IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

No. 08-0308V

Filed: August 26, 2013

* * * * * * * * * * * * * * * * * * * * * * * * * * * *

Osob Hashi, by SAFIA WEGED and *

HUSSEIN H. HASHI, her parents, *

* Autism; Statute of Limitations; First

Petitioners, * Symptom or Manifestation of Onset;

v. * Significant Aggravation

*

SECRETARY OF HEALTH AND *

HUMAN SERVICES, *

*

Respondent. *

* * * * * * * * * * * * * * * * * * * * * * * * * * * *

Elaine W. Sharp, Esq., Whitfield, Sharp & Sharp, Marblehead, MA, for petitioners.

Traci R. Patton, Esq., U.S. Dept. of Justice, Washington, DC, for respondent. 

ORDER AND RULING DISMISSING CAUSATION IN FACT CLAIM1

Vowell, Special Master: 

On May 17, 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 their amended petition, filed June 29, 2011, asserted only 

an actual causation claim, petitioners appear to rely on a signification aggravation claim

in their response. 

For the reasons set forth below, I dismiss petitioners’ causation in fact claim. If 

petitioners intend to rely upon a significant aggravation claim, they shall file a second 

amended petition setting forth the facts upon which such claim is 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 Osob’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 

 

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

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, Safia Weged and Hussein Hashi [“Ms. Weged,” “Mr. Hashi,” or 

“petitioners”] filed the short-form petition authorized by Autism General Order #12for 

compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 

§ 300aa-10, et seq.

3

 [the “Vaccine Act” or “Program”], on behalf of their minor daughter, 

Osob Hashi [“Osob”]. By filing the short-form petition, petitioners joined the Omnibus 

Autism Program [“OAP”],4thereby asserting that Osob has an autism spectrum disorder 

[“ASD”]5and 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 Osob’s 

injuries with the short-form petition. 

On April 28, 2008, the presiding special master7ordered petitioners to complete 

their petition by filing the statutorily required medical documentation8and a “Statement 

Regarding Onset,” clearly detailing Osob’s first symptom or manifestation of onset or

significant aggravation of her injury. Order, issued Apr. 28, 2008. Respondent filed her 

Rule 4(c) report on May 20, 2008, noting that petitioners had yet to file any evidence

and thus, she could not assess the merits of the claim without the medical records. 

Respondent’s Report [“Res. Rpt.”] at 4. By October 23, 2008, petitioners filed 23 

exhibits of medical records,9but did not submit a “Statement Regarding Onset.” 

 

2

The text of Autism General Order #1 can be found at http://www.uscfc.uscourts.gov/sites/default/files/

autism/Autism+General+Order1.pdf, 2002 WL 31696785 (Fed. Cl. Spec. Mstr. July 3, 2002). 

3 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).

4

The OAP is discussed in detail in Dwyer v. Sec’y, HHS, No. 03-1202V, 2010 WL 892250, at *3 (Fed. Cl. 

Spec. Mstr. Mar. 12, 2010).

5

“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).

6

42 C.F.R. § 100.3 (2011).

7

This case was reassigned to me on July 1, 2011. 

8

Section 11(c)(2) of the Vaccine Act and Vaccine Rule 2 requires that the petition be accompanied by 

medical records and affidavits.

9

Petitioners initially labeled their 23 exhibits A-W. The National Vaccine Injury Compensation Program 

Guidelines for Practice indicates that petitioners’ exhibits should be labeled using Arabic numbers. 

Accordingly, petitioners refilled most of these exhibits using numbers as Petitioners’ Exhibits [“Pet. Exs.”]

1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, and 3. However, I was unable to located Petitioners’ Exhibit S in the 
3

No further activity occurred in this case until after the conclusion of the appeals in 

the OAP test cases. On January 25, 2011, in view of the test case findings of 

insufficient evidence linking vaccines and autism, petitioners were ordered to inform the 

court if they wished to proceed with their claim or if they wished to exit the Vaccine 

Program. If they wished to proceed, petitioners were ordered to file an amended 

petition. Order, issued Jan. 25, 2011. Petitioners filed their amended petition on June 

29, 2011, alleging that the measles, mumps, and rubella [“MMR”] vaccine Osob 

received on July 1, 2002, caused an encephalopathy and sequelae. Amended Petition 

[“Am. Pet.”] at ¶ 2-3. The amended petition also alleges that Osob was later diagnosed 

with a mitochondrial disorder, specifically a Complex I Electron Transport Chain [“ETC”]

deficiency. Id. at ¶ 4. 

