Grow v. Secretary of Health and Human Services ( 2020 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: November 24, 2020
* * * * * * * * * * * * * * *
BRADLEY GROW, * No. 16-13V
*
Petitioner, * Special Master Sanders
*
v. *
*
SECRETARY OF HEALTH * Decision; Entitlement; Ruling on the
AND HUMAN SERVICES, * Record; Influenza (“Flu”) Vaccine; Brachial
* Neuritis; Parsonage Turner Syndrome
Respondent. * (“PTS”).
* * * * * * * * * * * * * * *
Lisa A. Roquemore, Law Office of Lisa A. Roquemore, Rancho Santa Margarita, CA, for Petitioner.
Catherine E. Stolar, United States Department of Justice, Washington, DC, for Respondent.
DECISION ON ENTITLEMENT 1
On January 4, 2016, Bradley Grow (“Petitioner”) filed a petition for compensation in the
National Vaccine Injury Compensation Program (“the Program”). 2 ECF No. 1. Petitioner alleged
that the influenza (“flu”) vaccine he received on January 14, 2013, caused him to develop brachial
neuritis, also known as Parsonage Turner Syndrome 3 (“PTS”). Id. at 4. For the reasons discussed
herein, I deny Petitioner’s claim and find that Petitioner is not entitled to compensation.
1
This Decision shall be posted on the United States Court of Federal Claims’ website, in accordance with
the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the Decision will be available to anyone with access to
the Internet. In accordance with Vaccine Rule 18(b), a party has 14 days to identify and move to delete
medical or other information that satisfies the criteria in § 300aa-12(d)(4)(B). Further, consistent with the
rule requirement, a motion for redaction must include a proposed redacted Decision. If, upon review, the
undersigned agrees that the identified material fits within the requirements of that provision, such material
will be deleted from public access.
2
National Childhood Vaccine Injury Act of 1986, Pub L. No. 99-660, 100 Stat. 3755 (“the Vaccine Act”
or “Act”). Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent
subparagraph of 42 U.S.C. § 300aa (2012).
3
Brachial neuritis/Parsonage Turner Syndrome is another term for neuralgic amyotrophy, which “is an
uncommon disorder of the peripheral nervous system characterized by the sudden onset of extreme pain in
the upper extremity followed by rapid multifocal motor weakness and atrophy and a slow recovery in
months to years.” Dorland’s Illustrated Medical Dictionary 1263, 1391 (32nd ed. 2012) [hereinafter
“Dorland’s”].
I. Procedural History
Petitioner filed his petition on January 4, 2016. ECF No. 1. The next day, Petitioner
submitted several exhibits consisting of medical records from several of his treating physicians.
Pet’r’s Exs. 1–9, ECF Nos. 5-1–5-9. Petitioner filed his first statement of completion on January
19, 2016. ECF No. 9. Thereafter, Petitioner submitted additional medical records on January 27,
2016, April 18, 2016, and May 2, 2016. See Pet’r’s Exs. 10–12, ECF Nos. 10, 13, 15.
On April 4, 2016, Respondent filed a status report advising the Court that this claim was
appropriate for settlement and requesting that Petitioner provide a demand. ECF No. 12. In
response to the Court’s April 20, 2016 scheduling order, on May 20, 2016, Petitioner filed a status
report advising the Court as to the progress of settlement discussions between the parties. ECF
Nos. 14, 16. The parties continued to engage in settlement discussions throughout 2016 and
updated the Court accordingly. See ECF Nos. 17–19, 21, 25, 27–29. In furtherance of the parties’
settlement discussions, Petitioner submitted additional medical records. Pet’r’s Exs. 13–18, ECF
Nos. 20, 24, 26. On November 2, 2016, the Court issued a 15-Week Stipulation Order indicating
the parties had reached a tentative settlement agreement and requesting a status report from
Respondent by February 14, 2017. ECF No. 29. Yet, on February 1, 2017, Respondent submitted
a status report stating, “the settlement referenced by the 15-Week Stipulation Order of November
2, 2016, will not be approved,” and requesting a status conference to discuss further proceedings.
ECF No. 30. The status conference was scheduled for February 13, 2017. Non-PDF Order,
docketed Feb. 9, 2017.
On February 9, 2017, the same day the Court scheduled the status conference, the parties
filed a joint status report requesting that the status conference be removed from the calendar
because “the parties agreed that they would recommence settlement discussions.” ECF No. 31. On
February 10, 2017, the Court cancelled the status conference. Scheduling Order at 1, ECF No. 32.
The parties filed a joint status report regarding the progress of their settlement discussions on
March 22, 2017. ECF No. 33. The parties indicated they would like a status conference to discuss
how to proceed. Id. A status conference was held on March 30, 2017, whereby the parties
expressed that their settlement discussions were at an impasse but that they were not interested in
mediation. Scheduling Order at 1, ECF No. 35. Respondent was ordered to file his Rule 4(c) Report
by no later than May 2, 2017. Id. at 2.
Respondent filed his Rule 4(c) Report on May 2, 2017. Resp’t’s Report, ECF No. 36.
Respondent argued that the petition should be dismissed because Petitioner did not establish that
he suffered PTS as a result of the flu vaccine he received on January 14, 2013. Id. at 1. Respondent
further argued Petitioner failed to “proffer a medical theory sufficient to establish a logical cause
and effect relationship between the vaccination and his alleged injury.” Id. at 11.
On June 8, 2017, Petitioner filed an expert report from Dr. Eric Gershwin, M.D., and fifty-
two pieces of medical literature. Pet’r’s Exs. 23–72, ECF Nos. 41–46. Respondent filed a
responsive expert report from Dr. Thomas Leist, M.D., PhD, together with two pieces of medical
literature on October 3, 2017. Resp’t’s Exs. A, A-1, A-2, B, ECF Nos. 49-1–49-4. On November
21, 2017, Petitioner filed his first supplemental expert report from Dr. Gershwin. Pet’r’s Exs. 80–
82, ECF Nos. 51-1–51-3. The same day, Petitioner submitted additional evidence regarding the
2
judgment of dissolution of his marriage. Pet’r’s Ex. 83, ECF No. 52. On December 14, 2017,
Petitioner filed his own declarative response to Respondent’s expert report. Pet’r’s Ex. 84, ECF
No. 53. Respondent filed a supplemental expert report from Dr. Leist, along with supporting
literature, on February 27, 2018. Resp’t’s Exs. C, C-1, C-2, ECF Nos. 56-1–56-3. In response,
Petitioner submitted his second supplemental expert report from Dr. Gershwin, along with
supporting literature, on March 20, 2018. Pet’r’s Exs. 85–88, ECF Nos. 58-1–58-4.
I held a telephonic status conference with the parties on March 29, 2018. See Minute Entry,
docketed Mar. 30, 2018. During the conference, Respondent noted his concerns regarding the five-
month post-vaccination onset issue in this case and reiterated his view that Petitioner’s PTS began
when he complained of muscle weakness. See Scheduling Order at 1, ECF No. 59. I ordered
Petitioner to submit a status report outlining specific medical literature that addressed whether pain
heralds the onset of PTS or if muscle weakness is a necessary condition for diagnosis, id., which
Petitioner filed on April 3, 2018. ECF No. 60. Respondent filed a status report on May 16, 2018,
in which he stated that Dr. Leist’s supplemental expert report “adequately addressed all of the
points raised by [P]etitioner’s counsel in [P]etitioner’s status report of April 3, 2018.” ECF No.
61. Respondent contended that Dr. Leist had already shown that Petitioner’s injury does not fit the
normal progression of PTS with pain being the heralding event but instead presents with weakness
at the time of onset. Id. Respondent also requested that an entitlement hearing be scheduled. Id.
I held another telephonic status conference with the parties on May 30, 2018. See Minute
Entry, docketed May 30, 2018. During the conference, I noted that because the issues in contention
are well defined, this case may be appropriate for a ruling on the record. See Scheduling Order at
1, ECF No. 62. On September 6, 2018, Petitioner filed a motion for a ruling on the record, and
Respondent filed his response on October 22, 2018. ECF Nos. 64, 66. Petitioner filed his reply on
November 1, 2018. ECF No. 67.
Upon my thorough review of Petitioner’s medical records, I determined there were
inconsistencies regarding Petitioner’s description of his initial pain and the onset time he reported
to his treating physicians. See Scheduling Order at 1, ECF No. 71. I also required more information
from Petitioner’s expert, Dr. Gershwin, regarding “the causation theory and how it applies to
Petitioner’s PTS[.]” Id. Accordingly, on July 9, 2019, I ordered Petitioner to file an affidavit that
addressed these discrepancies, along with a concise supplemental expert report from Dr. Gershwin
explaining the role of the vaccine in the development of Petitioner’s PTS. Id. On August 8, 2019,
Petitioner filed his third supplemental expert report from Dr. Gershwin, along with four pieces of
supporting literature. Pet’r’s Exs. 90–94, ECF Nos. 72-1–72-5. The same day, Petitioner submitted
his supplemental affidavit regarding the discrepancies in his medical records. Pet’r’s Ex. 95, ECF
No. 73. On October 20, 2019, Respondent filed a responsive supplemental expert report from Dr.
Leist, along with a supporting exhibit, and an updated exhibit list. Resp’t’s Exs. D, D-1, ECF Nos.
75-1–75-2, 76. On November 26, 2019, Petitioner filed his fourth supplemental expert report from
Dr. Gershwin, along with a supporting exhibit, that mostly reiterated the assertions made in his
previous reports. Pet’r’s Exs. 96–97. ECF Nos. 77-1–77-2.
This matter is now ripe for consideration.
3
II. Evidence
A. Relevant Medical History
Petitioner is a fifty-year-old man whose medical history prior to vaccination is notable for
shoulder pain, back pain, and carpal tunnel syndrome. See generally Pet’r’s Exs. 1, 3, ECF Nos.
5-1, 5-3. Petitioner was seen by Dr. Peter Grant, M.D., a physical medicine and rehabilitation
specialist, on January 26, 2009 for a history of “very severe and chronic carpal tunnel syndromes
on the right greater than left sides[,]” for which he had “bilateral carpal tunnel decompressions”
with “good results.” Pet’r’s Ex. 3 at 1.
On April 5, 2010, Petitioner saw nurse practitioner (“N.P.”) Raymond Millette, in place of
a primary care physician, at Millette Family Medicine for “moderate back and shoulder pain.”
Pet’r’s Ex. 1 at 1. At that time, Petitioner denied numbness in both arms. Id. Petitioner described
his symptoms as “gradual in onset,” with an “aching, a throbbing, and an irritated quality.” Id. He
also stated that the “onset of [his] condition may have been associated with a sports[] injury” and
that it was “aggravated by lifting and movement,” although the use of NSAIDs, 4 marijuana, and
pain medication provided some relief. Id. Petitioner was diagnosed with muscle spasms and
myalgia and was prescribed methadone. 5 Id. at 2.
Petitioner visited N.P. Millette again on September 14, 2010 for the same “moderate back
and shoulder pain.” Id. at 4. Petitioner reported that he had been seeing a chiropractor, “that has
been helpful,” and that he experienced “left upper scapular muscle tension” when he was busy at
work. Id. He also reported that his pain, which he rated as a nine on a scale from one to ten, with
ten being very painful, decreased to a six or seven after using marijuana and pain medication. Id.
An examination revealed mid-thoracic and lumbar spine pain, as well as left upper trapezius 6 and
scapular 7 tension. Id. at 5. The diagnoses remained unchanged and Petitioner was again prescribed
methadone. Id. Petitioner saw N.P. Millette two-to-three times annually during 2011 and 2012 for
the same complaints of moderate aching and throbbing back and shoulder pain. See id. at 13–21,
24–25.
On January 9, 2013, Petitioner again saw N.P. Millette for “moderate back and shoulder
pain” that was “aggravated by lifting and movement.” Id. at 26. He reported that his pain was a
seven or eight on the pain scale, dropping to a five or six after using marijuana and pain medication.
Id. Petitioner also reported “foot pain that seem[ed] to be getting worse” and “denie[d
experiencing] numbness in [the] left arm and numbness in [the] right arm.” Id. The diagnoses
remained unchanged, with the addition of “pain in joint, ankle and foot.” Id. at 27.
On January 14, 2013, per a prescription record, Petitioner received the flu vaccine in
4
The term NSAIDs stands for nonsteroidal anti-inflammatory drugs. Dorland’s at 1293.
5
Methadone is “a synthetic opioid analgesic, possessing pharmacologic actions similar to those of morphine
and heroin[.]” Dorland’s at 1146.
6
The trapezius muscle “elevates [the] shoulder, rotates [the] scapula to raise [the] shoulder in abduction of
[the] arm, [and] draws [the] scapula backward.” Dorland’s at 1212.
7
The scapula is “the flat, triangular bone in the back of the shoulder . . . called also shoulder blade.”
Dorland’s at 1673 (emphasis in original).
4
question, but the prescription record does not indicate the site of vaccination. Pet’r’s Ex. 1 at 29.
A month later, on February 12, 2013, Petitioner called his chiropractor, Scott Thorsen, for “upper
back and shoulder pain” that Petitioner estimated had begun one week previously. Pet’r’s Ex. 2 at
1, 3, ECF No. 5-2. Petitioner visited his chiropractor on February 14, 2013. Id. Petitioner reported
that he had “received treatment from another chiropractor without much improvement” and that
he experienced “moderately severe constant upper back pain on the right.” Id. at 1. He also reported
that he experienced “frequent moderately severe stiffness with burning, dull, and achy pain
migrating to the posterior right upper shoulder and right deltoid area.” Id. A “[s]pinal evaluation
revealed a moderate degree of fixation at T3–T6, and a mild degree of restricted joint function at
C5–C6.” Id. A physical examination revealed “a moderate amount of muscle tightness in the
[t]rapezius and [l]evator scapulae 8 bilaterally and [p]osterior shoulder girdle 9 muscles on the
right[.]” Id. It also revealed “a severe degree of muscle tightness and stiffness in the [t]rapezius
and [l]evator scapulae on the right and [t]horacic paraspinal muscles on the right was elicited.” Id.
The examination also showed “moderate pain and discomfort at T3 to T5 on the right and a mild
degree of pain at T4 to T5 on the left.” Id. A Hawkins–Kennedy impingement test 10 was positive
bilaterally and Petitioner had reduced right-side range of motion (“ROM”) with moderate pain.
Id. Neurological tests were normal. Id. Petitioner was diagnosed with myofasciitis, 11
segmental/somatic dysfunction of the cervical and thoracic spine, and shoulder bursitis. 12 Id.
At a follow-up visit with Mr. Thorsen on February 19, 2013, Petitioner reported “noticeable
improvement in the severity of the thoracic region on the right.” Id. at 2. A physical examination
revealed “a decrease in the degree of hypertonicity in the [t]rapezius and [l]evator scapulae on the
right and [t]horacic paraspinal muscles on the right, and a moderate amount of muscle tightness in
the [t]rapezius and [l]evator scapulae on the left and [p]osterior shoulder girdle muscles on the
right.” Id. Mr. Thorsen’s assessment was that Petitioner’s “condition is improved and responding
normally to treatment.” Id.
On July 8, 2013, nearly six months after his vaccination, Petitioner returned to N.P. Millette
for weakness and loss of strength on his right side. Pet’r’s Ex. 1 at 30. Petitioner indicated he had
experienced these symptoms for the last two months. Id. He also complained of “moderate back
and shoulder pain.” Id. Petitioner reported that he had “been lifting weights and noticed his right
peck [was] weak and wasting,” and that he had experienced pain in both lower extremities “with
radiation down the left leg to the knee.” Id. An examination revealed mid-thoracic and lumbar
8
The levator scapulae is the muscle that raises the scapula. Dorland’s at 1207.
