Labounty v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-325V
Filed: December 28, 2020

************************* *
*
SHARON LABOUNTY, *
*
* TO BE PUBLISHED
Petitioner, *
*
v. *
* Special Master Katherine E. Oler
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, * Chronic Regional Pain Syndrome
*
* (CRPS); Flu Vaccine; Needle Stick
Respondent. *
*
************************* *

Howard Gold, Gold Law Firm, LLC, Wellesley Hills, MA for Petitioner
Christine Becer, U.S. Department of Justice, Washington, DC, for Respondent

RULING ON ENTITLEMENT1

On March 9, 2017, Sharon LaBounty (“Ms. LaBounty” or “Petitioner”) filed a petition
pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10.2 (“Vaccine
Act” or “the Program”) alleging that the flu vaccination she received on September 18, 2015
caused her to suffer a reaction which was diagnosed as brachial plexopathy and brachial neuritis.
Petition at 1, ECF No. 1. Petitioner filed an amended petition (“Amended Pet. 1”) on August 15,
2018 alleging her flu vaccination caused her to develop a shoulder injury related to vaccine
administration (“SIRVA”). Amended Pet. 1 at 1, ECF No. 23. On September 15, 2018, Petitioner
filed a second amended petition (“Amended Pet. 2”) alleging that the flu vaccination caused her
to develop Chronic Regional Pain Syndrome (“CRPS”). Amended Pet. 2 at 1, ECF No. 24.

1
This Ruling will be posted on the United States Court of Federal Claims’ website, in accordance with the
E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Ruling will be available to anyone
with access to the internet. As provided in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may
object to the Ruling’s inclusion of certain kinds of confidential information. To do so, each party may,
within 14 days, request redaction “of any information furnished by that party: (1) that is a trade secret or
commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or
similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine
Rule 18(b). Otherwise, this Ruling will be available to the public in its present form. Id.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (1986). Hereinafter,
for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C.
§ 300aa (2012).
1
 Upon review of the evidence submitted in this case, I find that Petitioner has met her burden
in showing that the flu vaccination she received on September 18, 2015 caused her to develop
CRPS. She is therefore entitled to compensation under the Vaccine Act.

I. Procedural History

Petitioner filed her petition on March 9, 2017; she alleged the flu vaccination she received
on September 18, 2015 caused her to suffer from brachial plexopathy and brachial neuritis.3 Pet.
at 1, ECF No. 1. On October 1, 2017, Respondent filed a Rule 4(c) Report stating that
compensation should be denied and the case should be dismissed. Resp’t’s Rep. at 1, ECF No. 11.
After multiple extensions of time, Petitioner filed a status report on July 31, 2018 indicating she
was “unable to offer an expert report in support of causation for the diagnosis of brachial plexus,”
and requested additional time to confer with her counsel on how she wished to proceed. Status
Rep. on 7/31/18, ECF No. 21.

On August 13, 2018, Petitioner filed a status report stating that her Petition alleging the flu
vaccination caused her to develop brachial plexus was based on her treating physician’s initial
diagnosis, however, “[h]e is unable to provide an expert report in support of this diagnosis.” Status
Rep. on 8/13/2018, ECF No. 22. Petitioner stated her medical records are consistent with a SIRVA
injury and requested time to file an amended petition and an expert report. See id.

Petitioner filed an amended petition on August 20, 2018 alleging the flu vaccine caused
her to suffer from “a table-injury, SIRVA”. Amended Pet. 1 at 1, ECF No. 23. On September 15,
2018, Petitioner filed another amended petition alleging the flu vaccine caused her to suffer from
CRPS. Amended Pet. 2 at 1, ECF No. 24. Petitioner filed an expert report written by Dr. Marcel
Kinsbourne on the same day. Ex. 11, ECF No. 25.

On November 16, 2018, I held a status conference with the parties. See Minute Entry on
11/19/2018; Scheduling Order on 11/19/2018, ECF No. 28. I informed the parties that Dr.
Kinsbourne did not utilize the Budapest Criteria in diagnosing Ms. LaBounty with CRPS and that
I understood the Budapest Criteria to be the current diagnostic standard. See Scheduling Order on
11/19/2018. I ordered both parties to file expert reports addressing the applicability of the
Budapest Criteria in the context of Petitioner’s symptoms. See id.

On December 17, 2018, Respondent filed an expert report from Brian Callaghan, M.D.,
M.S. Ex. A, ECF No. 29. In this report, Dr. Callaghan stated Petitioner had many pre-existing
conditions and the symptoms, which dated back to 2008 and that she experienced shortly after the
September 18, 2015 flu vaccination were more likely to be a “central sensitization syndrome.” Ex.
A at 2.

On January 15, 2019, Petitioner submitted a supplemental affidavit. Ex. 13, ECF No. 30.
On January 16, 2019, Petitioner submitted a supplemental expert report from Dr. Marcel

3
This case was initially assigned to Special Master Roth (ECF No. 4) and re-assigned to my docket on June
8, 2018 (ECF No. 19).
2
Kinsbourne. Ex. 14, ECF No. 31. On April 29, 2019, Respondent filed a supplemental expert
report from Dr. Callaghan. Ex. C, ECF No. 33.

On August 6, 2019, I held a status conference with the parties. See Minute Entry on
8/7/2019; Scheduling Order on 8/7/2019, ECF No. 34. Both parties agreed to a ruling on the record
after it was confirmed that all evidentiary materials were submitted. Scheduling Order on
8/7/2019, ECF No. 34. On September 6, 2019, the parties filed a joint status report stating they
had no additional evidentiary materials to submit. Status Rep. on 9/6/2019, ECF No. 35.

On October 18, 2019, Petitioner filed a Motion for a Ruling on the Record. Pet’r’s Mot.
on 10/18/2019, ECF No. 37. On the same day, Petitioner also filed additional medical literature.
Ex. 15a-f, ECF No. 38. On December 17, 2019, Respondent filed a Response to Petitioner’s
Motion for a Ruling on the Record. ECF No. 40. Petitioner filed a Reply brief on December 21,
2019. ECF No. 41.

On January 10, 2020, I held a status conference with the parties. See Minute Entry on
1/10/2020; Scheduling Order on 1/10/2020, ECF No. 42. I informed the parties that I had
additional questions for their experts with regards to CRPS and whether Petitioner met the
Budapest Criteria for a CRPS diagnosis. Scheduling Order on 1/10/2020, ECF No. 42. Petitioner
filed an expert report from Dr. Kinsbourne on March 29, 2020. Ex. 16, ECF No. 44. Respondent
filed an expert report from Dr. Callaghan on March 31, 2020. Ex. D, ECF No. 45.

I held another status conference on April 6, 2020 with the parties to discuss the parties’
recent filings. See Minute Entry on 4/6/2020; Scheduling Order on 4/6/2020, ECF No. 46. Dr.
Kinsbourne repeatedly referred to the IASP criteria but did not answer my questions concerning
Petitioner’s diagnosis based on the Budapest criteria, furthermore, inconsistencies with the font
and of the absence of a response to my third question caused me to question whether the report
was complete. See Scheduling Order on 4/6/2020, ECF No. 46. I ordered Petitioner to file a status
report on the completeness of Dr. Kinsbourne’s report. I also ordered Respondent to file a status
report regarding Dr. Callaghan’s position as to whether the Budapest criteria were the prevailing
criteria for a CRPS diagnosis. See id.

On April 7, 2020, Respondent filed a status report stating Dr. Callaghan concurred that the
Budapest Criteria were “the most accepted diagnostic criteria for the diagnosis of CRPS.” Resp’t’s
Status Rep., ECF No. 47. On April 25, 2020, Petitioner filed a supplemental report from Dr.
Kinsbourne. Ex. 17 at 2, ECF No. 48.

On May 24, 2020, the parties filed a joint status report indicating the record was complete
for a ruling on the record. Pet’r’s Status Rep., ECF No. 50.

II. Medical Records

A. Petitioner’s Health Prior to the Allegedly Causal Vaccination

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 Petitioner had a history of prediabetes, allergies, gastroesophageal reflux disease
(“GERD”), hiatal hernia, thyroid cancer, deep vein thromboses (“DVT”), irritable bowel syndrome
with constipation, anxiety, migraines, hypothyroidism, and appendicitis. Ex. 44 at 46; Ex. 7 at 4.

Petitioner saw Dr. Ingrid Fuller on March 26, 2014 for a medication follow-up. Ex. 4 at
92. During this appointment, Petitioner complained of cold and numb feet, migraines, fibroid pain,
and pain in her hands, wrists, and lower back. Id. Dr. Fuller noted Petitioner had joint pain but
stated it was unclear whether it was osteoarthritis or an autoimmune problem but referred
Petitioner to a rheumatologist to examine possible Raynaud’s phenomenon. Id.

On April 18, 2014, Petitioner saw Dr. Raymond Pertusi, a rheumatologist. Ex. 4 at 80. Dr.
Pertusi noted that since 2008 Petitioner has experienced pain and an aching sensation located in
her ankles, knees, hands, neck, lower back, and hips. Id. Dr. Pertusi also noted that Petitioner has
“1-3 fingers turn white on cold exposure” and she experienced fatigue, cramping, and numbness
in her fingers and toes. Id. Dr. Pertusi’s impression was that Petitioner’s “pain generator is likely
a central sensitization syndrome that could be related to remote trauma (Abuse x 3) and likely
PTSD.” Id. at 82.

On June 4, 2015, Petitioner visited an emergency room for chest pain and followed-up with
Dr. Fuller on June 9, 2015. Ex. 4 at 63. Petitioner also informed Dr. Fuller she was having
cramping in her legs, especially in her left leg, and was concerned of a blood clot or deep vein
thrombosis. Id. Petitioner obtained a CAT scan, which was negative for any pulmonary
embolisms. Id.

