Wright v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 16-498V
(Filed: July 16, 2019)
(Re-issued for Publication: February 19, 2020) 1
***********************
HEATHER WRIGHT, as the legal
representative of her minor son, B.W., National Childhood
Vaccine Injury Act;
Petitioner, Motion for review;
Severity requirement;
v. Residual effect; MMR
vaccine; Immune
SECRETARY OF HEALTH AND thrombocytopenic
HUMAN SERVICES, purpura (“ITP”).
Respondent.
***********************
Leah V. Durant, Washington, DC for petitioner.
Traci R. Patton, Senior Trial Attorney in the Torts Branch of the Civil
Division, Department of Justice, Washington, DC, with whom are, Joseph
H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio, Acting
Director, Catharine Reeves, Deputy Director, and Heather L. Pearlman,
Assistant Director, for respondent.
OPINION
BRUGGINK, Judge.
This case was brought by petitioner, Heather Wright, on behalf of her
minor son, B.W., under the National Childhood Vaccine Injury Act
1
Pursuant to Vaccine Rule 18(b), this opinion was initially filed under seal
to afford the parties14 days to propose redactions. The parties did not propose
any redactions. Accordingly, this opinion is reissued in its original form for
publication.
(“Vaccine Act”). The petition alleges that B.W. suffered from immune
thrombocytopenic purpura (“ITP”) after receiving his measles-mumps-
rubella (“MMR”) vaccine on March 28, 2014, and is entitled to compensation
because the management of the condition through repeated platelet tests
satisfies the statute’s six-month residual effect requirement. Respondent
moved to dismiss for failure to meet the severity requirement. The Special
Master agreed with respondent after further briefing and a hearing. The case
is now before this court on a motion for review of that decision. The motion
is fully briefed, and oral argument was held on July 11, 2019. Because we
find the Vaccine Act’s severity requirement met in these circumstances, we
grant the motion for review and reverse the Special Master’s decision.
The petitioner bears the burden of proving by a preponderance of the
evidence that it is entitled to compensation under the Vaccine Act. In a Table
claim, as is presented here, causation is presumed if the resulting injury,
disability, illness, or condition corresponds with the vaccine listed and occurs
within the designated time period. See 42 U.S.C.S § 300a-14 (2012); 42
C.F.R. § 100.3(a) (2017); W.C. v. Sec’y of Health & Human Servs., 704 F.3d
1352, 1356 (Fed. Cir. 2013). Still, petitioner must prove that the individual
experiencing the vaccine-related injury: (1) “suffered the residual effects or
complications of such illness, disability, injury, or condition for more than 6
months after the administration of the vaccine,” (2) died, or (3) was
hospitalized or underwent surgery in response to the vaccine-related illness,
disability, injury, or condition. 42 U.S.C.S. § 300aa-11(c)(1)(D).
BACKGROUND
I. Factual History
B.W. was born on March 21, 2012. At his two-year well-child visit
on March 28, 2014, he was relatively healthy, although he was behind on
vaccinations. He was thus administered MMR, DTap, ActHib,
pneumococcal, Hepatitis A, and Varicella vaccines at that visit.
On April 15, 2014, B.W.’s father and paternal grandmother brought
him to the Emergency Room at Ty Cobb Regional Medical Center in
Lavonia, Georgia after finding bruises on his forehead, abdomen, arms, and
legs. X-rays and blood tests were performed. The x-rays were normal but
the blood tests showed a low platelet count. His platelet count was 43,000,
far below the normal range of 150,000 to 400,000. He was diagnosed with
2
ITP and discharged that day with a recommendation to see his primary care
provider within a week in order to be referred to a hematologist. 2
Because Ms. Wright did not have many details regarding B.W.’s visit
to Ty Cobb the previous day, she was concerned about his ITP diagnosis and
brought BW to Children’s Healthcare of Atlanta (“CHOA”) the following
day, April 16, 2014. Another Complete Blood Count (“CBC”) was
performed, and B.W.’s platelet count was again found to be low at 68,000.
