Wright v. Secretary of Health and Human Services

IN THE UNITED STATES COURT OF FEDERAL CLAIMS

OFFICE OF SPECIAL MASTERS

No. 12-423V

Filed: September 21, 2015

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

MARY KATE WRIGHT and *

GARRY WRIGHT, * Table Encephalopathy;

as legal representatives of a minor child, M.W., * Postvaccinal Encephalopathy;

Petitioners, * Acute Encephalopathy; Chronic

v. * Encephalopathy; Severity

* Requirement; Corroboration

SECRETARY OF HEALTH * of Testimony

AND HUMAN SERVICES, *

Respondent. *

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

Mindy Michaels Roth, Britcher, Leone & Roth, LLC, Glen Rock, NJ, for petitioners.

Lara Ann Englund, U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT1

Vowell, Special Master:

On June 28, 2012, Mary Kate Wright and Garry Wright [“Mrs. Wright,” “Mr.

Wright” or “petitioners”] filed a petition on behalf of their minor child, M.W., for

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

§300aa-10, et seq. [the “Vaccine Act” or “Program”].2 The petition alleged that the

Pentacel vaccine (the trade name for a vaccine consisting of combined diphtheria,

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

Haemophilus influenzae type B [“Hib”] vaccines) M.W. received on July 6, 2009 caused

seizures and subsequent encephalopathy. Petition at 1.

1 Because this ruling contains a reasoned explanation for my action in this case, it will be posted on the

United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub.

L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). As provided by Vaccine Rule 18(b), each party

has 14 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 entire decision will be available to the public.

2National 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 (2012)

To prevail under the Vaccine Act, a petitioner must prove either a “Table” injury3

or that a vaccine listed on the Table was the cause in fact of an injury (an “off-Table”

injury). While the DTaP, IPV, and Hib vaccines are listed on the Vaccine Injury Table,

only the DTaP vaccine is associated with the Table injury of “encephalopathy.”4 The

petition’s first paragraph asserted that, within hours of the administration of the DTaP-

containing vaccine, M.W. “suffered from seizures and subsequent encephalopathy as

set forth in the ‘Table.’” Paragraph 74 of the petition alleged that M.W. “suffered an

encephalopathy and an autism spectrum disorder, which was caused-in-fact by the

Pentacel vaccination.” At the hearing, petitioners proceeded under both the Table injury

and the causation in fact claim.

The issue of whether M.W. experienced a Table encephalopathy after his

Pentacel vaccination is an extremely close call. Based on the facts of this case, the

definitions in the Qualifications and Aids to Interpretation [“QAI”] section of the Vaccine

Injury Table,5 and the opinions of the testifying experts and M.W.’s physicians, I

conclude that petitioners presented preponderant evidence that M.W. experienced a

seizure accompanied by brief loss of consciousness shortly after his receipt of a

pertussis-containing vaccination, and an acute encephalopathy which lasted for more

than 24 hours thereafter, and the postvaccinal changes in behavior displayed thereafter

qualified as a chronic encephalopathy persisting for more than six months. Although

there was some evidence suggesting that M.W. was ill prior to receipt of the Pentacel

vaccination, such evidence did not rise to the level of alternate cause. Similarly, M.W.’s

behavior prior to the vaccination may have included some symptoms suggestive of

atypical development, but the presence or lack of such behaviors (which do not

constitute symptoms of an encephalopathy) does not affect a determination that M.W.

experienced an acute encephalopathy followed by a chronic encephalopathy.

M.W.’s current diagnoses include an autism spectrum disorder [“ASD”].6 Some

of the behavioral symptoms of this disorder constitute the persisting encephalopathic

3 A “Table” injury is an injury listed in the Vaccine Injury Table (42 C.F.R. § 100.3 (2011)), corresponding

to the vaccine received within the time frame specified.

4See 42 C.F.R. § 100.3(b)(2). The Table definition of “acute encephalopathy,” is more restrictive than the

common medical meaning of the term. Encephalopathy is defined very broadly as “any degenerative

disease of the brain.” DORLAND’S ILLUSTRATED MEDICAL DICTIONARY [“DORLAND’S”] (32d ed. 2012) at 614.

An encephalopathy may be static or progressive.

5See 42 C.F.R. § 100.3(b). The QAI section of the Vaccine Injury Table, 42 C.F.R. § 100.3(b), contains

definitions for the terms used in the Table. See Althen v. Sec’y, HHS, 58 Fed. Cl. 270, 280 (2005), aff’d,

418 F.3d 1274 (Fed. Cir. 2005) (noting that the QAI should be used to interpret key terms found in the

FTable).

6 Respondent’s expert, Dr. Max Wiznitzer, defined an autism spectrum disorder as a neurodevelopmental

disorder that manifests with significant impairments in socialization and social communication and with

restricted interests and repetitive behaviors. Transcript [“Tr.”] at 328-29. Those with ASD have

“qualitative differences in how they interact and how they use their language to interact in a social

manner,” with “language” including “both verbal and nonverbal abilities.” Tr. at 329. They also have “an

exaggerated manifestation of typical childhood behaviors, such as opening and closing doors, playing

2

condition necessary to satisfy the remainder of the Table injury requirements—that a

chronic encephalopathy persist for at least six months and include symptoms persisting

from the acute encephalopathy.

This is not to say that the vaccine was the actual cause of M.W.’s ASD or of any

symptom of M.W.’s ASD. This decision should not be construed as holding that a

vaccine can or does cause ASD.

The legislative scheme that created Table injuries established a presumption of

causation that obviates any need for an actual causation determination. Congress

established the Table with full knowledge that applying the Table definitions would result

in compensation for some injuries not truly vaccine-caused. H.R. REP. 99-908, 18,

1986 U.S.C.C.A.N. 6344, 6359.7 See also Tr. at 326, 375-76 (Dr. Wiznitzer’s discussion

concerning the compensation of individuals for a Table injury at an earlier time in the

existence of the Vaccine Program who were later determined to have Dravet’s

syndrome (a genetic condition unrelated to vaccination)).

However, because petitioners presented actual causation evidence, I address

that evidence very briefly here. Had it been necessary to determine actual causation in

this case, petitioners would have failed to meet their burden. Doctor Yuval Shafrir’s

opinion that M.W. sustained an autoimmune reaction (that, is, an antibody response) to

Pentacel within an hour or two of the vaccination was, frankly, absurd and biologically

impossible. His opinion that M.W. experienced autoimmune encephalitis was highly

speculative, unsupported, and completely unpersuasive. In a matchup concerning

whether vaccines can or do actually cause ASD, Dr. Wiznitzer is far more qualified to

opine and is more persuasive than Dr. Shafrir. Doctor Wiznitzer’s better qualifications

and Dr. Shafrir’s poor courtroom demeanor8 have little bearing on the largely factual

and legal issues presented in this case.

with light switches,” which are seen in most toddlers, but those with ASD take it to excess. Tr. at 329. He

described those with ASD as having “areas of major fascination, numbers, letters, signs, certain subjects,”

“resistance to change in routine,” and very rigid behaviors. Tr. at 329. They are often hypersensitive or

hyposensitive to stimuli, meaning that they are “bothered by visual or auditory or tactile” stimuli much

more than the average child. Tr. at 330. They may appear insensitive to pain. Tr. 330. Symptoms of

ASD generally manifest in the second year of life, usually manifesting between 18-24 months of age.

Although subtle features of ASD may be present earlier, they become more obvious when social

demands rise. Tr. at 330-31.

7 “The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally

occur within a short time of vaccination. The Committee further recognizes that the deeming of a vaccine-

relatedness adopted here may provide compensation to some children whose illness is not, in fact,

vaccine-related.”

8 Doctor Shafrir presents challenges in a courtroom setting. Repeatedly, both when sitting at counsel

table and when on the witness stand, Dr. Shafrir muttered, sometimes apparently to himself and

sometimes in answer to questions. He interrupted questions, attempting to answer before the question

was fully framed, and tried to answer the question he wanted asked, rather than the ones counsel and I

were asking. I had to ask him repeatedly to speak up or repeat himself. At times, he used the witness

stand as a bully pulpit, railing against the autism establishment, and the mainstream approach to

3

After considering the record as a whole, I hold that petitioners are entitled to

compensation for M.W.’s condition.

I. Procedural History.

Shortly after they filed their petition, petitioners filed medical records, affidavits,

and a report from a neurologist, Dr. Arnold P. Gold. Petitioners’ Exhibit [“Pet. Ex.”] 24.9

They filed their statement of completion on August 9, 2012. Respondent’s Vaccine Rule

4(c) report, filed on December 18, 2012, recommended against compensation.

At a status conference on February 6, 2013, the special master previously

assigned to this case observed that the symptoms described in the records did not

appear to meet the Table definition of an acute encephalopathy. Petitioners requested

a fact hearing to elicit the parents’ testimony concerning M.W.’s health in the days and

months following the July 6, 2009 vaccination. Order, issued Feb. 8, 2013. The hearing

was subsequently scheduled for May 15, 2013. Order, issued Mar. 13, 2013, at 1.

The case was reassigned to me on April 2, 2013. I conducted a telephonic

status conference on April 10, 2013 to discuss the arrangements for the fact hearing,

which was to remain as previously scheduled. I ordered petitioners to file affidavits from

two additional witnesses prior to the fact hearing. Order, issued Apr. 10, 2013. On

March 24, 2013, petitioners filed affidavits from Donna Sierra and Mary Valentine. Pet.

Exs. 88 and 89, respectively.10

diagnosis and treatment of ASD. He claimed that ASD was not genetic in nature, because there was no

such thing as a “genetic epidemic.” His hyperboles were not helpful in explaining the basis for his

opinions and made them appear less than reliable. For example, at one point Dr. Shafrir claimed that the

increase in ASD prevalence was akin to epidemics such as polio, the plague, and the Black Death (all of

which he agreed were communicable diseases, unlike ASD). Tr. at 259, 417, 425-26. While I did not

reject Dr. Shafrir’s opinions based on his fervor and hyperbole, both detracted from his presentation. In

this case, he did a poor job of advancing his belief that some forms of autistic regression are, in fact, a

form of autoimmune encephalitis — one that he recently presented in a somewhat more coherent and

focused fashion, albeit unsuccessfully (see Lehner v. Sec’y, HHS, No. 08-554V, 2015 WL 5443461 (Fed.

Cl. Spec. Mstr. July 22, 2015))

9In this decision, citations to medical records, laboratory reports, and similar documents are made using

a “Pet. Ex. #, p. #” format. Citations to other petitioners’ exhibits, such as affidavits, expert reports, and

medical literature use a “Pet. Ex. # at __” format. Transcript pages also use an “at” format. Respondent’s

exhibits are cited using “Res. Ex. at __.” format.

10Petitioners did not assign exhibit numbers to these affidavits when they were filed. See ECF No. 33. In

a May 1, 2013 non-pdf order, I designated them as Pet. Exs. 27 (affidavit of Donna Sierra) and 28

(affidavit of Mary Valentine). However, petitioners later assigned these exhibit numbers to other

documents. See Pet. Ex. List, filed June 30, 2014. Therein they acknowledged the duplication, but did

not assign these affidavits new exhibit numbers. Therefore, Ms. Sierra’s affidavit is redesignated as Pet.

Ex. 88, and Ms. Valentine’s affidavit is redesignated as Pet. Ex. 89.

4

After receipt of the additional affidavits and telephone records produced in

response to the subpoena, I held a telephonic status conference on May 6, 2013.

During the status conference, petitioners indicated their intention to proceed solely on

an off-table causation theory. I therefore cancelled the hearing and ordered the filing of

expert reports.11 Order, issued May 6, 2013.

Over the next seven months, the parties each filed expert reports. Respondent

also filed medical literature and a supplemental Rule 4(c) report. I conducted a Vaccine

Rule 5 status conference on November 21, 2013. Based on the matters discussed, I

ordered the parties to propose dates for a two-day entitlement hearing. Order, filed

Nov. 22, 2013. Between the Rule 5 status conference and the hearing, petitioners filed

updated medical records, medical literature, photographs and two supplemental expert

reports from their expert, Dr. Yuval Shafrir. Respondent also filed a supplemental

expert report from her expert, Dr. Max Wiznitzer. Because Dr. Shafrir’s second

supplemental expert report was filed so close to the hearing date, I ordered that

respondent would be permitted to make any response to it via testimony at the hearing.

Based on Dr. Shafrir’s expert report, the issue of whether M.W. sustained a Table

encephalopathy was raised anew, and I permitted petitioners to proceed on both Table

injury and causation in fact claims at the hearing.

The two-day hearing was held in Newark, N.J. on July 15-16, 2014. During the

hearing I ordered petitioners to file the package insert for the Sanofi Pasteur Pentacel

vaccine discussed during the hearing. This document was filed on August 15, 2014,

and was designated as Pet. Ex. 73.

On July 22, 2014, I issued a post-hearing order permitting the parties to file

additional medical literature to support the expert testimony. Order, issued Jul. 22,

2014. I stipulated that such literature be highlighted or otherwise reflect relevant

provisions, and that it be filed by August 21, 2014. I also ordered the parties “to file

additional medical journal articles or other authoritative literature supportive of each

party’s position on the timing requisite for an antibody response from the challenge of a

vaccination” with regard to M.W.’s fourth dose of DTaP vaccine. I specified that this

literature should address whether an antibody response could occur within 24 hours of

the vaccination. Id.

Petitioners exceeded the limitations I placed on post-hearing evidence. On

August 21, they filed an expert report and curriculum vitae [“CV”] from a specialist in

allergies and immunology, Dr. Jay M. Kashkin (Pet. Exs. 75-78), and additional medical

literature.12 On August 21, 2014, respondent complied with my order to file additional

11Although petitioners filed two reports from a treating physician, Dr. Gold (see Pet. Exs. 24 and 30),

they were more in the nature of medical records than an expert report. They are discussed in more

detail, infra.

12 They also filed an affidavit from Ms. Kathleen McAllister (Pet. Ex. 74), but I had authorized them to do

so during the hearing. See Tr. at 5-6. Although I indicated that respondent could propound

interrogatories to Ms. McAllister (Tr. at 6), respondent’s counsel never requested to do so.

