Thompson v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 15-1498V

(to be published)

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

*

CANDACE M. THOMPSON and STEPHEN E. * Special Master Corcoran

POWELL, parents of A.H.P., a minor, *

*

Petitioners, * Filed: May 16, 2017

*

v. * Decision Without Hearing;

* Dismissal; Diphtheria Tetanus

SECRETARY OF HEALTH AND * acellular Pertussis (“DTaP”)

HUMAN SERVICES, * Vaccine; Table

* Encephalopathy; Autism Spectrum

Respondent. * Disorder; Acute and Chronic

* Encephalopathy.

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

Phyllis Widman, Widman Law Firm, LLC, Ocean City, NJ, for Petitioners.

Camille Collett, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION GRANTING MOTION TO DISMISS CASE1

On December 11, 2015, Candace Thompson and Stephen Powell, on behalf of their son,

A.H.P., filed a petition seeking compensation under the National Vaccine Injury Compensation

Program (the “Vaccine Program”).2 In it, Petitioners alleged that the Diphtheria Tetanus acellular

Pertussis (“DTaP”), haemophilus influenza B (“Hib”), inactivated Polio (“IPV”), pneumococcal

1

This decision will be posted on the United States Court of Federal Claims website, and later on will be made

generally available to the public in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As

provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published 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 in its present 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. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the

Act”]. Individual section references hereafter will be to § 300aa of the Act.

conjugate (“PCV”), and rotavirus vaccines A.H.P. received on December 11, 2012, caused him

to experience a Table encephalopathy, or (alternatively) that the DTaP vaccine caused A.H.P’s

encephalopathy as well as his subsequent autism spectrum disorder (“ASD”). Amended Petition

at 2-3.

After the medical records and statement of completion were filed, Respondent filed his

Rule 4(c) Report, which included a specific motion to dismiss the petition. See Respondent’s

Rule 4(c) Report, filed on October 17, 2016 (ECF No. 27) (“Mot.”). I ordered Petitioners to

respond, and they did so on December 19, 2016. See Response to Respondent’s Rule 4 Report,

filed on December 19, 2016 (ECF No. 34) (“Opp.”). Having completed my review of the

evidentiary record and the parties’ filings, I hereby GRANT Respondent’s Motion for a Ruling

on the Record Dismissing the Case, and DISMISS Petitioners’ claim, for the reasons stated

below.

I. FACTUAL BACKGROUND

Early Medical History and Vaccination

A.H.P. was born via caesarian section on August 5, 2012, following a normal pregnancy,

and was discharged home two days later. Ex. 22 at 2. A.H.P was healthy throughout his first few

months of life, although he experienced some gastroesophageal reflux about 12 days after birth.

Ex. 4 at 72. He was seen routinely for his well-baby check-ups at Le Bonheur Pediatrics (“LBP”)

in Memphis, Tennessee,3 including his two-month visit on October 5, 2012, when Ms.

Thompson reported that his prior gastrointestinal issues had improved. At that visit A.H.P.

received the DTaP, Hib, IPV, hepatitis B (“Hep B”), PCV, and Rotavirus vaccines. Id. at 67.

Two months later, on December 11, 2012, A.H.P was seen for his four-month well-baby

exam, where he was noted to be developing normally. A.H.P. now received his second doses of

the DTaP, Hib, IPV, PCV, and Rotavirus vaccines. Id. at 65. It was the administration of these

vaccines that Petitioners allege produced A.H.P.’s subsequent injuries.

Post-Vaccination Medical History

The afternoon of A.H.P.’s December 11, 2012, well-baby visit, Petitioners began to

notice that A.H.P. was fussy and irritable; he also ran a temperature which rose to about 102

degrees. Ex. 2 at 3. Petitioners became increasingly concerned that day with A.H.P.’s condition,

leading them to call a nurse at LBP, who instructed them to administer Tylenol. Id. A.H.P.’s

3

A.H.P. saw his primary care physician, Leon O. Livingston (or Marybeth Huggins) at LBP for these well-baby

visits as well as for routine sicknesses. See generally Ex. 4.

2

symptoms persisted despite the Tylenol, so Petitioners brought him to the emergency room

(“ER”) at Le Bonheur Children’s Hospital (“LBCH”) in Memphis, Tennessee on the evening of

December 11th, around 9:30 pm. The treating physician at the ER noted A.H.P.’s irritability and

fever, as well as the fact that he had displayed no such symptoms prior to receiving his

vaccinations. Id. While at the ER, A.H.P. underwent cerebral spinal fluid (“CSF”) testing, urine

analysis, a complete blood count (“CBC”), and CT scan. Id. at 7.

Initially, A.H.P.’s differential diagnosis included “fever, viral syndrome, urinary tract

infection, sepsis, bacteremia, meningitis, [or] reaction to immunizations.” Ex. 2 at 6. The testing

results were normal, however, with the exception of a result establishing that A.H.P. was positive

for the flu virus, and fullness in the bilateral lateral ventricles and anterior fontanelle of his brain

on the CT. Id. at 10, 12. By 11:00 p.m. that evening (less than two hours from the time of his

arrival at the ER), A.H.P. was noted to be improving. Id. at 9. He appeared better, and was noted

to be “smiling, happy in dad’s lap,” and was therefore discharged home at 12:05 am on

December 12, 2012, with a diagnosis of an “[a]cute febrile illness, Influenza B, Irritability” and

was prescribed Tamiflu.4 Id. at 10-11.

Petitioners were instructed to follow up with A.H.P.’s primary care physician the next

day, and they did so on December 13, 2012 at 4:15 p.m. Ex. 4 at 62. At this visit, A.H.P. was still

intermittently fussy and running a low grade fever, but he was consolable, and was eating and

drinking well. Ex. 4 at 62. The physician specifically noted at the time that A.H.P.’s mother was

herself experiencing flu symptoms. Id. A handwritten note from the pediatrician on December

14, 2012, stated “child is afebrile/feeding well.” Ex. 1 at 14.

A.H.P’s next visit to the pediatrician was on January 29, 2013, over a month after receipt

of the vaccines in question, due to a cough, congestion, and fussiness. Ex. 4 at 61. His past

medical history was noted to be unchanged since his last visit, and he otherwise appeared

healthy. Id. He was diagnosed with otitis media and an upper respiratory infection and was

prescribed amoxicillin. Id. at 62. A.H.P continued to experience coughing and wheezing,

however, and was seen two days later by his pediatrician. Id.at 58. He was diagnosed with

bronchiolitis and was treated with Albuterol Sulfate5 and was prescribed an inhaler to use as

needed for coughing and wheezing. Id.

