Court Opinion

ID: 4375713
Source: CourtListenerOpinion
Date Created: 2019-03-11 16:02:32.692776+00
Date Added: 2024-06-11T14:49:25.285823
License: Public Domain

REISSUED FOR PUBLICATION
                                                                                                     MAR 11 2019
                                                                                                      OSM
                                                                                          U.S. COURT OF FEDERAL CLAIMS
               Jfn tbe Wniteb �tates Q.Court of jfeberal Q.Claints
                                     OFFICE OF SPECIAL MASTERS
                                             No. 17-1418V
                                          (not to be published)
********************                          *****
K.N. and C.L., on behalf ofJJ.N.,                       *
                                                        *        Special Master Corcoran
                                                        *
                                                        *        Filed: February 4, 2019
                            Petitioners,                *
         v.                                             *
                                                        *        Dismissal of Petition; Vaccine
SECRETARY OF HEALTH                                     *        Act; Denial Without Hearing.
AND HUMAN SERVICES,                                     *
                                                        *
                           Respondent.                  *
                                                        *
*************************
K.N. & C.L.,pro se, Brockton, MA.

Voris E. Johnson, U.S. Dep't of Justice, Washington, D.C. for Respondent.

                 DECISION DISMISSING CASE FOR INSUFFICIENT PROOF 1

        On October 3, 2017, K.N. and C.L. filed a petition seeking compensation under the
National Vaccine Injury Compensation Program on behalf of their minor son, J.J.N.2 Petitioners
allege that certain childhood vaccines that J.J.N. received on September 24, 2014, caused him to
suffer from seizures, aphasia, and developmental delays. Am. Pet. at 1-2, filed Feb. 14, 2018 (ECF
No. 14). They also maintain that additional vaccines J.J.N. received on November 25, 2014,
precipitated an encephalopathy, and that he was also subsequently harmed by another vaccine
administered to him on January 6, 2018. Id at 1, 3-4. The medical records filed in this case

1
  Although this Decision has been formally designated "not to be published," it will nevertheless be posted on the
Court of Federal Claims's website in accordance with the E-Govemment Act of 2002, 44 U.S.C.§3501 (2012)). This
means that the Decision will be available to anyone with access to the internet. As provided by 42 U.S,C. § 300aa-
 12(d)(4)(8), however, the parties may object to the Decision's inclusion of ce1tain kinds of confidential information.
Specifically, under Vaccine Rule 18(b), each party has fourteen 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 whole Decision will be available to the public
in its cun-ent form. Id.
2
  The Vaccine Program comprises Part 2 ofthe National Childhood Vaccine Injury Act ofl986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-to through 34 (2012) ("Vaccine Act" or "the Act").
Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix).
establish that J.J.N. has been diagnosed with an autism spectrum disorder ("ASD"). See Ex. 1 at
1,filedOct.3,2017(ECFNo. l-l).

         The case was initially assigned to Special Master Gowen, but then transfen-ed to me in May
2018. By that time, the Petitioners had filed an amended petition and a large number of medical
record documents. See generally Am. Pet.; Exhibits 1-16; Exhibit 18; Exhibits 21-23, filed Feb.
14, 2018 (ECF Nos. 14-4-14-23). 3 After reassignment, I held a status conference with the parties
in July to discuss the nature of Petitioners' allegations. At that time (and after I had conducted an
initial review of the claim and documents offered in its support), I explained to Petitioners that the
claim faced considerable obstacles. See generally Order, dated July 16, 2018 (ECF No. 25). In
particular, I noted that (a) the record did not suggest that J.J.N. had experienced an
"encephalopathy" leading to developmental problems, and (b) it appeared that the Petitioners
wished to argue that J .J .N. 's autism was vaccine-caused, even though such claims have never once
succeeded in the Vaccine Program (at least as non-Table claims in which causation had to be
established). Id. at 1-2.