5

medical literature, filing Res. Exs. D-J. Petitioners filed more medical literature on

September 2, 2014, again without leave of court to do so. Pet. Exs. 79-87.

Although post-hearing briefs on specific issues were discussed at the hearing

(see Transcript [“Tr.”] at 433-35) and in my initial post-hearing order, I did not order

briefs to be filed, based on the matters submitted post-hearing and my review of the

transcripts. Neither party specifically requested the opportunity to file post-hearing

briefs.

With the last filing of medical literature on September 2, 2014, this matter

became ripe for resolution. I regret that my decision to award compensation has taken

more than a year to issue but, as indicated above, the issue of whether M.W. sustained

a Table injury was an extremely close call. The Federal Circuit’s guidance on how to

resolve cases where the evidence is in equipoise remains somewhat muddled. See,

e.g., Althen v. Sec’y, HHS, 418 F.3d 1274, 1280 (Fed. Cir. 2005) (close calls should be

resolved in favor of petitioner); but see Knudsen v. Sec’y, HHS, 35 F.3d 543, 550 (Fed.

Cir. 1994) (when evidence is in equipoise, the party with the burden of proof fails to

meet that burden). Although the evidence here is close, it is not in equipoise, and I find

in favor of petitioner.

II. Requirements for a Table Encephalopathy.

To prove a Table injury, petitioners must show that “the first symptom or

manifestation of the onset…of any such illness, disability, injury, or condition…occurred

within the time period after vaccine administration set forth in the Vaccine Injury Table.”

Shalala v. Whitecotton, 514 U.S. 268, 270 (1995) (quoting 42 U.S.C. §11(c)(1)(C)(i)). In

such cases, causation is presumed. See 42 C.F.R. § 100.3. To establish a Table

encephalopathy, petitioners must demonstrate that M.W. suffered an “encephalopathy”

as defined by the QAI section of the Vaccine Injury Table within seventy two hours of

his DTaP vaccination.

1. The Table Definitions.

According to the QAI, 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 if a chronic

encephalopathy is present for more than six months after the immunization. 42 C.F.R.

§ 100.3(b)(2).

An acute encephalopathy is “one that is sufficiently severe so as to require

hospitalization (whether or not hospitalization occurred).” 42 C.F.R. § 100.3(b)(2)(i).

It must persist for at least twenty-four hours and must meet at least two of the following

criteria: (1) a significant change in mental status, specifically a state of confusion,

delirium, or psychosis, that is not medication related; (2) a significantly decreased level

of consciousness, which is independent of a seizure and cannot be attributed to the

6

effects of medication; and (3) a seizure associated with loss of consciousness. 42

C.F.R. § 100.3(b)(2)(i)(B).

A significantly decreased level of consciousness is indicated by the presence of

one of three clinical signs for a period of at least 24 hours: “(1) Decreased or absent

response to environment (responds, if at all, only to loud voice or painful stimuli); (2)

Decreased or absent eye contact (does not fix gaze upon family members or other

individuals); or (3) Inconsistent or absent responses to external stimuli (does not

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

irritability (fussiness), high-pitched and unusual screaming, persistent inconsolable

crying, and bulging fontanelle are insufficient, standing alone or in combination, to

demonstrate an acute encephalopathy.” 42 C.F.R. § 100.3(b)(2)(E).

A chronic encephalopathy is defined in the QAI as “a change in mental or

neurologic status, first manifested during the applicable time period [that] persists for a

period of at least 6 months from the date of vaccination.” 42 C.F.R. § 100.3(b)(2)(ii). If

a person returns to a typical neurologic state after suffering an acute encephalopathy,

he or she is not presumed to have suffered residual neurologic damage and “any

subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute

encephalopathy.” Id.

2. Interpretation of the Table Provisions.

“The symptoms associated with an acute encephalopathy are neither subtle nor

insidious.” Waddell v. Sec’y, HHS, No. 10-316, 2012 WL 4829291, at *6 (Fed. Cl. Spec.

Mstr. Sept. 19, 2012). As noted in Waddell, “[t]he hospitalization requirement

underscores how serious the symptom presentation must be after vaccination to merit

classification as a Table encephalopathy.” Id. at *7 (citing to Revision of the Vaccine

Injury Table, 60 Fed. Reg. 7,685, 7,687 (Feb. 20, 1997) (preamble to final rule) (“[W]e

did not intend that hospitalization be viewed as an absolute requirement to establish an

acute encephalopathy, but rather as an indicator of the severity of the acute event.”).

In contrast, encephalopathy,13 as commonly used in the medical community,

encompasses a much broader class of injuries than the more stringent definition of

acute encephalopathy found in the QAI. As explained in Waddell, “[t]he scope of the

medical term ‘encephalopathy’ is more expansive than the narrower, statutory definition

set forth in the Table.” Id. at *12 (referencing Hazlehurst v. Sec’y, HHS, No. 03-654V,

2009 WL 332306, at *26-29 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473

(2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010)). The QAI definition of acute

encephalopathy simply does not encompass every type of brain dysfunction to which

the broader meaning of “encephalopathy” applies.

13 Encephalopathy is defined as “any degenerative disease of the brain.” DORLAND’S at 614. There are a

number of specific types of encephalopathy, with a variety of causes ranging from infections such as HIV

to mitochondrial disorders with neurologic manifestations. Id. at 614-15.

7

As noted in Waddell by then Chief Special Master Campbell-Smith,14 the QAI

definition of significantly decreased level of consciousness implies “a state of diminished

alertness that is much more than mere sleepiness or inattentiveness . . . [it] requires

markedly impaired - or strikingly absent - responsiveness to environmental or external

stimuli for a sustained period of at least twenty-four hours.” Waddell, 2012 WL

4829291, at *7.

The revised QAI definition aimed to differentiate between the “diminished

alertness and motor activity [] which characterize [a] lethargic infant or child” and the

“more serious impairment of consciousness that is the hallmark of encephalopathy (i.e.,

obtundation, stupor and coma).”15 Revision of the Vaccine Injury Table, 60 Fed. Reg. at

7687; see also Romano v. Sec’y, HHS, No. 90-1423, 1993 WL 472879, at *6 (Fed. Cl.

Spec. Mstr. Nov. 1, 1993) (citing Gerald Fenichel, CLINICAL PEDIATRIC NEUROLOGY (1st

ed. 1988) at 42) (explaining that among the altered states of consciousness associated

with an encephalopathy are states of: (1) increased consciousness, which can present

as delirium; and (2) decreased consciousness, which can present as lethargy,

obtundation, stupor, or coma.). Dramatic or severe symptoms must be present to meet

the Table encephalopathy definition.16

III. Evidence and Factual Findings.

The only real factual dispute in this case is what happened immediately before

and after M.W.’s July 6, 2009 vaccination. I therefore set forth his uncontested medical

history in a summarized fashion, followed by the matters in conflict.

14 On September 19, 2013, Chief Special Master Campbell-Smith was appointed Judge of the U.S. Court

of Federal Claims. On October 21, 2013, Judge Campbell-Smith was designated as the Chief Judge of

the U.S. Court of Federal Claims.

15Obtundation is “mental blunting with mild to moderate reduction in alertness.” Dorland’s at 1310.

“Stupor” is defined as “a lowered level of consciousness manifested by the subject’s responding only to

vigorous stimulation.” Id. at 1789

16 See, e.g., Jay v. Sec’y, HHS, 998 F.2d 979, 981, 984 (Fed. Cir. 1993) (noting the Special Master’s

comment that “[w]ith an encephalopathy we have typically seen at least one dramatic aspect. This aspect

is what separates the events from the normal range of DTP reactions” and concluding that the “dramatic

aspect” in the case was the child’s death); Gamache v. Sec’y, HHS, 27 Fed. Cl. 639, 642 (1993)

(upholding a dismissal decision in which the special master had concluded that “screaming and crying in

and of themselves are not conclusive evidence of encephalopathy. [The vaccinee’s] high-pitched and

unusual screaming and inconsolable crying are explainable as a local, systemic reaction to the DPT

vaccine rather than as indicia of encephalopathy.”); Watt v. Sec’y, HHS, No. 99-25V, 2001 WL 166636,

at *8 (Fed. Cl. Spec. Mstr. Jan. 26, 2001) (citing expert testimony that the symptoms relied upon to

establish a Table encephalopathy “cannot merely be crying, it cannot--inconsolable crying; it cannot

merely be crankiness; it cannot merely be a number of things.”).

8

A. Health and Development through 19 Months of Age.

M.W. was born in early December 2007, after an uneventful pregnancy. Pet.

Exs. 1; 4, p. 289; Tr. at 9. He appeared to develop normally. Pet. Ex. 4, pp. 279-80,

282-83. He passed a developmental screening test administered at his nine month

well-child visit; he crawled, pulled to stand, and said “mama” and “dada.” Id., p. 274.

A switch in pediatricians to Valley Pediatric Associates [“Valley Pediatrics”]

occurred around the time of his first birthday. At M.W.’s one year well-child visit, his first

visit to Valley Pediatrics, he walked, babbled, and had good receptive language.17 Pet.

Ex. 5, p. 325; see also Pet. Exs. 6 and 7 (parent affidavits indicating that M.W. was

meeting developmental milestones at one year of age: walking, talking a bit, and

feeding himself). At his 15 month well-child visit, he was mildly ill, and was reported to

say “mommy,” “daddy,” “Lily” (the name of M.W.’s older sister) and two other

undecipherable words.18 Pet. Ex. 5, p. 332.

The only thing at all unusual regarding M.W.’s well-child appointments was his

parents’ attitude toward the routine childhood immunizations. Although the vaccine

schedule calls for the initial hepatitis B vaccination to be administered shortly after birth,

his parents declined it then and again at his two week well-child visit.19 Pet. Ex. 4, pp.

282, 301. The record from this visit indicated that vaccines were discussed, but the

content of the discussion was not reflected.20 Id., p. 282. M.W. missed his one month

well-child visit, but at a visit two weeks later, the file reflected that M.W. would start

receiving his vaccines at two months of age, and that the revised schedule would

require an additional dose of the hepatitis B vaccine. Id., p. 283.

A very short note reflecting concern about immunizations appears on the record

for M.W.’s two month well-child visit, but he received his initial vaccinations (Pediarix,

Hib, Prevnar, and Rotateq) at this February 11, 2008 visit. Pet. Ex. 4, pp. 267, 284. No

reports of ill effects appear in the medical records as a result of these vaccinations, but

Mrs. Wright’s December 2009 narrative of M.W.’s medical history reflected that he had

17Unlike many pediatric practices, Valley Pediatrics did not use different preprinted forms for well-child

and sick-child visits. However, the well-child visits can be discerned by the check marks on the

“Education” section of the form.

18 The handwriting on many of the Valley Pediatrics records was unusually poor. See generally Pet. Ex.

5.

19 The childhood vaccination schedule recommended by the Centers for Disease Control and Prevention

[“CDC”] may be found at the following: http://www.cdc.gov/vaccines/schedules/easy-to-read/child.html

(last visited Sept. 9, 2015).

20Mrs. Wright testified that she initially refused the hepatitis B vaccination because it could be

administered as part of another vaccine and would thus subject M.W. to fewer shots. Tr. at 96-97. M.W.

received the Pediarix vaccine at 10 weeks, four months, and six months of age. See Pet. Ex. 4, p. 267.

Pediarix is the trade name for a combined diphtheria, pertussis, and tetanus [“DTaP”], hepatitis B, and

inactivated polio [“IPV”] vaccination. PHYSICIANS’ DESK REFERENCE [“PDR”] at 1285 (66th ed. 2012). at

1285 Thus, M.W. received in one injection what would otherwise have been three separate injections.

9

a fever after these vaccinations and received Tylenol.21 Pet. Ex. 25, p. 850. He

received the same types of vaccinations at his four month well-child visit. Pet. Ex. 4, p.

280. Again, Mrs. Wright reported in her December 2009 narrative that he had a fever

that responded to Tylenol after these vaccinations, but no other “major reactions.” Pet.

Ex. 25, p. 851. He had the same vaccinations at his six month well-child visit. Pet. Ex.

4, p. 279. There was no report of any reaction to these vaccinations. At nine months of

age, Mrs. Wright refused the recommended influenza vaccine for M.W.22 Id., p. 274.

At M.W.’s first visit to Valley Pediatrics, the influenza vaccine was discussed, but

not administered. Pet. Ex. 5, p. 325. He received Prevnar and a varicella vaccination at

this December 15, 2008 visit. Id. At his 15 month well-child visit, for reasons not stated

in the record, his measles, mumps, and rubella [“MMR”] vaccination was postponed.23

It does not appear that this vaccination was ever administered. See id., p. 324

(vaccination record). Mrs. Wright had no clear explanation for why M.W. did not receive

this vaccination. She testified that she thought it was being given when a child was two

years of age. Tr. at 98. She later told Dr. Neubrander that she was “not going to give

[M.W.] another shot after the experience he had in July after that Pentacel shot.” Pet.

Ex. 25, p. 832. However, that did not explain why the MMR was not given in April 2009

as planned, which even Dr. Shafrir thought was very surprising. Pet. Ex. 27 at 970.

Between January 2008 and July 2009, petitioners took M.W. to see his

pediatricians for several childhood illnesses. M.W. had a gastrointestinal and

respiratory illness, accompanied by thrush, when he was a little over a month old. Pet.

Ex. 4, p. 294. The illnesses resolved but the thrush returned about two weeks later and

was treated with Nystatin, an antifungal medication. Id., p. 283. In February 2008,

M.W. saw his pediatrician on three successive days for symptoms of an upper

respiratory infection. Id., pp. 291-93. He was not seen again for illnesses until he was a

little over a year old, when he had pneumonia and an ear infection. He was seen on

four occasions for this illness, twice before Christmas Day and twice afterwards. Pet.

