Flores v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 18-759V
Filed: November 30, 2021†
SARAH FLORES and RYAN C. FLORES,
on behalf of M.F., a minor child,
Petitioners,
v.
SECRETARY OF HEALTH AND
HUMAN SERVICES,
Respondent.
Jennifer Anne G. Maglio, Maglio Christopher & Toale, Sarasota, Florida, for Petitioner.
Kyle E. Pozza, Trial Attorney, Traci R. Patton, Assistant Director, Heather L. Pearlman, Acting
Deputy Director, C. Salvatore D’Alessio, Acting Director, and Brian M. Boynton, Acting
Assistant Attorney General, Torts Branch, Civil Division, United States Department of Justice,
Washington, D.C., for Respondent.
MEMORANDUM OPINION AND ORDER
TAPP, Judge.
Stripped of legalese and dense medical terminology, this case involves the effects of the
measles, mumps, and rubella (“MMR”) vaccine on a 14-month-old infant (“M.F.”). Shortly
following vaccination, M.F. developed an illness that Sarah Flores and Ryan C. Flores, parents
and natural guardians of M.F., believed could be attributed to the administration of the vaccine.
They filed a petition seeking compensation pursuant to the National Childhood Vaccine Injury
Act of 1986, Pub. L. No. 99-660, title III, Nov. 14, 1986, 100 Stat. 3755 (codified as amended at
42 U.S.C. §300aa-10, et seq.) (the “Vaccine Act” or “Vaccine Law”).
The compensation program established by the Vaccine Act qualifies petitioners for
compensation if they can establish that a vaccine injury led to “inpatient hospitalization and
surgical intervention,” (“surgical intervention provision”) or caused “residual effects or
†
This opinion was originally filed under seal on November 5, 2021. Pursuant to Vaccine Rule
18(b), the Court provided the parties with the opportunity to review this opinion for any
proprietary, confidential, or other protected information and submit proposed redactions no later
than November 26, 2021. The parties did not propose any redactions, and, accordingly, this
opinion is reissued for public access without redactions.
complications” that lasted “for more than 6 months after the administration of the vaccine”
(“residual effect provision”). 42 U.S.C. §300aa-11(c)(1)(D)(i),(iii). Here, the Chief Special
Master found that the child qualified for compensation under both conditions. The Respondent,
Secretary of Health and Human Services (“the Secretary”) objects. The Court affirms the Chief
Special Master’s finding that the Petitioner qualifies for compensation because of the residual
effects of her injury but sets aside the Chief Special Master’s finding that the child underwent
“inpatient hospitalization and surgical intervention.”
I. BACKGROUND
On June 23, 2016, M.F. received an MMR vaccine. This vaccine protects against three
diseases: measles, mumps, and rubella.1 (Petitioner’s Exhibit “Ex.” 1 at 1, ECF No. 7).
Following vaccination, and after two accidental falls, M.F.’s parents noticed bruising and small
red spots (later assessed to be petechiae) on her body. (Ex. 2 at 53). M.F.’s parents transported
her to the Emergency Room on July 20, 2016, where she was assessed with a scalp contusion
from her fall and diagnosed with severe idiopathic thrombocytopenic purpura (“ITP”), a
condition in which a significant decrease in the number of blood platelets contributes to
excessive bleeding and significant bruising. (Ex 9. at 33–34). Laboratory tests showed that
M.F.’s blood platelet count was at two thousand.2 (Ex. 10 at 9).
Doctors admitted M.F. to the hospital on July 20, for a hematology consultation. (Id.).
She began receiving intravenous immune globulin (“IVIG”), with the goal of elevating her
platelet counts.3 (Id.) doctors recommended discharging M.F. after platelet levels went beyond
20 thousand. (Ex. 10 at 9–13). The medical assessment also noted that, should her platelet counts
remain low, a “bone marrow/biopsy” needed to be considered “as next step in order to consider
steroid trial as long as bone marrow findings are consistent with ITP.” (Id.).
After M.F.’s platelet count reached 23 thousand, doctors discharged M.F. from the
hospital on July 23, 2016, with follow-up labs scheduled with her pediatrician. (Id. at 9, 13, 216).
During her follow up visit, lab tests again showed a short-lived response to IVIG treatment, with
blood platelet levels back at 2 thousand. (Id. at 216, 219). M.F.’s pediatrician and the hospital
determined that she should be re-admitted to the hospital to begin steroid treatment and “likely
1
Measles, Mumps, and Rubella (MMR) Vaccination: What Everyone Should Know, CENTERS
FOR DISEASE CONTROL & PREVENTION, https://www.cdc.gov/vaccines/vpd/mmr/public/
index.html#what-is-mmr (last visited Oct. 22, 21).
2
The normal range for children is between 150-400, and for infants between 200-475. K. Pagana
& T. Pagana, MOSBY’S MANUAL OF DIAGNOSTIC AND LABORATORY TESTS (4th. Ed. 2010) at
416.
3
IVIG treatment introduces immunity against a specific disease to immunodeficient persons
through the intravenous (“IV”) administration of immunoglobulin (“IG”), an antibody-containing
solution derived from the plasma of adult humans. Robert M. Kliegman et al., NELSON
TEXTBOOK OF PEDIATRICS 881-82 (19th ed. 2011).
2
undergo bone marrow testing” to “confirm diagnosis.” (Id. at 216; Ex.15 at 164). On July 26th,
M.F. underwent bone marrow aspiration and biopsy. (Ex. 10 at 494). The results of the operation
indicated that “[t]he morphology in bone marrow and peripheral blood” were most consistent
with ITP and that “[n]o evidence of Leukemia” was seen. (Id. at 448).
