disease (“COPD”). Id. at 41-42. Her neurological examination
was otherwise normal. Id. at 121.

       In the medical records that record the history of petitioner’s present illness, it was
noted that Ms. Perez had been experiencing chronic lower back pain for the past three
months, pet. ex. 6 at 31, 95, although in other notations, her back pain was described
as beginning suddenly while she was sleeping. Id. at 163. She also stated that she had
been experiencing intermittent chest pain three to four times daily, five to seven times a
week, for the last year. Id. at 166. Petitioner’s medical records note that she had
undergone myocardial perfusion imaging in April 2011, the results of which were
normal. Id. at 207-08. At the time of examination, Ms. Perez complained of numbness
in both of her arms as well as abdominal pain. Id. at 95. She stated that her pain was
not radiating in her legs at the time of her exam, but that it had previously. Id. The
impression was spinal stenosis and facet joint arthropathy of the lumbar spine. Id. at
96. Ms. Perez was discharged on February 24, 2012. Id. at 93.

       On February 25, 2012, petitioner was seen at Avon Emergency Department for
complaints of back pain, specifically in her tailbone, for one week and lower back pain
that began three months prior. Pet. Ex. 6 at 4-5. She reported that she had been
discharged from EMH the day prior, after being admitted for complaints of chest pain

3
  While the undersigned has considered all the evidence in this case and the record as a whole, the
following is a brief summary of the medical records taken from the record in the case. This is by no
means a complete recitation of all the relevant facts and evidence considered. See § 300aa-13(a)
(stating that the special master should consider the “record as a whole”).

                                                    3
and tailbone pain, but was discharged without medication to manage her pain other
than ibuprofen. Id. at 3. On examination, petitioner had normal strength and sensation.
Id. at 6. She reported feeling slightly better and was discharged with instructions to
follow-up with her physician. Id. at 8.

        On February 27, 2012, petitioner was transported by ambulance from her home
to the emergency room at Mercy. Pet. Ex. 9 at 4. Her husband reported to paramedics
that petitioner began acting confused and weak for approximately an hour prior to their
arrival. Id. The medical records document that petitioner had no facial droop but that
she was slurring her words and acting confused. Id. Petitioner was admitted to Mercy
for evaluation of a possible transient ischemic attack. Pet. Ex. 7 at 181-82.

       On February 27, 2012, petitioner was evaluated by a neurologist, Dr. Norman
Sese, who upon examining petitioner, noted that the deep tendon reflexes were absent
in her knees and ankles. Pet. Ex. 7 at 39. He ordered an MRI of her brain, thoracic and
cervical spine, and noted that her symptoms were highly suggestive of GBS. Id.; Pet.
Ex. 4 at 38-39. Ms. Perez was transferred to University Hospital on February 29, 2012.
Pet. Ex. 12 at 472.

        On admission to University Hospital, Ms. Perez reported a history of chronic back
pain, a one to two week history of altered mental status and difficulty ambulating. Pet.
Ex. 12 at 472. She also stated that she had a “bad upper respiratory infection about 2
weeks ago but no recent gastrointestinal illness in the past few weeks, but is currently
constipated.” Id. at 11. A neurological examination revealed that petitioner had unequal
pupils, a mild left facial droop, and decreased temperature on the left side of her face.
Id. at 12. Petitioner’s reflexes were diminished and the sensation was impaired in her
left leg. Id. The results of her lumbar puncture showed elevated protein levels. Id. at
13. It was noted that petitioner’s symptoms were suggestive of GBS. Id. at 15. She
underwent a five day course of IVIG therapy. Id. at 729.

       Upon discharge on March 12, 2012, petitioner’s mental status and the strength in
her lower extremities had improved. Pet. Ex. 12 at 472-73. She was transferred to
Mercy’s rehabilitation facility and was instructed to follow up with her primary care
physician upon discharge from rehabilitation. Id. at 474.