On July 27, 2015, Petitioner saw Dr. Susan Shih for five years of joint pain in her mid-
lower back, hips, ankles, wrists, and “pain in her right hand associated with swelling in the right
fourth and fifth PIP (“proximal interphalangeal”) joints.” Ex. 4 at 55.

Petitioner received a flu vaccination in her left deltoid at a CVS Pharmacy on September
18, 2015. Ex. 3.

B. Petitioner’s Health after the Allegedly Causal Vaccination

On September 29, 2015, Petitioner saw her primary care physician (“PCP”), Dr. Ingrid
Fuller for pain she experienced in her upper left arm “fifteen minutes after she received the flu
injection.” Ex. 4 at 44. Dr. Fuller noted that it was Ms. LaBounty’s first flu shot and Petitioner
had trouble lifting her left arm because of the pain, but there was no swelling. Id. The pain in her
left arm began improving after a week and her right arm began to hurt. See id. Petitioner did not
have a fever but felt feverish. Petitioner had seen a rheumatologist for finger and wrist joint
swelling but the finger swelling appeared before she received the flu vaccine. See id.

On September 30, 2015, Petitioner visited Dr. Susan Shih a rheumatologist, for an “urgent
evaluation”. Ex. 4 at 43. Dr. Shih noted that Petitioner received a flu shot on September 18, 2015
and

4
Exhibit 4 and Exhibit 9 are identical. Therefore, only Exhibit 4 will be cited for the sake of clarity.

4
 almost immediately developed severe pain in the left upper arm. This then spread
down into the left lower arm and hand, subsequently across her neck and down into
the right arm as well. She describes pain and swelling in the left and right second
fingers, diffusely through the finger, but with the pain mostly localized near the
MCP (metacarpophalangeal) joint. The patient also noted some numbness and
tingling as well as some burning in the hands. She has had some similar sensation
in the feet as well. The patient has never had a flu shot in the past and this may have
caused this pain…. She does have Volargen gel, but has not been using this
regularly. She did see Dr. Fuller yesterday who feels that the myalgias are likely
related to the flu vaccine and will likely resolve with time.

Ex. 4 at 43. Petitioner returned to Dr. Shih for a follow-up on October 14, 2015 complaining of
worse pain in her hands and left arm. Id. at 42. Dr. Shih noted Petitioner was experiencing some
pain in her wrists and there was swelling in her fifth finger in her right hand and had possible
swelling in her wrists. Id. The pain in her hands was described as a “burning, numbness or tingling
kind of sensation” and were so weak that she required two hands to lift a teapot. Id.

On November 6, 2015, Petitioner presented to Dr. Shih complaining of worse pain in her
hands and left shoulder. Id. at 41. Dr. Shih noted there was some swelling in the “second and fifth
digits of the right hand.” Id. Petitioner also had difficulty making a fist that morning. Id. Dr.
Shih stated that Petitioner’s symptoms suggested inflammatory arthritis but paresthesia was
suggestive of carpal tunnel syndrome. Id.

Petitioner saw Dr. Donny Chang, who specializes in endocrinology, on November 16, 2015
for a follow-up regarding her prediabetes. Ex. 4 at 38-40; Ex. 8 at 4-5. Dr. Chang did not note
anything regarding Petitioner’s pain.

On December 3, 2015, Petitioner saw her PCP, Dr. Fuller, for an urgent visit. Ex. 4 at 32.
Petitioner reported

an 11 week history of problems with both arms and rotator cuff tendinitis/tear. She
reports that her problems began when she got a flu shot at CVS on November [sic]
18th. She is in a great deal of pain. At night, she cannot sleep. Her symptoms are
getting worse. She has decreased sensation in her right hand and left hand also as
well as the arm. Her rheumatologist has ordered an MRI of her shoulder and this
showed a low-grade partial intrasubstance tear of the infraspinatus and mild
supraspinatus tendinopathy. An EMG showed carpal tunnel, but she is feeling
frustrated because she was expecting to have an EMG of both arms and it was just
the wrist and hand area that was evaluated. I had diagnosed her with tennis elbow,
but she does not feel that this is an issue at this time. Her right hand has been
swollen for two months. Her neck has locked up, and this began around October or
November. She has been seeing the chiropractor every week.5 She has been there
about three times. The neck is better, but both arms are terrible, she reports.

5
No chiropractic records have been filed.

5
Id. Dr. Fuller noted that the differential diagnosis was not clear, but that Petitioner’s pain was
inconsistent with the MRI. Id. Petitioner was prescribed an increase dosage of Vicodin and
referred for an MRI and x-ray. Id. Petitioner was to follow-up with Dr. Michael Brown, who
specializes in orthopedics, “for her left shoulder rotator cuff and neurology to evaluate her pain
issue, question vaccine related myelopathy.” Id.

On December 11, 2015, Petitioner saw Dr. Jordan Eisenstock at Community Neuroscience
Services with complaints of “arm pain/ s/p [status post] flu shot”. Ex. 4 at 29; Ex. 7 at 9. Dr.
Eisenstock noted that

The patient states that her current problem started when she received a flu shot on
November 18.6 Since that time she’s been in great pain, initially involving just the
left upper extremity but then spreading to the right upper extremity as well. She did
have an MRI of her left shoulder which showed partial tear of the infraspinatus and
supraspinatus tendinopathy. An EMG later showed bilateral carpal tunnel
syndrome but no other significant findings. Her pain is now greatly debilitation and
very limiting… she has continued to have migraines for many years and states that
the frequency is actually increased recently because of all of the stress.

Ex. 4 at 29; Ex. 7 at 9. Dr. Eisenstock reviewed a C-spine MRI and noticed “some disc bulging
and some CSF (cerebrospinal fluid) changes but I suspect only reminiscent of DJD [degenerative
joint disease] and not a larger problem.” Ex. 4 at 30; Ex. 7 at 10. Dr. Eisenstock assessed Petitioner
as having “nerve root and plexus disorder, unspecified” and migraines. Ex. 4 at 30, Ex. 7 at 10.
Dr. Eisenstock also noted that “Patient’s a picture [sic] many symptoms appear to be temporarily
correlated with flu vaccine. I wonder if there was an underlying vulnerability or predisposition but
blood work and examination have largely been unrevealing. Well underlying etiology is uncertain
treatment for a possible comp which regional pain syndrome or simply neuropathic pain, NOS [not
otherwise specified], is most likely indicated.” Ex. 4 at 30; Ex. 7 at 10. Dr. Eisenstock started
Petitioner on Topiramate. Ex. 4 at 30; Ex. 7 at 11.

On December 14, 2015, Petitioner presented to Drs. Hanbing Zhou and Michael Brown
with bilateral shoulder pain, left worse than right. Ex. 4 at 24. The records note that

she had a flu shot on September 18, 2015 on the left shoulder, she has significant
should pain on both sides started on the left side since the flu shot, but now the right
side is bothering her as well. The patient does report a numbness as well tingling
as well as burning sensation in the C5-C6 distribution on occasions. The patient
reports significant amount of pain 9-10/10 with any sort of overheard activities
since flu shot. The patient reports the weakness she experiences secondary to pain.
The patient also reports cervical radiculopathy symptoms where there is shooting
pain coming from her neck and it travels to the posterior scapula and along the
posterior aspect of the both of her arms.

6
The vaccine was administered on September 18, 2015.
6
Id. Drs. Zhou and Brown reviewed Petitioner’s MRIs and found that she had bilateral shoulder
inflammation on the left side and a very low-grade partial tear of the infraspinatus and a herniated
disk at the C5-C6 level. Id. at 25. Petitioner was injected with Marcaine with Depo-Medrol for
“rotator cuff inflammation of both shoulders”. Id. Drs. Zhou and Brown also recommended that
Petitioner begin physical therapy. Id.

Petitioner saw Dr. Michael Stauff on January 4, 2016. Ex. 4 at 18-19. Dr. Stauff, an
orthopedist, reviewed her cervical MRI and observed disc degeneration and spondylosis at C5-C6
with mild central and bilateral foraminal stenosis. Id. at 19. Dr. Stauff also noted that “I have no
explanation for why her symptoms cropped up after her flu shot. She has no radicular or
myelopathy symptoms. She has neck pain associated with disk [sic] degeneration. I recommend
activity based treatment and nonnarcotic pain medication. I have given her a prescription for
therapy.” Id.

On January 12, 2016, Petitioner saw Alixis Vanhorn, A.R.N.P., for arm, shoulder, and back
pain. Ex. 4 at 14; Ex. 7 at 4. N.P. Vanhorn noted the same symptoms as documented in Petitioner’s
other medical records. N.P. Vanhorn gave Petitioner a prescription for OT/PT and advised her to
get regular neck and back massages, use ice, and avoid positions which exacerbate pain. Petitioner
returned to N.P. Vanhorn on February 12, 2016. Ex. 4 at 12; Ex. 7 at 14. The reason for
appointment was “arm and hand pain” and “paresthesia of UE’s”. Ex. 4 at 12; Ex. 7 at 14. N.P.
Vanhorn noted

paresthesia and numbness and weakness in UE’s bilat, R>L. Referred to and seen
in OT/PT, got splints to wear at night that help with pain; pain in back persistent….
Has been biking at gym, doing PT exercises on her own. Continues with significant
pain in hands bilat, especially thumb and pointer finger.

Ex. 4 at 12; Ex. 7 at 14.

Petitioner returned to Community Neuroscience Services on February 24, 2016 to see Dr.
Eisenstock. Ex. 4 at 7; Ex. 7 at 17. Petitioner noticed that the injections she received in December
2015 “significantly improved her pain for a period of time. Unfortunately the pain has since
returned and she is not in the same excruciating pain is only [sic] first met but still very
uncomfortable at this moment.” Ex. 4 at 7; Ex. 7 at 17. Dr. Eisenstock increased the dosage of
Petitioner’s Topiramate prescription for neuropathic pain management and migraines. Ex. 4 at 8;
Ex. 7 at 18.

