Schmidt v. Secretary of Health and Human Services ( 2021 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 17-1530V
UNPUBLISHED
RYAN M. SCHMIDT, Chief Special Master Corcoran
Petitioner, Filed: October 7, 2021
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Site of Vaccination
HUMAN SERVICES, Influenza (Flu) Vaccine; Shoulder
Injury Related to Vaccine
Respondent. Administration (SIRVA)
David J. Ward, Michel & Ward PC, Chattanooga, TN, for Petitioner.
Claudia Barnes Gangi, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT 1
On October 16, 2017, Ryan Schmidt filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq. 2 (the
“Vaccine Act”). Petitioner alleges that he suffered “injuries, including bursitis with left
shoulder impingement, frayed and torn labrum, inflamed bursa, rotator cuff inflammation,
extensive changes in the supraspinatus, and infraspinatus tear” resulting from the
adverse effects of an influenza (“flu”) vaccine received on October 18, 2014. 3 Petition at
1
Because this unpublished Fact Ruling contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the Fact Ruling will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
3
Petitioner subsequently filed an amended petition clarifying that he is alleging an on-Table injury and, in
the alternative, causation-in-fact. ECF 17.
1. The case was assigned to the Special Processing Unit of the Office of Special Masters
(the “SPU”).
The ruling herein resolves certain fact dispute between the parties bearing on
Petitioner’s entitlement claim. Based on my determinations below, it appears Petitioner’s
claim may not be well-founded, and therefore Petitioner must seriously consider its
voluntary dismissal.
I. Relevant Procedural History
During an initial status conference, it was noted that while Petitioner is alleging a
left shoulder injury, the records contemporaneous to the date of vaccine reflect that the
flu vaccination was administered in his right arm. ECF 12. Petitioner was thereafter
ordered to file any additional evidence he wished to have considered regarding the
injection site of his alleged injury-causing vaccination, as well as an amended petition, if
desired. Id. Mr. Schmidt subsequently filed an amended petition, in which he alleged both
a Table injury and a causation-in-fact claim. ECF 17. On July 27, 2018, Respondent filed
a status report indicating that he intended to oppose compensation and requesting a
deadline for his Rule 4(c) Report. ECF 26.
On September 25, 2018, Respondent filed his Rule 4(c) Report, asserting therein
that there is not a preponderance of evidence demonstrating that the flu vaccine was
administered in Petitioner’s left shoulder. ECF 28. Another status conference was held
on October 16, 2018, after which Petitioner filed a supplemental affidavit, additional
medical records, and a timesheet from his employer. ECF 30; ECF 33-35.
After reviewing the newly-submitted records, Respondent filed another status
report stating that he “maintains his position . . . that this case should be dismissed in the
absence of further evidence that the vaccination at issue was administered in
[P]etitioner’s left arm.” ECF 37. Petitioner was then ordered to file the MRI images of his
left shoulder, and Respondent filed a motion for leave to file an expert report interpreting
these images. ECF 38; ECF 39.
On May 16, 2019, former Chief Special Master Dorsey 4 held a status conference
with the parties to discuss Respondent’s motion, which she then granted. ECF 41.
Respondent filed an expert report from Dr. Geoffrey Abrams on June 28, 2019. ECF 44.
4
From July 2014 until September 2015, the SPU was overseen by former Chief Special Master Vowell. For
the next four years, until September 30, 2019, all SPU cases, including the majority of SIRVA claims, were
assigned to former Chief Special Master Dorsey, now Special Master Dorsey. In early October 2019, the
majority of SPU cases were reassigned to me as the current Chief Special Master.
2
Petitioner was provided the opportunity to file a responsive report, but later represented
that he planned to rely solely on the previously-submitted affidavit of Dr. David Bruce, his
treating orthopedist. ECF 45.
After I became Chief Special Master (and thus responsible for SPU cases), I held
a status conference to discuss the parties’ current positions, and then ordered Petitioner
to file a status report indicating his preference for resolving the issue of site of vaccination
through briefing or a fact hearing. Petitioner filed a status report requesting resolution
through briefing, and both parties have briefed this issue. ECF 49; ECF 50; ECF 52.
Therefore, this matter is now ripe for adjudication.
II. Issue
At issue is whether Petitioner received the vaccination alleged as causal in his left
arm. 42 C.F. R. § 100.3(a)(XIV)(B) (2017).
III. Authority
Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a
preponderance of the evidence, the matters required in the petition by Vaccine Act
Section 11(c)(1). 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.” Cucuras v. Sec’y of Health & Human Servs.,
993 F.2d 1525, 1528 (Fed. Cir. 1993).
Accordingly, where medical records are clear, consistent, and complete, they
should be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-
1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule
does not always apply. In Lowrie, the special master wrote that “written records which
are, themselves, inconsistent, should be accorded less deference than those which are
internally consistent.” Lowrie, at *19. Further 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,
1383 (Fed. Cir. 2021) (emphasis added).
3
The United States Court of Federal Claims has recognized that “medical records
may be incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed.
Cl. 381, 391 (1998). The Court later outlined four possible explanations for
inconsistencies between contemporaneously created medical records and later
testimony: (1) a person’s failure to recount to the medical professional everything that
happened during the relevant time period; (2) the medical professional’s failure to
document everything reported to her or him; (3) a person’s faulty recollection of the events
when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did
not exist. La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013),
aff’d, 746 F.3d 1335 (Fed. Cir. 2014).