The treating physician at CHOA discharged B.W. that day with a diagnosis
of “‘thrombocytopenia likely secondary to acute ITP.’” Wright v. Sec’y of
Health & Human Servs., No. 16-498V, 2019 WL 1061472 at 3 (Fed. Cl.
Spec. Mstr. Jan. 18, 2019) (hereinafter “Decision”) (quoting Pet’r’s Ex. 4 at
91). She also recommended following up with a hematology clinic and
suggested finding one closer to home because petitioner lived three hours
from CHOA.
Over the next few weeks, B.W.’s platelet count was checked every
three to four days by pediatricians at The Longstreet Clinic in Gainesville,
Georgia. The counts were as follows: 180,000 on April 21, 181,000 on April
25, 80,000 on April 29, 68,000 on May 2, and 111,000 on May 7. On April
29, 2014, Dr. Garrick Bailey, M.D. referred B.W. to the
Hematology/Oncology Department of CHOA. On May 13, 2014, B.W. saw
hematologists Benjamin Watkins, M.D. and Michael Briones, D.O., at which
point his platelet count was 80,000. 3 Drs. Watkins and Briones reviewed the
previous platelet counts and concluded that B.W. had ITP as a result of his
MMR vaccine. They recommended follow-up visits “‘every 1-2 months
until resolution’” since his ITP was not viewed as severe. Id. (quoting Pet’r’s
Ex. 2 at 127).
A follow-up visit was scheduled for June 10, 2014, but was canceled
by petitioner due to a stomach bug and never rescheduled. However, on July
2
Thrombocytopenia purpura is defined in the Vaccine Act’s regulations “by
the presence of clinical manifestations, such as petechiae, significant
bruising, or spontaneous bleeding, and by a serum platelet count less than
50,000/mm3 with normal red and white blood cell indices.” 42 C.F.R. §
100.3(c)(7).
3
The International Working Group on ITP uses a platelet count of less than
or equal to 100,000/mm3 to diagnose ITP. Resp’t’s Ex. B at 2. This is higher
than the 50,000/ mm3 used in the statute. See 42 C.F.R. § 100.3(c)(7).
3
8, 2014, Dr. Bailey performed another platelet count at petitioner’s request
and concluded that B.W.’s ITP had “resolved.” Id. (quoting Pet’r’s Ex. 2 at
144).
Given B.W.’s history of ITP, the pediatricians who saw him over the
next two years continued to order platelet testing in response to his continued
presentation with bruising. On September 14, 2014, B.W. was seen for
bruising and headaches. His platelet count was 312,000. On January 26,
2015, B.W.’s platelets were counted when he was seen for bruising on his
shins and abdomen; the count at that visit was 381,000. On April 13, 2016,
platelet testing was ordered after B.W. was brought in for bruising on his
back and extremities, as well as petechiae on his mid and lower back. 4 Pet’r’s
Ex. 9 at 41. B.W.’s platelet count was 289,000. Lastly, on September 14,
2016, B.W. was seen again for bruising and the platelet test showed a platelet
count of 318,000.
Between these visits, B.W. was seen several times for bruising, or
bruising was indicated on his medical record if he was seen for something
else. Those dates include: October 9, 2014 (experienced bruising after falling
from a cart), December 5, 2014 (bruising), April 16, 2015 (bruises noted at
three-year well-child visit), June 28, 2015 (finger contusion due to car door),
and March 2016 (bruises on face after dog bite). 5
II. Procedural History
On April 21, 2016 Heather Wright filed a petition for compensation
on behalf of her minor son under the National Childhood Vaccine Injury Act,
42 U.S.C.S. §§ 300aa-1 to-34 (2012). Petitioner alleged that her son had
developed ITP as a result of receiving the MMR vaccine on March 28, 2014.
Originally, this case was assigned to the Special Processing Unit because it
looked to be a Table claim that was likely to settle. See 42 C.F.R. § 100.3(a).
