VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-01933
Package ID: USCOURTS-cofc-1_18-vv-01933
Petitioner: Robert Galante
Filed: 2018-12-18
Decided: 2022-11-30
Vaccine: influenza
Vaccination date: 2016-09-07
Condition: shoulder injury related to vaccine administration (SIRVA)
Outcome: entitlement_granted_pending_damages
Award amount USD: 

AI-assisted case summary:
Robert Galante, an adult, received an intradermal influenza vaccine on September 7, 2016. Within hours, he developed left shoulder pain and dysfunction, diagnosed as shoulder injury related to vaccine administration (SIRVA). Mr. Galante presented medical records and expert testimony from an immunologist and an orthopedic surgeon, arguing that improper administration of the vaccine led to an inflammatory response causing his shoulder injury. Respondent contended that the vaccine's needle was too short to cause deep tissue injury and that Mr. Galante's condition was due to pre-existing degenerative changes or coincidence. The Special Master found that Mr. Galante's testimony and medical records credibly established that his shoulder pain began immediately after the vaccination, well within the 48-hour timeframe. The court accepted the theory that improper administration, including excessive force and incorrect technique, caused the vaccine to be deposited deeper than intended, leading to inflammation and pain. The court found that Mr. Galante proved causation by a preponderance of the evidence, entitling him to compensation, with damages to be determined in a separate order.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_18-vv-01933-0
Date issued/filed: 2022-11-30
Pages: 40
Docket text: PUBLIC RULING (Originally filed: 11/9/2022) regarding 70 Ruling on Entitlement Signed by Special Master Thomas L. Gowen. (slw) Service on parties made.
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Case 1:18-vv-01933-UNJ Document 72 Filed 11/30/22 Page 1 of 40
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: November 9, 2022
* * * * * * * * * * * * *
ROBERT GALANTE, * UNPUBLISHED
*
Petitioner, * No. 18-1933V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Ruling on Entitlement;
AND HUMAN SERVICES, * Intradermal Influenza (“flu”)
* Vaccine; Shoulder Pain and
Respondent. * Dysfunction.
* * * * * * * * * * * * *
Bridget Candace McCullough, Muller Brazil, LLP, Dresher, PA, for petitioner.
Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT1
On December 18, 2018, Robert Galante (“petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program.2 Petitioner alleges that as a result of
receiving an intradermal influenza (“flu”) vaccine on September 7, 2016, in his left arm he
suffered a shoulder injury related to vaccine administration (“SIRVA”) that was caused in fact by
the flu vaccination. Petition (ECF No. 1). After a review of the record as a whole, including
expert reports, medical records, affidavits, entitlement hearing testimony, and briefings by the
parties, and for the reasons set forth below, I find that petitioner is entitled to compensation.
I. Procedural History
Petitioner filed his petition for compensation on December 18, 2018, alleging he
sustained a left shoulder injury related to vaccine administration (“SIRVA”) as a result of
1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The Court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion
is posted on the Court’s website, each party has 14 days to file a motion requesting 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). An objecting party must provide the Court with a proposed
redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will
be posted on the Court’s website without any changes. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.
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receiving an intradermal influenza (“flu”) vaccination on September 7, 2016. Petition at
Preamble. The case was initially referred to the Special Processing Unit (“SPU”), with former
Chief Special Master Dorsey as the presiding Special Master. See SPU Initial Order (ECF No. 5).
The case was assigned to my docket on March 13, 2019. See Notice of Reassignment (ECF No.
9).
On April 3, 2019, I held a status conference in this case, and ordered petitioner to file
additional medical records, affidavits, and other evidence to establish onset of his shoulder
injury. (ECF No. 10). On June 3, 2019, petitioner filed a statement of completion after filing
updated medical records and affidavits. (ECF Nos. 11, 13, 14).
On August 30, 2019, petitioner filed expert reports by Dr. Eric Gershwin,3 an
immunologist, and Dr. Russell Huffman,4 an orthopaedic surgeon. Petitioner’s Exhibit (“Pet.
Ex.”) 10; Pet. Ex. 11 (ECF No. 20). Dr. Gershwin stated that “there is evidence that intradermal
vaccines can cause a systemic inflammatory response.” Pet. Ex. 10 at 1. Dr. Huffman stated that
Mr. Galante had both a local and regional response causing restriction of motion secondary to
pain. Tr. 131.
On January 6, 2020, respondent filed an expert report by Dr. Paul J. Cagle,5 an
orthopaedic surgeon. Respondent’s Exhibit (“Resp. Ex.”) A (ECF No. 23). On February 6, 2020,
respondent filed an expert report by Dr. Harry W Schroeder, Jr., MD,6 an immunologist. Resp.
3 Dr. Gershwin graduated with a Bachelor of Science degree in mathematics from Syracuse University in 1966 and a
medical degree from Stanford University in 1971. Pet. Ex. 22 at 1. He completed an internship and residency at
Tufts-New England Medical Center, then served as a clinical associate in immunology at the National Institutes of
Health. Id. at 2. In 1975, Dr. Gershwin joined the University of California Davis (UC Davis) School of Medicine to
start its immunology program. Id. at 1. He is currently the Jack and Donald Chia Professor and a Distinguished
Professor of Medicine in the divisions of Rheumatology/ Allergy and Clinical Immunology at UC Davis. Id. Dr.
Gershwin is licensed to practice medicine in the state of California. He is board-certified in internal medicine,
rheumatology, allergy, and clinical immunology. Id. at 2. Dr. Gershwin highlighted that he has been awarded an
honorary doctorate degree by the University of Athens, home of the Hippocratic Oath, for lifetime achievement in
immunology. Id. at 1.
4 Dr. Huffman is a shoulder and elbow surgeon and an Associate Professor of Orthopedic Surgery and Director of
the Shoulder and Elbow Surgery Fellowship at the University of Pennsylvania Medical Center. Pet. Ex. 23 at 1. Dr.
Huffman earned his M.D. at Duke University School of Medicine, completed his surgical internship and orthopaedic
surgery residency at the University of California, San Francisco, and completed shoulder and elbow fellowships at
the University of Southern California and Mayo Clinic. Id. He has authored over 100 publications and lectured
nationally and internationally. Id. He researches shoulder and elbow issues and has diagnosed and treated patients
with SIRVA for over eight years. Id. Dr. Huffman is currently investigating a SIRVA protocol at the University of
Pennsylvania. Id.
5 Dr. Paul J. Cagle is an orthopaedic surgeon who serves as an Assistant Professor and Associate Program Director
in the Department of Orthopaedic Surgery at the Icahn School of Medicine at Mount Sinai. Resp. Ex. B at 1. Dr.
Cagle received his medical degree from the Loyola University Chicago Stritch School of Medicine. Id. He did a
residency in orthopaedic surgery at the University of Minnesota Academic Health Center and Medical School from
2008-2013. Id. He board certified in orthopaedic surgery. Id. Prior to working at Mount Sinai, Dr. Cagle was an
assistant professor and interim chair of the Department of Orthopaedic Surgery at Southern Illinois University
School of Medicine. Id. He has published numerous articles in peer reviewed journals. Id. at 3-14.
6 Dr. Schroeder is currently a professor of medicine, microbiology and genetics at the School of Medicine at the
University of Alabama (“UAB”). Resp. Ex. D at 1. Dr. Schroeder received his undergraduate degree from Texas
A&M in 1974 and his medical degree from Baylor College of Medicine in 1981. Resp. Ex. B at 2. Additionally, he
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Ex. C (ECF No. 26). The same day respondent filed his Rule 4(c) report recommending that
compensation be denied. Resp. Report (ECF No. 27). Respondent noted that the flu vaccine
petitioner received on September 7, 2016, was administered intradermally and not
intramuscularly and therefore is not eligible for a Table SIRVA. Id. at 6-7. Respondent asserted
that petitioner must provide a medical theory for how a vaccine administered intradermally could
cause a left shoulder injury. Id. Respondent asserted that petitioner has not provided sufficiently
reliable, preponderant evidence of causation that satisfies the elements of Althen. Id. at 7.
Specifically, respondent asserted that there is no evidence in the record of systemic inflammatory
response to the vaccination in question. Id. at 7-8.
On March 11, 2020, I held a Rule 5 status conference in this case and issued a Rule 5
order ordering petitioner to convey a modest demand to respondent. Rule 5 Order (ECF No. 28).
On April 14, 2020, petitioner filed a supplemental expert report by Dr. Gershwin. Pet. Ex. 24
(ECF No. 29). On May 14, 2020, petitioner filed a status report indicating that he provided
respondent with a settlement demand that day. (ECF No. 31). On June 19, 2020, respondent
submitted a status report indicating that he will not entertain settlement negotiations. (ECF No.
32). The same day I ordered petitioner to file a supplemental expert report.
On August 3, 2020, petitioner filed a supplemental expert report by Dr. Russell Huffman.
Pet. Ex. 36 (ECF No. 33). On November 3, 2020, I held a status conference and ordered the
parties to propose dates for an entitlement hearing. (ECF No. 35). On January 11, 2021, I issued
a hearing order to schedule an entitlement hearing on April 15-16, 2021. Hearing Order (ECF
No. 40).
On February 11, 2021, petitioner filed a pretrial memorandum. (ECF No. 45). On March
12, 2021, respondent filed prehearing submissions. (ECF No. 46). On April 1, 2021, respondent
filed a Motion in Limine to exclude the testimony of Melissa Dell’Orfano, the vaccine
administrator. (ECF No. 51). Petitioner filed a response to the motion on April 2, 2021, urging
the court to deny respondent’s motion. (ECF No. 53). On April 7, 2021, I issued a hearing order
denying respondent’s motion, and ordering the fact witnesses and expert immunologists to testify
on April 15, 2021, and the expert orthopedists to testify at a later date. Hearing Order (ECF No.
54). The entitlement hearing occurred on April 15, 2021, and I issued a hearing order for the
continuation of the entitlement hearing to be completed on June 10, 2021. Hearing Order (ECF
No. 55).
On May 26, 2021, I held a status conference regarding the six cases involving intradermal
flu vaccines, and respondent objected to the prospect of any mandatory omnibus proceeding and
expressed the desire to move forward with each case individually. Order (ECF No. 58). On
October 15, 2021, petitioner filed his post hearing brief. Pet. Brief (ECF No. 63). On January 26,
received his PhD in cell biology in 1979. Id. Dr. Schroeder did his residency at the University of Kentucky Medical
Center from 1982-1984. Id. He has been teaching at the University of Alabama since July 1988. Id. Additionally,
Dr. Schroeder is the editor of the textbook Clinical Immunology: Principles and Practices, and he has conducted
clinical practice at UAB evaluating patients with immune mediated diseases. Resp. Ex. A at 1. Finally, Dr.
Schroeder is active in academic research. Resp. Ex. B at 11-15. Dr. Schroeder was admitted as an expert in
immunology during the hearing. Tr. 73.
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2022, respondent filed his post hearing brief. Resp. Brief (ECF No. 66). On March 18, 2022,
petitioner filed a post hearing brief reply. Pet. Reply (ECF No. 69).
The matter is now ripe for adjudication.
II. Petitioner’s Medical History
a. Medical Records
At an appointment with his primary care physician (“PCP”) on September 7, 2016, Mr.
Galante complained of ongoing right knee pain over the last six months, with a “pain intensity of
8/10.” Pet. Ex. 1 at 19. It was noted under “Assessment and Plan,” that the findings were
indicative of overuse injury with meniscus injury, and petitioner was referred to an orthopedist.
Id. at 21. During that appointment petitioner received the intradermal flu vaccine administered in
his “left arm (upper).” Id. at 20.
On September 30, 2016, petitioner presented to orthopedic surgeon, Dr. Thomas J. Gill,
M.D., complaining of right knee pain, starting six months ago. Pet. Ex. 2 at 8. Petitioner was
assessed to have a medial meniscus tear, and Dr. Gill ordered an MRI. Id. at 9. Following the
MRI, petitioner returned to Dr. Gill and the ongoing plan was physical therapy. Id. at 7.
Petitioner began physical therapy for his right knee on October 20, 2016. Pet. Ex. 4 at 5.
On January 20, 2017, petitioner was seen by his PCP, Dr. Jennifer Powell, D.O., with
complaints of left shoulder pain, that started “after having [a] flu shot in September, [and]
ongoing for the past [four] months.” Pet. Ex. 1 at 14. Petitioner stated that he took Advil at night
because it “hurts more at night,” he was having problems with his range of motion, no acute
swelling, difficulty laying on his left arm, and no acute fever or chills. Id. at 14. Dr. Powell
wrote that petitioner “was found to have limited range of motion with concerns of possible
rotator cuff injury from the influenza vaccine.” Id. at 17.
Petitioner returned to Dr. Gill’s office on January 27, 2017, and was seen by Brian
Petrone, PA-C for “lateral shoulder pain after the flu shot.” Pet. Ex. 2 at 6. Petitioner stated, “he
has always had mild pain to the shoulder with [decreased range of motion] and [decreased]
strength.” Id. 7 Further, his general pain and range of motion did not improve. Id. It was
recorded that petitioner “is not progressing,” with “worsening pain despite conservative
treatment.” Id. An MRI was recommended to check for “[rotator cuff tear].” Id.
The same day, January 27, 2017, petitioner had an MRI of his left shoulder. Pet. Ex. 3 at
3. The MRI showed moderate degenerative changes with “mild glenohumeral joint chondrosis
with degeneration of the superior/posterosuperior labrum and possible tearing of the superior
labrum…mild biceps long head and minimal supraspinatus tendinosis without discrete
tearing…AC joint degenerative changes.” Id. On February 3, 2017, petitioner returned to Dr.
Gill to discuss surgical options regarding his right knee pain. Pet. Ex. 2 at 5. Dr. Gill also
reported that petitioner “had a shoulder [MRI] last Friday for left shoulder pain which may be
7 Petitioner testified that he “emphatically” stated that his shoulder pain began “immediately following the flu shot.”
Tr. 22.
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related to a flu shot [on] 9/16.” Id. Dr. Gill noted that petitioner wanted to pursue a right knee
scope and for his left shoulder he will start physical therapy for “[rotator tear cuff]
strengthening.” Id.
On February 28, 2017, petitioner underwent a right-knee arthroscopy to correct a medial
and lateral meniscal tear. Pet. Ex. 28 at 2. During a post-surgery physical therapy appointment on
March 9, 2017, petitioner reported “[left] shoulder pain that began in fall 2016 after getting a
vaccine, pain worsened as time passed. Patient got an MRI that showed the bursa was affected
during administration of the shot. His shoulder has ached since the shot.” Pet. Ex. 4 at 33. At his
next physical therapy appointment on March 15, 2017, it was noted that “he shoveled snow
yesterday – no swelling after, some soreness this morning.” Id. at 37.
On March 28, 2017, at another post-surgery physical therapy session it was noted that
petitioner reported shoulder pain and that it “has been getting worse. Id. at 41. The physical
therapy note [also noted “[moderate]-[severe] tenderness [of the] posterior shoulder,” and the
“[left] shoulder pain consistent with rotator cuff tendinopathy.” Id. On April 11, 2017, petitioner
started shoulder muscle energy technique “for rotator cuff tendinopathy.” Id.
To address the left shoulder pain, petitioner initiated physical therapy for his shoulder on
October 24, 2017. Pet. Ex. 4 at 50. Petitioner reported the “mechanism of injury was secondary
to getting a flu shot too high up on the shoulder.” Id. Further he expressed his frustration
regarding his shoulder pain and that it “has been going on for so long,” and “can only sleep 1-2
hours at a time currently. Id. at 51. Under “Assessment,” the physical therapist noted that
petitioner “presents with signs and symptoms consistent with a diagnosis of [left] shoulder pain
presenting as contractile pathology.” He participated in a total of nine physical therapy sessions,
between October 31, 2017, and December 19, 2017. Petitioner reported in the final session that
his shoulder does not bother him during a workout, but “bothers him when he tries to fall
asleep.” Id. at 54-72. During cross-examination, petitioner was asked what types of workouts he
was able to complete without his shoulder giving him pain. Tr. 36-37. Petitioner testified that his
workouts include riding a bicycle and a lot of walking. Id. at 37. Petitioner further explained he
used to weightlift and stopped in September 2016, and into the fall through winter of 2016 and
2017. Id. at 38.
b. Hearing Testimony
1. Testimony of Petitioner
During the hearing held on April 15-16, 2021, petitioner testified that on September 7,
2016, he went to Hallmark Medical Associates in Malden, Massachusetts to see his primary care
physician for ongoing knee pain. Transcript (“TR.”) at 6. He stated that he was seated in an exam
room, a “rather low chair,” and the nurse administered the intradermal flu vaccination on the left
shoulder. Tr. 7-8. He testified that the vaccination was administered “kind of high, mid to back.”
Id. at 8. The Court asked petitioner to put his finger on the end of the acromion bone, “the
shoulder bone that comes to the end of your shoulder,” and asked how many inches below the
vaccine was administered. Id. Petitioner testified that it was about an inch and a half or so from
the acromion bone. Id. at 8-9.
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Petitioner recalled that when he arrived at the appointment, he did not have any pain in
his left shoulder. Tr. 9. But when he left, he was experiencing left shoulder pain. Tr. 9. He
stated that his pain level was a 9 out of 10 and when he got home, he immediately took pain
medication and iced his left shoulder. Tr. 10. Petitioner testified that he was unable to get a full
night’s sleep that night because he “could still feel the stinging” in his arm. Id. He testified that
in the days following September 7, 2016, the pain persisted and stayed about the same, with
constant stinging, redness, hot to the touch, lasting for over a month, and with a hard lump that
got larger “for a couple days and then it started to eventually disappear.” Id. at 11-12. Further,
the lump was present for about three weeks to a month. Id. at 13.
On cross examination, petitioner was asked if the pain in his shoulder was similar to pain
he had experienced after past immunizations. Tr. 39. Petitioner stated, “Upon immediately
receiving the flu shot, it was similar. But this was a little bit more painful than the normal flu
shot.” Id. Petitioner was asked why he did not report his left shoulder pain to his orthopedic
surgeon Dr. Gill during a September 30, 2016. Tr. 30-31. Petitioner stated that the September
30th appointment was for his knee pain, and he felt “a little embarrassed that [he] had received
the flu shot and didn’t want to discuss the pain over a flu shot with a couple of guys.” Id. at 31.
Petitioner stated that immediately following the shot he was having difficulty moving his
left shoulder, and it lasted “for quite a while, even a few years,” and as a result he did not like to
raise his left shoulder joint. Tr. 13. When asked what at-home remedies helped with the
symptoms, petitioner explained that he took Advil and continued icing it to this day, April 15,
2021. Tr. 14. He stated that this pain made it hard to do day-to-day chores, and while petitioner
had retired from his job as a biomedical engineer, he had recently started an LLC in the field of
clinical cardiac devices. Tr. 14-15. When asked how his symptoms impacted his ability to
perform activities in the LLC, he explained that he “just didn’t have the drive that [he] used to
because of a little bit of the fatigue from not sleeping primarily.” Tr. 15. He also cancelled an
annual ski trip because of the pain in his left shoulder. Id. at 16.
Petitioner testified that by January 2017 his left shoulder pain was so disruptive to his
sleep that his wife urged him to seek treatment. Tr. 17. Petitioner stated that he told Dr. Jennifer
Powell that, “my shoulder was absolutely killing me and I was surprised the pain was still there
after receiving the flu shot at her office.” Id. Petitioner explained that his pain had been
“continuous” from the time he received the flu shot until mid-January 2017. Id. at 18. He stated
that Dr. Powell “put me on a higher dose regimen of Advil, ibuprofen,” and he was given a
muscle relaxer as well. Id. at 18. Further, Dr. Powell gave him a referral to Boston Sports
Medicine. Id.
Later that week, petitioner had an appointment with Physician’s Assistant, Mr. Brian
Petrone at Boston Sports Medicine. Tr. 19. Petitioner stated that he had told Mr. Petrone that his
left shoulder pain “began immediately following the flu shot,” and that he meant to relay that he
had “always had pain with decreased motion since receiving the flu shot. I was very clear about
that.” Id. at 22. Petitioner was recommended to start physical therapy and undergo an MRI of
the left shoulder. Id. Petitioner testified that he returned to Boston Sports Medicine to review the
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MRI. Id. Petitioner explained that after the MRI of his left shoulder, he had appointments at
Boston Sports Medicine for both his knee and shoulder. Id. at 23.
When petitioner was asked about an appointment from January 2014, which noted a
“history of radiculopathy,” petitioner responded that he did not “know what that means,” and that
he did not believe he had “radiating nerve sensations to any of his extremities around 2014.” Tr.
29. Further, petitioner clarified that he experienced knee pain in 2015, but initially sought care
in 2016. Id. Petitioner was also asked if he ever had seen Dr. Daniel Ward, an orthopedic
surgeon that petitioner was referred to by Dr. Commito and petitioner responded that he did not
recall if he had met with Dr. Ward. Id.
Petitioner testified that sometime in 2015 he was having pain in his knee, which is what
originally brought him to the September 2016 appointment where the flu shot was administered.
Tr. 23. During cross-examination petitioner testified that he was prescribed physical therapy for
his knee in October 2016 until December 20, 2016, when he was discharged. Tr. 32. He was
also asked why he never mentioned his shoulder pain to the physical therapist. Id. Petitioner
testified that he “did mention it to them, but they were just primarily focused on the knee.” Id.
During cross-examination and by the Court petitioner was asked about the specific exercises
completed during this time period of physical therapy, and he explained that it primarily
“focused on leg stretches.” Id. at 34.
Petitioner testified that the physical therapy was largely unsuccessful, later requiring an
arthroscopic surgery to fix a meniscus tear in March 2017. Id. at 24. He explained that the main
focus in the later winter and spring of 2017 was his knee. Id. at 25. During cross-examination,
respondent pointed to post-surgery physical therapy record from March 9, 2017, at which time
petitioner told the physical therapist about his shoulder pain. Tr. 32. Petitioner was asked if
shoveling the snow bothered his shoulder. Id. Petitioner stated, “It did. It absolutely did. I also
have a snowblower with a clutch, and I could engage the clutch to push the snowblower. It
would almost self-drive itself, but occasionally you need to shovel to get areas where I couldn’t
get in with the snowblower.” Id. Respondent’s counsel questioned whether shoveling snow
would be a “bad idea because of [the] shoulder pain,” and petitioner responded, “…I know it was
a bad idea to do a lot of silly things, you know, trying to-because I have got such a physically fit
mentality that I continually want to challenge myself to do the things that I used to do, but it’s
always met with a lot of pain.” Tr. 39.
Petitioner was asked if the physical therapy for his post-surgery knee and for his shoulder
were by the same medical practice group. Tr. 26. Petitioner testified that they were the same
practice, but different locations, the practice for his shoulder was closer to his home. Id. When
asked for clarification from the court regarding his physical therapy sessions, petitioner
responded that during the post-surgery physical therapy appointments the physical therapist
noticed that he was favoring his shoulder, and therefore he had a few sessions where he worked
on his shoulder as well. Id. at 27.
Petitioner explained that his shoulder never felt better while attending physical therapy
for his shoulder, and to the day of the hearing he “can still feel the pain in the shoulder,” and
feels “like there’s a bee stinger” in his shoulder. Id.
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2. Testimony of Cheryl Galante, Petitioner’s Wife
Mrs. Galante, petitioner’s wife, has known her husband for 45 years and has been
married to him for 35 years. Tr. 41. She testified that she remembers the day he got the
vaccination because she urged him to go to the doctor to address his ongoing knee pain. Id. She
stated that nothing was out of the ordinary directly after the appointment, but that he was unable
to sleep well, “he was moving around a lot, getting up and just not sleeping.” Id. at 42. She stated
that she asked her husband why he wasn’t sleeping well and he responded that his arm was
bothering him following the flu shot. Id. She stated that he mentioned the pain in his shoulder to
her about a week following the flu vaccination. Id. at 43.
Mrs. Galante stated that she remembered looking at her husband’s shoulder and she
observed it was “red, raised, and like hard in the middle.” Tr. 43. She described the point on the
shoulder as “higher up,” and that it looked “like a circle, and it was raised up, and it was red
around it…and it did feel a little hard like in the center.” Id. Further, she stated the mark was “a
little bigger than a quarter.” Id. at 44. During cross-examination, petitioner was asked why she
did not reference the redness and other symptoms in her 2019 affidavit. Id. at 47. She explained
that it was a long time ago and she didn’t know why she didn’t write this in her affidavit. Id. at
47-48. The Court asked Mrs. Galante, “when did the notion that this felt like a bee sting first
come up?” Id. at 48. She testified that when she touched his shoulder, “you could feel like it was
something hard…it felt like when you get stung by a bee.” Id. She also stated this was in the
early months after the flu vaccine. Id.
She testified that prior to the September 2016 flu vaccination he never complained of
pain and injuries in his left shoulder. Id. Following the vaccination, Mrs. Galante testified that
his “range of motion stopped [and] he couldn’t lift it up.” Id. During the hearing the Court
verbalized what Mrs. Galante was demonstrating with her own shoulder, to demonstrate that her
husband could “raise his arm to about shoulder level but not higher.” Id. at 45.
Mrs. Galante testified that as a result of his shoulder pain he “couldn’t really do a
lot…shoveling was hard [and] he would ask me not to buy anything that needed to be put
together.” Tr. 45. She stated that she saw her husband use a lot of at-home remedies such as
Advil, and ice. Id. By January, she stated that she pushed him to go to the doctor because
something was wrong with his left shoulder. Id. at 46. When asked why she pushed him to go,
she testified, “because he doesn’t go to the doctor and he just sucks it up. I just knew something
was wrong…and he finally made the appointment.” Id.
Mrs. Galante testified that her husband is “still in a lot of pain. I can see it. You can’t
even touch him over there. He does still take a lot of Advil. He does have sleepless nights. It’s
still painful for him, but he just goes through the pain and just carries on.” Tr. 46. She explained
that her husband’s shoulder injury has impacted the family, as he “can’t do a lot of things he
would normally do for us,” and “he’s not doing the things that he would normally do since this
has happened to him.” Id. at 46-47.
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3. Testimony of Melissa Dell’Orfano, Vaccine Administrator
Ms. Melissa Dell’Orfano, was the vaccine administrator at Hallmark Health Medical
Associates (“Hallmark Health”) who administered the injection to Mr. Galante. Tr. 49-50, 62-63.
She testified that her job title is a Medical Assistant, and she obtained a certificate to become a
medical assistant. Id. at 50. She testified that she attended the Bryman Institute and then
attended Salter, both educational institutions in the Boston area and the total schooling took a
little over a year. Id. Ms. Dell’Orfano testified during her education she had to take tests
throughout, and complete “180 hours of actual in-office training,” over the course of two months
in the Hallmark Health office. Id. at 51. Following the training, she began working at Hallmark
Health full time in June 2015. Id. at 52.
Ms. Dell’Orfano described her normal day at the office, which included getting patients
to their rooms, taking their vitals, administering vaccines intramuscularly, subcutaneously and
less frequently intradermally, give medication, demonstrate how to use at home machines, draw
blood, keep clinical areas and rooms clean, check patients in, schedule appointments, and triage
patients on the phone. Tr. 53-54. She testified that she was trained to administer vaccines in
school and during her in office training with Hallmark Health. Id. at 54. She testified that as
part of her regular job duties she regularly administered “intramuscular, sub-Q…PPDs8 that are
just administered underneath the skin…[and] any other kind of medication injection.” Id. Ms.
Dell’Orfano stated that over the course of her career she has administered thousands of
intramuscular vaccinations, and regularly administered subcutaneous vaccination, “but it’s not as
frequent as the [intramuscular].” Id. at 55. She estimated that she likely only used the
intradermal injector about 50 times and it was only used in the 2016-2017 flu season. Tr 63. She
agreed, that given that Mr. Galante received his flu vaccine on September 7, 2016, that that
would have been early in the time that they were using the intradermal injector. Id.
Ms. Dell’Orfano testified that she was specifically trained on the administration of
intradermal vaccination by a nurse on staff in late August or early September 2016. She stated
that the staff “were kind of pushed to give this one more” at the start of the flu season in 2016.
Id. at 55-57. This was the first time that they were given the intradermal injector for the flu
vaccine. She testified that she practiced on a patch attached to the shoulder, and “you would
press the button on the back and it would sort of inject into the patient’s arm.” Id. at 56. She
stated it was a “very small needle,” and added that “the company that gave us the vaccines came
and made sure that we were doing it correctly.” Id. at 57.
Ms. Dell’Orfano was then asked to walk through the process of intradermal vaccine
administration, and she responded that “we were told to put three fingers from the top of your
8 A PPD is a “purified protein derivative, a solution injected under the skin. PPD is a protein that comes from the
bacteria that causes TB. It is administered by injecting a small amount of purified protein from the mycobacterium
tuberculosis complex. If it is suspected that a person has been exposed to tuberculosis it is usually administered
intradermally in the forearm to test for the presence of the bacteria. A different type of needle is used than that in
question in this case. Tuberculosis (TB) Test, CLEVELAND CLINIC,
My.ClevelandClinic.org/health/diagnostics/22751-tuberculosis-tb-test (last visited Sept. 21, 2022).
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shoulder down…that’s where you would inject the [intramuscular].” Id. at 57-58. Ms.
Dell’Orfano further testified that the location of administration for the intradermal and
intramuscular vaccines is the same. Id. at 58-59. She testified that the main difference between
an intramuscular and an intradermal vaccination is in an intramuscular “you have the syringe
where you push it in, the medication goes in,” with the intradermal “you just sort of tap the back
and it clicks it in.” Id. at 58. She testified that “you basically put it to the skin where you are
going to inject it…and you would just click and it injects the medication into the patient.” Id.
She testified that pressure had to be added “because you have to hear that click to know that the
medication actually went into the patient. And it sort of retracted the needle into the syringe.” Id.
at 60. Ms. Dell’Orfano demonstrated her technique for using the intradermal injector. She
demonstrated that she placed the injector against the skin and pressed down with her thumb Id.
Even though the instructions specifically said to grip the injector between the thumb and second
finger and press lightly with the index finger. Resp. Ex. C-2 at 4.
During cross-examination, Ms. Dell’Orfano was asked to look at a picture of the
intradermal vaccine apparatus. Tr. 64. She testified that there is a circle around the needle, and
when you administer the vaccine that circle sits flush against the skin, and regardless of how
much pressure is put on, there is no way to control how far the needly goes in or does not go into
the skin. Id. at 64-65.
In response to a question regarding the creation of vaccine administration records at
Hallmark Health, petitioner testified that doctors would put orders in the system for a flu
vaccine, and Ms. Dell’Orfano would ask each patient if they would prefer the intradermal or
intramuscular vaccine, she would then go to the fridge to get the vaccine, print the vaccine
administration form, place the sticker off the vaccine and onto the consent form, and circle L or
R to indicate which arm it was administered in. Tr. 60-61. She explained that she would then
bring everything to another medical assistant or a nurse to cross-check everything, then sign off
on that, go back into the room with the patient, have them sign the consent, ask a series of
questions regarding allergies, and administer the vaccine. Id. at 61. She confirmed that she
administered the flu vaccine to petitioner, based on the medical records that indicate “Given By:
Dellme,” a user ID created in the medical record system to identify her. Id. at 62.
She testified that during the 2016 to 2017 flu season she administered approximately 50
intradermal flu vaccines. Id. at 64. In response to a question from the Court regarding the date of
vaccination on September 7, 2016, and Mrs. Dell’Orfano responded it was early in the year the
office was using intradermal vaccines. Id.
III. Expert Opinions Regarding Intradermal Vaccine Causation
a. Petitioner’s Experts’ Opinions on Causation
1. Dr. M. Eric Gershwin’s opinion
Petitioner submitted two expert reports by Dr. Eric Gershwin, an immunologist, to
provide an opinion on vaccine causation. Pet. Ex. 10 (ECF No. 20); Pet. Ex. 24 (ECF No. 29).
Dr. Gershwin reviewed petitioner’s medical records and a scheduling order I issued questioning
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the immune response in intradermal vaccines. Pet. Ex. 10 at 1. Dr. Gershwin opined that “there is
evidence that intradermal vaccines can cause a systemic inflammatory response.” Id.
In his first report, Dr. Gershwin stated that “intradermal injections are actually difficult
and often lead to local bleeding, and not uncommonly, become subcutaneous injections.” Pet.
Ex. 10 at 1. He drew a comparison between systemic reactions in allergy skin tests, to
intradermal vaccines as seen in this case. Id. Referencing the Rosenbaum et. al. article, Dr.
Gershwin stated that “the authors documented that even though the injection was intradermal,
there was evidence of systemic inflammation confirmed by molecular signatures, including the
upregulation of IL-6 and TNF and acute phase response signaling.” Pet. Ex. 10 at 2.9 The
authors of the study sought to better understand early systemic changes, including changes at the
site of injection which are responsible for a protective immune response generated by the
intradermal injection of a modified Ankara vaccine. Pet. Ex. 19, Tab E. The authors explained
that “the skin is an ideal target for vaccine injection due to the diversity of resident and recruited
immune cells, including macrophages, Langerhans cells, and several subsets of dermal dendritic
cells. Id. at 2. Further, they noted “a strong early local and systemic inflammatory response that
peaked at 24 hours post-vaccination, which was then progressively replaced by an adaptive
response.” Id.
Dr. Gershwin testified specifically as to “whether the intradermal injection could produce
a systemic reaction…not to provide any opinion whatsoever regarding the etiology of the
shoulder complaints.” Tr. 67. Further, he stated that vaccines must elicit a systemic reaction
“otherwise you wouldn’t have an immune response and your vaccine wouldn’t work.” Id. at 68.
Dr. Gershwin stated that an intradermal vaccination is ideal, “because the skin is the second
largest immune organ in the body, and it’s an ideal way to present antigen and elicit an immune -
protective response.” Id.
When asked if petitioner had a systemic reaction to the intradermal vaccination, Dr.
Gershwin opined that he did not, and testified that “it sounded so immediate that it sounds more
of acute discomfort than an immunological reaction.” Tr. 69. Further Dr. Gershwin stated the
response was “certainly acute and local,” and he didn’t “believe the immediate reaction he’s
describing is either immune or inflammatory. It may well have gone on to be inflammatory, but
in terms of what I have done, I don’t believe there was systemic [reaction] and I don’t believe
acutely it was immunological either.” Id. at 69-70.
The Court asked Dr. Gershwin about the immunological ability of the intradermal
vaccine to cause the type of pain that was described by petitioner. Tr. 70-71. Dr. Gershwin
testified that he cannot explain immunologically why petitioner experienced acute pain, “in the
absence of swelling of lymph nodes, which can certainly happen, it won’t happen as quickly as
he described it.” Id. at 71. Additionally, the Court asked about the redness, swelling, and
hardness at the site of vaccination and if Dr. Gershwin could explain what was causing that pain.
Id. at 72. Dr. Gershwin stated that without an early MRI he “couldn’t come up with an
immunological explanation,” for Mr. Galante’s early onset pain. Id. He testified that it was
9 Rosenbaum, et. al., Molecular and Cellular Dynamics in the Skin, the Lymph Nodes, and the Blood of the Immune
Response to Intradermal Injection of Modified Vaccinia Ankara Vaccine, 9 Frontiers of Immunology 87 (2018).
[Pet. Ex. 9, Tab E].
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possible Mr. Galante’s threshold was lower than someone else, but he could not “come up with
an immunological explanation.” Id.
In his supplemental expert report, Dr. Gershwin stated that his opinion on causation “is
not based on the depth of the needle and I agree completely that an intradermal injection will not
directly injure the tendons.” Pet. Ex. 24 at 1. Dr. Gershwin wrote that “vaccination leads to
firstly a local immune response within the nearby lymphatics, which will then traffic through the
interstitium through other lymph nodes. It is also well known that reactions can lead to
significant swelling and this is part of the systemic reaction. In other words, the response to
vaccination includes an inflammatory response.” Id. at 2. He stated that, “This inflammatory
response, like any other mechanical event, can obstruct or impinge on adjacent tissues, including
the bursa, the tendon, and the local nerves.” Id. He wrote that his opinion “regarding lymphatics
is well documented in the literature,” and referenced the Swartz et al., review article to provide
an overview of the lymphatic system and its role in immune responses to antigens. Id. at 2. The
Swartz article explains “Dendritic cells (“DCs”) are the most potent and important antigen-
presenting cells (“APCs”) because of their capacity to take up and process antigens and present
them to naive T cells. ….dendritic cells are physically positioned to take up antigen from
peripheral tissues and carry them to the lymph node so that circulating T cells only need to traffic
through the lymph nodes to interact with all APCs.” Pet. Ex. 25 at 1.10 Further, Swartz states
