In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

Case No. 10-615V

Filed: March 7, 2014

* * * * * * * * * * * * * * * * PUBLISHED

MELISSA DAVIS & CECIL DAVIS, SR., *

As the Parents and Natural Guardians of * Special Master Dorsey

C.D.J., an Infant, *

 * Entitlement; Decision without

Petitioners, * a hearing; Ruling on the record;

 * Pediarix; Prevnar; PedvaxHIB;

v. * RotaTeq; Encephalopathy; Seizures;

 * Congenital disorder of glycosylation;

SECRETARY OF HEALTH * Mutation of PIGT gene.

AND HUMAN SERVICES, *

 *

Respondent. *

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

Mark Theodore Sadaka, Englewood, NJ, for petitioners;

Justine Elizabeth Daigneault, U.S. Department of Justice, Washington, DC, for respondent.

DECISION ON ENTITLEMENT1

I. Introduction

On September 14, 2010, Melissa Davis and Cecil Davis, Sr. (“petitioners”), as the parents 

and natural guardians of C.D.J., an infant, filed a petition for compensation under the National 

Vaccine Injury Compensation Program (“the Program”2), alleging that numerous vaccinations,

including Pediarix,

3 Prevnar,4 PedvaxHIB,5 and RotaTeq6 that C.D.J. received on September 26, 

1 This Decision was originally filed on February 19, 2014. On March 5, 2014, petitioners 

requested a redaction. The motion was granted in an Order filed on March 7, 2014. In the 

reissued version, the minor child’s birth date is redacted and this footnote is changed to reflect 

the redaction. The remainder of the Decision is unchanged. 

2 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 

U.S.C. §§ 300aa-10 et seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual 

section references will be to 42 U.S.C. § 300aa of the Act.

3 Pediarix consists of diphtheria-tetanus-acellular-petussis (“DTaP”), hepatitis B, and inactivated 

polio virus (“IPV”) vaccines. See Centers for Disease Control & Prevention, Pediarix Vaccine: 

Questions and Answers, http://www.cdc.gov/vaccines/vpd-vac/combo-vaccines/pediarix/faqshcp-pediarix.htm.

1

 
2007, caused him to suffer from epileptic seizures and hypotonia.

7

 Petition at 1. The medical 

records and other information in the record, however, do not support a finding that petitioners are 

entitled to compensation under the Program. 

Under the Program, petitioners may not receive compensation based solely upon their 

claims. In order to receive compensation, the petition must be supported by either medical 

records or by the opinion of a qualified physician proving a causal relationship. See § 300aa13(a)(1). Here, the medical records do not support petitioners’ claims, so a medical opinion is 

required. Id. Petitioners have offered the opinion of Dr. Garrett C. Burris, a pediatric 

neurologist. See Petitioners’ Exhibit (“Pet’rs’ Ex.”) 13 at 1. But, as described in detail below, 

Dr. Burris’ opinion fails to provide support for the elements necessary to prove causation. 

Additionally, petitioners have failed to provide any expert report or opinion addressing the fact 

that C.D.J. has been diagnosed with an inherited genetic disorder, which is a “congenital disorder 

of glycosylation8 with two mutations in the PIGT gene.” Pet’rs’ Ex. 45 at 1.9

 For these reasons, 

and the reasons discussed below, petitioners have failed to demonstrate that they are entitled to 

compensation. 

II. Procedural History

4 Prevnar 13 is a pneumococcal conjugate vaccine, also known as PCV 13. See Centers for 

Disease Control & Prevention, Pneumococcal Vaccination, 

http://www.cdc.gov/VACCINES/vpd-vac/pneumo/default.htm.

5 PedvaxHIB is a Haemophilus inflenzae type b vaccine which prevents meningitis (an infection 

of the covering of the brain and spinal cord), pneumonia (lung infection), epiglottitis (a severe 

throat infection), and other serious infections caused by a type of bacteria called Haemophilus 

influenza type b. See Centers for Disease Control & Prevention, Hib Vaccination, 

http://www.cdc.gov/Vaccines/vpd-vac/hib/default.htm.

6 RotaTeq is a vaccine used to prevent severe rotavirus disease in infants and children. See

Centers for Disease Control & Prevention, Statement Regarding Rotarix and RotaTeq Rotavirus

Vaccines and Intussusception, http://www.cdc.gov/vaccines/vpd-vac/rotavirus/intussusceptionstudies-acip.htm.

7 Hypotonia is “a condition of diminished tone of the skeletal muscles, so that they have 

diminished resistance to passive stretching and are flaccid.” Dorland’s Illustrated Medical 

Dictionary (32d ed. 2012) (“Dorland’s”) at 907.

8 Glycosylation is “the formation of linkages with glycosyl groups.” Dorland’s at 794.

9 Petitioners have filed another petition for compensation on behalf of their other child, C.D., in 

which they allege that the same vaccines C.D.J. received caused the same injuries C.D. suffered. 

See Davis v. Sec’y of Health & Human Servs., No. 09-684V. A similar Decision has issued in 

that case. See Davis v. Sec’y of Health & Human Servs., No. 09-684V, Decision, filed February 

19, 2014.

