Court Opinion

ID: 4436141
Source: CourtListenerOpinion
Date Created: 2019-09-05 20:01:43.586449+00
Date Added: 2024-06-11T14:53:06.234593
License: Public Domain

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

*********************
HEATHER SPRACKLEN and JOE *
HIGGINS, on Behalf of M.H.,          *
a Minor,                             *
                                     *      No. 16-559V
                  Petitioners,       *      Special Master Christian J. Moran
                                     *
v.                                   *
                                     *      Filed: July 31, 2019
SECRETARY OF HEALTH                  *
AND HUMAN SERVICES,                  *      Entitlement, diagnosis,
                                     *      acute disseminated
                  Respondent.        *      encephalomyelitis (ADEM)
*********************
John Robert Howie, Jr., Howie Law, PC, Dallas, TX, for petitioners;
Darryl R. Wishard, United States Dep’t of Justice, Washington, DC, for
respondent.

            PUBLISHED DECISION DENYING COMPENSATION1

      Heather and Joe Spracklen alleged that the mumps-measles-rubella
(“MMR”) vaccine caused their daughter, M.H., to suffer acute disseminated
encephalomyelitis (“ADEM”). Pet’rs’ Prehear’g Br., filed Nov. 20, 2018, at 13.
To assist them, the Spracklens retained a neurologist, Steven Lovitt. The Secretary
disagreed with the allegations and retained a pediatric neurologist, Peter Bingham.

      Due to the dispute between the experts, the case proceeded to a hearing,
which was held in Dallas, Texas, on February 8, 2019. At the end of the hearing,
the undersigned presented preliminary views but allowed the parties to file briefs

       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 decision 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.
tightly focused on whether M.H. suffered from ADEM. The parties have done so,
and both attorneys advocated effectively.
       Establishing by preponderant evidence that M.H. suffered from ADEM is a
required part of the Spracklens’ case. However, the evidence considered, as a
whole, does not support this finding. Thus, the Spracklens have not established
that they are entitled to compensation.

I.     Brief Overview of M.H.’s Chronology2
      Ms. Spracklen gave birth to M.H. on April 26, 2012, a date that was earlier
than expected. M.H. suffered from intrauterine growth restriction and was born
with a low birth weight: 2,100 grams. Exhibit 4 at 31; exhibit 5 at 8.

      For the next year, M.H. was developing normally. When she had her well-
baby checkup shortly after turning one year old, she passed the 12-month
milestones. Exhibit 6 at 13-18. In this appointment, which was on May 10, 2013,
she received the allegedly causal MMR vaccine. Exhibit 6 at 1, 15, 17.
       On May 27, 2013, M.H. seemed to go limp when her mom was tossing her
into the air. The Spracklens brought her to an emergency room at Stillwater
Medical Center. A nurse noted that M.H. was fussy with a weak cry. The doctor
indicated that M.H. had a shoulder problem. Exhibit 5 at 55-59. After being
discharged home, M.H. slept restlessly.

       The next morning, when Mr. Spracklen picked M.H. up from bed, she
seemed to be having a seizure. Her parents rushed her to a nearby firehouse. The
firefighters called an ambulance and the ambulance brought M.H. to Stillwater
Medical Center. Exhibit 11.

        M.H. remained at Stillwater Medical Center for a few hours. Medical
personnel provided some initial care to M.H. and then determined that M.H. should
be transferred to a facility offering more enhanced medical services, Saint Francis
Hospital. See exhibit 5 at 107. The reason for the transfer was that M.H. had
limited range of motion. She could not move her arms or legs and she could not
lift her head. Id. at 73, 103.

       2
           The undersigned has reviewed all the records. However, this decision does not recite all
of them.

                                                     2
      In Saint Francis Hospital, M.H. underwent a series of MRIs. The MRI of
her brain was normal. The MRI of her cervical spine showed a very large lesion.
Exhibit 7 at 68-69 (May 29, 2013).

