Sharpe v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 14-65V
(Filed: April 18, 2019)1
Opinion originally issued under seal on April 2, 2019
)
HEIDI SHARPE, as legal )
representative of her minor child, ) Vaccine; Encephalopathy; Table
L.M., ) Significant Aggravation; Off-Table
) Significant Aggravation;
Petitioner, ) Qualifications and Aids to
) Interpretation.
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Curtis R. Webb, Twins Falls, ID for petitioner.
Amy P. Kokot, Civil Division, United States Department of Justice, Washington, D.C.,
with whom were Joseph H. Hunt, Assistant Attorney General, C. Salvatore D’Alessio,
Acting Director, Catherine E. Reeves, Deputy Director, and Heather L. Pearlman,
Assistant Director, for respondent.
OPINION
FIRESTONE, Senior Judge
Heidi Sharpe (“petitioner”), as the legal representative of her daughter, L.M.,
1
Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of Federal
Claims (“RCFC, App. B”), this Opinion was initially filed under seal on April 2, 2019. The
parties had fourteen days from the date of filing of this Opinion to propose
redactions of any of the information herein. Neither party submitted any redactions.
seeks review of the Special Master’s Decision Denying Entitlement under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1 to -34 (“Vaccine Act” or
“Act”), as amended. Sharpe v. Sec’y of Health & Human Servs., No. 14-65V, 2018 WL
7625360 (Fed. Cl. Spec. Mstr. Nov. 5, 2018) (“Decision” or “Dec.”) (ECF No. 102).
I. BACKGROUND
A. Factual Background
The essential facts of this case are set forth in the Special Master’s Decision, see
generally Dec. at 2-7, and may be summarized as follows. L.M. was born on July 26,
2010. Dec. at 2. Over the next six months, she received routine childhood vaccinations
without incident, including Pediarix (diphtheria-tetanus-acellular pertussis (“DTaP”),
hepatitis B, and inactivated polio), haemophilus influenzae type B (“Hib”),
pneumococcal conjugate, and rotavirus. Id. On January 17, 2011, L.M. had a well-child
visit. Id. Petitioner stated that L.M. had developed symptoms of an upper respiratory
infection (“URI”) and a rash; she was diagnosed with a viral infection that causes rashes,
but she was otherwise healthy. Id. at 2, n.4. L.M.’s vaccinations were postponed due to
her illness. Id. at 2. The next day, petitioner brought L.M. to the emergency room
reporting “inconsolable crying” for one hour; her examination was normal. Id.
On February 2, 2011, petitioner brought L.M. to her doctor’s office describing
congestion and thick nasal drainage for six weeks. Id. at 3 (citing Petitioner’s Exhibit
(“Pet. Ex.”) 2 at 8). L.M. was diagnosed with congestion, and an antibiotic was
prescribed. Dec. at 3.
On February 10, 2011, L.M. received her third DTaP, Hib, and pneumococcal
2
conjugate vaccinations. Dec. at 3. The next afternoon, petitioner phoned L.M.’s
pediatrician, reporting that L.M. “had ‘developed a fever and [was] whimpery [and]
wak[ing] up “screaming.’”2 Id. (quoting Pet. Ex. 2 at 19). Petitioner stated that L.M. had
not reacted to her previous immunizations she received in the fall. Id. L.M.’s doctor
“proposed ‘that this [was] most likely not related to the injections,’ and attributed L.M.’s
symptoms to a possible viral illness[.]” Id.
On February 15, 2011, petitioner brought L.M. to the emergency room because
she “had ‘suddenly become “stiff all over” [and] unresponsive,’” which had lasted
approximately thirty seconds. Dec. at 3. During the episode, L.M. was afebrile. Id.
Petitioner conveyed that one month earlier, L.M. had “experienced an ‘unexplained
episode of sudden flaccidity [and] unresponsiveness’ for approximately thirty seconds,
followed by several minutes of crying and irritability.” Id.; see also id. at 8 n.10 (stating
that petitioner recounted “‘a few other episodes of [L.M.] “spacing out” where she had a
strange look in her eye and was not responsive for several seconds’”). L.M.’s
temperature was 97.5 degrees Fahrenheit, and she was alert. Id. at 3. Yet she was
observed to have “‘floppy’ motor control and skills” and poor head control. Id.
Later that day, L.M. had another seizure, and she was transferred to St. Vincent
Hospital. Id. at 4. During her stay, she had an evaluation with Tarif Bakdash, M.D., a
2
Petitioner contacted L.M.’s doctor’s office and the emergency room earlier in the day as well on
February 11, 2011, and she filed phone records to document these calls. See Pet. Ex. 73 at 17;
Pet. Ex. 74 at 1-2. She averred that on February 12 and 13, 2011, L.M. had a high fever and
displayed “floppiness and an uncharacteristic disinterestedness.” Dec. at 3. Petitioner claimed
that she phoned the emergency room twice to report these concerns, and she was “rebuffed,”
although no records confirm these calls. Id.
3
pediatric neurologist. Id. Petitioner described L.M. as “‘being hypotonic or floppy’ since
birth.” Id. Dr. Bakdash summarized L.M.’s seizure-like activity, which included three
spells over the past twenty-four hours. Id. His impression was that L.M. suffered from a
generalized seizure pattern and infantile spasms. Id.
The following day’s electroencephalogram (“EEG”) revealed hypsarrhythmia, a
“primary clinical characteristic of infantile spasms.” Id. On February 17, 2011, L.M.
was discharged with a diagnosis of infantile spasms, also known as West Syndrome. Id..
at 5. Although L.M. had returned to her pre-hospitalization baseline (with some
generalized hypotonia), she returned to the emergency room on March 21, 2011, due to
ongoing seizures and URI symptoms. Id. At that time, L.M. was having five or six
seizures per day. Id. Upon discharge, she had no new diagnoses. Id. (citing Pet. Ex. 3
at 57).
Throughout the remainder of 2011, L.M. had several appointments with Dr.
Bakdash and with her pediatrician. Id. at 5. Another EEG, performed on April 18, 2011,
again showed hypsarrhythmia, as well as new-onset seizure activity in the left temporal
region. Id. As of November 8, 2011, Dr. Bakdash’s differential diagnoses for L.M.
included infantile spasms, complex partial seizures, and global developmental delay. Id.
at 6 (citing Pet. Ex. 7 at 8)
Other specialists also evaluated L.M. Id. On October 27, 2011, Laura Nicholson,
M.D., a developmental and behavioral pediatrician, “diagnosed L.M. with static
encephalopathy with epilepsy.” Id. She concluded that L.M.’s condition “appeared
metabolic, ‘with a sudden onset with the stress of the six month shots, recurrent
4
regression with illness . . . [i]t looks like a mitochondrial disorder . . . but the initial labs
do not show acidosis.’” Id. (quoting Pet. Ex. 10 at 357-58).
Samuel Yang, M.D., a geneticist, examined L.M. on December 8, 2011. Id. at 6.
He observed that although L.M.’s EEG was consistent with infantile spasms, “her clinical
picture and lack of response to steroids were ‘more typical for complex partial seizures.’”