9
The shoulder girdle is “a complex arrangement of bones, ligaments, muscles, and tendons,” whose
“primary function . . . is to give strength and range of motion to the arm.” Andrew Chung, Shoulder
Structure, Function and Common Problems, HEALTHPAGES.ORG, https://www.healthpages.org/anatomy-
function/shoulder-structure-function-and-problems/ (last visited Sept. 9, 2020).
10
The Hawkins–Kennedy impingement test “is commonly used to identify possible subacromial
impingement syndrome.” Hawkins/Kennedy Impingement Test of the Shoulder, PHYSIOPEDIA,
https://www.physio-pedia.com/Hawkins_/_Kennedy_Impingement_Test_of_the_Shoulder (last visited
Sept. 9, 2020).
11
Myofasciitis is “inflammation of a muscle and its fascia, particularly of the fascial insertion of muscle to
bone.” Dorland’s at 1223.
12
Bursitis is defined as “inflammation of the bursa,” which is “a sac or saclike cavity filled with a viscid
fluid and situated at places in the tissues at which friction would otherwise develop.” Dorland’s at 262,
264.
5
spine pain, left upper trapezius muscle and scapular tension, bilateral foot pain, and right pectoral
muscle wasting “with neuropathic pain, [and] positive straight leg r[aise.]” Id. at 31. Petitioner’s
previous diagnoses of muscle spasms, myalgia, and pain in joint, ankle and foot remained
unchanged. Id. However, Petitioner was also diagnosed with low back pain and back pain with
radiation. Id. N.P. Millette ordered further imaging and gave Petitioner a nine-day prescription of
prednisone. 13 Id. at 31–32.
On October 17, 2013, Petitioner underwent CT myelograms 14 of the cervical and thoracic
spine. Id. at 33. The cervical CT myelogram showed “mild diffuse disc bulges and mild to
moderate uncovertebral spurring 15” at C4–C5 and C5–C6, with mild narrowing of the thecal sac 16
at those levels. Id. The cervical CT myelogram revealed mild to moderate foraminal narrowing at
C5 and C6. Id. It also highlighted “neural foraminal narrowing” 17 at the left C6 level. Id. The
thoracic CT myelogram showed “mild to moderate focal left posterior lateral narrowing of the
thecal sac at the T11–T12 disc level” caused by a “bony spur projecting into the spinal canal from
the left T10 lamina 18 and T11 pedicle.” 19 Id. at 35.
On December 2, 2013, Petitioner saw N.P. Millette for “moderate back and shoulder pain.”
Id. at 37. Petitioner reported that although he had not been lifting weights, the muscle wasting of
his right shoulder and pectoral muscle had continued. Id. He was again diagnosed with low back
pain, muscle spasms, and pain in joint, ankle and foot. Id. at 38. Petitioner was scheduled to see a
pain specialist and was prescribed methadone. Id. at 37–38.
On December 9, 2013, Petitioner saw Dr. Joseph Savino, a pain specialist, for “[m]uscle
loss over the right shoulder and anterior chest.” Pet’r’s Ex. 5 at 1, ECF No. 5-5. Petitioner reported
that the previous “spring he awoke one morning with mild neck and mid[-]back pain that was
extending into his right shoulder region[,]” which “was treated with chiropractics [sic] and
eventually the pain resolved.” Id. Petitioner also reported that he “ha[d] had progressive muscle
loss affecting his right pectoralis 20 region, triceps, and deltoid regions[,]” but he “denie[d] any
13
Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as an anti[-
]inflammatory and immunosuppressant.” Dorland’s at 1509.
14
A myelogram is “a radiograph of the spinal cord.” Dorland’s at 1219.
15
Uncovertebral spurring is “an abnormal bony projection” “pertaining to or affecting the uncinate
processes of a vertebra.” Dorland’s at 1757, 2001.
16
Thecal sac is sometimes referred to as “dural sac” and is “the portion of the spinal dura mater extending
caudally from the level of the first or second lumbar vertebrae to the attachment at the filum terminale
externum…and containing the lumbar cistern, cauda equina, cerebrospinal fluid, and filum terminale
internum.” Dorland’s at 1660.
17
Neural foraminal narrowing, also known as neural foraminal stenosis, “is a type of spinal stenosis [that]
occurs when the small openings between the bones in [the] spine . . . narrow or tighten.” Neural Foraminal
Stenosis: Overview, HEALTHLINE, https://www.healthline.com/health/neural-foraminal-stenosis (last
visited Sept. 23, 2020).
18
Lamina is a term that “is often used alone to mean the lamina arcus vertebrae,” i.e., “either of the pair of
broad plates of bone flaring out from the pedicles of the vertebral arches and fusing together at the midline
to complete the dorsal part of the arch and provide a base for the spinous process.” Dorland’s at 1000.
19
The pedicle or pediculus arcus vertebrae is defined as “one of the paired parts of the vertebral arch that
connect a lamina to the vertebral body.” Dorland’s at 1401.
20
It is unclear whether the notes refer to the pectoralis major or the pectoralis minor. The pectoralis major
6
injury or known trauma[,]” stating that he was “in little to no pain at all.” Id. The physical
examination revealed that Petitioner had a full ROM in his neck, shoulders, upper and lower
extremities bilaterally, and lumbar spine. Id. at 2. The examination also showed no pain or
tenderness in the upper extremities and the thoracic and lumbar spine. Id. It also revealed “[n]o
subacromial 21 or subdeltoid 22 bursa tenderness” or impingement signs. Id. A neurological
examination showed that Petitioner had “atrophy of [his] right pectoralis major and triceps muscle
groups.” Id. Dr. Savino noted that Petitioner “ha[d] a build consistent with a weight lifter[,]
demonstrating hypertrophy throughout both upper extremities.” Id. He also noted that Petitioner’s
condition was “likely consistent with brachial plexitis 23 (Parsonage[]Turner [s]yndrome) or
plexopathy. 24” Id.
On February 4, 2014, Petitioner returned to Dr. Grant for an electromyogram (“EMG”) 25
of the injured area. Pet’r’s Ex. 3 at 1. Petitioner reported that his symptoms had begun
approximately a year earlier “rather insidiously,” with severe pain in the right periscapular and
shoulder area. Id. He also reported that the pain had subsided “within a week or two” with
chiropractic treatment. Id. He then noticed “some weakness in different areas of the chest and arm,
as well as some atrophy,” which had remained unchanged over the previous six to nine months.
Id. A physical examination showed atrophy of the right pectoralis and triceps 26 muscles. Id. at 2.
Deep tendon reflexes (“DTRs”) 27 were “absent at the right triceps and 1+ at the left triceps” and
both biceps. 28 Id. Muscle testing revealed right elbow and right wrist weakness with “some residual
loss of sensation in [the] median [nerve] distribution bilaterally.” Id. The EMG revealed “chronic,
persistent, and severe denervation” of the pectoralis, triceps, and pronator teres 29 muscles on the
right, with “a lesser amount of involvement in a[n] extensor carpi radialis longus 30 on the right.”
Id. “[S]ignificant neuropathic motor unit abnormalities” were observed in these muscles. Id. Dr.
Grant’s impressions were that the “[r]ight upper extremity denervation and neuropathic disease
is a “greater pectoral muscle” that “adducts, flexes, [and] rotates [the] arm medially.” The pectoralis minor
is a “smaller pectoral muscle” that “draws [the] shoulder forward and downward, [and] raises [the] third,
fourth, and fifth ribs in forced inspiration.” Dorland’s at 1208.
21
Subacromial means “inferior to the acromion,” which is defined as “the lateral extension of the spine of
the scapula, projecting over the shoulder joint and forming the highest point of the shoulder.” Dorland’s at
20, 1789.
22
Subdeltoid means “beneath the deltoid muscle.” Dorland’s at 1790.
23
Brachial plexitis is defined as an inflammation of a nerve of the brachial plexus, which is a network of
nerves “composed successively of anterior branches and trunks” and “[s]ituated partly in the neck and partly
in the axilla.” Dorland’s at 1462.
24
Brachial plexopathy is “any neuropathy of the brachial plexus.” Dorland’s at 1462.
25
An electromyogram is “the record obtained by electromyography,” which in turn is defined as “an
electrodiagnostic technique for recording the extracellular activity . . . of skeletal muscles at rest, during
voluntary contractions, and during electrical stimulation.” Dorland’s at 602.
26
The triceps muscle “extends [the] forearm, [while its] long head adducts and extends [the] arm.”
Dorland’s at 1212.
27
Deep tendon reflexes are “involuntary contraction[s] of a muscle after brief stretching caused by
percussion of its tendon.” Dorland’s at 1615.
28
The biceps brachii muscle “flexes [the] forearm [and] supinates [the] hand.” Dorland’s at 1203.
29
The pronator teres muscle “flexes [the] elbow and pronates [the] forearm.” Dorland’s at 1209.
30
The extensor carpi radialis longus is defined as the “long radial extensor muscle of [the] wrist” that
“extends and abducts [the] wrist joint.” Dorland’s at 1204.
7
affect[ed] mainly C7 innervated muscles” and that the findings were most consistent with
Parsonage Turner syndrome. Id. at 3. He wrote, however, that “the persistent denervation and the
localization to mainly C7 muscles at least suggest[ed] the possibility of an ongoing C7
radiculopathy, 31” while noting that minimal neck and shoulder pain, as well as “fairly clear
imaging studies[,] might speak against this[.]” Id. Dr. Grant’s recommendation was to treat
Petitioner’s condition as a right C7 radiculopathy because there was “no good treatment for
neuralgia amyotrophy 32 [Parsonage Turner syndrome] . . . .” Id.
On February 24, 2014, Petitioner had a follow-up visit with Dr. Savino, who noted that the
EMG was most consistent with Parsonage Turner syndrome. Pet’r’s Ex. 5 at 4. Dr. Savino also
noted that despite Dr. Grant’s suggestion to treat Petitioner’s condition as a cervical radiculopathy,
Petitioner felt no pain and his imaging studies had shown no evidence of nerve root impingement
that would necessitate such treatment. Id. at 6. Therefore, Dr. Savino did not believe that epidural
injections for a radiculopathy were warranted, and instead, diagnosed Petitioner with a brachial
plexus disorder. Id.
On April 9, 2014, Petitioner saw N.P. Millette to discuss treatment for muscle loss to his
right side. Pet’r’s Ex. 1 at 40. Petitioner reported moderate neck pain and “right shoulder pain with
muscle wasting,” as well as “weakness in [his] right hand and numbness in [his] right arm.” Id.
He also reported that his condition “started after he had a [f]lu shot” and it was “aggravated by
movement.” Id. Petitioner was referred to a neurologist. Id. at 42. Prior to seeing a neurologist, on
April 22, 2014, Petitioner saw Dr. Savino for muscle atrophy in his right arm. Pet’r’s Ex. 5 at 8.
Dr. Savino recommended physical therapy but Petitioner did “not have the [financial] resources to
go to physical therapy.” Id. at 9. Dr. Savino stated that a trial of epidural steroids or a nerve root
block were options but thought they would be “low yield and certainly not diagnostic.” Id. He
recommended a neurological assessment. Id.
On June 23, 2014, Petitioner saw Dr. Zakir Ali, a neurologist, for his “weakness and
atrophy in the right arm.” Pet’r’s Ex. 4 at 1, ECF No. 5-4. Petitioner reported that immediately
after his flu vaccine, “he developed sudden onset pain in the right shoulder region.” Id. Dr. Ali
noted, however, that “[t]his was not in the same area where the injection was given.” Id. A physical
examination revealed 4/5 weakness in the right elbow extension with otherwise normal tone and
strength. Id. The examination also showed evidence of right arm atrophy, with Petitioner’s mid-
upper arm circumference measuring 37.5 cm on the right side, compared with 41 cm on the left
side. Id. There was also “atrophy of the right pectoralis muscle,” while DTRs were absent in the
right triceps and measured 1/2 for all other upper extremity muscle groups. Id. Dr. Ali wrote that
Petitioner “had a very typical presentation of [PTS]/neuralgic amyotrophy/idiopathic brachial
plexitis a year ago.” Id. at 2. He also noted the temporal association with the flu vaccine in question
and stated that Petitioner’s condition “is a very well[]known idiopathic plexitis that can occur with
multiple different associations,” and that “[v]accinations are common associations.” Id.
31
Cervical radiculopathy is a disease of the “cervical nerve roots, often with neck or shoulder pain;
compression of nerve roots is a common cause in this area.” Dorland’s at 1571.
32
Neuralgic amyotrophy is defined as “pain across the shoulder and upper arm, with atrophy and paralysis
of the muscles of the shoulder girdle.” Dorland’s at 70.
8
On April 22, 2015, Petitioner saw N.P. Millette again for “shoulder pain.” Pet’r’s Ex. 1 at
52. Petitioner reported that he “ha[d] const[ant] neuropathic pain that [was] lasting longer and
coming on more frequently” and that “there [was] nothing that t[ook] the pain away.” Id. Upon
physical examination, N.P. Millette noted that Petitioner had “radicular pain . . . extend[ing] from
the . . . shoulder, elbow and through the right hand, [with] grip decreased on [the] right.” Id. at 54.
Petitioner was referred to the Oregon Health & Science University’s (“OHSU”) department of
neurology for a consultation regarding his diagnosis of PTS. Id.
On September 14, 2015, Petitioner had a follow-up visit with N.P. Millette. Id. at 56.
Petitioner reported that his neuropathic pain was constant, his “right hand ha[d] gotten worse, his
[right] hand f[ell] asleep when he shave[d,] and his index finger f[ell] asleep all the time.” Id.
Upon examination, N.P. Millette noted that Petitioner had “radicular pain . . . extend[ing] from the
right shoulder, elbow and through the right hand, [with] grip decreased on [the] right.” Id. at 58.
Petitioner was advised to call or return if his symptoms worsened or persisted. Id.
On January 21, 2016, Petitioner had a follow-up with his neurologist, Dr. Ali. Pet’r’s Ex.
10 at 1, ECF No. 10. Dr. Ali noted Petitioner “has had not much improvement in the last year from
the atrophy and weakness in the right arm . . . [that] started approximately a year and a half ago.”
Id. Dr. Ali indicated that Petitioner’s condition had remained unchanged and “ha[d] not worsened.”
Id. He noted Petitioner “continued to have atrophy in the right triceps and the right pectoralis
muscles.” Id. Dr. Ali diagnosed Petitioner with PTS, recommended physical therapy, and
prescribed a “[t]rial of [G]abapentin 33 for neuropathic pain in the right arm.” Id. at 1–2.
On February 12, 2016, Petitioner underwent a physical therapy (“PT”) evaluation with Mr.
Edsen Donato at Asante Three Rivers Medical Center (“Asante”). Pet’r’s Ex. 11 at 1, ECF No. 13.
Petitioner complained of “[r]ight shoulder pain and weakness with muscle atrophy, left shoulder
pain [and] numbness of the left dorsal thumb and index finger.” Id. Petitioner reported that “due
to his condition, he compensated by using his left shoulder more and that, as a result, he began to
have left shoulder pain as well.” Id. The physical therapist noted “no significant tenderness . . . in
the right shoulder, but . . . significant atrophy . . . in the right triceps and pectoralis musculature.”
Id. at 2. He also noted that the ROM of Petitioner’s right shoulder was “grossly [eighty percent]
of normal due to pain limitations[,] while his strength was “grossly 4/5.” Id. Mr. Donato’s
impression was “[m]uscle power deficit/deconditioning syndrome of bilateral shoulders[]” and
“[p]robable left shoulder impingement syndrome due to overuse.” Id. at 3. He recommended PT
two times per week for four-to-six weeks. Id.
Petitioner had a total of eight PT sessions at Asante from February 12, 2016 to July 1, 2016.
Pet’r’s Ex. 13 at 3, ECF No. 20. Petitioner made a PT re-certification request on July 1, 2016. Id.
In the PT re-certification and plan of care report, Mr. Donato noted that Petitioner had “[p]ersistent
right shoulder pain (6/10) with radiation to his right arm with numbness in his right dorsal hand.”