This case was reassigned to me on July 1, 2011. During a status conference 

held 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. I cautioned

petitioners’ counsel against obtaining an expert report at that time, in view of the 

unsettled state of the law regarding the Vaccine Act’s statute of limitations and its effect 

on payment of fees and costs on unsuccessful cases.10 Order, issued July 20, 2011. 

Between August 3, 2011, and October 18, 2011, petitioners filed a total of eight 

additional exhibits addressing Osob’s more recent medical treatment. Shortly 

thereafter, petitioners’ counsel reported that neuro-geneticist Katherine Sims had been 

retained as an expert to evaluate claims of vaccine causation and an expert report was 

forthcoming. Petitioners’ Status Report, filed Oct. 19, 2011. 

In response to petitioners’ status report, I reiterated my caution about retaining 

an expert prior to a determination that this case was timely filed. I emphasized that, 

given Osob’s age and ASD diagnosis at the time this petition was filed, a significant 

issue in this case was an absence of records of Osob’s routine pediatric care from birth 

onward, and I ordered petitioners to refocus their efforts toward developing a complete 

medical record. Order, issued Nov. 1, 2011. Additionally, I ordered petitioners to 

provide medical records identifying the physician or other specialist who diagnosed 

Osob with ASD. Order, issued Dec. 2, 2011. 

Between early December 2011 and April 2012, petitioners filed eight additional 

exhibits containing Osob’s educational and medical records from birth to early 

childhood. During this time, petitioners submitted a status report indicating that Osob 

 

subsequently filed documents, and it continues to be identified as Pet. Ex. S in his ruling. 

10 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 (Fed. Cir. 

2011), cert. denied, 132 S. Ct. 1908 (2012). 
4

suffered a pre-existing injury, specifically a mitochondrial disorder, which was 

exacerbated by repeated vaccinations. Status Report, filed Dec. 16, 2011. However, 

the report did not identify which specific vaccines were believed to have aggravated 

Osob’s disorder. 

On May 17, 2012, respondent filed a motion to dismiss petitioners’ claim, arguing

that the petition was filed approximately two years and four months after the expiration 

of the statute of limitations.11 Respondent’s Motion to Dismiss [“Res. Mot.”] filed May 

17, 2012, at 5 (noting that the petition should have been filed by December 31, 2002). 

In response, petitioners filed a joint opposition to respondent’s motions to dismiss in 

both of their children’s cases.12 In their opposition, petitioners assert that the diphtheria, 

tetanus, acellular, and pertussis [“DTaP”], MMR, and inactivated polio virus [“IPV”] 

vaccines administered on April 22, 2006,13 significantly aggravated Osob’s pre-existing 

mitochondrial disorder and that the short-form petition was filed on April 22, 2008, within 

the statute of limitations period.

14

 Petitioners’ Joint Opposition to Respondent’s Motions 

To Dismiss [“Pet. Opp.”] at 2, 5. 

As I indicated in my September 6, 2012 order, the filed medical records showed

that Osob received DTaP, MMR, and IPV vaccines on April 24, 2006, but did not include 

Dr. Peter Masucci’s consultation notes from that date or any particulars about the 

vaccinations, such as the lot number or manufacturer. Order, issued Sept. 6, 2012. 

Petitioners then filed Dr. Masucci’s complete consultation notes for Osob’s visits 

occurring between March 2005 and August 2006 as Pet. Ex. 18. 

II. Facts. 

A. Osob’s Early Health and Development. 

Osob was born on June 30, 2001.

15

 See generally, Pet. Ex. 13. She received a 

hepatitis B vaccine prior to her discharge from the hospital and continued to receive 

routinely-administered childhood vaccinations in her first year of life, without apparent ill 

 

11 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).

12 In addition to this case, petitioners have filed a petition on behalf of their daughter Sahra. (No. 08-

307V).

13 The record petitioners cited for this date, Pet. Ex. 7, pp. 2-3, is a visit from June 9, 2007. I note that the 

date of the DTaP, MMR, and IPV vaccines listed in Osob’s consultation notes is April 24, 2006, and not, 

as petitioners allege, April 22, 2006. 

14 This claim differs from petitioners’ amended petition, which identified the July 2002 MMR vaccine as 

causing Osob’s encephalopathy and sequelae. Am. Pet. at ¶ 3. 

15 Records indicate that Ms. Weged had gestational diabetes and that there was moderate meconium 

staining in the amniotic fluid, which may indicate a degree of fetal distress. However, Dr. Stratton noted 

that Osob was a well newborn. Pet. Ex. 13, pp. 141-42. 
5

effects. Id. At six months of age, pediatrician Dr. Lawrence Stratton described her as 

having excellent growth. Id., p. 128. 

