       In the United States Court of Federal Claims
                             OFFICE OF SPECIAL MASTERS
                                            No. 13-631V
                                     Filed: February 23, 2015
                                       (Not to be published)

*************************
DOUGLAS ORTON                                *
as Personal Representative of the Estate of, *
WALTER J ORTON, III                          *
                                             *
                     Petitioner,             *        Ruling on Record; Influenza Vaccine;
       v.                                    *        numbness, tingling, fingertips; parathesias;
                                             *        unsteady gait; Guillain-Barré syndrome
SECRETARY OF HEALTH                          *
AND HUMAN SERVICES,                          *
                                             *
                     Respondent.             *
*************************

Diana Stadelnikas Sedar, Esq., Maglio Christopher and Toale, PA, Sarasota, FL for petitioner.
Gordon E. Shemin, Esq., United States Department of Justice, Washington, DC for respondent.

                UNPUBLISHED DECISION DENYING COMPENSATION1

Gowen, Special Master:

        On August 30, 2013, Douglas Orton filed a petition as personal representative of the estate
of Walter J. Orton, III under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-1 et
seq. (2006) (“Vaccine Act”). Petition at Preamble. Petitioner alleged that Walter J. Orton, III (“Mr.
Orton” or “the decedent”) received an influenza (“flu”) vaccine on October 3, 2011, and as a result
developed Guillain-Barré syndrome (“GBS”) three days later. Id. at ¶ 4. The petition further alleges
that Mr. Orton’s course of GBS progressed rapidly and that on October 23, 2011 he suffered
complete respiratory arrest and passed away after failed resuscitation efforts. Id. at 6.

1
  Because this unpublished decision contains a reasoned explanation for the action in this case, the
undersigned intends to post this decision 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 and note (2006)). In accordance with Vaccine
Rule 18(b), a party has 14 days to identify and move to delete medical or other information, that
satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the rule requirement, a motion
for redaction must include a proposed redacted decision. If, upon review, the undersigned agrees
that the identified material fits within the requirements of that provision, such material will be
deleted from public access.


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      On December 4, 2014, petitioner filed a motion for a ruling on the record. See Petitioner’s
Motion for Decision on the Record (“Motion”). Respondent filed a response to petitioner’s motion
on December 22, 2014. See Response to Petitioner’s Motion for Decision on the Record (“Resp.”).

       The undersigned finds that petitioner has not satisfied his burden of proof as required in an
off-Table claim, and thus is not entitled to compensation.

    I.       Procedural Background

         Petitioner filed an affidavit and medical records from several treating physicians in support
of the petition. See Petitioner’s Exhibits (“Pet. Ex(s).”) 1-10. On December 16, 2013, respondent
filed a Rule 4(c) Report in which she concludes compensation is not appropriate in this case. On
May 7, 2014, the undersigned ordered petitioner to file an expert report addressing the Althen2
criteria, particularly, whether it is medically appropriate to infer vaccine causation when the onset
of the decedent’s GBS occurred within a day, or several days, of receipt of the flu vaccination. See
Scheduling Order, docket no. 21. Petitioner was granted two motions for extension of time to file
an expert report. On December 4, 2014, in lieu of an expert report, petitioner filed a motion for a
decision on the record. Respondent filed a response, thus making this case ripe for a decision.

    II.      Factual History

          Mr. Orton was eighty-four years old when he received a flu vaccination on October 3,
2011. Pet. Ex. 1 at 1. His prior medical history was significant for prostate cancer that was
successfully treated with radiation, non-insulin dependent diabetes, cataract surgery, and a left
knee replacement surgery. Pet. ex. 2 at 2; pet. ex. 6 at 27. Two days after receiving a flu vaccine,
Mr. Orton presented to the emergency department at Millard Fillmore Gates Hospital in Buffalo,
New York complaining of paresthesias3 at the tips of his fingers on both hands, and an unsteady
gait. Id. at 13. The initial impression at the emergency room was that he was experiencing a non-
hemorrhagic cerebral vascular event. Id. at 14. Mr. Orton was discharged home with a consultation
order to complete an acute stroke study and an MRI. Id. at 16.

        A neurology consultation note on October 6, 2011 places the onset of Mr. Orton’s
symptoms of paresthesias and difficulty walking just one day after receipt of a flu vaccine. Id. at
36. An MRI of the brain was unremarkable, however the treating neurologist, Dr. Shakeel,
suspected GBS. Id. at 41. Dr. Shakeel recommended that Mr. Orton be admitted to the hospital for
IVIG treatment, close observation of his respiratory status due to decreasing FVC4 values, and
further consideration of a lumbar puncture procedure to be completed after seven days from the
onset of symptoms. Id.

