            In the United States Court of Federal Claims
                                           No. 16-185
                                (Filed Under Seal: May 27, 2020)
                                     Reissued: June 17, 20201

                                               )
    CHRISTIE KIRBY,                            )
                                               )
                       Petitioner,             )
                                                       Vaccine Case; Motion for Review;
                                               )
                                                       Influenza Vaccine; Radial Nerve Injury;
    v.                                         )
                                                       Radial Neuritis; Injection Injury; Althen;
                                               )
                                                       Burden of Proof; Causation; Severity
    SECRETARY OF HEALTH AND                    )
                                                       Requirement.
    HUMAN SERVICES,                            )
                                               )
                       Respondent.             )
                                               )

Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.

Daniel Anthony Principato, Vaccine/Torts Branch, Civil Division, United States Department of
Justice, Washington, DC, for respondent.

                                           OPINION

SMITH, Senior Judge

        Respondent, Secretary of the Department of Health and Human Services, seeks review of
a decision issued by Special Master Daniel T. Horner awarding the petitioner, Christie Kirby,
damages for vaccine injury compensation. Petitioner brought this action pursuant to the National
Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 to -34 (2012) (“Vaccine Act”), alleging
that the influenza (“flu”) vaccine that she received on October 8, 2013, caused her pain and
numbness in her right arm. On November 1, 2019, the Special Master issued a ruling on
entitlement in favor of the petitioner, finding that the petitioner suffered a right radial nerve
injury that was caused-in-fact by the injection of her flu vaccination. Kirby v. Sec’y of Health
and Human Servs., No. 16-185, 2019 WL 6336026 (Fed. Cl. Spec. Mstr. Nov. 1, 2019)
(hereinafter “Kirby”). On December 30, 2019, respondent filed a proffer on award of
compensation, to which petitioner agreed. See generally Proffer, ECF No. 67. That same day,
the Special Master awarded the petitioner compensation pursuant to the terms of that proffer.
See generally Decision of the Special Master, ECF No. 68. Respondent now moves the Court to
review the Special Master’s November 1, 2019 decision on entitlement. For the reasons that
follow, the Court GRANTS respondent’s Motion for Review and REVERSES the Ruling on
Entitlement by the Special Master.
1
        An unredacted version of this opinion was issued under seal on May 27, 2020. The
parties were given an opportunity to propose redactions, but no such proposals were made.
    I.      Background

         A brief recitation of the facts provides necessary context.2

        Petitioner’s prior medical history is unremarkable with respect to symptoms or conditions
potentially related to petitioner’s alleged vaccine injury, which she claims occurred on October
8, 2013. Additionally, the Special Master’s decision does not note any pre-existing conditions or
injuries related to petitioner’s right arm prior to the alleged vaccine injury. Rather, petitioner’s
medical records indicate that, in 2007, Ms. Kirby injured her left ankle and fractured her left
wrist during a fall, the latter of which was treated with a fiberglass cast. Beginning in 2009,
petitioner sought treatment for her left ankle, including a surgical procedure to treat that injury in
March of 2009. Though subsequent treatment failed to alleviate her pain, petitioner continued to
seek treatment for her ankle up to and after the alleged vaccine injury occurred in October of
2013, which is reflected in her medical records.

        On October 8, 2013, Ms. Kirby received a seasonal flu vaccination in her right deltoid
muscle at the Department of Corrections, her place of employment. One week later, on October
15, 2013, petitioner saw Jennifer Chandler, Nurse Practitioner (“NP”), at Pike Bowling Green
Clinic. At that appointment, Ms. Kirby complained of persistent right arm numbness and
tingling that she began experiencing one week prior. NP Chandler reviewed and examined
petitioner’s musculoskeletal system3 and noted the presence of myalgia.4 Based on that physical




2
        As the basic facts here have not changed significantly, the Court’s recitation of the
background facts herein draws from the Special Master’s earlier decision in Kirby v. Secretary of
Health and Human Services, No. 16-185, 2019 WL 6336026 (Fed. Cl. Spec. Mstr. Nov. 1,
2019), including the exhibits cited therein.
3
        The musculoskeletal system is “the muscles (muscular system) and the bones and joints
(skeletal system) of the body, considered as one unit.” Musculoskeletal system, Dorland’s
Medical Dictionary (hereinafter “Dorland’s”),
https://www.dorlandsonline.com/dorland/definition?id=111871 (last visited May 14, 2020).
4
        Myalgia is defined as “pain in a muscle or muscles.” Myalgia, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=32592 (last visited May 14, 2020).
                                                   2
examination, NP Chandler diagnosed petitioner as having right arm paresthesia5 and prescribed a
Depo-Medrol-Methylprednisolone acetate6 injection, prednisone7 packet, and ibuprofen.

