Barlow v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: August 18, 2020

* * * * * * * * * * * * * * *
MARLIE BARLOW, * PUBLISHED
*
Petitioner, * No. 17-513V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Ruling on the Record; Influenza (“Flu”)
AND HUMAN SERVICES, * Vaccine; Peripheral Neuropathy; Carpal
* Tunnel Syndrome (“CTS”); Significant
Respondent. * Aggravation.
*
* * * * * * * * * * * * * * *

Joseph A. Vuckovich, Maglio Christopher and Toale, P.A., Washington, DC, for petitioner.
Camille M. Collett, United States Department of Justice, Washington, DC, for respondent.

DECISION1

I. INTRODUCTION

On April 12, 2017, Marlie Barlow (“petitioner”) filed a petition under the National
Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”),2 42 U.S.C. § 300aa-
10 et seq. (2012), alleging left shoulder and left arm pain following an influenza (“flu”)
vaccination administered on October 2, 2015. Petition at ¶¶ 1, 3, 6, 9. Subsequently, petitioner
alleged that the vaccination significantly aggravated his left arm peripheral neuropathy and
carpal tunnel syndrome (“CTS”). Petitioner’s Motion for Findings of Fact and Conclusions of

1
Because this Decision contains a reasoned explanation for the undersigned’s action in this case,
the undersigned intends to post this Decision on the website of the United States Court of Federal
Claims, in accordance with the E- Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). This means the
Decision will be available to anyone with access to the Internet. As provided by Vaccine
Rule 18(b), each party has 14 days within which to 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).
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C. §§ 300aa-10 to -34 (2012). All citations in this Decision to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
1
Law (“Pet. Mot.”), filed Nov. 15, 2019, at 1 (ECF No. 31).

Petitioner has suffered serious and significant illnesses. However, after carefully
analyzing and weighing all of the evidence and expert reports presented in this case in
accordance with the applicable legal standards, the undersigned finds that petitioner is not
entitled to compensation. Therefore, petitioner’s case must be dismissed.

II. PROCEDURAL HISTORY

Petitioner, Mr. Marlie Barlow, filed for compensation under the Vaccine Act on April 12,
2017. Petition at 1. Initially, petitioner alleged that he suffered left shoulder and arm pain
following the flu vaccine that he received on October 2, 2015. Petition at ¶¶ 3, 6, 9. However,
subsequently, petitioner alleged that the receipt of a flu vaccine significantly aggravated existing
peripheral neuropathy in his left arm and significantly aggravated his left arm CTS.3 Pet. Mot. at
1. Petitioner filed medical records on June 27, 2017. Petitioner’s Exhibits (“Pet. Exs.”) 1-4.
Respondent filed a status report on October 6, 2017, indicating that petitioner had missing
medical records. Respondent’s Status Report (“Resp. Status Rept.”), filed Oct. 6, 2017 (ECF
No. 10). On October 10, 2017, petitioner filed additional medical records. Pet. Ex. 5.

On January 22, 2018, respondent filed a Motion to Stay the Rule 4(c) Report. Resp. Mot.
to Stay, filed Jan. 22, 2018 (ECF No. 15). In a non-PDF Order, the Court denied respondent’s
motion. Non-PDF Order Denying Motion to Stay dated Jan. 23, 2018. Respondent filed the
Rule 4(c) Report on February 7, 2018 recommending against compensation. Resp. Rept. at 1
(ECF No. 17).

On August 17, 2018, petitioner filed a Motion to Stay Proceedings on the ground that the
parties had agreed to explore settlement. Pet. Mot. to Stay Proceedings, filed Aug. 17, 2018, at 1
(ECF No. 20). Petitioner indicated that he had transmitted a demand to respondent on August
15, 2018. Id. Settlement discussions were not productive, and, following a status conference
held on September 20, 2018, the Court issued a non-PDF Order setting a new deadline for
petitioner’s expert report. Non-PDF Scheduling Order dated Sept. 20, 2018.

On November 9, 2018, petitioner filed an expert report from Dr. Brad Klein accompanied
by supporting medical literature. Pet. Exs. 6-12. On May 30, 2019, respondent filed an expert
report from Dr. Miles Steven Evans. Resp. Ex. A. On July 11, 2019, petitioner filed additional
medical records. Pet. Ex. 13. Petitioner then filed a supplemental expert report and additional
medical literature from Dr. Klein on July 31, 2019. Pet. Exs. 14-18.

The Court held a status conference on September 5, 2019, and the special master issued a
non-PDF Scheduling Order setting a briefing schedule for this matter. See Non-PDF Scheduling
Order dated Sept. 5, 2019. On October 3, 2019, this case was reassigned to the undersigned.
Notice of Reassignment dated Oct. 3, 2019 (ECF No. 29). Respondent filed a supplemental
expert report from Dr. Evans on November 1, 2019. Resp. Ex. C.

On November 15, 2019, petitioner filed a Motion for Findings of Fact and Conclusions of
3
The undersigned has analyzed causation and significant aggravation as both have been alleged.
2
Law. Pet. Mot. On February 12, 2020, respondent filed a response to petitioner’s motion. Resp.
Response to Pet. Brief in Support of His Claim (“Resp. Response”), filed Feb. 12, 2020 (ECF
No. 37). On March 9, 2020, petitioner filed a second supplemental report from Dr. Klein and a
Reply to respondent’s brief. Pet. Ex. 20; Reply Memorandum in Support of Pet. Mot. (“Pet.
Reply”), filed Mar. 9, 2020 (ECF No. 39).

Pursuant Vaccine Rule 3(b)(2), special masters must “afford[] each party a full and fair
opportunity to present its case and creat[e] a record sufficient to allow review of the special
master’s decision.” Kreizenbeck v. Sec’y of Health & Hum. Servs., 945 F.3d 1362, 1366 (Fed.
Cir. 2020). Vaccine Rule 8(d), also provides that “the special master may decide a case on the
basis of written submissions without conducting an evidentiary hearing.” Id. at 1365. Prior
decisions have recognized that a special master’s discretion in deciding whether to conduct an
evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to afford each party a “full
and fair opportunity to present its case.” Hovey v. Sec’y of Health & Hum. Servs., 38 Fed. Cl.
397, 400-01 (Fed. Cl. 1997) (citing Rule 3(b)). But that rule also includes the obligation of
creation of a record “sufficient to allow review of the special master’s decision.” Id. at 401; see
also Kreizenbeck, 945 F.3d at 1366. Here, the petitioner has filed complete medical records and
the parties have filed a number of expert reports and supportive medical literature. Additionally,
they have fully briefed the issues. Therefore, the undersigned finds that the record is sufficiently
developed to allow a thorough analysis and decision regarding entitlement.

III. ISSUES TO BE DECIDED

The parties dispute causation. Petitioner asserts that his flu vaccination caused and/or
significantly aggravated his existing peripheral neuropathy and CTS, and maintains that he has
proven by preponderant evidence the standards articulated in Althen and Loving. See Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005); Loving v. Sec’y of Health
& Hum. Servs., 86 Fed. Cl. 135, 142-44 (2009). Respondent disagrees. Respondent contends
that petitioner’s claim fails because he has not satisfied the Althen requirements. Resp.
Response at 1-2.

IV. FACTUAL SUMMARY

A. Petitioner’s Past Medical History

Petitioner was eighty-two years old at the time of vaccination, and had an extensive and
complicated medical history, including significant cardiac problems. Petitioner is left-hand
dominant. Pet. Ex. 5 at 258.

On May 9, 2011, petitioner was treated for dysuria, constipation, and an abdominal mass.
Pet. Ex. 3 at 784. His problem list for this visit included coronary artery disease,
cardiomyopathy, type II diabetes, history of right frozen shoulder, and history of pulmonary
emboli. Id. at 784-85. He was diagnosed with acute kidney injury secondary to obstructive
uropathy, prostatic hypertrophy/hyperplasia, worsening bilateral lower extremity edema, chronic
left lower extremity deep venous thrombosis, and congestive heart failure. Id. at 786. In
November 2011, his records indicate that he required the use of a walker. Pet. Ex. 2 at 186.

3
 On December 19, 2012, petitioner was seen by Dr. Merritt Hougen, his primary care
doctor, for a review of EKG and echocardiogram results. Pet. Ex. 2 at 161-66. The notes from
this visit discuss the patient’s diabetes and his “mild peripheral neuropathy” and “mild peripheral
numbness,” as well as his diminished peripheral sensation. Id. at 161, 163. Petitioner’s
assessment for this appointment included diabetes mellitus, type II diabetes mellitus with
peripheral circulatory disorder, (lower) leg localized swelling bilateral, chronic non-decubitus
ulcer of the toes of the right foot, chronic peripheral venous insufficiency, coronary artery
disease, hypertension, and hyperlipidemia. Id. at 161. Dr. Hougen noted that petitioner’s
peripheral edema had “markedly improved.” Id. Physical examination revealed 1-2+ peripheral
edema.4 Id. at 162.

Throughout 2013, petitioner’s medical records show that he had chronic peripheral
edema, often categorized as 2 or 3+. For example, on June 4, 2013, petitioner’s records show 2+
peripheral edema. Pet. Ex. 2 at 137. On September 30, 2013, petitioner presented to Dr. Hougen
for cellulitis, exacerbation of peripheral neuropathy, and venous stasis due to insect bites. Id. at
129. He had “2+ peripheral edema with increased local left ankle edema.” Id. at 129, 131. His
blood glucose level was elevated at 145 mg/dL.5 Id. at 132. On October 14, 2013, petitioner had
2+ peripheral edema with increased left ankle edema, and on October 31, he had 3+ pitting
edema at the ankles. Id. at 120, 127.

On January 6, 2014, petitioner was seen by Dr. Virginia Knight at Scripps Urgent Care
after injuring his left wrist while lifting heavy boxes. Pet. Ex. 2 at 290. His wrist was “swollen
and painful” with “some throbbing into his left fingers.” Id. Physical examination revealed
moderate bruising and edema of the wrist with limited range of motion. Id. Additionally,
petitioner had “redness and streaking extending up the anterior forearm.” Id. at 291. X-rays
showed “scaphoid lunate separation and chondrocalcinosis and osteoarthritis” without evidence
of “fracture or dislocation.” Id. at 292. Petitioner was diagnosed with acute left wrist trauma
and cellulitis. Id.

Petitioner had a follow-up visit for his wrist injury on January 15, 2014 with Dr. Lorenzo
Pacelli. Dr. Pacelli diagnosed petitioner with “possible rupture of the flexor carpi radialis
tendon.”6 Pet. Ex. 2 at 265. After a discussion of treatment options, petitioner elected
4
Edema is the presence of abnormal fluid in subcutaneous tissues, often due to renal or heart
failure. Dorland’s Illustrated Medical Dictionary 587 (33d ed. 2020). In pitting edema, pressure
applied to the tissues reveals pits. Id. It may be quantified on a scale of 1+ to 4+ with 4+ being
most severe. Id.
5
For fasting glucose samples, the American Diabetes Association recommended decision limits
are: 70-99 mg/dL is Normal; 100-125 mg/dL is Impaired Fasting Glucose; >125 mg/dL is
Diabetes. Pet. Ex. 2 at 97.
6
The flexor carpi radialis tendon is a radial flexor muscle extending from the wrist to the base of
second metacarpal, or index finger. Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=90710 (last accessed May 28, 2020).
The innervation of this muscle is provided by the median nerve and allows for flexion and
abduction of the wrist joint. Id.
4
conservative treatment. Id.

On April 17, 2014, petitioner developed congestive heart failure and had a dual-chamber
pacemaker placed for sick sinus syndrome. Pet. Ex. 2 at 103. He then experienced abdominal
discomfort and was diagnosed with acute cholecystitis. Id. Following robotic surgery, he was
discharged, and subsequently readmitted with ischemic cardiomyopathy. Id. His discharge
summary indicated that he had three hospitalizations in one month’s time for congestive heart
failure. Id.

Moving forward to 2015, petitioner was seen by Dr. Hougen on January 13, 2015, for
recent abrasive trauma to his head. Pet. Ex. 2 at 56. Dr. Hougen documented the presence of 2+
peripheral edema and weeping cellulitis of the left leg. Id. at 56-59. On June 23, 2015, Dr.
Hougen saw petitioner and noted 2+ peripheral edema with “marked left leg cellulitis.” Id. at 45.

B. Petitioner’s Vaccination and Post-Vaccination Medical History

On October 2, 2015, petitioner received a Fluzone high-dose flu vaccination in his left
shoulder. Pet. Ex. 1 at 1. On October 8, 2015, he was seen at a Scripps Urgent Care facility by
Dr. Steven Henderson for a pruritic skin eruption. Pet. Ex. 2 at 285-86. Physical examination
showed scabbing and excoriations of the bilateral shoulders, chest, and base of the neck. Id. at
286. Petitioner reported that he had a history of sensitive skin, and thought that the rash was due
to a change in detergent. Id. Dr. Henderson’s diagnosis was “some type of exposure with
secondary staph infection,” dermatitis, and possible occult scabies. Id. Petitioner was placed on
a steroid and Eurax cream. Id. Dr. Henderson did not document any swelling, edema, bruising,
or numbness of petitioner’s left shoulder, forearm, or wrist.

