Court Opinion

ID: 4583632
Source: CourtListenerOpinion
Date Created: 2020-11-04 18:01:17.287615+00
Date Added: 2024-06-11T13:44:36.214075
License: Public Domain

In the United States Court of Federal Claims
                             OFFICE OF SPECIAL MASTERS

*********************
ANNE ABBOTT,                        *
on behalf of her minor child, R.A., *              No. 14-907V
                                    *              Special Master Christian J. Moran
                   Petitioner,      *
                                    *
v.                                  *              Filed: July 9, 2018
                                    *
SECRETARY OF HEALTH                 *              Measles, mumps, and rubella
AND HUMAN SERVICES,                 *              (“MMR”) vaccine; encephalitis;
                                    *              Table claim.
                   Respondent.      *
*********************

Andrew D. Downing, Van Cott & Talamante, PLLC, Phoenix, AZ, for petitioner;
Jennifer L. Reynaud, United States Dep’t of Justice, Washington, DC, for
respondent.

           PUBLISHED RULING REGARDING ON-TABLE CLAIM1

      Anne Abbott filed a petition under the National Childhood Vaccine Injury
Act (“Act”), 42 U.S.C. §§ 300aa-10 through 34 (2012), on September 26, 2014, on
behalf of her minor child, R.A. Ms. Abbott’s petition alleged that R.A.’s June 12,
2012 measles, mumps, and rubella (“MMR”) vaccine caused her to develop
Rasmussen’s encephalitis. The petition claimed compensation via both as an on-
Table and off-Table cause of action.

       1
          The E-Government Act, 44 U.S.C. § 3501 note (2012) (Federal Management and
Promotion of Electronic Government Services), requires that the Court post this ruling on its
website. Pursuant to Vaccine Rule 18(b), the parties have 14 days to file a motion proposing
redaction of medical information or other information described in 42 U.S.C. § 300aa-12(d)(4).
Any redactions ordered by the special master will appear in the document posted on the website.
       For the on-Table claim alone, Ms. Abbott filed a Motion for Decision on the
Record Regarding Table Claim. Ms. Abbott’s pending motion is based upon the
following basic chronology. When R.A. was just under two years old on June 12,
2012, she received an MMR vaccination.2 Exhibit 1, ¶ 2; exhibit 4 at 17-18. On
June 28, 2012, 16 days later, R.A. became unresponsive at home. R.A. was taken
to the hospital where doctors confirmed that she had suffered a seizure and had a
temperature of 101.5°F. Exhibit 2 at 66. R.A. was eventually diagnosed with
Rasmussen’s encephalitis in February 2014. Exhibit 6 at pdf 5245 (internal page
4061).

       The Secretary opposed Ms. Abbott’s motion, arguing that Ms. Abbott did
not satisfy the time range requirement for an on-Table claim. The Vaccine Table
associates the measles vaccine with encephalitis that occurs only 5-15 days after
vaccination. Because R.A.’s first seizure happened 16 days after vaccination, the
Secretary argues that Ms. Abbott cannot prevail on her on-Table claim.

       For the reasons explained below, Ms. Abbott has not presented persuasive
evidence that R.A. suffered an encephalitis within the time required by the Table.
Ms. Abbott, however, might cure this deficiency in her evidence by obtaining a
report from an expert. Therefore, although her motion for a decision in her favor is
denied, she may continue her pursuit of compensation as an on-Table claim.

           I.   Facts3

      If the assertions in the affidavits are accepted as accurate, Ms. Abbott’s on-
Table claim hinges on whether various symptoms are manifestations of an
encephalitis. Thus, the fact recitation draws mostly from the affidavits and is
limited to the relevant time period from vaccination to initial seizure.

       2
        R.A. also received the diphtheria-tetanus-acellular pertussis (DTaP) vaccination at the
same appointment, exhibit 4 at 17-18, but Ms. Abbott has not claimed compensation based on
the DTaP vaccination in the present motion.
       3
         For purposes of responding to the pending motion only, the Secretary assumed the
accuracy of the facts presented in the text. Resp’t’s Rep. at 5. The Secretary could make this
assumption because the remainder of the Secretary’s response argued that even with the affiants’
assertions accepted as facts, Ms. Abbott cannot establish that R.A. suffered an on-Table injury
within the time set forth in the Table.

