VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00313
Package ID: USCOURTS-cofc-1_20-vv-00313
Petitioner: Rosa Soto Galvan
Filed: 2020-03-20
Decided: 2021-01-11
Vaccine: unclear
Vaccination date: 2018-09-26
Condition: anaphylaxis and related complications, including serum sickness-like syndrome
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Rosa Soto Galvan received hepatitis A, hepatitis B, influenza, and pneumococcal conjugate vaccines on September 26, 2018. Within hours, she experienced symptoms including nausea, vomiting, abdominal pain, chest pain, headache, dizziness, and swelling in her right hand and knee, along with cellulitis on her right forearm. She was hospitalized from September 26 to October 1, 2018, with an initial diagnosis of 'other complications following immunization, not elsewhere classified' and a discharge diagnosis of 'post-vaccination fever.' During her hospitalization, she underwent an arthrocentesis of her right knee to remove fluid due to swelling and pain. Galvan filed a petition alleging anaphylaxis and serum sickness-like syndrome, claiming the arthrocentesis constituted a surgical intervention that met the Vaccine Act's severity requirement. The Secretary moved to dismiss, arguing that arthrocentesis was not a surgical intervention. The Special Master agreed, finding that arthrocentesis, while an intervention, was not a surgical procedure and therefore Galvan failed to meet the severity requirement. The court affirmed this decision on review, finding it was not arbitrary, capricious, or otherwise not in accordance with law. The petition was dismissed.

Theory of causation field:
unclear

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00313-0
Date issued/filed: 2020-07-31
Pages: 18
Docket text: PUBLIC DECISION (Originally filed: 7/6/2020) regarding 19 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (et) Service on parties made.
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Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 1 of 18
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-313V
Filed: July 6, 2020
PUBLISHED
ROSA SOTO GALVAN,
Special Master Horner
Petitioner,
v.
Dismissal; Motion to Dismiss;
SECRETARY OF HEALTH AND
Severity Requirement; Surgical
HUMAN SERVICES,
Intervention; Arthrocentesis
Respondent.
Kristina Kay Green, Kravolec, Jambois & Schwartz, Chicago, IL, for petitioner.
Mary Eileen Holmes, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On March 20, 2020, petitioner, Rosa Soto Galvan, filed a petition under the
National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012)2, alleging that
she suffered anaphylaxis and related complications, including serum sickness-like
syndrome, following administration of hepatitis A, hepatitis B, influenza, and
pneumococcal conjugate vaccinations on September 26, 2018. (ECF No. 1, p. 1.) To
satisfy the Vaccine Act’s severity requirement (§300aa-11(c)(1)(D)), petitioner alleged
that she experienced inpatient hospitalization and surgical intervention, specifically
arthrocentesis of her right knee, a procedure in which accumulated fluid is removed
from a joint cavity by needle. (ECF No. 1, p. 5.) Respondent now moves to dismiss,
arguing that petitioner’s arthrocentesis was not related to her alleged vaccine reaction
and does not constitute a surgical intervention within the meaning of the Vaccine Act.
For all the reasons discussed below, I conclude that petitioner’s arthrocentesis, though
an intervention, is not a surgical procedure. Accordingly, respondent’s motion is
granted and this petition is dismissed.
1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), 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 the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2 Hereinafter, all references to “§300aa” refer to sections of the Vaccine Act.

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 2 of 18
I. Procedural History
As noted above, this case was filed on March 20, 2020. (ECF No. 1.) Along with
her petition, petitioner filed medical records and an affidavit marked as Exhibits 1-4.
She filed a Statement of Completion on March 25, 2020. (ECF No. 8.) Following a Pre-
Assignment Review (“PAR”), the case was assigned to me on April 13, 2020. (ECF
Nos. 9-10.)
On May 12, 2020, respondent filed his motion to dismiss pursuant to RCFC
12(b)(6). (ECF No. 13.) He indicated that “[f]ollowing a review of the records,
respondent has determined that petitioner’s claim does not satisfy the Vaccine Act
severity requirement . . . [and] the petition must be dismissed for failure to state a claim
upon which relief may be granted, pursuant to RCFC 12(b)(6).” (Id. at 1)
Petitioner filed a response to the motion on June 3, 2020. (ECF No. 15.) In her
response, petitioner explained that “[a]s petitioner does not contend or allege her
vaccine injury symptoms persisted for more than six months, and respondent does not
dispute petitioner required inpatient hospitalization for her vaccine injury, the only issues
to be decided are: (1) whether petitioner’s right knee arthrocentesis was performed as a
result of her vaccine injury; and (2) whether petitioner’s right knee arthrocentesis
constitutes surgical intervention within the meaning of the Vaccine Act.” (Id. at 3.)
Along with her response, petitioner filed additional exhibits marked as Exhibits 5-
8. (ECF Nos. 15-16.) These exhibits include an affidavit by petitioner’s adult son
accompanied by photographs of petitioner’s arthrocentesis procedure being performed
(Ex. 5),3 as well as internet-sourced materials defining serum sickness, surgery, and
arthrocentesis (Exs. 6-8).
Respondent filed his reply on June 9, 2020. (ECF No. 18.) This issue is now
ripe for resolution.
II. Factual History
On September 26, 2018, petitioner received hepatitis A, hepatitis B, influenza,
and pneumococcal vaccinations from her primary care doctor. (Ex. 1, p. 62.) Petitioner
avers that she was previously in good health; however, relevant to respondent’s motion,
she did have a history of osteoarthritis. (Ex. 2, p. 2; Ex. 4, p. 220.) Later that day, she
reportedly developed nausea, vomiting, abdominal pain, chest pain, headache and
dizziness. (Ex. 4, p. 247.) She also developed swelling of the right hand, dorsum, and
joints of the right hand and right knee. (Id. at 220.) She developed a right knee effusion
and a cellulitis of the right forearm. (Id.)
3 Initially petitioner filed an unsigned copy of the affidavit marked as Exhibit 5. (ECF No. 16-1.)
Subsequently, a signed copy was filed as “Amended Exhibit 5.” (ECF No. 17-1.) For purposes of this
decision, the unsigned affidavit will not be referenced and the executed affidavit will be referenced as
Exhibit 5.
2

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 3 of 18
Petitioner was hospitalized from September 26 to October 1. (Id. at 220.) Her
intake diagnosis was “other complications following immunization, not elsewhere
classified” and her discharge diagnosis was “post vaccination fever.” (Id. at 220, 222.)
However, she also had 23 secondary diagnoses considered during her hospitalization.
(Id. at 219.) Petitioner was discharged with instructions to follow up with her primary
care physician. (Ex. 4, p. 221.) That primary care physician in turn recorded a history
of “serum sickness-like reaction” and recorded an impression of “adverse reaction to
mixed bacteria vaccine.” (Ex. 1, pp. 33, 35.) However, it was noted that petitioner
“feels better and right shoulder is healing.” (Id. at 33.) She does not contend that she
experienced residual effects lasting six months. (ECF No. 15, p. 3.)
During her hospitalization, petitioner was observed to have had right knee
swelling and pain significant enough that she could not bend her right knee. (Ex. 4, p.
52.) This was specifically identified as a “right knee effusion” and rheumatology was
consulted. (Id. at 53.) The reason for that rheumatology consult was “painful swollen
joint” and the assessment/plan indicated “[p]ainful swollen joint, possible septic arthritis
versus inflammatory arthritis versus crystal arthropathy. I will perform arthrocentesis of
the right knee.” (Id. at 249-50.) The records indicate that 30ml of fluid was removed
from petitioner’s knee. (Id. at 250.)
Petitioner confirms that the procedure was done bedside and that only oral
consent was obtained. (ECF No. 15, p. 13, n.3.) Petitioner filed an affidavit by her adult
son that included photographs of petitioner’s arthrocentesis being performed. (Ex. 5.)
The photographs show petitioner gowned and laying supine in a hospital bed without
guardrails with her legs fully extended and somewhat spread. Petitioner’s
rheumatologist, dressed in plain clothes and not surgical scrubs, reached over
petitioner’s left leg to reach her right leg. A needle of indeterminate size was inserted
into petitioner’s joint and two syringes of fluid were extracted. (Id.) Petitioner described
the arthrocentesis procedure as painful (Ex. 2, p. 1); however, Dr. Syed W. Rizvi
indicated that petitioner tolerated the procedure well and no further follow up was
recorded. (Ex. 4, p. 250.) Petitioner’s discharge summary indicates that her right knee
joint effusion had resolved by the time of discharge. (Ex. 4, p. 220.)
III. The Vaccine Act Severity Requirement and Surgical Intervention
In order to state a claim for a vaccine-related injury under the Vaccine Act, a
vaccinee must have either:
(i) suffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.
§300aa-11(c)(1)(D).
3