The Court has also said that medical records may be outweighed by testimony that
is given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed.
Cl. at 391 (citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL
408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering
such testimony must also be determined. Andreu v. Sec’y of Health & Human Servs., 569
F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d
1570, 1575 (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); Doe/70 v.
Sec’y of Health & Human Servs., 95 Fed. Cl. 598, 608 (2010) (“[g]iven the inconsistencies
between petitioner’s testimony and his contemporaneous medical records, the special
master’s decision to rely on petitioner’s medical records was rational and consistent with
applicable law”), aff’d, Rickett v. Sec’y of Health & Human Servs., 468 F. App’x 952 (Fed.
Cir. 2011).
In reaching a decision in this case, I have considered other decisions issued by
special masters involving similar injuries, vaccines, or circumstances. I also reference
some of those cases in this decision, in an effort to establish common themes, as well as
to demonstrate how prior determinations impact my thinking on the present case. There
is no error in doing so. It is certainly correct that prior decisions in different cases do not
control the outcome herein, as each case presents different medical histories, experts,
4
and treatment, and could therefore reasonably result in contrary determinations. 5 See
Boatmon v. Sec’y of Health & Human Servs., 941 F.3d 1351, 1358–59 (Fed. Cir. 2019);
Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998).
However, it is equally the case that special masters may reasonably draw upon
their experience in resolving Vaccine Act claims. Doe v. Sec’y of Health & Human Servs.,
76 Fed. Cl. 328, 338–39 (2007) (“[o]ne reason that proceedings are more expeditious in
the hands of special masters is that the special masters have the expertise and
experience to know the type of information that is most probative of a claim”) (emphasis
added). I would thus be remiss in ignoring prior cases presenting similar theories or
factual circumstances, along with the reasoning employed in reaching such decisions.
Even if the Federal Circuit does not require special masters to distinguish other relevant
cases (Boatmon, 941 F.3d at 1358), it is still wise to do so.
IV. Factual History as Set Forth in Medical Records
At approximately 5:30 pm on October 18, 2016, Petitioner, a production manager
at the Volkswagen Chattanooga Assembly Plant in Chattanooga, Tennessee, received
the flu vaccine at the Volkswagen Onsite Medical Clinic (“VOMC”). Ex 1 at 3. There are
two records documenting the administration of the vaccine. The first, from Petitioner’s
VOMC electronic medical record, reflects that (1) the “injection [was] given to [the] right
deltoid,” (2) Petitioner signed the vaccine consent form, and (3) Petitioner “tolerated
[vaccination] well and denies any needs at completio[n] of visit.” Id. The second record is
a handwritten “Seasonal Influenza Immunization Consent Form” reflecting the injection
site as “RA”:
5
By contrast, Federal Circuit rulings concerning legal issues are binding on special masters. Guillory v.
Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see
also Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec.
Mstr. Jan. 16, 2014).
5
Id. at 12.
Approximately 24 hours later, Petitioner returned to VOMC with complaints of left
arm pain “after receiving a flu shot yesterday evening.” Ex 1 at 3. The examining
physician, Dr. David Darden, noted that Petitioner “[c]almly complains of intense pain and
cannot raise arm above a certain level as he demonstrate[s] the level by raising his arm
to above the waist.” Id. Physical examination of the left shoulder showed no redness or
swelling, and Dr. Darden could not visualize any injection site. Id. at 3, 15. Petitioner’s left
deltoid muscle was “soft,” and he displayed a “very strong grip.” Id. at 3. Neurologic
examination was normal, and no limitations were noted on passive range of motion of the
left shoulder. Id. Petitioner was assessed with “subjective complaint of left arm pain and
inability to lift arm with no objective findings.” Id. Dr. Darden informed Petitioner that he
could work at “full duty” and explained that “there was no physiological or anatomic reason
[Petitioner] could not lift his arm.” Id. Despite this, Petitioner requested a work excuse,
and he was noted to be upset when one was not granted. 6 Id.Later that same evening, Mr. Schmidt presented to the emergency room (ER) with
a complaint of “complications from flu shot” in his left shoulder starting at approximately
2:00 am on October 19, 2016. Ex 8 at 3. Physical examination revealed decreased range
of motion of the left upper extremity but normal sensation and motor strength. Id. at 8.
While Petitioner was diagnosed with “post injection arm pain,” the ER physician noted he
was “unsure why [Petitioner] is having pain,” but that he would treat Petitioner’s symptoms
with pain medication and a sling. Id. at 7, 9.
One month later, on November 14, 2016, Petitioner presented to Chattanooga
Bone and Joint Surgeons (CBJS) for evaluation of left shoulder pain. Ex 2 at 12. He
reported left shoulder pain and weakness that began on October 9, 2016 7 after receiving
a flu shot. Examination by Mark Cloutier, a nurse practitioner, revealed no abnormality of
the left shoulder and no erythema or ecchymosis of the skin. Id. During range of motion
exercises, Mr. Schmidt began “to have a lot of pain and apprehension at 90 degrees of
forward flexion and abduction.” Id. He displayed 4/5 abduction strength and 3/5 external
rotation strength but no motor or sensory deficits. Id. NP Cloutier referred Petitioner for
an MRI, which demonstrated evidence of (1) supraspinatus and infraspinatus tendinosis
without significant tear, (2) intra-articular bicipital tendinosis with extra-articular
tenosynovitis, (3) posterior labral superficial and intrasubstance degenerative changes
6
While Petitioner was not granted a work excuse, he apparently chose to take leave that day, as his
employment records reflect an “excused absence unpaid” on October 19, 2016 and “paid time off” on
October 20, 2016. ECF 34, Attachment 1.
