In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: January 5, 2021
*************************
SHANNA SALAZAR, * PUBLISHED
*
Petitioner, * No. 15-817V
*
v. * Special Master Nora Beth Dorsey
*
SECRETARY OF HEALTH * Ruling on Entitlement; Causation-in-Fact;
AND HUMAN SERVICES, * Influenza (“Flu”) Vaccine; Right-Sided
* Ulnar Neuropathy.
Respondent. *
*
*************************
Max J. Muller, Muller Brazil, LLP, Dresher, PA, for petitioner.
Lynn C. Schlie, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
I. INTRODUCTION
On July 31, 2015, Shanna Salazar (“petitioner”) filed a petition for compensation under
the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42
U.S.C. § 300aa-10 et seq. (2012).2 Petitioner alleged that she suffered pain, limited range of
motion, limited use, various shoulder injuries, and right ulnar neuropathy as the result of an
1
The undersigned intends to post this Ruling on the United States Court of Federal Claims’
website. This means the Ruling will be available to anyone with access to the internet. In
accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion
of privacy. If, upon review, the undersigned agrees that the identified material fits within this
definition, the undersigned will redact such material from public access. Because this published
Ruling contains a reasoned explanation for the action in this case, undersigned is required to post
it on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services).
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 Ruling to individual sections of the
Vaccine Act are to 42 U.S.C. § 300aa.
influenza (“flu”) vaccination she received on October 2, 2014. Petition at Preamble, ¶¶ 4, 8
(ECF No. 1). Subsequently, petitioner amended her petition to also allege that due to her right
upper extremity vaccine injury, she overused her left upper arm, resulting in an injury of left
ulnar neuropathy. Amended (“Am.”) Petition, filed Feb. 24, 2020 (ECF No. 113).
After a review of the record as a whole, medical records, expert reports, medical
literature, briefing by the parties, and for the reasons set forth below, the undersigned finds that
petitioner has established by preponderant evidence that she sustained a right ulnar neuropathy
caused by her October 2, 2014 flu vaccination and is thus entitled to compensation for that
condition. However, the undersigned denies compensation for petitioner’s left arm injury, as
petitioner did not provide preponderant evidence of vaccine causation.
II. PROCEDURAL HISTORY
Petitioner filed her petition on July 31, 2015, alleging that she sustained shoulder injuries
caused by a flu vaccine administered to her on October 2, 2014. Petition at Preamble. From
August 2015 to July 18, 2016, petitioner filed medical records. Petitioner’s Exhibits (“Pet.
Exs.”) 1-14. On November 4, 2016, petitioner submitted a motion to issue subpoena. Pet.
Motion (“Mot.”) to Issue Subpoena, filed Nov. 4, 2016 (ECF No. 37). Petitioner filed worker’s
compensation documentation on January 5, 2017. Pet. Ex. 15.
On February 22, 2018, petitioner filed an expert report from one of her treating
physicians, Dr. Pradeep Chopra. Pet. Ex. 16. Petitioner then filed additional medical records on
February 27, 2018. Pet. Exs. 17-21.
On September 12, 2018, respondent filed the Rule 4(c) Report, arguing against
compensation. Respondent’s Report (“Resp. Rept.”) at 1 (ECF No. 76). On the same day,
respondent filed an expert report from Dr. Vinay Chaudhry with supporting medical literature.
Resp. Exs. A-E. On February 26, 2019, petitioner filed an affidavit. Pet. Ex. 22. Thereafter, on
March 11, 2019, petitioner filed an expert report from Dr. Lawrence Steinman with supporting
medical literature. Pet. Ex. 23.
On March 28, 2019, the undersigned held a Rule 5 status conference. See Rule 5 Order
dated Mar. 29, 2019 (ECF No. 85). During the Rule 5 conference, the undersigned opined that
based on the weight of the evidence, right ulnar neuropathy was the proper diagnosis. Id. at 1.
She also found that the petitioner had proposed two mechanisms for her injury, positioning at the
time of vaccination or misguided injection, satisfying Althen Prong One. Id.; see Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Further, the undersigned
concluded that petitioner’s vaccination and her injury were linked by a logical sequence of cause
and effect. Rule 5 Order at 1. The undersigned also found that based on the medical records, as
well as the support offered by Dr. Steinman and petitioner’s treating physicians, the time frame
between petitioner’s vaccination and the onset of her right ulnar neuropathy was medically
appropriate. Id. at 2. The undersigned encouraged the parties to engage in settlement
negotiations. Id.
2
After the Rule 5 status conference, respondent filed a status report on June 3, 2019 stating
respondent was not interested in settlement at that time and requested the parties schedule an
entitlement hearing. Resp. Status Rept., filed June 3, 2019 (ECF No. 88). Subsequently, an
entitlement hearing was set for March 25 and 26, 2020 in Providence, Rhode Island. See Pre-
hearing Order dated Aug. 1, 2019 (ECF No. 91). On October 25, 2019, petitioner filed medical
records. Pet. Exs. 24-25. On November 25, 2019, petitioner filed additional medical records and
a statement of completion. Pet. Exs. 26-27; Statement of Completion, filed Nov. 25, 2019 (ECF
No. 98).
On December 30, 2019, the undersigned issued an order referring the case to Alternative
Dispute Resolution (“ADR”). Order Referring Case to ADR dated Dec. 30, 2019 (ECF No.
100). Petitioner filed an affidavit and her pre-hearing submissions on January 24, 2020. Pet. Ex.
28; Pet. Pre-Hearing Brief (“Br.”), filed Jan. 24, 2020 (ECF No. 104). On February 12, 2020, the
special master presiding over ADR issued an order removing the case from ADR. Order
Removing Case from ADR Process dated Feb. 12, 2020 (ECF No. 105).
On February 13, 2020, petitioner filed a motion to amend the petition caption from
Shanna Molina to Shanna Salazar.3 Pet. Mot. to Amend Caption, filed Feb. 13, 2020 (ECF No.
107). Petitioner’s motion was granted the same day. Order Granting Pet. Mot. to Amend
Caption dated Feb. 13, 2020 (ECF No. 109). Petitioner then filed additional medical records and
an amended petition on February 20 and 24, 2020. Pet. Exs. 29-30; Am. Petition. In her
amended petition, petitioner alleged that that she “developed ulnar neuropathy in her left upper
extremity as a result of overuse from the initial right ulnar neuropathy injury.” Am. Petition at 1.
Petitioner reiterated the facts supporting her right arm right ulnar neuropathy and asserted
additional facts to support her position that she sustained an injury in her left upper arm due to
overuse of the left arm due to her right arm injury. See id. at 2-4. Thus, petitioner alleged both
right and left ulnar neuropathy as a result of her October 2, 2014 flu vaccination. Id. at 4.
Respondent filed his pre-hearing brief on February 24, 2020. Resp. Pre-Hearing Br.,
filed Feb. 24, 2020 (ECF No. 119). Petitioner filed updated medical literature on the same day.
Pet. Ex. 31. On February 25, 2020, respondent filed a supplemental expert report from Dr.
Chaudhry and supporting medical literature. Resp. Exs. G-H.
The undersigned held a status conference on March 12, 2020 because the Federal District
Courthouse in Providence, Rhode Island cancelled the entitlement hearing scheduled there for
March 25-26, 2020 due to COVID-19 health and safety concerns. See Order dated Mar. 13,
2020 (ECF No. 125). Subsequently, petitioner filed a joint status report indicating that the
parties wished to decide entitlement with a Ruling on the Record. Joint Status Rept., filed Mar.
19, 2020 (ECF No. 126).
Petitioner filed a second supplemental expert report from Dr. Steinman on June 18, 2020.
Pet. Ex. 32. Petitioner also filed a brief in support of entitlement to damages. Pet. Br. in Support
of Entitlement to Damages, filed June 18, 2020 (ECF No. 131). The next day petitioner filed her
motion for a Ruling on the Record. Pet. Mot. for Ruling on the Record (“Pet. Mot.”), filed June
3
Petitioner changed her last name due to marriage. Pet. Mot. to Amend Caption.
3
19, 2020 (ECF No. 132). In her motion for Ruling on the Record, petitioner seeks only
compensation for “right ulnar neuropathy caused by the [flu] vaccination administered on
October 2, 2014.” Id. at 8.
On August 19, 2020, respondent filed his response to petitioner’s motion. Resp.
Response to Pet. Mot. (“Resp. Response”), filed Aug. 19, 2020 (ECF No. 134). In respondent’s
response, respondent stated, that while petitioner appears to no longer seek entitlement for her
left arm injury “respondent believes that the record is complete with regard to this issue, and this
is also an appropriate time for the Court to determine the extent of petitioner’s alleged injury.”
Id. at 23. On October 19, 2020, petitioner filed a Reply. Pet. Reply to Resp. Response (“Pet.
Reply”), filed Oct. 19, 2020 (ECF No. 135).
The matter is now ripe for adjudication.
III. ISSUES TO BE DECIDED
First, the parties dispute three factual issues: “a) the nature of petitioner’s right arm
injury, including the diagnosis of her injury; b) the nature of petitioner’s left arm injury,
including the diagnosis of her injury; and c) whether petitioner had a pre-existing cubital tunnel
syndrome in her right and/or left arms prior to vaccination.” Joint Pre-Hearing Submissions,
filed Feb. 24, 2020, at 1 (ECF No. 115).
As for causation, the parties dispute: “a) whether the flu vaccine administered to
petitioner on October 2, 2014, caused petitioner’s alleged right arm injuries; and, b) whether the
flu vaccine administered to petitioner on October 2, 2014, caused petitioner’s alleged left arm
injuries.” Joint Pre-Hearing Submissions at 2.
Although the parties agreed to the causation issues framed above, in her motion for a
Ruling on the Record, and accompanying briefs, petitioner asserts that her vaccination caused a
“significant aggravation of previously dormant cubital tunnel syndrome.” Pet. Mot. at 10; Pet.