                                               2
       R.A.’s June 12, 2012 vaccination was in the middle of her Bible school, June
11-15, 2012, and the Abbotts stated that volunteers at the Bible school observed
that R.A. “didn’t play much.” Exhibit 28 ¶2, exhibit 29 ¶2. For a few days
following the vaccination, R.A. had a red, sore area at the injection site, her thigh.
Id.

      About one week after the vaccination, the Abbotts commented generally that
R.A. seemed “off,” not as responsive, more fussy, and lethargic. Exhibit 1 ¶4,
exhibit 29 ¶2. At R.A.’s birthday party on June 17, 2012, family members
commented that R.A. was sluggish and not very active. Exhibit 28 ¶3, exhibit 29
¶4. The Abbotts were surprised when R.A. fell asleep around 4 P.M., causing
them to end the party early, and she essentially slept until the next morning. Id.

       Over the next few days, Ms. Abbott stated that R.A. stayed inside because it
was extremely hot outside, and generally observed that R.A. was “a little spacey at
times and lethargic on and off” and was not talking as much. Exhibit 28 ¶4. After
spending the day at her grandparents’ house on June 22, 2012, the Abbotts were
told that R.A. did not do her “normal” things, did not play, and did not eat much.
Exhibit 28 ¶5, exhibit 29 ¶5.

       At a wedding reception on June 23, 2012, the Abbotts observed that R.A. did
not eat or play much and seemed irritable and tired. Exhibit 28 ¶6, exhibit 29 ¶6.
The Abbotts dropped R.A. and her brother off at their grandparents’ house around
6 P.M. Id. When picking up R.A. later that evening, Mr. Abbott heard that R.A.
had been asleep since she had been dropped off, and Ms. Abbott heard that R.A.
had been acting tired and dazed. Id.

       On June 27, 2012 (15 days from the MMR vaccination), Mr. Abbott came
home from work and played with R.A. outside until he noticed her being sluggish.
Exhibit 29 ¶7. Due to the heat outside, Ms. Abbott took R.A.’s temperature and
stated initially that “she had a fever.” Exhibit 1 ¶4. Later, Mr. Abbott and she
stated her temperature was “around 100 degrees.” Exhibit 28 ¶7, exhibit 29 ¶7.

       After playing outside on another hot day on June 28, 2012, Mr. Abbott
brought R.A. inside to take a shower. Exhibit 29 ¶8. Following the shower, Mr.
Abbott set R.A. down on a chair, left the room briefly, and came back to find R.A.
unresponsive. Id. He then immediately took R.A. to the Wilson Memorial
Hospital emergency room where she was found to have a fever of 101.5 and to be
in a full tonic clonic seizure. Exhibit 2 at 66.

                                          3
       At the emergency room, Ms. Abbott reported that R.A. had “felt a little bit
hot earlier in the day” on June 28, 2012. Exhibit 2 at 66. After her transfer to
Dayton Children’s Hospital late that night, Ms. Abbott reported a tactile fever
before R.A.’s seizure. Exhibit 5 at 35. Elsewhere in Dayton’s records, there are
notes that prior to her seizure R.A. “had not been ill-acting or febrile” and “there
has been no fevers, no cold symptoms … no ill contacts at home.” Id. at 40, 44.

       II.     Procedural History

      Ms. Abbott filed the petition on September 26, 2014, and with it her first
affidavit. The initial affidavit sets forth a series of assertions that are not
corroborated in medical records from June 2012. Exhibit 1. Ms. Abbott later
added details to her first affidavit by filing her second affidavit, exhibit 28, and an
affidavit from her husband, Matt Abbott, exhibit 29.

       After Ms. Abbott had filed R.A.’s medical records and a statement of
completion, the Secretary determined that the record was complete and was
ordered to file his Rule 4 report. Order, issued Dec. 16, 2014. Before the Rule 4
report was filed, Ms. Abbott filed an expert report from Dr. David Axelrod on
January 5, 2015. Exhibit 12. Dr. Axelrod generally opined that the MMR and
DTaP vaccinations were the cause-in-fact of R.A.’s seizures.

