RlG\NAL REISSUED FOR PUBLICATION
NOV 14 2017
OSM
U.S. COURT OF FEDERAL CLAIMS
Jfn tbe Wniteb ~tates ~ourt of jfeberal ~lfr:ttl•l?.. E D
OFFICE OF SPECIAL MASTERS
No. 16-1478V SEP 18 2017
(to be published) OSM
U.S. COURT OF
FEDERAL CLAIMS
* * *** ** **** ** **** *** ** ** *
PHILIP NGO, as father and legal guardian *
of A.N., a minor, * Special Master Corcoran
*
Pe ti ti oner, * Filed: September 18, 20 17
*
v. * Decision Without Hearing;
* Dismissal; Measles-Mumps
SECRETARY OF HEALTH * Rubella ("MMR") Vaccine;
AND HUMAN SERVICES, * Autism Spectrum Disorder ("ASD").
*
Respondent. *
*
** *** ** **** ** ** *** ** ** ** *
Philip Ngo, pro se, Portland, OR, for Petitioner.
Linda Renzi, U.S. Dep' t of Justice, Washington, DC, for Respondent.
DECISION DISMISSING CASE 1
On November 9, 2016, Philip Ngo, on behalf of his daughter, A.N., filed a petition
seeking compensation under the National Vaccine Injury Compensation Program (the "Vaccine
Program").2 In it, Petitioner alleged that the measles-mumps-rubella ("MMR") vaccine A.N.
received on November 18, 2013, caused her to develop an autism spectrum disorder ("ASD").
Petition at 1.
1
This Decision will be posted on the Court of Federal Claims's website in accordance with the E-Govemment Act
of 2002, 44 U.S.C. § 350 1 (2012). T his m eans the decision will be ava ilable to anyone with access to th e
internet. As provided by 42 U.S.C. § 300aa- J2(d)(4)(8), however, the parties may object to the decision 's inclus ion
of certain kinds of confidential information. Specifica ll y, under Vaccine Ru le J8(b), each party has fourtee n days
within which to request redaction "of any informati on furni shed by that party: ( I) that is a trade secret or
commercial or financial in substance and is privileged or confidential; or (2) that includes medical fi les or similar
files, the disclosure of which would constitute a clearly unwarranted in vasion of pri vacy." Vaccine Rule l 8(b).
Otherwi se, the Decision in its present form wi ll be avai lable. Id.
2The Vaccine Program comprises Part 2 of the National Chi ldhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
JOO Stat. 3758, codified as a mended, 42 U.S.C. §§ 300aa-I O through 34 (2012) [hereinafter "Vaccine Act" or " the
Act"]. Individual section references hereafter will be to § 300aa of the Act.
After some of the medical records were filed , Respondent filed his Rule 4(c) Report. See
Respondent' s Rule 4(c) Report, filed on June 7, 2017 (ECF No. 18) ("Rule 4"). Shortly
thereafter, I issued an order directing Petitioner to show cause why his case should not be
dismissed based on its factual similarity to other unsuccessful autism claims. See Order to Show
Cause, dated June 28, 2017 (ECF No. 20) ("OSC"). Petitioner filed a letter on August I 0, 2017
attempting to support his claim. See Letter, filed Aug. 10, 2017 (ECF No. 22). Respondent has
not filed a brief in reaction.
I. FACTUAL BACKGROUND
There have been less than one hundred pages of medical records filed in this case, despite
my allowing Petitioner nearly six months to perform record collection. 3 The records filed include
A.N. 's vaccination record, lab results from a few months post-vaccination, and records for
treatment and evaluations A.N. received a year or more after vaccination.
A.N. was born on November 7, 2012, but no birth or pregnancy records were ever filed,
making it difficult to determine if A.N. (or her mother) had any health compl ications.
Petitioner' s Medical Records I at 5 ("MRI "). Later doctor's visits elicited statements from
Petitioner indicating that although A.N. ' s mother was 40 years old, it was an uncomplicated
pregnancy and delivery. MRI at 2. In her first few months of life, A.N. was described as healthy
without any major illnesses, and she began crawling at four months and babbling at 3 months of
age. Id.