        Between October 16, 2013, and November 7, 2013, petitioner saw Dr. Gregory L. Henry,
D.O., at the Hannibal Regional Medical Group Occupational Medicine on three separate
occasions, complaining of moderate, persistent pain and numbness in her upper right arm that
radiated8 into the right side of her neck and down to her right hand and fingers. During the first
visit, Dr. Henry noted “decreased radial nerve distribution regarding light touch and reduced
muscle strength in petitioner’s right upper extremity.” Dr. Henry ordered a routine muscle test9
and a limited electromyography10 (“EMG”) with nerve conduction study11 to test for a radial12



5
         Paresthesia is “an abnormal touch sensation, such as burning, prickling, or formication,
often in the absence of an external stimulus.” Paresthesia, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=37052 (last visited May 14, 2020).
6
         Depo-Medrol is the “trademark for preparations of methylprednisolone acetate.”
Depo-Medrol, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=13281&searchterm=Depo-Medrol
(last visited May 14, 2020). Methylprednisolone acetate is “the 21-acetate ester of
methylprednisolone, administered topically as an antiinflammatory, by intramuscular injection in
replacement therapy for adrenocortical insufficiency, and by intra-articular, intramuscular,
intralesional, or soft-tissue injection as an antiinflammatory and immunosuppressant in a wide
variety of disorders.” Methylprednisolone acetate, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=89217 (last visited May 14, 2020).
7
         Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as
an antiinflammatory and immunosuppressant in a wide variety of disorders.” Prednisone,
Dorland’s, https://www.dorlandsonline.com/dorland/definition?id=40742 (last visited May 14,
2020).
8
         To radiate is “to diverge or spread from a common point.” Radiate, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=42722 (last visited May 14, 2020).
9
         A muscle test, or “manual muscle test” is when a “therapist manually puts the patient’s
body part through a range of motion and records the extent of function and limitations.” Manual
Muscle Test, Dorland’s, https://www.dorlandsonline.com/dorland/definition?id=112750 (last
visited May 14, 2020).
10
         Electromyography is defined as “an electrodiagnostic technique for recording the
extracellular activity (action potentials and evoked potentials) of skeletal muscles at rest, during
voluntary contractions, and during electrical stimulation performed using any of a variety of
surface electrodes, needle electrodes, and devices for amplifying, transmitting, and recording the
signals.” Electromyography, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=15854&searchterm=electromyography
(last visited May 14, 2020).
11
         A nerve conduction study (electroneurography) is “the measurement of the conduction
velocity and latency of peripheral nerves.” Electroneurography, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=15860 (last visited May 14, 2020).
12
         Radial is defined as “pertaining to the radius” Radial, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=42718 (last visited May 14, 2020).
                                                 3
nerve injury. Dr. Henry also noted that petitioner may require Magnetic Resonance Imaging13
studies of the right brachium14 for possible abscess15 formation and of the neck for petitioner’s
radicular16 pain. Based on his examination of Ms. Kirby, Dr. Henry diagnosed petitioner as
“having a complication due to vaccination, infection following immunization, and radial
neuritis.”

        On October 23, 2013, during a second visit, Dr. Henry again examined petitioner, who
complained of a persistent pattern of pain over the prior fifteen days, which she described as
mild to moderate and characterized as throbbing, aching, and feeling weak. Upon examining the
petitioner, Dr. Henry noted that, while Ms. Kirby’s strength had improved in her right arm, her
right thumb was numb and she had a knot at the injection site. Dr. Henry found normal strength
and tone in petitioner’s right wrist and “normal grip strength and range of motion in her hand.”

        During petitioner’s November 7, 2013 doctor’s visit, she reported experiencing a
persistent pattern of mild to moderate pain in her upper right arm over the prior thirty days and
stated that she had numbness in her right thumb. During that visit, petitioner informed Dr. Henry
that she had returned to working regular duties despite her hand and wrist feeling very weak, and
that she could not write for long periods of time. Upon examining Ms. Kirby, Dr. Henry found
decreased sensation in the dorsum17 of her right thumb and mild tenderness over the spiral
groove. Dr. Henry prescribed a routine physical therapy evaluation and treatment for post
vaccination radial neuritis,18 a routine limited EMG with nerve conduction study, and a routine
EMG one-limb muscle test for radial neuropathy post-vaccination.


