FULL TEXT: AUTISM VACCINE CASE

IN 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.

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

Comments

[Sue]

This article could have been describing my son's early years, his symptoms caused by Fragile X Syndrome - the most common form of inherited intellectual disability and an "Autism Spectrum" disorder. Fragile X is one genetic disorder that has been identified in causing Autistic symptoms - how many have not yet been discovered.

[AJ Loewer]

S.L.: Does it really matter whether or not genuine Autism was detected? I think the point is that vaccines can be harmful and cause longterm or permanent ill-effects on children. You make it sound like having a child with "regressive encephalopathy with features consistent with an autistic spectrum disorder" is not as bad as a having a child with Autism.

In David Kirby's article, he suggests that many children with Autism may have been misdiagnosed (so this whole vaccine-autism debate is mislabeled):

"Is it possible that 10%-20% of the cases that we now label as "autism," are not autism at all, but rather some previously undefined "look-alike" syndrome that merely presents as "features" of autism?

"This question gets to the heart of what autism actually is. The disorder is defined solely as a collection of features, nothing more. If you have the features (and the diagnosis), you have the disorder. The underlying biology is the great unknown.

"But let's say the government does determine that these kids don't have actual "autism" (something I speculated on HuffPost a year ago). Then shouldn't the Feds go back and test all people with ASD for impaired oxidative phosphorylation, perhaps reclassifying many of them?

"If so, will we then see "autism" cases drop by tens, if not hundreds of thousands of people? Will there be a corresponding ascension of a newly described disorder, perhaps something like "Vaccine Aggravated Mitochondrial Disease with Features of ASD?"

I believe the point of the noted case is that vaccinations can cause damage to some children. The fact that this CHILD may not really have Autism, but something that mimics autism is secondary to the point, IMO.

[Suzie Q]

"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."

Apparently, there MUST be a God. Watch how the drama unfolds. We have waited for this for a long long time. Maybe NOW the media will pick it up before its too late or else they might miss the bus. Maybe the media is waiting for the next bombshell to fall. Wonder what it will be next!!

[biomedmama7]

WOW! I just read this on Huffington Post! http://www.huffingtonpost.com/david-kirby/every-american-should-rea_b_88558.html

David Kirby wrote:

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

[biomedmama7]

Mercury causes mitochondrial damage, genetic mutations....among other things.

Back to the text of the case: How can a child be tested for MD in the absence of mercury poisoning when babies get a mercury laden hepatitis shot on their first day of life? Maybe the NTs and Amish should also be tested for MD? Otherwise, I don't see how they could know which came first.

I also don't understand the decision about the seizure diagnosis. Our child has had seizures since shortly before age 1, two weeks after a hepatitis booster. There have been many EEGs over the years that have been both positive and negative. If a seizure doesn't occur during the scan, it just means a seizure didn't occur during the scan. Our diagnosis of autism came more than a year after the first seizure. Also, for years our child was unable to sit still and concentrate in school. This did not look like seizure activity to us but after a while we convinced the doctors to look deeper and not simply pass this off as a symptom of autism. It was an almost constant stream of small seizures that were totally invisible to our trained eyes.

I remember Dr. Aposhian's testimony about vaccines - how mercury (paraphrased) causes immune system damage and then the live viruses wreak more havoc. I remember that a child in one of the test cases who received the MMR had non-wild type measles in the ileum. I remember another mom posting here that her child has non-wild type measles in the colon, also having received the MMR vaccine.

Even though there are billions of dollars involved, I still cannot fathom how this issue still seems to up for debate - how people can attempt to justify and deny the deliberate poisoning and damaging of our children. It gets more insulting with each passing day. There are so many things about my country that I am so ashamed of and I really hate that greedy insidious people have done this to her.

[TCS]

Uhhh Did you read the whole decision? It's a mitochodrial defect not Autism. Not vaccine damage but aggravated by Vaccines. It's not a nail in the coffin, but a pandora's box for mitochondrial testing looking for a gene defect in kids diagnosed with the regressive forms of Autism.

[Richard]

The apologists for pharma are very,very,quiet.
The protectors of Pharma find their world is falling apart and their reputations will be forever damaged.
The most horrible consequences(for those that still have a conscience)is that they will now go to bed and lie awake knowing that they were complicit in thwarting justice and delaying help to thousands of suffering children and families.
These children in some cases have passed the window of opportunity to be able to be helped in a significant way because of the actions of these monsters.

[Leila]

My son never had any reactions to vaccines, and he's still autistic. On the other hand, all my friends' kids reacted with fevers to vaccines and DID NOT develop autism... I just think it's hard to prove that a child's fever, days after a vaccination, is necessarily due to the shots. Babies get sick ALL THE TIME. I'd be interested to learn how the government lost that case, and what arguments were used by the plaintiffs to prove their claim.

[Barbie Hines]

"Mitochondria may not function correctly due to a genetic defect, damage caused by drugs, or damage caused by free radicals (destructive molecules)."

"It is estimated that mitochondrial disease affects between 40,000 and 70,000 Americans, occurring in one in 2,500 to 4,000 births."

The first quote above is interesting...I'm certain we could all list some 'destructive molecules' that have perhaps led to our childrens' mitochondrial disease. Additionally, I do believe the estimated number of Americans now affected with mitochondrial disease would be somewhere close to say 1 in 150?!

Landmark day for all of us...regardless of what they are calling it...still, landmark day.

[mauricesdaughter]

I am blown away by the significance of this story and would like to bring it to the attention of some people (who will not want to hear it) in the UK.

Is there a reference for what is described above as 'Full text: Autism vaccine case'? I want to be able to quote the following passage from the text: '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'

and be sure that I am quoting directly from an official summary of the court case. Can anyone tell me the provenance of the report above?

[Kevin Barry]

“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).”

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?

[S.L.]

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.

[Gatogorra]

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.

[The Unatutor]

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.

[Gayatri]

"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."

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.

[JB Handley]

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