Presumably at her one year well-child exam, on November 18, 20 13, A.N. received her
hepatitis A and MMR vaccines. MRI at 29, 33. There has been no record evidence or reports
submitted that A.N. had an immediate reaction after her vaccines. Rather, it appears that
Petitioner first became concerned about A.N. between 16-18 months of age (four to six months
after vaccination), when he reported her babbling had reduced. Id. at 29.
A.N. was first evaluated for autism on April 17, 2015, at Oregon Health and Science
University ("OHSU"), when she was two years and five months old. It appears, however, that
prior to this evaluation, A.N. was seen at Sellwood Family Medicine several times during
2014-beginning in May 201 4, six months after vaccination. Petitioner' s Medical Records 2 at
54-57 ("MR2"). There is no information about what was discussed at this visit, but a patient plan
3 The original statement of completion deadline in this case was February 8, 2017. Initial Order, dated Nov. 11, 20 16
(ECF No. 4). On February 2, 2017, Petitioner filed 59 pages of medical records, however, followed shortly by a
status report filed by Respondent identifying outstanding records that needed to be filed . See Status Report, filed on
Feb. 8, 2017 . Petitioner later filed additional documents, but those documents were invoices for treatment rather
than treatment records. See Medical Records, dated April 13, 20 17.
2
was filed, which seems to indicate that A.N. was prescribed a new vitamin supplement regimen,
and Petitioner was instructed on dietary modification to attempt to treat A.N. 's condition. 4 Id.
The notes from A.N. ' s first evaluation for Autism at OHSU reveal that she was referred
there by her primary health provider, John Njenga, PA, based on his concerns that A.N. was
exhibiting autism symptoms. MRI at 5. Dr. Lark Huang-Storms, PhD, was the psychologist that
evaluated AN. Id. at 4. In recording AN. 's medical history, Dr. Huang-Storms noted that A.N.
had not experienced any significant health issues as a child, except at 18 months old, when her
father reported that she fell and hit her head on the floor. Id. at 5. Regarding A.N.'s
developmental progression, Dr. Huang-Storms recorded the concerns of Petitioner about AN.
stopping babbling, her late ability to walk and toe-walking when she did begin walking, and that
A.N. could not use words or make spontaneous gestures. Id. at 5-6. The conclusions of this visit
were that A .N. was showing "significant symptoms of an Autism Spectrum Disorder
(ASD) . . . repetitive behaviors (e.g. toe-walking, hand twisting/clapping), restricted interests (e.g.,
particular toys), limited joint attention, and does not use words or babble (most of her sound are
made with a closed mouth)." Id. at 10.
A.N. has subsequently been evaluated by other providers who have similarly noted that
AN. shows significant symptoms of autism, and requires educational and therapeutic treatments.
MRI at 2-10, 23.
II. PARTIES' RESPECTIVE ARGUMENTS
Petitioner alleges that A.N. suffers from autism as a result of her receipt of the MMR
vaccine in November 2013. Petition at 1. As stated previously, due to the large number of
unsuccessful autism cases over the past ten year in the Vaccine Program, I ordered Petitioner to
offer further support for his claim, or risk its dismissal. OSC at 1-2. Specifically, I instructed
Petitioner to focus on distinguishing the facts of his case from those previously-dismissed autism
cases. Id. at 2.
Petitioner attempted to do so in a letter, arguing a theory that the Centers for Disease
Control ("CDC") had evidence (suppressed by the U.S. Government) that showed that the MMR
vaccine has been linked to children developing autism. See Letter at 1. The short, two-page letter
did not, however, address A.N. ' s specific reaction, nor it did it contrast her condition from the
other factual scenarios previously rejected by the Program.
Respondent chose not to file a brief reacting to the letter. In his Rule 4 (c) Report
however, he stated that the case should be dismissed because no evidence of causation had been
produced by Petitioner linking the MMR vaccine to A.N.'s condition. Rule 4 (c) Report at 5.
4
Based on invoices, it appears that A.N. also began applied behavior analysis therapy after these visits. MR2 at 12.
3
In add ition to the letter filed by Petitioner, the only causal evidence that has been
presented was a two page statement written by Petitioner citing to studies which purport to link
autism to vaccines. MRI at l-2.