Close to two months later (and three months from the December 11, 2012 vaccinations),

A.H.P was seen for his six month well-baby exam on March 19, 2013. Ex. 4 at 55. The record

characterized the exam as a normal, routine visit, and A.H.P. was described as a well-developed

4

Tamiflu is the trademark for oseltamivir phosphate, which is an inhibitor of viral neuraminidase used to treat the

flu. Dorland's Medical Dictionary 1342 (32nd ed. 2012) (hereinafter “Dorland’s”).

5

Albuterol is administered by inhalation as a bronchodilator for the treatment and prophylaxis of bronchospasm

associated with bronchitis. Dorland’s at 45.

3

baby who babbled, made vowel sounds, enjoyed vocal turn-taking, rolling over, and passing

objects between his hands. Id. at 56. He received his third dose of the PCV and Rotavirus

vaccines, and at the request of his mom to split vaccine administration due to his purported

previous reaction he was scheduled to receive the DTaP and Hib vaccines in two weeks,

followed two weeks later by the IPV and Hep B vaccines. Id. at 56.

A.H.P. returned to LBP on April 8-9, 2013 for complaints of vomiting, congestion,

cough, high fever, and fussiness. Ex. 4 at 51. At the exam, A.H.P. was irritable, and both of his

tympanic membranes were erythematous, leading to a diagnosis of otitis media. Id. at 51-52. The

next day, Petitioners returned with A.H.P. reporting that his ears had improved overnight. Id. at

49.

First Record Evidence of Developmental Regression

A.H.P. did not return to LBP for the remainder of the spring or summer of 2013. His next

medical visit occurred on September 18, 2013, for his 12-month well-baby exam (now eight

months after the vaccinations in question). Ex. 4 at 47. In the review of systems section of the

medical records from this visit, Ms. Thompson is noted to have reported that A.H.P. had no

problems in the various identified physiologic fields.6 Id. The pediatrician, Dr. Leon Livingston,

stated that A.H.P. was meeting “normal 9-month milestones drinks from cups, feeds self with

finger, and waves bye-bye. Does not say Mama or Dada specifically. Walks holding on to

furniture.”7 Id. at 48. A.H.P now received his third doses of the DTaP and IPV vaccines, as well

as the first dose of Hepatitis B. Id. Dr. Livingston instructed Petitioners to return for A.H.P.’s 15

month well-baby exam, and to “consider hearing screen if speech does not improve.” Id.

Although the basis for this comment is not explicitly set forth in this particular record, it most

likely was in response to the reports of A.H.P.’s parents regarding his inability to say mama or

dada.

About three months later, on December 13, 2013, A.H.P. returned to LBP for his 15-

month well-baby visit. Ex. 4 at 45. The examining pediatrician noted that A.H.P. did not have a

vocabulary of three to six words, although his motor skills (with respect to handling a bottle)

seemed normal, and he displayed other indicia of normal development (i.e., would bring and

show toys, scribbled, etc.). Id. at 46. A.H.P. received the fourth dose of the DTaP vaccine,

varicella, and influenza vaccines. Id. The visit was generally characterized as a “normal routine

history and physical well-baby,” but the treating doctor added that there was a “concern for

speech delay,” and that a hearing test would therefore be scheduled. Id.

6

The areas covered in the review of systems was, systemic, otolaryngeal, cardiovascular, pulmonary,

gastrointestinal, genitourinary, musculoskeletal, and skin system. Ex. 4 at 47.

7

Although this visit occurred when A.H.P was thirteen months old, the records reference nine month milestones.

Notably, however, A.H.P. appears to have not had a nine-month well-baby exam.

4

A.H.P. was seen for his 18-month well-baby exam on March 14, 2014. Ex. 4 at 42.

Again, Dr. Livingston noted concerns about speech delay, stating that A.H.P. lacked the

expected vocabulary of a child of his age. Id. at 43. In the “development” section of this record,

Dr. Livingston specifically stated that A.H.P. “was normal for 18 mnth [sic] milestones except

scored a zero in communication. MCHAT [Modified Checklist for Autism in Toddlers] score:

failed screening.” Id. At this visit A.H.P. was also screened for lead, chemical, and heavy metal

poisoning. Id. Likely, because of growing concern about A.H.P’s speech delay, Dr. Livingston

proposed moving A.H.P.’s audiology appointment to an earlier date. Id. As scheduled, however,

A.H.P. also received the Hib and Hep A vaccines. Id.

Thereafter, from April to December 2014, A.H.P. was seen several times by Dr.

Livingston for minor, common childhood illnesses. Ex. 4 at 21-41. It was noted at each of those

visits that A.H.P. had a speech delay. Id. at 21, 23-24, 26, 29, 31, 33, 35-36, and 38. On July 7,

2014, Ms. Thompson herself reported that although A.H.P. walked, ran, and climbed like other

toddlers, she had concerns that he was not talking. Id. at 36.

A.H.P. received a formal developmental evaluation at the Boling Center for the

Developmental Disabilities (“BCDD”), in Memphis, Tennessee on November 20, 2014. See

generally, Ex. 15. He was referred for this evaluation by Dr. Livingston to “rule out an autism

spectrum disorder and possible speech delay.” Ex. 15 at 1. The report indicated that while A.H.P.

began babbling near 14 months of age, he had not by that date said his first word, nor was he

able to follow basic instructions. Id. The evaluation determined that A.H.P. had auditory

comprehension at a ten-month level, total language ability at an 11-month level, receptive

language of six months, and expressive language of seven months. Id. at 2. His scores indicated

that he had a “severe mixed receptive and expressive language delay relative to his chronological

age.” Id.

Further Evaluation for Autism and Mitochondrial Dysfunction

On January 14, 2015, A.H.P. returned to LBP for treatment of a cough and congestion.

Ex. 4 at 18. Mr. Powell informed the treaters about A.H.P.’s developmental evaluation at BCDD,

but that he had received no additional information regarding next steps. Id. at 19. Dr. Livingston

thus began a discussion with the Petitioners about having A.H.P. evaluated through

chromosomal analysis if an ASD was confirmed to be the diagnosis. Id. In the meantime,

Petitioners told Dr. Livingston that A.H.P. would begin speech therapy with Tennessee Early

Intervention (“TEI”). Id.