1. Onset of Developmental Delay. 

Doctor Stratton first expressed concerns about Osob’s development on April 9, 

2002, at her nine month well child visit. Pet. Ex. 13, pp. 115-20. He referred Osob to 

Early Intervention [“EI”] services on May 8, 2002, noting that she had normal 

development until about nine months of age, but at that point she could not sit 

independently. Id., pp. 111-14. 

Osob received an MMR vaccine two months later at her one year well child visit 

on July 1, 2002. Pet. Ex. 13, p. 107. She was not seen again until August 29, 2002, 

and was diagnosed with a corneal abrasion. No concerns of vaccine reaction were 

expressed at this visit. Id., pp. 101-03. 

In the summer of 2002, Dr. Stratton remained concerned about Osob’s persistent 

developmental problems. See, e.g., Pet. Ex. 13, p. 108. On December 31, 2002, about 

five months after receiving the July 2002 MMR vaccine, he noted that Osob exhibited

mild language delays and her motor skills appeared to be worsening. Id., p. 94. She 

was approximately 18 months of age at the time of this visit and was still unable to walk 

without assistance. Id.

At a follow up appointment on April 29, 2003, Dr. Stratton reported that with the 

help of intervention services, Osob had begun walking and spoke a few words, but still 

exhibited motor delay. Pet. Ex. 13, pp. 80-84. He twice expressed his suspicion that 

lack of stimulation or cultural issues were causal. Id., pp. 88 (noting suspicion on Apr. 

1, 2003), 94 (noting suspicion on Dec. 31, 2002). 

Osob was formally diagnosed with developmental delay at Massachusetts 

General Hospital on June 16, 2003, when she was nearly two years old.

16

 Pet. Ex. 2.3, 

p. 24. Under the care of EI services, Osob gained milestones in both her motor and 

language development. See, e.g., Pet. Ex. 13, p. 84. Doctor Stratton noted that, at 28 

months of age, Osob was walking better and could speak about 15-20 words. Id., p. 59.

2. Events Leading to Autism Diagnosis. 

In January 2004, at about two and half years of age, Osob began to lose 

developmental milestones. Pet. Ex. 13, p. 54. Early Intervention services re-evaluated 

Osob and found global delays, noting that she previously put two words together, but no 

longer spoke many words at all. Id. On January 22, 2004, Dr. Stratton noted that Osob 

 

16 Doctor Stratton had used the International Classification of Disease Code for developmental delay in 

Osob’s records prior to this date, but his narratives expressed concern rather than a definitive diagnosis. 

See, e.g., Pet. Ex. 13, pp. 80-84. 
6

had been examined by a neurologist who indicated that she might have pervasive 

developmental disorder [“PDD”] or autism.17 Id. 

Osob subsequently underwent a full neurodevelopmental evaluation at the 

Boston Children’s Hospital on October 12, 2004. Pet. Ex. 8, pp. 5-12. According to the

report, Osob had normal language development up until 18 months of age and began 

regressing at around 20 to 22 months of age. Id., pp. 5-6. At the time of the evaluation, 

all of Osob’s developmental milestones were delayed. Id. Additionally, Dr. Ronald E.

Becker at the Children’s Hospital found that Osob’s regression and impaired social 

development were consistent with the diagnostic criteria for autism. Id., p. 12.

On November 4, 2004, Dr. Stratton noted that Osob, then three years of age, had 

regressed to rare spoken words, such as “mama,” “baby,” and “hello,” (Pet. Ex. 13, p. 8) 

and by late April 2005, nearing her fourth birthday, she became nonverbal (Pet. Ex. S). 

On April 27, 2005, neurologist Martha R. Herbert at the Massachusetts General Hospital 

noted that Osob had “complete lack of verbal language” in addition to developmental 

delay. Pet. Ex. S. She also concluded that Osob met all the criteria for autism disorder.

C. Osob from Five to Six Years of Age. 

1. April 2006 Vaccinations. 

Doctor Peter Masucci served as Osob’s primary care physician beginning in late 

2004. See generally, Pet. Ex. 7. Between November 2004 and February 2006, Osob 

presented to him on at least 16 separate occasions for a number of infections, including 

otitis media, acute sinusitis, and unspecified viral infections. Id., pp. 15-16. 

 

Osob received DTaP, MMR, and IPV vaccines at her five year well child visit on 

April 24, 2006. Pet. Ex. 18, p. 1; see also Pet. Ex. 7, p. 14. Doctor Masucci noted her 

history of autism, but indicated that she appeared well at the visit. Pet. Ex. 18, p. 2. 