Id. Petitioner described his pain as “dull [and] achy.” Id. at 4. Petitioner also reported that “his left
shoulder ha[d] improved by about [ten percent] since beginning therapy.” Id. at 3. Petitioner stated
that his condition, particularly in the left side, was aggravated when “[r]eaching overhead, lifting,
[or] carrying objects.” Id. at 4. A physical examination revealed “no redness, bruising or swelling
33
Gabapentin is “an anticonvulsant that is a structural analogue of γ-aminobutyric acid (GABA), used as
adjunctive therapy in the treatment of partial seizures.” Dorland’s at 753.
9
noted in the shoulders . . . no significant tenderness . . . in the right shoulder, but . . . significant
atrophy . . . in the right triceps and pectoralis musculature.” Id.
In July and August 2016, Petitioner underwent six additional PT sessions. See id. at 6–11;
Pet’r’s Ex. 18, ECF No. 26-2. Petitioner continued to complain of “persistent mild to moderate
pain and weakness in his left shoulder especially with overhead activities, and a persistent pain in
his right[-]side neck/shoulder region that radiate[d] down to his right hand.” See Pet’r’s Ex. 18 at
2. He also reported that “the pain in his right shoulder [was] more bothersome to him than his left
shoulder.” Id. At his last PT session on August 3, 2016, Petitioner reported that he was “[f]eeling
like it [was] not getting any better[;] left side maybe slightly.” Id. at 1.
B. Petitioner’s Affidavits
Petitioner submitted three separate affidavits in support of his claim. Petitioner executed
his first affidavit on December 20, 2015, but it was not filed until June 11, 2019. Pet’r’s Ex. 89,
ECF No. 69. In this affidavit, Petitioner adopted all the statements made in his petition as true
under penalty of law. Id. at 1–2. Petitioner also noted that, although “fairly accurate,” 34 the medical
records “do not reflect all discussions had by and between [his] treating physicians or every detail
of those discussions.” Id. at 1. He also noted that the records sometimes erroneously document that
his pain occurred on his left side rather than on his right. Id. at 1–2.
In the petition, Petitioner stated that “prior to his vaccine injury, [he] enjoyed early morning
gym workouts which included bench pressing [three hundred and fifteen] pounds[.]” Pet. at 1.
Petitioner elaborated that “[o]n the weekends, he enjoyed hiking, biking, boating, snowboarding,
[and] waterboarding[.]” Id. He also wrote that “[h]e owns his own landscaping business,” and that
his work involves “[s]ignificant heavy lifting[,]” with long ten to twelve-hour workdays, five to
six days a week. Id. Petitioner explained that his previous sports injury “would cause moderate
pain in his lower back and later on his left side[]” when it became irritated. Id. at 2. He also noted
that prior to his vaccination, he was “successfully” treating this injury “with the use of methadone
and chiropractic care.” Id.
Petitioner stated that he “continues to suffer” from his PTS and does not receive much
treatment for it. Id. at 3. He explained that he “has not sought out much more treatment as he can
ill afford numerous doctor visits” and because Dr. Ali informed him that “there really was no
treatment[.]” Id. He noted that “the pain on his right comes and goes[]” and that “[t]he intermittent
pain, numbness[,] and tingling in his hands and pain in his arm and shoulder cause[] issues with
daily activities such [as] shaving, brushing his hair[,] and brushing his teeth.” Id. at 4. Petitioner
also reported that his “extreme fatigue and weakness remain[]” and that he can no longer “weight
train as he used to and also go to work.” Id. Petitioner stated that he has been unable “to take part
in his weekend recreational activities[]” because of his PTS. Id. He also noted that “[d]riving has
become difficult[,]” and that on a trip to San Jose, CA, on April 22, 2015, “the pain was so severe[,]
he had to stop and wasn’t sure he would be able to drive home.” Id. at 3–4.
34
Petitioner noted that the records filed in support of his claim sometimes erroneously document that his
pain occurred on his left side rather than on his right side. See Pet’r’s Ex. 89 at 1–2.
10
Petitioner also explained that PTS has affected his professional life as well. He indicated
that he “had to hire an employee to help with what he can no longer complete in a day due to his
fatigue and exhaustion[,]” and he now “has to go home in the middle of the workday to take a
nap.” Id. at 4. He also stated that “his arm especially bothers him when he is installing irrigation
control clocks, digging, raking, lifting, working overhead and trying to lift heavy items.” Id.
Petitioner submitted a supplemental affidavit on December 14, 2017, in the form of a
declarative response to Dr. Leist’s expert report. Pet’r’s Ex. 84, ECF No. 53-1. Petitioner wrote
that his sports injury prior to the vaccination in question was “related to [his] left side, which is
clearly indicated in [his] medical records.” Id. at 1 (emphasis in original). He also noted that he
“developed an immediate pain in [his] right shoulder region[]” after receiving the flu vaccine,
which “was very different from [his] left shoulder [pain].” Id. at 1–2 (emphasis in original).
Petitioner explained that although he did not report the right shoulder pain to a doctor
immediately after the vaccination, he did so when the “pain to [his] right shoulder blade area
commenced on or about February 7, 2013, approximately 24 days after the vaccination[.]” Id. at
2. He indicated that soon after, he called “Thorson chiropractic on February 12, 2013, when the
pain did not go away.” Id. Petitioner also noted that because he had not injured his right shoulder
prior to the vaccination in question, his chiropractor’s notes “clearly indicate[] a new injury on
[his] right side.” Id. (emphasis in original). In response to Dr. Leist’s statement that Petitioner’s
medical records do not indicate his “weakness” until approximately five months after receiving
the vaccine, Petitioner wrote that Dr. Grant’s notes from February 4, 2014, indicating that
Petitioner’s atrophy and weakness lasted “six to nine months[,]” are “consistent with [his]
recollection of events regarding [his] weakness and the commencement of muscle mass loss.” Id.
at 2–3.
Petitioner also expressed that, contrary to Dr. Leist’s claim, his divorce in the spring of
2013 was not “a psychological stressor [that] may have been a cause of [his] brachial neuritis.” Id.
at 3. In fact, Petitioner explained, his “divorce was a very simple, uncontested, and reasonably
amicable dissolution.” Id. Petitioner argued that this is supported by the fact that his “former wife
and [he] lived together during the divorce . . . until [she] could find an appropriate residence.” Id.
Petitioner also noted that he “assisted with [his former wife’s] move” and “did not consider this
mutual dissolution a stressful situation.” Id.
In response to my July 9, 2019 scheduling order, Petitioner submitted his second
supplemental affidavit on August 8, 2019. See Pet’r’s Ex. 95. Petitioner wrote that, “from [his]
interpretation of the Order, [he] ha[d] been asked to provide an explanation for discrepancies
within the medical records regarding the severity of the pain experienced and the onset time.” Id.
at 2. He explained, “[a]s a rule, [he] ha[s] a pretty high tolerance for pain; and, [he is] not one to
complain, in general.” Id. Petitioner further expressed that if he had known he would later require
use of the Program, “[he] would not have been so careless with reporting when the pain actually
started[,] or its severity.” Id.
Petitioner explained that what he did know regarding the time of onset was that “it cause[d
him] to call [his] chiropractor on February 12, 2013 and that the pain had been around for a week
before that.” Id. Petitioner also wrote that he “find[s] it difficult to quantify the intensity of pain
11
when given a scale of 1 to 10.” Id. For example, Petitioner asked, “[w]hat is a 10?” Id. Nonetheless,
Petitioner noted that he reported his pain “was constant, dull, burning[,] and getting worse.” Id.;
see also Pet’r’s Ex. 2 at 3. Yet, Petitioner highlighted that “every doctor described [his] pain
differently.” Pet’r’s Ex. 95 at 3. Petitioner noted that the doctor who described his pain as starting
“rather insidiously[,]” applied his own terminology since “[t]he word ‘insidiously’ is not a term
[he] ha[s] ever used.” Id. However, Petitioner clarified that the pain in his neck and shoulder “was
suddenly there and with great intensity about a week before [he] saw [his] chiropractor on February
14, 2013.” Id.
III. Expert Reports
A. Petitioner’s Expert, M. Eric Gershwin, M.D., M.A.C.P., M.A.C.R.
Dr. Gershwin received his medical degree from Stanford University in 1971. Pet’r’s Ex.
24 at 1, ECF No. 41-2. He is licensed to practice in several states, including California, and holds
board-certifications in internal medicine, internal medicine with a subspecialty in rheumatology,
and allergy and clinical immunology. Id. at 2. He also holds a Master of Science in Astronomy
and Astrophysics from the Centre for Astrophysics and Supercomputing in Melbourne, Australia.
Id. Dr. Gershwin has an honorary doctorate, or “Honoris Causa,” from the University of Athens,
Greece, in recognition of his lifetime contributions in immunology and medicine. Id. Dr. Gershwin
has also been awarded the AESKU Prize in Autoimmunity for his lifetime contribution in
immunology, and the Vasco Da Gama Prize for “a lifetime of deep explorations in immunology
to benefit mankind.” Id.
Dr. Gershwin’s post-doctoral training includes a two-year residency at the Tufts-New
England Medical Center in Boston, Massachusetts, two years as a clinical associate in immunology
at the National Institutes of Health in Bethesda, Maryland, and two years as an Assistant Professor
of Medicine in Rheumatology and Allergy at the University of California School of Medicine in
Davis, California (“UC Davis”). Id. at 2. Dr. Gershwin then went on to become the Director of the
Special Immunology Diagnostic Laboratory at UC Davis. Id. He has been a Professor of Medicine,
specializing in Rheumatology and Allergy, at UC Davis since 1981 and a Chief of the Division of
Rheumatology/Allergy and Clinical Immunology since 1982. Id. at 1.
Dr. Gershwin is also a fellow with the American Academy of Allergy and Immunology,
the American College of Physicians, and the American College of Rheumatology. Id. at 3–4. He
currently serves as the editor-in-chief for the Journal of Autoimmunity and Clinical Reviews in
Allergy, as co-editor-in-chief for Autoimmunity Reviews, and as co-editor for Reviews in
Autoimmunity. Id. at 5. Dr. Gershwin’s curriculum vitae lists numerous books, book chapters, and
research papers of which he is a listed author. See id. at 8–125.
Dr. Gershwin submitted one expert report and four supplemental reports in this case. See
Pet’r’s Ex. 23, ECF No. 41-1; Pet’r’s Ex. 80, ECF No. 51-1; Pet’r’s Ex. 85, ECF No. 58-1; Pet’r’s
Ex. 90, ECF No. 72-1; Pet’r’s Ex. 96, ECF No. 77-1.
12
1. Dr. Gershwin’s Expert Report
Dr. Gershwin submitted his expert report on June 8, 2017. Pet’r’s Ex. 23. Dr. Gershwin
opined that Petitioner’s PTS, “or right-sided brachial plexus neuritis[,] . . . occurred because of the
inflammatory response secondary to the influenza vaccine that he received on January 14, 2013.”
Id. at 5. He noted that “the inflammatory response and, in particular, the homing and traffic
following inflammatory stimulation[,] . . . led to this injury.” Id.
Dr. Gershwin wrote that PTS is a “rare disorder,” affecting “1.64 cases per [one hundred
thousand]” 35 people annually, that is “typically characterized by an abrupt onset of upper extremity
pain followed by progressive neurologic deficits, including weakness, atrophy, and occasionally
sensory abnormalities.” 36 Id. at 2. He also noted that the acute form of brachial neuritis “is
characterized by a rapid or acute onset of pain, accompanied by profound weakness.” Id. Dr.
Gershwin explained that although the etiology of PTS is “unknown[,] . . . the inciting event may
be trauma, extreme exercise, surgery, childbirth, bacterial, viral or parasitic infections,
immunization[,] or botulinum toxin A injection.” 37 Id. He did note, however, that “in most cases
there is no obvious precipitating event.” Id. Dr. Gershwin further explained that “[t]he diagnosis
is made on the basis of the medical history, the presence of decreased muscle strength and atrophy,
the electrophysiologic findings[,] and the exclusion of other possible causes . . . .” 38 Id. Dr.
Gershwin cited a case study by Devathasan et al. of twenty-one patients with neuralgic amyotrophy
to note that the five criteria proposed for diagnosing PTS are, “weakness of the shoulder muscles,
exclusion of other possible causes of the shoulder problem, pain in the affected region,
electromyographic findings, and spontaneous recovery, whether complete or incomplete.” 39 Id.
The authors of the study concluded that “[w]hile the first two [criteria] are taken as absolute
criteria, the remaining three are very characteristic but may not be present when the patient is first
seen.” See Pet’r’s Ex. 47 at 1, ECF No. 43-5.
35
Citing Pet’r’s Ex. 44, ECF No. 43-2, Beghi E., et al., Brachial Plexus Neuropathy in the Population of
Rochester, Minnesota, 1970–1981, ANN. NEUROL. 1985; 18:320–23.
36
Citing Pet’r’s Ex. 25, ECF No. 41-3, Smith C.C., & Bevelaqua A.C., Challenging Pain Syndromes:
Parsonage-Turner Syndrome, PHYS. MED. REHABIL. CLIN. N. AM. 2014; 25:265–77.
37
Citing Pet’r’s Ex. 37, ECF No. 42-5, Vanermen B., et al., The Syndrome of Parsonage and Turner.
Discussion of Clinical Features with a Review of 8 Cases, ACTA. ORTHO. BELG. 1991; 57:414–19; Pet’r’s
Ex. 40, ECF No. 42-8, Malamut R.I., et al., Postsurgical Idiopathic Brachial Neuritis, MUSCLE NERVE
1994; 17:320–24; Pet’r’s Ex. 41, ECF No. 42-9, Lederman R.J. & Wilbourn A.J., Postpartum Neuralgic
Amyotrophy, NEUROL. 1996; 47:1213–19; Pet’r’s Ex. 42, ECF No. 42-10, Hamati-Haddad A. & Fenichel
G.M., Brachial Neuritis Following Routine Childhood Immunization for Diphtheria, Tetanus, and Pertussis
(DTP): Report of Two Cases and Review of the Literature, PEDIATRICS 1997; 99:602–03; Pet’r’s Ex. 43,
ECF No. 43-1, Sheean G.L., et al., Pain and Remote Weakness in Limbs Injected with Botulinum Toxin A
for Writer’s Cramp, LANCET 1995; 346:154–56.
38
Citing Pet’r’s Ex. 45, ECF No. 43-3, Flaggman P.D. & Kelly J.J., Jr., Brachial Plexus Neuropathy. An
Electrophysiologic Evaluation, ARCH. NEUROL. 1980; 37:160–64; Pet’r’s Ex. 46, ECF No. 43-4,
Subramony S.H., AAEE Case Report #14: Neuralgic Amyotrophy (Acute Brachial Neuropathy), MUSCLE
NERVE 1988; 11:39–44.
39
Citing Pet’r’s Ex. 47, ECF No. 43-5, Devathasan G. & Tong H.I., Neuralgic Amyotrophy: Criteria for
Diagnosis and a Clinical with Electromyographic Study of 21 Cases, AUST. N. Z. J. MED. 1980; 10:188–
91.