Petitioner was seen on October 22, 2015, by his cardiologist physician assistant, Ms.
Saunders, P.A. Pet. Ex. 2 at 34. Petitioner reported that over the prior week, he had increasing
swelling of his legs. Id. at 35. Petitioner did not report swelling of his arms. Ms. Saunders
performed and documented a physical examination, which revealed 2-3+ pitting edema of both
legs, left greater than right and “[i]ndurated erythematous warm tissue left leg,” indicating
cellulitis. Id. at 34, 37. Ms. Saunders did not document any pain, swelling, edema, bruising, or
numbness of the left arm, forearm, or wrist.

Petitioner was seen again by Ms. Saunders on October 27, 2015, for continued
management of his fluid overload and congestive heart failure. Pet. Ex. 2 at 30; Pet. Ex. 5 at 67-
69; Pet. Ex. 13 at 157. At that visit, Ms. Saunders noted that petitioner had an abnormal stress
test positive for ischemic cardiomyopathy. Pet. Ex. 5 at 67-69. He was diagnosed with coronary
artery disease, cardiomyopathy, and congestive heart failure. Id. at 67. Ms. Saunders
documented mild swelling of petitioner’s right and left legs. Id. Ms. Saunders did not document
swelling, edema, bruising, numbness, or pain of petitioner’s shoulders, forearms, or wrists.

On November 24, 2015, petitioner presented to Scripps Dermatology outpatient center
and was seen by Dr. Roger Cornell for complaints of a spot on his cheek and a rash on his lower
left leg. Pet. Ex. 2 at 28. Petitioner reported that he had the spot on his right cheek for over two
years and the rash on his leg for one month. Id. Petitioner also told Dr. Cornell that his arthritis

5
was better. Id. Under the review of symptoms, Dr. Cornell checked “no” under “other problems
elsewhere on the skin,” as well as “no” under additional musculoskeletal issues. Id. at 29. Dr.
Cornell did not document any swelling, edema, bruising, numbness, or pain related to
petitioner’s left shoulder, forearm, or wrist.

On December 3, 2015, petitioner had a follow up appointment with Dr. Hougen. Pet. Ex.
2 at 20. Dr. Hougen stated that Mr. Barlow was doing well, and had “excellent reduction of his
peripheral edema.” Id. at 19. Dr. Hougen specifically noted that petitioner had right shoulder
pain. Id. at 20. Dr. Hougen stated, “[h]e has marked compromise of his right shoulder given his
walker and degenerative changes of the shoulder.” Id. at 19. Petitioner was to see orthopedics
for a possible injection for degenerative joint disease in his right shoulder. Id. Dr. Hougen
inspected petitioner’s “joints, bones, and muscles” and noted that he had a “[f]rozen right
shoulder with marked crepitus.” Id. at 23. Dr. Hougen also documented that petitioner had
occasional foot numbness. Id. at 20. Petitioner’s “strength [was] 5/5 in upper and lower
extremities.” Id. at 23. Petitioner’s skin examination revealed that his cellulitis was “markedly
diminished.” Id. Petitioner’s blood glucose level was elevated at 151 mg/dL. Id. at 307. Dr.
Hougen did not document any swelling, edema, bruising, numbness, or pain related to
petitioner’s left shoulder, forearm, or wrist.

Petitioner complained to Dr. Hougen of his right shoulder pain again on February 2,
2016. Pet. Ex. 2 at 10-19. Dr. Hougen order an X-ray and physical therapy. Id. at 10. Dr.
Hougen again performed a physical examination, noting that petitioner had marked right
glenohumeral crepitus with abduction restricted to 70° in his right shoulder. Id. at 14. Dr.
Hougen’s skin examination showed resolving cellulitis and stasis dermatitis in his leg. Id. Dr.
Hougen did not document pain, swelling, edema, numbness, or bruising of petitioner’s left
shoulder, forearm, or wrist.

The first documentation of Mr. Barlow’s complaints related to his left arm occurred on
March 19, 2016, five months after the administration of the flu vaccination. Pet. Ex. 5 at 294.
Mr. Barlow presented to Scripps Urgent Care where he was evaluated by Dr. Robert K.
Kakehashi. Pet. Ex. 2 at 283-84. Dr. Kakehashi wrote,

The patient . . . complains of left arm numbness and tingling since receiving a flu
shot in October. He states that he received a flu vaccination on the left upper arm.
He recalls that there is something wrong with the first injection and he received a
second injection immediately in the same area. Following this, he noted swelling
and firmness of that area as well as the appearance of ecchymoses of the biceps
region which did extend down to his forearm. This slowly resolved . . . but he did
note some swelling of his forearm. He states that he has pain of the biceps area
that radiates down the radial aspect of his forearm and he claims that he has
numbness of his 3rd, 4th, and 5th digits.

Id.

Dr. Kakehashi examined petitioner’s left arm and noted two dried scabs of his biceps
deltoid region with what appeared to be residual halo of ecchymoses. Pet. Ex. 2 at 284. There

6
was no fluctuance or firmness in the area and palpation of the upper arm and lower arm revealed
no cords or crepitus. Id. Grip strength was 5/5. Id. Dr. Kakehashi assessed Mr. Barlow with
“left arm paresthesias since receiving the flu vaccination.” Id. Dr. Kakehashi did not note
swelling or edema of petitioner’s left shoulder, forearm, or wrist.

Mr. Barlow was subsequently seen by neurologist, Dr. John S. Romine, on March 28,
2016. Pet. Ex. 2 at 261-63. Dr. Romine recorded, “patient states that in October of last year, he
had a flu shot in the left upper arm and the area ‘turned purple’ and was painful. He states that
the whole arm turned purple, but over time this has gradually resolved.” Id. at 262. On
examination, Dr. Romine noted, “[t]here is a residual faint halo of chemosis[7] around the left
deltoid region laterally in the left upper extremity. There is mild swelling of the left forearm.”
Id. “Sensory examination reveals inability to distinguish sharp from dull in the thumb, index,
and middle fingers. There also decrease to touch in the distribution of the left radial, sensory
cutaneous nerve.” Id. Initial diagnoses were “[s]tatus post remote flu immunization (October
2015); local reaction with ecchymosis and swelling of the left upper extremity, improved” and
“[p]robable left carpal tunnel syndrome; possible left radial, sensory cutaneous neuropathy.” Id.

On April 19, 2016, petitioner was seen again by Dr. Romine, complaining of persistent
numbness in the thumb, index, and middle fingers. Pet. Ex. 5 at 41. Electromyography
(“EMG”) of his left arm showed severe left median neuropathy at the wrist and coexistent
diffuse mild sensory motor polyneuropathy. Id. at 523. Needle EMG was normal in the first
dorsal interosseous, extensor indicis, pronator, deltoid, triceps, and biceps muscles. Id. There
were mild chronic neurogenic changes confined to the abductor pollicis brevis muscle.8 Id. Dr.
Romine opined, “electrodiagnostic studies done today confirmed severe left carpal tunnel
syndrome. In addition, there is associated mild coexistent sensory motor neuropathy, which is
probably idiopathic.” Id. at 41. Dr. Romine believed the main source of symptoms was the
significant left CTS. Id. He referred petitioner to an orthopedic hand surgery specialist. Id. Dr.
Romaine did not attribute petitioner’s severe CTS or mild sensory motor neuropathy to his prior
flu vaccination.

On April 21, 2016, petitioner was seen in consultation by orthopedist Dr. Jake Hamer.
Pet. Ex. 2 at 258; Pet. Ex. 5 at 259. Petitioner gave a history of discomfort in his left arm from
his shoulder to his hand associated with numbness and tingling in the thumb, index, and middle
fingers. Pet. Ex. 2 at 258. Dr. Hamer noted, “[h]e believes his symptoms began on October 2,
2015, after . . . the flu shot.” Id. On examination petitioner had mild left thenar atrophy,
negative Tinel’s of the ulnar nerve at the elbow, but positive Tinel’s over the median nerve at the
wrist with 4+/5 strength in the abductor pollicis brevis. Id. at 260. Diagnosis was severe chronic
left CTS and endoscopic left carpal tunnel release was recommended. Id. Dr. Hamer did not
7
Chemosis is inflammation of the conjunctiva, an eye membrane. Pet. Mot. at 18 n.1. Petitioner
suggests that taken in context, Dr. Romine probably meant to write “ecchymosis.” Id.
8
The abductor pollicis brevis is a muscle located in the hand between the wrist and the base of
the thumb. Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=90615 (last accessed Apr. 20, 2020).
This muscle allows for the abduction of the thumb, or to move the thumb away from the palm.
Id.
7
note any association between petitioner’s flu vaccination and his CTS.

Petitioner had a pre-operative physical with Dr. Hougen on April 25, 2016. Pet. Ex. 5 at
246. Dr. Hougen noted “both peripheral neuropathy and his median neuropathy reviewed at his
request. Peripheral neuropathy is consistent with diabetes. He has a left median nerve
diagnostic EMG nerve conduction consistent with carpal tunnel syndrome.” Pet. Ex. 2 at 247.
Dr. Hougen stated, “[h]e equates this to [flu] shot. However, EMG and nerve conduction shows
a median nerve entrapment at the carpal tunnel.” Id.

Petitioner underwent endoscopic left carpal tunnel release surgery on May 23, 2016. Pet.
Ex. 2 at 255; Pet. Ex. 5 at 254-55. There were no complications. During a follow-up visit on
May 31, 2016, Dr. Hamer noted that petitioner’s surgical incision was healing well without
redness or drainage. Pet. Ex. 2 at 4. Dr. Hamer explained that due to petitioner’s “severe carpal
tunnel syndrome, he may not appreciate change in sensation even over time.” Id.

On June 8, 2016, petitioner saw Dr. John Kelso, an immunologist at Scripps Clinic. Pet.
Ex. 5 at 257. During the visit, Dr. Kelso took a history from petitioner, stating that petitioner
“reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his
left arm. Later that day he had some redness around the injection site. By the next day he
developed bruising at the site and lower down onto arm below the elbow.” Id. Dr. Kelso also
wrote, “[h]e recently underwent [] nerve release in his wrist but this has not helped as yet.” Id.
During the physical examination, Dr. Kelso noted “some bruising discoloration of his left arm.”9
Id. Dr. Kelso assessed petitioner with “neuromuscular and dermatologic abnormalities following
influenza vaccination.” Id. Dr. Kelso suggested that petitioner’s neurologic symptoms may have
been secondary to brachial neuritis due to reports describing brachial neuritis after injections,10
thought to represent an inflammatory response around nerves and/or be related to the trauma of
the injection itself. Id. Dr. Kelso thought the dermatologic abnormalities were not associated
with brachial neuritis, but may have represented a delayed hypersensitivity reaction. Id.

There are no tests to definitively prove that the abnormalities are the result of the
immunization although the temporal association makes this seem likely and a
report will be filed with the vaccine adverse event reporting system (VAERS).
The only conceivable treatment would be corticosteroids to dampen the
inflammation although the inflammation has likely come and gone with a
resultant nerve damage and skin changes and the corticosteroids would likely not
be helpful at this point.

Id. He recommended avoiding further injections in the left arm. Id.
9
The undersigned notes that the bruising described at this visit was likely due to petitioner’s
recent CTS surgery.
10
Dr. Kelso’s observation is consistent with the Vaccine Injury Table, which identifies brachial
neuritis as a covered injury for vaccines containing tetanus toxoid. See §§ 11(c)(1), 13(a)(1)(A).
Brachial neuritis is defined as follows: “dysfunction limited to the upper extremity nerve plexus
(i.e., its trunks, divisions, or cords). A deep, steady, often severe aching pain in the shoulder and
upper arm usually heralds onset of the condition.” 42 C.F.R. § 100.3(c)(6) (2020).
8
 Petitioner saw Dr. Hougen for congestive heart failure and persistent left arm numbness
and pain on July 12, 2016. Pet. Ex. 5 at 29. Petitioner related his medical history to Dr. Hougen,
who noted, “felt to be contributed by a polyneuropathy secondary to his injection along with
severe carpal tunnel syndrome and a left shoulder adhesive capsulitis.” Id. Dr. Hougen
performed a physical examination and noted, “[l]eft supraspinatous tenderness with restricted
range of motion to 80°.” Id. at 33. He also documented “stasis dermatitis with peripheral
edema.” Id.