Ex. 5., pp. 326-30. At the last visit, his fever was decreased and his pneumonia had

resolved. Id., p. 330. He was seen once more in follow-up for this illness, on January 5,

21 This narrative, entitled “[M.W.]’s Story” [hereinafter “narrative”], was prepared by Mrs. Wright in

December 2009 for Dr. Neubrander, a DAN! physician. See Pet. Ex. 25, pp. 849-54. Defeat Autism Now

[“DAN!”] physicians subscribe to treatment protocols developed by the Autism Research Institute. These

treatments may include chelation and other therapies not vetted as efficacious by controlled clinical

studies. Dwyer v. Sec’y, HHS, No. 03-1202V, 2010 WL 892250, at *20, *178 (Fed. Cl. Spec. Mstr. Mar.

12, 2010).

22 She testified that she refused this vaccination because she had an uncle who had reacted badly to the

influenza vaccine and her husband had felt “lousy” after receiving one. She added that even though she

used to receive influenza vaccines routinely, she “still got sick and still got the flu.” Tr. at 97. She added

that she did not have a lot of faith in the efficacy of the influenza vaccine. Id.

23 An entry on this form accompanying the notation about postponing the MMR vaccination appears to be

either “H/B” or “Hib,” but his vaccination record does not reflect any Hib vaccine being administered on

this date, March 12, 2009. Pet. Ex. 5, pp. 324, 332. “H/B” could refer to “husband,” in which case the first

part of the “Plan” section of the form would read “[husband] will not “r” MMR until 4/09.” Id., p. 332.

10

2009; both the pneumonia and ear infection were resolved, although he remained on

antibiotics. Id., p. 331. M.W. had a mild upper respiratory infection at the time of his 15

month well-child visit in March 2009, and another upper respiratory infection in May

2009. Id., pp. 332-33. He did not have another physician’s visit until July 2009, at

which the allegedly causal vaccinations were administered.

B. Events Surrounding M.W.’s 19 Month Vaccinations.

1. The Vaccination.

M.W., then 19 months old, was seen for his 18 month well-child appointment on

July 6, 2009.24 Pet. Ex. 5, pp. 324, 339. Mrs. Wright testified that she had driven back

from her mother’s home in upstate New York the evening prior to M.W.’s Monday

morning well-child visit. Tr. at 14. They got up early and Mr. Wright took M.W.’s older

sister to the babysitter (Mrs. Donna Sierra) while she drove M.W. to his appointment,25

which was scheduled for 8:45 AM. She and M.W. arrived early, so they walked around

in the very hot weather, trying to kill time. Tr. at 13-15; see also Pet. Ex. 6, ¶ 16.

While waiting to see the doctor, M.W. had a snack and a drink. He became

impatient and upset at the long wait and vomited and became more upset and agitated

after vomiting. Tr. at 14-18, 68; Pet. Ex. 6, ¶16. Mrs. Wright informed the pediatrician,

Dr. Leifer, that M.W. had vomited in the waiting room and asked if he should still be

vaccinated. Doctor Leifer examined M.W., questioned Mrs. Wright about how he was

feeling, and Mrs. Wright said he was fine. According to Mrs. Wright, Dr. Leifer found

M.W. “to be a happy, playful and a well-child”26 and the Pentacel vaccine was

administered by a nurse at about 9:30 AM. Tr. at 16-17, 19; Pet. Ex. 6, ¶ 16; Pet. Ex. 5,

p. 334.

Mrs. Wright’s narrative, prepared in December 2009 for Dr. Neubrander, differed

only slightly from her affidavit. She wrote that M.W. projectile-vomited going into the

doctor’s office (Pet. Ex. 25, p. 852), rather than while in the reception area as stated in

her affidavit. The other point where the affidavit and the narrative differ was that the

narrative reflected that M.W. was hysterically crying while being examined, and

24 Unlike the other well-child visits at Valley Pediatrics, the “Education” section of the form contains no

check marks, but the fact that this was a well-child visit was not contested and the “Assessment” section

of the form reflected that M.W. was a well 19 month old. Pet. Ex. 5, p. 334.

25 This conflicts with Ms. Sierra’s affidavit, which stated that M.W. had been at her home on July 6, 2009,

prior to his vaccination and that he had vomited while at her home. Pet. Ex. 88, ¶ 4. However, she

testified that she was mistaken in her affidavit, explaining that she did not care for M.W. until later in the

week after his vaccination. Tr. at 208, 218.

26The top portion of the medical records for this visit reflected the “happy/playful” comment Mrs. Wright

referenced, and likely referred to M.W.’s presentation before he vomited. Pet. Ex. 5, p. 334. The two

words which follow this remark are not decipherable. Id. The next line appears to read “Drank/ate” but

the next two-three words are also indecipherable. Id. The last two lines read “Vomited post crying in

waiting room.” Id.

11

indicated that the physician urged her to have M.W. vaccinated so that he would not

have to be put through the same scenario again. Id., p. 853. Mrs. Wright testified that

M.W. was quite upset when the nurse came into the room to administer the vaccination.

Tr. at 19.

The physical examination section, which is usually completed by the physician

performing the examination, does not reflect anything abnormal; the assessment

section reflected “Well 19 mo old” and “Crying 2° [secondary] to” what appears to be

“evaluation.” The next section simply contains the word “Pentacel.” Pet. Ex. 5, p. 334

Mrs. Wright testified that immediately after the administration of the vaccine, “I

held him [in my lap] and he was crashed; he was out.” Tr. at 19. She elaborated that

after the shot “I grabbed him, and he just kind of collapsed into me, like someone who's

just, you know, shagged out and tired and done.” Tr. at 71. Her narrative reflected that

after the vaccination, M.W. was listless, which Mrs. Wright attributed to being tired out

“from throwing a fit.” Pet. Ex. 25, p. 853. This account differs slightly (but not

materially) from Mrs. Wright’s 2012 affidavit. She asserted that M.W. “appeared

spacey” after the vaccination and then “fell asleep,” which did not concern her because

it was near his naptime. Pet. Ex. 6 at ¶ 20.

Mr. Wright testified that M.W. had not been sick the prior weekend and had

appeared to be having a great time. He did not appear to be sick the morning of the

vaccination either. Tr. at 117.

Based on this evidence, I conclude that M.W. ate and drank while in the waiting

room, vomited in the waiting room, became agitated and upset, and was still more

agitated while being examined. The pediatrician, Dr. Leifer, examined M.W. and did not

record anything to suggest that he was acutely ill or too ill to receive a vaccination.

M.W. received the Pentacel vaccination the morning of July 6, 2009, and most likely did

so around the time (9:30 AM) reported by Mrs. Wright.

2. Post-Vaccination Drive Home.

The issue in controversy regarding what happened during the drive home from

Valley Pediatrics concerns what Mrs. Wright was describing when she used the term

“convulsed.”

I begin with the very abbreviated description in M.W.’s records. A continuation

page for the pediatric records of the July 6, 2009 visit reflects: “Mother called. Pt

[patient] vomited on way home.” Pet. Ex. 5, p. 335. The next word is difficult to read,

but might be “Discussed.” Id. The next entry reads “ø resp distress,” which I interpret to

mean “No respiratory distress.” Id. The last line above the signature (which appears to

be the same as the signature of the physician who performed the well-child

examination) is “will observe [and] call when gets home.” Id.

12

Mrs. Wright’s narrative, affidavit, and testimony are more detailed. The narrative

reported:

In the car on the way home he convulsed but had nothing left to throw up.

I now realize he most likely had a seizure. I pulled the car over and called

the Dr’s office because he was just kind of staring into space. They asked

me a bunch of questions but thought I didn’t need to come back or go to

the ER and I should just give him some Tylenol/Motrin when I got home.

Pet. Ex. 25, p. 853.

This account differs slightly (but not materially) from Mrs. Wright’s 2012 affidavit.

She reported:

On the way home from the doctor’s office [M.W.] convulsed and vomited.

I immediately pulled over to the side of the road and felt his forehead. He

was warm. His head rolled backwards and he was not responding to me.

Pet. Ex. 6 at ¶ 21. The report in the affidavit concerning her call to the pediatrics

practice was essentially the same account she made in her narrative for Dr.

Neubrander, but she added, “I was assured that he would be fine.” Id.; see also Tr. at

27.

Mrs. Wright testified that, as she drove M.W. home around 10:00 a.m., she

noticed that he was failing to interact with her. Tr. at 20. When she looked back at him,

his head was back and to the side, his eyes were rolled back, and he “convulsed,”

which she described as shaking. She could not recall if he stiffened as well. Tr. at 73.

She called his name and he did not respond (“seemed out of it”). Tr. at 20-21, 73. She

pulled the car to the side of the road, and went over to his side of the car, by which time

he had stopped convulsing. Tr. at 73-74. He vomited after he stopped shaking, and the

shaking did not last very long. Tr. at 21-22, 73. She described him as “spacey” and

“out of it.” Tr. at 21. M.W. did not look at her. Mrs. Wright said he was “just out of it

and zoned out.” Tr. at 21.

Using 411 services, she reached Valley Pediatrics, where she reported that M.W.

had “just convulsed” and asked to speak to the doctor. Tr. at 21-22. Doctor Leifer

came on the telephone quickly, and asked Mrs. Wright to describe what had happened.

Mrs. Wright asked if she should take M.W. to the emergency room or back to the

practice. The doctor told her to take him home and monitor him, and that someone from

the practice would call. Tr. at 22. Mrs. Wright testified that her cell phone records

showed that the call occurred at about 10:08 or 10:10. Tr. at 72. This would have been

about 15-20 minutes after leaving the practice. Tr. at 72-73.

In his testimony and affidavit, Mr. Wright also recounted what he was told about

the events in the car. His affidavit reflected that his wife called him on her way home

13

and reported that “[M.W.] convulsed and vomited in the car. She stated that M.W. was

running a fever and she believed he had a seizure of some sort” and that she had called

the doctor’s office and was told he would be fine and that this was normal after

vaccinations. Pet. Ex. 7, ¶ 10. I note that at no point in her testimony did she claim that

M.W. had a fever in the car, although consistent with her affidavit, Pet. Ex. 6 at ¶ 21,

she said he felt “warm.” Tr. at 29, 75. She also testified that it was 90° that day and

she didn’t know if M.W. was running a fever or not. Tr. at 75.

Mr. Wright testified similarly, but did not mention the fever in the car. He

described Mrs. Wright as “quite unconsolable” and that she was “really scared or really

upset.” Tr. at 115. He mentioned fever in the context of the advice from the pediatric

practice to monitor M.W.’s temperature because “he was apparently getting a fever.”

Tr. at 115.

Ms. Sierra testified that Mrs. Wright called her the afternoon of July 6, 2009, to

tell her that she would not bring M.W. over for babysitting; instead, because of the

convulsions in the car, she was taking him home. Tr. at 208-09.

M.W.’s great aunt, Mary Valentine,27 signed an affidavit in April 2013, which

reflected that her niece had called her the day of the vaccinations and reported that

M.W. threw up in the doctor’s office and recounted Mrs. Wright’s telephone

conversation with the pediatric practice. Pet. Ex. 89 at ¶ 7. Ms. Valentine also

indicated that Mrs. Wright asked if she should take M.W. to the emergency room. Id. At

the hearing, she acknowledged that there was no telephone call to or from her and the

petitioners that day, but rather that the call occurred on July 10. Tr. 180-81, 193.

Ms. Valentine testified that when she spoke with Mrs. Wright on July 10, 2009,

Mrs. Wright informed her that M.W. had thrown up, had convulsed in the car, that M.W.

was just lying around, and that she had called the pediatrician’s office several times. Tr.

at 181-82. Ms. Valentine testified that she shared her story of her daughter’s lethargic

reaction after a vaccine with Mrs. Wright, as she was “trying to make her feel better.”

Tr. at 182.

One of the post-hearing filings by petitioners was an affidavit from another of

Mrs. Wright’s aunts, Ms. Kathleen McAllister. See Pet. Ex. 74. During the hearing, Mrs.

Wright testified that some of the telephone calls listed on Pet. Ex. 26 placed on July 6-7,

and 9-10, 2009, were calls to or from “Aunt Kathy.” She explained that the calls she

thought were made to Ms. Valentine were actually to her other aunt, Kathy McAllister.

Tr. at 38-42. Ms. McAllister’s affidavit confirmed that these calls were made and that

they discussed M.W.’s condition after his vaccination on July 6. Pet. Ex. 74. Ms.

McAllister did not profess an exact memory of what was said, but she did remember

27Ms. Valentine is a teacher with over 28 years of experience, and has taught special education students.

Tr. at 177. She indicated that she was teaching first grade at the time of the hearing. Id.

14

Mrs. Wright reporting that M.W. convulsed in the car on the way home from the doctor’s

office and asked the doctor if she should take him to the emergency room. Id. at ¶¶ 6-7.

Doctor Shafrir did not really address what he thought had transpired in the car,

other than to say that he thought M.W. experienced an acute encephalopathy. Tr. at

288. He thought, based on Mrs. Wright’s descriptions, that M.W. lost consciousness

during the seizure. Tr. at 234, 292.

Doctor Wiznitzer testified that, based on Mrs. Wright’s descriptions of the events

in the car, he could not determine what she meant by “convulsion,” because she simply

said that M.W. shook. Tr. at 347. Rather than an epileptic event or a seizure, he

referred to the event as a paroxysmal28 event, and added “if you want to use the generic

term ‘seizure’ to apply to things that may be epileptic or non-epileptic; in other words,

arising from the brain or not, then you can use that term.” Tr. at 347. He added that

there are many reasons why children have paroxysmal events. Tr. at 347, 392. He

explained that the shaking she described could simply have been associated with the

subsequent vomiting. Tr. at 348. He indicated that vomiting was not a common event

after experiencing a seizure, although it could happen. Tr. at 391.

I find that the events in the car occurred within two hours of M.W.’s initial

vomiting episode, and within one hour of his vaccination. I base these time frames on

Mrs. Wright’s testimony about the time of the appointment (8:45 AM), on some time

being spent in the waiting room, on the vaccines being administered after M.W. was

examined by Dr. Leifer, on Mrs. Wright’s being 15 to 20 minutes into the drive home

when M.W. convulsed and vomited, and on her making the telephone call to the

pediatric practice at around 10:08 to 10:10 AM.