2

 
Petitioners filed their action for compensation on September 14, 2010, and the case was 

initially assigned to Special Master Gary Golkiewicz. Petitioners filed numerous medical 

records related to C.D.J.’s birth and medical care on November 23, 2010. The case was 

reassigned to Special Master Dee Lord on December 7, 2010. Respondent filed her Report

pursuant to Vaccine Rule 4(c), in which she stated that the medical personnel of the Division of 

Vaccine Injury Compensation had reviewed the petition and medical records and concluded that

petitioners had not proven that C.D.J.’s injury had been caused by the vaccine(s), and that the 

case was therefore not appropriate for compensation under the Program. Respondent’s Report

(“Resp’t’s Rep’t”), filed February 22, 2011, at 2. 

On August 11, 2011, and February 1, 2012, petitioners filed the expert report and 

supplemental expert report of Dr. Garrett Burris. Pet’rs’ Ex. 13; Pet’rs’ Ex. 18. On June 11, 

2012, respondent filed the expert report of Dr. Gerald V. Raymond. Respondent’s Exhibit 

(“Resp’t’s Ex.”) A. 

Petitioners were ordered to file an amended petition to clarify their allegations, Order, 

filed July 13, 2012, which they did on August 3, 2012. In their amended petition, petitioners 

allege that C.D.J. “developed vaccine-induced encephalopathy resulting in epileptic seizures and 

hypotonia after receiving second doses of Pediarix, Prevnar, PedvaxHIB and Rotateq on 

September 26, 2007.” Amended Petition (“Am. Pet.”) at 1. Petitioners further allege that C.D.J.

was assessed as a “well child” prior to the stated vaccines but that he had an “undiagnosed 

condition . . . generally termed as a ‘metabolic disorder’” and that persons with “metabolic 

disorders” are more susceptible to vaccine-related injury. Id. at 3. Petitioners allege that 

PedvaxHIB “contains antigens that induce the body to produce antibodies to the disease.” Id. 

These antibodies can “cross-react with antigens similar to what is contained in the vaccine.” Id.

at 4. 

Petitioners allege that C.D.J. had his first seizure on October 1, 2007, about six days after 

receiving the vaccinations at issue. Id. His seizure activity consisted of “severe jerking of his 

upper and lower extremities.” Id. Then, in December 2007, C.D.J. had jerking in his face. Id. 

In January 2008, C.D.J. was hospitalized with “pneumonia and status epilepticus.” Id. As a 

result of receiving vaccinations on September 26, 2007, petitioners allege that C.D.J. suffered a 

regression of his motor skills, constant seizures, encephalopathy, epilepsy, and a decrease in his 

muscle tone. Id. at 4. 

Notwithstanding the submission of Dr. Burris’ expert report and supplemental expert 

report, counsel for petitioners indicated during a November 29, 2012, status conference that they

would likely be switching experts in the near future. Order, filed Nov. 30, 2012, at 1. On 

January 28, 2013, petitioners filed a status report stating that although they had made 

“continuous efforts,” they had been unable to find a new expert. See Status Report, filed Jan. 28, 

2013, at 1.

On February 22, 2013, the case was reassigned to the undersigned, and a status 

conference was held on March 28, 2013. During the status conference, petitioners were ordered 

to file an expert report by May 31, 2013. Order, filed Mar. 28, 2013, at 1-2. Additional medical 

records were filed on March 29, 2013. On May 31, 2013, petitioners filed an unopposed motion 

for an extension of time until July 30, 2013, to file an expert report. That motion was granted. 

3
Order, filed May 31, 2013. On July 30, 2013, petitioners filed another motion for an extension 

of time in which to file an expert report, until August 29, 2013. Again, that motion was granted. 

Order, filed July 30, 2013, at 1. Meanwhile, petitioners were also investigating the results of 

genetic testing that had been performed on C.D.J., so that the results of such testing could be 

obtained and filed. See Status Report, filed Aug. 16, 2013, at 1. Petitioners did not file an expert 

report by August 29, 2013, as ordered.

A subsequent status conference was held on September 3, 2013. During the status 

conference, counsel for petitioners stated that petitioners intended to file a motion for a decision 

on the record. The issue of genetic test results was again discussed and the petitioner was 

ordered to obtain and file all records from the National Institutes of Health (“NIH”) and all

results regarding any genetic testing. See Order, filed Sept. 18, 2013, at 1. A motion for 

judgment on the administrative record was filed on October 17, 2013, and a letter from the NIH 

Undiagnosed Diseases Program, reporting on C.D.J.’s genetic tests results, was filed on October 

31, 2013. Pet’rs’ Ex. 45. Petitioners also filed a status report stating that petitioners had been 

informed that both C.D.J. and C.D. had received a confirmed diagnosis of a “congenital disorder 

of glycosylation with two different mutations in the PIGT gene. This diagnosis is an inherited 

autosomal recessive disease.” Status Report, filed Oct. 31, 2013, at 1. 