Medical professionals use bone marrow biopsy to assist in determining whether the
marrow is producing a normal level of blood cells.4 Dependent on the circumstances, such
biopsies may be done on an in-patient or out-patient basis and may use general or local
anesthetics. See Bone Marrow Biopsy and Aspiration, Mayo Clinic; see also, e.g., Faup v. Sec’y
of Health & Hum. Servs., No. 12-87V, 2017 WL 2257429, at *2 (Fed. Cl. Apr. 21, 2017). Here,
the biopsy’s pre-operation steps included filling out a “pre-surgery” checklist and completing
surgical and anesthesia consent forms. (Ex. 10 at 294–303, 312). During the procedure, which
was conducted under general anesthesia, a radiologist made a 3-millimeter incision in M.F.’s
pelvis, inserted a boring needle through the bone into the marrow, and then aspirated marrow
needed for testing. (Ex. 10 at 222, 317, 483, 494). After the procedure was completed, M.F.
spent an hour and a half in the hospital’s post-anesthesia care unit (“PACU”) (Id. at 456). After
the bone marrow operation, M.F. remained in the hospital to begin the steroid course that same
night, consisting of Prednisone and Zantac for gastrointestinal protection. (Id. at 220). Doctors
released M.F. from the hospital on July 28, 2016, with a blood platelet count of 6 thousand; the
treatment plan included Prednisone and Zantac and checking platelet counts weekly to wean off
the prescription as platelet counts normalized. (Id.)
Gradually, M.F.’s blood platelet counts returned to normal levels, and M.F.’s treating
physician ordered a reduction in her medications in early September 2016. (Ex. 2 at 41, 53–54).
Despite fluctuating, M.F.s platelet counts remained within the normal range long enough for the
doctors to again decrease her steroid dosage later that month. (Ex. 2 at 33–35). Thereafter,
M.F.’s blood platelets remained “within normal limits” over the upcoming months. (Ex. 2 at 19).
On November 4, 2016, she was reported to be “fully off medication . . . for a couple of days,” to
“take a break,” from lab testing. (Ex. 2 at 12). M.F. continued to be tested throughout the rest of
2016, and as late as February 10, 2017 (six months and 21 days after M.F. was first assessed with
ITP); the lab tests showed that she maintained normal platelet count. (Ex. 2 at 6–7, 11).
On May 30, 2018, M.F.’s parents filed a petition for compensation under the Vaccine Act
and submitted medical records establishing the facts described above. (See generally Pet., ECF
No. 1). The Petition claimed that M.F. was entitled to compensation because the “related injuries
[had] lasted more than six months,” and “the minor child underwent hospitalization and surgical
intervention as the result of her vaccine injury.” (Id. at 3). The Chief Special Master issued the
Ruling on Entitlement on February 1, 2021, finding that the Petitioner was entitled to
compensation. (See ECF No. 59). Subsequently, the Chief Special Master issued a decision
awarding damages according to the parties’ agreement. (ECF No. 67). The Secretary reserved the
right to seek review of the Chief Special Master’s Findings of Fact and Conclusion of Law and
4
Bone Marrow Biopsy and Aspiration, Mayo Clinic, https://www.mayoclinic.org/tests-
procedures/bone-marrow-biopsy/about/pac-20393117 (last visited Oct. 25, 2021).
3
filed the motion to review on June 6, 2021. (Mot. for Review (“Resp’t’s Mot.”), ECF No. 68; see
also Findings of Fact and Conclusions of Law (“Facts and Law Ruling”), ECF No. 50).
II. ANALYSIS
Under the Vaccine Act, the judges of the Court of Federal Claims review a decision from
the Office of Special Masters to determine if it is “arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law[.]” 42 U.S.C. § 300aa-12(e)(2)(B). Upon review, the Court
may either uphold findings of fact and conclusions of law, remand the petition to the special
master for further action, or set aside the findings of fact or conclusions of law and issue its own.
Id. In considering the Motion for Review and the record below, the Court applies the arbitrary
and capricious standard to factual findings and reviews all legal conclusions de novo. Munn v.
Sec’y of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
A. Inpatient Hospitalization and Surgical Intervention
The parties disagree on whether the legislative language that seeks to compensate those
with vaccine-related injuries who undergo “inpatient hospitalization and surgical intervention”
extends to patients who receive bone marrow aspiration and biopsy. (See Resp’t’s Mot. at 7). The
Vaccine Act does not define “inpatient hospitalization and surgical intervention.” Neither has the
Federal Circuit addressed the definition before. A few decisions by the special masters have
sought to define its contours. First, in Stavridis v. Sec’y of Health & Hum. Servs., No. 07-261V,
2009 WL 3837479 (Fed. Cl. Spec. Mstr. Oct. 29, 2009), the question revolved around whether
intravenous steroid treatments and blood transfusion qualified as surgical intervention. There, the
Special Master refused to adopt a broad medical dictionary definition of “surgical intervention,”
holding that neither “the proposed medical definition of surgery” nor “lay persons”
understanding of that term’s ordinary meaning would encompass procedures such as “injections
of medication or blood transfusions.” Id. at *6.
Subsequently, in Spooner v. Sec’y of Health & Hum. Servs., No. 13-159V, 2014 WL
504728 (Fed. Cl. Spec. Mstr. Jan. 16, 2014), the Special Master reviewed the question of
whether a lumbar puncture and IVIG treatment qualified patients. The petitioner in Spooner
preferred a broad definition. Id. at *7. They argued that any “invasive” procedure that aims “to
remove or repair part of the body or to find out whether disease is present” qualifies as a surgical
intervention. Id. at *8. The respondent in Spooner focused instead on the underlying purpose of
the intervention, intending to draw a clearer line between “diagnostic procedures” and
“treatment[s].” Id. The respondent in Spooner also urged the Special Master to consider the type
of healthcare professional who performs a given procedure, as well as other trappings of the
procedure, such as the use of general anesthesia, as relevant factors in determining whether a
medical procedure counts as surgical intervention. Id. at *8–9. Reviewing the medical dictionary
definitions of the terms “surgical” and “intervention,” Spooner arrived at the following definition
for “surgical intervention”: “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. at *10.
