Heller v. Secretary of Health and Human Services ( 2023 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-792V
Filed: January 4, 2023
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HEATHE HELLER and JENNA HELLER, **
parents of H.H., a minor, * TO BE PUBLISHED
*
Petitioners, *
*
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v. * Ruling on Remand; Type I
* Interferonopathy; Significant Aggravation
SECRETARY OF HEALTH AND *
HUMAN SERVICES, *
*
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Respondent. *
*
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Margaret Guerra, Margaret M. Guerra, Attorney at Law, Fort Worth, TX, for Petitioners
Tyler King, U.S. Department of Justice, Washington, DC, for Respondent
RULING ON REMAND GRANTING ENTITLEMENT1
Oler, Special Master:
On July 27, 2015, Heathe Heller (“Mr. Heller”) and Jenna Heller (“Ms. Heller”)
(collectively “Petitioners”) filed a petition for compensation under the National Vaccine Injury
Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Act” or “Program”) alleging,
in part, that as a result of his October 17, 2013 influenza and Prevnar vaccinations and his October
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 in 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object
to the Ruling’s inclusion of certain kinds of confidential information. To do so, each party may, within 14
days, 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, this Ruling will be available to the public in its present form. Id.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa
(2012).
1
23, 2013 vaccination with Pentacel, H.H. experienced either the onset or the significant
aggravation of his degenerative neurologic disorder.
I held an entitlement hearing on January 22, 2020. In a decision issued on April 15, 2022,
I found preponderant evidence in support of the fact that H.H. has “a genetic type I
interferonopathy that is either [Aicardi-Goutières Syndrome (“AGS”)] or AGS-like.” Heller v.
Sec’y of Health & Hum. Servs., No. 15-792V, 2022 WL 16575744 at *51 (Fed. Cl. Spec. Mstr.
Apr. 15, 2022) (“Entitlement Decision”). I further found that the Pentacel vaccine did not
significantly aggravate H.H.’s type I interferonopathy. Id. at *61. Petitioners sought review and
the Court vacated my decision and remanded the case to me for further evaluation. Heller v. Sec’y
of Health & Hum. Servs., 162 Fed. Cl. 621 (2022) (“Remand Opinion”). For the reasons discussed
below, I find that Petitioners are entitled to compensation.
I. Brief Procedural History
On July 27, 2015, Heathe and Jenna Heller, on behalf of their minor son, H.H. filed a
petition seeking compensation under the Vaccine Act, alleging that H.H. suffered from dystonia
and encephalopathy as a result of the influenza (“flu”) and Prevnar vaccinations he received on
October 17, 2013, and/or the DTaP-IPV-Hib (“Pentacel”) vaccine he received on October 23,
2013. Pet. at 1.
My Entitlement Decision narrowed the issues present in the case. I determined that the
October 17, 2013 flu and Prevnar vaccines did not impact H.H., a determination that the Court
upheld. Entitlement Decision at *51; see also Remand Opinion at 638. I further found that the
onset of H.H.’s AGS-like disease began shortly before his receipt of the Pentacel vaccine on
October 23, 2013. Entitlement Decision at *51. As a result, the proper analysis for the claim was
one of significant aggravation. Id.In analyzing the case pursuant to Loving v. Secretary of Health & Human Services, I
determined that H.H.’s receipt of the Pentacel vaccine did not significantly aggravate his
neurologic condition. 86 Fed. Cl. 135 (2009) (citing Althen v. Sec’y of Health & Hum. Servs, 418
F.3d 1274 (Fed. Cir. 1995)). Specifically, I found that Petitioners did not present 1) a reliable
medical theory explaining how the Pentacel vaccine can cause the significant aggravation of a type
I interferonopathy; 2) preponderant evidence that H.H.’s Pentacel vaccine did cause a significant
aggravation of his pre-existing condition; or 3) evidence of a proximate temporal relationship
between the significant aggravation of H.H.s vaccination and his condition. Entitlement Decision
at *55, *58, *61.