Reply at 4. Respondent asserts that petitioner has raised conflicting theories of causation: “first,
that the flu vaccination she received caused her cubital tunnel syndrome, and second, that the flu
vaccine she received significantly aggravated her ‘previously dormant’ cubital tunnel
syndrome.” Resp. Response at 11. Respondent further asserts that petitioner is not entitled to
compensation for her alleged left arm overuse injury, and asks the Court to adjudicate this issue.
Resp. Response at 23.
IV. ULNAR NERVE INJURY AND CUBITAL TUNNEL SYNDROME
A. Ulnar Nerve Injuries Caused by Injection
4
The ulnar nerve runs from the “medial cord of the brachial plexus formed by C8 and T1
spinal roots,” down the arm to the hand.4 Pet. Ex. 23.1 at 4. The nerve innervates muscles that
move the wrist, hand, and fingers and “provides sensory innervation” to parts of the hand. Id.
While injection related injuries to the ulnar nerve are rare, they have been reported in the
literature. Kim et. al. studied 645 patients who had ulnar nerve injuries and found that two were
caused by injection. Id. Geiringer and Leonard reported two cases of ulnar injury after the same
nurse administered vaccinations to two different patients, calling into question whether the
nurse’s injection technique was the cause of the injuries.5 Pet. Ex. 23.2 at 1. When
administering the vaccinations, the nurse directed the patients to place their hands on their hips
and internally rotate their arms.” Id. at 2. “Both patients were injected on the left, [and] the
nurse [wa]s right handed.” Id. Geiringer and Leonard opined that when “[c]ombined with a
‘sidearm’ delivery, this positioning likely facilitated missing the deltoid completely, skirting
medial . . . and entering the medial-lying neurovascular bundle . . . [where] the ulnar nerve is
susceptible.” Id. An ulnar nerve injury was also described by Salanga and Hahn6 after a
vaccination administered by jet injection in a petite patient with “small muscle mass.” Pet. Ex.
23.1 at 4.
The probable path of the vaccination needle described above by Geiringer and Leonard is
described in their illustration below.
Pain is the most common symptom of ulnar nerve injury caused by injection. Pet. Ex.
23.1 at 4. Other symptoms “include numbness, paresthesias, and other sensory disturbances.”
4
Hyun Kim et al., Upper Limb Nerve Injuries Caused by Intramuscular Injection or Routine
Venipuncture, 12 Anesthesiology & Pain Med. 103 (2017).
5
Steven Geiringer & James Leonard, Jr., Injection-Related Ulnar Neuropathy, 70 Archives
Physical Med. Rehab. 705 (1989).
6
V.D. Salanga & J.F. Hahn, Traumatic Ulnar Neuropathy from Jet Injection: Case Report, 19 J.
Trauma 283 (1979). This article not filed into evidence by the parties, but referenced by Kim et
al.
5
Id. There may be “weakness of finger abduction and adduction, fourth and fifth finger flexion,
wrist adduction and wrist flexion.” Id. The clinical course after “needle-related nerve injury
[may] range from transient minor pain to severe sensory disturbance.” Id. at 6. One study
showed that most patients have a full recovery with some experiencing residual mild numbness.
Id. However, in another study, “21.6% of patients suffered pain/sensory changes more than 1
year.” Id. Axonal regeneration occurs after nerve injury and symptoms usually improve over
time. Id.
B. Cubital Tunnel Syndrome
Cubital tunnel syndrome also occurs as a result of injury to the ulnar nerve, however, it is
usually due to “compression and traction on the ulnar nerve” at the elbow.7 Resp. Ex. D at 1.8
The area around the elbow has a number of structures that can cause compression of the ulnar
nerve, including connective tissue, ligaments, and the cubital tunnel itself. Id. The cubital tunnel
is comprised of connective tissue, and made up of by the medial epicondyle (bony bump at the
bottom of the humerus on the medial side of the elbow), the elbow joint, and the medial
collateral ligament (which unites the humerus to the ulna). Id. at 1-2. The roof of the tunnel is
formed by an aponeurosis, or fibrous tissue, that attaches muscles to bone. Pet. Ex. 31 at 2.9
When the elbow is flexed, there is a significant decrease in the size of the canal through which
the ulnar nerve passes. Id.; Resp. Ex. D at 2. Normal range of motion of the elbow joint subjects
the ulnar nerve to “compression, traction, and frictional forces.” Pet. Ex. 31 at 2.
Cubital tunnel syndrome is thought to be multi-factorial, caused by repetitive motion,
prolonged flexion, or direct compression of the ulnar nerve. Pet. Ex. 31 at 1. Onset is generally
insidious, especially when caused by repetitive motion and activities. Id. “There are numerous
other causes of ulnar neuropathy at the elbow.” Id. at 4. These include “osteoarthritis,
rheumatoid arthritis[,] . . . or trauma to the nerve.” Id. In some persons, the ulnar nerve may
become subluxed, or displaced, out of the retro epicondylar groove, the notch in the elbow that
normally houses the nerve, during elbow flexion. Pet. Ex. 30 at 1-2.10 Research has shown that
in “10% to 16% of the healthy population, the ulnar nerve may sublux anterior . . . when the
elbow is flexed.” Pet. Ex. 31 at 3.
7
While ulnar nerve injury may also be referred to as cubital tunnel syndrome, the undersigned
will use the phrase ulnar nerve injury or ulnar neuropathy throughout this ruling. The phrase
cubital tunnel syndrome will be used when citing to medical records, medical literature, or expert
reports that refer to that phrase.
8
Jonathan Robert Staples & Ryan Calfee, Cubital Tunnel Syndrome: Current Concepts, 25 J.
Am. Academy Orthopaedic Surgeons e215 (2017).
9
David Bozentka, Cubital Tunnel Syndrome Pathophysiology, 351 Clinical Orthopaedics &
Related Rsch. 90 (1998).
10
Jan Michael Lleva & Ke-Vin Chang, Ulnar Neuropathy (StatPearls Publishing, Jan. 2020).
6
Cubital tunnel syndrome is a clinical diagnosis based on history and physical
examination. Resp. Ex. D at 2. Patients may complain of altered sensation of the ring finger and
little finger. Id. Pain may be present along the course of the nerve from the elbow into the
forearm or hand. Id. Electrodiagnostic studies (“EMGs”) “may inform but do not establish the
diagnosis.” Id. at 3. Nonsurgical management consisting of activity modification and splints are
recommended for mild to moderate forms of the syndrome, whereas surgical intervention is
warranted in more severe cases. Id. at 4.
V. FACTUAL SUMMARY
A. Summary of Relevant Facts11
On October 2, 2014, petitioner, a registered nurse, received the flu vaccination in her
right shoulder at her place of employment, The Miriam Hospital (“Miriam”). See Pet. Ex. 1 at 1;
Pet. Ex. 2 at 9. Prior to vaccination, petitioner had no history of neurological or shoulder
injuries. Pet. Ex. 3 at 4; Pet. Ex. 22 at 1. At the time of vaccine administration, petitioner was
asked to bend her right arm 90 degrees at the elbow, place her hand on her hip, and flex forward.
Pet. Ex. 3 at 4; Pet. Ex. 22 at 1. Immediately following the injection, petitioner felt a sensation
of pins and needles down her arm and numbness from her elbow to her pinky finger. Pet. Ex. 20
at 64. Petitioner reported her vaccine reaction to employee health personnel and the reaction was
documented. Id. The nurse who documented petitioner’s vaccine reaction advised that
petitioner could not lift her right arm. Id.
The next day, October 3, 2014, petitioner presented to Dr. Dana Sparhawk at Miriam.
Pet. Ex. 20 at 61. Petitioner reported that she received a flu shot the prior day and had
experienced “numbness almost immediately.” Id. She also had numbness into her “ulnar
forearm and pinky and fourth finger.” Id. Petitioner stated she felt weakness and a burning
sensation in her right arm. Id. Dr. Sparhawk noted the flu shot appeared to be given in the
appropriate area of the deltoid. Id. Tinel’s12 test caused tingling “down the ulnar aspect of
[petitioner’s] forearm into her fourth and fifth fingers. Tinel’s on the left elbow reveals similar
symptoms but much less intense.” Id. Dr. Sparhawk diagnosed petitioner with “neuropraxia of
upper extremity.” Id. She concluded that petitioner “had some nerve root irritation as a result of
the injection.” Id.
On October 6, 2014, petitioner presented to Dr. Nancy Littell at Rhode Island Hospital
complaining of tingling down her right arm since the flu shot. Pet. Ex. 20 at 31. Petitioner
complained of pain and weakness in her right arm and numbness of “the ulnar side of forearm”
with “pain [that] sometimes radiates upward toward the shoulder.” Id. Petitioner felt “as though
11
Additional factual summaries are set forth in the parties’ briefs. See Pet. Mot.; Resp.
Response.
12
The Tinel sign produces “a tingling sensation in the distal end of a limb when percussion is
made over the site of a divided nerve. It indicates a partial lesion or the beginning regeneration
of the nerve.” Dorland’s Illustrated Medical Dictionary 1687 (33d ed. 2020). It may also refer
to “distal tingling on percussion.” Id.
7
her arm distal to the elbow [was] being squeezed as if in a tourniquet.” Id. There was no other
history of trauma or injury to account for petitioner’s symptoms. Dr. Littell diagnosed petitioner
with neuropraxia and neuritis. Id. at 32. She concluded, “I think the nerve was irritated either by
the needle or the liquid when she was given the flu shot.” Id. Petitioner had approximately nine
follow-up appointments with Dr. Littell between October 9 and December 8, 2014. At her last
visit, petitioner continued to have “diminished sensation in the ulnar distribution of the right
hand.” Id. at 15.