7
Petitioner received his flu shot on October 18, 2016. Ex 1 at 3, 12.
6
with a small focal linear tear, but no detached or displaced labral tear, and (4) no
significant subacromial subdeltoid bursal fluid. Id. at 20.
Mr. Schmidt returned with his MRI results to CBJS the next day, at which time NP
Cloutier diagnosed him with rotator cuff tendinitis and referred him to physical therapy. 8
Ex 2 at 12. At a follow-up visit on December 12, 2016, Petitioner displayed left upper
extremity forward elevation to 170 degrees and active abduction to 90 degrees. Id. at 10.
NP Cloutier also noted that Petitioner had “pain with rotator cuff strength testing, but his
strength is still there.” Id. Petitioner was thereafter administered a cortisone injection in
his left shoulder. Id.On January 16, 2017, Petitioner returned to CBJS and was evaluated by Dr. David
Bruce, an orthopedic surgeon, at which time Petitioner underwent a second cortisone
injection. Ex. 2 at 8. Dr. Bruce also administered two more cortisone injections to the left
shoulder on February 17 and March 31, 2017. 9 Id. at 4, 6. Several months later, on June
7, 2017, Dr. Bruce performed a left shoulder arthroscopy with arthroscopic bursectomy,
debridement, and subacromial decompression. Id. at 1. The operative report includes
findings of anterior labral fraying, intact biceps anchor, inflammatory changes of the
supraspinatus but no tearing or other changes in the intra-articular space, and
inflammatory changes but no evidence of tearing of the rotator cuff. Id. at 1-2. No
additional medical records have been submitted.
V. Expert and Treater Opinions
a. Dr. David Bruce
As noted above, Petitioner was provided the opportunity to file an expert report,
but instead chose to rely on an affidavit from Dr. Bruce, his treating orthopedic surgeon.
ECF 45. In that affidavit, dated January 10, 2019, Dr. Bruce averred that he is board
certified by the American Academy of Orthopaedic Surgeons with a fellowship in
8
While not determinative regarding the site of vaccination, the record also reflects that Petitioner attended
19 sessions of physical therapy to treat left shoulder pain from November 18, 2016 to September 15, 2017.
Ex 4 at 5.
9
Although the specific locations of the first and third steroid injections in the left shoulder are not noted in
the record, Dr. Bruce’s notes reflect that the second injection, on January 16, 2017, was administered “in
the subacromial space in the joint” and the fourth, on March 31, 2017 was injected into the “bursal and
glenohumeral” area. Ex 2 at 4, 8.
7
shoulder/sports medicine. Ex 6 at ¶ 3. He has been a practicing orthopedic surgeon for
over 20 years, 10 and he treated Petitioner for approximately five months. Id. at ¶¶ 3, 13. 11
In his affidavit, Dr. Bruce notes that after reviewing the x-ray films “from Erlanger
at Volkswagen” 12 and the November 2016 MRI, he was able to visualize the “track made
by the needle which delivered the influenza vaccine in [Petitioner’s] left arm” and that this
finding “correlated exactly with where [Petitioner] reported the vaccine needle had been
placed.” Ex 6 at ¶ 13. During his first appointment with Petitioner, Dr. Bruce informed
Petitioner that “his left arm was acting just like every other misplaced flu shot injection
that [he] had ever seen, of which [he] ha[d] seen and treated several.” 13 Id. at ¶¶ 14-15.
Dr. Bruce further avers that “the injection site in [Petitioner’s] left arm could be
visualized [on the MRI] directly into the rotator cuff,” and the “appearance of the tear
caused by the needle c[an] best be seen on . . . Slice 5 of the . . . MRI.” Ex 6 at ¶¶ 13, 16.
In an attachment to his affidavit, Dr. Bruce drew a line marking the “site of the tear” on
Slide 18 of the MRI. See ECF 33. He also asserts that the imaging “revealed that the
misplacement of the needle and subsequent injection of the vaccine into the wrong area
of [Petitioner’s] left arm caused significant inflammation of his infraspinatus and
supraspinatus,” resulting in Petitioner’s “external and rotation and abduction weakness
and pain.” Ex 6 at ¶ 13.
Dr. Bruce also maintains that during Petitioner’s surgery, he “located the track of
the needle in [Petitioner’s] left arm” and “could see where the bursa had . . . been
injected.” Ex 6 at ¶¶ 24, 30a. His observations during surgery led him to conclude that the
“irritation and inflammation [of Petitioner’s rotator cuff] appeared to be as a result of the
acromial injection of the influenza vaccine.” Id. at ¶ 28. And his operative report indicates
that “[t]his does appear to be acromial injection of the flu shot material 14 based on the
clinical evidence from the patient and the evidence from the scope.” Ex 2 at 2.
