Sick Kids behind the Curtain

[Guest guest]

Kirby posted the following at his web page:

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, 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 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 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. 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.

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. 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 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/ 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

__________________________________________________

[Guest guest]

I believe this IS about the Poling case.christine <christine@...> wrote: Just to be clear— this ISN’T the Polings, right?Interesting- another girl.Also, while I’m reading this I’m thinking, “I’ve heard this story many time before”.Thanks for the info & Bob.-On 4/12/08 9:54 AM, "bob meyer" <mtbike4114 > wrote: Kirby posted the following at his web page: 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. <http://www.huffingtonpost.com/david-kirby/government-concedes-vacci_b_88323.html> 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 CLAIMSOFFICE 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, 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 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 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. 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. 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. 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 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. KEISLERAssistant Attorney GeneralTIMOTHY P. GARRENDirectorTorts Branch, Civil DivisionMARK W. ROGERSDeputy DirectorTorts Branch, Civil DivisionVINCENT J. MATANOSKIAssistant DirectorTorts Branch, Civil Divisions/ S.

Renzi by s/ Lynn E. RicciardellaLINDA S. RENZISenior Trial CounselTorts Branch, Civil DivisionU.S. Department of JusticeP.O. Box 146 lin StationWashington, D.C. 20044(202) 616-4133 DATE: November 9, 2007__________________________________________________

[Guest guest]

this was posted on this list some time ago by DK. Maurinebob meyer <mtbike4114@...> wrote: Kirby posted the following at his web page: 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 CLAIMSOFFICE 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, 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 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 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. 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. 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. 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 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. KEISLERAssistant Attorney GeneralTIMOTHY P. GARRENDirectorTorts Branch, Civil DivisionMARK W. ROGERSDeputy DirectorTorts Branch, Civil DivisionVINCENT J. MATANOSKIAssistant DirectorTorts Branch, Civil Divisions/ S. Renzi by s/ Lynn E. RicciardellaLINDA S. RENZISenior Trial

CounselTorts Branch, Civil DivisionU.S. Department of JusticeP.O. Box 146 lin StationWashington, D.C. 20044(202) 616-4133 DATE: November 9, 2007 __________________________________________________