N. v. Secretary of Health and Human Services ( 2020 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 19-976V
(Not to be published)
*************************
E.C.N., * Chief Special Master Corcoran
on behalf of D.A.N.B, a minor, *
* Filed: February 10, 2020
Petitioners, *
v. * Autism; Autism Spectrum Disorder;
* Statute of Limitations; Evidentiary
SECRETARY OF HEALTH * Basis for Claim.
AND HUMAN SERVICES, *
*
Respondent. *
*
*************************
E.C.N., San Diego, CA, pro se Petitioner.
Heather Pearlman, U.S. Dep’t of Justice, Washington, D.C., for Respondent.
DECISION DISMISSING CASE1
On July 8, 2019, E.C.N. filed a petition on behalf of her minor son, D.A.N.B., seeking
compensation under the National Vaccine Injury Compensation Program (“Vaccine Program”),2
Petitioner alleged that D.A.N.B. developed a toxin-induced encephalopathy manifesting as
torticollis, global development delay, and autism spectrum disorder (“ASD”) following a series of
vaccinations he received between December 2, 2014 and January 27, 2018. Petition at 1 (“Pet.”).
After several status conferences, during which I highlighted the numerous obstacles
Petitioner’s claim faced, I issued an order directing Petitioner to show cause why her case should
1
This Decision will be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of
2002, 44 U.S.C. § 3501 (2012). This means that the Decision will be available to anyone with access to the
internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion
of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days
within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial
or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the
disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the
whole Decision will be available to the public in its current form. Id.
2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter “Vaccine Act” or “the Act”).
All subsequent references to sections of the Vaccine Act shall be to the pertinent subparagraph of 42 U.S.C. § 300aa.
not be dismissed based on its factual similarity to other unsuccessful autism claims. See Scheduling
Order, dated Oct. 17, 2019 (ECF No. 9). Petitioner filed a brief on January 9, 2020 in support of
her claim. See Case Brief, filed Jan. 9, 2020 (ECF No. 16). On January 30, 2020, she filed a
compact disc containing numerous pieces of literature to further bolster her allegations.
Respondent filed his Response Brief on January 30, 2020. Response, filed Jan. 30, 2020 (ECF No.
18).
I. FACTUAL BACKGROUND
D.A.N.B. was born on September 18, 2014 via spontaneous vaginal delivery. Ex. 1 at 1.
During his first six months of life, D.A.N.B. received several vaccinations without any reported
adverse effects. Ex. 1 at 1; Ex. 2; Ex. 3 at 2–3. On April 16, 2015, one week after D.A.N.B.’s six-
month well-baby check, Petitioner sent an email to D.A.N.B.’s pediatrician, Dr. Saemae Erfani,
M.D., stating that D.A.N.B.’s head was tilting towards his left shoulder, and his left eye was
pointing towards the middle of his face. Ex. 4 at 3. A week later, on April 23, 2015, Petitioner took
D.A.N.B. to Dr. Erfani for a physical evaluation. Ex. 5a. During the visit, Dr. Erfani noted that
D.A.N.B. had a one-week history of head tilting and intermittent eye crossing. Id. at 1. Dr. Erfani
diagnosed D.A.N.B. with torticollis3 and congenital pseudostrabismus4 and referred him to an
ophthalmologist as well as physical and occupational therapy.5 Id. at 2.
At D.A.N.B.’s nine-month well-baby visit on June 30, 2015, Dr. Erfani noted D.A.N.B.
was healthy, and that his growth and development were within normal limits—though Dr. Erfani
also noted that D.A.N.B. was not yet pulling himself up or standing. Ex. 5b at 1–2. Petitioner later
took D.A.N.B. back to Dr. Erfani for his twelve-month well-baby visit. Id. at 6. At that time, Dr.
Erfani noted that D.A.N.B. was able to walk with support, pick up small objects, say words, and
play pat-a-cake. Id. His physical examination again revealed growth and development within
normal limits. Id. at 7. During the visit, D.A.N.B. received the Dtap, Hepatitis A, Varicella, MMR,
and Prevnar vaccines with no adverse effect reported. Id. at 8; Ex. 2.
