Markarian v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-397V
Filed: December 28, 2022
* * * * * * * * * * * * * * *
RAYMOND MARKARIAN, * TO BE PUBLISHED
*
Petitioner, * Ruling on the Record;
v. * Tetanus Diphtheria Acellular-Pertussis
* (Tdap) Vaccine; Shoulder Injury Related
SECRETARY OF HEALTH * To Vaccine Administration (SIRVA);
AND HUMAN SERVICES, * Brachial Neuritis
*
Respondent. *
* * * * * * * * * * * * * * *
Bridget McCullough, Esq., Muller Brazil, LLP, Dresher, PA, for petitioner.
Claudia Gangi, Esq., U.S. Department of Justice, Washington, DC, for respondent.
RULING ON THE RECORD1
Roth, Special Master:
On March 15, 2018, Raymond Markarian (“Mr. Markarian” or “petitioner”) filed a petition
for compensation pursuant to the National Vaccine Injury Compensation Program.2 Petitioner
alleges he suffered “Parsonage Turner Syndrome resulting from the adverse effects of the TDaP
vaccination” received on November 11, 2016. See Petition, ECF No. 1. An amended petition was
filed on June 11, 2018, alleging that petitioner suffered “brachial neuritis caused-in-fact by the
TDaP vaccination (an ‘off-Table’ injury), received on November 11, 2016.” Amended Petition,
ECF No. 17. Respondent filed his Rule 4(c) Report on April 22, 2019, stating that this matter was
not appropriate for compensation. Resp. Report, ECF No. 27.
1
This Ruling has been designated “to be published,” which means I am directing it to be posted on the
Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347,
116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). This means the Ruling will
be available to anyone with access to the internet. However, the parties may object to the Ruling’s
inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen days within which to request redaction “of any information furnished by that party: (1) that is
a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes
medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of
privacy.” Vaccine Rule 18(b). Otherwise, the whole Ruling will be available to the public. Id.2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
Petitioner filed a motion for ruling on the record on December 11, 2020. Motion for Ruling
on the Record (“Motion”), ECF No. 46. On January 25, 2021, respondent filed a response to
petitioner’s motion. Response, ECF No. 48. Petitioner filed a reply on February 24, 2021. Reply,
ECF No. 52.
After carefully analyzing and weighing the evidence presented in this case in accordance
with the applicable legal standards, the undersigned finds that petitioner has provided preponderant
evidence that his Tdap (Tetanus/diphtheria/acellular pertussis) vaccination caused him to suffer
brachial neuritis, satisfying petitioner’s burden of proof under Althen v. Secretary of Health and
Human Service, 418 F.3d 1274, 1280 (Fed. Cir. 2005). Accordingly, petitioner is entitled to
compensation.
I. Background and Factual History
A. Procedural History
The petition was filed on March 15, 2018, alleging that petitioner suffered from Parsonage
Turner Syndrome, also known as brachial neuritis, as a result of the Tdap vaccine he received on
November 11, 2016. Petition, ECF No. 1. Petitioner also filed medical records and an affidavit on
March 15, 2018. Petitioner’s Exhibits (“Pet. Ex.”) 1–4, ECF No. 1. On March 19, 2018, the petition
was assigned to the Special Processing Unit (“SPU”). Initial Order at 1–4, ECF No. 5. Petitioner
continued to file medical records until May 17, 2018. Pet. Ex. 5, ECF No. 14. Petitioner filed a
statement of completion that same day. ECF No. 15.
An amended petition was filed on June 11, 2018, alleging that petitioner’s brachial neuritis
was “caused-in-fact by” the Tdap vaccine. Amended Petition, ECF No. 17. After several status
reports requesting additional time to review the medical records, respondent advised that he would
be defending this case. Resp. S.R. at 1, ECF Nos. 19, 21, 24. A government shutdown was in effect
from December 22, 2018 until January 25, 2019.
Respondent filed his Rule 4(c) Report on April 22, 2019, stating that this matter was not
appropriate for compensation. Resp. Report, ECF No. 27. Petitioner was ordered to file an expert
report addressing the issues raised in respondent’s Rule 4(c) Report. Scheduling Order at 1, ECF
No. 28.
On November 4, 2019, petitioner filed an expert report from Dr. Naveed Natanzi with
supporting literature. Pet. Ex. 6–25, ECF No. 33. On March 27, 2020, respondent filed an expert
report from Dr. Thomas P. Leist with supporting medical literature. Resp. Ex. A, Tabs 1–5, B,
ECF No. 37.
On April 20, 2020, this case was assigned to the undersigned. Notice of Assignment, ECF
No. 39. At a status conference held on May 28, 2020, a review of petitioner’s medical history and
the parties’ expert reports were discussed. Petitioner was to submit a demand for respondent’s
consideration. Scheduling Order at 1–2, ECF No. 40. Petitioner confirmed his submission of a
demand to respondent by status report filed on July 19, 2020. Pet. S.R., ECF No. 41. On August
2
19, 2020, respondent filed a status report stating he considered the demand but was not interested
in pursuing settlement. Resp. S.R. at 1, ECF No. 42.
On September 30, 2020, petitioner filed a status report advising that he would like to
proceed with a ruling on the record. Pet. S.R., ECF No. 43. Petitioner filed his motion for ruling
on the record on December 11, 2020, alleging that he suffered from both SIRVA and brachial
neuritis. Motion, ECF No. 46. Respondent filed a response on January 25, 2021, maintaining that
petitioner had not met his burden regarding either injury alleged. Response, ECF No. 48. Petitioner
filed a reply on February 24, 2021. Reply, ECF No. 52.
I have determined that the parties have had a full and fair opportunity to present their cases,
and I agree with the parties that this matter can be resolved on the record without a hearing. See
Vaccine Rule 8(d); Vaccine Rule 3(b)(2); Kreizenbeck v. Sec’y of Health & Human Servs., 945
F.3d 1362, 1366 (Fed. Cir. 2020); see also Hooker v. Sec’y of Health & Human Servs., No. 02-
472V, 2016 WL 3456435, at *21 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous cases
where special masters decided cases on the papers in lieu of hearings and those decisions were
upheld). “Special masters must determine that the record is comprehensive and fully developed
before ruling on the record.” Kreizenbeck, 945 F.3d at 1366. The Vaccine Act and Rules not only
contemplate but encourage special masters to decide petitions on the papers where, in the exercise
of their discretion, they conclude that doing so will properly and fairly resolve the case. See 42
U.S.C. § 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record in lieu of a hearing
has been affirmed on appeal. I am simply not required to hold a hearing in every matter, no matter
the preferences of the parties. Hovey v. Sec’y of Health & Human Servs., 38 Fed. Cl. 397, 402–03
(1997) (determining that the special master acted within his discretion in denying an evidentiary
hearing); Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993); Murphy v.
Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Fed. Cl. Spec. Mstr. Apr.
19, 1991).
Accordingly, this matter is now ripe for resolution.
B. Medical Terminology
Prior to discussing the case at hand, a brief explanation of the medical conditions
mentioned throughout this Ruling is necessary.
Acute brachial neuritis (“BN”) is a distinct plexus disorder. It is known by many names,
including brachial plexus neuropathy, local neuritis of the shoulder girdle, acute brachial plexitis,
acute shoulder neuritis, paralytic neuritis, and Parsonage Turner Syndrome. Pet. Ex. 18.3 Viral
etiology has been proposed; studies show that infection precedes onset in as many as 25% of cases
and up to 15% of cases follow vaccination. Id. But “[w]hether an injection injury to a peripheral
nerve is caused by direct injury to the nerve or secondary to chemical insult is unclear.” Pet. Ex.
23 at 3.4 The imaging in a case study filed by petitioner suggested that the “nerve injury was caused
3
Jimmy D. Miller, M.D. et al., Acute Brachial Plexus Neuritis: An Uncommon Cause of Shoulder Pain,
62 AM. FAMILY PHYSICIAN 2067 (2000), filed as “Pet. Ex. 18.”
4
Pedro K. Beredjiklian, M.D. et al., Isolated Radial Nerve Palsy Secondary to Influenza Vaccination: A
Case Report with Imaging Correlation, PRACTICAL NEUROLOGY (2012), filed as “Pet. Ex. 23.”
3
by injection of the vaccination into the nerve sheath and not the nerve itself. . . The etiology of
injury—direct trauma to the nerve versus indirect injury via an inflammatory process—” was also
unclear. Id.BN presents with severe, acute, burning pain in the shoulder and upper arm with no
apparent cause. Pet. Ex. 18 at 2.5 It may awaken a patient from sleep. Id. In most, the pain subsides
over the following days to weeks, resulting in a subsequent weakness in the upper arm—at times
to the point of muscle flaccidity. Id.; see also Pet. Ex 19 at 2;6 Pet. Ex. 20 at 1.7 This temporal
profile of initial arm and shoulder pain followed by muscle weakness as the pain subsides is an
important characteristic of acute brachial plexus neuritis. Id.The brachial plexus is a network of nerves with its lymphatic system and blood vessels
“originating from the anterior rami of spinal nerves C5-8 and T1. Situated partly in the neck [] and
partly in the axilla.”8 It is subdivided into “5 anterior rami, 3 trucks [], 6 divisions [], and 3 cords,”
and has numerous branches. Id. The usual abnormality evident on physical examination is one of
a brachial plexus lesion, as indicated by involvement of two or more nerves. Pet. Ex. 18 at 2.9
Weakness is commonly in the supraspinatus, infraspinatus, deltoid and/or bicep muscles usually
involving the upper plexus. Id.Diagnostic evaluation for BN includes magnetic resonance image (“MRI”), which may
show high signal abnormality of affected muscles, or electromyography (“EMG”), which will
localize the lesion to the brachial plexus and will reveal fibrillation potentials and positive waves
suggestive of muscle denervation around three weeks following onset. Pet. Ex. 18 at 3.10 But nerve
conduction studies (“NCS”) of the medial and ulnar nerves are generally within normal limits in a
patient with BN. Id.Treatment of BN includes analgesics, sometimes narcotics (such as hydrocodone), and
physical therapy. Pet. Ex. 18 at 3.11 Corticosteroids may also be used, but they have not shown any
“proven benefit.” Id. In most patients, recovery of muscle strength occurs within roughly 3 months
with complete resolution in 89% of patients within 3 years; however, some patients will
unfortunately have permanent weakness. Pet. Ex. 19 at 2.12
Cervical radiculopathy, unlike BN, presents with pain beginning in the neck area and
radiating down the arm for variable distances. Pet. Ex. 18 at 2.13 Patients with cervical
radiculopathy may awaken in the morning with pain but have no obvious preceding etiology. Id.5
Miller, M.D. et al., supra note 3.