Under this definition, in Spooner, neither the lumbar puncture nor the IVIG treatment
qualified as surgical interventions for different reasons. IVIG treatment did improve health or
alter the course of the disease (therefore, was an intervention) but was not a surgery, because it
4
was administered by a nurse, carried low risk, and did not require anesthesia. Id. at *12–13. A
lumbar puncture, on the other hand, did qualify as a surgery, as it was performed in an operating
room with the use of general anesthesia yet was not an “intervention” because it was mainly
conducted for diagnostic purposes (therefore, not intended to improve health or alter the course
of the disease). Id. at *11–13.
Ivanchuk v. Sec’y of Health & Hum. Servs., No. 15-357V, 2015 WL 6157016 (Fed. Cl.
Spec. Mstr. Sept. 18, 2015), followed and was the first attempt at resolving whether a bone
marrow biopsy constituted “surgical intervention.” Ivanchuk adopted Spooner’s definition of
surgical intervention. Id. at *2. First, Ivanchuk held that a bone marrow operation is a surgical
operation due to the use of anesthesia, existence of a preoperative checklist and consent forms,
and the potential risks of such a procedure. Id. But in determining whether the operations
qualified as an “intervention,” Ivanchuk recognized that Spooner’s exclusion of diagnostic
procedures from the definition presented “an incomplete characterization.” Id. at *3. That is
because, even though the bone marrow aspiration and biopsy did not directly improve health or
alter the course of the disease, they might have done so indirectly. Id. Concerned with the full
application of Spooner, the special master in Ivanchuk narrowly tailored its finding to the facts of
the case, holding that because the bone marrow operation played “an integral part” in
determining the course of the treatment going forward, it did constitute an intervention. Id.Uncertainty persisted as to whether procedures that are not mainly aimed at treating the
underlying condition can be considered intervention merely because they can have an impact on
the course of treatment. After Ivanchuk, Leming v. Sec’y of Health & Hum. Servs., No. 18-232V,
2019 WL 5290838 (Fed. Cl. Spec. Mstr. July 12, 2019), wrestled with the same issue, and the
Special Master once again departed from the bright-line rule in Spooner. Id. at *6 (describing
that the case presented an “atypical situation” outside of Spooner’s definition of “intervention”).
In that instance, the Special Master found that because the bone marrow operation had an impact
on the course of steroid treatments prescribed after the operation, it was not merely diagnostic
and qualified as an “intervention.” Id. Following a motion for review from that case, the Court of
Federal Claims reversed that decision. Leming v. Sec’y of Health & Hum. Servs., 154 Fed. Cl.
325, 2021 WL 2708938 (2021).5 Chief Judge Kaplan agreed with the Special Master that the use
of general anesthesia, existence of surgical consent forms, and characterization of an incision
wound qualified the bone marrow operation as a surgery. Id. at *6. Chief Judge Kaplan,
however, reversed the Special Master’s determination that the operation involved an
“intervention,” holding that the qualification should be exclusively reserved for surgical
procedures that are administered “to directly treat” the underlying illness after it has been
diagnosed. Id. at *7.
Against the background of this Vaccine Act case law, in this case, the Chief Special
Master’s Findings of Fact and Conclusions of Law regarding M.F.’s bone marrow biopsy
determined that her biopsy was “somewhat diagnostic,” and therefore qualified as a surgical
5
Neither previous decisions of special masters nor other decisions of the Court on this matter set
binding precedent for a separate and distinct case pending in the Court such as this. W. Coast
Gen. Corp. v. Dalton, 39 F.3d 312, 315 (Fed. Cir. 1994).
5
intervention. (Facts and Law Ruling at 7, ECF No. 50). The Secretary urges the Court to reverse
the Chief Special Master’s decision and reject the reasoning that bone marrow operations can
qualify as a “surgical intervention” even if they can be conceived as having a “dual character”
(having seemingly assisted in both diagnosis and treatment). (Resp’t’s Mot. at 16, ECF No. 68).
Further, the Secretary contends that categorizing bone marrow operations as “somewhat
diagnostic”—as the Chief Special Master did—creates a slippery slope whereby any diagnostic
procedure with some “bearing on subsequent treatment” will be considered an “intervention.”
(Id. at 11). Such an approach, the Secretary argues, betrays the congressional intent behind the
Vaccine Act’s severity requirement by allowing minimally invasive cases to qualify for
compensation. (Id. at 18–19). Conversely, the Petitioner argued that adherence to a bright-line
rule separating diagnostic procedures from curative procedures fails to capture the complexity of
many medical procedures that blur that line. (Petitioner’s Response to Motion to Review (“Pet.’s
Resp.”) at 15, ECF No. 72).6
As the post-Spooner Vaccine Act case law indicates, this case presents the rare case in
which the dictionary definition adds to the ambiguity in the phrase “surgical intervention,” as
opposed to curing it. Although Spooner’s dictionary-guided definition attempts to extrapolate the
meaning of “intervention” as the act of “improving health or altering the course of a disease,”
that phrase does not announce its relationship to the term diagnosis any better than the term
“intervention” does. The dictionary definitions of the term intervention, though informative,
simply do not resolve the ambiguity as to what surgical procedures were intended to be covered
by the law. The Court must therefore resort to a deeper analysis of the context in which the
phrase surgical intervention appears in order to resolve the ambiguity.
In interpreting statutes, the Court must adhere to plausible interpretations of the statutory
text that would “give effect to the intent of Congress.” In re Swanson, 540 F.3d 1368, 1375 (Fed.
Cir. 2008). The Court therefore looks not only to the particular text but “to the design of the
statute as a whole and to its object and policy.” Id. (citing Crandon v. United States, 494 U.S.
152, 158 (1990)).
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. Sec’y of Health & Hum. Servs., 195 F.3d 1302, 1307 (Fed. Cir.
1999). The Vaccine Act created the National Vaccine Injury Compensation Program, through
6
The Petitioner incorrectly frames the Chief Special Master’s decision with regards to the
surgical intervention provision as one of applying an already “accepted interpretation of the
statute” to the facts of this case. (Pet.’s Resp., at 5). Based on this framing, the Petitioner
believes that the decision should be reviewed under the more deferential arbitrary and capricious
standard of review. (Id.). The Chief Special Master’s decision involved reviewing a “divergence”
in case law on how to interpret the surgical intervention provision’s language and ultimately
adopting one approach in favor of the other. (Facts and Law Ruling, at 4,7). Statutory
interpretation is a question of law, and, therefore, the Court reviews that ruling de novo. Hanlon
v. Sec’y of Health & Hum. Servs., 191 F.3d 1344, 1348 (Fed. Cir. 1999); see also Leming, 154
Fed. Cl. 325, 333 n.6 (2021).