On March 7, 2016, Petitioner had a follow-up appointment with Dr. Fuller for her
medication. Ex. 4 at 6. Petitioner’s symptoms remained consistent, with notes of some relief after
cortisone injections in both shoulders. Petitioner indicated she needed another round of injections.
Id. Petitioner reported she has hand pain all day and “feels like her fingers get swollen, but no one
can see it.” Id. Dr. Fuller assessed Petitioner with cervical radiculopathy, temporomandibular
joint pain and migraines. Id.

On March 11, 2016, Petitioner followed up with Dr. Eisenstock. Ex. 4 at 3; Ex. 7 at 19.
Petitioner relayed to Dr. Eisenstock that she was experiencing increased shortness of breath and

7
possible over-sedation. Ex. 4 at 3; Ex. 7 at 19. Dr. Eisenstock decreased Petitioner’s Topiramate
dosage and started her on Lamictal for pain. Ex. 4 at 4; Ex. 7 at 20.

Petitioner met with Dr. Ross to follow up on her thyroid cancer. Ex. 5 at 8. In an “other
problems” section, Dr. Ross noted “Brachial neuritis after a flu shot, but bilateral (the second
started a couple of weeks later)”. Id. at 9. No other notations were made about Petitioner’s pain.

On March 17, 2016, Petitioner met with Mary Seguin, N.P., for bilateral shoulder pain.
Ex. 4 at 1. Petitioner requested and received two corticosteroid injections in her shoulders with
Dr. Brown’s permission. Id.

On May 11, 2016, Petitioner met with Dr. Eisenstock for a follow-up appointment. Ex. 7
at 22. There were no adjustments made to her medication because she was unable to tolerate a
higher dose, but the records indicate the medications were “otherwise helping”. Id. at 22-23.

Petitioner returned to Dr. Eisenstock on October 5, 2016 to review her medications. Ex.
10 at 8. Petitioner informed Dr. Eisenstock of increased numbness and tingling in both of her
hands and fifth digits of both hands. Id. Petitioner also said injections have had “up-and-down
benefits” but help with the pain. Id. On physical examination, Petitioner “did have positive
Tinel’s7 and both medial epicondyles8 of the elbows…. She had negative Tinel’s though at both
wrists. There was no obvious thenar or hyperthenar atrophy.” Id. at 9.

On February 6, 2017, Petitioner saw Dr. Eisenstock to discuss obtaining another EMG.
Ex. 10 at 3. Petitioner’s symptoms remained largely unchanged, but she had questions regarding
ulnar neuropathies. Id. Petitioner informed Dr. Eisenstock that she could probably tolerate an
increase in dosage of Lamictal but was in the process of obtaining a GI workup for elevated liver
enzymes. Id. Dr. Eisenstock did not recommend an increased dose until her GI workup returned.
Id. at 3-4.

On March 3, 2017, Petitioner saw Breta Boots, D.O., with complaints of “tingling and pain
in the upper extremities bilaterally, left greater than right, extending from elbow to forearm and
involving all 5 fingers, also left greater than right.” Ex. 10 at 11. Dr. Boots reviewed Petitioner’s
EMG and opined it was “mildly abnormal”. Id. The EMG showed

There is electrophysiological evidence of median nerve mononeuropathy (as can
be seen in carpal tunnel syndrome) at the wrists bilaterally which is mild in severity
on the left and minimal on the right. There is no evidence of any other superimposed

7
Tinel’s is “a tingling sensation in the distal end of a limb when percussion is made over the site of a
divided nerve. It indicates a partial lesion or the beginning regeneration of the nerve.” Tinel sign,
DORLAND'S MEDICAL DICTIONARY ONLINE (hereinafter “DORLAND’S”), https://www.dorlandsonline.com/
dorland/definition?id=106510 (last visited on December 14, 2020).
8
An epicondyle is “an eminence on a bone above its condyle.” Epicondyle, DORLAND'S,
https://www.dorlandsonline.com/dorland/definition?id=16789 (last visited on December 16, 2020). A
condyle is “a rounded projection on a bone, usually for articulation with another.” Condyle, DORLAND'S,
https://www.dorlandsonline.com/dorland/definition?id=10794 (last visited on December 16, 2020).
8
 mononeuropathies (i.e. ulnar nerve, radial nerve) in either upper extremity. Needle
examination reveals some mild, likely chronic, changes in a few muscles in the left
upper extremity which could raise the possibility of a very mild left-sided cervical
radiculopathy at the level of C7-8.

Id. at 11-12.

Petitioner followed up with Dr. Eisenstock on March 6, 2017. Ex. 10 at 1. Dr. Eisenstock
reviewed Petitioner’s EMG and found it showed some chronic innervation changes in the lower
cervical area, mild carpal tunnel bilaterally and no findings of ulnar neuropathy. Id. He informed
Petitioner that “no additional intervention is required other than neuropathic pain management.”
Id. at 2.

III. Affidavit

Petitioner filed an affidavit on April 10, 2017, which she signed on October 18, 2016. Ex.
2. Petitioner stated she felt immediate pain after the flu vaccine which spread down her arm all
the way to her hand. Ex. 2 at 1. The pain was so severe that she “was unable to lift [her] arm to
take [her] clothes off.” Id. Petitioner added that, “[t]he pain then spread across my back and into
my right shoulder and arm.” Id. Petitioner stated that she required assistance from her husband
with normal activities like dressing and pulling the covers off to get out of bed. Id. Mr. LaBounty
also drove Petitioner to medical appointments and to work when she was unable to because of the
pain. Id.

Petitioner stated she was diagnosed with brachial neuritis and underwent two rounds of
physical therapy with minimal improvement. Ex. 2 at 2. Petitioner indicated that she was fully
employed but had to take time off for her symptoms and took medication that made her very
forgetful. Id. Petitioner stated that “[m]any aspects of [her] life have been negatively affected by
this injury.” Id.

On January 15, 2019, Petitioner submitted a supplemental affidavit. Ex. 13. Petitioner
stated that since the vaccination, her feet and hands get very cold and her hands “get so cold that
they actually hurt.” Id. at 1. These were not symptoms she experienced prior to the vaccination.
See id. Additionally, Petitioner stated “[t]hese specific symptoms occurred during the time of my
severe back and neck pain.” Id. Petitioner described these symptoms to her doctors as a
“decreased sensation, because they feel numb when cold.” Id.

IV. Expert Opinions

A. Dr. Marcel Kinsbourne

Petitioner filed an expert report and three supplemental reports from Dr. Kinsbourne. Exs.
11 (“First Kinsbourne Rep.”), 15 (“Second Kinsbourne Rep.”), 16a (“Third Kinsbourne Rep.”), 17
(“Fourth Kinsbourne Rep.”).

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 Although no curriculum vitae was submitted for Dr. Kinsbourne, I am aware from previous
cases that Dr. Kinsbourne received his medical degree from Oxford University in 1955. See Bryan
v. Sec’y of Health & Hum. Servs., No. 14-898, 2020 WL 7089841, at *12 (Fed. Cl. Spec. Mstr.
Oct. 9, 2020). Dr. Kinsbourne completed post-doctoral training in neurology and pediatrics and
is Board Certified in Pediatrics. See id. Dr. Kinsbourne has had a number of hospital and academic
appointments and has been 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. Id.
Dr. Kinsbourne serves on numerous editorial boards, including Brain Research, Cognitive
Neuropsychiatry, Journal of Psycholinguistic Research, and many others. Id. Dr. Kinsbourne has
published over 400 articles regarding pediatrics and neurology. Id.

1. Dr. Kinsbourne’s First Report

In Dr. Kinsbourne’s first report, he summarized Petitioner’s symptoms as “severe
neuropathic pain in the absence of focal neurological signs and without clear etiology.” First
Kinsbourne Rep. at 2. Based on Petitioner’s initial symptom of severe pain around the injection
site, the immediate onset suggested a SIRVA. Id. at 3. However, according to Dr. Kinsbourne,
her pain became more widespread, leading to a possible diagnosis of brachial neuritis. Id., see
also Pet. However, Petitioner’s symptomology did not follow the typical disease trajectory
because Petitioner did not develop muscle weakness. First Kinsbourne Rep. at 3.

Dr. Kinsbourne noted that Dr. Eisenstock entertained a CRPS diagnosis. First Kinsbourne
Rep. at 3; see also Ex. 4 at 30; Ex. 7 at 10. Dr. Kinsbourne provided an overview of the signs and
symptoms of CRPS and cited the International Association for the Study of Pain’s (“IASP”)
criteria for a CRPS diagnosis. See generally First Kinsbourne Rep. at 3-4. Dr. Kinsbourne
“confirmed” a CRPS diagnosis by stating:

Presence of an initiating noxious event or a cause of immobilization. Sharon
LaBounty received an intramuscular injection of influenza vaccine.

Continuing pain, allodynia or hypalgesia [sic] with which pain is disproportionate
to any inciting event. Her influenza vaccination triggered disproportionate pain.

Evidence at some time of edema, changes in skin blood flow or abnormal
sudomotor activity in the region of the pain. She had swelling of her fingers.

Diagnosis is excluded by existence of other conditions that would otherwise
account for the degree of pain and dysfunction. No such conditions (brachial
neuritis, cervical spondylosis) could be corroborated.

Id. at 4. Dr. Kinsbourne also noted that the temporary help of corticosteroid injections
corroborated the CRPS diagnosis. See generally id. at 4-5. Dr. Kinsbourne cited a 2003 case study
in which four patients developed CRPS after receiving hepatitis B vaccinations. Id. at 5. In
explaining how Petitioner’s vaccination caused her disease, Dr. Kinsbourne stated, “CRPS can be
caused by vaccination with diverse vaccines, consistent with the view that it was mechanical

10
trauma due to the injection rather than a chemical effect due to a particular vaccine that caused the
disorder.” Id.