The radius is “the bone on the outer or thumb side of the forearm.” Radius, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=42874
(last visited May 14, 2020).
13
         Magnetic resonance imaging (“MRI”) is “a method of visualizing soft tissues of the body
by applying an external magnetic field that makes it possible to distinguish between hydrogen
atoms in different environments.” Magnetic resonance imaging, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=81954 (last visited May 14, 2020).
14
         Brachium is defined as the “arm: the part of the upper limb from shoulder to elbow.”
Brachium, Dorland’s, https://www.dorlandsonline.com/dorland/definition?id=6767 (last visited
May 14, 2020).
15
         Abscess is “a localized collection of pus within tissues, organs, or confined spaces.”
Abscess, Dorland’s, https://www.dorlandsonline.com/dorland/definition?id=185 (last visited
May 14, 2020).
16
         Radicular means “of or pertaining to a root or radicle.” Radicular, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=42733 (last visited May 18, 2020).
17
         Dorsum refers to “1. the back. 2. the aspect of an anatomic part or structure
corresponding in position to the back; posterior, in the human neck, trunk, and limbs.” Dorsum,
Dorland’s, https://www.dorlandsonline.com/dorland/definition?id=14818&searchterm=dorsum
(last visited May 18, 2020).
18
         Neuritis is defined as “inflammation of a nerve, with pain and tenderness, anesthesia and
parasthesias, paralysis, wasting, and disappearance of the reflexes.” Neuritis, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=33645&searchterm=neuritis
(last visited May 14, 2020).
                                                 4
        On November 12, 2013, per Dr. Henry’s referral, petitioner met with Brock Mitchell, a
physical therapist at Advance Physical and Sports Medicine, for an initial evaluation. There,
petitioner reported having no prior injury, but she noted having a lot of arm pain and hand
weakness two days after she received the flu shot. The physical therapist noted that petitioner
would require physical therapy in conjunction with a home exercise program in order to address
her problems and achieve the goals discussed during their visit. He also stated that the expected
length of therapy required to treat Ms. Kirby’s condition would be one month.

        Between November 13, 2013, and December 10, 2013, Ms. Kirby completed eleven
physical therapy sessions. By the end of the sixth session, she was able to complete treatment
without complaints of pain or difficulty and was on schedule to achieve her recovery goals. On
December 10, 2013, Ms. Kirby was discharged from rehabilitative therapy, having largely met
all her goals. Except for a 4/5 score on her right thumb extension muscle testing, Ms. Kirby
scored 5/5 on all muscle testing, having previously scored 4/5 during her initial assessment in
November of 2013. Upon discharge, the physical therapist recorded Ms. Kirby’s pain as a 0/10
rating, although she still reported numbness.

        On November 14, 2013, amid attending physical therapy sessions, petitioner visited Dr.
Boris Khariton, M.D., P.C., for a motor nerve study. Dr. Khariton noted that petitioner had right
arm pain as well as right thumb numbness and tingling since October of 2013. Upon examining
the petitioner, Dr. Khariton concluded that Ms. Kirby had normal manual motor testing,
decreased sensation in her right thumb compared with the left side, and mild pain during
palpation19 of her right lateral20 arm.

        On November 21, 2013, Ms. Kirby returned to Dr. Henry for a follow-up visit, reporting
pain in an intermittent pattern over the previous forty-three days. At this appointment, Dr. Henry
interpreted Ms. Kirby’s EMG as negative, and his physical examination revealed that Ms. Kirby
regained normal sensation and normal muscle strength. Ms. Kirby visited Dr. Henry again on
December 12, 2013, complaining of mild pain in the morning that would fade as the day went
on, and occasional tingling down her right arm over the previous sixty-four days. During that
visit, Ms. Kirby’s physical exams were normal in all aspects, including sensation, coordination,
strength, and tone. According to Dr. Henry, “petitioner had reached maximum medical
improvement (‘MMI’) with no impairment,” and therefore concluded that she could resume
regular duties. After that appointment, “petitioner’s medical records do not address her right arm



19
         Palpation is “the act of feeling with the hand; the application of the fingers with light
pressure to the surface of the body for the purpose of determining the consistency of the parts
beneath in physical diagnosis.” Palpation, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=36456&searchterm=palpation (last
visited May 18, 2020).
20
         Lateral denotes “a position farther from the median plane or midline of the body or of a
structure. 2. pertaining to a side.” Lateral, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=27702&searchterm=lateral
(last visited May 18, 2020).
                                                 5
pain again until nearly two years later,” though, in the interim, petitioner “had a number of
medical appointments unrelated to her arm pain.”

        On January 16, 2014, petitioner returned to Pike Bowling Green Clinic for a general adult
physical exam and to complete certain Family and Medical Leave Act paperwork related to her
prior ankle injury. At that appointment, NP Chandler noted that the petitioner had joint pain
associated with her ankle. On October 28, 2014, petitioner again visited NP Chandler,
complaining of a foot problem without any associated injury. The medical report detailed pain
and swelling in her legs and ankles and noted that weight bearing, walking, or standing
exacerbated her symptoms. Petitioner’s medical records from that visit noted the absence of
muscle pain, tingling, and numbness.

        Petitioner returned for three additional follow-up visits with NP Chandler between
October of 2014 and July of 2015. On petitioner’s February 3, 2015 visit, NP Chandler noted
neuropathy21 as “Not Present.” The medical report from petitioner’s March 19, 2015 visit
described shooting pains in petitioner’s left leg for the preceding two weeks and documented the
absence of joint and muscle pain. The medical report from petitioner’s July 21, 2015 visit noted
that “patient feels well with no complaints,” that petitioner had “[p]ain in feet and Muscle Pain
(chronic foot pain),” and once more indicated the absence of neuropathy.

