Wright v. Hhs ( 2022 )

Case: 21-1524 Document: 51 Page: 1 Filed: 01/05/2022
United States Court of Appeals
for the Federal Circuit
______________________
HEATHER WRIGHT, AS MOTHER AND NATURAL
GUARDIAN OF MINOR CHILD, B.W.,
Petitioner-Appellee
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellant
______________________
2021-1524
______________________
Appeal from the United States Court of Federal Claims
in No. 1:16-vv-00498-EGB, Senior Judge Eric G. Bruggink.
______________________
Decided: January 5, 2022
______________________
Case: 21-1524 Document: 51 Page: 2 Filed: 01/05/2022
2 WRIGHT v. HHS
MICHAEL P. MILMOE, Law Offices of Leah V. Durant,
PLLC, Washington, DC, argued for petitioner-appellee.
TRACI PATTON, Torts Branch, Civil Division, United
States Department of Justice, Washington, DC, argued for
respondent-appellant. Also represented by BRIAN M.
BOYNTON, C. SALVATORE D'ALESSIO, HEATHER LYNN
PEARLMAN.
______________________
Before PROST, TARANTO, and HUGHES, Circuit Judges.
HUGHES, Circuit Judge.
The son, B.W., of Petitioner-Appellee Heather Wright
experienced immune thrombocytopenic purpura after re-
ceiving his measles, mumps, and rubella vaccine. Later
blood tests showed his condition had resolved. More than
six months after he was first diagnosed, B.W. presented
with bruising, a possible symptom of immune thrombocy-
topenic purpura, but blood tests showed the condition had
not recurred. The Court of Federal Claims held that those
blood tests, occurring more than six months after his initial
diagnosis, were “residual effects” of B.W.’s vaccine injury
that satisfied the severity requirement of 42 U.S.C.
§ 300aa-11(c)(1)(D). We disagree. A residual effect must be
a change within the patient that is caused by the vaccine
injury. Because B.W.’s later bruising was not caused by his
vaccine injury, and his tests did not reveal, constitute, or
cause any somatic change, we reverse the Court of Federal
Claims’s decision.
BACKGROUND
A
In 1986, Congress established the National Vaccine
Program within the Department of Health and Human
Services “to achieve optimal prevention of human infec-
tious diseases through immunization and to achieve
Case: 21-1524 Document: 51 Page: 3 Filed: 01/05/2022
WRIGHT v. HHS 3
optimal prevention against adverse reactions to vaccines.”
42 U.S.C. § 300aa-1. With the same statute (the “Vaccine
Act”), Congress also established the National Vaccine In-
jury Compensation Program, “under which compensation
may be paid for a vaccine-related injury or death.” Id.
§ 300aa-10(a). A petitioner seeking compensation must es-
tablish by a preponderance of the evidence that the injury
or death was caused by a vaccine. See id. §§ 300aa-
11(c)(1)(C), -13(a)(1). The petitioner may establish causa-
tion in two ways. First, the petitioner may prove that the
injury is one listed in the Vaccine Injury Table, 42 U.S.C.
§ 300aa-14(a); 42 C.F.R. § 100.3(a) (2020), and occurred
within the time provided within the Table, establishing a
presumption of causation. See Capizzano v. Sec’y of Health
& Hum. Servs., 440 F.3d 1317, 1319–20 (Fed. Cir. 2006).
Alternatively, for injuries not listed in the Vaccine Injury
Table, the petitioner may prove causation in fact. Id. at
1320 (citing 42 U.S.C. § 300aa-13(a)(1), -11(c)(1)(C)(ii)(I)).
The causation-in-fact inquiry is governed by traditional
principles of tort law described in the Second Restatement
of Torts. Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d
1344, 1351–52 (Fed. Cir. 1999).