6
which claimants could petition for compensation due to alleged vaccine-related injuries or death.
42 U.S.C. § 300aa-10(a). Most importantly, although Congress realized that experiencing
adverse events after vaccination was a common occurrence, the goal of the Vaccine Act was not
to compensate individuals for every unavoidable side-effect of vaccination.
The intent of the law, from its inception and through its amendments, has been to
compensate those who suffer grave and serious injuries. See H.R. Rep. No. 99-908, at 4 (1986),
reprinted in 1986 U.S.C.C.A.N. 6344, 6345 (describing the proposed Vaccine Act as protection
for “a small but significant number” of recipients who “have been gravely injured”); Cloer v.
Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1335 (Fed. Cir. 2011) (en banc) (quoting H.R.
Rep. No. 100-391 (1), at 699 (1987)) (noting that the Vaccine Act’s “6 month requirement”
should also be read to limit the availability of compensation to only those “who are seriously
injured”); see also 145 Cong. Rec. S15213-03 (Nov. 19, 1999) (statement from Sen. Jim Jefford)
(stating that the 2000 amendment was intended to protect those suffering from “cases of
intussusception” who needed more than “only minimal treatment”).
Congress amended the Vaccine Act in 2000 to expand compensation coverage in cases
where the vaccine-related injury resulted in inpatient hospitalization and surgical intervention.
See Children’s Health Act of 2000, Pub. L. 106-310, § 1701, 114 Stat. 1151 (“2000
Amendment”). The Vaccine Act’s 2000 Amendment evinces the same objective and policy as
the original act. The main impetus behind passage of the 2000 Amendment was to address an
ongoing issue with the administration of the Rotavirus vaccine. 145 Cong. Rec. S15213-14 (Nov.
19, 1999). In 1999, the CDC’s Advisory Committee on Immunization Practices (“ACIP”)
informed Congress of an increased rate of intussusception among infants who had received the
Rotavirus immunization. See Vaccines—Finding the Balance Between Public Safety and
Personal Choice, 106th Cong. 40 (Aug. 3, 1999). ACIP described the condition to Congress as
one in which segments of the intestine “telescop[es]” inside of another, causing an intestinal
obstruction. See FACA: Conflicts of Interest and Vaccine Development—Preserving the
Integrity of the Process, 106th Cong. 112 (June 15, 2000). Although most cases of
intussusception were, and continue to be, treated by barium enema procedures, some patients
require surgical operation. Id; see also Spooner, 2014 WL 504728, at *6. Because those patients
who would undergo surgical operation would likely recover under six months, they were not
qualified for compensation under the Vaccine Law as it existed. See Revisions and Additions to
the Vaccine Injury Table, 66 Fed. Reg. 36735, at 36737 (proposed July 13, 2001) (“[M]ost
patients with intussusception recover after immediate treatment and do not suffer lasting
complications for more than 6 months.”); see also Spooner, at *11. Congress found the surgical
operation involved in treating intussusception severe enough that the law was amended
accordingly to add an exception for those patients who undergo “inpatient hospitalization and
surgical intervention.” Id. In other words, in the surgical treatment protocol for intussusception,
Congress saw a medical procedure that by itself could be severe enough to entitle patients for
compensation even when their injuries did not last beyond the recovery from the medical
procedure or up to six months. Id. Therefore, the legislative history of the 2000 amendment
indicates that Congress must have fashioned the phrase “inpatient hospitalization and surgical
intervention” to serve as a statutory proxy for measuring the degree of severity of individual
invasive medical procedures. Id. This was done to ensure that medical operations that are similar
in their degree of severity to the intussusception surgery would qualify under the Vaccine Act in
the future. Id.
7With this legislative background in mind, the Court finds that neither the Secretary nor
the Petitioner’s textual interpretation of the phrase “inpatient hospitalization and surgical
intervention” is correct. The Petitioner overreads the statutory text while the Secretary
underreads it. See Nat’l Veterans Legal Servs. Program v. United States, 968 F.3d 1340, 1350
(Fed. Cir. 2020). The Secretary’s interpretation would improperly exclude a class of medical
procedures that, despite their underlying diagnostic nature, are severe enough in magnitude to
match intussusception surgery; the Petitioner’s interpretation will improperly expand the scope
of the law to cover minimally invasive diagnostic procedures. See Young v. United Parcel Serv.,
575 U.S. 206 (2015) (rejecting statutory interpretations that would “fail to carry out a key
congressional objective in passing the Act.”).
First, under the Secretary’s interpretation, many of the other medical procedures that
equally blur the line between diagnostic and curative—but are far more invasive and riskier than
a bone marrow biopsy—would fail the test merely because they are diagnostic. See, e.g., Harmon
v. Sec’y of Health & Hum. Servs., No. 12-298V, 2015 WL 6157016 (Fed. Cl. Spec. Mstr. June 6,
2017) (brain biopsy to assess diagnosis of chronic autoimmune demyelinating illness as a result
of receiving the Gardasil vaccination for the human papillomavirus (“HPV”) vaccine); Althen v.
Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005) (conducting a brain biopsy
to find causes of optic neuritis that could have been caused by tetanus toxoid (“TT”)
vaccination); Portee v. Sec’y of Health & Hum. Servs., No. 16-1552V, 2018 WL 5284599 (Fed.
Cl. Sept. 14, 2018) (conducting diagnostic arthroscopic surgery in case of shoulder injury after
influenza vaccination); Fields v. Sec’y of Health & Hum. Servs., No. 02-311V, 2008 WL
2222141, at *13 (Fed. Cl. May 14, 2008) (receiving a kidney biopsy to diagnose the cause of
renal failure that could have been caused by hepatitis B vaccine).7
Second, the Secretary’s bright-line rule for excluding all diagnostic procedures from the
definition of “inpatient hospitalization and surgical intervention” cannot be easily squared with
the legislative history of the 2000 Amendment. As noted, the legislative history behind the 2000
Amendment clearly indicates that Congress included the language “inpatient hospitalization and
surgical intervention” to cover those who had required surgery to recover from intussusception.