On March 21, 2017, petitioner followed up with Dr. Romine, who noted lack of
improvement of carpal tunnel symptoms and diagnosed him with persistent numbness and
sensory deficit of the left arm and hand. Pet. Ex. 5 at 19-20. Dr. Romine’s physical examination
showed petitioner had “weakness of the left [abductor pollicis brevis] with otherwise normal
motor function in the upper extremities.” Id. Petitioner saw Dr. Hamer the same day. Id. at 21-
22. Dr. Hamer reported “[p]ersistent numbness and tingling in the left hand despite carpal tunnel
release” and commented that the patient would “have numbness and tingling chronically, which
will not completely resolve.” Id. at 22.

Petitioner saw Dr. Romine again on April 6, 2017. Pet. Ex. 5 at 3. Dr. Romine noted,
“he relates the history of the [] symptoms appearing following a flu shot in October 2015, which
the arm became numb and swollen and red with eventual resolution of those symptoms with
persistence of the sense of numbness.” Id. Dr. Romine’s diagnoses were, “1) status post left
carpal tunnel release-persistent numbness of hand as well as forearm-localization/cause unclear.
2) Persistent numbness and sensory deficit of left forearm and hand status post remote flu shot -
? possible residual post immunization brachial neuritis?” Id. at 3-4.

As of April 7, 2019, both CTS and “upper extremity neuropathy (chronic)” were listed
among Mr. Barlow’s active problems in his medical record. Pet. Ex. 13 at 11.

C. Petitioner’s Affidavit

In his affidavit, petitioner stated that he received a Fluzone high-dose flu vaccination.
Pet. Affidavit (“Aff.”) at ¶ 1. Petitioner alleges that he sustained a left shoulder injury which was
caused by the vaccine and that he suffered the residual effects and complications of the injury for
more than six months after the administration of the vaccine. Id. at ¶¶ 3-4.

D. Carpal Tunnel Syndrome

The American Academy of Orthopaedic Surgeons Clinical Guidelines on the Diagnosis
of CTS defines CTS as a symptomatic compression neuropathy of the median nerve at the level
of the wrist. Pet. Ex. 9 at 2. The median nerve, which runs from the forearm into the palm of the
hand, provides sensation to the fingers and controls certain muscles at the base of the thumb.
Pet. Ex. 6 at 8. The carpal tunnel, a bony canal consisting of carpal bones, contains flexor
tendons and the median nerve which enter the tunnel in the midline of the wrist or slightly radial
to it. Pet. Ex. 9 at 3. CTS is a neuropathy caused when the tendons of the carpal tunnel are

9
irritated and become swollen, resulting in compression of the median nerve at the wrist. Id. at 2.
As the median nerve is compressed, it becomes irritated and inflamed. Id.

Figure 1.11

Ibrahim et al.12 identifies CTS as the most frequent entrapment neuropathy, believed to
be present in 3.8% of the general population. Pet. Ex. 9 at 2. Symptoms of CTS include pain in
the hand, unpleasant tingling, pain or numbness in the distal distribution of the median nerve
(thumb, index, middle finger and the radial side of the ring finger), and a reduction of the grip
strength and function of the affected hand. Id. at 3. The most significant risk factors of CTS
include, “prolonged postures in extremes of wrist flexion or extension, repetitive use of the
flexor muscles, and exposure to vibration.” Id. at 3-4. Other risk factors include conditions that
alter the fluid balance in the body and increase the volume in the carpal tunnel, such as
pregnancy, obesity, renal failure, hypothyroidism, use of oral contraceptives, and congestive
heart failure. Id. at 4. Neuropathic factors, such as diabetes, alcoholism, vitamin toxicity or
deficiency, and exposure to toxins, can also play a role in triggering CTS. Id. Diabetic patients
tend to develop the condition due to their reduced threshold for sustaining nerve damage. Id. An
MRI may be used to determine whether surgery is appropriate. Id. at 5. If performed, an MRI
may show swelling of the median nerve or its myelin sheath. Id.

CTS is more common in females than in males, and its occurrence is commonly bilateral
with a peak age range of 40 to 60 years, although it occurs in all age groups. Pet. Ex. 9 at 1. The
treatment of CTS falls under two categories: conservative and surgical. Id. at 5.
11
This image shows the median nerve within the in carpal tunnel. Image taken from Dorland’s
Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=110370&searchterm=carpal+tunnel+syn
drome (last accessed on Apr. 29, 2020).
12
I. Ibrahim et al., Carpal Tunnel Syndrome: A Review of the Recent Literature, 6 Open
Orthopaedics J. 69 (2012).
10
 E. Expert Qualifications and Opinions

i. Expert Qualifications

a. Petitioner’s Expert, Dr. Brad Klein

Dr. Brad Klein is a board-certified neurologist by the American Board of Psychiatry and
Neurology. Pet. Ex. 6 at 1. He majored in both biology and psychology at Rutgers College,
New Jersey, and graduated with highest honors, equivalent to summa cum laude. Id. Dr. Klein
received his M.D. from Jefferson Medical College, in Philadelphia, and then completed a year of
medical residency, followed by three years of neurology residency, and a year-long fellowship in
headache and neuromuscular medicine at Thomas Jefferson University in Philadelphia. Id. He
is currently a Clinical Associate Professor of Neurology at Sidney Kimmel Medical College of
Thomas Jefferson University and the Medical Director of Abington Headache Center at
Abington Memorial Hospital in Abington, Pennsylvania. Pet. Ex. 7 at 1.

b. Respondent’s Expert, Dr. Miles Steven Evans

Dr. Miles Steven Evans is a practicing general neurologist subspecializing in the
diagnosis and treatment of epilepsy. Resp. Ex. A at 1. He graduated cum laude from the
University of Kentucky with a major in psychology. Resp. Ex. B at 1. Dr. Evans received his
M.D., cum laude, from the University of Louisville School of Medicine. Id. He completed his
neurology residency training and chief residency at Barnes Hospital and the Washington
University School of Medicine. Id. After residency, he completed a research fellowship in
neuropharmacology, the National Research Service Award, at the same institution. Resp. Ex. A
at 1. He is currently a professor in the Department of Neurology of the University of Louisville,
in Louisville, Kentucky and was formerly Professor of Neurology and
Microbiology/Immunology at the Southern Illinois University School of Medicine, in
Springfield, Illinois. Id. Dr. Evan is board-certified in Neurology, Clinical Neurophysiology and
Epilepsy. Id.

ii. Expert Opinions

a. Petitioner’s Expert, Dr. Klein13

Dr. Klein opined that petitioner’s peripheral neuropathy and CTS were significantly
aggravated due to a reaction to the flu vaccine that he received on October 2, 2015. Pet. Ex. 6.
Dr. Klein differentiates petitioner’s peripheral neuropathy and CTS as separate injuries that the
flu vaccine exacerbated by direct and ongoing compression and inflammation of petitioner’s left
median nerve. Id. at 8.

1. Althen Prong One: Petitioner’s Medical Theory

Dr. Klein began his report by discussing the two injuries at issue. He defined CTS as the
13
Petitioner filed three expert reports authored by Dr. Klein. Pet. Exs. 6, 14, 19.
11
result of irritation and inflammation as the median nerve is compressed. Pet. Ex. 6 at 8. Dr.
Klein next defined “peripheral neuropathy” as damage to the peripheral nerves of the body—the
nerves outside the brain and spinal cord. Id. Peripheral nerves provide sensory input for touch,
balance, temperature, and pain, and send signals to muscles to contract, which allows movement
to occur. Id. Damage to peripheral nerves can result in abnormal signals, causing perception of
pain or other abnormal sensations, such as numbness. Id.

With regard to his causal opinion, Dr. Klein stated that ecchymosis (“discoloration of the
skin resulting from bleeding underneath typically caused by bruising”) and “swelling can occur
in any inflammatory state.” Pet. Ex. 6 at 9. Inflammation increases the blood flow to an area of
injury or infection, which can result in swelling. Id. Consequently, Dr. Klein opined that
swelling in the carpal tunnel may increase pressure on the median nerve. Id. Additionally, Dr.
Klein stated that swelling around fragile nerves, resulting from inflammation caused by a
vaccine, can exacerbate any underlying pathology. Id.

As for the mechanistic cause of inflammation described above, Dr. Klein opined that
petitioner’s left shoulder vaccination resulted in dermatitis and “delayed immunologic
hypersensitivity” and “prolonged inflammation due to a hypersensitivity reaction.” Pet. Ex. 6 at
9; Pet. Ex. 14 at 3. Dr. Klein did not define or describe what he meant by hypersensitivity, or
hypersensitivity reaction, or how either causes inflammation.

In regard to his theory of causation, Dr. Klein stated that “[w]hatever the ultimate cause
of either condition, both peripheral neuropathy and carpal tunnel syndrome would be
exacerbated by direct and/or ongoing compression of the affected nerve.” Pet. Ex. 6 at 8.

Dr. Klein next addressed Dr. Evans comments on the improbability of a vaccination to
trigger swelling. Dr. Klein cited Woo et al.14 to support his opinion that limb swelling can occur
due to vaccination. See Pet. Ex. 18. Woo et al. reviewed cases of extensive limb swelling
occurring after vaccination reported to the Vaccine Adverse Event Reporting System
(“VAERS”). Id. at 1. “Extensive limb swelling” was defined as “edema extending at least to the
elbow or knee of a vaccinated extremity.” Id. The authors identified 497 cases. Id. Generally,
symptoms began within one day after vaccination and involved erythema, warmth, or pain. Id. at
1-2. Among the single limb and single vaccine cases, the most common associated vaccines
included polyvalent pneumococcal, tetanus, diphtheria and pertussis, and flu. Id. at 3-4. There
were approximately thirty reported cases of swelling associated with the flu vaccine. See id. at 4
fig.2. While the study supported Dr. Klein’s assertion that the flu vaccine can cause limb
swelling, it did not address the question of whether extensive limb swelling can cause or
significantly aggravate CTS or peripheral neuropathy.

Further, the authors of the Woo et al. study recognized the limitations of using VAERS
data and noted that incidence rates and relative risks cannot be calculated from the data. Pet. Ex.
18 at 5. The authors questioned whether extensive limb swelling “might be an exaggerated
injection-site reaction.” Id. at 6. Also, the authors concluded that extensive limb swelling after
vaccination generally resolves without permanent sequelae. Id. at 7. There were no reports of
14
Emily Jane Woo et al., Extensive Limb Swelling After Immunization: Reports to the Vaccine
Adverse Event Reporting System, 37 Clinical Infectious Diseases 351 (2003).
12
permanent injury or disability.

2. Althen Prong Two: Logical Sequence of Cause and
Effect

Dr. Klein next addressed logical sequence of cause and effect. He readily conceded that
petitioner had “underlying carpal tunnel syndrome and peripheral neuropathy [] as a
complication of diabetes,” and that “his diabetes was not well controlled at the time of
vaccination.” Pet. Ex. 6 at 8. However, Dr. Klein opined that, “the vaccination more likely than
not was a substantial causal factor in the development of the upper extremity inflammation and
edema that resulted in worsening damage to the median nerve resulting in paresthesias, aching
pain and discomfort, and weakness, in addition to the paresthesias of the radial nerve.” Pet. Ex.
19 at 3. Dr. Klein did not describe what type of hypersensitivity reaction was at play, or how the
alleged hypersensitivity reaction caused petitioner’s inflammation and edema.

Dr. Klein did explain how diabetes causes peripheral neuropathy. He cited Yagihashi et
15
al. to explain how diabetes and elevated blood glucose acts as a poison to nerves over time.
Pet. Ex. 12 at 1. The Yagihashi article states that diabetes is the most common cause of
neuropathy due to the metabolic aberrations caused by diabetes which damage peripheral nerves.
Id.

Dr. Klein then reviewed petitioner’s medical history after he received the flu vaccination
on October 2, 2015. Petitioner presented with dermatitis and skin eruption affecting his upper
body, requiring an urgent care visit on October 8, 2015. Pet. Ex. 2 at 285-86. Subsequently,
petitioner reported left arm numbness and tingling, and physical examination showed objective
findings of dried scabs and ecchymoses of the left upper arm on March 19, 2016 by Dr.
Kakehashi. Id. at 283-84. Neurological examination by Dr. Romine on March 28, 2016, was
significant for “chemosis around the left deltoid region . . . [and] mild swelling of the left
forearm.” Id. at 262. Dr. Klein also observed that Dr. Kelso noted that petitioner appeared to
have developed an inflammatory response to the immunization, perhaps including a delayed
immunologic hypersensitivity. See Pet. Ex. 5 at 257; Pet. Ex. 6 at 9.

Based on the examinations performed by Dr. Kakehashi on March 19, 2016 and Dr.
Romine on March 28, 2016, Dr. Klein opined that petitioner’s left arm, from the shoulder to the
wrist, was inflamed by the vaccine. Pet. Ex. 2 at 262, 283-84; Pet. Ex. 6 at 9. Dr. Klein stated
that due to petitioner’s diabetes, the affected nerves were more susceptible to additional injury.
Pet. Ex. 6 at 9. Dr. Klein averred that also due to petitioner’s older age, he was more susceptible
to stress and deterioration than a healthy younger person individual. Id. Dr. Klein stated that
additional edema and inflammation around a nerve, already subject to pathology, is highly
dangerous for the health of the nerve. Id. He opined that, therefore, the swelling caused by the
vaccination significantly exacerbated petitioner’s existing peripheral neuropathy and CTS. Id.

