Sharpe v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-65V
(to be published)

*************************
HEIDI SHARPE, as legal representative * Chief Special Master Corcoran
of her minor child, L.M., *
*
* Filed: February 19, 2021
Petitioner, *
*
v. *
*
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
Respondent. *
*
*************************

Curtis Webb, Twin Falls, ID, for Petitioner.

Voris Johnson, U.S. Dep’t of Justice, Washington, DC, for Respondent.

RULING ON REMAND GRANTING ENTITLEMENT 1

Heidi Sharpe, as legal representative of her child, L.M., filed a petition on January 27,
2014, seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine
Program”). 2 Pet. at 1 (ECF No. 1). Among other things, Ms. Sharpe alleged a causation-in-fact
claim that the diphtheria-tetanus-acellular pertussis (“DTaP”) and other vaccinations administered
to L.M. on February 10, 2011, caused L.M. to experience significant aggravation of a preexisting
seizure disorder associated in some part with an underlying genetic mutation. Pet. at 2.

1 This Ruling will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Ruling will be available to anyone with access
to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published
Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party
has fourteen (14) days within which to request redaction “of any information furnished by that party: (1) that is a trade
secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or
similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).
Otherwise, the entire Ruling will be available in its current form. Id.
2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-
10–34 (2012) (hereinafter “Vaccine Act” or “the Act”). Individual section references hereafter shall refer to § 300aa
of the Act.
 After a two-day hearing in March 2018, I denied entitlement in November 2018. Sharpe v.
Sec’y of Health & Hum. Servs., No. 14-65V, 2018 WL 7625360 (Fed. Cl. Spec. Mstr. Nov. 5,
2018) (ECF No. 102) (“Entitlement Decision”). Although my decision was initially affirmed by
the Court of Federal Claims, it has since been vacated and reversed in part by the Federal Circuit.
Sharpe v. Sec’y of Health & Hum. Servs., 964 F.3d 1072 (Fed. Cir. 2020) (the “Federal Circuit
Decision”). In particular, dismissal of Petitioner’s Table claim was affirmed, but my rejection of
her off-table significant aggravation claim was vacated and remanded for further proceedings.

After remand, on November 16, 2020, I ordered Respondent to show cause why a ruling
on entitlement in Petitioner’s favor was not appropriate given the findings in the Federal Circuit
Decision. See Order, dated Nov. 16, 2020 (ECF No. 125). In reaction, on January 8, 2021,
Respondent filed a brief maintaining that Petitioner had not met her burden of proving entitlement
to compensation in this case even in light of the Federal Circuit’s instruction on the proper
interpretation of the significant aggravation legal standard, plus the other fact-findings and
evidence-weightings the Circuit panel performed. Brief, dated Jan. 8, 2020 (ECF No. 127) (“Resp.
Br.”). On January 21, 2021, Petitioner opposed Respondent’s argument, maintaining that
Petitioner had established that the vaccinations that L.M. received in February 2011 were the likely
reason for the significant aggravation of her pre-existing seizure disorder, and thus entitlement to
compensation should be granted. Brief, dated Jan. 21, 2021 (ECF No. 129) (“Pet.’s Br.”).

Based upon evaluation and review of these filings, the Federal Circuit Decision, and my
own extensive review of the records filed in this case, I hereby find Petitioner is entitled to an
award of damages, for the reasons set forth below.

Brief Procedural History

The November 2018 Entitlement Decision

This ruling incorporates by reference the Entitlement Decision and the Federal Circuit
Decision. 3 In summary, I initially determined (after a hearing involving the testimony of four
experts) that Petitioner had not satisfied enough of the prongs of an off-Table significant
aggravation case (as set forth in Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144
(2009)) to establish that her preexisting seizure disorder, associated with an identified genetic
mutation, was likely worsened by receipt of the DTaP vaccine (the vaccine most focused-upon in
the case—although not exclusively). Entitlement Decision at *32. That seizure disorder was agreed
by the parties to have a relationship to the “DYNC” (as defined in the Entitlement Decision)4

3
Citations to specific pages within these two published decisions will be to the official Westlaw versions, although I
will refer to the decisions generally by their defined titles in this Ruling.
4
See Entitlement Decision at *39.

2
genetic mutation L.M. unquestionably possessed—and it was also agreed that the mutation was
predictive and causal of some future seizure disorder issues in an infant, although Petitioner
maintained that but for vaccination L.M.’s course would have been far less severe.