Compensation is not available for minor injuries,
whether on or off the Table. Instead, a showing of severity
is required. As originally enacted, 42 U.S.C. § 300aa-
11(c)(1)(D) required that a petition for compensation con-
tain
(1) . . . an affidavit, and supporting documentation,
demonstrating that the person who suffered such
injury or who died . . .
(D)(i) suffered the residual effects or com-
plications of such illness, disability, injury,
or condition for more than 1 year after the
administration of the vaccine, (ii) incurred
unreimbursable expenses due in whole or
in part to such illness, disability, injury, or
Case: 21-1524 Document: 51 Page: 4 Filed: 01/05/2022
4 WRIGHT v. HHS
condition in an amount greater than
$1,000, or (iii) died from the administration
of the vaccine.
National Childhood Vaccine Injury Act of 1986, Pub. L.
No. 99–660, § 2111, 100 Stat. 3743, 3760–61. (1986). A
1987 amendment shortened “1 year” to “6 months” and
combined subsections (i) and (ii), allowing compensation
with a showing of six months of residual effects and $1,000
in unreimbursable expenses. Vaccine Compensation
Amendments of 1987, Pub. L. No. 100–203 § 4304(b)(2),
101 Stat. 1330, 1330-223 to -224 (1987). The legislative his-
tory explains that the 1987 amendment
limits compensation program to cases in which a
person dies from the result of vaccine or in which a
person incurs unreimbursable medical expenses of
more than $1,000 and suffers ongoing disabilities
for at least six months. This subsection eliminates
the Act’s provision of eligibility for persons who in-
cur expenses in excess of $1,000 but do not suffer
ongoing disabilities. The effect of this provision is to
limit the availability of the compensation system to
those individuals who are seriously injured from
taking a vaccine.
H.R. Rep. No. 100-391, pt. 1, at 699 (1987). A 1998 amend-
ment eliminated the $1,000 requirement altogether. Vac-
cine Injury Compensation Program Modification Act, Pub.
L. No. 105-277 § 1502, 112 Stat. 2681, 2681-741 (1998). To-
day, the petitioner must show that the injured person
(D)(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, in-
jury, or condition from the vaccine which resulted
in inpatient hospitalization and surgical interven-
tion.
Case: 21-1524 Document: 51 Page: 5 Filed: 01/05/2022
WRIGHT v. HHS 5
42 U.S.C. § 300aa-11(c)(1)(D).
B
Thrombocytopenic purpura is included in the Vaccine
Injury Table for the measles, mumps, and rubella (MMR)
vaccine. 42 C.F.R. § 100.3(a) (2015). At the time this peti-
tion was filed, thrombocytopenic purpura was defined as “a
serum platelet count[ 1 ] less than 50,000/mm3.” 2 Id. at
§ 100.3(b)(8). A normal platelet count is between 150,000
1 Platelet counts reveal “the number of platelets (throm-
bocytes) per cubic milli[meter] of blood.” Crabbe v. Sec’y of
Health & Hum. Servs., No. 10-762V, 2011 WL 4436724, at
*2 n.9 (Fed. Cl. Spec. Mstr. Aug. 26, 2011) (quoting Kath-
leen D. Pagana & Timothy J. Pagana, Mosby’s Manual of
Diagnostic and Laboratory Tests 416 (4th ed. 2010)).
2 “Thrombocytopenia” is defined as a platelet count less
than 150,000/mm3. National Vaccine Injury Compensation
Program: Revisions and Additions to the Vaccine Injury
Table—II, 60 Fed. Reg. 56,289, 56,295 (Nov. 8, 1995). “Pur-
pura” refers to a pattern of bleeding under the skin which
is “generally only seen when the platelet counts are less
than 50,000/mm3,” id., although such patterns were not
part of the definition of thrombocytopenic purpura in the
Vaccine Injury Table at the time this claim was filed, 42
C.F.R. § 100.3(b)(8) (2015).