In Dr. Klein’s first supplemental expert report, he agreed with Dr. Evans, that a patient’s
complaints associated with a causal event should normally occur soon after the event in question.
15
S. Yagihashi et al., Mechanism of Diabetic Neuropathy: Where Are We Now and Where to
Go?, 2 J. Diabetes Investigation 18 (2010).
13
Pet. Ex. 14 at 1. However, he observed it is important to note that visits with providers are often
problem focused, and “if patients do not provide added history because they are also focused on
a more pressing issue at hand, then the other concerns will not be addressed and hence will not
be documented by the treating physician.” Id.

Dr. Klein also asserted that damage to the median nerve is often a slowly progressive
problem. Pet. Ex. 14 at 2. Dr. Klein stated that even though petitioner may not have been
experiencing the same amount of swelling and pain at the time of his March 19, 2016 visit to Dr.
Kakehashi as he was when he first received the vaccination, the edema from the vaccine, over
time, resulted in exacerbating damage to the median nerve. Id. Dr. Klein cited the article
Werner et al.16 to support his opinion that CTS has an asymptomatic latency period or a period
when symptoms are noticeable, but not so severe that a patient will complain. Pet. Ex. 17.

In Werner et al., employees from various industrial industries were studied to determine
whether asymptomatic workers with or without median nerve neuropathy developed symptoms
consistent with CTS over an extended period of time, and what other factors influenced the onset
of CTS symptoms. Pet. Ex. 17 at 2. The authors found that workers with an abnormal median
nerve conduction test had an increased risk of developing CTS symptoms later in life than the
group with normal nerve conduction findings. Id. at 5. The other risk factors for the
development of CTS included older age, higher body mass index (“BMI”), and more repetitive
work. Id. The Werner et al. study supports Dr. Klein’s assertion CTS has a latency period. The
study shows that at a follow-up of seventeen months, there was no increased risk of developing
CTS symptoms based on initial nerve conduction findings. Id. However, at the seventy-month
follow-up, participants did have an increased risk of developing CTS symptoms. Id.

Dr. Klein also cited Stevens et al.17 to show that symptoms often begin at night and are
initially considered insignificant by the patient. Pet. Ex. 16. Stevens evaluated the distribution
of CTS symptoms in 100 patients with symptomatic, EMG verified, CTS, who had no other
condition that might produce upper extremity symptoms. Id. at 1. The authors found there was a
wide range of sensory symptoms deficits seen in CTS. Id. at 8. The study cited another article
that reported CTS patients “insist[ed] that the whole hand gets numb and tingles at night.” Id. at
4. The study therefore demonstrated some subjects with CTS have progressively worse
symptoms over time.

Dr. Klein stated that the fact that petitioner’s symptoms became clinically apparent in
March 2016 does not mean that was the onset of the disease process. Pet. Ex. 14 at 2-3. Dr.
Klein opined that in petitioner’s case, the best way to account for the progression of his illness as
reported in the medical records is to conclude that his October 2015 flu shot caused swelling that
greatly exacerbated nerve damage, which subsequently manifested as clinically significant CTS.
Id.

16
R.A. Werner et al., Prolonged Median Sensory Latency as a Predictor of Future Carpal Tunnel
Syndrome, 24 Muscle & Nerve 1462 (2001).
17
J.C. Stevens et al., Symptoms of 100 Patients with Electromyographically Verified Carpal
Tunnel Syndrome, 22 Muscle & Nerve 1448 (1999).
14
 Lastly, Dr. Klein noted that petitioner continued to be symptomatic even after his carpal
tunnel surgery on May 23, 2016. See Pet. Ex. 5 at 254-55; Pet. Ex. 6 at 10. Dr. Klein opined
this was due to the existing damage noted on petitioner’s EMG. Pet. Ex. 6 at 10. Dr. Klein also
averred that Mr. Barlow’s potential diagnosis of brachial neuritis, as referenced by Dr. Kelso,
was not supported by the diagnostic studies performed. See Pet. Ex. 2 at 2; Pet. Ex. 6 at 9.

3. Althen Prong Three: Proximate Temporal
Relationship

With regard to onset, Dr. Klein agreed there was a delay between the date of vaccination,
October 8, 2015, and the date that petitioner’s symptoms were first documented, March 28,
2016. Pet. Ex. 6 at 10. Based on his experience, however, Dr. Klein opined that it is not
uncommon for patients like petitioner, who suffer from a variety of conditions, to treat one while
foregoing treatment of another. Id. In particular, given that petitioner already suffered from
diabetic neuropathy, Dr. Klein believed it was plausible for petitioner to prioritize treatment for
his other problems over his neurological symptoms. Id. Beyond that, Dr. Klein found nothing in
petitioner’s records that gives any reason to doubt the accuracy of his report of exacerbation of
neurologic symptoms beginning as early as several days following vaccination. Id.

Dr. Klein addressed Dr. Evans assertion that it was “implausible” for petitioner’s
physicians not to note Mr. Barlow’s left arm complaints or physical signs earlier if they existed.
Pet. Ex. 19 at 1. Dr. Klein asserted that it cannot be assumed that petitioner’s primary care
provider, Dr. Hougen, noted all of petitioner’s signs and symptoms at Mr. Barlow’s various
appointments. Id. at 2. Dr. Klein then stated it is “unclear why Dr. Evans assumes that the
cardiology [physician assistant] who treated Mr. Barlow’s left leg skin pathologies would have
noted any signs and symptoms in his left arm.” Id.; see Pet. Ex. 2 at 34. Dr. Klein stated that
Mr. Barlow’s left leg issues were more pressing at that appointment, and the physician assistant
was trained in cardiology, not dermatology or neurology. Pet. Ex. 19 at 2.

Additionally, Dr. Klein believed petitioner’s left arm symptoms could have been
overlooked because it is common for physicians to make diagnostic errors. Pet. Ex. 19 at 2. He
cited the study by Schiff et al.18 to support his argument that physician error is common. Pet. Ex.
20. Schiff et al. analyzed self-reported diagnostic errors by physicians and found that physicians
rated 28% of these errors as “major.” Id. at 3. The study also found that “drug reactions or
overdose” were the second most commonly missed or delayed category of diagnosis. Id. Dr.
Klein characterized petitioner’s complications from vaccination as a “drug reaction.” Pet. Ex. 19
at 2. The authors of the study concluded that, “[p]hysicians readily recalled multiple cases of
diagnostic errors.” Pet. Ex. 20 at 7. Based on the article’s findings, Dr. Klein concluded that Dr.
Evans’ confidence in the ability of clinicians to note and respond to all relevant symptoms,
including symptoms outside their specialties, is overly optimistic. Pet. Ex. 19 at 2.

Dr. Klein relied on the fact that Mr. Barlow’s treating physicians appeared to accept
petitioner’s accounts regarding onset as accurate. Pet. Ex. 6 at 10. Dr. Klein opined that the
close temporal association between vaccination and dermatitis/swelling, quickly followed by
worsening of neurological symptoms as noted by Mr. Barlow’s physicians, strengthens the case
18
G.D. Schiff et al., Diagnostic Error in Medicine, 169 Archives Internal Med. 1881 (2009).
15
for a causal connection between the vaccine and the exacerbated pathologies. Id.

Further, Dr. Klein asserted that ongoing nerve damage may not result in clinical
symptoms early on. He explained that a patient may not feel that his symptoms are significant
until they reach a threshold, encouraging a patient to seek treatment. Pet. Ex. 14 at 2. Dr. Klein
stated that there is some experimental evidence from Ibrahim et al. that the severity of neural
dysfunction in the carpal tunnel is directly correlated with the duration and severity of pressure
on the median nerve. Id.; see Pet. Ex. 15. This suggests that, all other things being equal,
aggravation of carpal tunnel symptoms by vaccine-induced inflammation and swelling would
become more severe over time. Pet. Ex. 14 at 2. Dr. Klein concluded that after vaccination, Mr.
Barlow may have found his symptoms harder to ignore as time went on. Id.

Dr. Klein stated that “[n]either Dr. Evans nor I was present when Dr. Kakehashi
examined Mr. Barlow on 3/19/16, so the best that we can do is to carefully assess Dr.
Kakehashi’s physician notes.” Pet. Ex. 14 at 2. Dr. Klein provided that because neither of the
experts examined petitioner, they should defer to Dr. Kakehashi’s apparent acceptance of
petitioner’s account of onset. Id. Moreover, Dr. Klein opined there is no clear reason why Mr.
Barlow would have stated that his symptoms started over five months before they actually did.
Id.

Dr. Klein then questioned Dr. Evans’ skepticism of Dr. Kakehashi’s acceptance of
petitioner’s onset history. A doctor’s decision, opined Dr. Klein, is “to accept the history given
by a patient based on his or her considered professional judgment.” Pet. Ex. 14 at 3. If one
accepts the history given by petitioner to Dr. Kakehashi, Dr. Klein believes that “the most
reasonable interpretation” of the medical records is that petitioner had “latent carpal tunnel
syndrome, either secondary to diabetes or independently of it, and that this condition was
exacerbated by edematous swelling in response to vaccination.” Id. Dr. Klein opined that
petitioner’s condition would have gotten worse over time, and it is possible that Mr. Barlow’s
CTS would have eventually become clinical even in the absence of vaccination, but given the
swelling following vaccination, it is highly likely that the vaccine accelerated the process. Id.

b. Respondent’s Expert, Dr. Evans19

1. Althen Prong One: Respondent’s Medical Theory

Dr. Evans disagrees with Dr. Klein’s proposed mechanism that swelling of the left arm
following a flu vaccination can cause and/or exacerbate CTS and peripheral neuropathy for four
reasons. First, in order to develop CTS and/or peripheral neuropathy secondary to limb edema,
Dr. Evans opines that the limb swelling must be severe. Resp. Ex. A at 10-11. Second, the
resulting CTS or neuropathy must be acute and not chronic in nature, as a reflection of the
proposed mechanism. Id. Third, the flu vaccine has not been implicated as causally related to
these conditions. Id. And fourth, CTS and peripheral neuropathy are associated with diabetes,
and therefore, it is not necessary to invoke a vaccine-related cause here. Resp. Ex. C at 2.

As for the first principal, Dr. Evans agreed that Dr. Klein’s theory could be true in cases
19
Respondent filed two expert reports authored by Dr. Evans. Resp. Exs. A, C.
16
of “compartment syndrome.” Resp. Ex. A at 10-11. In compartment syndrome, pressure in an
anatomic compartment (i.e., forearm) is increased to levels that harm neural, muscular, or
vascular elements within the compartment. Id. Compartment syndrome, however, is a medical
emergency, and the pain associated with it is severe. See Resp. Ex. A-10 at 2.

To illustrate this point, Dr. Evans cited to a case report by Mohamed Ali Sbai et al.20
Resp. Ex. A-10. In the case report, a patient presented to the Emergency Department with
extreme pain, swelling, and inability to move her fingers. Id. at 2. The patient was taken into
surgery immediately. Id. Dr. Evans used the report to show that compartment syndrome is an
acute emergency, and not a condition that could occur over a period of weeks, or longer, and it is
unlikely that a physician would fail to document its signs and symptoms. Id.

Dr. Evans conceded that other edematous conditions, such as those created by burns,21
pregnancy,22 and post-mastectomy lymphedema,23 have also been reported to cause CTS and
other neuropathies. Resp. Ex. A at 11. However, again, Dr. Evans explained that those
conditions manifest significant trauma and edema, resulting in nerve damage associated with
CTS. Id.

Secondly, Dr. Evans explained that compartment syndrome, and other edematous
conditions causally associated with CTS, are more acute, instead of chronic, in nature. In
support of this aspect of his opinion, Dr. Evans cited Tosti and Ilyas.24 Resp. Ex. A-11. The
authors define acute CTS as “rapid onset of median neuropathy caused by sudden increases in
carpal tunnel pressures, which leads to ischemia of the median nerve. The most common cause
is traumatic injury, although atraumatic sources should also be recognized.” Id. at 2. Traumatic
injuries include fractures, lacerations, burns, animal bites, and high-pressure injection injuries.
Id. Rare atraumatic sources listed in the article include edematous states that raise intracanal
pressures, for example, “pregnancy, burns, venom and toxins, and pancreatic transplant
recipients.” Id. The Tosti and Ilyas article does not identify vaccinations as a cause of CTS.