that “The lymphatic vessels are thus critical for transporting activated dendritic cells from their
periphery to the lymph node. They constantly deliver a representative sampling of interstitial
fluid to the lymph node, allowing immature dendritic cells and macrophages there to screen
potential antigens and also to carry inflammatory signals from the tissue to the lymph node faster
than peripheral, migrating dendritic cells can, possibly preparing the lymph node for the need to
increase surveillance there in preparation for a pending immune response.” Id. The authors
explain that “vaccine strategies have targeted peripheral dendritic cells by delivering antigen to
peripheral dendritic cells in the skin….which in turn migrate to and enter the lymphatic
capillaries, and subsequently migrate to the lymph nodes to present antigen and co-stimulatory
molecules to T-cells.” This process stimulates the adaptive immune system. Dr. Gershwin
concluded that the petitioner suffered a shoulder injury caused by his inflammatory reaction to
the intradermal flu vaccine. Pet. Ex. 24 at 2.
2. Dr. G. Russell Huffman’s opinion
Petitioner’s orthopedic expert, Dr. G. Russell Huffman, opined that petitioner’s
presentation is consistent with rotator cuff inflammation or bursitis in the subacromial space,
injuries consistent with a SIRVA injury. Pet. Ex. 11; Pet. Ex. 26. He further testified that
vaccine deposited into the adipose tissue beneath the dermis would cause pain and was likely to
have caused petitioner’s pain. Tr 131.
Dr. Huffman testified that the dermal layer can be “as thin as 3 mm.” Tr. 107. He
acknowledged that the length of the intradermal vaccine is 1.5 mm, or a “fixed length.” Tr. 107-
08, 121. However, he argued, “Should one push with force….You could easily get to a depth of
close to a centimeter with this needle.” Tr. 107. Dr. Huffman stated, “the dermis is only so
10 Swartz, M., et al., Lymphatic drainage function and its immunological implications: from dendritic cell homing to
vaccine design, 20 Seminar in Immunol. 147-156 (2008). [Pet. Ex. 25].
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thick, but we know that skin is compliant because it moves around our joints….so with force
enough to dispose the needle or retract the needle, I suspect that this went in quite a ways deeper
than it was intended, possibly more than a centimeter or more.” Tr. 107. After he reviewed the
transcript from the vaccine administrator, he stated “clearly the device was not properly used and
too much force was used to administer…the microliters of volume that was in” the vaccination at
issue. Id. at 8. Dr. Huffman analogized the intradermal needle to a thumbtack. Tr. 110. Dr.
Huffman testified that “if I were to take a thumbtack, being about a centimeter in length, and
push it into the side of someone’s shoulder, it would stop at the depth of a centimeter.” Id. He
argued that “if I push with more force, the investing skin and soft tissue would also indent and
the needle would go further and further as I push harder and harder.” Id. Dr. Huffman stated,
“That’s not to say that the plastic portion of the piece of the thumbtack is going to penetrate the
skin, but the needle depth will be determinant on the amount of force used to imprint the
thumbtack in that region.” Id. Dr. Huffman also observed that the Fluzone intradermal packet
insert itself indicates that local adverse reactions are more common with the intradermal
vaccination than the intramuscular injection. Tr. 124; see also Resp. Ex. C, Tab 2. He stated,
“specifically with this quadrivalent vaccine, the local adverse reactivity was 76 percent, which is
interesting.” Tr. 124. He stated that “induration, swelling, itching, and even bruising was 50
percent or higher in a lot of cases.” Id. Dr. Huffman was asked if he was aware of any medical
literature around the risk of overpenetration with the Fluzone Intradermal apparatus, Dr.
Huffman responded, “No, but I think that’s why there was caution to keep the needle short and to
be very explicit in the instructions.” Tr. 117.
Dr. Huffman opined that petitioner had both a “local response” and a “regional reaction”
Tr. 112. He described the local reaction to be evidenced by the hardened area that persisted for
weeks near the injection site. Id. Dr. Huffman testified that “there’s an early inflammatory
response that’s expected and hoped for, but also there could be a regional immunologic response
as well, including lymphatic drainage.” Tr. 112. Dr. Huffman opined that for a SIRVA and a
local reaction, the needle does not need to go directly into the bursa, but “can have a response
adjacent to that area and still have an effect.” Tr. 114. Dr. Huffman opined that “if the vaccine
is placed in proximity, not necessarily in directly, into a space like the bursa, that is a
proinflammatory space with synovioctye-like cells that love to regulate the vascularity of itself in
response to trauma.” Tr. 113. He stated that “the blood supply is very rich there. Macrophages
and other cells can be recruited very quickly, and we see that with the calcific tendinopathy, with
contusions adjacent to bursal areas can create bursitis or inflammatory response in the bursa.”
Id. Dr. Huffman stated, “…it’s very plausible that…were there [be] an injection adjacent to the
bursa with an inflammatory response that the bursa would become involved as well in the
regional response.” Tr. 113. On cross-examination, Dr. Huffman explained further that
inflammation could spread to the bursa from adjacent areas. Tr. 122. He stated, “…we will see
contusions to the deltoid and adjacent areas or if we do surgery or have trauma to bones and
structures near the bursa, [the bursa] can be involved in an inflammatory process which can
entail pain and/or stiffness.” Id.
Dr. Huffman stated that petitioner’s symptoms were consistent with rotator cuff
inflammation or bursitis in the subacromial space. Tr. 115; Pet. Ex. 11 at 5. Dr. Huffman stated
that petitioner’s MRI findings of a glenoid labrum tear and degeneration within the
acromioclavicular joint “have been observed to be typical findings even in asymptomatic
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individuals undergoing MRI of the shoulder and are unrelated to the symptoms described by Dr.
Gill. Pet. Ex. 11 at 5. However, all the symptoms that petitioner reported to his doctor post-
vaccination, including limited range of motion and pain, were consistent with rotator cuff
inflammation or bursitis and “there was no clear documentation that those [other MRI findings]
were actually bothering [the petitioner].” Tr. 115. When asked if he agreed that there was no
evidence of bursitis on the MRI, he stated, “I think there was a trace amount of fluid that I
discussed. You know, scar tissue inflammation along the bursa is not always seen and there are
plenty of patients where I will go at the time of surgery and notice a lot of adhesion scar tissue
that is not visible on MRI. It’s a clinical diagnosis. Not a radiologic diagnosis.” Id. at 123.
Dr. Huffman opined that the proposed mechanisms outlined in the papers “range from
direct injection into the bursa with a resultant inflammatory response, to injury from the needle,
and a regional immunogenic response.” Pet. Ex. 11 at 5. Dr. Huffman opined that petitioner
“exhibits symptoms identical to documented cases of shoulder injuries related to flu vaccine
administration in the deltoid.” Id. at 6. The Cook article explains that “the deltoid muscle of the
upper arm is a site generally accepted for the injection of vaccines in children aged 12-18
months, older children and adults. Injection site reactions, such as pain, erythema, induration
and swelling at the injection site are commonly recognized transient sequelae of intramuscular
vaccination of the muscle in adults. Much less frequently, persistent dysfunction has been
reported following injection of the subdeltoid/subacromial bursa, anterior branch of the axillary
nerve and the radial nerve.” Pet. Ex. 15 at 1.11 Cook states that there are four different methods
recommended for site selection for intramuscular injection of the deltoid muscle, but “all the
injection site selection methods currently recommended have the potential to cause injury to the
subdeltoid/subacromial bursa and/or the anterior branch of the axillary nerve within the arm in
the neutral position.” Id. at 3. Additionally, Cook opines that the complications from post-
vaccination shoulder injuries are “presumably result from a lack of awareness of the anatomical
position of these structures within and near the deltoid muscle.” Id. at 1.
The Bodor article hypothesized shoulder pain and weakness following vaccination was
because the vaccine was injected into the subdeltoid bursa, caused a periarticular inflammatory
response, subacromial bursitis, bicpital tendonitis, and adhesive capsulitis.” Pet. Ex. 14 at 2.12
The authors found that the “skin to subdeltoid bursa distance” in their male patient was 0.6 cm.
Id. at 2. The authors stated, “Given that the subdeltoid bursa is contiguous with the subacromial
bursa, this led to subacromial bursitis, bicipital tendonitis, and inflammation of the shoulder
capsule.” Id.
The Okur article examined MRI imaging results of four patients with shoulder pain
following the flu vaccination. Pet. Ex. 18 at 1.13 The authors found that small fluid within the
subacromial/subdeltoid bursa was found in three of the four patients in the study, and that
11 Ian F. Cook, An evidence based protocol for the prevention of upper arm injury related to vaccine administration
(UAIRVA), 7 Human Vaccines 8, 845-848 (Aug. 2011). [Pet. Ex. 15].
12 Marko Bodor & Enoch Montalvo, Vaccination-related shoulder dysfunction, Vaccine 25, 585-587 (2007). [Pet.
Ex. 14].
13 Gokcan Okur et. al., Magnetic resonance imaging of abnormal shoulder pain following influenza vaccination,
Skeletal Radiol. 43, 1325-1331 (2015) [Pet. Ex. 18].
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“unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an
inflammatory reaction.” Id. at 5. It should be noted that the MRIs in this study were performed
at 10, 20, 24 and 30 days post injection. Id. In the fourth case reported about in Okur, the
patient complained of severe pain localized at the injection site following the flu vaccination and
he had a subjective decrease in range of motion due to pain. Id. at 3. The authors noted that the
patient had a subcutaneous fat thickness of only 4.2 mm. Id. Additionally, the authors opined
that “an improper angle of approach of the needle or increased needle length may result in bursal
or cortical penetration, particularly in those with low BMI.” Id. at 5. The Okur authors endorsed
Bodor’s theory that the vaccines triggered an inflammatory response by the antigenic or non-
antigenic components of the vaccine in the shoulder structure, resulting in shoulder symptoms.
Id. at 6.
During the hearing, the Court asked Dr. Huffman to opine on “the outcome if the needle
was pressed through the intradermal space and was delivered into the adipose tissue.” Tr. 127.
Dr. Huffman stated that the adipose tissue is also a very vascular area,” and if the needle is
injected with force “that fluid will be pushed several millimeters deeper than the actual needle.”
Tr. 127. He further opined that the adipose tissue is innervated with pain fibers and that if the
vaccine was delivered into the adipose tissue, as opposed to the intradermal space it could
“potentially cause the type of pain that [petitioner] experienced.” Id. at 128.
The Court asked Dr. Huffman whether the vaccine administered beneath the dermis but
not all the way into the deltoid muscle could still cause pain, and he responded that “it was likely
to have caused his pain.” Tr. 131. The Court additionally asked if the pain “would cause
limitation of his range of motion as experienced here,” and Dr. Huffman opined that it would
cause limitation secondary to pain as opposed to something like adhesive capsulitis. Id.
Regarding whether petitioner’s ongoing pain after five years was likely the result of the
vaccination Dr. Huffman opined that “it sounds consistent with the pain he experienced shortly
after the vaccination. So my opinion would be that it is.” Id. at 132-133. Dr. Huffman clarified
that his opinion, offered to a reasonable degree of medical certainty was that Mr. Galante’s
injury and pain was more likely than not caused by the intradermal injection. Tr. 129-130.
b. Respondent’s Experts’ Opinions Regarding Intradermal Vaccine Causation
1. Dr. Harry W. Schroeder’s opinion
Respondent submitted one expert report by Dr. Schroeder, an immunologist, and he
opined that petitioner suffered from degenerative changes in his shoulder that manifested with
persistent pain and he did not believe the condition was either caused or even aggravated by the
intradermal flu vaccine he received on September 7, 2016. Resp. Ex. C at 12. He stated that,
“the cause of Mr. Galante’s condition is more likely the sequelae of his previous avid pursuit of
contact sports and engagements, and the only link between his disease and the vaccination is at
best due to chance alone.” Id.
Dr. Schroeder opined that he agrees with the diagnosis of degenerative changes of the AC
joint, tendinosis without tear of the biceps long head and supraspinatus, tearing of the labrum,
degeneration of the superior/posterosuperior labrum and possible tearing of the superior labrum
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as visualized by a radiologist during his treatment course, and confirmed by Dr. Thomas Gill.
Resp. Ex. C at 11. He also agreed with Drs. Huffman and Gershwin that vaccinations can have
adverse consequences, however he did not believe that the flu vaccination was the cause of the
left shoulder symptomatology in Mr. Galante. Id.
In his expert report he provided three reasons why the intradermal flu vaccine was not the
cause of petitioner’s left shoulder symptomatology. Resp. Ex. C at 11. First was that there was
insufficient documentation of the temporal relationship between the administration of the
vaccination and the onset of petitioner’s left shoulder pain. Id. at 11. He notes that the first
medical documentation of petitioner’s left shoulder pain was on January 20, 2017, more than
four months after vaccine administration.
Secondly, Dr. Schroeder opined that the Fluzone vaccine utilized “a microinjection
system…to deliver the vaccine into the dermis,” and it “is simply not long enough to enter the
joint and deposit vaccine substance and thus his injury by definition cannot be attributed to
SIRVA.” Id. at 7, 11-12. He stated that the microinjection system, “employs a tiny hollow
microneedle that penetrates 1.5 mm into skin from the outer skin surface to deliver a volume in
the range of 100-200µl.” Id. Dr. Schroeder posited that the vaccine would be delivered into the
intradermal space and while he could understand a hypersensitivity reaction with local pain at the
site of the injection occurring, he did not see how a patient could suffer shoulder pain and
limitation of range of motion because of the local reaction to an intradermal injection. Tr 87-89.
Thirdly, Dr. Schroeder opined that the pain petitioner experienced in his right knee and
left shoulder “appear to result from degenerative changes in his joints.” Id. at 12. Dr. Schroeder
referenced the Possley article, which explored musculoskeletal injuries sustained in modern army
combat, in relation to petitioner’s hobby of mixed martial arts. Resp. Ex. C, Tab 4.14 Dr.
Schroeder opined that the physical complaints in Mr. Galante’s knee and shoulder are most
likely related to the “sequelae of pursuit of his athletic hobbies,” and that the onset of pain in
proximity to the vaccination was merely a coincidence. Resp. Ex. C at 12; Tr. 86.
During the hearing, Dr. Schroeder stated that the likely mechanism for a SRIVA with an
intramuscular vaccine, is the “needle, instead of going into the muscle, goes into the synovial
space in the joint. And then [one] can deposit the vaccine material there, and that will elicit a
local immune response that can lead to joint pain.” Tr. 77. He explained that “you don’t want to
have it high enough where [the injection] would go into the joint.” Id. He testified that the
intradermal injection was designed “to avoid that possibility.” Id. Dr. Schroeder cited to the
picture from his expert report to describe the dimensions of the intradermal vaccine injector,
which contains a needle that was 1.5 millimeters long. Tr. 78. He stated that the depth of the
skin is 2 to 4 millimeters. Id. He opined, the “needle will not penetrate the skin and thus, in no
way can enter in the joint space and cause the arthritis that’s caused by your deposition of
energetic material that could be caused by doing an intramuscular injection in the wrong place.”
Id.
14 Daniel R. Possley & Anthony E. Johnson, Muscoskeletal Injuries Sustained in Modern Army Combatives, 60
Military Medicine 177, 60-63 (2012), [Resp. Ex. C Tab 4].
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During cross-examination, Dr. Schroeder was asked to read from his expert report
regarding the “adverse reactions to Fluzone Intradermal Quadrivalent vaccine.” See Resp. Ex. C
at 7; Tr. 79. He testified that his expert report acknowledged that “pain is a common injection
site reaction,” and that “redness or erythema is also a common injection site reaction,” to the
intradermal vaccine. Tr. 79-80; see also Resp. Ex. C. at 7. He also acknowledged that petitioner
had testified that he experienced pain, redness, and swelling after receiving the intradermal
vaccine and that these were all common side effects listed on the package insert. Tr. 80.
However, he denied that “decreased range of motion” was a “common reaction to the
vaccination.” Id.
Dr. Schroeder was also asked if his opinion about vaccine causation in this case changed
based on petitioner’s testimony that his left shoulder pain began immediately after receiving the
intradermal vaccine. Tr. 81. Dr. Schroeder replied that the “description that we have of the
event is a new description that was not present in the information given to me before….The
description that we had this morning from the plaintiff and his wife describing what happened
locally…after the vaccination…was new to me.” Id. However, he agreed with “Dr. Gershwin
that the initial pain that [petitioner] suffered was likely not immunologic but an irritant.” Id. at
82.
He stated that the hardness petitioner described after 48 hours and then the slow
resolution of the hardness and redness “sounds very much like a Type IV hypersensitivity
reaction.” Id. Dr. Schroeder defined a Type IV hypersensitivity reaction to be a reaction that
typically takes 24 to 48 hours to develop, and what you see is “local swelling, redness, and
induration.” Tr. 88. It’s the type of reaction you elicit when you have a TB skin test, which is
also done intradermally.” Id. at 82. Dr. Schroeder stated:
the immune system has T-cells that are specific to the antigen in question, and when you
deposit the antigen within the skin, T-cells become attracted to the antigen. And the
hardness is due to the accumulation of T-cells where they stick to the site of
inflammation. It takes a while for T-cells to be engaged, about 24 to 48 hours. That’s why
the hardness and induration is most prominent at about 48 hours…It can take several days
to even a few weeks for all the redness to go away.
Tr. 82-83. In his opinion, the redness and hardness petitioner experienced was “a completely
local reaction.” Id. at 83. The Court then asked Dr. Schroeder’s opinion on why petitioner
experienced “redness, swelling, and pain,” immediately following the vaccine. Id. Dr.
Schroeder responded, “[Petitioner] had a local reaction, which is actually in the list of side
effects that you can have from the vaccine: erythema, redness, swelling and induration, hardness.
So these are common local side effects from intradermal injections.” Id. He continued, by
stating, “…in some cases they are done on an irritant basis. In some cases they are done as a
result of innate immune response. In some cases, there’s a delay type hypersensitivity response
due to the activity of T-cells. But they are localized. They don’t involve the shoulder.” Id. at
84-85.
The Court also asked Dr. Schroeder his opinion on how the initial pain and hard spot
from the vaccination “persisted” so much that petitioner pursued physical therapy. Tr. 85. Dr.
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Schroeder responded, “My interpretation of the data is that this is two separate issues. Issue
number one is the local inflammation that occurred as a result of the injection with local pain at
the site of injection. But….I can’t think of a mechanism how that local pain and irritation would
then extend into the joint itself.” Id. at 86. Dr. Schroeder attributed the petitioner’s decreased
range of motion and decreased strength to “degenerative changes,” as evidenced in the MRI and
“can occur to anyone and certainly someone who is active as [petitioner] has been.” Id. He went
on to characterize it as a “coincidence that the pain in the shoulder is associated temporally with
the injection that he received.” Id.
The Court prompted Dr. Schroeder to “not think about the interior of the joint, but think
about the pain reaction in the intradermal area,” and asked if it is “possible that you can get
persistent pain in the area, in the surface area of the shoulder that remains painful over a long
period of time.” Tr. 86. Dr. Schroeder testified that one way to evaluate patients for evidence of
immune deficiency is to check for efficacy and ability of the patient to produce a Type IV
hypersensitivity reaction, in which patients usually develop “the local pain and irritation that
[petitioner] described.” Id. at 87. Dr. Schroeder additionally testified that “it sounds again a bit
more intense than what we would see with most patients, but we have had patients that weeks
after they have had the intradermal injection can point to the site at which it occurred and still
feel some evidence of local discomfort of the skin at that site.” Id.
The Court asked if it was possible that petitioner developed impairment in his range of
motion because of pain protective behavior, and Dr. Schroeder responded that he cannot see a
correlation, but he is an immunologist, not orthopedist or neurologist. Id. at 88. The Court also
asked a question regarding operator error with overpressure with the vaccination in question. He
acknowledged that none of the studies he cited accounted for operator error or over pressure in
administering the vaccine, but he said the whole intent of the intradermal vaccination is that its
“supposed to be less sensitive to operator error.” Id. at 90-91.
2. Dr. Paul J. Cagle’s opinion
Respondent submitted on expert report by Dr. Cagle, an orthopedic surgeon, in which he
opined that the timing, mechanism, and injury in petitioner’s case has not been established to
connect the vaccination event and the onset of shoulder pain. Resp. Ex. A at 2. Dr. Cagle opined
that beyond petitioner’s own reporting, there is no medical record that established a “48-hour
link between the vaccination event and the onset of shoulder pain.” Id. Dr. Cagle then responded
to Dr. Huffman’s suggestion that the pain is linked to the vaccination, and responded that there is
not a “viable theory nor an exact diagnosis for what was injured,” and “no description of how an
intradermal injection was able to penetrate all the way to the bursal area or the biceps area.” Id.
at 2-3. Dr. Cagle also responded to Dr. Gershwin’s theory regarding a systemic response
following the flu vaccination that can cause a local shoulder response. Id. Dr. Cagle concluded
that there is no “literature presented which links a systemic event to a local joint pain event.” Id.
Regarding the MRI, Dr. Cagle opined that petitioner’s case is “in stark contradiction to
the published SIRVA literature,” and the MRI performed on January 27, 2017 “demonstrated no
significant joint effusion or bursitis but there is a notation of chronic shoulder conditions
consisting of labral degeneration, mild biceps tendinosis and minimal rotator cuff (supraspinatus)
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tendinosis.” Resp. Ex. A at 3; Pet. Ex. 3 at 3-4. Dr. Cagle testified that in SIRVA cases fluid in
the area of the bursa is a common finding on MRI. Tr 160. He testified that the MRI findings in
this case did not provide objective support for a localized inflammation in the bursa. Id. at 161.
During cross-examination, Dr. Cagle testified that “according to documented literature on
SIRVA” the fact that the MRI was not done until four and a half months after the vaccination, it
is still an appropriate time frame to demonstrate bursal fluid. 15 Tr. 162. He argued that in
petitioner’s case the MRI report said no significant amount of fluid seen, so in his opinion that
meant that there wasn’t even a small or a trace amount seen at this point in time.” Id.
Regarding how the intradermal vaccine caused a deep inflammatory localized shoulder
reaction, Dr. Cagle opined that “it would require a needle over 1 inch in length to penetrate the
bursa of a person in [petitioner’s] weight range.” Id. at 4. Dr. Cagle cited to a study by Poland,
which found that a one-inch needle was determined to be “safe and recommended for patients
weighing between 60 and 90 kg.” Id.; Resp. Ex. A, Tab 11.16 He testified that the likely
mechanism for a SIRVA injury is overpenetration, “that by placing the injection with a long
needle, [or using]a bad technique or a combination of both, that you over penetrate the deltoid
muscle, causing either a penetrating sharp injury and/or an immune response to the vaccine
contents and/or the adjuvant.” Tr. 139. Dr. Cagle testified that in this case, the administrator
used 1.5 millimeter needle, and “that would not have been capable of penetrating through the
skin, subcutaneous tissue and muscle.” Id. at 140. During cross-examination, Dr. Cagle testified
that the layer of the dermis can be anywhere from 1.5 to 4 millimeter. Tr. 157.
In response to Dr. Huffman’s testimony analogizing a thumbtack to the intradermal
vaccine, Dr. Cagle did not “disagree with him that the thumbtack has the capacity to penetrate
one centimeter into the skin because the typical metal shank length of a thumbtack is 1.2
centimeters.” Id. at 141. But he clarified that he did not think it was possible for a “1.5 millimeter
needle to press through those layers of tissues,” because “the muscle, the adipose tissue layer and
the bursa would all somehow have to be compressed down to less than 1.5 millimeters, which
seems virtually impossible.” Tr. 141-42.
Dr. Cagle agreed with Dr. Huffman, that “the findings on the MRI are findings that can
be chronic degenerative changes that can be incidentally found on MRI findings of the
shoulder.” Tr. 145. Dr. Cagle testified that multiple studies in the SIRVA literature demonstrate
“increased fluid signal in the bursa,” and in this case petitioner did not have increased fluid
signal. Id. Dr. Cagle opined that the MRI findings of “mild biceps long head and minimal
supraspinatus tendinosis without discrete tearing,” indicate “indeterminate age-related
change…nothing specific about this finding.” Id. at 146. Dr. Cagle testified that petitioner “was
not diagnosed with adhesive capsulitis. Tr. 173.
In response to Dr. Huffman’s testimony that the vaccination caused a tendinopathy in this
case, Dr. Cagle testified that “I am unaware of any scientific connection between skin irritation
15 Dr. Cagle did not make specific references to an article for the proposition that fluid in the area of the bursa would
most likely be present on an MRI taken over four months post vaccination.
16 Gregory A. Poland, et. al., Determination of Deltoid Fat Pad Thickness: Implications for Needle Length in Adult
Immunization, 277 JAMA 21, 1709-1711 (1997). [Resp. Ex. A Tab 11].
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and rotator cuff tendinopathy. I don’t know how those two are connected, how it would skip the
deltoid or the bursal layer or how it would individually choose the rotator cuff tendon.” Id. at
147-148. When Dr. Cagle was asked if he knew of any evidence in the record of any injury that
could have caused petitioner’s shoulder symptoms, he replied that he did not. Tr. 149. Dr. Cagle
stated that he “would not consider something that caused a 1.5 mm depth of penetration to the
skin to be something of a significant injury or even something that [he] would classify in that
category.” Id. Additionally, he testified that there is no evidence that the vaccination in this case
caused damages to adipose tissue which resulted in sustained injury that lasted at least six
months. Id
During cross-examination, Dr. Cagle was asked about the proper administration of the
intradermal vaccination, specifically that Ms. Dell’Orfano (the vaccine administration) testified
that she used her thumb instead of her index finger. Tr. 150-151. Dr. Cagle agreed that the
administration technique of Ms. Dell’Orfano was inconsistent with what was seen in the Fluzone
administration packet. Tr. 151; Pet. Ex. 29 at 3. Further, he agreed that Ms. Dell’Orfano
“activated the shield,” by “pushing with her thumb until she heard the click.” Id. at 152. Dr.
Cagle testified that “it’s highly unlikely that [the vaccine] penetrated deep to the skin given the
body habitus of the reported individual and the medical record as well as the length of the
needle.” Tr. 158.
IV. Finding of Fact
Before reaching the question of vaccine causation, I must resolve the factual issue of
onset. Petitioner alleges that he experienced pain within 48 hours of the intradermal vaccination.
Respondent asserts that the medical records do not establish that petitioner’s pain began within
48 hours of vaccination because he did not seek medical care for his left shoulder pain and
dysfunction for four and half months post-vaccination. Resp. Post-Hearing Brief at 7, n. 2.
a. Legal Authority for Finding of fact
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. 42 U.S.C. § 300aa-11(c)(2). The special master
is required to consider “all [ ] relevant medical and scientific evidence contained in the record,”
including “any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is
contained in the record regarding the nature, causation, and aggravation of the petitioner's illness,
disability, injury, condition, or death,” as well as “the results of any diagnostic or evaluative test
which are contained in the record and the summaries and conclusions.” 42 U.S.C. § 300aa-
13(b)(1). The undersigned must weigh the submitted evidence and the testimony of the parties’
offered experts and rule in petitioners’ favor when the evidence weighs in their 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 (“close calls” are
resolved in petitioner’s favor).
The special master is then required to weigh the evidence presented, including
contemporaneous medical records and testimony. See, e.g. Burns v. Sec'y of Health & Human
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Servs., 3 F.3d 415, 417 (Fed. Cir. 1993). Specifically, “[t]he special master or court may find the
first symptom or manifestation of onset of an injury, disability, illness, condition, or death
described in a petition occurred within the time period described in the Vaccine Injury Table
even though the occurrence of such symptom or manifestation was not recorded or was
incorrectly recorded as having occurred outside such period.” 42 U.S.C. § 300aa-13(b)(2). If the
medical records are clear, consistent, and complete, then they should be afforded substantial
weight. Lowrie v. Sec'y of Health & Human Servs., No. 03-1585V, 2005 WL 6117475, at *19-20
(Fed. Cl. Spec. Mstr. Dec. 12, 2005).
However, there is no presumption that medical records are complete as to all of a
patient’s conditions, as the Federal Circuit recently “reject[ed] as incorrect the presumption that
medical records are accurate and complete as to all the patient’s physical conditions.”. Kirby v.
Sec’y of Health & Human Servs., 997 F.3d 1378, 1382-83 (Fed. Cir. 2021). Afterall, “[m]edical
records are only as accurate as the person providing the information.” Parcells v. Sec’y of Health
& Human Servs., No. 03-1192V, 2006 WL 2252749, at *2 (Fed. Cl. Spec. Mstr. July 18, 2006).
And, importantly, “the absence of a reference to a condition or circumstance is much less
significant than a reference which negates the existence of the condition or circumstance.”
Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (quoting the decision
below), aff’d per curiam, 968 F.2d 1226 (Fed. Cir. 1992). The Murphy Court also observed that
“[i]f a record was prepared by a disinterested person who later acknowledged that the entry was
incorrect in some respect, the later correction must be taken into account.” Id.
Although witness testimony may be offered to overcome the weight afforded to
contemporaneous medical records, it must be “consistent, clear, cogent, and compelling.”
Camery v. Sec'y of Health & Human Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec'y
of Health & Human Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June
30, 1998)). Further, the Special Master must consider the credibility of the individual offering
the testimony. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health and Human Servs., 991 F.2d
1570, 1575 (Fed. Cir. 1993). In determining whether to afford greater weight to
contemporaneous medical records or other evidence there must be evidence that this decision
was the result of rational determination. Burns v. Sec’y of Health & Human Servs., 3 F.3d 415,
417 (Fed. Cir. 1993). The Special Master is obligated to consider and compare the medical
records, testimony, and all other “relevant and reliable evidence contained in the record.” La
Londe v. Sec’y Health & Human Servs., 110 Fed. Cl. 184, 204 (2013) (citing § 12(d)(3); Vaccine
Rule 8), aff’d, 746 F.3d 1334 (Fed. Cir 2014); see also Burns, 3 F.3d at 417.
b. Finding of Fact
1. Parties’ arguments regarding onset
The petitioner claims that he suffered significant pain almost immediately after he
received the flu injection on September 7, 2016, that the pain was caused by the injection and
that that pain persisted for many months up to and including the time of the hearing. See Pet.
Brief; Tr. 9-10, 27.
Respondent argues that there is insufficient evidence as to when the petitioner’s pain
began because petitioner did not seek medical treatment for four months after vaccination and
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further argues that petitioner has not established that the appropriate temporal relationship
between vaccination and the onset of his shoulder pain is 48-hours. Resp. Brief at 7, 16.
Respondent stated that petitioner first complained of left shoulder pain on January 20,
2017, four months and thirteen days after the vaccination. Id. at 3; see also Resp. Ex. C at 6.
Respondent’s expert, Dr. Schroeder, implied that petitioner’s decision not to seek treatment for
his left shoulder pain, while at the same time seeking treatment for right knee pain is
contradictory of petitioner’s statements that “it was not in my nature to complain about pain.”
Resp. Ex. C at 6. Dr. Schroeder stated, “A viable rationale for why it [was] acceptable to admit
to pain in the right knee and accept therapy while it is not acceptable to admit to pain in the left
shoulder and accept therapy at the same time has not been offered.” Id. at 11.
In petitioner’s reply, he argued that his symptoms occurred within the appropriate period
after the administration of the influenza vaccination. Pet. Reply at 6. He reiterated that his left
his shoulder pain began the same date as the influenza vaccination. Id.
2. Discussion and conclusion regarding the onset of petitioner’s left shoulder
pain and dysfunction
Petitioner has demonstrated by preponderant evidence that his left shoulder symptoms
began within forty-eight hours of receiving the intradermal flu vaccine on September 7, 2016.
More specifically, petitioner provided preponderant evidence that soreness leading to pain began
on the same day as the vaccination.17
The testimony from the petitioner and his wife demonstrated that petitioner experienced
soreness the same day he received the vaccine and that the lump that formed on his shoulder was
there for “three weeks, a month or so following the vaccination. Maybe a month and a half,” and
the soreness leading to pain led to difficulties moving his left shoulder. Tr. 9-13. Petitioner
testified credibly that his left shoulder felt sore and was painful after he received the intradermal
flu vaccine. Tr. 9. Petitioner described the pain “like getting stung by a large bee, and it felt like
the stinger was still in my arm.” Tr. 9. Petitioner testified that his pain started directly following
the September 7, 2016, vaccination and that the pain was “localized to that immediate area where
I received the shot.” Tr. 9-10. He testified that the vaccine administrator was standing above him
while he was seated, and the intradermal flu vaccination was administered “kind of high, mid to
back,” close to the acromion bone. Tr. 8.
Petitioner described the pain on the day of the vaccination at a 9 out of 10 on the pain
scale, and that he was unable to sleep that night due to the “stinging” in his arm. Tr. 9-10. He
testified that he took Advil and iced his shoulder when he returned home. Tr. 10. In petitioner’s
affidavit he averred that “several days passed and the pain from the needle ‘shot’ did not
diminish.” Pet. Ex. 6 at ¶, Pet. Ex. 7 at ¶ 4. He also testified that “the pain persisted…[and]
lasted for over a month.” T. 11-12. Petitioner testified that he had difficulty moving his shoulder
“immediately following the shot,” and explained he still has “difficulty only because it causes
17 This section only provides a finding of fact for when petitioner’s left shoulder pain began. A discussion of the
appropriate proximal temporal relationship between the intradermal vaccine and alleged injury is found in Althen
prong three.
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pain.” Tr. 13. He testified that in mid-January 2017, at his wife’s urging, he visited Dr. Powell at
Hallmark Health Medical and described his pain level while relating it back to the vaccine at
issue. Tr. 17; Pet. Ex. 1 at 14-17.
Petitioner’s testimony was corroborated by the testimony of Mrs. Cheryl Galante, his
wife of 35 years, that his shoulder pain began the same day he received the intradermal flu
vaccination which she noticed because of his inability to sleep at night. Tr. 42. Mrs. Galante
testified that the day petitioner received the vaccine, he did not sleep well, and approximately
one week later “he finally said, you know, the flu shot I got, my arm’s been bothering me, so I
think that’s why I’m restless.” Tr. 42-43. She also confirmed the redness on petitioner’s left
shoulder and observed that his shoulder was “red, raised and like hard in the middle.” Tr. 43.
Mrs. Galante explained that petitioner is not the type of person to complain about pain, and he
never had any injuries to his left shoulder prior to September 2016. Tr. 44. She stated that
following the vaccination “his range of motion stopped…he couldn’t lift it up.” Id. Mrs. Galante
stated that petitioner used at-home remedies to treat his pain with “a lot of Advil,” and she would
“see him ice it now and then.” Tr. 45. She also explained that she pushed petitioner to go to the
doctor in January 2017 because “something [was] wrong,” and “because he doesn’t go to the
doctor and he just sucks it up.” Tr. 45-46.
The testimony by the witnesses is consistent with the medical records, in which petitioner
consistently related the onset of his shoulder pain and dysfunction to the vaccination on
September 7, 2016. On January 20, 2017, petitioner presented to Dr. Jennifer Powell at
Hallmark Health Medical Associates for an “acute visit” for “pain in flu shot area,” which
“occurred after having had a flu shot in September, ongoing for the past four months.” Pet. Ex. 1
at 14. Specifically, the note states, “having problems with range of motion, issues of raising his
arm in flexion.” Id. at 15. Then on January 27, 2017, when petitioner was seen by Brian Petrone,
PA-C at Boston Sports Medicine, the note states that petitioner is being seen for “lateral shoulder
pain after the flu shot.” Pet. Ex. 2 at 6. The appointment note also states that petitioner reported
that “he has always had mild pain to the shoulder with [decreased range of motion] and
[decreased] strength.” He remains with persistent pain. The general pain and range of motion
has not improved. He has difficulty with range of motion and grabbing things above male’s
shoulder area. Id. The same day he underwent an MRI of the left shoulder. On physical exam his
forward flexion was limited to 100 degrees in flexion and abduction actively and 130 degrees
passively. Muscle strength was 3/5. Pet. Ex. 2 at 6. Petitioner testified that he had never
presented to any provider for pain in his left shoulder at any time prior to the January 20,
appointment with Dr. Powell. Tr. 20-21. Petitioner returned to Boston Sports Medicine on
February 3, 2017, and Dr. Gill noted in part “he also had a shoulder MR last Friday for left
shoulder pain which may be related to a flu shot in 9/16.” Pet. Ex. 2 at 5. On March 9, 2017,
petitioner once again related his shoulder pain to the flu vaccine by reporting “left shoulder pain