A.H.P. was next seen at Le Bonheur Early Intervention and Development (“LBEID”) for

a behavior early intervention observation and interview on February 5, 2015. See generally Ex.

9. The records from the visit reference a prior initial development test conducted by TEI, which

5

concluded that A.H.P. was 25 percent delayed in social emotional skills, and 40 percent delayed

in motor skills, cognition, communication, and self-help skills.8 Id. at 1. The evaluators at

LBEID determined through the Screening Tool for Autism in Toddler and Young Children that

A.H.P. scored the minimum score to be considered at risk for autism. Id. at 5.

Shortly thereafter, on February 11, 2015, A.H.P. was referred by BCDD for a

psychological evaluation at the University of Tennessee Health Science Center in Memphis. See

generally Ex. 11. It was noted that A.H.P. had a maternal family history of schizophrenia,

anxiety, depression, and paternal family history of bipolar disorder and behavioral problems. Id.

at 1. Petitioners now reported that their concerns about A.H.P. had only begun when he was 18

months old (a year after his December 2012 vaccinations), as evidenced by his delayed language

development. Id. at 2. After evaluation, it was determined that A.H.P. met the criteria for an

ASD, a global development disorder, and a language disorder. Id. at 8.

Dr. Livingston subsequently referred A.H.P. to Kathleen Jalandoni, M.D., a neurologist,

for further evaluation and for consideration of the significance of a recent “staring spell.” See

generally Ex. 7. Dr. Jalandoni performed a full exam on March 26, 2015, noting that Petitioners

reported A.H.P.’s behavior had been present for the past three to six months (meaning that it did

not begin before the fall of 2014). Id. at 1. The diagnosis section of the report listed otitis media,

asthma, head injury,9 “head trauma-CT normal since April 2014,” multiple ear infections, and

reaction to immunizations at four months old. Id. at 2-3. Dr. Jalandoni ordered and

electrocardiogram, fragile X, cytogenomic microarray analysis (“CMA”), chromosomal analysis,

and an MRI of A.H.P.’s brain.10 Id. at 4. The CMA showed interstitial deletion that involved two

exons of the NRXN1 gene, which the report stated “ha[s] been associated with autism,

intellectual disability, and schizophrenia.” Ex. 8 at 3. Both the chromosomal analysis and the

fragile X testing came back showing no significant abnormalities. Id. at 1.

On April 1, 2015, A.H.P. was seen at Mid-South Ear, Nose and Throat, in Memphis,

Tennessee, for multiple ear infections (four in the past year). Ex. 24 at 1. The treating doctor

8

Although this visit at TEI is mentioned in multiple records, it does not appear that the record of this prior visit was

filed in this case.

9

It is unclear what the head injury was. When A.H.P. was six weeks old he fell out of a hammock. Ex. 11 at 2.

Other evaluations have also documented self-injurious behavior, which could also account for this notation. Id.

10

Fragile X testing examines the X chromosome to determine if there is a fragile site, indicating that a patient has a

fragile X syndrome, which is characterized by mental retardation and enlarged facial features. Dorland’s at 1830.

CMA is a “novel diagnostic tool for individuals with unexplained developmental delay, autism spectrum disease,

and mental retardation.” Insights: Testing for Developmental Diseases, Mayo Clinic (Sept. 5, 2014)

https://news.mayomedicallaboratories.com/2014/09/05/testing-for-developmental-diseases/ (last visited March 30,

2017). Chromosomal analysis also called karyotyping analyzes the karyotypes of an individual’s chromosomes

looking for abnormalities. Dorland’s at 977. MRI stands for Magnetic Resonance Imaging. Id. at 1184.

6

determined that a myringotomy and tubes were necessary, placement of which would be

scheduled. Id. at 8. It was also noted that “patient is at increased risk of speech, language, or

learning problems from otitis media due to baseline factors.” Id. The procedure to insert the

Sheehy Activent Tubes was on April 30, 2015 and was well tolerated by A.H.P. with no

complications. Id. at 10. He was subsequently seen at two follow-up visits (on June 17, 2015 and

December 16, 2015), which noted that his ears looked good and he should follow-up every six

months. Id. at 13, 16.

Due to Petitioners’ increasing concern for A.H.P.’s development, they sought an

evaluation at Janna Hacker and Associates, speech and language pathologists, in Germantown,

Tennessee, on November 4, 2015. See generally Ex. 3. Dr. Janna Hacker noted that A.H.P’s

medical history was remarkable for “encephalopathy, dairy allergy, encephalitis, RSV, high

fevers, anxiety, apraxia, ADD/ADHD, PDD/Autism, chronic colds, reflux, frequent ear

infections, and PE tubes.” Id. at 1. This record does not elaborate on the basis for her statement

that A.H.P. had in fact experienced an encephalopathy, however. She performed a

comprehensive speech and language evaluation and concluded that A.H.P. “demonstrates a

severe receptive-expressive language disorder, pragmatic disorder, and feeding disorder.” Id. at

4.

On December 17, 2015, A.H.P. was seen for a consultation with Dr. Jill Dickerson at

Vibrant Kids Pediatrics, in Newnan, Georgia. See generally Ex. 17. The concerns expressed at

the visit included speech delay, mood swings (anger and rage), attacking violently (including

himself), picky eater, obsessive/compulsive behaviors, and sensory issues. Id. at 31. Dr.

Dickerson also listed several ongoing issues including purported chronic Lyme disease, coughing

fits-choking, knot behind left shoulder.11 Id. at 33. The record also noted “encephalopathy after

reaction to vaccines?” without explanation for that conclusion or proposition. Id. On January 28,

2016, Dr. Dickerson wrote a letter medically exempting A.H.P. from future vaccinations stating

“[i]t is now being shown in Vaccine Court that children with mutation in the MTHFR gene have

more adverse reactions to vaccines. In light of this knowledge, [A.H.P.] will receive no further

vaccines. He is medically exempted.” Ex. 6 at 1.

Beginning in February 2016, A.H.P. received therapy at the Germantown Speech

Language and Learning Clinic, in Germantown, Tennessee. See generally Ex. 25. The records

from these therapy sessions are brief entries describing what occurred on each particular visit. At

one such visit on February 15, 2016, Mr. Powell “questioned if behavior is all Lyme’s Disease -

not sure Autism is an appropriate diagnosis.” Id. at 8. In June 2016, Ms. Thompson indicated a

concern about plastic in the house and her efforts to remove all plastic. Id. at 6. In addition, she

11

This is the first record evidence of Lyme disease. Later in the record it purports that “mom thinks she may have

Lyme.” Ex. 17 at 33.

