Court Opinion

ID: 2796590
Source: CourtListenerOpinion
Date Created: 2015-04-27 13:01:31.664487+00
Date Added: 2024-06-11T08:50:13.890874
License: Public Domain

IN THE UNITED STATES COURT OF FEDERAL CLAIMS
                      OFFICE OF SPECIAL MASTERS
                                               No. 08-0307V
                                          Filed: August 26, 2013

****************************
Sahra Hashi, by SAFIA WEGED and *
HUSSEIN H. HASHI, her parents,  *
                                *                            Autism; Statute of Limitations; First
                 Petitioners,   *                            Symptom or Manifestation of Onset;
                                *                            Significant Aggravation
             v.                 *
                                *
SECRETARY OF HEALTH AND         *
HUMAN SERVICES,                 *
                                *
                 Respondent.    *
****************************

Elaine W. Sharp, Esq., Whitfield, Sharp & Sharp, Marblehead, MA, for petitioners.
Heather L. Pearlman, Esq., U.S. Dept. of Justice, Washington, DC, for respondent.

            ORDER AND RULING DISMISSING CAUSATION IN FACT CLAIM1

Vowell, Special Master:

       On April 11, 2012, respondent filed a motion to dismiss this claim, asserting that
the petition was untimely filed. Petitioners filed their response to respondent’s motion
on July 16, 2012. Although petitioners’ amended petition, filed June 29, 2011, asserts
both an actual causation and significant aggravation claim,2 petitioners appear to rely
only on a signification aggravation claim in their response to respondent’s motion to
dismiss.

       For the reasons set forth below, petitioners’ causation in fact claim is
DISMISSED. If petitioners intend to continue pursuing a significant aggravation claim,
they shall file a second amended petition setting forth the facts upon which such claim is

1
   Because this ruling and order contains a reasoned explanation for the action in this case, I intend to post
it on the United States Court of Federal Claims' website, in accordance with the E-Government Act of
2002, Pub. L. No. 107-347, § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note
(2006)). In accordance with Vaccine Rule 18(b), petitioners have 14 days to identify and move to delete
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will delete such material from
public access.
2
 Petitioners allege that Sahra’s vaccines “caused or exacerbated progressive encephalopathy with
autistic features, the severe sequelae of which continue to date.” Amended Petition at ¶ 11.
based by September 25, 2013. Petitioners are also hereby ordered to file an expert
report to support their significant aggravation claim by November 25, 2013. Such a
report must clearly indicate the expected progression of Sahra’s disorder and how that
progression was altered by vaccines received less than 36 months from the date of
filing of the original petition in this case. If the expert relies upon facts other than those
set forth in Section II below, the expert must identify the source of the information upon
which he or she relies, and explain why he or she does so.

                                        I. Procedural History.

       On April 22, 2008, petitioners filed a short-form petition authorized by Autism
General Order #13 for compensation under the National Vaccine Injury Compensation
Program, 42 U.S.C. § 300aa-10, et seq.4 [the “Vaccine Act” or “Program”], on behalf of
their minor daughter, Sahra Hashi [“Sahra”]. By filing a short form petition, petitioners
joined the Omnibus Autism Program [“OAP”],5 alleging that Sahra had a disorder on the
autism spectrum and that one or more vaccines listed on the Vaccine Injury Table6 were
causal of her condition. Petitioners did not file any medical records or details regarding
Sahra’s injuries with their short-form petition.

       The special master previously assigned to this case ordered petitioners to
complete their petition by filing the statutorily required medical records7 and a
“Statement Regarding Onset” addressing the timeliness of the petition. Order, issued
Apr. 28, 2008. On May 20, 2008, respondent filed her Rule 4(c) report [“Res. Rpt.”],
stating that she could not assess the merits of petitioners’ claim without the outstanding
medical records. Res. Rpt. at 1.