        On October 13, 2015, petitioner visited NP Chandler once more, complaining of pain in
her right arm that had been gradually and intermittently occurring since she received the flu
vaccine. NP Chandler documented that Ms. Kirby was experiencing neuropathic pain of the
upper extremity, but no treatment plan was recorded. Petitioner’s medical records documented
petitioner’s complaint of ongoing symptoms, including muscle pain and nerve pain in her right
arm, and the records linked petitioner’s symptoms and pain to the influenza vaccine that she
received three years prior.22 Petitioner’s records from that visit further indicated that she did not
have any physical limitations stemming from the pain.

       A. Procedural History

       Petitioner filed her Petition with the Office of Special Masters on February 8, 2016. See
generally Petition, ECF No. 1. On February 20, 2017, petitioner filed the expert report of
neurologist Dr. Marcel Kinsbourne, B.M., B.Ch., M.D.23 On June 30, 2017, respondent filed the

21
        Neuropathy is defined as “a functional disturbance or pathologic change in the peripheral
nervous system limited to noninflammatory lesions as opposed to those of neuritis; the etiology
may be known or unknown.” Neuropathy, Dorland’s,
https://www.dorlandsonline.com/dorland/definition?id=33813 (last visited May 21, 2020).
22
        The Special Master concluded that the petitioner actually received the vaccine two years
prior, not three years prior. Kirby, at *19 n.25.
23
        Dr. Kinsbourne obtained his B.M. and B.Ch. from Oxford Medical School in 1955 and
his M.D. from the State of North Carolina in 1967. See Kirby, at *8; see also Petitioner’s Expert
Report, ECF No. 27 (hereinafter “Pet’r’s Expert Rep.”) Ex. 3, at 1. Dr. Kinsbourne has served as
a senior fellow at the Center for the Study of Aging and Human Development at Duke University
since 1974, an adjunct professor of Neurology at Boston University School of Medicine since
                                                  6
expert report of neurologist Dr. Peter Donofrio, M.D.24 On September 8, 2017, petitioner filed a
supplemental expert report in which Dr. Kinsbourne revised his assessment of the onset of
petitioner’s symptoms following her vaccination and provided an alternative theory that
petitioner suffered direct nerve trauma from an injection needle. Respondent filed a
supplemental expert report from Dr. Donofrio on November 14, 2019, responding to Dr.
Kinsbourne’s alternate theory. An entitlement hearing was held July 22, 2019. On November 1,
2019, Special Master Horner found that petitioner was entitled to compensation, finding
“preponderant evidence that petitioner experienced residual effects of her radial nerve injury for
more than six months.” Kirby, at *1, *20. Respondent filed its Motion for Review and
Memorandum of Objections on January 1, 2020. See generally Respondent’s Motion for
Review, ECF No. 71; Respondent’s Memorandum of Objections, ECF No. 72 (hereinafter
“Resp’t’s Mem.”). On February 21, 2020, petitioner filed her Response to respondent’s Motion
for Review and Memorandum of Objections. See generally Petitioner’s Memorandum in
Response to Respondent’s Motion for Review, ECF No. 74 (hereinafter “Pet’r’s Mem.”).
Respondent’s Motion is fully briefed and ripe for review.

   II.      Standard of Review

        Under the Vaccine Act, this Court may review a Special Master’s decision upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2) (2018). In reviewing such a
request, this Court may:

         (A) uphold the findings of fact and conclusions of law . . . , (B) set aside any
         findings of fact or conclusion of law . . . found to be arbitrary, capricious, an abuse
         of discretion, or otherwise not in accordance with law . . . , or, (C) remand the



1987, a research professor at the Center for Cognitive Studies at Tufts University since 1992, and
a professor of psychology at New School University since 1995. See Id.; see also Pet’r’s Expert
Report Ex. 3, at 1–2. Dr. Kinsbourne testified that although he has retired from hospital-based
clinical practice, he still occasionally sees patients, primarily regarding pediatric neurology. See
Transcript (hereinafter “Tr.”) at 71:5–12, 109:15–111:11.
24
        Dr. Donofrio obtained his B.S. from the University of Notre Dame in 1972 and obtained
his M.D. from Ohio State University School of Medicine in 1975. See Respondent’s Expert
Report, ECF No. 34 (hereinafter “Resp’t’s Expert Report”) Ex. 4, at 2. Dr. Donofrio is a
professor of neurology at Vanderbilt University Medical Center, Director of Vanderbilt’s
Neuromuscular Section, Director of the Muscular Dystrophy Association Clinic and
Amyotrophic Lateral Sclerosis Clinic, and member of the Medical Advisory Committee of the
Guillan-Barré Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy (GBS/CIPD)
International Foundation. Kirby, at *10; see Resp’t’s Expert Report Ex. 4, at 4–9. He is board
certified in neurology, internal medicine, EMG, and neuromuscular disorders and has treated
patients with Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM),
Transverse Myelitis (TM), and brachial neuritis. Id.; Resp’t’s Expert Report Ex. 4, at 3. He is
published in Guillan-Barré Syndrome (GBS), Chronic Inflammatory Demyelinating
Polyneuropathy (CIDP), and other neuropathies, including his textbook on peripheral
neuropathy. Id.; see generally Resp’t’s Expert Report Ex. 4, at 19–31.
                                                   7
          petition to the Special Master for further action in accordance with the court’s
          direction.