6
Maliha Farhana Shaikh et al., Acute Brachial Neuritis Following Influenza Vaccination, BMJ CASE REP.
(2012), filed as “Pet. Ex. 19.”
7
John S. Taras et al., Brachial Neuritis Following Quadrivalent Human Papilloma Virus (HPV)
Vaccination, 6 HAND 454 (2011), filed as “Pet. Ex. 20.”
8
Dorland’s Illustrated Medical Dictionary 1440 (33d ed. 2019).
9
Miller, M.D. et al., supra note 3.
10
Id.
11
Id.
12
Shaikh et al., supra note 6.
13
Id.
4
The pain is associated with partial weakness in the muscles supplied by the involved nerve root
and sensory loss in the appropriate dermatome. Id. Unlike BN, the pain, weakness, and sensory
loss associated with cervical radiculopathy tends to occur simultaneously. Id. Additionally, BN
involves multiple nerves of the brachial plexus, while radiculopathy, by definition, is restricted to
one nerve root. Id.
C. Shoulder Injuries Defined by the Vaccine Program
Brachial neuritis occurring within 2 to 28 days after tetanus toxoid vaccines is a covered
condition by the Vaccine Act, as set forth on the Vaccine Injury Table. 42 C.F.R. § 100.3(a)(I)(B).
A vaccine recipient shall be considered to have suffered brachial neuritis as a Table injury if such
recipient manifests the following:
(i) Pain in the affected arm and shoulder is a presenting syndrome and occurs
within the specified time-frame;
(ii) Weakness;
(A) Clinical diagnosis in the absence of nerve conduction and
electromyographic studies requires weakness in the muscles supplied
by more than one peripheral nerve.
(B) NCS and EMG studies localizing the injury to the brachial plexus
are required before the diagnosis can be made if weakness is limited to
muscles supplied by a single peripheral nerve.
(iii) Motor, sensory, and reflex findings on physical examination and the
results of NCS and EMG studies, if performed, must be consistent in
confirming that dysfunction is attributable to the brachial plexus; and
(iv) No other condition or abnormality is present that would explain the
vaccine recipient’s symptoms.
42 C.F.R. 100.3(c)(6) (2017).
Shoulder injury related to vaccine administration is another listed injury on the Vaccine
Injury Table. 42 C.F.R. 100.3(a)(I)(C) (2017). The Table states that SIRVA manifests as shoulder
pain and limited range of motion occurring after the administration of a vaccine intended for
intramuscular administration in the upper arm. 42 C.F.R. 100.3(c)(10) (2017). SIRVA is caused
by an injury to the musculoskeletal structures of the shoulder (e.g., tendons, ligaments, bursae,
etc.). Id. As defined by the Vaccine Injury Table, a vaccine recipient shall be considered to have
suffered SIRVA if such recipient manifests the following:
(i) No history of pain, inflammation, or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the
alleged signs, symptoms, examination findings, and/or diagnostic studies
occurring after vaccine injection;
(ii) Pain occurs within specified-time frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which the
intramuscular vaccine was administered; and
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(iv) No other condition or abnormality is present that would explain the
patient’s symptoms (e.g., NCS/EMG or clinical evidence of radiculopathy,
brachial neuritis, mononeuropathies, or any other neuropathy).
42 C.F.R. 100.3(c)(10) (2017).
D. Medical History
1. Petitioner’s Medical History Prior to the Allegedly Causal Tdap Vaccination
Petitioner’s prior medical history was non-contributory. He was a carpenter with associated
arthralgias from physical labor over the years. Pet. Ex. 2 at 52. Petitioner had no history of
neurological injury or disease and no musculoskeletal or left shoulder pain or injury. Id. at 23.
On November 11, 2016, petitioner presented to Dr. Jarrett Gavin Williams at Santa Clarita
Medical Office for lower left abdominal pain that had been progressively getting worse for three
weeks. Pet. Ex. 2 at 182. His mother had been diagnosed with cancer three weeks earlier and he
believed his symptoms were stress related. Id. at 184. His physical examination was normal, and
he was noted to be a “healthy adult.” Id. at 183–87. He deferred medication for his stomach because
his discomfort was not severe. Id. at 187. His record included discontinued medications prescribed
in the past, including Cipro and cholecalciferol. Id. at 201. X-ray of his abdomen on that date was
documented with “[N]o worrisome findings on xr” and was compared to those from 2014. Id. at
187; 191-92. Petitioner had no neurological complaints and no signs of fever. Id. at 184-85. Dr.
Williams noted petitioner to be pre-diabetic and to have a vitamin D deficiency. Id. at 184.
Petitioner declined the flu vaccine during this visit, but the subject Tdap vaccination was
administered. Id. at 182–85, 192.
2. Petitioner’s Medical History Following the Allegedly Causal Tdap Vaccination
On November 12, 2016, at 1:53am, petitioner presented to Panorama City Hospital
Emergency Department (“ED”) complaining of arm pain. Pet. Ex. 2 at 211. He reported receipt of
a Tdap vaccine at 9am the morning of November 11, 2016, went to bed that evening around 9-
10pm and awoke at 12:30am with shaking, chills, numbness, and tingling in the left hand and
weakness in the left arm that had worsened. Id. at 212. At the hospital, he was unable to lift his left
arm. Id. He also reported light headedness and a headache. Id. At around 2:30am, petitioner
experienced tingling of the left side of his face and body. Id. at 213. He had pain with range of
motion of the left arm at the deltoid, acute tenderness to palpation over the injection site with no
visible swelling and mild palpable firmness. Id. at 214. His left fingers were cool to the touch
compared to the right with slight erythema. Id. He was positive for rash and myalgias but had no
joint pain or fever. Id. at 262. He also had significant weakness in his left radial, median, and ulnar
nerves. Id. at 214. The ED doctor, Dr. Linda Szema, initially thought petitioner was having a
stroke, but electrocardiogram (“EKG”) and computerized tomography (“CT”) scans were
negative/normal. Id. at 232-34. A Telemedicine visit with neurologist Dr. Rita Ceponiene ruled
out stroke with neurological symptoms thought to be due to pain. Id. at 217, 220. Dr. Ceponiene
noted that “[a]cute demyelinating plexopathy or acute immune – mediated encephalomyelitis are
6
(sic) unlikely given the immediate time line post vaccination.” Id. at 225. Dr. Szema’s impression
was possible SIRVA or BN from Tdap vaccination. Id. at 218; see also Pet. Ex. 5.
Petitioner followed up that day, November 12, 2016, with Dr. David Wong for left arm
pain following the Tdap vaccine. Pet. Ex. 2 at 260. Dr. Wong’s primary encounter diagnosis was
“adverse drug reaction.” Id. at 263.
It was noted at a follow up examination on November 14, 2016, that the ED doctors
believed petitioner’s symptoms to be muscle spasms from the tetanus vaccine. Pet. Ex. 2 at 284.
Petitioner’s primary care physician (“PCP”) referred him for a neurological consultation
with Dr. Marika Issakhanian on November 15, 2016 due to continuing numbness, lack of sensation
in his left hand, and difficulty lifting his left arm. Pet. Ex. 2 at 296–302. He reported receipt of a
Tdap vaccine with almost immediate pain at the injection site. Id. at 297. The pain worsened
awaking him from sleep, which prompted him to go to the ED. Id. The pain improved the next
day, but the numbness and difficulty lifting his arm continued. Id. The numbness radiated from his
upper arm down to his fingers and he could not raise his left arm. Id. His main complaints included
some pain in the deltoid and lack of sensation in the left hand mainly in the small, ring, and middle
fingers with some involvement of the second digit. Id. He reported a prior tetanus shot while in
the military without issue but believed it was given in the buttocks. Id. Dr. Issakhanian, along with
a colleague with expertise in neuromuscular disorders and EMG, evaluated petitioner. Id. at 300.
The impression was weakness of the left arm with distribution “beyond a single nerve injury or
even radiculopathy,” with symptoms “more consistent with brachial plexus issue” not suspected
to be due to trauma from the injection but rather related to an autoimmune reaction to the vaccine.
Id. An EMG was discussed, as was occupational therapy (“OT”) and a trial of steroids. Id.Petitioner did not want to pursue any treatment at that time because he was caring for his mother
throughout her chemotherapy. Id.During a telemedicine visit with Dr. Issakhanian on November 22, 2016, petitioner
complained of pain and weakness when he tried to lift his left arm sideways. Pet. Ex. 2 at 308. He
continued to have numbness in the tips of his fingers, and his arm and hand would become stiff
when he did not use them. Id.At a December 1, 2016 follow up telemedicine visit, petitioner reported that he was unable
to see the in-network physical therapist because they were not flexible with scheduling, so he asked
for an in-network chiropractor. Pet. Ex. 2 at 313.
On December 7, 2016, petitioner advised Dr. Issakhanian by phone that he was doing
exercises on his own but was not sure he was doing them correctly. Pet. Ex. 2 at 324. It was still
difficult to feel his left fingers. Id. The doctor discussed medications for neuropathic pain, an MRI
with contrast, NCS/EMG testing, physical therapy, and steroids with petitioner. Id. Petitioner was
also cautioned about the importance of avoiding a frozen shoulder. Id. He expressed a willingness
to try Neurontin (gabapentin) for neuropathic pain but wanted a second opinion before undergoing
any testing. Id. Petitioner advised that he was unable to do the physical type of work that he used
to. Id. The impression was Parsonage Turner Syndrome or brachial plexus injury. Id.7
When petitioner presented for occupational therapy on December 12, 2016, he had
decreased range of motion, grip strength, and pinch strength. Pet. Ex. 2 at 351. He reported trouble
with activities of daily living including dressing, bathing, grooming, functional mobility and
transfers, vacuuming, and cooking. Id.On December 21, 2016, petitioner reported taking Neurontin at night, but the pain relief
effect wore off by mid-day. Pet. Ex. 2 at 368. The Neurontin was increased to twice a day—once
in the morning and once at night. Id. at 368, 370.