that began in fall 2016 after getting a vaccination, pain worsened as time passed.” Pet. Ex. 4 at
33. His shoulder has ached since the shot.” Id.
Dr. Schroeder argued that petitioner had not provided a “viable rationale” for why
petitioner sought treatment for his right knee pain but did not seek treatment for his left shoulder
pain. See Resp. Ex. C at 6. However, petitioner persuasively testified that his delay in seeking
treatment for his left shoulder pain was because it was consistent with how he addressed other
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injuries. In his affidavit, petitioner stated that he had “held out hope that whatever injury I had
sustained would eventually heal itself….I have been an athlete my entire life playing varsity
hockey and participating in mixed martial arts. It is not my nature to complain about pain. I was
taught to push through the pain.” Pet. Ex. 7 at ¶ 6. Consistent with his affidavit, petitioner
testified that he had also delayed treatment for his right knee pain, and only went to get it
examined at his wife’s urging. Tr. 17, 23. Petitioner testified that it was a long time between
when [he] first started experiencing the knee pain and when he finally got his knee examined and
even then, he had done so at the urging of his wife. Tr. 23. He also testified that he had used
ibuprofen and ice to alleviate the pain in his right knee. Id. The credibility of petitioner’s
testimony that he tended to put off seeking medical treatment for pain, was reinforced by the fact
that when he did seek treatment for the knee it was discovered that he had a torn meniscus
requiring surgical repair.
Similarly, delaying treatment for his left shoulder pain, petitioner testified, “I figured the
pain would stop.” Tr. 17. He explained that he used Advil and ice daily to treat his left shoulder
pain. Tr. 14. He testified that his wife “was the catalyst to push me to go do something about
[the left shoulder],” after she had noticed him using ice and not sleeping on his left shoulder. Tr.
17. When petitioner was asked if he had mentioned his left shoulder pain to his physical
therapist, he testified, “I actually did mention it to them, but they were just primarily focused on
the knee. And I brought it up a few times to them. I don’t know the exact nature of referrals, but
I was there for my knee, and I think that’s what they were focused on.” Tr. 32. As the medical
records indicate, petitioner was referred to ProEx Physical Therapy for “pain in the right knee.”
See Pet. Ex. 4 at 5. The records demonstrate that the physical therapy was solely focused on
treating petitioner’s right knee pain. Id.
In Kirby, the Federal Circuit clarified Cucuras, stating, “We did not hold that medical
records are presumptively accurate and complete. Nor did we state that when a person is ill, he
reports all his problems to his doctor, who then faithfully records everything he is told. We
reject as incorrect the presumption that medical records are accurate and complete as to all the
patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383
(Fed. Cir. 2021). The Circuit held that a reasonable fact finder could find that petitioner’s
testimony of ongoing pain did not conflict with the records as the records are also silent about
the nonexistence of such symptoms. Id. at 1383. Following Kirby, a special master must
consider the context of a medical encounter before concluding that it constitutes evidence
regarding the absence of a condition. See Kirby, 997, F.3d 1378. The fact that the physical
therapy records from October through December 2016 do not mention left shoulder pain does not
conflict with petitioner’s testimony that he had left shoulder pain from the flu vaccine, as these
records were silent about the nonexistence of such symptoms. Petitioner was referred to the
physical therapist for right knee pain, and thus treated for right knee pain, while at the same time
believing his left shoulder pain would not need medical attention. Additionally, petitioner
testified that he had mentioned his left shoulder pain during the physical therapy sessions, but it
was not recorded as the focus of the physical therapy referral was for knee pain. Tr. 32.
Additionally, a delay in seeking treatment or a failure to report symptoms to a physician
during an appointment for other issues is not necessarily dispositive of whether a petitioner’s
symptoms began within the appropriate timeframe. See Stephens v. Sec’y of Health & Human
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Servs., No. 19-1685V, 2021 WL 482355 (Fed. Cl. Spec. Mstr. Sept. 15, 2021) (finding that
petitioner’s onset of pain was within the appropriate timeframe with a 70-day delay in seeking
treatment for a SIRVA); McGee v. Sec’y of Health & Human Servs., No. 18-1778V, 2021 WL
6059588 (Fed. Cl. Spec. Mstr. Nov. 30, 2021) (finding onset of shoulder pain within the
appropriate timeframe with a five-month delay in treatment); Desai v. Sec’y of Health & Human
Servs., No. 14-811V, 2020 WL 4919777 (Fed. Cl. Spec. Mstr. July 30, 2020) (finding petitioner
had established onset of pain within 48 hours of vaccination even though she delayed treatment
for three months); see also Forman-Franco v. Sec’y of Health & Hum. Servs., No. 15-1479V,
2018 WL 1835203 (Fed. Cl. Spec. Mstr. Feb. 21, 2018); Tenneson v. Sec’y of Health & Hum.
Servs., No 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018), mot. rev. denied
142 Fed. Cl. 329 (2019); Gurney v. Sec’y of Health & Hum. Servs., No 17-481V, 2019 WL
2298790 (Fed. Cl. Mar. 19, 2019).
In this case, the testimony provided by witnesses was consistent with one another and
consistent with the medical records that the onset of petitioner’s pain began immediately after the
vaccination, well within 48-hours of receiving the intradermal flu vaccination on September 7,
2016. Even though petitioner delayed medical care for his shoulder until the pain persisted for
four months, all subsequent records with physicians and physical therapists consistently attribute
the onset of pain to a reaction to the flu shot beginning with the injection. Additionally, the
medical records also demonstrate that petitioner consistently related the onset of his pain to the
flu vaccine he received in September 2016 and there is no record that is inconsistent with that
history. Therefore, I conclude that testimony and medical records credibly and persuasively
establish that petitioner’s shoulder pain began immediately after the vaccination in question and
continued to be painful for a considerable period of time, in excess of six months.
V. Causation 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 & Hum. Servs., 35 Fed. Cl. 1, 7 (1996) (quoting H.R.
Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
To receive compensation through the Program, petitioner must prove either (1) that she
suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a
vaccine that she received, or (2) that he suffered an injury that was actually caused by a
vaccination. See §§ 11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of Health & Hum. Servs., 440 F.3d
1317, 1319-20 (Fed. Cir. 2006). Because petitioner does not allege that he suffered a Table
Injury, he must prove that a vaccine he received caused his injury. To do so, he must establish,
by preponderant evidence: (1) a medical theory causally connecting the vaccine and his injury
(“Althen Prong One”); (2) a logical sequence of cause and effect showing that the vaccine was
the reason for her injury (“Althen Prong Two”); and (3) a showing of a proximate temporal
relationship between the vaccine and her injury (“Althen Prong Three”). § 13(a)(1); Althen, 418
F.3d at 1278. In this case, petitioner is not alleging a Table Injury, as the Table designation is
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limited to vaccines intended for intramuscular injection. Thus, petitioner must demonstrate that
the vaccine was the cause of his shoulder injury.
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The
preponderance standard requires a petitioner to demonstrate that it is more likely than not that the
vaccine at issue caused the injury. Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d 1315,
1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health
& Hum. Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, petitioner must prove that the
vaccine was “not only [the] but-for cause of the injury but also a substantial factor in bringing
about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Hum. Servs.,
165 F.3d 1344, 1352-53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Hum. Servs.,
451 F.3d 1352, 1355 (Fed. Cir. 2006). 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).
The causation theory must relate to the injury alleged. The petitioner must provide a
sound and reliable medical or scientific explanation that pertains specifically to this case,
although the explanation need only be “legally probable, not medically or scientifically certain.”
Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994). Recently, in
Kottenstette, the Federal Circuit reiterated that proof of causation does not “require identification
and proof of specific biological mechanisms[.]” Kottenstette v. Sec’y of Health & Hum. Servs., -
-Fed.Appx.—(Fed. Cir. June 15, 2021) (citing Knudsen v. Sec’y of Health & Hum. Servs., 35
F.3d 543, 549 (Fed. Cir. 1994). Causation “can be found in vaccine cases….without detailed
medical and scientific exposition of the biological mechanisms.” Knudsen, 35 F.3d 543, 548-49
(Fed. Cir. 1994). It is not necessary for a petitioner to point to conclusive evidence in the
medical literature linking a vaccine to the petitioner’s injury, as long as the petitioner can show
by a preponderance of evidence that there is a causal relationship between the vaccine and the
injury, whatever the details of the mechanism may be. Moberly v. Sec’y of Health & Hum.
Servs., 592 F.3d 1315, 1325 (Fed. Cir. 2010).
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).
In Vaccine Act cases, expert testimony may be evaluated according to the factors for
analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579,
594-96 (1993); see also Cedillo, 617 F.3d at 1339 (citing Terran v. Sec’y of Health & Hum.
Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). In Vaccine Program cases, the Daubert analysis
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has been used in the weighing of the scientific evidence actually proffered and heard rather than
as a tool for the pre-trial exclusion of expert testimony. Davis v. Sec'y of Health & Hum. Servs.,
94 Fed. Cl. 53, 66–67 (Fed. Cl. 2010) (“uniquely in this Circuit, the Daubert factors have been
employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”), aff'd, 420 F. App'x 923 (Fed. Cir. 2011). The flexible use of
the Daubert factors to determine the persuasiveness and/or reliability of expert testimony in
Vaccine Program cases has routinely been upheld. See, e.g., Snyder v. Sec'y of Health & Hum.
Servs., 88 Fed. Cl. 706, 742–45 (2009).
Where both sides offer expert testimony, a special master's decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec'y of Health & Hum. Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d 1357, 1362 (Fed. Cir. 2000)). However,
nothing requires the acceptance of an expert's conclusion “connected to existing data only by the
ipse dixit of the expert,” especially if “there is simply too great an analytical gap between the
data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner,
522 U.S. 146 (1997)). Weighing the relative persuasiveness of competing expert testimony,
based on a particular expert's credibility, is part of the overall reliability analysis to which special
masters must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325–26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility
determinations”); see also Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1250 (Fed.
Cir. 2011) (“this court has unambiguously explained that special masters are expected to
consider the credibility of expert witnesses in evaluating petitions for compensation under the
Vaccine Act”).
A special master must consider, but is not bound by, any diagnosis, conclusion,
judgment, test result, report, or summary concerning the nature, causation, and aggravation of
petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical
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.” Curcuras v. Sec’y of
Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).
The special master is obligated to fully consider and compare the medical records,
testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110
Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health &
Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (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).
Close calls regarding causation must be resolved in favor of the petitioner. Althen, 418
F.3d at 1280 (holding that Congress created a system in which “close calls regarding causation
are resolved in favor of injured claimants”); Knudsen, 35 F.3d at 551 (“If the evidence (on
alternative cause) is seen in equipoise, then the government has failed in its burden of persuasion
and compensation must be awarded.”).
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VI. Causation Analysis
a. Althen prong one
Under Althen prong one, the causation theory must relate to the injury alleged. The theory
must be based on a “sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at
548. It must only be “legally probable, not medically or scientifically certain.” Id. at 549.
However, the theory still must be based on a “sound and reliable medical or scientific
explanation.” Id. at 548. The Federal Circuit explained in Althen that “while [that petitioner’s
claim] involves the possible link between [tetanus toxoid] vaccination and central nervous
system injury, a sequence hitherto unproven in medicine, the purpose of the Vaccine Act’s
preponderance standard is to allow the finding of causation in a field bereft of complete and
direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280 (emphasis added).
1. Background on the intradermal flu vaccination
According to the Fluzone intradermal Quadrivalent package insert (“package insert”), the
intradermal quadrivalent flu vaccine is intended for adults 18-64 years of age and contains 0.1 ml
of fluid. Resp. Ex. C Tab 2. The insert notes that the “preferred site of injection is the skin in the
region of the deltoid.” Id. at 2. The microneedle injection system, pictured below, uses a hollow
microneedle that “penetrates 1.5 mm into the skin from the outer skin surface.” Resp. Ex. C at 7.
The vaccine administrator is to hold the device perpendicular to the skin, between the thumb and
middle finger, keeping the index finger free to compress the plunger. Resp. Ex. C Tab 2 at 3-4.
The packet insert explains, “because the vaccine is injected into the skin, a wheal (superficial
bump) and/or redness may be visible at the injection site.” Id. at 4. In a controlled safety and
immunogenicity study of the Fluzone Intradermal Quadrivalent vaccine, 53% of recipients
reported pain at the injection site within seven days of vaccination, compared to 48% of those
who received an intradermal trivalent flu vaccine. Id. at 8. Additionally, 11% of those that
reported pain at the injection site who received the Fluzone Intradermal Quadrivalent
characterized the pain as having “some or significant interference with daily activities.” Id. at 9.
This was compared to 9% who received the intradermal trivalent flu vaccine. Id. Further, 19% of
participants who receive the Fluzone Intradermal Quadrivalent vaccine reported swelling at the
injection site, compared to 14% who received the other intradermal vaccinations. Id.
Resp. Ex. C at 7.
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Petitioner also submitted a Vaccine Administration Comparison Sheet, which gave an
overview of the difference between intramuscular and intradermal administration. Pet. Ex. 29.
The fact sheet demonstrated that the injection site for the Fluzone intradermal vaccine is intended
to be perpendicular to the deltoid region of the arm, the vaccine administrators should place their
index finger on the plunger to lightly pierce the skin and “apply very little pressure.” Id. at 3.
Further, it showed that when the plunger is fully depressed the vaccination is complete. To
dispose of the device the vaccine administrators should use their thumb to “firmly push on the
plunger to activate [the] needle shield.” Id.
The Lambert et al., article, submitted by respondent, explained that the skin was
recognized “as a potentially excellent site for vaccination,” because, in part, it “has both cellular
and humoral immune system components.” Resp. Ex. C Tab 1.18 Further, the article noted that,
“intradermal influenza vaccination in elderly subjects (0.1 ml dose) induced a humoral immune
response superior to the [intramuscular] control against all three strains.” Id. at 3. The
Rosenbaum et al., article, submitted by petitioner, explained that that “skin is an ideal target for
vaccine injection due to the diversity of resident and recruited immune cells, including
macrophages, Langerhans cells, and several subsets of dermal dendritic cells.” Pet. Ex. 19. The
authors found “a strong early local and systemic inflammatory response that peaked at 24 hours
post-vaccination, which was the progressively replaced by an adaptive response.” Id.
2. Discussion and Conclusion of Althen prong one
Petitioner’s experts opined that the intradermal flu vaccine was mis-administered
resulting in an inflammatory response in and around the structures of the shoulder that
manifested as immediate pain and reduced mobility of the left shoulder. See Pet. Ex. 24 at 2;
Pet. Ex. 11 at 6; Pet. Post-Hearing Brief at 9. Respondent argued that the 1.5 mm needle used
for the intradermal flu vaccination could not directly penetrate the subdeltoid/subacromial bursa,
and therefore, could not have caused petitioner’s left shoulder pain and dysfunction. See Resp.
Post Hearing Brief at 13-15; Tr. 140-142; Resp. Ex. C Tab 3 at 1; Resp. Ex. A Tab 11 at 1.
Respondent asserted that even if the vaccine was administered improperly, the needle is not
sufficiently long to deliver the antigen into the bursa. Id. at 13-14. Respondent’s experts also
argued that petitioner only had a local reaction, outside the shoulder anatomy, that cannot explain
shoulder symptomatology. Resp. Post-Hearing Brief at 11; Tr. 82-86.
Petitioner has provided a sound and reliable theory which demonstrates how the
intradermal flu vaccine, administered improperly, initiated an inflammatory response in and
around the structures of his left shoulder, sufficient to induce pain and shoulder dysfunction.
Petitioner’s expert, Dr. Huffman asserted that the improper vaccination technique used by
the vaccine administrator injected the vaccine “deeper than was intended,” below the dermal
layer, and into the shoulder structure near the bursa, causing an inflammatory response, which
led to shoulder pain and reduced range of motion. Pet. Post-Hearing Brief at 11-12; Tr. 113-15.
Dr. Huffman testified that the needle has a “fixed length” of 1.5 mm and the skin can be as “thin
18 Lambert, P. and Laurent, P., Intradermal vaccine delivery: Will new delivery systems transform vaccine
administration? 26 Vaccine 3197-3208 (2008). [Resp. Ex. C Tab 1].
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as 3 millimeters.” Tr. 107. He opined that “with force” the needle could “get to a depth of close
to a centimeter.” Id. Dr. Huffman stated, “….I suspect that this went in quite a ways deeper than
it was intended, possibly more than a centimeter or more.” Id. He testified that he had reviewed
the testimony from the vaccine administrator, Ms. Dell’Orfano, and stated “clearly the device
was not properly used and too much force was used to administer [the vaccine].” Id. at 108. Dr.
Huffman analogized the misadministration of the intradermal vaccine to a thumbtack being
pressed into the skin stating, “…if I were to take a thumbtack and push it into the side of
someone’s shoulder, it would stop at the skin depth of a centimeter. However, if I push with
more force, the investing skin and soft tissue would also indent, and the needle would go further
and further as I pushed harder and harder.” Tr. 110. Additionally, Dr. Huffman explained that
the vaccine antigen that is being injected “extrude[s] out from the needle in a fair way,” when the
needle is injected with force. Tr. 127. He stated, “…If I [inject with a needle] more forcefully
and suddenly, not only will the skin indent, but that fluid will be pushed several millimeters
deeper than the actual needle.” Id.
The testimony of the vaccine administrator, Ms. Dell’Orfano, supports Dr. Huffman’s
opinion that the intradermal vaccine was improperly administrated, injecting the antigen further
than the intended dermal layer. Tr. 59-63; see also Resp. Ex. C, Tab 2. Ms. Dell’Orfano
explained that the flu season of 2016 was the first time she was “regularly administrating
intradermal vaccinations.” Tr. 56. She also stated that administering the Fluzone on September
7, 2016 would have been early in the time in which she began using the intradermal vaccine. Tr.
64. During her testimony, Ms. Dell’Orfano demonstrated that she would “use her thumb” to
press the injector when the injector system was against a patient’s skin. Tr. 58-59. She also
testified that you would need to use “a little bit of pressure because you have to hear that click to
know that the medication actually went into the patient.” Tr. 59.
A review of the instructions for administration on the Fluzone package insert, indicate
that Ms. Dell’Orfano did not understand or follow those instructions. First, the package insert
demonstrates the intended use of the intradermal injection directing to “position the device in
your hand between the thumb and middle finger, keeping the index finger free.” Resp. Ex. C,
Tab 2 at 3. The vaccine administrator is to “Hold the device by placing the thumb and middle
finger on the finger pads above device window. Keep the index finger free.” Id. at 4. As
depicted below, the vaccine administrator is to “gently pierce the skin perpendicular to the
deltoid region,” using “light pressure.” Id. (emphasis added).
Id. at 4. Then, “using index finger, gently press the plunger to inject the vaccine.” Id. The
package states that only once the needle is removed from the skin, the vaccine administrator is to
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“push very firmly with the thumb on the plunger to activate the needle shield.” Id. As Ms.
Dell’Orfano demonstrated during the hearing, she held the device such that she used her thumb
to press firmly down on the plunge, contrary to the instructions directing the vaccine
administrator to use an index finger and “gently press the plunger”. Tr. 59-60. Further, she
stated that she pressed the plunger until she heard a “click.” Tr. 60. However, the instructions
provides that “When the plunger stop, vaccination is complete….Excessive pressure on the
plunger may prematurely activate the needle shield on the patient’s arm.” Resp. Ex. C, Tab 2 at
4. Only when disposing of the injection system do the instructions indicate that the vaccine
administrator should use their thumb and would hear a “click.” Id.
In addition to the improper vaccination technique used by Ms. Dell’Orfano, petitioner
testified that he was sitting, while Ms. Dell’Orfano was standing. Tr. 8. Further, petitioner
testified that the vaccine was injected “on the left shoulder, kind of high, mid to back. Id.
Petitioner pointed to an area approximately an inch and half below his acromion bone. Id. The
Atanasoff article explains that “while patients are often seated for vaccinations, the standing
position of the provider administering the injection may also contribute to injecting inadvertently
high…” Resp. Ex. A, Tab 9 at 4. The article also noted that approximately half of patients in
their case series “reported vaccine administration “too high” in the shoulder,” and the authors
opined that “in some of our cases the injury may have been the result of improper injection
technique.” Id.
Respondent’s expert, Dr. Cagle, conceded that Ms. Dell’Orfano administered the vaccine
inconsistently with the instructions provided on the package insert. Tr. 151. Thus, the
demonstration and testimony of Ms. Dell’Orfano about the technique she used in comparison to
the instructions from the package insert, the seated position of petitioner during vaccine
administration, and the location in which petitioner received the vaccine sets forth a sound basis
for concluding that it is likely that there was overpenetration and deposition of the vaccine into
the tissue beneath the skin.
Dr. Huffman explained that the likely place the intradermal vaccine was administered
was into the hypodermis layer, which is an area “prone to inflammation.” Tr. 129. He testified
that the hypodermis layer is not the surface layer, but soft tissue, which has a “rich blood supply
in lymphatics,” and when the vaccine was injected into this area, it could cause pain. Id. The
Lambert article, filed by respondent and referenced by Dr. Huffman, depicts the skin anatomy,
and indicates that the hypodermis layer sits approximately 3 mm to 100 mm below the skin
surface, depending on body mass, body sites, age, and gender. Resp. Ex. C, Tab 1 at 3. Dr.
Cagle’s opined that it would be “virtually impossible” for a 1.5 mm needle to penetrate the
deltoid muscle and that a needle would need to be at least 1 centimeter long to reach the deltoid
layer. Tr. 143-44. However, petitioner’s theory is not that the vaccine was injected into the
deltoid, but instead, reached the hypodermis, which lays above the deltoid muscle, and only 3
mm below the surface of the skin. Further, consistent with Dr. Huffman’s theory, the Poland
article explained, “Use of shorter needles…resulted in deposition of vaccine into the
subcutaneous tissue, which is well innervated with pain fibers compared with poorly innervated
muscle tissue.” Resp. Ex. A, Tab 11 at 3; Tr. 164. As is well documented in the evidence in this
case, the intradermal needle was designed to be shorter than the traditional intramuscular needle
and intended to deposit the vaccine material into the intradermal space. In the scenario that the
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needle was pushed through the dermis with excessive force, the vaccine could easily be
deposited in the subcutaneous tissue giving rise to pain and later shoulder dysfunction.
Petitioner’s experts opined that the vaccine being injected into the hypodermal space
caused both a local and regional inflammatory reaction, which led to shoulder pain and reduced
mobility. Tr. 112. Dr. Gershwin stated, “It is well known that vaccination leads to firstly a local
immune response within the nearby lymphatics, which will then traffic through the interstitium
through other lymph nodes.” Pet. Ex. 24 at 1. He stated that, “It is also well known that
reactions can lead to significant swelling, and this is part of the systemic reaction. In other
words, the response to vaccination includes an inflammatory response. This inflammatory
response, like any other mechanical event, can obstruct or impinge on adjacent tissues, including
the bursa, tendon, and local nerves.” Id. Consistent with Dr. Gershwin’s opinion, Dr. Huffman
testified that vaccines are “meant to engender a broader systemic inflammatory and immunologic
response,” but the vaccine can also elicit a local inflammatory response. Tr. 112. Dr. Huffman
testified that there is an “early inflammatory response that’s expected and hoped for,” through
vaccination, but that petitioner also had a local response as evidenced by petitioner’s description
of the hardened area where he received the vaccine. Id. Dr. Huffman observed that the reported
local adverse reactions to the intradermal vaccine were more common than the intramuscular flu
vaccine. Tr. 124. The package insert provides that 76.4% of intradermal vaccine recipients had
injection-site erythema, compared to 13.2% of patients who received the intramuscular flu
vaccine. Resp. Ex. C, Tab 2 at 10. Injection-site induration, injection-swelling, and injection-
site pruritis were also elevated compared to the intramuscular flu vaccinations. Id. The
incidence of pain was found to be equal to that seen in intramuscular injections. Id.
Respondent’s expert, Dr. Schroeder agrees that the intradermal vaccine can elicit a
systemic reaction, but he argued that petitioner’s experts did not demonstrate how a systemic
inflammatory response could result in an inflamed shoulder. Resp. Ex. C at 8. However, during
the hearing, Dr. Schroeder conceded that petitioner likely had a “local reaction” to the
intradermal vaccine. Tr. 86. He argued that petitioner had “local inflammation that occurred as
a result of the injection with local pain at the injection site,” but then the petitioner’s decreased
range of motion and decreased strength was only because of degenerative changes in petitioner’s
shoulder and possibly the petitioner’s lifestyle. Id. Dr. Schroeder offered a similar argument in
Lagle, in which he conceded that the intradermal caused a local inflammatory response, but that
the changes in the petitioner’s shoulder was totally unrelated to the vaccination. See Lagle v.
Sec’y of Health & Human Servs., No. 16-1053, 2022 WL 2299003, at * 30 (Fed. Cl. Spec. Mstr.
May 25, 2022). Like in Lagle, Dr. Schroeder’s opinion that the vaccination was simply
coincidental to the onset of petitioner’s pain and shoulder dysfunction, even with evidence of a
local inflammatory event, is not credible as it fails to account for the lack of any prior shoulder
symptoms and the immediate onset of pain after the vaccination.
Dr. Huffman opined that petitioner’s symptoms were most consistent with rotator cuff
inflammation or bursitis in the subacromial space. Pet. Ex. 11 at 5; Tr. 115. Dr. Huffman
observed that petitioner did not experience any symptoms related to shoulder dysfunction prior
to the vaccination. Pet. Ex. 11 at 5. Dr. Huffman explained that petitioner’s MRI showed some
other pathology, but that “there was no real clear documentation that those things were actually
bothering [the petitioner].” Tr. 115. Dr. Huffman testified that it was common for people the
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same age as the petitioner to have asymptomatic rotator cuff pathology. Tr. 130. Dr. Cagle
agreed with Dr. Huffman, that degenerative changes in the shoulder can be found on MRIs
which are unrelated to the symptoms of post-vaccination shoulder pain. Tr. 144-45. However,
Dr. Cagle argued that petitioner had “pre-existing shoulder pain,” and that the identified shoulder
pathology became “clinically relevant,” at some point after the intradermal flu vaccine, but
without identifying another inciting event. Id. at 148. The Atanasoff article explains, “Although
shoulder dysfunction due to mechanical or overuse is always a diagnostic consideration, the
rapid onset of pain with limited range of motion following vaccination….is consistent with a
robust and prolonged immune response with already-sensitized shoulder structures following
injection of antigenic substance.” Pet. Ex. 12 at 3; Resp. Ex. A, Tab 9. The authors theorized
that some of the MRI findings in their patients, such as rotator cuff tears, “may have been present
prior to vaccination and became symptomatic as a result of vaccination-associated synovial
inflammation.” Id. at 3. Dr. Huffman opined that the intradermal vaccine, administered
incorrectly, caused an inflammatory reaction in the area around the pre-existing shoulder
pathology, it could lead to pain, resulting in a reduced range of motion. Tr. 130-31. Dr. Cagle
also conceded shoulder injuries from post-vaccination administration manifest in “pain.”
The petitioner’s experts did not argue that the intradermal vaccination can cause an
underlying rotator cuff tear, but that the intradermal vaccine can cause local and regional
inflammation that resulted in pain and reduced shoulder motion. The authors in Atanasoff
recognized that asymptomatic shoulder pathology may pre-exist vaccination but observed that
the prompt onset of pain after vaccination is consistent with a robust and prolonged immune
response with already-sensitized shoulder structures following injection of antigenic substance.
See Pet. Ex. 12 at 3. The Poland article discussed the presence of abundant pain fibers in the
subdermal or hypodermal space that can give rise to pain when a vaccine is deposited into that
space. The explanation by Dr. Huffman that the application of even a fairly slight amount of
excess pressure during the intradermal vaccine administration, as appeared to be well
demonstrated by Ms.Dell’Orfano, could readily compress the skin and other soft tissue and allow
penetration beyond the dermis into this pain sensitive area provides a sound and reliable
explanation of the way an intradermal flu vaccine can cause inflammation in the shoulder
structure that results in pain and shoulder dysfunction. Further, the package insert also found
that the reports of pain at the injection site with an intradermal injector is equal to that seen in
intramuscular injections. See Resp. Ex. C, Tab 2 at 10.
Thus, the respondent’s argument that the needle must penetrate deep into the structure of
the shoulder to cause shoulder pain is sufficiently rebutted by the explanation of excess pressure
compressing the skin and adipose tissue during the injection allowing penetration well beyond
the intradermal space. Further, Dr. Huffman’s explanation that when that occurs the fluid may
penetrate well beyond the length of the needle into the highly innervated soft tissue is also
instructive. The occurrence of such penetration high in the arm where structures like the bursa
are closest to the skin, also makes more likely the spread of inflammatory pain in the region of
shoulder structures.
For all of the above reasons I conclude that petitioner has presented a reputable scientific
theory based on a sound and reliable medical explanation explaining how the flu vaccine
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administered with the intradermal injector can cause shoulder pain and dysfunction, thus
satisfying Althen prong one.
b. Althen prong two
Under Althen prong two, petitioner must prove “a logical sequence of cause and effect
showing that the vaccination was the reason for [her] injury.” Althen, 418 F.3d at 1278. This
prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the
vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is
relative to the injury, a petitioner must provide a reputable medical or scientific explanation that
pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of
causation. See Grant v. Sec’y of Health & Hum. Servs., 9556 F.2d 1144, 1148 (Fed. Cir. 1992).
This sequence of cause and effect is usually supported by facts derived from petitioner’s medical
records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326;
Grant, 956 F.2d at 1148.
Petitioner’s experts opined that the intradermal flu vaccine caused a local and regional
inflammatory response after being mis-administered. Pet. Post-Hearing Brief at 12. The flu
antigen being administered into the hypodermal layer, below the dermal layer, caused an
inflammatory immune response which led to pain and reduced range of motion secondary to
pain. Tr. 129-30. Dr. Huffman testified that the inflammation led to petitioner having rotator
cuff tendinopathy and bursitis. Pet. Ex. 11 at 5.
Both Drs. Schroeder and Cagle opined that the 1.5 mm needle was not sufficiently long
to cause petitioner’s shoulder pain and reduced mobility. See Resp. Ex. A at 4; Resp. Ex. C at
10. Dr. Schroeder stated that depth of the skin is between 2 to 4 mm in length and that the 1.5
mm needle “in no way can enter into the joint space,” and cause a local immune response that
leads to joint pain. Tr. 77. Dr. Cagle stated, “I don’t think it’s possible for a 1.5 mm needle to
press through those layers of tissue,” and opined that “…the muscle, the adipose tissue layer, and
the bursa would all somehow have to be compressed down to less than 1.5 mm,” for the needle
to penetrate further than the layers of skin. Tr. 141-42. Further, Dr. Schroeder asserted that the
intradermal flu vaccine applicator was designed to be “less sensitive to operator error. Tr. 89.
Additionally, Dr. Schroeder argued that the petitioner’s local reaction was a “common local side
effect from intradermal injections.” Tr. 84. Dr. Schroeder asserted that some of the local
reactions to the intradermal flu vaccine, like erythema, redness, swelling, induration and
hardness, can be caused “on an irritant basis,” or “as a result of innate immune response.” Tr.
84-85. However, he argued that the local inflammatory reaction could not cause tendonitis. Id.
Instead, he argued that petitioner’s decreased range of motion and decreased strength was more
likely a result of “definitive evidence of degenerative changes that can occur to anyone and
certainly someone who is as active as [petitioner].” Tr. 86. Dr. Cagle also implied that
petitioner’s shoulder pain was more related to “chronic-style wear and tear degenerative
changes,” that were present on petitioner’s MRI and that it became “clinically relevant later.”
Tr. 148. It was his opinion that the intradermal vaccine could not exacerbate underlying
shoulder pathology, making it painful.
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Dr. Huffman concluded that the intradermal flu vaccine could be administered deeper
than the intended dermal layer and deposited into the hypodermal layer, causing pain. Dr.
Huffman opined that when a needle is “inject[ed] with force, it’s going to extrude out from that
needle in a fair way.” Tr. 127. Further, he testified that if more force is used on the needle and it
is injected suddenly, “not only will the skin indentate, but that the fluid will be pushed several
millimeters deeper than the actual needle.” Id. He stated that the vaccine could be inadvertently
administered into the hyodermis or “the adipose layer,” which is an area prone to inflammation.”
Tr. 129. He observed that the Lambert article, showed that the dermis layer is approximately 1.5
mm to 3 mm thick, with the hypodermis directly beneath the dermal layer. Resp. Ex. C, Tab 1 at
3. The Poland article also explains that the “use of shorter needles” in intramuscular vaccines,
“resulted in the deposition of vaccine into the subcutaneous tissue, which is well innervated with
pain fibers compared with the poorly innervated muscle tissue.” Resp. Ex. A, Tab 11 at 3.
Dr. Huffman stated that it was likely that most of the vaccine was delivered into the hypodermis
area on the petitioner, which caused petitioner pain. Tr. 130.
Additionally, the vaccine administrator, Ms. Dell’Orfano, testified that the first time she
had administered the intradermal flu vaccine was in 2016. Tr. 56. She stated that September 7th
would have been “early in the time” that she had been using the intradermal vaccines. Tr. 64.
Ms. Dell’Orfano stated that when administering the intradermal vaccine she had to use “a little
pressure” because the administrator had to “hear the click to know that the medication actually
went into the patient.” Tr. 60. When she demonstrated how she administered the intradermal
vaccines, she used her thumb to press on the injector. Id. As discussed above, the way that Ms.
Dell’Orfano described how she administered the Fluzone intradermal vaccine was inconsistent
with directions provided in the package insert. Respondent’s expert, Dr. Cagle, also conceded
that Ms. Dell’Orfano testimony regarding the administration of the vaccine was “inconsistent”
with the directions included in the package insert. Tr. 153; see also Resp. Ex. C, Tab 2 at 3-4.
Further, petitioner testified that Ms. Dell’Orfano was standing while he was seated during
the vaccination. Tr. 8. Petitioner also stated that the vaccine was “on his left shoulder, kind of
high, mid to back.” Id. As explained in the Atanasoff article, about half of the patients who
experienced post-vaccination shoulder pain indicated that the vaccination was “too-high.” Resp.
Ex. A Tab 9. Further, the article states that “while patients are often seated for vaccinations, the
standing position of the provider administering the injection may also contribute to injecting
inadvertently high into the deltoid.” Resp. Ex. A Tab 9 at 4. Given that the vaccine was
administered high on petitioner’s left shoulder while he was seated, the microinjector was
relatively new technology to the vaccine administrator, and Ms. Dell’Orfano’s demonstration of
how she administered the vaccine was inconsistent with the package instructions, support a
misadministration of the vaccine where the antigen was deposited below the dermal layer and
resulted in an inflammatory reaction that caused pain and reduced shoulder mobility.
Dr. Huffman opined that the vaccine, being administered below the dermal area, into the
hypodermal space, was the cause of petitioner’s pain and reduced shoulder mobility. Tr. 129-30.
Dr. Huffman observed that petitioner had a hardened area where the vaccine was administered
on his left shoulder. Tr. 112. Further, he stated that if the vaccine was placed into a space with
proximity to the shoulder structures, such as the bursa, it can create bursitis or an inflammatory
35

