In the United States Court of Federal Claims
No. 09-585 V
(Filed December 19, 2013)1
* * * * * * * * * * * * * * *
LAMONA DODD, parent of S.S., *
a minor, *
*
Petitioner, * Vaccine Injury; National
* Childhood Vaccine Injury Act of
v. * 1986, 42 U.S.C. §§ 300aa-1 to -
* 34 (2006); Proof
SECRETARY OF HEALTH AND * of Causation; Whether Petitioner
HUMAN SERVICES, * Established a Logical Sequence
* of Cause and Effect.
Respondent. *
* * * * * * * * * * * * * * *
Ronald C. Homer, Boston, MA, for petitioner.
Voris E. Johnson, Jr., United States Department of Justice, with whom were
Stuart F. Delery, Assistant Attorney General, Rupa Bhattacharyya, Director,
Vincent J. Matanoski, Deputy Director, Catharine E. Reeves, Assistant Director,
Washington, DC, for respondent.
________________________________
OPINION AND ORDER
________________________________
Bush, Senior Judge.
1
/ Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of
Federal Claims, this Opinion and Order was initially filed under seal on November 25, 2013.
Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the
information contained therein on or before December 13, 2013. No proposed redactions were
submitted to the court.
Now pending before the court is petitioner’s motion for review of the Chief
Special Master’s June 5, 2013 final decision (Dec.) denying Ms. Lamona Dodd’s
petition for compensation under the National Childhood Vaccine Injury Act of
1986, 42 U.S.C. §§ 300aa-1 to -34 (2006) (the Vaccine Act).2 The court relies on
the record of underlying proceedings in this matter,3 as well as petitioner’s motion
for review (Pet.’s Mot.) and respondent’s response to that motion (Resp.’s Resp.).4
For the reasons stated below, the court denies petitioner’s motion for review and
affirms the decision of the Chief Special Master.
BACKGROUND
I. Factual History5
Lamona Dodd’s son S.S. was healthy at birth, suffered common childhood
ailments and received normal childhood immunizations. Dec. at 4-5. At age four,
he received three vaccinations on October 1, 2007: measles-mumps-
rubella (MMR), Diphtheria-Tetanus-acellular-Pertussis (DTaP) and Polio. Ex. 11
at 6. Only the MMR vaccine, and, in particular, its measles vaccine component,
2
/ The re-captioned, redacted public version of the Chief Special Master’s decision,
issued on June 21, 2013, is the one cited to in this opinion. The page references are to the
version found on this court’s website; the decision is also available at Dodd v. Sec’y of Health &
Human Servs., No. 09-585V, 2013 WL 3233210 (Fed. Cl. Chief Spec. Mstr. June 5, 2013); Dodd
v. Sec’y of Sec’y of Health & Human Servs., No. 09-585V, 2013 U.S. Claims LEXIS 701 (Fed.
Cl. Chief Spec. Mstr. June 5, 2013). The Chief Special Master’s decision provides a more
detailed examination of the circumstances of the vaccine injury alleged in the petition and an
explanation of medical terms relevant to this case.
3
/ Petitioner’s exhibits in this case are numbered (Exs. 1-18, 18-A through 18-I, 19-20,
20-A through 20-E, 21-24), whereas respondent’s exhibits are marked alphabetically (Exs. A,
A-1 through A-3, B).
4
/ Petitioner’s memorandum in support of her motion for review was first filed on July 5,
2013, as an attachment to a motion to exceed page limits, and again on July 10, 2013 as a
separate docket entry. All citations to petitioner’s motion for review are to the memorandum of
law filed on July 10, 2013.
5
/ The chronology recounted here is largely undisputed, although the parties dispute the
significance of certain well-established facts.
2
are at issue in petitioner’s theory of vaccine injury causation.
According to his mother, about a week after the vaccination S.S. experienced
coughing accompanied by fever, but continued to attend preschool. Ex. 12 at 1.
On October 15, 2007, however, S.S. was brought to the emergency room where he
presented, without a fever, as follows:
This is a 4-year-old African American male who was
brought to the emergency room by his mom with history
that the child became sick this evening, complained of a
headache, abdominal pain, and probably had total of
about 6 episodes of vomiting. Had one episode of
diarrhea and urinary incontinence. [He] was thought
beginning about 8 p.m. to be having some seizure
activity. No prior history of seizures and child has some
history of chronic illness. The mom said that the seizures
would start, last [a] few minutes and go away, and he
would be able to talk between the episodes but was not
himself.
Ex. 3 at 169. The hospital staff noted at the time that there was some family
history of seizures.6 Id.
S.S. was discharged the next day on anti-seizure medication. The parties
dispute the severity of the seizures experienced by S.S. on October 15, 2007,
although certain facts are undisputed. As noted by petitioner’s expert, on October
15, 2007 S.S. exhibited several episodes of “staring spells,” a “left focal
tonic-clonic seizure” that lasted a couple of minutes, “left-sided postictal
paralysis,” and his EEG showed “subtle slowing intermittently throughout the right
6
/ The medical records of S.S. as a whole reflect that a maternal great-aunt or aunt had
an onset of seizures in her childhood and suffered from epilepsy. See Ex. 3 at 169; Ex. 7 at 4,
94; Ex. 8 at 10; Ex. 14 at 4, 17; see also Ex. 18 at 1 (petitioner’s expert report noting that S.S.’s
“family history was void of neurological disorders except for a maternal great-aunt with
epilepsy”). But see Ex. 3 at 177 (hospital physician notes stating that S.S. had “no family history
of seizures”).
3
hemisphere.”7 Ex. 18 at 1. The etiology of these “[n]ew onset seizures” was
unclear to his treating physicians. See, e.g., Ex. 3 at 169-70; Ex. 7 at 93; Ex. 14 at
11. None of the medical personnel treating S.S. hypothesized a causal link
between the vaccinations that took place on October 1, 2007 and his subsequent
diagnosis of epilepsy, although petitioner raised this issue in various treatment
settings.
Unfortunately, two elements of the discharge plan developed on October 16,
2007 were not accomplished. S.S. stopped taking his anti-seizure medications and
he was not seen for a neurological follow-up. Instead, S.S. was seen again in the
emergency room, on December 9, 2007, for seizure activity of far greater severity
than the seizure activity experienced on October 15, 2007. Hearing Transcript
(Tr.) at 13, 66, 83-84, 95-96, 98, 110.
S.S. was kept in the hospital for two days to bring his seizures under control.
Upon follow-up, he was diagnosed with secondary general epilepsy. Further
doctor visits followed, both scheduled and emergent in nature. Several changes to
his seizure medications were made. During the next few months, S.S. was noted to
have developmental delays and hyperactivity problems. Although S.S. eventually
controlled his seizures through medication, he has been placed in a special
education program.