10
In his brief, Petitioner asserts that Dr. Bruce “has been in practice for more than 28 years and has had
significant experience treating people who have encountered SIRVA injuries;” but Petitioner did not file Dr.
Bruce’s CV or other evidence confirming this information. ECF 50 at 13.
11
While Petitioner began treating at CBJS (Dr. Bruce’s practice) in November 2016, he was evaluated and
treated by NP Cloutier at his first three visits. Ex 2 at 8-14. Petitioner had his first visit with Dr. Bruce on
January 16, 2017. Id. at 7.
12
There is no mention of x-rays in the records from VOMC, and Petitioner has not submitted an x-ray report
from this provider. See Ex 1.
13
Dr. Bruce has not provided any specificity as to how many vaccine-related shoulder injuries he has
treated. See Ex 6 at ¶¶ 14-15.
14
The operative report is unclear as to what finding Dr. Bruce is referring to with the use of “this” or where
specifically the “flu shot material” was observed. Ex 2 at 1-2.
8
Based upon his review of the records and his treatment of Petitioner, Dr. Bruce
reached the following conclusions “within a reasonable degree of medical certainty:” (1)
the influenza vaccine was more likely than not given in Petitioner’s left, rather than right,
arm, and (2) the “misplaced” vaccination more likely than not caused Petitioner to suffer
inflammation in his supraspinatus, infraspinatus, rotator cuff, and subacromial space. Ex
6 at ¶ 30a-b.
b. Dr. Geoffrey Abrams
Dr. Abrams acted as Respondent’s expert and filed a report with accompanying
literature on June 25, 2019. Exs A-B. Dr. Abrams is a Board Certified Orthopedic Surgeon
with a subspeciality in Sports Medicine. Ex A at 1; Ex C at 2. His report concludes the flu
vaccine in question was more likely administered in Petitioner’s right arm.
Dr. Abrams’s surgical practice focuses on orthopedic conditions of the shoulder,
and he has published extensively on shoulder pathology. Ex A at 1; Ex C at 2-9. 15 At the
time of his report, he served as Assistant Professor of Orthopedic Surgery at Stanford
University School of Medicine; held the appointments of Staff Physician at the VA Palo
Alto Health Care Division, Director of Sports Medicine for Stanford University Varsity
Athletics, and Director of the Lacob Family Sports Medicine Center at Stanford University;
and served as team physician for numerous professional and collegiate sports teams in
the San Francisco Bay Area. Id.In preparing his report, Dr. Abrams reviewed Petitioner’s Exhibits 1-8. Ex A at 1-4.
He begins by addressing Dr. Bruce’s claim that he could “visualize” evidence of the
injection on Petitioner’s MRI, specifically the alleged “needle track” on Slides 5 and 18. In
contrast with Dr. Bruce, Dr. Abrams states that his review of both MRI slides highlighted
by Dr. Brace and the original MRI images do not demonstrate a needle track. Ex A at 4.
In fact, Dr. Abrams argues that “to be able to see a needle trac[k] on an MRI nearly one
month after the supposed injection is extremely unlikely.” Id. Instead, “similar to a scar or
scratch on one’s skin, the soft tissues around any track (or hole) . . . made by a needle
would ‘heal’ or ‘scar in’ and [would] no longer be visible shortly after the injection.” Id.Dr. Abrams further asserts that Dr. Bruce’s conclusions are undermined by the fact
that there was no visible evidence of soft tissue inflammation within the subcutaneous
tissue or deltoid musculature on Petitioner’s MRI to indicate an injection near the area
where the vaccine was allegedly administered. Ex A at 5. In making this argument, Dr.
Abrams referred to a case report addressing shoulder pain following influenza
15
Dr. Abrams’ CV reflects 73 peer reviewed publications, as well as “podium presentations” at conferences
and meetings of the American Academy of Orthopedic Surgeons and American Shoulder and Elbow
Surgeons, among others. Ex C at 2-10. He is also the author of multiple book chapters on the shoulder and
serves as a reviewer of the Journal of Bone and Joint Surgery, the Journal of the American Academy of
Orthopedic Surgeons, and the Journal of Shoulder and Elbow Surgery. Id. at 19-21, 23.
9
vaccination, which he filed with his expert report. G. Okur et. al., Magnetic Resonance
Imaging of Abnormal Shoulder Pain Following Influenza Vaccination, 43 Skeletal Radiol.
1325-31 (2014), filed as Ex B (“Okur”). Okur examined MRIs of patients with suspected
SIRVA, and reported that the most common finding was “intrasubstance fluid-like signal
in deep muscular and/or tendinous structures.” Id. at 1329. Focal bone marrow signal
within the humeral head and inflammatory changes in the subacromial/subdeltoid bursa
were also observed. Id. Dr. Abrams asserts that “[n]one of these findings were present
on [P]etitioner’s shoulder MRI,” which did not show excess fluid within the subacromial
space or bursa to indicate inflammation, “a supposed cause (due to vaccine
administration) of [P]etitioner’s shoulder pain according to Dr. Bruce.” Ex A at 5.