7

noted that she “met Wakefield and further discussion regarding infant shots as “cause” of Autism

diagnosis.”12 Id.

II. PROCEDURAL HISTORY

As noted above, this action was initiated in December 2015. Petition at 1. From that date

to March 8, 2016, Petitioners filed medical records, designated as Exhibits 1 through 9. On

March 9, 2016, Respondent indicated that there were still outstanding medical records, which

(after conferring with Petitioners) he anticipated could be filed in 90 days. Petitioners filed

Exhibits 10-27 and an amended petition by July 27, 2016, and subsequently filed a status report

indicating that the record was complete. See Joint Status Report, filed on July 29, 2016 (ECF No.

23).

Respondent filed his Rule 4(c) Report in October 2016 recommending that compensation

be denied and the Petition be dismissed. See generally Mot. I subsequently held a status

conference on November 4, 2016, where I discussed how the case should move forward in light

of the arguments made by Respondent in his Motion. In particular, I raised concerns about the

apparent weaknesses in the case, and the fact that the claim seemed little different from

numerous other similar claims alleging that a vaccine precipitated a developmental problem in a

child. See Scheduling Order, filed on November 4, 2016 (ECF No. 28), at 1-2. I allowed

Petitioners time to respond to the motion, specifically instructing them to attempt to identify

proof of developmental issues in close proximity to his four-month vaccination, in order to

distinguish their case from those that were unsuccessfully litigated in the Omnibus Autism

Proceeding (“OAP”) as well as thereafter.

Petitioners undertook to produce such evidence and file their brief, which was due on

December 5, 2016. On that date, Petitioners requested an extension of time in order to obtain

testing information from a mitochondrial specialist and from Dr. Dickerson. See Unopposed

Motion for an Extension of Time, filed on Dec. 5, 2016 (ECF No. 32). I denied this motion on

the grounds that it lacked sufficient reasoning as to why Petitioners could not comply with my

previously-scheduled order, and instead ordered Petitioners to file their overdue brief on or

before December 19, 2016, but allowed them to explain how mitochondrial testing would

possibly assist them in their claim. See Order Denying Motion for an Extension of Time, filed on

12

Although the record does not specify, “Wakefield” is presumably a reference to Dr. Andrew Wakefield. Dr.

Wakefield is known for creating, with the help of some of is colleagues, “the hypothesis that the receipt of the MMR

vaccine results in the development of autism spectrum disorders and gastrointestinal problems in certain children.”

The techniques used by Dr. Wakefield and his colleagues to implicate the measles vaccine in the development of

inflammatory bowel disease were criticized as flawed. Eventually, Dr. Wakefield's hypothesis was dismissed by the

scientific community following the publication of a series of methodologically sound studies by a number of groups

in the late 1990s unable to replicate the alleged findings of Dr. Wakefield.” Mead v. Sec’y of Health & Human

Servs., No. 03-215V, 2010 WL 892248 n.70 (Fed. Cl. Spec. Mstr. March 12, 2010).

8

Dec. 5, 2016 (ECF No. 33) at 2. Petitioners filed their response on December 19, 2016, and the

next day Respondent indicated in a status report that he did not intend to file a reply. See Status

Report, filed on Dec. 20, 2016 (ECF No. 35).

III. PARTIES’ RESPECTIVE ARGUMENTS

Petitioners allege that A.H.P. suffered a table encephalopathy following his receipt of the

DTaP vaccine in December 2012. Alternatively, they maintain that A.H.P.’s vaccinations caused

an acute and chronic encephalopathy and subsequent ASD. Respondent’s Motion, however,

contends that dismissal is appropriate due to a lack of evidence in support of either claim –

deficiencies that are self-evident at this stage in the case and that cannot be remedied later. Mot

at 8-12.

First, Respondent asserts that A.H.P. did not suffer a Table encephalopathy, which (in

accordance with the “qualifications and aids to interpretation” (“QAI”) promulgated by the

regulations governing the Table) requires a decreased level of consciousness lasting for at least

24 hours, and occurring within 72 hours of vaccination. Mot. at 8-9, citing 42 C.F.R. §

100.3(b)(2). The medical records, however, indicate that although A.H.P. was seen at the ER the

same day as vaccination on December 11, 2012, there was no change in his consciousness lasting

24 hours, noting that A.H.P. was “awake, smiling, and happy” not long after being brought in,

and that he was discharged from the ER a few hours after he was admitted. Id. at 9.

Petitioners’ opposition brief contests the above, pointing to purported evidence of

A.H.P.’s regression that was close in time to the vaccination – mainly statements by the

Petitioners about their observations of A.H.P. rather than contemporaneous proof. See generally

Opp. at 1-8. Although Petitioners concede that the “first documentation [in the medical records]

was eight months” after vaccination, they argue that their case is nevertheless factually similar to

those Table encephalopathy cases that have been successful, such as Wright v. Sec’y of Health

and Human Servs., No. 12-423V, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015). Opp.

at 10. They further argue that the medical records do not accurately reflect the concerns

expressed by Petitioners about A.H.P.’s development to treaters at the time, and therefore that

there is evidence of an earlier reaction sufficient to meet the Table definition. Id. at 1-2.

Second, Respondent’s motion argues that Petitioners have not established a logical

sequence of cause and effect between vaccination and injury, as they are required to do when

attempting to establish a causation claim. Mot. at 10. Petitioners have also not established an

appropriate medical timeframe between vaccine and injury, given that the records reflect no

concerns about A.H.P.’s development until eight months after vaccination—a timeframe too

attenuated for vaccine causation. Id. In addition, Respondent asserts that Petitioners’ claim

9

ignores other, more likely causes for A.H.P.’s regression, such as his underlying chromosomal

deletion and genetic mutations, both of which are commonly associated with ASD. Id. at 10-11.

In response, Petitioners argue that the “medical record is clear evidence of the temporal

relationship between the vaccine administration and A.H.P’s reaction,” despite their own

admission that the first documented sign of developmental issues was in fact eight months after

vaccination. Opp. at 9. They also assert that they are still exploring potential diagnoses or causes,

such as a possible underlying mitochondrial disorder, and therefore their claim should not be

dismissed until they are permitted time to flesh out such possible explanations for A.H.P.’s

injury, or before expert opinions have been offered in support. Id.