Stavridis, 2009 WL 3837479, at *3. Yet, the surgical operation associated with intussusception
itself does not fit comfortably in either the diagnostic or curative categories. As our Vaccine Act
case law indicates, intussusception is commonly treated by conducting a surgical operation
which entails making a comparatively large incision in the abdomen to gain access to the
abdominal cavity. Spooner, 2014 WL 504728, at *4. In many cases of intussusception, the
procedure is followed by the curative step of bowel resection to remove parts of the intestine.
See, e.g., Carda v. Sec’y of Health & Hum. Servs., No. 14-191V, 2017 WL 6887368, at *6 (Fed.
Cl. Nov. 16, 2017). However, in other instances, the same surgical procedure can be conducted
7
It is irrelevant whether patients in the preceding cases were found to be entitled to
compensation or even if the petitions sought compensation under the surgical intervention
provision. The underlying fact patterns of such cases are merely illustrative of the universe of
relatively similar medical procedures that the Court is likely to be presented with again in the
future that under the Secretary’s definition would be categorically excluded despite being more
invasive than the bone marrow biopsy and aspiration in the present case.
8
in a more diagnostic nature and is aptly referred to as an “exploratory” laparotomy or celiotomy.
See, e.g., Brooks v. Sec’y of Health & Hum. Servs., No. 14-563V, 2016 WL 2656110, at *2 (Fed.
Cl. Feb. 26, 2016) (“An exploratory laparotomy and small bowel resection were performed . . .
revealing a postoperative diagnosis” of intussusception). Therefore, because the exact procedure
that motivated Congress to enact the 2000 Amendment could potentially be administered for
either curative or diagnostic reasons, it is difficult to imagine that Congress intended to exclude a
surgical procedure solely due to the underlying purpose behind its administration. Stated plainly,
this reading would have excluded many vaccine-injury victims that Congress intended to protect.
Third, the Secretary’s position fails to account for cases in which a patient’s experience
with a diagnostic procedure can be described as severe due to rare complications that can occur
as a result of such diagnostic procedures. See, e.g., Puroll v. Sec’y of Health & Hum. Servs., No.
14-1112V, 2017 WL 3598108, at *4 (Fed. Cl. July 28, 2017) (developing an infection following
an exploratory laparoscopy, extending hospital stay); (see also Ex. 10 at 295–303) (listing pain,
bleeding and damage to surrounding areas as potential side effects of bone marrow biopsy).
As the Secretary contends, the rationale in allowing all cases of ITP in which the injured
person undergoes bone marrow aspiration and biopsy, regardless of the outcome of the
operation, belies the congressional intent to limit compensation to cases where injury is clearly
severe. See Cloer, 654 F.3d at 1335 (Fed. Cir. 2011) (finding that petition requirements in the
Vaccine Act are “intended to restrict eligibility to the compensation program”). Yet the
Secretary’s position, by tethering the definition of surgical intervention to the underlying purpose
of the procedure equally risks betraying congressional intent.
Because the Court finds the dictionary definitions of “surgical intervention” inadequate in
defining the full scope of that phrase, it must look to other tools of statutory construction to
clarify its full meaning. See United States v. Trek Leather, Inc., 767 F.3d 1288, 1300 (Fed. Cir.
2014) (finding that in analyzing statutory language, the court “is not limited to the particular
legal theories advanced by the parties, but rather retains the independent power to identify and
apply the proper construction of governing law.”) (citing Kamen v. Kemper Fin. Servs., Inc., 500
U.S. 90, 99 (1991)). When the dictionary definition does not resolve an ambiguity, the next best
clues are neighboring terms and phrases. See Life Technologies Corp. et al. v Promega Corp,
137 S. Ct. 734 (2017); see also United States v. Williams, 553 U.S. 285, 294 (2008) (“[A] word
is given more precise content by the neighboring words with which it is associated.”). The
maxim noscitur a sociis—that a word is known by the company it keeps—is used to define
phrases that are capable of many meanings and to ground the definition of ambiguous phrases in
a way that would avoid giving the Acts of Congress “unintended breadth.” Jarecki v. G.D. Searle
& Co., 367 U.S. 303, 307 (1961).
The Court begins its analysis of the text with the cardinal proposition that a statute is to
be read as a whole. Massachusetts v. Morash, 490 U.S. 107, 115 (1989). The meaning of the
statutory language depends on the context, as words “have only a communal existence.”
Florsheim Shoe Co., Div. of Interco v. United States, 744 F.2d 787, 795 (Fed. Cir. 1984) (citing
National Labor Relations Board v. Federbush Co., 121 F.2d 954, 957 (2d Cir. 1941) (Hand, J.)).
Each word takes its meaning from the setting it is used in, and each meaning, in turn,
interpenetrates the other. Shell Oil Co. v. Iowa Dept. of Revenue, 488 U.S. 19, 26 (1988).
9
The first operative term in the phrase “inpatient hospitalization and surgical intervention”
is “inpatient.” Given the fact that most patients seeking treatment for intussusception were likely
to be admitted to the hospital, the Court must analyze why Congress qualified the term
hospitalization with the term “inpatient.” See Duncan v. Walker, 533 U.S. 167, 174 (2001)
(statutes must be construed so as to avoid rendering any word insignificant or superfluous). The
best way to understand this is that Congress believed that, just like the term intervention, the
phrase “inpatient hospitalization” also qualified the scope of the term surgical. Under this
reading, whether a procedure is carried out on an inpatient or outpatient basis will have some
bearing on the severity of the operation. By including the term inpatient, Congress was
communicating that outpatient procedures should not normally meet the severity qualifications.
