The Vaccine-Autism Court Document Every American Should Read

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

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

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

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

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

CHILD, a minor,

by her Parents and Natural Guardians,

Petitioners,

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

RESPONDENT'S RULE 4(c) REPORT

In accordance with RCFC, Appendix B, Vaccine Rule 4(c), the Secretary of Health and Human Services submits the following response to the petition for compensation filed in this case.

FACTS

CHILD ("CHILD") was born on December --, 1998, and weighed eight pounds, ten ounces. Petitioners' Exhibit ("Pet. Ex.") 54 at 13. The pregnancy was complicated by gestational diabetes. Id. at 13. CHILD received her first Hepatitis B immunization on December 27, 1998. Pet. Ex. 31 at 2.

From January 26, 1999 through June 28, 1999, CHILD visited the Pediatric Center, in Catonsville, Maryland, for well-child examinations and minor complaints, including fever and eczema. Pet. Ex. 31 at 5-10, 19. During this time period, she received the following pediatric vaccinations, without incident:

Vaccine Dates Administered

Hep B 12/27/98; 1/26/99

IPV 3/12/99; 4/27/99

Hib 3/12/99; 4/27/99; 6/28/99

DTaP 3/12/99; 4/27/99; 6/28/99

Id. at 2.

At seven months of age, CHILD was diagnosed with bilateral otitis media. Pet. Ex. 31 at 20. In the subsequent months between July 1999 and January 2000, she had frequent bouts of otitis media, which doctors treated with multiple antibiotics. Pet. Ex. 2 at 4. On December 3,1999, CHILD was seen by Karl Diehn, M.D., at Ear, Nose, and Throat Associates of the Greater Baltimore Medical Center ("ENT Associates"). Pet. Ex. 31 at 44. Dr. Diehn recommend that CHILD receive PE tubes for her "recurrent otitis media and serious otitis." Id. CHILD received PE tubes in January 2000. Pet. Ex. 24 at 7. Due to CHILD's otitis media, her mother did not allow CHILD to receive the standard 12 and 15 month childhood immunizations. Pet. Ex. 2 at 4.

According to the medical records, CHILD consistently met her developmental milestones during the first eighteen months of her life. The record of an October 5, 1999 visit to the Pediatric Center notes that CHILD was mimicking sounds, crawling, and sitting. Pet. Ex. 31 at 9. The record of her 12-month pediatric examination notes that she was using the words "Mom" and "Dad," pulling herself up, and cruising. Id. at 10.

At a July 19, 2000 pediatric visit, the pediatrician observed that CHILD "spoke well" and was "alert and active." Pet. Ex. 31 at 11. CHILD's mother reported that CHILD had regular bowel movements and slept through the night. Id. At the July 19, 2000 examination, CHILD received five vaccinations - DTaP, Hib, MMR, Varivax, and IPV. Id. at 2, 11.

According to her mother's affidavit, CHILD developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent, high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was having a normal reaction to her immunizations. Id. According to CHILD's mother, this behavior continued over the next ten days, and CHILD also began to arch her back when she cried. Id.

On July 31, 2000, CHILD presented to the Pediatric Center with a 101-102 degree temperature, a diminished appetite, and small red dots on her chest. Pet. Ex. 31 at 28. The nurse practitioner recorded that CHILD was extremely irritable and inconsolable. Id. She was diagnosed with a post-varicella vaccination rash. Id. at 29.

Two months later, on September 26, 2000, CHILD returned to the Pediatric Center with a temperature of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and pulling at her left ear. Id. at 29. Two days later, on September 28, 2000, CHILD was again seen at the Pediatric Center because her diarrhea continued, she was congested, and her mother reported that CHILD was crying during urination. Id. at 32. On November 1, 2000, CHILD received bilateral PE tubes. Id. at 38. On November 13, 2000, a physician at ENT Associates noted that CHILD was "obviously hearing better" and her audiogram was normal. Id. at 38. On November 27, 2000, CHILD was seen at the Pediatric Center with complaints of diarrhea, vomiting, diminished energy, fever, and a rash on her cheek. Id. at 33. At a follow-up visit, on December 14, 2000, the doctor noted that CHILD had a possible speech delay. Id.

CHILD was evaluated at the Howard County Infants and Toddlers Program, on November 17, 2000, and November 28, 2000, due to concerns about her language development. Pet. Ex. 19 at 2, 7. The assessment team observed deficits in CHILD's communication and social development. Id. at 6. CHILD's mother reported that CHILD had become less responsive to verbal direction in the previous four months and had lost some language skills. Id. At 2.

On December 21, 2000, CHILD returned to ENT Associates because of an obstruction in her right ear and fussiness. Pet. Ex. 31 at 39. Dr. Grace Matesic identified a middle ear effusion and recorded that CHILD was having some balance issues and not progressing with her speech. Id. On December 27, 2000, CHILD visited ENT Associates, where Dr. Grace Matesic observed that CHILD's left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The tube was replaced on January 17, 2001. Id.