Id. Dr. Yang proposed that L.M. could have a cerebral folate deficiency, and he
recommended treatments aimed at addressing the deficiency. Id.
L.M. had improved by March 14, 2012, when she returned to Dr. Bakdash. Id.
Since starting treatment for the folate deficiency, L.M.’s generalized seizures had ceased,
and an EEG showed no hypsarrhythmic changes. Id. Although L.M. still had infantile
spasms, petitioner believed they were less frequent. Id. At that time, L.M. was receiving
occupational, physical, and speech therapies. Id. On May 1, 2012, Dr. Yang indicated
that L.M.’s seizure frequency had decreased, and her spasms occurred only once or twice
per week. Id. Her diagnoses included cerebral folate deficiency, infantile spasms, global
developmental delay, and esotropia. Id.
On January 12, 2016, genetic testing revealed that L.M. was “‘heterozygous for
the alteration in the DYNC1H1 [dynein cytoplasmic 1 heavy chain 1] gene.’” Id. at 7; see
also id. (quoting respondent’s geneticist: “L.M. is ‘heterozygous for the alteration
c.3278T>C (p.F1093S) in DYNC1H1 in exon 13’”). These records conclude that
“‘[c]ollectively, the evidence supports the likelihood that the alteration in the DYNC1H1
gene . . . is the cause of [L.M.’s] clinical symptoms.’” Id. (quoting Pet. Ex. 42 at 38); see
also id. (quoting Pet. Ex. 42 at 40 (“Based on the available evidence, the clinical overlap
5
of this gene with [L.M.’s] reported phenotype is positive. [L.M.’s] overlapping features
include infantile spasms, intellectual disability, ongoing refractory epilepsy, and diffuse
hypotonia.”)). Moreover, the report refers to another female patient with the same de
novo mutation who experienced infantile spasms, intellectual disability, autism spectrum
disorder, and reduced muscle tone. Id. at 7, 24. L.M.’s geneticist confirmed that her
“clinical picture is consistent with the central nervous system involvement seen with this
[genetic] condition, which can include developmental delays and seizures.” Pet. Ex. 42
at 32.
On February 12, 2016, L.M.’s geneticist documented epilepsy, global
developmental delay without speech, hypotonia, and mental retardation. Dec. at 7; Pet.
Ex. 42 at 31-32. To date, L.M. continues to experience seizures and developmental
delays. Dec. at 6.
B. Procedural Background
On January 27, 2014, petitioner filed for compensation under the Act. Dec. at 1-2.
After twice amending the petition, petitioner’s ultimate allegations were that the DTaP
and other vaccinations administered to L.M. on February 10, 2011, caused L.M. to suffer:
(1) an on-Table injury with regard to the significant aggravation of her underlying
condition; and (2) an off-Table injury with regard to the significant aggravation of her
underlying condition. L.M.’s “underlying condition” was characterized as a “brain
malformation/white matter deficiency/other genetic mutation” that “constituted an
encephalopathy.” Id. The petitioner relies on L.M.’s de novo mutation of the DYNC1H1
gene to support her claim that L.M. had a pre-existing encephalopathy.
6
In support of L.M.’s petition, petitioner filed three opinions from pediatric
neuropathologist Robert Shuman, M.D., and one from geneticist Richard Boles, M.D. Id.
at 10-21. The Respondent offered two medical expert reports from pediatric neurologist
and epileptologist John Zempel, M.D., Ph.D., and one from geneticist Maria Descartes,
M.D. Id. at 21-30.3
An entitlement hearing was held in March 2018. Id. at 31. Drs. Shuman and
Boles, as well as L.M.’s parents testified for petitioner,4 and Drs. Zempel and Descartes
testified for respondent.
The Special Master issued his Decision on November 5, 2018, denying
compensation. Following a comprehensive review of the record, the Special Master
determined that petitioner failed to establish that L.M.’s vaccinations significantly
aggravated her underlying condition to meet the standards for an on- or off-Table claim.
First, the Special Master concluded that L.M. did not suffer from an encephalopathy under
the Qualifications and Aids to Interpretation. The Special Master also found regardless of
3
In addition, on February 26, 2016, petitioner filed a Motion for a Determination of Law
Governing Petitioner’s Table Significant Aggravation Claim. Dec. at 44. Respondent filed a
response on April 25, 2016, and petitioner replied on May 13, 2016. Id. at 47 n.45. The issue
concerning the proof needed for petitioner’s on-Table significant aggravation claim will be
discussed at length in this opinion.
4
L.M’s parents offered factual testimony regarding L.M.’s medical history and development
prior to her vaccinations on February 10, 2011, as well as their recollections about L.M.’s
symptoms over the ensuing days. See Dec. at 8-10. During her testimony, petitioner disputed
the accuracy of the records that mentioned seizures prior to the vaccinations at issue. See id. at 8
& n.10. She also “denied informing treaters that L.M. had been floppy or hypotonic since her
birth.” Id. at 8. Petitioner further testified that between February 11 and 15, 2011, L.M.
“remained in a distressed condition,” but she did not “opt to bring L.M. in for a visit, maintaining
that a nurse had made her feel that she was overreacting and that [the pediatrician’s] office was
otherwise booked up.” Id. at 9.
7
whether petitioner had met her burden that the respondent had established that a “factor
unrelated” to the vaccinations was the cause of L.M.’s current condition. See Dec. at 50-
51, n. 47; 56. Petitioner timely moved for review of the Special Master’s Decision on
December 5, 2018. (ECF No. 104). The respondent filed a response (ECF No. 108) and
on January 18, 2019 the court asked the parties to file supplemental responses (ECF No.
111). Argument was heard on March 21, 2019.
II. DISCUSSION
A. Legal Standards
1. Standard of Review of Special Master’s Decision
The Court of Federal Claims may set aside a Special Master’s findings of fact or
conclusions of law only if “arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B); RCFC, App. B, Vaccine Rule
27(b). Under established precedent, this court does “not reweigh the factual evidence,
assess whether the [S]pecial [M]aster correctly evaluated the evidence, or examine the
probative value of the evidence or the credibility of the witnesses – these are all matters
within the purview of the fact finder.” Porter v. Sec’y of Health and Human Servs., 663
F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health and Human
Servs, 618 F.3d 1339, 1349 (Fed. Cir. 2010)). As long as “the [S]pecial [M]aster has
considered the relevant evidence,” “drawn plausible inferences,” and stated, “a rational
basis for the decision,” reversible error is extremely difficult to establish. Hines v. Sec’y
of Health and Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991).
2. The Standards for Proving On-Table and Off-Table Claims
8
In this case, petitioner alleged that L.M.’s vaccinations, administered on February
10, 2011, resulted in a significant aggravation of a preexisting encephalopathy as the
basis for her on-Table and off-Table claims. It is not disputed that the diphtheria-tetanus-
acellular pertussis (“DTaP”) is the only vaccine that could serve as the “the basis for a
Table claim alleging significant aggravation of a preexisting encephalopathy.” Dec. at 44
n.44. According to petitioner the DTaP vaccination caused L.M. to suffer: (1) an on-
Table injury with regard to the significant aggravation of her underlying condition; and
(2) an off-Table injury with regard to the significant aggravation of her underlying
condition.