      The Rule 4 report deadline was suspended, and the Secretary was ordered to
address three of Ms. Abbott’s assertions that support her Table claim. Order,
issued Jan. 9, 2015.4 In a status report, the Secretary denied that there was a
preponderance of evidence to support any of the three assertions. Over the next
few status conferences, the parties agreed to develop the record further, and Ms.
Abbott was ordered to file additional affidavits and other evidence. Orders, issued
Feb. 5, 2015; Mar. 10, 2015; Apr. 16, 2015. Ms. Abbott and her husband
submitted affidavits dated February 20, 2015. Exhibits 28, 29.

      4
          The Secretary was ordered to respond to these assertions:

     1. Ms. Abbott claims that [R.A.] suffered a fever on June 27, 2012, which is 15 days after
        vaccination. Exhibit 1 (affidavit) at ¶4.
     2. This fever begins a process that led to [R.A.] having seizures on June 28, 2012.
     3. The seizures and [R.A.]’s behavior on June 28, 2012 satisfy the definition of “acute
        encephalopathy” (setting aside the day of onset).

                                                4
      The parties continued to develop evidence, primarily related to the off-Table
       5
claim. Ms. Abbott filed an expert report from Dr. David Seigler on June 29, 2015.
Exhibit 30 (corrected version, court document no. [31]). On October 16, 2015, the
Secretary filed expert reports from Dr. Thomas Forsthuber and Dr. John Zemple.
Exhibits A, C. Ms. Abbott filed a second expert report from Dr. Seigler on January
4, 2016. Exhibit 47. She later stated that she believed that Dr. Seigler’s report was
adequately responsive to the Secretary’s expert reports. Status Rep., filed Feb. 5,
2016.

      On February 9, 2016, an entitlement hearing and a briefing schedule were
set. The hearing was later cancelled due to scheduling issues, and Ms. Abbott
advised that she would retain a new neurology expert to file another report. Order,
issued July 15, 2016. Due to the new expert’s schedule, Ms. Abbott did not file an
expert report from Dr. Lawrence Steinman until February 15, 2017. Exhibit 51.

      On May 8, 2017, the Secretary filed a responsive expert report from Dr.
Forsthuber. Exhibit S. On May 16, 2017, the parties were ordered to coordinate
on scheduling an entitlement hearing and were also ordered to file briefs regarding
Ms. Abbott’s Table claim.

       On July 12, 2017, Ms. Abbott filed the pending Motion for Decision on the
Record Regarding Table Claim and a status report on hearing logistics. In the
status report, Ms. Abbott also stated that a favorable ruling on the Motion for
Decision would obviate the need for an entitlement hearing on the causation-in-fact
claim.

      The Secretary filed a response to the Motion for Decision on August 14,
2017. Ms. Abbott then filed a reply. Accordingly, the Ms. Abbott’s motion for
decision is now ready for adjudication.

       III.   Analysis

      Ms. Abbott’s present motion seeks to prove entitlement to compensation
under the Program for a “Table injury” – i.e., an injury falling within the Vaccine
Injury Table – corresponding to R.A.’s MMR vaccination. See 42 U.S.C. § 300aa-
       5
         One aspect of an off-Table claim is determining when a vaccinee experienced the first
sign or symptom of the injury for which compensation is claimed. Bazan v. Sec'y of Health &
Human Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008). Thus, in the context of presenting
causation-in-fact opinions, some experts discussed onset.

                                               5
13(a)(1)(A). Pending resolution of this motion on the Table claim, Ms. Abbott is
reserving her causation-in-fact claim for a possible entitlement hearing.

       To establish a Table injury under the Act, a petitioner must prove that (1)
that the vaccinee received a vaccine listed on the Table, (2) the vaccinee suffered
an injury corresponding to that vaccine, and (3) the vaccinee suffered the injury
within the time range listed. 42 C.F.R. § 100.3(a) (2011); Hellebrand v. Sec'y of
Dep't of Health & Human Servs., 999 F.2d 1565, 1569-70 (Fed. Cir. 1993).

      As noted above, it is not disputed that R.A. received an MMR vaccination
on June 12, 2012, which is listed on the Vaccine Table. 42 C.F.R. § 100.3(a)(III)
(2011). Thus, for Ms. Abbott to prevail on her Table claim, she must establish the
second and third elements listed above: that R.A.’s injury was a Table encephalitis
and that R.A. suffered the “first symptom or manifestation of onset” of the Table
encephalitis within the applicable time frame. 42 C.F.R. § 100.3(a)(III)(B).