Id. § 300aa-12(e)(2)(A)–(C). Findings of fact and discretionary rulings are reviewed under the
arbitrary and capricious standard, while legal conclusions are reviewed de novo. Munn v. Sec’y
of Dep’t of Health and Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).

        This Court cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder v. Sec’y of Health and Human Servs., 88
Fed. Cl. 706, 718 (2009). Rather, “[r]eversal is appropriate only when the special master’s
decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law.” Id.
Under this “highly deferential” standard, a Special Master’s decision need only “articulate a
rational connection between the facts found and the choice made” in order to be upheld.
Cucuras v. Sec’y of Dep’t of Health and Human Servs., 26 Cl. Ct. 537, 541 (1992) (citing
Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962), aff’d, 993 F.2d 1525
(Fed. Cir. 1993)). As such, if the Special Master “has considered the relevant evidence of
record, drawn plausible inferences[,] and articulated a rational basis for the decision, reversible
error will be extremely difficult to demonstrate.” Id. at 541–42; (quoting Hines ex rel. Sevior v.
Sec’y of Dep’t of Health and Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).

   III.      Discussion

        Althen v. Secretary of Health and Human Services provides the evidentiary burden for
petitioners to establish a prima facie case on causation in order to succeed in a vaccine petition.
418 F.3d 1274, 1278 (Fed. Cir. 2005); see also Pafford v. Sec'y of Health and Human Servs., 451
F.3d 1352, 1355 (Fed. Cir. 2006); Boley v. Sec’y of Health and Human Servs., 86 Fed. Cl. 294,
302 (2009). A petitioner can prove causation by either showing that the injury falls under the
Vaccine Injury Table, which provides a presumption of causation, or by proving causation in fact
for an injury not listed on the Vaccine Injury Table. Nunez v. Sec’y of Health and Human Servs.,
144 Fed. Cl. 540, 544 (2019). As the injury in the case at bar is not listed on the Vaccine Injury
Table, to prove causation in fact, the petitioner must “show by preponderant evidence that the
vaccination brought about [petitioner’s] injury by providing” the following: “(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, 418 F.3d at 1278. To
succeed on the claim, a petitioner must provide a “reputable medical or scientific explanation”
for their claim. Id. Additionally, the petitioner must satisfy the “severity requirement” under the
Vaccine Act, 42 U.S.C. § 300aa-11(c)(1)(D)(i), which, as a threshold matter, requires that the
petitioner “show that the injury from the vaccine persisted for at least six months.” Boley, 86
Fed. Cl. at 302 (citing 42 U.S.C. § 300aa-11(c)(1)(D)(i)); see also Cloer v. Sec’y of Health and
Human Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011).

        Within this framework, respondent makes three numbered objections to the Special
Master’s November 1, 2019 decision. See Resp’t’s Mem. at 9, 11–12, 13. First, respondent
asserts that the Special Master erred by applying an erroneous legal standard under the guise of a
credibility determination. Id. at 9. Second, respondent argues that the Special Master applied an

                                                 8
impermissibly low burden of proof in analyzing the first two prongs of Althen. Id. at 11–12.
Finally, respondent asserts that the Special Master engaged in arbitrary and capricious
fact-finding and applied an incorrect legal standard in evaluating whether the petitioner satisfied
the Vaccine Act’s severity requirement. Id. at 13.