The Act provides a presumption of vaccine injury “if the petitioners have shown
that the injury is ‘on-Table.’” Turner v. Sec’y of Health and Human Servs., 268 F.3d
1334, 1337 (2001). Once the petitioner has shown that the injury is on-Table and
afforded the presumption, the government may “rebut the presumption of an on-Table
injury by showing the injury complained of resulted from some factor unrelated to the
vaccine.” Id.In order to be afforded the presumption of causation for an on-Table claim with
regard to a significant aggravation of an underlying condition, the petitioner had to
establish by a preponderance of the evidence that the requisite vaccine “significantly
aggravated . . . any illness, disability, injury, or condition set forth in the Vaccine Injury
Table,” and that “the first symptom or manifestation . . . of the significant aggravation of
9
any such illness, disability, injury, or condition . . . occurred within the time period5 after
vaccine administration set forth in the Vaccine Injury Table.” 42 U.S.C. § 300aa-
11(c)(1)(C)(i). The Act defines “significant aggravation” as “any change for the worse in
a preexisting condition which results in markedly greater disability, pain, or illness
accompanied by substantial deterioration of health.” 42 U.S.C. § 300aa-33(4).
In Whitecotton v. Sec’y of Health and Human Servs., 81 F.3d 1099, 1107 (Fed.
Cir. 1996), the Federal Circuit set out a four-part test for analyzing claims alleging
significant aggravation of a Table injury. Under Whitecotton, the Special Master must:
(1) assess the individual’s condition prior to vaccination; (2) assess the individual’s
current condition; (3) determine if the individual’s current condition constitutes a
“significant aggravation” of her condition prior to vaccination within the meaning of the
statute; and (4) determine whether the first symptom or manifestation of the significant
aggravation occurred within the time period specified by the Table. Whitecotton, 81 F.3d
at 1107. In Whitecotton, the Federal Circuit further stated that “the permissible scope of
the special master’s inquiry is virtually unlimited. Congress desired the special masters
to have very wide discretion with respect to the evidence they would consider, and the
weight assigned that evidence. . . . Thus, the special master is free to consider evidence
from outside the table time period in determining whether an individual suffered the first
symptom or manifestation of a significant aggravation of an injury within the table time
5
The Vaccine Injury Table provides that the applicable time period for an encephalopathy to
occur in order to meet the Table’s definition is within 72 hours of the administration of the
vaccine. 42 U.S.C. §300aa-14(a).
10
period.” Id. at 1108. If the petitioner meets these tests with a preponderance of the
evidence, compensation will be awarded unless the respondent shows by a preponderance
of the evidence that the injury was “due to factors unrelated” to the vaccine. See 42
U.S.C. § 300aa-13(a)(1)(B).6
In deciding whether a petitioner has suffered either an on-Table injury or a
significant aggravation of an on-Table injury, Special Masters apply the Qualifications
and Aids to Interpretation (“QAI”) set forth in regulations. 42 U.S.C. § 300aa-14(b).
These QAI are read in conjunction with the Table and define its key terms. See 42 C.F.R.
§ 100.3(b) (effective July 22, 2011, to July 22, 2015).7 Pursuant to the QAI, an
individual has suffered an encephalopathy only if she “manifests, within the applicable
period, an injury meeting the description [herein] of an acute encephalopathy, and then a
chronic encephalopathy persists in such person for more than 6 months beyond the date
of vaccination.” 42 C.F.R. § 100.3(b)(2). The QAI set forth detailed criteria for both
“acute” and “chronic” encephalopathy. See id. § 100.3(b)(2)(i)-(ii).8 The QAI defines
6
A “factor unrelated” may include “infection, toxins, trauma (including birth trauma and related
anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but
which in the particular case are shown to have been the agent or agents principally responsible”
for causing the petitioner’s injury or death. 42 U.S.C. § 300aa-13(a)(2)(B).
7
The Vaccine Injury Table was amended after this petition was filed. The amended Table only
governs petitions filed on or after March 21, 2017, the effective date of the final rule. 42 C.F.R.
§ 100.3(e)(1); 82 Fed. Reg. 11321 (Feb. 22, 2017). Therefore, citations are to the Table that was
in effect when this petition was filed.
8
See also id. § 100.3(b)(2)(iii) (stating that “[a]n encephalopathy shall not be considered to be a
condition set forth in the Table if . . . it is shown by a preponderance of the evidence that the
encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a structural lesion,
a genetic disorder or trauma (without regard to whether the cause of the infection, toxin, trauma,
metabolic disturbance, structural lesion or genetic disorder is known).”).
11
“encephalopathy” in relevant part as follows:
[A] vaccine recipient shall be considered to have suffered an
encephalopathy only if [she] manifests, within the applicable period, an
injury meeting the description below of an acute encephalopathy, and then
a chronic encephalopathy persists in such person for more than 6 months
beyond the date of vaccination.
(i) An acute encephalopathy is one that is sufficiently severe so as to
require hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a
significantly decreased level of consciousness lasting for at least 24 hours.
Those children less than 18 months of age who present following a seizure
shall be viewed as having an acute encephalopathy if their significantly
decreased level of consciousness persists beyond 24 hours and cannot be
attributed to a postictal state [seizure] or medication.
Id. The application of the QAI for proving on-Table significant aggravation claims is at
issue in this petition.
If a petitioner is unable to establish an on-Table claim, a petitioner may seek
compensation for pre-existing injuries that are “significantly aggravated” by a
vaccination under the Act as an off-Table claim or causation-in-fact claim. 42 U.S.C.
§ 300aa-11(c)(1)(C)(ii); id. § 300aa-33(4). The Federal Circuit has explained that a
petitioner bears a heavy burden to meet the preponderance standard in causation-in-fact
cases. See Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir.
2005); see also Hodges v. Sec’y of Health and Human Servs., 9 F.3d 958, 961 (Fed. Cir.
1993). The elements of proof needed to establish an off-Table claim were set forth by
this court in Loving v. Sec’y of Health and Human Servs., 86 Fed. Cl. 135, 144 (2009)
and endorsed by the Federal Circuit in W.C. v. Sec’y of Health and Human Servs., 704
F.3d 1352, 1357 (Fed. Cir. 2013).
12
Under Loving, a petitioner who alleges an off-Table significant aggravation claim
must by the preponderance of the evidence establish the below-listed six elements:
(1) the person’s condition prior to administration of the vaccine, (2) the
person’s current condition (or the condition following the vaccination if that
is also pertinent), (3) evidence that the person’s current condition constitutes
a “significant aggravation” of the person’s condition prior to vaccination, (4)
a medical theory causally connecting such a significantly worsened condition
to the vaccination, (5) a logical sequence of cause and effect showing that
the vaccination was the reason for the significant aggravation, and (6) a
showing of a proximate temporal relationship between the vaccination and
the significant aggravation.
Loving, 86 Fed. Cl. at 144 (citing Whitecotton, 81 F.3d at 1107; Althen, 418 F.3d at
1278); see also id. (“[T]he appropriate framework for determining whether a petitioner
has made a prima facie showing that she has a compensable significant-aggravation off-
Table claim is a combination of the first three prongs of the Whitecotton test with the
three-part test articulated in Althen.”).