At his December 27, 2016 visit to OT, petitioner reported left arm and hand weakness,
numbness, and severe pain in the left shoulder after a tetanus shot, although the pain was
improving. Pet. Ex. 2 at 373, 375. Petitioner also reported stiffness in the morning and use of heat
for relief. Id. at 375. By January 3, 2017, petitioner reported feeling a little better and was trying
to complete the prescribed exercises. Pet. Ex. 2 at 381.
Petitioner complained of increased pain on January 9, 2017, after trying to vacuum. Pet.
Ex. 2 at 387. On January 31, 2017, he reported continued left arm and hand weakness, numbness,
and pain after the tetanus shot. Id. at 398.
On February 7, 2017, while participating in rehabilitation for his wrist and hand, petitioner
reported weakness of his left arm and pain in his left bicep, but his left shoulder felt 20-25% better
since his last visit. Pet. Ex. 2 at 406-08.
On February 16, 2017, petitioner presented for OT with pain in his upper arm and his “only
problem is lifting [his] arm up.” Pet. Ex. 2 at 416. Petitioner continued to note shoulder problems,
including decreased range of motion, grip strength, and pinch strength at his February 21, 2017
OT visit. Id. at 423.
At a March 1, 2017 visit, petitioner reported continued but improved numbness in his small,
ring, and middle finger. Pet. Ex. 2 at 436. During his March 16 and March 23, 2017 visits,
petitioner reported left shoulder pain and “stabbing” left shoulder pain, respectively. Id. at 457. By
March 30, 2017, however, he reported that the pain was not as bad. Id. at 464. He had been using
weights with no problem and was doing some resisted shoulder exercises using a bottle of water.
Id. He wanted to return to archery. Id.On April 25, 2017, petitioner reported weakness in his left hand, but his sensory and focal
weakness was much improved. Pet. Ex. 2 at 483. He was continuing with OT and working hard
on his own to improve his strength. Id. at 484. At his neurology follow up on April 25, 2017,
Parsonage Turner and autoimmune reaction to injection were listed in the differential. Id. at 483.
An EMG and steroids were again discussed, but petitioner declined additional testing and
treatment because he had some improvement and was busy taking care of his mother. Id. He
reported being able to hold his bow in his left arm, but pain limited his ability to use the bow
effectively. Id. at 484. He reported that the Department of Fish and Wildlife would allow him to
use a disabled archer’s permit and crossbow instead if a form were completed by his physician. Id.8
At his April 26, 2017 OT visit, petitioner reported improvement of shoulder pain and
continued resistance exercises with a bottle of water. Pet. Ex. 2 at 494. On May 2, 2017, petitioner
presented with numbness in the ulnar distribution of his left hand, resolved forearm and upper arm
pain, and pain improving in his left shoulder. Pet. Ex. 2 at 505. He described discomfort in his
shoulder. Id. He attended OT on May 8, May 15, May 30, and June 12, at which point he was
discharged. Id. at 509, 515, 522, 532-33.
On June 28, 2017, petitioner again presented with abdominal pain similar to what he had
experienced in the past. Pet. Ex. 2 at 539-40. As he had done in the past, petitioner reported being
under stress because his mom had pancreatic cancer. Id.At a telemedicine appointment on August 29, 2017, petitioner reported that he had stopped
taking Neurontin since his last visit, was doing curls with weights, and his shoulder was “doing
fine.” Pet. Ex. 3 at 27. However, he continued to have a “twinge of pain” in his shoulder when
raising his arm overhead. Id. The two fingertips on his left hand were still numb, and his small
finger still fell asleep with use of his hand. Id.Petitioner presented with abdominal pain in September and October of 2017. Pet. Ex. 3 at
32, 51,142, 144, 200.
At a December 14, 2017 visit, petitioner reported that his symptoms were much improved
overall, although he still had some numbness in his fingertips. Pet. Ex. 3 at 320. He again declined
EMG and MRI testing or steroids. Id. He inquired if anything could be done for the numbness in
his fingers. He was given a referral for a second opinion. Id.Petitioner presented for a second neurological opinion with Dr. Nastaran Rafiei on
December 22, 2017 reporting continued numbness in his fingers and weakness of the left arm. Pet.
Ex. 3 at 327, 330. Dr. Rafiei believed petitioner’s symptoms “could be due to a Parsonage Turner
with patchy involvement of brachial plexus but cannot not rule out other possibilities like cervical
radiculopathy or compression neuropathy.” Id. at 330. Petitioner reported a fear of needles and
would not proceed with any treatment that involved needles. Id. at 331. Dr. Rafiei advised
petitioner to contact her if he changed his mind. Id.E. Petitioner’s Affidavit
On March 15, 2018, petitioner filed his affidavit. Pet. Ex. 4. Petitioner’s affidavit affirmed
receipt of the Tdap vaccination on November 11, 2016, his diagnosis of Parsonage Turner
Syndrome caused by the Tdap vaccination, and that he suffered residual effects from his injury in
excess of six months. Id. at 1.
II. Issues to be Determined
Petitioner alleges that he suffered from both BN and SIRVA. See Motion. Respondent
argues that because petitioner has BN, he could not have suffered from a SIRVA; further,
because the onset of his BN was less than two days after receipt of the vaccine, he did not suffer
from a Table vaccine related BN injury. See generally Response. Thus, petitioner must
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demonstrate that the vaccine was the cause-in-fact of one or both of his injuries to be entitled to
compensation. See Veryzer v. Sec’y of Health & Human Servs., 100 Fed. Cl. 344, 351 (Sept. 29,
2011) (“To be compensated under the Vaccine Act, petitioners must prove that an injury was
caused by a vaccine listed on the Vaccine Injury Table”) (emphasis added).
III. Expert Reports
A. Petitioner’s Expert, Dr. Naveed Natanzi
1. Qualifications
Petitioner filed an expert report from Dr. Naveed Natanzi. See Pet. Ex. 6. Dr. Natanzi
obtained his medical degree from Western University of Health Sciences and completed his
residency at University of California, Irvine. Pet. Ex. 25 at 1-2. He is board certified in physical
medicine and rehabilitation and founded the Regenerative Sports and Spine Institute in Sherman
Oaks, California. Id. at 1.
2. Dr. Natanzi’s Report
In Dr. Natanzi’s opinion, petitioner suffered from both a SIRVA and BN injury as a result
of the Tdap vaccine he received on November 11, 2016.
Dr. Natanzi submitted that petitioner’s “presentation clearly meets the accepted temporal
relationship for a SIRVA diagnosis” with pain or dysfunction within 48 hours after vaccination.
Pet. Ex. 6 at 7. Further, petitioner felt a protracted course of pain that began almost immediately
after the injection, attributable to overpenetration of the vaccine needle resulting in contact with
the subacromial bursa and/or rotator cuff. Id.14, 15
In addition to onset within 48 hours of vaccination, Dr. Natanzi explained that those with
SIRVA commonly present with symptoms and physical signs, such as a limited range of motion
in the rotator cuff muscles, weakness due to pain of the rotator cuff muscles, and tenderness at the
rotator cuff. Pet. Ex. 6 at 9-10. Clinical signs of capsulitis, tendinitis, and impingement may also
be seen with SIRVA. Id. at 10.
Dr. Natanzi pointed to specific entries in the medical record regarding the onset of
petitioner’s pain to satisfy the SIRVA requirements. Pet. Ex. 6 at 7. First, on November 12, 2016,
14
Dr. Natanzi wrote that this was caused by petitioner being seated while the vaccine administrator was
standing when the vaccine was administered. This information is not contained in the medical record or
petitioner’s affidavit. It appears that Dr. Natanzi spoke with petitioner at some point, and this may have
been discussed, but Dr. Natanzi does not reference where this information came from.
15
Dr. Natanzi noted that the exact location of vaccination on the deltoid was not recorded, no imaging or
ultrasound was used to confirm needle placement, and there was no report of type or length of needle used.
Pet. Ex. 6 at 7. Petitioner denied strenuous or atypical work or injury to the neck or shoulder in the days
preceding the vaccination. Id. In the subsequent days, weeks, and months, petitioner felt numbness, pain,
and limited functional use of the left upper limb with sluggish progressive improvement of his symptoms.
Id.
10
Drs. Szema and Ceponiene documented that petitioner experienced pain following receipt of a
vaccination on November 11, 2016. Id.; Pet. Ex. 2 at 212, 221. Second, on November 15, 2016,
Dr. Issakhanian documented that petitioner “almost immediately had some pain at the site of
injection.” Pet. Ex. 6 at 7; Pet. Ex. 2 at 297. Third, on December 22, 2017, Dr. Rafiei documented
petitioner’s belief that all his symptoms started after the Tdap vaccine because he “almost
immediately” had pain at the injection site. Pet. Ex. 6 at 7; Pet. Ex. 3 at 327. Finally, petitioner
reported to Dr. Natanzi that his immediate post-vaccination pain was a 4/10, when he usually
experienced no pain after receiving a vaccine. Pet. Ex. 6 at 7.
Dr. Natanzi submitted that the medical records also support a structural injury of the
shoulder consistent with SIRVA. Pet. Ex. 6 at 10. He noted that Dr. Issakhanian expressed concern
that petitioner take care to avoid frozen shoulder. Id.; Pet. Ex. 2 at 321. Petitioner’s OT record
from June 12, 2017 documented pain with overhead activities characteristic of rotator cuff
mediated pain. Pet. Ex. 6 at 10; Pet. Ex. 3 at 5. Further, petitioner reported difficulty and pain when
blow drying his hair, which requires flexion and internal/external rotation of the arm, reproducing
orthopedic maneuvers used to test for strain and impingement of the rotator cuff. Pet. Ex. 6 at 10;
Pet. Ex. 3 at 27. Dr. Natanzi concluded that, even though a complete musculoskeletal examination
was not conducted on petitioner and an MRI was not done, within a reasonable degree of medical
probability, there were signs of rotator cuff mediated pain suggestive of SIRVA. Pet. Ex. 6 at 10.