          Petitioners filed their first set of medical records on October 25, 2010.8 No

3
  Autism General Order #1, 2002 WL 31696785 (Fed. Cl. Spec. Mstr. July 3, 2002), is available at:
http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf. The theories of
causation specifically addressed in Autism Gen. Order #1 were that the measles, mumps, and rubella
[“MMR”] vaccine was causal, that the vaccines containing thimerosal, a mercury-based preservative, were
causal, or that a combination of the MMR vaccine and vaccines containing thimerosal were causal.
4
 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2006).
5
 The OAP is discussed in detail in Snyder v. Sec’y, HHS, No. 01-162V, 2009 WL 332044, at *4 (Fed. Cl.
Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009) and Dwyer v. Sec’y, HHS, 2010 WL 892250, at
*3 (Fed. Cl. Spec. Mstr. Mar. 12, 2010).
6
    42 C.F.R. § 100.3 (2011).
7
 Section 11(c)(2) of the Vaccine Act and Vaccine Rule 2 require that petitions be accompanied by
medical records and affidavits.
8
 The five sets of medical records were initially filed as Petitioners’ Exhibits [“Pet. Ex.”] 13.1-13.10;
14.1-14.3; 15.1; 16.1-16.2; and 17.1. Petitioners had incorrectly correlated the exhibit numbers with the
docket entry number (e.g., the exhibit filed in docket entry 15 was labeled as Exhibit 15.1). Petitioners re-

                                                      2
further activity occurred in this case until after the conclusion of the appeals in the OAP
test cases. On January 25, 2011, in light of the test case findings, petitioners were
ordered to inform the court if they wished to proceed with their claim or exit the Vaccine
Program. In the event, they decided to proceed, petitioners were ordered to file an
amended petition. Order, issued Jan. 25, 2011. Petitioners filed an amended petition
on June 29, 2011, alleging that one or more of the vaccinations that Sahra received
between birth and four and half years of age “caused or exacerbated progressive
encephalopathy with autistic features” and the sequelae. Amended Petition [“Am. Pet.”]
at 2.

       This case was reassigned to me on July 1, 2011. During a status conference on
July 20, 2011, I advised petitioners’ counsel that this claim appeared to have been filed
outside the Vaccine Act’s 36 month statute of limitations.9 Order, issued July 20, 2011.

        Between October 2011 and April 2012, petitioners filed additional exhibits
detailing Sahra’s health from birth to early childhood. On February 27, 2012,
respondent was ordered to file a statement indicating whether, based on the available
medical records, she believed petitioners’ claim should proceed.

        On April 11, 2012, in lieu of filing a statement, respondent moved to dismiss
petitioners’ claim, asserting that the petition was filed after the expiration of the Vaccine
Act’s statute of limitations. Motion at 1, 4-5. Respondent argued that the petition
should have been filed no later than November 2, 2007, because the first symptom or
manifestation of onset of Sahra’s autism spectrum disorder [“ASD”]10 occurred as early
as November 2, 2004. Id. at 2-3, 5.

      On July 16, 2012, petitioners filed a joint opposition to respondent’s motions to
dismiss in both of their children’s cases.11 In their response, petitioners assert that the
diphtheria, tetanus, acellular, and pertussis [“DTaP”] and inactivated polio virus [“IPV”]
administered on January 8, 2007, significantly aggravated Sahra’s pre-existing

filed these records as Pet. Exs. 1-7 on August 3, 2011.
9
  At the time of this status conference, interpretation of the Vaccine Act’s statute of limitations was under
review by the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit, siting en banc, heard
oral argument in Cloer v. Sec’y, HHS, on May 10, 2011. Because the outcome of that case could affect
my determination of timeliness in this case, I opted to wait for the Federal Circuit’s decision before
ordering petitioners to obtain an expert report. On August 5, 2011, the Federal Circuit reiterated that the
first symptom recognized by the medical community at large as a symptom of a disorder triggered the
running of the statute of limitations in Vaccine Act cases. Cloer v. Sec’y, HHS, 654 F.3d 1322, at *1335
(Fed. Cir. 2011), cert. denied, 132 S. Ct. 1908 (2012).
10
   “Autism spectrum disorder” is an umbrella term encompassing several neurological disorders
manifesting in early childhood with impairments in communication and social interaction, and the display
of restricted, repetitive, or stereotypical patterns of behavior, interests, and activities. A more complete
description of the disorder is contained in White v. Sec’y, HHS, No. 04-337V, 2011 WL 6176064 (Fed. Cl.
Spec. Mstr. Nov. 22, 2011).
11
     Petitioners also filed a petition on behalf of their daughter Osob. (No. 08-308V).