IV. APPLICABLE LEGAL STANDARDS

A. Claimant’s Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that

he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –

corresponding to one of the vaccinations in question within a statutorily prescribed period of

time or, in the alternative, (2) that 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).13

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

13

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. App’x 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).

10

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).

1. Table Claim Elements

Petitioners in this case argue that A.H.P suffered a Table encephalopathy. According to

the QAI applied to vaccine Table claims, a vaccinee is considered to have suffered a Table

encephalopathy if he or she manifests an injury encompassed in the definition of an “acute”

encephalopathy within the appropriate time period, and then a “chronic” encephalopathy is

present for more than six months after the immunization. 42 C.F.R. § 100.3(b)(2) (emphasis

added). In accordance with the QAI, an acute encephalopathy must be sufficiently serve to

require hospitalization (regardless of whether the vaccinee is actually hospitalized). 42 C.F.R. §

100.3(b)(2)(i). Children less than 18 months of age presenting after a seizure are considered to

have an acute encephalopathy if they have experienced a “significantly decreased level of

consciousness” that persists beyond 24 hours and cannot be attributed to the seizure or

medication. Id. The referenced phrase “significant decreased level of consciousness” must be

evidenced by the presence of at least one of the following clinical signs for at least a 24-hour

period: “(1) [d]ecreased or absent response to environment (responds, if at all, only to loud voice

or painful stimuli); (2) [d]ecreased or absent eye contact (does not fix gaze upon family members

or other individuals); or (3) [i]nconsistent or absent responses to external stimuli (does not

recognize familiar people or things).” 42 C.F.R. § 100.3(b)(2)(i)(D).

The acute encephalopathy must also be followed by a chronic encephalopathy (as defined

by the QAIs) in order to succeed on a table claim of encephalopathy. 42 C.F.R. § 100.3(b)(2). A

chronic encephalopathy exists if the change in mental state that began with the acute

encephalopathy persists for at least six months. 42 C.F.R. § 100.3(d)(1)(i). However, there is the

express caveat that;

Individuals who return to their baseline neurologic state, as confirmed by clinical

findings, within less than 6 months from the first symptom or manifestation of onset or of

significant aggravation of an acute encephalopathy or encephalitis shall not be presumed

to have suffered residual neurologic damage from that event; any subsequent chronic

encephalopathy shall not be presumed to be a sequela of the acute encephalopathy or

encephalitis. 42 C.F.R. § 100.3(d)(1)(ii).

11

2. Non-Table Claim Elements

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 v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005): “(1)

a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of

cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of

a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.

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.

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 v. Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . .

in many cases may be enough to satisfy Althen prong one” (emphasis in original)). But this does

not negate or reduce a petitioner’s ultimate burden to establish his overall entitlement to damages

by preponderant evidence. W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1356 (Fed.

Cir. 2013) (citations omitted).

The second 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 ‘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

12

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).

However, medical records and/or statements of a treating physician’s views do not per se

bind the special master to adopt the conclusions of such an individual, even if they must be

considered and carefully 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 also be

weighed against other, contrary evidence also present in the record – including conflicting

opinions among such individuals. Hibbard v. Sec’y of Health & Human Servs., 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); Caves v. Sec’y

of Health & Human Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App’x 932 (Fed. Cir.

2012); Veryzer v. Sec’y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17

(Fed. Cl. Spec. Mstr. Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344, 356 (2011), aff’d

without opinion, 475 Fed. App’x 765 (Fed. Cir. 2012).

The third 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.”

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 also coincide 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. den’d after

remand, 105 Fed. Cl. 353 (2012), aff’d mem., 2013 WL 1896173 (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 review den’d (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Law Governing Factual Determinations

The process for making determinations in Vaccine Program cases regarding factual issues

begins with consideration of the medical records. Section 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

13

in the record regarding the nature, causation, and aggravation of the petitioner’s illness,

disability, injury, condition, or death,” as well as “the results of any diagnostic or evaluative test

which are contained in the record and the summaries and conclusions.” Section 13(b)(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 a

determination is evidenced by a rational determination).

Medical records that are created contemporaneously with the events they describe are

presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s

health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. 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, Rickett v. Sec’y of Health &

Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption

is based on the linked propositions that (i) sick people visit medical professionals; (ii) sick

people honestly report their health problems to those professionals; and (iii) medical

professionals record what they are told or observe when examining their patients in as accurate a

manner as possible, so that they are aware of enough relevant facts to make appropriate treatment

decisions. Sanchez v. 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 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners

would fail to accurately report the onset of their daughter’s symptoms. It is equally unlikely that

pediatric neurologists, who are trained in taking medical histories concerning the onset of

neurologically significant symptoms, would consistently but erroneously report the onset of

seizures a week after they in fact occurred”).

Accordingly, if the medical records are clear, consistent, and complete, then they should

be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005

WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneously medical

records are generally found to be deserving of greater evidentiary weight than oral testimony –

especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;

see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d

1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v.

United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral

testimony which is in conflict with contemporaneous documents is entitled to little evidentiary

weight.”)).

14

However, there are situations in which compelling oral testimony may be more

persuasive than written records, such as where records are deemed to be incomplete or

inaccurate. Campbell v. 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 those which are internally consistent”) (quoting Murphy v. Sec’y of

Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir.

1992)). 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. La Londe v. Sec’y 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 over contrary testimony, there must be evidence that

this decision was the result of a rational determination. Burns, 3 F.3d at 417.

C. Determination to Resolve Case Without Hearing

I have opted to decide entitlement in this case based on written submissions and

evidentiary filings filed by each side. The Vaccine Act and Rules not only contemplate but

encourage special masters to decide petitions on the papers rather than via evidentiary hearing,

where (in the exercise of their discretion) they conclude that the former means of adjudication

will properly and fairly resolve the case. Section 12(d)(2)(D); Vaccine Rule 8(d). The choice to

do so has been affirmed on appeal. See Hooker v. Sec’y of Health & Human Servs., 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

15

v. Sec’y of Health & Human Servs., No. 90-882V, 1991 WL 71500, at *2 (Ct. Cl. Spec. Mstr.

Apr. 19, 1991).