The third basis for Dr. Evans’ opinion is that CTS has only rarely been reported

20
Mohamed Ali Sbai et al., Acute Carpal Tunnel Syndrome of the Hand Following a Cat Bite,
21 Pan African Med. J. 206 (2015).
21
See C. Balakrishnan et al., Acute Carpal Tunnel Syndrome from Burns of the Hand and Wrist,
17 Can. J. Plastic Surgery e33 (2009).
22
M. Breborowicz et al., Symptomatology of Carpal Tunnel Syndrome During Pregnancy and
Puerperium, 84 Ginekologia Polska 841 (2013). Respondent provided the abstract because the
full text was in Polish.
23
A. Ganel et al., Nerve Entrapments Associated with Postmastectomy Lymphedema, 44 Cancer
2254 (1979).
24
R. Tosti & A.M. Ilyas, Acute Carpal Tunnel Syndrome, 43 Orthopedic Clinics North Am. 459
(2012).
17
following any vaccinations. Resp. Ex. A at 10. In Janier et al.,25 CTS occurred after accidental
injection of BCG vaccine into the wrist. Resp. Ex. A-8. Thus, the Janier et al. case presents a
different factual scenario than shoulder vaccination. Id. Ray et al.26 reported that rubella
vaccination may be associated with a small risk of chronic arthropathy, which in turn has been
associated with CTS. Resp. Ex. A-9 at 1. Similarly, Hale and Ruderman27 detailed a case of
CTS onset six weeks after rubella vaccination. Resp. Ex. A-6. The subject noted stiffness in her
hands and swelling of her joints three weeks after vaccination. Id. at 1. Six weeks after
vaccination, doctors noted swelling, redness, and warmth of her wrist. Id. After treatment, her
symptoms disappeared. Id. at 3-4. None of the case reports implicate Dr. Klein’s theory of post-
vaccination hypersensitivity inflammation and edema as causal mechanism for CTS.

Dr. Evans’ fourth reason for disagreeing with Dr. Klein’s mechanism is that CTS is an
exceedingly common condition, especially in patients who have diabetes. See Resp. Ex. A at 10.
Therefore, it is not necessary to invoke the flu vaccine as a cause in a patient with diabetes and
pre-existing peripheral neuropathy.

In support of this opinion, Dr. Evans cites Gamstedt et al,28 in which the authors reported
rates of CTS up to 20% in patients with diabetes. Resp. Ex. A-4 at 1. The Gamstedt article
investigated the prevalence of CTS in patients with diabetes mellitus and the association between
the hand abnormalities and diabetic variables. Id. The study postulated that increased
glycosylation of proteins,29 diabetic microangiopathy, and diabetic neuropathy are the
mechanisms that can cause CTS in diabetic patients. Id. at 4-5.

2. Althen Prong Two: Logical Sequence of Cause and
Effect

Dr. Evans agrees with petitioner’s expert, Dr. Klein, as to petitioner’s diagnoses of CTS
and peripheral neuropathy, but does not believe that petitioner’s flu vaccine caused or
exacerbated his conditions.
25
M. Janier et al., Carpal Tunnel Syndrome Due to Mycobacterium Bovis BCG, 58 Sem Hop.
977 (1982) (author’s transl.). The full text was not available, and only the abstract was filed with
the Court. The BCG vaccine is typically used to vaccinate against tuberculosis.
26
P. Ray et al., Risk of Chronic Arthropathy Among Women After Rubella Vaccination, 278
JAMA 551 (1977).
27
M.S. Hale & J.E. Ruderman, Carpal Tunnel Syndrome Associated with Rubella Immunization,
52 Am. J. Physical Med. 189 (1973).
28
A. Gamstedt et al., Hand Abnormalities are Strongly Associated with the Duration of Diabetes
Mellitus, 234 J. Internal Med. 189 (1973).
29
A glycosyl is the radical formed from a saccharide and glycosylation is the linkage of glycosyl
groups. Dorland’s Medical Dictionary Online,
https://www.dorlandsonline.com/dorland/definition?id=20670&searchterm=glycosylation (last
accessed July 14, 2020).
18
 Dr. Evans agreed with Dr. Romine’s diagnosis of March 19, 2016, finding left median
neuropathy and CTS. Resp. Ex. A at 9; Pet. Ex. 5 at 19-20. An EMG/NCV showed definitive
evidence supporting the diagnosis of severe, chronic left median neuropathy consistent with the
diagnosis of CTS, along with mild sensorimotor neuropathy of the type usually associated with
diabetes mellitus. Resp. Ex. A at 9. Dr. Evans also agreed with Dr. Klein that the diagnosis of
brachial neuritis is not supported. Id.

While Dr. Evans agreed that severe swelling can exacerbate CTS, he does not believe that
Mr. Barlow’s swelling was sufficient to cause the condition. Resp. Ex. C at 2. Dr. Evans stated
that the fact that none of the medical practitioners petitioner visited between the date of his
vaccination and the date that he first complained of symptoms, over five months later, ever
observed any significant swelling in Mr. Barlow’s arm is evidence that the swelling was
insufficient to cause injury. Id. If severe swelling had occurred, Dr. Evans would have expected
petitioner to report it and his physicians to document it. Id.

Dr. Evans also disagreed with Dr. Klein’s statement that the experts should “defer to Dr.
Kakehashi’s impression” of petitioner’s injury. Resp. Ex. C at 1. Dr. Evans opined that Dr.
Kakehashi did not observe the swelling, weeping, and ecchymoses that reportedly occurred after
vaccination, he only recorded what the patient told him. Id. at 1-2. Further, Dr. Evans found that
Mr. Barlow’s own medical record contradicts his report to Dr. Kakehashi. Id. at 1. To
demonstrate this, Dr. Evans pointed to the Urgent Care visit six days after vaccination. Pet. Ex.
2 at 285; Pet. Ex. 5 at 296-302. At that appointment, petitioner complained of dermatitis of the
shoulders, chest, and lower back. Pet. Ex. 2 at 285-86. However, during that visit there was no
note of symptoms in the left arm or forearm, and specifically no note of swelling.

Next, Dr. Evans noted that Mr. Barlow visited his dermatologist 53 days after
vaccination. Pet. Ex. 5 at 63. At this visit, lesions on the face and left leg were noted, but there
was no indication of swelling or other symptoms in the left arm. Id. Mr. Barlow also had two
visits to his cardiology physician assistant for treatment of left leg cellulitis, two visits to the
office of his primary care internist, and two visits to his podiatrist, and none recorded a
complaint or physical sign related to the left arm. Resp. Ex. C at 1-2; Pet. Ex. 2 at 8-27, 34, 38;
Pet. Ex. 5 at 45, 54-62, 66, 70-74.

Dr. Klein attributed the absence of recorded complaints about petitioner’s alleged
symptoms of CTS by his practitioners to be due to the “problem-focused” nature of the visits.
See Resp. Ex. C at 2. Dr. Evans found that to be plausible in the case of the podiatry visits, in
which both the physician and patient would expect only foot complaints to be relevant, but
unlikely for the other visits. Id. Dr. Evans opined, “it is implausible for visits to his primary
internist and dermatologist, and implausible also for the cardiology [physician’s assistant] who
treated his left leg cellulitis with edema and stasis dermatitis—any of these practitioners would
be expected to note if the patient had left arm complaints or if there were significant left arm
physical signs.” Id. Dr. Evans stated that the practitioners may defer action on the problem, or
refer to another practitioner for treatment, but they would not ignore it. Id. Dr. Evans found it
especially unlikely for petitioner’s visit to his dermatologist, who noted spots on his cheek and
spots on his leg, to have failed to record severe dermatological signs and symptoms in the left

19
arm. Id. Dr. Evans believed, therefore, that the medical records contradict Mr. Barlow’s
recollection of events as documented by Dr. Kakehashi, so long (169 days) after vaccination. Id.

Further, Dr. Evans opined that Mr. Barlow’s peripheral neuropathy and CTS were
chronic conditions, and not acute, and therefore, inconsistent with cases reported as associated
with vaccination. Resp. Ex. A at 11. On April 19, 2016, Dr. Romine opined petitioner had
chronic neurogenic changes consistent with entrapment of the median nerve. Pet. Ex. 5 at 523.
On April 21, 2016, petitioner’s orthopedist Dr. Hamer diagnosed petitioner with left severe
chronic CTS. Id. at 259. Chronic neuropathy and chronic CTS are identified as active problems
in petitioner’s medical record. See Pet. Ex. 13 at 11. Because petitioner’s peripheral neuropathy
and CTS were diagnosed as chronic and not acute, by both his orthopedist and neurologist, his
clinical course is different than the case reported by Tosti and Ilyas. See Resp. Ex. A-11 at 2. In
summary, Dr. Evans asserted the flu vaccination did not create a sufficiently edematous
condition enough to cause acute increased pressure within petitioner’s carpal tunnel. Resp. Ex.
A at 11. If it had, it would have been reported at petitioner’s Urgent Care visit six days after
vaccination. See Resp. Ex. C at 2.

Next, Dr. Evans found that the medical literature did not support a causal connection
between the flu vaccine and CTS. He explained that the literature demonstrates a different
clinical course than what Mr. Barlow experienced. See Resp. Ex. A at 10. Petitioner did not
have injection or trauma at the wrist. For example, in Janier et al., the subject received an
injection into her wrist, whereas petitioner was vaccinated in his shoulder. Resp. Ex. A-8. Ray
et al. reported that the rubella vaccination may be associated with a small risk of chronic
arthropathy, which in turn has been associated with CTS. Resp. Ex. A-9 at 1. Petitioner was not
diagnosed with wrist arthropathy prior to his CTS, and Dr. Klein does not offer that mechanism
here. Additionally, in the Hale and Ruderman’s case report, the patient’s symptoms resolved
after treatment. Resp. Ex. A-6 at 3-4. Here, Mr. Barlow’s CTS symptoms never resolved.

Dr. Evans opined the most likely cause of the exacerbation of petitioner’s CTS and
peripheral neuropathy was his diabetes. Resp. Ex. C at 2. Dr. Evans averred “that a risk factor
for carpal tunnel syndrome in Mr. Barlow’s case is diabetes. I would go further to state that it is
the only documented risk factor.” Id. Dr. Evans referred to Gamstedt et al. to show CTS “is an
exceedingly common condition” in patients with diabetes. Resp. Ex. A at 10; Resp. Ex. A-4.
According to the medical records submitted by petitioner, petitioner had uncontrolled diabetes
since 2011. See Pet. Ex. 3 at 784. Petitioner’s expert also conceded that petitioner’s diabetes
was not well controlled at the time of vaccination. Pet. Ex. 6 at 9.

3. Althen Prong Three: Proximate Temporal
Relationship

As stated above, Dr. Evans found the fact that Mr. Barlow had no documented
complaints about his vaccinated left arm until March 19, 2016—about five-and-one-half months
after his vaccination—despite having many visits to various medical providers, implausible.
Resp. Ex. A at 8-9. Between petitioner’s vaccination on October 2, 2015 and the first report of
left arm symptoms almost six months later, Mr. Barlow had eight documented visits to medical
providers, including to his long-time internist Dr. Hougen. Id. at 9. None of these medical

20
providers documented the left arm problems, and none of them documented any problems related
to the vaccination. Id.

Dr. Evans opined that if left arm swelling occurred as later-in-time reported by petitioner,
it occurred with such a long delay as to make a relationship to vaccination very unlikely, and
persisted for such a short period of time that injury to the median nerve would likewise be
unlikely. Resp. Ex. A at 11. In summary, Dr. Evans stated that although the records show that
petitioner had CTS, they also make it clear that his vaccination was unlikely to have caused or
exacerbated his condition. Id.

V. LEGAL FRAMEWORK AND ANALYSIS

A. Standards for Adjudication—Causation

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

Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). 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, petitioner must prove that 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, 1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Hum.
Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner who satisfies this burden is entitled to
compensation unless respondent can prove, by a preponderance of the evidence, that the
vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” §
13(a)(1)(B).

B. Causation Theory

To receive compensation under the Program, petitioner must prove either: (1) that he
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that he suffered an injury that was caused by a vaccination. See
§§ 11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319-20
(Fed. Cir. 2006). Petitioner must show that the vaccine was “not only a but-for cause of the
injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface, 165 F.3d at 1352-53).

Because petitioner does not allege that he suffered a Table injury, he must prove that the
vaccine caused his illness. To do so, he must establish, by preponderant evidence: (1) a medical

21
theory causally connecting the vaccine and his injury (“Althen Prong One”); (2) a logical
sequence of cause and effect showing that the vaccine was the reason for her injury (“Althen
Prong Two”); and (3) a showing of a proximate temporal relationship between the vaccine and
his injury (“Althen Prong Three”). § 13(a)(1); Althen, 418 F.3d at 1278.