Today, thrombocytopenic purpura is defined in the Ta-
ble “by the presence of clinical manifestations, such as pe-
techiae, significant bruising, or spontaneous bleeding, and
by a serum platelet count less than 50,000/mm3 with nor-
mal red and white blood cell indices.” 42 C.F.R.
§ 100.3(c)(7) (2020). The International Working Group on
ITP uses a platelet count of less than or equal to
100,000/mm3 for diagnosis. Appx33 n.3.
Case: 21-1524 Document: 51 Page: 6 Filed: 01/05/2022
6 WRIGHT v. HHS
and 400,000/mm3. Crabbe v. Sec’y of Health & Hum. Servs.,
No. 10-762V, 2011 WL 4436724, at *2 n.20 (Fed. Cl. Spec.
Mstr. Aug. 26, 2011) (citing Kathleen D. Pagana & Timothy
J. Pagana, Mosby’s Manual of Diagnostic and Laboratory
Tests 416 (4th ed. 2010)). Thrombocytopenic purpura pro-
duces bruising as well as more unusual patterns of bleed-
ing under the skin called petechiae and purpura. See
National Vaccine Injury Compensation Program: Revisions
and Additions to the Vaccine Injury Table—II, 60 Fed. Reg.
56,289, 56,295 (Nov. 8, 1995). As the Secretary recognized
when adding it to the Table, thrombocytopenic purpura is
rarely chronic, i.e., lasting more than 6 months, and
chronic cases are thought to be the result of an autoim-
mune disorder rather than viral vaccination or viral infec-
tion. Id.C
B.W. was a two-year-old in good health. At his well-
child visit on March 28, 2014, B.W. received the MMR vac-
cine. About two weeks later, B.W. presented to an emer-
gency room with bruises on his forehead, abdomen, and all
four extremities. B.W.’s platelet count was only
43,000/mm3. He was diagnosed with thrombocytopenia and
discharged. The following day, B.W. arrived at Children’s
Healthcare of Atlanta, where his platelet count was found
to be 68,000/mm3. His treating physicians diagnosed B.W.
with “thrombocytopenia likely secondary to acute ITP.” 3
Appx4.
3 ITP stands for immune thrombocytopenic purpura or
immune thrombocytopenia. “Immune” refers to the cause
of the thrombocytopenia and distinguishes thrombocytope-
nia associated with anti-platelet antibodies, which may be
caused by viral infections and vaccinations, from other
forms of thrombocytopenia, such as heparin-induced
thrombocytopenia or congenital thrombocytopenia. See
Case: 21-1524 Document: 51 Page: 7 Filed: 01/05/2022
WRIGHT v. HHS 7
Over the following weeks, B.W. saw various pediatri-
cians for frequent blood tests. His platelet count fluctuated
between 68,000 and 180,000/mm3. B.W.’s hematologists
concluded that he had thrombocytopenic purpura resulting
from his MMR vaccination, but noted that his thrombocy-
topenia was “not severe at this time” and recommended fol-
low-up visits “every 1–2 months until resolution.” Appx4.
On July 8, 2014—less than three months after onset of
his thrombocytopenic purpura—B.W.’s pediatrician or-
dered a platelet count, which came back normal. The pedi-
atrician concluded that B.W.’s thrombocytopenic purpura
had “resolved.” Appx4.
On several occasions in the following two years, B.W.
returned to his pediatrician with bruising and had his
platelet count tested. Each time he was seen, his platelet
count was well above 50,000/mm3 and within the normal
range. B.W. was seen for bruising and headaches; his plate-
let count was 312,000/mm3. He was seen for bruising on his
shins and abdomen; his platelet count was 381,000/mm3.
He was seen for bruising on his back and extremities, as
well as petechiae on his mid and lower back; his platelet
count was 289,000/mm3. He was seen again for bruising;
his platelet count was 318,000/mm3.