4
Petechiae are “‘small hemorrhages in the skin.’” Crabbe v. Sec’y of Health
& Human Servs., No. 10-762V, 2011 WL 4436742, at *7-8, n.9 (Fed. Cl.
Spec. Mstr. Aug. 26, 2011) (quoting Kathleen D. Pagana & Timothy J.
Pagana, Mosby’s Manual of Diagnostic and Laboratory Tests (4th ed. 2010)
at 416).
5
B.W. was also seen on May 6, 2016, for a nosebleed. Nosebleeds are also
a common symptom of ITP. See Guido v. Sec’y of Health & Human Servs.,
No. 16-435V, WL 4277579, at *7 (Fed. Cl. Spec. Mstr. Aug. 25, 2017).
4
Respondent, however, filed a combined Vaccine Rule 4(c) Report and a
Motion to Dismiss on September 21, 2016, at which point the case was
reassigned to Special Master Corcoran. In it, respondent argued that
petitioner could not meet the severity requirement for compensation under
the Vaccine Act because B.W.’s ITP resolved in less than six months after
he received the vaccine. The motion was fully briefed and an evidentiary
hearing was held on September 21, 2017.
At the hearing, both parties provided expert testimony. Dr. Catherine
Shaer testified for petitioner, and Dr. Joan Gill testified for respondent. Dr.
Shaer testified that the continued platelet testing that B.W. underwent when
he was seen for bruising, even after Dr. Bailey concluded that B.W.’s
condition had resolved, constituted “management of his condition.” Hr’g Tr.
22. She explained that, when a child with a recent history of ITP is presented
to a medical professional because he exhibits bruising, it is appropriate for
platelet counts to be tested. Even though bruises are not in and of themselves
diagnostic of ITP, they are “one of the manifestations of a low platelet count
that you can actually visually see.” Hr’g Tr. 19 (Dr. Shaer).
Dr. Gill, on the other hand, focused on Dr. Bailey’s July 8, 2014
declaration that B.W.’s ITP had resolved. She explained the differences
between acute and chronic ITP and opined that, though the subsequent
testing that B.W. underwent was related to his history of ITP, the platelet
counts show that his ITP in fact never returned. Dr. Gill noted, like Dr. Shaer,
that, although bruising is symptomatic of ITP, it is not diagnostic unless it is
accompanied by a low platelet count.
After a thorough analysis of the facts, Special Master Corcoran found
Dr. Gill persuasive and concluded that petitioner had not met the Vaccine
Act’s severity requirement. He held that subsequent monitoring of an earlier-
resolved condition was insufficient without recurrence of the condition more
than six months after the vaccine administration. Based on the testimony at
the hearing, however, the Special Master found it conceivable that B.W. may
have suffered a psychological response lasting more than six months (and
thus satisfying the severity requirement) and requested post-hearing briefs
and supporting evidence from each party to that respect. Post-hearing briefs
were filed on December 29, 2017, by petitioner and on February 12, 2018,
by respondent. Both parties filed expert reports on the psychological issue
after that.
5
Special Master Corcoran issued his opinion dismissing the complaint
on January 18, 2019. He concluded that this case was indistinguishable from
Crabbe v. Secretary of Health & Human Services, No. 10-762V, 2011 WL
4436742 (Fed. Cl. Spec. Mstr. Aug. 26, 2011), in which the Special Master
held that neither monitoring ITP through platelet counts nor the possibility
of recurrence were residual effects. He further held that, even if continued
testing constituted “management,” that would not mean that the management
was necessary to manage symptoms or sequelae of ITP. Decision at 14.
The Special Master also rejected petitioner’s separate argument that
B.W. showed evidence of separation anxiety that could be traced to the ITP
episode. It is not necessary to discuss that issue in any detail, however,
because we grant the petitioner’s motion on other grounds.
On February 19, 2019, petitioner filed the present motion for review.