On October 10, 2014, petitioner presented to the Emergency Department at Rhode Island
Hospital for right arm pain, tingling, and numbness. Pet. Ex. 2 at 3-4, 9. Petitioner reported she
received a flu shot and “instantly had numbness and shooting pain in her [right] arm down to her
4th/5th digit.” Id. at 9. Weakness was noted in her right hand. Id. at 9-10. Petitioner returned
the next day and her physical assessment was “[p]ositive for right arm and right shoulder
tenderness; right shoulder stiffness,” “[p]ositive for right neck stiffness,” and “[p]ositive for
numbness, tingling, weakness, in right hand, especially in fourth and fifth digits, right elbow,
right forearm.” Id. at 12. Dr. Jonathan Schimmel noted the cause of petitioner’s symptoms was
unknown, “but some inflammation around one of the nerves in the arm related to the flu shot is
possible.” Id. at 7. Flexeril, a muscle relaxant, was prescribed for petitioner’s pain. Id. at 8.
On December 4, 2014, petitioner saw Dr. Petro Karanasias for a neurology consultation
on referral from Dr. Littell. Pet. Ex. 3 at 4. Once again, petitioner repeated the history of an
immediate reaction to the flu vaccination and the pain and numbness in her right arm since
vaccination. Id. Dr. Karanasias found “normal range of motion in the right shoulder and
elbow[,]” “no muscle atrophy, edema, or discoloration in that extremity[,] . . . a positive Tinel’s
sign in the right elbow . . . tenderness to palpation in the right elbow, specifically around the
cubital tunnel[,]” and “mild hypoesthesia to pinprick within the right distal ulnar nerve
distribution.” Id. at 5. Dr. Karanasias performed an EMG and found no abnormalities. Id. His
diagnosis was right ulnar neuropathy of relatively mild severity of unclear etiology. Id. He
stated, “[m]y best guess is that it relates to irritability of the nerve in its segment across the
elbow, and the positioning of her arm at the time of the flu shot could be the culprit. I do not feel
that the flu shot in itself is directly responsible for the neuropathy.” Id. at 5. He reported that
petitioner’s symptoms were improving and should continue to improve. Id. Dr. Karanasias
advised petitioner to avoid repetitive activities that involved her elbow joint such as repetitive
lifting. Id. at 6.
On January 22, 2015, petitioner presented to Dr. Thomas McGunigal for a
neurophysiologic consultation of her right upper arm. Pet. Ex. 19 at 3. Petitioner complained of
right hand numbness that began after her October 2, 2014 flu shot. Id. Petitioner reported pain
ranging from a 3/10 to 6/10 depending on activity, with symptoms worse at night. Id. On
physical examination Dr. McGunigal noted, “severe tenderness to palpitation of the right ulnar
nerve at the right elbow, specifically at the retrocondylar groove and this reproduces and
increases the symptoms in her right ulnar hand.” Id. at 4. Dr. McGunigal performed ultrasound
of the ulnar nerve that showed enlargement and tenderness. Id. EMG diagnostic testing showed
“focal slowing . . . of the right ulnar motor velocity across the elbow localized to the
retrocondylar groove . . . [and] relatively prolonged right ulnar F wave.” Id. Dr. McGunigal
8
diagnosed mild right ulnar neuropathy at the elbow and moderate right ulnar neuropathy at the
retrocondylar groove. Id.
Petitioner returned to see Dr. McGunigal on February 5, 2015. Pet. Ex. 19 at 1. At that
visit, ultrasound revealed that petitioner’s right radial nerve was abnormally enlarged. Id. Dr.
McGunigal noted tenderness and increased numbness in the right dorsal hand. Id. Dr.
McGunigal diagnosed petitioner with right radial neuropathy at the spiral groove. Id. He noted
that this injury had “been reported to occur from misdirected intramuscular deltoid injections.
Healing can take up to 1 year of time and may be incomplete.” Id.
On April 7, 2015,13 petitioner presented to Dr. Steven Graff at Pawtucket Orthopedic for
right hand surgical consultation on referral by Dr. Sparhawk. Pet. Ex. 5 at 5. At that visit,
petitioner “demonstrated full range of motion of the elbow, forearm, wrist and digits, but
complained of various vague aches and pains in the extremity at all endpoints and through the
actual arc of motion.” Id. at 6. Examination of the ulnar nerve revealed a positive Tinel’s at the
right carpal tunnel “positive to the ulnar distribution.” Id. Dr. Graff’s diagnosis was “right
upper extremity global complaints of pain and numbness that cannot be explained by any
anatomically based diagnosis.” Id. at 7.
Petitioner returned to Dr. Sparhawk for a follow up on April 8, 2015. Pet. Ex. 5 at 9. Dr.
Sparhawk noted petitioner’s pain was better and her pain rating had decreased from 4/10 to 2/10.
Id. On examination, petitioner had “continued tenderness in the posterior humerus region and
pressure on this area cause[d] tingling going into the extensor portion of the forearm into the
ulnar aspect of the hand.” Id. Tinel’s test of the elbow was negative. Id. Sensory exam
revealed diminished sensation in the third, fourth, and fifth fingers. Id. Dr. Sparhawk diagnosed
petitioner with neuropraxia of right upper extremity. Id.
In her affidavit, petitioner averred that in April 2015, she began having left arm soreness
due to overuse of it to compensate for her injuries in the right arm. Pet. Ex. 22 at ¶ 12. In June
2015, petitioner reported to her counselor, Peter Erickson, that she was having soreness in her
left arm from overcompensation. Pet. Ex. 7 at 4.
Petitioner had an independent medical examination (“IME”)14 on June 10, 2015 by Dr.
Steven G. McCloy. Pet. Ex. 15 (part 2) at 163. After a review of medical records and physical
examination, Dr. McCloy diagnosed petitioner with “complication of vaccination, [] resolved . . .
causally related to an event at work.” Id. Dr. McCloy concluded that her vaccine-related
condition had resolved and that she had a co-existing diagnosis of “somatoform disorder.” Id.
With regard to her left arm symptoms, Dr. McCloy diagnosed petitioner with mild left ulnar
neuropathy, “not causally related” to her vaccination. Id. Dr. McCloy opined that there was “no
13
Petitioner’s Exhibit 5 states the date May 18, 2015, but is electronically signed on April 7,
2015. The undersigned defers to the parties’ apparent agreement that this appointment took
place on April 7, as indicated in both parties’ briefs.
14
This IME was done “at the request of . . . Claims Strategies,” the Workers’ Compensation
claims management company for her employer. Pet. Ex. 15 (part 2) at 155.
9
connection between the shot that [petitioner] received [] and the development of left ulnar
neuropathy.” Id. at 164.
On August 6, 2015, petitioner presented to Dr. Pradeep Chopra, at the Interventional Pain
Management Center. Pet. Ex. 8 at 1. Dr. Chopra noted petitioner’s history of pain and
numbness of the right upper arm since her flu shot on October 2, 2014. Id. On physical exam,
petitioner had “tenderness to the right biceps tendon and the bicipital groove” and “dysesthesias
to the right ulnar nerve distribution,” as well as the “right deltoid area” and “posterior aspect of
her right wrist and hand.” Id. at 3. Dr. Chopra diagnosed petitioner with “right brachial plexus
injury to the radial and ulnar nerve at the axilla.” Id. Dr. Chopra suspected that petitioner had
right ulnar and right radial neuritis. Id. He recommended that she continue Neurontin and try
low dose naltrexone for pain. Id.
Petitioner returned to see Dr. Chopra for a follow up on August 25, 2015. Pet. Ex. 8 at 4.
Dr. Chopra documented pain in both arms. Id. Petitioner’s right arm pain was characterized as
“neuropathic pain as a result of her flu vaccination.” Id. Dr. Chopra also documented that
petitioner had “diffuse musculoskeletal pain to her left upper extremity from overuse” and noted
tenderness to her “left medial epicondyle.” Id. Petitioner received a left elbow intra-articular
joint injection. Id.
Petitioner continued to see Dr. Chopra for treatment. See Pet. Ex. 12; Pet. Ex. 13 at 1-9.
On September 10, 2015, Dr. Chopra noted that petitioner had “left upper pain [] as a result of her
repetitive strain injury since she is unable to use her right upper extremity.” Pet. Ex. 13 at 7. On
November 23, 2015, Dr. Chopra noted that petitioner had been receiving physical therapy for her
left arm and was better. Id. at 1. On March 4, 2016, Dr. Chopra again noted that petitioner had
pain in both upper arms. Pet. Ex. 12 at 1.
On March 31, 2016, petitioner presented to Dr. Julia Katarincic at University
Orthopaedics for evaluation of bilateral ulnar neuropathies and continued left elbow pain. Pet.
Ex. 14 at 6; Pet. Ex. 22 at ¶ 20. Dr. Katarincic diagnosed “bilateral cubital tunnel.” Pet. Ex. 14
at 6. She stated that petitioner had “tried and exhausted conservative therapy with no relief to
her symptoms.” Id. Dr. Katarincic discussed petitioner’s surgical options and petitioner elected
to proceed with left ulnar nerve transposition surgery. Id.
On April 22, 2016, Dr. Katarinicic performed surgical submuscular transposition of
petitioner’s left ulnar nerve. Pet. Ex. 17 at 7. During surgery, petitioner’s triceps muscle was
noted to be pushing her left ulnar nerve over the epicondyle during flexion. Pet. Ex. 21 at 1-2.
Dr. Katarincic observed that “every time she bent the elbow, that ulnar nerve kicked up over the
epicondyle.” Id. at 1. Dr. Katarinicic’s post-operative diagnosis was “left cubital tunnel with
subluxation of ulnar nerve over the left medial epicondyle.” Pet. Ex. 17 at 16.
Petitioner followed up with Dr. Katarincic on June 23, 2016, for her post-operative visit.
Pet. Ex. 14 at 1. Dr. Katarincic documented that petitioner was doing well and could go back to
work full duty on July 1, 2016. Id. Petitioner’s right arm was tender at the cubital tunnel and
she had a positive Tinel’s sign. Id.