D
Ms. Wright filed a petition for compensation alleging
that B.W.’s MMR vaccine caused thrombocytopenic pur-
pura. The Secretary filed a Motion to Dismiss, arguing that
Ms. Wright could not meet the “severity requirement” of 42
generally 42 C.F.R. § 100.3(b)(7); National Vaccine Injury
Compensation Program, 60 Fed. Reg. at 56,295; Thrombo-
cytopenia, Dorland’s Illustrated Medical Dictionary 1892
(33d ed. 2020); Douglas B. Cines et al., Congenital and Ac-
quired Thrombocytopenia, 2004 Hematology 390.
Case: 21-1524 Document: 51 Page: 8 Filed: 01/05/2022
8 WRIGHT v. HHS
U.S.C. § 300aa-11(c)(1)(D), given that B.W.’s thrombocyto-
penic purpura had resolved less than six months after he
got the vaccine. The special master dismissed the petition
for failure to meet the severity requirement. The special
master held that “testing for a possible recurrence is not a
‘residual effect’ within the meaning of the statute.” Wright
v. Sec’y of Health & Hum. Servs., No. 16-498V, 2019 WL
1061472, at *11 (Fed. Cl. Spec. Mstr. Jan. 18, 2019) (Spe-
cial Master Decision) (quoting Crabbe, 2011 WL 4436724,
at *5).
Ms. Wright filed a motion for review of the Special Mas-
ter Decision by the Court of Federal Claims. The court
ruled that the special master erred as a matter of law in
holding that there was no residual effect of B.W.’s throm-
bocytopenic purpura. Wright v. Sec’y of Health & Hum.
Servs., 146 Fed. Cl. 608, 615 (2019) (Court of Federal
Claims Decision). The court reasoned that “ordering plate-
let counts when a patient with a history of ITP is presented
with bruising” was “within the doctor’s reasonable stand-
ard of care” and that B.W.’s testing was “causally connected
to the vaccine injury” because “it [wa]s unlikely B.W. would
have undergone continued platelet testing if it were not for
his history with ITP.” Id. at 614 & n.8. The court held that
testing for a condition that could return ought to be
compensated under the Vaccine Act when that test-
ing is causally connected to the underlying vaccine
injury and triggered by subsequent symptoms of
the conditions. The fact that those tests did not re-
veal the presence of ITP is not controlling. The
tests became necessary when later symptoms trig-
gered concern because of the earlier injury; they
were not mere monitoring.
Id. The court remanded to the special master, who awarded
damages. Wright v. Sec’y of Health & Hum. Servs., No. 16-
498V, 2020 WL 6281782, at *1, *3 (Fed. Cl. Spec. Mstr.
Case: 21-1524 Document: 51 Page: 9 Filed: 01/05/2022
WRIGHT v. HHS 9
Sept. 25, 2020). The Secretary timely appealed. We have
jurisdiction pursuant to 42 U.S.C. § 300aa-12(f).
DISCUSSION
The facts of this case are not disputed. The construction
of “residual effects” in the Vaccine Act is a question of law,
which we review de novo. Flowers v. Sec’y of Health &
Hum. Servs., 49 F.3d 1558, 1559 (Fed. Cir. 1995).
A
The “starting point” in statutory construction “is the
language of the statute”—not a single sentence or word of
the statute, but rather the “provisions of the whole law,” its
object, and its policy. Dole v. United Steelworkers of Am.,
494 U.S. 26, 35 (1990). The term “residual effects,” read
with the entirety of 42 U.S.C. § 300aa-11(c)(1)(D)(i), re-
quires a change within the patient that is caused by the
vaccine injury.
The language “effect . . . of such illness, disability, in-
jury, or condition” dictates that a residual effect must be
caused by the vaccine injury. The Vaccine Compensation
Program was intended as an alternative to the tort system.
See Shalala v. Whitecotton, 514 U.S. 268, 269–70 (1995)
(citing H.R. Rep. No. 99-908, at 3–7 (1986)) (explaining that
the Act “establishes a scheme of recovery designed to work
faster and with greater ease than the civil tort system”).
