The opinion
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.
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
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
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
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 29 th 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
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
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
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
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
(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
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
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
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
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
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
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
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
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