                                                        3
mitochondrial disorder and that the short-form petition filed on April 22, 2008, was
therefore filed well within the statute of limitations period. Response at 2, 5.

       On July 17, 2012, petitioners filed Mr. Hashi’s affidavit, in which he provides his
recollection of what happened to Sahra after she received the alleged causal vaccines.
Pet. Ex. 18.

                                    II. Relevant Medical History.

A. Birth to Fourth Birthday (November 2002 to November 2006).

        1. Early Health and Development.

       Sahra was born on November 2, 2002. Pet. Ex. 1, p. 1. She was delivered full-
term without any complications and her Apgar scores were 9 and 9,12 reflective of a
healthy newborn. Id., pp. 1-2. She received a hepatitis B vaccine prior to her discharge
from the hospital, id., p. 4, and continued to receive routinely-administered childhood
vaccinations in her first three years.13 Pediatrician Lawrence Stratton’s records indicate
that Sahra continued to meet the appropriate developmental milestones at two and four
months of age. Pet. Ex. 4-2,14 pp. 48-50, 53-55.

        2. Initial Concerns of Developmental Delay.

       Doctor Stratton first expressed concern about Sahra’s development at her six
month well child visit on May 15, 2003. Pet. Ex. 4-2, pp. 43, 46. At that visit, he noted
“[d]evelopmental delay and referred Sahra for an Early Intervention evaluation. Id., p.
46. Later, at Sahra’s nine month well child visit on August 13, 2003, Dr. Stratton noted
“mild motor delays.” Id., p. 41.

        On April 2, 2004, Sahra was seen by Dr. Stratton to follow up on his concerns
regarding her development. Pet. Ex. 4-2, p. 29. Doctor Stratton noted that Sahra was

12
  An Apgar score is a numerical assessment of a newborn’s condition (with lower numbers indicating
problems), usually taken at one minute and five minutes after birth. The score is derived from the infant’s
heart rate, respiration, muscle ton, reflex irritability, and color, with from zero to two points awarded in
each of the five categories. DORLAND’S ILLUSTRATED MEDICAL DICTIONARY [“DORLAND’S”] at 1682 (32nd ed.
2012).
13
  Between November 2002, and May 2004, Sahra received the follow vaccines: hepatitis B vaccine on
November 3, 2002, and again on December 11, 2002; DTaP, Haemophilus influenzae type B [“Hib”], IPV,
and pneumococcal conjugate vaccines [“Prevnar”] on January 9, 2003, March 13, 2003, and on May 15,
2003; IPV, measles, MMR, and varicella vaccines on November 4, 2003; and DTaP, Hib and Prevnar on
May 20, 2004. See Pet. Ex. 19.
14
  Petitioners’ Exhibit 4 was filed as two separate pdf files; the first (4-1) containing 64 pages and the
second (4-2) 87 pages. Instead of consecutively numbering the pages from the two files 1 to 151,
petitioners individually numbered the contents of the files. Therefore, this decision refers to Exhibits 4-1
and 4-2 and not simply Exhibit 4.

                                                      4
making slow progress, with no loss of milestones, and recommended continuing the
Early Intervention services. Id., p. 32. At Sahra’s belated 15 month well child visit on
May 20, 2004, when she was more than 18 months of age, she was still not walking and
had a vocabulary of six to twelve words. Id., p. 18.

        On September 7, 2004, when she was about 22 months of age, Sahra was
diagnosed with developmental delay by her pediatrician. 15 Pet. Ex. 4-1, pp. 31, 33. At
that time, Dr. Stratton noted that Sahra had not lost any milestones, could speak
approximately 20 words, understands well, but had not begun walking and was
“following [the] same pattern as [her] sister.” Id., p. 31, 33.