Max v. Gen. Revenue Corp., 568 U.S. 371 (2013) (the courts should resort to the canon of
expressio unius, the inclusion of a term means exclusion of the other, when the context indicates
that Congress indeed considered “the unnamed possibility and meant to say no to it.”). Following
this reasoning, the phrase “inpatient hospitalization” can be read to qualify the reach of the
phrase “surgical intervention,” limiting its application to operations that are accompanied by
inpatient care (an overnight stay in the hospital) to guide and monitor the recovery from the
operation. See Dorland’s Illustrated Medical Dictionary at 903 (29th ed. 2000) (defining
inpatient as “a patient who comes to a hospital or other healthcare facility for diagnosis or
treatment that requires an overnight stay.”). Under this reading, the scope of the term surgical is
modified by both the word “intervention” and the phrase “inpatient hospitalization.” In
particular, Congress coupled the phrase surgical intervention with the phrase inpatient
hospitalization to provide at least one clear benchmark for severity of surgeries: surgical
operations that are severe enough to require at least one overnight stay in the hospital.
As Spooner noted, unlike the statute’s six-month limitation which focuses on the whole
picture of the patient’s vaccine-related illness and its long-term and temporal consequences, the
surgical intervention provision narrows the lens to one potentially severe medical procedure. The
Congressional intent behind the surgical intervention provision was to focus on “medical
procedures” that 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.” Spooner, 2014 WL 504728, at *11.
While it is conceivable that Congress intended a more tenuous relationship between
inpatient hospitalization and the surgical operation, unmooring the two phrases from each other
will clearly open the door for compensation in cases that seem to betray Congress’s focus on
severity and lead to absurd results. For example, program case law has clearly established that
many common vaccine-related treatments that have resulted in inpatient hospitalization by
themselves do not qualify for compensation under the surgical intervention provision. See, e.g.,
Stavridis, 2009 WL 3837479, at *3–4 (denying compensation to a patient who received four days
of inpatient hospitalization because blood transfusion did not constitute a surgery). Decoupling
inpatient hospitalization and surgical intervention would lead to an absurd result. Hellebrand v.
Sec’y of Health & Hum. Servs., 999 F.2d 1565, 1570–71 (Fed. Cir. 1993) (“court[s] 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.”). Patients who receive inpatient
hospitalization solely to receive minimally invasive and non-surgical treatments, such as IVIG
treatment or blood transfusion, can subsequently elect for a diagnostic bone marrow biopsy
operation, which today can be routinely carried out on an outpatient basis. See e.g., Faup, 2017
WL 2257429, at *2 (involving a patient who received bone marrow biopsy on an outpatient
10
basis).8 The patient can then claim that the two isolated episodes of inpatient hospitalization and
outpatient operation qualify them for compensation, even though no indicia of severity would be
present in such a case. Therefore, both the term “inpatient hospitalization” and the term “surgical
intervention” must be understood to apply to a medical procedure and not the underlying illness
in general.
In this case, the record indicates that M.F.’s bone marrow operation and biopsy were not
severe enough to have a connection with her inpatient hospitalization. Although M.F. was
admitted to the hospital on July 25, 2016, a day before her bone marrow operation, the record
indicates she was admitted on July 25th due to another episode of critically low blood platelet
count as a short-lived response to IVIG treatment. (Ex. 10 at 226, 228 (indicating that the
medical team approved of discharging M.F. only after her platelet levels reached 6 thousand)).
The inpatient hospitalization was therefore not caused by the surgical intervention itself. After
M.F. received her bone marrow operation on July 26th, the post-operation notes clearly indicated
that the operation itself was not severe enough to require further inpatient care. The Physician’s
Post Procedure Orders indicated that M.F. only needed to stay in PACU for an hour and a half.
(Ex. 10 at 313 (admitted at 1:01 PM and discharged at 2:50 PM)). Critically, the records of
M.F.’s bone marrow biopsy procedure also indicate that further inpatient hospitalization after the
bone marrow operation was due to management of M.F.’s still-low blood platelets levels, and not
associated with the bone marrow operation itself. (Ex. 10 at 219–220 (physician notes indicating:
“Goal >20 platelets for discharge”; “If platelet counts >20, ok for discharge home.”)). See Uetz v.
Sec’y of Health & Hum. Servs., No. 14-29V, 2014 WL 7139803, at *4 (Fed. Cl. Spec. Mstr. Nov.
21, 2014) (finding the petitioner who received a lumbar puncture procedure to be ineligible for
compensation because the procedure was not coupled with inpatient hospitalization).
Accordingly, M.F.’s case fails to meet the statutory definition of “inpatient
hospitalization,” and therefore fails to qualify under the surgical intervention provision of the
Vaccine Law. Because the Court finds that M.F.’s bone marrow operation fails to meet the first
clause of “inpatient hospitalization and surgical intervention,” it need not consider the question
of whether the bone marrow operation constituted surgical intervention. Answering whether a
bone marrow operation—or a biopsy procedure in general—can constitute a surgical intervention
is more suitably left for a case in which the patient’s overnight stay at the hospital had a closer
connection to the bone marrow operation, meeting the requirements of inpatient hospitalization.
The Chief Special Master’s finding of law that M.F. qualified for compensation because she
received “inpatient hospitalization and surgical intervention” is reversed.9
8
Bone marrow operations are “usually performed as an outpatient procedure with the use of
local anesthesia.” Standard Process for Bone Marrow Transplant, JOHNS HOPKINS MEDICINE,
https://www.hopkinsmedicine.org/kimmel_cancer_center/cancers_we_treat/bone_marrow_transp
lant/standard_bone_marrow_transplant.html (last visited Nov. 5, 2021).
9
The Secretary also argued that the Chief Special Master’s finding that a bone marrow biopsy is
a “surgical intervention” improperly expanded the Vaccine Act’s limited waiver of sovereign
11
B. Residual Effects of Injury
The Secretary also argues that the Chief Special Master erred as a matter of law in
finding that M.F. qualified for compensation under an alternative theory—namely, that she
“suffered the residual effects or complications” of her injury for more than six months.” 42
U.S.C. § 300aa-11(c)(1)(D)(i)). The Secretary’s argument is twofold. (Resp’t’s Mot. 14–16).