      The Qualifications and Aids to Interpretation for the 2011 Table do not
contain a definition for “encephalitis.” 42 C.F.R. § 100.3(b).6 In absence of a
regulatory definition, Ms. Abbott offered that “encephalitis” simply means
“inflammation in the brain.” Pet’r’s Mot. at 4. The Secretary maintained that
“inflammation in the brain” as a definition of encephalitis was “too broad for
program purposes” because that definition does not describe clinical symptoms
that Ms. Abbott would have to establish to demonstrate that R.A. actually
experienced brain inflammation. Resp’t’s Resp. at 8-9 (citing Nuttall v. Sec'y of
Health & Human Servs., No. 07-0810V, 2015 WL 691272, at *10 (Fed. Cl. Spec.
Mstr. Jan. 20, 2015), mot. for rev. denied, 122 Fed. Cl. 821 (2015), aff’d, 640 F.
App'x 996, 997 (Fed. Cir. 2016) (per curiam)). Ultimately, the Secretary did not
propose a definition for encephalitis.7

       6
          Because Ms. Abbott filed her petition on September 26, 2014, the Vaccine Table in
effect at that time, the 2011 Table, is the correct Table to use to evaluate her claim. 42 U.S.C. §
300aa-14(c)(4); Revisions to the Vaccine Injury Table, 76 Fed. Reg. 36367-68 (June 22, 2011)
(effective July 22, 2011). As Ms. Abbott noted, using the current (2017) Table to evaluate her
claim would be legal error. Pet’r’s Reply at 4-5.
       7
          The Secretary argued that because R.A’s particular type of encephalitis is known
(Rasmussen’s), then Ms. Abbott should be required to demonstrate the initial symptom/onset that
is specific to Rasmussen’s encephalitis, not the initial symptoms of encephalitis when more
generally defined. Resp’t’s Resp. at 9-10. Ms. Abbott countered that the Secretary’s proposed
distinction between encephalitis generally and Rasmussen’s encephalitis does not matter because
the both injuries share the same pattern of onset with the distinguishing trait for Rasmussen’s
encephalitis being that it leads to more severe outcomes. Pet’r’s Reply at 7.
                                                 6
      While the term “encephalitis” appears in the 2011 version of the Vaccine
Table, the term “encephalitis” first appeared in the initial Vaccine Table that
Congress created. See 42 U.S.C. § 300aa-14(a)(II)(B) (1988); National Childhood
Vaccine Injury Act of 1986, Pub. L. No. 99–660, 100 Stat 3743, 3764 (1986).
“Congress intended this statute to be understood — and to be applied — as it
would be by a medical professional.” Abbott v. Secʼy of Health & Human Servs.,
27 Fed. Cl. 792, 794 (1993), aff'd on this point, rev'd on other grounds and
remanded, 19 F.3d 39 (Fed. Cir. 1994) (Table) (Text in Westlaw, 1994 WL
32656).8

      A medical professional’s understanding of “encephalitis” can be found in a
medical dictionary. See Munn v. Secʼy of Health & Human Servs., 970 F.2d 863,
867 n.5 (1992) (citing the American Heritage Dictionary and Dorland’s Illustrated
Medical Dictionary to define the term “sequela”). Here, a medical dictionary
defines “encephalitis” as “inflammation of the brain.” Dorland’s Illustrated
Medical Dictionary 436 (26d ed. 1981).

      This definition matches the definition that Special Master Hastings used in
Nuttall. In Nuttall, the petitioners attempted to establish that either a DTaP or an
MMR vaccine caused their son to suffer encephalitis under the Vaccine Table.
2015 WL 691272, at *1. The petitioners in Nuttall, like Ms. Abbott here, put
forward the definition of “brain inflammation.” The Secretary proposed that the