        3. Diagnosis of Autism.

       In October 2006, Dr. Peter Masucci, Sahra’s pediatrician at the time, noted that
she had been diagnosed with autistic disorder. Pet. Ex. 11, pp. 17-18. The source for
his notation was not specifically identified, but likely was based on two evaluations
Sahra underwent in September 2006.

        On September 26, 2006, at almost four years of age, Sahra was evaluated at the
Massachusetts General Hospital’s [“MGH”] Department of Speech, Language, and
Swallowing Disorders by Dr. Jean Ashland. Based on the report, Sahra had normal
speech and language development in her early childhood and began regressing at
approximately two years of age. Pet. Ex. 11, pp. 91. According to petitioners, Sahra
used two to three word combinations at two years of age and was no longer using more
than single words. Id. Although the evaluation was focused on her expressive and
receptive language skills, the report did note that Sahra exhibited decreased eye
contact, lack of imaginative play, and general “deficits in social/pragmatic and play
skills.” Id., pp. 92-93. Doctor Ashland was concerned about her speech and language
regression, particularly in light of the family history of autism.16 Id., p. 92.

       Earlier in the month, on September 19, 2006, petitioners met with the Everett
Public Schools concerning Sahra’s Individualized Education Program [“IEP”]. The IEP
form noted her disability as pervasive developmental delay, and indicated that she “was
on the spectrum of an individual with Autism.” Pet. Ex. 15, pp. 2-3. Pervasive
developmental disorder or “PDD” is the umbrella term used in the fourth edition of the
Diagnostic and Statistical Manual of Mental Disorders [“DSM”] for certain developmental
disorders, including autism (also referred to as autistic disorder), pervasive
developmental disorder-not otherwise specified [“PDD-NOS”], and Asperger’s

15
   In earlier records developmental delay was listed in the “Problems” section of the visit note. The record
from September 7, 2004 is the first to include developmental delay in the “Diagnosis” section of the note.
Within the diagnosis section of the record from the September 7, however, the “recorded start date” for
her developmental delay is May 15, 2003, the date of Sahra’s six month well child visit.
16
  Sahra’s older sister, Osob, has a diagnosis on the autism spectrum. Additionally, Sahra’s cousin has a
diagnosis of autism. Pet. Exs. 4-2, p. 32; 7, p. 17.

                                                     5
Disorder.17 There is possible confusion between “PDD” (the umbrella term referring to
the general diagnostic category) and “PDD-NOS,” which is a specific diagnosis within
the general diagnostic category of PDD. It is not uncommon for parents and even
health care providers to use these terms in non-specific ways, such as referring to a
child as having an “autism diagnosis,” even though the specific diagnosis is PDD-NOS.
In conveying that Sahra had pervasive developmental delay and was on the autism
spectrum, the school official was likely referring to the DSM-IV umbrella category of
PDD when describing the nature of her disability and reason for the IEP evaluation.

B. Ages Four and Five (November 2006 to November 2008).

       1. Primary Care Visits.

       On January 8, 2007, at her four year well child visit, Dr. Masucci noted that Sahra
had unspecified pervasive developmental disorder with “up and down” progression.
Pet. Ex. 11, pp. 9-10. She received the DTaP and IPV vaccines at this visit.

        She did not present to the pediatrician again until March 23, 2007, about three
months after receiving the January 2007 vaccines. Pet. Ex. 11, pp. 7-9. She was
diagnosed with acute sinusitis. Id., p. 8. No concerns about a vaccine reaction were
expressed at this visit. She was seen on April 2, 2007, and diagnosed with possible
viral gastroenteritis or an upset stomach caused by the antibiotics she was prescribed
for her sinusitis. Id., p. 7. Again, no concerns of a vaccine-related injury were recorded.