   A. Severity Requirement of the Vaccine Act

        In its third numbered objection, respondent argues that it was arbitrary and capricious for
the Special Master to find that the petitioner satisfied the Vaccine Act’s severity requirement
given petitioner’s testimony and the evidence in the record. Resp’t’s Mem. at 13–14.
Specifically, respondent asserts that the Special Master erred in relying on petitioner’s testimony
alone to conclude that the petitioner established that she suffered residual symptoms for at least
six months. Id. at 14–15. Respondent argues that the Special Master erred in relying on
petitioner’s testimony, as petitioner’s testimony conflicted with “presumptively accurate
contemporaneous medical records.” Id. at 15. Respondent cites to case law from this Court to
support its claim that, when a Special Master bases a finding on lay testimony, there must also be
corroborating evidence, medical or otherwise, to support petitioner’s claim and testimony;
respondent contends that there is no such corroborating evidence in the case at bar. Id. at 14
(citing Epstein v. Sec’y of Dep’t of Health and Human Servs., 35 Fed. Cl. 467, 478 (1996)).
Further, respondent argues that medical records created contemporaneously with the events they
describe are presumed to be accurate and complete. Id. at 13. See Cucuras, 993 F.2d at 1528;
see also Robi v. Sec’y of Health and Human Servs., No. 12-352, 2014 WL 1677116, at *1 (Fed.
Cl. Spec. Mstr. Apr. 4, 2014). In support of its argument, respondent asserts that petitioner’s
medical records show that she was treated for her condition for approximately three months, and
that by January 16, 2014, petitioner was “feeling fine” and reported no symptoms related to her
shoulder. Resp’t’s Mem. at 14 (citing Medical Records, ECF No. 9 (hereinafter “Medical
Records”) Ex. 3, at 25). Respondent further argues that the medical records between January of
2014 and July of 2015 reflect multiple medical visits with NP Chandler, during which petitioner
did not report “shoulder pain, arm pain, weakness, or thumb numbness.” Id. (citing Medical
Records Ex. 4, at 29–44).

         In response, petitioner asserts that any “[d]iscrepancies between the testimony and
records or gaps in the medical records are not in and of themselves decisive; clear, cogent, and
consistent testimony can overcome such missing or contradictory medical records.” Pet’r’s
Mem. at 14 (quoting Stevens v. Sec’y of Dep’t of Health and Human Servs., No. 90-221, 1990
WL 608693, at *3 (Cl. Ct. 1990)). Petitioner additionally argues that “[o]ther records and Ms.
Kirby’s testimony presented clear, cogent and consistent evidence that Ms. Kirby’s symptoms
did, in fact, continue for at least six months.” Id. at 15.

        As relevant to the case at bar, the severity requirement under the Vaccine Act states that a
petitioner seeking “compensation under the Program for a vaccine-related injury” must include
with such petition “an affidavit, and supporting documentation, demonstrating that the person
who suffered such injury . . . suffered the residual effects or complications of such illness,
disability, injury, or condition for more than 6 months after the administration of the
vaccine . . . .” 42 U.S.C. § 300aa-11(c)(1)(D)(i). The Vaccine Act further provides that “a
special master or court may not make a finding [that petitioner met the requirements under 42

                                                 9
U.S.C. § 300aa-11] based on the claims of a petitioner alone, unsubstantiated by medical records
or medical opinion.” 42 U.S.C. § 300aa-13(a)(1). Rather, a petitioner must demonstrate that she
satisfied the requirements under 42 U.S.C. § 300aa-11(c)(1) by a preponderance of the evidence.
42 U.S.C. § 300aa-13(a)(1)(A); see also D’Tiole v. Sec’y of Health and Human Servs., 726 F.
Appx. 809, 810 (Fed. Cir. 2018).

        The Special Master accorded substantial weight to petitioner’s testimony claiming that
she experienced continuous symptoms past the requisite six-month period after receiving the
vaccine. Thus, despite petitioner reporting that she was “feeling fine” at her January 16, 2014
appointment, the Special Master concluded that such statement “is relatively vague and does not
rule out the possibility of ongoing, but less significant, symptoms related to petitioner’s radial
nerve injury.” Kirby, at *19. The Special Master made this determination despite petitioner’s
medical records not corroborating that testimony, as he accorded substantial weight to the
credibility of testimony and a discrete excerpt from records of an October 13, 2015 doctor’s
office visit in concluding that petitioner’s symptoms persisted after the December 12, 2013
doctor’s visit. Id. at *13, *19. Specifically, the Special Master found that the statement “Patient
complains today that nerve pain is still present but has decreased tremendously from when the
injury occurred” from the October 13, 2015 report demonstrated that the petitioner experienced
persistent symptoms from December 12, 2013, to October 13, 2015, thereby satisfying the six-
month severity requirement under the Vaccine Act. Id. at *19. Special Master Horner did,
however note that after petitioner’s December 12, 2013 visit to the doctor’s office, “petitioner’s
medical records do not address her right arm pain again until nearly two years later,” and that,
“[i]n the interim, petitioner had a number of medical appointments unrelated to her arm pain.”
Id. at *6. Nevertheless, Special Master Horner was “not persuaded by respondent’s contention
that petitioner’s condition does not meet the severity requirements of the Vaccine Act,”
concluding that “there is preponderant evidence that petitioner’s condition lasted for at least six
months.” Id. at *17

