CHILD, a minor,
by her Parents and
Natural Guardians,
Petitioners,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent.
RESPONDENT'S RULE 4(c) REPORT
In accordance with RCFC, Appendix B,
Vaccine Rule 4(c), the Secretary of
Health and Human Services submits the
following response to the petition for
compensation filed in this case.
FACTS
CHILD ("CHILD") was born on December
--, 1998, and weighed eight pounds, ten
ounces. Petitioners' Exhibit ("Pet.
Ex.") 54 at 13. The pregnancy was
complicated by gestational diabetes. Id.
at 13. CHILD received her first
Hepatitis B immunization on December 27,
1998. Pet. Ex. 31 at 2.
From January 26, 1999 through June
28, 1999, CHILD visited the Pediatric
Center, in Catonsville, Maryland, for
well-child examinations and minor
complaints, including fever and eczema.
Pet. Ex. 31 at 5-10, 19. During this
time period, she received the following
pediatric vaccinations, without
incident:
Vaccine Dates Administered
Hep B 12/27/98; 1/26/99
IPV 3/12/99; 4/27/99
Hib 3/12/99; 4/27/99; 6/28/99
DTaP 3/12/99; 4/27/99; 6/28/99
Id. at 2.
At seven months of age, CHILD was
diagnosed with bilateral otitis media.
Pet. Ex. 31 at 20. In the subsequent
months between July 1999 and January
2000, she had frequent bouts of otitis
media, which doctors treated with
multiple antibiotics. Pet. Ex. 2 at 4.
On December 3,1999, CHILD was seen by
Karl Diehn, M.D., at Ear, Nose, and
Throat Associates of the Greater
Baltimore Medical Center ("ENT
Associates"). Pet. Ex. 31 at 44. Dr.
Diehn recommend that CHILD receive PE
tubes for her "recurrent otitis media
and serious otitis." Id. CHILD received
PE tubes in January 2000. Pet. Ex. 24 at
7. Due to CHILD's otitis media, her
mother did not allow CHILD to receive
the standard 12 and 15 month childhood
immunizations. Pet. Ex. 2 at 4.
According to the medical records,
CHILD consistently met her developmental
milestones during the first eighteen
months of her life. The record of an
October 5, 1999 visit to the Pediatric
Center notes that CHILD was mimicking
sounds, crawling, and sitting. Pet. Ex.
31 at 9. The record of her 12-month
pediatric examination notes that she was
using the words "Mom" and "Dad," pulling
herself up, and cruising. Id. at 10.
At a July 19, 2000 pediatric visit,
the pediatrician observed that CHILD
"spoke well" and was "alert and active."
Pet. Ex. 31 at 11. CHILD's mother
reported that CHILD had regular bowel
movements and slept through the night.
Id. At the July 19, 2000 examination,
CHILD received five vaccinations - DTaP,
Hib, MMR, Varivax, and IPV. Id. at 2,
11.
According to her mother's affidavit,
CHILD developed a fever of 102.3 degrees
two days after her immunizations and was
lethargic, irritable, and cried for long
periods of time. Pet. Ex. 2 at 6. She
exhibited intermittent, high-pitched
screaming and a decreased response to
stimuli. Id. MOM spoke with the
pediatrician, who told her that CHILD
was having a normal reaction to her
immunizations. Id. According to CHILD's
mother, this behavior continued over the
next ten days, and CHILD also began to
arch her back when she cried. Id.
On July 31, 2000, CHILD presented to
the Pediatric Center with a 101-102
degree temperature, a diminished
appetite, and small red dots on her
chest. Pet. Ex. 31 at 28. The nurse
practitioner recorded that CHILD was
extremely irritable and inconsolable.
Id. She was diagnosed with a post-varicella
vaccination rash. Id. at 29.
Two months later, on September 26,
2000, CHILD returned to the Pediatric
Center with a temperature of 102
degrees, diarrhea, nasal discharge, a
reduced appetite, and pulling at her
left ear. Id. at 29. Two days later, on
September 28, 2000, CHILD was again seen
at the Pediatric Center because her
diarrhea continued, she was congested,
and her mother reported that CHILD was
crying during urination. Id. at 32. On
November 1, 2000, CHILD received
bilateral PE tubes. Id. at 38. On
November 13, 2000, a physician at ENT
Associates noted that CHILD was
"obviously hearing better" and her
audiogram was normal. Id. at 38. On
November 27, 2000, CHILD was seen at the
Pediatric Center with complaints of
diarrhea, vomiting, diminished energy,
fever, and a rash on her cheek. Id. at
33. At a follow-up visit, on December
14, 2000, the doctor noted that CHILD
had a possible speech delay. Id.