Dr. Andrew Zimmerman, a pediatric neurologist, evaluated CHILD at the Kennedy Krieger Children's Hospital Neurology Clinic ("Krieger Institute"), on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after CHILD's immunizations of July 19, 2000, an "encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness." Id. He noted a disruption in CHILD's sleep patterns, persistent screaming and arching, the development of pica to foreign objects, and loose stools. Id. Dr. Zimmerman observed that CHILD watched the fluorescent lights repeatedly during the examination and

would not make eye contact. Id. He diagnosed CHILD with "regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development." Id. At 2. Dr. Zimmerman ordered genetic testing, a magnetic resonance imaging test ("MRI"), and an electroencephalogram ("EEG"). Id.

Dr. Zimmerman referred CHILD to the Krieger Institute's Occupational Therapy Clinic and the Center for Autism and Related Disorders ("CARDS"). Pet. Ex. 25 at 40. She was evaluated at the Occupational Therapy Clinic by Stacey Merenstein, OTR/L, on February 23, 2001. Id. The evaluation report summarized that CHILD had deficits in "many areas of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a result." Id. at 45. CHILD was evaluated by Alice Kau and Kelley Duff, on May 16, 2001, at CARDS. Pet. Ex. 25 at 17. The clinicians concluded that CHILD was developmentally delayed and demonstrated features of autistic disorder. Id. at 22.

CHILD returned to Dr. Zimmerman, on May 17, 2001, for a follow-up consultation. Pet. Ex. 25 at 4. An overnight EEG, performed on April 6, 2001, showed no seizure discharges. Id. at 16. An MRI, performed on March 14, 2001, was normal. Pet. Ex. 24 at 16. A G-band test revealed a normal karyotype. Pet. Ex. 25 at 16. Laboratory studies, however, strongly indicated an underlying mitochondrial disorder. Id. at 4.

Dr. Zimmerman referred CHILD for a neurogenetics consultation to evaluate her abnormal metabolic test results. Pet. Ex. 25 at 8. CHILD met with Dr. Richard Kelley, a specialist in neurogenetics, on May 22, 2001, at the Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILD's history and lab results were consistent with "an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression." Id. at 7. He continued to note that children with biochemical profiles similar to CHILD's develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress. Id. Dr. Kelley described this condition as "mitochondrial PPD." Id.

On October 4, 2001, Dr. John Schoffner, at Horizon Molecular Medicine in Norcross, Georgia, examined CHILD to assess whether her clinical manifestations were related to a defect in cellular energetics. Pet. Ex. 16 at 26. After reviewing her history, Dr. Schoffner agreed that the previous metabolic testing was "suggestive of a defect in cellular energetics." Id. Dr. Schoffner recommended a muscle biopsy, genetic testing, metabolic testing, and cell culture based testing. Id. at 36. A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation. Id. at 22. A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three. Id. at 3. The most prominent findings were scattered atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected myofibers, and occasional myofiber with reduced cytochrome c oxidase activity. Id. at 7. After reviewing these laboratory results, Dr. Schoffner diagnosed CHILD with oxidative phosphorylation disease. Id. at 3. In February 2004, a mitochondrial DNA ("mtDNA") point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C). Id. at 11.

CHILD returned to the Krieger Institute, on July 7, 2004, for a follow-up evaluation with Dr. Zimmerman. Pet. Ex. 57 at 9. He reported CHILD "had done very well" with treatment for a mitochondrial dysfunction. Dr. Zimmerman concluded that CHILD would continue to require services in speech, occupational, physical, and behavioral therapy. Id.

On April 14, 2006, CHILD was brought by ambulance to Athens Regional Hospital and developed a tonic seizure en route. Pet. Ex. 10 at 38. An EEG showed diffuse slowing. Id. At 40. She was diagnosed with having experienced a prolonged complex partial seizure and transferred to Scottish Rite Hospital. Id. at 39, 44. She experienced no more seizures while at Scottish Rite Hospital and was discharged on the medications Trileptal and Diastal. Id. at 44. A follow-up MRI of the brain, on June 16, 2006, was normal with evidence of a left mastoiditis manifested by distortion of the air cells. Id. at 36. An EEG, performed on August 15, 2006,

showed "rhythmic epileptiform discharges in the right temporal region and then focal slowing during a witnessed clinical seizure." Id. At 37. CHILD continues to suffer from a seizure disorder.

ANALYSIS

Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits. After a thorough review, DVIC has concluded that compensation is appropriate in this case.

In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).

DVIC has concluded that CHILD's complex partial seizure disorder, with an onset of almost six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury.

Respectfully submitted,

PETER D. KEISLER
Assistant Attorney General

TIMOTHY P. GARREN
Director
Torts Branch, Civil Division

MARK W. ROGERS
Deputy Director
Torts Branch, Civil Division

VINCENT J. MATANOSKI
Assistant Director
Torts Branch, Civil Division

s/ Linda S. Renzi by s/ Lynn E. Ricciardella
LINDA S. RENZI
Senior Trial Counsel
Torts Branch, Civil Division
U.S. Department of Justice
P.O. Box 146
Benjamin Franklin Station
Washington, D.C. 20044
[phone]

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

Comments

[altohone]

When Big Pharma hires the former dissemblers for the tobacco industry and global warming deniers to "win" the fight against public impression, we should all pay attention.