Dr. Natanzi further opined that petitioner suffered BN as a result of the Tdap vaccine. Pet.
Ex. 6 at 8. Dr. Natanzi acknowledged that the Table recognizes BN injury from a tetanus vaccine
when onset occurs within 2-28 days of vaccination; he conceded that petitioner’s onset was 15.5
hours after vaccination. Id. However, Dr. Natanzi submitted that when petitioner received his
vaccine at 9am the morning of November 11, 2016, his “initial atypical pain” was related to
SIRVA—not BN. Id. When he awoke around 12:30am or roughly 15.5 hours after vaccination
with severe intense pain, weakness, numbness and tingling, that was BN. Id. Dr. Natanzi submitted
that in speaking with petitioner, petitioner expressed his pain as a 4/10 following receipt of the
vaccine but a 15/10 when it awoke him from sleep 15.5 hours later. Id. Accordingly, Dr. Natanzi
concluded that petitioner’s initial pain immediately following the vaccine was related to SIRVA,
while the intense 15/10 pain that awoke petitioner from sleep was BN. Id.
Noting that the onset of petitioner’s BN pain was 32 hours short of the timeframe contained
in the Vaccine Injury Table, Dr. Natanzi argued that the timeframes on the Table are merely
guidelines. Pet. Ex. 6 at 8; see 42 C.F.R. § 100.3. He explained that every person’s body responds
differently to any given stimulus. Id. For example, some people may swell and itch immediately
after a mosquito bite, while others barely notice any symptoms. Id.To support his opinion that petitioner suffered BN within 15.5 hours of the Tdap vaccine,
Dr. Natanzi submitted several case studies in which the onset of BN was less than two days after
vaccine. Pet. Ex. 6 at 8. In Weintraub & Chia, onset of paralytic BN was 17 hours after a swine
flu vaccine. Id.; Pet. Ex. 21.16 In Taras and Beredjiklian, onset of radial palsy, which is similar to
16
M. I. Weintraub, M.D & D. T. S. Chia, M.D., Paralytic Brachial Neuritis After Swine Flu Vaccination,
34 ARCHIVES OF NEUROLOGY 518 (1977), filed as “Pet. Ex. 21.”
11
BN in pathophysiology, occurred 12 hours and 16 hours after flu vaccination, respectively. Pet.
Ex. 6 at 8; Pet. Ex. 23;17 Pet. Ex. 24.18
Dr. Natanzi also relied on an article in which the authors reviewed FEDRA (the Adverse
Reaction Data of the Spanish Pharmacovigilance System database) for the risk of shoulder
injuries following vaccination. Pet. Ex. 16.19 They found “6 in 8 FEDRA patients complained of
increasing severity pain starting within the first 24 [hours] or few days (4-7 days) post-
vaccination.” Id. at 3. They further determined that “the patients had inmmediate (sic) pain or
pain arising within the first 24 h post-vaccination in 81.1% of cases.” Id. A table contained
therein showed onset of bursitis only “a few hours” after PPV vaccine, and onset of tenosynovitis
only “a few hours” after flu vaccination. Id. at 2 Table 1. The authors included a second table in
the article, documenting cases of shoulder injuries related to the administration of vaccines
published in medical literature. Id. at 4 Table 2. Included were 13 cases of bursitis, tendonitis,
and torn rotator cuff with immediate onset or onset within 24 hours following flu vaccines and
TD vaccines. Id.Additionally, Dr. Natanzi relied on Miller et. al, which described BN as most commonly
presenting in males between the ages of 20-60 with characteristic awaking from sleep with pain
like petitioner. Pet. Ex. 6 at 8; Pet. Ex. 18.20 Further, case reports document BN following a variety
of vaccinations, presenting with a period of severe and intense pain for days to weeks that improves
and is followed by a period of significant weakness. Id. at 8-9. EMG testing typically shows
positive signs of acute denervation within three weeks with weakness present in the supraspinatus,
infraspinatus and/or deltoid muscles, and occasionally the bicep muscles. Id. At 9.
Dr. Natanzi opined that petitioner’s presentation was consistent with what is seen in BN.
Petitioner developed severe pain, numbness, and tingling with weakness of the deltoid muscle, as
described by Dr. Szema in the ER. Pet. Ex. 6 at 9; Pet. Ex. 2 at 221. He was diagnosed with possible
BN that gradually improved with ongoing persistent neurological symptoms of weakness and
paresthesia. Pet. Ex. 6 at 9; Pet. Ex. 2 at 218, 296, 483. On April 25, 2017, Dr. Issakhanian
documented that petitioner’s pain subsided, but the neurological symptoms of weakness and
paresthesia persisted. Pet. Ex. 6 at 9; Pet. Ex. 2 at 482. Similar findings of a pins-and-needles
sensation in petitioner’s hands and fingers were present at his visit over 13 months after
vaccination in December of 2017 when Dr. Rafiei noted improvement of shoulder pain but
lingering numbness and weakness and diminished sensation in his left hand. Pet. Ex. 6 at 9; Pet.
Ex. 3 at 327, 330. Even though an EMG was not performed, Dr. Natanzi opined that “there [was]
enough clear-cut clinical data to make the diagnosis without it. This notion is further supported by
the clinical suspicion of BN by nearly all treating providers, including Drs. Szema, Ceponiene,
Issakhanian, and Rafiei.” Pet. Ex. 6 at 9.
17
Beredjiklian, M.D. et al., supra note 4.
18
John S. Taras, M.D. & Kenneth W. Donohue, M.D., Radial Nerve Motor Palsy Following Seasonal
Influenza Vaccination: A Case Report, 23 J. OF SURGICAL ORTHOPAEDIC ADVANCES 42 (2014), filed as
“Pet. Ex. 24.”
19
L.H. Martín Arias et al., Risk of Bursitis and Other Injuries and Dysfunctions of the Shoulder Following
Vaccinations, 35 VACCINE 4870 (2017), filed as “Pet. Ex. 16.”
20
Miller, M.D. et al., supra note 3.
12
Dr. Natanzi concluded that a causal relationship existed between the Tdap vaccine and the
development of petitioner’s BN, given the acute onset of pain that progressively improved,
followed by a protracted course of neurological symptoms like weakness and numbness, and the
characteristic epidemiologic profile. Pet. Ex. 6 at 9. Petitioner’s onset of symptoms was “in line
with a BN diagnosis,” even though his onset occurred sooner than what has been documented in
other BN cases and on the Vaccine Injury Table. Id. at 8. In Dr. Natanzi’s opinion, petitioner was
injured by the vaccination and his clinical course was “highly suggestive of BN.” Id.
Dr. Natanzi further concluded that petitioner had an overlap of symptoms of SIRVA and
BN, but with symptoms exclusive to both injuries. Pet. Ex. 6 at 10. Acute severe onset of pain with
accompanying numbness, marked weakness, and subsequent protracted course of neurologic
deficits in the hand were related to BN—not SIRVA. Id. In contrast, the immediate discomfort
following vaccination and signs and symptoms of what seem to be persistent rotator cuff mediated
pain was suggestive of a SIRVA—not BN. Id. Both were caused by the Tdap vaccine administered
on November 11, 2016. Id.
B. Respondent’s Expert, Dr. Thomas P. Leist
1. Qualifications
Respondent filed an expert report from Dr. Thomas P. Leist. See Resp. Ex. A. Dr. Leist
obtained his medical degree from University of Miami and completed his residency at Cornell
Medical Center/Sloan Kettering Memorial Cancer Center. Resp. Ex. B at 1. He is board certified
in psychiatry and neurology. Id. Dr. Leist specializes in the field of neuroimmunology and directs
a clinical program in that neurologic subspecialty. Resp. Ex. A at 1. He has been a Professor of
Neurology at Thomas Jefferson University since 2014. Resp. Ex. B at 1.
2. Dr. Leist’s Report
Dr. Leist disagreed that petitioner suffered either SIRVA or BN as a result of his Tdap
vaccine. Resp. Ex. A at 5-6. Dr. Leist opined that the shoulder pain petitioner experienced soon
after the vaccination may have been due to a localized reaction to the Tdap vaccine, which is
common according to the CDC Pink Book, or the onset of his neurological condition
“coincidentally occurring at the time soon after vaccination.” Id. at 4-6; see Resp. Ex. A, Tab 5.
According to Dr. Leist, the symptoms associated with SIRVA include pain, reduced range
of motion limited to the vaccinated shoulder, and the absence of another condition that would
explain the symptoms, such as BN or cervical radiculopathy. Resp. Ex. A at 5; Pet. Ex. 11.21 Even
though petitioner had an onset of symptoms within 48 hours of receipt of the Tdap vaccine as
required by the Vaccine Table for SIRVA injury, his symptoms were not consistent with SIRVA
but more likely a local vaccine reaction or the onset of his neurological condition. Resp. Ex. A at
6; see 42 C.F.R. § 100.3.
21
S. Atanasoff et al., Shoulder Injury Related to Vaccine Administration (SIRVA), 28 VACCINE 8049,
8051-52 (2010), filed as “Pet. Ex. 11.”
13
Dr. Leist opined that petitioner developed “a temporary self-resolving swelling in the area
of the administration of Tdap” vaccine, which occurs in about one fifth of patients. Resp. Ex. A at
8. The CDC Pink Book notes local reactions, including erythema, induration, and pain at the
injection site following diphtheria and tetanus toxoid vaccination to be common. Id. at 4; Resp.