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 4 of 18
There is no definition of “surgical intervention” within the Vaccine Act. See
§300aa-33 (Definitions). Nor is there any Federal Circuit decision interpreting that term.
As described in prior decisions by special masters, the “surgical intervention” language
was added to the Vaccine Act in the year 2000 to allow for recovery for intussusception,
which is an intestinal prolapse that is often severe enough to require surgery but which
typically does not include significant residual effects after surgery. See, e.g., Spooner v.
Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728 (Fed. Cl. Spec. Mstr.
Jan. 16, 2014); Stavridis v. Sec’y of Health & Human Servs., No. 07-261V, 2009 WL
3837479 (Fed. Cl. Spec. Mstr. Oct. 29, 2009).
The first case to address in detail the meaning of “surgical intervention” within the
context of the Vaccine Act was Stavridis v. Secretary of Health & Human Services.4
2009 WL 3837479. In that case, petitioner argued that treatment with intravenous
steroids and blood transfusions constituted surgical interventions. Id. at *2. Petitioner
urged application of combined dictionary definitions of surgical and intervention
respectively. Id. at *4. Specifically, petitioner contended that a “surgery,” akin to an
“operation,” is defined as “any methodical action of the hand, or of the hand with
instruments, on the human body, to produce a curative or remedial effect, as in
amputation, etc.” while an intervention is “the act or fact of interfering so as to modify.”
Id. at n.8.
However, the Stavridis special master was concerned that “[i]f petitioner’s
cobbled-together definition were accepted, it seems a great number of minor
procedures would qualify as surgical intervention.” Id. at *4. Moreover, respondent
provided evidence from a hematologist explaining that blood transfusions and
intravenous delivery of medications are considered non-operative by the International
Classification of Disease. Id. at *5.
Ultimately, the Stavridis special master rejected petitioner’s proposed definition,
stressing that the addition of the surgical intervention language into the Vaccine Act was
meant to allow additional serious injuries to be compensated, not to diminish the
severity requirement itself. Id. at *5. He found that “petitioner’s definition casts too wide
a net even though it is taken from a medical dictionary.” Id. at *6. Moreover, he
rejected the specific contention that either intravenous steroid injections or blood
transfusions represent surgical interventions. He further explained:
It is foreseeable that numerous cases will present before this court,
challenging the breadth of procedures that constitute “surgical intervention.”
One can imagine a potentially large gray area between treatments that are
definitively considered “surgical intervention” and those that are not.
4 In a prior case, a petitioner was found entitled to compensation based in part on the idea that a lumbar
puncture constituted a surgical intervention, but the meaning of surgical intervention was not actually
analyzed. Hocraffer v. Sec’y of Health & Human Servs., 63 Fed. Cl. 765 (2005). The Court requested
supplemental briefs addressing that very question; however, respondent did not object to petitioner’s
characterization of a lumbar puncture as constituting a surgical intervention and the issue was therefore
treated as conceded. Id. at n.4.
4

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 5 of 18
Support from medical treatises or doctors will be needed to determine the
appropriate boundaries of what constitutes surgical intervention.
Id. at *6.
Subsequently, in 2014, the definition of “surgical intervention” was again
examined in Spooner v. Secretary of Health & Human Services. 2014 WL 504728. In
Spooner, petitioner contended that a lumbar puncture5 and IVIG6 treatment were
surgical interventions within the meaning of the Vaccine Act. Id. at *4-5. As in Stavridis,
the petitioner urged a broad, dictionary-based definition combining the respective
definitions of surgery and intervention. Id. at *8. Specifically, the petitioner urged the
special master to consider a surgery “[a] procedure to remove or repair part of the body
or to find out whether disease is present” and an intervention “a treatment or action
taken to prevent or treat disease, or improve health in other ways.” Id.
As in Stavridis, the special master considered the fact that the legislative history
showed intussusception to be the specific injury for which the Vaccine Act’s severity
requirement was amended; however, he also stressed that the language of the
amendment was not limited to surgeries to correct intussusception. Id. at *11. Citing
prior Federal Circuit cases that allowed for the use of medical dictionaries to define
medical terms, he also explored such definitions.7 Id. at *10 (citing Abbott v. Sec’y of
Health & Human Servs., No. 93-5129V, 19 F.3d 39, slip op. at *6 (Fed. Cir. 1994). He
ultimately concluded that:
Congress indicated that, for an injury to be compensable, it must meet a
severity threshold. In amending the Act to include the “inpatient
hospitalization and surgical intervention” alternative, Congress indicated
that certain medical procedures are so traumatic as to serve as a suitable
statutory proxy for a serious injury equivalent to more than six months of
pain and suffering. An intervention of the magnitude contemplated by
5 A “lumbar puncture,” also known as a “spinal tap,” is “the withdrawal of fluid from the subarachnoid
space in the lumbar region, usually between the third and fourth lumbar vertebrae, for diagnostic or
therapeutic purposes. Dorland’s Illustrated Medical Dictionary, p. 1532, 1842 (33rd ed. 2019).
6 “IVIG” stands for intravenous immunoglobulin. Neil M. Davis, Medical Abbreviations, p. 317.
7 Specifically, the special master explained that at the time the Vaccine Act was amended, the 29th Edition
of Dorland’s Medical Dictionary defined “surgical” as “the branch of medicine that treats diseases, injuries,
and deformities by manual or operative methods.” He noted the 27th edition of Stedman’s Medical
Dictionary then in publication provided a nearly identical definition. Spooner, 2014 WL 504728, at *10.
“Operative methods,” in turn, are defined as “any act performed with instruments or by the hands of a
surgeon.” Using the same sources, the special master noted that “intervention” is defined by Dorland’s
29th edition as either “the act or fact of interfering so as to modify” or “specifically, any measure whose
purpose is to improve health or to alter the course of a disease.” Stedman’s 27th Edition defines
intervention as “an action or ministration that produces an effect or that is intended to alter the course of a
pathological process.” Id. Accordingly, the special master concluded the definition of “surgical
intervention” is “the treatment of a disease, injury, and deformity with instruments or by the hands of a
surgeon to improve health or alter the course of a disease.” Id.
5

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 6 of 18
Congress and akin to that undertaken to treat severe cases of
intussusception is consistent with the definition of “surgery” as the treatment
of an injury with instruments or by the hands of a surgeon.
Id. at *11.
In applying that definition, however, the special master in Spooner concluded that
neither a lumbar puncture nor IVIG treatment constitute surgical interventions. He
explained that “[a]lthough the scope of the phrase ‘surgical intervention’ is broader than
merely the surgery performed to correct intussusception, it is not so broad as to exceed
the common meaning of its component terms in the medical community.” Id.
With regard to lumbar punctures, the special master explained that such
procedures are not always performed by a surgeon and may not be performed under
general anesthesia; however, when performed under general anesthesia in an
operating room, he concluded that a lumbar puncture is surgical in nature. Id. at *11-12.
Nonetheless, because lumbar punctures are generally considered diagnostic, he
concluded that they do not improve or alter the course of a disease or condition and
therefore are not “interventions.” Id. at *12.
Conversely, the special master concluded that IVIG treatments are interventions
because they have a curative or therapeutic purpose and effect. Id. at *12. However,
unlike the lumbar puncture, IVIG treatments are a nursing function and are therefore not
surgical. Id. The special master stressed that in amending the severity requirement,
the legislative history showed that Congress distinguished between intussusceptions
reduced by surgery under general anesthesia and those reduced by other, less invasive
means, such as hydrostatic or pneumatic reductions which are not performed with
general anesthesia. He concluded that IVIG, as an intravenous treatment, was more
akin to the less severe type of intussusception treatment that was not included in the
newly amended statutory language.8 Id.
Subsequent decisions by other special masters have followed the definition of
“surgical intervention” described in Spooner and reached different results based upon
the fact pattern. In Uetz v. Secretary of Health & Human Services, the parties again
presented the question of whether a lumbar puncture constitutes a surgical intervention;
however, because the procedure was conducted on an out-patient basis, the special
master did not determine whether a surgical intervention occurred. No. 14-29V, 2014
WL 7139803 (Fed. Cl. Spec. Mstr. Nov. 21, 2014). In Ivanchuk v. Secretary of Health &
Human Services, the special master concluded that a bone marrow aspiration9 and
8 Notably, special masters have repeatedly held that barium enemas to reduce intussusceptions do not
constitute surgical interventions. E.g., Green v. Sec’y of Health & Human Servs., No. 19-1295V, 2020
WL 1845325 (Fed. Cl. Spec. Mstr. Mar. 18, 2020); Carda v. Sec’y of Health & Human Servs., No. 14-
191V, 2017 WL 6887368 (Fed. Cl. Spec. Mstr. Nov. 16, 2017).
9 A bone marrow biopsy or aspiration is a procedure in which the bone is punctured with a needle
attached to a syringe to remove soft bone marrow tissue for testing. Aspiration biopsy, DORLAND’S
6

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 7 of 18
biopsy did constitute a surgical intervention consistent with the Spooner definition. No.
15-357V, 2015 WL 6157016 (Fed. Cl. Spec. Mstr. Sept. 18, 2015). As in Spooner, the
special master stressed that the procedure occurred in accordance with hospital policies
for a surgical procedure (written consent, post-operative recovery) and occurred under
general anesthesia. In contrast to Spooner, the special master concluded the bone
marrow aspiration and biopsy at issue was an intervention, because, while not a
treatment itself, it was performed as part of a protocol for administering steroid
treatment. Id. at *2-3.
Most recently, in Leming v. Secretary of Health & Human Services, a second
decision issued that followed Ivanchuk in determining that a bone marrow biopsy
constitutes a surgical intervention. No. 18-232V, 2019 WL 5290838 (Fed. Cl. Spec.
Mstr. July 12, 2019). As in Ivanchuk, the Leming child was placed under general
anesthesia and the hospital followed surgical protocols including consent and post-op
recovery. Id. at *6. Notably, that decision rejected respondent’s invitation to examine
the Congressional intent behind the “surgical intervention” amendment. Rather, the
special master concluded that she “does not agree that the statutory language is
sufficiently ambiguous to allow consideration of Congressional intent.” Id. at *6. The
special master noted that the prior Spooner decision did examine legislative intent, but
also found the Spooner definition persuasive based on the fact that “surgical
intervention” is adequately defined by the appropriate discipline. Id.
IV. Party Contentions
a. Respondent’s Motion
As a starting point, respondent notes that petitioner’s medical records do not
reflect six months of residual symptoms following her alleged vaccine reaction.
Accordingly, the question of whether petitioner experienced “inpatient hospitalization
and surgical intervention” as pleaded by petitioner (arthrocentesis) is dispositive. (ECF
No. 13, p. 6, n.2.) Respondent does not dispute that petitioner experienced inpatient
hospitalization but does dispute that arthrocentesis constitutes a surgical intervention.
(Id.)
Regarding petitioner’s arthrocentesis, respondent cites approvingly to the above-
discussed Spooner decision, arguing that “[t]he insertion of a needle, in and of itself, is
not considered ‘surgical.’” (Id. at 7.) Respondent notes that the procedure did not
involve general anesthesia, was conducted bedside rather than in an operating room,
and the medical records contain no consent forms. In sum, respondent argues that
“[t]he hospital did not treat this procedure as if it were surgical,” a point which
respondent indicates was stressed in Spooner. (Id. at 8.)
MEDICAL DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=60555 (last visited
July 2, 2020).
7