With respect to Loving prong four/Althen prong one, I found that Petitioners’ theory that
vaccination can cause persistently elevated levels of interferon alpha unpersuasive. Entitlement
Decision at *54-55. While Petitioners are not required to present medical literature or
epidemiological evidence, their theory must be supported by a reputable medical or scientific
explanation, and I did not believe Petitioners presented such a theory in this case. Id.Regarding Loving prong five/Althen prong two, I also found that Petitioners had not
demonstrated by preponderant evidence that the Pentacel vaccine did significantly aggravate
2
H.H.’s type I interferonopathy. Entitlement Decision, at *58. H.H. received the Pentacel vaccine
on October 23, 2013, after he had already been experiencing heel cord tightness which was a
physical sign of his type I interferonopathy. Id. at *23. Therefore, Petitioners had the burden of
demonstrating that H.H.’s deterioration was caused in part by the Pentacel vaccine he received,
and I found that Petitioners did not preponderantly do so. Id. at *58.
Lastly, as to Loving prong six/Althen prong three, I found that the onset of H.H.’s
interferonopathy occurred around the time of his October 17, 2013 vaccinations and that
Petitioners’ evidence pertaining to timing did not support their contention that the Pentacel vaccine
caused or significantly aggravated H.H.’s condition. Entitlement Decision at *51, *61.
On May 16, 2022, Petitioners file a Motion for Review of my Entitlement Decision. ECF
No. 122.
After the parties filed briefs and had oral argument on September 13, 2022, the Court issued
an opinion on October 13, 20223 remanding this case back to me. ECF No. 134. The Court’s
Remand Opinion held (1) that I erred by mischaracterizing H.H.’s interferonopathy as AGS or
AGS-like because this finding “effectively eliminated the possibility” of a conclusion that the
vaccine had significantly aggravated H.H.’s condition; and (2) that my findings that Petitioners
had failed to carry their burden under Loving prongs four, five, and six were arbitrary and
capricious. Remand Opinion at 644, 652, 655, 657. The Court ultimately remanded the case back
to me to determine whether Petitioners can satisfy Loving prongs four, five, and six and
demonstrate that the Pentacel vaccine did significantly aggravate H.H.’s type I interferonopathy.
Id. at 657.
After the Court remanded the case to me, I held a status conference on October 19, 2022,
and instructed Respondent to show cause as to why I should not rule in favor of Petitioners, given
the Court’s decision. ECF No. 135. I gave the parties an opportunity to brief this matter.
Respondent filed his brief on November 18, 2022. ECF No. 138 (“Resp’t’s Br.”). Petitioners filed
a reply on December 17, 2022. ECF No. 139 (“Pet’rs’ Br.”). This matter is now ripe for a
determination.
II. The Parties’ Arguments
A. Respondent
In his response to my show cause order, Respondent maintained that Petitioners have failed
to provide preponderant evidence that the Pentacel vaccine significantly aggravated H.H.’s
interferonopathy. Resp’t’s Br. at 1. Respondent disagreed with the Court that my findings that
H.H. experienced AGS or an AGS-like interferonopathy “foreclosed a finding of significant
aggravation,” and that I erred in my analysis of Loving prong four. Id. at 3.
3
The Remand Opinion was issued on October 13, 2022 and the parties were given 14 days to file a Motion
for Redaction. Neither party moved for redactions. The Court reissued the opinion on October 31, 2022 in
its original form. ECF No. 136.
3
As to Loving prong four/Althen prong one, Respondent argued that Petitioners have not
provided a “sound and reliable medical or scientific explanation” for significant aggravation for
two reasons. Resp’t’s Br. at 3-4. First, Dr. Steinman failed to explain how activation of the
NALRP3 inflammasome is linked to the development of interferonopathy. Id. at 4. Second, Dr.
Steinman’s theory was supported by medical literature discussing experimental autoimmune
encephalomyelitis (EAE), which is an injury entirely different from interferonopathy. Id.Respondent argued that Petitioners’ evidence does not pertain to H.H.’s actual injury, and thus
does not satisfy the preponderant evidence standard for Loving prong four. Id.As to Loving prong five/Althen prong two, Respondent contended that Petitioners have not
met their burden to provide preponderant evidence that the Pentacel vaccine did in fact
significantly aggravate H.H.’s interferonopathy. Resp’t’s Br. at 5. First, Respondent argued that
the opinions of H.H.’s treating physicians that his injury was aggravated by the vaccine are
rebuttable and not dispositive. Id. Respondent further stated that my decision to credit the opinion
of Respondent’s expert over that of Petitioners’ expert was appropriate. Id. at 6.