II. Procedural History
Ms. Dodd filed a petition under the Vaccine Act on September 4, 2009
alleging that the vaccinations S.S. received on October 1, 2007 caused S.S. to
develop epilepsy and developmental delays. Pet.’s Mot. at 1-2. Petitioner retained
Dr. Marcel Kinsbourne as an expert while respondent retained Dr. John T.
MacDonald; both physicians filed expert reports regarding the petition. Upon
request, the Chief Special Master allowed petitioner to file a supplemental expert
report from Dr. Kinsbourne.
A hearing was scheduled to be held in Boston, Massachusetts on March 18,
2011. Petitioner had thus far relied upon fourteen medical articles; respondent had
7
/ The left-sided postictal paralysis was not complete – his condition was also described
as left-sided hemiparesis or weakness, which resolved before S.S. was discharged. See Ex. 3 at
167, 178. The term “postictal” refers to the post-seizure state.
4
relied upon three medical articles. In her pre-hearing order, the Chief Special
Master required that each party denote the significance of any medical articles
relied upon by that party:
Any party wishing to rely upon a medical article is
directed to file simultaneously a short explanation of the
proposition that the article is intended to support. . . .
This explanation may be encompassed in a pre-hearing
memorandum, or may appear in a separate document.
Order of January 18, 2011. Respondent provided the required explanation;
petitioner did not:
Dr. Kinsbourne, as S.S.’s medical expert, is more
qualified than petitioner’s counsel to explain the medical
articles that support his medical theory. As such, Dr.
Kinsbourne will address the proposition that the medical
articles intend to support at the hearing.
Pet.’s February 28, 2011 Resp. to January 18, 2011 Order, at 4 n.4.
The hearing transcript shows that each party had ample opportunity to elicit
testimony from the experts. A post-hearing briefing schedule was established.
Petitioner filed her brief first (Pet.’s Post-Hr’g Br.), respondent filed the next brief
(Resp.’s Post-Hr’g Br.), and petitioner concluded the briefing (Pet.’s Post-Hr’g
Reply). The Chief Special Master’s decision was filed on June 5, 2013, and was
later redacted to remove the child’s name and birth date and re-captioned to reflect
the name change of petitioner. See supra note 2.
The Chief Special Master held that petitioner had failed to establish a prima
facie case of vaccine injury causation. In her motion for review, petitioner has
raised four specific objections to the decision denying her compensation under the
Vaccine Act. The holdings of the Chief Special Master denying petitioner
entitlement to compensation, and the objections thereto, will be addressed in the
Analysis section of this opinion. The court turns now to the standard of review
applicable here.
DISCUSSION
5
I. Standard of Review
This court has jurisdiction to review the decision of a special master in a
Vaccine Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court
of Federal Claims reviews the decision of the special master to determine if it is
‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
law[.]’” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed.
Cir. 2008) (quoting 42 U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005)); see also Hanlon v.
Sec’y of Health & Human Servs., 191 F.3d 1344, 1348 (Fed. Cir. 1999) (“Under
the Vaccine Act, the Court of Federal Claims may not disturb the factual findings
of the special master unless they are ‘arbitrary, capricious, an abuse of discretion,
or otherwise not in accordance with law.’” (quoting 42 U.S.C.
§ 300aa-12(e)(2)(B))). This court uses three distinct standards of review in
Vaccine Act cases, depending upon which aspect of a special master’s judgment is
under scrutiny:
These standards vary in application as well as degree of
deference. Each standard applies to a different aspect of
the judgment. Fact findings are reviewed . . . under the
arbitrary and capricious standard; legal questions under
the “not in accordance with law” standard; and
discretionary rulings under the abuse of discretion
standard.
Munn v. Sec’y of Dep’t of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed.
Cir. 1992).
The arbitrary and capricious standard of review is used to consider factual
findings by the special master. Id. The scope of this review is limited, and highly
deferential. Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed.
Cir. 2000); Burns by Burns v. Sec’y of Dep’t of Health & Human Servs., 3 F.3d
415, 416 (Fed. Cir. 1993). “If the special master has considered the relevant
evidence of record, drawn plausible inferences and articulated a rational basis for
the decision, reversible error will be extremely difficult to demonstrate.” Hines ex
rel. Sevier v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed.
Cir. 1991); see also Burns, 3 F.3d at 416. This court’s review of the fact findings
6
of a special master under the arbitrary and capricious standard is “well understood
to be the most deferential possible.” Munn, 970 F.2d at 870 (citations omitted).
When the court’s review of a special master’s decision involves statutory
construction or other legal issues, the “not in accordance with law” standard is
applied. Hines, 940 F.2d at 1527. The third standard of review, abuse of
discretion, is applicable when a special master excludes evidence or otherwise
limits the record upon which she relies. See Munn, 970 F.2d at 870 n.10.
II. Burden of Proof in an Off-Table Vaccine Injury Case
There are two distinct avenues for recovery under the Vaccine Act. See 42
U.S.C. § 300aa-11(c). First, a petitioner who has received a vaccination listed on
the Act’s Vaccine Injury Table (Vaccine Injury Table or Table) may recover for
any resulting illness, disability, injury or condition that is also listed on the Table,
or a significant aggravation thereof. Id. § 300aa-11(c)(1)(C)(i); see also id.
§ 300aa-14(a); 42 C.F.R. § 100.3 (2012) (current version of the Vaccine Injury
Table). Second, a petitioner who has received a vaccination listed on the Table,
but whose vaccine-related injuries do not meet Table requirements, may recover
under the “off-Table” theory of recovery. 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii),
300aa-13(a)(1)(A). Under this theory, a petitioner may make out a prima facie
case of entitlement to compensation by showing, by a preponderance of the
evidence, that a Table vaccine actually caused the petitioner to sustain an illness,
disability, injury or condition which is not listed on the Table, or that first appeared
outside the time limits set by the Table. 42 U.S.C. § 300aa-11(c)(1)(C)(ii); Pafford
v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006).
A petitioner such as Ms. Dodd who hopes to recover for an off-Table claim
must establish causation-in-fact. See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-
13(a)(1); Pafford, 451 F.3d at 1355. This requires “preponderant evidence both
that [the] vaccination[] [was] a substantial factor in causing the illness, disability,
injury or condition and that the harm would not have occurred in the absence of the
vaccination.” Pafford, 451 F.3d at 1355 (citing Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999)). The vaccination “must be a
‘substantial factor’” in bringing about the injury, but “it need not be the sole factor
or even the predominant factor.” Id. at 1357 (quoting Shyface, 165 F.3d at 1352-
53).