       On May 17, 2007, Sahra was seen with complaints of a runny nose and cough.
Pet. Ex. 11, pp. 3-5. Her problem history was reviewed and remained the same as
September 9, 2006. She was diagnosed with acute bronchitis. Id., p. 5. Less than a
month later, on June 9, 2007, Sahra returned to Dr. Masucci, where she was “more
interactive and cooperative than usual” during her examination, and was diagnosed with
an acute upper respiratory infection. Id., pp. 2-3.

       Her five year well child visit was performed by Dr. Marc Rosenthal with Harvard
Vanguard Medical Associates, Burlington Pediatrics on November 19, 2007. Pet. Ex.
10, p. 8. It was Sahra’s first visit to the practice group, and prior to the visit Dr.
Rosenthal had reviewed her medical records and spoken with her neurologist. Id., p. 9.
He questioned whether Sahra had experienced a true regression of skills, indicating that
she probably exhibited “slow increase and variability of development” and “continues to
gain new skills but others seem to fall away.” Id., p. 10. Sahra returned to Burlington
Pediatrics on January 15, 2008. Doctor Hoder diagnosed her with a probable upper
respiratory infection. Id., p. 7.

17
  The fifth edition of the DSM, released in May 2013, uses the umbrella term “Autism Spectrum Disorder”
rather than PDD.

                                                   6
        2. Visits to Medical Specialists.

       Doctor Ann Neumeyer, a pediatric neurologist affiliated with MGH’s Learning and
Developmental Disabilities Evaluation and Rehabilitation Services [“LADDERS”],
examined Sahra on November 15, 2006. Based on parental reports, Dr. Neumeyer
indicated that “after the age of 2 [Sahra] began loosing [sic] some words.” Pet. Ex. 7, p.
24. Doctor Neumeyer noted the strong history of developmental regression in Sahra’s
family, and suggested that Sahra was having a similar developmental regression. Id., p.
26. Sahra returned to LADDERS in December 2006. Doctor Neumeyer was concerned
that there was a genetic component to the developmental issues present in Sahra and
her older sister and encouraged a thorough consideration of possible etiologies. Id., pp.
21-22.

       Sahra was evaluated Children’s Hospital of Boston’s Developmental Medicine
Center on January 23, 2007, by Dr. Ronald Becker, a behavioral and developmental
pediatrician, and Dr. Rachel Hundley, a staff psychologist. Pet. Exs. 3, pp. 2-13; 11, pp.
71-78. They noted that when Sahra was between 36 and 40 months of age she may
have experienced language regression, and that she currently spoke only single words
or made non-word vocalizations. Pet. Ex. 3, p. 3. Based on the evaluation, which used
various assessment procedures,18 Sahra met the diagnostic criteria for autistic disorder.
She was also diagnosed with mental retardation, severity unspecified. Pet. Ex. 3, p. 10.

        On July 12, 2007, Dr. Neumeyer reported that Sahra appeared to have made
significant progress since her last visit to LADDERS on March 27, 2007. Pet. Ex. 11, p.
61. She was using single words and occasionally used full and scripted sentences. Id.
Doctor Neumeyer also noted that what was previously described as a large regression
was in fact more behavioral and Sahra “has not really lost much language at all since
birth.” Id.

        Sahra and her older sister, Osob, had an appointment at MGH’s Mitochondrial
Clinic on August 15, 2007. They were evaluated by pediatric neurology resident Dr.
David Dredge and Dr. Katherine Sims, the attending physician. Her parents reported
that their concerns started when she was approximately two years of age, and that they
felt she had a significant decline in language skills around 24 to 30 months of age. Pet.
Ex. 11, p. 53. Given her abnormal laboratory results in the past, Drs. Dredge and Sims
suggested that Sahra may have an “underlying disorder of cellular metabolism
contributing to her [austistic] symptoms.” Id., p. 54. Because of the similarity in
symptoms between Sahra and Osob, petitioners elected to initially only perform genetic
tests on Osob. Depending on the results, testing would then be conducted on Sahra.
Id., p. 55.