ANALYSIS

I. Petitioners Cannot Meet Their Evidentiary Burden Given the Facts of this Case

After careful review of the medical records, and the arguments of both sides, I conclude

that Petitioners will not be able to establish preponderant evidence in favor of their claim, and

therefore the matter should not proceed, even if expert reports have not yet been obtained. My

decision is rooted in both the facts of this case as well as applicable decisions in previously-

litigated matters involving causation theories highly similar to the present, and which have been

exhaustively litigated since resolution of the OAP test cases.14

A. The Petitioners Cannot Establish a Table Encephalopathy

First, the record evidence does not support Petitioners’ principal allegation: that A.H.P.

experienced a table encephalopathy after his December 2012 vaccinations. In analyzing this

component of Petitioners’ claim, I apply the “very restrictive” definition of encephalopathy

utilized in Table cases, where causation is presumed only after relevant factual predicates are

14

Several years ago, more than 5,400 cases were initially filed under short form petition in the OAP, where

thousands of petitioners’ claims that certain vaccines caused autism were joined for purposes of efficient resolution.

A “Petitioners’ Steering Committee” was formed by many attorneys who represent Vaccine Program petitioners,

with about 180 attorneys participating. This group chose “test” cases to represent the entire docket, with the

understanding that the 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 measles, mumps, rubella (“MMR”) vaccine

precipitated autism, or, in the alternative, that MMR plus thimerosal-containing vaccines caused autism, while the

second theory alleged that the mercury contained in thimerosal-containing vaccines could affect an infant’s brain,

leading to autism.

The first theory was 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, 605 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 eleven 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 petitioners’

claims. These decisions found no persuasive evidence that the MMR vaccine or thimerosal-containing vaccines

16

established). Dixon v. Sec’y of Health & Human Servs., No. 01-605V, 2003 WL 23218020, at *4

(Fed. Cl. Spec. Mstr. Nov. 25, 2003), mot. for review den’d, 61 Fed. Cl. 1 (2004).

Petitioners cannot meet their evidentiary burden under that definition based on the

medical records. As Respondent points out, A.H.P. never experienced any significant change in

consciousness or the hospitalization required by the QAI to constitute an “acute”

encephalopathy. A.H.P. was seen at the hospital the night he received his vaccination, but the

records indicate that within three hours, he was noted to be “smiling, happy in dad’s lap” and

was discharged home with a diagnosis of an “Acute febrile illness, Influenza B, Irritability.” Ex.

2 at 10. What is more, there is no record evidence suggesting a subsequent “chronic”

encephalopathy extending for more than six months from vaccination. Indeed – the first evidence

of any developmental problems at all in the records does not occur until the fall of 2013, with no

intervening incidents that could help flesh out Petitioners’ claim of an ongoing encephalopathy

after the December 11th vaccinations.

B. The Petitioners’ Non-Table Claim Cannot Succeed Given the Record Facts

Second, Petitioners’ non-table causation-in-fact claim is not supported by the record

evidence, which fails to establish that A.H.P. suffered an encephalopathic event after vaccination

later resulting in autism and/or developmental problems. At best, and as Petitioners concede, the

first recorded evidence of a developmental problem is eight months after vaccination at A.H.P.’s

12-month well-baby exam. Ex. 4 at 48. That temporal gap is problematic for Petitioners, as it is

far too distant from the date of vaccination to possibly evidence an encephalopathic occurrence.

See Murphy v. Sec’y of Health & Human Servs., No. 05-1063, 2016 WL 3034047, at *35 (Fed.

Cl. Spec. Mstr. April 25, 2016). To prove the existence of an encephalopathy, Petitioners would

need some evidence closer in time to the vaccinations of neurologic injury – yet even when I

specifically instructed the Petitioners to point to all record evidence of regression or other harm,

this remains the best evidence they can muster.

Petitioners maintain that their own testimony can help remedy this evidentiary gap,

maintaining that their concerns about A.H.P. were voiced to treaters but not set down in the

medical records. As a general matter, however, contemporaneously-recorded medical records are

generally found to be deserving of greater evidentiary weight than after-the-fact oral testimony –

especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;

see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d

1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v.

United States Gypsum Co., 333 U.S. 364, 396 (1947). The assertion that medical records

consistently failed to include parental developmental concerns are not well-founded or

persuasive, and are not otherwise corroborated by any other evidence that would bulwark

caused autism. The OAP proceedings concluded in 2010.

17

Petitioners’ own assertions about A.H.P.’s medical status in this time period. The record suggests

more strongly the opposite conclusion: A.H.P. did not experience an encephalopathy after his

December 2012 vaccinations.

C. This Case is Similar to Other Unsuccessful Cases Alleging Vaccine- Caused

Autism

Dismissal of this case is also warranted given its high similarity to the many other

dismissed non-Table claims alleging that a vaccine caused an autism or ASD-like developmental

injury. As I have noted in other similar cases, in the wake of the OAP petitioners seeking to

establish an autism injury after vaccination face a very high bar – for to date, no such claims

have succeeded. See Wolf v. Sec’y of Health & Human Servs., No. 14-342V, 2016 WL 6518581,

n. 13 (Fed. Cl. Spec. Mstr. Sept. 15, 2016). Indeed, more recent efforts by petitioners to cast their

claim as autism indirectly caused by a vaccine-induced encephalopathy (as the Petitioners argue

herein) have been noted by the Court of Federal Claims to reflect attempts to evade the long line

of cases casting considerable doubt on theories involving autism and vaccines. Cunningham v.

Sec’y of Health & Human Servs., No. 13-483V, 2016 WL 4529530 (Fed. Cl. Spec. Mstr. Aug. 1,

2016) aff’d, 2017 WL 1174448 (Fed. Cl. March 22, 2017) (disregarding “petitioner’s attempt to

differentiate this case from other autism cases by creating this second step”—that post-

vaccination developmental regressions can be attributed to a vaccine-induced encephalopathy

even if there is no evidence of an encephalopathic reaction). While the outcome herein is not

determined by these numerous prior decisions, which do not control my decision from a

precedential standpoint, they persuasively suggest that this case should be resolved in similar

fashion.

Because of the foregoing, I ordered Petitioners to explain what made this case different –

factually or otherwise – from those that have gone before it. In response, Petitioners have

referenced Poling v. Sec’y of Health & Human Servs., No. 02-1466v, 2008 WL 1883059 (Fed.

Cl. Spec. Mstr. Apr. 10, 2008) and Wright v. Sec’y of Health & Human Servs., No. 12-423V,

2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015). See Opp. at 10. They argued that, like

the petitioners in those purportedly-successful cases, A.H.P.’s ER visit the night of his

vaccination showed “clear causation, demonstrating the extreme factual circumstances reflecting

an encephalopathy.” Opp. at 10. It is instructive to consider the particular facts of those two

cases – for each is readily distinguishable, as I have explained before in other decisions.