IV. APPLICABLE LEGAL STANDARDS
A. Claimant's Burden in Vaccine Program Cases
To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a "'Table Injury" - i.e., an injury fal ling within the Vaccine Injury Table -
corresponding to one of the vaccinations in question within a statutorily prescribed period of
time or, in the alternative, (2) that hi s illnesses were actuall y caused by a vaccine (a "Non-Table
Injury"). See Sections 13(a)( l )(A), ll(c)(l ), and 14(a), as amended by 42 C.F.R. § 100.3; §
l l (c)( l )(C)(ii)(l); see also Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1321
(Fed. C ir. 2010); Capizzano v. Sec'y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed . Cir.
2006). 5 Here, Petitioner alleges only a non-table injury.
For both Table and Non-Table claims, Vaccine Program petlt10ners bear a
"preponderance of the evidence" burden of proof. Section 13( 1)(a). That is, a petitioner must
offer evidence that leads the "trier of fact to believe that the existence of a fact is more probable
than its nonexistence before [he] may find in favor of the party who has the burden to persuade
the judge of the fact's existence." Moberly, 592 F.3d at 1322 n.2; see also Snowbank Enter. v.
United States, 6 Cl. Ct. 476, 486 ( 1984) (mere conjecture or speculation is insufficient under a
preponderance standard). Proof of medical certainty is not required. Bunting v. Sec'y of Health &
Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In particular, a petitioner must demonstrate
that the vaccine was " not on ly [the] but-for cause of the injury but also a substantial factor in
bringing about the injury." Moberly, 592 F.3d at 1321 (quoting Shy/ace v. Sec'y of Health &
Human Servs., 165 F.3d 1344, 1352-53 (Fed . Cir. 1999)); Pafford v. Sec'y of Health & Human
Servs. , 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner may not receive a Vaccine Program
award based solely on his assertions; rather, the petition must be supported by either medical
records or by the opini on of a competent physician. Section 13(a)(1 ).
In attempting to establish entitlement to a Vaccine Program award of compensation fo r a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in A/then v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): "(1)
5 Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon v. Sec'y of Health & Human Servs., 40 Fed. C l. 625, 630 ( 1998). By contrast, Federal Ci rcuit
rulings concerning legal issues are binding on special masters. Guillory v. Sec'y of Health & Human Servs., 59 Fed.
Cl. 121 , 124 (2003), ajf'd, 104 F. App'x 712 (Fed. Cir. 2004); see also Spooner v. Sec'y of Health & Human Servs.,
No. l 3- l 59V, 2014 WL 504 728, at •7 n. 12 (Fed. Cl. Spec. Ms tr. Jan. 16, 20 14).
4
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." A/then, 418 F.3d at 1278.
Each of the Althen prongs requires a different showing. Under Althen prong one,
petitioners must provide a " reputable medical theory," demonstrating that the vaccine received
can cause the type of injury alleged. Pafford, 45 l F.3d at 1355-56 (citations omitted). To satisfy
this prong, a petitioner's theory must be based on a "sound and reliable medical or scientific
explanation." Knudsen v. Sec'y of Health & Human Servs., 35 F.3d 543 , 548 (Fed. Cir. 1994).
Such a theory must only be "legally probable, not medically or scientifically certain." Id. at 549.
Petitioners may satisfy the first A/then prong without resort to medical literature,
epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical
theory. Andreu v. Sec'y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir. 2009)
(citing Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not
empowered by statute to conclusively resolve what are essentially thorny scientific and medical
questions, and thus scientific evidence offered to establish A/then prong one is viewed "not
through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act's
preponderant evidence standard." Id. at 1380. Accordingly, special masters must take care not to
increase the burden placed on petitioners in offering a scientific theory linking vaccine to injury.
Contreras v. Sec 'y of Health & Human Servs., 121 Fed. CI. 230, 245 (2015) ("[p ]lausibility ...
in many cases may be enough to satisfy A/then prong one" (emphasis in original)). But this does
not negate or reduce a petitioner' s ultimate burden to establish his overall entitlement to damages
by preponderant evidence. W. C. v. Sec'y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed.
Cir. 2013) (citations omitted).