        The July 3, 2008 consult note from LADDERS indicates that although Sahra had

18
  The procedures included the Stanford-Binet Intelligence Scales, Bayley Scales of Infant and Toddler
Development-Third Edition, Autism Diagnostic Observation Schedule, and the Vineland Adaptive
Behavior Scales. Pet. Ex. 11, pp. 72-73.

                                                   7
not undergone a muscle biopsy, based on the results from Osob’s biopsy showing a
complex I electron transplant chain deficiency, she had begun to take a mitochondrial
cocktail.19 Pet. Ex. 7, p. 10. Since starting the cocktail in April 2006, Sahra had made
progress in her language and communication skills. However, because this
improvement coincided with an improvement in the school program she was attending,
Dr. Neumeyer noted the cause for her progress could not be conclusively identified but
recommended that Sahra continue taking the mitochondrial cocktail. Id., p. 11.

D. Further Exploration of Possible Mitochondrial Disorder.

       On January 22, 2010, Sahra was examined by Dr. Daniel Doody. She was
referred to him for a consideration of skin and muscle biopsies. He reported that Sahra
began to exhibit signs of a developmental regression at age 4. Pet. Ex. 9, p. 21-22.
However, a week later during the pre-anesthesia telephone consult, it was reported that
her language regression began at age 3. Id., p. 23.

       Sahra underwent a muscle and skin biopsy on February 3, 2010. Pet. Ex. 9, pp.
151, 178-185. The electron microscopy analysis of the muscle tissue revealed “small
subsarcolemnal clusters of mitochondria with pleomorphic shapes and increased
internal complexity.” Id., p. 186. Pathologist Dr. Anat Stemmer-Rachamimov indicated
that those findings are “non-specific, but may be seen in mitochondrial disorders.” The
skin biopsy uncovered “no definitive evidence of mitochondrial abnormality.” Id., p. 187.

       The Baylor College of Medicine’s Medical Genetics Laboratory reported the
results of their mtDNA complex 1 subunits sequencing analysis of Sahra’s sample on
May 24, 2010. The analysis detected “an apparently homoplasmic familial m.5194C>T
(p.P242L, ND2) variant.” Pet. Ex. 3, p. 17. The report noted that the laboratory was
requested to evaluate the sample for the found variant, which had previously been
found in Sahara’s mother and older sister. Other regions of the mitochondrial genome
were not sequenced. Id. The ND2 gene variant observed was listed in MitoMap as a
polymorphism, but at the time of the report was not listed in mtDB.20

        Sahara had a follow-up visit at MGH’s Mitochondrial Clinic on October 6, 2010.
Doctor Sims reported that since her April 2010 clinic visit, Sahra had been making
progress at school. Ms. Weged expressed frustration as to the pace of the progress,
but agreed there had been no regression in skills. Pet. Ex. 9, p. 129. In reviewing the
biopsy results, Dr. Sims noted that the observed “mtDNA change is of unclear
significance.” Id., p. 130.

          On June 2, 2011, Sahra had a follow-up appointment with Dr. Neumeyer at

19
  The cocktail consisted of thiamine, riboflavin, vitamin C, vitamin E, carnitine, alpha-lipoic acid,
coenzyme Q, and creatine monohydrate. Pet. Ex. 7, p. 11.
20
     Petitioners’ Exhibit 3, p. 17 referencing http://www.mitomap.org and http://www.genpat.uu.se/mtDB.

                                                       8
LADDERS.21 The past medical history section of the consult note indicates that Sahra’s
evaluation at the Cleveland Clinic did not confirm or uncover a mitochondrial disorder.
Pet. Ex. 9, p. 113. No date was given for the evaluation.

                               III. Applying the Facts to the Law.

A. Untimely Filing.

        The Vaccine Act’s statute of limitations provides in pertinent part that, in the case
of:

        a vaccine set forth in the Vaccine Injury Table which is administered after
        October 1, 1988, if a vaccine-related injury occurred as a result of the
        administration of such vaccine, no petition may be filed for compensation
        under the Program for such injury after 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 such injury . . .