Ex. A, Tab 5. Additionally, the prescribing information for Adacel (the Tdap vaccine received by
petitioner) documents that about two thirds of the individuals in trials reported pain at the injection
site; almost 25% of the patients had redness at the injection site; and more than 20% experienced
swelling. Id.Dr. Leist agreed that petitioner suffers from BN but disagreed it was the result of the Tdap
vaccine. Resp. Ex. A at 6. He noted that Dr. Szema found weakness on examination at around 2am
on November 12, 2016 – roughly 17 hours after vaccination. Pet. Ex. 2 at 211-14. However, that
weakness was of the muscles supplied by the radial, median ulnar distribution, not the axillary
nerve. Id. at 214. Further, ultrasound of petitioner’s upper arm was normal. Resp. Ex. A at 6.22
According to Dr. Leist, there is “no recognized mechanism by which local injection-related injury
can cause relatively immediate distant de novo neurologic dysfunction.” Id. at 5. He added that
Dr. Szema wrote that she did “not suspect axillary nerve injury given patient able to hold arm in
abduction and lack of numbness in the shoulder.” Id.; Pet. Ex. 2 at 218.
Dr. Leist took issue with the characterization that the 2-28 day timeframe for BN following
tetanus vaccine set forth in the Vaccine Injury Table was merely a guideline, submitting that the
onset within 2-28 days “takes into consideration the minimal, biologically plausible time interval
necessary for a putative vaccine relate (sic) immune response to occur and to cause brachial
neuritis, which usually presents with abrupt onset of generally unilateral shoulder pain.” Resp. Ex.
A at 6. The initial pain is then followed by “progressive neurologic deficits over a course of a few
days to weeks with progressive weakness, reflex changes, and sensory abnormalities involving the
shoulder girdle musculature and proximal upper arms.” Id. BN is thought to be caused by either a
viral illness that affects the brachial plexus or an immune response against a virus or a viral antigen.
Id.; Resp. Ex. A, Tab 3.23 To that end, Dr. Leist argued that petitioner was prescribed Cipro for a
gastrointestinal virus at the time he received the Tdap vaccine which was the cause of his BN; the
timing of the Tdap vaccine was merely a coincidence. Resp. Ex. A at 2, 4.
Dr. Leist relied on Rowhani-Rahbar et al. to show that, at minimum, two days are necessary
for a “vaccine-induced immune response cross-reactive with nerve cells of the brachial plexus to
occur.” Resp. Ex. A at 6; Resp. Ex. A, Tab 4.24 He conceded the study did not specifically include
BN, but claimed that it “propose[d]” a 2-42 day interval for the development of neurologic illness
following vaccination as biologically plausible. Id. Further, Dr. Leist noted that there was no
22
After careful review of the medical records, it appears that a diagnostic ultrasound of petitioner’s upper
arm was not performed. The only ultrasounds documented in the records were part of petitioner’s OT
treatment. See Pet. Ex. 2 at 352, 374, 380, 386, 399-400, 406-07, 415-16, 422-23, 435-36, 441, 450, 456,
463, 495, 504, 510, 516, 523, 530; Pet. Ex. 3 at 4. The “normal” ultrasound to which Dr. Leist referred is
unclear since he did not provide a citation to the medical records.
23
Joseph H. Feinberg, M.D. & Jeffrey Radecki, M.D., Parsonage-Turner Syndrome, 6 HOSPITAL FOR
SPECIAL SURGERY 199 (2010), filed as “Resp. Ex. A, Tab 3.”
24
Ali Rowhani-Rahbar, Biologically Plausible and Evidence-Based Risk Intervals in Immunization Safety
Research, 31 VACCINE 271 (2012), filed as “Resp. Ex. A, Tab 4.”
14
indication that petitioner suffered an anaphylactic reaction before he went to bed on the evening
of November 11, 2016. Resp. Ex. A at 7. Thus, the 15-16-hour onset seen here is too short to
implicate the Tdap vaccine as the cause of petitioner’s BN. Id. at 6.
Further, Dr. Leist referenced petitioner’s medical records including the ED record for
November 12, 2016, in which Dr. Szema documented weakness involving several peripheral
nerves, the left brachial plexus in a widespread fashion, and nerve roots likely from C5/C6 to T1.
Resp. Ex. A at 7. Dr. Issakhanian’s notes on November 15, 2016, which documented that the
“distribution of numbness, weakness goes beyond a single nerve injury or even a radiculopathy.”
Id.; Pet. Ex. 2 at 300. Dr. Rafiei’s December 22, 2017 record which documented “mild weakness
of mainly proximal LUE in C4-C6 myotomes” and “numbness mainly in left C8 versus ulnar
dermatome” with cervical radiculopathy possible. Resp. Ex. A at 7; Pet. Ex. 3 at 330. Dr. Leist
then concluded that based on these records, cervical radiculopathy could not be excluded. Resp.
Ex. A at 7. He added that the documented findings between November 12, 2016 and December
22, 2017 showed little difference, petitioner’s symptoms apparently did not worsen between 2-28
days following the administration of the Tdap vaccine, which was unusual for BN because that
is the timeframe listed on the Table for the onset of BN symptoms following a Tdap vaccination.
Id. at 7-8.
Dr. Leist opined that the “constellation of neurologic symptoms” petitioner presented with
15-16 hours after the Tdap vaccine were not consistent with SIRVA, based on symptoms, or with
BN, based on timing. Resp. Ex. A at 8. Rather, petitioner had a three-week gastrointestinal issue
for which he was seen on November 11, 2016, which could have been the infection that triggered
his injury. Id. Further, Dr. Leist opined that petitioner developed common swelling at the injection
site, but the Tdap vaccine did not cause petitioner’s injury and did not lead to enduring aggravation
of a pre-existing injury. Id. It is unclear what pre-existing injury Dr. Leist was referring to as there
is no record of petitioner having any pre-existing left shoulder injury.
IV. Discussion
A. Legal Standard
The Vaccine Act was established to compensate vaccine-related injuries and deaths. §
10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a
simple, fair and expeditious means for compensating vaccine-related injured persons. The Program
was established to award ‘vaccine-injured persons quickly, easily, and with certainty and
generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R. Rep.
No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). The petitioner need not make a specific type
of evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological
markers or genetic predisposition, or general acceptance in the scientific or medical communities
15
to establish a logical sequence of cause and effect.” Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1325 (Fed. Cir. 2006). Instead, petitioner may satisfy his burden by presenting
circumstantial evidence and reliable medical opinions. Id. at 1325-26.
In particular, a petitioner must prove that the vaccine was “not only [the] but-for cause of
the injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321(quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999));
see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). The
received vaccine, however, need not be the predominant cause of the injury. Shyface, 165 F.3d at
1351. A petitioner who satisfies this burden is entitled to compensation unless respondent can
prove, by a preponderance of the evidence, that the vaccinee’s injury is “due to factors unrelated
to the administration of the vaccine.” § 13(a)(1)(B). However, if a petitioner fails to establish a
prima facie case, the burden does not shift. Bradley v. Sec’y of Health & Human Servs., 991 F.2d
1570, 1575 (Fed. Cir. 1993).
“Regardless of whether the burden ever shifts to the respondent, the special master may
consider the evidence presented by the respondent in determining whether the petitioner has
established a prima facie case.” Flores v. Sec’y of Health & Human Servs., 115 Fed. Cl. 157, 162-
63 (2014); see also Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012)
(“[E]vidence of other possible sources of injury can be relevant not only to the ‘factors unrelated’
defense, but also to whether a prima facie showing has been made that the vaccine was a substantial
factor in causing the injury in question”); de Bazan v. Sec’y of Health & Human Servs., 539 F.3d
1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is permitted to offer evidence
to demonstrate the inadequacy of the petitioner’s evidence on a requisite element of the petitioner's
case-in-chief”); Pafford, 451 F.3d at 1358-59 (“[T]he presence of multiple potential causative
agents makes it difficult to attribute ‘but for’ causation to the vaccination. . . . [T]he Special Master
properly introduced the presence of the other unrelated contemporaneous events as just as likely
to have been the triggering event as the vaccinations”).
B. Factual Issues
A petitioner must prove, by a preponderance of the evidence, the factual circumstances
surrounding his claim. § 13(a)(1)(A). The process for making determinations in Vaccine Program
cases regarding factual issues begins with analyzing the medical records, which are required to be
filed with the petition. § 11(c)(2). Medical records created contemporaneously with the events they
describe are generally considered to be more trustworthy. Cucuras v. Sec’y of Health & Human
Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993); but see Kirby v. Sec’y of Health & Human Servs.,
993 F.3d 1378, 1382-83 (Fed. Cir. 2021) (clarifying that Cucuras does not stand for proposition
that medical records are presumptively accurate and complete). While not presumed to be
complete and accurate, medical records made while seeking treatment are generally afforded more
weight than statements made by petitioner after-the-fact. See Gerami v. Sec'y of Health & Human
Servs., No. 12-442V, 2013 WL 5998109, at *4 (Fed. Cl. Spec. Mstr. Oct. 11, 2013) (finding that
contemporaneously documented medical evidence was more persuasive than the letter prepared
for litigation purposes), mot. for rev. denied, 127 Fed. Cl. 299 (2014). Indeed, “where later
testimony conflicts with earlier contemporaneous documents, courts generally give the
contemporaneous documentation more weight.” Campbell ex rel. Campbell v. Sec’y of Health &
16
Human Servs., 69 Fed. Cl. 775, 779 (2006); see United States v. U.S. Gypsum Co., 333 U.S. 364,
396 (1948).
Despite the weight afforded medical records, special masters are not bound rigidly by those
records in determining facts such as the onset of a petitioner’s symptoms. Vallenzuela v. Sec’y of
Health & Human Servs., No. 90-1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30,
1991); see also Eng v. Sec’y of Health & Human Servs., No. 90-175V, 1994 WL 67704, at *3 (Fed.
Cl. Spec. Mstr. Feb 18, 1994) (explaining that § 13(b)(2) “must be construed so as to give effect
to § 13(b)(1) which directs the special master or court to consider the medical record...but does not
require the special master or court to be bound by them”); see also Burns, 3 F.3d at 417 (holding
that it is within the special master's discretion to determine whether to afford greater weight to
medical records or to other evidence, such as oral testimony surrounding the events in question
that was given at a later date, provided that such determination is rational).
There are situations in which compelling oral testimony may be more persuasive than
written records. See Campbell, 69 Fed. Cl. at 779 (2006). When witness testimony contradicts
medical records, such testimony must be consistent, clear, cogent, and compelling to be persuasive.