Dr. Abrams also addresses Dr. Bruce’s assertion in his operative report that he
could identify “where the [bursa] had actually been injected.” Ex A at 5 (citing Ex 2 at 1-
2). However, by the time Petitioner underwent surgery, he had received multiple 16 steroid
injections in his left shoulder, and Dr. Abrams argues that “it is nearly certain that these .
. . injections, all within quick succession, were responsible for any ‘inflamed and injected’
bursa rather than any purported single vaccine injection eight months prior to surgery.”
Ex A at 5. In fact, Dr. Abrams asserts that Dr. Bruce’s claims regarding the “MRI and intra-
operative evidence of needle tracks, tearing, and inflammation from a supposed vaccine
injection do not hold up to medical scrutiny.” Id. Based on his review of the entirety of the
record, Dr. Abrams concludes that “this case does not meet the requirements for a SIRVA
diagnosis as there is no evidence to support the claim that [P]etitioner received the
injection into his left shoulder.” Id.VI. Analysis
a. Fact Evidence
Petitioners in other Vaccine Program cases have successfully established a fact
through their own testimony, though usually in instances where the records are silent or
do not directly contradict the fact at issue. See, e.g., Syed v. Sec’y of Health & Human
Servs., No. 19-1364V, 2021 WL 2229829, at *4-5 (Fed. Cl. Spec. Mstr. Apr. 28, 2021)
(finding that the vaccine was administered in the alleged arm in part because the VAR
from the computerized system was incomplete); Hanna v. Sec’y of Health & Human
Servs., No. 18-1455V, 2021 WL 3486248, at *1, 8-10 (Fed. Cl. Spec. Mstr. July 15, 2021)
(giving more weight to subsequent treatment records when the preprinted form prompting
16
Dr. Abrams indicates that Petitioner had three prior steroid injections, in December 2016 and in January
and February 2017. Ex A at 5. However, the record reflects that Petitioner had a fourth steroid injection in
March 2017. Ex 2 at 4.
10
identification of the injection site was left blank, while an “ambiguous” handwritten notation
of “L” appeared elsewhere in the document).
However, when the contemporaneous medical records are in direct conflict with a
petitioner’s testimony, the medical records are usually considered to be more reliable and
are afforded more weight (even if the Federal Circuit now instructs that records are not
presumptively correct). See, e.g., Rich v. Sec’y of Health & Human Servs., No. 12-742V,
2015 WL 5882324, at *11 (Fed. Cl. Spec. Mstr. Sept. 16, 2015) (finding petitioner’s
testimony alleging an earlier onset of symptoms less persuasive than the
contemporaneous medical records that did not reference any of the alleged symptoms at
that time); Robi v. Sec’y of Health & Human Servs., No. 12-352V, 2014 WL 1677116, at
*5 (Fed. Cl. Spec. Mstr. Apr. 4, 2014) (petitioners gave compelling testimony regarding
the onset of their child’s symptoms, but the medical records were nonetheless found to
be more persuasive in determining the date the symptoms began); Bradley, 991 F.2d at
1573, 1575 (although the special master believed that Petitioner was telling the truth as
she remembered events, her recollections were not credible and persuasive because the
record lacked corroborating medical evidence); Keaton v. Sec’y of Health & Human
Servs., No. 12-444V, 2014 WL 3696349, at *8 (Fed. Cl. Spec. Mstr. July 2, 2014)
(dismissing claim where contrary to the petitioner’s recollection, the medical records
strongly suggested that no vaccine was given). 17
Here, Mr. Schmidt has not presented sufficient evidence to conclude that the
contemporaneous vaccination records are incomplete or inconsistent. Both the VOMC
electronic medical record and the handwritten log reflect the right arm as site of
vaccination. These records are also consistent with evidence documenting that Petitioner
received the flu vaccine in his right arm in prior years. Ex 1 at 4, 6. And the vaccination
record suggests Petitioner signed off on its contents as well. Ex. 1 at 3. Such records are
clear, consistent, and complete, and therefore are deserving of substantial weight. See
Lowrie, 2005 WL 6117475, at *20.
Petitioner, by contrast, has not presented preponderant evidence to support his
counter-argument that the vaccine was actually administered in his left arm. Mr. Schmidt
claims he has a “clear and specific recollection that [he] received [the flu vaccine] in his
17
In another case involving the issue of situs, I credited a petitioner’s testimony over the contemporaneous
records. Gallo v. Sec’y of Health & Human Servs., No. 18-1298V, 2019 WL 7496617, at *5 (Fed. Cl. Spec.
Mstr. Dec. 5, 2019). The Gallo petitioner, however, provided a detailed explanation to support his
recollection -- that he had suffered an adverse reaction to the same vaccine as a child, and had as a result
requested that the vaccine be administered in his non-dominant arm. I deemed it to present a “close call,”
meaning it should be resolved in the claimant’s favor. Gallo, 2019 WL 7496617, at *5. Here, by contrast,
the vaccine records are in direct conflict with Petitioner’s affidavit testimony, and no additional corroborative
proof exists to confirm Petitioner’s recollection.