CHILD was evaluated at the Howard
County Infants and Toddlers Program, on
November 17, 2000, and November 28,
2000, due to concerns about her language
development. Pet. Ex. 19 at 2, 7. The
assessment team observed deficits in
CHILD's communication and social
development. Id. at 6. CHILD's mother
reported that CHILD had become less
responsive to verbal direction in the
previous four months and had lost some
language skills. Id. At 2.
On December 21, 2000, CHILD returned
to ENT Associates because of an
obstruction in her right ear and
fussiness. Pet. Ex. 31 at 39. Dr. Grace
Matesic identified a middle ear effusion
and recorded that CHILD was having some
balance issues and not progressing with
her speech. Id. On December 27, 2000,
CHILD visited ENT Associates, where Dr.
Grace Matesic observed that CHILD's left
PE tube was obstructed with crust. Pet.
Ex. 14 at 6. The tube was replaced on
January 17, 2001. Id.
Dr. Andrew Zimmerman, a pediatric
neurologist, evaluated CHILD at the
Kennedy Krieger Children's Hospital
Neurology Clinic ("Krieger Institute"),
on February 8, 2001. Pet. Ex. 25 at 1.
Dr. Zimmerman reported that after
CHILD's immunizations of July 19, 2000,
an "encephalopathy progressed to
persistent loss of previously acquired
language, eye contact, and relatedness."
Id. He noted a disruption in CHILD's
sleep patterns, persistent screaming and
arching, the development of pica to
foreign objects, and loose stools. Id.
Dr. Zimmerman observed that CHILD
watched the fluorescent lights
repeatedly during the examination and
would not make eye contact. Id. He
diagnosed CHILD with "regressive
encephalopathy with features consistent
with an autistic spectrum disorder,
following normal development." Id. At 2.
Dr. Zimmerman ordered genetic testing, a
magnetic resonance imaging test ("MRI"),
and an electroencephalogram ("EEG"). Id.
Dr. Zimmerman referred CHILD to the
Krieger Institute's Occupational Therapy
Clinic and the Center for Autism and
Related Disorders ("CARDS"). Pet. Ex. 25
at 40. She was evaluated at the
Occupational Therapy Clinic by Stacey
Merenstein, OTR/L, on February 23, 2001.
Id. The evaluation report summarized
that CHILD had deficits in "many areas
of sensory processing which decrease[d]
her ability to interpret sensory input
and influence[d] her motor performance
as a result." Id. at 45. CHILD was
evaluated by Alice Kau and Kelley Duff,
on May 16, 2001, at CARDS. Pet. Ex. 25
at 17. The clinicians concluded that
CHILD was developmentally delayed and
demonstrated features of autistic
disorder. Id. at 22.
CHILD returned to Dr. Zimmerman, on
May 17, 2001, for a follow-up
consultation. Pet. Ex. 25 at 4. An
overnight EEG, performed on April 6,
2001, showed no seizure discharges. Id.
at 16. An MRI, performed on March 14,
2001, was normal. Pet. Ex. 24 at 16. A
G-band test revealed a normal karyotype.
Pet. Ex. 25 at 16. Laboratory studies,
however, strongly indicated an
underlying mitochondrial disorder. Id.
at 4.
Dr. Zimmerman referred CHILD for a
neurogenetics consultation to evaluate
her abnormal metabolic test results.
Pet. Ex. 25 at 8. CHILD met with Dr.
Richard Kelley, a specialist in
neurogenetics, on May 22, 2001, at the
Krieger Institute. Id. In his
assessment, Dr. Kelley affirmed that
CHILD's history and lab results were
consistent with "an etiologically
unexplained metabolic disorder that
appear[ed] to be a common cause of
developmental regression." Id. at 7. He
continued to note that children with
biochemical profiles similar to CHILD's
develop normally until sometime between
the first and second year of life when
their metabolic pattern becomes
apparent, at which time they
developmentally regress. Id. Dr. Kelley
described this condition as "mitochondrial
PPD." Id.
