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 AdministeredHep 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
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
Digressing just slightly.......
Speaking from having been exposed to the vaccine vs autism relationship for quite some time (from various national disability advocacy lists), hearing Texas force young girls to take Gardisil, HPV vaccine, last year when we had barely seen it approved for use by the FDA months earlier absolutely has sent these fingertips over the rooftop in frustration........
Ten, twenty years down the road from now and with the vaccine/autism relationship in mind, what nasty little side effects will those poor young women be facing in their productive adult years when, as children now, they are by law being forced beyond their control to basically become our country's next great commercialized experiment..
:scrunches lips then frowns:
If a baby were to to develop an encephalitis type reaction to a vaccine, he would not be able to describe it and the symptoms would be fever and fussiness. In a child, whose brain is still developing, a mild reaction like mine could cause subtle neurological damage that would not become apparent right away.
I am all for tetanus and a few other vaccines to prevent fatal diseases that children catch. However, I believe that most vaccines can wait until adolescence, when the brain is more fully developed and when kids have a better more lasting immune response. Many of them have to be repeated then anyway.
Since infants have their mother's antibodies and breast fed infants keep getting antibodies, I do not understand why we keep assaulting new born infants with so many vaccines when their brains are so vulnerable. Maybe under universal health care, when every child has a doctor, we can wait until it is time.
Thanks!
Great interview Autism One, Mr. Kirby, Dr. Geier, and Ms. Arranga!
I think this will provide further clarification.
Accordingly to this "verbatim copy," the government conceded that a legal standard had been met in a single case involving a plaintiff who may or may not have been diagnosed on the autism spectrum (that bit isn't clear). The government did not concede that there was a causal connection between vaccines and autism.
The only legal recourse for parents of children injured by vaccines is to go through the dog and pony show that the government set up to try vaccine cases because this neat little clause was passed in the Homeland Security Act that protects vaccine manufacturers from litigation in the "rare" event that their vaccine might cause an adverse reaction. That should give you a little bit of an idea of who's covering whose bottoms.
I'm not going to deny the benefits of vaccination. In many cases, yes, they have improved our lives. They have gotten rid of Polio, Smallpox, Dyptheria and several other deadly diseases. To the government, the overall benefits outweigh the injuries, something that is known in the ethics community as Utilitarianism. In other words, the needs of the many outweigh the needs of the few. However, and I say this VERY firmly, there is NO acceptable risk when it comes to a child! None! If the Government and the medical community have been knowingly poisoning our children, they need to be held accountable. They know this! Which is why they are so adamantly denying the connection.
Either that, or they are waiting until the statute of limitations for all of these kids expires, and then who cares, right? The medical industry isn't about the patient anymore; its only about money. Deny that all you want, too, but try to go to a hospital with no medical insurance and then tell me that you get the same treatment as those with medical insurance.
http://www.vaccinationnews.com/DailyNews/2003/May/09/Hospital&Child9.htm
Gives you faith in America, don't it?
For anyone who can't get their mind beyond the pseudo-scientific black-and-white indoctrination that something is either "the only cause," or not a cause, let's remember that there is such a thing as a significant contributing factor-- and also the health principle of "first do no harm."
The rising rates of autism in the wake of the implementation of the 1990 vaccine schedule (and the ensuing need for compensation) are not about folks frivolously seeking payback for a bad purchase. They are about the lives of infants and their families permanently destroyed emotionally, physically, and economically by a government mandated, medically recommended practice-- and our societal failure to face up to and address this tragic experimentation upon our young.
Keep up the good work, David. As a fellow journalist, I sleep better at night because of your dedication to this issue.
The sequence of events this child went through very closely mirrors the events our son experienced.
Why would anyone give 5 vaccines with multiple components to a child at one time. That alone should be negligence. If you read the vaccine inserts it will tell you not to give a vaccine to a sick person and that they have not been tested together. Lets all stop pointing fingers and admit we dont know but need to find out what causes the damage.
Thanks for getting this document online so quickly.