The second A/then prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner' s medical records. A/then, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec'y of Health & Human Servs.,
956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine "did cause" injury, the
opinions and views of the injured party ' s treating physicians are entitled to some weight. Andreu,
569 F.3d at 1367; Capizzano, 440 F.3d at 1326 ("medical records and medical opinion testimony
are favored in vaccine cases, as treating physicians are likely to be in the best position to
determine whether a ' logical sequence of cause and effect show[s] that the vaccination was the
reason for the injury" ') (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed
as particularly trustworthy evidence, since they are created contemporaneously with the
treatment of the patient. Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed.
Cir. 1993).
5
However, medical records and/or statements of a treating physician's views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully eva luated . Section 13(b)(I) (providing that "[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shal l not be binding on the special master
or court"); Snyder v. Sec'y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) ("there
is nothing ... that mandates that the testimony of a treating physician is sacrosanct- that it must
be accepted in its entirety and cannot be rebutted"). As with expert testimony offered to establish
a theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as
the reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record - including conflicting
opinions among such individuals. Hibbard v. Sec 'y of Health & Human Servs. , l 00 Fed. Cl. 742,
749 (20 11 ) (not arbitrary or capricious for special master to weigh competing treating
physicians' conclusions against each other), affd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec'y
of Health & Human Servs., 100 Fed. Cl. 119, 136 (20 11), affd, 463 F. App'x 932 (Fed. Cir.
2012); Veryzer v. Sec'y of Health & Human Servs. , No. 06-522V, 20 11WL1935813, at *17
(Fed. Cl. Spec. Mstr. Apr. 29, 20 11 ), mot. for review den 'd, 100 Fed. Cl. 344, 356 (2011), aff'd
without opinion, 475 Fed. App ' x 765 (Fed. Cir. 2012).
The third A/then prong requires establishing a " proximate temporal relationship" between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to
the phrase " medically-acceptable temporal relationship." Id. A petitioner must offer
"preponderant proof that the onset of symptoms occurred within a timeframe which, given the
medical understanding of the disorder' s etiology, it is medically acceptable to infer causation."
Bazan v. Sec 'y of Health & Human Servs. , 539 F.3d 1347, 1352 (Fed. Cir. 2008). The
explanation for what is a medicall y acceptable timeframe must also coincide with the theory of
how the relevant vaccine can cause an injury (A /then prong one's requirement) . Id. at 1352;
Shapiro v. Sec 'y of Health & Human Servs., 10 1 Fed. Cl. 532, 542 (20 11 ), recons. den'd after
remand, 105 Fed. Cl. 353 (20 12), aff'd mem., 20 13 WL 1896 173 (Fed. Cir. 20 13); Koehn v.
Sec 'y of Health & Human Servs., No. l l-355Y, 20 13 WL 32 14877 (Fed. Cl. Spec. Mstr. May
30, 20 13), mot.for review den'd(Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir. 20 14).
B. Law Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 1 l (c)(2). The special master is required
to consider "all [] relevant medical and scientifi c evidence contained in the record," including
"any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained
in the record regarding the nature, causation, and aggravation of the petitioner' s illness,
disability, injury, condition, or death," as well as "the results of any diagnostic or evaluative test
which are contained in the record and the summaries and conclusions." Section 13(b)(l )(A). The
special master is then required to weigh the evidence presented, including contemporaneous
6
medical records and testimony. See Burns v. Secy of Health & Human Servs., 3 F.3d 415, 417
(Fed. Cir. 1993) (it is within the special master' s discretion to determine whether to afford
greater weight to contemporaneous medical records than to other evidence, such as oral
testimony surrounding the events in question that was given at a later date, provided that such a
determination is evidenced by a rational determination).
Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and "complete" (i.e., presenting all relevant information on a patient's
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Secy of Health & Human Servs., 95
Fed. Cl. 598, 608 (2010) ("[g]iven the inconsistencies between petitioner's testimony and his
contemporaneous medical records, the special master's decision to rely on petitioner's medical
records was rational and consistent with applicable law"), aff'd, Rickett v. Secy of Health &
Human Servs., 468 F. App'x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption
is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick
people honestly report their health problems to those professionals; and (iii) medical
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Sanchez v. Secy of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2
(Fed. Cl. Spec. Mstr. Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537,
543 ( 1992), aff'd, 993 F.2d 1525 (Fed. Cir. 1993) ("[i]t strains reason to conclude that petitioners
would fail to accurately report the onset of their daughter's symptoms. It is equally unlikely that
pediatric neurologists, who are trained in taking medical histories concerning the onset of
neurologically significant symptoms, would consistently but erroneously report the onset of
seizures a week after they in fact occurred").