First, the Petitioner did not properly allege that M.F. was qualified for compensation under the
residual effects provision, and, therefore, the Chief Special Master could not use that reasoning
as a basis for granting compensation. (Id.). Second, the Secretary argues that the Chief Special
Master erred in finding that evidence of continual testing and check-up for potential reoccurrence
of a vaccine-injury was enough to constitute “residual effects or complications” of injury, even
though the underlying vaccine-injury had, by all signs, subsided. (Id.)
Neither argument is availing. The Secretary’s claim that the Petitioner “did not allege that
M.F. had suffered the residual effects of her ITP beyond six months to satisfy the Act’s residual
effects requirement” is incorrect. The Petition, after claiming vaccine causation, expresses a
claim based on residual effects, reading in relevant part: “M.F.’s related injuries have lasted
more than six months; the minor child underwent hospitalization and surgical intervention as the
result of her vaccine injury.” (Pet. at 4); see also RCFC, App. B, Vaccine Rule 2(c)(1) (“Vaccine
Rules”) (“The petition must set forth “a short and plain statement” of the grounds for an award”).
Likewise, the Secretary’s argument that the Petitioner failed to rebut its statement that
“[p]etitioners do not allege that M.F. suffered the residual effects of her ITP beyond six months”
is also inaccurate. (Resp’t’s Mot. at 15). Vaccine Rules 8(f) only requires that facts or arguments
be raised “in the record before the Special Master” to be preserved. Accordingly, the issue was
not waived.
Secondly, the main interest protected by the waiver doctrine is ordinarily presumed to be
preserving the opposing party’s right to be notified and the fair opportunity to respond. Ultra-
Precision Mfg., Ltd. v. Ford Motor Co., 411 F.3d 1369, 1376 (Fed. Cir. 2005) (citing Smith v.
Sushka, 117 F.3d 965, 969 (6th Cir. 1997)). Given the record below, it can hardly be credibly
argued that the parties were deprived of adequate notice and the opportunity to respond to the
Chief Special Master’s reasoning. During the hearing conducted on October 2, 2020, the Chief
Special Master clearly laid out his reasoning prior to issuing a ruling on entitlement and notified
both parties that the upcoming ruling will rely on both his definition of “surgical intervention” as
it applied to the facts of the case and his finding that the Petitioner had satisfied the six-months
requirement for residual effects. (See Transcript, ECF No. 52 at 17–19). After notifying both
parties of the basis of his forthcoming ruling on entitlement, the Chief Special Master also gave
the Secretary the opportunity to express any objections “to other aspects of the claim” in a status
report in advance of the ruling being issued. (Id.) The record does not suggest that the Secretary
used this opportunity to object. See also Vaccine Rule 20(a)(3) (motions can also be made at any
time “orally during a hearing”).
immunity. (Resp’t’s Mot. at 12). Because the Court sets aside that finding, it finds the
Secretary’s sovereign immunity argument to be moot at this juncture.
12
Speedy resolution of Vaccine Law cases is exceedingly important. As the Supreme Court
has noted, the Act established a no-fault compensation program that is particularly designed to
“work faster and with greater ease than the civil tort system.” Shalala v. Whitecotton, 514 U.S.
268, 269 (1995). To that end, the Federal Circuit has confirmed that the Vaccine Act eschews
many procedural elements of tort litigation with a goal of establishing what instead could be
labeled as a “compensation program.” Knudsen v. Sec’y of Health & Hum. Servs, 35 F.3d 543,
549 (Fed. Cir. 1994). Under this system, petitioners’ claims are to be reviewed and handled
“quickly, easily, and with certainty and generosity.” Id. Congress has routinely stressed the need
for preserving the “informal, flexible, and expeditious,” nature of the vaccine injury
compensation system. H.R. Rep. No. 101-247, at 510 (1989). The Vaccine Rules of the Federal
Court of Claims also clearly embody this spirit. For example, Vaccine Rule 1(b) provides that in
all matters not specified by the vaccine rules, the special master and the court may regulate the
practice “with the purpose of the vaccine act” in mind: “to decide the case promptly and
efficiently.” Vaccine Rule 3(b)(2) emphasizes the role of the special master in “endeavoring to
make the proceedings expeditious, flexible, and less adversarial,” but with an eye towards
“creating a record sufficient to allow review of the special master’s decision.” With this goal
established, an adequate record has been created before the Chief Special Master in this case to
consider the Petitioner’s claim for qualifying under the residual effects provision.
As to the merits of the Chief Special Master’s finding that M.F. qualifies for
compensation under the residual effects provision, the Court finds no error. Under that provision,
patients are qualified for compensation if they can establish that they “suffered the residual
effects or complications” of their “illness, disability, injury, or condition for more than 6 months
after the administration of the vaccine.” 42 U.S.C. §300aa-11(c)(1)(D)(i).
The parties agree on the following timeline: M.F. received her vaccine on June 23, 2016.
The first symptoms of M.F.’s injury appeared only a few days after. M.F. was hospitalized
intermittingly in July 2016 and began a course of steroid treatment on July 26, 2016. M.F.’s
blood platelet count entered the normal range on or around September 1, 2016. When the
decision was made to cut the steroid dose in half in response to those numbers, M.F.’s platelet
count dropped once again, and the dosage was increased again. Throughout the rest of September
2016, M.F.’s platelet level returned to normal again, with fluctuations. On October 5, 2016,
M.F.’s mother was directed to decrease the dosage again, and labs from the end of October
showed platelet count that was within normal limits. At the end of October, M.F.’s mother was
instructed to reduce the dosage to “every other day for a week, then stop.” (Ex. 12 at 18). By
November 4, 2016, M.F.’s mother reported that she had been “off medication now for a couple
of days,” and that the plan was to “take a break” from lab testing. (Ex. 2 at 12). The final medical
test on the record for M.F. is from February 10, 2017, showing a normal platelet count.