         The Secretary has not provided any authority for why petitioner would have to establish
the initial symptom/onset for a sub-set of encephalitis (Rasmussen’s) rather than the initial
symptom/onset for “encephalitis,” the injury listed in the Vaccine Table. Without any authority
in support, requiring petitioner to establish a more specific initial symptom/onset would add to
petitioner’s burden. The undersigned declines to require Ms. Abbott to establish initial
symptom/onset specific to Rasmussen’s encephalitis.
       8
         Congress authorized the Secretary to modify the Vaccine Table administratively. See
Terran v. Secʼy of Health & Human Servs., 195 F.3d 1302, 1312-15 (Fed. Cir. 1999) (rejecting
argument that administrative changes to a statute were unconstitutional). In 2017, the Secretary
exercised his authority to define “encephalitis.” Revisions to the Vaccine Injury Table, 82 Fed.
Reg. 6294, 6302 (Jan. 19, 2017); Delay of Effective Date, 82 Fed. Reg. 11321, (Feb. 22, 2017)
(changing effective date of revisions to Mar. 21, 2017). However, the 2017 changes do not
establish the definition of encephalitis in Ms. Abbott’s case. See footnote 6, above.

                                                7
special master adopt a draft of a proposed rule. Id. at *10.9 Special Master
Hastings accepted “brain inflammation” as a definition of “encephalitis.” Id.10

       Having defined “encephalitis” as “brain inflammation,” Special Master
Hastings evaluated opinions from experts as to whether the vaccinee in Nuttall
suffered brain inflammation. The key to the experts’ opinions were MRIs because
the child’s clinical symptoms were not dispositive. Id. at *11. Ultimately, the
special master found that the petitioners did not carry their burden to show an
encephalitis happened in their child. Id. at *11-20.

      Consequently, the undersigned holds that “inflammation in the brain” is an
adequate definition for “encephalitis.” The ensuing question is how do petitioners,
such as Ms. Abbott, present preponderant evidence that the vaccinee suffers from
inflammation in the brain. An easy way would be to present the results of imaging
such as MRIs that can detect inflammation in the brain. However, R.A. did not
have any imaging in the relevant time period.

       In lieu of direct evidence of brain inflammation, Ms. Abbott is relying upon
circumstantial evidence, including a medical article, affidavits, and expert’s
reports. To begin, Ms. Abbott cited a medical reference book for the proposition
that “phase one [of Rasmussen’s encephalitis] is a ‘prodromal state’ during which
seizures are infrequent.” Pet’r’s Mot. at 4 (citing exhibit 15 (Tiziana Granata &
Frederick Andermann, Rasmussen encephalitis, in Handbook of Clinical
Neurology, Vol. III, Pediatric Neurology Part I (O. Dulac, M. Lassonde, and H.B.
Sarnat, eds., 3rd Series 2013)) at 1); Pet’r’s Reply at 7. While this reference to a
“prodromal state” seems to offer Ms. Abbott some support, the authors of this
article also report “the onset [of Rasmussen’s encephalitis] is marked, in almost all
cases by focal or secondarily generalized seizures.” Exhibit 15 at 1. Testimony
from an expert could help explain the connection between “prodromal state” and
“onset.”
       9
          Unlike in Nuttall, the Secretary here has not put forward a definition of “encephalitis.”
Although the Secretary did eventually propose and adopt a regulatory definition of encephalitis,
the parties agree that the 2017 regulatory definition does not define “encephalitis” for Ms.
Abbott’s case.
       10
          The Secretary’s brief does not cite Nuttall accurately. The Secretary states that
defining encephalitis as brain inflammation is “‘too broad for Program purposes.’” Resp’t’s
Resp. at 9. However, the phrase “too broad for Program purposes” comes from an unpublished
order a different special master issued earlier in Nuttall. The Secretary’s brief fails to note that
Special Master Hastings resolved the case based upon the definition of “brain inflammation.”

                                                  8
       Ms. Abbott further relies upon assertions contained in affidavits from her
husband and herself. See Pet’r’s Mot. at 8, citing exhibits 1, 28, and 29. As noted
earlier, the Secretary has accepted such assertions for the limited purpose of
determining whether these assertions are material.

       It appears that the assertions about R.A.’s behavior in the days shortly before
her first seizure are material because one expert, Dr. Siegler, seems to accept that
within 5-15 days of the MMR vaccination, R.A. was fussy, not responsive,
lethargic, and tired. Exhibit 30 at 1-2. From this starting point, Dr. Siegler opines
that R.A.’s “symptoms that appeared within 5 to 15 days of her MMR vaccination
were the first onset of her symptoms” of Rasmussen’s encephalitis. Id. at 2.