The causation theory must relate to the injury alleged. Thus, petitioner must provide a
reputable medical or scientific explanation for his theory, although the explanation need only be
“legally probable, not medically or scientifically certain,” it must be “sound and reliable.”
Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1360 (Fed. Cir. 2019); Knudsen v.
Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot
establish entitlement to compensation based solely on assertions. Rather, a vaccine claim must
be supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether petitioner is entitled to compensation, the special master shall consider all
material contained in the record, including “any . . . conclusion, [or] medical judgment . . . which
is contained in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh
the submitted evidence and the testimony of the parties’ offered experts and rule in petitioner’s
favor when the evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of
fact are entitled—indeed, expected—to make determinations as to the reliability of the evidence
presented to them and, if appropriate, as to the credibility of the persons presenting that
evidence.”); Althen, 418 F.3d at 1280 (noting that “close calls” are resolved in petitioner’s
favor).

i. Law Governing Analysis of Fact Evidence

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. § 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.” § 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 415, 417 (Fed. Cir. 1993)
(noting 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 a determination is
evidenced by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir.
1993); Doe/70 v. Sec’y of Health & Hum. Servs., 95 Fed. Cl. 598, 608 (2010) (“Given 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.”); 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 propositions that (i) sick

22
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), vacated, on
other grounds, 809 F. App’x 843 (Fed. Cir. 2020); see also Cucuras, 993 F.2d at 1528.

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) (“It has generally
been held that oral testimony which is in conflict with contemporaneous documents is entitled to
little evidentiary weight.” (citing United States v. U.S. Gypsum Co., 333 U.S. 364, 396 (1947)),
aff’d, 968 F.2d 1226 (Fed. Cir. 1992).

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) (“[L]ike
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 (“Written 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 v. Sec’y of Health &
Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs.,
991 F.2d 1570, 1575 (Fed. Cir. 1993).

ii. Evaluation of Expert Testimony

Another important aspect of the causation-in-fact case law under the Vaccine Act
concerns the factors that a special master may consider in evaluating the reliability of expert
testimony and other scientific evidence. In Daubert v. Merrell Dow Pharmaceutical, Inc., the
Supreme Court listed certain factors that federal trial courts should utilize in evaluating proposed
expert testimony concerning scientific issues. 509 U.S. 579 (1993). In Terran v. Secretary of
Health & Hum. Services, the Federal Circuit ruled that it is appropriate for special masters to
utilize the Daubert factors as a framework for evaluating the reliability of causation-in-fact
theories presented in Program cases. 195 F.3d 1302, 1316 (Fed. Cir. 1999).

Daubert instructs fact-finders to consider:

(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

23
 acceptance within a relevant scientific community.

Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-95). In addition, 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 v. Sec’y of Health & Hum.
Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000)). 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
v. Sec’y of Health & Hum. Servs., 88 Fed. Cl. 706, 743 (2009) (quoting Gen. Elec. Co. v. Joiner,
522 U.S. 136, 146 (1997)).

A treating physician’s opinions are considered “quite probative,” as treating physicians
are in the “best position” to evaluate the vaccinee’s condition. Capizzano, 440 F.3d at 1326.
However, no treating physician’s views bind the special master, per se; rather, their views should
be carefully considered and evaluated. § 13(b)(1); Snyder, 88 Fed. Cl. at 745 n.67. Each
opinion from a treating physician should be weighed against other, contrary evidence present in
the record—including conflicting opinions from other treating physicians. Hibbard v. Sec’y of
Health & Hum. Servs., 100 Fed. Cl. 742, 749 (Fed. Cl. 2011), aff’d, 698 F.3d 1355 (Fed. Cir.
2012); Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 136 (2011), aff’d, 463 F.
App’x 932 (Fed. Cir. 2012); Veryzer v. Sec’y of Health & Hum. Servs., No. 06-522V, 2011 WL
1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for rev. denied, 100 Fed. Cl. 344
(2011).

iii. Consideration of Medical Literature

Both parties filed medical and scientific literature in this case, including some articles
that do not weigh heavily on the outcome herein. The undersigned has reviewed and considered
all of the medical literature submitted in this case, though the undersigned only discusses those
articles that are most relevant to entitlement and/or are central to petitioner’s case—just as the
undersigned has not exhaustively discussed every individual medical record filed. 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 he does not explicitly
reference such evidence in his decision.”); see also Paterek v. Sec’y of Health & Hum. Servs.,
527 F. App’x 875, 884 (Fed. Cir. 2013) (“Finding certain information not relevant does not lead
to—and likely undermines—the conclusion that it was not considered.”).

C. Analysis

i. Althen Prong One: Petitioner’s Medical Theory

Under Althen Prong One, petitioner must set forth a medical theory explaining how the
flu vaccination can cause significant aggravation of peripheral neuropathy and CTS. Andreu,
569 F.3d at 1375; Pafford, 451 F.3d at 1355-56. The theory of causation must be informed by a
reputable medical or scientific explanation, although the explanation need only be “legally
probable, not medically or scientifically certain,” it must be “sound and reliable.” Boatmon, 941

24
F.3d at 1359; Knudsen, 35 F.3d at 548-49; see also Veryzer v. Sec’y of Health & Hum. Servs.,
98 Fed. Cl. 214, 223 (2011) (noting that special masters are bound by both § 300aa-13(b)(1) and
Vaccine Rule 8(b)(1) to consider only evidence that is both “relevant” and “reliable”). If
petitioner relies upon a medical opinion to support his theory, the basis for the opinion and the
reliability of that basis must be considered in the determination of how much weight to afford the
offered opinion. See Broekelschen, 618 F.3d at 1347 (“The special master’s decision often times
is based on the credibility of the experts and the relative persuasiveness of their competing
theories.”); Perreira v. Sec’y of Health & Hum. Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)
(“Expert opinion is no better than the soundness of the reasons supporting it.” (citing Fehrs v.
United States, 620 F.2d 255, 265 (Ct. Cl. 1980))).

This case presents an alleged novel injury in the Vaccine Program—CTS following flu
vaccination in the shoulder.30 Petitioner’s causal theory is that the flu vaccine, administered in
the left shoulder, caused “prolonged inflammation due to a hypersensitivity reaction” and/or a
“delayed immunologic hypersensitivity” reaction. Pet. Ex. 6 at 9. However, Dr. Klein fails to
define or describe “hypersensitivity reaction” or how it causes inflammation.

Dorland’s defines hypersensitivity as “a state of altered reactivity in which the body
reacts with an exaggerated or inappropriate immune response to what is perceived to be a foreign
substance.” Dorland’s Illustrated Medical Dictionary 884 (33d ed. 2020). Hypersensitivity
reactions are classified as types I to IV. Type I hypersensitivity occurs “within minutes” of
exposure and the symptoms can range from a localized rash to systemic anaphylaxis. Id. at
1574. Type II hypersensitivity causes tissue or cell damage due to the “interaction of antibodies
and antigens on cell surfaces.” Id. at 1575. A transfusion reaction is an example of type II
hypersensitivity. Id. Type III is a “local or general inflammatory response due to formation of
circulating antigen-antibody complexes and their deposition in tissues,” often referred to as
immune complex-mediated hypersensitivity. Id. An example is “systemic lupus
erythematosus.” Id. And type IV is an “immune response [] initiated by antigen-specific T
lymphocytes,” also called “cell-mediated immunity or T cell-mediated hypersensitivity.” Id.

30
A Decision on Joint Stipulation was issued in 2014, in McCray v. Secretary of Health & Hum.
Services, where petitioner alleged flu vaccine caused brachial neuritis, and/or complex regional
pain syndrome, and/or CTS. No. 11-567V, 2014 WL 2920799 (Fed. Cl. Spec. Mstr. June 2,
2014). However, the McCray petitioner, unlike Mr. Barlow, alleged two alternative injuries,
brachial neuritis and complex regional pain syndrome. Brachial neuritis is a Table Injury for
vaccines that contain tetanus toxoid, and has also been seen in the context of other vaccines. See
42 C.F.R. § 100.3(c)(6); Greene v. Sec’y of Health & Hum. Servs., No. 11-631V, 2019 WL
4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019), mot. for rev. denied, 146 Fed. Cl. 655 (2020);
McNorton v. Sec’y of Health & Hum. Servs., No. 13-35V, 2014 WL 6704500, at *1 (Fed. Cl.
Spec. Mstr. Nov. 4, 2014); Ebbs v. Sec’y of Health & Hum. Servs., No. 18-0260V, 2020 WL
1488640 (Fed. Cl. Spec. Mstr. Feb. 18, 2020). Post-vaccination complex regional pain syndrome
has also been the subject of vaccine cases following various vaccines. See Dixon-Jones v. Sec’y
of Health & Hum. Servs., No. 14-934V, 2019 WL 7556374 (Fed. Cl. Spec. Mstr. Sept. 4, 2019);
Lusk v. Sec’y of Health & Hum. Servs., No. 15-1190V, 2016 WL 2616997 (Fed. Cl. Spec. Mstr.
Jan. 28, 2016).

25
 Here, petitioner did not identify the type of hypersensitivity, describe the process by
which hypersensitivity can cause inflammation and/or injury to the median nerve, or offer any
literature or other evidence to support this fundamental aspect of the proffered causal theory.
Given that hypersensitivity reactions are varied and complex, a conclusory theory is insufficient.
Specifically, petitioner did not explain how an immunization in the shoulder caused a
hypersensitivity reaction resulting in inflammation and swelling of the structures in the carpal
tunnel and injury to the median nerve so as to cause or aggravate petitioner’s pre-existing CTS.
See Pet. Ex. 6 at 9; Pet. Ex. 14 at 3. According to petitioner, this same theory of swelling and
compression also aggravated his pre-existing peripheral neuropathy in his left upper extremity.

Respondent’s expert, Dr. Evans, agrees that CTS and peripheral neuropathy can result
from conditions that cause significant edema, including compartment syndrome, or edematous
conditions caused by trauma, burns, pregnancy, or postmastectomy lymphedema. However, Dr.
Evans disagrees that vaccination can lead to the alleged conditions here without evidence to
support the type of edema or swelling associated with the conditions described above.

Balakrishnan et al. explains the mechanism whereby compartment syndrome can cause
carpal tunnel syndrome. See Resp. Ex. A-1. Compartment syndrome occurs when the pressure
within a compartment is increased to the point that there is vascular compromise of the structures
within a compartment. Id. at 1. Hypoxia and ischemia of the microcirculation occurs. Id. at 2.
“When intracarpal canal interstitial pressure rise above a critical threshold pressure capillary
blood flow is reduced below the level required for median nerve viability.” Id. Further, the
sequence of events that lead to CTS, and vascular compromise described in the medical
literature, is generally described as painful. Id. In case reports, the patients who developed CTS
secondary to edema sought medical attention due to the severity of their pain.

While the Woo et al. article supports Dr. Klein’s assertion that limb swelling can occur
after vaccination, it did not address the issue of whether limb edema can cause or significantly
aggravate CTS or peripheral neuropathy. See Pet. Ex. 18. The authors did not address Dr.
Klein’s mechanistic theory. Moreover, in Woo, the authors reported that extensive limb swelling
after vaccination generally resolves without permanent injury or disability. Id. at 3.

Petitioner cited a number of other medical articles, but none of them provide support for
Dr. Klein’s opinion that a vaccine given in the deltoid muscle of the upper arm can result in
swelling within the carpal tunnel so as to cause compression of the median nerve. And none of
the articles describe a hypersensitivity reaction that results in CTS or peripheral neuropathy.

The National Institutes of Health article on CTS provides an overview of factors that can
cause swelling of the wrist.31 Pet. Ex. 8. Notably, these risk factors include trauma or injury
directly to the wrist. See id. at 1. The article does not identify vaccination as a risk factor. The
Ibrahim article provides a review of recent literature, and the authors conclude that CTS is a
common condition. Pet. Ex. 9 at 1. Vaccination is not discussed as a risk factor or cause. In

31
Nat’l Inst. of Neurological Disorders & Stroke, Carpal Tunnel Syndrome Fact Sheet,
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Carpal-Tunnel-
Syndrome-Fact-Sheet (last modified Apr. 7, 2020).
26
Fullerton,32 ischemia of the median nerve was studied, but again, there was no reference to
vaccinations. See Pet. Ex. 10. And in Werner, the risk factors identified included older age and
higher BMI, but swelling due to vaccination was not identified. See Pet. Ex. 17. None of these
articles addressed swelling or nerve compression caused by a hypersensitivity reaction.

Similarly, the medical literature about peripheral neuropathy fails to identify vaccination
or post-vaccination inflammation as a cause or risk factor. Diabetes is the leading cause, and 60-
70% of diabetics have mild to severe peripheral neuropathy.33 Pet. Ex. 11 at 3. Yagihashi et al.
describes the mechanics of diabetic neuropathy. See Pet. Ex. 12. Swelling due to vaccination is
not discussed. The Stevens et al. study cited by petitioner makes no mention of vaccination as a
risk factor or cause of peripheral neuropathy. See Pet. Ex. 16.