Their "experts" have penned numerous press releases whenever a study is released... touting those that show no link and attacking those that may show a link.


All the money being spent fighting this... in the hospital rooms and clinics... in the press and the court room...

... you'd think that an alternative to using a toxic heavy metal as a vaccine preservative could have been developed.

[beauley]

What about the "Amish"? Do some research...Only one out of 180,000 was found to have Autism and was found to have been adopted from China where vaccines are mandatory????

[AutismNewsBeat]

According to Dan Olmsted, who didn't visit the Clinic for Special Children in Lancaster County, PA. The clinic treats dozens of children who present with autistic behaviors.

http://tinyurl.com/ywtyw8

[CraigWilloughby]

Don't forget the Homeland Security Act and how that neat little clause in there protects Big Pharm.

[blueraven]

"Aggravate" isn't "cause," so the continued claim the vaccines are the criminal is an exaggeration. And what of the children who develop autism without the precursor being traceable to a vaccination? And would it be the fact the child had to be caught up on her shots that may have overloaded her system, not the vaccines in and of themselves? I still see post hoc ergo propter hoc logic in this argument.

[BlackJAC]

It's simply Ambulance Chasing 101. "Have you ever gone outside? Used a product? Interacted with another human being? Then someone, somewhere owes you a huge cash settlment! Call the Mobile Law Office [not a joke] at 1-800-BIG-TORT for a free consultation! You don't pay unless we win!"

[usna73]

Go away. Your tired cliches are of no use whatsoever.

Telling this to the parent of a hopelessly disabled child only exposes your callous disregard for human life.

[GnitenGoodLk]

Good catch. The use of the words "aggravates existing" makes the link very weak, but conversely, the condition it aggravates is not mild, it's permanent and disabling, therefore the award percentage would reflect the damage incurred.

This isn't about get-overs who sue because their cup of coffee was too hot and were burned when it spilled. These are children who had a significant reaction to components of the vaccine because of a previously mild pre-existing condition, a permanent and disabling reaction. And parents are not given a choice. They are required. It's the most heartrending gamble these companies callously watch us take as parents.

My son developed a mild fever after his last immunizations, and I freaked. He's fine now, but I would be furious if he hadn't been, enough to slam the makers of the vaccine so further testing/development and over site is made to save future kids. Vaccine makers think it is more cost effective to wait for kids to die or be permanently affected and post warnings than it is to continue developing, researching and refining their product and the conditions under which they should not be administered.

Out-sourcing experimental trials if you will. Every parent should read this post.

[hartkid]

I realize that this is off topic, but in response to your "get-overs who sue because their cup of coffee was too hot and were burned when it spilled" I encourage you to examine the facts of that case. On August 17, 1994, a state court jury in Albuquerque, New Mexico, awarded 81-year old Stella Liebeck $160,000 in compensatory damages and $2.7 million in punitive damages, after she was burned by coffee purchased from a drive-through window at a McDonalds restaurant. The trial judge later reduced the punitive damages to $480,000, and the parties settled the case before an appeal. According to news reports, Mrs. Liebeck contended that for taste reasons McDonalds served coffee about 20 degrees hotter than other fast food restaurants, and in spite of numerous complaints, had made a conscious decision not to warn customers of the possibility of serious burns. The jury's verdict received world-wide attention. And the press took little time ridiculing the case. Tort reformers constantly used it as a rallying cry. What is never mentioned is that this 81-year old woman had third-degree burns on her inner thighs and labia. She had to have reconstructive surgery and suffered permanent scarring. The other fact that is never mentioned by tort "reformers" is that McDonalds kept the coffee so hot because it stayed fresh tasting longer at higher temperatures. McDonalds accordingly saved millions every day by not having to throw old coffee out. Maybe Miss Liebeck should have just "got over it." Coffee's supposed to be hot right? See Andrea Gerlin, A Matter of Degree: How a Jury Decided That One Coffee Spill Is Worth $2.9 Million, Wall St. J. Europe, Sept. 2, 1994, available in 1994 WL-WSJE 2037634.

[CraigWilloughby]

You bring up a very interesting an fantastic point! Parents are often not given any choice. In some states, the child is vaccinated as soon as they are born. In many states, it is impossible for the parent to refuse vaccination, and if they do, they are brought to Child Protective Services for endangering their children. And if the child has a bad reaction to the vaccine? Oh its normal, nothing to worry about. If the reaction is permanent? Too bad, so sad, buh bye.

They don't warn families or parents, even after the fact, because it implies responsibility. God knows that the government doesn't want to take responsibility for knowingly poisoning children.

[hopeless277]

If the criminal Republican government of this country doesn't care about protecting the population from food poisioning, what makes you think they care about autism? Big Pharma pays the congresspeople to do their bidding. Not one person in this current government gives a shit about us or our children. Not one.

[Pyrum]

What about Ron Paul(R-TX)? He wants to end federally mandated vaccinations.

[Tannim]

Yup, but nobody wants to vote for a man--a physician, no less!--who exercises and expounds such common sense ideas like making your own decisions on health concerns...

...proving once again how stupid the electorate in general has become.