Based on testimony at the entitlement hearing plus the medical records and numerous items
of medical and scientific literature filed in this matter, I found that Ms. Sharpe had at least satisfied
Loving prongs one, two, and six. Entitlement Decision at *41. There was no dispute that L.M.
possessed the DYNC genetic mutation prior to vaccination (Loving prong one) but had only
displayed some mild initial seizure activity, and the nature and status of her overall seizure disorder
post-vaccination was also established in the record (Loving prong two). In addition, the record
supported Petitioner’s claim that the timeframe for onset of her alleged vaccine-caused worsening
of the disorder was medically acceptable, assuming the theory itself had been preponderantly
established (Loving prong six). Id. at *10-11, *41.

However, Petitioner’s significant aggravation claim still failed, in my initial estimation.
Regarding the third Loving prong, I found that Ms. Sharpe had not established that L.M.’s post-
vaccination course varied enough from what otherwise would be expected for a child possessing
the DYNC mutation to be deemed a “significant aggravation” of the otherwise genetically-caused
seizure disorder. Petitioner’s geneticist, Dr. Richard Boles, 5 did not preponderantly establish
through his testimony that the precise location of the mutation on the DYNC gene was predictive
of severity/outcome, since other reliable evidence offered in the case demonstrated instances that
contradicted his assertions. A case report involving L.M. herself and a comparable child lent
support for the contrary conclusion (since both featured mutations in the same gene location, and
both had experienced comparable seizure courses). Entitlement Decision at *17-18, *36-37.

By contrast, Respondent’s pediatric seizure expert, Dr. John Zempel, persuasively
demonstrated that L.M.’s course would more likely than not have been the same even if the DTaP
vaccine had temporarily triggered some intervening seizure activity. Entitlement Decision at *21-
22. Unlike Dr. Boles, Dr. Zempel regularly treated infants with seizure disorders, giving his
opinions a heft that Petitioner’s expert opinions lacked. He established the low likelihood that

5
I similarly rejected the opinion offered by Petitioner’s other expert, Dr. Robert Shuman, that a brain malformation
explained L.M.’s seizure disorder, since his opinion predated discovery of the mutation and was otherwise
unpersuasive. Entitlement Decision at *38-39. The core of Dr. Shuman's testimony and opinion arose from his
interpretation of L.M.'s various MRIs, which he proposed demonstrated the existence and extent of an underlying
encephalopathic condition. Id. at *8. Dr. Shuman maintained that the vaccines precipitated her seizures (although he
did not maintain that the vaccines caused the preexisting abnormalities themselves), and in particular that pertussis
toxin-containing vaccines, such as the DTaP vaccine L.M. received, promote seizure activity. Id. at *10. However, as
I discussed in the Entitlement Decision, Dr. Shuman relied heavily on outdated medical literature involving the DPT
vaccine (which the DTaP vaccine supplanted), conflating the two as equally-dangerous even though the DTaP version
(which L.M. received) was well-known to be less likely to provoke seizures. Id. at *38. And Dr. Shuman also did not
persuasively establish that L.M. possessed the proposed brain malformation, or that vaccination exacerbated it. The
Federal Circuit did not disturb this component of the Entitlement Decision.

3
intervening vaccination would push an otherwise genetically-caused seizure disorder onto a more
dire course. In so finding, I relied on prior cases (decided by the Court of Federal Claims as well
as the Federal Circuit) holding that a showing of expected course/illness trajectory was required
when asserting an off-Table significant aggravation claim, since the concept of worsening could
not be itself addressed without some consideration of the otherwise-expected course. Id. at *35-
36. I also noted that L.M.’s mutation was somewhat analogous to the SCN1A mutation, which is
also known to be causal of seizure disorders but understood not to be worsened by vaccination (as
confirmed in a series of Vaccine Act decisions). Id. at *30, *40.

In addition, I determined that Petitioner’s Loving showing was deficient in two other
respects. First, I reasoned that Petitioner had not preponderantly demonstrated that Loving prong
four (which corresponds to the first prong of the Federal Circuit’s non-Table causation test set
forth in Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (2005)) was satisfied—that the
DTaP vaccine “can cause” worsening of a DYNC mutation. Entitlement Decision at *38-39.
Petitioner provided little in the way of a persuasive and scientifically-reliable explanation for how
the DTaP vaccine could provoke worsening of an otherwise-predictable seizure disorder. Id. at
*40. Dr. Boles instead largely relied on self-reported anecdotal instances of vaccines worsening
genetically-caused conditions and the role environmental impacts can play, but he could not back
up his contentions with immunologically-based argument establishing the bones of a theory for
how vaccination could worsen the condition’s course. He particularly struggled to offer reliable
scientific or medical proof associating vaccines of any kind with the sparking of a seizure disorder
connected to the DYNC mutation or some other comparable genetic mutation. Id. at *15. His lack
of specific immunologic expertise also was unhelpful to the persuasiveness of his testimony on
these matters. And my decision pointed out that the DTaP vaccine is no longer believed to be as
associated with provoking of seizures as its predecessor version (the DPT vaccine). Id. at *31-32.