        Despite my initial misgivings about the substantive strength of the claim, however, I
informed the Petitioners that (because in a few rare circumstances claimants have succeeded in
establishing that a vaccine induced a Table-defined encephalopathy that produced developmental
regression or plateauing) I would afford them the opportunity to file whatever medical records
they proposed could establish this had occun-ed-although I also invited Respondent (in his then-
yet-unfiled Rule 4(c) Report) to seek the claim's dismissal. Order at 2-3.

        Respondent did in fact request dismissal as anticipated. See Rule 4( c) Report, dated Aug.
31, 2018 (ECF No. 26) ("Mot."). Petitioners thereafter filed a response opposing the motion
(although they filed no additional medical records even after my warning in July). See Petitioners'
Response, dated Dec. 26, 2018 (ECF No. 32) ("Opp."). I have now had the opportunity to review
both filings, and in light of them plus the record, hereby (and for the reasons set forth below)
dismiss the claim.

I.       Brief Factual Summary

        J.J.N. was born on June 19, 2013. Ex. 1 at 1 (ECF No. 14-4); see generally Ex. 2. Before
receiving the vaccinations in question in this case, there were some vague preliminary signs
(reflected in the medical record) that he might have developmental problems. For example, at his
nine-month well-baby exam in February 2014, C.L. reported occasional hand flapping, although
the exam did not conclude at this time that J.J.N. was in fact autistic or developmentally delayed.

3The exhibits filed in this case were not numbered consistently. Two documents were filed as Exhibit 1 (ECF No. 1-
1 and ECF No. 14-4), and no Exhibit I 7, 19, or 20 was ever filed. For the sake of clarity, references to either Exhibit I
will include the ECF number throughout this Decision.

                                                            2
Ex. 8 at 15-16. Ear flapping was reported at a sick visit that April. Ex. 9 at 6. However, no treater
determined that such behaviors were true warning signs prior to the vaccinations in question.

        On September 24, 2014, J.J.N. (then fifteen months old) was seen for a well-baby visit, at
which time her received the first vaccines at issue (inactivated polio virus, pneumococcal
conjugate, haemophilus influenzae, and influenza). Ex. 8 at 18-19. There is no recorded reaction
to these vaccinations; indeed, J.J.N. had sick visits to his pediatrician several times in the next six
weeks for a variety of conditions (including a tick bite in early October), but there is no report of
a reaction independent from the primary reasons for seeking treatment on each occasion. See, e.g.,
Ex. 9 at 13-14 (October 1, 2014-tick bite), 15-16 (October 3, 2014-viral illness), 17
(November 3, 2014-diarrhea and fever).

       On November 5, 2014, at a follow-up appointment to assess the status of J.J.N.'s recovery
from the tick bite the month before, C.L. reported to the pediatrician her concern that J.J.N. had
become fussy, would not make eye contact (and had not been doing so for several weeks), and was
writhing intermittently as if in pain. Ex. 9 at 18. His grandmother was also concerned that he
seemed withdrawn and had not been making eye contact for three to four weeks. Id. The exam was
normal, however, and J.J.N. was noted merely to have experienced "fever" and "behavioral
change." Id; see also Ex. 7 at 2.

        Less than two weeks later, on November 13, 2014, J.J.N. returned to his pediatrician with
reports that he might have been experiencing seizures, as well as other behaviors often associated
with developmental difficulties (for example, walking on tiptoes). Ex. 9 at 21-22. C.L. noted at
this time that she had called a developmental pediatrician, who recommended a neurological
evaluation. Id. She repeated such concerns at the end of the month, on November 25, 2014, when
J.J.N. was taken for his eighteen-month well-baby visit. Ex. 8 at 21-22. At that time J.J.N. received
several additional vaccines (measles-mumps-rubella ("MMR"), varicella, diptheria-tetanus-
acellular pertussis ("DTaP"), and another flu vaccine). Id.