          Upon admission to the hospital, Mr. Orton’s course of GBS progressed rapidly. On October
2
  Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005).
3
  “An abnormal touch sensation, such as burning, prickling or formication, often in the absence of
an external stimulus.” Dorland’s Illustrated Medical Dictionary 1371 (30th ed. 2003).
4
  Or, Forced Vital Capacity, is a measurement of lung function. Topic Overview, WEBMD (Feb.
20, 2015), http://www.webmd.com/lung/tc/forced-expiratory-volume-and-forced-vital-capacity-
topic-overview.
                                                  2
7, 2011, he was transferred to the Intensive Care Unit and electively intubated. Id. A five-day
course of IVIG5 treatment resulted in no significant improvement. Id. at 375. A lumbar puncture
performed on October 10, 2011 was negative for malignancy. Id. at 147. Five cycles of
plasmapharesis,6 which were completed by October 21, 2011, resulted in some improvement in
his motor strength; however, he still required full ventilator support. Id. at 442. Sadly, on October
23, 2011, Mr. Orton went into heart failure and died. Pet. Ex. 6 at 453.

        Petitioner’s exhibit 9 is a death certificate which lists the immediate cause of death as
asystole due to ventricular tachycardia.7 Pet. Ex. 9 at 1. GBS was listed as one of several
“significant conditions contributing to [Mr. Orton’s] death.” Pet. Ex. 9 at 1.

    III.   Summary of the Parties’ Arguments

        Petitioner has submitted his case for a decision on the medical records alone, without
offering an expert report to set forth a reliable medical theory of causation or to explain a logical
sequence of cause and effect showing that the vaccine in question was the cause of the alleged
injury and death. See Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Neither has
petitioner submitted evidence addressing a medically appropriate timeframe, as is also required
under Althen. Petitioner avers that “[a]fter further analysis of the medical records, science and
expert consultation, [he] will not be filing a medical expert opinion” and would like a decision to
be made on the record as it stands. Motion at ¶ 8.

        Respondent contends that petitioner has failed to meet his burden of proof, as he has not
provided sufficient evidence to establish a more likely than not causal connection between Mr.
Orton’s receipt of the flu vaccine on October 3, 2011, and the onset of his GBS within twenty-four
hours. Resp. at 1-2. Respondent further contends that petitioner has not provided a medical expert
report that advances a theory on causation, a logical sequence of cause and effect, or a medically
appropriate timeframe for the onset of Mr. Orton’s GBS and the flu vaccine at issue here. Resp. at
1-2. Respondent asks the Court to deny petitioner’s claim and dismiss the petition accordingly.
Resp. at 2.

    IV.    Analysis

           a. Applicable Legal Standard

       In order to prevail under the Program, petitioner must prove either a ATable@ injury8 or that
a vaccine listed on the Vaccine Table was the cause-in-fact of an injury. Based on the record as

5
  Intravenous immunoglobulin is a blood product used to treat immune deficiency. Intravenous
Immunoglobulin, MEDSCAPE (Feb. 20, 2015), http://emedicine.medscape.com/article/210367-
overview.
6
  “The removal of plasma from withdrawn blood, with re-transfusion of the replaced plasma into
the donor.” Dorland’s Illustrated Medical Dictionary 1446 (30th ed. 2003).
7
  Aystole is the absence of heartbeat. Id. at 170.
8
  A ATable@ injury is an injury listed on the Vaccine Injury Table, 42 C.F.R. ' 100.3, corresponding
to the vaccine received within the time frame specified.

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a whole, the undersigned finds that petitioner has not established that Mr. Orton suffered a Table
injury, as GBS is not an injury listed on the Vaccine Table. Therefore, petitioner must prove that
the influenza vaccine caused-in-fact the alleged injury.

        The Vaccine Act provides that a special master may not make a finding awarding
compensation based on the claims of petitioner alone, unsubstantiated by medical records or
medical opinion. See ' 13(a)(1). To satisfy his burden of proving causation-in-fact in this case,
petitioner must Ashow by preponderant evidence that the vaccination brought about [the
decedent’s] injury by providing: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for
the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.@
Althen v. Sec=y, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); see also Hines v. Sec=y, HHS, 940
F.2d 1518, 1525 (Fed. Cir. 1991). He must show "that the vaccination was the reason for the
injury. A reputable medical or scientific explanation must support this logical sequence of cause
and effect." Grant v. Sec=y, HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992). Circumstantial evidence
and medical opinions may be sufficient to satisfy the Althen prongs. Capizzano v. Sec=y, HHS,
440 F.3d 1317, 1325 (Fed. Cir. 2006). However, mere temporal association is not sufficient to
prove causation in fact. See Grant v. Sec’y of HHS, 956 F.2d 1144, 1147 (Fed. Cir. 1992).