10
On February 13, 2017, petitioner returned to Dr. Chopra stating she was doing much
better and had decreased her pain medications. Pet. Ex. 18 at 1. She reported, however, that
typing and holding a hair dryer in her right arm caused her pain. Id. Dr. Chopra’s diagnosis of
right brachial plexus injury to the radial and ulnar nerve at the axilla remained unchanged. Id. at
2.
In December 2017, petitioner injured her shoulder lifting weights. Pet. Ex. 24 at 29; Pet.
Ex. 26 at 32. On December 26, 2017, petitioner presented to Performance Physical Therapy
reporting left shoulder pain “that started 2 weeks ago.” Pet. Ex. 26 at 32. From July 2018
through July 2019, petitioner sought treatment from physiatrist, Dr. Claudia Wheeler. Pet. Ex.
24 at 29-32; Pet. Ex. 27 at 2-4. Petitioner reported injuring her “left shoulder in December
2017,” and an MRI showed “subacromial bursitis and distal osteolysis.” Pet. Ex. 24 at 30.
Physical examination revealed that petitioner had normal bilateral upper extremity strength (5/5),
normal musculoskeletal exam, and no neurological abnormalities of the right arm. Id. at 32.
B. Expert Reports
1. Petitioner – Dr. Pradeep Chopra
a. Background and Qualifications
Dr. Pradeep Chopra began treating petitioner on August 6, 2015. Pet. Ex. 16 at 1. Dr.
Chopra is Director of the Interventional Pain Management Center in Pawtucket, Rhode Island.
Id. He is also a Clinical Assistant Professor in the Department of Medicine at Brown Medical
School and is board certified in pain management. Id. Petitioner submitted one expert report
authored by Dr. Chopra. Pet. Ex. 16.
b. Opinion
Although petitioner seeks compensation for alleged injuries to both her right and left
arms, Dr. Chopra’s opinions appear to be limited to petitioner’s right arm, the arm in which she
received the vaccination on October 2, 2014. In his expert report, he did not reference
petitioner’s history, symptoms, diagnosis, or treatment of her non-vaccinated left arm.
In his report, Dr. Chopra first addressed the position of the petitioner at the time of
vaccine administration. Prior to administering the vaccine, the nurse asked petitioner “to place
her hand on her thigh with her right upper extremity medially rotated and abducted.” Pet. Ex. 16
at 1. The vaccine was then injected into the petitioner’s upper arm. Id. Petitioner “felt severe
paresthesias in her arm that shot down [] to her fingers.” Id. Petitioner subsequently had an
EMG, “significant for right ulnar neuropathy.” Id. Dr. Chopra performed a physical
examination of the petitioner on August 6, 2015, which was significant for “dysesthesia to the
right ulnar nerve distribution . . . and patchy areas of dysesthesia to the right deltoid . . . [and]
right wrist and hand.” Id. Petitioner also had tightness in the muscles of her upper back
(rhomboid and upper trapezius). Id.
11
Dr. Chopra opined that petitioner “developed symptoms of right brachial plexus injury to
the radial and ulnar nerve at the upper arm.” Pet. Ex. 16 at 1. The “mechanism of injury” was
direct injury to the ulnar and radial nerves from the needle used for vaccination. Id. He
explained that
the needle used to administer the flu vaccine passed inferior to the humerus as the
arm was placed in an abducted and internally rotated position and struck her ulnar
nerve as it originated from the medial cord of the brachial plexus. It then
proceeded deeper into the posterior cord of the brachial plexus which eventually
becomes the radial nerve.
Id.
Dr. Chopra opined within a reasonable degree of medical certainty that the October 2,
2014 flu shot “clearly caused her injuries.” Pet. Ex. 16 at 1. The basis for his opinion was two-
fold: (1) petitioner did not have any pre-existing pain in her arm prior to vaccination, and (2) she
experienced “severe neuropathic pain” at the time of injection. Id. Dr. Chopra opined that
petitioner would have symptoms of neuropathic pain for an indefinite period of time as
neuropathic pain is “notoriously slow to resolve if at all.” Id. at 2.
While Dr. Chopra attributed petitioner’s ulnar and radial nerve injuries to her flu
vaccination, he opined that petitioner’s cubital tunnel syndrome was not related to her vaccine
injury. Pet. Ex. 16 at 1. He did not explain the reasons for this opinion.
2. Petitioner – Dr. Lawrence Steinman
a. Background and Qualifications
Dr. Lawrence Steinman received his B.A. from Dartmouth College and his M.D. from
Harvard Medical School. Pet. Ex. 23-8 at 1. He then completed residencies in neurology and
pediatrics at Stanford University. Id. He has worked as a professor of neurology and pediatrics
at Stanford for the past thirty-nine years. Pet. Ex. 23 at 1. Dr. Steinman is board certified in
neurology. Id. He has cared for hundreds of adults and children with various forms of injury to
the brachial plexus, various forms of peripheral neuropathy, as well as various autoimmune
neurologic conditions including diseases of the autonomic nervous system, central nervous
system, and peripheral nervous system. Id. In 2015, Dr. Steinman received the Cerami Prize in
Translational Research and published a scientific autobiography describing his research career
studying the immune response to flu virus at Jonas Salk’s New Institute. Id. at 4. Dr. Steinman
submitted two expert reports in this case. Pet. Exs. 23, 32.
b. Opinion
i. Diagnosis
Dr. Steinman opined that as a result of her flu vaccination on October 2, 2014, petitioner
sustained a “significant aggravation of an underlying previously asymptomatic ulnar
12
neuropathy,” which he also referred to as “cubital tunnel syndrome.” Pet. Ex. 23 at 1. Dr.
Steinman did not specify which arm had this diagnosis.
Although Dr. Steinman opined that significant aggravation of a previously asymptomatic
cubital tunnel syndrome was the proper diagnosis, the balance of his opinion was based on
causation, not significant aggravation. His expert reports, reviewed as a whole, and in context
with petitioner’s medical records, treating physician opinions, and clinical course, establish by
preponderant evidence that but for petitioner’s vaccination, she would not have sustained right
ulnar neuropathy.
ii. Althen Prong One: Medical Theory of Causation
Dr. Steinman’s medical theory is that acute injury to the ulnar nerve can occur due to
“misguided injection into the deltoid.” Pet. Ex. 23 at 1, 7. In support of his opinion, Dr.
Steinman cited an article by Kim et al., describing a review of scholarly databases for reports of
upper extremity nerve injuries following intramuscular injection or venipuncture. Id. Based on
the research, Kim et al. concluded that while upper limb nerve injury following injection is rare,
it can occur.15 Pet. Ex. 23.1 at 1.
Kim et al. identified the mechanisms by which nerve injuries occur due to injections.
These include, “injection-related nerve injury; direct needle trauma; toxic effects of injected
agents on nerve fibers and surrounding tissues; [and] nerve compression due to hematoma or
edema.” Pet. Ex. 23.1 at 2. Of these, direct injury to a nerve from needle trauma was identified
as the most common causal mechanism. Id.
Specifically related to ulnar nerve injury caused by injection, Dr. Steinman cited another
article by Geiringer and Leonard, who reported two cases of vaccine injection ulnar nerve injury.
Pet. Ex. 23.2. Both patients were administered vaccinations by the same nurse, who instructed
the patients to “fixate their hands on the hips and rotate their arms.” Id. at 4. The vaccine was
then “administered to patients’ sidearm while the nurse was standing at the patients’ side.
Combining this position of arm rotation with a sidearm delivery facilitated administration on the
medial-lying neurovascular bundle instead of the target deltoid muscle.” Pet. Ex. 23.1 at 4.
The first patient was a 24-year-old man who received a measles, mumps, and rubella
(“MMR”) vaccination in the left upper arm, using a 5/8-inch needle. Pet. Ex. 23.2 at 1. He
complained of numbness and paresthesias in his left fourth and fifth fingers within 30 minutes of
vaccination, that worsened over the next two days. Id. Three days after vaccination, he
developed “subtle weakness of the [] ulnar-innervated intrinsic hand muscles.” Id. He also had
diminished sensation in the ulnar distribution of the fingers and wrist. Id.
The second patient was a 26-year-old female who received a Haptavax B vaccination
using a one-inch needle in the left upper arm. Pet. Ex. 23.2 at 1. She had numbness of several
15
Kim et al. estimated the annual incidence was 3.38 per 1 million intramuscular injections, of
which 8% occurred in the arm. Pet. Ex. 23.1 at 2.
13
fingers several hours after vaccination that increased over the next 24 hours. Id. EMG
performed one month later showed mild abnormalities in muscles of the forearm and hand. Id.
Dr. Steinman’s opinions as to causation referenced petitioner’s vaccinated arm (right
arm). He did not offer a causation opinion related to petitioner’s left arm. Specifically, Dr.
Steinman did not address petitioner’s assertion that to compensate for her injured right arm, she
overused her left arm, resulting in injury.
iii. Althen Prong Two: Logical Sequence of Events
Dr. Steinman’s opinion as to Prong Two is premised on a “two hit” theory. Pet. Ex. 23 at
7. First, he noted that injury to the ulnar nerve can occur after injections into the deltoid, as
supported by the medical literature cited above. Id. at 6. Here, Dr. Steinman opined that
petitioner sustained an injury to her ulnar nerve from the flu vaccination (first hit), and that this
injury “provoked chronic neuropathic pain from a previously asymptomatic cubital tunnel
syndrome” (second hit). Id. at 7. These two hits “combined to provoke chronic pain and
functional impairment.” Id.
Put in other words, Dr. Steinman opined that the damage to the petitioner’s ulnar nerve
caused by vaccination, “unmasked neuropathology that had been dormant previously.” Pet. Ex.