        J.J.N. received the neurologic evaluation that had been previously recommended on
December 11, 2014, when he was seen by Eugene Roe, M.D., and Sara Delvecchio, N.P., at Boston
Children's Hospital Weymouth Neurology clinic. See generally Ex. 12 at 1-4. The record from
this visit references "a history of two episodes of altered consciousness" beginning in early
October 2014, with a second in the first half of November; the first was observed by C.L. and
seemed like a seizure, while in the second he was found limp and face down after jumping on an
indoor trampoline. Id. at 1. C.L. also reported observing eye fluttering "over the past couple of
months" and an inability to make eye contact. Id. at 2. She squarely informed these treaters of her
concern that J.J.N.'s symptoms constituted "the presentation of autism." Id. She made no mention
of the vaccinations J.J.N. had received in September or November as having any relationship in
her understanding to his symptoms, although she did mention the early October tick bite. Id.

                                                   3
        The exam of J.J.N. revealed no obvious problems but did confirm his difficulty in
maintaining eye contact. Ex. 12 at 2-3. Nurse Practitioner Delvecchio recommended an EEG,
MRI, and early intervention for language development, as well as a genetics evaluation (based on
reported attention deficit/hyperactivity disorder running in the family). Id. at 3. The prescribed
EEG was performed in January 2015 and came back normal. Ex. 21 at 1-3. In addition, an
infectious disease work-up (noting that J.J.N. had tested negative for Lyme disease after the early
October tick bite) was also negative, with the treaters who performed it informing Petitioners that
there was no known link between autism and prior infection in any event. Ex. 13 at 1-2. The brain
MRI performed at the end of January 2015, however, revealed a "highly unusual configuration of
the corpus callosum." Ex. 6 at 1.

         On March 4, 2015, J.J.N. saw Nurse Practitioner Delvecchio for follow-up. Petitioners
informed her that J.J.N. 's behavior issues and communication deficits were now heightened,
leading her to deem them "strongly suggestive" of autism spectrum disorder, and to recommend
that he receive specialized therapies aimed at treating ASD symptoms. Ex. 12 at 9-11. The medical
record for the subsequent timeframe discloses Petitioners' consistent efforts to provide J.J.N. the
care necessary to treat his developmental problems, but largely do not impact analysis of the
present claim, and therefore are not further discussed.

II.     Parties' Respective Arguments

        As noted, Respondent requested the claim's dismissal in his Rule 4( c) Report. Mot. at 11.
He argues that Petitioners' claim that J.J.N. experienced an encephalopathy after his November
2014 vaccinations fails because the medical record does not reveal facts that would support the
Table definition of that term. Id. at 7-8 (citing 42 C.F.R. § 100.3(c)(2)(i)(A)(l)). In particular, (a)
the record reveals that J.J.N. experienced a "decreased level of consciousness" (a requirement to
establish encephalopathy under the Table) on two occasions before the November vaccinations-
not after, and (b) there was no evidence of post-vaccination chronic encephalopathy either. Id. at
8. The Petitioners had also not demonstrated the nature of J.J.N. 's injury after the September 2014
vaccinations. Id. at 9-10. And to the extent the Petitioners sought recovery for J.J.N. 's
developmental problems (whether or not they were deemed indicative of an ASD), the
overwhelming majority of cases litigated in the Program since the time of the Omnibus Autism
Proceedings (the "OAP") 4 had rejected any causal association between vaccination and ASD,
including where a claimant alleged a non-Table claim based on a purpmied vaccine-induced
encephalopathy. Id. at 10-11 (citations omitted).

4
  My July 2018 Status Conference Order discussed above includes a lengthy footnote addressing the history and
ultimate disposition of the OAP cases. See Order at I n. I, dated July 16, 2018 (ECF No. 25).