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Secy of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneously medical
records are generally found to be deserving of greater evidentiary weight than oral testimony -
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Secy of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), affd, 968 F.2d
1226 (Fed. Cir.), cert. den 'd, Murphy v. Sullivan , 506 U.S. 974 (1992) (citing United States v.
United States Gypsum Co., 333 U.S. 364, 396 (1947) ("[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.")) .
However, there are situations in which compelling oral testimony may be more
persuasive than written records, such as where records are deemed to be incomplete or
inaccurate. Campbell v. Secy of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (" like any
norm based upon common sense and experience, this rule should not be treated as an absolute
7
and must yield where the factual predicates for its application are weak or lacking"); Lowrie,
2005 WL 6117475, at * 19 ("[w]ritten records which are, themselves, inconsistent, should be
accorded less deference than those which are internally consistent") (quoting Murphy v. Secy of
Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), affd per curiam, 968 F.2d 1226 (Fed. Cir.
1992)). Ultimately, a determination regarding a w itness's credibility is needed when determining
the weight that such testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Secy of
Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).
When witness testimony is offered to overcome the presumption of accuracy afforded to
contemporaneous medical records, such testimony must be "consistent, clear, cogent, and
compelling." Sanchez, 20 13 WL 1880825, at *3 (citing Blutstein v. Sec 'y of Health & Human
Servs., No. 90-2808V, 1998 WL 408611 , at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In
determining the accuracy and completeness of medical records, the Court of Federal Claims has
li sted four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (I) a person's fai lure to recount to the medical professional
everything that happened during the relevant time period; (2) the medical professional's fai lure
to document everything reported to her or him; (3) a person's faulty recollection of the events
when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not
exist. La Londe v. Secy Health & Human Servs., 110 Fed. Cl. 184, 203 -04 (2013), aff'd, 746
F.3d 1334 (Fed. Cir. 20 14). In making a determination regarding whether to afford greater
weight to contemporaneous medical records over contrary testimony, there must be evidence that
this decision was the result of a rational determination. Burns, 3 F.3d at 417.
C. Determination to Resolve Case Without Hearing
I have opted to decide entitlement in this case based on written submissions and
evidentiary filings filed by each side. The Vaccine Act and Rules not only contemplate but
encourage special masters to decide petitions on the papers rather than via evidentiary hearing,
where (in the exercise of their discretion) they conclude that the former means of adjudication
will properly and fairl y resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The choice to
do so has been affirmed on appeal. See Hooker v. Secy of Health & Human Servs. , No. 02-
472V, 2016 WL 3456435, at *2 1 n.19 (Fed. Cl. Spec. Mstr. May 19, 2016) (citing numerous
cases where special masters decided on the papers in lieu of hearing and that decision was
upheld). I am simply not required to hold a hearing in every matter, no matter the preferences of
the parties. Hovey v. Secy of Health & Human Servs., 38 Fed. Cl. 397, 402-03 (1997) (special
master acted within his discretion in denying evidentiary hearing); Burns, 3 F.3d at 417; Murphy
v. Secy of Health & Human Servs., No. 90-882V, 199 1 WL 71500, at *2 (Ct. Cl. Spec. Mstr.
Apr. 19, 1991).
8
ANALYSIS
I. Petitioners Cannot Meet Their Evidcntiary Burden Given the Facts of this Case
After careful review of the medical records, and Petitioner's filings I conclude that
Petitioner will not be able to establish preponderant evidence in favor of his claim, and therefore
the matter should not proceed, even if expert reports have not yet been obtajned. My decision is
rooted in both the facts of this case as well as applicable decisions in previously-l itigated matters
involving causation theories highly similar to the present, and which have been exhaustively
litigated since resolution of the Omnibus Autism Proceedings ("OAP") test cases.6
Petitioner's non-table causation-in-fact claim is not supported by the record evidence,
which fails to attribute A.N. 's autism to the MMR vaccine. Nor is there record proof establish ing
any post-vaccination reaction that arguably could result in a developmental problem. Unlike
many autism claims, Petitioner does not argue that A.N. suffered an encephalopathic reaction
following closely with vaccination, nor is there any evidence of such a reaction.