Respondent filed a response to petitioners’ motion for judgment on the administrative 

record on January 17, 2014. Respondent argues that Dr. Burris’ “opinion regarding the genetic 

nature of [C.D.J.]’s condition is simply incorrect” and that “there is no reliable evidence that any 

of [C.D.J.]’s clinical manifestations were caused or exacerbated by any of the immunizations that 

he received.” Respondent’s Response to Petitioner’s Motion for a Decision on the Record 

(“Resp’t’s Resp.”), filed Jan. 17, 2014, at 16. Rather, respondent claims that all of C.D.J.’s 

“symptoms . . . are presentations of [his] . . . genetic disorder.” Id. at 14. Thus, respondent 

asserts that, “[o]n the present record, petitioners have clearly failed to meet their burden of 

proving by preponderant evidence that C.D.J.’s vaccinations either caused his injury or 

significantly aggravated his preexisting condition.” Id. at 1. 

The case is now ripe for a ruling on petitioners’ motion for judgment on the 

administrative record. 

III. Summary of Relevant Medical Records and Other Filed Exhibits

C.D.J. was born on [redacted], at thirty-one weeks gestation. Pet’rs’ Ex. 2 at 41-42. He

was apneic10 at birth and required ventilation by bag and mask and ventilator. Pet’rs’ Ex. 11 at 

525. His Apgar scores were 4, 5 and 7 at 1, 5, and 10 minutes, respectively. Id. C.D.J. was 

unresponsive to tactile stimulation, jittery, and had significant tremors of his lower extremities. 

Pet’rs’ Ex. 2 at 43. C.D.J. was admitted to the neonatal intensive care unit (“NICU”) from the 

date of his birth until he was discharged on June 27, 2007. Pet’rs’ Ex. 2 at 41. During this 

admission, he was diagnosed with numerous problems, including respiratory distress syndrome, 

prematurity, suspected sepsis, apnea, and feeding difficulties. Id. C.D.J.’s family history was

significant in that he had a one-year-old sister, C.D., who had been diagnosed with a metabolic 

disorder and significant cognitive and motor developmental delay. Id. at 42. C.D. also had a 

10 Apnea is a “cessation of breathing.” Dorland’s at 116.

4

 
complex epilepsy disorder and a suspected mitochondrial disorder, but there was no specific 

diagnosis for her condition. Id. at 42. 

C.D.J.’s physical exam in the NICU was significant in that he had dysmorphic facial 

characteristics and prominent gum ridges. Id. at 44. He had myoclonic11 jerks and jitteriness 

with immature motor control. Id. He also had periodic tremors in his hands and clonus12 of his 

ankles. Id. C.D.J. had cardiac abnormalities, including dilated right atrium, atrial septal defect 13

with a left to right shunt, atrial septal aneurysm,14 and dysplastic tricuspid value.15 Id. at 43. 

C.D.J. had poor feeding with periods of apnea during feedings. Id. On C.D.J.’s discharge from 

the NICU, a genetics consult was recommended. Id. at 46. C.D.J. was suspected to have a 

mucolipidosis disorder. Id.; Pet’rs’ Ex. 35 at 7. 

On July 2, 2007, C.D.J. was referred to the Arkansas infant and toddler program, First 

Connections, for premature birth, possible developmental delay, and an occupational therapy 

evaluation. Pet’rs’ Ex. 5 at 62-63. On August 6, 2007, when C.D.J. was 2 months and 21 days 

old, an occupational therapy (“OT”) evaluation was done by Ms. Carly Hill, OTR/L, which 

revealed slight delays in fine motor skills, prematurity, low muscle tone, and tremors. Id. at 93, 

96. C.D.J. was also noted to have frequent tremors and jitteriness of his extremities. Id. at 94. 

C.D.J. had limited range of motion, generalized hypotonia, poor head control, delayed visual 

behaviors, and was unable to track objects. Id. at 94-95.

At his two-month well child visit on July 9, 2007, C.D.J.’s pediatrician, Dr. Carl

Engmann, noted abnormal findings on physical examination, including heart murmur, “coarse 

features,” tremors and jitteriness, and clicks in the hips and right shoulder. Pet’rs’ Ex. 32 at 1. 

Dr. Engleman’s assessment was “? metabolic disorder.” Id. 

At a subsequent visit on July 25, 2007, C.D.J.’s mother was concerned that he was 

sleeping too much. Id. at 2. At that visit, C.D.J. received his first doses of Pediarix, Prevnar, 

PedvaxHIB and RotaTeq. Id. 

11 Myoclonus is “shocklike contractions of a portion of a muscle, an entire muscle, or a group of 

muscles, restricted to one area of the body or appearing synchronously or asynchronously in 

several areas.” Dorland’s at 1222.

12 Clonus is an “alternate muscular contraction and relaxation in rapid succession.” Dorland’s at 

373.

13 An atrial septal defect is a congenital cardiac anomaly where there is a persistent patency of 

the atrial septum due to failure of fusion between either the septum secundum or the septum 

primum and the endocardial cushions. Dorland’s at 476.

14 An atrial septal aneurysm is “a rare malformation of the interatrial septum in which the sac 

protrudes into one of the atria.” Dorland’s at 82.