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 8 of 18
Noting that arthrocentesis can be either diagnostic or therapeutic, respondent
also disputes that petitioner’s procedure was an intervention. Respondent explains that
in petitioner’s own case, her medical records reflect that the procedure was performed
to rule out septic arthritis and was therefore diagnostic and did not alter the overall
course of her alleged injury. (Id. at 8.)
Finally, respondent also disputes that petitioner’s arthrocentesis was related to
the serum sickness-like syndrome that forms the basis of her petition. (Id. at 8-9.)
Respondent contends that petitioner’s medical records reflect her joint swelling to have
been related to osteoarthritis and none of petitioner’s treating physicians attributed her
joint swelling to the possible vaccine reaction for which she was hospitalized.10 (Id. at
9.)
b. Petitioner’s Response
In her response, petitioner confirmed that she does not allege her injury to have
persisted for more than six months and that she agrees that the question of whether she
had a surgical intervention is at issue. (ECF No. 15, p. 3.) Petitioner argues that, when
her medical record is considered as a whole, it is evident that her arthrocentesis was
performed in connection with her alleged vaccine reaction. (Id. at 9-11.)
Petitioner approves of the Spooner decision’s reliance on medical dictionaries to
define “surgical intervention,” but proposes a different, more detailed definition as
instructive based on a definition of “surgery” proposed by a statement from the
American College of Surgeons subsequently adopted by the American Medical
Association (“AMA”), which is discussed in detail further below. (Id. at 12 (citing Ex. 8).)
Petitioner argues that the finding in Spooner that a lumbar puncture was surgical,
as well as the findings in both Leming and Ivanchuk that bone marrow aspiration and
biopsy were surgical interventions, support petitioner’s position that arthrocentesis is a
surgical intervention. (Id. at 13.) Specifically, “[p]etitioner’s right knee arthrocentesis is
very similar to both lumbar puncture and bone marrow aspiration and biopsy in that all
three procedures involve puncturing or penetrating the cutaneous and subcutaneous
tissue with a needle by a physician; removal, draining or aspiration of bodily fluid, and
typically some type of microbiologic analysis of the fluid extracted.” (Id.)
Petitioner acknowledges the distinctions raised by respondent – petitioner had
local instead of general anesthesia, her procedure was conducted bedside rather than
in an operating room, and consent was obtained only orally. (Id.) However, petitioner
argues that none of these factors are contained in the statutory language, the definition
followed by Spooner, or petitioner’s preferred definition by the AMA, “because they are
not defining characteristics of surgery.” (Id. at 14.) Petitioner argues that a finding that
10 Respondent also argues that this petition lacks a reasonable basis. (ECF No. 13, pp. 9-10.) However,
in the absence of any application for attorneys’ fees and costs, I am not reaching that question at this
time.
8

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petitioner’s arthrocentesis does not constitute a surgery based on these factors “would
be inserting requirements not present in the statutory language itself or any of the
definitions of surgery discussed above.” (Id. at 15.)
With regard to whether arthrocentesis constitutes an intervention, petitioner
agrees with respondent that the procedure can be both diagnostic and therapeutic. (Id.)
Petitioner stresses, however, that 30 ml of fluid was extracted from petitioner’s knee
whereas only 3 ml of fluid was required for the laboratory analysis. Accordingly,
petitioner argues that it is “nonsensical” to argue that such a substantial amount of
excess fluid was drained for no medical purpose and without any therapeutic effect. (Id.
at 15-16.) Moreover, petitioner argues that draining an effusion necessarily constitutes
an intervention because it altered the course of petitioner’s condition. (Id. at 16.)
c. Respondent’s Reply
In his reply, respondent contends that petitioner is proposing a “novel”
interpretation of surgical intervention. (ECF No. 18, p. 1.) Respondent argues that
petitioner’s proposed interpretation of surgical intervention “would broaden the Act’s
narrow waiver of sovereign immunity to a point of absurdity.” (Id. at 7.) Specifically,
respondent contends that “petitioner’s arthrocentesis procedure lacks the traumatic
aspect necessary to serve as a proxy for six months of pain and suffering” and,
moreover, that since the severity requirement constitutes a waiver of sovereign
immunity, it must be construed narrowly. (Id. at 10.) Respondent notes, for example,
that petitioner’s proposed interpretation would fail to distinguish between a surgical
intervention and a routine blood draw. (Id. at 11.)
Respondent also argues that petitioner misconstrues the prior precedents of
Spooner, Leming and Ivanchuk. Respondent stresses that these prior decisions “based
their finding of whether a surgery occurred from the perspective of the hospital
performing the surgery,” explaining that in those prior cases the hospital “took notable
steps to classify the questioned procedure as a surgery” and respondent “argues that
the hospital is in the best position to define a surgery.” (Id. at 8.)
Respondent also reiterated his position that petitioner’s arthrocentesis does not
constitute an intervention. Additionally, he explained further why he does not believe
petitioner’s arthrocentesis was performed in treatment of her alleged vaccine injury. (Id.
at 2-6.)
V. Applicable Legal Standard for Motions to Dismiss
Although the Vaccine Act and the Vaccine Rules contemplate case dispositive
motions (see §300aa-12(d)(2)(C-D); Vaccine Rule 8(d)), the dismissal procedures
included within the Vaccine Rules do not specifically include a mechanism for a motion
to dismiss (see Vaccine Rule 21). However, Vaccine Rule 1 provides that for any
matter not specifically addressed by the Vaccine Rules the special master may regulate
applicable practice consistent with the rules and the purpose of the Vaccine Act.
9

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(Vaccine Rule 1(b).) Vaccine Rule 1 also provides that the Rules of the Court of
Federal Claims (“RCFC”) may apply to the extent they are consistent with the Vaccine
Rules. (Vaccine Rule 1(c).)
Accordingly, there is a well-established practice of special masters entertaining
motions to dismiss in the context of RCFC 12(b)(6), which allows the defense of “failure
to state a claim upon which relief can be granted” to be presented via motion.11 See,
e.g., Herren v. Sec’y of Health & Human Servs., No. 13-1000V, 2014 WL 3889070 (Fed.
Cl. Spec. Mstr. July 18, 2014); Bass v. Sec’y of Health & Human Servs., No. 12-135V,
2012 WL 3031505 (Fed. Cl. Spec. Mstr. June 22, 2012); Guilliams v. Sec’y of Health &
Human Servs., No. 11-716V, 2012 WL 1145003 (Fed. Cl. Spec. Mstr. Mar. 14, 2012);
Warfle v. Sec’y of Health & Human Servs., No. 05-1399V, 2007 WL 760508 (Fed. Cl.
Spec. Mstr. Feb. 22, 2007). And, significant to this case, this practice has included
decisions by special masters specifically addressing whether a petitioner’s alleged injury
has satisfied the Vaccine Act’s severity requirement. E.g., supra, at Herren; Spooner,
2014 WL 504728; Uetz, 2014 WL 7139803.
Under RCFC 12(b)(6), a case should be dismissed “when the facts asserted by
the claimant do not entitle him to a legal remedy.” Extreme Coatings, Inc. v. United
States, 109 Fed Cl. 450, 453 (2013) (quoting Lindsay v. United States, 294 F.3d 1252,
1257 (Fed Cir. 2002)). In considering a motion to dismiss under RCFC 12(b)(6),
allegations must be construed favorably to the pleader. Id. However, the pleading must
“contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is
plausible on its face.’” Golden v. United States, 137 Fed. Cl. 155, 169 (2018) (quoting
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)); see also Bell Atlantic Corp. v. Twombly,
550 U.S. 544 (2007).
“To determine whether a complaint states a plausible claim for relief, the court
must engage in a context-specific analysis and ‘draw on its judicial experience and
common sense.’” Id. (quoting Iqbal, 556 U.S. at 679). However, “Rule 12(b)(6) does
not countenance . . . dismissals based on a judge’s disbelief of a complaint’s factual
allegations.” Bell Atlantic Corp., 550 U.S. at 555 (quoting Neitzke v. Williams, 490 U.S.
319, 327 (1989)). Nonetheless, on a motion to dismiss courts “are not bound to accept
as true a legal conclusion couched as a factual allegation.” Id. (quoting Papasan v.
Allain, 478 U.S. 265, 286 (1986)). In assessing motions to dismiss in the Vaccine
Program, special masters have concluded that they “need only assess whether the
petitioner could meet the Act’s requirements and prevail, drawing all inferences from the
available evidence in petitioner’s favor. Herren, 2014 WL 38889070, at *2; Warfle, 2007
WL 760508, at *2.
11 Moreover, it has been observed that the standards for pleading in the Vaccine Program are similar to
the standards for pleading in traditional civil litigation such that application of Rule 12(b)(6) is appropriate.
E.g., Herren, 2014 WL 3889070, at *1.
10

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VI. Discussion
My review of the complete record compiled to date reveals that petitioner did not
(and will not be able to) state a claim for which relief can be granted because she has
not met the severity requirement contained within the Vaccine Act. As described above,
the parties agree that petitioner did not experience at least six months of residual effects
from her alleged injury. They further agree that she did experience inpatient
hospitalization. Accordingly, the issue to be resolved is whether she underwent any
“surgical intervention” pursuant to §300aa-11(c)(1)(D) during her hospitalization.
I conclude that the dispositive factor in this case is that petitioner’s arthrocentesis
is not a surgical procedure. First, I examine this question in light of petitioner’s proffered
evidence regarding the correct understanding of “surgery.” I then turn to whether
arthrocentesis should be considered surgical in light of prior Program cases interpreting
the relevant statutory language.
For the sake of clarity regarding the scope of this decision, I will also briefly
address those aspects of the case that do not favor dismissal of this case at this time.
Specifically, drawing all inferences in favor of petitioner, there is sufficient evidence on
this record that petitioner’s arthrocentesis likely did constitute an intervention for
purposes of the Vaccine Act’s severity requirement. The remaining question is whether
that intervention was in treatment of petitioner’s alleged vaccine injury. This decision
will not resolve that question as it would require further development of the record.
a. Petitioner’s Proffered Definition of Surgery Does Not Support Her
Claim
Because this decision addresses a motion to dismiss, all inferences must be
drawn in petitioner’s favor. Accordingly, I will start by accepting as accurate petitioner’s
proffered evidence regarding the definition of surgery and description of knee
arthrocentesis. (Exs. 7-8.) This includes a January 2020 online article titled “Knee
Arthrocentesis” by Akbarnia and Zahn from the National Center for Biotechnology
Information (“NCBI”) “Bookshelf” service (Ex. 7) and the above referenced definition of
“surgery” as adopted by the AMA based on a statement from the American College of
Surgeons (Ex. 8). Comparing these pieces of evidence, the specific AMA definition of
surgery preferred by petitioner does not support petitioner’s claim that arthrocentesis
constitutes a surgery. The AMA definition of surgery provides three separate
descriptions of what constitutes a surgery. Arthrocentesis does not fit into any of the
three descriptions.
Arthrocentesis is a procedure performed to aspirate synovial fluid from a joint
cavity. (Ex. 7, p. 1.) It can be performed by a clinician or by other medical care
professionals or healthcare workers and typically does not require any assistance. (Id.
at 2-3.) For arthrocentesis of the knee, a patient is placed in a comfortable position with
the knee fully extended at 15-20 degrees. (Id.) A local, lidocaine anesthetic is used.
(Id.) The procedure itself involves insertion of an 18g needle with a 30-60cc syringe into
11