Respondent filed a response on March 21, 2019. Oral argument was held on
July 11, 2019.
DISCUSSION
I. Standard of Review
On a motion for review, the court can: (1) uphold the special master’s
finding of fact and conclusions of law and sustain his decision, (2) set aside
any of the special master’s finding of fact or conclusions of law that are found
to be “arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law” and issue our own findings of fact and conclusions of
law, or (3) remand to the special master for further action according to this
court’s discretion. 42 U.S.C.S. § 300aa-12(e)(2)(A)-(C) (2012).
Findings of fact are reviewed under the arbitrary and capricious
standard; legal conclusions are reviewed de novo, and discretionary
decisions are reviewed under the abuse of discretion standard. Munn v. Sec’y
of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
Weighing and evaluating factual evidence and determining its probative
value are within the Special Master’s purview as fact finder. Broekelschen
v. Sec’y of Health & Human Servs., 89 Fed. Cl. 336, 343-44 (2009). On
review, we do not reweigh, reevaluate or redetermine the value of factual
evidence unless the Special Master is found to have been arbitrary and
capricious, in which case we may “substitute [our] own findings of fact” if
6
we determine that the Special Master was arbitrary and capricious in his
review. Id.; Munn, 970 F.2d at 870.
In this case, we have no reason to question the Special Master’s
thorough analysis of the facts; rather, we reach a different conclusion on an
admittedly close question of law.
II. Petitioner’s Record Demonstrates That Petitioner Suffered Residual
Effects Of The Vaccine-Related Illness More Than Six Months After
Receiving The Vaccine
Petitioner argues that the Special Master erred in holding that B.W.’s
repeated platelet testing six months after receiving the vaccination and
beyond was not a residual effect or complication as required by the statute.
Because the platelet tests were necessary given the subsequent manifestation
of symptoms, petitioner asserts that this was treatment or management of
B.W.’s condition and thus met the statutory requirement.
In doing so, Ms. Wright also challenges the Special Master’s reliance
on Crabbe because, unlike in Crabbe, her son’s treating physicians ordered
subsequent platelet counts in response to his history of ITP and “their desire
to ensure that his platelets permanently stabilized so he would not suffer any
relapses.” Pet’r’s Mot. for Review 16. Petitioner cites two other cases as
helpful, H.S. v. Secretary of Health & Human Services, No. 14-1057V, 2005
WL 1588366 (Fed. Cl. Spec. Mstr. Mar. 13, 2015) and Faup v. Secretary of
Health & Human Services, No. 12-87V, 2015 WL 443802 (Fed. Cl. Spec.
Mstr. Jan. 13, 2015). In those cases, the doctors’ concern about the presence
of a vaccine-injury, as evidenced by continuing physical restrictions and on-
going medication, were found to be residual effects of the injuries, even if
the patient was asymptomatic at the time of these continuing effects.
Petitioner analogizes this to her case, arguing that, just as relapse-preventing
restrictions and medication are residual effects because they manage the
“underlying vaccine injury,” B.W.’s platelet tests are residual effects because
they too manage his underlying vaccine-injury. Pet’r’s Mot. for Review 17.
At oral argument, petitioner argued that the court need not narrowly
construe the statute using medical definitions because the plain meaning of
“residual effects” is clear. Counsel urged the court to define the term broadly
to encompass any subsequent monitoring for an earlier vaccine-related injury
even if the injury has been resolved.
7
For its part, respondent agrees with the Special Master that petitioner
did not show by a preponderance of evidence that B.W. suffered residual
effects of his vaccine-related injury for more than six months. It emphasizes
Dr. Bailey’s July 8, 2014 notation that B.W.’s ITP was resolved and cites
Crabbe as persuasive. 6 Respondent argues that only “symptoms that
manifest because of the vaccine-related injury” are residual effects
necessitating compensation under the Vaccine Act. Resp’t’s Resp. 8
(emphasis omitted) (citing Parsley v. Sec’y of Health & Human Servs., No.