Finally, Respondent argued that Petitioners have not met their burden under Loving prong
six/Althen prong three because they failed to marshal preponderant evidence that the significant
aggravation of H.H.’s interferonopathy occurred within a medically acceptable timeframe after
vaccination. Resp’t’s Br. at 6. Respondent maintained that Petitioners have not shown that three
weeks after vaccination is a medically acceptable onset interval. Id. at 7. Respondent pointed out
that Dr. Steinman relied on medical literature discussing Guillain-Barré syndrome (GBS) and acute
disseminated encephalomyelitis (ADEM), both of which are entirely different injuries from an
interferonopathy. Id.B. Petitioners
In their response brief, Petitioners urged that Respondent has failed to show cause as to
why I should not find for Petitioners. Pet’rs’ Br. at 1. Petitioners argued that the Court’s analysis
“demonstrate[s] that Petitioners met their burden of proof for ‘significant aggravation’ by the
Pentacel vaccine under Loving prongs four, five, and six.” Id. at 2.
As to Loving prong four, Petitioners asserted that they have met their burden and that
Respondent’s expert failed to rebut the medical literature provided by Petitioner’s expert. Pet’rs’
Br. at 3. As to prong five, Petitioners echoed the Court’s observation that Dr. Marks, H.H.’s
treating physician, opined that H.H.’s condition was the result of the vaccines he received. Id. As
to prong six, Petitioners argued that they provided sufficient evidence to meet their burden and
repeated the Court’s opinion that my decision did not provide enough analysis on this point. Id.III. Analysis
In any remanded case, the special master is bound by the determinations of the Court on
matters of law and fact. Rickett v. Sec’y of Health & Hum. Servs., 468 F. App’x 952, 959 (Fed.
Cir. 2011) (quoting Hanlon v. Sec’y of Health & Hum. Servs., 40 Fed. Cl. 625, 630 (Fed. Cl.
1998)). Petitioners challenged my analysis of H.H.’s clinical presentation/diagnosis and my legal
conclusions as to prongs four, five, and six of the Loving analysis. Remand Opinion at 632.
4
A. Loving Prong Four
Under Loving prong four, a petitioner must provide a “reputable medical theory” that the
vaccine can significantly aggravate the type of injury in question. Loving, 86 Fed. Cl. at 144;
Pafford v. Sec'y of Health & Hum. Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006). The theory
must be based on “sound and reliable medical or scientific explanation.” Knudsen v. Sec'y of
Health & Hum. Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). The theory must be “legally probable,
not medically or scientifically certain.” Id. at 548-49.
In my entitlement decision, I noted the lack of medical literature exploring a causal link
between the flu, pneumonia, or Pentacel vaccines and type I interferonopathy. Entitlement
Decision at *55. I analyzed the medical literature submitted by Dr. Steinman and found that it did
not supply “a sound and reliable medical theory explaining how vaccination causes the chronic
overproduction of interferon.” Id. Accordingly, I found that Petitioners had failed to carry their
burden under Loving prong four. Id.The Court stopped short of finding that I erred in my assessment of the medical literature.
Remand Opinion at 650. However, the Court’s Loving prong four analysis made it clear that the
Court finds the medical literature upon which Dr. Steinman relied more persuasive than I did. Id.
at 646-52. The Court discussed each of the seven studies cited by Dr. Steinman in support of his
causal theory. Id. The first article, Fadugba, concluded that DTaP vaccination results in an increase
in gamma interferon. Id. at 646. The Court determined that this particular point discussed in
Fadugba “carries significant weight in favor of petitioners satisfying their burden” under Loving
prong four. Id. The Court further discussed the other six studies, similarly noting that each of them
“add[] further support” or “weigh in favor” of petitioners providing preponderant evidence in
support of the fourth Loving prong. Id. at 647-49. Ultimately, the Court concluded that the cited
studies “cumulatively carry significant weight in favor of petitioners satisfying their burden.”
Remand Opinion at 651 (emphasis added).