2. Dr. Kinsbourne’s Second Report

Dr. Kinsbourne opined that the “Budapest criteria are an elaboration of the IASP format
that subdivides the questionnaire items into those that are subjective and those that are
observative.” Second Kinsbourne Rep. at 1. The IASP criteria “maximize sensitivity at the
expensive of specificity” while the Budapest criteria are “far more conservative”. Id. Dr.
Kinsbourne listed the four criteria (sensory, vasomotor, sudomotor, motor/trophic) and referenced
the correlating records that satisfied these criteria:

1. Sensory: Pain from things that are not normally painful
Ms. LaBounty had pain from joint movement; raising left arm above shoulder
level. Also burning pain waking her at night. She was unable to dress herself,
pull covers off the bed or drive, due to excessive pain (Affidavit, October 18,
2016)

2. Vasomotor
Abnormally cold feeling in both hands (Affidavit, January 10, 2019)
Fingers blanch (Exhibit 4, p. 32).

3. Sudomotor
Edema; swelling dorsum of hands (Exhibit 4, p. 3, Exhibit 9, pp. 32, 43)

4. Motor/trophic
Inability to move left arm
Weakness both arms (Exhibit 4, pp. 10, 12, 32) weak right hand intrinsic
muscles, weak abduction of fingers (Exhibit 4, p 11).

Id. at 2. Based on his interpretation of Petitioner’s records, Dr. Kinsbourne opined that she had
CRPS pursuant to the Budapest criteria. Id. Regarding my question whether Petitioner showed
symptoms of hyperesthesia and allodynia, Dr. Kinsbourne stated that Petitioner’s behavior
“indicated” hyperesthesia of the affected limb and “allodynia is consistent with Ms. LaBounty’s
actions, such as guarding her arm from perturbations”. Id. at 3.

Dr. Kinsbourne also responded to Dr. Callaghan’s first expert report. Dr. Kinsbourne did
not address Petitioner’s previous diagnosis of central sensitization syndrome but cited medical
literature regarding the relationship between CRPS and migraines. See Second Kinsbourne Rep.
at 2-3. Dr. Kinsbourne added that Petitioner’s history of migraines and dysmenorrhea were risk
factors for CRPS. Id. at 3. Dr. Kinsbourne maintained that the type of vaccine is irrelevant to the
development of CRPS but that a needle-induced soft tissue injury could cause CRPS. Id.

3. Dr. Kinsbourne’s Third Report

11
 Dr. Kinsbourne filed a third report to answer additional questions that I posed. Dr.
Kinsbourne opined that Petitioner’s CRPS began 15 minutes after the “needle-stick for the
influenza vaccination” and that there was no medically appropriate onset interval for CRPS after
needle stick but cited medical literature that showed that onset was “’immediate after the injury’”.
Third Kinsbourne Rep. at 1. Dr. Kinsbourne restated his position that Petitioner met both the IASP
and the Budapest criteria. He further clarified that Petitioner’s finger blanching did not constitute
a color change for purposes of the criteria but “is secondary to vasomotor dysregulation”. Id. at 2.
Finally, Dr. Kinsbourne stated that the symptoms of CRPS do wax and wane over time. Id. at 3-
4.

4. Dr. Kinsbourne’s Fourth Report

Dr. Kinsbourne copied his assessment of the Budapest criteria from his first supplemental
report and restated his opinion that Petitioner met the four categories of the criteria. Fourth
Kinsbourne Rep. at 1-2.

B. Dr. Brian Callaghan

Respondent filed an expert report and two supplemental reports from Dr. Callaghan. Exs.
A (“First Callaghan Rep.”), C (“Second Callaghan Rep.”), D (“Third Callaghan Rep.”).

Dr. Callaghan received his medical degree from the University of Pennsylvania in 2004.
Ex. B (hereinafter “Callaghan CV”) at 1. Dr. Callaghan completed his residency in neurology at
the University of Pennsylvania and completed two fellowships at the University of Michigan. Id.
Dr. Callaghan is board certified in neurology and electrodiagnostic medicine. Id. He is a professor
at the University of Michigan, Ann Arbor and VA Ann Arbor Healthcare system. Id. Dr.
Callaghan is the director of the ALS Clinic and a Staff Physician in the Department of Neurology
at the VA Ann Arbor Health System. Id. at 1-2. Dr. Callaghan is actively involved in research, is
on the editorial board of Innovations in Care Delivery (Neurology) and is a journal reviewer for
an extensive number of publications including but not limited to Annals of Neurology, Brain, Brain
and Behavior, Diabetes, Lancet, Neurology. Id. at 3-5. Dr. Callaghan has published over 70 peer
reviewed papers and book chapters. He has presented at many conferences and institutions, both
nationally and internationally. Id. at 6-15.

1. Dr. Callaghan’s First Report

Dr. Callaghan opined that the Budapest Criteria are “the most accepted diagnostic criteria
for the diagnosis of CRPS.” Resp’t’s Status Rep. on 4/7/2020, ECF No. 47. The Budapest Criteria
require that a patient have three of four categories of symptoms (sensory, vasomotor,
sudomotor/edema, and motor/trophic) and two of four signs (sensory, vasomotor,
sudomotor/edema, motor/trophic). First Callaghan Rep. at 2. Dr. Callaghan stated that CRPS
should only be considered when there is no better alternative diagnosis available. Id. Dr.
Callaghan indicated that Petitioner’s diagnosis of central sensitization syndrome, or chronic
overlapping pain conditions, was correct and that Petitioner’s symptoms correlate best with this
diagnosis. Id. at 2-3. Petitioner’s extensive history of migraines, temporal mandibular joint pain,

12
low back pain, and irritable bowel syndrome indicate that she has central sensitization syndrome
and Petitioner’s post-vaccination arm pain qualifies as a chronic overlapping pain condition. Id.

Additionally, Dr. Callaghan stated that there has not been any epidemiological support to
show that a flu vaccination can cause CRPS. The few case studies filed by Petitioner provide a
small sample size and do not apply to this case because different vaccines were involved in the
case studies. First Callaghan Rep. at 3.

2. Dr. Callaghan’s Second Report

Dr. Callaghan reiterated that Petitioner does not meet the criteria for CRPS because she
has experienced pain since 2008 and was diagnosed with central sensitization syndrome which
“better explains her signs and symptoms”. Second Callaghan Rep. at 2. Petitioner’s extensive
pain history which included fibromyalgia, migraines, low back pain, temporal mandibular joint
pain, and irritable bowel syndrome, is consistent with central sensitization syndrome. Id. While
Petitioner had migraines and dysmenorrhea, which are risk factors for CRPS, she had other chronic
pain conditions. Id. Dr. Callaghan also stated that Dr. Kinsbourne provided no evidence to support
his theory of causation other than case reports, however “these are the lowest form of
epidemiologic support.” Id. at 1-2.

3. Dr Callaghan’s Third Report

Dr. Callaghan submitted his third and final report answering additional questions that I
posed. Dr. Callaghan stated that Petitioner did not meet the Budapest Criteria for CRPS because
she exhibited neither vasomotor nor sudomotor/edema symptoms. Third Callaghan Rep. at 1. The
Budapest criteria require a patient to meet three out of four categories of symptoms and two out of
four categories of signs. Dr. Callaghan disputed Dr. Kinsbourne’s assessment of coldness in
Petitioner’s hands as a vasomotor symptom. Id. Dr. Callaghan also noted that Petitioner
experienced a mild edema, which was “not a symptom”. Id. Important in the Budapest criteria
are the asymmetry of symptoms. Petitioner did not exhibit temperature asymmetry, skin color
asymmetries, or trophic changes (skin, hair, nails). Id.

Regarding needle stick, Dr. Callaghan opined that he did not believe needle sticks are
sufficient to cause CRPS. Id. He cited medical literature that noted triggers for CRPS included
“fractures, sprains, contusions, crush injuries and surgeries” with fractures (42%), blunt traumatic
injuries (21%), and surgery (12%) the most common causes of CRPS. Id. With regards to the
case reports that Dr. Kinsbourne cited, Dr. Callaghan noted none were after a seasonal flu
vaccination and in one of the articles, it found no increase in the observed and expected numbers
of CRPS after HPV vaccination. Id. It is Dr. Callaghan’s opinion that CRPS cannot be caused by
needle stick and even if it could, Petitioner did not have CRPS. Id. at 2.

Dr. Callaghan next opined that the symptoms of CRPS do not wax and wane, as Petitioner’s
symptoms did. Third Callaghan Rep. at 2. CRPS can worsen and improve over time but would
not have dramatic changes month to month. Id. Furthermore, CRPS is unlikely to respond to
treatments for shoulder pain (steroid shots) or carpal tunnel syndrome (splints), which Petitioner
received. Id.

13
 V. Applicable Law

A. Petitioner’s Burden in Vaccine Program Cases

Under the Vaccine Act, a petitioner may prevail in one of two ways. First, a petitioner may
demonstrate that she suffered a “Table” injury—i.e., an injury listed on the Vaccine Injury Table
that occurred within the time period provided in the Table. § 11(c)(1)(C)(i). “In such a case,
causation is presumed.” Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1320 (Fed.
Cir. 2006); see § 13(a)(1)(B). Second, where the alleged injury is not listed in the Vaccine Injury
Table, a petitioner may demonstrate that he suffered an “off-Table” injury. § 11(c)(1)(C)(ii).

For both Table and non-Table claims, Vaccine Program petitioners bear a “preponderance
of the evidence” burden of proof. § 13(1)(a). That is, a petitioner must offer evidence that leads
the “trier of fact to believe that the existence of a fact is more probable than its nonexistence before
[she] 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 & Hum. Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010); see
also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or speculation
is insufficient under a preponderance standard). Proof of medical certainty is not required.
Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a
petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the injury but
also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface
v. Sec’y of Health & Hum. Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999)); Pafford v. Sec’y of Health
& Hum. Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine
Program award based solely on her assertions; rather, the petition must be supported by either
medical records or by the opinion of a competent physician. Section 13(a)(1).

In attempting to establish entitlement to a Vaccine Program award of compensation for a
non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005). Althen requires
that petitioner establish by preponderant evidence that the vaccination he received caused his
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.” Id. at
1278.