       A neurologist, David Siegler, saw M.H. on May 29, 2013. Dr. Siegler noted
that M.H. was suffering from quadriplegia. Dr. Siegler was concerned about an
infectious or inflammatory process and started steroids. Exhibit 7 at 16-18.

      After M.H. completed a 5-day course of steroids, Dr. Siegler saw her again
on June 3, 2013. M.H. had weakness in all her extremities. Dr. Siegler diagnosed
M.H. as suffering from an inflammatory myelitis and recommended intravenous
immunoglobulin. Exhibit 7 at 18-19.

       On June 7, 2013, an infectious disease specialist, Michael Chang, saw M.H.
He recorded that M.H. had not suffered any illness preceding the onset of her
paralysis. Dr. Chang agreed with the diagnosis of transverse myelitis. Dr. Chang
also stated that he would report M.H.’s case to the Vaccine Adverse Events
Reporting System (VAERS) although it was unlikely for the vaccine to have
caused her condition. Exhibit 7 at 22-24.
       The doctors repeated the MRIs on June 10, 2013. The brain MRI continued
to show no abnormality. The cervical spine was improved as it showed minimal
signal abnormality. Exhibit 7 at 75-77.

       Saint Francis discharged M.H. on June 11, 2013. In reciting M.H.’s history,
the author of the discharge report mentions that M.H. had received immunizations.
But, the writer did not directly link the vaccinations to M.H.’s conditions. “The
patient had a significant workup for what seems to be an infectious or
inflammatory process causing her acute onset of flaccid paralysis.” “As discussed
with infectious disease and neurology, it seems like transverse myelitis possibly
from an inflammatory or infectious process.” Exhibit 7 at 15.

      From Saint Francis, M.H. went to the Children’s Center Rehabilitation
Hospital. Upon admission, a doctor from the Children’s Center, Justin Ramsey,
authored a report about M.H.: “This is a young woman. I am somewhat perplexed
by her history. Working diagnosis from Saint Francis is transverse myelitis.”
Exhibit 9 at 192.

      To assist in M.H.’s care, Dr. Ramsey requested that a pediatric neurologist
from Oklahoma University see her. This physician was Gabriella Purcarin. In Dr.
Purcarin’s initial report, she recorded that before the onset of M.H.’s paralysis,
“she had 2 weeks of increased irritability and low grade fevers, after her one year
                                               3
vaccinations.” Exhibit 10 at 169. Dr. Purcarin’s diagnosis for M.H. was: grand
mal seizure, quadriparesis, myelopathy which was likely autoimmune
inflammatory.” Id.

      M.H. remained in the Children’s Center Rehabilitation Hospital until July
19, 2013. At the time of discharge, Dr. Purcarin was planning to see M.H. in late
August. Exhibit 9 at 9-19.

      Within a week of being discharged from the rehabilitation facility, M.H. saw
her usual pediatrician, Scott Martin. Dr. Martin noted that M.H. had weakness
secondary to transverse myelitis. Exhibit 6 at 18.

       On July 30, 2013, M.H. had a febrile seizure lasting approximately one
minute. Exhibit 5 at 573. This seizure was in the context of a urinary tract
infection. Exhibit 7 at 441.
      Following this seizure, M.H. returned to Dr. Martin. He stated M.H. had
“recent paralysis and transverse myelitis without clear source.” He planned to
discuss how to control M.H.’s seizures with a neurologist. Exhibit 6 at 22.

      The scheduled follow-up with Dr. Purcarin occurred on August 28, 2013.
Preliminarily, M.H. had another MRI, which showed significant improvement in
her cervical spine. The radiologist who interpreted the MRI listed potential
diagnoses as idiopathic transverse myelitis, ADEM, West Nile, and neuromyelitis
optica. Exhibit 10 at 28. Dr. Purcarin noted M.H.’s improvement. Id. at 147.
      Approximately five months later, M.H. returned to Dr. Martin for her two-
year-old well-child visit. Exhibit 6 at 28 (Feb. 3, 2014). Dr. Martin commented
that M.H.’s “growth has slowed over [the] last year due to her difficulties post
transverse myelitis.” Id. at 31. Dr. Martin also recorded that M.H. was failing
some milestones relating to motor coordination. However, M.H. was meeting the
milestones relating to expressive language. Id. at 29.