The United States Court of Appeals for the Federal Circuit has summarized
7
the evidentiary burden associated with causation-in-fact in off-Table cases. The
Federal Circuit explained that a petitioner who wishes to demonstrate that a
vaccination brought about an injury must present:
(1) a medical theory causally connecting the vaccination
and the injury; (2) a logical sequence of cause and effect
showing that the vaccination was the reason for the
injury; and (3) a showing of a proximate temporal
relationship between vaccination and injury.
Althen, 418 F.3d at 1278. These three factors required to prove causation-in-fact in
Vaccine Act cases are now commonly referred to as the three Althen prongs.
As to the evidence related to the three factors, “these [Althen] prongs must
cumulatively show that the vaccination was a ‘but-for’ cause of the harm, rather
than just an insubstantial contributor in, or one among several possible causes of,
the harm.” Pafford, 451 F.3d at 1355. Further, “[a]lthough probative, neither a
mere showing of a proximate temporal relationship between vaccination and
injury, nor a simplistic elimination of other potential causes of the injury suffices,
without more, to meet the burden of showing actual causation.” Althen, 418 F.3d
at 1278 (citing Grant v. Sec’y of Dep’t of Health & Human Servs., 956 F.2d 1144,
1149 (Fed. Cir. 1992)). It is likewise critical to recognize that the special master
may not make a finding of causation that is based on the claims of a petitioner
alone, which are not substantiated by medical records or by medical opinion. See
42 U.S.C. § 300aa-13(a)(1). Thus, the presentation of medical records or medical
opinion supporting a claim is a prerequisite to recovery. Id. Only if a petitioner
presents adequate evidence on the three essential aspects of causation, and thus
makes a prima facie case for liability, does the burden shift to the Secretary to
prove, also by a preponderance of the evidence, an alternate cause of the alleged
injury. Althen, 418 F.3d at 1278; de Bazan, 539 F.3d at 1352 (citations omitted).
When a petitioner seeks to demonstrate causation-in-fact by meeting the three
Althen requirements, each of those requirements must be proven by a
preponderance of the evidence. See de Bazan, 539 F.3d at 1351-52.
III. Causation of S.S.’s Epilepsy and Developmental Delays
A. Petitioner Met Her Burden for Althen Prongs One and Three
8
1. Althen Prong One
Althen Prong One requires that “a claimant’s theory of causation . . . be
supported by a reputable medical or scientific explanation.” Broekelschen v. Sec’y
of Health & Human Servs., 618 F.3d 1339, 1351 (Fed. Cir. 2010) (internal
quotations and citations omitted). Here, petitioner proposed a medical theory
based on Dr. Kinsbourne’s expert reports and his testimony at the hearing. Pet.’s
Post-Hr’g Br. at 18-23. Petitioner also asserted that Dr. MacDonald conceded that
certain key elements of that theory were indeed valid. Id. at 23-24.
Simply put, petitioner’s medical theory rests on the assumption that “the
measles component of the MMR vaccine is essentially the same as the wild virus
that leads to . . . measles.” Id. at 19. According to Dr. Kinsbourne, “it would be
logical to conclude that the measles vaccine, a weakened version of the natural
disease, can cause the same types of symptoms and adverse events as the natural
disease,” including seizures and encephalopathies. Id. In turn, seizures and anti-
seizure medication regimens can cause developmental delays and behavior
problems such as hyperactivity, according to petitioner’s expert. Id. at 21-22.
Thus, the measles component of the MMR vaccine, according to this theory, can
cause epilepsy and subsequent developmental delays, even though a precise
biological mechanism has not been identified.
Based on a preponderance of the evidence, the Chief Special Master found
that petitioner had met her burden under Althen Prong One to establish a
“reputable, reliable and biologically plausible” medical theory of causation for
epilepsy and developmental delays. Dec. at 29-30. The analysis of Althen Prong
One provided in the Chief Special Master’s decision is thorough, logical and
detailed. The court reviews this factual finding with great deference. See, e.g.,
Munn, 970 F.2d at 870. Under the standard of review required here, the Chief
Special Master’s holding as to Althen Prong One must be affirmed.8
8
/ The court notes that the government mounted a vigorous challenge to the medical
theory proposed by Dr. Kinsbourne in the Secretary’s post-hearing brief. Resp.’s Post-Hr’g Br.
at 10-18. Nothing in the record before the court establishes that the Chief Special Master’s
ruling on Althen Prong One was arbitrary or capricious. In its brief opposing petitioner’s motion
for review, the government does not renew its attack against Dr. Kinsbourne’s medical theory or
challenge the Chief Special Master’s finding as to Althen Prong One.
9
2. Althen Prong Three
a. Petitioner Met Her Burden of Proof to Establish a
Proximate, Medically-Acceptable Temporal
Relationship
Althen Prong Three “requires 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-in-fact.” de Bazan,
539 F.3d at 1352. Here, two weeks elapsed between the date of the MMR
vaccination and the onset of S.S.’s seizures. According to petitioner, “two weeks
is an appropriate temporal relationship between the MMR vaccine and a seizure
disorder to occur.” Pet.’s Post-Hr’g Br. at 30. In Dr. Kinsbourne’s first expert
report, he asserted that “[s]eizure onset within two weeks after MMR vaccination is
a well-recognized adverse reaction to this vaccination.” Kinsbourne Report at 2.
As support for this assertion, Dr. Kinsbourne testified that certain medical
articles noted adverse events such as seizures that have occurred in this time-frame
after MMR vaccination. Tr. at 15-16. He also testified that the presence of the
wild measles virus in the blood peaks (peak viremia) during the second week
following exposure. Id. at 25-26, 60-61. Petitioner noted, too, that a five to fifteen
day onset of encephalitis or encephalopathy after MMR vaccination is the time-
frame specified in the Vaccine Injury Table. Pet.’s Post-Hr’g Br. at 31. For all of
these reasons, petitioner asserted that Ms. Dodd had established a “proximate
temporal relationship between the vaccine and the injury” so as to satisfy Althen
Prong Three. Id. at 29.