Second, I found that the fifth Loving prong (comparable to Althen prong two)—that the
vaccine in question “did cause” worsening of L.M.’s genetically-caused seizure disorder—was not
preponderantly established. Entitlement Decision at *40-41. My review of the medical record
suggested to me that any post-vaccination fever L.M. had experienced had been transient, and thus
had not been demonstrated to possess more than a temporal relationship to any subsequent
worsening of her seizure activity. Id. at *41. I also noted that the record established that L.M.’s
seizure course had likely already begun before vaccination, with evidence of initial seizure activity
within the month prior to vaccination (making it difficult to conclude that the vaccine’s
interposition necessarily was an inflection point in her subsequent downward progression). Id.
Indeed, I concluded that Dr. Boles placed undue stock in the temporal relationship as proof of
vaccine causation, something other Federal Circuit cases warn against. Id. (citing McCarren v.
Sec’y of Health & Human Servs., 40 Fed. Cl. 142, 147 (1997)).

4
 2020 Federal Circuit Decision

The Circuit overturned my dismissal of the claim—based not only upon its determination
that I erroneously applied Loving, but also that certain of my underlying fact or credibility
determinations were arbitrary and capricious.

With respect to the law, the appellate panel held that Loving prong three does not require a
petitioner to demonstrate an expected outcome, such that her current-post vaccination condition
was worse than such expected outcome. Federal Circuit Decision at 1081. The Circuit based this
holding on the fact that the Vaccine Act only requires a “comparison of the person’s pre-
vaccination condition with the person’s current, post-vaccination condition.” Id. (citing 42 U.S.C.
§ 300aa-33(4)). In so doing, the panel attempted to explain what role remained for consideration
of the fact (inherent to any significant aggravation claim) that an injured party’s injury was
connected to some pre-vaccination condition, allowing that “evidence of other possible sources of
injury can be relevant not only to the ‘factors unrelated [inquiry], but also to whether a prima facie
showing has been made that the vaccine was a substantial factor in causing the injury in question.”
Id. (citing Stone ex rel. Stone v. Secretary of Health & Human Services, 676 F.3d 1373 (Fed. Cir.
2012)). But there was a “fine line” between a court properly considering evidence in the record
(Stone, 676 F.3d at 1380) and improperly placing the burden on the petitioner to prove that her
significantly aggravated condition was not caused by her pre-existing condition. Id. at 1082. In the
Circuit’s reasoning, requiring a comparative showing of expected versus actual outcome on this
prong crossed that line. 6

Regarding Loving prong four (congruent with Althen’s “can cause” first prong), the Circuit
emphasized that a petitioner may be able to make out a prima facie case that the vaccine could
cause the condition at issue without eliminating a pre-existing condition as the more likely cause
of her significantly aggravated injury. Federal Circuit Decision at 1083. If a petitioner successfully
does so, the burden later shifts to Respondent under the “factor unrelated” inquiry to show that the
pre-existing condition likely caused the significantly worsened condition. Id. (citing Walther v.
Sec’y of Health & Human Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007). 7

6
In so determining, the Circuit panel announced a somewhat novel interpretation of the significant aggravation
standard, requiring far less of petitioners in the non-Table context than in the past. And although the panel deemed its
construction of this Loving prong consistent with its prior decisions, Respondent took issue with that assertion—as
reflected in the fact that Respondent moved for en banc reconsideration of the Circuit’s decision. Fed. Cir. Doc. No.
48. The reconsideration motion argued that the Circuit Decision on this Loving prong conflated decisions interpreting
the significant aggravation standard applied in the Table context (where causation is presumed—and thus claimants
are tasked with satisfying a somewhat lower legal standard of evidentiary sufficiency) with non-Table, causation-in-
fact claims—and thus effectively endorsed a lowered evidentiary standard for non-Table claims contrary to the
Circuit’s own prior decisions on this very subject. The motion was rejected without a reasoned decision addressing
Respondent’s objections.
7
The Federal Circuit Decision also repeatedly used the term “plausible” to characterize the causation showing a
petitioner alleging a non-Table significant aggravation claim must make. See, e.g., Federal Circuit Decision at 1075,