15 Dysplastic tricuspid valve means abnormal development of the tricuspid valve of the heart. 

See Dorland’s at 1965.

5

 
C.D.J. returned to his pediatrician for his four-month visit on September 26, 2007. Id. at 

3. At that visit, C.D.J. was noted to have tightness in his muscles and, again, the family 

expressed concerns about the fact that he was sleeping a lot, was fussy, and cried a lot. Id. At 

that visit, C.D.J. received his second doses of Pediarix, Prevnar, PedvaxHIB, and RotaTeq. Id.

Based upon a history given by C.D.J.’s mother to Gretchen A. Golas, C.R.N.P., on May 

19, 2009, at the NIH, C.D.J. began having jerking of his arms and legs on October 1, 2007, one 

week after receiving his second set of vaccinations, when he was about five months old. Pet’rs’ 

Ex. 11 at 526, 529. There are no contemporaneous medical records that document the events of 

October 1, 2007. 

On December 12, 2007, at about seven months of age, C.D.J. presented to his pediatrician

with cold and cough symptoms. Pet’rs’ Ex. 32 at 4. He was diagnosed with an upper respiratory 

illness. Id. In the notes for that visit there is no reference to the events of October 1, 2007, 

regarding C.D.J. having jerking of his arms and legs. 

On December 19, 2007, the pediatrician’s office notes document that C.D.J. had six 

seizures on the previous day, and that he had rhinorrhea,16 hypotonia, and motor delay. Id. at 5. 

The office records from that visit state that “Mom has noticed some twitching ... of his upper 

limbs as well as dropping his head.” Id. at 6. C.D.J. was diagnosed with a possible seizure 

disorder. Id. C.D.J. received his third doses of Pediarix, Prevnar, and RotaTeq at that visit. Id.

at 5. On December 20, 2007, an EEG was performed, which was interpreted as normal, although 

it was noted that the study was technically difficult. Pet’rs’ Ex. 41 at 1. 

 

Moving forward to 2008, on January 4, 2008, C.D.J. was noted to have hypotonia, 

jerking movements of both upper and lower extremities, an absent walking reflex, and moderate 

to severe delay in his gross motor skills. Pet’rs’ Ex. 5 at 88-91. In February 2008, C.D.J. had an 

EEG, which was abnormal and consistent with generalized epilepsy. Pet’rs’ Ex. 11 at 526. On 

March 8, 2008, C.D.J. presented to the emergency department at North West Medical Center 

with seizures and a temperature of 102.7oF. Pet’rs’ Ex. 6.1 at 104. Physical examination was 

significant for mild microcephaly.17 Pet’rs’ Ex. 6.2 at 112. Past history was notable for 

“congenital developmental delay . . . and mitochondrial abnormality.” Id. 

On May 20, 2008, C.D.J. received his one-year vaccinations, including MMR, Varicella, 

Hepatitis A, and Prevnar. Pet’rs’ Ex. 32 at 11. A barium swallow test performed in June 2008 

revealed that C.D.J. had a weak suck, delayed swallow, and incoordination of suck and swallow. 

Pet’rs’ Ex. 8.1 at 163. In August 2008, when C.D.J. was 14 months old, he was noted to have

had no progression in his development since age five months. Pet’rs’ Ex. 11 at 526. He was not 

able to sit, roll or track objects. Id. His diagnosis was intractable myoclonic epilepsy and 

developmental delay. Id. He was also noted to have “coarse features similar to his sibling’s.” 

Id. 

16 Rhinorrhea is “the free discharge of a thin nasal mucus.” Dorland’s at 1640.

17 Microcephaly is “abnormal smallness of the head, usually associated with mental retardation.” 

Dorland’s at 1157. 

6

 
On August 6, 2008, Dr. Rolla Shbarou, pediatric neurologist, diagnosed C.D.J. with 

“intractable myoclonic epilepsy, developmental delay, visual impairment, [and] course facial 

features.” Pet’rs’ Ex. 14.4 at ACH 332. In December 2008, C.D.J. was hospitalized for status 

epilepticus, pneumonia, respiratory failure, and increased seizures. Pet’rs’ Ex. 11 at 526. At that 

time, C.D.J. required intubation and ventilation. Id. at 527; Pet’rs’ Ex. 8.2 at 197. A chest x-ray 

showed cardiomegaly18 and an echocardiogram showed a large left to right shunt through the 

atrial septal defect, along with other abnormalities. Pet’rs’ Ex. 11 at 527. In January 2009, 

C.D.J. had a gastronomy tube placed for feeding due to his history of aspiration and pneumonia. 

Id.; see also Pet’rs’ Ex. 8.9 at 286. 

At age 2, from May 18 to 22, 2009, C.D.J. was admitted to the NIH Undiagnosed Disease 

Program for evaluation by Gretchen A. Golas, C.R.N.P., and Dr. William A. Gahl. They 

documented that his “[c]oarse features and tapered fingers suggest a storage disorder or other 

syndrome.” Pet’rs’ Ex. 11 at 515. C.D.J. was noted to have bilateral corneal clouding, high 

triglycerides, aminoaciduria,19 osteopenia,20 and immunoglobulin A (“IgA”) deficiency. Id. at 

519. C.D.J. was also diagnosed with “profound global developmental delay,” “epileptic 

encephalopathy,” atrial septal defect with “significant left to right shunt with right 

cardiomegaly,” hypotonia, and dysmorphic features. Pet’rs’ Ex. 11 at 519. On discharge, 

genetic tests were pending. Id. 