CTS has been reported following vaccination, but the case reports do not support the
causal mechanism posited by Dr. Klein. Several of the case reports describe CTS following
rubella vaccination.34 The rubella vaccine is a live attenuated virus vaccine, unlike the flu
vaccine. The vaccine recipients had arthropathy, with stiffness and swelling of the hands and
joints, and/or “marked synovial swelling over [the] wrists.” Resp. Ex. A-6 at 1. The mechanism
in the rubella vaccination cases is thought to be a “viral induced tenosynovitis.” Id. at 5. In the
Dyro35 case report, the vaccine developed a mononeuropathy of the left radial nerve affecting
muscle in the left arm and wrist following the New Jersey/76 Swine Flu vaccination. Resp. Ex.
A-3. The median nerve was not affected. See id. None of these cases implicate Dr. Klein’s
theory of hypersensitivity reaction leading to inflammation as the mechanism of CTS.

When evaluating whether petitioners have carried their burden of proof, special masters
consistently reject “conclusory expert statements that are not themselves backed up with reliable
scientific support.” Kreizenbeck v. Sec’y of Health & Hum. Servs., No. 08-209V, 2018 WL
3679843, at *31 (Fed. Cl. Spec. Mstr. June 22, 2018), mot. for rev. denied, 141 Fed. Cl. 138
(2018), aff’d, 945 F.3d 1362 (Fed. Cir. 2020). The undersigned will not rely on “opinion
evidence that is connected to existing data only by the ipse dixit of the expert.” Prokopeas v.
Sec’y of Health & Hum. Servs., No. 04-1717V, 2019 WL 2509626, at *19 (Fed. Cl. Spec. Mstr.
May 24, 2019) (quoting Moberly, 592 F.3d at 1315). Instead, special masters are expected to
carefully scrutinize the reliability of each expert report submitted. See id.

In summary, petitioner has not offered a sound and reliable medical theory in support of
his claim. Petitioner has not met the preponderant evidentiary standard with respect to the first
Althen prong.
32
P.M. Fullerton, The Effect of Ischemia on Nerve Conduction in the Carpal Tunnel Syndrome,
26 J. Neurology Neurosurgery Psychiatry 385 (1963).
33
Nat’l Inst. of Neurological Disorders & Stroke, Peripheral Neuropathy Fact Sheet,
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Peripheral-
Neuropathy-Fact-Sheet (last modified Mar. 16, 2020).
34
See Resp. Ex. A-9; Resp. Ex. A-6.
35
F. M. Dyro, Vaccination Mononeuropathy, 3 Annals Neurology 468 (1978).
27
 ii. Althen Prong Two: Logical Sequence of Cause and Effect

Under Althen Prong Two, petitioner must prove by a preponderance of the evidence that
there is a “logical sequence of cause and effect showing that the vaccination was the reason for
the injury.” Capizzano, 440 F.3d at 1324 (quoting Althen, 418 F.3d at 1278). Petitioner must
show “that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine
was the ‘reason for the injury.’” Pafford, 451 F.3d at 1356 (citations omitted).

Since petitioner has failed to prove Althen Prong One, it follows that he cannot prove
Althen Prong Two. However, even if petitioner had proven a sound and reliable causal
mechanism, he has failed to prove by preponderant evidence a logical sequence of cause and
effect, showing his flu vaccine caused or significantly aggravated his CTS and peripheral
neuropathy for three reasons. First, petitioner failed to show that the proposed causal theory is
consistent with his clinical course. Second, petitioner’s treating physicians’ records and opinions
do not support vaccine causation, and third, Dr. Evans’ opinions are more persuasive.36

As for the first reason, petitioner, through his expert, fails to explain or show that his
clinical course was consistent with a hypersensitivity reaction induced inflammation that
aggravated petitioner’s CTS or peripheral neuropathy. Dr. Klein does not point to any diagnostic
tests, any facts, or any other evidence to show that petitioner’s CTS or peripheral neuropathy
occurred due to a hypersensitivity reaction.

Dr. Klein asserts that petitioner’s flu vaccination caused a “cascade of clinical concerns,
beginning with [] dermatitis and skin eruption.” Pet. Ex. 6 at 9. Petitioner was diagnosed with
dermatitis shortly after receipt of his flu vaccine, but neither he nor the Urgent Care physician
who treated him attributed it to the flu vaccine or a hypersensitivity reaction caused by the
vaccine. Specifically, petitioner told Dr. Henderson that he had a history of sensitive skin and
thought the rash was due to a change in detergent. Pet. Ex. 2 at 286. Dr. Henderson concluded
that petitioner’s dermatitis was due to “some type of exposure.” Id. In context, this reference
relates to petitioner’s history of sensitive skin and belief that his dermatitis was due to detergent
exposure. Dr. Henderson did not suggest that petitioner’s dermatitis was caused by the flu
vaccine.

Moving forward, more than five months later, Dr. Kakehashi documented a residual halo
from bruises of the deltoid (upper arm), but did not document any hypersensitivity reaction, or
inflammation or swelling. Notably, Dr. Kakehashi did not document any history or physical
finding to suggest that petitioner’s left arm from the shoulder to the wrist had been or was
inflamed. When seen by Dr. Romine on March 28, 2016, petitioner reported that his “whole arm
turned purple, but over time this resolved.” Pet. Ex. 2 at 262. Dr. Romine noted “mild swelling”
36
In his Memorandum, petitioner agrees that while both Dr. Klein and Dr. Evans are qualified to
give expert opinions in this matter, that Dr. Klein is “better suited” because his CV shows that he
has expertise in electrodiagnostic and neuromuscular conditions. Pet. Mot. at 8. The
undersigned agrees that both experts are qualified, and acknowledges Dr. Klein’s subspecialty
and professional associations. However, given all of the evidence here, the undersigned finds
Dr. Evans’ opinions more persuasive for all of the reasons stated.
28
of petitioner’s forearm. Id. But Dr. Romine did not document any history or physical finding
that petitioner’s left arm, from his shoulder to his wrist, was inflamed. There is no factual
support in the contemporaneous medical records that petitioner’s dermatitis triggered a “cascade
of concerns” or hypersensitivity reaction that played a role in causing or significantly
aggravating petitioner’s CTS or peripheral neuropathy. To the extent that hypersensitivity is
referenced, it is in regard to petitioner’s dermatitis, not his CTS or peripheral neuropathy.

Secondly, a careful review of the medical records reveals that the medical records and
opinions of the treating physicians do not support vaccine causation. The first time that
petitioner attributes any problem to his flu vaccine was March 19, 2016, when he was seen at
Urgent Care for pain and left arm paresthesias. Pet. Ex. 2 at 283. Dr. Kakehashi’s assessment
was “left arm paresthesias since receiving the flu vaccination.” Id. Other than noting the
temporal association, Dr. Kakehashi did not opine that the flu vaccine caused petitioner’s pain or
paresthesias. In fact, Dr. Kakehashi did not reach a diagnosis, but referred petitioner to a
neurologist.

Subsequently, petitioner was seen by neurologist, Dr. Romine, on March 28, 2016, who
made two diagnoses: “1. Status post remote flu immunization (October 2015); local reaction with
ecchymosis and swelling of the left upper extremity, improved. 2. Probable left carpal tunnel
syndrome; possible left radial, sensory cutaneous neuropathy.” Pet. Ex. 2 at 262. While Dr.
Romine did diagnosis a vaccine related local reaction, his diagnoses of CTS and possible radial
neuropathy were enumerated separately and not described as causally related to vaccination.

One year later, on March 21, 2017, Dr. Romine made the following diagnoses: “1. Status
post left carpal tunnel release – persistent numbness of hand . . . [and] forearm –
localization/cause unclear. 2. Persistent numbness and sensory deficit of left forearm and hand
status post remote flu shot -? possible residual post immunization brachial neuritis?” Pet. Ex. 5
at 20.

Dr. Romine did not attribute petitioner’s CTS to his flu vaccine, but stated that the cause
was unclear. As for petitioner’s numbness and sensory deficient, Dr. Romine only believed that
vaccine causation was “possible.” An opinion expressed as a possibility is insufficient to
establish causation.37

37
See LaCour v. Sec’y of Health & Hum. Servs., No. 90-316V, 1991 WL 66579, at *5 (Fed. Cl.
Spec. Mstr. Apr. 15, 1991) (“Expert medical testimony which merely expresses the possibility—
not the probability—of the occurrence of a compensable injury is insufficient, by itself, to
substantiate the claim that such an injury occurred.”); Moberly, 592 F.3d at 1322 (emphasizing
that “proof of a ‘plausible’ or ‘possible’ causal link between the vaccine and the injury” does not
equate to proof of causation by a preponderance of the evidence); Waterman v. Sec’y of Health
& Hum. Servs., 123 Fed. Cl. 564, 573-74 (2015) (denying petitioner’s motion for review and
noting that a possible causal link was not sufficient to meet the preponderance standard); De
Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008) (finding that
while certainty is by no means required, a possible mechanism does not rise to the level of
preponderance); see also Dobrydnev v. Sec’y of Health & Hum. Servs., 566 F. App’x 976, 981
(Fed. Cir. 2014).
29
 Petitioner later saw immunologist Dr. Kelso, who made two diagnoses. Dr. Kelso stated:

Neuromuscular and dermatologic abnormalities following influenza vaccination.
The neuromuscular abnormalities may represent brachial neuritis which has been
described after injections of vaccines . . . and is thought to represent an
inflammatory response around nerves and/or be related to the trauma of the
injection itself. The dermatologic abnormalities are not typically reported in
association with brachial neuritis but could also represent an inflammatory
response to the immunization perhaps including a delayed immunologic
hypersensitivity.

Pet. Ex. 2 at 2; Pet. Ex. 5 at 257.

This note shows that Dr. Kelso described two conditions with two respective causal
mechanisms. He stated that brachial neuritis following vaccination may be due to an
inflammatory response around the nerves or direct trauma from injection. He did not suggest
that brachial neuritis was caused by a hypersensitivity reaction. Dr. Kelso’s reference to post-
vaccination hypersensitivity reaction relates to dermatitis, not CTS or peripheral neuropathy.
Further, Dr. Kelso did not diagnose petitioner with CTS. And he did not attribute petitioner’s
CTS or peripheral neuropathy to the dermatological condition (dermatitis).

In summary, when Dr. Klein describes a “cascade of concerns,” he conflates two
different mechanisms described by Dr. Kelso, attributing both CTS and peripheral neuropathy to
a hypersensitivity reaction. But this interpretation is not supported by Dr. Kelso’s note, the
evidence, Dr. Klein, or the medical literature.

At the petitioner’s request, Dr. Hougen reviewed “both peripheral neuropathy and median
neuropathy [CTS]” with the petitioner. Pet. Ex. 2 at 247. Dr. Hougen noted that petitioner’s
peripheral neuropathy was consistent with his diabetes. And Dr. Hougen explained that
petitioner’s EMG showed “median nerve entrapment at the carpal tunnel.” Id. Dr. Hougen did
not opine that either condition was caused by the petitioner’s flu vaccine.

Therefore, the undersigned finds that none of petitioner’s treating physicians opined that
the flu vaccine caused or aggravated his CTS or peripheral neuropathy.

Third, the undersigned finds Dr. Evans’ opinions regarding petitioner’s clinical course to
be more persuasive because they are more consistent with the findings and conclusions of
petitioner’s treating physicians documented in the contemporaneous medical records. Excluding
his visits to a podiatrist,38 petitioner saw four different health care providers six times in a three-
month period immediately following vaccination. All four of these providers performed and
documented independent physical examinations of petitioner. During the six different visits,
petitioner had varied and specific complaints. His complaints were well described and
documented each visit. The four different providers included an urgent care physician, a
38
A podiatrist specializes in the care and treatment of the foot, and as such, would not be
expected to perform an evaluation of the upper extremities. For a definition of podiatrist, see
Dorland’s at 1455.
30
longstanding primary care physician, a cardiology physician assistant, and a dermatologist.
While Dr. Klein may be correct that physicians make errors, it would be quite a stretch to assume
that all four of these health care providers repeatedly failed to properly take or document a
history, or failed to perform or document an accurate physical examination. The undersigned
will not base her decision on allegations of improper medical care where there is no evidence of
such, other than medical literature which suggests that errors do occur.

Even assuming that petitioner had symptoms but failed to complain of them in the post-
vaccination period, the undersigned agrees with Dr. Evans’ conclusion that, “any of these
practitioners would be expected to note if the patient had . . . significant left arm physical signs”
or symptoms. Resp. Ex. C at 2. Based on experience and knowledge reviewing medical records,
adjudicating vaccine cases, the evidence in the medical records, the expert opinions, and all of
the evidence in this matter, the undersigned finds that petitioner’s contemporaneous medical
records provide accurate assessments of the petitioner’s history and physical examinations. See
Cucuras, 993 F.2d at 1528.