One month later, on November 18, 2015, D.A.N.B. returned to Dr. Erfani for his fourteen-
month well-child visit. Ex. 8. During the visit, Petitioner reported that D.A.N.B. was experiencing
car sickness. Id. at 1. D.A.N.B.’s physical examination was normal, and Dr. Erfani noted his
growth and development as being within normal limits. Id. at 2. At the conclusion of the visit,
3
Torticollis is the abnormal contraction of muscles in the neck, which in turn produces a twisting of the neck and
abnormal head positioning. Dorland’s Illustrated Medical Dictionary 602 (32 ed. 2012) (hereinafter “Dorland’s”).
4
Congenital Pseudostrabismus is a condition that is present at birth in which the eyes’ visual axes appear as though
they cannot be directed at the same point of fixation. It is caused by an overhanging fold of skin near the inner
corner of the eye. Dorland’s at 403, 630, 1546, 1778.
5
Petitioner did not file subsequent medical records related to ophthalmology appointments, physical therapy, or
occupational therapy.
2
D.A.N.B. received his fourth HiB vaccine in addition to a second flu vaccination. Ex. 2 at 1. No
adverse reaction was noted. Dr. Erfani also ordered a lead screening.6 Ex. 8 at 2.
On March 29, 2016, Petitioner took D.A.N.B. for his eighteen-month well-baby visit with
Dr. Erfani. Ex. 6. During the visit, Petitioner expressed concerns that D.A.N.B.’s speech was
delayed, that he continued to exhibit head tilting, and that he often experienced nausea and
vomiting while in the car or on the swing. Id. at 1. An autism screening was performed, but the
results of the screening were deemed normal. Id.at 2. D.A.N.B. was again noted as healthy and his
growth and development were within normal limits. Id. Dr. Erfani, however, noted that D.A.N.B.’s
constellation of symptoms warranted a consultation with neurology. Id.
On July 26, 2016, Petitioner met with Dr. Nidia Alduncin, M.D. regarding D.A.N.B.’s
symptoms. Ex. 9. During the visit, Dr. Alduncin discussed a “Multidisciplinary Diagnostic Autism
Clinic” summary report. While the report itself was not filed by Petitioner, it appears that the
results of the report led Dr. Alduncin to diagnose D.A.N.B. with ASD-Global Developmental
Delay. Id. at 1. No other medical records were filed in this matter.
II. PROCEDURAL HISTORY
On July 8, 2019, E.C.N. filed a Petition, along with less than forty pages of medical records
and various articles in support of her claim. An initial telephonic status conference was held with
the parties on August 30, 2019. During that conference, I expressed my concerns regarding the
viability of Petitioner’s claim. See Scheduling Order, dated Sept. 3, 2019 (ECF No. 7). I explained
that most of her claim was likely time-barred, given that the onset of D.A.N.B.’s symptoms
appeared to pre-date his June 23, 2016 ASD diagnosis. Id. at 2. The Act’s limitations period runs
from the first symptoms manifestation, regardless of whether it is recognized as such, but the facts
from the records in this case suggested D.A.N.B.’s onset occurred no later than March 2016—
more than three years from the July 2019 filing of this Petition. Additionally, I explained to
Petitioner that the claim was very unlikely to prevail on the merits in light of the vast number of
autism and ASD claims that have been unsuccessfully litigated in the Program. Id. at 2–4.
A second telephonic status conference was held with the parties on October 16, 2019.
During the status conference, I reiterated my concerns regarding the viability of the claim. I also
emphasized (in response to Petitioner’s objections to my comments on her claim’s viability) that
my role as a special master is inquisitorial, and thus any comments or opinions that I express
regarding the merits of her claim are not made out of animosity or malice, but instead reflect an
impartial evaluation meant to guide the parties to resolution of the claim. Despite my assurances
that my evaluation of the claim was unbiased and not directed at her personally, Petitioner
expressed concerns regarding her ability to pursue her claim before an impartial adjudicator and
indicated that she hoped to obtain a different neutral to resolve the claim. I therefore provided a
6
Petitioner did not file subsequent records documenting the results of the lead screening.
3
deadline by which she could file a motion for my recusal should she desire to do so. Scheduling
Order, filed Oct. 17, 2019 (ECF No. 9). I also provided a briefing schedule for her to file a brief
showing cause why her case should not be dismissed. Id. Respondent was similarly provided a
deadline by which to file a response to Petitioner’s brief. Id.