In re-analyzing Petitioners’ proffered evidence in support of their causal theory through
this lens, I conclude that Petitioners have provided preponderant evidence in support of Loving
prong four. Petitioners’ evidence supports the contention that the DTaP vaccine can trigger the
production of interferons. Furthermore, Dr. Steinman’s opinion and the Li article support
Petitioners’ position that the Pentacel vaccine activates the NALRP3 inflammasome, which,
according to Dr. Steinman “plays a key role in inducing interferonopathies.” First Steinman Rep.
at 12. Finally, Rodero and Crow question whether vaccination is a disease trigger for AGS. While
the continued high level of interferon production H.H. exhibited is not described in the medical
literature provided, I nevertheless find that Petitioners have provided a “reputable medical theory”
causally linking the Pentacel vaccine to significant aggravation of H.H.’s type I interferonopathy.
Pafford, 451 F.3d at 1355-56. In so concluding, I am cognizant that “[t]he purpose of the Vaccine
Act’s 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.” Althen, 418 F.3d at 1280. Accordingly,
Loving prong four is satisfied.
5
B. Loving Prong Five
Loving prong five/Althen prong two requires Petitioners to provide a logical sequence of
cause and effect demonstrating that the Pentacel vaccination did cause a worsening of H.H.’s pre-
existing interferonopathy. Althen, 418 F.3d at 1278; Andreu v. Sec’y of Health & Hum. Servs., 569
F.3d 1367, 1375 (Fed. Cir. 2009); Grant v. Sec’y of Health & Hum. Servs., 956 F.2d 1144, 1148
(Fed. Cir. 1992).
In my decision on entitlement, I found that both Dr. Hollis and Dr. Marks were
unpersuasive experts, in part because they either did not articulate a theory of causation (Dr. Hollis)
or because their proffered theory was unreliable (Dr. Marks). Entitlement Decision at *56-58. At
the entitlement hearing, Dr. Marks was unable to articulate a theory as to how the vaccines can
cause a significant aggravation of a type I interferonopathy, espousing the now-abandoned theory
of molecular mimicry, and repeatedly testifying that he was not an expert in vaccines. In fact, his
proffered causation theory was, in my view, so deficient that I informed Petitioners’ counsel they
could not meet their burden as the record currently stood, and gave Petitioners the opportunity to
hire another neurologist and file post-hearing expert reports.
The Court found that I erred in discrediting H.H.’s treating physicians, Drs. Marks and
Hollis, who both opined that the vaccines caused H.H.’s condition. Remand Opinion at 655. The
Court stated that I improperly considered Dr. Hollis’ lack of a theory, and Dr. Marks’ molecular
mimicry causation theory in evaluating the credibility of those experts concerning their opinion
that the vaccines “did cause” a significant aggravation of H.H.’s condition “because prong five
does not require a treating physician to opine on a medical theory to find their testimony
persuasive—only prong four requires opinion on a medical theory.” Id. I have reconsidered my
evaluation of Dr. Hollis and Dr. Marks in light of this statement. In so doing, I find that Drs. Marks
and Hollis’ opinions regarding vaccine causation provide preponderant evidence that H.H.’s
disease process was significantly aggravated by the Pentacel vaccine.
Dr. Hollis opined that H.H.’s “severe and rapid developmental regression is unusual for a
previously healthy child… his rapid decline can be attributed to receiving the vaccinations on
October 17, 2013 and October 23, 2013.” Ex. 66 at 3. In evaluating this statement without
considering the fact that Dr. Hollis did not provide a theory as to how this occurred, I find that Dr.
Hollis’ opinion constitutes strong evidence in support of Loving prong five. She was H.H.’s
pediatrician during his rapid decline post-vaccination and saw the disease progression take place.
Dr. Marks opined that H.H. experienced a persistent immune response since his
vaccination; H.H. “had persistent elevations of an immunologic marker usually seen in the context
of viral infections more than bacterial infections.” Tr. at 158-59. Dr. Marks further opined that it
is more likely than not that H.H.’s condition was significantly aggravated by the Pentacel vaccine,
rather than H.H. deteriorating due to a typical AGS pathology. See generally id. at 161. Dr. Marks
also noted that there is a “lack of any other explanation for why [H.H.] has developed severe and
rapidly progressing dystonia with encephalopathy at his age,” and concluded that the Pentacel
vaccine was “the most likely trigger for him to develop rapidly progressing dystonia with
encephalopathy to this degree.” Ex. 67 at 3-4. In considering this testimony without evaluating the
6
“can cause” element of his opinion, I find that Dr. Marks’ expert opinion provides additional and
substantial weight in support of Petitioners’ significant aggravation claim.