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 12 of 18
the joint to aspirate fluid. (Id.) Potential complications are generally limited to local
trauma and the procedure is typically completed on an outpatient basis. (Id. at 3.) In
this case, it was performed bedside while petitioner was otherwise hospitalized. (ECF
No. 15, p. 13; Ex. 4, p. 220; Ex. 5.)
Turning to the AMA definition of surgery, the AMA first indicates, most basically
and most severely, that surgery “is performed for the purpose of structurally altering the
human body by the incision or destruction of tissues and is part of the practice of
medicine.” (Ex. 8, p. 1.) Arthrocentesis does not fit this definition because it does not
structurally alter the body. Arthrocentesis of the knee removes synovial fluid from the
joint by needle. (Ex. 7.) It is not a structural alteration of the knee joint. Nor, for that
matter, does it reach the joint by incision or result in destruction of tissue.12
Expanding on that statement, the AMA provides a second description of
seemingly more minor surgery that does not require structurally altering the body,
indicating that “[s]urgery also is the diagnostic or therapeutic treatment of conditions or
disease processes by any instruments causing localized alteration or transposition of
live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes,
and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or
manipulated by closed reductions for major dislocations or fractures, or otherwise
altered by mechanical, thermal, light-based, electromagnetic, or chemical means.” (Id.)
This description does allow that procedures involving needles may constitute
surgery; however, it should be stressed that inclusion of the specific term “needle” is not
illuminating on its own. For example, needlescopic surgeries are performed by passing
surgical instruments through a hollow needle.13 This more detailed description is still
limited to the context of “localized alteration or transposition of live human tissue,” which
is not consistent with arthrocentesis. (Ex. 8.) Again, arthrocentesis only removes
synovial fluid from within the joint via needle puncture, it does not alter or transpose
tissue. (Ex. 7.) Here, respondent’s suggestion that petitioner’s proposed interpretation
fails to meaningfully distinguish between a surgical procedure and a routine blood draw
illustrates the point. (ECF No. 18, p. 11.)
12 Though it likely goes without saying, a quick review of medical terminology confirms that removal of
synovial fluid by needle puncture cannot be equated to an incision or destruction of tissue. “Incision”
refers to either “the act of cutting” or “a cut, or a wound produced by cutting with a sharp instrument.”
Dorland’s, p. 914. “Puncture” refers to “the act of piercing or penetrating with a pointed object or
instrument.” Id. at 1532. A “fluid” is “a liquid or gas” that is “composed of elements or particles that freely
change their relative positions without separating. Id. at 712. “Tissue” is loosely defined in medicine as
“an aggregation of similarly specialized cells united in the performance of a specialized function;” “cells”
being “the smallest living unit capable of independent function.” Id. at 307, 1901. Synovial fluid, or
synovia, in particular is “a transparent alkaline viscid fluid, resembling the white of an egg, secreted by the
synovial membrane, and contained in joint cavities, bursae, and tendon sheaths.” Id. at 1826.
13 Specifically, “needlescopic” is defined as a procedure “done with a minilaparoscopic technique in which
tiny instruments are passed through the lumen of a hollow needle such as a Veress needle. Dorland’s, p.
1219. A Veress needle is “a hollow needle consisting of a sharp trocar with a slanted end surrounding an
inner cylinder with a blunt end.” Id.
12

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Finally, the AMA definition of surgery also indicates that “[i]njection of diagnostic
or therapeutic substances into body cavities, internal organs, joints, sensory organs,
and the central nervous system also is considered to be surgery.” (Ex. 8)
Arthrocentesis, however, removes fluid. It does not inject any substance into the body.
(Ex. 7.) The fact that this description explicitly singles out needle injection of diagnostic
and therapeutic substances as surgical further suggests that the invasiveness of the
substance itself (and its effects), and not merely the needle puncture, helps give rise in
this context to the characterization of an injection as a surgical procedure.
Petitioner argues that penetration of the skin by a needle does constitute
“manipulation of live tissue with an instrument.” (ECF No. 15, p. 13.) Notably, however,
the AMA definition does not discuss manipulation of tissue broadly. Rather, it discusses
the specific procedure of “manipulation by closed reduction for major dislocations or
fractures.”14 (Ex. 8.) The AMA implicates needles only in two specific contexts,
localized alteration or transposition of live tissue or injection of therapeutic and
diagnostic substances. (Id.) As described above, arthrocentesis fits neither category.
Moreover, despite extensively listing specific means of altering tissue (including cutting,
burning, vaporizing, freezing, suturing, probing, or manipulating by closed reduction),
the definition does not otherwise suggest that mere puncturing by needle gives rise to a
surgery.15 Thus, I do not find that arthrocentesis constitutes a surgery under the specific
descriptions included in this definition.
Moreover, even if I accepted petitioner’s implicit argument that a needle puncture
of the cutaneous or subcutaneous tissue in itself was sufficient to constitute a
destruction or alteration of tissue under these descriptions, the definition as a whole still
makes clear that arthrocentesis of the knee lacks the requisite gravity to constitute a
surgery. Specifically, the AMA cautions that:
All of these surgical procedures are invasive, including those that are
performed with lasers, and the risks of any surgical procedure are not
eliminated by using a light knife or laser in place of a metal knife, or scalpel.
Patient safety and quality of care are paramount and, therefore, patients
should be assured that individuals who perform these types of surgery are
14 In medical terminology, a “reduction” refers to “the correction of a fracture, dislocation, or hernia.” A
“closed reduction” refers to “the manipulative reduction of a fracture or dislocation without incision.”
Dorland’s., p. 1584.
15 As discussed further below, in addition to advancing this definition of surgery, petitioner also argues
that her arthrocentesis should be considered surgical because of its similarity to the lumbar puncture and
bone marrow aspirations discussed in Spooner, Ivanchuk, and Leming; however, like arthrocentesis, it
does not appear that a lumbar puncture would satisfy this definition of surgery. This is at least partly
consistent with the conclusion reached in Spooner in that the special master concluded that not all lumbar
punctures may be deemed surgical. In contrast, the bone marrow aspirations in Ivanchuk and Leming
arguably meet this definition because they remove bone marrow from the body, which is a form of tissue,
but this distinguishes these precedents from the instant case. This underscores that the use of the word
“needle” in this definition does not bring all needle-based procedures within the definition of surgery.
13

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 14 of 18
licensed physicians (defined as doctors of medicine or osteopathy) who
meet appropriate professional standards.
(Ex. 8, p. 1.)
According to petitioner’s submission, however, although arthrocentesis is
characterized as a “minor surgical procedure,” it may be “performed by healthcare
workers who do have knowledge of the anatomy of joints.” (Ex. 7, p. 1 (emphasis
added).) This marks a contrast to the AMA definition above, wherein all of the
procedures included in the definition by any description are procedures that should be
reserved for execution by a licensed physician due to their inherent risks. (Ex. 8, p. 1.)
Moreover, even though petitioner’s arthrocentesis was performed by a physician in this
instance, the photographs petitioner submitted of her procedure being performed further
illustrate how minimally invasive and nontraumatic the bedside procedure at issue
actually was. (Ex. 5.)
b. Petitioner’s Allegation is Not Consistent with This Program’s Long-
Standing Understanding of “Surgical” Intervention
Petitioner also argues that her arthrocentesis constitutes a surgical intervention
when viewed in the context of this Program’s prior caselaw. Although special masters
are not bound by the prior decisions of other special masters,16 in this case I find the
prior decisions rendered in Stavridis, Spooner, Ivanchuk and Leming to be both
instructive and persuasive. Moreover, both parties framed their arguments within the
context of these prior decisions. Contrary to petitioner’s assertions, however, these
decisions do not support petitioner’s position in this case. Thus, even setting aside her
proffered definition of surgery, petitioner still does not prevail.
Like this case, Stavridis, Spooner, Ivanchuk, and Leming, each examined
needle-based procedures that occurred during the course of a hospitalization, including
blood transfusion and intravenous steroids (Stavridis), lumbar puncture and IVIG
treatment (Spooner), and bone marrow aspiration and biopsy (Ivanchuk and Leming).
In that regard, petitioner argues that “[p]etitioner’s right knee arthrocentesis is very
similar to both lumbar puncture and bone marrow aspiration and biopsy in that all three
procedures involve puncturing or penetrating the cutaneous and subcutaneous tissue
with a needle by a physician; removal, drainage or aspiration of bodily fluid; and
typically some type of microbiologic analysis of the fluid extracted.” (ECF No. 15, p. 13.)
Significantly, however, the key characteristic of lumbar punctures and bone marrow
aspirations is not that they merely penetrate the cutaneous and subcutaneous tissue,
but that they further penetrate the spinal canal and bone respectively. Moreover,
respondent correctly notes that in those prior cases where a surgical procedure was
found to have occurred, the hospital “took notable steps to classify the questioned
procedure as a surgery” whereas the procedure in this case did not involve general
anesthesia, was conducted bedside rather than in an operating room, and had no
written consent. (ECF No. 13, p. 8; ECF No. 18, p. 8.)
16 See, e.g., Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998).
14