        When a petitioner alleges an Aoff-Table@ injury, eligibility for compensation is established
when the petitioner demonstrates, by a preponderance of the evidence, that: (1) a vaccine set forth
on the Vaccine Injury Table was received; (2) the vaccine was received in the United States; (3)
the person in question sustained or had significantly aggravated an illness, disease, disability, or
condition caused by the vaccine; and (4) the condition has persisted for more than six months or
resulted in death. See § 11(c).

        Petitioner has established that the decedent did receive a covered vaccine under the Vaccine
Injury Table and that it was received in the United States. See Pet. Ex. 1 at 2. However, petitioner
has failed to establish that the decedent’s GBS, and ultimately his death, was caused by the flu
vaccination at issue.

           b. Althen Prong One

        Under the first prong of Althen, petitioner is required to 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 of the evidence 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 proposed and supported by a
sound and reliable medical or scientific explanation. Knudsen v. Sec’y, HHS, 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 resulting in death. Without a medical theory to elucidate the circumstances by which a
vaccine can cause a particular injury, there is hardly a basis to form a decision on causation.
Especially when, as in the case here, the decedent’s medical records raise questions bearing on

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causation. For example, respondent has submitted that the onset of Mr. Orton’s GBS was within
one day, which respondent contends, is “too short a time period to be medically appropriate to
infer vaccine causation.” See Respondent’s Report at 4. Petitioner has not provided an expert
opinion to indicate why an earlier onset would be reasonable in this case, which would be most
helpful in resolving this question and others raised by the record. As petitioner has not provided a
theory to preponderate the evidence in his favor, Althen prong one fails.

           c. Althen Prong Two

        The second Althen prong 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 HHS, 164 F.3d 1344, 1352 (Fed. Cir. 1999). Impressions from
treating physicians can be probative when evaluating the second Althen factor, as “treating
physicians are likely to be in the best position to determine whether a ‘logical sequence of cause
and effect show[s] that the vaccination was the reason for the injury.’” Capizzano v. Sec’y of HHS,
440 F.3d 1317, 1326 (Fed. Cir. 2006).

        However, in this case, although several of Mr. Orton’s treating physicians attributed his
GBS to the flu vaccination, see, e.g., pet. ex. 6 at 46, 54, 244 and pet. ex. 7 at 215, 218, none
provided an explanation of how receipt of the vaccine specifically caused the decedent’s GBS and
ultimate death. To prove causation under this prong, there must be more than a mere possibility of
a connection. Here, the statements of the decedent’s treating physicians do not go as far as to
provide an explanation of a causal relationship, but merely make note of a temporal relationship
between the vaccination and onset of symptoms, or at most, suggest a possible connection. Where
treating physicians simply indicate “an awareness of a temporal, not causal relationship[,]” a
special master may decline to afford significant weight to those statements. Cedillo v. Sec’y of
HHS, 617 F.3d 1328, 1347 (Fed. Cir. 2010). Accordingly, the undersigned finds the weight of Mr.
Orton’s treating physicians do not provide a sufficient basis to rule in favor of petitioner on Althen
prong two.

           d. Althen Prong Three

        The third Althen prong requires the petitioner to demonstrate that the injury “occurred
within a medically acceptable time frame.” Pafford v. Sec’y of HHS, 451 F.3d 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 HHS, 539 F.3d 1347, 1352 (Fed. Cir. 2008). The appropriateness of
timing of the onset of symptoms is fairly specific to the diagnosis and the alleged vaccine.

        As discussed above, respondent raises the issue of a rapid onset of symptoms of GBS.
While it may be medically acceptable in Mr. Orton’s case for the onset of symptoms of GBS to
occur within one day of receipt of a flu vaccine, the undersigned fact-finder cannot aptly decide
the issue without a medical opinion explaining how the vaccine could trigger the initial symptoms
of GBS within one day. Accordingly, petitioner has failed to meet his burden under Althen prong
three.

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    V.     Conclusion

        The medical records do not provide adequate support for, or an explanation of, a medical
theory to explain the decedent’s death as allegedly caused by GBS. Although petitioner’s treating
physicians noted a temporal relationship between the decedent’s flu vaccination and GBS, they
did not provide an opinion as to a causal relationship. Moreover, an appropriate medical timeframe
to infer vaccine causation is in dispute. The undersigned finds that petitioner has failed to meet his
burden under all three of the Althen prongs and the case must be dismissed.

    The Clerk shall enter judgment accordingly.9


                                                      s/ Thomas L. Gowen
                                                      Thomas L. Gowen
                                                      Special Master




9
  Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party filing a notice
renouncing the right to seek review.
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