The Vaccine-Autism Court Document Every American Should Read

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The Vaccine-Autism Court Document Every American Should Read

 

 

 

 

By David Kirby

February 26, 2008. The Huffington Post

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© 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,

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©(1)©(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

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