      On August 26, 2014, Dr. Purcarin also made a notation about M.H.’s
language. Dr. Purcarin wrote: “Speech and language normal for her age.” Dr.
Purcarin concluded that M.H. had no new neurologic deficits and Dr. Purcarin’s
impression was “acute myelopathy, most likely transverse myelitis.” Exhibit 10 at
91.

      For a well-child visit at 2.5 years old, Dr. Martin saw M.H. on November
12, 2014. In addition to noting M.H.’s muscle weakness, Dr. Martin added that

                                            4
M.H.’s speech was delayed. Exhibit 5 at 557. This referral seemed to lead to
speech therapy for M.H.
       The most recently filed records include an Individualized Education Plan
(“IEP”) that M.H.’s school issued on March 27, 2018. The educators noted that
M.H. has some great academic skills. She was also receiving speech language
services, occupational therapy services, and physical therapy services. Exhibit 66
at 18.
II.    Standards for Adjudication

      Petitioners are required to prove their cases by a preponderance of the
evidence. 42 U.S.C. § 300aa–13(a)(1). The preponderance of the evidence
standard, in turn, has been interpreted to mean that a fact is more likely than not.
Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir.
2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
       Distinguishing between “preponderant evidence” and “medical certainty” is
important because a special master should not impose an evidentiary burden that is
too high. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379-80
(Fed. Cir. 2009) (reversing special master’s decision that petitioners were not
entitled to compensation); see also Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357 (2000); Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961
(Fed. Cir. 1993) (disagreeing with dissenting judge’s contention that the special
master confused preponderance of the evidence with medical certainty). In this
regard, “close calls regarding causation are resolved in favor of injured claimants.”
Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005).
      When there is some dispute about a petitioner’s diagnosis, special masters
may find whether a preponderance of evidence supports any proposed diagnosis
before evaluating whether a vaccine caused that illness. Broekelschen v. Sec’y of
Health & Human Servs., 618 F.3d 1339, 1345-46 (Fed. Cir. 2010).

III.   Analysis

      The evidence fails to show that M.H. suffered ADEM. The reasons for this
finding are: (1) her treating doctors did not diagnose M.H. as suffering from
ADEM, (2) the medical records do not support Dr. Lovitt’s opinion that she suffers
from ADEM, and (3) M.H.’s current disabilities are not necessarily due to ADEM.
These reasons are explained below.

                                              5
       A.      The treating doctors did not diagnose M.H. with ADEM.

       The opinions of treating doctors can be quite probative. Cappizano v. Sec’y
of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). The views of
treating doctors about the appropriate diagnosis are often persuasive because the
doctors have direct experience with the patient whom they are diagnosing. See
McCulloch v. Sec’y of Health & Human Servs., No. 09-293V, 2015 WL 3640610,
at *20 (Fed. Cl. Spec. Mstr. May 22, 2015). However, the views of a treating
doctor are not absolute, Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl.
706, 745 n.67 (2009), even on the question of diagnosis, R.V. v. Sec’y of Health &
Human Servs., 127 Fed. Cl. 136, 141 (2016), appeal dismissed, No. 16-2400 (Fed.
Cir. Oct. 26, 2016).