23 at 7. Dr. Steinman opined, “even if there existed an anatomic basis for the cubital tunnel
syndrome, its clinical presentation had not been evident until immediately after the injection on
Oct. 2, 2014. This represents a significant aggravation of a previously silent, subclinical cubital
tunnel syndrome.” Id. Dr. Steinman concluded that “the October 2, 2014 immunization more
likely than not significantly aggravated an asymptomatic cubital tunnel syndrome. If not for the
injury to the ulnar nerve upon immunization on October 2, 2014 the cubital tunnel syndrome
would have remained dormant.” Id.
To support his opinion as to Prong Two, Dr. Steinman noted that petitioner’s symptoms
were consistent with cubital tunnel syndrome. Pet. Ex. 23 at 4-5. She had altered sensation of
the ring finger and little finger and her symptoms worsened with elbow flexion while sleeping.
Id. at 4. She also reported hand weakness, pain along the posteromedial elbow, and “weakness
of the ulnar innervated muscles (intrinsic muscles of the hand).” Id.
Dr. Steinman also reviewed petitioner’s diagnostic testing. Pet. Ex. 23 at 5. Testing by
nerve percussion at the retrocondylar groove reproduced pain and paresthesias. Id. Petitioner’s
EMGs showed decreased absolute conduction velocity at the level of the elbow consistent with
ulnar neuropathy. Id. Testing also ruled out other causes of petitioner’s symptoms, including
radial neuropathy, median neuropathy, brachial plexopathy, thoracic outlet syndrome, or C8/T1
radiculopathy. Id. Dr. Steinman also opined that petitioner had no complaints of right shoulder,
hand or arm complaints prior to her October 2, 2014 vaccination. Id. at 6. Petitioner’s “severe
pain and psychiatric issues related to her right shoulder, elbow, and hand as demonstrated
repeatedly in the medical record” appear only after October 2, 2014. Id.
Dr. Steinman disagreed with respondent’s expert, Dr. Chaudry, who opined that the
vaccine injection site was appropriate and the deltoid muscle was not missed. Pet. Ex. 32 at 1.
14
Dr. Steinman agreed that two of petitioner’s treating physicians noted the injection appeared to
be administered in the correct area of the deltoid, however, he stated, “[i]t’s entirely possible the
injection could have looked proper to the naked eye. However, without the specific information
about the strange positioning of the arm at the time of injection, it’s impossible for her doctors to
tell whether the injection was administered properly.” Id. “Considering the position of the arm
at the time of injection,” Dr. Steinman opined, “the needle [] penetrated the medial lying nerve
bundle.” Id.
Further, Dr. Steinman emphasized that many of petitioner’s treating physicians suggested
that she had a nerve injury from the flu vaccination. Pet. Ex. 32 at 2.
Dr. Steinman did not offer an opinion as to Althen Prong Two as it relates to petitioner’s
left arm condition. He did not opine on a logical sequence of cause and effect as to how a
vaccine administered in petitioner’s right arm, causing right ulnar injury, could cause left ulnar
nerve injury.
iv. Althen Prong Three: Proximate Temporal Relationship
In support of his opinion that there was a proximate temporal relationship between
vaccination and injury, Dr. Steinman cited the case report in Geiringer and Leonard, which
illustrated an abrupt onset of numbness following immunization. Pet. Ex. 23 at 6. In Geiringer
and Leonard, the patient who received the MMR vaccination had paresthesias and numbness in
the fingers within 30 minutes, that worsened over the next 48 hours. Pet. Ex. 23.2 at 1. Subtle
weakness of the hand muscles was noted in 72 hours. Id.
Dr. Steinman did not offer an opinion as to Althen Prong Three regarding petitioner’s left
arm condition.
3. Respondent – Dr. Vinay Chaudry
a. Background and Qualifications
Dr. Vinay Chaudry is a Professor of Neurology at the Johns Hopkins University School
of Medicine and Co-Director of the EMG Laboratory at Johns Hopkins Hospital. Resp. Ex. A at
1. He received his Bachelor of Medicine and Bachelor of Surgery from the All India Institute of
Medical Sciences in New Delhi, India, in 1980. Resp. Ex. B at 1. Dr. Chaudry is board certified
in neurology, neuromuscular diseases, electrodiagnostic medicine (nerve conduction and EMG),
and clinical neurophysiology. Resp. Ex. A at 1. He has had an active clinical practice for the
past twenty-five years and sees approximately 2,000 patients a year for problems related to
peripheral nerve disease. Id. Dr. Chaudry is involved in clinical research and has published over
120 publications which include peer reviewed articles, reviews, and book chapters. Id. Dr.
Chaudry submitted two expert reports in this case. Resp. Exs. A, G.
b. Opinion
i. Diagnosis
15
With regard to diagnosis, Dr. Chaudry noted petitioner’s symptoms, signs, EMG
findings, ultrasound examination, and response to treatment are all typical for ulnar neuropathy
at the elbow called cubital tunnel syndrome. Resp. Ex. A at 5. Like Dr. Steinman, all of Dr.
Chaudry’s opinions appear to relate to petitioner’s vaccinated arm (right arm).
In his review of the petitioner’s medical chronology, Dr. Chaudry noted that on March
31, 2016, petitioner saw Dr. Katarincic for “bilateral ulnar neuropathies.” Resp. Ex. A at 4. Dr.
Chaudry further noted that Dr. Katarincic “performed ulnar nerve transposition surgery” during
which petitioner was noted to have compression of the ulnar nerve. Id. However, Dr. Chaudry
did not note that petitioner’s surgery was performed on her left arm, not her vaccinated right arm.
ii. Althen Prong One: Medical Theory of Causation
Dr. Chaudry disagreed with Dr. Steinman that an injection in the deltoid region could
cause ulnar neuropathy at the level of the elbow. Resp. Ex. A at 6. According to Dr. Chaudry,
direct trauma by the needle in the upper arm cannot explain symptoms arising from the elbow.
Id. Dr. Chaudry opined “an injection given in the right deltoid region cannot cause the ulnar
nerve to be compressed at the elbow.” Id.
Further, Dr. Chaudry did not believe that an indirect immune-related phenomenon could
explain right ulnar neuropathy at the elbow caused by vaccine injection. Resp. Ex. A at 6. He
opined that an immune effect would at least take 24-48 hours before symptoms began, and that
even then, an immune response could not cause focal structural compromise of the ulnar nerve at
the elbow. Id.
Although Dr. Chaudry conceded that there was a possibility that positioning at the time
of injection could trigger an underlying and asymptomatic ulnar neuropathy at the elbow to
become transiently symptomatic, he did not believe such a scenario would cause persistent ulnar
neuropathy symptoms. Resp. Ex. A at 6-7.
In his first expert report, Dr. Chaudry appears to have erroneously believed that petitioner
had right instead of left ulnar nerve surgery. See Resp. Ex. A at 4-5. Dr. Chaudry stated that
petitioner had “[s]urgical submuscular transposition of the right ulnar nerve” on April 22, 2016,
and he attributed the operative findings of compression and subluxation of the ulnar nerve to be
on the right side. Id. at 5. The operative report clearly states that the surgery was done on the
left ulnar nerve, not the right. See Pet. Ex. 21 at 1-2. This confusion is emphasized as he cited
the Journal of Hand Surgery to support his position that compression of the ulnar nerve at the
elbow, where the ulnar nerve is prone to subluxation, could not be caused by injection or
positioning. Dr. Chaudry’s right/left confusion carries over to his second expert report.16 Resp.
Exs. E, G. Based in part on this confusion, he concludes that “[l]eft ulnar neuropathy at the
elbow could not have been related to injection or positioning.” Resp. Ex. A at 7.
16
J.J. O’Hara & J.H. Stone, Ulnar Nerve Compression at the Elbow Caused by a Prominent
Medial Head of the Triceps and an Anconeus Epitrochlearis Muscle, 21B J. Hand Surgery 133
(1996).
16
iii. Althen Prong Two: Logical Sequence of Events
Dr. Chaudry opined that direct trauma by the needle in the upper arm could not explain
symptoms arising from the elbow. Resp. Ex. A at 6. Dr. Chaudry explained that several of
petitioner’s treating physicians documented that the injection site in the deltoid region was
correct, and there was no evidence in the medical records of traumatic hematoma, swelling,
redness, or bruising in the area of injection. Id. Because petitioner’s ulnar neuropathy was
localized to the elbow, as all her clinical findings suggest, Dr. Chaudry believed that Dr.
Steinman’s causation argument suggesting an injury in the arm is flawed. Resp. Ex. G at 1.
If ulnar nerve injury occurred in the upper arm and was caused by the flu vaccination, as
purported to have occurred by Dr. Steinman, multiple medical examinations of the ulnar nerve
would be expected to be abnormal. Resp. Ex. G at 2. Dr. Chaudry stated, “[u]lnar nerve injury
should cause weakness in ulnar nerve distribution (intrinsic muscles/grip among others) and
sensory loss in the fourth and fifth digits.” Id. Dr. Chaudry asserted that petitioner showed
normal ulnar nerve distribution findings, as noted by physician examinations performed by
neurologists and hand surgeons. Id.
As for indirect immune-related trauma, Dr. Chaudry stated, petitioner’s symptoms
happened immediately, whereas an immune effect would at least take 24-48 hours to cause
symptoms. Resp. Ex. A at 6. Petitioner’s ulnar neuropathy was also clearly localizable to a
known site of compression at the elbow and was documented by the surgeon to be “definitely
compressed.”17 Id. Dr. Chaudry concluded that an immune response cannot cause focal
structural compromise of the ulnar nerve at the elbow or cause an enlarged triceps muscle. Id.
As for the possibility that an underlying asymptomatic ulnar neuropathy at the elbow
became symptomatic due to positioning at the time of injection, Dr. Chaudry stated this was
unlikely due to the few seconds of elbow flexion positioning needed for giving the injection.
Resp. Ex. A at 6-7.