Based on the evidence available, I find that M.W. most likely experienced a brief

seizure in the car on July 6, 2009. The description of his head thrown back and turned

to the side, eyes rolled back, and convulsive shaking are consistent with a seizure. His

lack of responsiveness to his name and his mother’s presence are consistent with a

loss of consciousness, and thus I find that the seizure was one accompanied by a loss

of consciousness. Mrs. Wright’s descriptions of M.W.’s behavior and symptoms after

the vaccination strongly suggest a post-ictal state.

I find it unlikely that she used the term “seizure” to anyone on the day of the

vaccination. Had she reported that M.W. had a seizure to anyone at the pediatrics

practice, most pediatricians would have reflected that in the record.29 Mrs. Wright was

28“Paroxysmal” is defined as a sudden intensification of symptoms, a spasm, or a seizure.” DORLAND’S at

1384. Thus, even Dr. Wiznitzer’s testimony is consistent with M.W. experiencing a seizure.

29Doctor Shafrir was highly critical of Valley Pediatrics’ record keeping, particularly regarding the lack of

documentation of the many telephone calls between the Wright residence and the practice. See Pet. Ex.

27 at 983. Doctor Wiznitzer conceded that the record keeping was poor and that conversations with the

doctor or nurse at Valley Pediatrics should have been documented. Tr. at 411-12.

15

clearly distressed by what she witnessed, and whatever she told the person who

answered the telephone at the pediatric practice sounded urgent enough to interrupt Dr.

Leifer and get her on the telephone. However, Dr. Leifer’s questioning of Mrs. Wright

about what had happened either did not elicit answers that would reflect that M.W. had

suffered a seizure or, alternatively, Dr. Leifer may simply have doubted her account.

That does not change the description provided in Mrs. Wright’s relatively consistent

affidavit, statement to Dr. Neubrander, reports to family members and Ms. Sierra,

reports to other physicians and, most importantly, her testimony at the hearing.30

3. M.W.’s Medical Condition During the Week after Returning Home.

M.W. did not see a physician between his 19 month well-child visit and his first

visit to Bergen West Pediatrics in October 2009. Pet. Ex. 8, p. 364 (reflecting the

October 26, 2009 visit).31 Mr. Wright briefly visited Valley Pediatrics on July 9, 2009 to

retrieve a copy of M.W.’s records,32 but the records do not reflect any discussion of

M.W.’s condition at this point. See Pet. Ex. 5, p. 335; Tr. at 147-48.

Thus, the only available evidence regarding M.W.’s condition after the

vaccination is from his family members and caregivers. Telephone records corroborate

that some of the telephone calls were made as reported.33 With the exception of Dr.

Neubrander’s records, which contain Mrs. Wright’s narrative, later medical records

contain little detail about what M.W. experienced in the week or so after the July 6, 2009

vaccinations. See Pet. Exs. 5, p. 335; 9, pp. 430-34; 13, p. 605.

b. Events Specific to July 6, 2009.

As advised by Dr. Leifer, Mrs. Wright continued the drive home. When she

arrived, she cleaned the vomit off M.W. and put him on the couch and then she cried

30 In my long experience as an attorney, judge, and special master, I have rarely seen prior statements of

lay witnesses at trial contain all the details that are elicited during testimony. This is not always because

the details did not occur, but because earlier statements are not prepared with the benefit of clarifying

questions from someone who did not observe the events described. Mrs. Wright appeared to me to be

testifying forthrightly. While recall of events that occurred years earlier is always colored by outside

factors, I found her testimony, affidavit, narrative, and histories provided to health care providers to be

relatively consistent.

31 There was an earlier telephone call to the NJ early intervention referral line, but no actual physician

visit. Pet. Ex. 9, pp. 430-34 (records from the referral line call).

32Mr. Wright testified that he made two such visits, one on July 8 and one on July 9, and that he was

quite irate at both visits. Tr. at 123, 168.

33The very fact that the pediatric practice called the Wright home so frequently in the days after the

vaccination reflects, based on my years of experience as a special master, some heightened degree of

concern about M.W.’s condition, and perhaps some second-guessing of the decision not to send M.W. to

the emergency room or back to the office to be checked out. It is far more likely for parents to report that

they contacted or tried to contact a pediatric practice than it is for the practice to make so many calls to

the patient’s parents.

16

because she was so upset by what had happened. Tr. at 23. She testified that she did

not take M.W.’s temperature after she got him home from the doctor’s office, but did

give him Tylenol.34 Tr. at 76. He spent the entire day on the couch so that she could

watch him, except when she carried him from room to room. M.W. slept off and on the

entire day. Tr. at 23-24; Pet. Ex. 6 at ¶ 22. Mrs. Wright testified that “I was tired, too, so

I was laying [sic] and sleeping with him all day long, too.” Tr. at 30; see also Tr. at 121.

Mrs. Wright testified that she did not speak to Dr. Leifer from her home telephone

that day. Tr. at 26. In the call documented as occurring at 12:26, the pediatric practice

called her to inquire if M.W. was okay. She testified that she told the office staff that

M.W. was “spaced out” and just “laying [sic] around.” Tr. at 27. According to the

telephone records, this call lasted 35 seconds. Pet. Ex. 26, p. 961 (first highlighted

record).

Mrs. Wright described M.W. as not talking, not responding, zoned out, and

spacey for the remainder of the day. Tr. at 23-24. Although the TV was on, M.W. was

not watching it. Tr. at 24. He did not play at all that day. Tr. at 30. When she stood in

front of him and said his name, he would “kind of look over.” Tr. at 24. M.W. did not

eat, but drank a bottle. He continued to produce urine. Tr. at 30-31. She recalled that

he felt warm, but did not think he had a fever. Tr. at 29. He was not fussy or irritable.

Tr. at 31. In essence, she described a child who was not responsive to her during the

few periods when he was awake.

According to her affidavit, Mrs. Wright called the pediatric office that day “to

reconfirm that I should not return with [M.W.].” She indicated that the doctor was

unavailable and that she spoke with a nurse who reassured her that the reaction was

normal. Pet. Ex. 6 at ¶23. Her testimony varied slightly; she testified that she made a

call to the pediatric practice at 16:19 (4:19 PM) that day. She was upset because no

one from the office had called her back.35 She spoke with receptionists who asked her

questions and told her to give M.W. Tylenol, and she asked to speak to a doctor or a

nurse. Tr. at 28. The telephone records reflect that this call lasted 104 seconds. Pet.

Ex. 26, p. 961 (call originated at 16:19:19, not highlighted). At that point, M.W. did not

have a fever, although he felt warm. Tr. at 28-29.

Although it is not clear from the transcript, it appears that Mrs. Wright then began

discussing the third telephone call between her home and the pediatric practice that

day. Tr. at 29. That call is reflected on the telephone records as a call from the home

34 Tylenol administration is often recommended prior to or after a vaccination to prevent fever and

alleviate the pain of the vaccination. Mrs. Wright’s narrative reflected that she usually gave M.W. Tylenol

after vaccinations. Doctor Leifer may have recommended administration of Tylenol during the post-

vaccination telephone call based on Mrs. Wright’s report that he felt warm.

35The telephone records reflect the call from the pediatric practice to the Wright home at 12:26 (12:26

PM), but no calls after that. Presumably, Mrs. Wright had anticipated another telephone call from the

practice that had not occurred.

17

to the practice at 17:03:33, lasting a little less than 10 minutes. Pet. Ex. 26, p. 961 (third

highlighted telephone call). Mrs. Wright indicated that she asked to talk to the nurse or

doctor, and was transferred to the nurse who administered the vaccination. She asked

if she should take M.W. to the ER because he “seemed out of it” and was “spacey.”

The nurse responded by asking if M.W. was responding to his name or if he came when

called for dinner. Mrs. Wright explained that he was just on the couch and did not seem

to be responding to her. Tr. at 29. The nurse then asked if he was eating or drinking,

and said that as long as he was drinking and urinating he was okay. Mrs. Wright

testified that M.W. was still on the couch, and had not gotten up at all to play. Tr. at 30.

He was not fussy or irritable, “just out of it.” Tr. at 31. He would take a drink and then

“go back to the couch.” Id. Mrs. Wright explained that M.W. was not walking; she was

carrying him to and from the couch. M.W. slept with his parents that night. Id.

Contrary to what has transpired in most hearings in my nearly 10 years as a

special master, Mrs. Wright’s testimony was not provided via leading questions. This

enhanced the credibility of her testimony.

Mr. Wright described M.W. not displaying any activity for the first day or two after

the vaccination, “not physically or emotionally or even verbally.” He said that M.W. “was

pretty much there but not there.” Tr. at 118. Mr. Wright testified that “M.W. was

physically and mentally somewhere else.” Tr. at 145. M.W. “basically stayed listless,”

in spite of Tylenol. Tr. at 118. He stared into space when he was awake. Tr. at 145-

46.. He agreed with his wife that M.W. slept most of the day and night of July 6, 2009.

Tr. at 121. He could not recall if M.W. was drinking or just “sucking on his baba,” but he

recalled that he was not eating. Tr. at 145. He testified that M.W. did not begin walking

until late Wednesday or Thursday (July 8-9), although he may have gotten out of bed

once on the second day, but that M.W. was basically immobile. Tr. at 150.

He recounted that Mrs. Wright wanted to take him to the emergency room or

back to the doctor, and he kept reminding her that the doctor said he would be fine. Tr.

at 121, 146-47.

c. Events Specific to July 7, 2009.

M.W. woke up during the night, and was given something to drink. Tr. at 32.

According to Mrs. Wright’s affidavit, M.W. slept nearly the entire day of July 7, 2009,

waking up for only a few minutes. At one point, he clutched his neck and vomited. Pet.

Ex. 6, ¶ 24. She indicated that she “kept calling the doctor’s office and they continued

to tell me to monitor him. I was very concerned because [M.W.] was not responding to

me when I said his name, it seemed like he could not hear, and he had no appetite.” Id.

She called the doctor’s office that afternoon, and Dr. Leifer again advised her to monitor

him throughout the night.36 Id.

36The telephone records reflect a call from the pediatric practice to the Wright home at 17:02:24, lasting 8

seconds; a similar call at 18:41:40 lasting 7 seconds, and one at 20:08:54, lasting 54 seconds. There

18

Her testimony was that M.W. did the same thing on July 7 that he had done the

prior day—he laid around all day. Tr. at 32. He had a fever and was taking fluids and

urinating. Id. She was annoyed at the doctor’s office because the calls that day were

from the receptionist, not the doctor. She testified that she talked to Dr. Leifer at the

third call that day, and that the doctor asked about urinating and keeping fluids down

and controlling his fever with Tylenol. Id.

Mr. Wright testified that M.W. “was basically catatonic for the entire day” of July

7. Tr. at 122. However, he continued to take a wait and see attitude.

Mrs. Wright testified that she made several calls on the morning of July 7 to one

of her aunts, because she was upset about M.W. Tr. at 38-43. Mr. Wright testified that

Mrs. Wright was upset, and particularly so after phone calls with the pediatric practice.

Tr. at 119-20.

The evening of July 7, M.W. slept in his own bed on the second floor, while Mrs.

Wright slept on the couch downstairs. At some point, he got up and got out of his railed

bed and came to the head of the stairs and sat down. He was holding and rubbing his

neck, and she went up the stairs to him. Tr. at 33. He was running a very high fever

and “was just out of it.” He pitched forward and vomited, but not copiously. She

administered Tylenol. Tr. at 33-34. The Tylenol worked to bring down the fever, but it

returned as the Tylenol wore off. Tr. at 34-35. She returned M.W. to his own bed, and

slept there with him for the rest of the night. Tr. at 35.

d. The Remainder of the Week.

M.W. was better on July 8, but was still taking Tylenol and was “still out of it.” Tr.

at 35-36. He responded better, and was likely eating, but not a lot. He still slept a lot.

Tr. at 36. There were no telephone calls on July 8th to or from M.W.’s pediatric practice.

Mrs. Wright testified that M.W. was not interacting with his older sister, and was still

sleeping most of the time. Tr. at 36.

Ms. Sierra saw M.W. on July 8, 2009. He recognized her by looking up at her,

but his greeting was different than in prior visits. Tr. at 210. Mrs. Wright told her then

that his fever was breaking. Tr. at 224. Ms. Sierra also testified that he did not look

flushed to her and she assumed that he was getting better. Id.

The fever broke on July 9. Tr. at 37. In the two telephone calls on the 9th from

the pediatric practice to the Wright home, Mrs. Wright explained that M.W.’s fever was

better. However, she was unhappy with the practice, in that receptionists were giving

were no telephone calls from the Wright’s home phone to the pediatric practice on July 7, 2009. Pet. Ex.

26 at 962. It is possible that Mrs. Wright confused the telephone calls on July 6 with those on July 7.

19

medical advice and that she could not get the doctor to call her back and had to beg to

talk with a nurse. Tr. at 37-38.

Mr. Wright visited the pediatrician’s office in person and demanded to see Dr.

Leifer.37 Tr. at 123. Upon the staff’s refusal, he demanded M.W.’s medical records,

which he could not recall obtaining, but which are recorded as being transferred to an

unidentified recipient on July 9. Id. at 123-24, 148, 174-75; Pet. Ex. 5, p. 335. This

incident, coupled with the parents’ overall frustration with Dr. Leifer’s office, apparently

lead him to believe that M.W. “didn't need any doctors.” Tr. at 128.

According to Ms. Sierra, she spoke with Mrs. Wright about M.W.’s condition. Tr.

at 209. Mrs. Wright complained that M.W. still had a slight fever and that he was still

getting Tylenol, but she also reported that he was starting to “be himself” again. Tr. at

209. On Wednesday or Thursday (July 8 or 9), Mrs. Wright told Ms. Sierra that M.W.

“was feeling better . . . I’ll bring him around to you tomorrow. He was all right, but he

was just laying [sic] around on the sofa watching TV.” Tr. at 210, see also Tr. at 224.

Mrs. Wright and her aunt, Mary Valentine, exchanged telephone calls on July 10.

Mrs. Wright explained that she was upset, having had “a rough couple of days” and that

she was concerned about M.W. Tr. at 43. Ms. Valentine testified that she saw M.W.

the weekend prior to his vaccination. Tr. at 180. When Ms. Valentine spoke with Mrs.