Absent legislative history to the contrary, we have applied
traditional principles of causation in tort law to the Vaccine
Act. See Shyface v. Sec’y of Health & Hum. Servs., 165 F.3d
1344, 1351–52 (Fed. Cir. 1999) (adopting the causation
standard from the Second Restatement of Torts for pur-
poses of proving causation for off-Table injuries under 42
U.S.C. § 300aa-11(c)(1)(C)(ii)). Here, Congress has not spo-
ken on the standard of causation, see H.R. Rep No. 99-908,
at 15 (1986) (not addressing causation for purposes of the
provision at the time of enactment); H.R. Rep. No. 100-391,
pt. 1, at 699 (1987) (not addressing causation at the time of
Case: 21-1524 Document: 51 Page: 10 Filed: 01/05/2022
10 WRIGHT v. HHS
amendment, when discussing the severity requirement).
Thus, we follow the Second Restatement and the causation
standards articulated for purposes of 42 U.S.C. § 300aa-
11(c)(1)(C)(ii). 4 Under this approach, it is sufficient that
the vaccine injury be both a but-for cause of the residual
effect and a substantial factor in bringing about the resid-
ual effect, even if it is not the predominant factor. Shyface,
165 F.3d at 1352 (citing Restatement (Second) of Torts).
Petitioner has not shown or argued in this case that
B.W.’s bruising after six months was caused by thrombocy-
topenic purpura. In fact, the later tests “did not reveal the
presence of ITP.” Court of Federal Claims Decision at 614.
So the bruising cannot itself be a “residual effect” under the
severity requirement.
The Court of Federal Claims concluded that B.W.’s
testing was “triggered by” his prior history of thrombocyto-
penic purpura and therefore “causally linked” to the condi-
tion. Court of Federal Claims Decision at 613. It cited
evidence of but-for causation. Id. at 614 n.8. But the court
identified a separate cause, bruising and petechiae, and
linked B.W.’s testing to his “presentation of symptoms of
ITP.” Id. at 614. Neither the Court of Federal Claims nor
the special master expressly applied a causation standard
or considered both the thrombocytopenic purpura and the
4 “Residual effects or complications” in the severity re-
quirement bears similarity to “complication or sequela” in
the Vaccine Injury Table, 42 C.F.R. § 100.3(b)(1), and the
Secretary has defined a but-for causation standard for that
language. 42 C.F.R. § 100.3(d)(3) (2020) (“Sequela means a
condition or event which was actually caused by a condition
listed in the Vaccine Injury Table.”). However, the Secre-
tary specifically defined the word “sequela,” not “complica-
tion,” and “sequela” does not appear in the severity
requirement.
Case: 21-1524 Document: 51 Page: 11 Filed: 01/05/2022
WRIGHT v. HHS 11
presentation of bruising after six months to determine
whether the thrombocytopenic purpura was a “substantial
factor” in bringing about the testing. But even if legally
caused by his thrombocytopenic purpura, B.W.’s testing
was not a “residual effect” for reasons discussed next.
“Residual” suggests something remaining or left be-
hind from a vaccine injury. See Parsley v. Sec’y of Health &
Hum. Servs., No. 08-781V, 2011 WL 2463539, at *16 (Fed.
Cl. Spec. Mstr. May 27, 2011) (“‘Residual’ is defined as ‘re-
maining or left behind.’” (quoting Dorland’s Illustrated
Medical Dictionary 1650 (31st ed. 2007))). An effect that is
“residual” or “left behind” is one that never goes away or
that recurs after the original illness. Because vaccine inju-
ries are somatic conditions defined by their signs and
symptoms within the patient, see 42 C.F.R. § 100.3(c), their
residues are similarly defined.