The Chief Special Master agreed. See Dec. at 32-33 (stating that “petitioner
relied primarily on a proximate temporal relationship which she proved and . . . the
undersigned is persuaded that petitioner has satisfied the . . . third prong[] of the
Althen test”). The Chief Special Master considered the opinion of Dr. Kinsbourne
as to the timing of onset of the alleged vaccine injury and concluded that Ms. Dodd
had proved by a preponderance of the evidence that there was the required
proximate temporal relationship between the MMR vaccination and S.S.’s epilepsy
and developmental delays. See id. at 4, 11-13, 21-22, 24, 32-33. The Chief
Special Master also noted that respondent had not mounted any challenge to
petitioner’s evidence regarding Althen Prong Three. See id. at 28 (“Respondent
does not dispute that petitioner has established a temporal relationship between the
10
administered MMR vaccine and thus, has satisfied the third Althen prong.”). The
court sees no reason, under the deferential standard of review applicable here, to
disturb the Chief Special Master’s finding as to Althen Prong Three.
b. Petitioner Criticizes the Chief Special Master’s
“Failure to Address” the Temporal Relationship
One of petitioner’s four challenges to the Chief Special Master’s denial of
her petition is a critique of the Chief Special Master’s consideration of the
temporal relationship between the MMR vaccination and S.S.’s alleged vaccine
injuries. In petitioner’s view, the Chief Special Master committed reversible error
by not adequately addressing Althen Prong Three, the proximate temporal
relationship prong of the causation analysis. Pet.’s Mot. at 27. It is obvious that
petitioner does not seek to overturn the Chief Special Master’s favorable ruling on
Althen Prong Three; instead, Ms. Dodd appears to attack the weight accorded to
the proximate temporal relationship in the Chief Special Master’s overall causation
analysis.
Perhaps recognizing that her petition depends largely on the proximate
temporal relationship between the MMR vaccination and S.S.’s seizures, Ms. Dodd
has repeatedly emphasized that evidence relevant to one Althen prong can be
applied to the analysis of another Althen prong. See, e.g., Petition at 20 (stating
that “evidence used to satisfy one prong of the test may overlap to satisfy another
prong” (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1326
(Fed. Cir. 2006)); Pet.’s Post-Hr’g Br. at 26 (asserting that Althen Prong Two is
satisfied because, among other reasons, “the symptoms of [S.S.’s] injury occurred
within a medically appropriate time after the MMR vaccine”); Pet.’s Post-Hr’g
Reply at 11 (stating that because petitioner has proven a “scientifically appropriate
temporal relationship between [S.S.’s] MMR vaccine and the onset of his
symptoms [and other elements, she] has satisfied Althen prong 2”); Pet.’s Mot. at
18 (describing the fact “that the onset of symptoms was within an appropriate time
period” as a critical factor in the Althen Prong Two analysis). Petitioner would
have preferred, it appears, that the Chief Special Master had given more weight to
the proximate temporal relationship between the MMR vaccination and the onset
of S.S.’s seizures in her analysis of Althen Prong Two. See Pet.’s Mot. at 18
(asserting that the Chief Special Master “apparently gave no probative value” to
factors such as the proximate temporal relationship between the vaccination and
the alleged injury in her Althen Prong Two analysis), 28 (stating that “the Chief
11
Special Master trivialized the probative significance of . . . an appropriate temporal
relationship between the MMR vaccine and the onset of S.S.’s symptoms”), 29
(alleging that “the existence of an appropriate temporal relationship – not too soon
or too late – is highly probative” for the causation analysis). Although petitioner
concedes that “the existence of a strong
temporal relationship between a vaccine and an injury, by itself, is not proof of
causation,” she apparently disagrees with the significance accorded the proximate
temporal relationship issue by the Chief Special Master in this case. Id. at 29.
Respondent argues that the Chief Special Master afforded adequate attention
to Althen Prong Three, Resp.’s Resp. at 13, and the court must agree. The decision
evinces adequate attention to the chronology of relevant events and to Dr.
Kinsbourne’s arguments regarding the appropriate timing of the onset of symptoms
in this case. See Dec. at 4-6, 11-13, 21-22, 24, 32-33. Petitioner has not cited to
any authority that specifies the degree to which a special master must elaborate
upon the subject of an appropriate temporal relationship when the government has
not contested Althen Prong Three. As for Capizzano, 440 F.3d at 1326, which is
cited by petitioner for the proposition that evidence may overlap between the
Althen prongs, the court finds in that decision no standard which requires a more
exhaustive review of Althen Prong Three and the proximate temporal relationship
issue than that provided by the Chief Special Master in her decision in this case.
Indeed, the Federal Circuit expressly approved a truncated discussion of this prong
when a petitioner had shown a proximate temporal relationship between a
vaccination and an alleged vaccine injury. See Hibbard v. Sec’y of Health &
Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012) (“The special master
acknowledged that the temporal requirement (the third Althen factor) was satisfied
in this case. He therefore had no need to discuss that factor in any detail.”). For
these reasons, the court must reject this particular challenge to the Chief Special
Master’s ruling on entitlement.
B. Althen Prong Two
The court now addresses two separate but intertwined challenges to the
Chief Special Master’s ruling on Althen Prong Two, i.e., that the petitioner failed
to provide “a logical sequence of cause and effect showing that the vaccination was
the reason for the injury.” 418 F.3d at 1278. First, petitioner argues that the new
onset seizures on October 15, 2007 were severe enough to lower S.S.’s seizure
threshold, giving rise to more severe seizures on December 9, 2007, and that the
12
Chief Special Master’s holding to the contrary, in light of “overwhelming”
evidence, was arbitrary, capricious, an abuse of discretion and contrary to law.
Pet.’s Mot. at 15, 23. Second, petitioner attacks the Chief Special Master’s
conclusion that “‘[o]ther than [the] temporal relationship, there is nothing to
suggest that the seizures S.S. suffered on October 15, 2007[] were caused by the
measles vaccine.’” Id. at 23 (quoting Dec. at 32). This conclusion, according to
petitioner, is illogical in the face of the evidence relevant to Althen Prong Two that
should have been weighed differently by the Chief Special Master. Id. at 26-27.
1. Ruling Regarding the Alleged Lowering of S.S.’s Seizure
Threshold
a. The Chief Special Master’s Finding of Fact
Several portions of the Chief Special Master’s decision address petitioner’s
contention that the October 15, 2007 seizures lowered S.S.’s seizure threshold and
made him more susceptible to the severe seizures he experienced on December 9,
2007.9 First, the Chief Special Master summarized the divergent views of the
experts on this topic. Dr. Kinsbourne, for example, described the new onset
seizures as brief and less serious than those that followed in December of that year.
Dec. at 14-15 (citing Tr. at 22-23, 37). Dr. Kinsbourne nonetheless insisted that
during the October 15, 2007 episode S.S. was in an acute and abnormal
neurological state, a condition which caused lasting damage and which lowered
S.S.’s seizure threshold. Id. at 21 (citing Ex. 20 at 1; Tr. at 65-66, 83-84).