Instead , Petitioner conclusory relies on the purported ex istence of epidemiological
evidence showing an association between the MMR vaccine and auti sm, thus proving hi s claim.
But reliable evidence in support of such contentions is non-existent.
6
Several years ago, more than 5,400 cases were initially filed under short form petition in the OAP, where
thousands of petitioners' claims that certain vaccines caused autism were joined for purposes of efficient resolution.
A " Petitioners' Steering Committee" was formed by many attorneys who represent Vaccine Program petitioners,
with about 180 attorneys participating. This group chose " test" cases to represent the entire docket, with the
understanding that the outcom es in these cases would be applied to cases with similar facts alleging similar theories.
The Petitioners' Steering Committee chose six test cases to present two different theories regarding
autism causation. The first theory alleged that the measles portion of the measles, mumps, rubella ("MMR") vaccine
precipitated autism, or, in the alternative, that MMR plus thimerosal-containing vaccines caused autism, while the
second theory alleged that the mercury contained in thimerosal-containing vaccines could affect an infant's brain,
leading to autism.
The first theory was rej ected in three test case decisions, all of which were subseq uentl y affirmed. See
generally Cedillo v. Secy of Health & Human Servs. , No. 98-9 I 6V, 2009 WL 33 1968 (Fed . C l. Spec. Mstr. Feb. 12,
2009), mot. for review den 'd, 89 Fed. C l. 158 (2009), ajf'd, 617 F.3d 1328 (Fed. C ir. 20 IO); Hazlehurst v. Secy of
Health & Human Servs., No. 03-654V, 2009 WL 332306 (Fed. C l. Spec. Mstr. Feb. 12, 2009), mot. for review
den 'd, 88 Fed. Cl. 473 (2009), ajf'd, 605 F.3d 1343 (Fed. Cir. 20 I 0); Snyder v. Secy of Health & Human Servs. , No.
Ol-162V, 2009 WL 332044 (Fed. C l. Spec. Mstr. Feb. 12, 2009), ajf'd, 88 Fed. Cl. 706 (2009).
The second theory was similarly rej ected. Dwyer v. Sec'y of Health & Human Servs., No. 03-1 202Y,
2010 WL 892250 (Fed . Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec'y of Health & Human Servs., No. 03-584V,
201 O WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 20 IO); Mead v. Sec'y of Health & Human Servs., No. 03-2 l 5V,
2010 WL 892248 (Fed. C l. Spec. Mstr. Mar. 12, 20 I 0).
Ultimately a total of eleven lengthy decisions by special masters, the judges of the U.S. Court of Federal
C laims, and the panels of the U.S. Court of Appeals for the Federal C ircuit, unanimously rej ected petitioners'
claims. These decisions found no persuasive evidence that the MMR vaccine or thimerosal-containing vaccines
9
The special masters presiding over the test cases in the OAP, after extensive research and
testimony, rejected theories of causation connecting the MMR vaccine to autism. See e.g. ,
Cedillo v. Sec'y of Health & Human Servs., No. 98-9 l 6V, 2009 WL 331968 (Fed. Cl. Spec.
Mstr. Feb. 12, 2009), mot. for review den 'd, 89 Fed. Cl. 158 (2009), aff'd, 617 F.3d 1328 (Fed.
Cir. 2010); Dwyer v. Sec 'y of Health & Human Servs., No. 03-1202V, 2010 WL 892250 (Fed .
Cl. Spec. Mstr. Mar. 12, 2010). I find no compelling reason to diverge from those cases, as
Petitioner has not offered evidence showing why A.N. 's case is different from those decided in
the OAP, nor has he suggested a novel theory not previously considered in the OAP.
Give the above, it is evident that Petitioners cannot meet their burden under the analysis
set forth in A/then for proving a causation-in-fact claim:
Prong One: Petitioner cannot present a reliable medical or scientific theory explaining
how the MMR vaccine could cause autism. Even if I were to allow Petitioners time to hire
experts and develop a theory, it is highly unlikely to be distinguishable from those that have been
repeatedly advanced but rejected in the Program.
