1

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.

DECISION

1

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. § 300aa10 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.
2

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.
3

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. 
4

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.
5

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 
6

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 
7

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.
8

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). 
9

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 
10

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).
11

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.
12

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).
13

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 

al.15 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). 
14

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).
15

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).
16

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.
17

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).
18

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 postvaccination 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).
19

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 
20

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 
21

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 
22

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 
23

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 
24

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 
25

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).
26

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-TunnelSyndrome-Fact-Sheet (last modified Apr. 7, 2020). 
27

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/PeripheralNeuropathy-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).
28

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.
29

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).
30

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 postvaccination 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 threemonth 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.
31

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 postvaccination 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 
32

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) postvaccination, 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 
33

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 offTable 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 
34

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).
35

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 
36

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