In Poling, the child in question (who was later diagnosed with a mitochondrial disease

that allegedly made her susceptible to adverse effects of vaccination) had received several

vaccinations, and then within 48 hours developed a high fever that became low-grade over the

next several days, along with inconsolable crying, sleeplessness, and significant, noticeable

motor problems that worsened over the next several days. Respondent settled that case before a

trial was held, and thus there was no adjudication in favor of the claimant. Thus, Poling not only

18

says nothing about the strength of this case (since there is no holding that can provide me with

guidance), but it also facially involves facts more extreme than the present circumstances (given

that A.H.P. has not been shown to have experienced immediate and/or dramatic changes in

behavior, consciousness, or otherwise after the December 11, 2012 vaccinations). A.H.P. did not

continue to have a low-grade fever, nor did he begin to show decreased motor function after his

ER visit the day of his vaccination, but instead experienced a rapid and immediate recovery. Ex.

4 at 61. The medical records would tell a completely different story if an encephalopathic

reaction had occurred.

In Wright, Petitioners met the Table criteria for an “acute encephalopathy” following

vaccination by establishing with preponderant evidence that the vaccinated child had

experienced a seizure followed by loss of consciousness shortly after receipt of pertussis-

containing vaccine; the severe reaction lasted for more than 24 hours, with resulting

demonstrable significant changes in behavior. No such facts are evident here. Moreover, Wright

provides little guidance in determining the outcome of a non-Table claim involving an alleged

encephalopathy resulting in autism – for as the special master responsible for that decision

(former Chief Special Master Vowell) explicitly noted in her decision, the petitioners’ expert

presented a causation opinion that she found “absurd and biologically impossible.” Wright, 2015

WL 6665600, at *2.

Given the above, it is evident that Petitioners have not established that this case is

anything like the very rare instances in which a vaccine has been held to be related to a child’s

developmental injury – while also failing to rebut the claim’s high similarity to the vast majority

of cases that have found such a theory wanting.

D. Petitioners Cannot Satisfy the Three Althen Prongs

Give the above, it is evident that Petitioners have not met their burden under the analysis

set forth in Althen for proving a causation-in-fact claim.

Prong One: Petitioners cannot present a reliable medical or scientific theory explaining

how the DTaP vaccine could cause a table encephalopathy, or (alternatively) cause an acute and

chronic encephalopathy leading to an ASD. Even if I were to allow Petitioners time to hire

experts and develop a theory, it is highly unlikely to be distinguishable from those that have been

repeatedly advanced but rejected in the Program. And in any event, my determination that under

the facts of this case A.H.P. did not experience an encephalopathy, and did not manifest

developmental problems in a medically-recognized and appropriate timeframe from his

December 2012 vaccinations, moots any possible successful showing Petitioners might make

with respect to theory. Combs v. Sec’y of Health & Human Servs., No. 08-0818 , 2014 WL

1677584, at n. 12 (Fed. Cl. Spec. Mstr. April 8, 2014).

19

Prong Two: Petitioners’ obligation under the second Althen prong was to demonstrate a

logical sequence of cause and effect connecting the particular facts of their case to their medical

theory. See, e.g., Sturdivant v. Sec’y of Health & Human Servs., No. 07-788V, 2016 WL 552529,

at *18 (Fed. Cl. Spec. Mstr. Jan. 21, 2016) (prong two requires a fact-based inquiry into whether

the vaccine in question did cause the particular injury). But the medical record is bereft of

reliable evidence that any reaction A.H.P. experienced the day of vaccination rose to the level of

an encephalopathy – or that this alleged encephalopathy subsequently lasted for several months

until the time that A.H.P. actually manifested developmental problems. Without such evidence,

Petitioners cannot succeed on a claim that A.H.P. suffered a table or non-table encephalopathy

leading to an ASD.

Prong Three: Even if I had accepted Petitioners’ theory that A.H.P. experienced an

encephalopathy, his ASD or developmental symptoms have not been shown to have occurred

within a medically appropriate timeframe from the date of the December 2012 vaccinations. The

Petitioners themselves admit that the medical records do not show developmental issues until

eight months after vaccination. Although they urge me to rely on their affidavits (that would

identify the symptoms beginning sooner) rather than the medical records, to do so would be at

odds with the established practice of the Program of giving greater weight to contemporaneous

medical evidence. Murphy, 23 Cl. Ct. 726, 733 (1991)(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.”). Here, the

temporal gap between receipt of the vaccines at issue and the documented beginning of A.H.P.’s

developmental problems is demonstrably too great to suggest a causal relationship.

II. Dismissal of the Claim is Appropriate at this Early Stage

A hearing provides a petitioner with the opportunity to put on live testimony, which aids

the special master most in cases where witness credibility is at issue or where there is a need to

pose questions to a witness in order to obtain information not contained in, or not self-evident

from, the existing filings. See, e.g., Hooker, 2016 WL 3456435, at *21 (discussing a special

master’s discretion in holding a hearing and the factors that weighed against holding a hearing in

the matter); Murphy, 1991 WL 71500, at *2 (no justification for a hearing where the claim is

fully developed in the written records and the special master does not need to observe the fact

witnesses for the purpose of assessing credibility). It may also permit a claimant to expand upon

or illuminate points already set forth in paper filings, or respond to unanticipated questions raised

in the matter – but again, only where necessary to reach a decision.

Prior decisions have recognized that a special master’s discretion in deciding whether to

conduct an evidentiary hearing “is tempered by Vaccine Rule 3(b),” or the duty to “afford[] each

party a full and fair opportunity to present its case.” Hovey, 38 Fed. Cl. at 400-01 (citing Rule

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3(b)). But that rule also includes the obligation of creation of a record “sufficient to allow review

of the special master’s decision.” Id. Thus, the fact that a claim is legitimately disputed, such that

the special master must exercise his intellectual faculties in order to decide a matter, is not itself

grounds for a trial (for if it were, trials would be required in every disputed case). Special

masters are expressly empowered to resolve fact disputes without a hearing.