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 15 of 18
Importantly, the above-referenced body of case law does not support the idea
that all needle-based procedures involving puncture wounds are inherently surgical.
Rather, it is the distinctions highlighted by respondent that have previously been found
instructive in determining whether a surgical procedure has occurred. Stavridis rejected
entirely the idea that either blood transfusion or intravenous steroid treatments were
surgical in nature. 2009 WL 3837479, at *5-6. Spooner subsequently distinguished
between lumbar punctures performed by non-surgeons without the use of general
anesthesia and those having the character of a surgery. 2014 WL 504728, at *11. In
contrast, the Spooner special master rejected the idea that IVIG was surgical. Id. at
*13. This is consistent with the explanation in both Stavridis and Spooner that the
addition of surgical interventions in the statutory language was not intended to diminish
the Vaccine Act’s severity requirement and that any surgical intervention at issue should
be understood as an equivalent stand-in for six months of sequela or residual effects.
2009 WL 3837479, at *5-6; 2014 WL 504728, at *11.
Additionally, Ivanchuk and Leming likewise stand for the proposition that needle-
based procedures such as bone marrow aspiration, though not inherently surgical, may
be considered surgical when they rise to a level of concern such that a hospital facility
treats them with the same gravity as other, more invasive surgical procedures. Both
Ivanchuk and Leming stressed that they were limited to their facts and that bone
marrow aspiration should not be considered surgical in all instances. 2015 WL
6157016, at *3; 2019 WL 5290838, at *6. These decisions explained that the
procedures at issue were treated in all regards by the treating hospital as surgical in
nature. The Ivanchuk decision also considered the fact that the procedure was
performed – likely with an appropriate degree of hesitation – on an “incredibly young”
child and, again, with the added risk of general anesthesia.17 2015 WL 6157016, at *3
Petitioner contends, however, that requiring indicia of surgery such as the use of
consent forms and general anesthesia would read additional requirements into the
statutory language. (ECF No. 15, p. 15.) Petitioner focuses on the fact that not all
surgical procedures bear all of these hallmarks. Petitioner argues, for example, that
intussusception surgeries, cesarean sections, and breast augmentation surgeries may
all be performed with either general or local anesthesia; a fasciotomy may be performed
bedside in an emergency department; and a failure to obtain written consent for open
heart surgery would not alter the nature of that procedure. (Id. at 14-15.) However,
petitioner’s argument rests on a much different starting premise, namely that incisional
procedures can be recognized as surgical regardless of these specific distinctions. In
that context, petitioner may be correct that hypothetically the type of consent, type of
anesthesia, or location of the procedure, would not necessarily cause a procedure
17 In both Ivanchuk and Leming, the special master stressed that the child had undergone post-operative
recovery and monitoring protocols for potential complications from general anesthesia. 2015 WL
6157016, at *2; 2019 WL 5290838, at *6. This underscores the fact that general anesthesia is not viewed
as merely a measure of the gravity of the procedure, but also as a factor contributing additional risk.
15

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 16 of 18
otherwise commonly understood to be surgical to be excluded from any definition of
surgery.
This case, however, represents a different context. Both the above-discussed
case law and petitioner’s proffered AMA definition make clear that needle punctures are
not in all (or even most) instances surgical. With that as a starting premise, the
question posed by prior cases has been whether any militating factors suggest that a
type of procedure that is not necessarily viewed as surgical in all instances can rise to
the level and character of a surgery in a specific instance based on how it is viewed and
handled by the treating hospital. Spooner, Ivanchuk and Leming all answered yes
based on specific fact patterns that do not match the facts of this case. It is immaterial
that consent forms, operating rooms, and general anesthesia are not fundamental
aspects of the definition of surgery. These factors need not be definitional to have
provided additional indicia that a surgical procedure occurred. However, the presence
of these factors in some cases does not confer the same significance to all needle
punctures in all cases. Accordingly, the absence of these added factors in this case
does prevent petitioner from meaningfully or persuasively relying on these prior cases
as precedent favoring petitioner’s claim. On the whole, precedent weighs against
petitioner’s claim.
Finally, petitioner also stresses that these prior decisions confirm that lumbar
puncture and bone marrow aspiration require only a physician and not a surgeon. (ECF
No. 15, p. 12.) Significantly, however, as described above, the material submitted by
petitioner in this case confirms that arthrocentesis does not require any physician at all.
(Ex. 7, p. 1.) The mere fact that petitioner’s arthrocentesis was performed in this
instance by a physician does not alter the overall character of the procedure as one that
is so low-risk and minimally invasive as to not necessarily require a physician. In that
regard, Spooner similarly rejected the suggestion that IVIG is surgical in nature because
it was considered a nursing function.
c. Petitioner’s Arthrocentesis Likely was an Intervention
Both parties rely on the definition of “intervention” discussed in Spooner, i.e. a
procedure that would “alter the course of a disease. (ECF No. 13, p. 7 (quoting 2014
WL 504728, at *12; ECF No. 15, p. 16.) This phrasing has generally been understood
to mean that to be an intervention, a procedure must be a part of a treatment protocol
rather than merely diagnostic. E.g., Ivanchuk, 2015 WL 6157016, at *2-3. In this case,
both parties acknowledge that arthrocentesis can be used both diagnostically and
therapeutically. (ECF No. 13, p. 7; ECF No. 15, p. 5; Ex. 7, p. 1.) Specifically,
arthrocentesis may be used diagnostically to differentiate between septic arthritis and
inflammatory causes of arthritis. (Ex. 7, p. 1.) Respondent stresses that in petitioner’s
case this was explicitly indicated as the reason for the procedure and that it was billed
as a diagnostic procedure. (ECF No. 13, p. 8; ECF No. 18, p. 3; Ex. 4, pp. 53, 219,
250.) And while this is correct, arthrocentesis is also used for pain relief for “large and
painful joint effusions.” (Ex. 7, p. 1.) Petitioner stresses this aspect of the procedure.
(ECF No. 15, p. 16.)
16

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 17 of 18
Respondent is correct that the procedure served a diagnostic function; however,
the records also include notations that may suggest the procedure was also pursued at
least in part as a response to petitioner’s painful swelling. Moreover, petitioner is also
correct that a joint effusion had been identified in petitioner’s right knee, that reduction
of effusions is a recognized use of arthrocentesis, that 30ml of fluid was removed from
the knee, and that the effusion resolved during petitioner’s hospitalization. Drawing all
inferences in petitioner’s favor, the records support petitioner’s contention that,
regardless of the initial purpose, petitioner’s right knee arthrocentesis likely had the
effect of reducing her effusion. Thus, for purposes of this motion, I find that petitioner’s
right knee arthrocentesis constitutes an intervention within the meaning of the Vaccine
Act.
d. Additional Evidence is Necessary to Determine Whether Petitioner’s
Right Knee Arthrocentesis was in Treatment of her Alleged Vaccine
Reaction
In his motion to dismiss, respondent argues that petitioner’s medical records
show that her joint swelling was related to osteoarthritis and unrelated to her alleged
vaccine reaction. (ECF No. 13, pp. 8-9.) He stressed that petitioner’s initial symptoms
dissipated and that upon discharge her diagnosis was only “post vaccination fever.” (Id.
at 4, 9 (citing Ex. 4, p. 39-52, 222).) He also stressed that serum sickness was
considered during petitioner’s hospitalization, but believed to be unlikely. (Id.)
Petitioner counters, however, that her joint effusion and arthrocentesis occurred
in the context of a hospitalization for which petitioner’s primary intake diagnosis was
“other complications following immunization, not elsewhere classified,” and that she had
secondary diagnoses including “other serum reaction due to vaccination, initial
encounter,” and “adverse effect of other viral vaccines, initial encounter.” (ECF No. 15,
p. 7 (quoting Ex. 4, p. 219).) Moreover, petitioner was discharged with instructions to
follow up with her primary care physician. (Ex. 4, p. 221.) That primary care physician
in turn recorded a history of “serum sickness-like reaction” and recorded an impression
of “adverse reaction to mixed bacteria vaccine.” (Ex. 1, pp. 33, 35.)
Respondent challenges the weight that should be afforded the specific notations
highlighted by petitioner; however, the conflicting medical record notations being
debated by the parties speak to the question of petitioner’s correct diagnosis and
whether that diagnosis accounts for all or only some of petitioner’s symptoms. These
issues go to the core allegations of petitioner’s claim and are not appropriately resolved
at this time and on this motion.
In determining eligibility to compensation, a special master must consider the
diagnoses, conclusions and medical judgments reflected in the medical records;
however, “[a]ny such diagnosis, conclusion, judgment, test result, report, or summary
shall not be binding on the special master or court.” 42 U.S.C. § 300aa-13(b)(1).
Instead, petitioner may support her claim by either medical records or medical opinion.
17

Case 1:20-vv-00313-DAT Document 20 Filed 07/31/20 Page 18 of 18
Id. Moreover, special masters “must determine that the record is comprehensive and
fully developed before ruling on the record.” Kreizenbeck v. Sec’y of Health & Human
Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020); see also Vaccine Rule 8(d); Vaccine Rule
3(b)(2).
Here, further development of the record could ultimately validate respondent’s
argument. However, at this early juncture, petitioner has highlighted medical records in
which her treating physicians at least contemplated the possibility that serum sickness-
like reaction could explain her symptoms. Moreover, petitioner has provided a further
offer of proof in the form of an internet publication suggesting that serum sickness can
present with rheumatic features, including arthralgia of the knees as well as “tenderness
to palpation and movement” in a minority of patients. (Ex. 6, p. 8.) This is enough to
suggest that petitioner could potentially develop the record of this case in meaningful
ways if provided the opportunity.
Whether petitioner’s right knee arthrocentesis was performed in treatment of her
alleged vaccine reaction depends on petitioner’s correct diagnosis which is debated by
the parties and subject of conflicting notations in the medical records. For the reasons
discussed above, that question cannot be answered on the existing record. Accordingly,
it does not serve as a basis for granting respondent’s motion to dismiss.
VII. Conclusion
For all the reasons discussed above, I find that petitioner’s right knee
arthrocentesis is not a surgical intervention. Specifically, I conclude that it is not a
surgical procedure. Therefore, even with the benefit of all inferences, petitioner has
failed to state a claim upon which relief can be granted because she cannot meet the
statutory severity requirements pursuant to the Vaccine Act at §300aa-11(c)(1)(D).
According, respondent’s motion is GRANTED and this petition is dismissed.18
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
18 In the absence of a timely-filed motion for review of this Decision, the Clerk of the Court shall enter
judgment accordingly.
18