Regarding causation posited by Dr. Chopra, Dr. Chaudry disagreed that the “flu vaccine
needle passed inferior to the humerus, struck the ulnar nerve as it originated from the medial
cord of the brachial plexus, and then the needle kept on going deeper into the posterior cord and
damaged the radial nerve part of the brachial plexus.” Resp. Ex. A at 8. Given the anatomy of
the brachial plexus and the number of other structures in the axilla, Dr. Chaudry deemed that
scenario unlikely. Id.; see Resp. Ex. F.18 Citing an article that reviewed the anatomy of the
brachial plexus in marmosets (species of monkeys), Dr. Chaudry opined it would be “almost
impossible for the needle to penetrate the length of the deltoid muscle all the way down to the
17
This statement is incorrect, as petitioner’s ulnar surgery was on her left ulnar nerve. There is
no evidence in the record to suggest that surgery was performed on her right ulnar nerve or that
her surgeon observed compression of the right ulnar nerve.
18
Kenji Emura et al., Anatomical Study of the Brachial Plexus in the Common Marmoset, 300
Anatomical Rec. 1299 (2017).
17
axilla and injure two nerves.” Resp. Ex. A at 8; see Resp. Ex. F. Further, Dr. Chaudry asserted
that petitioner did not have symptoms of radial nerve injury, which is “characterized by loss of
elbow, wrist, and finger extension, sensory loss in the distal extensor forearm, and loss of triceps
reflex.” Resp. Ex. A at 7. Dr. Chaudry stated that petitioner was not diagnosed with a radial
nerve injury by Dr. McGunigal, Dr. Graff, or Dr. McCloy. Id. He also noted that the EMGs did
not demonstrate abnormalities of petitioner’s radial nerve. Id. at 8. Similarly, Dr. Chaudry
opined that Dr. Chopra’s opinion that petitioner tight muscles in her upper back were related to
vaccination was erroneous, as these abnormalities of the muscles, “cannot occur from ulnar or
radial nerve injuries.” Id.
Dr. Chaudry concluded petitioner had the typical presentation of right ulnar nerve
compression at the elbow from subluxation and triceps muscle enlargement that existed prior to
the flu vaccine.19 Resp. Ex. A at 8. To a reasonable degree of medical certainty, Dr. Chaudry
opined, “[a]lthough it is possible that positioning during the injection, transiently causes
paresthesias, the compressive neuropathy of the ulnar nerve was not causally related to the flu
vaccine.” Id.
In his second expert report, Dr. Chaudry explained that he agreed with Dr. Steinman that
petitioner had “ulnar neuropathy localized to the cubital tunnel at the elbow,” but disagreed that
she also had an “ulnar injury at the level of the upper arm.” Resp. Ex. G at 1. Dr. Chaudry
argued that petitioner’s ulnar neuropathy was “localized to the elbow” based on her “clinical
findings, EMG findings, treatment strategies including surgery, and response to treatment
confirmed this diagnosis. None of her clinical findings suggested an injury in the arm.”20 Id.
Further, Dr. Chaudry asserted that Dr. Steinman provided no reference to support his opinion
that “the injection in the upper arm made an asymptomatic cubital tunnel at the elbow
symptomatic.” Id. at 8.
As for petitioner’s left ulnar symptoms, Dr. Chaudry opined that “compression of
[petitioner’s] left ulnar neuropathy at the elbow suggest[s] [petitioner’s] inherent vulnerability to
compressive neuropathy” unrelated to right arm vaccination. Resp. Ex. A at 7. Dr. Chaudry
opined that it is unlikely that petitioner’s left ulnar neuropathy at the elbow was related to
injection or positioning of the right arm at the time of vaccination. Id.
iv. Althen Prong Three: Proximate Temporal Relationship
Dr. Chaudry did not offer an opinion as to the appropriateness of petitioner’s injury onset
assuming a mechanism of direct trauma caused by administration (injection) of the vaccine. He
did, however, opine that “an indirect immune related phenomenon . . . would at least take 24-48
19
Again, Dr. Chaudry confuses the facts. The subluxation and triceps enlargement were noted
during surgery on petitioner’s left arm, not the right.
20
It is not clear here whether Dr. Chaudry is referring to petitioner’s ulnar neuropathy in her
right or left arm, since he mentions surgery, which occurred in petitioner’s left non-vaccinated
arm.
18
hours” before the onset of symptoms. Resp. Ex. A at 6. He implied that the indirect immune
mechanism could not be at play here because petitioner’s symptoms began immediately.
VI. DISCUSSION
A. Standard of Adjudication—Factual Issues
A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh
the evidence presented, which may include contemporaneous medical records and testimony.
See Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a
special master must decide what weight to give evidence including oral testimony and
contemporaneous medical records). Contemporaneous medical records are presumed to be
accurate. See Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
To overcome the presumptive accuracy of medical records testimony, a petitioner may present
testimony which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health &
Hum. Servs., No. 11-0685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013)
(citing Blustein v. Sec’y of Health & Hum. Servs., No. 90-2808V, 1998 WL 408611, at *5 (Fed.
Cl. Spec. Mstr. June 30, 1998)).
B. 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 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)); see also Pafford v. Sec’y of Health & Hum.
Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The received vaccine, however, need not be the
predominant cause of the injury. Shyface, 165 F.3d at 1351. 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).
To receive compensation through the Program, petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that she suffered an injury that was actually caused by a
19
vaccination. See §§ 13(a)(1)(A), 11(c)(1); Capizzano v. Sec’y of Health & Hum. Servs., 440
F.3d 1317, 1319-20 (Fed. Cir. 2006). Because petitioner’s claim predates the inclusion of
SIRVA on the Table, she must prove her claim by showing that her injury was caused-in-fact by
the vaccination in question. § 11(c)(1)(C)(ii). To do so, petitioner must establish, by
preponderant evidence: “(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.”
Althen, 418 F.3d at 1278.
The causation theory must relate to the injury alleged. The petitioner must provide a
sound and reliable medical or scientific explanation that pertains specifically to this case,
although the explanation need only be “legally probable, not medically or scientifically certain.”
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 her 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 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’ proffered experts and rule in
petitioner’s favor when the evidence weighs in her 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).
C. Analysis of Factual Issues
There are three factual issues to resolve: “a) the nature of petitioner’s right arm injury,
including the diagnosis of her injury; b) the nature of petitioner’s left arm injury, including the
diagnosis of her injury; and c) whether petitioner had a pre-existing cubital tunnel syndrome in
her right and/or left arms prior to vaccination.” Joint Pre-Hearing Submissions at 1. For ease of
discussion, these will be simplified into two sections, right (vaccinated) arm and left (non-
vaccinated) arm.
1. Petitioner’s Right Arm
The undersigned finds that petitioner sustained an ulnar nerve injury following her flu
vaccination. This finding is based on the medical records of petitioner’s treating physicians and
the expert reports of Dr. Steinman and Dr. Chaudry.
A number of petitioner’s treating physicians diagnosed her with a right ulnar nerve
injury. The day after vaccination, October 3, 2014, petitioner saw Dr. Sparhawk who diagnosed
petitioner with “neuropraxia of upper extremity.” Pet. Ex. 20 at 61. On October 6, 2014,
petitioner saw Dr. Littell, who diagnosed petitioner with neuropraxia and neuritis. On October
10, 2014, petitioner was evaluated by Dr. Schimmel, who questioned the possibility of whether
petitioner had “inflammation around one of the nerves in the arm related to the flu shot.” Pet.
20
Ex. 2 at 7. Petitioner was seen by neurologist, Dr. Karanasias, who diagnosed “right ulnar nerve
neuropathy.” Pet. Ex. 3 at 5. Petitioner saw Dr. McGunigal on January 22, 2015, who
conducted a physical examination, ultrasound and EMG testing, and diagnosed right ulnar
neuropathy at the elbow at the retrocondylar groove. Pet. Ex. 19 at 4. Dr. Chopra also
diagnosed petitioner with right ulnar neuritis. Pet. Ex. 8 at 3. In summary, five physicians
evaluated petitioner and diagnosed her with an ulnar nerve injury. These physicians used the
words irritation, irritability, inflammation, and neuritis to discuss the nature of the ulnar nerve
injury.
Likewise, both Dr. Steinman and Dr. Chaudry opined that petitioner’s right arm diagnosis
was ulnar neuropathy. See Pet. Ex. 23 at 1; Resp. Ex. A at 5. While Dr. Chaudry attributes the
cause to non-vaccine factors, he does not dispute that petitioner’s symptoms, signs, EMG
findings, ultrasound examination, and response to treatment are all typical for ulnar neuropathy
at the elbow. Resp. Ex. A at 5.
Next, the undersigned finds that there is no evidence in the record to suggest that
petitioner had pre-existing cubital tunnel syndrome in her right arm prior to vaccination. She did
not have any complaints of pain, paresthesias, numbness, or other symptoms of right ulnar nerve
pathology prior to vaccination. While Dr. Steinman opines that petitioner had an “underlying
asymptomatic ulnar neuropathy,” he cites no facts from petitioner’s history or medical records to
support this conclusion. Pet. Ex. 23 at 7. He cites no medical literature to explain his opinion. It
is conjecture without foundation.
In conclusion, the record persuasively establishes that the proper diagnosis of the
petitioner’s right arm condition is ulnar neuropathy. The record contains no evidence to suggest
that petitioner had pre-existing cubital tunnel syndrome in her right arm.
2. Petitioner’s Left Arm
The first reference in petitioner’s medical records to her left arm occurs one day post-
vaccination, during an evaluation by Dr. Sparhawk. Dr. Sparhawk performed Tinel’s tests on
both petitioner’s arms, and documented that the test was positive on the right arm, and that
“Tinel’s on the left elbow reveals similar symptoms but much less intense.” Pet. Ex. 20 at 61.
