Galvan v. Secretary of Health and Human Services

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

2

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.).

4

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.

5

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