       Here, the treating doctors consistently diagnosed M.H. as suffering from
transverse myelitis. None of the doctors diagnosed her with ADEM. At best,
ADEM appeared as an item in their list of differential diagnoses early in her
disease course. See exhibit 7 at 8 (ABEM). Following the August 28, 2013 MRI,
ADEM was also included among the differential diagnoses. Exhibit 10 at 28.
However, ADEM never advanced beyond a possibility among multiple
possibilities. Instead, as noted in the presentation of M.H.’s chronology, many
doctors diagnosed her as suffering from transverse myelitis without diagnosing her
as suffering from ADEM.

      In short, these multiple reports collectively constitute strong evidence that
transverse myelitis, not ADEM, is the appropriate diagnosis for M.H.

       B.     Dr. Lovitt’s opinion that M.H. suffered from ADEM is not consistent
       with the medical records.
      The Spracklens’ expert, Dr. Lovitt, reviewed the medical records and formed
an independent opinion that M.H. suffered from ADEM. Exhibit 15 at 7.
However, the Secretary’s expert, Dr. Bingham, disagreed. Exhibit A at 6.
Although there was a dispute about whether M.H. suffered from ADEM, there was
an agreement that Krupp set forth the diagnostic criteria for ADEM. See Pet’rs’
Prehear’g Br., filed Nov. 20, 2018, at 12-13; Resp’t’s Prehear’g Br., filed Dec. 12,
2018, at 7.3

       3
         Lauren B. Krupp et al., Consensus definitions proposed for pediatric multiple sclerosis
and related disorders, 68 (Suppl 2) Neurology S7 (2007), filed as exhibit 18.

                                                   6
      The complete diagnostic criteria are set forth in the appendix. Dr. Lovitt
emphasizes that the diagnostic criteria allow for exceptions. Tr. 78; see also
exhibit 18 at S11. For purposes of this decision, the two relevant criteria are MRI
imaging and the presence of an encephalopathy. Tr. 63.

     MRI imaging. During her stay in Saint Francis Hospital, M.H. underwent
two MRIs. Exhibit 7 at 68-69 (May 29, 2013), at 75 (June 11, 2013). Both brain
MRIs failed to detect any abnormalities.
      The failure of both MRIs to reveal any problems within M.H.’s brain weighs
heavily against a finding that M.H. suffered from ADEM. In his career, Dr. Lovitt
has not seen a case of ADEM with a negative MRI. Tr. 262.

       In lieu of MRI findings, the Spracklens and Dr. Lovitt appear to offer an
alternative way of demonstrating that M.H.’s brain was damaged. See Pet’rs’
Prehear’g Br. at 21. They point to records showing that M.H. had problems
controlling her tongue and swallowing. The nerves that control the tongue and
swallowing originate in the brain stem. Tr. 255.

       Determining the extent of any problem with tongue control or swallowing –
or even if M.H. were having a problem – is difficult. On the day of the MMR
vaccination, M.H. was drinking milk and eating table food. Exhibit 6 at 13. But,
after vaccination, the records about eating, swallowing, and tongue control vary.

      The Spracklens emphasize that on her admission to the Children’s Center
Rehabilitation Hospital, Dr. Ramsey indicated that M.H. was having trouble
controlling her tongue. Exhibit 9 at 2-3. However, this is the only mention of a
problem with tongue control in the record. See Tr. 173. In the Children’s Center,
M.H. seems to have one episode of coughing while eating. Exhibit 9 at 13, 248.
      Previously, at her stay in Saint Francis Hospital, there is no record of
swallowing problems. Tr. 59 (Dr. Lovitt). Actually, some records show normal
swallowing and/or a normal diet. See, e.g., exhibit 7 at 144, 323, 60.4
      Overall, evidence that M.H. suffered from an injury in her brain is not
persuasive. The MRIs did not detect any lesions. Importantly, M.H. underwent
two MRIs, approximately two weeks apart. The repetition blunts the persuasive
value of any argument that the first MRI was administered too quickly to see any

       4
         Somewhat inconsistently, a record from the Children's Center indicates that when M.H.
was at Saint Francis Hospital, M.H. coughed during oral intake. Exhibit 9 at 245.