Dr. MacDonald, on the other hand, relied on his current clinical experience
and his understanding of relevant literature to testify that the brief seizures
experienced on October 15, 2007 did not lower S.S.’s seizure threshold, trigger an
acute encephalopathy, cause encephalitis, or result in lasting brain damage. Dec. at
16-18 (citing Tr. at 95-96, 99, 134). Dr. MacDonald noted that the medical records
of this event showed no signs that S.S. experienced anything more than a transient
episode of brief seizures. Id. Although Dr. MacDonald conceded that repetitive
9
/ The court notes that neither petitioner’s post-hearing brief nor petitioner’s post-hearing
reply brief contained any mention of Dr. Kinsbourne’s testimony or opinion that the October 15,
2007 seizures lowered S.S.’s seizure threshold. It is somewhat incongruous that petitioner now
seeks review of the Chief Special Master’s finding of fact regarding an aspect of petitioner’s
case that was presented only indirectly for her consideration.
13
seizures may lower a patient’s seizure threshold, he saw no evidence that S.S.
experienced seizure activity of such a damaging nature on October 15-16, 2007.
Id. at 18 (citing Tr. at 117-18, 134).
The Chief Special Master agreed with the clinical assessment of Dr.
MacDonald and rejected Dr. Kinsbourne’s assertion that S.S.’s seizure threshold
was lowered by the October 15, 2007 seizures. Dec. at 32 (citing Tr. at 113). She
relied on concessions made by Dr. Kinsbourne on cross-examination and on the
testimony of Dr. MacDonald. Id. at 31-32. In addition, the Chief Special Master
stated that Dr. Kinsbourne used circular logic to demonstrate that S.S.’s seizure
threshold was lowered, and that his circular logic was unconvincing. See id. at 22
(“In support of his assertion that the seizures S.S. experienced on October 15,
2007[] led to a lowering of his seizure threshold and caused him to suffer seizure
events on December 9, 2007 (and thereafter), Dr. Kinsbourne relies heavily on the
fact that the later seizures occurred.” (citing Tr. at 83-84)).
The Chief Special Master also discussed the sole medical article (Holmes
article) relevant to this issue that was proffered by petitioner and that was
discussed by the experts during the hearing.10 Dec. at 27-28. She quoted various
statements in the Holmes article that were relevant to the question of whether
S.S.’s seizure threshold could have been lowered by the October 15, 2007 seizures.
Id. at 27. Her analysis of the Holmes article, and of Dr. MacDonald’s testimony
regarding its content, is more thorough than the brief discussion of this article
presented in Dr. Kinsbourne’s report. Compare Dec. at 27-28, with Ex. 18 at 4. In
her pre-hearing submissions, petitioner neglected to explain the significance of the
Holmes article, see Pet.’s February 28, 2011 Response to January 18, 2011 Order,
10
/ Dr. Kinsbourne did not address any specific statements in this article during the
hearing, or reference the article by title or author’s name, but may have alluded to the Holmes
article obliquely in this statement: “And from any number of studies, scientific studies,
including animal models, would show that seizures are capable of lowering seizure thresholds,
which is how many epilepsies get set up.” Tr. at 84. Dr. MacDonald was extensively cross-
examined about the Holmes article. Id. at 115-22. Petitioner’s counsel also cross-examined Dr.
MacDonald about an article (Crino article) that he had attached to his expert report that might
have had some tangential relevance to Dr. Kinsbourne’s lowered seizure threshold hypothesis.
Id. at 113-15. The Chief Special Master did not discuss the Crino article, as this article was not
one of those primarily relied upon by the parties. See Dec. at 22 n.23 (“The parties submitted a
total of 17 articles and studies; only those articles on which the parties appeared to rely most
heavily are discussed in detail . . . .”).
14
at 4 n.4., and in her post-hearing briefing, petitioner failed to cite any testimony
from Dr. Kinsbourne on the general topic of the lowering of seizure thresholds and
failed to cite the Holmes article for any purpose. The Chief Special Master
concluded that the Holmes article, and other articles proffered by petitioner,
provided “little or no evidentiary support for [petitioner’s] theory of causation as
applied to S.S.’s circumstances.” Dec. at 28.
The Chief Special Master therefore made the following finding of fact:
Dr. Kinsbourne admitted that the seizure event S.S.
experienced on October 15, 2007[] consisted of several
“staring spells, each lasting for less than a minute” and a
seizure that lasted a few minutes. Tr. at 37. Moreover,
Dr. Kinsbourne acknowledged that S.S. was “behaving
normally and had no neurological symptoms the day after
his hospital admission, and that this EEG was consistent
with a postictal state and showed no evidence of seizure
activity or brain damage. Tr. at 37-39, 41-42. As Dr.
M[a]cDonald testified, and the undersigned similarly
finds, S.S.’s brief seizure and staring spells on October
15, 2007[] were not of the prolonged and repetitive
nature needed to lower S.S.’s seizure threshold. Tr. at
113.
Id. at 31-32.
b. The Parties’ Arguments Regarding the Chief Special
Master’s Finding of Fact
Petitioner’s first contention is that the Chief Special Master
“mischaracteriz[ed]” and “minimize[d]” the severity of the October 15, 2007
seizures experienced by S.S. Pet.’s Mot. at 18, 21. Citing various portions of the
record, petitioner asserts that the “seizure period . . . extend[ed] over 3 hours.” Id.
at 19-20. Petitioner also cites to Dr. Kinsbourne’s testimony, the Holmes article,
the Sutula article (not discussed during the hearing), and certain alleged
“concessions” of Dr. MacDonald. Id. at 21-23. Describing this cited evidence as
“overwhelming,” Ms. Dodd asserts that the Chief Special Master’s finding that the
October 15, 2007 seizures did not lower S.S.’s seizure threshold cannot withstand
15
review.
Respondent counters that there was ample evidence in the record to support
the Chief Special Master’s finding of fact regarding the duration of the October 15,
2007 seizures and the improbability that these new onset seizures lowered S.S.’s
seizure threshold. Resp.’s Resp. at 10-11. The government notes, in particular,
that there is no real dispute as to the events of October 15, 2007 and the brief
duration of each seizure experienced by S.S. that evening. Id. at 11-12.
Respondent also notes that the Sutula article was not discussed by either expert
during the hearing, and that the Holmes article was not discussed by Dr.
Kinsbourne at the hearing; for these reasons respondent argues that petitioner has
no reason to complain that the Chief Special Master agreed with Dr. MacDonald,
the only expert who testified about specific statements in the relevant scientific
literature in the record. Id. at 12. Finally, the government argues, the so-called
“concessions” of Dr. MacDonald are better described as testimony taken out of
context. Id.
The issue of the Chief Special Master allegedly ignoring Dr. MacDonald’s
alleged concessions, Pet.’s Mot. at 23, is quickly resolved. The court agrees with
respondent that “Dr. MacDonald was unequivocal in his testimony that S.S.’s brief
seizures on October 15, 2007[] were not sufficient to lower his seizure threshold.”