13
Dr. Gershwin opined that, based on Petitioner’s medical records and the above facts
regarding PTS, Petitioner’s PTS is not the result of a trauma but instead “is secondary to the
inflammatory response to the vaccination” in question. Pet’r’s Ex. 23 at 3. Dr. Gershwin explained
that “[t]he vaccination produced a significant cytokine response that facilitated recruiting and
homing of lymphocytes.” Id. He wrote that this “[r]ecruitment of white cells or leukocytes is a
critical response to virtually everything from infection to non-specific tissue injury and in fact
interplays with diseases as diverse as rheumatoid arthritis, 40 atherosclerosis 41[,] and virtually every
other autoimmune disease.” 42 Id. Dr. Gershwin relied on the literature to explain that “flowing
leucocytes roll along the endothelium, 43 in a manner dependent on the binding of selectins 44 to
their ligands.” 45, 46 Id. “The rolling-dependent slowing down of leucocytes,” he continued,
“promotes the exposure of leucocytes to chemokines deposited on the endothelial cell surface.” 47
Id. Chemokines then “induce the activation of leucocyte and their integrins, thereby promoting
high-affinity integrin-dependent firm leucocyte arrest.” Id. Dr. Gershwin also explained that
“[s]electin-mediated and integrin-dependent adhesive events synergize in the process of slow
rolling, which follows fast rolling and precedes firm [leucocyte] arrest[.]” 48 Id. Dr. Gershwin
40
Rheumatoid arthritis is defined as “a chronic systemic disease primarily of the joints, usually
polyarticular, marked by inflammatory changes in the synovial membranes and articular structures and by
muscle atrophy and rarefaction of the bones. In late stages, deformity and ankylosis develop. The cause is
unknown, but autoimmune mechanisms and virus infection have been postulated.” Dorland’s at 157.
41
Atherosclerosis is “a common form of arteriosclerosis with formation of deposits of yellowish plaques
(atheromas) containing cholesterol, lipoid material, and lipophages in the intima and inner media of large
and medium-sized arteries.” Dorland’s at 172. Arteriosclerosis is “characterized by thickening and loss of
elasticity of arterial walls.” Id. at 144.
42
Citing Pet’r’s Ex. 57, ECF No. 44-5, Chavakis T., Leucocyte Recruitment in Inflammation and Novel
Endogenous Negative Regulators Thereof, EUR. J. CLIN. INVEST. 2012; 42:686–91.
43
The endothelium is “the layer of epithelial cells that lines the interior of structures such as the cavities of
the heart, the lumina of blood and lymph vessels, and the serous cavities of the body; it originates from the
mesoderm.” Dorland’s at 621.
44
The function of selectins is to “mediate the binding of leukocytes to the vascular endothelium.” Dorland’s
at 1689.
45
A ligand is “a molecule that binds to another molecule, used especially to refer to a small molecule that
binds specifically to a larger molecule, e.g., an antigen binding to an antibody, a hormone or
neurotransmitter binding to a receptor, or a substrate or allosteric effector binding to an enzyme . . . .”
Dorland’s at 1051.
46
See Chavakis, supra note 42, at 686–91.
47
Citing Pet’r’s Ex. 59, ECF No. 44-7, Chavakis E., et al., Novel Aspects in the Regulation of the Leukocyte
Adhesion Cascade, THROMB. HAEMOST. 2009; 102:191–97; Pet’r’s Ex. 64, ECF No. 45-2, Hyduk S.J., et
al., Phospholipase C, Calcium, and Calmodulin Are Critical for Alpha4betal Integrin Affinity Up-
regulation and Monocyte Arrest Triggered by Chemoattractants, BLOOD 2007; 109:176–84; Pet’r’s Ex. 65,
ECF No. 45-3, Kinashi T., Intracellular Signalling Controlling Integrin Activation in Lymphocytes, NAT.
REV. IMMUNOL. 2005; 5:546–59; Pet’r’s Ex. 66, ECF No. 45-4, Lafuente E. & Boussiotis V.A., Rap1
Regulation of RIAM and Cell Adhesion, METHODS ENZYMOL. 2006; 407:345–58; Pet’r’s Ex. 67, ECF No.
45-5, Shamri R., et al., Lymphocyte Arrest Requires Instantaneous Induction of an Extended LFA-1
Conformation Mediated by Endothelium-bound Chemokines, NAT. IMMUNOL. 2005; 6:497–506.
48
Citing Pet’r’s Ex. 73, ECF No. 43-1, Zarbock A., et al., Spleen Tyrosine Kinase Syk is Necessary for E-
selectin-induced Alpha(L)beta(2) Integrin-mediated Rolling on Intercellular Adhesion Molecule-1,
IMMUNITY 2007; 26:773–83; Pet’r’s Ex. 75, ECF No. 46-3, Salas A., et al., Rolling Adhesion Through an
Extended Conformation of Integrin AlphaLbeta2 and Relation to Alpha I and Beta I-like Domain
14
stressed the immune response’s dependence “on the ‘co-ordination of lymphocyte migration.’” 49
Id. He explained that the “orchestration of immune cell movement is provided by specific homing
signals that leucocytes receive via chemokines and chemokine receptors.” Id. at 3–4. He also noted
that chemokines “are key factors in lymphocyte trafficking[]” and their “biology is exerted through
chemokine receptors,” which “are particularly amenable to pharmacological blockade with small
molecule inhibitors or receptor antagonists.” Id. at 4.
Regarding the timing of onset of Petitioner’s PTS symptoms, Dr. Gershwin stated that they
“are consistent with what we would expect.” Id. Specifically, Dr. Gershwin wrote that “the new
onset of severe discomfort in [Petitioner’s] right shoulder” occurred approximately three weeks
post-vaccination, i.e., on February 7, 2013. Id. He then used the example of tetanus toxoid-type
vaccinations to gauge onset, arguing that “the vaccine injury table acknowledges that the onset of
brachial neuritis could be anywhere between [two to twenty-eight] days.” Id. He also argued that
“the original report by Parsonage and Turner from Lancet in 1948 specifically points [vaccination]
out as a precipitating factor[,]” with eleven out of sixty-seven vaccinees developing shoulder-
girdle symptoms four weeks post-vaccination and six within two weeks. 50 Id. However, the
original report by Parsonage and Turner discusses one specific case of a man “given intravenous
T.A.B. 51. . .” rather than the influenza vaccine. See Pet’r’s Ex. 31 at 2. The authors continued,
“[t]wo hours later he developed severe pain across the back of both shoulders, . . .” and the next
day “he developed a complete paralysis of the left serratus magnus. 52” Id. Dr. Gershwin
emphasized:
the initial (can be microscopic) onset of inflammation would occur within days but
the expansion that will produce the requisite magnitude of inflammation to become
clinically significant will vary between individuals, . . . and can take much longer
for a clinical response to be perceived as neuropathic to the patient; [six] weeks
would be the outside limits.
Pet’r’s Ex. 23 at 4. He argued that although tetanus vaccinations are most commonly cited because,
like the flu vaccine, they are “often given multiple times to patients over a lifetime and therefore
more likely to elicit an immediate and more intense response[] . . . any vaccine including influenza
can have the same potential, dictated by previous exposure and/or the nature and intensity of an
individual response to a vaccination.” Id. Overall, Dr. Gershwin concluded that, more likely than
not, Petitioner’s flu vaccination led to his PTS.
Interaction, IMMUNITY 2004; 20:393–406.
49
Citing Pet’r’s Ex. 76, ECF No. 46-4, Comerford I., et al., Advances in Understanding the Pathogenesis
of Autoimmune Disorders: Focus on Chemokines and Lymphocyte Trafficking, BR. J. HAEMATOL. 2014;
164:329–41.
50
Citing Pet’r’s Ex. 31, ECF No. 41-9, Parsonage M.J. & Turner J.W., Neuralgic Amyotrophy; the
Shoulder-girdle Syndrome, LANCET 1948; 1:973–78.
51
This vaccine is used to fight against typhoid fever. Pet’r’s Ex. 31 at 1–2.
52
The serratus magnus is one of the serratus muscles of the shoulder and thorax. Dorland’s at 1201.
15
2. Dr. Gershwin’s First Supplemental Expert Report
In response to Dr. Leist’s responsive expert report, Dr. Gershwin submitted his first
supplemental expert report on November 21, 2017. Pet’r’s Ex. 80. In his report, Dr. Gershwin first
addressed certain “factual errors” Dr. Leist made in his report. Id. at 1. Dr. Gershwin noted, as an
example, that in “a number of notations[,]” Dr. Leist failed to make the distinction that Petitioner’s
pre-vaccine sports injury was “on [Petitioner’s] lower back and his ‘left’ side.” Id. (emphasis in
original). Dr. Gershwin opined that “one could interpret this lack of clarity as an indication that
[Petitioner] had a pre-existing injury[; h]e did have a pre-existing injury but it was to his left side.”
Id. He then clarified that Petitioner’s “post[-]vaccine injury was to his right side.” Id. (emphasis
in original).
Next, Dr. Gershwin highlighted the differences with respect to his and Dr. Leist’s
interpretation of the mechanisms which led to Petitioner’s PTS. See id. First, Dr. Gershwin stated
that he was “surprised” that Dr. Leist analogized PTS and Guillain-Barré syndrome (“GBS”) to
explain that the time interval for the onset of symptoms is similar in both illnesses. Id. Dr.
Gershwin indicated that “there are no immunological similarities between Guillain-Barr[é] and
Parsonage Turner.” Id. He continued that “the latency time between the onset of autoimmune
diseases and the first appearance of autoantibodies can range from days to years.” Id. But he argued
that even if the timing of onset between the two diseases was the same, Petitioner’s phone call to
his chiropractor on February 12, 2013, and subsequent visit two days later show that the onset of
his symptoms “commenced around February 5, 2013[,] directly down the strike zone of Dr. Leist’s
opinion as to when one would see first onset symptoms in a GBS case.” Id. at 1–2. Dr. Gershwin
expressed his opinion that he “do[es] not interpret the records to indicate that [Petitioner’s] onset
symptoms occurred five-(5) month[s] after administration of the influenza vaccine.” Id. at 2.
Further, Dr. Gershwin noted that Dr. Leist cited a case report by Weintraub and Chia 53 to
argue that muscle atrophy occurs within two weeks post-vaccination in PTS cases and not five
months later as reported in Petitioner’s case. Id. However, Dr. Gershwin argued that “the spectrum
of how Parsonage Turner can evolve is vast and does not turn on just one case report.” Id. He also
argued that Petitioner’s reporting of right pectoral muscle atrophy on July 8, 2013, does not
necessarily mean that that was the onset of his weakness but simply the date on which it “was
reported and recorded in a medical record.” Id. (emphasis in original).
Additionally, Dr. Gershwin opined that Petitioner’s weakness is not the most important
symptom because “it is not the heralding event” of PTS. Id. Rather, he explained, the Vaccine
Injury Table’s “Qualifications and Aid to Interpretation [for PTS] “states, among other things[,]
that ‘a deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset
of the condition.’” 54 Id. (emphasis in original). Dr. Gershwin opined “that’s exactly what we have
here in [Petitioner’s] case[,]” and argued that although “the medical records are unclear as to when
the weakness commenced[,]” they clearly show when Petitioner’s pain commenced, as the “quality
of his workouts changed significantly” at that time. Id. Dr. Gershwin also wrote that “most vaccine
injuries are, by definition, atypical[,]” with “approximately [fifteen percent] of [PTS] cases
53
Citing Resp’t’s Ex. A-2, ECF No. 49-3, Weintraub M.I. & Chia D.T.S., Paralytic Brachial Neuritis After
Swine Flu Vaccination, ARCH. NEUROL. 1977; 34:518.
54
See 42 U.S.C.A. § 300aa-14(c)(6).
16
occur[ring] after immunization.” 55 Id. He also noted that PTS “is typically characterized by an
abrupt onset of upper extremity pain followed by progressive neurologic deficits, including
weakness, atrophy and occasionally sensory abnormalities[,]” as seen in Petitioner’s case. Id. Dr.
Gershwin also cited the van Alfen and van Engelen study, 56 which included two-hundred and
forty-six PTS patients, to show that pain was the most important onset symptom, with weakness
appearing “in 27.2 [percent] of all cases . . . [more] than two weeks later.” Id.
Dr. Gershwin noted that Dr. Leist used the van Alfen and van Engelen study to specify four
events as a cause for PTS: “infection, exercise, surgery[,] and peripartal.” Id. at 3. However, Dr.
Gershwin argued that the study authors themselves “indicated that the broad range of symptoms
encountered in their study could be influenced by the fact that about a third of the patients were
especially referred to their center because of a somehow atypical clinical picture, according to their
referring physician.” Id. He also wrote that the letter to the editor 57 cited by Dr. Leist
“acknowledges that Parsonage Turner may occur after inoculations[,]” and that “‘[t]he cause of
paralytic brachial neuritis usually is considered to be a post[-]infectious reaction or a reaction
secondary to an allergic or hypersensitivity response.’” Id. Additionally, Dr. Gershwin explained
that, unlike Dr. Leist’s claims to the contrary, Petitioner’s divorce could not have led to his PTS
because his “divorce was reasonably amicable and [was] an undisputed divorce done by a
paralegal.” Id. Regarding Dr. Leist’s claim that Petitioner’s exercise regimen could have caused
his PTS, Dr. Gershwin opined that that would “be unlikely as [Petitioner] had been in sports . . .
quite some time without brachial neuritis, but, developed Parsonage Turner/brachial neuritis right
after the flu vaccine.” Id. Therefore, his opinion remained unchanged that “more likely than not[,]
it was the flu vaccine that caused Parsonage Turner, or at [a] minimum, was the substantial factor
in causing it.” Id.
Lastly, Dr. Gershwin reiterated that “vaccination promotes inflammation in the draining
lymph node, something which is directly relevant to [Petitioner].” Id. Specifically, Dr. Gershwin
opined that “genetic predisposition is critical to understanding the rare events that can occur in
individuals following vaccination[,]” implying that genetic predisposition could have played a role
in the instant case. Id. He also explained that “[t]he mechanism by which inflammation influences
the adaptive response to vaccines is not fully understood.” Id. Nevertheless, he continued, lymph
node macrophages (“LNMs”) play an important role “in the induction of the cytokine storm
triggered by inactivated influenza virus vaccine.” Id. He explained that “LNMs undergo
inflammasome-independent necrosis-like death [post vaccination, which] . . . releases prestored
interleukin-lα (IL-lα).” Id. “[A]ctivated medullary macrophages [also] produce interferon-β (IFN-
β) that induces the autocrine secretion of IL-1α.” Id. He continued, “macrophage depletion
promotes lymph node-resident dendritic cell (“LNDC”) relocation and affects the capacity of CDl
lb+ LNDCs to capture virus and express co-stimulatory molecules.” Id. Thus, “[i]nhibition of the
IL-lα-induced inflammatory cascade reduce[s] B cell responses, while co-administration of
recombinant IL-1α increase[s] the humoral response.” Id.
55
See Smith & Bevalaqua, supra note 36, at 265–77.
56
See Pet’r’s Ex. 26, ECF No. 41-4, van Alfen N. & van Engelen B.G., The Clinical Spectrum of Neuralgic
Amyotrophy in 246 Cases, BRAIN 2006; 129:438–50.
57
See Weintraub & Chia, supra note 53, at 518.
17
3. Dr. Gershwin’s Second Supplemental Expert Report
Dr. Gershwin submitted his second supplemental expert report on March 20, 2018, in
response to Dr. Leist’s first supplemental report. Pet’r’s Ex. 85. In his report, Dr. Gershwin
explained “the mechanism of [Petitioner’s] injury relates entirely to the milestones and chain of
events that occurred following his vaccination.” Id. at 1. He then addressed “critical notations
within the records” which he believes Dr. Leist “missed . . . that make his interpretation of the
chronology incorrect.” Id.
Dr. Gershwin expressed that it is important to understand the progression of PTS in order
to appreciate the onset of PTS symptoms in Petitioner. Id. Dr. Gershwin explained that the
symptoms of PTS “can vary from acute to insidious[,]” with “[a]cute onset [being] characterized
by pain in the shoulder or upper arm, while insidious onset can manifest as progressive pain,
evolving numbness, weakness of selected muscles, or any combination.” 58 Id. In the early stages
of the disease, he continued, “distinguishing between symptoms arising from bones and ligaments
about the shoulder and those from nerves in the plexus may be difficult.” Id. He also wrote, “[a]cute
onset, in the absence of trauma, favors a metabolic or inflammatory process[,]” while clinical signs
“include muscle weakness, atrophy, and sensory loss.” Id. Additionally, because “it may be
difficult to distinguish true weakness from reduced effort due to pain[,] . . . [m]uscle atrophy may
not be appreciated for several weeks.” Id.