The words “suffered” and “complication,” used in asso-
ciation with “residual effects” in § 300aa-11(c)(1)(D)(i), also
suggest that Congress contemplated residual effects to be
detrimental conditions within the patient, such as linger-
ing or recurring signs and symptoms.
“Suffered” suggests something detrimental, especially
something painful. See Suffer, Webster’s Third New Inter-
national Dictionary 2284 (1986) (“to be subjected to physi-
cal or mental pain because of : endure with distress”). One
does not naturally “suffer” from ongoing, minimally inva-
sive monitoring or diagnostic testing, particularly when
the underlying injury was found to have resolved.
In the context of the Vaccine Injury Table, “complica-
tion” is understood to have its medical meaning, “[a] mor-
bid process or event occurring during a disease which is not
an essential part of the disease, although it may result
from it.” Abbott v. Sec’y of Dep’t of Health & Hum. Servs.,
27 Fed. Cl. 792, 794 (1993) (citing Stedman’s Medical Dic-
tionary 336 (25th ed. 1990), aff’d in pertinent part, re-
manded in part, 19 F.3d 39 (Table) (Fed. Cir. 1994)); see
Case: 21-1524 Document: 51 Page: 12 Filed: 01/05/2022
12 WRIGHT v. HHS
also Parsley v. Sec’y of Health & Hum. Servs., No. 08-781V,
2011 WL 2463539, at *16 (Fed. Cl. Spec. Mstr. May 27,
2011) (defining “complication” for purposes of the severity
requirement as “‘disease or diseases concurrent with an-
other disease’ or as ‘the concurrence of two or more diseases
in the same patient’” (quoting Dorland’s Illustrated Medi-
cal Dictionary 404 (31st ed. 2007))). These medical defini-
tions characterize complications as “diseases” and “morbid
processes.” Read together, “residual effects” and “complica-
tions” appear to both refer to conditions within the patient,
with “residual effects” focused on lingering signs, symp-
toms, or sequelae characteristic of the course of the original
vaccine injury, and “complications” encompassing condi-
tions that may not be “essential part[s] of the disease” or
may be outside the ordinary progression of the vaccine in-
jury.
Read in context, “residual effects” is focused on effects
within the patient, particularly lingering signs and symp-
toms of the original vaccine injury. B.W.’s testing did not
fall into this category. The tests revealed B.W. had no lin-
gering symptoms or recurrence of thrombocytopenic pur-
pura. And although Petitioner contends that the testing
itself was a “residual effect,” there has been no showing or
argument that it was detrimental to B.W.’s health such
that it might qualify under § 300aa-11(c)(1)(D)(i) as a “re-
sidual effect” or a “complication” of thrombocytopenic pur-
pura.
B
The legislative history accords with this interpretation.
See Flowers v. Sec’y of Dep’t of Health & Hum. Servs., 49
F.3d 1558, 1560 (Fed. Cir. 1995) (“Our statutory interpre-
tation begins with the language of the statute itself, which
must ordinarily be regarded as conclusive absent a clearly
expressed legislative intent to the contrary.” (citing Con-
sumer Prod. Safety Comm’n v. GTE Sylvania, Inc., 447 U.S.
102, 108 (1980))). The elimination of the $1,000
Case: 21-1524 Document: 51 Page: 13 Filed: 01/05/2022
WRIGHT v. HHS 13
requirement as a standalone option under § 300aa-
11(c)(1)(D) and the accompanying legislative history illus-
trate Congress’s intent to require changes within the pa-
tient.
The 1987 amendment “eliminate[d] . . . eligibility for
persons who incur expenses in excess of $1,000 but do not
suffer ongoing disabilities” and are not “seriously injured.”