Under the first prong of Althen, petitioners must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford, 451 F.3d at
1355-56 (citations omitted). To satisfy this prong, a petitioner’s theory must be based on a “sound
and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Hum. Servs., 35
F.3d 543, 548 (Fed. Cir. 1994). Proof that the proffered medical theory is reasonable, plausible,
or possible does not satisfy a petitioner’s burden. Boatmon v. Sec’y of Health & Hum. Servs., 941
F.3d 1351, 1359-60 (Fed. Cir. Nov. 7, 2019).

Petitioners may satisfy the first Althen prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical

14
theory. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009) (citing
Capizzano, 440 F.3d at 1325-26). However, special masters are “entitled to require some indicia
of reliability to support the assertion of the expert witness.” Boatmon, 941 F.3d at 1360, quoting
Moberly, 592 F.3d at 1324. Special Masters, despite their expertise, are not empowered by statute
to conclusively resolve what are complex scientific and medical questions, and thus scientific
evidence offered to establish Althen prong one is viewed “not through the lens of the laboratorian,
but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.” Id. at
1380. Accordingly, special masters must take care not to increase the burden placed on petitioners
in offering a scientific theory linking vaccine to injury. Contreras v. Sec’y of Health & Hum.
Servs., 121 Fed. Cl. 230, 245 (2015), vacated on other grounds, 844 F.3d 1363 (Fed. Cir. 2017);
see also Hock v. Sec’y of Health & Hum. Servs., No. 17-168V, 2020 U.S. Claims LEXIS 2202 at
*52 (Fed. Cl. Spec. Mstr. Sept. 30, 2020).

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, 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’”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the treatment
of the patient. Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing … that mandates that the testimony of a treating physician is sacrosanct -- that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record -- including conflicting
opinions among such individuals. Hibbard v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 742,
749 (2011) (not arbitrary or capricious for special master to weigh competing treating physicians’
conclusions against each other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Health &
Hum. Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot.
for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 Fed. App’x 765 (Fed.
Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to
the phrase “medically-acceptable temporal relationship.” Id. A petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de
Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation
for what is a medically acceptable timeframe must also coincide with the theory of how the relevant

15
vaccine can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of
Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353
(2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Hum. Servs.,
No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed.
Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Analysis of Fact Evidence

The process for making factual determinations in Vaccine Program cases begins with
analyzing the medical records, which are required to be filed with the petition. Section 11(c)(2).
The special master is required to consider “all [] relevant medical and scientific evidence contained
in the record,” including “any diagnosis, conclusion, medical judgment, or autopsy or coroner’s
report which is contained in the record regarding the nature, causation, and aggravation of the
petitioner’s illness, disability, injury, condition, or death,” as well as the “results of any diagnostic
or evaluative test which are contained in the record and the summaries and conclusions.” Section
13(b)(1)(A). The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See Burns v. Sec’y of Health & Hum. Servs., 3
F.3d 413, 417 (Fed. Cir. 1993) (it is within the special master’s discretion to determine whether to
afford greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such
determination is evidenced by a rational determination).

Medical records created contemporaneously with the events they describe are presumed to
be accurate and “complete” such that they present all relevant information on a patient’s health
problems. Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598,
608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his contemporaneous
medical records, the special master’s decision to rely on petitioner’s medical records was rational
and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health & Hum. Servs., 468 F. App’x
952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is based on the linked
proposition that (i) sick people visit medical professionals; (ii) sick people honestly report their
health problems to those professionals; and (iii) medical professionals record what they are told or
observe when examining their patients in as accurate a manner as possible, so that they are aware
of enough relevant facts to make appropriate treatment decisions. Sanchez v. Sec’y of Health &
Hum. Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr. Apr. 10, 2013), mot.
for review den’d (Fed. Cl. Feb. 11, 2019), vacated on other grounds, 809 Fed. Appx. 843 (Fed.
Cir. 2020); Cucuras v. Sec’y of Health & Hum. Servs., 26 Cl. Ct. 537, 543 (1992), aff’d, 993 F.2d
at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately
report the onset of their daughter’s symptoms.”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony --
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (1991), aff’d per curiam,
968 F.2d 1226 (Fed. Cir. 1992), (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396

16
(1947) (“[i]t has generally been held that oral testimony which is in conflict with contemporaneous
documents is entitled to little evidentiary weight.”)).

However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Hum. Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon common
sense and experience, this rule should not be treated as an absolute and must yield where the factual
predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19 (“[w]ritten
records which are, themselves, inconsistent, should be accorded less deference than those which
are internally consistent”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a determination
regarding a witness’s credibility is needed when determining the weight that such testimony should
be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570,
1575 (Fed. Cir. 1993).

When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be “consistent, clear, cogent and
compelling.” Sanchez, 2013 WL 1880825, at *3 (citing Blutstein v. Sec’y of Health & Hum. Servs.,
No. 90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In determining the
accuracy and completeness of medical records, the Court of Federal Claims has listed four possible
explanations for inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that happened
during the relevant time period; (2) the medical professional’s failure to document everything
reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony;
or (4) a person’s purposeful recounting of symptoms that did not exist. LaLonde v. Sec’y of Health
& Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014). In making
a determination regarding whether to afford greater weight to contemporaneous medical records
or other evidence, such as testimony at hearing, there must be evidence that this decision was the
result of a rational determination. Burns, 3 F.3d at 417.

C. Analysis of Expert Testimony

Establishing a sound and reliable medical theory connecting the vaccine to the injury often
requires a petitioner to present expert testimony in support of her claim. Lampe v. Sec’y of Health
& Hum. Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is
usually evaluated according to the factors for analyzing scientific reliability set forth in Daubert
v. Merrell Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Hum.
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Hum. Servs., 195
F.3d 1302, 1316 (Fed. Cir. 1999). “The Daubert factors for analyzing the reliability of testimony
are: (1) whether a theory or technique can be (and has been) tested; (2) whether the theory or
technique has been subjected to peer review and publication; (3) whether there is a known or
potential rate of error and whether there are standards for controlling the error; and (4) whether the
theory or technique enjoys general acceptance within a relevant scientific community.” Terran,
195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95).

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora. Daubert factors are employed by judges to exclude

17
evidence that is unreliable and potentially confusing to a jury. In Vaccine Program cases, these
factors are used in the weighing of the reliability of scientific evidence. Davis v. Sec’y of Health
& Hum. Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate
persuasiveness and reliability of expert testimony has routinely been upheld. See, e.g., Snyder, 88
Fed. Cl. at 743. In this matter, (as in numerous other Vaccine Program cases), Daubert has not
been employed at the threshold to determine what evidence should be admitted, but instead to
determine whether expert testimony offered is reliable and/or persuasive.

Respondent frequently offers one or more experts of his own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). A “special master is entitled to
require some indicia of reliability to support the assertion of the expert witness.” Moberly, 592
F.3d at 1324. Weighing the relative persuasiveness of competing expert testimony, based on a
particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Id. at 1325-26 (“[a]ssessments as to the
reliability of expert testimony often turn on credibility determinations”); see also Porter v. Sec’y
of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this court has unambiguously
explained that special masters are expected to consider the credibility of expert witnesses in
evaluating petitions for compensation under the Vaccine Act”).

D. Consideration of Medical Literature

Although this decision discusses some but not all of the medical literature in detail, I
reviewed and considered all of the medical records and literature submitted in this matter. See
Moriarty v. Sec’y of Health & Hum. Servs., 844 F.3d 1322, 1328 (Fed. Cir. 2016) (“We generally
presume that a special master considered the relevant record evidence even though [s]he does not
explicitly reference such evidence in h[er] decision.”); Simanski v. Sec’y of Health & Hum. Servs.,
115 Fed. Cl. 407, 436 (2014) (“[A] Special Master is ‘not required to discuss every piece of
evidence or testimony in her decision.’” (citation omitted)), aff’d, 601 F. App’x 982 (Fed. Cir.
2015).

VI. Analysis

Because Petitioner does not allege an injury listed on the Vaccine Injury Table, her claim
is classified as “off-Table.” As noted above, to prevail on an “off-Table” claim, Petitioner must
prove by preponderant evidence that she suffered an injury and that this injury was caused by the
vaccination at issue. See Capizzano, 440 F.3d at 1320.

18
 A. CRPS Generally

CRPS is a chronic pain condition “characterized by spontaneous and evoked regional
pain”. S. Bruehl, Complex regional pain syndrome, BMJ at 1 (2015) (filed as Ex. E). CRPS
generally begins in an extremity and the pain experienced is disproportionate to the injury. Id.
The typical characteristics of CRPS include continuous pain, sensory, vasomotor,
sudomotor/edema, and motor/trophic signs and symptoms. Ott & Maihöfner, Signs and Symptoms
in 1,043 Patients with Complex Regional Pain Syndrome, 19 THE JOURNAL OF PAIN 6, 599-611
(2018) (filed as Ex. F) (hereinafter “Ott & Maihöfner”). CRPS pain has been described as
“’burning,’ ‘pins and needles’ sensation, or as if someone were squeezing the affected limb.”
Complex Regional Pain Syndrome Fact Sheet, National Institutes of Neurological Disorders and
Stroke, National Institutes of Health (filed as Ex. 11c) (hereinafter “NIH Fact Sheet”). CRPS can
also travel to the opposite extremity. Id. at 1. In the initial acute stage of CRPS, “inflammation is
common and can be targeted with corticosteroid therapy.” See M. Ferguson, Steroids for Complex
Regional Pain Syndrome?9

The cause of CRPS is unknown. The NIH Fact Sheet estimates that 90% of CRPS cases
are triggered by trauma or an injury. NIH Fact Sheet at 2. The severity of trauma is not linked to
the development of CRPS. Marinus et al., Clinical features and pathophysiology of complex
regional pain syndrome, THE LANCET NEUROLOGY, vol. 10, 637-648 (2011) (filed as Ex. 15d)
(hereinafter “Marinus”). It is generally understood that CRPS is a disorder associated with “an
aberrant host response to tissue injury.” Id. at 1.