In addition to the foregoing, for an off-Table claim, the petitioner must prove by a
preponderance of the evidence “that the vaccine . . . was the actual cause of the injury.”
Munn v. Sec’y of Health and Human Serv., 970 F.2d 863, 865 (Fed. Cir. 1992). The
Special Master must assess whether the petitioner has established that the vaccine –
rather than the natural course of the pre-existing condition – is responsible for the post-
vaccination outcome. See Locane v. Sec’y of Health and Human Servs., 685 F.3d 1375,
1381 (Fed. Cir. 2012) (upholding the determination that the petitioner’s “condition was
not inconsistent with the disease generally” and unaffected by vaccination); see also
Faoro v. Sec’y of Health and Human Servs., No. 10-704V, 2016 WL 675491, at *27
(Fed. Cl. Spec. Mstr. Jan. 29, 2016). The medical theory must be “persuasive” – that is,
13
specific to the petitioner’s case and supported by a “reputable” (i.e., reliable) scientific or
medical explanation. Moberly v. Sec’y of Human and Health Servs., 592 F.3d 1315, 1322
(Fed. Cir. 2010).
Under Federal Circuit precedent, proving causation by the preponderance of
evidence does not mean proof to a scientific certainty. See Bunting v. Sec’y of Health
and Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). The Circuit has explained that
the “preponderance standard is to allow the finding of causation in a field bereft of
complete and direct proof of how vaccines affect the human body,” and a petitioner may
use circumstantial evidence to meet her burden. Althen, 418 F.3d at 1280. It is not,
however, enough to demonstrate a “plausible” or “possible” causal link between a
vaccination and an injury to meet this standard. LaLonde v. Sec’y of Health and Human
Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014); see also W.C., 704 F.3d at 1356. Rather,
“the statutory standard of preponderance of the evidence requires a petitioner to
demonstrate that the vaccine more likely than not caused the condition alleged.”
LaLonde, 746 F.3d at 1339. Thus, a Special Master may conclude that there is simply too
great an analytical gap between the data and the opinion proffered, if the petitioner has
failed to produce sufficiently reliable evidence. Cedillo v. Sec’y of Health and Human
Servs., 617 F.3d 1328, 1339 (Fed. Cir. 2010) (quoting Gen. Elec. Co. v. Joiner, 522 U.S.
136, 146 (1997)). Finally, a Special Master may not award compensation “based on the
claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”
42 U.S.C. § 300aa-13(a)(1).
The respondent is “‘permitted to offer evidence to demonstrate the inadequacy of
14
the petitioner’s evidence on a requisite element of the petitioner’s case-in-chief.’” Stone
v. Sec’y of Health and Human Servs., 676 F.3d 1373, 1379-80 (Fed. Cir. 2012) (quoting
de Bazan v. Sec’y of Health and Human Servs, 539 F.3d 1347, 1353 (Fed. Cir. 2008)).
The Special Master may weigh that evidence in determining whether a petitioner has met
her burden. See id.; see also Doe v. Sec’y of Health and Human Servs., 601 F.3d 1349,
1358 (Fed. Cir. 2010).
As with on-Table cases, if a petitioner proves a prima facie case of causation, the
burden switches. The respondent, government, then bears the burden of showing by a
preponderance of the evidence that some factor other than the vaccine was the actual
cause of the injury. Walther v. Sec’y of Health and Human Servs., 485 F.3d 1146, 1151
(Fed. Cir. 2007).
B. The Special Master’s Decision Was Not Arbitrary, Capricious, an Abuse
of Discretion, or Otherwise Not in Accordance with Law.
In this case, L.M. was found to possess a de novo mutation of the DYNC1H1 gene,
which the petitioner contends is the basis for L.M.’s pre-existing encephalopathic
disorder. See Dec. at 2, 7, 22-23, 30. The impact of that diagnosis on her on-Table and
off-Table claims is at the heart of the Special Master’s decision denying petitioner’s on-
Table and off-Table claims. We begin with summarizing the Special Master’s factual
findings and then review his denial of petitioner’s on-Table and off-Table claims.
1. The Special Master’s Review of Expert Testimony
The petitioner relied on the expert testimony of Drs. Robert Shuman and Richard
15
Boles.9 They opined that L.M.’s immunizations significantly aggravated her pre-existing
genetic condition stating that her condition would have been milder had she not been
vaccinated. Specifically, they opined that L.M.’s post vaccination seizures were evidence
of a new symptom that she had not previously experienced and proved an aggravation.
See, e.g., Dec. at 16, 21, 51.
Dr. Shuman testified that L.M.’s imaging studies revealed “structural
deficiencies,” and that she had a type of white matter deficiency known as Perinatal
TeloLeukoEncephalopathy (“PNTLE”), which “he characterized as ‘part of the
preexistent encephalopathy of [L.M.]’s genetic disease.’” Id. at 11-12, 51 (citation
omitted). In his view, L.M.’s vaccinations aggravated these deficiencies and prompted
her seizures. Id. at 13. Specifically, Dr. Shuman reasoned that a person like L.M. would
be vulnerable to “decompensation” if she was hit with the immunologic stress of
vaccination. Id. at 16 (citing Tr. at 131). In concluding that L.M. suffered from
structural deficiencies he relied on MRIs obtained on February 16, 2011, April 2011, and
May 2012 to conclude that L.M.’s brain had PNTLE. Id. at 11-12. In support of the
causal relationship between vaccination and L.M.’s symptoms, Dr. Shuman relied on the
9
Dr. Shuman is a pediatric neuropathologist with expertise in child neurology. He received his
M.D. from Stanford, completed his residency in pediatrics at the University of Colorado, a
residency in pathology at the University of Washington, and a residency in child neurology at the
University of Kentucky. He is board certified in pathology, neuropathology, and child
neurology. Dec. at 11.
Dr. Boles received his M.D. from the University of California Los Angeles where he completed
a pediatrics residency, followed by a genetics fellowship at Yale University. He was a professor
of clinical pediatrics at the University of Southern California from 1993 until 2014. Dec. at 17.
16
“National Childhood Encephalopathy Study” performed in the United Kingdom in the
late 1970s. Id. at 14 (citing Richard Alderslade et al., The National Childhood
Encephalopathy Study: A Report of 1000 Serious Cases of Serious Neurological
Disorders in Infants and Young Children from the NCES Research Team, Reports from
the Comm. on Safety of Med. & Joint Comm. on Vaccination & Immunisation (1981)).
However, on cross-examination, Dr. Shuman acknowledged that his conclusion that
L.M.’s seizure disorder/development problems by vaccination were worsened by the
vaccination beyond what would otherwise have been expected given her genetic mutation
lacked a sufficient basis. Id. at 17 (citing Tr. at 151).