H.R. Rep. No. 100-391, pt. 1, at 699 (1987) (emphases
added). Injuries and disabilities are detrimental changes
within the patient. Further, Congress contrasted “ongoing
disabilities” with expenses in excess of $1,000. Unlike ongo-
ing disabilities, expenses are decidedly external effects more
clearly meant to encompass the detriments of ongoing mon-
itoring. With its 1998 amendment, Congress wrote expenses
out of the severity requirement altogether, indicating our
analysis should focus on the vaccine injury and its medical
consequences.
By pairing “suffer” with “ongoing disability” and equat-
ing that with being “seriously injured,” Congress further
demonstrated that it intends the word “suffered” to require
painful or otherwise detrimental effects. And like its use in
the text of the statute, the repeated use of the word “suffer”
in the 1987 report and the stated intent to limit compensa-
tion to only those individuals who are “seriously injured
from taking a vaccine,” H.R. Rep. No. 100-391, pt. 1, at 699
(1987), show that the types of residual effects contemplated
by the statute do not encompass relatively non-invasive
testing.
B.W.’s relatively non-invasive ongoing monitoring is
neither an “ongoing disability” nor indicative that he “suf-
fered” or was “seriously injured” within Congress’s in-
tended meaning of the severity requirement. B.W. did not
suffer ongoing disabilities from his vaccine and in fact was
not shown to have suffered any lingering somatic effects at
all after six months.
Case: 21-1524 Document: 51 Page: 14 Filed: 01/05/2022
14 WRIGHT v. HHS
C
We do not disturb existing case law holding that a
course of treatment lasting longer than six months can be
a “residual effect.” See H.S. v. Sec’y of Health & Hum.
Servs., No. 14-1057V, 2015 WL 1588366 (Fed. Cl. Spec.
Mstr. Mar. 13, 2015) (holding that restriction on physical
activity after a concussion, which was medically necessary
to prevent further consequences, was a residual effect);
Faup v. Sec’y of Health & Hum. Servs., No. 12-87V, 2015
WL 443802 (Fed. Cl. Spec. Mstr. Jan. 13, 2015) (holding
that an individual’s chronic arthritis was a residual effect
even though it was well-controlled by medication). During
a long course of treatment, the patient generally has some
lingering condition such that symptoms will likely recur if
the treatment were stopped. Otherwise, the long course of
treatment would not be necessary.
We do not decide today whether a course of testing or
monitoring that is part of the management or treatment of
a condition, necessary even in the absence of possible
symptoms, could be a “residual effect.” In such a case, the
monitoring may be considered part of treatment of a condi-
tion that has not resolved, if the patient’s somatic condition
increases the risk of recurrence. For example, if a patient
were shown to have a chronic condition that does not ordi-
narily resolve on its own within six months, and where
some somatic change (e.g., a dormant infection or autoim-
mune condition) underlies the chronic condition, then test-
ing might be medically appropriate as part of the course of
treatment even in the absence of recurring symptoms.
We also do not decide whether diagnostic procedures
that are more invasive, high-risk, or painful than the rou-
tine blood draws of this case may be “residual effects” or
“complications” even for a condition that has resolved. Such
testing may be more in line with Congress’s intent to com-
pensate those who “suffered” for more than six months. In
addition, such procedures could cause somatic changes that
Case: 21-1524 Document: 51 Page: 15 Filed: 01/05/2022
WRIGHT v. HHS 15
are “complications” within the meaning of 42 U.S.C.
§ 300aa-11(c)(1)(D)(i).
Finally, although we focus here on medical effects, we
do not intend to exclude psychological effects from the def-
inition of “residual effects.” See Special Master Decision at
*11 (citing Tauer v. Sec’y of Health & Hum. Servs., No. 08-
703V, 2009 WL 2045676, at *1 (Fed. Cl. Spec. Mstr. June
22, 2009) (decision on stipulation)).
CONCLUSION
Because the Court of Federal Claims erred in holding
that B.W.’s platelet count tests were residual effects within
the meaning of the statute, we reverse the Court of Federal
Claims Decision.
REVERSED
COSTS
No Costs.