B. Petitioner Has Carried Her Burden of Proof

1. There is Preponderant Evidence that Petitioner Suffers from CRPS

The first step in an “off-Table” claim is to “determine what injury, if any, was supported
by the evidence presented in the record.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d
1343, 1353 (Fed. Cir. 2011). The Vaccine Act “places the burden on the petitioner to make a
showing of at least one defined and recognized injury,” and “[i]n the absence of a showing of the
very existence of any specific injury[,] . . . the question of causation is not reached.” Id.; see
Broekelschen, 618 F.3d at 1346 (explaining that “identifying the injury is a prerequisite to the
[causation] analysis”). In this case, there is a dispute as to whether Petitioner suffered from CRPS.

In order to be diagnosed with CRPS, a patient must have continuing pain disproportionate
to any inciting event, display the signs and symptoms enumerated in the Budapest Criteria, and
establish that no other diagnosis better explains the patient’s signs and symptoms.

a. Diagnostic Criteria

Both experts agree that the Budapest Criteria are an appropriate diagnostic standard for

9
https://www.practicalpainmanagement.com/treatments/pharmacological/non-opioids/steroids-complex-
regional-pain-syndrome#fieldset; (filed as Ex. 11f) (last accessed December 15, 2020).

19
CRPS. See Second Kinsbourne Rep. at 1-2; Resp’t’s Status Rep. dated April 7, 2020, ECF No.
47. The Budapest Criteria were discussed in a 2007 article by Harden et al..”10 The criteria
include:

1) Continuing pain, which is disproportionate to any inciting event
2) Must report at least one symptom11 in three of the four following categories:
- Sensory: reports of hyperesthesia and/or allodynia
- Vasomotor: reports of temperature asymmetry and/or skin color changes and/or
skin color asymmetry
- Sudomotor/edema: reports of edema and/or sweating changes and/or sweating
asymmetry
- Motor/trophic: reports of decreased range of motion and/or motor dysfunction
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
(3) Must display at least one sign at time of evaluation in two or more of the following
categories:
- Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch
and/or deep somatic pressure and/or joint movement)
- Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or
asymmetry
- Sudomotor/edema: evidence of edema and/or sweating changes and/or sweating
asymmetry
- Motor/trophic: evidence of decreased range of motion and/or motor dysfunction
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
(4) There is no other diagnosis that better explains the signs and symptoms

i. Continuing Pain Disproportionate to any Inciting Event

The experts generally agree that Petitioner meets the first three criteria. First, Petitioner
does have continuing pain, documented throughout her medical records which is disproportionate
to the needle stick on September 18, 2015. In fact, Dr. Fuller described her pain as an “[e]xtreme
increase in her arm and shoulder pain out of proportion to what is seen on MRI of the left shoulder.”
Ex. 4 at 32.

ii. Reported Symptoms

Petitioner also described symptoms in three of the four categories as required by the second
criterion. Dr. Kinsbourne opined and Dr. Callaghan conceded that Petitioner does have the sensory
symptom of allodynia. See Second Kinsbourne Rep. at 2; Third Kinsbourne Rep. at 3; Fourth
Kinsbourne Rep. at 1; Third Callaghan Rep. at 1.

10
Harden et al., Proposed New Diagnostic Criteria for Complex Regional Pain Syndrome, 8 PAIN
MEDICINE 4 (2007) (filed as Ex. 15c).
11
A sign is defined as “an indication of the existence of something; any objective evidence of a disease,
i.e., such evidence as is perceptible to the examining physician, as opposed to the subjective sensations
(symptoms) of the patient.” Sign, DORLAND’S, https://www.dorlandsonline.com/dorland/
definition?id=45805 (last visited on December 16, 2020).
20
 In addition, Petitioner satisfied the sudomotor category based on the report of edema in her
medical records. Dr. Callaghan disagreed with this point indicating that Petitioner’s medical
record describes signs and not symptoms of edema. See Third Callaghan Rep. at 1. While true
for the particular record that he referenced (Ex. 4 at 32), there are other medical records where
Petitioner discussed swelling of her hands that was not observed by her doctor. For example,
during her visit with Dr. Eisenstock on March 11, 2016, the HPI states, “After her injections [s]he
states that there was a significant relief of symptoms involving her left upper extremity and that
she also notices some swelling in her hands had been improved.” Ex. 4 at 3. There was no swelling
documented on exam during this visit. On October 14, 2015, Petitioner described swelling in her
right fifth finger and her wrists. Id. at 42. Additionally, during a September 30, 2015 visit with
Dr. Shih, the subjective section of the record states, “She describes pain and swelling in the left
and right second fingers, diffusely through the finger…” Ex. 9 at 43. The physical exam portion
of the record indicates Petitioner had “[g]ood range of motion of elbows, wrists, fingers with no
active synovitis.” Id. Based on the foregoing, I find that Petitioner has experienced symptoms of
edema.

I agree with Dr. Callaghan that there is not evidence Petitioner experienced vasomotor
symptoms consistent with the Budapest Criteria (reports of temperature asymmetry and/or skin
color changes and/or skin color asymmetry). Dr. Kinsbourne initially opined that Petitioner met
this criterion due to her “abnormal[] cold feeling in both hands” and the fact that her “fingers
blanch”. See Second Kinsbourne Rep. at 2. While Petitioner did describe that her hands were
cold, she did not describe temperature asymmetry. In addition, I specifically asked Dr. Kinsbourne
whether blanching of the fingers due to swelling constitutes a color change. He responded, “Not
in the sense called for by diagnostic criteria. A color change should characterize the skin of the
affected limb independent of swelling. Blanching is secondary to vasomotor dysregulation…” Id.

Finally, I find that Petitioner also experienced motor symptoms. Petitioner made several
reports of pain with overhead movement throughout her medical records. For example, Petitioner
visited Dr. Zhou on December 14, 2015. This record notes that she reported “significant amount
of pain 9-10/10 with any sort of overhead activities since the flu shot.” Ex. 4 at 24. On September
30, 2015, Dr. Shih noted that Petitioner “has pain with full abduction of both shoulders, as well as
external and internal rotation…” Id. at 43. Further, Dr. Callaghan agreed that Petitioner did
experience motor symptoms which included pain with movement and pain limiting movement.
Third Callaghan Rep. at 1.

The Budapest criteria require that Petitioner experience at least one symptom in three of
the four categories. The above analysis demonstrates that Petitioner has met the requirements of
the second criterion.

iii. Documented Signs

I find that the medical records document that Petitioner displayed signs in two of the four
categories of the Budapest Criteria: sudomotor/edema and motor/trophic.

21
 On December 3, 2015, Petitioner visited Dr. Fuller. Dr. Fuller conducted a physical
examination and noted that “[t]here is mild swelling of the dorsum of the right hand and fingers
compared with the left side.” Ex. 4 at 32. Both Dr. Kinsbourne and Dr. Callaghan agree that this
documented instance of edema constitutes a sudomotor sign. See First Kinsbourne Rep. at 4;
Second Kinsbourne Rep. at 2; Fourth Kinsbourne Rep. at 1; Third Callaghan Rep. at 1.

On February 12, 2016, Petitioner visited N.P. Vanhorn. On physical examination, N.P.
Vanhorn noted “some discomfort on PROM at shoulder and with abduction of fingers.” Ex. 4 at
11. She also noted “Normal strength except some slight (5-/5) in right hand intrinsics and in finger
abduction, R>L.” Id. On December 3, 2015, Dr. Fuller noted the following on physical exam:

There is discomfort around the deltoid muscle of the right shoulder. There is
decreased sensation to light touch over the left upper extremity laterally and a mild
decreased sensation in the left hand and numbness in the right hand. DTRs 1 +
bilaterally in the arms. There is decreased power, about 4/5 bilaterally. There is
some mild discomfort to palpation in the cervical paravertebral areas.

Id. at 32. Dr. Kinsbourne opined that each of these examples from the medical records constitute
examples of motor signs. See Second Kinsbourne Rep. at 2; Fourth Kinsbourne Rep. at 1. Dr.
Callaghan also agreed that Petitioner experienced motor signs which included pain with movement
and pain limiting movement. Third Callaghan Rep. at 1.

The Budapest criteria require that Petitioner experience at least one sign in two of the four
categories. The above analysis demonstrates that Petitioner has met the requirements of the third
criterion.

iv. There is No Other Diagnosis that Better Explains the Signs
and Symptoms

The only question that remains is whether Petitioner has another diagnosis that better
explains her signs and symptoms. Dr. Callaghan has opined that Petitioner’s diagnosis of central
sensitization syndrome explains her signs and symptoms and precludes a diagnosis of CRPS. In
describing central sensitization syndrome, he stated:

Another term used for this disorder is chronic overlapping pain conditions, which
includes fibromyalgia, migraines, low back pain, temporal mandibular joint pain,
and irritable bowel syndrome. She had all of these conditions as documented above.
Therefore, by far the most likely cause of her unexplained bilateral arm pain is a
chronic overlapping pain condition such as fibromyalgia or myofascial pain
syndrome.12

12
Dr. Kinsbourne responded by stating there is not evidence in the medical records that Petitioner met the
diagnostic criteria for either fibromyalgia or myofascial pain syndrome. Second Kinsbourne Rep. at 3. In
response, Dr Callaghan wrote as follows: “Dr. Kinsbourne notes that she does not meet formal criteria for
fibromyalgia or myofascial pain syndrome. While correct that no one formally investigated whether she

22
First Callaghan Rep. at 1-2.

Dr. Callaghan cited to the April 18, 2014, visit with Raymond Pertusi, D.O. as support for
his opinion that Petitioner’s central sensitization syndrome explained her signs and symptoms. In
the HPI section of this record, Dr. Pertusi noted that:

This 49 YO F, a patient of Dr. I. Fuller, saw her on 3/26/14 and was noted to have
joint pains. Question OA vs. autoimmune?13 if she has Raynaud's. Does she have a
rheumatologic issue?