5
 Loving prong five requires a petitioner to show “a logical sequence of cause and effect
showing that the vaccination was the reason for the significant aggravation.” Loving, 86 Fed. Cl.
at 144. The Circuit explained that since a significant aggravation claim, by definition, requires a
petitioner to possess some pre-existing condition or injury subject to worsening, the fact that a
petitioner suffers from symptoms of her pre-existing injury prior to vaccination should have no
negative affect on the petitioner’s case. Federal Circuit Decision at 1079-80.

With the foregoing as a framework, the Circuit made some fact findings relevant to the
Loving prongs I decided. For example, I initially found that preponderant evidence had been
offered by Respondent showing not only that the DYNC mutation is generally associated with
poor outcomes, but also that an individual with the same mutation and location as L.M. had
experienced a parallel course—suggesting to me that location was not necessarily determinative
of outcome. Entitlement Decision at *42 n.47. I acknowledged that Dr. Boles maintained that
L.M.’s mutation was expected to be mild because it was located in the stem/tail region of the gene,
and not the motor region, and did offer some reasonable/reliable evidence to support his
contention. Entitlement Decision at *12. But I ultimately concluded that Respondent’s genetics
expert (Dr. Maria Descartes) was more persuasive on this point. Id at 39. I also gave some weight
to evidence offered relating to the SCN1A mutation, also responsible for seizure disorders but not
deemed to be worsened by vaccination. Id.

The Circuit, however, found (based upon its own review of the record) that this finding
lacked evidentiary support. Rather, the location of L.M.’s mutation, in the stem region as opposed
to the motor region, was in the Circuit’s view more likely than not associated with non-severe,
non-cognitive disorders such as spinal muscular atrophy with lower extremity predominance.
Federal Circuit Decision at 1086. As a result, L.M.’s stem-located mutation was not likely the sole,
substantial factor causing her severe seizure disorder. Id. The Circuit further emphasized that given
the complexity of a significant aggravation claim generally, a Vaccine Act petitioner should not
be required to disprove at the outset that a pre-existing genetic mutation caused her significant
aggravation. Id. at 1087. Most importantly, the Circuit deemed Dr. Descartes to have conceded
outright that vaccination generally could adversely impact a preexisting DYNC mutation. Federal
Circuit Decision at 1085. 8 As a result, the third and fourth Loving prongs should have been decided

1083, 1085. This interpretation of Loving prong four/Althen prong three is inconsistent with other, prior Circuit
determinations that clearly reject plausibility as inconsistent with preponderance. See Boatmon v. Sec’y of Health &
Human Servs., 941 F.3d 1351, 1359 (Fed. Cir. 2019); see also LaLonde v. Sec’y of Health & Human Servs., 746 F.3d
1334, 1339 (Fed. Cir. 2014) (“[h]owever, in the past we have made clear that simply identifying a ‘plausible’ theory
of causation is insufficient for a petitioner to meet her burden of proof”).
8
The record on this point is less crystal clear than the Federal Circuit Decision suggests. Dr. Descartes only agreed
that an infection—an active and invasive process substantially more difficult to process than vaccination, even if the
two are on the same spectrum—could be something a child with a preexisting genetic disorder might find difficult to
cope with biologically. She unquestionably did not concede that vaccination was comparable. Compare Circuit

6
for Petitioner, and that my contrary determinations were in error. It remanded the matter for final
disposition.

Order to Show Cause and Parties’ Respective Positions

Given the above, it seemed likely to me that an entitlement ruling for Petitioner was now
not only contemplatable but mandated. However, I determined that I would give each side a chance
to propose what was left to decide in the matter that could conceivably result in a second
unfavorable entitlement decision, since the scope of the remand remained vague in some respects.

Respondent went first. He acknowledged the factual findings made by the Circuit
supportive of entitlement, specifically admitting (while not conceding the persuasiveness of the
controlling findings) that I am bound both to find that Loving’s “can cause” fourth prong is
effectively satisfied, and also that (had I gone on to apply the burden-shifting analysis after a
petitioner meets her prima facie case) Respondent had not preponderantly satisfied the “factor
unrelated” defense. Resp. Br. at 2-3. Thus, Respondent seems to accept that my sole remaining
task is to evaluate if Loving prong five has been met.