On July 21, 2009, C.D.J. had closure of his atrial septal defect by Dr. Paul Seib. Pet’rs’ 

Ex. 14.13 at 940. C.D.J. continued to have severe progressive encephalopathy. C.D.J.’s 

condition continued to progressively worsen over time. Moving forward to 2011, an MRI 

performed on April 7, 2011, showed “cerebellar and possibly brainstem atrophy.” Pet’rs’ Ex.

14.1 at 7. On June 20, 2011, Dr. Tonya Balmakund documented that C.D.J., at that time age 4, 

had a neurodegenerative disease and intractable epilepsy with a markedly abnormally EEG. 

Pet’rs’ Ex. 14.1 at 83-84. 

Genetic testing with a final report date of February 12, 2013, identified that C.D.J. had 49 

“clinically novel” genes. Pet’rs’ Ex. 37 at 2. “A clinically novel gene is a previously 

undescribed gene, not currently known to underlie a genetic condition.” Id. The results 

indicated that “the underlying cause of the patient’s clinical symptoms has not been discovered.” 

Id. Phosphatidylinositol glycan anchor biosynthesis, class T (PIGT) was one of the novel genes 

identified. Id. at 3.

Neurology clinic notes dated June 6, 2013, by Dr. Balmakund, describe C.D.J. as a “6-

year-old little boy with a history of intractable epilepsy and significant encephalopathy and 

hypotonia related to an underlying neurodegenerative disorder of uncertain etiology.” Pet’rs’ Ex.

38 at 3. Dr. Balmakund noted that the family history is “remarkable for a sibling with a similar 

disease.” Id. On July 20, 2011, C.D.J. was seen by Dr. Jerie B. Karkos, for rehabilitative 

18 Cardiomegaly is “abnormal enlargement of the heart from either hypertrophy or dilatation.” 

Dorland’s at 294. 

19 Aminoaciduria is “an excess of amino acids in the urine.” Dorland’s at 61.

20 Osteopenia is “any decrease in bone mass below the normal.” Dorland’s at 1347.

7

 
services, who noted that C.D.J. had microcephaly with a head circumference in the 2% range. 

Pet’rs’ Ex. 14.1 at 31. On July 25, 2011, Dr. Balmakund and C.D.J.’s mother corresponded by 

email, and Dr. Balmakund explained that C.D.J.’s and C.D.’s conditions were not due to any 

alternative acquired disease, and that the “children are word for word out of texts for several 

metabolic and neurodegenerative diseases.” Id. at 75-76.

On October 29, 2013, petitioners received a letter from Ms. Golas and Dr. Cynthia J. 

Tifft, Director of the NIH Pediatric Undiagnosed Diseases Program. Pet’rs’ Ex. 45. The letter 

states, in pertinent part, the following:

This letter is to confirm our recent phone conversation regarding the molecular diagnosis 

of a congenital disorder of glycosylation with two different mutations in the PIGT gene 

for both your children, [C.D.] and [C.D.J.] . . . . Both [C.D. and C.D.J.] have inherited an 

autosomal recessive disease called a congenital disorder of glycosylation involving

mutations in the PIGT gene. The complex pathway of glycosylation involves many 

different genes participating in the biochemical process of adding and removing sugars 

to/from proteins. PIGT is a gene that has been only very recently identified (May 2013)

in the medical literature as an additional cause of a type of congenital disorders of 

glycosylation with the feature of intellectual disability.

Id. at 1.

Petitioners subsequently filed a copy of a medical article referenced in the above letter.21

The article reports on the “novel autosomal recessive syndrome, characterised by distinct facial 

features, intellectual disability, hypotonia and seizures, in combination with abnormal skeletal,

endocrine, and ophthalmologic findings.” Pet’rs’ Ex. 46 at 1. The authors examined four 

patients with a similar phenotype, using whole exome sequencing and identified a “homozygous 

mutation, c.547A>C . . . in PIGT.” Id. at 1. Further study revealed that this mutation was the 

cause of a “novel autosomal recessive intellectual disability syndrome.” Id. Patients with PIGT

mutations have clinical findings which include hypotonia, mild microcephaly, impaired motor 

and cognitive development, severe motor and intellectual disability, abnormal brain imaging, 

seizures, initially normal EEG with subsequent development of seizures, impaired vision, renal 

abnormalities, skeletal abnormalities, cardiac abnormalities, mild dysmorphic facial features, and 

global cerebral atrophy. Id. at 2-3. The authors conclude that they have found “strong evidence 

that a syndrome of intellectual disability, hypotonia, seizures, and skeletal and ophthalmologic 

findings seen in the patients of this study is caused by mutations in PIGT.” Id. at 7. 