Wright on July 10, Mrs. Wright told her that he had convulsed in the car and had thrown

up and that she thought he was acting differently. Mrs. Wright reported that she was

worried and, according to Ms. Valentine, she “sounded very, very upset.” Tr. at 181-82.

On July 10, 2009, Ms. Sierra cared for M.W. She testified that he laid on the

couch on his blanket with his bottle. Although he got down and crawled around a little,

he was not as “perky” as he had been before the vaccination. Tr. at 210. He was less

interactive with her own daughter, and Ms. Sierra described him as “spacey” or “starey-

eyed.” Tr. at 211-12. She indicated that he did not ask her for cookies. Id.

e. Findings.

I find that during the period from July 6-7, M.W. displayed a significantly

decreased level of consciousness. He was not responsive to parents or his sister. He

did not maintain eye contact or fix his gaze on people or objects such as the television.

He did not respond to his name. He was not talking, walking, or playing. Although he

drank and urinated, he did not eat. This decreased level of consciousness lasted for

more than 24 hours after arriving back home on July 6, 2009. This decreased level of

consciousness cannot be attributed to the only medication M.W. was taking, which was

Tylenol, and was independent of M.W.’s brief prior seizure.

37Mr. Wright testified about two trips to Dr. Leifer’s office, one on the 8th and one on the 9th of July, and on

one of those days, he told the staff that he wanted to see “a real doctor.” Tr. at 168.

20

Based on the record as a whole, including the parents’ descriptions and their

reports to family and Ms. Sierra, I find that M.W. was more than simply lethargic during

the period from arrival at home through the next 24 hours; he was obtunded and

perhaps even stuporous.

C. M.W.’s Emerging Problems Post-Vaccination.

After the July 2009 immunizations, M.W.’s babysitter and family members all

described changed behaviors. The common changes in those affidavits are that M.W.

no longer responded quickly to his name, spoke less, no longer slept through the night,

did not want to play with others, and his eye contact grew worse. Pet. Exs. 6, pp. 343-

44; 7 p. 351; 27, pp. 967-68.

For the rest of the summer, Mrs. Wright noticed M.W.’s worsening eye contact,

decreased interest in play, irregular sleeping patterns, fixation with television, a

heightened interest in the mechanics of toys and lettering, a need to arrange household

items in a particular order, and his reaction when the order of objects was altered. Tr. at

44-45; see Tr. at 130-31. M.W. also failed to acknowledge his mother’s calls for

attention, leading her to suspect a problem with his hearing. Id. Similarly, Mr. Wright

noticed a lack of acknowledgment from M.W. like “[h]i, Daddy,” or other usual greetings

like hugs. Id. at 126.

When Ms. Valentine visited M.W. on July 25, 2009, she recalled that, while he

ordinarily would greet her and her son with a hug, he failed to acknowledge her

presence or interact with her the way he did previously. Tr. at 183-84. This was a

significant change, as she had seen M.W. over the weekend prior to his vaccination.

For instance, M.W. failed to respond when she spoke to him. Id. at 186. Similarly,

while he used to enjoy watching her son destroy towers of blocks, M.W. became very

upset when they were knocked over, insisting that they be reconstructed in the same

way they were before. Id. at 183. Ms. Valentine also noticed that his sleep pattern was

irregular and she noticed him repeating his alphabet at nighttime. Id. at 184.

Ms. Valentine’s affidavit stated that during her visit lasting several days at the

end of July 2009, M.W. “was not talking,” but during her testimony she clarified that

“[M.W.] was not talking as much as he had….[but] I can't say in the six days he never

spoke at all.” Tr. at 196; Pet. Ex. 89 at ¶10.

Mr. Wright testified that in the days and weeks afterwards, M.W. “was in his own

little world.” Tr. at 126,151. He did not smile or run to his father. Tr. at 126. He

described M.W. as replaying or reliving June. The things M.W. wanted to do were

repetitive. He was intolerant of change. He stopped sleeping well. Tr. at 129-30. He

was not speaking, not making eye contact, and responded to his name only after being

called five or six times. Tr. at 130-31.

21

On October 21, 2009, Mrs. Wright called the New Jersey Early Intervention

telephone line with concerns about M.W.’s speech, sporadic eye contact, and lack of

response to his name.38 She also expressed concern that he did “not follow directions

all the time” and that he ignored his mother “a lot.” Pet. Ex. 9, p. 430; see also Tr. at 50.

The form indicated that Mrs. Wright had spoken with M.W.’s pediatrician the day prior,

but that the doctor was not concerned.39 Pet. Ex. 9, p. 432. In her testimony, Mrs.

Wright confirmed the family’s general concerns over M.W.’s delayed speech. Tr. at 87-

89.

The new pediatrician was likely Dr. Slavin at Bergen West Pediatrics, as a record

dated in October 2009 could read October 20, 2009.40 Pet. Ex. 8, p. 364. The reason

for the visit was that M.W., then 22 months old, was not making eye contact and there

were concerns about his behavior, specifically about autism. The notes indicated that

M.W. did not always respond to his name; sometimes lined up objects, but not

excessively; pointed, imitated, showed objects to his parents; did make eye contact; did

not always understand what people said; did not engage in pretend play, and spoke

about 5-10 words. He was very fussy at the visit and could not be examined or

weighed. Another note reflected that he failed 4 of 23 questions on the “M-CHAT

screening test.”41 Id.; see also Pet. Ex. 8, pp. 361-62 (reflecting the Denver

Prescreening Questionnaire, rather than the M-CHAT about which Mrs. Wright testified).

The physician thought M.W. had developmental delay, possibly mild “PDD.”42 Referrals

for a hearing evaluation,43 to early intervention, and to the child development center

were made. Id. at 364. These referrals indicated that the pediatrician did have

concerns about what Mrs. Wright had reported.

A second visit to Bergen West Pediatrics practice took place on November 2,

2009, about two weeks after the contact with the Early Intervention program. The

38 Mrs. Wright also testified that Mr. Wright called Early Intervention as well, but did not specify when. Tr.

at 86-87.

39What Mrs. Wright interpreted as a lack of concern on the part of M.W.’s pediatrician was certainly not

reflected in the notes of the actual visit, as the assessment performed the prior day reflected that M.W.

had developmental delay and possibly a mild autism spectrum disorder. See Pet. Ex. 8, p. 364.

40 Mrs. Wright’s testimony indicated that this pediatrician was likely Dr. Slavin. Tr. at 50.

41What the medical record (and Dr. Shafrir) referred to as the M-CHAT could be the Denver Prescreening

Questionnaire that appears in the Bergen West Pediatrics records. Pet. Ex. 8, pp. 361-62. No copy of

the M-CHAT appears in the Bergen West records. According to the Denver Prescreening Questionnaire,

M.W. did not copy housework (pretend play). He could not take off clothes; point to body parts, feed

himself with a spoon or fork without spilling much, or kick a small ball. Id., p. 361. If an M-CHAT was

completed at this visit, it was not included in the records from Bergen West Pediatrics.

“PDD” stands for pervasive developmental delay,” and was the umbrella term in the DSM-IV-TR for

42

what are now called autism spectrum disorders in the DSM-V.

43The hearing evaluation, performed on November 11, 2009, was “insufficient to make a definitive

statement about [M.W.]’s hearing,” but the limited data obtained suggested that he had “sufficient hearing

for normal speech and language development.” Pet. Ex. 11, p. 444.

22

record reflects that M.W. had problems with sleeping, diet, and excessive urination.

M.W. used to sleep all night, but was waking up several times a night, needed his

parents in the room to fall asleep while he drank a bottle, and usually napped two hours

at mid-day. The previous evening, M.W. was up from 1-4 AM. He did not have

excessive thirst, but was reported to drink excessive amounts of milk a day, with a

limited diet of meatballs, chicken, and some fruits and vegetables. Pet. Ex. 8, p. 363.

The assessment was that M.W. had sleep problems and excessive milk intake. Id.

D. Early Intervention and ASD Diagnosis.

On November 18, 2009, the Regional Early Intervention Team evaluated M.W.

and recommended applied behavioral analysis [“ABA”]44, speech, and occupational

therapies. Pet. Ex. 12, pp. 446-51; Tr. at 51. M.W. was assessed as more than 25%

delayed in adaptive, social/emotional, and communication skills.45 Pet. Ex. 12, p. 450.

Mrs. Wright testified that at this point “he wasn't talking as much as he used to talk” and

she suspected that M.W.’s lack of communication led to him regularly throwing tantrums

out of frustration. Tr. at 51-52.

Mrs. Wright completed a parent questionnaire form for Sanzari Children’s

Hospital on November 24, 2009. Pet. Ex. 13, pp. 605-12. Her concerns were M.W.’s

eye contact, inconsistent response to his name, lack of understanding of verbal

directions, and sleep difficulties coupled with hyperactivity. She reported that these

problems were first noticed in July 2009. She indicated that she was very concerned

that M.W. was on the autistic spectrum. Id., p. 605; see also Pet. Ex. 8, p. 364; Tr. at

85, 90-91. In the “Development” section of the form, she did not respond to a question

about when M.W. used the terms “mama” or “dada” with meaning, and she answered

the question about when M.W. responded to his name with “sometimes responds but

not all the time.” Pet. Ex. 13, p. 608. She reported he was “behind in speech” and that

he did not use a fork or spoon, and that he had “convulsed after 18 month shots.” Id.

She described him as throwing up and listless for four days after the Pentacel

vaccination. Id., p. 609. In a narrative, she reported that M.W.’s “speech skills seem

very behind, but he knows all his A,B,Cs and the phonics to each letter. But he doesn’t

say Hi or Bye unless we do it and tell him to do it. (and will only say bye then).” Id., p.

612 (emphasis original).

44ABA therapy consists of the “application of learning theory based on operant conditioning” and “is the

only intervention recommended by the Surgeon General” for ASD. Dwyer v. Sec’y, HHS, No. 03-1202V,

2010 WL 892250, at 272, n.650 (Fed. Cl. Spec. Mstr. March 12, 2010) (internal citations omitted).

45 At this evaluation, M.W. was reported to use least 10 words as labels, not counting letters. Pet. Ex. 12,

p. 449. The Battelle Developmental Inventory II test, which includes a communication module, was

administered (see id., p. 446), and M.W. scored at 5 months of age for receptive and 9 months of age for

expressive language (id., p. 450). The specific test components for language evaluation are at id., pp.

482-83 and reflected that M.W. could not attend to someone talking to him for at least 10 seconds,

identify family members when named, follow three or more verbal commands, wave bye-bye,

spontaneously imitate sounds, words, or gestures for objects in his immediate environment, or use 10 or

more words.

23

As Mr. Wright reported to a physician at Bergen West Pediatrics in December

2009, M.W. was using many new words, his eye contact was improving, and he was

seeking out other kids, but still not responding to his name. His diet was more varied.

His sleeping problems were improving as well, and he was not taking as many naps.

Pet. Ex. 8, p. 365. Mr. Wright declined an MMR vaccination at this visit, but indicated

he would discuss this with Mrs. Wright. Id.

In an evaluation on December 21, 2009 (Pet. Ex. 15, pp. 617-22), Dr. Lisa

Nalven noted that M.W.’s parents had initial concerns about his development at about

18 months of age, when Mrs. Wright observed decreased eye contact (id., p. 617). This

coincided with his 19 month vaccination and high fever. The Wrights thought that

“overall he had always made progress without loss of skills.” Id. They described M.W.

as advanced in some areas and behind in others. He used language to label, rather

than to communicate, and, in labeling, had a good vocabulary. They reported he could

identify letters and numbers, but appeared to overfocus on this. They also reported that

he used “Daddy” for his father more than he called his mother, and did not use a word

for his sister. Id.

The Wrights denied the accuracy of Dr. Nalven’s records, specifically indicating

that the histories were incorrect, and that “the first [report] we got from her was a cut-

and-paste job, and it stands out that the name [of another person] was all over it, not

[M.W.].” Tr. at 92-93; 162-63. Mrs. Wright denied that they had said he had always

made progress without loss of skills. Tr. at 92. Mr. Wright was less definite, indicating

that he had “[p]robably not” said that. Tr. at 162. However, he specifically denied

saying that M.W.’s eye contact has not always been optimal. Id.

Doctor Nalven also recorded that Mr. and Mrs. Wright did “not report the

development of early pretend play.” Mrs. Wright denied that this was accurate. Tr. at

93. However, I note that the M-CHAT Mrs. Wright completed on the day of the Pentacel

vaccination reflected that M.W. engaged in pretend play only sometimes. See Pet. Ex.

5, p. 338. This suggests that Dr. Nalven’s notation was probably accurate. Doctor

Nalven also noted that M.W. had “a tendency to toe walk,” as did both of his parents, his

father currently and his mother in the past. Pet. Ex. 15, p. 619. She also noted that Mr.

Wright did not talk until he was three years of age. Id. Both of these reports were also

made to other physicians. The report about toe walking was made to Dr. Neubrander

(see Pet. Ex. 25, p. 834) and Mr. Wright’s slow development of language was reflected

in Dr. Gold’s records from March 2010 (see Pet. Ex. 17, p. 636).

Doctor Nalven’s impressions were that M.W. had “differences in brain

development and function, which meet diagnostic criteria for an autism spectrum

disorder.” Pet. Ex. 15, p. 621. She described delays and qualitative differences in each

of the three domains of communication, social interaction, play and behaviors. Id. She

ordered a number of tests, and suggested re-contacting early intervention to obtain ABA

services. Id.

24

Doctor Neubrander’s December 31, 2009 findings were also “consistent with

ASD.” Pet. Ex. 25, pp. 865-67. Mrs. Wright indicated that she had sought out Dr.

Neubrander because she wanted a DAN! doctor after she looked into biomedical

approaches to autism treatment on the internet. She wanted a physician who would

help with supplements and gut issues and anything that might make M.W. healthier and

sleep better. Id., p. 826. Mrs. Wright’s history regarding any regression or lack of

progression was that M.W. was developing normally until the Pentacel vaccination.

“After that, both my babysitter and I started to notice he stopped consistently responding

to his name and his eye contact was not the same as before.” Id., p. 831.