In so doing, however, Respondent maintained that the Circuit appeared to embrace an
unsound legal standard. Thus, the panel specifically proposed that I determine whether evidence
that a vaccine can cause an injury (Loving prong four), combined with a proximate temporal
relationship (Loving prong six), can satisfy petitioner’s burden of proving a logical sequence of
cause and effect showing that the vaccine in fact did cause injury (Loving prong five). Resp. Br.
at 1, citing Federal Circuit Decision at 1072 n.5. Respondent argued that this construction of the
law was based on dicta rather than existing Federal Circuit precedent, reflected an improper
muddling of the otherwise-distinct legal standards separating Table from causation-in-fact claims,
and would, if embraced, “negate” a petitioner’s obligation to prove with preponderant evidence
the “did cause” Loving prong. Resp. Br. at 5-6. This was especially so since other Circuit precedent
clearly stands for the proposition that a temporal association between vaccine and injury (here,
worsening of a preexisting injury) is not enough upon which to prevail. Respondent otherwise took
issue with the strength of Petitioner’s showing on the fifth Loving prong, maintaining that it relied
too much on a mere proximate temporal relationship between vaccination and worsening. Id. at 3-
4.

Petitioner in response has argued that my own Entitlement Decision plus the Federal
Circuit Decision have resolved all Loving prongs in her favor but the fifth. Pet’s Br. at 1-2. Thus,
the only question remanded for my consideration is whether the Petitioner demonstrated a logical

Decision at 1085 with Entitlement Decision at *18. Respondent’s experts never embraced the contention that
vaccination likely worsens preexisting seizure disorders. Tr. at 323-328.

7
sequence of cause and effect that showed that L.M.’s vaccinations were the reason for the
significant aggravation of her preexisting condition. Id. at 2. To do so, Petitioner maintains that I
should accept the Circuit’s formulation of the standard (i.e. that satisfaction of prongs four and six
could also meet the fifth, if supplemented with expert support), over Respondent’s position that it
reflected dicta. Id. at 11-12. 9

To support her contention, Petitioner notes a number of items of evidence or factual
determinations. She references the testimony of Dr. Boles as well as her other expert, Dr. Robert
Shuman (although his causal opinion arose from contentions about a purported preexisting brain
malformation that I did not deem persuasive or reliable—conclusions the Federal Circuit Decision
did not overturn or contest). Pet.’s Br. at 4. She also noted the testimony of Dr. Descartes, whom
the Circuit found had conceded that a vaccine might promote neurologic deterioration in someone
with a preexisting genetic mutation. Id. at 5-7. Thus, because of the above, and given that the
record establishes that L.M. experienced a seizure within four days of her February 11, 2011
vaccination (a timeframe I unquestionably found to be medically reasonable under Petitioner’s
causation theory), the “did cause” Loving prong was met. Id. at 10.

ANALYSIS

The Federal Circuit’s Decision unquestionably forecloses further consideration of
Respondent’s success in establishing alternative cause/factor unrelated based on the DYNC
mutation. 10 When a petitioner carries her initial burden to prove causation-in-fact, the burden shifts
to the Respondent to show by a preponderance of the evidence that a “factor unrelated” to the
vaccine was the “sole and substantial factor in bringing about the injury.” Hammit v. Sec.’y of
Health & Human Servs., 98 Fed. Cl. 719, 726 (2011), aff’d, Stone v. Sec’y of Health & Human
Servs., 676 F.3d 1373 (Fed. Cir. 2012). In my Entitlement Decision, I found that L.M.’s DYNC
gene mutation was the most likely sole, substantial factor in causing L.M.’s seizure disorder
(although I did so in the context of evaluating whether Petitioner’s prima facie case was met, and

