Opinion

Sharpe v. Secretary of Health and Human Services

Court: United States Court of Federal Claims
Filed: Apr 18, 2019
Status: Published
Cited by: 0 cases
Authority: More cited than 7.5%

upholding the Special Master’s finding that the “petitioner’s condition was not inconsistent with the disease generally and not affected by the vaccinations”

How later courts described this case

upholding the Special Master’s finding that the “petitioner’s condition was not inconsistent with the disease generally and not affected by the vaccinations”
“[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.”
upholding the determination that the petitioner’s “condition was not inconsistent with the disease generally” and unaffected by vaccination

Written by the judges who cited it.

The opinion

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.,

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

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

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.

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

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

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.

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

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.

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.

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

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

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

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).

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

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).

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.

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).”).

“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).

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,

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

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

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

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.

“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

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

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.

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.

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;