See Sanchez v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *3 (Fed. Cl.
Spec. Mstr. Apr. 10, 2013) (vacated on other grounds, Sanchez by & through Sanchez v. Sec’y of
Health & Human Servs., No. 2019-1753, 2020 WL 1685554 (Fed. Cir. 2020), review denied,
Sanchez by & through Sanchez v. Sec’y of Health & Human Servs., 152 Fed. Cl. 782 (2021))
(quoting Blutstein v. Sec’y of Health & Human Servs., No. 90-2808V, 1998 WL 408611, at *85
(Fed. Cl. Spec. Mstr. June 30, 1998)); see, e.g., Stevenson ex rel. Stevenson v. Sec’y of Health &
Human Servs., No. 90-2127V, 1994 WL 808592, at *7 (Fed. Cl. Spec. Mstr. June 27, 1994)
(crediting the testimony of a fact witness whose “memory was sound” and “recollections were
consistent with the other factual evidence”). Special masters may also consider other types of
evidence, such as unsworn statements, on the grounds that the Vaccine Program was designed to
have “flexible and informal standards of admissibility of evidence.” 42 U.S.C. § 300aa-
12(d)(2)(B); see also Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 873 (Fed. Cir. 1992).
On the whole, a special master’s fact findings are to be upheld when the special master’s
evaluation is evidence-based and not wholly implausible. See Colon v. Sec’y of Health & Human
Servs., 156 Fed. Cl. 534 (2021).
C. Causation
To receive compensation through the Program, petitioner must prove either (1) that he
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that he received, or (2) that he suffered an injury that was actually caused by a vaccination.
See §§ 11(c)(1), 13(a)(1)(A); Capizzano, 440 F.3d at 1319-20. Where petitioner does not allege
that he suffered a Table Injury, he must prove that the vaccine he received caused his injury. See
generally Motion. To do so, petitioner must establish, by preponderant evidence: “(1) a medical
theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and
effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate
temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
17
The causation theory must relate to the injury alleged. The petitioner must provide a sound
and reliable medical or scientific explanation that pertains specifically to this case, although the
explanation need only be “legally probable, not medically or scientifically certain.” Knudsen v.
Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot establish
entitlement to compensation based solely on his assertions; rather, a vaccine claim must be
supported either by medical records or by the opinion of a medical doctor. § 13(a)(1). In
determining whether petitioner is entitled to compensation, the special master shall consider all
material in the record, including “any . . . conclusion, [or] medical judgment . . . which is contained
in the record regarding . . . causation.” § 13(b)(1)(A). The undersigned must weigh the submitted
evidence and the testimony of the parties’ proffered experts and rule in petitioner’s favor when the
evidence weighs in his favor. See Moberly, 592 F.3d at 1325-26 (“Finders of fact are entitled—
indeed, expected—to make determinations as to the reliability of the evidence presented to them
and, if appropriate, as to the credibility of the persons presenting that evidence”); Althen, 418 F.3d
at 1280 (noting that “close calls” are resolved in petitioner’s favor).
D. Analysis of Althen Prongs
In his Motion for Ruling on the Record, petitioner alleges that he suffered both a SIRVA
and a BN injury. See Motion at 1. Respondent opposed petitioner’s claim that he suffered a SIRVA
injury and only submitted arguments against Althen Prongs II and III regarding petitioner’s claim
of BN injury. Response at 1. Petitioner need only carry his burden of an injury alleged to be entitled
to compensation. See Veryzer, 100 Fed. Cl. at 351 (“To be compensated under the Vaccine Act,
petitioners must prove that an injury was caused by a vaccine listed on the Vaccine Injury Table”)
(emphasis added); Knudsen, 35 F.3d at 550 (stating that petitioners “need not explain all other
symptoms or injuries by reference to the [] vaccination”). Because I find that petitioner suffered a
BN injury as a result of his receipt of the Tdap vaccine, only BN is addressed below.
Due to the onset of petitioner’s symptoms of BN between 15 and 16 hours after the Tdap
vaccine, rather than within the 2-28 day time period set forth in the Vaccine Table, petitioner’s
claim for BN injury is classified as an “off-Table” claim. Therefore, petitioner must show by
preponderant evidence that his injury resulted from the vaccination at issue. Capizzano, 440 F.3d
at 1320. Doing so shifts the burden to respondent to show that the injury was caused by factors
unrelated to the vaccination. Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717
F.3d 1363, 1367 (Fed. Cir. 2013).
1. Petitioner has Advanced a Sound and Reliable Medical Theory
The first Althen Prong requires that petitioner provide a “reputable medical theory”
demonstrating that the vaccines received can cause the type of injury alleged. Pafford, 451 F.3d at
1355-56 (citation omitted). To satisfy this Prong, petitioner’s “theory of causation must be
supported by a ‘reputable medical or scientific explanation.’” Andreu ex rel. Andreu v. Sec’y of
Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (quoting Althen, 418 F.3d at 1278).
This theory need only be “legally probable, not medically or scientifically certain.” Id. at 1380(emphasis omitted) (quoting Knudsen, 35 F.3d at 548). This standard was recently clarified by the
Federal Circuit. See Boatmon, 941 F.3d at 1359-60 (stating that the correct standard for Althen
Prong one is “reputable” and “sound and reliable”—not a “lower reasonable standard” (internal
18
quotations omitted)). Nevertheless, “petitioners [must] proffer trustworthy testimony from experts
who can find support for their theories in medical literature.” LaLonde v. Sec’y of Health & Human
Servs., 746 F.3d 1334, 1341 (Fed. Cir. 2014).
Respondent submitted that “for purposes of petitioner’s motion in this case, he would not
challenge the alleged causal connection between the Tdap vaccination and brachial neuritis” and
directed his arguments exclusively to Prongs II and III. Response at 13, ECF No. 48.
Therefore, because the Vaccine Program recognizes that Tdap can cause BN and because
respondent presented no argument to the contrary, Prong I is satisfied.
2. Petitioner has Provided a Logical Connection and Demonstrated a Proximal
Temporal Relationship satisfying Prongs II and III.
The second Althen Prong requires proof of a “logical sequence of cause and effect.”
Capizzano, 440 F.3d at 1326 (quoting Althen, 418 F.3d at 1278). In other words, even if the
vaccinations can cause the injury, petitioner must show “that it did so in [this] particular case.”
Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 962 n.4 (Fed. Cir. 1993) (citation omitted).
A sound and reliable “medical or scientific explanation must support this logical sequence of cause
and effect,” id. at 961 (citation omitted), and “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,” Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1385
(Fed. Cir. 2015) (quoting Andreu, 569 F.3d at 1375). Petitioner is not, however, required “to
eliminate alternative causes as part of establishing [their] prima facie case.” Doe v. Sec’y of Health
& Human Servs., 601 F.3d 1349, 1357-58 (Fed. Cir. 2010); see Walther v. Sec’y of Health &
Human Servs., 485 F.3d 1146, 1152 (Fed. Cir. 2007) (holding that a “petitioner does not bear the
burden of eliminating alternative independent potential causes”).
In evaluating whether Prong II is satisfied, the opinions and views of the vaccinee’s treating
physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326(“[M]edical records and medical opinion testimony are favored in vaccine cases, as treating
physicians are likely to be in the best position to determine whether a ‘logical sequence of cause
and effect show[s] that the vaccination was the reason for the injury’” (quoting Althen, 418 F.3d
at 1280)). Medical records are generally viewed as trustworthy evidence since they are created
contemporaneously with the treatment of the vaccinee. Cucuras, 993 F.2d at 1528. The petitioner
need not make a specific type of evidentiary showing, i.e., “epidemiologic studies, rechallenge,
the presence of pathological markers or genetic predisposition, or general acceptance in the
scientific or medical communities to establish a logical sequence of cause and effect.” Capizzano,
440 F.3d at 1325. Instead, petitioner may satisfy his burden by presenting circumstantial evidence
and reliable medical opinions. Id. at 1325-26.
To satisfy the third Althen Prong, petitioner must establish a “proximate temporal
relationship” between the vaccination and the alleged injury. Althen, 418 F.3d at 1281. This
“requires preponderant proof that the onset of symptoms occurred within a timeframe for which,
given the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation-in-fact.” de Bazan, 539 F.3d at 1352. Typically, “a petitioner’s failure to satisfy the
19
proximate temporal relationship Prong is due to the fact that onset was too late after the
administration of a vaccine for the vaccine to be the cause.” Id. However, “cases in which onset is
too soon” also fail this Prong; “in either case, the temporal relationship is not such that it is
medically acceptable to conclude that the vaccination and the injury are causally linked.” Id.; see
also Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1381 (Fed. Cir. 2012) (“[If] the
illness was present before the vaccine was administered, logically, the vaccine could not have
caused the illness”).
Respondent agreed that petitioner suffered from BN but argued that the onset of his
symptoms was too soon after vaccination to implicate the vaccine as the cause and therefore his
BN was unrelated to the Tdap vaccine he received. Response at 14-16, 21. Accordingly,
respondent’s arguments regarding both Prongs II and III revolve around timing. Thus, the two
Prongs are more easily addressed together.
i. The Parties’ Arguments
Petitioner argued that he suffered from BN pursuant to the Qualifications and Aids to
interpretation (“QAI”), which defines BN as “dysfunction limited to the upper extremity nerve
plexus (i.e. its trunks, divisions, or cords).” 42 C.F.R. 100.3(c)(6) (2017). A deep, steady, often
severe aching pain in the shoulder and upper arm usually heralds onset of the condition. Id. The
pain is typically followed in days or weeks by weakness in the affected upper extremity muscle
groups. Id. Sensory loss may accompany the motor deficits but is generally a less notable clinical
feature. Id. Atrophy of the affected muscles may occur. Id. Further, up to 15% of BN cases have
been reported to be after vaccination. Motion at 5. Specifically, immune mediated demyelinating
responses to tetanus toxoid are believed to cause post-vaccination BN. Pet. Ex. 20 at 2.25
Petitioner further argued that he showed by a preponderance of evidence that the Tdap
vaccine was the cause in fact of his BN, even though his onset was outside the 2 to 28 days listed
on the Vaccine Injury Table. Motion at 6. He claimed that onset 15 hours post-vaccination is still
“within a medically acceptable timeframe.” Id.Dr. Natanzi submitted that no two individuals are the same in their immunologic responses,
resulting in outliers to the Table’s expected timeframe of 2-28 days for onset of BN after Tdap
vaccination. Motion at 6; Pet. Ex. 6 at 8. Petitioner relied on case studies that reported onset of
nerve injury symptoms in less than 2 days and between 16-17 hours after vaccination. Pet. Ex.