Prong Two: Petitioner' s obligation under the second A/then prong was to demonstrate a
logical sequence of cause and effect connecting the particular facts of their case to their medical
theory. See, e. g., Sturdivant v. Sec'y of Health & Human Servs., No . 07-788Y, 2016 WL 552529,
at * 18 (Fed . Cl. Spec. Mstr. Jan. 21 , 2016) (prong two requires a fact-based inquiry into whether
the vaccine in question did cause the particular injury). But the medical record is bereft of
reliable evidence that A.N. had any reaction to her vaccines nor did any treaters suggest it to be
the case .
Prong Three: Even ifI had accepted Petitioner' s theory, A.N. ' s developmental symptoms
have not been shown to have occurred within a medically appropriate timeframe from the date of
the November 2013 vaccinations. The lack of medical records filed in this case make this
analysis more difficult, but even so it appears that evaluations for a developmental disorder did
not occur until about six months after vaccination. Although some statements by Petitioner made
to later treaters may suggest an onset of developmental-related symptoms earlier than six
months, at best, even those statements put onset occurring three months after vaccination. Here,
the temporal gap between receipt of the vaccines at issue and the documented beginning of
A.N. 's developmental problems is demonstrably too great to suggest a causal relationship.
Thompson v. Sec'y of Health & Human Servs., No . 15- l 498V, 2017 WL 2926614, at * 14 (Fed.
Cl. Spec. Mstr. May 16, 2017).
caused autism. The OAP proceedings concluded in 20 I 0.
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II. Dismissa l of the Claim is Appropriate at this Early Stage
A hearing provides a petitioner with the opportunity to put on live testimony, which aids
the special master most in cases where witness credibility is at issue or where there is a need to
pose questions to a wi tness in order to obtain information not contained in, or not self-evident
from, the ex isting fi lings. See, e.g., Hooker , 20 16 WL 3456435, at *2 1 (discussing a special
master ' s d iscretion in holding a hearing and the factors that weighed against holding a hearing in
the matter); Murphy, 199 1 WL 7 1500, at *2 (no justifi cation for a hearing where the claim is
fully developed in the written records and the special master does not need to observe the fact
witnesses for the purpose of assessing credibi lity). It may al so permit a claimant to expand upon
or illuminate points already set forth in paper filings, or respond to unanticipated questions raised
in the matter - but again, onl y where necessary to reach a decision.
Prior decisions have recognized that a special master's discretion in deciding whether to
conduct an evidentiary hearing " is tempered by Vaccine Rule 3(b)," or the duty to "afford[] each
party a full and fa ir opportunity to present its case." Hovey, 38 Fed. Cl. at 400-0 1 (citing Rule
3(b)). But that rule also includes the obli gation of creation of a record " suffi cient to allow review
of the special master's decision." Id. Thus, the fact that a claim is legitimately disputed, such that
the special master must exercise his intellectual faculties in order to decide a matter, is not itself
grounds for a trial (for if it were, trials would be required in every disputed case). Special
masters are expressly empowered to resolve fact disputes without a hearing.
In thi s case, live witness testimony is not required in order fo r me to reach a reasoned
decision. The flaws in Petitioner' s theory and factual arguments are self-evident from review of
the medical records.
At bottom, I cannot conclude that Petitioners' claim should proceed further, due to the
lack of success of cases with factually similar ci rcumstances and causation theories. The theory
that the vaccines A.N. received could have caused her development of autism and other
developmental problems, remains unreliable and lacks critical scientific support, especially given
the weak facts of thi s case. Under such circumstances, allowing the m atter to continue on does a
disservice to Petitioner, while misallocating judicial resources away from cases in which factual
and legal disputes warrant more attention.
CONCLUSION
The factual record does not support the Petitioner's contention that A.N. suffered from a
as a result of receiving her MMR vaccine. Thus, Petiti oner has not established entitlement to a
damages award I must DISMISS their claim.
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In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the Clerk SHALL ENTER JUDGMENT in accordance with this decision.7
IT IS SO ORDERED.
/
7 Pursuant to Vaccine Rule I !(a), the parties may exped ite entry of j udgment by filing a joint notice renouncing their
right to seek review.
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