Other than the Tinel’s test referenced by Dr. Sparhawk, there is no evidence that petitioner had
ever complained of any signs or symptoms of any nerve problem in her left arm. There is no
evidence of prior arm pain, numbness, tingling, or weakness.
The first time petitioner was diagnosed with a left ulnar problem was when she had an
IME by Dr. McCloy on June 10, 2015. He diagnosed “mild left ulnar neuropathy, not causally
related to her vaccination.” Pet. Ex. 15 (part 2) at 163. Dr. McCloy opined that this condition
had “no connection” with her vaccination. Id. at 164.
From August through November 2015, petitioner saw Dr. Chopra who assessed petitioner
with “diffuse musculoskeletal pain” in her left arm due to “overuse.” Pet. Ex. 8 at 4. On
September 10, 2015, Dr. Chopra opined that petitioner’s left arm pain was “a result of her
repetitive strain injury since she is unable to use her right upper extremity.” Pet. Ex. 13 at 7. In
21
November, Dr. Chopra noted that petitioner’s left arm was better after physical therapy. Id. at 1.
Dr. Chopra did not diagnose petitioner with left ulnar neuropathy.
Dr. Katarincic diagnosed petitioner with bilateral ulnar neuropathies in March 2016.
Petitioner had left ulnar nerve surgery in April 2016. In the operative note, Dr. Katarincic
describes how petitioner’s left ulnar nerve was being pushed over the epicondyle during elbow
flexion. Postoperatively, Dr. Katarincic noted the diagnosis of “left cubital tunnel with
subluxation of ulnar nerve over the left medial epicondyle.” Pet. Ex. 21 at 1. Read in context,
the operative note suggests that petitioner’s ulnar nerve was subluxed, causing the symptoms that
she was experiencing.
Neither Dr. Steinman nor Dr. Chaudry offer an opinion as to the diagnosis of petitioner’s
left arm.
The undersigned finds that based on the medical records of Dr. McCloy and Dr.
Katarincic, petitioner was initially diagnosed with left sided ulnar neuropathy in June 2015, and
underwent surgery in April 2016. Thus, the proper diagnosis relative to petitioner’s left arm is
left ulnar neuropathy.
The only early evidence of any abnormality of petitioner’s left arm is the positive Tinel’s
test performed by Dr. Sparhawk the day after vaccination, October 3, 2015. However, Dr.
Sparhawk did not make a diagnosis of left ulnar neuropathy. There has been no testimony or
evidence proffered as to the significance of the Tinel’s test. Thus, documentation of a positive
Tinel’s test, without more, is insufficient to establish the petitioner had a pre-existing condition
in her left arm. Therefore, the undersigned finds that petitioner did not have pre-existing cubital
tunnel syndrome in her left arm.
D. Causation Analysis
The parties dispute two issues: a) whether the flu vaccine administered to petitioner on
October 2, 2014 caused her right arm injuries; and b) whether the flu vaccine administered to
petitioner on October 2, 2014 caused her left arm injuries.
1. Althen Prong One: Medical Theory of Causation
The first causation question at issue is whether a flu vaccine administered by injection
into a vaccinee’s arm can cause ulnar neuropathy. Under Althen Prong One, petitioner must set
forth a medical theory explaining how the received vaccine could have caused the sustained
injury. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009);
Pafford, 451 F.3d at 1355-56. Petitioner’s theory of causation need not be medically or
scientifically certain, but it must be informed by a “sound and reliable” medical or scientific
explanation. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019);
see also Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Health & Hum. Servs., 98 Fed. Cl. 214,
223 (2011) (noting that special masters are bound by both § 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 her theory, the basis for the opinion and the reliability of that basis must be
22
considered in the determination of how much weight to afford the offered opinion. See
Broekelschen v. Sec’y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (“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) (stating that an “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))).
Here, the undersigned finds petitioner has shown by preponderant evidence a sound and
reliable theory that a flu vaccination administered intramuscularly can cause ulnar nerve injury
and neuropathy, and therefore, petitioner has satisfied the first Althen prong. This finding is
based on medical literature, published case reports, the petitioner’s medical records, and the
opinions of petitioner’s treating opinions.
Petitioner’s theory, as proffered by Dr. Steinman, is that injury to the ulnar nerve can
occur due to a misguided injection. This mechanism is supported by medical literature authored
by Kim et al., Geiringer and Leonard, and Salanga and Hahn, which explains that ulnar nerve
injuries can occur after injection, including intramuscular injections of vaccines, administered in
the deltoid region of the upper arm. Kim et al. identified the mechanisms of injury to include
direct needle trauma, toxic effects of vaccine ingredients on the nerve and adjacent tissues, and
nerve compression due to bruising or inflammation. Of these, direct injury to the ulnar nerve
caused by the needle was the most common causal mechanism.
Geiringer and Leonard describe two case reports where a nurse’s vaccine administration
technique caused ulnar nerve injuries to two patients. The position of the patients’ arms,
combined with a sidearm delivery, resulted in the needle hitting the nerve bundle on the medial
side of the arm instead of the deltoid muscle. These reports illustrate that ulnar nerve injury can
occur due to improper administration of a vaccine.
That vaccine administration can cause injury to the ulnar nerve appears to be established
knowledge within the medical community, given the fact that several of petitioner’s treating
physicians expressed an opinion that direct injury to the ulnar nerve can occur due to
vaccination. Dr. Littell opined that the ulnar “nerve was irritated either by the [vaccine] needle
or the liquid.” Pet. Ex. 20 at 32. Dr. Karanasias suggested that positioning at the time of
vaccination “could be the culprit.” Pet. Ex. 3 at 5. Dr. McGunigal noted that ulnar nerve injury
had been reported following “misdirected intramuscular deltoid injections.” Pet. Ex. 19 at 1.
These statements illustrate that the petitioner’s theory of misguided needle causing needle trauma
is a not a novel theory, but a mechanism known by physicians.
For the above reasons, the undersigned finds that petitioner has established by
preponderant evidence that a vaccine administered by injection into the upper arm can cause
injury to the ulnar nerve to be a sound and reliable causal theory.
However, petitioner has not provided preponderant evidence of a sound and reliable
causal theory to explain how ulnar neuropathy can occur in the non-vaccinated arm. Dr.
Steinman did not offer a causal theory as to how a vaccination injected into the right arm can
23
cause ulnar neuropathy in the opposite arm. He did not address petitioner’s contention that
compensation for an injured arm can cause overuse and ulnar injury of the other arm. Other than
several conclusory statements in some of the petitioner’s medical records, there was no evidence
offered to support this overuse theory. Petitioner offered no medical opinion, medical literature,
case reports, or explanation of this theory relative to the left arm. As such, the undersigned finds
that petitioner has failed to establish by preponderant evidence a sound and reliable medical
theory for how injury can occur to the ulnar nerve of a non-vaccinated arm.
2. Althen Prong Two: Logical Sequence of Events
The second causation issue is whether the flu vaccine administered to petitioner on
October 2, 2014, caused her to sustain right and/or left ulnar neuropathy. 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 (internal citations omitted).
In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s
treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d
at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as
treating physicians are likely to be in the best position to determine whether a ‘logical sequence
of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen,
418 F.3d at 1280)). Medical records are generally viewed as trustworthy evidence, since they are
created contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528. The
petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies,
rechallenge, the presence of pathological markers or genetic predisposition, or general
acceptance in the scientific or medical communities to establish a logical sequence of cause and
effect.” Capizzano, 440 F.3d at 1325. Instead, petitioner may satisfy her burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.
With regard to the second Althen prong, the undersigned finds there is preponderant
evidence to support a logical sequence of cause and effect showing the October 2, 2014 flu
vaccination caused petitioner’s right ulnar neuropathy. See Althen, 418 F.3d at 1278. This
finding is based primarily on the records and opinions of petitioner’s treating physicians.
Petitioner’s medical records establish that the day after vaccination, October 3, 2014,
petitioner saw Dr. Sparhawk, who diagnosed petitioner with “neuropraxia of upper extremity”
and concluded that petitioner had “nerve root irritation as a result of the injection.” Pet. Ex. 20 at
61. On October 6, 2014, petitioner saw Dr. Littell, who diagnosed petitioner with neuropraxia
and neuritis. Dr. Littell concluded that petitioner’s “nerve was irritated either by the needle or
the liquid when she was given the flu shot.” Id. at 32. October 10, 2014, petitioner was
evaluated by Dr. Schimmel, who questioned the possibility of whether petitioner had
“inflammation around one of the nerves in the arm related to the flu shot.” Pet. Ex. 2 at 7.
Petitioner was seen by neurologist, Dr. Karanasias on December 4, 2014, who diagnosed
petitioner with “right ulnar nerve neuropathy.” Pet. Ex. 3 at 5. Dr. Karanasias believed
24
petitioner’s symptoms were caused by the “irritability of the nerve in its segment along the
elbow” and he opined that positioning at the time of vaccination “could be the culprit.” Pet. Ex.
3 at 5. Petitioner saw Dr. McGunigal on January 22, 2015, who diagnosed right ulnar
neuropathy at the elbow and retrocondylar groove. Pet. Ex. 19 at 3. Subsequently, Dr.
McGunigal noted that this type of injury had been reported following “misdirected intramuscular
deltoid injections.” Id. at 1. Finally, Dr. Chopra, opined that petitioner’s flu shot “clearly caused
her injuries.” Pet. Ex. 16 at 1.
In summary, these treating physicians attributed petitioner’s right ulnar nerve injury to
nerve irritation, caused by either by the needle or the vaccine ingredients, the positioning at the
time of vaccine injection, or to a misdirected intramuscular deltoid injection. Thus, five of
petitioner’s treating physicians offered opinions that support petitioner’s causal theory.21
Further, there is no evidence to suggest that petitioner’s right ulnar injury was caused by
a factor unrelated to vaccination. She did not sustain any other trauma, other than vaccination, or
have any prior or pre-existing injury to her right arm.