================================================================================
DOCUMENT 2: USCOURTS-cofc-1_20-vv-00313-1
Date issued/filed: 2021-01-11
Pages: 10
Docket text: PUBLIC DECISION (Originally filed: 12/17/2020) regarding 25 Order on Motion for Review, Judge Vaccine Order/Opinion. Signed by Judge David A. Tapp. (emc) Service on parties made.
--------------------------------------------------------------------------------
Case 1:20-vv-00313-DAT Document 27 Filed 01/11/21 Page 1 of 10
In the United States Court of Federal Claims
No. 20-313V
Filed1: January 11, 2021
ROSA SOTO GALVAN,
Plaintiff,
Keywords: National Vaccine
v.
Injury Compensation Program, 42
U.S.C. §§ 300aa-10 et seq. (2012);
SECRETARY OF HEALTH AND
Motion for Review; Arthrocentesis;
HUMAN SERVICES,
Severity Requirement.
Defendant.
Kristina K. Green, Kralovec, Jambois, & Schwartz, Chicago, IL, for Plaintiff.
Mary E. Holmes, Trial Attorney, Darryl R. Wishard, Assistant Director, Catherine E. Reeves,
Deputy Director, C. Salvatore D’Allessio, Acting Director, and Ethan P. Davis, Acting Assistant
Attorney General, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., for Defendant.
MEMORANDUM OPINION AND ORDER
TAPP, Judge.
In this vaccine case, Petitioner, Rosa Soto Galvan (“Galvan”), petitioned for
compensation pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§
300aa-10 et seq. (2012) (“Vaccine Act”), alleging that she suffered complications following the
administration of various vaccinations. (Compl., ECF No. 1). Regarding the Vaccine Act’s
severity requirement for remedies, Galvan alleged she experienced inpatient hospitalization and
surgical intervention, specifically arthrocentesis—a procedure in which accumulated fluid is
removed from a joint cavity by a needle. (Id. at 5). The Special Master reviewed Galvan’s claim,
ultimately concluding that Galvan “cannot meet the statutory severity requirements pursuant to
1 This Order was originally filed under seal on December 17, 2020, (ECF No. 25). The Court
provided parties the opportunity to review this opinion for any proprietary, confidential, or other
protected information and submit proposed redactions no later than January 6, 2021. The parties
did not file a status report indicating proposed redactions. In accordance with RCFC, App. B,
Vaccine Rule 18(b)(2), “an objecting party must provide the court with a proposed redacted
version of the decision. In the absence of an objection, the entire decision will be made public.”
Thus, the sealed and public versions of this Order are identical, except for the publication date
and this footnote.

