The Vaccine-Autism Court Document Every American Should Read

by David Kirby
Posted February 26, 2008 | 02:38 PM (EST)
Read More: Maryland , Breaking Living News


Below is a verbatim copy of the US Government concession filed last
November in a vaccine-autism case in the Court of Federal Claims, with the
names of the family redacted. It is the subject of my post yesterday.


Every American should read this document, and interpret for themselves what
they think their government is trying to say about the relationship, if
any, between immunizations and a diagnosis of autism spectrum disorder.

If you feel this document suggests that some kind of link may be possible,
you might consider forwarding it to your elected representatives for
further investigation.

But, of course, if you feel that this document in no way implicates
vaccines, then let's just keep going about our business as usual and not
pay any attention to all those sick kids behind the curtain.


    IN THE UNITED STATES COURT OF FEDERAL CLAIMS
    OFFICE OF SPECIAL MASTERS


    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



PS: On Friday, February 22, HHS conceded that this child's complex partial
seizure disorder was also caused by her vaccines. Now we the taxpayers will
award this family compensation to finance her seizure medication. Surely
ALL decent people can agree that is a good thing.

By the way, it''s worth noting that her seizures did not begin until six
years after the date of vaccination, yet the government acknowledges they
were, indeed, linked to the immunizations of July, 2000, - DK


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