        This Court has explained that, where testimony conflicts with contemporaneous medical
records, “the Special Master generally should afford contemporaneous medical records greater
weight than conflicting testimony offered after the fact.” Caron v. Sec’y of Health and Human
Servs., 136 Fed. Cl. 360, 377 (2018) (citing Murphy v. Sec’y of Health and Human Servs., 23 Cl.
Ct. 726, 733 (1991), aff'd, 968 F.2d 1226 (Fed Cir. 1992)). That standard exists because
“medical records created contemporaneously with the events they describe are presumed to be
accurate and complete.” Id. (citing Cucuras, 993 F.2d at 1528 (“Medical records, in general,
warrant consideration as trustworthy evidence. The records contain information supplied to or
by health professionals to facilitate diagnosis and treatment of medical conditions. With proper
treatment hanging in the balance, accuracy has an extra premium. These records are also
generally contemporaneous to the medical events.”). However, a Special Master may also
consider oral testimony in reaching a decision, and “there are situations when oral testimony may
be more persuasive than written records,” such as when medical records are inaccurate or
incomplete. See id. (citing Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69
Fed. Cl. 775, 779 (2006)). Where oral testimony is inconsistent with medical records,
“discrepancies between the testimony and records or gaps in the medical records are not in and
of themselves decisive; clear, cogent, and consistent testimony can overcome such missing or
contradictory medical records.” Stevens, 1990 WL 608693, at *3; see also Caron, 136 Fed. Cl.

                                                10
at 377–78 (quoting Camery v. United States, 42 Fed. Cl. 381, 391 (1998) (“‘Oral testimony that
is inconsistent with medical records must be consistent, clear, cogent and compelling to
outweigh the medical records prepared for the purpose of diagnosis and treatment.’”)).

        Petitioner’s testimony and medical records evidence that the petitioner received treatment
for her vaccine injury from October 15, 2013, to December 13, 2013, a two-month period of
time. See generally Medical Records Ex. 3, Ex. 4, at 1–28. Petitioner’s medical records from
January of 2014 through October of 2015, however, lack sufficient documentation to establish
that the petitioner experienced continuous symptoms in her arm related to her vaccine during that
period of time. Instead, petitioner’s medical records reflect that between January of 2014 and
October of 2015, the petitioner visited NP Chandler four times, exclusively seeking treatment for
her ankle. See Medical Records Ex. 4, at 29–44. Petitioner’s testimony likewise fails to
demonstrate that the petitioner’s symptoms were consistent and present from January of 2014
through October of 2015. See Tr. 24:10–38:12. The Special Master acknowledged that, at trial,
“petitioner could not recall any significant detail when her injury resolved,” and thus “a precise
date for the resolution of her injury is difficult, if not impossible, to ascertain.” Kirby, at *17.
Though the petitioner testified to telling NP Chandler of her recurring symptoms, petitioner’s
testimony failed to identify on what date she mentioned those recurring symptoms. See id. The
Court therefore concludes that petitioner’s medical records do not establish that she experienced
symptoms related to her alleged vaccine injury for at least six months, and that petitioner’s
medical records also do not corroborate her testimony in which she stated that she experienced
recurring symptoms after her December 12, 2013 visit with Dr. Henry. See Medical Records Ex.
4, at 29–44. As such, the Court determines that it was arbitrary and capricious for the Special
Master to conclude that the petitioner’s medical records and testimony establish that the
petitioner experienced symptoms stemming from her vaccine injury over a six-month period of
time, as required by 42 U.S.C. § 300aa-11(c)(1)(D)(i).

        Dr. Kinsbourne’s testimony before the Special Master likewise fails to establish or
corroborate petitioner’s claim that she experienced vaccine-related symptoms for longer than six-
months. In Epstein v. Secretary of Health and Human Services, this Court held that, “in cases in
which a court has based a finding on lay testimony, there must be corroborating evidence, either
medical or other to support the claim.” 35 Fed. Cl. at 478. The Epstein Court further held that
expert testimony based solely on medical records does not corroborate lay testimony that seeks
to establish a medical timeline where the expert had not physically examined the petitioner
during the period in question. Id. at 476. This Court reached that conclusion because “neither of
the[] physicians could offer contemporaneous, first-hand knowledge based on personal
observation, about the period of time [in question].” Id. Instead, examples of corroborating
evidence that adequately support lay testimony can include a lay-person’s personal calendar, a
billing statement for medical services, hospital records, and testimony from the petitioner’s
regular treating physician who also administered the vaccination at issue. Id. at 478; see also
Brown v. Sec’y of Dep’t of Health and Human Servs., 18 Cl. Ct. 834, 840 (1989), rev’d on other
grounds, 920 F.2d 918 (Fed. Cir. 1990); Berry v. Sec’y of Dep’t of Health and Human Servs.,
No. 90-339, 1990 WL 293448, at *3 (Cl. Ct. Spec. Mstr. Nov. 15 1990); Alger v. Sec’y of Dep’t
of Health and Human Servs., No. 89-31, 1990 WL 293408, at *7 (Cl. Ct. Spec. Mstr. Mar. 14,
1990).