        From March 12, 2012, until April 11, 2012, petitioner underwent inpatient
rehabilitation at Mercy. Pet. Ex. 7 at 247-891. From April until August 29, 2012,
petitioner continued her physical therapy at Mercy on an out-patient basis. Pet. Ex. 7 at
1-51. Upon discharge on August 29, 2012, it was noted that petitioner had reached a
“functional plateau,” with her physical therapy, but that she was able to function at
home. Id. at 8.

        Petitioner continued to treat with Dr. Sese after her discharge from physical
therapy. At her most recent visit (as noted in the records) on August 19, 2014,
petitioner was able to ambulate with a walker and was taking Gabapentin and Zoloft.
Pet. Ex. 4 at 2-4.


                                            4
IV.    Analysis

          a. Applicable Legal Standard

       The Vaccine Act established the Program to compensate vaccine-related injuries
and deaths. § 300aa-10(a). “Congress designed the Vaccine Program to supplement
the state law civil tort system as a simple, fair and expeditious means for compensating
vaccine-related injured persons. The Program was established to award ‘vaccine-
injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of
Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. REP. No. 908 at 3,
reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).

        To receive compensation under the Vaccine Act, a petitioner must prove either:
(1) that she suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—
corresponding to a vaccine that she received, or (2) that she suffered a “causation-in-
fact” injury, that is an injury that was actually caused by the vaccine she received. See
§§ 300aa-13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y of Health & Human Servs., 440
F.3d 1317, 1319-20 (Fed. Cir. 2006). Petitioner must show that the vaccine was “not
only a but-for cause of the injury but also a substantial factor in bringing about the
injury.” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir.
2010) (quoting Shyface, 165 F.3d at 1352-53 (Fed. Cir. 1994)).

        To establish causation in fact, a petitioner must show by a preponderance of the
evidence that but for the vaccination, petitioner would not have been injured, and that
the vaccination was a substantial factor in bringing about the injury. Cedillo v. Sec’y of
Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010); Shyface v. Sec’y of
Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Proof of actual
causation must be supported by a sound and reliable “medical or scientific explanation
that pertains specifically to the petitioner’s case, although the explanation need only be
‘legally probable, not medically or scientifically certain.’” Moberly, 592 F.3d at 1321
(quoting Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49); see also
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)(medical
theory must support actual cause). “[A] petitioner must demonstrate the reliability of any
scientific or other expert evidence put forth to carry this burden . . . . Expert testimony, in
particular, must have some objective scientific basis in order to be credited by the
Special Master.” Jarvis v. Sec’y of Health & Human Servs., 99 Fed. Cl. 47, 54-55
(2011) (citing Moberly, 592 F.3d at 1322; Cedillo, 617 F.3d at 1339; Terran v. Sec’y of
Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)).

        “The special master…may not make [ ] a finding based on the claims of a
petitioner alone, unsubstantiated by medical records or by medical opinion.” § 300aa-
13(a)(1). Causation is determined on a case-by-case basis, with “no hard and fast per
se scientific or medical rules.” Knudsen, 35 F.3d at 548. A petitioner may use
circumstantial evidence to prove the case, and “close calls” regarding causation must



                                               5
be resolved in favor of the petitioner. Althen v. Sec’y of Health & Human Servs., 418
F.3d 1274, 1280 (Fed. Cir. 2005).

        If there is no Table Injury, petitioners must prove that the vaccine caused J.H.’s
injury. To do so, they must establish, by preponderant evidence: (1) a medical theory
causally connecting the vaccine and the injury (“Althen Prong One”); (2) a logical
sequence of cause and effect showing that a vaccine was the reason for his injury
(“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between
the vaccine and injury (“Althen Prong Three”). Althen, 418 F.3d at 1278; § 300aa–
13(a)(1) (requiring proof by a preponderance of the evidence).

          b. Althen Prong One

       Under the first prong of Althen, petitioner must set forth a reliable medical theory
that explains how a particular vaccination can cause the injury in question. Althen, 418
F.3d at 1279. Scientific certainty is not required to establish causation under the
Vaccine Act. Id. at 1280 (holding that the purpose of the Vaccine Act’s preponderance
standard is “to allow the finding of causation in a field bereft of complete and direct proof
of how vaccines affect the human body”). However, a causation theory or mechanism
must be supported by a sound and reliable medical or scientific explanation. Knudsen
v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994).