Petitioner filed a motion seeking my recusal on November 5, 2019. Motion to Disqualify,
filed Nov. 5, 2019 (ECF No. 10) (“Mot. to Disqualify”). The motion also contained discovery
requests seeking “all filings related to” four cases unrelated to the present matter as well as requests
for the production of “[a]ll books, records, expert testimonies and documents which oppose Ms.
E.C.N.’s allegation that D.A.N.B. developed toxin-induced encephalopathy manifesting as
torticollis, global developmental delay, and [ASD] following a series of vaccinations.” Id. at 5.
Respondent reacted to the motion on November 13, 2019, and I issued a decision denying both
discovery and my recusal on November 20, 2019. Response to Mot. to Disqualify, filed Nov. 13,
2019 (ECF No. 11); Order Denying Mot. to Disqualify, filed Nov. 20, 2019 (ECF No. 13).
On January 9, 2020, Petitioner filed her brief showing cause why her claim should not be
dismissed pursuant to my October 17, 2019 Order. Shortly thereafter, Petitioner filed a compact
disc containing D.A.N.B.’s vaccination record, as well as several pieces of literature to support her
claim. Respondent filed his opposition to Petitioner’s brief on January 30, 2020.
III. PARTIES’ RESPECTIVE ARGUMENTS
A. Petitioner
In her four-page brief, Petitioner again raises the issues of recusal and discovery, and
spends nearly two pages reiterating the arguments she previously made in her now-dismissed
Motion to Disqualify. See Case Brief at 2–4; see also Mot. to Disqualify. On the last page of her
brief, Petitioner dedicates two paragraphs to explaining why her claim should not be dismissed.
Case Brief at 4. She argues that the literature she submitted “support[s] the finding that the
aluminum, formaldehyde and mercury/thimerasol in the vaccines D.A.N.B. received injured him
into a toxin induced encephalopathy manifesting as torticollis, global developmental delay, and
[ASD].” Id. She also maintains that Respondent “has not proven” otherwise, and that Respondent
has failed to produce any literature disproving that vaccines induced D.A.N.B.’s injury. Id.
B. Respondent
Respondent argues that Petitioner’s claims are time-barred and are not otherwise
preponderantly supported by the record, thereby warranting dismissal. Regarding the first point,
Respondent cites the Vaccine Act’s statutory limitations period, which requires that a petition be
filed prior to “the expiration of 36 months after the date of the occurrence of the first symptom or
manifestation of onset or of the significant aggravation of [the alleged] injury.” Response at 5
(citing Section 16(a)(2)). In order for me to find Petitioner’s July 8, 2019 filing of the claim timely,
4
Respondent argues that the latest D.A.N.B. could have experienced onset of his symptoms could
not have occurred before July 8, 2016. Id. But the onset of D.A.N.B.’s torticollis began in April
2015 (fifteen months outside of the statute of limitations), and the onset of his developmental delay
and ASD also pre-date June 23, 2016 (approximately one month outside of the statute of
limitations). Id. While Respondent does acknowledge the Vaccine Act’s provision regarding
equitable tolling, he argues that it is not applicable in this case Id. at 6–8.
Regarding the merits of the case, Respondent emphasizes that the record does not
preponderantly support a causal relationship between the vaccines D.A.N.B. received and his
subsequent diagnoses. Id. at 8–9. In support of this proposition, Respondent notes that claims
alleging that vaccines can cause—or aggravate—autism or autism-like symptoms have generally
not been met with success as reflected in the Omnibus Autism Proceedings (“OAP”) and
subsequent decisions.7
IV. APPLICABLE LEGAL STANDARDS
A. Petitioner’s Overall 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 falling within the Vaccine Injury Table—
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
7
These theories were first advanced in proceedings related 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 outcomes 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 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 rejected in three test case decisions, all of which were subsequently affirmed. See generally
Cedillo v. Sec'y of Health & Human Servs., No. 98–916V, 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); Hazlehurst v. Sec'y of Health &
Human Servs., No. 03–654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for review den'd, 88 Fed.Cl.