21;26 Pet. Ex. 23;27 Pet. Ex. 24.28 Based on the findings in those studies, Petitioner argued that
symptom onset outside the timeframe set forth in the Vaccine Injury Table is still consistent with
post-vaccination BN. Motion at 7.
Further, petitioner relied on the opinions of his treating physicians as evidence that his
symptoms satisfy the criteria for BN following Tdap vaccine. In the emergency room on November
12, 2016, Dr. Szema noted concern for BN, documenting weakness of his left radial, median, and
25
Taras et al., supra note 7.
26
Weintraub & Chia, supra note 16.
27
Beredjiklian, M.D. et al., supra note 4.
28
Taras & Donohue, supra note 18.
20
ulnar nerves. Motion at 7; Pet. Ex. 2 at 214. On November 15, 2016, Dr. Issakhanian and her
colleague suspected BN and agreed that petitioner’s injury went beyond a single nerve injury.
Motion at 7; Pet. Ex. 2 at 300. Dr. Issakhanian maintained her assessment that petitioner had BN
and treated him for that injury over the next year. Motion at 7. Further, petitioner sought a second
opinion from Dr. Rafiei in December of 2017, who documented his symptoms as BN with “patchy
involvement of the brachial plexus.” Motion at 7-8; Pet. Ex. 3 at 330.
Respondent did not dispute that Tdap vaccine can cause BN, or that petitioner has BN, or
that his onset of BN occurred after receipt of the Tdap vaccine. Rather, respondent argued that it
is petitioner’s burden to provide evidence establishing that the particular causation theory set forth
by his expert, including the appropriate timeframe for onset of symptoms under the theory, applies
specifically to petitioner. Response at 12-13, 16.
Respondent argued that the case studies relied on by petitioner to show onset of BN-like
symptoms in less than two days after Tdap are insufficient to meet his burden. Response at 14.
First, some of the studies relied on involved swine flu and influenza vaccines—not Tdap vaccines.
Id. Second, of the case reports that studied potentially vaccine-caused BN, onset occurred in 3-7
days after vaccination. Id. at 14-15; See Pet. Ex. 19;29 Pet. Ex. 20.30 In those studies the timing of
onset fell squarely within the Table’s 2–28-day timeframe after vaccination. Id. Respondent further
noted that one of the case reports submitted showed surgery, viral disease, infection, autoimmune
mechanism, and immunization as precipitating factors of BN; and in 30-85% of cases, an
“antecedent event” occurred 3-14 days prior to the initial onset of pain. Response at 15; Pet. Ex.
20 at 1.31 Thus, none of the literature supports the proposed causal theory of an immune-mediated
local demyelinating response to the tetanus toxoid component of Tdap, resulting in onset of
symptoms within 15 hours. Id.
Respondent relied on Dr. Leist’s opinion that the Table’s 2-28-day timeframe takes into
consideration the minimal biologically plausible time interval necessary for a vaccine-related
immune response to occur and cause BN. Response at 15; Resp. Ex. A at 6. Respondent agreed
with Dr. Natanzi that individuals respond differently with varying intensities of immunogenic
response but submitted that biologically plausible limits exist for how quickly observable
immunologic response can occur. Response at 15. The timeframe seen here—15-16 hours—is too
short for a vaccine induced immune response to be cross reactive with nerve cells of the brachial
plexus. Id.; Resp. Ex. A at 6; Resp. Ex. A, Tab 4.32 To support this contention, respondent referred
to petitioner’s treating physician Dr. Ceponiene’s record that demyelinating plexopathy was
“unlikely given the immediate timeline post vaccination.” Response at 15; Pet. Ex. 2 at 225.
Respondent concluded that 15 hours between receipt of the Tdap vaccine and observable
weakness and neurological symptoms was simply too soon to ascribe causation to the vaccination
under accepted theories of autoimmunity. Response at 15-16, citing de Bazan, 539 F.3d at 1352;
Moberly, 592 F.3d at 1322.
29
Shaikh et al., supra note 6.
30
Taras et al., supra note 7.
31
Id.
32
Rowhani-Rahbar, supra note 24.
21
ii. Analysis of the Parties’ Arguments
Petitioner argued that his presentation is consistent with both a SIRVA and BN. As stated
above, petitioner need only carry his burden on an injury alleged to be entitled to compensation.
See Veryzer, 100 Fed. Cl. at 351; Knudsen, 35 F.3d at 550. Because the BN claim is dispositive,
only BN is being addressed.
Dr. Natanzi opined that petitioner’s BN presented when he developed significant pain,
weakness, tingling, and numbness that awoke him from sleep at 12:30am—roughly 15 hours post-
vaccination—necessitating a visit to the ER. Pet. Ex. 2 at 212.
Petitioner’s treaters, Dr. Szema, Dr. Issakhanian, and Dr. Rafiei, all associated petitioner’s
arm pain with the receipt of the Tdap vaccine and diagnosed him with symptoms induced by
vaccination. In the ER, Dr. Szema referred to possible SIRVA or BN from vaccination. Pet. Ex. 2
at 218. In a follow up appointment, Dr. Wong documented the “primary encounter diagnosis” as
an adverse drug reaction. Id. at 263. Dr. Issakhanian’s assessment was left shoulder pain and arm
weakness after Tdap vaccine and symptoms consistent with BN, potentially due to an autoimmune
reaction to the Tdap vaccination. Id. at 300. Though cervical radiculopathy was mentioned during
the course of treatment, it was referred to as “possible” and in the context of a brachial plexus
injury—not as an alternative diagnosis. Id. Further, Dr. Issakhanian wrote “distribution of
numbness, weakness goes beyond . . . a radiculopathy.” Id. Petitioner’s treating physicians
specifically referenced involvement of more than one nerve, indicative of BN, not radiculopathy.
Id.; Pet. Ex. 18 at 2.33
Though the arguments of the parties and their experts are expectedly contrary, the opinions
of petitioner’s treating physicians are consistent and carry significant weight.34 Petitioner
experienced the onset of severe pain approximately 15.5 hours after vaccination, waking him from
sleep in the middle of the night and prompting an emergency room visit. Pet. Ex. 2 at 212-14.
Those symptoms were determined to be neurologic in nature and involved more than one nerve,
indicative of BN. Id. at 300.
Dr. Leist argued that petitioner had a gastrointestinal virus requiring a prescription for
Cipro on the date of vaccination and that the gastrointestinal virus was the cause of his BN—not
the Tdap vaccine. Resp. Ex. A at 2, 4. However, the contemporaneous medical records do not
support a gastrointestinal virus or that Cipro was prescribed on November 11, 2016. Rather, the
medical records show that Cipro was prescribed in December of 2015 and re-prescribed in January
of 2016. Pet. Ex. 2 at 84, 94. The record for the date of the Tdap vaccine, November 11, 2016,
however, lists Cipro as a discontinued medication. Id. at 201. Similarly, the record lists other
medications “discontinued” as of November 11, 2016, suggesting that the record documented past
medications that were no longer being prescribed on the date of vaccination. Id. at 97, 184, 201.
Further, the records show that petitioner suffered repeated bouts of stomach issues both before and
after the date of his vaccination typically attributed to stress—not infection. See id. at 182, 539.
33
Miller, M.D. et al., supra note 3.
34
Other cases in the Vaccine Program have noted that “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.” Paluck, 786 F.3d at 1385 (quoting Andreu, 569 F.3d at 1375 (Fed. Cir. 2009)).
22
This was the case on November 11, 2016 as well. Id. at 189. The record from that appointment
documented a normal examination, no neurological complaints, and no signs of fever. Id. at 184-
85. Petitioner was noted to be “healthy adult” with “[N]o worrisome findings on xr.” Id. at 183–
87, 191-92. The subject Tdap was administered. Id. at 192.
The case studies submitted have shown onset of post-vaccination BN symptoms in less
than 24 hours. Pet. Ex. 21;35 Pet. Ex. 23;36 Pet. Ex. 24.37 In one case report, Drs. Weintraub and
Chia described a 57-year-old healthy man who developed discomfort, pain, and weakness of both
upper extremities within 17 hours after receipt of a swine flu vaccine. Pet. Ex. 21.38 They noted
that “[i]rrespective of the vaccine used in immunization, reactions occur and brachial neuritis is
frequently seen.” Id.
Another case report documented a 26-year-old physician who developed progressively
worsening weakness over his distal left upper extremity within 16 hours after receipt of a flu
vaccine. Pet. Ex. 23 at 1-2.39 The authors noted that “[t]here are several reports of peripheral nerve
injuries following intramuscular vaccine injection.” Id. at 1. Further, while offering their support
for routine flu vaccines for healthcare personnel, the authors acknowledged that “inadvertent injury
may be inevitable” given the sheer volume of vaccines administered. Id. at 3.
Further, in another report by Drs. Taras and Donohue, a 26-year-old surgical resident
developed symptoms within 12 to 16 hours after a flu vaccine, with “complete wrist drop with lack
of digital extension over 3 to 4 hours” after vaccination. Pet. Ex. 24 at 1-2.40 Although the authors
did not explain the timing of the patient’s symptoms, they noted that BN has been “linked to
postvaccination neuropathy.” Id. at 1. They also included a table in their report that listed tetanus
toxoid as an “offending agent[],” after which post-injection neuropathy is “well-reported.” Id. at
1, 2 at Figure 1.