Dr. Boles opined that the mutation’s location on the DYNC1H1 “chromosomal
protein chain was critical in determining the symptoms an individual would experience
when the mutation is expressed.” Id. at 17. He hypothesized that because L.M.’s
mutation was in the gene’s stem or tail, as opposed to the motor or stalk domain, her
outcome should have been less severe. Id. at 17-18. Dr. Boles claimed that L.M.’s
vaccinations “worsened the expected, comparatively milder course otherwise attributable
to her mutation[.]” Id. at 19; see also id. at 51. Dr. Boles reasoned, that the vaccine
constituted a sufficient “‘environmental insult’” to exacerbate the effects of L.M.’s
underlying mutation which made the progress of the encephalopathic disorder more
severe than it would have been otherwise. Id. at 20 (quoting Tr. at 188, 220).
The Special Master also heard testimony from Dr. Maria Descartes, one of the
17
respondent’s two experts,10 who explained that a DYNC1H1 mutation “impact[s] the
function of a gene intended to code the production of dynein, a protein important to cell
function[.]” Dec. at 22. She described L.M.’s mutation as rare and severe, as de novo
mutations “are more commonly associated with negative outcomes.” Id. at 23. In
particular, “[p]atients with de novo DYNC1H1 mutations have been identified with severe
intellectual handicaps,” as well as seizures and hypotonia. Resp. Ex. R at 6 (ECF No. 67-
1 at 6); see also Dec. at 23-25 (summarizing literature on DYNC1H1 mutations). Dr.
Descartes testified as to literature on L.M.’s mutation which references another female
patient who had infantile spasms, like L.M, and had intellectual disabilities, autism
spectrum disorder, and reduced muscle tone. Dec. at 24. Dr. Descartes noted that the
individual in the literature has a phenotypic presentation “highly similar” to L.M.’s in
that she had “infantile spasms coupled with a subsequent epileptic encephalopathy[.]” Id.
at 24-25. This patient, as reported in the medical literature, Dr. Descartes emphasized,
shows “the commonalities between the [DYNC1H1] mutation and the kinds of symptoms
L.M. experienced.” Id. at 25; see also id. at 30, 53.
The Special Master also heard additional testimony from Dr. John Zempel,11 the
10
Dr. Descartes received her M.D. from the University of Puerto Rico. She completed a
residency at San Juan City Hospital in Puerto Rico as well as fellowship in genetics at Baylor
College of Medicine in Houston, Texas. She is board certified in genetics as well as pediatrics.
Dec. at 22.
11
Dr. Zempel received an M.D. and Ph.D. from Washington University in St. Louis. He
completed residencies in pediatrics, adult neurology, and child neurology as well as fellowships
in pediatric epilepsy and clinic neurophysiology. He is board certified in neurology, child
neurology and psychiatry. Dec. at 26.
18
other expert for the respondent, who explained that L.M. likely was suffering from
seizures prior to her vaccination, whether or not the seizures were recognized as such,
and that the “course of her illness from before vaccination to the present” was consistent
with that of “treatment-nonresponsive” individuals suffering from infantile spasms. Id. at
29, 55. The Special Master found Dr. Zempel’s testimony regarding prior seizures
persuasive, reiterating in his opinion that “parents often do not recognize initial seizure
activity as part of a greater disorder before a more alarming seizure incident.” Id. at 55;
see also id. at 16.
After considering the testimony of all experts, the Special Master determined that
petitioner’s theories regarding both her on-Table and off-Table claims lacked reliable
scientific support. Dec. at 51-54. He explained that Dr. Shuman’s opinion was “the
weaker of the two,” particularly because his first two reports were filed prior to the
discovery of L.M.’s DYNC1H1 mutation, and “thus proposed a theory that did not take
into account a significant fact.” Id. at 51. The Special Master explained that Dr. Shuman
“did not abandon his initial theory” at the hearing which the Special Master found made
his opinion questionable. See id. The Special Master also determined that Dr. Shuman’s
opinion that L.M. had a pathogenic brain malformation was uncorroborated by her
records. Id. The Special Master further determined that Dr. Shuman’s assertion that
L.M. had a white matter deficiency was not well-supported. Id. The Special Master
stated that Dr. Shuman “relied upon a diagnosis that not only L.M. never received but
which elevated a diagnostic concept (PNTLE) into something that it does not appear
medical science recognizes with any degree of trustworthy sufficiency.” Id.; see also id.
19
at 48.12 Finally, the Special Master determined that Dr. Shuman’s opinion regarding
pertussis toxin-containing vaccines and his contention that they could promote seizures
was not well supported or persuasive. The Special Master explained that Dr. Shuman
relied on obsolete literature “and/or involved conflation of the DPT vaccine with the
DTaP version L.M. actually received.” Id. at 51.
The Special Master found Dr. Boles’s opinion testimony to be similarly
unpersuasive. See Dec. at 52-54. According to the Special Master, Dr. Boles failed to
“establish with reliable proof [the] contention that location [of the gene mutation] was as
outcome-determinative as he maintained[.]” Id. at 52 (emphasis in original). In this
regard, the Special Master explained that he found the opinion of the respondent’s expert,
Dr. Descartes, that the DYNC1H1 mutation itself matters far more than its location, was
more persuasive. Id. at 52; see id. at 23. Dr. Decartes challenged Dr. Boles’s contention
that mutations on the stem or tail domain “were invariably associated only with more
benign outcomes[,]” and she discussed several articles in support of her opinion. See id.
at 23-25, 52-53. Dr. Decartes opined that an individual with a DYNC1H1 mutation on the
motor or stalk domain can have a mild outcome, and, as here, an individual with a
mutation on the stem or tail domain can have one that is more severe. See id. at 52. In
this connection, the Special Master found particularly “compelling” the evidence that the
medical literature contained evidence of another patient with L.M.’s identical mutation
12
Dr. Zempel noted that PNTLE is “not a commonly-employed diagnostic term,” and it is
“subsumed within the category of periventricular leukomalacia,” a common and severe
complication of extreme prematurity. Id. at 27. L.M. was not born prematurely. Id. n.31.
20
who had similar symptoms without reference to the location of the gene mutation. Id.
The Special Master found such evidence demonstrates that “the location of a genetic
mutation is not alone predictive of mutation outcome.” Id. (describing the individual
with the same DYNC1H1 mutation in the stem/tail domain who suffered from infantile
spasms and an epileptic encephalopathy).
The Special Master also determined that neither Dr. Shuman nor Dr. Boles
articulated how any of L.M.’s vaccinations, including the DTaP, could interact with her
genetic disorder to worsen her outcome significantly. Id.. at 51, 53-54. For example, he
found that Dr. Shuman ‘s opinion “lacked a basis for the conclusion that L.M.’s seizure
disorder/developmental problems were worsened by vaccination beyond what would
otherwise have been expected given her alleged encephalopathic brain malformation/
white matter deficiency.” Id. at 17. There, the Special Master cited to Dr. Shuman’s
opinion testimony wherein he admitted on cross-examination that he had “no evidence”
that L.M’s seizure threshold had been reduced and that the vaccination worsened her
genetic condition. Tr. 151:15-22. In addition, the Special Master noted that Dr. Boles
offered no reliable support or literature “addressing the propensity of any vaccine to
exacerbate a disease otherwise attributable to a genetic mutation, and this component of
his overall opinion had a conclusory character to it, relying more on his ipse dixit than
independent evidence.” Id. at 20; see also id., n.25 (“Dr. Boles admitted he could not
pinpoint which specific vaccine received by L.M. was causal of her illness, but proposed
awareness that the MMR and DTaP had been implicated in other contexts.”).