08-781V, 2011 WL 2463539, at *16 (Fed. Cl. Spec. Mstr. May 27, 2011)).
Further, respondent disputes that the tests B.W. received more than
six months after his vaccination were monitoring or treatment of ITP because
CBCs are merely diagnostic tests and did not show a recurrence of the injury.
The tests were not a residual effect because B.W. was never re-diagnosed
with ITP, urges Respondent. To be compensable, the government argues,
the residual effects or complications “must manifest as a symptom.” Resp’t’s
Resp. 12. The government also flags in the record the notation that the
subsequent tests were ordered at Ms. Wright’s request, and suggests that they
are thus not reflective of any concern of the treating physicians.
The question posed by the respondent is whether what occurs after the
six-month period must be a recurrence within the patient of the prior medical
condition or of some physical sequela resulting from that condition, as
opposed to merely treatment or management done to the patient, even if
physical symptoms trigger a concern that there has been a relapse.
There is no question that the testing was triggered by the prior ITP.
In that sense, the testing is causally linked to the condition. We understand
respondent’s concern that, if a condition has fully resolved, prescribing
monitoring to occur beyond the six-month period is a very attenuated link to
the severity concerns of the Act. For that reason, respondent argues that the
“residual effects” requirement should involve something more than mere
cause and effect in a general sense. Instead, it prefers the medical definition
of “residual effect” relied on in Parsley: “refer[s] to something left behind or
6
Respondent also relies on testimony from Drs. Shaer and Gill for this point.
8
resulting from an illness, disability, or condition.” 2011 WL 2463539 at
*61. 7 I.e., a return of the condition or physical sequela.
This definition often precludes claimants who suffer a vaccine related
injury from compensation if the injury resolves before the six-month time
frame and not does return, even if the patient is tested for possible recurrence
later. See, e.g., Id. at *16; Crabbe, 2011 WL 4436742 at *20. Petitioner did
not offer a competing dictionary definition but, at oral argument, suggested
that the Act’s severity requirement be interpreted based the plain meaning of
its terms because it is not ambiguous. Under either approach, we find that
petitioner has met the test. See United States v. Ron Pair Enters., 489 U.S.
235, 240-41 (1989) (explaining that a court need not inquire beyond a
statute’s plain language when the statutory scheme is coherent and
consistent).
The Special Master relied on Crabbe, calling it “indistinguishable”
from the case before us. In Crabbe, a child was diagnosed with ITP after
receiving the MMR vaccine and underwent platelet counts more than six
months after the vaccination, once when he was presented with “redness
around his eyes and neck” and the other when he was presented with a runny
nose and high fever. Both blood tests showed normal platelet levels; thus,
the Special Master concluded that platelet tests were not “residual effects”
because they were merely testing for a possible recurrence of ITP. In
Crabbe, the petitioner did not offer expert witness testimony to the effect that
the child’s “problems [were] related to the vaccine injury.” Crabbe, No. 10-
762V, 2011 WL 4436742 at *17 (citing Song v. Sec’y, Health & Human
Servs., 31 Fed. Cl. 61, 63 (1994)).
Unlike in Crabbe, however, the platelet tests B.W. underwent after
September 28, 2014 (January 26, 2015, April 13, 2016, and September 14,
2016), were ordered because B.W. presented with bruising and, in one
instance, petechiae, both of which are symptoms of ITP. See 42 C.F.R. §
100.3 (c)(7). The record is clear that the treating physicians ordered platelet
7
Both parties refer to this definition of residual effects, and it is the definition
relied upon in Crabbe. See Resp’t’s Resp. 8; Pet’r’s Mot. for Review 15 n.4;
Crabbe, 2011 WL 4436742 at *20. The Special Master in Parsley relied on
Abbott v. Sec’y of Health & Human Servs., 27 Fed. Cl. 792 (1993), rev’d on
other grounds, 19 F.3d 39 (Fed. Cir. 1994) to define residual effect based on
how a medical professional would understand the term.