In this case, live witness testimony was not required in order for me to reach a reasoned

decision. The medical record itself was expansive and contained sufficient evidence upon which

to base my decision. The flaws in Petitioners’ theory and factual arguments were self-evident

from review of the medical records. Petitioners’ witness statements were uncorroborated by, or

contrary to, the contemporaneous medical record. Such evidentiary deficiencies did not require

oral testimony to be understood for purposes of deciding the case. On the contrary: the

congruence between the theory espoused herein and numerous, previously-rejected variations on

the same theme counseled against expending the time and effort necessary for a hearing.15

In seeking to avoid dismissal, Petitioners also argue that they should have the opportunity

to explore further diagnoses and expert opinions. Opp. at 8-11. But the basis for my decision is

rooted in the undisputed facts - the lack of recorded medical evidence documenting regression

shortly after vaccination, as well as the absence of evidence that A.H.P. suffered a sufficiently

severe neurologic injury that could have precipitated developmental issues.

None of the above would be ameliorated by an expert opinion. In the Vaccine Program,

an expert opinion must rely on the correct facts if it is to have evidentiary value. Davis v. Sec’y

of Health & Human Servs., 20 Cl. Ct. 168, 173 (1990) (expert’s conclusions are only as sound as

their factual predicate); Loesch v. United States, 645 F.2d 905, 915 (1981), citing State of

Washington v. United States, 214 F.2d 33, 43 (9th Cir.), cert denied, 348 U.S. 862 (1954); Fehrs

v. United States, 620 F.2d 255, 265 (1980). Given that the facts of this case neither suggest that

A.H.P. suffered an encephalopathy nor a developmental problem sufficiently associated

temporally with his December 2012 vaccinations to meet the preponderant tests for a causation

claim, the mere ipse dixit of an expert willing to say the contrary would not change the outcome

of this case.

Petitioners similarly request additional time to explore whether A.H.P. suffered from a

mitochondrial disease16 or disorder that could have interacted with the December 11, 2012

15

The decision not to hold a hearing because the claim reflected a frequently-litigated theory is not something that

would only ever negatively impact a petitioner. The opposite circumstances – where a petitioner asserted a claim

that has repeatedly succeeded in the past (for example, the allegation that the flu vaccine can cause Guillain-Barré

syndrome) – would motivate me to act in the same manner, and propose to Respondent that either the case be settled

or that it be resolved on the papers.

16

A mitochondrial disease or disorder is a maternally inherited, multi-systemic disorder, caused by mutations in the

mitochondrial DNA. Dorland’s at 539. As noted below, Program petitioners have frequently alleged that a child’s

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vaccines and produced his autism/developmental problems. Opp. at 8. At the outset, I note than

no such testing has been forthcoming despite Petitioners’ representations; their brief purported

that A.H.P. was scheduled to have such testing performed at the end of March 2017, but no

records have been produced from that visit indicating the findings (let alone corroborating the

claim that A.H.P. has some form of mitochondrial dysfunction).

More fundamentally, however, the very claim that an underlying mitochondrial disease is

a component in a child’s vaccine-induced autism has (like the theory that encephalopathy

inherently precedes autism) been repeatedly tested in the Vaccine Program - without success.

Many special masters have analyzed the medical literature on the proposed link between

vaccination and cause of an ASD due to aggravation of an existing mitochondrial disorder, but

found that persuasive evidence of such a relationship does not exist. See e.g., R.V. v. Sec’y of

Health & Human Servs., No. 08-504V, 2016 WL 3882519, at *25 (Fed. Cl. Spec. Mstr. Feb. 19,

2016) citing Hardy v. Sec’y of Health & Human Servs., No. 08-108V, 2015 WL 7732603, at *35

(Fed. Cl. Spec. Mstr. Nov. 3, 2015) (“in no case presented to me…has there been presented any

persuasive evidence that even in a child with an actual mitochondrial disorder, vaccines can

cause or aggravate that child’s ASD”); Myers v. Sec’y of Health & Human Servs., No. 13-885V,

2016 WL 7665435, at *13 (Fed. Cl. Spec. Mstr. Nov. 17, 2016); Miller v. Sec’y of Health &

Human Servs., No. 02–235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Aug. 18, 2015).17 I myself

have addressed the issue on more than one occasion. See, e.g., R.V., 2016 WL 3882519, at *25.

And I have also been previously asked to permit a claimant to look for expert support for

mitochondrial dysfunction, even though the record provides no corroboration for the conclusion

that the child in question might have such a condition. Murphy v. Sec’y of Health & Human

Servs., No. 05-1063, 2016 WL 3034047, at *37 (Fed. Cl. Spec. Mstr. April 25, 2016). There is

no more reason here for allowing the case to telescope out in a fruitless search for such evidence

than there has been in similar situations in the past.

Given all of the above, I cannot conclude that Petitioners’ claim should proceed further,

due to the lack of success of cases with factually similar circumstances. The theory that the

preexisting mitochondrial dysfunction or disease could cause the child to experience a negative reaction to a

vaccine, thereafter resulting in sufficient neurologic injury to produce a developmental condition like autism.

17

The only exception to the above is Paluck v. Sec'y of Health & Human Servs., 786 F.3d 1373 (Fed. Cir. 2015).

There, the Federal Circuit affirmed a Court of Federal Claims’s determination that a special master erred in denying

compensation to petitioners claiming (in a non-Table case) that the MMR, varicella, and pneumococcal vaccines

significantly aggravated their child's mitochondrial disease, resulting in severe neurodegeneration with

developmental effects. However, that case is readily distinguishable – both because the record evidence established

far more conclusively an obvious immediate reaction (that, significantly, was classified as “neurodegenerative,”

rather than as an ASD), and also because the child’s underlying mitochondrial dysfunction was largely not in

dispute. Id. The result in Paluck is thus sui generis, and also underscores the kind of significant and persuasive

showing a claimant must make in these circumstances.

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vaccines A.H.P. received could have caused an encephalopathy sufficient to manifest as autism

or other developmental problems, remains unreliable and lacks critical scientific support,

especially given the weak facts of this case. Under such circumstances, allowing the matter to

continue on does a disservice to the Petitioners, while misallocating judicial resources away from

cases in which factual and legal disputes warrant more attention.

CONCLUSION

The factual record does not support the Petitioners’ contention that A.H.P. suffered from

a table encephalopathy, nor does his clinical progression support a causal relationship necessary

for a non-table claim. Petitioners have similarly not established that the vaccines could cause

autism or something resembling it. Thus, Petitioners have not established entitlement to a

damages award I must DISMISS their 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.18

IT IS SO ORDERED.

/s/ Brian H. Corcoran

Brian H. Corcoran

Special Master

18

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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