Dr. Gershwin continued his criticisms of Dr. Leist and noted that Dr. Leist characterized
the onset of Petitioner’s PTS by the sensation of weakness five months post-vaccination, thereby
“ignor[ing an] . . . earlier notation of pain within the records.” Id. at 2. Thus, he argued, Dr. Leist
erroneously “concludes that the onset is too late for a vaccine association.” Id. By contrast, he
argued, based on Petitioner’s medical records, “the onset would be approximately February 4,
2013, with weakness occurring a week or two after the visit to the chiropractor.” Id. Dr. Gershwin
also pointed out “that this chronology of [Petitioner’s] symptoms is very consistent with the
description” he provided of PTS. Id.
Dr. Gershwin also wrote that “[he] cannot understand why Dr. Leist believes that the
influenza vaccine was not administered in the right deltoid muscle.” Id. He continued that Dr. Leist
misinterpreted Dr. Ali’s notes in his assessment of Petitioner’s injury during his June 23, 2014
visit. Id. Specifically, Dr. Gershwin argued that Dr. Leist “t[ook] one sentence from a medical
record note out of context when compared to the totality of the records.” Id. He argued that Dr.
Leist failed to interpret the notation “from the patient perspective, who . . . differentiates between
his shoulder blade region from his right deltoid muscle, the deltoid, being . . . the site where most
arm vaccines are administered.” Id. (emphasis added). He also noted that Petitioner’s earlier
chiropractor records state that Petitioner “‘developed severe pain in his right shoulder blade
area.’” 59 Id. (emphasis in original). Dr. Gershwin therefore argued that the record in its totality
shows that “the vaccine was given in the right deltoid muscle, which is not the same area as where
the pain commenced[]”– the right shoulder blade area. Id.
58
Dr. Gershwin relies on an excerpt from the UpToDate website regarding brachial plexus syndrome,
available at https://www.UpToDate.com/contents/brachial-plexus-syndromes/print.
59
Citing Pet’r’s Ex. 2 at 4–5.
18
Dr. Gershwin stated that Dr. Leist’s disagreement with the lymph node drainage
mechanism proposed by Dr. Gershwin is “a misinterpretation.” Id. He explained that “virtually
every physician is aware of the local swelling of lymph nodes which can occur following a
vaccination[,]” and that “injections in either arm can produce bilateral swelling.” Id. (emphasis in
original). He therefore argued that “it does not matter which arm received the injection[]” in
Petitioner’s case. Id. In fact, he continued, “the Vaccine Injury Table – Qualifications and Aids to
Interpretation for Brachial Neuritis (c)(6) acknowledges this point[,]” explaining that “‘[t]he
neuritis, or plexopathy, may be present on the same side or on the side opposite the injection. It is
sometimes bilateral, affecting both upper extremities . . . .’” 60 Id.
Dr. Gershwin concluded by arguing that Dr. Leist was incorrect in asserting that “‘the onset
of weakness reported by [Petitioner] on July 8, 2013[,] to have arisen two months earlier . . . is
outside the time window . . . for an immune complication following non-live influenza vaccine.’” 61
Id. at 3. He argued that Dr. Leist misinterpreted the relevant medical record, which states that
Petitioner reported that he had been “‘very weak and ha[d] lost a lot of strength on his right[-]side
x 2 months.’” 62 Id. A closer reading of the notation, Dr. Gershwin argued, shows that Petitioner
did not report that his weakness had occurred two months before July 8, 2013. Id. Overall, Dr.
Gershwin opined that Dr. Leist had not read or interpreted the medical records correctly. Id.
4. Dr. Gershwin’s Third Supplemental Expert Report
Dr. Gershwin submitted his third supplemental expert report on August 8, 2019, in
response to my order requesting a more concise report regarding the causation theory as it applies
to Petitioner’s PTS. Pet’r’s Ex. 90 at 1. In support of his arguments in this report, Dr. Gershwin
submitted literature generally describing the mechanics of lymph circulation. 63 Id. at 2. Based on
this, Dr. Gershwin maintained that Petitioner developed PTS due to the flu vaccine. Id. He relied
on the fact that “[Petitioner’s] right upper extremity had no significant pathology prior to
vaccination[] . . . [and t]here are no other physical insults that [he] ha[s] found within the medical
records . . . that can explain the development of PTS.” Id. at 1–2.
Dr. Gershwin further explained that, “[f]ollowing [a] vaccination, one would expect the
development and recruitment of regional lymph nodes . . . [which] may lead to localized pain at
the injection site.” Id. at 1. This recruitment of such lymphocytes and the successful development
of vaccine antibodies requires the immune system to process the vaccine. Id. Doing so “lead[s] to
lymphocyte activation, particularly in regional lymph nodes.” Id. Dr. Gershwin applied the concept
of lymphocyte activation to Petitioner’s PTS and opined that Petitioner’s “pain in his right shoulder
blade area approximately three weeks following the vaccination[,] . . . would be consistent with
irritation and pressure from expanding regional lymph nodes secondary to the vaccine.” Id. Dr.
60
See 42 U.S.C.A. § 300aa-14(c)(6).
61
Citing Resp’t’s Ex. C at 4.
62
Citing Pet’r’s Ex. 1 at 30.
63
Pet’r’s Ex. 92, ECF No. 72-3, Reddy N.P., Lymph circulation: physiology, pharmacology, and
biomechanics, CRIT. REV. BIOMED. ENG. v. 14(n. 1), 1986, p. 45–91; Pet’r’s Ex. 93, ECF No. 72-4,
Moore J.E., et al., Lymphatic System Flows, ANN. REV. FLUID MECH. 2018; 50:459–82; Pet’r’s Ex. 94,
ECF No. 72-5, Macdonald A.J., et al., Modeling flow in collecting lymphatic vessels: one-dimensional flow
through a series of contractile elements, AM. J. PHYSIOL. HEART CIRC. PHYSIOL. 2008; 295:H305–313.
19
Gershwin asserted that had a physical or CT scan been performed by Petitioner’s chiropractor
during his February 14, 2013, examination, it would have been “consistent with an inflammatory
pressure impinging on his brachial plexus.” Id.
Dr. Gershwin cited the Shaikh et al. case study 64 to analogize Petitioner’s case with a 46-
year-old woman who developed PTS following an influenza vaccine. Id. The subject of the Shaikh
et al. study presented “with a month’s history of severe left shoulder pain[]” with acute onset
“developing a few days after an influenza vaccination in the left deltoid muscle.” See Pet’r’s Ex.
91 at 1. ECF No. 72-2. Dr. Gershwin argued that, like Petitioner, the woman in the study also
developed weakness soon-after the onset of pain and was subsequently diagnosed with brachial
neuritis. Id. In an effort to further clarify the theory of causation as it relates to the flu vaccine and
Petitioner’s PTS, Dr. Gershwin pointed to several pieces of submitted literature explaining
generally that “a number of cases of PTS following various vaccines, including the influenza
vaccine, have been reported.” 65 Pet’r’s Ex. 90 at 1. Dr. Gershwin maintained “the flow of
lymphatics as well as the response to antigenic challenges is well[-]known and anatomically
explicable [to Petitioner’s case].” 66 Id. at 2. He therefore relied on this “medically accepted”
principle to conclude Petitioner’s PTS was caused by the flu vaccine. Id.
5. Dr. Gershwin’s Fourth Supplemental Expert Report
Dr. Gershwin submitted his fourth and final supplemental expert report on November 26,
2019, in response to Dr. Leist’s second supplemental report. Pet’r’s Ex. 96. In this report, Dr.
Gershwin was quick to note that Dr. Leist’s latest report “presented no new argument.” Id. at 1.
However, Dr. Gershwin highlighted that Dr. Leist relied on “irrelevant information” to argue that
“the lymphadenopathy leading to compression of the brachial plexus was not listed in the
prescribing information[]” for the Afluria injection, or flu vaccine. Id. Dr. Gershwin stated that Dr.
Leist submitted a package insert for the Afluria injection “relating to the 2017–2018 formula.” Id.
(emphasis in original). He argued, this package insert is, in fact, inapplicable to Petitioner’s case
because Petitioner received the 2013 formula of the Afluria injection. Id. A comparison of the
package inserts from 2013 67 and 2017–2018 68 shows the contents of the respective vaccines are
“completely different.” Id. (emphasis in original). Therefore, he argued, Dr. Leist’s reliance on this
insert is wholly irrelevant. Id.
Dr. Gershwin questioned Dr. Leist’s assertion that the “influenza vaccine could cause
lymphadenopathy leading to compression of the brachial plexus” stating this information was not
listed in the prescribing information for Afluria. Id. He argued that both package inserts indicate
“that nervous system disorders, including neuropathy and GBS have been reported.” 69 Id.
(emphasis in original). Dr. Gershwin opined that “[j]ust like GBS, [PTS] a.k.a. brachial neuritis is
64
Citing Pet’r’s Ex. 91, ECF No. 72-1, Shaikh M.F., et al., Acute brachial neuritis following influenza
vaccination, BMJ CASE REPORTS 2012.
65
Citing Pet’r’s Ex. 38 at 4, ECF No. 42-6, Tsairis P., et al., Natural History of Brachial Plexus Neuropathy:
Report on 99 Patients, ARCH. NEUROL. 1972; 27:110; see also Shaikh, supra note 64.
66
See generally, supra note 63.
67
Citing Pet’r’s Ex. 97 at 5, 9, ECF No. 77-2.
68
Citing Resp’t’s Ex. D-1 at 3, 5–6, ECF No. 75-2.
69
Citing Pet’r’s Ex. 97 at 10; Resp’t’s Ex. D-1 at 11.
20
a form of peripheral neuropathy.” Id. at 2. (emphasis in original). Dr. Gershwin continued that
“[i]t is readily accepted that GBS, a peripheral neuropathy, may commence after a flu vaccine
almost immediately and up to [six]…to [eight] weeks after the receipt of a flu vaccine.” Id. He
compared GBS to PTS, which may also be “a table case if the symptoms began within [two]-
[twenty-eight] days.” Id. He noted that “the heralding onset symptom of pain[]” in Petitioner’s
case “commenced approximately [three] weeks after the receipt of his [flu] vaccine.” Id. Based on
this, Dr. Gershwin concluded that Petitioner’s onset symptom of pain “fits very nicely within the
time parameters” set forth for other forms of peripheral neuropathies such as GBS. Id.
B. Respondent’s Expert, Thomas P. Leist, M.D., Ph.D.
Dr. Leist is a board-certified neurologist. Resp’t’s Ex. B at 1–2, ECF No. 49-4. He attended
the University of Zurich, Switzerland, for his undergraduate and doctoral studies in biochemistry.
Id. at 1. Dr. Leist also attended medical school in the United States at the University of Miami in
Florida. Id. He then completed a residency in neurology at Cornell Medical Center/Sloan Kettering
Memorial Cancer Center before becoming a senior clinical staff associate at the National Institutes
of Health in Bethesda, Maryland. Id.
Dr. Leist currently serves as director of the Clinical Neuroimmunology Division at the
Comprehensive Multiple Sclerosis Center. Id. He also serves as a neurology consultant for the
Inglis Foundation, and as director of Hospital-based Neurology Infusion Service. Id. Dr. Leist is
also a professor of neurology at Thomas Jefferson University in Philadelphia, Pennsylvania, where
he directs the Comprehensive Multiple Sclerosis Center and the Clinical Neuroimmunology
Fellowship Program. Id. Dr. Leist has given lectures on Multiple Sclerosis in various locations
around the world, and his curriculum vitae lists numerous books, book chapters, and research
papers of which he is a listed author. Id. at 2–11.
Dr. Leist submitted one expert report and two supplemental expert reports in this case.
Resp’t’s Ex. A, ECF No. 49-1; Resp’t’s Ex. C, ECF No. 56-1; Resp’t’s Ex. D, ECF No. 75-1.
1. Dr. Leist’s Expert Report
Dr. Leist submitted his responsive expert report on October 3, 2017, in response to Dr.
Gershwin’s expert report. Resp’t’s Ex. A. In his report, Dr. Leist described Petitioner’s extensive
“history of shoulder pain that reportedly increased with activity, tenderness of the lumbar and
thoracic region, and foot pain.” Id. at 5. Dr. Leist highlighted that “[t]he contemporary records
document ongoing pain affecting neck and shoulder girdle and spine that had been present for
years[,] and was ongoing on January 14, 2013[]” – the day he received the flu vaccine. Id. He also
focused on the fact that to cope with this ongoing pain, Petitioner “was on long[-]term pain
management with methadone, oxycodone, and cannabis[,] before as well as after January 14,
2013.” 70 Id. He noted that Petitioner’s pain, prior to and leading up to the vaccine, ranked at a “7–
8 out of 10[,] to 5–6 with cannabis[.]” Id. Dr. Leist further noted that Petitioner described his pain
as increasing during the winter but said that taking ‘“[one] OxyContin a day for [two] months []
helps[.]’” 71 Id.
70
Citing Pet’r’s Ex. 1 at 4, 7, 24, 26–27.
71
See id. at 19, 26.
21
Next, Dr. Leist argued that Dr. Gershwin’s assertion that Petitioner “d[id] not have any
traumatic basis for his brachial plexitis[]” erroneously “suggests that trauma represents the only
alternate cause of [PTS] besides vaccinations.” Id. at 8. In fact, he continued, the van Alfen and
van Engelen study 72 analyzed data from two-hundred and forty-six patients with PTS and showed
that “[e]xercise was the second most frequently reported event[,]” whereas “[a] temporal
association with trauma and vaccination were each reported by [five] individuals . . . and so was
psychological stress.” Id. He also noted that Petitioner had been “exercising vigorously and had
been lifting weights when he became aware of the muscle weakness[]” 73 and had been “in the
middle of a divorce in the spring of 2013[.]” 74 Id. He therefore argued that, in his report, Dr.
Gershwin failed to consider “other preceding events associated with [PTS] that were temporally
proximate in [Petitioner’s] case to the onset of weakness in May 2013.” Id.
Dr. Leist opined that the onset of Petitioner’s symptoms, specifically weakness, is outside
the interval expected for PTS. Id. at 7–8. In support of his assertion, Dr. Leist cited a case report
by Weintraub and Chia 75 of a patient with “suspected brachial neuritis/[PTS] following swine flu
vaccination[.]” Id. at 7. Dr. Leist explained that in that case, the patient experienced “paralysis of
the upper extremities” approximately seven days post-vaccination and muscle atrophy within two
weeks. Id. He then compared that finding with Petitioner’s case, stating that “[n]either weakness,
nor worsening symptoms, nor atrophy were present in [Petitioner’s] case [until five] weeks after
vaccination[.]” Id. Dr. Leist did concede, however, that the case report authors “d[id] not provide
information beyond the temporal association of the swine flu vaccine and the observed weakness.”
Id. He also highlighted that Petitioner’s flu vaccine was “distinct from the one the patient in the
case report received[,]” and therefore can only be used on an informative basis. Id.
Dr. Leist noted that, despite previous reports to healthcare practitioners, Petitioner
“reported a [two]-month history [of] weakness in the right pectoralis muscles during follow-up
with [his nurse practitioner] on July 8, 2013.” 76 Id. This interval, he argued, “would put onset of
weakness into early May, or about [five] months after administration of [the] influenza vaccine on
January 14, 2013[, . . . which] is well outside the time interval noted for the patient described by
Weintraub and Chia[,]” who experienced paralysis of the upper extremities within a week of
vaccination. Id. Dr. Leist also considered the time interval reported by Langmuir et al. 77 for GBS
onset after receiving the swine flu vaccination. Id. While Dr. Leist acknowledged that Petitioner
does not have GBS as a result of the swine flu vaccine, he found the comparison can “inform on a
rational time interval during which [PTS] could potentially occur following [an] influenza
vaccination[.]” Id. He noted that the five-month interval in Petitioner’s case “is also well beyond
the [forty-two]-day risk interval” found by Langmuir et al. for GBS. Id. at 8. Based on Petitioner’s
long history of pain and the five-month time interval between vaccination and onset of weakness,
72
See van Alfen & van Engelen, supra note 56.