§ 300aa-16(a)(2).

         Because petitioners filed the petition on behalf of Sahra on April 22, 2008, the
first symptom or manifestation of onset of Sahra’s autism cannot have occurred before
April 22, 2005, in order for the petition to be considered timely. See Markovich v. Sec’y,
HHS, 477 F.3d 1353, 1357 (Fed. Cir. 2007) (holding that “either a ‘symptom’ or a
‘manifestation of onset’ can trigger the running of the statute [of limitations], whichever
is first”); Cloer v. Sec’y, HHS, 654 F.3d 1322, 1335 (Fed. Cir. 2011) (holding that the
“analysis and conclusion in Markovich is correct. The statute of limitations in the
Vaccine Act begins to run on the date of the occurrence of the first symptom or
manifestation of onset.”). Furthermore, the date of the occurrence of the first symptom
or manifestation of onset “does not depend on whether petitioner knew or reasonably
should have known” about the injury. Cloer, 654 F.3d at 1339. Nor does it depend on
petitioner’s knowledge as to the cause of injury. Id. at 1338.

        In Cloer, the Federal Circuit also acknowledged that equitable tolling applies to
Vaccine Act cases, but only under very limited circumstances, such as when a petitioner
was the victim of fraud or duress, or when a procedurally deficient pleading was timely
filed. Cloer, 654 F.3d at 1344-45. The Federal Circuit rejected the notion that equitable
tolling should apply only because the application of the statute of limitations would
otherwise deprive a petitioner from bringing a claim. Id.

      The medical records establish, and petitioners appear to concede, that the claim
was not timely filed. Doctor Stratton’s records clearly convey that concerns regarding
Sahra’s developmental delay existed as early as May 15, 2003, when he referred her

21
  This is the most recent relevant medical record filed. The most recent record filed is from July 11, 2011
when Sahra was seen for a swollen bug bite on her check. There was no evidence of infection, and
petitioners were instructed to observe the area. Pet. Ex. 9, p. 60.

                                                     9
for Early Intervention services. While previous records listed developmental delay as a
“problem,” on September 7, 2004, Dr. Stratton listed it as a “diagnosis.” At the same
visit, he noted that she only spoke 20 words.22 Additionally, a number of medical
records note that parental concerns regarding Sahra’s speech began around November
2004, when she was two years of age. I thus find that the first symptom or
manifestation of Sahra’s autism spectrum disorder occurred prior to the critical date of
April 22, 2005.

      Petitioners have not asserted any extraordinary circumstances which would merit
equitable tolling of the Vaccine Act’s statute of limitations. I therefore conclude that this
case was untimely filed.

B. Significant Aggravation.

        To recover under a significant aggravation theory, petitioners must demonstrate
that the vaccination caused a “change for the worse in a preexisting condition which
results in markedly greater disability, pain, or illness accompanied by substantial
deterioration in health.” § 33(4); Hennessey v. Sec’y, HHS, No. 01-190V, 2009 WL
1709053 at *1 (Fed. Cl. Spec. Mstr. May 29, 2009), aff’d, 91 Fed. Cl. 126 (2010). In
Loving v. Sec’y, HHS, 86 Fed. Cl. 135, 144 (2009), the Court of Federal Claims created
a six-factor test for significant aggravation, requiring a petitioner to establish by
preponderant evidence: (1) the vaccinee’s condition prior to administration of the
vaccine; (2) the vaccinee’s current condition or condition following the vaccine; (3)
whether the comparison of the two conditions constitutes a significant aggravation of the
person’s condition; (4) a medical theory causally connecting a significantly worsened
condition to the vaccine; (5) a logical sequence of cause and effect demonstrating that
the vaccine was the reason for the significant aggravation; and (6) a proximate temporal
relationship between the vaccine and the significant aggravation. This test has been
cited with approval by the Federal Circuit. W.C. v. Sec’y, HHS, 704 F.3d 1352, 1357
(Fed. Cir. 2013).