Resp.’s Resp. at 12. Dr. MacDonald’s testimony was accurately summarized by
the Chief Special Master in this regard. Dec. at 32 (citing Tr. at 113). The alleged
“concessions” of Dr. MacDonald cited by petitioner concern his testimony that
seizures can, in some instances, lower seizure thresholds, and that S.S.’s October
15, 2007 and December 9, 2007 seizure episodes might have been related. Tr. at
110-12. The Chief Special Master’s decision adequately takes this testimony into
account in her analysis of Althen Prong Two. Dec. at 27, 31-32.
c. The Chief Special Master’s Finding of Fact Survives
Review
The Chief Special Master thoroughly analyzed petitioner’s causation
arguments as they could be applied to S.S.’s alleged injury, as well as the evidence
of record. At one point, she described Dr. Kinsbourne’s theory of causation as
“cobbled” together. Dec. at 22. At another point, she described the evidentiary
record as “not close” to meeting petitioner’s burden regarding Althen Prong Two.
Id. at 33. Here, as to whether the October 15, 2007 seizures experienced by S.S.
16
lowered his seizure threshold, the court finds nothing in petitioner’s motion for
review, or in the underlying record in this case, to disturb the Chief Special
Master’s finding of fact. The court defers, as it must, to the Chief Special Master’s
rational weighing of the evidence. E.g., Munn, 970 F.2d at 870. It was not, on
this record, arbitrary or capricious to find that “S.S.’s brief seizure and staring
spells on October 15, 2007[] were not of the prolonged and repetitive nature
needed to lower S.S.’s seizure threshold.” Dec. at 32.
Finally, tucked away in a footnote at the end of the argument section of her
brief devoted to petitioner’s challenge to this aspect of the Chief Special Master’s
decision, Ms. Dodd contends that the Chief Special Master inappropriately
required petitioner to “prove the precise mechanism of [S.S.’s] injury, [and thus]
elevated [her] proof requirement and violated established Federal Circuit
precedent.” Pet.’s Mot. at 23 n.14 (citing Knudsen by Knudsen v. Sec’y of Dep’t of
Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)). Petitioner’s argument
fails because the Chief Special Master did not deny the petition based on
petitioner’s failure to identify a precise mechanism of causation.11 Instead, the
Chief Special Master tested the proposed mechanism of causation identified by
petitioner’s expert and found that the proposed mechanism, as applied to the facts
of S.S.’s seizures on October 15, 2007 and December 9, 2007, failed to provide a
logical sequence of cause and effect. See Dec. at 31 & n.28 (holding that “the
theory advanced by Dr. Kinsbourne is not supported by the facts of this case . . .
[because] the evidence of record is insufficient to show” a lowering of S.S.’s
seizure threshold). The court finds that the Chief Special Master neither
impermissibly heightened petitioner’s burden of proof nor violated established
Federal Circuit precedent. See, e.g., Hibbard, 698 F.3d at 1364 & n.2 (noting that
a failure to substantiate a critical step in the logical sequence of cause and effect
proposed by the petitioner’s expert is equivalent to a failure to prove Althen Prong
Two by a preponderance of the evidence); Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1324 (Fed. Cir. 2010) (rejecting a “proposed mechanism” of
causation because the petitioner’s expert “conceded that there was no evidence in
the record suggesting that the proposed mechanism was at work in [that] case”).
11
/ Indeed, the Chief Special Master cited Knudsen for the rule of law relied upon by
petitioner for her argument. See Dec. at 30 (citing Knudsen, 35 F.3d at 549). This binding
precedent holds that “to require identification and proof of specific biological mechanisms [of
causation] would be inconsistent with the purpose and nature of the vaccine compensation
program.” Knudsen, 35 F.3d at 549.
17
Ms. Dodd has shown no error of law in the Chief Special Master’s analysis of
Althen Prong Two in this case.
2. Ruling Regarding a Logical Sequence of Cause and Effect
Linking the Alleged Injury to the MMR Vaccination
a. The Chief Special Master’s Finding of Fact
The court now turns to another link in the logical sequence of the cause and
effect argument proffered by petitioner, i.e., the proposition that the measles
vaccine caused S.S.’s October 15, 2007 new onset seizures. The Chief Special
Master conducted a painstaking review of the record and engaged in a thorough
analysis of the parties’ arguments in this regard. Her decision on entitlement
includes a detailed chronology of relevant events, including a discussion of S.S.’s
childhood illnesses, his vaccinations on October 1, 2007, his symptoms a week
later, his symptoms on October 15-16, 2007, and medical records pertinent to the
onset of seizures and subsequent treatment. Dec. at 5-10 & nn.6-7, 10-11. The
opinion of each expert as to a causal link between the vaccination and alleged
injury is explained in detail, and the differences in expert opinions are presented in
an objective, balanced, and well-organized analysis. Id. at 11-18. The Chief
Special Master correctly cites the governing law regarding petitioner’s burden of
proof on causation and applies this precedent to the facts in the record.
In her decision, the Chief Special Master correctly concludes that the logical
sequence of cause and effect asserted by petitioner depends on two critical links:
first, the measles vaccine caused the October 15, 2007 seizures; second, the
October 15, 2007 seizures lowered S.S.’s seizure threshold which led to his
epilepsy and developmental delays, as discussed supra. Dec. at 21-22, 31-32. In
addition to medical records, expert reports and expert testimony, the Chief Special
Master reviewed the medical literature most heavily relied upon by the parties. Id.
at 22-27. These articles, for the most part, provide little support for the causation
theory presented by Ms. Dodd, because, in the words of the Chief Special Master,
“the literature petitioner filed does not pertain to the factual circumstances of S.S.’s
case.” Id. at 28.
The court will not reproduce every finding relevant to this controversy, but
provides here the most persuasive and determinative findings of the Chief Special
Master in that regard. “S.S.’s treating physicians did not know the cause of S.S.’s
18
epilepsy.” Dec. at 31 (citing Ex. 14 at 17). Additionally, an alternative
explanation for S.S.’s epilepsy was a “likely genetic predisposition to have a
seizure condition” because of a family history of epilepsy.12 Id. at 32. Much of the
evidence of a causal link between the measles vaccine and seizures in the literature
relied upon by petitioner was specific to seizures accompanied by fever, not
afebrile seizures, as was the case here. Id. at 24, 27-28, 32. Furthermore, Dr.
Kinsbourne’s theory of causation relied upon a connection between peak viremia
and seizures, although the typical symptoms of peak viremia were not present at
the time of S.S.’s new onset seizures. Id. at 22, 32.