Case 1:20-vv-00313-DAT Document 27 Filed 01/11/21 Page 2 of 10
the Vaccine Act at § 300aa-11(c)(1)(D)” because “arthrocentesis, though an intervention, is not a
surgical procedure.” (Galvan v. Sec’y of Health & Human Servs., No. 20-313V 2020 WL
4593163 (Fed. Cl. Spec. Mstr. July 6, 2020) at *1, *18, “Decision”, ECF No. 20). Consequently,
on July 6, 2020, the Special Master granted Respondent, the Secretary of Health and Human
Services’ (“the Secretary”), motion to dismiss pursuant to RCFC 12(b)(6).
On August 3, 2020, Galvan filed a Motion for Review, (ECF No. 22), before this Court
arguing that the Special Master’s legal conclusions and attendant factual findings should be set
aside as arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
(Pet.’s Mot. for Rev., ECF No. 22-1 at 20). The sole issue before the Court is whether the Special
Master’s conclusion is “arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B); RCFC, App. B, Vaccine Rule 27(b). As
explained below, the Court finds that the Special Master’s decision was not arbitrary, capricious,
or otherwise not in accordance with law. Therefore, the Court DENIES Galvan’s Motion for
Review and AFFIRMS the Special Master’s decision.
I. Background
On September 26, 2018, Galvan received vaccines for Hepatitis A, Hepatitis B,
Influenza, and Pneumococcal Conjugate (PVC 13). (Compl. at 2). Within one hour of the
administration of these vaccines, Galvan experienced abdominal pain and chills, and within four
hours, she experienced headache, nausea, vomiting, dizziness, chest pain and tightness, and
tachycardia. (Id. at 2). The same day, Galvan presented at and was admitted to the Emergency
Department at MacNeal Hospital in Berwyn, Illinois, where she would remain hospitalized until
October 1, 2018. (Id. at 2). Shortly after arrival, Galvan developed a fever and an abnormal
rhythm of sinus tachycardia. (Id. at 2–3). Thereafter, Galvan experienced swelling in her right
knee and effusion, along with redness and blistering on the right arm at the site of the vaccine
injection. (Compl. at 3, Ex. 4 at 220). Upon intake, Galvan was diagnosed with “other
complications following immunization, not elsewhere classified” and her discharge diagnosis
was “post-vaccination fever.” (Id. at 220, 222). During hospitalization, Galvan underwent
arthrocentesis of her right knee, a procedure where a needle is injected into the knee to drain
excess synovial fluid (i.e., effusion), thereby reducing swelling and pressure contributing to pain.
(Compl. at 3; see Compl., Ex. 4 at 220; Pet.’s Mot. for Rev. at 6). A rheumatologist performed
the arthrocentesis. (Pet.’s Ex. 5 at 3, ECF No. 17-1).
Galvan petitioned for vaccine compensation on March 20, 2020, claiming that
arthrocentesis constitutes a surgical procedure caused by her vaccine injury and that she was
entitled to compensation under the Vaccine Act. (See generally Compl.). The Secretary moved
for dismissal pursuant to RCFC 12(b)(6), arguing that Galvan’s claim failed to satisfy the
Vaccine Act’s severity requirement. (Mot. to Dismiss, ECF No. 13). The Special Master found
that arthrocentesis, though an intervention, is not a surgical intervention and granted the
Secretary’s Motion to Dismiss. (Decision at *1).
In 1986, Congress passed the Vaccine Act, establishing a program administered by the
Secretary of Health and Human Services to increase the safety and availability of vaccines. 42
U.S.C. § 300aa-1; Terran v. HHS, 195 F.3d 1302, 1307 (Fed. Cir. 1999). The Vaccine Act
created the National Vaccine Injury Compensation Program, through which claimants could
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petition for compensation due to alleged vaccine-related injuries or death. 42 U.S.C. § 300aa-
10(a). Under the Vaccine Act, there are two methods by which a petitioner may demonstrate
eligibility for an award. A petitioner may demonstrate with reliable medical evidence that
an injury listed on the Vaccine Injury Table occurred within the requisite period or that an
unlisted injury was caused-in-fact by a vaccine listed on the Table. 42 C.F.R. § 100.3; 42 U.S.C.
§ 300aa-11(c)(1)(C). In either instance, the Vaccine Act imposes a “severity requirement” on
petitioners. A petitioner must prove that the individual experiencing the alleged vaccine-related
injury:
(i) suffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury, or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.
42 U.S.C. § 300aa-11(c)(1)(D) (severity requirement). The underlying Motion to Dismiss was
predicated on whether Galvan met the requirement for “surgical intervention,” as it applies to the
severity requirement. To determine whether Galvan’s arthrocentesis constitutes a “surgical
intervention,” the Special Master considered: (1) Galvan’s “proffered evidence regarding the
correct understanding of ‘surgery;’” and (2) whether arthrocentesis should be considered surgical
in light of prior Vaccine Program case law (“Program case law”), interpreting the relevant
statutory language. (Id. at 11).2
Galvan cited the definition of “surgery” adopted by the American Medical Association
(“AMA”) based on a statement from the American College of Surgeons, which provides:
Surgery is performed for the purpose of structurally altering the human body
by the incision or destruction of tissues and is part of the practice of medicine.
Surgery also is the diagnostic or therapeutic treatment of conditions or
disease processes by any instruments causing localized alteration or
transposition of live human tissue which include lasers, ultrasound, ionizing
radiation, scalpels, probes, and needles. The tissue can be cut, burned,
vaporized, frozen, sutured, probed, or manipulated by closed reductions for
major dislocations or fractures, or otherwise altered by mechanical, thermal,
light-based, electromagnetic, or chemical means. Injection of diagnostic or
therapeutic substances into body cavities, internal organs, joints, sensory
organs, and the central nervous system also is considered to be surgery (this
does not include the administration by nursing personnel of some injections,
subcutaneous, intramuscular, and intravenous, when ordered by a physician).
All of these surgical procedures are invasive, including those that are
2 The Special Master also addressed whether Galvan’s arthrocentesis constituted an
“intervention” and whether it was the result of her alleged vaccine reaction, finding that Galvan’s
arthrocentesis likely constituted an “intervention” but that additional evidence was necessary to
determine whether the arthrocentesis was in treatment of her vaccine reaction. (Decision at 16–
18). This issue is not before the Court.
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performed with lasers, and the risks of any surgical procedure are not
eliminated by using a light knife or laser in place of a metal knife, or scalpel.
Patient safety and quality of care are paramount and, therefore, patients
should be assured that individuals who perform these types of surgery are
licensed physicians (defined as doctors of medicine or osteopathy) who meet
appropriate professional standards.
(Pet.’s Ex. 8, ECF No. 16-4) (emphasis added; bolding in original). Galvan further cited an
article describing how knee arthrocentesis is performed.3 (Halleh Akbarnia & Elise Zahn, Knee
Arthrocentesis, NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION (NCBI) BOOKSHELF,
Feb. 10, 2020; Pet.’s Ex. 7, ECF No. 16-3). Drawing all inferences in favor of Galvan, and
accepting the AMA definition and article, the Special Master concluded that arthrocentesis did
not fall within any of the three AMA descriptions of what constitutes surgery. (Decision at *9).
In relevant part, the Special Master found that the inclusion of the specific term “needle”
in the second description was not dispositive, as the description was “limited to the context of
‘localized alteration or transposition of live human tissue.’” (Id. at *10). The Special Master also
noted a distinction between drawing or removing fluid and injecting diagnostic and therapeutic
substances and agreed with the Secretary that Galvan’s proposed interpretation “fails to
meaningfully distinguish between a surgical procedure and a routine blood draw[.]” (Id.). In
response to Galvan’s argument that penetration of the skin by a needle constitutes “manipulation
of live tissue with an instrument,” the Special Master explained that “the AMA definition does
not discuss manipulation of tissue broadly . . . [r]ather, it discusses the specific procedure of
manipulation by closed reduction of major dislocations or fractures.” (Id. (internal quotations
omitted)).
The Special Master determined that the AMA definition as a whole makes clear that
arthrocentesis lacks the requisite gravity to constitute surgery, pointing to the AMA’s statement
that “[p]atients should be assured that individuals who perform these types of surgery are
licensed physicians (defined as doctors of medicine or osteopathy) who meet appropriate
professional standards.” (Decision at *11; Pet.’s Resp. Ex. 8 at 1). The Special Master
highlighted that arthrocentesis may be performed by a healthcare worker who has knowledge of
the anatomy of joints, thus it is distinguishable from the procedures included in the AMA
definition that are reserved for execution by licensed physicians. (Id.).
After finding that arthrocentesis did not constitute “surgery” under the AMA definition,
the Special Master analyzed prior Program case law that interpreted the term “surgical
intervention” and reached the same conclusion. (Id. at *11–14). The Special Master considered
3 The article describes knee arthrocentesis as a procedure performed to aspirate synovial fluid
from a joint cavity. (Pet.’s Ex. 7, at 1). Knee arthrocentesis can be performed by a clinician or
other medical care professional or healthcare worker and typically does not require assistance.
(Id.). The patient is placed in a comfortable position with the knee extended at 15–20 degrees
and a local anesthetic is used. (Id.). Knee arthrocentesis is normally performed as an outpatient
procedure. (Id.).
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four prior Program decisions that address whether certain needle-based procedures performed
during hospitalization constituted “surgical interventions” under the Vaccine Act. (Id. at *11–13
(citing Stavridis v. Sec’y of Health & Human Servs., No. 07-261V, 2009 WL 3837479 (Fed. Cl.
Spec. Mstr. Oct. 29, 2009); Spooner v. Sec’y of Health & Human Servs., No. 12-159V, 2014 WL
504728 (Fed. Cl. Spec. Mstr. Jan. 16, 2014); Ivanchuk v. Sec’y of Health & Human Servs., No.
15-357V, 2015 WL 6157016 (Fed. Cl. Spec. Mstr. Sept. 18, 2015); and Leming v. Sec’y of
Health & Human Servs., No. 18-232V, 2019 WL 5290838 (Fed. Cl. Spec. Mstr. July 12, 2019)).
Stavridis examined whether treatment with blood transfusion and intravenous steroids
constituted surgical interventions. 2009 WL 3837479, at *2. Ultimately, the Stavridis Special
Master rejected the petitioner’s proposed broad definition, finding that classifying intravenous
steroid injections or blood transfusions as surgical interventions would be overly inclusive. Id. at
*6. In 2014, Spooner considered whether a lumbar puncture and intravenous immunoglobulin
treatment were surgical interventions within the meaning of the Act. 2014 WL 504728, at *5.
Spooner deemed “surgery” to mean “the treatment of an injury with instruments or by the hands
of a surgeon.” Id. at *11. Using that definition, the Special Master in Spooner concluded that
neither a lumbar puncture nor intravenous immunoglobulin treatment constitutes surgical
interventions, explaining that “[a]lthough the scope of the phrase ‘surgical intervention’ is
broader than merely the surgery performed to correct intussusception, it is not so broad as to
exceed the common meaning of its component terms in the medical community.” Id. at *11.
Applying the Spooner definition, Ivanchuk yielded a different result. Ivanchuk, 2015 WL
6157016. There, the Special Master concluded that bone marrow aspiration and biopsy were
surgical interventions because, while not a treatment itself, it was performed as part of a protocol
for administering steroid treatment. Id. at *2–3. The Special Master in Leming likewise agreed
that a bone marrow biopsy constitutes a surgical intervention. 2019 WL 5290838.
Galvan argued that arthrocentesis is similar to both lumbar punctures and bone marrow
aspiration and biopsy, which were found to be “surgical” in Ivanchuk and Leming. (Pet.’s Resp.
at 13). Galvan further argued arthrocentesis is akin to these procedures because arthrocentesis,
lumbar punctures, as well as bone marrow aspiration and biopsy involve a needle penetrating the
cutaneous and subcutaneous tissue and some type of microbiologic analysis being performed
after extraction. (Id. at 13). The Special Master disagreed, finding that the “key characteristic” of
lumbar punctures and bone marrow aspirations is that they penetrate beyond the cutaneous and
subcutaneous tissue. (Decision at *11). Further, the Special Master distinguished Galvan’s
arthrocentesis from the facts in Ivanchuk and Leming on the basis that MacNeal Hospital—where
Galvan was treated—did not take steps to classify the arthrocentesis as “surgical,” namely that
arthrocentesis at MacNeal Hospital did not require general anesthesia, was conducted bedside
rather than in an operating room, and did not require written consent. (Id.). The Special Master
also relied on the fact that arthrocentesis does not require a physician at all and found the fact
that a physician performed Galvan’s procedure was not dispositive. (Id. at *13).
In addition, the Special Master partially relied upon the legislative history of the Vaccine
Act’s severity requirement, noting that the addition of surgical interventions in the statutory
language was not intended to diminish the Vaccine Act’s severity requirement and that any
surgical intervention at issue should be understood as an equivalent stand-in for six months of
sequela or residual effects. (Id. at *12 (citing Stavridis, 2009 WL 3837479 at *5–6; Spooner,
2014 WL 504728 at *11)). Galvan challenges these conclusions.
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II. ANALYSIS
Under the Vaccine Act, the Court reviews a decision of the Special Master upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2) (2018). In reviewing such
decisions, the Court may:
(A) uphold the findings of fact and conclusions of law . . . , (B) set aside any
findings of fact or conclusion of law . . . found to be arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with law . . . , or, (C)
remand the petition to the Special Master for further action in accordance
with the court’s direction.
42 U.S.C. § 300aa-12(e)(2)(A)–(C). Findings of fact and discretionary rulings are reviewed