In view of my reevaluation of the weight of Drs. Hollis’s and Marks’s opinions regarding
H.H.’s rapid deterioration after vaccination and Dr. Steinman’s theory regarding how the Pentacel
vaccine could have contributed to the significant aggravation of H.H.’s condition, I find that
Petitioners have provided preponderant evidence that the Pentacel vaccine did significantly
aggravate H.H.’s type I interferonopathy.
C. Loving Prong Six
The final prong of the Loving analysis requires Petitioners to demonstrate a “proximate
temporal relationship” between the significant aggravation of H.H.’s condition and the vaccine.
Loving, 86 Fed. Cl. at 144; see also Althen, 418 F.3d at 1278. Petitioners must offer “preponderant
proof that the onset of symptoms occurred within a timeframe for which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The proximate temporal
relationship requirement has two components. First, Petitioners must establish the “timeframe for
which it is medically acceptable to infer causation” and second, they must demonstrate that the
onset of the disease occurred in this period. Shapiro v. Secʼy of Health & Hum. Servs., 101 Fed.
Cl. 532, 542-43 (2011), recons. denied after remand on other grounds, 105 Fed. Cl. 353 (2012),
aff’d without op., 503 F. App’x 952 (Fed. Cir. 2013).
In my entitlement decision, I found that Petitioners had failed to meet their burden under
both components of Loving prong six. Having previously found that onset of H.H.’s condition
occurred “close-in-time to his October 17, 2013 vaccinations and before he received the Pentacel
vaccine,” I found that Petitioners had not established that H.H.’s condition began or was
significantly aggravated three weeks after the Pentacel vaccine as Dr. Steinman claimed.
Entitlement Decision at *59-61. I also found that Petitioners had not established that three weeks
was a medically acceptable timeframe to infer causation because the medical literature upon which
Dr. Steinman relied pertained to GBS and ADEM, conditions dissimilar to H.H.’s injury, and
conditions caused by a different immune-mediated mechanism than the one espoused by Dr.
Steinman. Id. at *60-61.
In his decision remanding this case to me, the Court found that I had not considered Dr.
Steinman’s significant aggravation analysis and that I “did not provide an analysis to discuss the
timeline of H.H.’s injuries or whether H.H.’s injuries were significantly aggravated.” Remand
Opinion at 657. The Court further found that I had failed to articulate a rational basis for my
decision and that my decision was unsupported by the record. Id. The Court left the determination
as to whether Petitioners have met the requirements of Loving prong six to me. Id.Before re-analyzing these issues, it is important to clarify one aspect of Dr. Steinman’s
opinion. In my Entitlement Decision, I concluded that Dr. Steinman opined “H.H.’s disease course
began three weeks after his receipt of the Pentacel vaccine.” Entitlement Decision at *59. This
determination was based on several of Dr. Steinman’s statements in his expert reports. For
example, Dr. Steinman opined that “[n]ot until three weeks after the Pentacel immunization on
7
October 23, 2013 was there any symptomatology related to an interferonopathy.” First Steinman
Rep. at 16. In support of Althen prong three, Dr. Steinman also stated “‘A showing of a proximate
temporal relationship between vaccination and injury’ is met from similar studies on other
neuroinflammatory conditions linking neuroinflammation and immunization, with onset at
approximately 3 weeks post-Pentacel vaccine.” Id. Dr. Steinman further opined: “Onset of
significant deterioration occurred within about 3 weeks after the Pentacel immunization or four
weeks from the influenza and Prevnar 13 immunizations.” Id. at 8 (emphasis in original).4
Dr. Steinman’s reliance on Schonberger to support his opinion further indicated to me that
he was in fact opining that H.H.’s disease course was significantly aggravated three weeks after
his receipt of the Pentacel vaccine. Schonberger demonstrates that the swine flu vaccine can cause
GBS, a demyelinating disease of the peripheral nervous system. Schonberger found that “[t]he
peak relative risks … occurred in weeks 2 and 3 after vaccination.” Schonberger at 112.