                                                     4
         Petitioners have opposed Respondent's motion, and in doing so make several fact
arguments (although these arguments were not substantiated with additional records or other proof
not previously filed in the case). Thus, looking at J.J.N.'s medical history prior to the September
2014 vaccinations, they maintain that he experienced a level of eczema as of the winter of2014
(after receiving prior doses of the DTaP vaccine) recognized as an "autoimmune issue," suggesting
that his alleged subsequent reactions to later doses may have been autoimmune in character as
well. Opp. at 2 ~ 5. They also claim that they sought to bring J.J.N. in for emergency medical
treatment in early November 2014 for "meningitis, encephalitis, or something similar," but that
the documented November 5th doctor's visit reflected in the existing medical record did not
accurately record the alarming degree of his symptoms ("he was writhing in agony, arching his
back"). Id at 2 ~ 7. 5 And Petitioners similarly maintain that after the November vaccinations, J .J .N.
experienced "3 days of acute lethargy," again proposing that the contemporaneous record's failure
to c01Toborate such allegations is attributable to those records being in error. Id. at 3 ~ 9.

        Based upon the above, Petitioners maintain that their claims are well-founded. They assert
that prior Program case law involving the OAP or autism is not relevant because they do not seek
to establish a relationship between J.J.N. 's vaccinations and autism (although they simultaneously
maintain that his "severe neurologic injury" was sufficient for an autism diagnosis regardless).
Opp. at 5 ~~ 23, 26. Rather, they maintain that his symptoms were precipitated by an
encephalopathy, which began after the September 2014 vaccinations and was exacerbated by those
received in November. Id. at 5 ~ 24. J.J.N. 's purported eczema is evidence of an autoimmune
intolerance to vaccination. Id. They also focus on his alleged reaction after the November 2014
vaccinations as sufficient to meet the Table's encephalopathy definitions. Id. at~ 28.

                                                    ANALYSIS

       To receive compensation under the Vaccine Program, a petitioner must prove either (I)
that he suffered a "Table Injury"-i.e., an injury falling within the Vaccine Injury Table-
corresponding to one of her vaccinations (in which case establishing causation-in-fact is not
required), or (2) that he suffered an injury that was actually caused by a vaccine. See Sections
13(a)(l)(A) and 1 l(c)(l). Petitioners seeking to establish entitlement via a causation-in-fact must
meet the three-prong test for such a claim set forth by the Federal Circuit in A/then v. Secretary of
Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005).

        The evidence filed in this matter does not establish the Table requirements for
encephalopathy. I have discussed in prior cases the evidentiary burdens a petitioner must satisfy
to establish a child experienced a post-vaccination encephalopathy. See, e.g., Thompson v. Sec'y

5
 This paragraph of Petitioners' Opposition also suggests an intent to file declarations substantiating these allegations,
but none were ever filed.

                                                           5
of Health & Human Servs., No. 15-1498V, 2017 WL 2926614, at *7-8 (Fed. Cl. Spec. Mstr. May
16, 2017) (dismissing Table claim that post-vaccination encephalopathy occutTed and resulted in
ASD). Here, it is self-evident from the present record that these strict requirements are not met.
The contemporaneous medical record establishes no evidence that (however legitimately alarming
the symptoms may have been) J.J.N. experienced an acute (meaning sufficient to require
hospitalization) or subsequent chronic encephalopathy after his September or November 2014
vaccinations. Indeed, J.J.N.'s instances of altered consciousness preceded the November
vaccinations, further harming the argument that that date was the start of a Table encephalopathy,
and the most alarming medical occurrence after the September vaccinations was the October tick
bite. Petitioners' desire to vary what the existing records establish with their own recollections fly
in the face of long-standing Program law holding that contemporaneous records are deemed
accurate except in limited circumstances not established to be relevant here. Burns v. Sec'y of
Health & Human Servs., 3 F.3d 415,417 (Fed. Cir. 1993). And in any event, Petitioners did not
file any such additional evidence, despite having had more than three months to act since the filing
of Respondent's motion to dismiss.