Case 1:18-vv-01933-UNJ Document 72 Filed 11/30/22 Page 36 of 40
response in the bursa. Tr. 113. Dr. Huffman opined that petitioner’s symptoms were “most
consistent with rotator cuff inflammation or bursitis in the subacromial space.” Tr. 115.
Dr. Schroeder agreed that petitioner had a local inflammatory reaction at the site of
vaccine injection. Tr. 93. However, Dr. Schroeder contended that the “local inflammation that
occurred as a result of the injection was consistent with local pain at the site of injection,” did not
extend into the [shoulder] joint itself, causing decreased range of motion. Tr. 86. Dr. Schroeder
offered a similar opinion in Lagle, another intradermal Fluzone case. See Lagle v. Sec’y of
Health & Human Servs., No. 16-1053, 2022 WL 2299003, at *31 (Fed. Cl. Spec. Mstr. May 25,
2022). In Lagle, Dr. Schroeder also argued that the petitioner had a local reaction to the vaccine,
but that the petitioner’s reduced shoulder mobility was “totally unrelated to the vaccination,”
despite being unable to identify specific evidence that would have caused a previously
asymptomatic rotator cuff tear to become painful. Id. In this case, Dr. Schroeder offers an
almost identical opinion, stating that “the complaints of decreased range of motion and decreased
strength, and then…the results of the MRI is definite evidence of degenerative changes that can
occur to anyone and certainly someone who is as active as [petitioner] has been. So I think it’s
just a coincidence that the pain in the shoulder is associated temporally with the injection that he
received.” Tr. 86. As in Lagle, I find Dr. Schroeder’s opinion that that petitioner’s prolonged
local inflammatory response was simply coincidental to his shoulder dysfunction unpersuasive.
Dr. Schroeder’s speculative opinion fails to account for petitioner’s lack of pain in that shoulder
prior to the injection and then immediate pain thereafter.
Dr. Cagle argued that petitioner’s shoulder injury was inconsistent with a post-
vaccination shoulder injury because there was no increased fluid signal in the bursa and that he
“did not see any signs of a diffuse inflammatory rotator cuff response,” on petitioner’s MRI. Tr.
145. He agreed with Dr. Schroeder’s opinion that local inflammatory reaction (which Dr. Cagle
characterized as a “localized skin irritation), could not cause rotator cuff tendinopathy. Tr. 148.
However, Dr. Cagle conceded that petitioner had an initial local inflammatory response to the
vaccine that began immediately after the vaccination. Tr. 170. Additionally, in response to
questions from the Court, Dr. Cagle stated that “a localized inflammatory pain” can cause a
person to guard or reduce range of motion. Tr. 171-72.
As both Drs. Huffman and Schroeder observed, the Fluzone package insert provides that
the Fluzone intradermal vaccine causes injection-site induration, swelling, pruritus and erythema
at significantly higher rates compared to an intramuscularly administered flu shot. See Resp. Ex.
C, Tab 2 at 10. Induration, pruritus and erythema are all caused by some type of inflammatory
reaction. Additionally, “injection-site pain” was reported at approximately the same rate as the
intramuscular flu shot. Id. Further, the Atanasoff article explained, “Although shoulder
dysfunction due to mechanical or overuse injury is always a diagnostic consideration, the rapid
onset of pain with limited range of motion following vaccination….is consistent with a robust
and prolonged immune response within already-sensitized shoulder structures following
injection of antigenic substance into…the area around the rotator cuff tendon.” Resp. Ex. A, Tab
9 at 3. Here, there is credible evidence that the vaccine was mis-administered and likely resulted
in the deposit of the antigen below the dermal layer high on the shoulder where the bursa are
closest to the surface causing an inflammatory reaction in the shoulder area Drs. Huffman and
Gershwin also explained, which Dr. Schroeder did not dispute, that the vaccine is intended to
36