Based on these findings, and others related to the literature relied upon by
the parties, the Chief Special Master concluded that although “the measles vaccine
can cause seizures in rare circumstances involving fever o[r] gastrointestinal illness
. . . , petitioner has failed to prove, and the evidence of record is insufficient to
show, that [such an] event occurred in this case.” Dec. at 31. The Chief Special
Master summarized her analysis by stating that “[o]ther than the temporal
relationship, there is nothing to suggest that the seizures S.S. suffered on October
15, 2007[] were caused by the measles vaccine.” Id. at 32. According to the Chief
Special Master, a proximate temporal relationship and a “dubious claim that no
other potential cause for S.S.’s injuries existed” are not sufficient to meet Ms.
Dodd’s burden to show a logical causal sequence so as to satisfy Althen Prong
Two. Id. at 32-33.
b. The Parties’ Arguments Regarding the Chief Special
Master’s Finding of Fact
As a threshold issue, the court must identify the type of attack petitioner has
mounted against the Chief Special Master’s finding of fact on causation. Although
petitioner’s argument as a whole must properly be characterized as an assertion
that the Chief Special Master’s finding of fact was arbitrary and capricious, see
Pet.’s Mot. at 27 (asserting that the ruling on causation was “illogical”), Ms. Dodd
also asserts that “[t]he Chief Special Master abused her discretion by ignoring
relevant evidence,” id. Petitioner has failed, however, to identify a specific
discretionary ruling of the Chief Special Master, evidentiary or otherwise, which
12
/ Dr. MacDonald opined, both in his expert report and at the hearing, that it was more
likely than not that S.S.’s epilepsy had a genetic basis, not a vaccine-related cause. See Ex. A at
4; Tr. at 101-04, 134.
19
this court could review for abuse of discretion. See, e.g., Munn, 970 F.2d at 870
n.10 (stating that “discretionary rulings [are reviewed] under the abuse of
discretion standard . . . [and this standard] will rarely come into play”).
Having determined that the arbitrary and capricious standard, not the abuse
of discretion standard, applies here, the court notes, at the outset, that any
invitation to re-weigh the evidence is improper:
Clearly it is not then the role of this court to reweigh the
factual evidence, or to assess whether the special master
correctly evaluated the evidence. And of course we do
not examine the probative value of the evidence or the
credibility of the witnesses. These are all matters within
the purview of the fact finder.
Id. at 871. Regrettably, petitioner’s challenge to the Chief Special Master’s fact
finding is indeed a fruitless invitation to this court to re-weigh the evidence
evaluated by the Chief Special Master. Ms. Dodd’s challenge to the Chief Special
Master’s analysis of the link between the MMR vaccination and S.S.’s new onset
seizures offers a catalog of the evidence that, in Ms. Dodd’s view, compels a ruling
in petitioner’s favor.
First, Ms. Dodd emphasizes the “highly probative” nature of the proximate
temporal relationship between S.S.’s MMR vaccination and his new onset seizures,
and cites to testimony of Dr. Kinsbourne in this regard. Pet.’s Mot. at 24-25.
Second, she references the medical literature relied upon by Dr. Kinsbourne as
support for his testimony that the measles vaccine caused S.S.’s October 15, 2007
seizures. Id. at 25-26 (citing Tr. at 15-17, Exs. 18-A, 18-D at 1461, 18-I). Third,
petitioner asserts that the record shows the “absence of an alternative cause” for
S.S.’s seizures. Id. at 26-27. She concludes her invitation to re-weigh the evidence
with a list of the evidence that the Chief Special Master is alleged to have ignored
or evaluated illogically:
[S.S.’s] medical records, the strong temporal relationship
between the vaccine and the symptoms, the absence of an
alternative cause, the medical theory provided by
Dr. Kinsbourne, the scientific literature upon which Dr.
Kinsbourne relies, [and] the concessions made by Dr.
20
MacDonald all demonstrate that it is logical to conclude
that the MMR vaccine caused S.S.’s epilepsy and
developmental delays.
Id. at 27.
Respondent argues that the Chief Special Master’s rulings on causation are
not arbitrary or capricious:
In her Decision, the Chief Special Master properly and
thoroughly considered the record evidence as a whole,
and correctly found that petitioner failed to satisfy her
burden of proving that the measles-mumps-rubella
(“MMR”) vaccine caused her son S.S. to suffer epilepsy,
developmental delay and hyperactivity.
Resp.’s Resp. at 1-2. Respondent asserts, further, that the motion for review
“amounts to nothing more than a disagreement with the Chief Special Master’s
well-supported factual findings.” Id. at 2. The governments notes, in particular,
that Dr. Kinsbourne did not establish that S.S.’s seizures were accompanied by
fever, and did not address the issue of whether or not S.S. was experiencing
gastrointestinal illness at the time of his new onset seizures; thus, Dr. Kinsbourne’s
theory of causation, which relied in part on studies of febrile seizures or seizures
that accompanied gastrointestinal illness, was not persuasive. Id. at 9-10.
Respondent also notes that no treating physician opined that S.S.’s epilepsy or
developmental delays were caused by the measles vaccine. Id. at 11. Thus, in
respondent’s view, the evidentiary record fully supports the Chief Special Master’s
finding of fact on causation.
c. The Chief Special Master’s Finding of Fact Survives
Review
The court has considered the parties’ arguments, the evidence of record and
the thorough evaluation of that evidence that is set forth in the Chief Special
Master’s decision on entitlement. The court finds that the Chief Special Master
“considered the relevant evidence of record, dr[ew] plausible inferences and
articulated a rational basis for [her] decision.” Hines, 940 F.2d at 1528. She
neither ignored relevant evidence nor arrived at illogical conclusions. There is no
21
reversible error in her conclusion that
petitioner has failed to establish a logical sequence of
cause and effect–consistent with her proposed
theory–proving that the measles vaccine S.S. received on
October 1, 2007 did cause his injuries. Thus, petitioner
has failed to satisfy the second prong of the Althen test.
Dec. at 32. Under the deferential standard applicable here, the Chief Special
Master’s ruling on causation is unassailable. Specifically, her analysis with respect
to the second prong of the Althen test demonstrates that the Chief Special Master’s
ruling was neither arbitrary or capricious.
First, the court must agree with respondent that the Chief Special Master
undertook a “thorough evaluation of the medical literature submitted by the
parties.” Resp.’s Resp. at 10. Her analysis of these articles was the foundation for
her reasonable conclusion that while the theory advanced by Dr. Kinsbourne might
support vaccine injury causation in other cases, that theory, and the medical
literature underpinning that theory, did not fit the facts of the onset of S.S.’s
epilepsy. Dec. at 31 & n.28 (citing Hibbard, 698 F.3d at 1362-63). In other
words, the medical literature cited by petitioner did not provide the Chief Special
Master with enough evidentiary support to carry petitioner’s burden on Althen
Prong Two. Id. at 28. The court sees no flaw in this aspect of the Chief Special
Master’s ruling.