Additionally, the petitioner’s clinical course is strikingly similar to the two cases reported
by Geiringer and Leonard of injection related ulnar neuropathy.22 “Case one” had paresthesias
and numbness in his fourth and fifth fingers within 30 minutes of vaccination. Pet. Ex. 23.2 at 1.
After petitioner received her flu vaccination by intramuscular injection in her right deltoid, she
returned to employee health about 10 to 15 minutes later complaining of “numbness to her right
pinky and tingling down the right elbow to the hand” on October 2, 2014. Pet. Ex. 1 at 1; Pet.
Ex. 20 at 63.
Like the patients in Geiringer and Leonard, petitioner was asked to bend her right arm
and place her hand on her hip, and flex her arm forward.23 Following her vaccination,
petitioner’s employee health record confirms that she reported pain and numbness down her arm
to her pinky finger. Petitioner’s symptoms included pain, numbness, and mild sensory
disturbance in the ulnar distribution, consistent with ulnar nerve symptoms reported in the
medical literature. Petitioner underwent EMG testing, interpreted by Dr. McGunigal as
diagnostic for right ulnar neuropathy.
21
None of petitioner’s treating physicians diagnosed her with pre-existing right ulnar
neuropathy. Further, their opinions were not premised on significant aggravation of pre-existing
ulnar neuropathy.
22
The patients in these case reports did not have pre-existing ulnar neuropathy. Further, the
authors opinions as to the mechanisms of causation were not premised on significant aggravation
of any prior condition.
23
Of note, the person who administered the petitioner’s vaccination was instructed on the proper
technique for vaccine administration following petitioner’s adverse reaction. See Pet. Ex. 20 at
64.
25
For all of these reasons, the undersigned finds that petitioner has provided preponderant
evidence of causation that her right ulnar neuropathy was caused by her flu vaccination.
However, petitioner has not shown by preponderant evidence that her left ulnar injury
was caused by her flu vaccination administered in her right arm on October 2, 2014. The first
reference in petitioner’s medical records to her left arm occurs one day post-vaccination, during
an evaluation by Dr. Sparhawk. Dr. Sparhawk performed Tinel’s tests on both petitioner’s arms,
and documented that the test was positive on the right arm, and that “Tinel’s on the left elbow
reveals similar symptoms but much less intense.” Pet. Ex. 20 at 61. Dr. Sparhawk did not
document or describe the significance of the test result relative to the left side. Dr. Sparhawk
made no diagnosis as to petitioner’s left arm.
The first reference to petitioner’s left arm symptoms appear in June 2015. On June 8,
2015, petitioner told her counselor, Peter Erickson, that her left arm hurt because she had been
using it “in a compensatory manner.” See Pet. Ex. 7 at 4. On June 10, 2015, petitioner was
evaluated by Dr. McCloy for an IME, and he diagnosed “mild left ulnar neuropathy, not causally
related to her vaccination.” Pet. Ex. 15 (part 2) at 163. Dr. McCloy further opined that this
condition had “no connection” with her vaccination. Id. at 164.
From August through November 2015, petitioner saw Dr. Chopra who documented that
she had “diffuse musculoskeletal pain” in her left arm due to “overuse.” Pet. Ex. 8 at 4. On
September 10, 2015, Dr. Chopra noted that petitioner had left arm pain was “a result of her
repetitive strain injury since she is unable to use her right upper extremity.” Pet. Ex. 13 at 7.
Although he did not explain what he meant by the words, “repetitive strain injury,” when read in
context with his note that petitioner had musculoskeletal pain, one thinks of a musculoskeletal
type strain, not a nerve injury. Subsequently, in his expert report, Dr. Chopra opined that
petitioner’s diagnosis of cubital tunnel syndrome was not related to petitioner’s vaccine injury.24
See Pet. Ex. 16 at 1.
Dr. Katarincic diagnosed petitioner with bilateral ulnar neuropathies in March 2016, with
“subluxation” on the left side. See Pet. Ex. 14 at 6. Dr. Katarincic performed left ulnar nerve
surgery on petitioner in April 2016; petitioner’s postoperative diagnosis was “left cubital tunnel
syndrome with subluxation of the ulnar nerve over the left medial condyle.” Pet. Ex. 21 at 1-2.
There is nothing in any of Dr. Katarincic’s records to suggest that petitioner’s left ulnar injury
was caused by vaccination.
24
Dr. Chopra does not specify whether this opinion relates to the right or left arm, and thus, his
opinion is confusing. If he was referencing the right arm, then his expert report does not address
the left ulnar neuropathy. Assuming he was referencing the right arm, however, the opinion is
inconsistent with his opinion that petitioner’s left upper extremity neuropathic pain was caused
by the flu vaccination.
26
In July 2018, petitioner reported to physiatrist Dr. Wheeler that she had arm pain from
her vaccination, and that her “[right] arm was becoming sore from overuse.”25 See Pet. Ex. 24 at
29. Dr. Wheeler offered no opinion about the as to whether petitioner’s left arm pain was caused
by overuse due to vaccination in the opposite arm. Pet. Ex. 24 at 29-32.
Neither Dr. Steinman nor Dr. Chaudry offered an opinion as to the diagnosis or cause of
any problem with petitioner’s left arm.
In summary, the record contains several entries where the petitioner reported that because
of the injury to her right arm, she was overusing her left arm, causing pain in her left arm.
However, statements made by the petitioner do not constitute medical evidence of causation. No
physician opined that petitioner had left ulnar neuropathy caused by overuse of the left arm due
to petitioner’s inability to use her right arm. The record is void of medical evidence to connect
the left arm nerve pathology to the vaccination administered in petitioner’s right arm. Therefore,
the undersigned finds that petitioner has failed to show by preponderant evidence that her
vaccination caused any injury to her left arm.
3. Althen Prong Three: Proximate Temporal Relationship
Althen Prong Three requires petitioner to establish a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been
equated to mean a “medically acceptable temporal relationship.” Id. The petitioner must offer
“preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disease’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
explanation for what is a medically acceptable time frame must also coincide with the theory of
how the relevant vaccine can cause the injury alleged (under Althen Prong One). Id.; Koehn v.
Sec’y of Health & Hum. Servs., 773 F.3d 1239, 1243 (Fed. Cir. 2014); Shapiro v. Sec’y of
Health & Hum. Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl.
353 (2012), aff’d mem., 503 F. App’x 952 (Fed. Cir. 2013).
Based on medical records, affidavits, and a review of the record as a whole, the
undersigned finds the onset of petitioner’s right arm pain occurred immediately upon vaccination
or shortly thereafter, as reflected by the employee health service records. The timing of onset
shows a proximate temporal relationship between vaccination and injury, and is consistent with
the case reports of ulnar nerve injuries described after vaccination. The temporal association is
appropriate given the mechanism of injury. Thus, petitioner has satisfied the third Althen prong
for her right ulnar neuropathy.
Because the petitioner has failed to establish preponderant evidence to support Althen
Prong One or Two for her left ulnar neuropathy, she has failed to establish preponderant
evidence of causation. Additionally, petitioner has offered no evidence as to what the
appropriate temporal association should be given her theory of left ulnar injury due to overuse
25
Dr. Wheeler appears to have confused the left and right arm. Based on the medical records
and affidavit of petitioner, Dr. Wheeler probably meant to say “left” arm.
27
caused by overcompensation. Because she has offered no evidence on this element of causation,
the undersigned finds she has failed to prove Althen Prong Three as to her left arm injury.
E. Standards for Adjudication—Significant Aggravation
The elements of an off-Table significant aggravation case are set forth in Loving. See
Loving v. Sec’y of Health & Hum. Servs., 86 Fed. Cl. 135, 142-44 (2009); see also W.C. v.
Sec’y of Health & Hum. Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (holding that “the Loving
case provides the correct framework for evaluating off-table significant aggravation claims”).
The Loving court combined the Althen test, which defines off-Table causation cases, with a test
from Whitecotton. Whitecotton v. Sec’y of Health & Hum. Servs., 17 F.3d 374 (Fed. Cir. 1994),
rev’d sub nom., Shalala v. Whitecotton, 514 U.S. 268 (1995) (concerning on-Table significant
aggravation cases). The resultant test has six components, which are:
(1) the person’s condition prior to administration of the vaccine, (2) the person’s
current condition (or the condition following the vaccination if that is also
pertinent), (3) whether the person’s current condition constitutes a ‘significant
aggravation’ of the person’s condition prior to vaccination, (4) a medical theory
causally connecting such a significant worsened condition to the vaccination, (5) a
logical sequence of cause and effect showing that the vaccination was the reason
for the significant aggravation, and (6) a showing of a proximate temporal
relationship between the vaccination and the significant aggravation.
Loving, 86 Fed. Cl. at 144.
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). Here, petitioner has failed to show that she had pre-
existing ulnar neuropathy. Thus, she is unable to show significant aggravation of her prior
condition. Petitioner’s theory of causation, as explained by her treating physicians, Dr.
Steinman, and the medical literature, are not premised on any underlying pre-existing neuropathy
or significant aggravation. Instead, petitioner has presented a causation theory, that but for her
flu vaccination, she would not have sustained injury to her right ulnar nerve. Under the facts and
circumstances unique to this case, petitioner need not invoke a theory based on significant
aggravation to show that she is entitled to compensation.
As for her left arm, petitioner has failed to prove Althen Prongs One, Two, and Three.
These three prongs constitute three of the six elements necessary to establish significant
aggravation (elements four through six). Therefore, petitioner’s claim for significant aggravation
as to her left arm also fails.
VII. CONCLUSION
The undersigned finds there is preponderant evidence to satisfy all three Althen prongs
and to establish that petitioner’s October 2, 2014 flu vaccination caused her right ulnar injury,
and thus, she is entitled to compensation for that injury.
28
Petitioner has failed to establish by preponderant evidence that her left ulnar injury is
compensable.
A separate damages order will issue.
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Special Master
29