Case 1:18-vv-01933-UNJ Document 72 Filed 11/30/22 Page 37 of 40
cause a systemic immunological reaction in order to offer the person receiving the vaccine
immunity. See Pet. Ex. 24 at 1; Resp. Ex. C at 9. Dr. Gershwin opined that the local
inflammatory response “can obstruct or impinge on adjacent tissues, including the bursa, the
tendon, and the local nerves.” Pet. Ex. 24 at 1. As Dr. Huffman explained, petitioner’s
symptoms best reflected inflammation of the rotator cuff or bursitis in the subacromial space
near where the injection was given high in the arm just below the end of the acromion. Tr. 115;
Pet. Ex. 11 at 5.
Prior to receiving the vaccine, petitioner did not experience shoulder pain and
dysfunction that impacted his quality of life. Tr. 130. Petitioner received the intradermal flu
vaccination on September 7, 2016. Pet. Ex. 1; Tr. 11-12. He recalled that when he arrived at the
appointment on September 7, 2016, he was not experiencing any left shoulder pain, and when he
left the appointment, his pain was at a 9 on a scale of 1-10. He immediately took pain medication
and iced his left shoulder. Id. at 10. Petitioner testified that after he left the appointment his
shoulder “felt just like getting stung by a large bee, and it felt like the stinger was still in my
arm.” Tr. 9. That evening petitioner “could still feel the stinging in my arm and I continued to
toss and turn.” Tr. 10.
On January 20, 2017, petitioner was seen by his primary care physician, Dr. Powell with
complaints of left shoulder pain, relating the pain to the flu vaccination he received on
September 7, 2016. Pet. Ex. 1 at 14. The physical exam noted “limited range of motion with
concerns of possible rotator cuff injury from the influenza vaccine.” Id. at 17. Petitioner again
related the pain in his left shoulder to the vaccination at an appointment with Dr. Gill on January
27, 2017, at which time it was noted that his pain was worsening despite conservative treatment.
Pet. Ex. 2 at 6. Petitioner also underwent an MRI on January 27, 2017, because of his report of
shoulder pain that began at the time of the vaccination. The MRI showed mild to moderate
degenerative changes in different parts of the shoulder.
Petitioner participated in physical therapy for his shoulder from October 24, 2017, to
December 19, 2017, and patient reported at physical therapy discharge that the “shoulder does
not bother him during working out or daily tasks but still bothers him when he tries to fall
asleep.” Pet. Ex. 4 at 70. On January 18, 2018, “pain in left shoulder” was listed as a current
problem, along with others. Pet. Ex. 1 at 2-7. During the hearing, petitioner testified that he “can
still feel the pain in the shoulder” and it “feel[s] still like there’s a bee stinger in my shoulder.”
Tr. 26. Petitioner testified that the pain caused him to limit his use of the arm and that he had
difficulty with various activities such as reaching above the shoulder and sleeping. See Tr. 10,
17. Further, petitioner explained that his pain was localized to the “immediate area where he
received the shot.” Tr. 10.
Finally, Drs. Schroeder and Cagle opinion that the onset of petitioner’s pain was
unrelated to the intradermal vaccine is unconvincing. Dr. Cagle asserted that petitioner’s left
shoulder pain was more attributable to “chronic-style wear and tear degenerative changes [that]
were present in the [petitioner’s] shoulder” and that at some point later the petitioner’s shoulder
pathology became clinically relevant, but could not point to a specific injury or event in the
record that would explain the onset of pain. Tr. 148. Dr. Schroeder averred that petitioner’s
shoulder pain “appears to be the consequence of tearing, degeneration, and inflammation in his
37