Second, the Chief Special Master corrected a misreading of S.S.’s medical
records that was presented in petitioner’s arguments regarding Althen Prong Two.
Petitioner had consistently maintained that S.S.’s treating physicians had observed
a causal connection between his vaccinations and his epilepsy. See, e.g., Pet.’s
Post-Hr’g Br. at 27 (“[S.S.] submits that his treating physicians also associated his
MMR vaccine with his injuries, and provide supporting evidence of causation in
his case.”). The record does not support this contention, and the Chief Special
Master accurately noted that no such causal hypothesis by S.S.’s treating
physicians can be found in his medical records. Dec. at 31. This finding, too, is
sound.
Third, and perhaps most importantly, the Chief Special Master found Dr.
Kinsbourne’s opinion regarding the causation of S.S.’s alleged vaccine injuries to
22
be less than persuasive. She found his causation arguments to lack coherence, to
employ circular logic, and, in the end, to be unsound. Dec. at 21-22. His theory of
causation failed to persuade, at least in part, because of a lack of consistency
between the biological mechanisms he described and the actual onset of S.S.’s
epilepsy. Id. at 31-32. The court defers to the Chief Special Master’s weighing of
the opinion of Dr. Kinsbourne, Munn, 970 F.2d at 870, and finds no error in this or
any other aspect of her ruling regarding Althen Prong Two.
C. Evidence of Alternative Causation
Finally, Ms. Dodd argues that the “Chief Special Master’s determination that
S.S. had ‘a likely genetic predisposition to have a seizure condition’ because
‘S.S. had a maternal great aunt with epilepsy’ is arbitrary, capricious, and not in
accordance with law.” Pet.’s Mot. at 29 (capitalization altered). This challenge to
the ruling on entitlement can be divided into two sub-parts. First, indulging in the
assumption that petitioner has proven her prima facie case of causation, Ms. Dodd
argues that the evidentiary record is insufficient to meet respondent’s burden to
prove alternative causation. See id. at 29 (“Having demonstrated that the petitioner
satisfied the Althen prongs, the burden shifted to the respondent to show S.S.’s
MMR vaccine is unrelated to his seizure disorder and developmental delays.”), 31
(“The respondent clearly failed to prove that an alternative cause of S.S.’s injury
existed.”). Here, however, the Chief Special Master found that petitioner did not
meet her burden to establish a prima facie case of causation, a finding that has been
affirmed by this court, see supra; thus, the burden to prove alternative causation
has not shifted to respondent. E.g., Doe 11 v. Sec’y of Health & Human Servs.,
601 F.3d 1349, 1358 (Fed. Cir. 2010) (citations omitted). Any speculation of
petitioner as to whether on this record the government has proved alternative
causation for S.S.’s epilepsy and developmental delays is irrelevant.
Second, petitioner argues that the Chief Special Master’s evaluation of the
evidence of alternative causation is arbitrary and capricious. See Pet.’s Mot. at 30
(“[T]here is no explained, known, or documented evidence in the record indicating
that S.S. has an underlying genetic disorder that caused his epilepsy.”) (emphasis
removed); 32 (“A thorough review of the evidence in S.S.’s case clearly
demonstrates the [ab]sence of any explained, known, or documented evidence in
the record indicating an alternative cause to S.S.’s seizure disorder and subsequent
developmental delays.”). The court must disagree. A family history of epilepsy
was documented in S.S.’s medical records. See supra note 6. Dr. MacDonald
23
testified that it was his opinion that a genetic disorder was the most likely cause for
S.S.’s seizure disorder and developmental delays. Tr. at 134; see also Ex. A at 4
(opining in his expert report that S.S.’s seizure disorder had a genetic basis). The
Chief Special Master’s consideration of this evidence has not been shown to be
arbitrary or capricious. She “considered the relevant evidence of record [and]
dr[ew] plausible inferences.” Hines, 940 F.2d at 1528.
It is important to note that petitioner, attempting to establish a logical
sequence of cause and effect in order to satisfy Althen Prong Two, relied to a great
extent on a proximate temporal relationship between the MMR vaccination and
S.S.’s new onset seizures, as well as an alleged absence of alternative causes.
Pet.’s Post-Hr’g Br. at 26-29; Pet.’s Post-Hr’g Reply at 9-11. It was therefore
within the Chief Special Master’s purview to review evidence regarding alternative
causation:
As this court explained in Walther, when petitioners
attempt to eliminate other possible causes to buttress
their theory of causation, the special master should
evaluate such evidence in determining whether a prima
facie case has been established.
Doe 11, 601 F.3d at 1358 (citing Walther v. Sec’y of Health & Human Servs., 485
F.3d 1146, 1151 (Fed. Cir. 2007) and Pafford, 451 F.3d at 1359). Here, although
there was limited evidence of alternative causation, the Chief Special Master
rationally concluded that this evidence weakened petitioner’s causation arguments.
Furthermore, there is no indication that the Chief Special Master
impermissibly required petitioner to eliminate alternative causes. See Dec. at 32
(“‘[T]he Vaccine Act does not require [a] petitioner to bear the burden of
eliminating alternative causes where the other evidence on causation is sufficient to
establish a prima facie case[.]’” (quoting Walther, 485 F.3d at 1150)). Nor is there
any sign that the Chief Special Master violated restrictions on the type of evidence
that may be considered in the alternative causation inquiry. See Doe 11, 601 F.3d
at 1358 (noting that a special master may make findings on any evidence which
bears directly on the issue of causation (citing de Bazan, 539 F.3d at 1354)). The
court sees no error of law in the Chief Special Master’s consideration of evidence
of alternative causation. Applying the deferential arbitrary and capricious standard
of review to the fact finding of a special master, this court affirms the Chief Special
Master’s findings on alternative causation and rejects petitioner’s final challenge to
24
the ruling denying entitlement.
CONCLUSION
For all of the above reasons, the court holds that the Chief Special Master’s
decision in this case was not arbitrary, capricious, an abuse of discretion, or
otherwise not in accordance with law.
Accordingly, it is hereby ORDERED that
(1) Petitioner’s Motion for Review, filed on July 5, 2013, is DENIED;
(2) The decision of the Chief Special Master, filed on June 5, 2013, is
SUSTAINED;
(3) The Clerk’s Office is directed to ENTER final judgment dismissing
the petition; and,
(4) The parties shall separately FILE any proposed redactions to this
opinion, with the text to be redacted clearly marked out and enclosed
in brackets, on or before December 13, 2013.
/s/ Lynn J. Bush
LYNN J. BUSH
Senior Judge
25