        In this case, petitioner has failed to proffer a theory explaining how the flu
vaccine can cause GBS more than four months after the vaccine was administered to
her. Without a medical theory to explain the circumstances by which a vaccine can
cause a particular injury as has been alleged in Ms. Perez’s case, there is no basis to
find in petitioner’s favor. This is especially the case when, as in here, petitioner’s
medical records raise questions bearing on causation. For example, in her Rule 4(c)
report and response to Motion for Decision, respondent notes that not only has
petitioner not proffered a plausible medical theory or logical sequence of events linking
the flu vaccine to her condition, but none of her treating physicians determined that the
vaccine was the likely cause of her GBS, and none offered a theory connecting the
vaccine to her injuries. And importantly, petitioner has failed to set forth a theory
explaining how GBS can result four months after the administration of a flu vaccine. As
Ms. Perez has not offered a theory to preponderate the evidence in her favor, Althen
prong one fails.

          c. Althen Prong Two

        The second prong of Althen requires petitioner to establish that the vaccine was
the reason for the injury – not only a but-for cause of the injury but also a substantial
factor in bringing about the injury. See Shyface v. Sec’y of Health & Human Servs., 164
F.3d. 1344, 1352 (Fed. Cir. 1999). Impressions from treating physicians can be
probative when evaluating the second Althen prong, as “treating physicians are likely to
be in the best position to determine whether a ‘logical sequence of cause and effect



                                              6
show[s] that the vaccination was the reason for the injury.’” Cappizzano v. Sec’y of
Health & Human Servs., 440 F.3d. 1317, 1326 (Fed. Cir. 2006).

       In this case, none of Ms. Perez’s treating physicians attributed her flu vaccination
to her GBS, and thus the undersigned finds that petitioner has not provided a sufficient
basis to rule in her favor on Althen prong two.

          d. Althen Prong Three

        Althen prong three requires Ms. Perez to demonstrate that her injury “occurred
within a medically acceptable time frame.’’ Pafford v. Sec’y of Health & Human Servs.,
451 F.2d 1352, 1358 (Fed. Cir. 2006). Petitioner must establish a proximate temporal
relationship, which “requires preponderant proof that the onset of symptoms occurred
within a timeframe for which, given the medical understanding of the disorder’s etiology,
it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of Health &
Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).

        As respondent has noted, the first symptoms of Ms. Perez’s GBS appear to have
started on February 22, 2012, almost 20 weeks after her October 7, 2011 vaccinations.
She has not offered any argument or expert testimony arguing otherwise. Respondent
cites the IOM’s (Institute of Medicine) finding that “the expected latency between an
antecedent event ... and the first symptom of GBS is mainly between 7 and 21 days.
Occasional cases appear to have latencies between 22 and 42 days.” Respondent’s
Exhibit A at 4. Indeed, claims where petitioners have attempted to seek compensation
for similar types of claims outside of this time frame have failed. See Schmidt v. Sec’y
of Health & Human Servs., No. 13-382V, 2015 WL 1088225 (Fed. Cl. Spec. Mstr. Feb.
13, 2015)(12-week time gap between receipt of flu vaccine and onset of GBS was not a
medically accepted temporal relation); Aguayo v. Sec'y of Health & Human Servs., No.
12–563V, 2013 WL 441013, at *3 (Fed. Cl. Spec. Mstr. Jan. 15, 2013) (three and one-
half months between vaccination and GBS was rejected as too long); Corder v. Sec'y of
Health & Human Servs., No. 08–228V, 2011 WL 2469736, at *27–*29 (Fed. Cl. Spec.
Mstr. May 31, 2011) (proposed four month onset period from vaccination to GBS too
long; two months is longest reasonable timeframe). Without any further support for her
position, petitioner’s claim must also fail on Althen prong three.

V.     Conclusion

       For the reasons discussed above, the undersigned finds that petitioner has not
established entitlement to compensation and her petition must be dismissed.
Therefore, 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


                                             7