Case 1:18-vv-01933-UNJ Document 72 Filed 11/30/22 Page 38 of 40
joints.” Resp. Ex. C at 12. He stated, “A more likely explanation for his physical complaints is
that he is suffering from the sequelae of pursuit of his athletic hobbies rather than the
consequence of an intradermal vaccination.” Id. at 12. During the hearing, Dr. Schroeder
testified that the onset of petitioner’s pain at the time of receiving the intradermal vaccine was a
“coincidence.” Tr. 86. Dr. Huffman acknowledged that petitioner likely had pre-existing
shoulder pathology, but those issues, such as the glenoid labrum tear and degeneration within the
acromioclavicular joint were “unrelated to the symptoms described by petitioner,” and petitioner
was not treated for those issues. Tr. 130; Pet. Ex. 11 at 5. Dr. Huffman stated that it was his
understanding that petitioner never experienced left shoulder pain that affected his quality of life,
disrupted his sleep, or for which he sought medical treatment prior to the intradermal
vaccination. Tr. 130. The Atanasoff article explains that MRI studies of asymptomatic patients
past middle age found that 39% of the patients had partial or complete rotator cuff tears. Resp.
Ex. A, Tab 9 at 3. The article explains that these conditions can cause no symptoms until
provoked by trauma or other events. Id. Thus, Dr. Schroeder and Dr. Cagle’s opinions that
petitioner’s life-style or the underlying shoulder pathology “coincidentally” became symptomatic
the day of the vaccination is unpersuasive as it fails to account for the prior lack of pain and the
sudden onset of significant pain immediately after receipt of the vaccination. While the MRI
demonstrated that petitioner had some degenerative conditions in his shoulder, the medical
literature explains that many people of his age have similar conditions and they are often
asymptomatic, as petitioner testified was true in his case. Speculation from respondent’s experts
that an underlying degenerative condition suddenly became symptomatic after the vaccination,
but had nothing to do with the vaccination is unpersuasive when compared with the clear,
consistent and logical history given by the petitioner and his wife and which is consistent with
the medical records.
Petitioner presented evidence that the vaccine administrator failed to follow the proper
vaccine administration instructions, likely leading to the deposition of the vaccine into the
hypodermal space, resulting in both a local and regional inflammatory response that caused
immediate pain and shoulder dysfunction. Accordingly, the petitioner has proven Althen prong
two by a preponderance of the evidence.
c. Althen prong three
Under Althen Prong Three, petitioner must establish a “medically acceptable temporal
relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That
term has equated to the phrase, “medically-acceptable temporal relationship.” Id. A petitioner
must offer “preponderant proof that the onset of symptoms occurred within a timeframe which,
given the medical understanding of the disorder’s etiology, it is medically acceptable to infer
causation.” de Bazan v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008).
The explanation for what is medically acceptable timeframe must also coincide with the theory
of how the relevant vaccine can cause an injury (Althen prong one). Id. at 1352.
Petitioner argued that the appropriate timeframe for a shoulder injury following the
influenza vaccination is 48-hours. Pet. Brief at 13. Petitioner’s expert, Dr. Huffman opined that
petitioner suffered from an immediate local response, as demonstrated by the hardened area on
petitioner’s left shoulder that persisted for weeks, and that he also had a regional inflammatory
38