473 (2009), aff'd, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec'y of Health & Human Servs., No. 01–162V, 2009
WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd, 88 Fed.Cl. 706 (2009).
The second theory was similarly rejected. Dwyer v. Sec'y of Health & Human Servs., No. 03–1202V, 2010 WL
892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec'y of Health & Human Servs., No. 03–584V, 2010 WL
892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec'y of Health & Human Servs., No. 03–215V, 2010 WL
892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).
Ultimately a total of 11 lengthy decisions by special masters, the judges of the U.S. Court of Federal Claims, and the
panels of the U.S. Court of Appeals for the Federal Circuit, unanimously rejected the petitioners' claims. These
decisions found no persuasive evidence that the MMR vaccine or thimerosal-containing vaccines caused autism. The
OAP proceedings concluded in 2010.
5
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).8
In this case, Petitioner does not assert a Table claim.
For both Table and Non-Table claims, Vaccine Program petitioners 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
only [the] but-for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface 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 opinion of a competent
physician. Section 13(a)(1).
In attempting to establish entitlement to a Vaccine Program award of compensation for a
Non-Table claim, a petitioner must satisfy all three of the elements established by the Federal
Circuit in Althen: “(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 proximate temporal relationship between vaccination and injury.” Althen,
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, 451 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.
8
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. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings
concerning legal issues are binding on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121,
124 (2003), aff’d 104 F. Appx. 712 (Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-
159V, 2014 WL 504728, at *7 n.12 (Fed. Cl. Spec. Mstr. Jan. 16, 2014).
6
Petitioners may satisfy the first Althen 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 Althen 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,
121 Fed. Cl. at 245 (“[p]lausibility . . . in many cases may be enough to satisfy Althen prong one”
(emphasis in original)).
In discussing the evidentiary standard applicable to the first Althen prong, many decisions
of the Court of Federal Claims and Federal Circuit have emphasized that petitioners need only
establish a causation theory’s biological plausibility (and thus need not do so with preponderant
proof). Tarsell v. United States, 133 Fed. Cl. 782, 792–93 (2017) (special master committed legal
error by requiring petitioner to establish first Althen prong by preponderance; that standard applied
only to second prong and petitioner’s overall burden); see also Contreras, 121 Fed. Cl. at 245;
Andreu, 569 F.3d at 1375. At the same time, there is contrary authority from the Federal Circuit
suggesting that the same preponderance standard used overall in evaluating a claimant’s success
in a Vaccine Act claim is also applied specifically to the first Althen prong. See, e.g., Broekelschen,
618 F.3d at 1350 (affirming special master’s determination that expert “had not provided a ‘reliable
medical or scientific explanation’ sufficient to prove by a preponderance of the evidence a medical
theory linking the [relevant vaccine to relevant injury].”) (emphasis added). Regardless, one thing
remains: petitioners always have the ultimate burden of establishing their Vaccine Act claim
overall with preponderant evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356
(Fed. Cir. 2013) (citations omitted); Tarsell, 133 Fed. Cl. at 793 (noting that Moberly “addresses
the petitioner’s overall burden of proving causation-in-fact under the Vaccine Act” by a
preponderance standard)9.
The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 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
9
Although decisions like Contreras suggest that the burden of proof required to satisfy the first Althen prong is less
stringent than the other two, there is ample contrary authority for the more straightforward proposition that when
considering the first prong, the same preponderance standard used overall is also applied when evaluating if a reliable
and plausible causal theory has been established. Broekelschen, 618 F.3d at 1350.
7
‘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).
Medical records and statements of a treating physician, however, do not per se bind the
special master to adopt the conclusions of such an individual, even if they must be considered and
carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, judgment,
test result, report, or summary shall 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 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., 100 Fed. Cl. 742, 749 (2011) (not arbitrary or
capricious for special master to weigh competing treating physicians’ conclusions against each
other), aff’d, 698 F.3d 1355 (Fed. Cir. 2012); Veryzer v. Sec’y of Dept. of Health & Human Servs.,
No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review
denied, 100 Fed. Cl. 344, 356 (2011), aff’d without opinion, 475 F. Appx. 765 (Fed. Cir. 2012).
The third Althen 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.” de Bazan
v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for
what is a medically acceptable timeframe must align with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 503 F. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec’y of Health & Human Servs., No. 11-
355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for rev. denied (Fed. Cl. Dec.