under the arbitrary and capricious standard, while legal conclusions are reviewed de novo. Munn
v. Sec’y of Dep’t of Health and Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). This
Court cannot “substitute its judgment for that of the Special Master merely because it might have
reached a different conclusion.” Snyder v. Sec’y of Health and Human Servs., 88 Fed. Cl. 706,
718 (2009). Rather, “[r]eversal is appropriate only when the Special Master’s decision is
arbitrary, capricious, an abuse of discretion, or not in accordance with the law.” Id. Under this
“highly deferential” standard, a Special Master’s decision need only “articulate a rational
connection between the facts found and the choice made” in order to be upheld. Cucuras v. Sec’y
of Dep’t of Health and Human Servs., 26 Cl. Ct. 537, 541 (1992), aff’d, 993 F.2d 1525 (Fed. Cir.
1993) (citing Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). As such,
if the Special Master “has considered the relevant evidence of record, drawn plausible
inferences[,] and articulated a rational basis for the decision, reversible error will be extremely
difficult to demonstrate.” Id. at 541–42 (quoting Hines ex rel. Sevior v. Sec’y of Dep’t of Health
and Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
Galvan’s Motion for Review raises three objections to the Special Master’s decision.
(Pet.’s Mot. for Rev. at 3). Namely, Galvan objects to the Special Master’s application of the
AMA definition, his analysis of case law, and the characterization of arthrocentesis as a nursing
function. (Id.). Galvan requests that “this Court set aside the Special Master’s legal conclusion
that Petitioner’s arthrocentesis was not a surgical procedure and attendant factual findings and
issue its own finding that Petitioner’s arthrocentesis was in fact surgical within the meaning of
Vaccine Act, . . .[and] reinstate the Petition for further proceedings.” (Id. at 20). In the
alternative, Galvan requests that “this Court set aside the Special Master’s legal conclusion that
Galvan’s arthrocentesis is not a surgical procedure and attendant factual findings,” reinstate the
Petition and remand this matter back to the Special Master for an opportunity to obtain an expert
medical opinion as to whether arthrocentesis is surgical in nature. (Id. at 20–21). The Court will
address Galvan’s arguments in turn.
Principally, Galvan argues that the Special Master erred by “mischaracterizing” the
“precedent” in prior Program cases. (Pet.’s Mot. for Rev. at 3–4, 9–12). Galvan further asserts
that the Special Master’s decision is contrary to the plain meaning of the statutory language and,
in effect, creates new limitations and conditions on the severity requirement that the legislature
did not intend to create. (Id. at 4). That assertion is incorrect. Citing Stavridis and Spooner, the
Special Master determined that “the addition of surgical interventions in the statutory language
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was not intended to diminish the [severity requirement] and that any surgical intervention at
issue should be understood as an equivalent stand-in for six months of sequela or residual
effects.” (Decision at *12 (citing prior Program cases)). Galvan argues that this statement creates
an incorrect bright-line rule that surgical interventions “which are minor, low-risk, minimally
invasive or relatively simple are insufficient to satisfy the [severity requirement],” and that this
proposition is both unsupported by case law and the plain meaning of the Vaccine Act statutory
language. (Pet.’s Mot. for Rev. at 10). (Id.).4
In reaching his conclusion, the Special Master relied upon Program case law, the
surrounding statutory language, and legislative history of the Vaccine Act in concluding that
arthrocentesis did not satisfy the Vaccine Act’s severity requirement. Though prior Program case
law is not binding upon Special Masters, it may be used as an analytical tool. Other Special
Masters have followed this framework in interpreting the severity requirement. (Decision at *11
(citing Stavridis, 2009 WL 3837479; Spooner, 2014 WL 504728)). Further, the statute must be
interpreted as a unified whole. See Spooner, 2014 WL 504728, at *10 (citing Saunders v. HHS,
25 F.3d 1031, 1035 (Fed. Cir. 1994) (“[I]t is a settled rule of statutory interpretation that a statute
is to be construed in a way which gives meaning and effect to all of its parts.) “It is a principle of
statutory interpretation . . . that a court should seek to avoid construing a statute in a way which
yields an absurd result and should try to construe a statute in a way which is consistent with the
intent of Congress.” Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1570–71
(Fed. Cir. 1993). Following that logic, prior Program case law has held that “a court should
‘construe a statute in a way which is consistent with the intent of Congress,’ [thus] it is also
appropriate to consider the Act’s legislative history.” Spooner, 2014 WL 504728, at *10 (quoting
Hellebrand, 999 F.2d at 1570–71). Galvan presents no reason why this framework, followed by
other Special Masters in analyzing an issue similar to that presented here, is contrary to law.
Following this analysis, the Special Master correctly considered case law and the Vaccine
Act’s legislative history. The Special Master concluded that Galvan’s proposed definition of
“surgical” did not comport with the section of the statute where the term appears. (Decision at
*12). This argument is facially inconsistent with other provisions of the statute and was properly
rejected by the Special Master through his analysis of Spooner and Stavridis. (Id. (“[B]oth
Stavridis and Spooner [explain] that the addition of surgical interventions in the statutory
language was not intended to diminish the Vaccine Act’s severity requirement and that any
surgical intervention at issue should be understood as an equivalent stand-in for six months of
sequela or residual effects.”)). The Special Master appropriately considered petitioner’s knee
arthrocentesis in the context of 42 U.S.C. § 300aa-11(c)(1)(D) as a whole and concluded the
severity requirement was not met, and it cannot be said that this conclusion is arbitrary,
capricious, or otherwise not in accordance with the law.
4 Galvan points to Leming, where the Special Master refused to consider the legislative history of
the severity requirement. Leming v. Sec’y of Health & Human Servs., No. 18-232V, 2019 WL
5290838 at *6 (Fed. Cl. Spec. Mstr. July 12, 2019). As previously noted, prior Program cases are
not binding on Special Masters, thus the Special Master’s analysis in Leming is not dispositive.
See Hanlon, 40 Fed. Cl. at 630.
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In reference to the Special Master’s finding that arthrocentesis did not fit any of the three
AMA descriptions of “surgery,” (Decision at *9–12), Galvan presents two arguments to the
contrary. (Pet.’s Mot. for Rev. at 13–14). First, Galvan argues that the Special Master’s
interpretation of the AMA definition is too narrow. (Id. at 14). Galvan posits that the AMA
definition discusses the manipulation of tissue more broadly, including both the manipulation of
tissue “by closed reduction for major dislocations . . .” or “otherwise altered by mechanical . . .
means.” (Id. at 14). Second, Galvan argues that the alteration of tissue in arthrocentesis is more
extensive than the Special Master considered. (Id.). Galvan explains that the needle utilized
during arthrocentesis does not merely penetrate the skin and remove bodily fluid, but also
penetrates the tissue, joint cavity, and synovial membrane. (Id.). Thus, Galvan argues that the
Special Master’s finding that arthrocentesis does not fit the AMA definition should be set aside.
Because the Vaccine Act does not define “surgical intervention,” standard medical definitions
are informative as to the meaning of Section 11(c)(1)(D)(iii). See Spooner, 2014 WL 504728 at
*10 (citing Abbot v. Sec’y of Health & Human Servs., No. 93-5129V, 19 F.3d 39, slip. op. at *6
(Fed. Cir. 1994)). The Special Master accepted Galvan’s proposed AMA definition and
thoroughly detailed his conclusion that arthrocentesis did not fit within that definition. (Decision
at *9–12). The Special Master accepted and analyzed whether arthrocentesis is “surgical” in the
context of the AMA definition but ultimately relied upon case law, the surrounding statutory
language, and the legislative history of the Vaccine Act. (See id.). Special masters may consider
definitions from other sources, such as the AMA, but they are not bound to apply them. Medical
dictionary definitions are informative, but the relevant statutory language is controlling on term
interpretation. Hellebrand, 999 F.2d at 1570–71 (citing Haggar Co. v. Helvering, 308 U.S. 389,
394 (1940)). Galvan’s arguments to this point have not presented any reason to abandon this
fundamental principle. Here, the Special Master considered the AMA definition of arthrocentesis
but ultimately found the procedure did not satisfy the severity requirement. (Decision at *9–12).
Although Galvan disagrees with the Special Master’s analysis, it is supported by substantial
evidence and not contrary to law, thus the Court will not substitute its own judgment for that of
the Special Master. Snyder, 88 Fed. Cl. at 718.
Lastly, in an effort to argue that arthrocentesis is not a nursing function akin to blood
draws, Galvan points to various medical articles that indicate arthrocentesis cannot be performed
by any healthcare worker, as suggested by the Special Master’s decision. (Pet.’s Mot. for Rev. at
15–20). Specifically, Galvan objects to the Special Master’s finding that “there are no
distinctions between Petitioner’s knee arthrocentesis and IVIG treatment, blood transfusions or
blood draws[.]” (Pet.’s Mot. for Rev. at 15–20; Decision at *10). Galvan asserts that these
findings were merely an adoption of the Respondent’s lay arguments and were not reasonably
based on medical opinion. (Pet.’s Mot. for Rev. at 3–4, 15–20). The United States argues that the
Decision did not rest solely upon the identity or qualifications of persons able to perform
arthrocentesis. (Respondent’s Resp. at 12). The Court finds that this argument mischaracterizes
the Special Master’s findings and ultimately agrees with the Secretary. The underlying decision
states, “the mere fact that petitioner’s arthrocentesis was performed in this instance by a
physician does not alter the overall character of the procedure as one that is so low-risk and
minimally invasive as to not necessarily require a physician.” (Decision at *13). This statement
indicates that the identity of the person performing the procedure was ancillary to the character
of the procedure itself. In reference to the character of the procedure, the Special Master
accepted Galvan’s proffered AMA definition and after careful analysis, found that arthrocentesis
did not fit any of the three descriptions, showing that the Special Master conducted a detailed
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review of the AMA definition as a whole as well as considering the three discrete definitions of
surgery. (Id. at *9–12). As such, the identity of the person who performs the arthrocentesis, while
it was considered, was merely a single element in a host of other factors considered by the
Special Master and not dispositive to the decision. Based on the foregoing, the evidence
presented in Galvan’s Motion for Review regarding the qualifications needed to perform
arthrocentesis does not constitute grounds for reversal.
As an alternative, Galvan summarily requests a remand to present expert testimony on
whether her procedure was “surgical.” (Pet.’s Mot. for Rev. at 20). Galvan’s argument is largely
predicated on Stavridis where the Special Master relied on the unrebutted medical testimony
from the respondent’s expert who testified that blood transfusions and intravenous delivery of
medications are considered non-operative. (Id. (citing 2009 WL 3837479, at *5)). The Secretary
disagrees that Stavridis stands for the premise that expert testimony is necessary when
considering surgical intervention and argues that courts may reasonably use resources such as
medical dictionaries and treating physician records to determine whether a procedure is
“surgical.” (Respondent’s Resp. at 14).
The Court of Federal Claims may remand a vaccine case to the Special Master “for
further development of the evidentiary record, as well as additional fact-finding.” See Hokkanen
v. Sec’y of Health & Human Servs., 94 Fed. Cl. 300, 302 (2010); 42 U.S.C. § 300aa–12(e)(2). In
keeping with the “inquisitorial format” of Vaccine Program proceedings, Special Masters
exercise unique control over the evidence to be adduced and considered. Snyder ex rel. Snyder,
88 Fed. Cl. at 738 (citing H.R.Rep. No. 101-386, at 87). This Court sees no need for additional
proceedings in this case, as the Special Master was perfectly capable of gatekeeping and
consideration of evidence before him. Before the Special Master were Primary Care Associates
records (Compl., Ex. 1), an Affidavit by Galvan (Compl., Ex. 2), Jen Care Senior Center records
(Compl., Ex 3), and MacNeal Hospital records (Compl., Ex. 4), totaling 929 pages of records. In
reference to the Secretary’s Motion to Dismiss, Galvan produced 91 pages of additional exhibits.
(See Pet.’s Ex. 5–16, ECF Nos. 16, 21). The development of a more profuse record is unlikely to
alter the result of the Special Master’s findings. Thus, remand for the admittance of expert
testimony would be futile. The Court finds that the record before Special Master was appropriate
to make the requisite findings of fact and conclusions of law and prepare its decision dismissing
Galvan’s petition. As such, remand is unwarranted.
III. Conclusion
Based on the foregoing, the Court finds that the Special Master considered the relevant
evidence of record, drew plausible inferences, and articulated a rational basis for the decision.
the Special Master’s July 6, 2020 decision was not arbitrary, capricious, an abuse of discretion,
or contrary to law. Thus, the Court hereby DENIES Galvan’s Motion for Review, (ECF No. 22),
and AFFIRMS the Special Master’s July 6, 2020 decision. The Clerk is directed to enter
judgment accordingly.
The Court has filed this ruling under seal. The parties shall confer to determine proposed
redactions to which all the parties agree. Per Vaccine Rule 18(b), no later than January 4, 2021,
the parties shall file a joint status report indicating their agreement with the proposed redactions,
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attaching a copy of those pages of the Court’s ruling containing proposed redactions, with all
proposed redactions clearly indicated.
IT IS SO ORDERED.
s/ David A. Tapp
DAVID A. TAPP, Judge
10