It is notable, however, that Dr. Steinman also states that H.H.’s significant aggravation
occurred “within three weeks” of his receipt of the Pentacel vaccine. See, e.g., First Steinman Rep.
at 15; Second Steinman Rep. at 3.
The Court found Dr. Steinman’s use of the word “within” to indicate that significant
aggravation began at some time during the three-week period following vaccination. Remand
Opinion at 657 (“The Court remands and leaves the ultimate conclusion to the Special Master
regarding whether there was a proximate-temporal relationship in light of Dr. Steinman’s opinion
stating aggravation would occur within three weeks and whether this theory satisfies Loving prong
six.”). Based on this instruction, I have re-analyzed Loving prong six and have assumed Dr.
Steinman opined that the significant aggravation of H.H.’s interferonopathy began within three
weeks of the Pentacel vaccine.
I first analyze whether Petitioners have provided a medically acceptable time frame such
that significant aggravation of interferonopathy “within three weeks” after receipt of Pentacel can
be inferred.
Respondent’s expert, Dr. McGeady, disagreed with Dr. Steinman’s proposed timeframe,
opining that he would expect vaccine-induced excessive interferon production to result in central
nervous system injury “sooner than several weeks following the immunizations.” Second
McGeady Rep. at 2. Dr. McGeady opined as follows:
Type I interferons are produced by cells of the innate immune system upon
activation by a variety of pattern recognition receptors. They detect molecular
patterns that are prevalent in pathogenic organisms, but not found in mammals, and
their detection leads, among other responses, to the generation of type I interferons
4
Although Dr. Steinman used the phrase “within three weeks” here, when read in conjunction with the
sentence’s second clause, “or four weeks from the influenza and Prevnar 13 immunizations,” his meaning
appeared to be that onset of H.H.’s interferonopathy took place three weeks after Pentacel and four weeks
after flu/pneumonia vaccines.
8
(1).5 Since this immune response is among the host’s first to resist a potentially
lethal infection, it is rapidly deployed, and type I interferons are present in
measurable quantities within 12 hours following a viral exposure (2). In view of
this kinetic pattern, and knowing that interferon production promptly decreases
following a non-progressive provocation, it would be expected that an acute injury
to the CNS due to excessive type I interferon would appear sooner than several
weeks following the immunizations if vaccines are to be suspected as the initiating
event.
Id. Although Dr. McGeady did not specify the appropriate temporal interval for vaccine-induced
interferon production and subsequent CNS injury, he did note that “the Vaccine Injury Table
stipulates a time of up to 72 hours for an encephalopathy as the period in which such an adverse
event might be attributed to the DTaP component of Pentacel…” Id. at 3. Dr. McGeady’s position
that both interferon production and CNS injury following the DTaP component of the Pentacel
vaccine occur within 72 hours of vaccination is consistent with other reported Vaccine Program
cases which discuss cytokine-driven responses. Loving v. Sec’y of Health & Hum. Servs., 86 Fed.
Cl. 135, 148 (2009) (noting that “warnings establish that adverse events occurring within seventy-
two hours of [pertussis] vaccination are typical.”); Jimenez v. Sec’y of Health & Hum. Servs., No
17-1190V, 2021 WL 3179643, at *14 (Fed. Cl. Spec. Mstr. Jun. 23, 2021) (citing medical literature
which notes that cytokine response occurs between 3 and 72 hours post vaccination); Brunson v.
Sec’y of Health & Hum. Servs., No 17-530V, 2020 WL 5755502, at *20 (Fed. Cl. Spec. Mstr. Sep.
3, 2020) (citing Petitioner’s expert for the proposition that SIDS deaths typically occur within 72
hours of immune provocation, correlating with “peak post-vaccination cytokine production.”);
Wolf v. Sec’y of Health & Hum. Servs., No 14-342V, 2016 WL 6518581, at *16 (Fed. Cl. Spec.
Mstr. Sep. 15, 2016) (concluding that petitioner did not meet her burden, due, in part, to the fact
that cytokine upregulation would be underway “in less than 72 hours,” yet petitioners did not bring
R.W. to the doctor until one month post vaccination). Although these opinions are not binding on
me, they provide persuasive authority on this point.