9
Petitioner also addressed Respondent’s assertion that the Circuit’s decision created a “new class of ‘Table’ claims”
subject to a reduced evidentiary standard. Pet.’s Br. at 11-12 (citing Resp. Br. at 5). She argued this was incorrect,
since the Circuit had noted that the evidence used to satisfy the fourth and sixth Loving prongs would still need to be
linked to some medical opinion that the vaccine was likely causal of the injured party’s worsening. Pet.’s Br. at 12.
Petitioner maintained she had done so, since she presented two expert witnesses who testified that the circumstances
of L.M.’s injury provided a logical sequence of cause and effect associating L.M.’s 2011 vaccinations with the
significant aggravation of her preexisting condition. Id. Of course, as I noted in my original decision, Dr. Boles’s
opinion on this point was itself heavily reliant on the temporal association—meaning that, in my estimation, he did
not provide much of an independent basis for finding that the vaccine was likely causal. Dr. Boles did, however, also
reference his own anecdotal experience regarding the impact of vaccines on a person like L.M. already challenged by
a preexisting mutation-associated seizure disorder.
10
My initial decision only addressed Respondent’s success in meeting this burden-shifting obligation as a footnote,
since I had determined that Petitioner’s failure to meet all of the Loving prongs meant the burden never shifted to
Respondent. Entitlement Decision at *36 n.47.

8
considered the issue specifically under Loving prong three). Entitlement Decision at *36.
Regardless of whether that analysis was properly conducted, the Circuit has found that the DYNC
mutation does not likely explain L.M.’s overall post-vaccination seizure disorder course, and I
must proceed from that determination.

Both sides otherwise seem to agree that resolution of the fifth Loving prong remains the
prime issue to be decided on remand. But they disagree as to the construction of this prong under
the circumstances. Contrary to Petitioner (and to the Circuit’s reference to the matter—which by
its own terms left it as an undecided issue), I do not find that a Vaccine Program claimant could
prevail on the fifth Loving prong simply by relying on her success in establishing the other two
prongs and then combining that with an expert opinion, without any consideration by the special
master as to the evidentiary value or weight that kind of opinion should receive. Rather, the fifth
Loving prong, like the other two, requires a preponderant showing—and that in turn means that
the items of evidence offered to satisfy it must be reliable. Success on two of the prongs in itself
does not obviate that requirement.

My conclusion flows from the best understanding of how the “did cause” prong under
Loving or Althen should be applied. As observed in my Entitlement Decision, evidence to establish
“a logical sequence of cause and effect” is “usually supported by facts derived from a petitioner’s
medical records.” Entitlement Decision at *24. Certainly the opinions of treaters who have
provided medical care to an alleged vaccine-injured person are entitled to weight in the Program,
and such an opinion, bulwarked with record evidence that the injured party’s experience was
consistent with what a vaccine injury is theorized to look like, can be sufficient to meet this Loving
prong (as well as its counterpart Althen prong). But at the same time, a conclusory opinion that a
vaccine was likely causal—mainly because (a) the injury post-dated vaccination, and (b) the
opining treater/expert cannot identify anything else causal—is not especially persuasive. To allow
that sort of opinion alone to satisfy the “did cause” prong, simply because two other prongs had
already been met, would be akin to permitting Petitioners to ignore the requirement that they meet
all prongs with preponderant evidence. Althen, 418 F.3d at 1278. It would also run up against the
prohibition on granting entitlement simply on the basis of the showing that the injury post-dated
vaccination.

It is also, however, the case that many kinds of evidence can be offered in support of a
Vaccine Injury claim, with no one category “required.” See Capizanno v. Sec’y. of Health &
Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir. 2006). Subsumed within that general proposition
is the concept that any evidence might be offered to support any particular Althen or Loving prong
(with the obvious proviso that some items of evidence might be less useful in proving one kind of
claim element than other categories). Thus, a medical treater’s opinion that a vaccine likely caused
a person’s injury might have some Althen prong one bearing (although less so than an expert
qualified to opine on causation in a specific case), with the opposite also true (since causation
experts are often also asked to review a claimant’s medical record in order to give support to the

9
“did cause” prong). And just as the third Althen prong is correctly understood to mix the first two
(since a successful claimant must demonstrate that the timing of injury onset as reflected in the
medical record coincides with what the causation theory proposes could occur), there is no reason
why evidence pertaining to timeframe might also bear on whether the vaccine did cause the injury
alleged.

Thus, although the fact of a petitioner’s success in establishing prongs four and six of the
Loving test cannot be leveraged to meet the fifth simply because it is hitched to an expert/treater
opinion, the evidence that was offered to satisfy those former prongs can unquestionably be applied
to the latter. And an expert report, coupled with such other evidence, might be enough to
demonstrate the vaccine in question did aggravate a preexisting condition (depending of course on
the weight the report receives).