Her pain began about 2008. It's all day every day but worse in the morning. Less
dietary gluten helps. It's aching. No radiation. It's moderately severe. Joints/areas
affected include all 4 quadrants: ankles, knees, hands, shoulders, neck, LB, and
hips. She has fatigue, cramping, and numbness in fingers and toes. Her 1-3 fingers
do turn white on cold exposure.

Ex. 4 at 80. After an examination, Dr. Pertusi’s impression was “Her pain generator is likely a
central sensitization syndrome that could be related to remote trauma (Abuse X 3) and likely
PTSD.” Ex. 4 at 82.

I will note that aside from the description in Dr. Callaghan’s expert report cited above,
there is no further information that explains central sensitization syndrome (or chronic overlapping
pain conditions). There is no discussion of the syndrome’s diagnostic criteria. No medical
literature has been filed in this case which addresses the condition. As a result, it is difficult to
assess whether Dr. Pertusi’s impression in 2014 that Petitioner’s “pain generator is likely a central
sensitization syndrome” precludes a CRPS diagnosis.

Further, the opinions of Petitioner’s treating neurologist help to inform this issue. After
examining Petitioner on December 11, 2015, Dr. Eisenstock, found that her “many symptoms
appear to be temporarily correlated with flu vaccine.” Ex. 4 at 30. Dr. Eisenstock further found
that treatment for “regional pain syndrome”14 was indicated. Id. He prescribed Topiramate for

met criteria, she still has a central sensitization syndrome as clearly documented in her medical record many
years prior to her shoulder/arm pain (Exhibit 4, page 80).” Second Callaghan Rep. at 1.
13
The fact that Dr. Pertusi questioned whether Petitioner’s joint pain was from osteoarthritis or from an
autoimmune disease raises a question as to whether a diagnosis of osteoarthritis and/or autoimmune disease
is consistent with the impression of central sensitization syndrome. It is difficult to put this notation in
context as no additional information on central sensitization syndrome has been filed.
14
In his first expert report, Dr. Kinsbourne stated that regional pain syndrome was CRPS. First Kinsbourne
Rep. at 2. As Dr. Callaghan did not contradict this statement, I presume it is true.

23
Petitioner’s neuropathic pain. Id. Topiramate is a drug generally used to treat seizures.15 The
NIH Fact Sheet indicates that treatment for CRPS can include, among other medications, drugs
initially developed to treat seizures which have now been demonstrated as effective in treating
neuropathic pain. NIH Fact Sheet at 4. Dr. Eisenstock did not diagnose Petitioner with central
sensitization syndrome or mention anything about a prior central sensitization syndrome diagnosis.
Although Dr. Eisenstock did not formally diagnose Petitioner with CRPS, his belief that is was
appropriate to treat her for this condition constitutes strong support that this is in fact her correct
diagnosis.

Further, in a letter dated September 21, 2018, Dr. Eisenstock wrote, “Given a correlation
in time with receiving the flu shot, I would entertain the possibility of a related complex regional
pain syndrome….” Ex. 12. Again, Dr. Eisenstock did not conclusively diagnose Petitioner with
CRPS. However, he did state that he would entertain a connection between Petitioner’s condition
and her flu vaccine. Implicit in this statement is that Dr. Eisenstock believes CRPS to be a
reasonable diagnosis. Also implicit in both Dr. Eisenstock’s treatment of Petitioner in 2015 and
in his letter from 2018 is that he does not entertain a diagnosis of central sensitization syndrome.
Presumably Dr. Eisenstock, a neurologist, is aware of the diagnostic criteria for CRPS, and that
there can be no other diagnoses that better explain a patient’s signs or symptoms. The fact that
Dr. Eisenstock considers CRPS to be a reasonable diagnosis suggests he does not believe Petitioner
has another diagnosis which explains her pain.

For the reasons discussed above, I find by preponderant evidence that Petitioner did not
have another diagnosis which better explained her signs and symptoms.

b. Two of Petitioner’s Pre-existing Conditions are a Risk Factors for
CRPS

In addition to meeting the diagnostic criteria, Petitioner has a well-documented history of
pre-existing migraine headaches and dysmenorrhea, which provides further support that she
suffers from CRPS. See Ex. 4 at 46; Id. at 55. Several pieces of medical literature filed in this
case articulate a connection between migraines and CRPS. For example, Peterlin et al. reported
that

(i) migraine occurs in a greater percentage of CRPS sufferers than expected in the
general population; (ii) the onset of CRPS is reported earlier in those with migraine
than in those without; and (iii) CRPS symptoms are present in more extremities in
those CRPS sufferers with migraine compared with those without.

Migraine may be a risk factor for the development of complex regional pain syndrome,
Cephalalgia; 30(2): 214–223 (2010) (filed as Ex. 15e). Additionally, de Mos et al., found that “a

15
Topiramate is “a substituted monosaccharide used as an anticonvulsant in the treatment of partial
seizures.” Topiramate, DORLAND’S, https://www.dorlandsonline.com/dorland/definition?id=50310 (last
accessed December 16, 2020).

24
medical history of migraine was associated with CRPS.” Medical history and the onset of complex
regional pain syndrome (CRPS), PAIN (2008), doi:10.1016/j.pain.2008.07.002 (filed as Ex. 16c)
(hereinafter “de Mos”). de Mos also noted an association between CRPS and menstrual cycle
abnormalities. Id. As Petitioner had both migraines and dysmenorrhea documented in her medical
records, Dr. Kinsbourne noted that “Mrs. LaBounty’s migraine and dysmenorrhea were risk factors
for CRPS.” Second Kinsbourne Rep. at 3. This point, when considered in conjunction with the
other evidence presented in this case, including Dr. Eisenstock’s letter and treatment of Petitioner,
and Dr. Kinsbourne’s opinion, preponderantly establish that CRPS is Petitioner’s correct
diagnosis.

C. Althen Prongs

I will address the Althen prongs in their order of significance based on the facts of this case.

1. Althen Prong 1

In the context of the Program, “to establish causation, the standard of proof is
preponderance of evidence, not scientific certainty.” Langland v. Sec’y of Health & Hum. Servs.,
109 Fed. Cl. 421, 441 (2013). Petitioner’s burden under Althen’s first prong is to provide a medical
theory causally connecting the vaccination and the injury. Id. This theory must be sound and
reliable. Boatmon, 941 F.3d at 1359. Petitioners need not precisely identify a causative
mechanism to prove causation in fact as the “identification and proof of specific biological
mechanisms would be inconsistent with the purpose and nature of the vaccine compensation
program.” Knudsen, 35 F.3d at 543.

As described by extensive literature and confirmed by both experts, the exact mechanism
for onset of CRPS is yet unknown. “CRPS represents an abnormal response that magnifies the
effects of the injury.” NIH Fact Sheet at 2. Minor trauma can amplify cytokine signaling;
“cytokines and nerve growth factor can excite nociceptors and induce long-term peripheral
sensitisation.” Marinus at 640. Generally, CRPS can develop after a surgery, traumatic event, or
even a non-traumatic minor injury. Dr. Kinsbourne has stated that CRPS can occur following
needle stick.

Dr. Kinsbourne’s opinion is generally supported by the literature filed in this case.16
According to the Complex Regional Pain Syndrome Fact Sheet, published by the National
Institutes of Neurological Disorders and Stroke17, in more than 90% of cases, CRPS is triggered
by “a clear history of trauma or injury.” NIH Fact Sheet at 2. The fact sheet goes on to state that
“the most common triggers are fractures, sprains/strains, soft tissue injury (such as burns, cuts, or

16
I also note that in a prior CRPS case that I adjudicated, I mentioned the opinion of Respondent’s expert,
Dr. Phillip Low that “CRPS is well-documented after needle.” Dixon Jones v. Sec’y of Health & Hum.
Servs., No. 14-934V, 2019 WL 7556374, at *26 (Fed. Cl. Spec. Mstr. Sept. 4, 2019). The testimony from
that published decision is consistent with the medical literature referenced in this Ruling.
17
The National Institutes of Neurological Disorders and Stroke is an institute within the National Institutes
of Health. See https://www.ninds.nih.gov/About-NINDS. (Last accessed December 14, 2020).

25
bruises), limb immobilization (such as being in a cast), surgery, or even minor medical procedures
such as needle stick.” Id. An additional piece of medical literature notes that “[t]he onset of CRPS
is usually linked to a history of trauma, immobilization, or a procedure such as venipuncture,
intramuscular injection, or surgery.” Raja and Grabow, Complex Regional Pain Syndrome I
(Reflex Sympathetic Dystrophy), 96 ANESTHESIOLOGY 1254-60 (2002) (filed as Ex. 11a).

In addition to the above, Dr. Kinsbourne cited three case reports in support of his
theory.18,19,20 While case reports are not robust evidence, they do constitute some evidence with
which petitioners can meet their burden in the Vaccine Program. See Contreras v. Sec’y of Health
& Hum. Servs., 107 Fed. C. 280 (Fed. Cl. 2012); see also Capizzano 440 F.3d at 1325-26.

Kwun et al. reported the case of a 17-year-old girl who received the H1N1 vaccine.
Approximately seven hours later, she reported tingling, as well as pain and edema from the arm to
the fingers. Kwun at 1. She also developed weakness of her left upper arm such that she was not
able to lift her arm over her shoulder. Id. Her doctor diagnosed her with CRPS. Id. Kwun
concluded that “injection trauma and stress or psychological factors were associated with the onset
and maintenance of symptoms of CRPS.” Id. at 3.

Richards et al. discussed five cases of CRPS temporally associated with vaccination. The
authors proposed that “intramuscular immunisation is sufficient painful stimulus to trigger the
development of CRPS-1, and that it is the process of a needle penetrating the skin that is the trigger,
rather than a particular vaccine antigen or adjuvant being causally related.” Richards at 3. The
article concluded by noting, “this case series of CRPS type 1 in adolescents temporally associated
with immunisation reflect a known complex pain response to a painful stimulus.” Id.