3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
B. Legal Governing Factual Determinations
The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master is required
to consider “all [] relevant medical and scientific evidence contained in the record,” including “any
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
8
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)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y 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 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. Sec’y 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 sub nom. Rickett v. Sec’y of Health
& Human Servs., 468 F. Appx. 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. Sec’y 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 at 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to
accurately report the onset of their daughter’s symptoms”).
Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie, 2005 WL 6117475, at *20. Indeed, contemporaneous
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, 23 Cl. Ct. at 733 (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.”)).
There are, however, 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. Sec’y 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 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
9
those which are internally consistent’”) (quoting Murphy, 23 Cl. Ct. at 733)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y 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, 2013 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
listed four possible explanations for inconsistencies between contemporaneously created medical
records and later testimony: (1) a person’s failure to recount to the medical professional everything
that happened during the relevant time period; (2) the medical professional’s failure 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. Lalonde v. Sec’y
of Health & Human Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1334 (Fed. Cir. 2014).
In making a determination regarding whether to afford greater weight to contemporaneous medical
records or other evidence, such as testimony at hearing, there must be evidence that this decision
was the result of a rational determination. Burns, 3 F.3d at 417.
C. Consideration of Literature
Petitioner filed several items of literature in this case, but not every filed item factored into
the outcome of this decision. While I have reviewed all the literature submitted in this case, I
discuss only those articles that are most relevant to my determination and/or are central to
Petitioner’s case. Moriarty v. Sec’y of Health & Human Servs., 844 F.3d 1322, 1328 (Fed. Cir.
2016) (“[w]e generally presume that a special master considered the relevant record evidence even
though he does not explicitly reference such evidence in his decision”) (citation omitted); see also
Paterek v. Sec’y of Health & Human Servs., 527 F. Appx. 875, 884 (Fed. Cir. 2013) (“[f]inding
certain information not relevant does not lead to—and likely undermines—the conclusion that it
was not considered”).
D. Resolution of Case Via Ruling on Record
I have opted to resolve this matter on the papers, rather than by holding a hearing. The
Vaccine Act and Rules not only contemplate but encourage special masters to decide petitions on
the papers where (in the exercise of their discretion) they conclude that doing so will properly and
fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The decision to rule on the record
in lieu of hearing has been affirmed on appeal. See Kreizenbeck v. Sec’y of Health & Human Servs.,
No. 08-209V, slip op. at 8 (Fed. Cir. Jan. 6, 2020); Hooker v. Sec’y of Health & Human Servs.,
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No. 02-472V, 2016 WL 3456435, at *21 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. Sec’y 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
23 Cl. Ct. at 730–31.
ANALYSIS
I. Petitioner’s Claim is Untimely
As noted, the statute of limitations prescribed by the Vaccine Act is three years (thirty-six
months), measured “after the expiration of 36 months after the date of the occurrence of the first
symptom of manifesting of onset or of the significant aggravation of such injury.” Section 16(a)(2).
The statute of limitations thus begins to run from the manifestation of the first objectively
cognizable symptom, whether or not that symptom is sufficient for diagnosis. Carson v. Sec’y of
Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013). Special masters have appropriately
dismissed cases that were filed outside the limitations period, even by a single day or two. See,
e.g., Spohn v. Sec’y of Health & Human Servs., No. 95-0460V, 1996 WL 532610 (Fed. Cl. Spec.
Mstr. Sept. 5, 1996) (dismissing case filed one day beyond the thirty-six-month limitations period),
aff’d, 132 F.3d 52 (Fed. Cir. 1997).
In her Petition, E.C.N. alleges that D.A.N.B.’s injury is the result of vaccinations he
received between December 2, 2014 and January 27, 2018. Pet. at 1. As the record reveals,
D.A.N.B. first experienced symptoms attributable to torticollis on April 16, 2015, when his mother
first noticed his head tilting. Case Brief at 1; Ex. 4 at 1. She then took D.A.N.B. to Dr. Erfani on
April 23, 2015, at which time Dr. Erfani noted that D.A.N.B. had been tilting his head for about
one week, which is consistent with Petitioner’s recollection. Ex. 5a at 1. Thereafter, D.A.N.B.
exhibited symptoms of ASD and global developmental delay, including delayed speech, which
was noted during an appointment with Dr. Erfani on March 29, 2016. D.A.N.B. was formally
diagnosed with ASD on June 23, 2016 during a meeting with a developmental behavioral
specialist, Dr. Alducin. Ex. 9 at 1.