Osob did not present to the pediatrician again until about a month later on May 30, 

2006, when Dr. Masucci diagnosed her with an acute upper respiratory infection [“URI”]. 

Pet. Ex. 7, p. 14. 

Osob continued to suffer from a number of infections from June 2006 through 

June 2007. Pet. Ex. 7, pp. 9-15. Based on the records, she was prescribed multiple 

 

17

 Pervasive developmental disorder or “PDD” is the umbrella term used in the Diagnostic and Statistical 

Manual of Mental Disorders (American Psychiatric Association, 4th ed. text revision 2000) [“DSM-IV-TR”] 

at 69, for certain developmental disorders, including autism (also referred to as autistic disorder), 

pervasive developmental disorder—not otherwise specified [“PDD-NOS”], and Asperger’s Disorder. 

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 PDDNOS. In conveying that Osob may have “PDD/autism,” the neurologist, Dr. Krishnamurthy, was likely 

referring to PDD-NOS and autism as specific diagnoses within the general category of PDD. The current 

DSM, DSM V, uses the term “Autism Spectrum Disorder” rather than PDD. 
7

antibiotics during that year for various infections, including otitis media, pharyngitis, URI, 

sinusitis, and streptococcal sore throat. Id., pp. 9-14, 21. 

2. January 2007 Hospitalization. 

Osob was seen by Dr. William E. Butler at the Massachusetts General Hospital 

on January 4, 2007, to discuss the results of her December 29, 2006 magnetic 

resonance imaging [“MRI”] scan, which revealed the appearance of an arachnoid cyst 

compressing the superior vermis of her cerebellum. Pet. Ex. 2.2, p. 2. Doctor Butler 

concluded that the progression of the cyst might be contributing to her gross motor 

imbalance. 

On January 29, 2007, Osob underwent surgery to decompress the cyst. Pet. Ex. 

2.3, p. 5. Shortly thereafter, on February 5, 2007, her physical therapist noted that 

Osob’s motor skills were improving. Pet. Ex. 2.2, p. 18. 

D. Osob’s More Recent Medical History. 

1. Primary Care Visits. 

Doctor Marc A. Rosenthal served as Osob’s primary care physician beginning in 

October 2007 until about March 2008. See generally, Pet. Ex. 6. On November 12, 

2007, he expressed concerns about her severe regression, noting that Osob had no 

verbal language and did not follow general directions. Id., p. 17. He was not convinced 

that autism was the most accurate diagnosis, but agreed that it defined her profile. Id., 

p. 18. 

Osob presented to Dr. Rosenthal again on January 18, 2008, for behavioral 

changes. Petitioners reported that recently Osob had become impulsively aggressive 

and appeared more irritated without apparent cause. Pet. Ex. 6, p. 11; see also Pet. Ex. 

3, p. 7. They believed that the onset of these behavioral difficulties began a few months 

after Osob’s surgery in January 2007 for cyst removal. Pet. Ex. 6, p. 12. During the 

evaluation, Dr. Rosenthal noted that Osob exhibited self-injurious behavior, hand 

flapping, an inability or refusal to follow commands, and lacked “social regard.” Id. He 

also noted that Osob had no history of current illness and attributed her behavioral 

changes to the “evolution of her developmental disorder/autism” and not to “a specific 

NEW cause.” Id. (emphasis original). 

2. Events Leading to Mitochondrial Disorder Diagnosis. 

On December 13, 2006, before her cyst surgery, Osob was evaluated at 

Learning and Developmental Disabilities Evaluation and Rehabilitation Services 

[“LADDERS”]. Pet. Ex. 3, pp. 1-2. Doctor Ann M. Neumeyer noted that Osob had 

continued to regress after the initial onset of regression at 18 months of age, and 

currently exhibited possible myopathy and proximal muscle weakness. She also 
8

discussed the strong possibility of a genetic and metabolic disorder underlying Osob’s 

developmental problems. Id. 

Osob was subsequently evaluated at the Massachusetts General Hospital’s 

Mitochondrial Disorders Clinic on August 15, 2007 by pediatric neurology resident Dr. 

David Dredge and attending physician Dr. Katherine Sims. Pet. Ex. 2.1, pp. 20-22. 

They noted that Osob had developed repetitive behaviors and stereotyped hand 

movements over the last few years and her parents were concerned that she was 

regressing. Id., p. 20. However, they indicated that Osob had no history of frequent 

illnesses and, apart from Osob’s initial regression, which was a common occurrence 

among autistic children, Osob had not exhibited any “clear regression or loss of skills in 

the last couple of years.” Id., p. 22. 