11
left shoulder,” because he is right-hand dominant, and thus generally requests that
“injections be given in [his] non-dominant left shoulder so that any resulting soreness does
not affect [his] ability to perform [his] duties at work and activities of daily living.” Ex 5 at
¶¶ 5-6. But this assertion is in direct contradiction with the evidence showing Petitioner
received flu vaccines in two prior 2014 and 2015 that were also both administered in the
right shoulder. 18 Ex 1 at 4, 6. These injections were given at the same worksite clinic
where Petitioner received his 2016 injection. Id. It seems reasonable that Petitioner would
have had similar concerns in 2014 and 2015 regarding his ability to maintain his work
duties and partake in activities of daily living, yet he still elected to receive the vaccine in
his right shoulder both years. Furthermore, Petitioner was provided with the opportunity
to explain why he may have gotten the flu shot on the left in 2016 despite receiving it on
the right in 2014 and 2015, yet he failed to do so. ECF 29 at 1-2.
In other cases, petitioners have provided sufficient evidence outside of their own
testimony to rebut the site of administration listed in the vaccine record. See, e.g.,
Rodgers v. Sec’y of Health & Human Servs., No. 18-0559V, 2020 WL 1870268 (Fed. Cl.
Spec. Mstr. Mar. 11, 2020); Mogavero v. Sec’y of Health & Human Servs., No. 18-1197V,
2020 WL 4198762 (Fed. Cl. Spec. Mstr. May 12, 2020); Gallo v. Sec’y of Health & Human
Servs., No. 18-1298V, 2019 WL 7496617, at *5 (Fed. Cl. Spec. Mstr. Dec. 5, 2019). But
such cases have often involved computerized vaccine records that require little thought
or effort on the part of the vaccine administrator when identifying the site of vaccination,
such as a “drop down” box. See, e.g., Rodgers, 2020 WL 1870268, at *5; Desai v. Sec’y
of Health & Human Servs., No. 14-0811V, 2020 WL 4919777, at *14 (Fed. Cl. Spec. Mstr.
July 30, 2020); Mezzacapo v. Sec’y of Health & Human Servs., No. 18-1977V, 2021 WL
1940435, at *4, 6 (Fed. Cl. Spec. Mstr. Apr. 19, 2021).
More reliable are situs records that requires specific action on the part of the
vaccine administrator, performed close in time to administration. For example, in
Marion, 19 under the section listing the site of administration on the consent form, the
vaccine administrator manually circled the option for “LA” rather than “RA.” Marion, 2020
WL 7054414, at *8. This notation was consistent with the computerized record. Id. Given
that the vaccine administrator there was required to manually circle the notation on the
consent form, I found this entry provided substantial evidence corroborating the
conclusion that the vaccine alleged as causal was administered in the non-injured arm.
18
In fact, the record for Petitioner’s October 2014 flu vaccine reflects that it was administered “in [right]
deltoid per [Petitioner’s] request.” Ex 2 at 6.
19
Marion v. Sec’y of Health & Human Servs., No. 19-0495V, 2020 WL 7054414 (Fed. Cl. Spec. Mstr. Oct.
27, 2020).
12
Id. I further concluded that the subsequent records were insufficient to overcome the clear
evidence provided in the contemporaneously created vaccine record. Id. at *9.
The contemporaneous documentation regarding situs in the present case is even
more persuasive. As in Marion, there are two separate but consistent documents in the
medical record identifying the location of vaccination. Further, the vaccine log was
completed by hand rather than as part of a prepopulated electronic form. It was signed
by both the vaccine administrator and Petitioner and is consistent with the notes in
Petitioner’s VOMC electronic medical record. The vaccine log also contains signatures
from multiple vaccine administrators, suggesting that the site of injection is not recorded
in advance and requiring thought on the part of the administrator. Absent evidence
suggesting that the vaccine administration record itself is unreliable, it remains the most
contemporaneous record of the vaccine injection site and warrants significant weight.
The record also includes numerous other inconsistencies that raise questions
regarding the credibility of Petitioner’s testimony. For example, in both his affidavit and at
his November 14, 2016 visit with NP Cloutier, Petitioner reported that he “could not finish
his shift at work on [the day of vaccination].” Ex 2 at 14; Ex 3 at ¶ 5. However, Petitioner’s
leave records reflect an “excused absence unpaid” on October 19, 2016, the day after
vaccination. 20 ECF 34. At the same visit with NP Cloutier, Petitioner also stated that he
“had severe pain with injection” – even though records from VOMC reflect that Petitioner
“tolerated [the vaccination] well and denie[d] any needs at completio[n] of visit.” Ex 1 at
3; Ex 2 at 14. Further, at the ER, rather than reporting pain immediately after vaccination,
Petitioner stated that his pain began at approximately 2:00 am on October 19, 2016. Ex
8 at 3. And at his October 19, 2016 visit to VOMC, Petitioner stated that he required his
wife’s assistance in getting dressed, yet he was able to drive himself to and from the
emergency room (with no reported issues) later that same day. Ex 1 at 4; Ex 8. In fact,
despite Petitioner’s allegations that he was experiencing severe pain that was interfering
with his activities of daily living and his sleep, Petitioner did not seek out any treatment
for his shoulder for one month after his discharge from the ER, despite being provided
with a referral to a primary care physician at that time. Ex 8 at 4.
Other allegations in the relevant pleadings also promote skepticism as to the
Petitioner’s assertions. For example, Mr. Schmidt’s brief contends that “by presenting at
[VOMC], and representing that the [vaccination] was received in his left arm, [he] would
be placing his very employment in jeopardy if that assertion were not true.” ECF 50 at 17.