Even taking the most liberal approach to determining the onset of D.A.N.B.’s symptoms—
an approach that would put onset coinciding with D.A.N.B.’s formal ASD diagnosis on June 23,
2016 thereby requiring Petitioner’s claim be filed by June 23, 2019—Petitioner’s filing the claim
on July 8, 2019 would still be untimely. I find, however, based upon the records filed in this case,
that it is more likely that D.A.N.B.’s symptoms pre-date his June 2016 ASD diagnosis. Thus, I
find that Petitioner’s claim must be dismissed as untimely.
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The Federal Circuit has held that the doctrine of equitable tolling can apply to Vaccine Act
claims in limited circumstances. See Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322,
1340–41 (Fed. Cir. 2011). These limited circumstances have been enumerated to include fraud and
duress. Cloer, 654 F.3d at 1344–45 (citing Bailey v. Glover, 88 U.S. 342, 349-350) (1874) (“[t]o
hold that by concealing a fraud, or by committing a fraud in a manner that it concealed itself until
such time as the party committing the fraud could plead the statute of limitations to protect it, is to
make the law which was designed to prevent fraud the means by which it is made successful and
secure.”)). However, the Federal Circuit has specifically stated that “equitable tolling under the
Vaccine Act due to unawareness of a causal link between an injury and administration of a vaccine
is unavailable” as a tolling mechanism. Id. at 1345.
Ultimately, none of the relevant circumstances that would permit tolling have been shown
by Petitioner to apply herein. Thus, the equitable tolling doctrine does not apply, and I must
therefore dismiss the present matter as untimely.
II. Petitioner’s Claim Lacks Sufficient Proof
Even if Petitioner’s claim had been timely filed, I find that the allegations contained therein
were not sufficiently supported by reliable medical or scientific evidence to warrant compensation.
Notably, less than forty pages of medical records were filed in this case, despite Petitioner having
seven months to file the relevant records. The sparse record that was provided is itself devoid of
any treater support for the proposition that D.A.N.B.’s torticollis, global developmental delay, and
ASD were causally the result of a toxin-induced encephalopathy. The records also lack any treater
support suggesting that D.A.N.B.’s condition is in any way related to the vaccinations he received.
Petitioner did offer a substantial amount of literature in support of her claim. The literature,
however, is woefully deficient in establishing a causal relationship between vaccines and the
alleged injuries. A large number of the articles cited by Petitioner in this case have already been
reviewed by myself and other special masters in the context of autism and ASD claims, and they
have time and time again been rejected due to overwhelmingly poor study designs and a general
lack of support within the medical and scientific communities. See Dwyer v. Sec’y of Health &
Human Servs., No. 03-1202V, 2010 WL 892250, at *102–03 (Fed. Cl. Spec. Mstr. Mar. 12, 2010)
(finding the strong evidence of erroneous results in A. Holmes et al., Reduced Levels of Mercury
in First Baby Haircuts of Autistic Children, Int’l J. Toxicology 22:277–85 (2003) sufficient to
discredit the study); King v. Sec’y of Health & Human Servs., No. 03-584V, 2011 WL 5926126,
at *21–23 (Fed. Cl. Spec. Mstr. Sept. 22, 2011) (discussing the medical and scientific community’s
condemning of several articles authored by David and Mark Geier and noting that an Institute of
Medicine committee tasked with reviewing several studies conducted by the Geiers found them to
be “so poorly done and so profoundly flawed that they effectively contributed nothing to the
causation issues that they addressed.”).
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CONCLUSION
The untimely filing of this claim, along with a factual record devoid of any support to
preponderantly establish Petitioner’s contention that D.A.N.B. developed torticollis, global
developmental delay, and ASD as a result of receiving his childhood vaccines, necessitate this
claim’s dismissal. Petitioner has not established entitlement to a damages award, and I must
therefore DISMISS her claim.
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.10
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
10
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
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