In light of the above, I note the following fact issues, which are either undisputed or have
been determined as a result of the Circuit’s decision. Neither party disputes L.M. had the DYNC
mutation and had begun to have seizures before vaccination, and Petitioner could not persuasively
show that L.M. would never have experienced any poor outcomes given it. However, it has also
been decided by the Circuit that the nature of the mutation in question (given Dr. Boles’s assertions
about its location) made it unlikely to have a severe outcome consistent with what L.M. has
experienced. And it is now determined (based largely on Dr. Descartes’ purported concession) that
vaccination could worsen an expected seizure course, presumably through neuro-inflammation
attributable to fever. Further, the onset/manifestation of L.M.’s worsened course began in a
medically-acceptable timeframe when measured from her date of vaccination four days prior.

So—did the DTaP vaccination that L.M. received, and that likely caused her to experience
(alone or in concert with the other vaccines she had simultaneously received) a fever, aggravate
her DYNC mutation-oriented condition? The evidence Petitioner offered on this point remains
quite thin. Dr. Boles was vague in explaining how vaccination worsened L.M.’s condition, beyond
reliance on generalities about environmental effects or his own experience with patients that he
could not corroborate. He certainly lacked the immunologic expertise to flesh out this aspect of his
opinion—and what Petitioner did offer about the DTaP vaccine relied on findings pertinent to its
predecessor version (DPT) that no longer hold true for the acellular version. I also observe that
Petitioner marshalled no direct treater support for her claim, from medical providers who actually
saw L.M. during her initial presentation, relying on the comparatively-weaker evidence from Dr.
Boles (who did not himself treat L.M.), although some later treaters associated the initial, vaccine-
caused fever with her progressive decline.

However, the record establishes that L.M. experienced some transient reaction the evening
of February 10, 2011, after administration of several vaccines including DTaP. Entitlement
Decision at *41. Several days later, she began experiencing seizure activity that was observed in
the contemporaneous medical record. And then as the months progressed, her condition
deteriorated. Clearly the significance of Dr. Descartes’s “concession” on causation is amplified by

10
the fact that L.M. in fact experienced a fever after vaccination—and this fever, under Petitioner’s
now-accepted significant aggravation theory, could worsen seizure activity, as the record reveals
occurred to L.M. not long thereafter, and in a timeframe I otherwise deemed medically acceptable.
I give far more weight to such contemporaneous record proof than to a conclusory opinion from
Dr. Boles on why L.M.’s course worsened.11

Thus, even though Petitioner’s overall showing on the fifth Loving prong was not notably
robust, it was preponderant enough to meet her burden of proof. As is well understood in the
Program, preponderance simply means more than fifty percent—a standard that can be difficult to
meet, but one that is far from requiring certainty. Bunting v. Sec. of Health & Human Servs., 931
F.2d 867, 873 (Fed. Cir. 1991). Indeed, even in a tie, where the evidence is in equipoise, persuasive
case law suggests that special masters should find for petitioners. Contreras v. Sec. of Health &
Human Servs., 107 Fed. Cl. 280, 292 (Fed. Cl. 2012) (citing Althen, 418 F.3d at 1280 (in the system
provided for deciding vaccine injury claims, close calls regarding causation are resolved in favor
of injured claimants) (internal citations omitted)). Here, such a weakly-preponderant showing has
been made. The record evidence about what actually happened to L.M. supports Petitioner’s claim
just enough for me to conclude that the evidence is at least in equipoise—meaning Petitioner
should receive the benefit of the doubt.

The admitted little that is still known about the DYNC mutation and its possible interaction
with vaccines is to no small extent another factor favoring Petitioner herein—as a comparison with
what is known about the SCN1A mutation reveals. A series of Program decisions involving the
SCN1A mutation has put to rest the prior view (for purposes of entitlement) that vaccination could
be causal of Dravet syndrome, a seizure disorder much like what L.M. has experienced. Before
scientific understanding on the matter had sufficiently advanced, cases involving Dravet syndrome
were routinely decided in petitioners’ favor—but not after. See, e.g., Oliver v. Sec'y of Health &
Human Servs., No. 10-394V, 2017 WL 747846, at *28 n.3 (Fed. Cl. Spec. Mstr. Feb. 1, 2017),
(setting forth 15 cases denying compensation for alleged vaccine-caused Dravet syndrome), mot.
for rev. den'd, 133 Fed. Cl. 341 (2017), aff'd, 900 F.3d 1357 (Fed. Cir. 2018); rehearing en banc
den'd, 911 F.3d 1381 (Fed. Cir. 2019).