IV. Expert Opinion

On August 11, 2011, petitioners filed the expert report of Dr. Garrett C. Burris, a child 

neurologist. Pet’rs’ Ex. 13. In his report, Dr. Burris provided a brief summary of medical facts 

beginning with C.D.J.’s birth and ending with a short paragraph about C.D.J.’s admission to the 

21 Pet’rs’ Ex. 43, Malin Kvarnung, et al., “A novel intellectual disability syndrome caused by 

GPI anchor deficiency due to homozygous mutations in PIGT,” 50 J. MED. GENETICS 8, 521-

28 (August 2013).

8

 
NIH in May 2009. Id. at 1-2. Dr. Burris omitted from his report pertinent facts, such as C.D.J.’s

“[c]oarse features and tapered fingers [which] suggest a storage disorder or other syndrome,” or 

his bilateral corneal clouding, high triglycerides, aminoaciduria, osteopenia, and IgA deficiency. 

See Pet’rs’ Ex. 11 at 515, 519. Dr. Burris failed to note that when C.D.J. was discharged from 

the NIH, genetic tests were pending. Id. at 519. Dr. Burris also failed to reference any records 

after 2009, although his report is dated August 9, 2011. Most notably, there is no reference to 

C.D.J.’s genetic mutation in Dr. Burris’ report. 

Dr. Burris opined that within a reasonable degree of medical certainty, C.D.J. had vaccine 

induced acute encephalopathy, consisting of “seizures and decreased consciousness lasting for 

longer than 24 hours .... occur[ring] within 5 days after the administration of vaccines.” Pet’rs’ 

Ex. 13 at 567. Dr. Burris also opined that C.D.J. had chronic encephalopathy, “severe global 

developmental retardation” and refractory seizures. Id. Dr. Burris concluded that “[t]he 

presence of acute encephalopathy and developmental regression with chronic encephalopathy 

following administration of vaccine is consistent with vaccine induced encephalopathy. There 

are no other causes of encephalopathy in this case.” Id.

In a supplemental expert report, Dr. Burris opined that C.D.J. had a metabolic disorder 

which made him more susceptible to developing an abnormal immune response to the 

vaccinations. Pet’rs’ Ex. 18 at 1. Dr. Burris stated that metabolic disorders produce a chronic 

inflammatory state. Id. Dr. Burris further stated that antigens, which are foreign substances that 

cause an immune response, elicit the production of antibodies, and that “[v]accinations are 

specifically designed to elicit this immune response resulting in the production of antibodies.” 

Id. The risk of developing an autoimmune disease increases when vaccines are given to a 

“patient with a chronic inflammatory condition caused by metabolic disorders,” like C.D.J.’s. Id. 

Dr. Burris identified four theories of autoimmunity: “molecular mimicry, bystander 

activation, persistent viral infections and fertile field.” Id. Generally, Dr. Burris believed that 

there are two causal pathways of autoimmune epilepsy and encephalopathy – one is “that the 

body produces auto-antibodies for specific proteins necessary for proper neurological function.” 

Id. at 2. The second is that an “increased number of antibodies can trigger seizures and 

encephalopathy.” Id. Dr. Burris did not know which causal pathway might be relevant in 

C.D.J.’s case. Id. But he concluded that the “record clearly shows the development of seizures 

within days after vaccination and both children suffer from chronic inflammation caused by

metabolic disorder.” Id.

Respondent filed the expert report of Dr. Gerald V. Raymond, a neurologist and clinical 

geneticist, and the Director of Neurogenetics Research at the Johns Hopkins School of Medicine. 

Resp’t’s Ex.s A and B at 1. Dr. Raymond has an active clinical practice evaluating children with 

genetic disorders, including those with “progressive neurodegenerative disorders.” Resp’t’s Ex.

A at 4.

In his report, Dr. Raymond noted that C.D.J. demonstrated motor abnormalities as 

documented in his NICU stay after birth, and that he also had “dysmorphic facies,” including 

“prominent gum ridges.” Id. at 1. After discharge from the NICU, he was referred to the Infant 

and Toddlers Program and in August 2007, where Ms. Hill, OTR/L, noted that C.D.J. had 

frequent tremors and jitteriness. Id. C.D.J. had other abnormalities including limited range of 

9
motion, generalized hypotonia, and poor head control. Id. at 1. In addition, he had “delayed 

visual behaviors and would not track any objects.” Id. C.D.J. subsequently developed seizures, 

on or about October 1, based upon family recollection. Id. at 2. Dr. Raymond described C.D.J.’s

history of seizures, abnormal EEG findings, hypotonia and severe global developmental delay. 

Id. at 2-3. He noted that C.D.J. was evaluated by Dr. Andrea Gropman, who documented 

C.D.J.’s “course features” and tapered fingers, which were “suggestive of a storage disease.” Id.

at 3. Dr. Raymond also noted that C.D.J. had microcephaly, and that an MRI showed cerebellar 

and brainstem atrophy. Id. at 4. 

Dr. Raymond explained that C.D.J. and his sister have a genetic disorder, which is 

probably autosomal recessive. Id. at 5. Dr. Raymond described the basis for his opinions, and 

provided a brief overview of autosomal recessive genetic disorders and how they occur. Id. He 

recommended that C.D.J. have whole exome sequencing testing to determine a genetic diagnosis. 