73
Citing Pet’r’s Ex. 1 at 30.
74
Citing Id. at 26.
75
See Weintraub & Chia, supra note 53, at 518.
76
Citing Pet’r’s Ex. 1 at 30.
77
Citing Resp’t’s Ex. A-1, ECF No. 49-2, Langmuir A., et al., An Epidemiologic And Clinical Evaluation
Of Guillain-Barré Syndrome Reported In Association With The Administration of Swine Influenza
Vaccines, AM. J. EPIDMIOL. 1984; 119:841–79.
22
Dr. Leist opined, to a reasonable degree of medical certainty, that Petitioner did not suffer an injury
related to the flu vaccine he received on January 14, 2013. Id. at 9.
2. Dr. Leist’s Supplemental Expert Report
Dr. Leist submitted his supplemental report on February 27, 2018, in response to Dr.
Gershwin’s first supplemental expert report. Resp’t’s Ex. C. Dr. Leist reiterated his opinion that
Petitioner’s PTS was not caused by the flu vaccine because his weakness developed approximately
five months post-vaccination, which “is beyond the time period described by Langmuir et al. for
[GBS] following influenza vaccine.” Id. at 5. He did not rely on pain as an onset symptom of PTS.
See, e.g., id. at 1–5. Dr. Leist stated that “Dr. Gershwin d[id] not provide specific mechanistic
evidence that shows to a reasonable degree of certainty a link between influenza vaccine and
neuralgic amyotrophy/[PTS].” Id.
Dr. Leist responded to criticisms and comments made by Dr. Gershwin in his first
supplemental expert report. First, regarding the “factual errors” Dr. Gershwin claimed that Dr.
Leist had made in his responsive expert report, Dr. Leist noted that a reading of the records shows
that Petitioner “complained of neck, shoulder, and back pain prior to January 13, 2013.” Id. at 2.
Dr. Leist noted, for example, that Petitioner saw Dr. Grant on January 26, 2009, with “a history of
bilateral carpal tunnel syndrome that was worse on the right than on the left and [he] had undergone
bilateral carpal tunnel surgery.” 78 Id. at 1. Dr. Leist further indicated that numerous records from
Petitioner’s nurse practitioner “from at least April 2010 to at least October 2015[,]” including the
one from the one for January 9, 2013, state “the patient also presents with moderate back and
shoulder pain . . . [but] denies numbness in the left arm and numbness in the right arm.” 79 Id. Dr.
Leist opined “[t]he specific listing of a pertinent negative, absence of numbness of either side,
suggests bilateral neck and shoulder involvement.” Id. He therefore argued that Dr. Gershwin’s
assertion that Petitioner’s symptoms developed “exclusively on the left” prior to January 14, 2013,
is not supported by the record. Id. at 2.
Second, in response to Dr. Gershwin’s criticism of his comparison of PTS with GBS, Dr.
Leist reiterated that such comparison was “introduced only to delineate a time interval based on
reputable scientific information, during which an adverse event following influenza vaccine, a
non-live vaccine, could be expected.” Id. He argued that “Dr. Gershwin’s statement [that] there
are no ‘immunological similarities between [GBS] and [PTS]’ may therefore be viewed as less
accurate when viewed in the context of a putative influenza vaccine[-]induced process . . . .” Id.
Dr. Leist opined that the time interval proposed by Langmuir et al. 80 “for influenza vaccine and
[GBS] represents the best available information regarding the putative timeframe between
influenza vaccine and neuralgic amyotrophy/[PTS].” Id. He therefore argued that the “vaccine[-
]induced mechanisms underlying the alleged adverse events would likely have to be significantly
the same.” Id.
Third, Dr. Leist addressed Dr. Gershwin’s assertion that “‘the latency time between the
onset of autoimmune disease and the first appearance of autoantibodies can range from days to
78
Citing Pet’r’s Ex. 3 at 1.
79
Citing Pet’r’s Ex. 1 at 26.
80
See Langmuir et al., supra note 77.
23
years[.]’” Id. at 3. Dr. Leist argued that “the suggestion that a prior vaccination could cause
autoimmune disease even years later would have to be viewed as speculative.” Id. He reiterated
that the “vaccine-induced mechanisms underlying alleged adverse events, including [GBS and] . .
. neuralgic amyotrophy/[PTS] would likely have to be significantly the same.” Id. Thus, he
continued, because no correlation between vaccination and PTS has been established, “it is not
known what an appropriated timeframe for neuralgic amyotrophy/[PTS] following influenza
vaccine might be.” Id. Nonetheless, Dr. Leist argued an association between the flu vaccine and
GBS, as well as acute disseminated encephalomyelitis (“ADEM”) “can also be informative” as to
an appropriate timeframe for PTS following a flu vaccine. Id. In support, Dr. Leist cited a study
by Rowhani-Rahbar et al. 81 on “biologically plausible and evidence-based risk intervals of
[ADEM]. . . following immunization.” Id. Dr. Leist noted that the study authors “‘concluded that
two sets of risk intervals to examine the association between vaccines and ADEM would be
appropriate.’” Id. They proposed an interval of two to forty-two days when “determining the
likelihood of a role of a vaccine in develop[ing a] neurologic illness” and an interval of five to
twenty-eight days “[f]or epidemiologic assessments of causality between a particular vaccine and
ADEM[.]” Id.
Finally, Dr. Leist responded to Dr. Gershwin’s statement that in Petitioner’s case “‘the
medical records are unclear as to when the weakness commenced.’” Id. Dr. Leist maintained his
opinion that Petitioner’s onset of weakness occurred two months prior to his July 8, 2013 visit with
his nurse practitioner. Id. at 4. He based this opinion on the fact that Petitioner saw his chiropractor
on February 14, 2013, with complaints of “a one[-]week history of ‘pain in mid[-]back increased
with arm use.’” Id. (emphasis added). He noted that Petitioner had a follow-up visit with his
chiropractor on February 19, 2013, and no weakness was reported at either visit. Id. Dr. Leist
argued that the onset of Petitioner’s weakness is “outside the time window described by Langmuir
et al. 82 for an immune complication following [a] non-live influenza vaccine.” Id. Had Petitioner
developed PTS as a result of the flu vaccine, Dr. Leist argued he would have experienced weakness
sooner than he did. Id.
Dr. Leist further addressed that although Petitioner’s vaccination records do not show the
administration site of the flu vaccine, Dr. Ali’s initial consultation notes from June 23, 2014,
document that Petitioner’s “weakness ‘was not [in] the same area where the injection was
given[.]’” 83 Id. This, he argued, suggests that “it is likely that the vaccine was given into the left
deltoid.” Id. Dr. Leist emphasized that the “[c]oncentration of vaccine constituents is greatest at
the site of administration and this is also the site of the needle trauma.” Id. Therefore, he argued
Dr. Gershwin failed to explain how the flu vaccine “could have caused relatively immediate [PTS]
in [Petitioner’s] right when [it] was . . . likely administered into the left arm.” Id. at 4–5. (emphasis
added). Dr. Leist postulated that Petitioner’s development of PTS in his right side despite receiving
the vaccine in his left side is contradicted by Weintraub and Chia’s case report, 84 which “describes
a case of hand weakness within hours following administration of influenza vaccine into the same
81
Citing Resp’t’s Ex. C-2, ECF No. 56-3, Rowhani-Rahbar A., et al., Biologically Plausible and Evidence-
based Risk Intervals in Immunization Safety Research, VACCINE 2012; 31:271–77.
82
See Langmuir et al., supra note 77.
83
Citing Pet’r’s Ex. 4 at 1.
84
See Weintraub & Chia, supra note 53, at 518.
24
arm[;]” and a case report by Taras et al., 85 which reported “onset of weakness in the same arm as
the [HPV] vaccine administration within [three] days following vaccination.” Id. at 5. As such, Dr.
Leist maintained his opinion that Petitioner “did not incur an injury due to the dose of influenza
vaccine he received . . . .” Id.
3. Dr. Leist’s Second Supplemental Expert Report
Dr. Leist submitted his second supplemental expert report on October 20, 2019, in response
to Dr. Gerswhin’s second supplemental report. Resp’t’s Ex. D. In this report, Dr. Leist took issue
with Dr. Gershwin’s assertion that Petitioner’s pain in his right shoulder blade area three weeks
post-vaccination “would be consistent with irritation and pressure from expanding regional lymph
nodes secondary to the vaccine.” Id. at 1. Dr. Leist responded by arguing that “[a]ny swelling
induced by influenza, a non-live vaccine, is expected to have peaked and have resolved before
[three] weeks following vaccination.” Id. As support, Dr. Leist cited the prescribing information
for Afluria (2017–2018 Formula), or the flu vaccine, which “lists that significant swelling (grade
[three] swelling/lump reaction) occurred in 0.1% of vaccinated individuals . . . [and] ‘began within
[seven] days of vaccination.’” 86 Id. He pointed out Dr. Gershwin’s failure to provide references
capable of showing sufficient “evidence that vaccines cause lymphadenopathy 87 leading to
external compression of nerves and/or brachial plexus injury[,]” as Dr. Gershwin claims occurred
in Petitioner’s case. Id. Dr. Leist argued this proposed scenario is not listed in the prescribing
information for Afluria. Id. Based on this, Dr. Leist opined that “[s]welling following vaccine
administration occurs at or around the injection site[] . . .[and i]t is unlikely that influenza vaccine
would have caused focal swelling in a distant limb.” Id. at 2.
Of the references Dr. Gershwin did submit, Dr. Leist found the Shaikh et al. 88 case report
to be “consistent with the opinion [he] expressed in [his] original report . . . that a relationship
between [PTS] and influenza vaccine has not been established beyond a temporal association.” Id.
Dr. Leist reiterated that the authors of the Shaikh et al. 89 case report posited that “[t]he aetiology
of brachial neuritis is unclear[,]” thus failing to identify a mechanism by which an influenza
vaccine could cause PTS. Id. at 1. Dr. Leist indicated that the articles submitted by Petitioner
“discuss fluid dynamics and mechanics of lymph nodes and the lymph system[, but] do not discuss
or describe the effects[] . . . of vaccines on these processes.” 90 Id. at 2. Dr. Leist concluded by
expressing “[he] was [also] unable to identify peer[-]reviewed articles that describe nerve injury
as a consequence of a vaccine in the manner Dr. Gershwin allege[d].” Id. Therefore, he maintained
Petitioner’s injury did not occur as a result of the influenza vaccine. Id.
85
Citing Resp’t’s Ex. C-1, ECF No. 56-2, Taras J.S., et al., Brachial Neuritis Following Quadrivalent
Human Papilloma Virus (HPV) Vaccination, HAND 2011; 6:454–56.
86
Citing Resp’t’s Ex. D-1 at 6.
87
Lymphadenopathy is defined as a “disease of the lymph nodes, usually with swelling[.] . . .It is considered
to be a nonmalignant hyperimmune reaction to chronic antigenic stimulation[.]” Dorland’s at 1083.
88
See Shaikh, supra note 64.
89
See id.
90
See generally, supra note 63.
25
IV. Arguments in Support of a Ruling on the Record
Petitioner filed his motion for a ruling on the record on September 6, 2018. Pet’r’s Mot.
Petitioner argued, among other things, that he has provided sufficient evidence to show that the
influenza vaccine “is the cause in fact of his PTS.” Id. at 18. In support of his argument, Petitioner
contended that he has demonstrated that pain is the onset symptom of PTS. Id. at 9–12. Petitioner
further argued he represented a classic presentation of PTS following a flu vaccination and that his
onset symptoms are consistent with those described in the medical literature. See id.
Petitioner argued that he satisfied the first prong of Althen because his expert, Dr.
Gershwin, “provided a medical theory causally connecting the vaccination with the resulting PTS.”
Id. at 19. He highlighted that Dr. Gershwin explained how Petitioner’s PTS “was due to an
inflammatory response to the vaccination.” Id. Petitioner characterized Dr. Gershwin’s explanation
of the “cytokine response that facilitated the recruiting and homing of lymphocytes[]” following
the vaccination as the medical theory required to satisfy prong one of Althen. Id. He reiterated Dr.
Gershwin’s purported theory:
examin[ing] the role of lymph node macrophages (LNMs) in the induction of the
cytokine storm triggered by inactivated influenza virus vaccine . . . [wherein] LNMs
undergo inflammosome-independent necrosis-like death that is reliant on MyD88
and Toll-like receptor 7 (TLR7) expression and releases pre-stored interlukin-1ɑ
(IL-1ɑ) . . . [s]timulation of the IL-1ɑ inflammatory pathway might therefore
represent a strategy to enhance antigen presentation by LNDCs and improve the
humoral response against influenza vaccines.
Id. at 20. However, Petitioner cited the Chatziandreou et al. study 91 and conceded that “[t]he
mechanism by which inflammation influences the adaptive response to vaccines is not fully
understood.” Id. Nonetheless, Petitioner argued that his expert posited a medical theory causally
connecting the flu vaccine and his PTS, thus satisfying prong one of Althen. Id.
Petitioner further argued that he satisfied the second prong of Althen because he “ha[s]
treating physicians indicating that the vaccination was the cause of his issues[.]” Id. at 22.
Petitioner cited to notes from his treating neurologist, Dr. Ali, attributing his issues to the flu
vaccine. Id.; see also Pet’r’s Exs. 4 at 1–2; 10 at 1. He also referred to notes from his nurse
practitioner, Ray Millette, N.P., indicating an association between the flu vaccine and his injuries.
Pet’r’s Mot. at 22; see also Pet’r’s Ex. 12 at 1–3. Petitioner continued that his “response to the
influenza vaccine was consistent with the theories articulated, including pain and later weakness
and atrophy, . . .” which constitutes further evidence that the flu vaccine caused his development
of PTS. Pet’r’s Mot. at 23–24.
Petitioner argued that he has also satisfied the third prong of Althen by establishing that
Petitioner’s injuries manifested within the medically acceptable timeframe for the development of
PTS following a flu vaccine. Id. at 24. He relied on his expert’s comparison of the onset of PTS
91
Citing Pet’r’s Ex. 82, ECF No. 51-3, Chatziandreou N., et al., Macrophage death following influenza
vaccination initiates the inflammatory response that promotes dendritic cell function in the draining lymph
node, CELL REPORTS 2017; 18:2427–2440.
26
following a tetanus-toxoid type vaccination, two to twenty-eight days, to explain that the onset of
PTS following a flu vaccine would be similar. Id. at 25. However, Petitioner first alleged that “[t]he
primary dispute in this case is what is the ‘onset’ symptoms of [PTS] (is it pain or is it weakness)
and when would such onset ordinarily occur.” Id. (emphasis in original). Petitioner argued that
“the onset symptom is pain; and, such pain, in this case, commenced within a time period
consistent with what one would expect.” Id. (emphasis in original). Petitioner attacked
Respondent’s expert’s comparison between the onset of GBS and PTS but nonetheless accepted it
as true and maintained that the onset of Petitioner’s symptoms “commenced around February 5,
2013[,] directly down the strike zone of Dr. Leist’s opinion as to when one would see first onset
symptoms in a GBS case.” Id. at 26. Petitioner reasserted his opinion that “[t]he most important
onset symptom [for PTS] is the pain” and concluded that the onset of his pain occurred around
February 5, 2013, within Dr. Gershwin’s purported timeframe described above. Id.