It transpires, then, that Dr. McGeady’s opinion and Dr. Steinman’s are not mutually
exclusive. Dr. Steinman opined that significant aggravation began “within” the first three weeks
after vaccination, and Dr. McGeady’s estimate of “sooner” than three weeks falls within that
period. Taking the two opinions together, I conclude that locating the start of significant
aggravation sometime within 72 hours of receiving Pentacel is medically reliable such that
causation can be inferred.6
5
Although Dr. McGeady indicated citation to medical literature, that literature was not listed in his report
or filed into the record.
6
For the reasons articulated in my original entitlement decision, I do not find Dr. Steinman’s discussion of
Schonberger or Bennetto & Scolding to be persuasive. The Schonberger article discusses a different
vaccine, both articles discuss different injuries, and importantly, both refer to different mechanisms of
disease initiation.
9
The medical records are sparse concerning the significant aggravation of H.H.’s condition
immediately after his receipt of the Pentacel vaccine, as H.H. did not see a medical provider until
his visit to Dr. Hollis on November 11, 2013. However, the parties did fill in some of these gaps
through testimony. See James-Cornelius v. Sec'y of Health & Hum. Servs., 984 F.3d 1374, 1380
(Fed. Cir. 2021) (concluding that “for many medical symptoms or events … the patient’s or a
parent’s testimony may be the best, or only, direct evidence of their occurrence.”). Ms. Heller and
H.H.’s grandmother testified that, after receiving the Pentacel vaccine on a Wednesday, H.H. had
a high fever and slept for much of the following weekend. Tr. at 18, 113. This testimony is
supported by the affidavit of Angela Kleinhans, who averred that H.H. had a high fever the
weekend after he received his vaccines. Ex. 92 at 2. Ms. Sewell, H.H.’s grandmother testified that
H.H. slept “more than he ever had before.” Tr. at 113. Dr. Marks testified that H.H.’s fever likely
constituted a vaccine reaction, and that it was likely the onset of his disease process. Id. at 195. Dr.
McGeady conceded that H.H.’s fever “could have been a reaction to the vaccine.” Id. at 227. Ms.
Heller described that the next week was Halloween week, and during that time, H.H. began
dragging his right leg. Id. at 18-19. Mr. and Ms. Heller and H.H.’s grandmother agreed that by
Halloween, H.H. was noticeably worse, dragging his leg and falling frequently while trying to
stand. Id. at 19-20, 99, 114. Sheri Huling’s letter, filed after the entitlement hearing, supports this
position. Ms. Huling stated that H.H. had right heel cord tightness soon before he received his
Pentacel vaccine on October 23, 2013. Ex. 102 at 1. Ms. Huling further stated that she saw H.H.
on Halloween and “noted worsening in his tightness in [his] right heelcord.” Id. (emphasis added).
Ms. Huling further averred that she saw H.H. fall once while sitting and once while standing. Id.Ms. Kleinhans remarked that H.H. got sick “and he was never the same again.” Ex. 92 at 2. The
statements of Ms. Huling, Ms. Kleinhans, H.H.’s grandmother, and Petitioners are consistent with
Dr. Hollis’s note at the November 11, 2013 appointment that H.H.’s development had regressed
“in the last month.” Ex. 49 at 41.
The lack of contemporaneous medical record documentation covering the three-week
period following Pentacel vaccination makes it difficult to pinpoint the specific date on which
significant aggravation began. However, I find that there is preponderant evidence in the record
that the significant aggravation of H.H.’s condition began with systemic symptoms a few days
after receiving the Pentacel vaccine and continued to progress over the following weeks with
worsening heel cord tightness, H.H.’s dragging of his right leg, and his progressive inability to sit
unassisted, stand without falling, or crawl. This timeline is consistent with Petitioners’ medical
theory. Petitioners have presented preponderant evidence in support of Loving prong six.
VI. CONCLUSION
For the foregoing reasons and in light of the Court’s Remand Opinion, I find that
Petitioners have satisfied each of the Loving prongs. Accordingly, Petitioners are entitled to
compensation under the Vaccine Act. An order regarding damages shall issue.
The Clerk’s Office is instructed to provide this Ruling to the assigned judge. See Vaccine
Rule 28.1(a).
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IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
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