However, Petitioner has never reported any type of adverse workplace action based on
his reports of left arm pain - despite the records showing that the flu vaccine was
20
As discussed above, Petitioner did visit VOMC at approximately 5:00 pm on October 19, 2016, at which
time he “calmly complain[ed] of intense pain” and requested a work excuse for the day. Ex 1 at 3.
13
administered in the right shoulder. Petitioner further states that in returning to VOMC less
than 24 hours after vaccination with complaints of left shoulder pain, “if he indeed knew
that the injection was given in his right shoulder” he would have to assume that the clinic
did not record the site of injection “or that the medical provider would not look back at the
records to make that determination” and that “[n]either is a reasonable assumption on the
part of Petitioner or any other person.” ECF 50 at 17. However, this post hoc ergo propter
hoc argument is insufficient to overcome the consistent, contemporaneous vaccination
administration records.
b. Treating Physician Statements and Expert Testimony
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 v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1325–26 (Fed. Cir. 2010) (“[a]ssessments as to
the reliability of expert testimony often turn on credibility determinations”); see also Porter
v. Sec'y of Health & Human 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”).
Although statements from treating physicians are generally favored, such evidence
is not sacrosanct, can be rebutted, and can be found as unreliable or not dispositive by a
special master based on the entirety of the record. See 42 U.S.C. § 300aa-13(b)(1)
(statements of treating physicians are not binding on special masters); Snyder v. Sec’y of
Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is nothing . . . that
mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted)”; Davis v. Sec’y of Health & Human
Servs., No. 07-451V, 2010 WL 1444056, at *14 (Fed. Cl. Spec. Mstr. Mar. 10, 2010),
aff’d, 94 Fed. Cl. 53 (2010), aff’d, 420 Fed. App’x 973, 2011 WL 1810619 (Fed. Cir. 2011);
Fadelalla v. Sec’y of Health & Human Servs., No. 97-573V, 1999 WL 270423, at *6 (Fed.
Cl. Spec. Mstr. Apr. 15, 1999), aff’d, 45 Fed. Cl. 196 (1999). As such, a treating
physician’s opinion on vaccine causation is only as strong as the underlying basis for the
opinion. See Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 n.6 (Fed.
Cir. 1994).
For example, if an evaluation of the record reveals that a physician received
inaccurate or incomplete information about a petitioner’s medical history, the weight given
to a statement or opinion from such a physician could be reduced. See, e.g., Fadelalla,
1999 WL 270423, at *3, 5-6. In Fadellala, the petitioner’s treating physician argued that
there must be a relationship between the vaccine and petitioner's injury (GBS) “based
upon other vaccine-related GBS cases he had seen” and “his conclusion that there was
14
an absence of any other cause.” 45 Fed. Cl. at 200. The special master found this
argument insufficient, and the court determined that that the special master did not act
arbitrarily or capriciously in determining that the treating physician’s testimony, as it
related to his diagnosis of the petitioner's GBS, failed to “prove that more likely than not
the vaccine caused her illness.” Id.
In the present case, while Dr. Bruce pointed to apparently objective signs that the
vaccine was administered in Petitioner’s left arm, he was undoubtedly influenced by
Petitioner’s own report, as he references it throughout his treatment records. 21 However,
the two contemporaneously-created vaccine records suggest that Petitioner may have
been mistaken in his recollection, thus providing Dr. Bruce with inaccurate information on
which to form his opinion on causation. Ex 6 at ¶ 30a. Furthermore, similar to the treating
physician in Fadelalla, Dr. Bruce also relied on his experience treating “vaccine-related
shoulder injuries,” and there is no evidence that he considered any alternative cause for
Petitioner’s symptoms. See Exs 2, 6. In his brief, Petitioner also appears to argue that
there could be no other cause for his left shoulder condition. ECF 50 at 17-18. But the
absence of an alternative cause does not relieve a petitioner of his or her duty affirmatively
to demonstrate by a preponderance of the evidence that a vaccine more likely than not
caused the injury. See 42 U.S.C. § 300aa-13(a)(1).
As noted above, after Petitioner was provided with the opportunity to file his own
expert report, he deferred, asserting that “to file additional expert testimony in this matter
would only be duplicative and redundant,” especially because of “the deference that
should be given to a treating physician’s opinion in these type of cases.” Brief at 2 (citing
Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
Petitioner further argues that Dr. Bruce’s opinion should be afforded greater weight when
compared with the opinion of Dr. Abrams, asserting that Dr. Bruce’s “personal knowledge”
of Petitioner “places him in a unique position to be able to evaluate if the condition for
which he performed [surgery] was caused by a misplaced influenza injection and if a
SIRVA diagnosis is appropriate in Petitioner’s case.” 22 ECF 45; ECF 50 at 14. He argues
21
For example, Dr. Bruce’s records from Petitioner’s January 2017 reflect his conclusion that the findings
shown on MRI “follows exactly . . . where [the vaccine] was injected by what [Petitioner] reports to me.” Ex
2 at 8 (emphasis added).
22
Petitioner also asserts that “Dr. Abrams does not state that he reviewed the affidavit authored by . . . Dr.