The undersigned also finds that petitioner’s clinical course is not consistent with vaccine
causation based on the case reports in the medical literature. Petitioner did not have brachial
plexus neuritis as confirmed by both experts. He did not receive a rubella vaccine. He did not
have an “abrupt onset of stiffness” in his hands or “marked synovial swelling over the wrists” as
described in Hale and Ruderman. Resp. Ex. A-6 at 1. Moreover, he was not diagnosed with
viral induced tenosynovitis, as the case report in Hale and Ruderman. Id.

For all of the reasons described above, the undersigned finds that petitioner has failed to
provide preponderant evidence of a logical sequence of cause and effect.

iii. Althen Prong Three: Proximate Temporal Relationship

Under Althen Prong Three, petitioner must provide “preponderant proof that the onset of
symptoms occurred within a timeframe for which, given the understanding of the disorder’s
etiology, it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of Health &
Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The acceptable temporal association will
vary according to the particular medical theory advanced in the case. See Pafford, 451 F.3d at
1358. A temporal relationship between a vaccine and an injury, standing alone, does not
constitute preponderant evidence of vaccine causation. See, e.g., Veryzer, 100 Fed. Cl. at 356
(explaining that “a temporal relationship alone will not demonstrate the requisite causal link” and
there must be “a medical theory causally connecting the vaccine and injury”).

The onset of petitioner’s peripheral neuropathy dates back to December 2012, when Dr.
Hougen noted that petitioner had mild peripheral neuropathy. The onset of his CTS dates back
to January 2014, when he injured his left wrist while lifting heavy boxes. His wrist was
described as swollen and painful, and he had throbbing in his fingers. Examination revealed
bruising and edema of petitioner’s wrist and limited range of motion. He was diagnosed with
left wrist trauma and possible rupture of the flexor carpi radialis tendon.

With regard to the onset of significant aggravation of petitioner’s CTS and peripheral

31
neuropathy, Dr. Klein agreed that petitioner’s symptoms became clinically apparent in March
2016. However, Dr. Klein disagreed that onset was that late. See Pet. Ex. 14 at 2-3. Instead, Dr.
Klein opined that petitioner had a progressive onset, or there was a latency period that began
after petitioner’s October 2015 flu shot that did not manifest as clinically significant CTS until
March 2016. Id. Alternatively, Dr. Klein attributed petitioner’s delay in reporting his left arm
complaints between the date of vaccination, October 8, 2015, and the first documentation of
symptoms, March 28, 2016, on petitioner’s decision to prioritize treatment of his other health
problems over his left arm symptoms.

Dr. Evans opined that petitioner’s onset was too long to be vaccine related. After
reviewing the well-documented medical chronology post-vaccination, Dr. Evans concluded that
the long delay between vaccination and first report of symptoms made a relationship to
vaccination very unlikely.

The undersigned finds Dr. Evans’ opinions to be more persuasive than Dr. Klein’s, which
are not well supported by the records. As noted by Dr. Evans, petitioner’s left arm was
examined six days after vaccination, but there was no reference to left arm symptoms, and no
physical finding of left arm, forearm, or wrist swelling. No adverse reaction to the vaccine was
noted. Twenty-five days after vaccination, petitioner complained of leg swelling, but there was
no mention of left arm swelling, pain, or other CTS symptoms. Almost eight weeks (53 days)
after vaccination, petitioner had a physical examination by a dermatologist. There was no
reference to pain, vaccination, or swelling of the left arm, forearm, or wrist. Almost nine weeks
(62 days) after vaccination, petitioner visited his primary care physician and complained of right
shoulder pain, but there is no documentation of left arm pain, swelling, or paresthesias. Over
four months (123 days) after vaccination, physical examination showed that petitioner had
limited range of motion and crepitus in his right shoulder, but there was no mention of any
problems in the left shoulder or arm, and no symptoms of CTS were documented.

The undersigned finds that the onset of petitioner’s significant aggravation of CTS and
peripheral neuropathy occurred approximately five months (169 days) after vaccination when he
presented to Dr. Kakehashi with the complaint of “left arm pain and numbness.” Pet. Ex. 2 at
283. Prior to that time, there is no evidence in the record that the petitioner experienced left arm
pain, swelling, or paresthesia.

Further, the undersigned agrees with Dr. Evans that an onset of approximately five
months is too long for there to be a temporal association between petitioner’s flu vaccination and
his alleged injuries. While neither expert provides a specific time frame within which onset
would be expected, the medical literature does provide a helpful framework.

In the case reported by Hale and Ruderman, the rubella vaccine recipient complained of
stiffness three weeks after vaccination. Resp. Ex. A-6 at 1. Six weeks (42 days) post-
vaccination, she developed “marked synovial swelling” over both wrists. Id. In Ray, the
researchers found no evidence of a causal association between the rubella vaccine and “persistent
joint symptoms.” Resp. Ex. A-9 at 4. While they did not find adverse reactions to be
statistically significant, the authors did observe that six vaccinees had joint symptoms within six
weeks of vaccination, including one diagnosed with CTS. Id. at 5. With regard to the rubella

32
vaccine, the postulated mechanism is viral induced tenosynovitis causing median neuropathy.
Although the theory is different than that proposed by Dr. Klein, these studies provide some
frame of reference with regard to temporal association between vaccines and onset of CTS.

An inflammatory mechanism was referenced by Tosti and Ilyas, although not in the
context of vaccination. In cases of acute CTS, “onset of symptoms is on the order of hours to
days following an initiating event. Patients will complain of pain and numbness over the median
nerve distribution, and progressive stages may reveal weakness.” Resp. Ex. A-11 at 4. Acute
CTS is “characterized by rapid onset of median neuropathy caused by sudden increases in carpal
tunnel pressures, which leads to ischemia of the median nerve. The most common cause is
traumatic injury, although atraumatic sources should also be recognized.” Id. at 5. Inflammatory
causes of acute CTS include overuse, gout, and rheumatoid arthritis. Id. at 3 tbl.1. Thus, Tosti
and Ilyas recognized an inflammatory mechanism, but described a fairly rapid onset when there
is a specific triggering event.

Based on a review of all of the evidence, the undersigned finds that petitioner has failed
to prove by preponderant evidence that an onset of symptoms occurring approximately five
months after vaccination is an appropriate time frame for significant aggravation of CTS and
peripheral neuropathy.

D. Standards for Adjudication—Significant Aggravation

Additional analysis is required to determine whether petitioner’s vaccination significantly
aggravated his pre-existing injury. The elements of an off-Table significant aggravation case are
set forth in Loving. See also W.C. v. Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed.
Cir. 2013) (holding that “the Loving case provides the correct framework for evaluating off-table
significant aggravation claims”). The Loving court combined the Althen test, which defines off-
Table causation cases, with a test from Whitecotton. Whitecotton v. Sec’y of Health & Hum.
Servs., 17 F.3d 374 (Fed. Cir. 1994), rev’d sub nom., Shalala v. Whitecotton, 514 U.S. 268
(1995) (concerning on-Table significant aggravation cases). The resultant test has six
components, which are:

(1) the person’s condition prior to administration of the vaccine, (2) the person’s
current condition (or the condition following the vaccination if that is also
pertinent), (3) whether the person’s current condition constitutes a ‘significant
aggravation’ of the person’s condition prior to vaccination, (4) a medical theory
causally connecting such a significant worsened condition to the vaccination, (5) a
logical sequence of cause and effect showing that the vaccination was the reason
for the significant aggravation, and (6) a showing of a proximate temporal
relationship between the vaccination and the significant aggravation.

Loving, 86 Fed. Cl. at 144.

E. Significant Aggravation Theory

i. Loving Prong 1: What Was Petitioner’s Condition Prior to

33
 Administration of the Vaccine?

The first step in the Loving test is to determine petitioner’s condition with regard to
peripheral neuropathy and CTS before he received the vaccination at issue. Here, the medical
records show that petitioner was diagnosed with peripheral neuropathy as early as December 19,
2012 by Dr. Hougen. Pet. Ex. 2 at 161-66. Dr. Hougen notes petitioner’s diabetes, “mild
peripheral neuropathy” and “mild peripheral numbness,” as well as his diminished peripheral
sensation. Id. at 161, 163.

The onset of petitioner’s CTS dates back at least to January 2014, when he injured his left
wrist while lifting heavy boxes. Pet. Ex. 2 at 290. His wrist was described as swollen and
painful, and he had throbbing in his fingers. Id. Examination showed bruising and edema of
petitioner’s wrist and limited range of motion. Id. at 291-92. He was diagnosed with left wrist
trauma and possible rupture of the flexor carpi radialis tendon. Id. at 292.

Pre-vaccination records verify that petitioner had risk factors for both CTS and peripheral
neuropathy, including diabetes, and congestive heart failure, which alters the fluid balance in the
body. Pet. Ex. 9 at 4. Immediately prior to vaccination, the medical records do not reference left
arm CTS or peripheral neuropathy.

ii. Loving Prong 2: What Is Petitioner’s Current Condition (or His
Condition Following the Vaccination, If Also Pertinent)?

The second part of the Loving test is to discuss “the person’s current condition (or
condition following the vaccination if that is also pertinent).” 86 Fed. Cl. at 144. Here,
petitioner’s condition following vaccination is most pertinent.

After petitioner received the flu vaccination, he did not report symptoms of CTS or
peripheral neuropathy to his treating physicians for over five months. Multiple physicians
performed physical examinations and treated Mr. Barlow between October 8, 2015 and February
2, 2016, however, none documented swelling, edema, bruising, numbness, or pain of petitioner’s
left shoulder, forearm, or wrist.

Following vaccination, and for months afterwards, the medical records do not reference
left arm CTS or peripheral neuropathy.

iii. Loving Prong 3: Does Petitioner’s Current Condition (or Condition
After Vaccination) Constitute a “Significant Aggravation” of His
Condition Prior to Vaccination?

The next prong of the Loving test is to determine whether there is a “significant
aggravation” of petitioner’s condition by comparing his condition before vaccination to his
condition after vaccination. The statute defines “significant aggravation” as “any change for the
worse in a pre-existing condition which results in markedly greater disability, pain, or illness
accompanied by substantial deterioration in health.” § 33(4).

34
 As set forth earlier, there is no factual support in the contemporaneous medical records to
support the type of edema or swelling associated with CTS or peripheral neuropathy occurred
after vaccination. Petitioner, through his expert, failed to explain or show that his clinical course
was consistent with a hypersensitivity reaction induced inflammation that aggravated petitioner’s
CTS or peripheral neuropathy. Dr. Klein does not point to any diagnostic tests, any facts, or any
other evidence to show that petitioner’s CTS or peripheral neuropathy occurred due to a
hypersensitivity reaction.

The onset of petitioner’s peripheral neuropathy dates back to December 2012, when Dr.
Hougen noted that petitioner had mild peripheral neuropathy due to his diabetes, and the onset of
his CTS dates back to January 2014, when he injured his left wrist while lifting heavy boxes.
Petitioner’s chronic condition is supported by the medical records, and there is no evidence of
that an acute event, such as vaccination, exacerbated petitioner’s condition.

iv. Loving Prong 4: Is There a Medical Theory Causally Connecting Such
a Significant Worsened Condition to the Vaccination?

As set forth in Section V.C.i above, petitioner failed to establish by a preponderance of
the evidence, a medical theory causally connecting petitioner’s condition, or any significant
aggravation. Therefore, petitioner failed to prove causation as to significant aggravation.

v. Loving Prong 5: Is There a Logical Sequence of Cause and Effect
Showing That the Vaccination Significantly Aggravated Petitioner’s
Condition?

For the same reasons set forth in Section V.C.ii above, petitioner failed to prove by
preponderant evidence a logical sequence of cause and effect showing that the vaccination
significantly aggravated his condition.

vi. Loving Prong 6: What Is a Proximate Temporal Relationship Between
the Vaccination and the Significant Aggravation?

The last element in the six-part Loving test has origins in Althen Prong 3. As stated in
Loving, this element is “a showing of a proximate temporal relationship between vaccination and
the significant aggravation.” 86 Fed. Cl. at 144. Again, for the same reasons set forth in Section
V.C.iii, petitioner failed to prove the third prong of Althen, which is the last element of the
Loving test.

VI. CONCLUSION

It is clear from the medical records that Mr. Barlow suffered as a result of his illnesses,
and the undersigned extends her sympathy to him. However, this case cannot be decided based
upon sympathy but rather by an analysis of the evidence.

For all of the reasons discussed above, the undersigned finds that petitioner has not
established by preponderant evidence that vaccination caused or significantly aggravated

35
petitioner’s CTS or peripheral neuropathy. Therefore, petitioner is not entitled to compensation
and his petition must be dismissed. In the absence of a timely filed motion for review pursuant
to Vaccine Rule 23, the Clerk of Court SHALL ENTER JUDGMENT in accordance with this
Decision.

IT IS SO ORDERED.

s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master

36