21
2. The Special Master’s Entitlement Decision Regarding
Petitioner’s On-Table Claim
After hearing the evidence, the Special Master turned first to the petitioner’s on-
Table claim. The Special Master began by examining whether petitioner had suffered a
pre-vaccination encephalopathy sufficient to qualify for a post-vaccination aggravation
claim. The petitioner argued in her Memorandum In Support of Determination of Law
Governing Petitioner’s Table Significant Aggravation Claim (ECF No. 41), that
petitioner should only have to establish a pre-existing encephalopathy consistent with
“the common, ordinary, and accepted meaning” of encephalopathy and not the definitions
of the condition set forth in the QAI. Pet. Mem. of Law (ECF No. 41). The respondent in
their response to the petitioner’s motion did not challenge the petitioner’s assertion that
L.M. had a preexisting encephalopathy. Resp. Mem. of Law (ECF No. 44). Rather,
respondent argued that the Special Master could not award compensation based on an on-
Table claim because “there is nothing beyond petitioner’s claim to support a finding that
L.M. suffered critical symptoms within seventy-two hours of her DTaP vaccination, let
alone those consistent with an acute encephalopathy.” Resp. Mem. of Law at 9. In
petitioner’s reply, she did not dispute the respondent’s contention that L.M. had not met
the criteria for an acute encephalopathy as defined by the QAI within 72 hours of her
vaccination. Rather, petitioner argued that it would be enough for her to show that within
72 hours, L.M. began to show some “change for the worse” of her pre-vaccination
encephalopathy even if that worsening was not sufficient to meet the QAI definition of
acute encephalopathy. Pet. Reply to Mot. at 2 (ECF No. 47). Specifically, the petitioner
22
argued that so long as she can establish that she experienced symptoms of “change for the
worse” within 72 hours of the February 10, 2011 DTaP vaccination, “those symptoms
need not satisfy the definition of encephalopathy in the Qualifications and Aids to
Interpretation[.]” Id. at 4.
The Special Master determined that petitioner had not established a pre-
vaccination encephalopathy to support an on-Table claim because she could not meet the
definition of encephalopathy in the QAI prior to receiving her vaccinations. Relying on
the decision in DeRoche v. Sec’y of Health and Human Servs., No. 97-643V, 2002 WL
603087, at *25 (Fed. Cl. Spec. Mstr. Mar. 28, 2002),13 the Special Master determined that
to establish an on-Table significant aggravation claim the petitioner had to prove “at a
minimum that L.M. experienced a pre-vaccination ‘acute’ encephalopathy as set forth in
the QAIs.” Dec. at 48. Based on his review of the evidence the Special Master concluded
that L.M.’s pre-vaccination symptoms never “rose to the level of an ‘acute
encephalopathy’” and therefore “Petitioner’s Table claim cannot succeed.” Dec. at 49.
13
In DeRoche, the then-Chief Special Master applied the QAI definition of encephalopathy to
the child’s underlying condition in denying compensation in the petitioner’s presumptive
significant aggravation claim. In DeRoche, the then-Chief Special Master stated, “[T]o prove a
Table significant aggravation claim brought pursuant to [Section] 11(c)(1)(C)(i), petitioner must
first demonstrate an underlying Table injury as that injury is defined by the applicable [QAI]”.
DeRoche v. Sec’y of Health & Human Servs., No. 97-643, 2002 WL 603087, *25 (Fed. Cl. Spec.
Mstr. Mar. 28, 2002). In applying the QAI definition, the Chief Special Master “read out” the
phrase “within the applicable period” (of vaccination) because for a significant aggravation
claim, an encephalopathy is necessarily pre-existing and thus cannot arise post-vaccination. Id.
at *27, *29. Similarly, he did not apply the “chronic encephalopathy” component because given
the compressed timetable for childhood vaccines, almost always, a child would receive an
immunization before six months had elapsed, rendering it difficult to establish a Table
encephalopathy. Id. He did, however, require the petitioner to show that there had been an
encephalopathy consistent with the QAI post-vaccination to support an on-Table significant
aggravation claim. Id at *31-32.
23
On appeal, petitioner argues that the Special Master’s on-Table entitlement
decision must be set aside because the Special Master applied the wrong legal definition
of “pre-vaccination encephalopathy.” See Mot. for Review at 9-17. Petitioner contends
she did not have to show that L.M. suffered an “encephalopathy” as defined in the QAI
regulations before L.M. received her vaccinations in order to establish an on-Table
significant aggravation claim. Id. at 15-16.14 She asserts that the Special Master erred in
following the approach set forth in DeRoche, and that the Special Master instead should
have “relied on the ‘common, ordinary and accepted meaning’ of encephalopathy for the
definition of a vaccine recipient’s pre-vaccination encephalopathy.” Id. at 15; see also
Dec. at 47-48.
The respondent does not directly challenge petitioner’s contention that DeRoche is
not the appropriate standard to apply for on-Table significant aggravation claims. Rather,
the respondent maintains, as it did before the Special Master, that it is not necessary to
14
As noted above, the QAI defines “encephalopathy” in part as follows (see 42 C.F.R. §
100.3(b)(2)):
[A] vaccine recipient shall be considered to have suffered an encephalopathy only
if [she] manifests, within the applicable period, an injury meeting the description below of
an acute encephalopathy, and then a chronic encephalopathy persists in such person for
more than 6 months beyond the date of vaccination.
(i) An acute encephalopathy is one that is sufficiently severe so as to require
hospitalization (whether or not hospitalization occurred).
(A) For children less than 18 months of age who present without an associated
seizure event, an acute encephalopathy is indicated by a significantly decreased level of
consciousness lasting for at least 24 hours. Those children less than 18 months of age who
present following a seizure shall be viewed as having an acute encephalopathy if their
significantly decreased level of consciousness persists beyond 24 hours and cannot be
attributed to a postictal state (seizure) or medication.
24
resolve whether L.M. met the QAI definition of encephalopathy pre-vaccination because
petitioner undisputedly failed to meet the QAI definition of acute encephalopathy within
72 hours of her DTaP vaccination as mandated by the statute. 42 U.S.C. § 300aa-
11(c)(1)(C)(i). The respondent argues that “[r]egardless of the definition the Special
Master employed for ‘pre-vaccination encephalopathy’ the outcome does not change.”
Resp. Supl. at 3.
The petitioner argues that if the Special Master’s pre-vaccination definition of
encephalopathy is corrected that she should prevail because the statute does not require
proof of an encephalopathy meeting the QAI definition within 72 hours to establish an
on-Table significant aggravation claim. The petitioner argues that under the language of
the Vaccine Injury Act, she only had to prove that L.M’s condition “changed for the
worse,” citing 42 U.S.C. § 300aa-33(4):
For the purposes of this subtitle . . . . .