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         During the hearing before the Special Master, petitioner’s expert Dr. Kinsbourne stated
that, prior to the hearing, he had never met the petitioner, and that he had never physically
examined her. Tr. at 114:21–115:10. Dr. Kinsbourne further testified that he had never spoken
directly with any of Ms. Kirby’s treating medical providers, and that he based his opinion
entirely on the petitioner’s medical records. Id. at 115:5–10. On this basis, the Court finds that it
was arbitrary and capricious for the Special Master to rely on Dr. Kinsbourne’s testimony or to
use such testimony in order to corroborate petitioner’s testimony in which she claims to have
experienced pain and numbness in her arm during the period between January 2014 and October
2015.

        This Court has routinely held that “[r]eversal is appropriate only when the special
master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the
law.” Snyder, 88 Fed. Cl. at 718. Here, the Court finds that the Special Master’s acceptance of
petitioner’s lay testimony, without the support of contemporaneous corroborating medical
records or evidence, to be arbitrary and capricious. As such, the Court concludes that the
petitioner failed to satisfy a fundamental prerequisite for establishing a claim under the Vaccine
Act, as the petitioner has not demonstrated that she suffered residual effects or complications of
her injury for at least six months after the administration of the vaccine. The Court therefore
reverses the Special Master’s decision on entitlement.

   B. Expert Credibility Determination and Althen Prongs

        In its Motion for Review and Memorandum of Objections, respondent also alleges that
the Special Master “erred by cloaking the application of an erroneous legal standard in the guise
of a credibility determination.” Resp’t’s Mem. at 9 (citing Andreu v. Sec’y of Dep’t of Health
and Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)). Respondent contends that the Special
Master inappropriately rejected the opinions of Dr. Donofrio, “the far-better-credentialed
expert,” in favor of those of Dr. Kinsbourne by framing that rejection as a credibility
determination. Id. at 10. In response, petitioner argues that the Special Master did not arbitrarily
evaluate the credibility of Dr. Donofrio’s opinions, alleging that, in actuality, Special Master
Horner found Dr. Donofrio’s opinions to be unpersuasive. Pet’r’s Mem. at 10–11. Petitioner
further claims that “the Special Master determined both experts were qualified to opine in the
case” and that it therefore “was not Dr. Donofrio’s credibility as an expert that was an issue for
the Special Master.” Id. at 11.

        In its second numbered objection, respondent alleges that the Special Master applied “an
incorrect standard in evaluating petitioner’s evidence of causation in violation of Althen v.
Secretary of Health and Human Services. Resp’t’s Mem. at 1. As to the analysis of the first
prong, respondent alleges that the Special Master erred in his treatment of Dr. Donofrio’s
concession that Dr. Kinsbourne’s theory is possible, arguing “[a] concession that a theory is
possible is not a concession that the theory is reputable, sound and reliable.” Id. at 12 (emphasis
in original); see Boatmon v. Sec’y of Health and Human Servs., 941 F.3d, 1351, 1359 (Fed. Cir.
1996). In response, petitioner argues that a petitioner’s theory “need only be ‘legally probable,
not medically or scientifically certain.’” Pet’r’s Mem. at 12 (quoting Knudsen v. Sec’y of Dep’t
of Health and Human Servs., 35 F.3d 543, 548–49 (Fed. Cir. 1994)). Petitioner further contends
that the word “possible” in this context means “can happen,” and that both Dr. Kinsbourne and

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Dr. Donofrio “testified it is medically, anatomically possible for a syringe to impact the radial
nerve.” Id.

        Regarding the second prong, respondent argues that the Special Master’s analysis was
flawed when he interpreted Dr. Donofrio’s acknowledgement that petitioner could conceivably
have had mild radial neuritis undetected by an EMG, despite “petitioner’s right arm study
[being] better than her left.” Resp’t’s Mem. at 12–13. Respondent further claims that in finding
the petitioner had radial neuritis, based in part on expert opinions, the Special Master applied an
inappropriately low burden of proof. Id. at 13. In response, petitioner asserts that “arguments
based on statistical probabilities are deemed irrelevant” and that “bare statistical facts have no
bearing on whether an injury in a particular case is vaccine related.” Pet’r’s Mem. at 13 (citing
Knudsen, 35 F.3d at 550).

       As the Court found the Special Master’s determination that the petitioner met the
six-month severity requirement to be arbitrary and capricious, the Court will not review in detail
the government’s remaining two objections to the Special Master’s treatment of the expert
opinions or his analysis of the Althen prongs. The Court does, however, think the government’s
arguments are well-founded.

III.   Conclusion

        For the foregoing reasons, the Court holds the Special Master’s decision finding that the
petitioner satisfied the severity requirement of the Vaccine Act to be arbitrary and capricious and
not in accordance with law. Accordingly, the Court hereby GRANTS respondent’s MOTION
for review, REVERSES the Special Master’s November 1, 2019 ruling on entitlement, and
VACATES the decision of the Special Master. The Clerk is directed to dismiss the Petition and
enter judgment for respondent.

       IT IS SO ORDERED.

                                                      s/   Loren A. Smith
                                                   Loren A. Smith,
                                                   Senior Judge




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