Doctor Neumeyer authored a letter, dated October 25, 2007, indicating that Osob 

had a notable family history of autism in that her paternal cousin and paternal uncle 

both had autism spectrum disorder. Pet. Ex. 3, p. 5. She also indicated that Osob’s

muscle biopsy revealed “some nonspecific features with complex mitochondrial cristae 

and some subsarcolemmal clusters with enlarged mitochondria.” Id. 

On January 23, 2008, petitioners’ related their concerns of behavioral changes in 

Osob to Dr. Neumeyer. Pet. Ex. 3, p. 7-8. Petitioners were worried that Osob’s 

language skills were worsening and felt that her behavior was similar to what was seen 

prior to the cyst removal. However, Dr. Neumeyer noted that Dr. Rosenthal had found 

no etiology for Osob’s behavioral changes and there was no current basis for 

concluding that it was related to a re-accumulation of the cyst. Id.

On February 6, 2008, Dr. Sims discussed the results of Osob’s earlier muscle 

biopsy with Ms. Weged, indicating that Osob had a mitochondrial complex I mutation 

and a selenium deficiency. Pet. Ex. 2.1, p. 17. At a follow up visit on April 2, 2008, Dr. 

Sims noted that, in addition to a complex I ETC deficiency, Osob also had “clinical 

features including autism-like global developmental delay, developmental regression, 

behavioral disorder and GI dysmotility.” Id., p. 12. Furthermore, she believed that 

Osob’s selenium deficiency might be the cause of the myopathy. Id., p. 13. 

3. Most Recent Medical Records. 

Following Osob’s seventh birthday on July 9, 2008, Dr. Sims reported that Osob 

was in good health and showed “excellent and improving pre-language skills.” Pet. Ex. 

2.1, p. 10. By late January 2009, Osob had made great strides in learning sign

language. Id., p. 6. 

In November 2012, the date of the most recent record, Osob remained

nonverbal, and exhibited stereotyped vocal responses, sensitivity to noise, and difficulty 

in attending to environmental cues. Pet. Ex. 9, pp. 2, 6. 
9

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 Osob on April 22, 2008, the first 

symptom or manifestation of onset of Osob’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

Osob’s developmental delay existed as early as April 9, 2002. On May 8, 2002, Dr. 

Stratton indicated that Osob had normal motor development until nine months but, at 

ten months, she could not sit well. Pet. Ex. 13, p. 114. Additionally, a number of 

medical records note that Osob had normal cognitive development until 18 months of 

age (see Pet. Exs. 3, p. 1; 5, p. 29; 8, p. 5), which places the onset of her 

developmental delay in late December 2002. I thus find that the first symptom or 

manifestation of Osob’s autism spectrum disorder occurred long prior to the critical date 

of April 22, 2005.
10

Even if the Vaccine Act’s statute of limitations ran from the date of diagnosis and 

not the first symptom or manifestation of onset, this case would still be untimely filed as 

Osob was diagnosed with autism in October 2004, six months prior to 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). 

Osob was diagnosed with autism in October 2004 and had been suffering from 

developmental problems at the time she received the April 2006 vaccinations. See Pet. 

Ex. 8, pp. 5-12. Following her April 2006 vaccines, she next sought medical care over a 

month later when she was seen for a URI. She was seen for a number of infections in 

the following year, received surgery for a brain cyst, and made gains in motor skills 

subsequent to the surgery. The first contemporaneous medical record to note 

regression was at a primary care visit in November 2007, 19 months after the April 2006 

vaccinations. In a non-contemporaneous history recorded in January 2008, petitioners 

dated Osob’s regression to a few months after the January 2007 surgery, placing onset 

of the regression about one year after the April 2006 vaccinations. Additionally, both Dr. 

Rosenthal and Dr. Neumeyer considered the progression of Osob’s developmental 

problems as consistent with her autism diagnosis. See Pet. Exs. 6, p. 12; 2.1, p. 22. 

Thus, it appears there is no close temporal connection between Osob’s worsened 

symptoms and the April 2006 vaccinations.18

 

18 On July 16, 2012, petitioners filed an affidavit from Mr. Hashi. He indicates that after receiving

vaccinations on April 22, 2006, Osob’s behavior changed. For example, she started to bite things, make 

loud vocalizations, have irregular sleep, and became non-verbal. Pet. Aff. at 2-3. 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 
11

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

 

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).