Bruce.” ECF 50 at 16. However, in the section labeled “Review of Material” in his report, Dr. Abrams
indicates that he reviewed exhibits 1-8, which includes Dr. Bruce’s affidavit, labeled as Exhibit 6. Ex A at 1.
Dr. Abrams also specifically cites to Dr. Bruce’s affidavit on multiple occasions throughout his report. Ex A
at 4. This, combined with the fact that Dr. Bruce’s affidavit primarily consists of a reiteration of the
information contained in the medical records, clearly establishes that Dr. Abrams reviewed Dr. Bruce’s
affidavit. Incidentally, I also note that while Dr. Bruce acknowledges that he reviewed portions of the medical
records from VOMC, he does not discuss the contemporaneous medical records from the clinic identifying
the right deltoid/arm as the site of vaccination. See Ex 6.
15
that less weight should be given to Dr. Abrams’ report because his opinion is based solely
on a review of the record. 23 Id.However, Dr. Abrams has raised reasonable concerns regarding the medical
reliability of the “objective” findings relied upon by Dr. Bruce in formulating his opinion. Ex
A. As summarized by Dr. Abrams, Dr. Bruce has provided no support for his theory that
he could visualize a “needle track” or “the injection site . . . into the rotator cuff” on an MRI
performed one month after vaccination. He also failed to explain how, even if he were
able to locate the “needle track” and “where the bursa . . . had been injected” during
arthroscopic surgery performed more than seven months after vaccination, he was able
to differentiate the “damage” made by the flu vaccine compared to the four interim
cortisone injections received by Petitioner, at least one of which (and the one Petitioner
received most close in time to surgery) was administered in the bursa. 24 Ex 2 at 4.
Dr. Bruce’s affidavit also includes statements that are inconsistent with the
objective medical evidence. For example, while he asserts that rotator cuff tearing was
shown on the MRI, his operative report reflects inflammatory changes but no tearing of
the supraspinatus tendon and rotator cuff. Ex 2 at 1-2. Furthermore, while Dr. Bruce
argues that excess fluid (caused by vaccination) in the subacromial space or bursa would
indicate inflammation that could serve as a supposed cause of Petitioner’s shoulder pain,
he fails to reconcile this assertion with the fact that Petitioner’s MRI did not show evidence
of significant subacromial subdeltoid bursal fluid. Ex 2 at 20; Ex 6 at ¶ 24. Dr. Bruce has
also neglected to provide a theory explaining how he was able to visualize “flu shot
material” in Petitioner’s shoulder during surgery more than seven months after
vaccination. Id. at 2.
23
Petitioner also argues that Dr. Bruce should be considered “better qualified” than Dr. Abrams because
he has completed fellowships in both shoulder/sports medicine and pediatric orthopedic surgery and has
been practicing longer than Dr. Abrams. ECF 50 at 15. While Dr. Bruce has been practicing longer than Dr.
Abrams, Dr. Bruce has almost 15 years of experience, which is certainly not an insignificant amount. In
making his argument that Dr. Bruce is “better qualified,” Petitioner also fails to address Dr. Abrams’
numerous publications, his role as an educator, and his presentations at surgical society conferences, as
referenced above. Further, Dr. Bruce’s fellowship in pediatric surgery is not particularly relevant, as
Petitioner was an adult at both the time of his injury and his surgery. Ultimately, I find Dr. Abrams’s report
to have been more persuasive than what Dr. Bruce offers.
24
Petitioner’s second injection, on January 16, 2017, was administered in the “subacromial space in the
joint.” Ex 2 at 8. Soft tissues, such as the bicep tendon, rotator cuff, and bursa are located in the
subacromial space. https://www.sports-health.com/glossary/subacromial-space (last visited September
29, 2021).
16
Finally, Petitioner asserts in his brief that by filing his affidavit, “Dr. Bruce is
testifying that a healthcare provider (the VOMC nurse) employed by his own employer 25
. . . misplaced the influenza vaccine injection with the resulting injuries” and that “[s]uch
testimony should be afforded a higher modicum of credibility.” ECF 50 at 15. This
argument stretches credulity. As emphasized by Petitioner himself, Dr. Bruce is an
experienced orthopedic surgeon with 28 years of experience and his records do not
reflect any concern that he was testifying “against” his employer, nor do they reference
that Petitioner received his vaccination at a clinic affiliated with Erlanger Hospital.
Therefore, for the reasons stated above, I find Dr. Abrams’ opinion more persuasive and
afford it greater weight.
VII. Conclusion
While Petitioner may honestly believe that he received the vaccine alleged as
causal in his left arm, the record as it now stands preponderantly supports the opposite.
I therefore find the vaccine at issue was more likely than not administered in Petitioner’s
right arm, consistent with the administration records.
VIII. Scheduling Order
On or before Monday, November 8, 2021, Petitioner is ordered to show cause as
to why this case should not be dismissed. A failure to respond to this order will be treated
as a failure to prosecute this claim. Respondent’s response to any filing from Petitioner
will be due fourteen days thereafter.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
25
Petitioner’s worksite medical clinic is affiliated with Baroness Erlanger Hospital. Ex 1 at 23. In his brief,
Petitioner claims that CBJS is a “part of the Erlanger Health System,” although he did not reference any
specific evidence to support this assertion. ECF 50 at 2.
17