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reaction. Tr. 112-13. Dr. Huffman also observed that the local adverse reactions that occurred
within seven days of the intradermal vaccine being administered was “very high.” Tr. 124.
Respondent argued that “petitioner inappropriately seeks the presumption the Vaccine
Injury affords with regard to SIRVA claims to satisfy the third prong of Althen.” Resp. Brief at
16. Respondent stated that the petitioner attempted to “bootstrap” the elements for establishing a
Table SIRVA claim to his off-Table shoulder injury claim.” Id. at 7, n. 3. Respondent stated
that “simple similarity to conditions or time periods listed in the Table is not sufficient evidence
of causation.” Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,1147-48 (Fed. Cir.
1992).
As discussed above, petitioner established by preponderant evidence that his pain began
immediately after receiving the intradermal flu vaccine. Petitioner’s expert, Dr. Huffman, stated
that petitioner’s shoulder pain was immediate after the vaccination he received on September 7,
2016. Pet. Ex. 26 at 2. Both of respondent’s experts also acknowledged that petitioner’s pain
began immediately after the intradermal vaccination. Tr. 86, 153. Indeed, respondent’s expert,
Dr. Schroeder asserted that a “local inflammatory reaction would likely occur within 24-48
hours” of an intradermal vaccination. Tr. 83. Further, Dr. Schroeder acknowledged that
petitioner had pain associated at the site of the injection immediately following the vaccination.
Tr. 86.
Additionally, the Fluzone Intradermal package insert vaccine explains that 76% of
vaccine recipients experienced injection-site erythema within seven days of receiving the
vaccination, 51% reported injection-site pain, and 56% of vaccine recipients reported injection-
site swelling. The Atanasoff article also explained that the 93% of patients with post-vaccination
shoulder injuries reported the onset of pain as occurring less than 24 hours after vaccination and
54% of the cases reported that the pain began immediately. Pet. Ex. 12 at 2. Additionally, Dr.
Huffman and Dr. Gershwin credibly explained that the intradermal vaccine can lead to a larger
systemic reaction that generates an inflammatory response. See Pet. Ex. 24 at 1. The package
insert establishes that the occurrence of pain within seven days post-vaccination as a medically
acceptable timeframe to establish that the intradermal flu vaccine can cause an inflammatory
reaction that leads to pain and shoulder dysfunction.
Finally, a similar timeframe between the intradermal flu vaccination and the onset of
shoulder pain and dysfunction have been in accepted in two other cases. See Lagle, 2022 WL
2299003, at *33; Allen v. Sec’y of Health & Human Servs. No. 15-1278, 2022 WL2255042, at
*24-25 (Fed. Cl. Spec. Mstr. June 2, 2022) (accepting a 48-hour timeframe between onset of
petitioner’s shoulder pain and reduced range of motion and receipt of the intradermal flu
vaccination).
In this case, the medical records, the testimony of the petitioner and his wife credibly
established that petitioner experienced significant pain at the injection site immediately after the
shot was given. The expert testimony from both parties acknowledged that petitioner
experienced a local inflammatory reaction well within the timeframe established in the package
insert and experts from both parties acknowledged that petitioner testified that he experienced
pain immediately following the vaccination. There is no reason to suggest that the onset of pain
39

