Full Text AUTISM VACCINE CASE

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02/26/2008

FULL TEXT: AUTISM VACCINE CASE

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

CHILD, a minor, by her Parents and Natural Guardians, MOM & DAD,

Petitioners,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

RESPONDENTS RULE 4© REPORT

In accordance with RCFC, Appendix B, Vaccine Rule 4©, 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, land, 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 CHILDs 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. CHILDs 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 mothers 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 CHILDs 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 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 CHILDs communication and social development. Id. at 6. CHILDs

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 CHILDs left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The

tube was replaced on January 17, 2001. Id.

Dr. Zimmerman, a pediatric neurologist, evaluated CHILD at the

Kennedy Krieger Childrens Hospital Neurology Clinic (Krieger Institute),

on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after

CHILDs 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 CHILDs 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 Institutes 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.

Kelley, a specialist in neurogenetics, on May 22, 2001, at the

Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILDs

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 CHILDs 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. 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 ish

Rite Hospital. Id. at 39, 44. She experienced no more seizures while at

ish 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©(1)©(ii).

DVIC has concluded that CHILDs 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/ 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

lin Station

Washington, D.C. 20044

(202) 616-4133

DATE: November 9, 2007

in Current Affairs, Kent Heckenlively/Legal, Vaccines | Permalink

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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©(1)©(ii).

Mitochondria are sometimes described as " cellular power plants " because

they generate most of the cell's supply of adenosine triphosphate (ATP),

used as a source of chemical energy.

Watch Mercury disrupt the generation of ATP.

http://commons.ucalgary.ca/mercury/

" Underlying mitochondrial disorder " ? Are they & ^%$ing kidding?

Posted by: Barry | 02/26/2008 at 02:59 PM

When and where was this child actually diagnosed with autism? I only see

" autistic features " which most certainly is not the same as a diagnosis of

Autism. It appears this child has " regressive encephalopathy with features

consistent with an autistic spectrum disorder " due to her oxidative

phosphorylation disease. Which, obviously, is much different than most

other children who are diagnosed with Autism, without mitochondrial

disease. I think that clarification needs to be made.

I strongly disagree with the DVIC's decision here.

Posted by: S.L. | 02/26/2008 at 02:16 PM

Evidence of Pharm. In the next year, a lot of information will come forward

as parants of ASD children seek cellular energy testing for their children.

Even if it isn't the major mechanism in the toxic injury but just part of

the big picture, I suspect many children will display the same test

results. I also suspect that a systematic study of cord blood samples- if

one were ever attempted- would show that this disorder wasn't present at

birth for most.

Posted by: Gatogorra | 02/26/2008 at 01:59 PM

I wonder if I will see that storey in the new york times or wall street

journal. I wonder if Dr. Zimmerman will advise his patient about vaccination.

Posted by: The Unatutor | 02/26/2008 at 01:54 PM

" DVIC has concluded that CHILDs complex partial seizure disorder, with an

onset of almost six years after her July 19, 2000 vaccinations, is not

related to a vaccine-injury. "

I wonder how the DVIC reached that particular conclusion. Did they enter

the brain of this child and specifically ask the seizure disorder this? And

did the seizure disorder reply that it in fact was a totally different

entity that had just decided upon this ailing child as a chance visitor to

have a look to see what all the hullabaloo was about? Apparently even the

seizure disorder was smart enough to know that a healthy child would not

welcome it. You evidently need to be smarter than the disease to banish it

to Perdition.

Posted by: Gayatri | 02/26/2008 at 01:17 PM

I know I am speaking for many when I say that it is so hard to read this

entire description of what happened to this child.

As we all know, we have heard this story hundreds, if not thousands of

times before.

A court of law has an interesting way of shaking the truth out of people.

Unlike a publication or an IOM committee, the court tends to lay you bare

to defending yourself against the facts. Make no mistake, this concession

was not done lightly. HHS knew they had no case, and they moved on.

While our press has not awoken to this story yet, make no mistake that this

is the single largest bombshell in the history of the vaccine-autism fight.

JB

Posted by: JB Handley | 02/26/2008 at 12:48 PM

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm Vaccine Dangers &

Childhood Disease & Homeopathy Email classes start in March