        The record is similarly unsupportive of Petitioners' non-Table claim that J.J.N. experienced
a reaction to his September and November 2014 vaccinations-whether separately or together-
culminating in the ASD symptoms he has experienced. 6 As noted, there is little in the record that
would corroborate allegations of a post-vaccination encephalopathy after either vaccination date.
The first concern expressed by Petitioners that J.J.N. might have an ASD is found in the
November 5, 2014 record, which falls between the two vaccination events, but without any
intervening evidence suggesting the early vaccinations led to this event and were then worsened
after the November vaccinations. There is also no treater support for Petitioners' contentions, and
some evidence that J.J.N. may have shown signs of developmental difficulties even before the
September 2014 vaccinations. 7 All that remains is the fact that Petitioners' observations of J.J.N. 's
symptoms led them to seek intervention afler the September vaccinations, with follow-up (and
more conclusive diagnoses of an ASD) occurring after the November vaccinations. This temporal
association is not enough for a successful Program claim. Mccarren v. Sec'y of Health & Human
Servs., 40 Fed. Cl. 142, 147 (1997).

6Petitioners' Opposition makes no mention of their prior assertion that J.J.N. experienced some kind of reaction after
receiving the Hep A vaccine in January 2018, and I similarly find that the record is not suppmtive of a Vaccine
Program award based upon such allegations.

7 Petitioners' asse1tions that J.J.N. displayed a sensitivity to the DTaP vaccine, revealed in the winter of2014 after
receiving initial doses of it, and that this sensitivity reflects a propensity for an autoimmune response (which
presumably occurred again after the November 2014 vaccinations) is also unsuppmted by the record. On May 20,
2015, J.J.N. saw Margaret Vallen-Mashinkien, M.D., an allergist. A history ofrepmted eczema plus an instance of
hives was provided, and the assessment was atopic dennatitis, allergic rhinitis, and recurrent bacterial infection. Ex.
18 at 5--0. No treater, however, linked any of the above to the DTaP vaccine or deemed it out of the ordinary, and
there is nothing from the 2014 record that would suggest any eczema revealed at that time was vaccine-related.

                                                          6
        Finally, Petitioners have not successfully distinguished this case from the many autism
claims that have been litigated unsuccessfully in the Program. I noted in Thompson that non-Table
claims alleging a vaccine-caused developmental problem (whether or not the petitioners agreed it
was autism) decided since the conclusion of the OAP had uniformly failed . Thompson, 2017 WL
2926614, at* 13 (citing Wolf v. Sec'y ofHealth & Human Servs., No. 14-342V, 2016 WL 651858,
at *15 (Fed. Cl. Spec. Mstr. Sept. 15, 2016)). The same is true for non-Table claims attempting to
characterize developmental symptoms as the secondary result of a vaccine-induced
encephalopathy. Id. at* 13 (citing Cunningham v. Sec'y ofHealth & Human Servs., No. 13-483V,
2016 WL 4529530 (Fed. Cl. Spec. Mstr. Aug. 1, 2016) mot.for review denied, 2017 WL 1174448,
at *5 (Fed. Cl. March 22, 2017) (disregarding "petitioner's attempt to differentiate this case from
other autism cases by creating this second step"- that post-vaccination developmental regressions
can be attributed to a vaccine-induced encephalopathy even if there is no evidence of an
encephalopathic reaction)). These cases underscore why proceeding with this case would be
reasonable given the present record.

                                                    CONCLUSION

        Under the Vaccine Act, a petitioner may not receive a Vaccine Program award based solely
on his claims alone. Rather, the petition must be supported by either medical records or by the
opinion of a competent physician. Section 13(a)( 1). In this case, there is insufficient evidence in
the record for Petitioners to meet their burden of proof, especially given the nature of injury
alleged. Petitioners' claim therefore cannot succeed and must be dismissed. Section 11 (c)(1 )(A).

      Thus, this case is dismissed for insufficient proof. The Clerk shall enter judgment
accordingly. 8

        IT IS SO ORDERED.

                                                                         Brian H. Corcoran
                                                                         Special Master

8Pursuant to Vaccine Rule 11 (a), the parties may expedite judgment by filing a joint notice renouncing their right to
seek review.

                                                          7