Petitioner argued that he has satisfied his burden by a preponderance of the evidence under
Althen and that the burden therefore shifts to Respondent to prove an alternative cause for
Petitioner’s injuries. Id. at 29. He continued that Respondent must show that “the unrelated factor
was the sole substantial factor in bringing about the injury.” Id. (citing de Bazan v. Sec’y of Health
& Hum. Servs., 539 F.3d 1347, 1354 (Fed. Cir. 2008)). Petitioner addressed Respondent’s expert’s
opinion that “[Petitioner’s] exercise regimen or his marital dissolution may have been the cause of
his PTS[,]” and vehemently disagreed. Id. at 30.
Respondent filed his response to Petitioner’s motion for a ruling on the record on October
22, 2018. Resp’t’s Resp. Respondent argued that, as a preliminary matter, Petitioner must establish
that his flu vaccination was administered on the right side, or alternatively, that PTS can present
in the shoulder opposite from the vaccine administration. Id. at 9. Respondent concluded that based
on the evidence, “Petitioner has failed to meet his burden to show that he received a flu vaccination
in his right arm and failed to demonstrate that a flu vaccine administered in his left deltoid could
result in [PTS] on his right side.” Id. at 10.
Respondent further argued that Petitioner has failed to meet his burden under prong one of
Althen. Id. at 11. In support of this argument, Respondent posited that “[i]n a winding and opaque
paragraph, Dr. Gershwin discusse[d] generally how inflammation may factor into autoimmune
disease.” Id.; see also Pet’r’s Ex. 23 at 3–4. However, Respondent maintained that “[t]his general
statement . . . fails under Althen to provide a theory that applies specifically to this case . . . [and]
is insufficient to meet [P]etitioner’s burden of proof on Althen prong [one].” Pet’r’s Mot. at 11–
12.
Respondent also argued that Petitioner has failed to satisfy prong two of Althen because he
has failed to establish a logical sequence of cause and effect. Id. at 13. Respondent indicated that
the physicians’ notes cited by Petitioner to support his theory of cause and effect cannot be given
much weight because they are based on Petitioner’s own reported history and provided more than
a year after the vaccination. Id. at 14. Respondent further argued there are alternative causes to
explain Petitioner’s development of PTS, including his extensive exercise regimen and the
psychological stressors of his divorce. Id. Such alternative causes, Respondent argued, are “closer
in proximity to the onset of Petitioner’s shoulder pain” and can explain his condition better than
the flu vaccine. Id.
27
Respondent argued Petitioner has also failed to meet his burden under prong three of
Althen. Id. at 15. Respondent indicated that Petitioner “had a long pre[-]vaccination history of
chronic shoulder pain, back pain, and carpal tunnel syndrome[,]” suggesting bilateral involvement,
since 2009. Id. at 15–16. Respondent’s expert argued that this pre-vaccination history likely
contributed to the complaints before and after the date of vaccination; thus, inhibiting Petitioner’s
ability to satisfy prong three of Althen. Id. at 16.
Respondent also responded to Petitioner’s arguments regarding the relevant onset symptom
of PTS – pain versus weakness. Id. Respondent maintained that weakness is the onset symptom of
PTS following a flu vaccine and indicated that “Petitioner placed weakness onset around May
2013, or about four to five months post[-]vaccination.” See id. Respondent argued Petitioner’s
onset of weakness is inconsistent with Respondent’s expert’s purported “[forty-two]-day risk
interval reported . . . for [GBS] after vaccination with a swine flu influenza.” Id.; see also Resp’t’s
Ex. A at 8. Respondent relied on the analogy between the onset of GBS following a swine flu
vaccine and the purported timeframe for the onset of weakness following a flu vaccine to argue
Petitioner’s onset of weakness – five months post-vaccination – is well-beyond the forty-two-day
timeframe expected for the development of weakness following a vaccine. Pet’r’s Mot. at 16.
Therefore, Respondent concluded Petitioner has failed to establish entitlement to compensation
under Althen.
Petitioner filed his reply to Respondent’s response to his motion for a ruling on the record
on November 1, 2018. Pet’r’s Reply. Petitioner first argued that as a preliminary matter, he does
not need to establish that the vaccine was administered in his right side, or that PTS can present in
the shoulder opposite the site of vaccine administration. Id. at 2. Petitioner maintained that his
expert’s interpretation of the medical records from neurologist, Dr. Ali, referenced pain in the right
shoulder region, but “[t]his was not in the same area where the injection was given.” Id.; see also
Pet’r’s Ex. 4 at 1–2. Petitioner argued that Dr. Gershwin’s opinion that “injections in either arm
can produce bilateral swelling and therefore it does not matter which side received the injection”
is substantiated by Petitioner’s medical records and other cases in the Vaccine Program. Pet’r’s
Reply at 3; see also Garner v. Sec’y of Health & Hum. Servs., Case No. 15-63V, 2017 WL 1713184(Fed. Cl. Spec. Mstr. Mar. 24, 2017), aff’d, 133 Fed. Cl. 140 (2017).
Petitioner further replied to Respondent’s assertions that he did not provide a medical or
scientific theory under prong one of Althen. Petitioner argued that he did provide a medical theory
“causally connecting the vaccination with the resulting PTS[,] . . . and Respondent’s expert did not
provide much of a rebuttal to Dr. Gershwin’s opinion.” Id. at 5. Petitioner repeated his previous
argument and maintained that he established a theory of cause and effect because he has treating
physicians’ notes showing an association between the flu vaccine and PTS. Id. He further argued
that Respondent’s expert’s reliance on an analogy of causation between the swine flu vaccine and
the development of PTS is incorrect. Id. at 6. Finally, Petitioner argued that he has established an
appropriate proximate temporal relationship between vaccination and injury by relying on the fact
that pain is the heralding onset symptom for PTS. Id. at 7. He argued that Respondent
mischaracterized weakness as the onset symptom for PTS, thus ignoring that the onset of
Petitioner’s symptoms – pain – occurred in the appropriate timeframe one would expect for the
development of PTS following a flu vaccine. Id. at 7–9. Therefore, Petitioner maintained that all
three prongs of Althen have been met by a preponderance of the evidence. Id. at 10.
28
V. Applicable Legal Standard
To receive compensation under the Vaccine Act, a petitioner must demonstrate either that:
(1) the petitioner suffered a “Table injury” by receiving a covered vaccine and subsequently
developing a listed injury within the time frame prescribed by the Vaccine Injury Table set forth
at 42 U.S.C. § 300aa-14, as amended by 42 C.F.R. § 100.3; or (2) that petitioner suffered an “off-
Table injury,” one not listed on the Table, as a result of his receiving a covered vaccine. See 42
U.S.C. §§ 300aa-11(c)(1)(C); Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d 1317, 1319-20 (Fed. Cir.
2006). Petitioner does not allege a Table injury in this case; thus, he must prove that his injury was
caused-in-fact by a Table vaccine.
To establish causation-in-fact, a petitioner must demonstrate by a preponderance of the
evidence that the vaccine was the cause of the injury. 42 U.S.C. § 300aa-13(a)(1)(A). A petitioner
is required to prove 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 1321–22 (quoting Shyface v. Sec’y of
Health & Hum. Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)).
In the seminal case of Althen v. Sec’y of the Dept. of Health & Hum. Servs, the Federal
Circuit set forth a three-pronged test used to determine whether a petitioner has established a causal
link between a vaccine and the claimed injury. See 418 F.3d 1274, 1278–79 (Fed. Cir. 2005). The
Althen test requires petitioners to set forth: “(1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination
was the reason for the injury; and (3) a showing of a proximate temporal relationship between
vaccination and injury.” Id. at 1278. To establish entitlement to compensation under the Program,
a petitioner is required to establish each of the three prongs of Althen by a preponderance of the
evidence. See id.A petitioner who demonstrates by a preponderance of the evidence that he suffered an
injury caused by vaccination is entitled to compensation unless the respondent can demonstrate by
a preponderance of the evidence that the injury was caused by factors unrelated to the vaccination.
See Althen, 418 F.3d at 1278; Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 547 (Fed.
Cir. 1994).
VI. Discussion
A. Althen Prong One
Under the first prong of Althen, a petitioner must offer a scientific or medical theory that
answers in the affirmative the question: “can the vaccine[] at issue cause the type of injury
alleged?” See Pafford v. Sec’y of Health & Hum. Servs., No. 01-0165V, 2004 WL 1717359, at *4
(Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19 (2005), aff’d, 451 F.3d 1352 (Fed. Cir.
2006). To satisfy this prong, a petitioner’s theory must be based on a “sound and reliable medical
or scientific explanation.” Knudsen, 35 F.3d at 548; see also Andreu v. Sec’y of Health & Hum.
Servs., 569 F. 3d 1367, 1375, 1379 (2009) (ruling that the petitioners had satisfied Althen prong
one where their expert witness had “presented a ‘biologically plausible’ theory”). Such a theory
29
must only be “legally probable, not medically or scientifically certain.” Knudsen, 35 F.3d at 548–
49. However, as the Federal Circuit has made clear, “simply identifying a ‘plausible’ theory of
causation is insufficient for a petitioner to meet her burden of proof.” LaLonde v. Sec’y of Health
& Hum. Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014) (citing Moberly, 592 F.3d at 1322). Rather,
“[a] petitioner must provide a reputable medical or scientific explanation that pertains specifically
to the petitioner’s case.” Moberly, 592 F.3d at 1322. In general, “the statutory standard of
preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely
than not caused the condition alleged.” LaLonde, 746 F.3d at 1339.
Petitioner fails to meet his burden under Althen prong one. Petitioner’s expert, Dr.
Gershwin, has failed to posit a reliable theory showing that the flu vaccine can cause PTS.
Petitioner argued that Dr. Gershwin “went into great detail on what happens when an inflammatory
response occurs and its mechanisms[,]” thus linking Petitioner’s inflammatory response to the flu
vaccine. See Pet’r’s Mot. at 19. In fact, however, Dr. Gershwin only generally describes how
inflammation may factor into autoimmune responses. Dr. Gershwin does not explain how an
inflammatory process is initiated by the flu vaccine specifically or how such a response leads to
PTS.
In his first expert report, Dr. Gershwin stated that “[t]he vaccination produced a significant
cytokine response that facilitated recruiting and homing of lymphocytes.” See Pet’r’s Ex. 23 at 3.
He continued, “[r]ecruitment of white cells or leukocytes is a critical response to virtually
everything from infection to non-specific tissue injury and in fact interplays with diseases as
diverse as [RA], atherosclerosis[,] and virtually every other autoimmune disease.” Id. (emphasis
added). This statement is the antithesis of what is needed to satisfy Petitioner’s burden to provide
a theory that specifically applies to his case. Dr. Gershwin relies on an article authored by
Chavakis 92 in an attempt to argue how the flu vaccine administered to Petitioner caused
inflammation leading to PTS. Id. However, this article only generally describes the recruitment of
leucocytes in inflammatory pathologies, which, as the article admits, is a “component of almost
any inflammatory pathology.” See Pet’r’s Ex. 57 at 1. Dr. Gershwin’s reliance on this article is
misplaced, as it is vague and wholly fails to address an inflammatory response caused by the flu
vaccine.
Dr. Gershwin further argued that “vaccination promotes inflammation in the draining
lymph node, which is relevant to [Petitioner’s] case” and can “lead to local inflammation[]”
following injection. Pet’r’s Ex. 80 at 3. Dr. Gershwin relied on an article by Chatziandreou et al. 93
to illustrate how vaccination initiates inflammation in the draining lymph node. Id. The authors of
this article considered at length “the role of lymph node macrophages (LNMs) in the induction of
the cytokine storm triggered by [an] inactivated influenza virus vaccine.” See Pet’r’s Ex. 82 at 1.
Yet, this theory that a flu vaccine creates a “cytokine storm” far surpasses the inflammatory
reaction one would expect from a flu vaccine. The authors presented “a strategy to enhance antigen
presentation by lymph node-resistant dendritic cells and improve the humoral response against
influenza vaccines[,]” but the article fell silent regarding the role of vaccines in the development
of autoimmune diseases generally, much less PTS specifically. Id. at 2. In fact, the authors readily
admit that “[t]he mechanism by which inflammation influences the adaptive response to vaccines
92
See Chavakis, supra note 42, at 686–91.
93
See Chatziandreou, supra note 91.
30
is not fully understood.” Id. If the general mechanism for vaccines as a whole is not fully
understood, the mechanism by which the flu vaccine causes PTS is even more conjectural.
Therefore, it is difficult to give Dr. Gershwin’s emphasis on this article much weight. His reliance
on this article weakens Petitioner’s argument that the flu vaccine caused his PTS, as it suggests
the mechanism for such a connection remains tenuous and unfounded.
Dr. Gershwin also insinuates that a genetic predisposition could explain the reaction that
occurred in Petitioner’s case. He briefly mentions heredity as a confounding factor by stating “that
genetic predisposition is critical to understanding the rare events that can occur in individuals
following vaccination.” Id. However, Petitioner has failed to present persuasive literature or further
evidence to explain the role that a genetic predisposition could play in the development of PTS
following a flu vaccine 94; therefore, Dr. Gershwin’s argument is unhelpful.
Due to Dr. Gershwin’s continued failure to describe the flu vaccine’s role in the
development of Petitioner’s PTS, I afforded Petitioner an additional opportunity to file a precise
expert report from Dr. Gershwin describing the flu vaccine’s role in the development of
Petitioner’s PTS. See Scheduling Order at 1, ECF No. 71. Instead, Petitioner submitted a
supplemental report and medical literature again describing generally how PTS occurs and the
body’s general response to vaccinations. 95 See Pet’r’s Exs. 92–94. This body of submitted
literature failed to address my pointed question in this case – what is the mechanism by which the
flu vaccine caused PTS?
Dr. Gershwin did submit one piece of medical literature describing a case study by Shaikh
96
et al. wherein the subject, a “normally fit and well” 46-year-old woman, developed PTS
following a flu vaccine. See Pet’r’s Ex. 90 at 1. However, Dr. Gershwin’s reliance on this article
does not advance Petitioner’s case. Although the case study describes an instance where a patient
developed PTS in close proximity to her receipt of the flu vaccine, the case study still fails to
identify the mechanism by which this “uncommon” phenomenon occurred, thus making Dr.
Gershwin’s reliance on it futile. See id. Instead of providing a mechanism by which the flu vaccine
could cause PTS, the authors of the study merely mention past reports linking the flu vaccine and
PTS. 97 See Pet’r’s Ex. 91 at 1–2. The authors do not rely on this patient’s case to identify the
mechanism by which the flu vaccine can lead to PTS; they use this patient’s case to educate
physicians on the challenges associated with diagnosing PTS and available treatment options. Id.
at 1–2. They describe the patient’s initial presentation – “a month’s history of severe left shoulder
pain . . .[w]ithin a week of the onset of pain, she developed left-upper-limb weakness with
difficulty in performing her usual activities.” Id. at 1. The authors note that “[t]he onset was acute,
developing a few days after an influenza vaccination[,]” but they do not identify how the flu
vaccine caused PTS. Id. Additionally, Dr. Gershwin’s reliance on this article is further unavailing,
as the authors state, “[b]rachial neuritis after administration of an influenza vaccination has
94
See Pet’r’s Mot. at 23. Petitioner cites to the Weintraub et al. article submitted by Respondent to support
his argument that genetic predisposition is critical to the understanding of the development of PTS. See
supra note 53, at 1. However, the article merely indicates “genetic predisposition is suggested[,]” without
providing further explanation of its relevancy. Id.
95
See supra note 63.
96
See Shaikh, supra note 64.
97
See Parsonage & Turner, supra note 50.
31
previously been reported in three publications[,] although the exact incidence is not known . . . and
currently there is insufficient evidence to accept (or reject) an association.” Id. at 1–2. Thus, Dr.
Gershwin did not establish a path between the flu vaccine and the development of PTS.
Therefore, despite numerous opportunities to do so, Petitioner has been unable to provide
a scientific or medical theory describing the flu vaccine’s role in the development of PTS. As a
result, Petitioner has failed to meet his burden to establish by a preponderance of the evidence that
the flu vaccine can cause PTS. Accordingly, I find Petitioner has failed to satisfy prong one of
Althen.