Importantly, undisputed medical records establish that M.F.’s treatment and monitoring
continued until finally discharged by the hematology clinic in August 2017. (Ex. 12 at 5). The
Secretary did not suggest, much allege or establish, that M.F.’s continual monitoring by the
hematology clinic was medically unnecessary or outside the appropriate standard of care.
Reviewing these facts, the Chief Special Master found that although M.F.’s blood platelet
levels (the most pronounced symptom of her vaccine-injury) stabilized in under six months, she
continued to be subject to “ongoing monitoring,” and a “need for medication,” beyond six-
months to ensure that her condition did not return. (Facts and Law Ruling at 7). This, the Chief
13
Special Master found, was enough to constitute “residual effect,” and qualify M.F. for
compensation. (Id.).
The Secretary finds that conclusion to be incompatible with Crabbe v. Sec’y of Health
and Hum. Servs., No. 10-762V, 2011 WL 4436724, at *5 (Fed. Cl. Spec. Mstr. Aug. 26, 2011).
In Crabbe, the vaccine-related injury was also ITP, and like this case, the patient’s medication
course had ended in under six months with all symptoms of ITP (low blood platelet count, rash,
or petechiae) successfully disappearing. Although the Special Master in Crabbe refused to
consider other medical visits made in the six-month period as “residual effects” of the injury, the
nature of those visits differed from the medical visit in this case. Importantly, in Crabbe, the
patient’s ongoing medical visits were brought about by bouts of illnesses unrelated to ITP; the
petitioner in Crabbe argued that each of these episodes of unrelated illness nonetheless triggered
in the patient’s parents a worry that their child’s ITP condition might have returned (concerns
that were negated through diagnosis). Id. at *4-5. The Crabbe special master therefore viewed
the argument presented as whether “a mere increased risk of recurrence of an injury” can
constitute “residual effect.” Id. Unlike Crabbe, the facts of this case indicate that M.F. received
“ongoing monitoring” of her condition and repeated check-ups on her platelet levels not because
of an unfounded fear that her ITP might have reoccurred but as an actual part of her ongoing
“treatment protocol” with the same medical team that had overseen her recovery from ITP. (Ex.
2 at 6, 19; Ex. 12 at 5–6) (detailing ongoing visits with the same hematology team that oversaw
M.F.’s ITP recovery). Reviewing the specific records in this case, the Chief Special Master gave
weight to the fact that unlike in Crabbe, M.F.’s continual monitoring was prescribed by her
medical team and therefore constituted part and parcel of a longer but uninterrupted treatment
plan (Facts and Law Ruling at 7); see also, Faup, 2015 WL 443802, at *2 (Fed. Cl. Spec. Mstr.
Jan. 13, 2015) (finding ongoing monitoring of the vaccine-related injury to be a residual effect
when routine check-ups were ordered by the medical team); H.S. v. Sec’y of Health and Hum.
Servs., No. 14-1057V, 2015 WL 1588366, at *3 (Fed. Cl. Spec. Mstr. March 13, 2015) (same).
At least one other judge on the Court of Federal Claims has determined that ongoing
monitoring or testing could constitute residual effects lasting more than six months from
administration of the vaccine so long as “testing is causally connected to the underlying vaccine
injury and triggered by subsequent symptoms of the conditions,” and even when monitoring and
testing do not reveal the reoccurrence of any ongoing symptoms. Wright v. Sec’y of Health &
Hum. Servs., 146 Fed. Cl. 608 (2019). Like this case, Wright also involved continual platelet
testing in response to ITP. Unlike this case, however, Wright involved the patient “repeatedly
undergoe[ing] unscheduled medical tests,” after the hematology team overseeing the onset of
symptoms had already viewed the ITP condition as “resolved.” Id. at 610, 614. Wright raises
more difficult questions over whether subsequent testing and check-ups conducted at the
patient’s behest can demonstrate residual effects after the original treatment course has ended.
Wright answers that in the affirmative. Yet Wright’s holding is inapplicable here because no part
of M.F.’s treatment was either elective or occurred after the original treatment course concluded.
Although M.F. ceased taking steroids in early November, the hematology team overseeing the
treatment saw this as “tak[ing] a break,” indicating that the medical team viewed M.F.’s
treatment as contingent and continuing. (Ex. 2 at 12). Doctors ordered both subsequent lab
drawings in late November and in February 2017. (Ex. 12 at 13, 15, 20). Both the decision to
“space[] out” the lab draws and to eventually stop them was made by the medical team. (Ex. 12
at 7,13). M.F.’s last visit to the hematology clinic in August of 2017 was also prescribed by the
14
medical team and viewed as a precondition for discharge from the hematology clinic, thereby
ending the course of treatment. (Ex. 12 at 5, 10 (clinical note reading: “Parents to notify us when
labwork obtained so we can follow up results. If normal, will discharge her from
Hematology.”).10 The Chief Special Master’s assessment that M.F.’s ongoing monitoring of her
condition satisfied the residual effect standard was not a legal error, and, therefore, the Chief
Special Master’s decision as to that issue should be affirmed.
III. Conclusion
Based on the foregoing, the Court hereby GRANTS the Secretary’s Motion for Review,
(ECF No. 68), and AFFIRMS IN PART and REVERSES IN PART the Chief Special Master’s
October 26, 2020 Findings of Fact and Conclusions of Law (ECF No. 50). Based on the Court’s
Findings of Fact and Conclusions of Law, the Court finds that the Petitioner is entitled to
compensation only under 42 U.S.C. §300aa-11(c)(1)(D)(i). The Chief Special Master’s ruling on
entitlement granting compensation to Petitioner is SUSTAINED. The Clerk is directed to enter
final judgment accordingly.
IT IS SO ORDERED.
s/ David A. Tapp
DAVID A. TAPP, Judge
10
It is conceivable that certain ITP treatment plans involve prescribed monitoring and checkups
for such an unreasonably extended period of time so as to fall outside any reasonable standard of
care. Because neither party has called the reasonableness of standard of care in this case into
question, the Court has no occasion to review or decide whether the ordered duration of
checkups and monitoring in this case falls short of that standard.
15