On October 4, 2001, Dr. John
Schoffner, at Horizon Molecular Medicine
in Norcross, Georgia, examined CHILD to
assess whether her clinical
manifestations were related to a defect
in cellular energetics. Pet. Ex. 16 at
26. After reviewing her history, Dr.
Schoffner agreed that the previous
metabolic testing was "suggestive of a
defect in cellular energetics." Id. Dr.
Schoffner recommended a muscle biopsy,
genetic testing, metabolic testing, and
cell culture based testing. Id. at 36. A
CSF organic acids test, on January 8,
2002, displayed an increased lactate to
pyruvate ratio of 28,1 which can be seen
in disorders of mitochondrial oxidative
phosphorylation. Id. at 22. A muscle
biopsy test for oxidative
phosphorylation disease revealed
abnormal results for Type One and Three.
Id. at 3. The most prominent findings
were scattered atrophic myofibers that
were mostly type one oxidative
phosphorylation dependent myofibers,
mild increase in lipid in selected
myofibers, and occasional myofiber with
reduced cytochrome c oxidase activity.
Id. at 7. After reviewing these
laboratory results, Dr. Schoffner
diagnosed CHILD with oxidative
phosphorylation disease. Id. at 3. In
February 2004, a mitochondrial DNA ("mtDNA")
point mutation analysis revealed a
single nucleotide change in the 16S
ribosomal RNA gene (T2387C). Id. at 11.
CHILD returned to the Krieger
Institute, on July 7, 2004, for a
follow-up evaluation with Dr. Zimmerman.
Pet. Ex. 57 at 9. He reported CHILD "had
done very well" with treatment for a
mitochondrial dysfunction. Dr. Zimmerman
concluded that CHILD would continue to
require services in speech,
occupational, physical, and behavioral
therapy. Id.
On April 14, 2006, CHILD was brought
by ambulance to Athens Regional Hospital
and developed a tonic seizure en route.
Pet. Ex. 10 at 38. An EEG showed diffuse
slowing. Id. At 40. She was diagnosed
with having experienced a prolonged
complex partial seizure and transferred
to Scottish Rite Hospital. Id. at 39,
44. She experienced no more seizures
while at Scottish Rite Hospital and was
discharged on the medications Trileptal
and Diastal. Id. at 44. A follow-up MRI
of the brain, on June 16, 2006, was
normal with evidence of a left
mastoiditis manifested by distortion of
the air cells. Id. at 36. An EEG,
performed on August 15, 2006,
showed "rhythmic epileptiform
discharges in the right temporal region
and then focal slowing during a
witnessed clinical seizure." Id. At 37.
CHILD continues to suffer from a seizure
disorder.
ANALYSIS
Medical personnel at the Division of
Vaccine Injury Compensation, Department
of Health and Human Services (DVIC) have
reviewed the facts of this case, as
presented by the petition, medical
records, and affidavits. After a
thorough review, DVIC has concluded that
compensation is appropriate in this
case.
In sum, DVIC has concluded that the
facts of this case meet the statutory
criteria for demonstrating that the
vaccinations CHILD received on July 19,
2000, significantly aggravated an
underlying mitochondrial disorder, which
predisposed her to deficits in cellular
energy metabolism, and manifested as a
regressive encephalopathy with features
of autism spectrum disorder. Therefore,
respondent recommends that compensation
be awarded to petitioners in accordance
with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).
DVIC has concluded that CHILD's complex
partial seizure disorder, with an onset
of almost six years after her July 19,
2000 vaccinations, is not related to a
vaccine-injury.
Respectfully submitted,
PETER D. KEISLER
Assistant Attorney General
TIMOTHY P. GARREN
Director
Torts Branch, Civil Division
MARK W. ROGERS
Deputy Director
Torts Branch, Civil Division
VINCENT J. MATANOSKI
Assistant Director
Torts Branch, Civil Division
s/ Linda S. Renzi by s/ Lynn E.
Ricciardella
LINDA S. RENZI
Senior Trial Counsel
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044
(202) 616-4133
DATE: November 9, 2007