B. Althen Prong Two
Under the second prong of Althen, a petitioner must prove that the vaccine actually did
cause the alleged injury in a particular case. See Pafford, 2004 WL 1717359, at *4; Althen, 418
F.3d at 1279. The second Althen prong requires proof of a logical sequence of cause and effect,
usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278;
Andreu, 569 F.3d at 1380; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Hum. Servs.,
956 F.2d 1144, 1148 (Fed. Cir. 1992). A petitioner does not meet this obligation by showing only
a temporal association between the vaccination and the injury; instead, the petitioner “must explain
how and why the injury occurred.” Pafford, 2004 WL 1717359, at *4 (emphasis in original). The
Court in Pafford noted petitioners “must prove [] both that her vaccinations were a substantial
factor in causing the illness . . . and that the harm would not have occurred in the absence of the
vaccination.” 2004 WL 1717359, at *4 (citing Shyface, 165 F.3d at 1352). Nevertheless,
“[r]equiring epidemiologic studies . . . or general acceptance in the scientific or medical
communities . . . impermissibly raises a claimant’s burden under the Vaccine Act and hinders the
system created by Congress . . . .” Capizzano, 440 F.3d at 1325–26.
In Program cases, contemporaneous medical records and the opinions of treating
physicians are favored. Capizzano, 440 F.3d at 1326 (citing Althen, 418 F.3d at 1280). This is
because “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.’” Id. In
addition, “[m]edical records, in general, warrant consideration as trustworthy evidence. The
records contain information supplied to or by health professionals to facilitate diagnosis and
treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an
extra premium. These records are also generally contemporaneous to the medical events.”
Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). While a special
master must consider these opinions and records, they are not “binding on the special master or
court.” 42 U.S.C. § 300aa-13(b)(1). Rather, when “evaluating the weight to be afforded to any
such . . . [evidence], the special master . . . shall consider the entire record . . . .” Id. The record
often includes “evidence of possible sources of injury” that can show alternate causes for the
alleged vaccine-related injury. See Stone v. Sec’y of Health & Hum. Servs., 676 F.3d 1373, 1379
(Fed. Cir. 2012).
While the parties do not dispute that Petitioner suffers from PTS, the parties do dispute
whether there is preponderant evidence indicating that the administration site of Petitioner’s flu
vaccine was in the right arm. Respondent argued, as a preliminary matter, Petitioner must establish
32
he received the flu vaccine in his right side, or alternatively, that PTS can present in the shoulder
opposite vaccine administration. See Resp’t’s Resp. at 9–10. In reply, Petitioner argued that the
medical records, relied upon by Dr. Gershwin, and Petitioner’s own accounts to treating physicians
indicate the flu vaccine was administered in Petitioner’s right side. Pet’r’s Reply at 2. However,
Respondent’s arguments regarding the site of vaccine administration are immaterial to my analysis
under Althen, as Petitioner’s claim fails under the second prong of Althen for distinct reasons
discussed herein. Nonetheless, after a review of the relevant medical records and reports, I will
assume arguendo that Petitioner received the flu vaccine in his right arm.
Petitioner has failed to demonstrate a logical sequence of cause and effect relating to how
the flu vaccine he received on January 14, 2013, caused his development of PTS. Petitioner’s
expert, Dr. Gershwin, provided ample literature and documentation showing that pain is the
heralding event of PTS. For example, in his first expert report, Dr. Gershwin relied on an article
by Smith and Bevelaqua 98 in which the authors explained that by definition, akin to the definition
provided by Dorland’s, supra note 3, PTS is “characterized by an abrupt onset of upper extremity
pain followed by progressive neurologic deficits, including weakness, atrophy, and [] sensory
abnormalities.” Pet’r’s Ex. 23 at 2. Dr. Gershwin also relied on the seminal study by Parsonage
and Turner 99 to demonstrate “pain is the predominant presenting symptom in 90% to 95% of
patients [with PTS].” Pet’r’s Ex. 31 at 2. The authors of the study continued that “the duration of
the pain is highly variable, ranging from several hours to months[]” and is described as “sharp,”
“stabbing,” and “throbbing.” Id. Dr. Gershwin cited an additional case study by van Alfen and van
Engelen 100 to further support the proposition that pain is the heralding event of PTS. Pet’r’s Ex.
80 at 3. The authors of this case study examined the progression and timing of onset symptoms in
two hundred and forty-six patients with PTS. See Pet’r’s Ex. 26 at 1. Of the symptoms observed,
pain proved to be the most important symptom in determining the time of onset. Id.
Dr. Gershwin relied on Petitioner’s medical records to opine that the pain Petitioner
experienced three weeks post-vaccination was the onset of his PTS. Dr. Gershwin is correct that
pain is the onset symptom of PTS. See, e.g., Pet’r’s Exs. 26 at 1, 4; 31 at 2. However, Dr. Gershwin
has not adequately accounted for Petitioner’s extensive pre-vaccination history of shoulder pain,
albeit that Petitioner’s pain originated on his left side. The medical records indicate that
Petitioner’s pain progressed and was, at times, bilateral. Therefore, Petitioner’s pre-vaccination
history is relevant to his purported theory of cause and effect. Years prior to receiving the flu
vaccine, Petitioner sustained a sports-related injury. Pet. at 2; see also Pet’r’s Ex. 3 at 1. When
irritated, this injury would cause pain in his lower back and his left side. Pet. at 2. Based on the
records, this injury can be attributed to Petitioner’s “enjoy[ment of] early morning gym workouts
which included bench pressing [three hundred and fifteen] pounds[.]” Id. at 1. As a result,
Petitioner maintained a “weightlifter” physique. See Pet’r’s Ex. 5 at 1. Further, he owns his own
landscaping business, which requires “[s]ignificant heavy lifting” during ten to twelve-hour days,
five to six days per week. Pet. at 1. In his free time, Petitioner “enjoyed hiking, biking, boating,
snowboarding, [and] waterboarding[.]” Id.
Since January 2009, in connection with the above-referenced injury, Petitioner has been
98
Smith & Bevelaqua, supra note 36.
99
Parsonage & Turner, supra note 50.
100
van Alfen & van Engelen, supra note 56.
33
treated for “very severe and chronic carpal tunnel syndromes on the right greater than left sides[,]”
for which he had “bilateral carpal tunnel decompressions” with “good results.” See Pet’r’s Ex. 3
at 1. In 2010, Petitioner was “seen for moderate, aching, and throbbing shoulder pain[]” on several
occasions. See Pet’r’s Ex. 1 at 1, 4–7. Petitioner’s description of his symptoms to his treating
physicians during this time are akin to those described in the Parsonage and Turner article, as those
symptoms relate to pain being the onset symptom of PTS. Pet’r’s Ex. 31 at 2. Additionally, in
2011, Petitioner reported back and left shoulder pain that, by 2012, was aggravated by movement
and lifting. Id. at 13, 16, 19. Petitioner’s pain has forced him to significantly alter his typical
activities, especially those relating to his workout routine and landscaping business. See, e.g., Pet.
at 4. Since 2009, Petitioner has been medicating with cannabis, methadone, and other medications,
including oxycodone and OxyContin, to alleviate his severe pain. The extent of Petitioner’s pain
management regimen indicates that his pain was, and continues to be, of the utmost severity.
Petitioner was relying on such pain management methods prior to and on the day he received the
flu vaccine; therefore, it is more likely the onset of his PTS occurred prior to the flu vaccination.
Indeed, the evidence indicates that it is more likely than not that the onset of Petitioner’s pain and
therefore PTS, could have been years before he received the flu vaccine in question.
Finally, despite Petitioner’s treating physicians’ notes documenting a temporal association
between the flu vaccine and Petitioner’s development of PTS, Petitioner has still failed to establish
a theory of cause and effect in this case. While contemporaneous medical records and opinions of
treating physicians are favored in the Program, such documentations are not always determinative.
See Capizzano, 440 F.3d at 1326. Here, notes from neurologist, Dr. Ali, differ from other medical
records from the same timeframe, in which other providers do not link the flu vaccine to
Petitioner’s PTS. See, e.g., Pet’r’s Exs. 1 at 30–40; 2 at 1, 3; 5 at 1. Instead, other medical records
note the onset of symptoms as occurring at conflicting times. See id. For example, Petitioner’s
nurse practitioner’s notes from April 9, 2014 attributing the flu vaccine to Petitioner’s PTS were
based on a new history provided by Petitioner over a year after the vaccination, a history that was
not reported immediately following the vaccine. Pet’r’s Ex. 1 at 40. This notation contradicts
earlier statements wherein Petitioner stated he experienced pain three weeks post-vaccination.
Pet’r’s Ex. 2 at 1, 3. Another notation from spring 2013 indicated Petitioner just “awoke one
morning with mild neck and mid[-]back pain that was extending to his right shoulder region[.]”
Pet’r’s Ex. 5 at 1. Therefore, the treating physicians’ notations temporally associating the flu
vaccine with PTS are entitled to little weight in Petitioner’s case, because the association is based
solely on a temporal relationship reported by Petitioner. See Resp’t’s Ex. A at 8; Pet’r’s Ex. 1 at
40. Thus, such notations are not helpful and do not support Petitioner’s theory that the flu vaccine
caused him to develop PTS.
Overall, Petitioner has failed to establish by a preponderance of the evidence that the flu
vaccine administered on January 14, 2013, caused him to develop PTS. Therefore, for the
numerous reasons described above, Petitioner cannot satisfy prong two of Althen.
C. Althen Prong Three
Under the third prong of Althen, a petitioner must show that the timing of the injury fits
with the causal theory. See Althen, 418 F.3d at 1278. For example, if a petitioner’s theory involves
a process that takes several days to develop after vaccination, an injury that occurred within a day
34
of vaccination would not be temporally consistent with that theory. Conversely, if the theory is
one that anticipates a rapid development of a reaction post-vaccination, the development of the
alleged injury weeks or months post-vaccination would not be consistent with that theory.
Causation-in-fact cannot be inferred from temporal proximity alone. See Grant, 956 F.2d at 1148;
Thibaudeau v. Sec’y of Health & Hum. Servs., 24 Cl. Ct. 400, 403–04 (1991); see also Hasler v.
United States, 718 F.2d 202, 205 (6th Cir. 1983) (“Without more, [a] proximate temporal
relationship will not support a finding of causation”).
Petitioner also fails to meet his burden under Althen prong three. Respondent’s expert, Dr.
Leist, proffered that the onset of the symptom of weakness in PTS is similar to that in GBS. See
Resp’t’s Ex. A at 7–8. He did so because both conditions affect the peripheral nerves. Based on
this comparison, Dr. Leist concluded that there was a “[forty-two] day risk interval” for the onset
of PTS symptoms, such as weakness, following a flu vaccination. Id. Dr. Leist, therefore,
concluded that, based on the medical records, Petitioner’s onset of weakness occurred
approximately five months post-vaccination, around May 2013, which is well-outside the
timeframe expected for onset of this injury. Id. Respondent therefore opined that Petitioner’s onset
of PTS is too temporally removed from his flu vaccination. Petitioner’s expert, Dr. Gershwin,
argued “there are no immunological similarities between [GBS] and [PTS]” making Dr. Leist’s
analogy seem needless. See Pet’r’s Ex. 80 at 1–2. Dr. Gershwin opined that the timeframe for the
onset of PTS following a flu vaccine is abrupt pain, usually within two to twenty-eight days,
followed by the first signs of weakness two weeks later. 101 Id. at 2.
However, as I discussed above, pain, not weakness, is the heralding event of the onset of
PTS in this case. Taking this into consideration, Respondent’s expert’s argument that the onset of
Petitioner’s weakness occurred outside of the purported timeframe for both GBS and PTS, while
correct, is misplaced. Dr. Gershwin’s argument that Petitioner has established a temporal
association between the flu vaccine and the development of PTS is also unpersuasive because of
Petitioner’s extensive pre-vaccination history. As the onset of Petitioner’s pain – the first symptom
of his PTS – occurred years prior to his receipt of the flu vaccine, Petitioner has failed to establish
a temporal relationship between the flu vaccine and the development of his PTS. Therefore, I find
Petitioner has failed to satisfy prong three of Althen, thus precluding Petitioner’s ability to receive
compensation for his injury.
D. Alternative Causes
If a petitioner presents a prima facie case, the Federal Circuit has held that the burden of
proof shifts to the government, and respondent must prove that the “‘injury . . . described in the
petition is due to factors unrelated to the . . . vaccine.’ 42 U.S.C. § 300aa-13(a)(1)(b).” Knudsen,
35 F.3d at 547. Yet, a petitioner’s failure to prove any element of his prima facie case mandates
that the Court deny entitlement. See id. Under such circumstances, the burden of proof does not
shift to the respondent to establish an alternate cause for the petitioner’s claimed injury. Althen,
418 F.3d at 1278; see also Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed.
Cir. 1993). However, in considering the reliability of a petitioner’s evidence of a prima facie case,
the special master may consider alternative causes for a petitioner’s condition that are reasonably
raised in the record, even if the respondent does not pursue a formal alternative cause argument.
101
van Alfen & van Engelen, supra note 56, at 6.
35
Doe v. Sec’y of Health & Hum. Servs., 601 F.3d 1349, 1358 (Fed. Cir. 2010). Thus, in weighing a
petitioner’s case-in-chief, a special master may consider evidence that the petitioner’s alleged
injury could have been caused by alternative causes. Id. In this case, Respondent does not have a
burden to prove Petitioner’s injury was caused by something other than his flu vaccine, as he has
not established a prima facie case of vaccine causation. See LaLonde, 746 F.3d at 1340. However,
since Respondent has presented arguments related to alternative causes, I will consider them
briefly.
Petitioner did not adequately address the alternative causes of PTS present in his history
and posited by Respondent’s expert, Dr. Leist. In his expert report, Dr. Leist cited to the same van
Alfen and van Engelen 102 article submitted by Petitioner to explain that there are several antecedent
events that have been attributed to the development of PTS. Resp’t’s Ex. A at 8. Of the listed
events – and most pertinent to Petitioner – exercise was the “second most frequently reported
event.” Id. Among the other reported antecedent events of PTS were trauma and psychological
stress. Id. Dr. Leist referenced both antecedent events in relation to the onset of Petitioner’s PTS
and noted that Petitioner’s expert wholly omitted these events from his analysis. Id. Despite this
fact, and even though Petitioner maintains that his divorce that occurred during the spring of 2013
was “amicable,” it is still relevant in my consideration of alternate causes of Petitioner’s
development of PTS. Id.; see also Garner v. Sec’y of Health & Hum. Servs., 2017 WL 1713184(Fed. Cl. Spec. Mstr. Mar. 24, 2017), aff’d, 133 Fed. Cl. 140 (2017) (finding that alternate causes
for PTS can be persuasive in establishing that a petitioner has failed to satisfy Althen prong two).
Based on the record, there are numerous factors that could have substantially contributed to or
directly caused Petitioner’s PTS, including his routine and robust exercise regimen and/or other
psychological stressors. It follows that Petitioner’s development of PTS would have occurred even
in the absence of the vaccine; thus, the vaccine cannot be the cause. See Pafford, 2004 WL
1717359, at *4; Shyface, 165 F.3d at 1352. Therefore, Petitioner cannot show the flu vaccine he
received on January 14, 2013, caused his PTS, because Petitioner’s onset of PTS likely occurred
years prior to his receipt of the flu vaccine.
VII. Conclusion
After a careful review of the record, including Petitioner’s medical records, expert reports,
and accompanying literature, Petitioner has failed to prove that it is more likely than not that he
suffered from a vaccine-caused injury. Accordingly, I have no choice but to DENY Petitioner’s
claim and DISMISS his petition. 103
IT IS SO ORDERED.
s/ Herbrina D. Sanders
Herbrina D. Sanders
Special Master
102
See id.103
Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of a notice
renouncing the right to seek review.
36