Respondent argued that the case studies submitted by petitioner showing onset of BN-like
symptoms within 12-17 hours following vaccination are inapplicable here because they involved
swine flu and influenza vaccines rather than the Tdap vaccine. Response at 14-15. However,
neither respondent or his expert explained how swine flu and/or influenza vaccine could cause
BN-like injuries within 16-17 hours but a Tdap vaccine could not. Further, one of the case reports
specifically listed tetanus toxoid as an “offending agent[]” known to be linked to postvaccination
neuropathy. See Pet. Ex. 24 at 1, 2 at Figure 1.41
Further, it remains unclear in the literature whether vaccine placement or the antigen itself
is to blame for development of BN following vaccination. See Pet. Ex. 23 at 3 (“[w]hether an
injection injury to a peripheral nerve is caused by direct injury to the nerve or secondary to
chemical insult is unclear. . . The imaging in this case study suggests that his nerve injury was
35
Weintraub & Chia, supra note 16.
36
Beredjiklian, M.D. et al., supra note 4.
37
Taras & Donohue, supra note 18.
38
Weintraub & Chia, supra note 16.
39
Beredjiklian, M.D. et al., supra note 4.
40
Taras & Donohue, supra note 18.
41
Id.
23
caused by injection of the vaccination into the nerve sheath and not the nerve itself. . . The etiology
of injury—direct trauma to the nerve versus indirect injury via an inflammatory process—remains
unclear);42 see also Pet. Ex. 16 at 1 (subdeltoid or subacromial bursitis and other lesions…may be
related to antigens or adjuvants contained in the vaccines that would trigger an immune response
or inflammatory condition. However, they are more likely to be the consequence of a poor injection
technique.).43 Thus, the type of vaccine may be less significant than the placement of the injection,
causing direct trauma to the nerve versus indirect trauma via inflammatory process versus antigens
contained in the vaccine that trigger an immune response or inflammatory condition irrespective
of what that antigen is. But clearly, tetanus toxoid contained in the Tdap vaccine has been reported
as the “offending agent” known to be linked to postvaccination neuropathy. Pet. Ex. 16 at 1;44 Pet.
Ex. 23 at 3;45 Pet Ex. 24 at 1, 2 at Figure 1.46
The following facts in this case are undisputed: Petitioner was otherwise healthy with no
prior shoulder injury or conditions and no prior cervical issues. Petitioner received a Tdap vaccine
on November 11, 2016 and experienced arm pain. Pet. Ex. 2 at 192, 297. Roughly 15.5 hours later,
petitioner was awoken from sleep due to severe pain, which resulted in an ER visit at around 1am.
Id. at 212-14. His treating physicians believed that he suffered a possible SIRVA or BN as a result
of the Tdap vaccine he received the previous morning. Id. at 218; see also Pet. Ex. 5. His BN
progressed characteristically with pain, numbness, weakness, and tingling in his arm and hand.
Pet. Ex. 2 at 300, 398, 416, 423. Throughout the months following vaccination, petitioner’s severe
pain subsided. Pet. Ex. 2 at 484. However, the sensory symptoms—the numbness and tingling in
his arm and hand—remained. Id. While petitioner did not undergo MRI or EMG testing due to a
long-professed fear of needles, neither petitioner nor respondent question that petitioner suffers
from BN. Pet. Ex. 3 at 331; see generally Motion; Response.
Therefore, this case comes down to petitioner’s onset of BN within 15.5 hours of his Tdap
vaccine rather than 2-28 days after his Tdap vaccine as set forth in the Vaccine Table. Dr. Leist
argued that the onset of petitioner’s neurologic symptoms was coincidental because it was 15.5
hours rather than 2 days after vaccination, concluding that onset that soon after vaccination is not
biologically possible. See generally Resp. Ex. A. However, the literature highlights that just like
peripheral nerve injuries from improper administration of vaccinations vary in severity and type
of injury and recovery, so does the onset of symptoms, with reports being as early as 12 -16 hours
after vaccination. Pet. Ex. 23.47 The literature submitted shows onset of symptoms in less than two
days and as early as “a few hours” after vaccination. See Pet. Ex. 16 at 2-3,48 which documented
bursitis and tenosynovitis within “a few hours” after vaccination with PPV and flu vaccines,
respectively; and 13 cases of bursitis, tendonitis, and tear of the rotator cuff that had an immediate
onset or onset within 24 hours following flu vaccines and TD vaccines; see also Pet. Ex. 24,49 a
case report of a 26-year-old who began having symptoms of clumsiness and wrist drop within 12-
42
Beredjiklian, M.D. et al., supra note 4.
43
Arias et al., supra note 19.
44
Id.
45
Beredjiklian, M.D. et al., supra note 4.
46
Taras & Donohue, supra note 18.
47
Beredjiklian, M.D. et al., supra note 4.
48
Arias et al., supra note 19.
49
Taras & Donohue, supra note 18.
24
16 hours after receiving the flu vaccine. While the cause of BN is usually considered to be a
postinfectious reaction or a reaction secondary to an allergic or hypersensitivity response, genetic
predisposition has also been suggested. Pet. Ex. 21 at 1.50 Further, according to the literature, it
remains unclear whether the cause of peripheral nerve injuries from improper administration of
vaccinations is from direct trauma to the nerve or from indirect injury via an inflammatory process.
Pet. Ex. 23 at 3.51
The Vaccine Injury Table creates a presumption of causation where symptoms of BN
manifest within 2-28 days after a Tdap vaccine. See 42 C.F.R. § 100.3(a); Andreu, 569 F.3d at
1374. To realize the purpose of the Vaccine Act, a timeframe had to be chosen. The timeframe of
2-28 days is appropriate because that is where the masses fall. However, not all people with BN
injuries caused by the Tdap vaccine will fit squarely within that timeframe, and there will be
outliers on either end of the spectrum. To illustrate this point, GBS is listed on the Table as a
peripheral neurologic injury following influenza vaccine within 3 to 42 days, but cases have been
determined to have symptom onset outside of the timeframe on the Table based on the totality of
the circumstance in a particular case. See Jewell v. Sec’y of Health & Human Servs., No. 16–
0670V, 2017 WL 7259139, at *3-4 (Fed. Cl. Spec. Mstr. Aug. 4, 2017) (citing to Atanasoff et al.—
filed as Pet. Ex. 1152 here—ruling for petitioner, although the medical records documented the
onset of petitioner’s symptoms as being outside the timeframe listed on the Table); Spayde v. Sec’y
of Health & Human Servs., No. 16-1499V, 2021 WL 686682, at *18 (Fed. Cl. Spec. Mstr. Jan. 27,
2021) (“However, for non-Table claims, or causation-in-fact claims, special masters have
generally found that petitioners are entitled to causation where onset occurs up to two months,
eight weeks or 56 days, following the flu vaccination”); see also Quackenbush-Baker v. Sec’y of
Health & Human Servs., No. 14–1000V, 2018 WL 1704523, at *20 (Fed. Cl. Spec. Mstr. Mar. 14,
2018) (ruling for petitioner where onset of the significant aggravation of multiple sclerosis was
within 41 hours, rather than the 2-42 day timeframe listed on the Table); but see Braun v. Sec’y of
Health & Human Servs., No. 16–1098V, 2018 WL 2375751, at *18 (Fed. Cl. Spec. Mstr. Apr. 24,
2018) (denying entitlement when onset of GBS was four months after flu vaccine but noting that
“timing somewhat outside of the Table window might support a finding of causation in fact”).
Further, although case reports contain specific individual case studies, they demonstrate
what is possible—even if it is not regularly documented in the literature or shown by
epidemiological evidence.53 This is particularly true for vaccine related injuries, which are rare.
The case reports submitted herein document the development of BN symptoms within 12-17 hours
of receipt of a vaccine rather than the 2-28 days listed on the Vaccine Injury Table. Pet. Ex. 21;54
Pet. Ex. 23;55 Pet. Ex. 24.56 Based on the literature submitted, BN associated with vaccination has
50
Weintraub & Chia, supra note 16.
51
Beredjiklian, M.D. et al., supra note 4.
52
Atanasoff et al., supra note 21.
53
It is worth noting once more that epidemiological evidence nor scientific certainty is required for a
petitioner to carry their burden in proving that their injury was caused by a vaccine. Capizzano, 440 F.3d
at 1325; Bunting, 931 F.2d at 873.
54
Weintraub & Chia, supra note 16.
55
Beredjiklian, M.D. et al., supra note 4.
56
Taras & Donohue, supra note 18.
25
occurred in rare cases in less than two days following a vaccine and is consistent with the medical
community’s current understanding of BN.
Respondent offered no convincing alternative explanation for petitioner’s injury. The
suggestion that petitioner suffered from a gastrointestinal illness as the cause of his BN is defeated
by the records before and after his vaccination showing that petitioner suffered from stomach
issues related to stress and associated with major life events, such as here where he was caring for
a sick parent. Pet. Ex. 2 at 182, 184, 539. Importantly, the contemporaneous medical record on the
date of the Tdap vaccine show petitioner to be healthy, with no fever or other evidence of illness
or active infection. Id. at 182-87, 201. Further, contrary to Dr. Leist’s suggestion, petitioner was
not prescribed Cipro on that date and Cipro was listed as a past medication along with others that
had been discontinued. See id. at 182-205.
I find that petitioner has provided preponderant evidence of a logical sequence of cause
and effect and a proximate temporal relationship based on expert opinion, literature, petitioner’s
clinical course, treating physician opinions, and a lack of evidence to support an alternative cause
for his BN following his Tdap vaccination. Through his expert and the literature submitted,
petitioner demonstrated that BN may on rare occasions have an onset within 15.5 hours after
vaccination. Preponderant evidence supports that his BN was caused by the Tdap vaccine he
received on November 11, 2016.
Thus, I find that petitioner has demonstrated that the Tdap vaccine was the cause-in-fact of
his BN injury, and he is entitled to compensation.
V. Conclusion
Upon careful evaluation of all the evidence submitted in this matter—including the medical
records, expert reports, and medical literature—I conclude that petitioner has shown by
preponderant evidence that he is entitled to compensation under the Vaccine Act. A separate
damages order will issue.
IT IS SO ORDERED.
s/ Mindy Michaels Roth
Mindy Michaels Roth
Special Master
26