Id. at 6. Dr. Raymond concluded that “to a reasonable degree of medical certainty” C.D.J. has a 

“genetic epileptic encephalopathy with dysmorphic features that were present at the time of 

birth.” Id. at 6. Dr. Raymond rejected the notion that C.D.J.’s injuries were caused by or 

exacerbated by vaccinations. Id. at 6-7.

Dr. Raymond disagreed with the opinions set forth by Dr. Burris. First, Dr. Raymond 

stated that C.D.J. did not have acute encephalopathy because he did not have any “alteration of 

consciousness at the time of onset of seizures beyond the brief events themselves.” Id. at 6. 

Second, Dr. Raymond opined that C.D.J. does not have various metabolic disorders; rather, he 

has a single genetic condition. Id. Third, C.D.J. has demonstrated many times that he responds 

appropriately to infections and that he does not have an “abnormal immune response.” Id. 

Fourth, there was no evidence or documentation to suggest that C.D.J. has had any adverse 

reaction to vaccines. Id. None of C.D.J.’s treating physicians has diagnosed him with a vaccinerelated disorder and, in fact, his treating physicians have continued to administer vaccinations to 

C.D.J.. Id. Fifth, while Dr. Raymond agreed that there are neurological conditions caused by 

antibodies, such conditions would not explain C.D.J.’s congenital abnormalities and dysmorphic 

features. Id. Dr. Raymond opined that “there is substantial evidence that he has exactly the 

same [genetic] condition as his older sister.” Id.

V. Standards for Adjudication – Causation 

The Vaccine Act established the Program to compensate vaccine-related injuries and 

deaths. § 300aa-10(a). “Congress designed the Vaccine Program to supplement the state law 

civil tort system as a simple, fair and expeditious means for compensating vaccine-related 

injured persons. The Program was established to award ‘vaccine-injured persons quickly, easily, 

and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs., 35 Fed. Cl. 1, 7 

(1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344). 

To establish causation in fact, a petitioner must show by a preponderance of the evidence 

that but for the vaccination, the petitioner would not have been injured, and that the vaccination 

was a substantial factor in bringing about the injury. Cedillo v. Sec’y of Health & Human 

Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010); Shyface v. Sec’y of Health & Human Servs., 165 

F.3d 1344, 1352 (Fed. Cir. 1999). Proof of actual causation must be supported by a sound and 

reliable “medical or scientific explanation that pertains specifically to the petitioner’s case, 

10
although the explanation need only be ‘legally probable, not medically or scientifically certain.’” 

Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010) (quoting 

Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)); see also

Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (medical theory 

must support actual cause). “[A] petitioner must demonstrate the reliability of any scientific or 

other expert evidence put forth to carry this burden . . . . Expert testimony, in particular, must 

have some objective scientific basis in order to be credited by the Special Master.” Jarvis v. 

Sec’y of Health & Human Servs., 99 Fed. Cl. 47, 54-55 (2011) (citing Moberly, 592 F.3d at 

1322; Cedillo, 617 F.3d at 1339; Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 

1316 (Fed. Cir. 1999)). 

Causation is determined on a case-by-case basis, with “no hard and fast per se scientific 

or medical rules.” Knudsen, 35 F.3d at 548. A petitioner may use circumstantial evidence to 

prove the case, and “close calls” regarding causation must be resolved in favor of the petitioner. 

Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005).

To receive compensation under the Program, petitioners must prove either: (1) that C.D.J.

suffered a “Table Injury”—i.e., an injury listed on the Vaccine Injury Table—corresponding to a 

vaccine that he received, or (2) that C.D.J. suffered an injury that was actually caused by the 

vaccine (or vaccines) he received. See §§ 300aa-13(a)(1)(A) and 11(c)(1); Capizzano v. Sec’y 

of Health & Human Servs., 440 F.3d 1317, 1319-20 (Fed. Cir. 2006). Petitioners must show that 

a vaccine was “not only a but-for cause of the injury but also a substantial factor in bringing 

about the injury.” Moberly, 592 F.3d at 1321 (quoting Shyface, 165 F.3d at 1352-53). 

Because petitioners do not allege that C.D.J. suffered a Table injury, they must prove that 

a vaccine C.D.J. received caused his injury. To do so, they must establish, by preponderant 

evidence: (1) a medical theory causally connecting a vaccine and C.D.J.’s injury (“Althen Prong 

One”); (2) a logical sequence of cause and effect showing that a vaccine was the reason for his 

injury (“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between a 

vaccinee and his injury (“Althen Prong Three”). Althen, 418 F.3d at 1278; § 300aa–13(a)(1) 

(requiring proof by a preponderance of the evidence). 