Pursuant to Dr. Neubrander’s order, M.W. was tested for MTHFR

polymorphisms, and was found to have one copy of the C677T and A1298C alleles.46

Pet Ex. 25, p. 858. Doctor Neubrander ordered methylcobalamin (B12) treatment, while

acknowledging that no well-designed clinical trials had shown its efficacy. Id., p. 864.

In February 2010, Mr. Wright visited Bergen West Pediatrics to talk to M.W.’s

doctor about the diagnosis of autism. Mr. Wright reported that speech and ABA therapy

through early intervention were helping. He also reported that M.W. had seen Dr.

Neubrander, who was described as an “alternative autism doctor” and that Dr.

Neubrander had recommended “B12” injections and hyperbaric oxygen therapy. The

pediatrician’s notes reflected a discussion “at length” about risks of alternative therapies

and the lack of evidence of benefit from (and specific advice against) using a hyperbaric

oxygen chamber. Pet. Ex. 8, p. 368. M.W. was assessed with mild autism, and a

number of tests recommend by Dr. Neubrander were ordered. Id., p. 369.

A developmental pediatric study was performed by developmental pediatrician

Jasmin Furman at Hackensack University Medical Center’s Institute for Child

Development in February 2010. This is the first medical record in which a physician

used the term “regression” to characterize the differences in M.W. after the vaccination,

based on the history provided by Mrs. Wright. Pet. Ex. 16, p. 624. Specifically, she

reported a regression in the use of words and eye contact after the immunization, the

same losses she reported to Dr. Neubrander in December 2009. Pet. Ex. 25, p. 831.

Mrs. Wright also reported the high fever, staring, and a possible seizure episode. Pet.

Ex. 16, p. 624.

The history also reflected that M.W. began using words at about 12-14 months of

age, but did not make much progress in vocabulary. M.W. was reported to have a

current vocabulary of 20-50 words, most of which involved labels for “numbers, letters,

46The laboratory report did not reflect any association of these mutations with ASD. It indicated that the

MTHFR enzyme was “responsible for creating the circulating form of folate” and that defects in the

enzyme could “indirectly cause elevated homocysteine levels,” which “have been associated with an

increased risk of cerebrovascular disease, coronary artery disease, myocardial infarction, and venous

thrombosis.” Pet. Ex. 25, p. 858.

25

or incidental objects.” Pet. Ex. 16, p. 624. ABA therapy had resulted in significant

improvement. Id.

Doctor Furman diagnosed M.W. with autism, “with significant language

communication deficits and overall low average cognitive abilities.” Id., p. 626. She

also noted a diagnostic impression of “[h]istory of high fever and change in

alertness/level of consciousness following a childhood immunization in the past.” Id.

On March 22, 2010, Dr. Gold considered M.W.’s condition and determined

M.W.’s neurologic evaluation evidenced “a static encephalopathy of uncertain etiology.”

Pet. Ex. 17, p. 638; see also id., pp. 636-37. When considering M.W.’s immunization

history, history of seizures, and regression of milestones, Dr. Gold considered the

possibility of a “post-vaccination encephalopathy.” Id., p. 638. Doctor Gold

recommended a number of tests for heavy metals and porphyrins, according to a

telephone message between Mr. Wright and someone at Bergen West Pediatrics. The

health care provider (based on handwriting, likely M.W.’s pediatrician) advised Mr.

Wright to have Dr. Gold order whatever specific tests he thought were appropriate. Pet.

Ex. 8, p. 370.

In June of 2010, 11 months after M.W.’s Pentacel vaccination, Dr. Holahan

performed a pediatric neurodevelopment evaluation. He summarized that M.W. had

autism, that his regression began at 19 months, and that it was “temporally associated

with vaccination.” Pet. Ex. 20, pp. 807-09. Doctor Holahan’s assessment was based

on his observations at the consultation, not M.W.’s post-immunization symptoms. Id.

Of note, Mr. Wright told Dr. Holahan that he thought he was “very similar to [M.W.] when

he was young.” Pet. Ex. 20, p. 808. Doctor Holahan summarized his findings

regarding M.W. as “consistent with a diagnosis of static, neurological impairment,

manifesting mild hypotonia and an autistic spectrum disorder. He is high functioning.

He has excellent language skills. He is very bright. There was the regression at 19

months of age, temporally associated with the vaccination.” Id., p. 809.

Doctor Gold referred M.W. to Dr. Wendy Chung for a genetic assessment. Her

history reflected that M.W. knew the alphabet at 15 months of age, and had a

vocabulary of 40-50 words at 18 months of age, and regressed after his 19 month

vaccination. Pet. Ex. 22, p. 814. She reviewed the prior genetic testing. Her

impression was that M.W. had “a history of normal development until approximately 19

months of age when he had a history of an intercurrent illness associated with vomiting

and fever that occurred concurrently with an immunization. After that time he had

developmental regression and a marked change in behavior.” Id., p. 815. She doubted

M.W. had genetic issues “based upon the initial history of normal development,

regression, and then gains.” Id., p. 816. She did not recommend any additional genetic

testing, but suggested an MRI.

This appears to be the only medical evaluation, other than Dr. Neubrander’s, in

which the history provided reflected that M.W. was ill (i.e. vomited prior to the

26

immunization). Doctor Chung attributed the vomiting and fever to an illness, just as Dr.

Wiznitzer did. See Pet. Ex. 22, p. 815; Tr. at 328.

A brain MRI was performed in November 2010. While no structural abnormalities

were identified, there was “[s]lightly asymmetric FLAIR hyperintensity (left greater than

right)” in the upper bilaterial periatrial regions. The report indicated that this could be

due to asymmetric myelination, “mild sequela of prior infectious, inflammatory or

ischemic etiologies” were possible explanations for the findings. Pet. Ex. 17, p. 642.

An overnight EEG was performed in October 2010. The attending neurologist

concluded that it was a normal prolonged video EEG.47

F. Condition at the Time of the Hearing.

M.W. has received a variety of therapies, first through the early intervention

system and later through the school system, which were augmented by privately

arranged therapy and a “shadow” aide for school. See, e.g., Pet. Ex. 31, p. 1029-30; Tr.

at 58-60.

At the time of the hearing, M.W. was six years old and enrolled in a kindergarten

program at St. Catherine's school, where he participated in a mainstream classroom

assisted by his own private classroom aide. Tr. at 60. Mrs. Wright reported that M.W.

was able to read and write, solve math equations, and use internet search databases.

Tr. at 61. Mr. Wright testified that “M.W.’s actually reasonably responsive, but he

struggles very much verbally, in and out, and he is still impulsive and he still has some

amount of the, ‘Hey, you're not allowed to change what I'm doing.’” Id. at 136. Doctor

Gold’s December 2013 report described M.W.’s abilities and disabilities in greater detail,

but in general observed that M.W. functioned well, but continued to struggle with

communication and socialization. See generally Pet. Ex. 30.

IV. Relevant Expert Opinions.

Two experts, Drs. Shafrir and Wiznitzer, testified at the hearing. Additionally, I

considered Dr. Gold’s opinions on the presence of a postvaccinal encephalopathy with

regard to the Table injury requirement that an encephalopathy must persist for more

than six months.

A. Doctor Gold.

No curriculum vitae was filed for Dr. Gold. According to his records, he practiced

at the “Neurological Institute” in New York City. His signature block reflected that he

47 An EEG, or electroencephalogram, records the electrical activity of brain cells. DORLAND’S at 600. It is

used to evaluate a patient for possible seizures. Id.

27

was a professor of clinical neurology and clinical pediatrics at Columbia University. See

Pet. Ex. 17, p. 640. Doctor Shafrir referred to him as “one of the giants of American

Child Neurology.” Pet. Ex. 27 at 976; see also id. at 983-94; Tr. at 268.

Doctor Gold, one of M.W.’s treating physicians, was originally scheduled to testify

at the July 2014 hearing, but did not appear due to ill health. Tr. at 4. Mr. and Mrs.

Wright testified about what Dr. Gold told them about M.W. (Tr. at 55-56; 134-35), but I

did not place much reliance on second-hand recounting, when the reports and records

speak for themselves. Two reports by Dr. Gold were filed as separate exhibits, Pet. Ex.

24, a neurological consultation conducted in December 2011, and a consultation from

December 2013, Pet. Ex. 30. Other treatment records from Dr. Gold were filed as Pet.

Ex. 17.

The December 9, 2011 report addressed causation quite summarily. Doctor

Gold referred to M.W. as a child “with a previously diagnosed postvaccinal

encephalopathy and a resultant static encephalopathy that is primarily manifested by

deficiencies in communication and socialization, consistent with the diagnoses [sic] of

an autism spectrum disorder.” Pet. Ex. 24, p. 821. He did not explain who had arrived

at that diagnosis or the basis for that conclusion. His December 2013 report began with

the same statement. Pet. Ex. 30, p. 1026.

Doctor Gold’s medical records, Pet. Ex. 17, answered the questions of who had

made the diagnosis and the matters pertinent to the diagnosis. He recorded the

following history:

On July 6, 2009 at age 19 months [M.W.] was given a Pentace [sic]

immunization which contained five organisms. Following the immunization

and while returning home with his mother in her car [M.W.] convulsed for a

brief period followed by five days of a febrile reaction with a temperature

elevation as high as 102 degrees. Subsequently there was a loss of

previously acquired skills, above all relative to communication and this

was coupled with a loss of eye contact and a change in sleep patterns and

diet.

Id., p. 634. He also recorded that M.W. used two-word phrases at 18 months of age.

Id., p. 635. He noted that M.W. “was precocious and has an intense interest in letter

and number recognition and this intense interest has continued to the present.” Id. He

did not specify whether this intense interest pre-dated the Pentacel vaccination.

Doctor Gold wrote in summary that M.W. had “evidence of a static

encephalopathy of uncertain etiology. The history relative to the vaccination followed by

a seizure and loss of previously acquired milestones suggests the possibility of a post-

vaccination encephalopathy.” Pet. Ex. 17, p. 638. He suggested an EEG to rule out a

partial seizure disorder. Id.

28

After reviewing the MRI and EEG, Dr. Gold wrote the Wrights to inform them of

the results. He noted that the EEG was normal. With regard to the MRI, Dr. Gold

commented on the FLAIR hyperintensity, indicating that it was “in all probability . . . a

nonspecific finding” but inflammation or ischemia could not be ruled out. Pet. Ex. 17, p.

640. He indicated that there was no evidence to suggest that M.W. had a progressive

encephalopathy. Id.

Some anomalous pages appeared in Dr. Gold’s records. Six pages were

downloaded on November 19, 2010, from a website or blog called the “Age of Autism.”

Pet. Ex. 17, pp. 648-53. The initial page discussed the Food and Drug Administration

approval for Pentacel. The pages contain a picture of a person or mask with a

pentagram on the forehead, a baby with a middle finger raised, and a number of anti-

vaccine comments. See id., p. 648. The remaining pages are the anti-vaccine

comment string. Id., p. 649-53.

At a December 2010 visit, Dr. Gold’s opinions on the uncertain etiology of M.W.’s

condition appeared to have changed. He wrote that at the initial visit, M.W. “showed

evidence of a static encephalopathy with a history that was highly suggestive of a static

encephalopathy secondary to a post-vaccination encephalopathy that was manifested

by an autistic spectrum disorder.” Pet. Ex. 17, p. 654. He subsequently recorded a

diagnosis of “Postvaccinal Encephalopathy with a result static encephalopathy,” and

attributed M.W.’s ASD diagnosis to this encephalopathy. Id., p. 661. Doctor Gold

documented the continuing need for various therapies at his annual re-evaluations of

M.W. See, e.g., id., pp. 656, 660.

B. Doctor Shafrir.48

Doctor Shafrir attended medical school in Israel and performed a pediatric

residency there between 1983 and 1985. Pet. Ex. 28 at 985. He then did a second

pediatric residence in New York at a hospital affiliated with Cornell University medical

school. Id. He completed a residency and fellowship in pediatric neurology at

Washington University Medical Center in St. Louis, MO, in 1991, followed by a

residency in pediatric neurophysiology and epileptology at Miami Children’s hospital

which he finished in 1992. Id. He is board certified in neurology, with special

qualifications in child neurology and clinical neurophysiology. Id. at 986. He was also

board certified in pediatrics, but let that certification lapse in 1998. Id.; Tr. at 228.

48As noted earlier, Dr. Shafrir presented challenges as an expert witness. He began his testimony by

scolding counsel and the court for asking questions about why the Wrights did not take M.W. to the

emergency room if he was as “out of it” as they claimed he was. He informed us that our questions were

not “relevant.” Tr. at 232. Given that he was opining that M.W. experienced a Table encephalopathy,

which requires that the vaccinee have an acute encephalopathy, defined as a condition ‘that is sufficiently

severe so as to require hospitalization (whether or not hospitalization occurred)” (42 C.F.R. §

100.3(b)(2)(i)), questions about M.W.’s condition and why he was not taken to the hospital would appear

highly relevant. I add that at no point did questioning by either counsel or my own questions for the

petitioners appear argumentative, condescending, or judgmental.

29

He is primarily a clinician, and is currently in an active private pediatric neurology

practice in Baltimore, MD, where he sees patients five days a week. Pet. Ex. 28 at 987;

Tr. at 228. He also teaches residents at Sinai Hospital, and is an Assistant Professor at

the University of Maryland’s School of Medicine. Pet. Ex. 28 at 987.

Most of Dr. Shafrir’s initial expert report (Pet. Ex. 27) consisted of a thorough

summary of the medical records and testing. Id. at 967-82. His opinions on causation

encompassed only a little more than one page. Id. at 982-84.

He opined that M.W. met the Table encephalopathy criteria based on the

presence of “a seizure associated with loss of consciousness and significantly

decreased level of consciousness, which was independent of the seizure...[and an]

encephalopathy [that] lasted more than 24 hours.” Pet. Ex. 27 at 983. He asserted that

M.W. “definitely” met “the criteria for significantly decreased level of consciousness” and

that he had a chronic encephalopathy that persisted for more than six months, based on

M.W.’s significant deficits. Id.