                                                  7
changes. Because the diagnostic criteria from Krupp requires positive findings on
an MRI, the negative MRIs weigh strongly against the ADEM diagnosis. See Tr.
78 (Dr. Lovitt acknowledging that M.H. does not meet the formal criteria for
ADEM because of the lack of findings on her MRIs).

      Encephalopathy. Krupp specifically defines encephalopathy as either
“behavioral change e.g., confusion, excessive irritability,” or “alteration in
consciousness e.g., lethargy, coma.” Exhibit 18 (Krupp) at S8. The experts
disagreed as to the expected degree of consistency in presentation. Dr. Lovitt
opined that the symptoms constituting encephalopathy could fluctuate. Tr. 108.
But, Dr. Bingham disagreed. Tr. 174.

      Initially, reports about M.H.’s behavior were inconsistent both internally and
externally. An example of an internally inconsistent record comes from when Mr.
and Ms. Spracklen brought M.H. to the fire station before EMTs brought her to
Stillwater Medical Center. M.H.’s score on the Glasgow coma scale was the
maximum rating: 15. Yet in the same report, an EMT described her as being alert,
verbal, in pain, and unresponsive. Exhibit 11 at 2. These data points are not
congruent. Tr. 106, see also Tr. 192, 231.

       Likewise, on May 28, 2013, two nurses described M.H. as “lethargic” and
“listless.” Exhibit 5 at 115-16. Dr. Lovitt saw these signs as consistent with an
encephalopathy. Tr. 57. However, Dr. Bingham offered other explanations for
M.H.’s behavior. Tr. 194, 234. Later, M.H. also took a drink from her bottle,
exhibit 5 at 115-16, an action that seems inconsistent with an encephalopathy.

       Regardless, these instances seem too isolated to support a finding of
encephalopathy. These reports must be placed in context of M.H.’s entire
hospitalization and rehabilitation for her transverse myelitis. See Tr. 202 (Dr.
Bingham opining that some abnormal behavior may have been because she was
sick). At Saint Francis, nurses checked M.H. often with their records running
nearly two hundred pages. The nurses appear not to worry about M.H. being
encephalopathic. Exhibit 7 at 75-267. On the two occasions when a neurologist
saw her, the neurologist did not diagnose encephalopathy. Exhibit 7 at 16-18, 18-
19.

       For these reasons, Dr. Lovitt has not offered a persuasive opinion for
overturning the views of the doctors who treated M.H. and did not diagnose her as
suffering from ADEM.

                                            8
       C.     M.H.’s current condition does not mean she suffered from ADEM.

      M.H.’s medical history did not stop when she was discharged from
rehabilitation on July 16, 2013. Dr. Lovitt relies upon M.H.’s current disabilities
to support an argument that the diagnosis of transverse myelitis is not sufficient to
explain everything wrong with M.H. Tr. 77.
       M.H.’s transverse myelitis is marked by an extensive lesion in her spinal
cord. This location means the lesion causes motor problems in her extremities.
But, a spinal cord lesion would not directly impair the nerves above the lesion,
including the nerves responsible for language.5

        M.H. currently has a problem with language. Her school system provides
speech language services because “She continues to show moderate delays in her
receptive and expressive language skills.” Exhibit 66 at 18 (2018 IEP). Based
upon records from M.H.’s pediatrician, Dr. Martin, and M.H.’s neurologist, Dr.
Purcarin, the Secretary asserts M.H.’s language problem appeared between August
26, 2014, and November 12, 2014. Resp’t’s Posthear’g Br., filed Mar. 11, 2019, at
2, citing exhibit 6 at 28 and exhibit 10 at 91, 129. The Spracklens did not counter
this persuasive analysis. See Pet’rs’ Reply, filed Mar. 20, 2019.