Jastaniah et al. examined three instances of CRPS following Hepatitis B vaccination. The
authors noted that “it seems likely that HBVx (either the trauma or the component of a vaccine)
precipitated the clinical syndrome in this predisposed group.” Jastaniah at 804. The authors
further indicated that they could not attribute causation of CRPS to the Hepatitis B vaccinations
“given the low reported case rate and the absence of long-term follow-up.” Id.

Dr. Callaghan disagrees that a needle stick can cause CRPS. In support of this position, he
cited to a retrospective epidemiological analysis of 1,043 CRPS patients. See Ott & Maihöfner.
Dr. Callaghan described the findings of this article: “the largest case series investigating antecedent
events in 1,043 patients with CRPS found that fractures (42%), blunt traumatic injuries (21%) and
surgery (12%) were the most common causes.” Third Callaghan Rep. at 1. Dr. Callaghan further

18
Kwun et al. Complex regional pain syndrome by vaccination: A case of complex regional pain syndrome
after vaccination of influenza A(H1N1), PEDIATR INT 2012; 54: e4-e6 (filed as Ex. 11b) (hereinafter
“Kwun”).
19
Richards et al., Complex regional pain syndrome following immunisation, 97 ARCH DIS CHILD; 913-15
(2012) (filed as Ex. 11d) (hereinafter “Richards”).
20
Jastaniah et al., Complex Regional Pain Syndrome After Hepatitis B Vaccine, 143 J PEDIATR, 802-04
(2003) (filed as Ex. 11e) (hereinafter “Jastaniah”).
26
stated that “[o]nly a single case of vaccination prior to CRPS was reported (0.09%), which is far
below what would be expected based on chance alone.” Id.

Epidemiologic evidence is relevant with respect to Althen prong one. See, e.g., D’Tiole v.
Sec’y of Health & Hum. Servs., 2016 U.S. Claims LEXIS 2003 (Fed. Cl. Spec. Mstr. Nov. 28,
2016), aff’d, 132 Fed. Cl. 421 (2017); Blackburn v. Sec’y of Health & Hum. Servs., No. 10–410V,
2015 WL 425935, at *28–30 (Fed. Cl. Spec. Mstr. Jan. 9, 2015). However, this type of evidence
is not required in order for a petitioner to establish that a vaccine can cause an injury. A vaccine
injury is a rare event that cannot be disproved because a vaccinee did not experience a response
consistent with that of the general population. See Harris v. Sec’y of Health & Hum. Servs., No.
10–322V, 2014 WL 3159377, at *11 (Fed. Cl. Spec. Mstr. June 10, 2014) (finding that
epidemiologic studies cannot absolutely refute causal connections, because it is possible that a
larger study could always detect an increased risk), mot. for review dismissed, 2015 U.S. App.
LEXIS 7921 (Fed. Cir. 2015).

It is settled that “close calls” as to the causal link between a vaccine and the injury asserted
by a Petitioner should be resolved in favor of the petitioner. Knudsen by Knudsen, 35 F.3d at 549.
Although the precise biological mechanism as to how needle stick can cause CRPS is not yet
known, the medical literature and case reports filed in this case, along with the opinion of Dr.
Kinsbourne provide preponderant evidence with respect to the first Althen prong.

2. Althen Prong 3

The timing prong contains two parts. First, a petitioner must establish the “timeframe for
which it is medically acceptable to infer causation” and second, she must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).

In this case, Petitioner developed pain in her left upper arm 15 minutes after her flu vaccine.
Ex. 4 at 44. Dr. Kinsbourne opined that this initial arm pain constituted the beginning of her CRPS.
See Third Kinsbourne Rep. at 1. I find that this opinion is supported by the evidence in the case.

Dr. Kinsbourne has further opined that 15 minutes is an appropriate temporal interval
between vaccination and onset of CRPS. See First Kinsbourne Rep. at 5. He based that opinion
primarily on the Maleki article. Maleki et al., Patterns of spread in complex regional pain
syndrome, type I (reflex sympathetic dystrophy), 88 PAIN 259-66 (2000) (filed as Ex. 16e)
(hereinafter “Maleki”). In that article, the authors analyzed the spread of disease in 27 patients
who were previously diagnosed with CRPS. This study documented the interval between the
initial trauma and onset of CRPS. In nine of the 27 patients (33%), onset is documented to have
occurred immediately after the initial trauma/injury. Maleki at 262.

Dr. Kinsbourne also pointed to case reports of CRPS, where the authors describe onset of
symptoms as immediate. See e.g., Richards (describing immediate onset of numbness or severe
pain after vaccination in two of five CRPS subjects, and onset within one hour to “hours” in two
others); Kwun (describing one CRPS patient who developed pain, edema, and color change seven

27
hours after vaccination); Jastaniah (detailing four cases of CRPS which began between 15 minutes
and one hour after vaccination).

Because the precise cause of CRPS is unknown, it is difficult to articulate the rationale
behind an appropriate temporal interval between vaccination and injury. In citing to the Maleki
article as well as the above-mentioned case reports, Dr. Kinsbourne has highlighted that there is
circumstantial evidence that onset of CRPS can occur immediately after vaccination. I find this
evidence is sufficient to meet Petitioner’s burden with respect to the third Althen prong. See Althen
(“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.”) 418 F.3d at
1280.

3. Althen Prong 2

Under Althen’s second prong, a petitioner must “prove a logical sequence of cause and
effect showing that the vaccination was the reason for the injury.” Althen, 418 F.3d at 1278. The
sequence of cause and effect must be “'logical' and legally probable, not medically or scientifically
certain.” Id. A petitioner is not required to show “epidemiologic studies, rechallenge, the presence
of pathological markers or genetic disposition, or general acceptance in the scientific or medical
communities to establish a logical sequence of cause and effect.” Id. (omitting internal citations).
Capizzano, 440 F.3d at 1325. Instead, circumstantial evidence and reliable medical opinions21
may be sufficient to satisfy the second Althen prong.

a. The Onset of Petitioner’s Arm Pain 15 Minutes after Vaccination Helps
Establish that the Vaccine Was a but-for Cause of her Condition

Petitioner’s upper left arm pain began 15 minutes after she received her flu vaccine in her
left shoulder. This fact was well-documented in her contemporaneous medical records. See Ex.
4 at 24, 29, 32, 43, 44. Prior to the administration of the vaccine, Petitioner was not experiencing

21
Several of Petitioner’s treating physicians have articulated a link between her flu vaccination and her
development of arm pain. Petitioner visited Dr. Fuller, her primary care doctor on September 29, 2015, 11
days after her flu vaccine. Dr. Fuller assessed her with “Myalgias following a flu vaccine. Possibly related
to the flu vaccine.” Ex. 4 at 44. On September 30, 2015, Petitioner was seen by Dr. Shih at UMass
Memorial Hospital. Dr. Shih noted that Petitioner presented with bilateral myalgia that began after her flu
vaccination. In the assessment portion of the record, Dr. Shih noted that Petitioner’s bilateral arm pain
“may be related in some way to the flu shot.” Ex. 4 at 43. Petitioner visited Dr. Eisenstock on December
11, 2015. Dr. Eisnestock noted that Petitioner’s symptoms “appear to be temporarily correlated with flu
vaccine.” Ex. 4 at 30. Further, in a letter dated September 21, 2018, Dr. Eisenstock wrote, “Given a
correlation in time with receiving the flu shot, I would entertain the possibility of a related complex regional
pain syndrome….” Ex. 12.

Dr. Fuller, Dr Shih, and Dr. Eisenstock each noted in the medical records that the onset of Petitioner’s pain
began after her vaccination. Each also expressed their belief that Petitioner’s symptoms of arm pain may
have been caused by her vaccination. While this evidence would certainly be stronger if the treating
physicians had offered a conclusive opinion, it is nonetheless some evidence that I have considered in
reaching my determination in this case.

28
any pain. She was evaluated by Dr. Fuller on September 11, 2015 (seven days before her
vaccination). The medical record from this visit noted that Petitioner had “[g]ood range of motion
of shoulders, elbows, wrists with no active synovitis.” Id. at 45. While it is an often-cited tenet in
the Vaccine Program that a close temporal interval between a vaccination and an injury does not
prove causation, I find it would be inappropriate to ignore what appears to be the obvious cause of
Petitioner’s left arm pain, pain which under Petitioner’s theory marked the beginning of her CRPS.
As Dr. Kinsbourne stated in his report, “for pain of cervical origin so suddenly to arise at the time
of vaccination by coincidence strains credulity.” First Kinsbourne Rep. at 3. I agree with this
assessment based on the specific facts of this case.

The fact that Petitioner has established that vaccination can cause CRPS and that the timing
prong has been met helps establish that she has also demonstrated that vaccination was a but-for
cause of her condition. The Federal Circuit has provided guidance with respect to this issue.

Evidence demonstrating petitioner's injury occurred within a medically acceptable
time frame bolsters a link between the injury alleged and the vaccination at issue
under the “but-for” prong of the causation analysis. See Capizzano, 440 F.3d at
1326 (finding medical opinions that explain how a vaccine can cause the injury
alleged coupled with evidence demonstrating a close temporal relationship “are
quite probative” in proving actual causation).

Pafford, 451 F.3d at 1358. See also Contreras (finding that there is a “logical overlap between the
three Althen prongs, and that evidence that goes to one prong may also be probative for another
prong”). 107 Fed. Cl. at 295. I find that Petitioner has presented preponderant evidence in support
of the second Althen prong.

VII. Conclusion

Based on the foregoing, I conclude that Petitioner has met her burden of proof under Althen.
Accordingly, Petitioner is entitled to compensation. An order regarding damages will issue
shortly.

IT IS SO ORDERED.

s/ Katherine E. Oler
Katherine E. Oler
Special Master

29