        Less than a month after her January 8, 2007 vaccinations, those petitioners point
to in their response to respondent’s motion as significantly aggravating her condition,
Sahra underwent a developmental evaluation at Children’s Hospital of Boston. The
report from her evaluation does not mention any parental concerns about a recent
regression or change in Sahra’s development. Doctors Becker and Hundley instead
reported that that parental concern of a regression in language skills occurred between
November 2005 and May 2006, when she was 36 to 40 months of age.23 In July 2007,

22
  The vocabulary of a typical child substantially grows between 18 and 24 months of age, increasing from
around 10-15 words to 50-100 words. R. Kliegman, et al., NELSON TEXTBOOK OF PEDIATRICS (19th ed.
2011) at 27. At the time of this visit, Sahra was 22 months of age.
23
  In most of Sahra’s developmental evaluations, petitioners reported their concerns arose when she was
24 to 30 months of age. See, e.g., Pet. Exs. 11, pp. 53-54 (August 15, 2007 MGH Mitochondrial Clinic
evaluation) and 91-92 (September 26, 2006 MGH Department of Speech, Language and Swallowing
Disorders evaluation); 7, pp. 24-25 (November 15, 2006 MGH LADDERS consultation).

                                                  10
Dr. Neumeyer reported significant progress in Sahra’s language skills. Additionally, she
noted that what had previously been categorized as a regression in Sahra’s skills was
more likely behavioral in nature and stated that Sahra had not undergone a significant
loss of language. Thus, it appears that the factual support for a significant aggravation
claim is lacking.24

                                           III. Conclusion.

        The Vaccine Act provides that “no petition may be filed . . . after the expiration of
36 months after the date of the occurrence of the first symptom or manifestation of
onset . . . of such injury.” § 16(a)(2). There is preponderant evidence that the causation
in fact claim was not filed within the 36-month period and petitioners have failed to
demonstrate any extraordinary circumstances warranting equitable tolling. Therefore,
petitioners’ causation in fact claim is dismissed.

        The contemporaneous record fails to demonstrate any proximate temporal
relationship sufficient to support a colorable significant aggravation claim, suggesting
petitioners lack a reasonable basis to proceed on a significant aggravation theory.
Nevertheless, if petitioners intend to pursue such a claim, as is suggested by their
response to respondent’s motion to dismiss, they must file a second amended petition
by no later than Wednesday, September 25, 2013. Additionally, petitioners must file
an expert report supporting a significant aggravation claim by Monday, November 25,
2013. A failure to meet these deadlines will result in dismissal of this petition.

IT IS SO ORDERED.

                                         s/Denise K. Vowell
                                         Denise K. Vowell
                                         Special Master

24
   On July 17, 2012, petitioners filed an affidavit from Mr. Hashi. He indicated that after her January 8,
2007 vaccinations, Sahra cried inconsolably, had a high fever, seemed spaced out, exhibited decreased
response to her environment, would not communicate, and became monotonic with her speech. Pet. Aff.
at 3. The symptoms listed in his affidavit do not match those contained in the contemporaneous medical
records. Conflicts between contemporaneous medical records and subsequent statements are common
in Vaccine Act cases, with Special masters frequently according more weight to the contemporaneously
recorded medical symptoms than those recounted in later medical histories, affidavits, or trial testimony.
“It has generally been held that oral testimony which is in conflict with contemporaneous documents is
entitled to little evidentiary weight.” Murphy, 23 Cl. Ct. at 733 (1991). See also Cucuras v. Sec’y, HHS,
993 F.2d 1525, 1528 (Fed. Cir. 1993). Memories are generally better the closer in time to the occurrence
reported and when the motivation for accurate explication of symptoms is more immediate. Reusser v.
Sec’y, HHS, 28 Fed. Cl. 516, 523 (1993). Inconsistencies between testimony and contemporaneous
records may be overcome by “clear, cogent, and consistent testimony” explaining the discrepancies.
Stevens v. Sec’y, HHS, No. 90-221V, 1990 WL 608693, at *3 (Fed. Cl. Spec. Mstr., Dec. 21, 1990).

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