Far less is currently understood about the DYNC mutation, making it much harder to say,
in the context of this legal proceeding, that preponderantly the mutation is likely to lead to
outcomes such as that experienced by L.M. Indeed, as even my Entitlement Decision
acknowledged, Petitioner’s arguments about outcomes associated with this mutation (when
evaluated in light of location of mutation) have reliability. Entitlement Decision at *36. In future

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Indeed—were this a case where the petitioner could not establish record evidence of a vaccine reaction, and relied
solely on the fact that her seizure activity worsened days after vaccination, I would not find this prong satisfied simply
on the basis of satisfaction of the other two prongs plus a conclusory expert opinion.

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Vaccine Act matters, 12 Respondent may be able to fill in these evidentiary holes, as he did with
respect to the SCN1A mutation before, making it easier to conclude defensibly that vaccination
could not worsen the DYNC mutation’s expected symptomatic course. But for now, the evidence
herein is enough to conclude that but for the DTaP vaccine, L.M.’s course would have likely been
less severe, and she therefore should receive compensation for her tragic injuries.

Conclusion

Although I have determined that the evidence preponderates in Petitioner’s favor on the
“did cause” Loving prong, reasonable considerations about the interests of justice in Vaccine
Program cases also support a prompt entitlement decision in Petitioner’s favor. This matter is now
more than seven years old. Even with my determination, it is likely the case will take significantly
more time to resolve damages, given the difficulties inherent in establishing a life care plan for a
child with the kind of intractable physiologic injuries L.M. unquestionably experiences. Should
further appeals ensue, the case’s life will be additionally prolonged. Under such circumstances, I
do not find it prudent, or fair to the Petitioner, to place additional obstacles in the path of the
matter’s final determination.

In order to guide the parties through the damages phase of the action, a separate damages
order will issue.

Pursuant to Vaccine Rule 28.1(a), the Clerk’s Office is instructed to deliver this decision
to the judge assigned to this case. 13 In the absence of a motion for review, the Clerk’s Office is
instructed to enter judgment in accord with this decision.

12
The Circuit panel took particular umbrage at my observation in the Entitlement Decision that Ms. Sharpe’s inability
to prove her case (in my initial estimation, of course) did not mean that scientific advancements and discoveries might
in future cases inure to the benefit of petitioners with similar claims. Entitlement Decision at *40. The Circuit deemed
this observation to be akin to requiring scientific certainty, and thus evidence of my misapplication of the legal
standard governing causation theories in the Program. Federal Circuit Decision at 1078 (“[t]he Special Master should
not have been concerned with what “future research” may show but rather with the research presented in the record”).
But this interpretation is facially contrary to my recitation of the legal standard, which readily acknowledges that
certainty is not required to prevail. See, e.g., Entitlement Decision at *23 (“[p]etitioners may satisfy the first Althen
prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a
generally accepted medical theory”). Moreover, my reference to scientific advancement, and its bearing on the case,
was far more anodyne than the Circuit’s decision suggests. I intended only to note that a determination that one
petitioner has not met his preponderant burden (because of an absence of sufficient preponderant evidence at that
moment in time) does not mean that a later petitioner—armed with more reliable science or medical evidence,
whatever the form it comes in, arising from new advancements in understanding of immunology or the injury at
issue—might succeed where the first failed. This is wholly consistent with the fact in the Program that some claimants
succeed where others fail (and vice-versa) despite overlapping factual circumstances—and that medical science is
always making new discoveries about the impact of vaccines on the human body that can later prove helpful in
deciding these cases.

The filing date of this Ruling on Remand is admittedly beyond the 90 days set by the Vaccine Rules for a special
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master to act on a remanded matter, if only by three days (since the action was formally remanded to me on November

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 IT IS SO ORDERED.
/s/ Brian H. Corcoran
Brian H. Corcoran
Chief Special Master

16, 2020—meaning acting on remand should have occurred on or before February 16, 2021). See Vaccine Rule 28(b).
However, the Court of Federal Claims has previously observed that “the Vaccine Act does not identify any
consequences for a special master’s failure to complete the task directed by the court on review within the statutory
ninety-day remand period.” Greene v. Sec’y of Health & Human Servs., No. 11-631V, slip. op., at 3 (Fed. Cl. May 30,
2018). In addition, even if this ruling had been issued within that 90-day timeframe, the case’s final disposition would
still remain for a later date, since the parties must now undergo the meticulous process of determining damages in a
case involving a plainly-catastrophic injury—and that process will surely take far longer than 90 days. As a result,
delay in issuance of my ruling prejudices neither party.

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