(4) The term ‘significant aggravation’ means any change for the worse in
a preexisting condition which results in markedly greater disability, pain,
or illness accompanied by substantial deterioration of health.
To prove an on-Table onset case based on an encephalopathy, the petitioner agrees
that she would have had to prove that the first symptom or manifestation of an
encephalopathy as defined by the QAI occurred within 72 hours. See 42 C.F.R. §
100.3(b)(2). But to prove an on-Table significant aggravation claim the petitioner
argues, she only needed to show a “change for the worse in a preexisting condition which
results in markedly greater disability, pain, or illness accompanied by substantial
deterioration of health.” 42 U.S.C. § 300aa-33(4). The petitioner argues that the QAI
25
definitions of encephalopathy are not relevant to on-Table significant aggravation claims.
Petitioner argues that she met her burden because the first symptom or manifestation of
L.M.’s significant aggravation occurred within 72 hours of her February 10, 2011 DTaP
vaccination. In addition, petitioner argues that a comparison of L.M.’s condition before
her February 10, 2011 DTaP vaccination to her current condition shows that L.M.
suffered a significant aggravation of her preexisting condition following her February 10,
2011 DTaP vaccination.
Petitioner argues her claim is supported by the Special Master’s acknowledgment
that L.M’s condition worsened within 72 hours after she received the DTaP vaccination:
The record does support the conclusion that L.M.’s condition was worse
immediately post-vaccination (if compared only to her immediate pre-
vaccination condition). In addition, Petitioner has pointed to evidence
from the medical record that L.M. displayed some motor control issues
and diminished responsiveness on February 15, 2011, after the seizure that
resulted in her being taken to the hospital . . .
Dec. at 50 (emphasis in the original).
The petitioner also relies on the affidavit of L.M.’s father in which he describes a
healthy baby at six months and compares that description to the Special Master’s
description of L.M.’s current condition:
At present, L.M. continues to experience seizures and developmental
delays. Petitioner alleges that, at 7 years and 5 months of age, L.M. can
crawl, as well as walk with a walker when aided (someone needs to direct
her and catch her if she stumbles). Tr. at 60-61. She takes the
anticonvulsant Tegretol and a low dose of CBD oil (medical marijuana)
to control her seizures. Tr. at 64. In her prehearing submission, Petitioner
asserts that L.M. experiences “occasional breakthrough seizures” even
during periods of relatively good health, has a poorly coordinated grasp,
suffers from cortical visual impairments, and is nonverbal, though she can
use a few signs to express ideas such as ‘hungry,’ ‘thirsty,” “I want,”
26
“yes,” and “no.” Pet’r’s Pre-Hr’g Brief at 12, dated Dec. 12, 2017, ECF
No. 73 (“Pet. Brief”).
Dec. at 6-7.
Whether a petitioner must meet the QAI definition prior to her vaccination or after
the vaccination to make an on-Table significant aggravation claim is the key issue to be
decided. The respondent argues that it is not necessary to determine whether an
encephalopathy meeting the QAI definition prior to the vaccination is necessary because
to establish an on-Table significant aggravation claim the petitioner must meet the QAI
definition of encephalopathy post-vaccination to meet the on-Table significant
aggravation standard.
The court agrees with the respondent that the purpose of on-Table claims is to
provide petitioners with a presumption of causation based on a defined set of symptoms
set by regulation in the QAI. If the defined set of QAI symptoms are not met, the
Vaccine Act allows for petitioners to seek redress under the procedures for off-Table
claims. The respondent correctly argues that the significant aggravation standard set in
the statute does not mean the QAI definitions of the Table injuries are irrelevant for the
purposes of determining if a petitioner suffered a significant aggravation of an on-Table
injury. In fact, the statutory scheme creating on-Table claims states that in order to
recover, the petitioner must experience within the applicable timeframe “the first
symptom or manifestation of onset or of the significant aggravation of such injuries,
disabilities, illnesses, conditions, and deaths” as provided for in the Table and as defined
by the QAI. 42 U.S.C. § 300aa-14(a). Thus, to prove a significant aggravation on-Table
27
claim, the petitioner must be able to show that the vaccine caused a significant
aggravation consistent with the QAI definition within the time-frames provided on the
Table.15
Here, the petitioner has not met her burden. The evidence in the record
established that L.M. never experienced an encephalopathy meeting the QAI definition
after she received her vaccination (within the relevant 72-hour period). The petitioner
only identified that L.M. had a fever with whimpering and screaming. Pet. Ex. 2 at 19.
Indeed, even outside of the 72-hour period provided by the Table, her condition did not
meet the QAI definition. When L.M. was taken to the emergency room by her mother,
the attending doctor stated she “was alert and playful, and although a ‘bit listless,’ she
displayed few other alarming clinical symptoms.” Dec. at 3 (citation omitted).
Additionally, neither of petitioner’s experts opined that L.M. suffered an acute
encephalopathy consistent with QAI definition during this period. Dr. Zempel, the
respondent’s expert, on the other hand, stated that a severe acute encephalopathy was not
present at the time of L.M.’s presentation or subsequently through the initial hospital
stay. Dec. at 26-28. This opinion was not refuted by petitioner’s experts.
It is for these reasons that the court finds that petitioner’s objections to the Special
15
The court notes that if it adopted the petitioner’s argument, the purpose of the on-Table
scheme would be undermined. Specifically, if a petitioner was not required to show the
manifestation of either an onset or a significant aggravation of a preexisting condition that was
consistent with the QAI definition for that on-Table condition, petitioners would be able take
advantage of the presumption of causation afforded by the on-Table scheme without meeting the
rigorous definition of the condition that was thought necessary for there to be a presumption of
causation.
28
Master’s conclusion that petitioner failed to establish an on-Table significant aggravation
claim cannot be sustained. Regardless of whether the DeRoche standard is correct,
petitioner did not present evidence to show the first symptoms of an acute
encephalopathy within 72 hours as required by the Vaccine Act for a significant
aggravation claim. For this reason, L.M. failed to establish that her post-vaccination
course constituted a “significant aggravation” of her prior condition. See 42 C.F.R.
§ 100.3(a)(II)(B); id. § 100.3(b)(2)(i)-(ii); 42 U.S.C. § 300aa-33(4). Petitioner’s on-
Table significant aggravation claim fails, and the Special Master’s rejection of the on-
Table significant aggravation claim is affirmed.
3. The Special Master’s Denial of Petitioner’s Causation-In-
Fact Aggravation Claim
As discussed above, to prevail on an off-Table significant aggravation claim,
petitioner had to meet the 6 elements set in Loving by the preponderance of the evidence:
(1) the person’s condition prior to administration of the vaccine, (2) the
person’s current condition (or the condition following the vaccination if that
is also pertinent), (3) evidence that the person’s current condition constitutes
a “significant aggravation” of the person’s condition prior to vaccination, (4)
a medical theory causally connecting such a significantly worsened condition
to the vaccination, (5) a logical sequence of cause and effect showing that
the vaccination was the reason for the significant aggravation, and (6) a
showing of a proximate temporal relationship between the vaccination and
the significant aggravation.