A supplemental report reiterated Dr. Shafrir’s opinions that M.W. experienced a

Table encephalopathy and his deference to Dr. Gold’s opinion about a postvaccinal

encephalopathy. Pet. Ex. 33 at 1041. Doctor Shafrir also opined that “[r]egressive

autism is a chronic encephalopathy” and that M.W. had symptoms of autism for more

than six months after the vaccination. Id. at 1041-42. He explained that he did not

discuss the Althen factors in his initial opinion because he was so positive that M.W.

met the Table criteria. Pet. Ex. 33 at 1042.

In his third expert report, he reiterated:

It is still my belief that [M.W.] meets the criteria of injury on the Vaccine

Injury Table for the DTaP, as applied to children above the age of 18

months. The lack of contemporaneous medical records describing the

encephalopathy and the fact that [M.W.] was not hospitalized was

explained by the parents in their affidavit, multiple phone calls to the

pediatrician over the days following the vaccine and the poor records of

the pediatrician as explained in my letter of July 17, 2013. The diagnosis

of post vaccine encephalopathy was made in the one of the prime

institutions in the United States by one of the giants of American child

neurology, Dr. Gold.

Pet. Ex. 33 at 1041.

C. Doctor Wiznitzer.

Doctor Wiznitzer completed a combined undergraduate school and medical

school program at Northwestern University, earning his medical degree in 1977. He

30

completed a residency in pediatrics and a fellowship in developmental disorders in

Ohio, a fellowship in pediatric neurology at the Children’s Hospital of Philadelphia, and a

National Institutes of Health fellowship in higher cortical functions. Res. Ex. B at 1-2

(citations to the page numbers of the CV itself). He is board certified in pediatrics,

neurology (with special qualification in child neurology), and neurodevelopmental

disabilities. Id. at 5; Tr. at 321-22. He has published extensively in the areas of ASD,

tuberous sclerosis, epilepsy and stroke, among others. Res. Ex. B at 13-24. He peer

reviews papers for many medical journals and sits on the editorial board of three

medical journals focused on neurology. Id. at 6. He regularly treats children with

autism, and has been doing so since 1984. Tr. at 322-23. See also Dr. Wiznitzer’s

expert report, Res. Ex. A, at 1-2.

Doctor Wiznitzer opined that, because M.W. vomited prior to administration of the

vaccination on July 6, 2009, any subsequent vomiting was due to an intercurrent illness.

His fever lasted too long for a post vaccination fever, and must therefore be attributed to

an intercurrent illness. He noted that there was no confirmation of a seizure event in the

car, and that a later EEG was normal. Res. Ex. A at 14. He further opined that an

encephalopathy severe enough to warrant hospitalization would interfere with oral

nutrition and hydration, which, in turn would result in dehydration for which medical care

would be necessary. Id. at 14-15. He thought that the failure to take M.W. to a

physician during the period after his vaccination through October 21, 2009, reflected

that M.W. did not have an abrupt regression, and that M.W.’s clinical presentation was

consistent with the natural evolution of ASD. Id. He also noted that there were some

areas of developmental concern prior to the immunization. Id. at 13-14. He based his

opinion on the medical records. Id. He addressed the Table encephalopathy claim only

in passing in his supplemental expert report, noting that there were some

developmental concerns in the records prior to the vaccination at issue. Res. Ex. C. at

1, 4.

IV. Evaluating Petitioners’ Table Encephalopathy Claim

A. Severity Requirement—Hospitalization Test.

The closest question in this case is whether M.W.’s condition after the

vaccination satisfied the requirement that any encephalopathy must be sufficiently

severe so as to require hospitalization whether or not hospitalization occurred. See 42

CFR 100.3(b)(2)(i). M.W. was not hospitalized; thus I must determine whether he was

sufficiently affected that hospitalization was “required.” The term “required” must mean

something other than “necessary to save the child’s life”; otherwise, entitlement to

compensation in the non-hospitalization cases would be limited to those in which the

child died. I interpret the term as requiring sufficient severity of illness or injury that

presentation at a hospital should result in some form of medical monitoring or being

“admitted for observation.” It does not require that medical intervention be necessary in

order to save a child’s life.

31

Doctor Wiznitzer opined that a child capable of drinking and urinating would not

meet the Table’s severity requirement. See Tr. at 328, 345. This opinion was

consistent with the advice given by the staff at Valley Pediatrics, that there was no need

to bring M.W. back to the practice or to the emergency room because he was capable

of drinking and producing urine. I note, however, that many individuals who are

hospitalized are capable of drinking and producing urine. The fact that M.W. was

drinking from a bottle (and there was no testimony that he was sitting up and drinking

from a cup), and taking in enough liquid to produce urine does not preclude the

necessity for hospitalization.

Doctor Wiznitzer conceded that a competent pediatrician who received the

information Mrs. Wright said she conveyed would tell her to return to the office or go to

the emergency room. Tr. at 410-11. He also conceded that the lack of ability to drink

and produce urine did not appear as a factor anywhere on the Vaccine Injury Table. Tr.

at 390.

Had Mrs. Wright shown up at an emergency room describing what happened in

the car, within a few hours of a vaccination, would she summarily have been turned

away or would M.W. have been admitted for observation? During the first 24 hours

after the brief seizure in the car, his parents described an altered mental state. While

there are no medical records reflecting what transpired after the vaccination, other than

Dr. Leifer’s very brief note, there are records of calls going back and forth between the

Wright home and the pediatric practice. The repeated calls by the practice are sufficient

corroboration that M.W. was experiencing something out of the ordinary. The pediatric

practice’s failure to document what transpired during the calls should not be held

against the Wrights. I note that the others Mrs. Wright talked to during the first week

after M.W.’s vaccination used the term “convulsion” when describing what happened in

the car. This is not an incident invented out of whole cloth.

I questioned Mr. Wright closely about why he thought M.W.’s condition was

severe, yet did not take him to a hospital. I questioned Mrs. Wright about the same

issue. Their explanations that Mrs. Wright wanted to do so and that Mr. Wright told her

she was, in effect, pregnant and hysterical, were given independently, in that Mr. Wright

was sequestered during Mrs. Wright’s testimony. Their testimony was not interlocking:

Mrs. Wright attempted to explain or minimize Mr. Wright’s “the doctor must be right”

reaction, while Mr. Wright admitted that he had been inappropriately tunnel-visioned

about what was happening. Both of Mrs. Wright’s aunts confirmed her testimony that

she wanted to take M.W. to the emergency room and that she was second-guessing or

at least seeking an opinion about the pediatric practice’s advice against doing so. What

rang clearly true in her testimony is the degree of concern she felt about M.W.’s

condition and how differently he was behaving, compared to his usual behavior.

The definitional criteria for encephalopathy found in the QAI are subparts to the

hospitalization requirement. I thus conclude that the hospitalization requirement is not

entirely independent of the symptoms reflected in those subparts, but a requirement to

32

emphasize the severity of the symptoms needed to constitute an acute encephalopathy.

I have previously held that transient or reduced eye contact—the lack of eye contact

often seen in ASD—is not sufficient, standing alone, to meet the “decreased or absent

eye contact” requirement of the QAI because that lack of eye contact is not sufficient to

meet the hospitalization requirement. Miller v. Sec’y, HHS, No. 02-235V, 2015 WL

5456093, at *38 (Fed. Cl. Spec. Mstr. Aug. 18, 2015); Blake v. Sec’y, HHS, No. 03-31V,

2014 WL 2769979, at *11-12 (Fed. Cl. Spec. Mstr. May 21, 2014), motion for

reconsideration denied, 2014 WL 7331948 (Fed. Cl. 2014); Mooney v. Sec’y, HHS, No.

05-266V, 2013 WL 3874444, at *8 (Fed. Cl. Spec. Mstr. July 3, 2013). Here, there was

far more than transient or reduced eye contact; the testimony was that M.W. was “out of

it,” “spacey,” “staring into space,” “physically and mentally somewhere else,” “minimally

responsive” to “nonresponsive, “catatonic,” and “basically immobile.”

In the Revision of the Vaccine Injury Table, 60 Fed. Reg. 7,685, 7,687 (Feb. 20,

1997) (preamble to final rule) the drafters explained that they “did not intend that

hospitalization be viewed as an absolute requirement to establish an acute

encephalopathy, but rather as an indicator of the severity of the acute event.” I

conclude, based on the facts of this case, that M.W.’s acute event was sufficiently

severe so as to meet the hospitalization requirement.

B. The Acute Encephalopathy Requirements.

Doctor Shafrir testified that the basis for his opinion that M.W. had suffered an

acute encephalopathy was that his condition satisfied the two criteria under the Table’s

definition of encephalopathy for adults and children 18 months of age or older: (1) a

significantly decreased level of consciousness, which is independent of a seizure and

cannot be attributed to the effects of medication; and (2) a seizure associated with loss

of consciousness. Tr. at 290-91; 42 C.F.R. § 100.3(b)(2)(i)(B)(2-3). He agreed that the

evidence of this was primarily found in petitioners’ affidavits. Tr. at 291; Pet. Ex. 27 at

983-84.

Respondent’s counsel raised the issue of whether the seizure event could have

been an absence seizure during her cross-examination of Dr. Shafrir. See Tr. at 292.

An absence seizure is specifically excluded as a seizure event qualifying as a Table

encephalopathy. See § 100(b)(4). An absence seizure is defined as a seizure

“consisting of a sudden momentary break in consciousness of thought or activity,

sometimes accompanied by automatisms or clonic movements, especially of the

eyelids.” DORLAND’S at 1688. Doctor Shafrir testified that a person having an absence

seizure would not “respond at all. Absence seizures don’t respond.” Tr. at 292.

What Mrs. Wright described when she looked into the rear seat after M.W. did

not respond to her voice (M.W.’s head tilted to the side, eyes rolled back, and shaking)

is not consistent with the DORLAND’S definition of absence seizure. I thus conclude that,

whatever type of seizure M.W. experienced in the car, it was not an absence seizure.

33

My factual findings in Section III above reflect that M.W.’s condition satisfied all of

the requirements for an acute encephalopathy. Although M.W. slept long and hard on

July 6 and 7, his sleepiness was not a basis for my conclusion regarding the presence

of an acute encephalopathy. Rather, it was the lack of responsiveness to his family

when he was awake. Even after the acute events of July 6-7, 2009, M.W. did not return

to baseline. Ms. Sierra’s testimony about his response to her on Thursday, July 8,

when he was recovering, and his behavior on July 9, when he was able to return to her

care reflect some degree of residual symptoms. Both are corroborative of the parents’

testimony about how ill he was earlier. Also corroborative is the fact that the pediatric

practice still thought it necessary to call three times on July 7 and twice on July 9 to

check on M.W.’s condition. Based on my years of experience as a special master, I

noted that the pediatric practice’s calls were highly unusual (and well-documented by

the telephone records (Pet. Ex. 26, pp. 961-62)) and had to reflect some heightened

degree of concern about M.W.’s condition.

Doctor Wiznitzer also testified that the events in the car might have been

precipitated by M.W.’s need to vomit due to illness. However, what Mrs. Wright

described was not the attempt to control vomiting or the need to vomit.

Doctor Wiznitzer’s testimony may have been shaped by his assertion that one

hour post vaccination was simply too soon biologically for an immunization to cause an

event. This testimony was highly relevant to the actual causation claim, but not at all

relevant to the Table injury claim. The Secretary, HHS, has been delegated the

authority to promulgate regulations to modify the Vaccine Injury Table. See § 14(c)(1).

The Secretary determined that the appropriate period for a Table encephalopathy to

manifest after receipt of a pertussis vaccination is 0-72 hours. Doctor Wiznitzer’s

opinion that it is biologically implausible for a seizure to manifest in one or two hours

after a tetanus-containing vaccination is, in the context of a Table injury, simply

irrelevant.49 To the extent that this biological plausibility argument was intended to

demonstrate that any seizure was more likely than not caused by an illness rather than

the vaccine, I will afford the testimony little weight. The Secretary writes the rules for a

Table injury, and her expert witnesses cannot rewrite them within the confines of a

vaccine injury proceeding.

Although Dr. Wiznitzer was critical of the lack of detail reflected in the records of

the physicians who recorded the history that M.W. had convulsed, I note that Dr.

Furman concluded from what Mrs. Wright told her that M.W. had decreased alertness

and a diminished level of consciousness post vaccination. I also observe that, in a

perfect world, when the treating physicians write patient contact notes with the

expectation that they will be parsed in the “Vaccine Court,” such uncertainties and

49In testifying on cross examination about this issue, Dr. Wiznitzer was asked why the Table used the 0-

72 hour time frame, and he responded” “you’d have to ask the people who developed the Table,”

maintaining that it would be “biologically impossible” for something to happen immediately after a

vaccination. Tr. at 396.

34

ambiguities will not exist. This is not that world. As a frequent witness in such

proceedings and, more importantly, a highly respected researcher in ASD and other

neurological conditions arising in the pediatric population, Dr. Wiznitzer understands the

importance of eliciting careful and precise histories. Busy clinicians may not.

Based on the record as a whole, and in accordance with my earlier factual

findings, I find that M.W.’s condition met the requirements of an acute encephalopathy

as set forth in the Vaccine Injury Table. See Riggs v. Sec’y, HHS, 40 Fed. Cl. 440

(1998) (reversing the special master’s decision that the infant had not suffered a Table

encephalopathy and finding that symptoms including sleeping 60 out of 72 hours after

vaccination, waking only on prompting, and disinterest in food constituted the

significantly decreased level of consciousness and inconsistent or absent responses to

external stimuli necessary to demonstrate a Table encephalopathy).

C. Chronic Encephalopathy.

Both Drs. Gold and Shafrir opined that, post vaccination, M.W. had an

encephalopathy. Doctor Gold saw M.W. for the first time more than six months after the

vaccination, and as late as 2013, still opined that he had a postvaccinal

encephalopathy, resulting in ASD symptoms.

Even Dr. Wiznitzer conceded that it would be possible, albeit rarely, for someone

who had experienced an encephalopathic event that would meet the definition of a

Table encephalopathy to thereafter manifest sufficient criteria to fall under the autism

spectrum. Tr. at 368. He thereafter qualified his answer to reflect that he would expect

to see evidence of an acquired injury to the brain on neuroimaging. Tr. at 370.

