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

In the United States Court of Federal Claims
No. 20-313V
Filed 1: January 11, 2021
ROSA SOTO GALVAN,
Plaintiff,
Keywords: National Vaccine
v.
Injury Compensation Program, 42
SECRETARY OF HEALTH AND U.S.C. §§ 300aa-10 et seq. (2012);
HUMAN SERVICES, Motion for Review; Arthrocentesis;
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.
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.
3
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
6
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.
7
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
8
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,
9
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