        Dr. Siegler’s analysis, however, does not quite hit the mark, at least for the
on-Table claim. As explained above, the critical question is whether preponderant
evidence establishes that R.A. had inflammation in the brain by 5-15 days after the
MMR vaccination. Dr. Siegler’s report, which refers to the “defined requirements
of encephalopathy/encephalitis found in the Aids to Interpretation,” id. at 1,
confuses the issue because the 2011 Aids to Interpretation do not define
“encephalitis.” Because the present ruling has defined “encephalitis,” Ms. Abbott
should have an opportunity to present an opinion from Dr. Siegler as to when R.A.
first displayed a symptom of brain inflammation.

      Similarly, reports from other experts are also not as precise as they could be.
Respondent’s expert, Dr. Zemple, stated that the “[t]iming of the vaccination and
onset of neurological symptoms is also clear.… [R.A.’s] first clear neurological
symptom occurred with seizure on June 28, 2012.” Exhibit C at 3.11 In light of the
Granata article’s description of both a “prodromal stage” and “onset” of
Rasmussen’s encephalitis, Dr. Zemple’s characterization of R.A.’s June 28, 2012
seizure as the “first clear neurological symptom” leaves open the question as to
“unclear” neurological symptoms. And the question that Dr. Zemple should
address is whether the constellation of R.A.’s behaviors reported by the affiants is,
more-likely-than-not, a manifestation of brain inflammation.

       11
          One of petitioner’s experts, Dr. Steinman, quoted the above statement from Dr.
Zemple’s report and agreed with his conclusion about R.A.’s first symptom or onset. Exhibit 51
at 4, 21.

                                              9
       Obtaining further reports from experts about brain inflammation is
appropriate. First, this ruling defines “encephalitis” and provides new information
for an expert to consider. Second, when the contemporaneously created medical
records do not establish that a vaccinee suffered an on-Table injury, the petitioner
must present expert testimony. See Paterek v. Secʼy of Health & Human Servs.,
No. 02-411V, 2008 WL 2485159, at *14 (Fed. Cl. Spec. Mstr. May 22, 2008)
(“The cases hold uniformly that if an injured person’s medical records do not
disclose a diagnosis that the injured person’s symptoms constitute a Table injury,
then the petitioner must submit a medical expert’s opinion interpreting the injured
person’s symptoms as a Table injury”), mot. for rev. denied in relevant part and
granted in non-relevant part, 84 Fed. Cl. 19, 46 (2008), on remand, 2009 WL
3288295 (Fed. Cl. Spec. Mstr. Jan. 16, 2009), mot. for review granted and decision
reversed, 88 Fed. Cl. 178 (2009), rev’d, 527 Fed. App’x 875 (Fed. Cir. 2013);
Carter v. Secʼy of Health & Human Servs., No. 04-1500V, 2007 WL 415185, at
*12 (Fed. Cl. Spec. Mstr. Jan. 19, 2007) (in resolving the pending on-Table claim,
“an expert is needed to interpret the information in the medical records and the
statements in the mother's affidavit”).

       In presenting opinions from experts about whether the behaviors described
in the affidavits are manifestations of brain inflammation, the parties are ordered to
direct their experts to assume that the allegations in the affidavits are correct.
However, Ms. Abbott still bears the burden of establishing the accuracy of the
affidavits. See Burns v. Secʼy of Health & Human Servs., 3 F.3d 415, 417 (Fed.
Cir. 1993). Thus, Ms. Abbott and the other percipient witnesses are likely to be
called to testify at any hearing.

       Accordingly, Ms. Abbott’s motion is DENIED. She may seek a ruling in
her favor regarding the on-Table claim after the parties submit additional evidence.

       A status conference is set, sua sponte, for Monday, July 30, 2018 at 2:00
P.M. Eastern Time. During this status conference, a deadline for simultaneous
submission of expert reports will be set. Given the length this case has been
pending and the narrowness of the issues for the experts to address, the deadline is
likely to be within 60 days of the status conference and unlikely to be extended.

      IT IS SO ORDERED.

                                               s/Christian J. Moran
                                               Christian J. Moran
                                               Special Master
                                          10