Loving, 86 Fed. Cl. at 144 (citing Whitecotton, 81 F.3d at 1107; Althen, 418 F.3d at
1278).
In rejecting petitioner’s off-Table significant aggravation claim, the Special
Master focused on petitioner’s failure to meet elements 3, 4, and 5 of the Loving test.
29
Petitioner challenges each of those conclusions and each are examined in turn below.
The Special Master, after reviewing the evidence, found that although the record
supported a finding that L.M.’s condition worsened immediately following her
vaccination, the evidence established that her “outcome would most likely be as it was
regardless of vaccination.” Dec. at 50. The petitioner takes issue with that statement
arguing that the decision must be reversed because the Special Master applied the wrong
legal standard. Specifically, petitioner argues that the Special Master erred because he
“unambiguously required [the petitioner] to predict [L.M.’s] current condition” had L.M.
not been vaccinated. Mot. for Review at 21.
The court finds that this is not a fair reading of the decision. The Special Master
correctly cited precedent for the proposition that to determine whether there was a
significant aggravation of a preexisting condition, the Special Master had to evaluate
what is known about L.M.’s preexisting condition. Therefore, the Special Master had to
evaluate what can be attributed to her genetic mutation and what impact the mutation
would have on her life without the vaccinations. Assessing an off-Table significant
aggravation claim therefore necessarily involves asking whether the individual’s “clinical
course and outcome [would have been] any different than it would have been if [she] had
not been vaccinated[.]” See, e.g., Oliver v. Sec’y of Health and Human Servs., No. 10-
394V, 2017 WL 747846, at *23 (Fed. Cl. Spec. Mstr. Feb. 1, 2017); Faoro, 2016 WL
675491, at *27 (citing Locane, 685 F.3d at 1375 (upholding the Special Master’s finding
that the “petitioner’s condition was not inconsistent with the disease generally and not
affected by the vaccinations”)).
30
A review of the decision demonstrates that the Special Master did not require
petitioner to prove the full trajectory of L.M.’s condition with her mutation to prove
causation. Petitioner relied on experts to say that L.M.’s trajectory should have been
mild. Here, a review of the record demonstrates that the Special Master, based on the
credible evidence presented about the DYNC1H1 mutation, reasonably determined that
L.M. was not guaranteed a mild outcome. Rather, her outcome, as demonstrated by the
medical literature, was consistent with children who experienced infantile spasms and
specifically the condition of another little girl with the same genetic mutation. Based on
the foregoing, the Special Master determined that the assumption of petitioner’s experts
to the effect that L.M.’s mutation would not have been as severe without the vaccination
was not established. Dec. at 49-50. The Special Master’s discussion of L.M.’s condition
was therefore consistent with the petitioner’s obligation to prove that the vaccine in fact
had worsened that condition. As discussed above, the respondent is permitted to
demonstrate the inadequacy of the petitioner’s evidence on a requisite element to prove
an injury claim and the Special Master may determine based on his consideration of all
the evidence presented that the petitioner did not meet her burden. Stone, 676 F.3d at
1379-80.
Petitioner also needed to show by a preponderance of the evidence a theory
causally connecting the DTaP vaccine to a significant worsening of her condition.
Loving, 86 Fed. Cl. at 144 (citing Althen, 418 F.3d at 1278). The Special Master
considered Dr. Boles’ opinion testimony regarding how the vaccine could impact L.M.’s
mutation and found that “Dr. Boles did not persuasively explain how the vaccines
31
interacted with the mutation.” Dec. at 52. The Special Master found Dr. Bole’s reliance
on “personal supposition, or the general proposition that vaccination constitutes an
environmental factor that can interact with genetic expression, basing such contentions on
his own generalized observations from the treatment of unspecified twins,” was not a
reliable theory of causation. Id. The Special Master also found that Dr. Shuman’s
statements regarding the seizure-inducing potential of the DPT vaccine were not
persuasive because L.M. did not receive the DPT vaccine but the different DTaP vaccine.
Dec. at 54. The petitioner therefore did not have any specific evidence to explain how
the DTaP vaccine that L.M. received could have caused a worsening of her condition.
The Special Master also properly considered if the logical sequence of events
could support a finding that the DTaP vaccination caused the alleged significant
aggravation of L.M.’s genetic condition. The Special Master agreed that L.M.
experienced a post-vaccination fever and a reaction but rejected petitioner’s claim that the
seizures L.M. started experiencing post-vaccination were new and the result the
vaccination. The Special Master reasonably concluded that the record demonstrated that
there was a strong “likelihood that L.M. had already experienced seizures before her
February 15th ER visit[,]” and that this evidence was consistent with Dr. Zempels’
testimony as confirmed by the medical literature, that parents often do not recognize
initial seizure activity before a more alarming incident. Dec. at 55.
In this connection, it is worth noting, that in rejecting the petitioner’s off-Table
claim the Special Master explained that even if L.M.’s expected prognosis should instead
be considered as a “factor unrelated” for which the respondent has the burden, that he
32
“would find that respondent did establish a ‘factor unrelated’ in the form of the
relationship between the DYNC mutation and L.M’s illness.” Id. at 50-51 n.47. In
reaching this conclusion, the Special Master relied on cases involving children with
Dravet syndrome (a rare seizure disorder involving a mutation in the SCN1A gene). See
id. at 29 n.35, 41-42. In the cases involving Dravet syndrome, as in this case, the
petitioners acknowledged that the children’s SCN1A mutations were responsible for
many of their symptoms but argued that their vaccinations had worsened their outcomes.
Id. at 41-42.16 While acknowledging that the evidence in this case was not as conclusive
as the evidence involving the SCN1A mutations and Dravet syndrome, he concluded that
in this case, as in those, the evidence established that the genetic mutation and not the
vaccination that was responsible for the child’s condition post-vaccination. Thus, the
Special Master stated that even if petitioner had proven her prima facie case, he would
nevertheless find that respondent established “a ‘factor unrelated,’ in the form of the
relationship between the [DYNC1H1] mutation and L.M.’s illness.” Dec. at 50-51, n.47.
Although this court does not have to reach whether the respondent met its burden
for proving a factor unrelated, given the Special Master’s conclusions regarding the
petitioner’s failure to establish a causal connection between L.M.’s DTaP vaccination and
her condition post-vaccination to establish a significant aggravation case, it is clear from
16
To date, compensation has been denied in more than one dozen such cases. See Oliver, 2017
WL 747846, at *1 & n.3 (listing the decisions), aff’d, 133 Fed. Cl. 341 (2017), aff’d, 900 F.3d
1357 (Fed. Cir. 2018).
33
the record that the Special Master considered the entire record and reached the rational
conclusion that petitioner’s had failed to establish that L.M.’s condition had worsened
because of her DTaP vaccination. For these reasons the Special Master’s decision
rejecting petitioner’s off-Table significant aggravation claim must be affirmed.
CONCLUSION
Because petitioner has failed to demonstrate that the Special Master erred in
applying the law, abused his discretion or that his findings were arbitrary or capricious
the Special Master’s decision is AFFIRMED.
IT IS SO ORDERED.
s/Nancy B. Firestone
NANCY B. FIRESTONE
Senior Judge
34