9
counts because of B.W.’s history of ITP. Both sides’ expert witnesses agreed
that this response—ordering platelet counts when a patient with a history of
ITP is presented with bruising—was within the doctor’s reasonable standard
of care. The present case, therefore, poses circumstances in between physical
sequela of the condition and mere monitoring. We thus conclude that it is,
in fact, distinguishable from Crabbe because the subsequent testing in this
case was directly related to B.W.’s presentation of symptoms of ITP.
The response of B.W.’s doctors to his bruising is analogous to that in
H.S. v. Secretary of Health & Human Services. In H.S., a patient who
fractured his skull after an episode of syncope following a vaccination was
compensated under the Vaccine Act because his physician’s instruction to
restrict physical activity continued more than six-months after he received
the vaccine, even though the patient did not exhibit on-going symptoms.
2005 WL 1588366 at *8-9. The Special Master concluded that the activity
restriction was a sufficient residual effect to allow for compensation. She
found that the patient’s doctors “believed that the restriction from activity
was medically necessary as part of H.S.’s treatment precisely to ensure that
further consequences of the injury would not manifest in the future.” Id. at
*8 (emphasis in original). Similarly, because B.W.’s doctors were exercising
a reasonable standard of care by testing his platelets in response to the
bruising he continued to exhibit more than six months after vaccination,
those tests were also causally connected to the vaccine injury, and, we
conclude, a residual effect. 8
Using either the definition supplied by Parsley or a more general
understanding of the terms, testing for a condition that could return ought to
be compensated under the Vaccine Act when that testing is causally
connected to the underlying vaccine-injury and triggered by subsequent
symptoms of the conditions. The fact that those tests did not reveal the
presence of ITP is not controlling. The tests became necessary when later
symptoms triggered concern because of the earlier injury; they were not mere
monitoring.
8
Respondent conceded at oral argument that B.W.’s platelet tests were
connected to his history of ITP. Dr. Gill, testifying on behalf of respondent
before the Special Master, likewise testified that it is unlikely B.W. would
have undergone continued platelet testing if it were not for his history with
ITP.
10
Our conclusion is consistent with the purpose of the Vaccine Act,
which is to award “vaccine-injured persons quickly, easily, and with
certainty and generosity.” Weddel v. Sec’y of Health & Human Servs., 100
F.3d 929, 932 (Fed. Cir. 1996) (quoting H.R. Rep. No. 99-908, at 3 (1986)).
The act was meant to remedy the problem that “the opportunities for redress
and restitution are limited, time consuming, expensive, and often
unanswered” “for the relatively few who are injured by vaccines—through
no fault of their own.” Cloer v. Sec’y of Health & Human Servs., 654 F.3d
1322, 1325 (Fed. Cir. 2011) (quoting H.R. Rep. No. 99-908, at 4 (1986)). By
establishing a rule of prima facie proof for Table claims, the Act further
“establishes a scheme of recovery designed to work faster and with greater
ease than the civil tort system.” Shalala v. Whitecotton, 514 U.S. 268, 269-
70 (1995) (citing H.R. Rep. No. 99-908, at 3-17 (1986)). Given this purpose,
we hold that the Act’s severity requirement is met when a petitioner has
suffered an injury recognized by the Act and, for more than six months after
the vaccine was administered, repeatedly undergoes unscheduled medical
tests triggered by symptoms directly linked to the asserted vaccine-related
injury.
CONCLUSION
Because the record indicates that B.W.’s on-going platelet counts
were a result of the ITP he suffered following his MMR vaccine, we conclude
that the Special Master erred as a matter of law in holding that there was no
residual effect of the vaccine-related injury within the meaning of the Act.
We therefore grant petitioner’s motion for review and remand the case back
to the Special Master for further proceedings consistent with this opinion.
s/Eric G. Bruggink
ERIC G. BRUGGINK
Senior Judge
11