       This onset of expressive language problems means that 15-18 months had
passed after the May 10, 2013 vaccination. It seems unlikely that a vaccination
would cause a problem that surfaced more than one year later. This delayed onset
is also inconsistent with how ADEM usually appears – acutely.
      In summary, the Spracklens did not establish that M.H. suffered from
ADEM. A finding of ADEM would implicitly upset the diagnoses of the doctors
who treated M.H. Such a finding would also be inconsistent with the preponderant
evidence contained in the medical records.

      Without the diagnosis of ADEM, there is no reason to analyze the Althen
prongs for a connection between the vaccinations and ADEM. See Hibbard v.
Sec’y of Health & Human Servs., 698 F.3d 1355, 1365 (Fed. Cir. 2012) (“If a
special master can determine that a petitioner did not suffer the injury that she
claims was caused by the vaccine, there is no reason why the special master should
be required to undertake and answer the separate (and frequently more difficult)

       5
         Dr. Bingham theorized that M.H.'s lack of motor coordination affects how she interacts
with the environment and this diminished interaction could contribute to language problems. Tr.
188.

                                                  9
question whether there is a medical theory”); Bell v. Sec’y of Health & Human
Servs., No. 13-709V, 2016 WL 8136297 (Fed. Cl. Spec. Mstr. Dec. 1, 2016)
(determining that the vaccinee did not suffer from ADEM and denying entitlement
to compensation).6

                                          Conclusion
       At the hearing, the Spracklens displayed great care and concern for their
injured daughter and M.H.’s condition merits sympathy. However, Congress
expected Special Masters to decide cases based upon the evidence, not sympathy.
Here, despite the able advocacy from their attorney, the Spracklens have not
presented preponderant evidence that M.H. suffered ADEM. Thus, they are not
entitled to compensation. In the absence of a motion for review filed pursuant to
RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.
       IT IS SO ORDERED.

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

       6
          At hearing, Dr. Lovitt supported a theory that the MMR vaccine can cause ADEM with
literature. See, e.g., exhibit 88 (PowerPoint presentation summarizing medical literature) at 17-
29. In contrast, Dr. Lovitt’s testimony about whether MMR vaccine can cause transverse
myelitis was fleeting at best. See, e.g., id. at 30, Tr. 69 (the link between vaccination and
transverse myelitis has not been studied adequately). Consequently, the undersigned tentatively
found that the Spracklens had not advanced the alternative theory that MMR vaccine can cause
transverse myelitis with any persuasiveness. Tr. 280-84.

                                                   10
                       Appendix: Diagnostic Criteria for ADEM
                         (Source: exhibit 18 (Krupp) at S7-8)
       1. A first clinical event with a presumed inflammatory or demyelinating
cause, with acute or subacute onset, that affects multifocal areas of the CNS. The
clinical presentation must be polysymptomatic and must include encephalopathy,
which is defined as one or more of the following:

               a. Behavioral change, e.g., confusion, excessive irritability OR
               b. Alteration in consciousness, e.g., lethargy, coma;

       2. Event should be followed by improvement, either clinically, on MRI, or
both, but there may be residual deficits;

         3. No history of a clinical episode with features of a prior demyelinating
event;
         4. No other etiologies can explain the event;

     5. New or fluctuating symptoms, signs, or MRI findings occurring within 3
months of the inciting ADEM event are considered part of the acute event;

      6. Neuroimaging shows focal or multifocal lesion(s), predominantly
involving white matter, without radiologic evidence of previous destructive white
matter changes:
                a. Brain MRI, with FLAIR or T2-weighted images, reveals large (>1
         to 2 cm in size) lesions that are multifocal, hyperintense, and located in the
         supratentorial or infratentorial white matter regions; gray matter, especially
         basal ganglia and thalamus, is frequently involved;
               b. In rare cases, brain MR images show a large single lesion (≥1 to 2
         cm), predominantly affecting white matter;
                c. Spinal cord MRI may show confluent intramedullary lesion(s) with
         variable enhancement, in addition to abnormal brain MRI findings above
         specified.

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