Although M.W.’s MRI was read as normal, the hyperintensity observed was consistent

with “mild sequela of prior infectious, inflammatory or ischemic etiologies.” Pet. Ex. 17,

p. 642. I note that it was after the MRI and genetic testing that Dr. Gold changed his

opinion on causation from an unknown etiology to a postvaccinal event.

Doctor Wiznitzer also testified that even if M.W. had been hospitalized with an

acute encephalopathy and thereafter developed ASD, he would not attribute the ASD to

the encephalopathy. Tr. at 374-75. He was cross-examined about a medical journal

article filed along with his expert report,50 which noted that about five percent of

newborns with encephalopathy were later diagnosed with an ASD. Tr. at 379-80;

Johnson, Res. Ex. A, Tab 1, at 1189. Doctor Wiznitzer did not disagree with the

numbers, but he observed that the article did not discuss cause, simply an association.

Tr. at 380-81.

Doctor Wiznitzer testified that the failure to take M.W. to a doctor over the

summer did not mean that M.W. was not encephalopathic, and he thought that the

50C. Johnson, et al., Identification and Evaluation of Children with Autism Spectrum Disorders, PEDIATR.

120:1183-1215 (2007), filed as Res. Ex. A, Tab 1 [hereinafter “Johnson, Res. Ex. A, Tab 1”].

35

parental conflict about whether M.W. needed to be seen was an explanation for why he

was not seen earlier than October. Tr. at 407-08. However, he thought the descriptions

of the relatively rapid onset of symptoms over the summer were affected by recollection

bias, and that they likely occurred more slowly. Tr. at 408.

However, the evidence in the record supports Mr. and Mrs. Wright’s testimony

that M.W.’s eye contact never returned to baseline after the events of July 6, 2009. He

continued to have poor response to his name, and seemed to be in his own world.

D. Alternate Cause.

Once petitioners establish a prima facie case for a Table encephalopathy, the

burden shifts to respondent to establish, by preponderant evidence, an alternate cause

for M.W.’s condition. Doctor Wiznitzer, relying largely on two pieces of evidence,

concluded that an unspecified gastrointestinal illness constituted an alternate cause for

M.W.’s condition. First, he pointed to the vomiting that occurred prior to the vaccination.

Second, he noted that M.W. got better when he was no longer febrile, and that a febrile

illness caused the change in his activity level. He thus concluded that M.W. “did not

suffer a post-vaccine table encephalopathy.” Tr. at 345. He pointed to the fact that

M.W. drank as an act that demonstrated responsiveness to his environment. Tr. at 345-

46. He observed that M.W. “complained” when his temperature was going up, let his

parents “know that he was in discomfort, that something was bothering him.” Tr. at 346.

He also testified that M.W. went to bed, got out of a crib in the middle of the night,

walked upstairs to the steps, sat down, rubbed his neck and looked for an adult, as

evidence that M.W. was not encephalopathic. Tr. at 346-47. Doctor Wiznitzer testified

that M.W.’s “change in behavior that he manifested immediately after the vaccination

was due to an intercurrent illness.” Tr. at 328. Dr. Wiznitzer also noted that “when the

fever improved, so did he.” Id. He further expressed his lack of “surprise” that “a child

with a febrile illness…didn’t have a lot of energy and…slept a lot.” Id.

Either Dr. Wiznitzer heard the testimony differently from how I heard it (and what

the transcript reflected) or he was dramatizing for effect.51 M.W. did not climb out of a

crib, but rather a bed with low rails. In her seventh month of pregnancy, Mrs. Wright

would not have climbed into a crib to spend the rest of the night of July 7-8 with M.W.

He did not walk upstairs—in fact, based on the testimony, Mrs. Wright was asleep and

did not notice how M.W. got to the landing at the top of the stairs. He could have

51 I do not intend to imply that Dr. Wiznitzer was deliberately misstating the evidence. Rather, I think he

had concluded when he wrote his initial expert report that this was not a Table case, and his recollection

of the evidence and the inferences he drew from that evidence were affected by his conclusion. It

appeared from some of Dr. Wiznitzer’s testimony that he doubted the existence of any Table

encephalopathy from a DTaP vaccination. See Tr. at 363-64. I have the utmost respect for Dr. Wiznitzer

as an expert and as an expert witness, but sometimes his testimony, particularly on cross-examination, is

more partisan than it should be.

36

crawled there.52 The evidence was that M.W. did not walk at all in the first two days

after his vaccination. Mr. Wright’s very brief comment that M.W. might have walked to

the bathroom was quickly retracted as he remembered that M.W. was 19 months old

and still in diapers.

Doctor Wiznitzer made it sound as though M.W. deliberately went looking for his

parents and actively sought his mother’s attention. I find her account of what happened

that night more consistent with a child with some degree of delirium. And, even if the

events had happened as Dr. Wiznitzer described, these incidents, including the point at

which M.W. got out of his bed, occurred well more than 24 hours after M.W.’s seizure,

and thus outside the period a Table encephalopathy must persist.

I have carefully searched the records in this case and have re-read the transcript

on several occasions, but I cannot find any evidence that M.W. complained during the

four days before he went back to his babysitter, other than perhaps in the fit he threw in

the doctor’s office. I find it far more likely that this fit was a complaint about being where

he was and recognizing the office as a place where strangers examined him and gave

him shots, rather than a complaint about being in discomfort. I note that his level of

agitation got worse when examined, suggesting that it was stranger anxiety or the

knowledge of the impending vaccination that was most likely responsible for that

escalation.

Doctor Wiznitzer conceded on cross examination that a child might throw up in a

doctor’s office for reasons other than being ill, although he caveated his answer by

saying it depended on the child’s personality and on the clinical course at the time,

intimating that M.W.’s clinical course was consistent with illness. Tr. at 390-91.

However, Dr. Leifer examined M.W. after he vomited and found no evidence that

he was acutely ill. A doctor about to order administration of a vaccination, faced with a

child who had recently vomited, would likely be in a heightened state of concern that the

child was well enough to receive a vaccination. I thus find Mrs. Wright’s testimony

about the degree of questioning by Dr. Leifer to be well corroborated. I am satisfied that

Dr. Leifer conducted a full examination, and found no signs of acute illness.

Second, Dr. Wiznitzer talked about the infection being gastrointestinal in nature,

but there was no evidence that M.W. experienced frequent vomiting and no evidence at

all that he had any diarrhea. While a child may have a gastrointestinal problem

involving either vomiting or diarrhea, the two symptoms appear frequently together in

the hundreds of medical records I have reviewed.

52 M.W. still crawled, occasionally at least, as Ms. Sierra testified that he usually crawled around on the

floor after his sister. Tr. at 210.

37

After the vomiting episode in the car (which was likely post-ictal in nature), there

was no evidence that M.W. vomited frequently in the next two days. 53 He vomited after

the event on the stairs, but at that point, he had quite a high fever, according to Mrs.

Wright. It was not the vomiting that concerned his parents; it was M.W.’s lack of

response to them and his surroundings.

Doctor Wiznitzer attributed M.W.’s behavior to fever and the fever to illness.

However, M.W. did not get better when given Tylenol. According to his parents, he was

being dosed with Tylenol or Motrin regularly, but remained “spaced out” and

unresponsive for most of the first two days after his vaccination. Thus fever was not

involved in causing the underlying behavior, although whatever caused the fever might

have been a factor.

To his credit, Dr. Shafrir agreed that an illness that could cause vomiting prior to

vaccination could also cause vomiting and convulsing; that a high temperature such as

one from an illness could cause vomiting, and that illness could cause “a couple of days

of lethargy” and abnormal sleepiness. Tr. at 293-94.

But that was not the entirety of M.W.’s presentation. These were not first-time

parents presented with a first illness of a child. Mrs. Wright came from a large family

and had frequent contact with babies and children, and M.W.’s older sister undoubtedly

experienced childhood illnesses. Petitioners described something profoundly different

in M.W.’s appearance and symptoms. M.W. may well have had some type of

intercurrent illness, but he did not have a high fever or episodes of frequent vomiting at

the time his mental and cognitive processes were at their lowest ebb. The high fever

came afterwards. M.W. simply presented with more severe neurological symptoms

than would normally be seen in a gastrointestinal illness, and lacked the high

temperature that might cause such symptoms at the time when they were most

prominent. The high fever did not present until the time of the event on the stairs, and

likely produced some of the delirium-like symptoms that occurred at that point.

Finally, respondent contends that M.W.’s pre-vaccination symptoms preclude a

finding that his post-vaccination encephalopathy (ASD) is the result of his acute

encephalopathy. Evidence that M.W. was not neurologically normal prior to the

vaccination is extremely sparse. There were no concerns about his language

development expressed in any of his pediatric records. The “well-child” aspects of his

July 6, 2009 appointment were not documented at all, but if Mrs. Wright had expressed

any concerns about his development, Dr. Leifer should have reflected them. While I do

not accept the reports about the extent of his vocabulary pre-vaccination to include 20-

53 To the extent that Mr. Wright’s and Mrs. Wright’s testimony about when and how often M.W. vomited

differ, I will accept Mrs. Wright’s accounts as more likely to be correct as she was the parent most actively

involved in M.W.’s care that week. Mr. Wright was home, but working from home, and thus did not spend

the same amount of time with M.W. that his mother did. Similarly, their reports about fever differed, and I

accept her accounts as more accurate.

38

50 words (even counting each letter of the alphabet and each number he could repeat

as a word), no one expressed any concern about his language skills pre-vaccination. I

find the contemporaneous records more likely reflected the extent of M.W.’s

communicative vocabulary at 15 months of age, which was two words in addition to the

names of his three family members. M.W. may well have been able to recite and

identify letters of the alphabet at or near 15 months of age, but he was not

communicating when he was doing so.54

According to testimony, prior to the vaccination M.W.’s parents observed him

playing with his sister, pointing to things in order to gain his parents’ attention, and

following simple directions. Tr. at 11. Mr. Wright described M.W. as playful and

attentive with others prior to 19 months. Tr. at 110-11. Ms. Valentine testified that in

M.W.’s first 19 months of life, he interacted socially with others by running towards

them, giving hugs, pointing to things, and playing with constructible toys. Tr. at 178; see

also Pet. Ex. 89 at ¶5. She made these observations while M.W. stayed at her home

overnight or during the day every three to four weeks. Tr. at 178, Pet. Ex. 89 at ¶4.

Ms. Donna Sierra, M.W.’s babysitter, began caring for him when he was six

weeks old. Tr. at 205. Before M.W. was 19 months old, Ms. Sierra testified that he

would interact with his siblings by seeking their attention by crawling towards them. Tr.

at 206; see also Pet. Ex. 88 at ¶ 3.55

The strongest evidence that M.W.’s development may not have been optimal

prior to the vaccination is in the M-CHAT Mrs. Wright completed at the July 6, 2009 visit

to Valley Pediatrics. It reflected that M.W. engaged in pretend play only “sometimes.”

and that he understood what people said “sometimes” as well. Pet. Ex. 5, p. 338.

“Sometimes” does not mean that the skills were absent and that he could not perform

them; it means that M.W. did perform them, but not all the time. After the vaccination,

he did not perform them at all. The only evidence that M.W.’s eye contact was not

“optimal” was in Dr. Nalven’s evaluation. Pet. Ex. 15, p. 617. Petitioners denied that

Mr. Wright made this comment (Tr. at 93, 162), which did not, in any event, specify

whether the lack of optimal eye contact existed before or after the vaccination. Mr.

Wright testified that M.W.’s eye contact prior to his July 2009 vaccination was

“[u]nremarkable in the sense that it was normal.” Tr. at 142.

54Some of the histories in later medical records also reflect a vocabulary of 40-50 words prior to the

Pentacel vaccination, but they do so in the context of labeling letters and numbers, rather than the use of

words in communication. See n.45 and accompanying text; see also Pet. Ex. 15, p. 617 (observing

M.W.’s use of language to label rather than to communicate); Pet. Ex. 20, p. 809 (indicating that M.W.

has excellent language skills). It does not appear that those physicians who elicited this history thought

that M.W.’s labeling of letters or numbers constituted communicative effort, in that he was reported as still

doing that labeling after the vaccination, but the physicians and speech therapists did not count such

“words” as part of M.W.’s vocabulary.

55I note that when M.W. was 19 months old, he had only one sibling. His younger brother was born in

September 2009. See Pet. Ex. 13, p. 606 (listing younger brother’s birthdate).

39

I find that M.W.’s development was, more likely than not, within normal limits

prior to his July 6 vaccinations. Thereafter, it deteriorated, and eventually he received

an ASD diagnosis. I am not required to find that the vaccination actually caused that

diagnosis. Rather, I find that the neurological and behavioral symptoms he displayed

for well more than six months after the vaccination constituted a chronic

encephalopathy, which meets the diagnostic criteria for ASD.

Many, if not most, cases of ASD constitute a chronic encephalopathy. However,

only rarely do the symptoms of ASD follow an acute encephalopathy, in which some of

those symptoms are part of the acute encephalopathic picture. This case is one of

those rare events. Because M.W. had an acute encephalopathy meeting the Table

requirements, followed by a chronic encephalopathy, a presumption of causation

attaches regarding his current condition.

I emphasize again that this is NOT a case in which a judicial determination has

been made that vaccines actually caused a child to develop ASD. Since I was assigned

to the “autism docket” in early 2007, as one of the three special masters to hear the

OAP test cases, I have had approximately 1800 cases alleging vaccine causation of

ASD on my docket. In my nearly nine years on this autism docket, I have not read or

heard any reliable evidence in any case, including this one, that vaccines can or do

cause ASD.

V. Conclusion.

M.W. experienced an acute encephalopathy, with onset beginning within two

hours of his Pentacel vaccination. The acute encephalopathy persisted for more than

24 hours. Although there is some evidence of an intercurrent illness, that evidence

does not reach the level of preponderant evidence of alternate cause. M.W. never

returned to baseline after the vaccination. He has a chronic encephalopathy which has

persisted for over six months.

Petitioners are therefore entitled to compensation for M.W.’s condition as a Table

encephalopathy. A damages order will be issued shortly.

IT IS SO ORDERED.

s/Denise K. Vowell

Denise K. Vowell

Special Master

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