A. Althen Prong One

Petitioners failed to submit any expert opinion addressing a theory of how the 

vaccinations at issue could cause the alleged injuries in a patient with C.D.J.’s established 

genetic mutations; that is, mutations in the PIGT gene. These genetic mutations have been

identified in the medical literature as a cause of congenital disorders of glycosylation with the 

feature of intellectual disability. Pet’rs’ Ex. 46 at 6. The PIGT gene functions to make a specific 

protein that helps other proteins attach to a sugar-fat structure called a glycolipid (“GPI”). Id. at 

4. GPI is found in all cells of the body and is “essential for life.” Id. at 4. A study of four other 

patients with the same genetic mutation revealed that this mutation was the cause of a “novel 

autosomal recessive intellectual disability syndrome.” Id. at 1. Patients with PIGT mutations 

have hypotonia, mild microcephaly, impaired motor and cognitive development, severe motor 

and intellectual disability, seizures, impaired vision, skeletal abnormalities, cardiac 

abnormalities, mild dysmorphic facial features, and global cerebral atrophy. Id. at 5-7. The 

authors of the study concluded that that there is “strong evidence that a syndrome of intellectual 

11
disability, hypotonia, seizures, and skeletal and ophthalmologic findings seen in the patients of 

this study is caused by mutations in PIGT.” Id. at 7. 

Petitioners’ expert, Dr. Burris, opined that C.D.J. has a metabolic disorder that produced

a chronic inflammatory state. Pet’rs’ Ex. 18 at 1. Dr. Burris stated that the risk of developing an 

autoimmune disease increases when vaccines are given to a “patient with a chronic inflammatory 

condition caused by a metabolic disorder,” like C.D.J.’s. Id. But Dr. Burris did not identify any 

metabolic disorder(s), nor did he set forth facts relevant to this case to support his opinion that a 

metabolic disorder was at play here. Likewise, Dr. Burris did not cite any facts or evidence from 

the medical records to show that C.D.J. has a chronic inflammatory condition. 

Dr. Burris identified four theories of autoimmunity: “molecular mimicry, bystander 

activation, persistent viral infections, and fertile field.” Id. Generally, Dr. Burris believes that 

there are two causal pathways of autoimmune epilepsy and encephalopathy – one is “that the 

body produces auto-antibodies for specific proteins necessary for proper neurologically

function.” Id. at 2. The second is that an “increased number of antibodies can trigger seizures 

and encephalopathy.” Id. Dr. Burris has not explained how or whether these theories might 

apply to patients with genetic mutations. 

Even if the undersigned were to assume that Dr. Burris’ theories of causation satisfied

Althen’s Prong One, Dr. Burris’ reports are deficient as to Prongs Two and Three of Althen, as 

discussed below. 

B. Althen Prong Two

Althen Prong Two requires petitioners to show by a preponderance of the evidence that 

the vaccinations caused C.D.J.’s injuries consistent with the medical theory or theories proposed 

by Dr. Burris. Because Dr. Burris did not address C.D.J.’s genetic disorder or point to factual 

support from C.D.J.’s medical records to support his opinions, petitioners have failed to meet 

their burden.

Dr. Burris opined that C.D.J. had a metabolic disorder which produced a chronic 

inflammatory state. Id. at 1. Dr. Burris stated that the risk of developing an autoimmune disease 

increases when vaccines are given to a “patient with a chronic inflammatory condition caused by 

a metabolic disorder,” like C.D.J.’s. Id. Dr. Burris did not, however, refer to facts from C.D.J.’s 

medical records or provide any other basis to support his opinion that C.D.J. had a metabolic 

disorder or a chronic inflammatory condition. Therefore, his opinions are without foundation. 

“An expert opinion is no better than the soundness of the reasons supporting it.” Perreira v. 

Sec’y of Health and Human Servs., 33 F.3d 1375, 1377 fn. 6 (Fed. Cir. 1994).

Moreover, although Dr. Burris identified four mechanisms of autoimmunity, he failed to

articulate how these theories apply to a patient with C.D.J.’s genetic mutations. Dr. Burris’

report does not discuss any logical sequence of cause and effect showing that C.D.J.’s 

vaccinations were the reason for his injuries. 

12
Whether or not C.D.J. is presumed to have a genetic mutation, Dr. Burris’ opinions fail

Althen Prong Two because they lack factual support or other foundation. Thus, petitioners have 

failed to provide preponderant evidence of actual causation under Althen Prong Two.

C. Althen Prong Three

Petitioners also failed to prove Althen Prong Three because Dr. Burris’ reports are 

deficient on this issue. Dr. Burris does not address the issue of a proximate temporal relationship 

between the vaccinations and injury other than to make a conclusory statement that C.D.J. had 

acute encephalopathy five days after the administration of the vaccines. Dr. Burris fails to cite 

any medical facts or evidence to support his conclusion that there existed a proximate temporal 

relationship between C.D.J.’s vaccines and his alleged encephalopathy. As such, petitioners 

have failed to provide preponderant evidence of a proximal temporal relationship between the 

vaccines and any alleged injury. 

VI. Conclusion

For the reasons discussed above, the undersigned finds that petitioners have not 

established entitlement to compensation and their petition must be dismissed. Therefore, this 

case is dismissed for failure to make a prima facie case. The Clerk shall enter judgment 

accordingly.22

IT IS SO ORDERED.

s/ Nora Beth Dorsey

Nora Beth Dorsey

Special Master

22 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint 

filing of notice renouncing the right to seek review.

13