Case 1:18-vv-01933-UNJ Document 72 Filed 11/30/22 Page 40 of 40
after an intradermal vaccination would occur in any time frame other than that even though the
package insert allows for seven days. As such he has proven by a preponderance of the evidence
that the timing of his injury was appropriate to demonstrate vaccine causation and has proven
Althen prong three.
VII. Conclusions
For all the reasons discussed above, petitioner has established by preponderant evidence
that he is entitled to compensation, demonstrating that the intradermal flu vaccine administered
on September 7, 2016, was the cause-in-fact of his right shoulder pain and dysfunction. A
separate damages order will be issued.
IT IS SO ORDERED.
s/Thomas L. Gowen
Thomas L. Gowen
Special Master
40

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_18-vv-01933-1
Date issued/filed: 2023-02-03
Pages: 4
Docket text: PUBLIC DECISION (Originally filed: 1/13/2023) regarding 76 DECISION on Damages - Proffer, Signed by Special Master Thomas L. Gowen. (slw) Service on parties made.
--------------------------------------------------------------------------------
Case 1:18-vv-01933-UNJ Document 79 Filed 02/03/23 Page 1 of 4
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: January 13, 2023
* * * * * * * * * * * * *
ROBERT GALANTE, * UNPUBLISHED
*
Petitioner, * No. 18-1933V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Decision on Damages; Proffer;
AND HUMAN SERVICES, * Intradermal Influenza (“flu”);
* Shoulder Pain and
Respondent. * Dysfunction.
* * * * * * * * * * * * *
Bridget Candace McCullough, Muller Brazil, LLP, Dresher, PA, for petitioner.
Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for respondent.
DECISION ON DAMAGES1
On December 18, 2018, Robert Galante (“petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program.2 Petitioner alleges that as a result of
receiving an intradermal influenza (“flu”) vaccine on September 7, 2016, in his left arm he
suffered a shoulder injury related to vaccine administration (“SIRVA”) that was caused in fact by
the flu vaccination. Petition (ECF No. 1). On November 9, 2022, the undersigned issued a Ruling
on Entitlement, finding that petitioner is entitled to compensation. Ruling on Entitlement (ECF
No. 70).
On January 12, 2023, respondent filed a Proffer of Award of Compensation, which
indicates petitioner’s agreement to compensation on the terms set forth therein. Proffer (ECF No.
75). The proffer is attached hereto as Appendix A and is incorporated into this decision as
though set forth in full.
1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a
reasoned explanation for the action in this case, I intend to post it on the website of the United States Court of
Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion is
posted on the court’s website, each party has 14 days to file a motion requesting 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). An objecting party must provide the court with a proposed
redacted version of the opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will be
posted on the court’s website without any changes. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.

Case 1:18-vv-01933-UNJ Document 79 Filed 02/03/23 Page 2 of 4
Consistent with the terms stated in the attached Proffer, I hereby award the
following in compensation for all damages that would be available under 42 U.S.C. §
300aa-15(a):
1) A lump sum payment of $55,000.00, representing compensation for pain and
suffering, in the form of a check payable to petitioner, Robert Galante.
The Clerk of the Court is directed to ENTER JUDGMENT in accordance with this
decision. 3
IT IS SO ORDERED.
s/Thomas L. Gowen
Thomas L. Gowen
Special Master
3 Entry of judgment is expedited by each party’s filing notice renouncing the right to seek review. Vaccine Rule
11(a).
2

Case 1:18-vv-01933-UNJ Document 79 Filed 02/03/23 Page 3 of 4
THE UNITED STATES COURT OF FEDERAL CLAIMS
OFFICE OF SPECIAL MASTERS
ROBERT GALANTE,
Petitioner,
v. No. 18-1933V
Special Master Thomas L. Gowen
SECRETARY OF HEALTH AND ECF
HUMAN SERVICES,
Respondent.
RESPONDENT’S PROFFER ON AWARD OF COMPENSATION
On December 18, 2018, Robert Galante (“petitioner”) filed a petition for compensation
under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34
(“Vaccine Act” or “Act”), alleging that he suffered “left shoulder injuries related to vaccine
administration.” See Petition at 1. In a November 9, 2022 Ruling on Entitlement, the Special
Master found petitioner entitled to compensation.1
Respondent now proffers that petitioner be awarded a lump sum payment of $55,000.00,
in the form of a check payable to petitioner, representing all elements of compensation to which
petitioner is entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. Petitioner is a competent
adult. Evidence of guardianship is not required in this case.2
1 Respondent has no objection to the amount of the proffered award of damages set forth herein.
Assuming the Special Master issues a damages decision in conformity with this proffer,
respondent waives his right to seek review of such damages decision. However, respondent
reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Special Master’s
November 9, 2022 Ruling on Entitlement.
2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court
for appropriate relief. In particular, respondent would oppose any award for future damages.

Case 1:18-vv-01933-UNJ Document 79 Filed 02/03/23 Page 4 of 4
Respectfully submitted,
BRIAN M. BOYNTON
Principal Deputy Assistant Attorney General
C. SALVATORE D’ALESSIO
Director
Torts Branch, Civil Division
HEATHER L. PEARLMAN
Deputy Director
Torts Branch, Civil Division
ALEXIS B. BABCOCK
Assistant Director
Torts Branch, Civil Division
s/ RYAN D. PYLES
RYAN D. PYLES
Senior Trial Attorney
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044-0146
Tel: (202) 616-9847
ryan.pyles@usdoj.gov
DATED: January 12, 2023

================================================================================
DOCUMENT 3: USCOURTS-cofc-1_18-vv-01933-cl-extra-10734340
Date issued/filed: 2024-09-04
Pages: 1
Docket text: Supplementary opinion from CourtListener cluster 10267750
--------------------------------------------------------------------------------
    In the United States Court of Federal Claims
                                   OFFICE OF SPECIAL MASTERS
                                        Filed: April 23, 2024

* * * * * * * * * * * * *                              *
ROBERT GALANTE,                                                  *
                           *
         Petitioner,       *                                     No. 18-1933V
                           *
v.                         *                                     Special Master Gowen
                           *
SECRETARY OF HEALTH        *
AND HUMAN SERVICES,        *
                           *
         Respondent.       *
* * * * * * * * * * * * * *
Bridget Candace McCullough, Muller Brazil PA, Dresher, PA, for Petitioner.
Ryan Daniel Pyles, United States Department of Justice, Washington, DC, for Respondent.

                         DECISION ON ATTORNEYS’ FEES AND COSTS1

       On June 21, 2023, Robert Galante, (“petitioner”) filed a motion for attorneys’ fees and
costs. Petitioner’s Motion for Attorney Fees (“Fees App.”) (ECF No. 84). For the reasons
discussed below, I GRANT Petitioner’s motion for attorneys’ fees and costs and award a total of
$68,358.27.

    I.        Procedural History

         On December 18, 2018, Robert Galante (“petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program.2 (Petition) (ECF No. 1). Petitioner
alleges that as a result of receiving an intradermal influenza (“flu”) vaccine on September 7, 2016,
in his left arm he suffered a shoulder injury related to vaccine administration (“SIRVA”) that was
caused in fact by the flu vaccination. Id. After a two-day hearing and a Ruling on Entitlement, on


1
  Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly
accessible and will be posted on the United States Court of Federal Claims' website, and/or at
https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002.
44 U.S.C. § 3501 note (2018) (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), Petitioner
has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will
redact such material from public access.
2
  The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Act of
1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to -34 (2018) (Vaccine Act or
the Act. All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C.A. § 300aa.
January 12, 2023, the parties filed a proffer, which I adopted as my decision awarding
compensation on January 13, 2023. (ECF No. 76).

        On June 23, 2023, Petitioner filed a motion for attorneys’ fees and costs. Petitioner requests
compensation in the total amount of $68,358.27, representing $46,620.20 in attorneys’ fees and
$21,738.07 in costs. Fees App. at 2. Pursuant to General Order No. 9, Petitioner warrants he has
not personally incurred any costs in pursuit of his claim. Id. Respondent reacted to the fees motion
on June 23, 2023, stating that “Respondent is satisfied the statutory requirements for an award of
attorneys’ fees and costs are met in this case.” Response at 2 (ECF No. 83). Petitioner did not file
a reply thereafter.

         The matter is now ripe for adjudication.

   II.      Analysis

       Under the Vaccine Act, the special master may award reasonable attorneys’ fees and costs
for a petition that does not result in an award of compensation but was filed in good faith and
supported by a reasonable basis. § 300aa–15(e)(1). Here, because Petitioner was awarded
compensation pursuant to a Ruling on Entitlement and a subsequent proffer, he is entitled to an
award of reasonable attorneys’ fees and costs.

         Petitioners “bea[r] the burden of establishing the hours expended, the rates charged, and
the expenses incurred” are reasonable. Wasson v. Sec'y of Health & Human Servs., 24 Cl. Ct. 482,
484 (1993). Adequate proof of the claimed fees and costs should be presented when the motion is
filed. Id. at 484 n. 1. The special master has the discretion to reduce awards sua sponte, independent
of enumerated objections from the respondent. Sabella v. Sec'y of Health & Human Servs., 86 Fed.
Cl. 201, 208–09 (Fed. Cl. 2009); Savin v. Sec'y of Health & Human Servs., 85 Fed. Cl. 313 (Fed.
Cl. 2008), aff'd No. 99–537V, 2008 WL 2066611 (Fed. Cl. Spec. Mstr. Apr. 22, 2008).

                a. Attorneys’ Fees

       Petitioner requests the following rates for the work of his counsel: for Ms. Bridget
McCullough, $225.00 per hour for work performed in 2018 and 2019, $250.00 per hour for work
performed in 2020, $275.00 per hour for work performed in 2021, $300.00 per hour for work
performed in 2022, and $350.00 per hour for work performed in 2023; and for Mr. Paul Brazil,
$317.00 per hour for work performed in 2018, $325.00 per hour for work performed in 2019, and
$375.00 per hour for work performed in 2021. These rates are consistent with what counsel has
previously been awarded in the Vaccine Program and I find them to be reasonable herein.

        Petitioner also requests the following rates for work performed by paralegals: for Stacie
Bole, Stacy Bowman, Michelle Coles, Maria Loecker, Virginia Schaffer, and Marcella Senerth,
$125.00 per hour for work performed during various years from 2017, through 2023; for Erik
Pavlacsek, $140.00 for work performed in 2023; and for Teresa Pavlacsek, $125.00 per hour for
work performed in 2018, $140.00 per hour for work performed in 2019, $150.00 per hour for work
performed in 2020, and $160.00 per hour for work performed in 2021. These rates are also
consistent with what has previously been awarded in the Vaccine Program and I find them to be
reasonable herein.

                                                    2
        Turning next to review of the submitted billing statement, I find that the overall hours spent
on this matter appear to be reasonable. The entries are reasonable and accurately describe the work
being performed and the length of time it took to perform each task. Respondent also has not
identified any particular entries as being objectionable. Therefore, Petitioner is entitled to final
attorneys’ fees of $ 46,620.20.

               b. Attorneys’ Costs

        Like attorneys’ fees, a request for reimbursement of costs must be reasonable. Perreira v.
Sec’y of Health & Human Servs., 27 Fed. Cl. 29, 34 (Fed. Cl. 1992). Petitioner requests total
attorneys’ costs in the amount of $21,738.07. This amount is comprised of acquiring medical
records, postage, transcription services, and the Court’s filing fee. Fees App. Ex. B at 1. These
administrative costs are typical in Vaccine Program cases and were reasonably incurred in this
matter. Petitioner also requests compensation for work performed by Petitioner’s medical experts,
M. Eric Gershwin, M.D. and George Russell Huffman, M.D. Fees App. Ex. B at 1. Dr. Gershwin’s
costs are reasonable and have been supported by Petitioner with adequate documentation.

        Dr. Huffman submitted a full and final invoice in the amount of $9,712.50. Fees App. Ex.
B at 14-15. The full and final invoice states the tasks completed and the date on which the tasks
were completed, but does not include the number of hours expended on these tasks or the rate
charged. Dr. Huffman submitted three additional supporting invoices including: a May 1, 2019
invoice for $2,000.00, for Dr. Huffman’s retainer; a November 14, 2019 invoice for 6.75 hours
billed at a rate of $550.00 per hour, totaling $3,712.50; and a March 15, 2023 invoice for $4,000.00
for his work related to the March 22, 2021 hearing. To the extent that Dr. Huffman has adequately
documented his rate, he has been traditionally awarded $500.00 per hour for his Vaccine Program
work. See Tumolo v. Sec'y of Health & Human Servs., No. 16-343V, 2021 WL 1761727, at *2
(Fed. Cl. Mar. 26, 2021); Anderson v. Sec’y of Health & Human Servs., No. 16-1099V, 2020 WL
6055038, at *3 (Fed. Cl. Sept. 9, 2020). As noted in Aycock v. Secretary of Health & Human
Services, No. 19-235V, 2023 WL 8869423, at *10 (Fed. Cl. Nov. 8, 2023), orthopedic shoulder
surgeons tend to command high rates for expert witness work. As such Dr. Hoffman’s rate of $550
an hour is reasonable.

   III.    Conclusion

       In accordance with the foregoing, I hereby GRANT petitioner’s motion for attorneys’ fees
and costs and find that Petitioner is entitled to a reimbursement of attorneys’ fees and costs as
follows:

 Attorneys’ Fees Requested                                            $46,620.20
 (Reduction of Fees)                                                       -
 Total Attorneys’ Fees Awarded                                        $46,620.20

 Attorneys’ Costs Requested                                           $21,738.07
 (Reduction of Costs)                                                      -
 Total Attorneys’ Costs Awarded                                       $21,738.07

 Total Attorneys’ Fees and Costs                                      $68,358.27

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       Accordingly, I award the following: a lump sum in the amount of $68,358.27,
representing reimbursement for Petitioner’s attorneys’ fees and costs, in the form of a check
payable to Petitioner and his attorney, Ms. Bridget McCullough.3

       In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance herewith.4

         IT IS SO ORDERED.

                                                      /s/Thomas L. Gowen
                                                      Thomas L. Gowen
                                                      Special Master




3
  This amount is intended to cover all legal expenses incurred in this matter. This award encompasses all charges by
the attorney against a client, “advanced costs,” and fees for legal services rendered. Furthermore, Section 15(e)(3)
prevents an attorney from charging or collecting fees (including costs) that would be in addition to the amount awarded
herein. See generally Beck v. Sec’y of Health & Human Servs., 924 F.2d 1029 (Fed. Cir. 1991).
4
 Entry of judgment can be expedited by each party’s filing of a notice renouncing the right to seek review. Vaccine
Rule 11(a).
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