Omnibus Court Rules against
The U.S. Court of Federal Claims has found no link between autism and vaccination. In 2009, in a stunning trio of decisions, Special Masters have concluded that no credible evidence exists that MMR (measles/mumps/rubella) or thimerosal-containing vaccines can combine to to cause autism. In 2010, in three more cases, the Special Masters concluded that the thimerosal itself was not a causative factor. The decisions also criticized doctors who base their treatments on these notions.
More than 5,000 families who claim that vaccines caused their children to become autistic have sought compensation under the National Vaccine Injury Compensation Program (VICP). The decisions came in six cases selected to "test" how similar cases should be handled.
The VICP is a federal no-fault program enacted in 1986 (and since amended) that was designed to deal with an epidemic of lawsuits that threatened the continued availability of childhood vaccines nationwide. Rather than suing a manufacture or provider through the civil tort system, claimants must petition for “no-fault” compensation with the U.S. Court of Federal Claims. The petition must also be served upon the Secretary of Health and Human Services, who replaces the vaccine manufacturer or administrator to defend the claim. Claimants need not prove negligence, failure to warn, or other tort causes of action; they only need to prove that a vaccine caused injury. The VICP now covers vaccines against 12 diseases: diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), polio, hepatitis B, hemophilus influenza type b (Hib), varicella (chicken pox), rotavirus, and the annual influenza (flu) vaccine.
The Act also created the Office of Special Masters within the Court of Federal Claims. The Special Masters function as trial judges with final decision-making authority. Their rulings can be appealed to the Court on an “arbitrary and capricious” standard, with further review available through higher federal courts. The VICP is funded by a 75¢-per-dose excise tax that goes into a trust that covers awards and administrative costs. The program provides compensation for past and future medical expenses; rehabilitation; therapies; special education; equipment; placement; pain and suffering ($250,000 limit); lost earnings; and vaccine-related death ($250,000).
In 2001, parents began filing petitions alleging that MMR vaccinations, the thimerosal ingredients in certain other vaccines, or a combination of factors might be causing or contributing to autism. When it became clear that thousands of cases would have similar allegations, the Omnibus Autism Proceeding was established. To proceed efficiently, the parties agreed to process "test cases" for each "general causation" theory presented by the Petitioners’ Steering Committee. Ultimately, two such theories were advanced:
- MMR vaccines and thimerosal-containing vaccines can combine to cause autism.
- Thimerosal-containing vaccines can cause autism.
Three Special Masters were each assigned one case for each theory. Evidentiary hearings on the first theory were conducted in 2007, after which the parties filed additional documents and briefs. In addition to 5,000 pages of transcripts and well over 700 pages of post-hearing briefs, the records in the first three cases contain 939 medical articles (a typical vaccine case presents about 10). A total of 50 expert reports were filed and 28 experts testified, whereas typical vaccine cases present 2-6 experts. Evidentiary hearings on the second causation theory were conducted in 2008 and generated 3,200 pages of transcripts. The evidence included over 1,200 articles and excerpts from the medical literature and testimony from 20 experts. The first set of Special Master decisions was issued in February 2009. The second set was issued in March 2010.
The First Set of Rulings
On February 12, 2009, all three Special Masters ruled that the MMR vaccine, whether administered alone or together with thimerosal-containing vaccines, was not a causal factor in the development of autism or autism spectrum disorders (ASD). The decisions completely debunked the notions and implied that doctors who base their treatments on them are unscientific and unethical.
In the case of Colten Snyder, Special Master Denise K. Vowell concluded.
Page 2: After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention.
Page 208: Doctor Rust used the term “scientific fraud” in describing the information upon which the MMR theory of causation is based. While noting that scientists are very careful about using that term, he testified that there was “abundant evidence” of scientific fraud in the body of evidence developed to support the MMR-autism hypothesis. Sadly, the petitioners in this litigation have been the victims of bad science, conducted to support litigation rather than to advance medical and scientific understanding of ASD.
Page 278: To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis. Although I have the deepest sympathy for families like Colten’s, struggling emotionally and financially to find answers about ASD’s causes, and reliable therapies to treat ASD’s symptoms, I must decide Colten’s case based on the evidence before me. That evidence does not establish an adequate factual basis from which to conclude that Colten’s condition was caused by his vaccines.
In the case of William Yates Hazlehurst, Special Master Patricia E. Campbell-Smith concluded:
Page 19: Petitioners’ expert witnesses . . . were not as disciplined in their discussion of topics where differences mattered, specifically, in degree of produced impairment, in type of mercury or type of measles virus (whether wild-type or vaccine-strain), and in exposure dosage. Additionally, when referring to the filed medical literature, petitioners’ experts tended to assign greater weight to speculative conclusions offered by the investigators involved in the studies than did the investigators themselves. Petitioners’ experts also urged reliance on a few carefully selected sentences from particular articles which, when considered in the proper context of the referenced articles, did not support the propositions advanced by the witnesses. Moreover, because petitioners’ experts relied on a number of scientifically flawed or unreliable articles for several important aspects of their causation theory, their testimony on those aspects of their offered theory could not be credited as sound or reliable. Finally, petitioners’ experts made several key acknowledgments during testimony that rendered their proposed theory of vaccine causation much less than likely.
In the case of Michelle Cedillo, Special Master George L. Hastings, Jr. concluded:
Page 2: The evidence was overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points. The numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction.
Page 173: The reports and advice given to the Cedillos by Dr. [Arthur] Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment.
The Special Masters' decisions were appealed to the U.S. Court of Federal Claims, which upheld them.
The Second Set of Rulings
On March 12, 2010, all three Special Masters ruled that the thimerosal in vaccines was not a causal factor in the development of autism or autism spectrum disorders. The decisions also implied that doctors who base their treatments on them are unscientific and unethical. Studies have found no correlation between vaccination rates, urine mercury levels, and autism. In an attempt to negate this finding, those who claim that thimerosal causes autism claim that autistic children test normal because they have "hidden stores" and that epidemiologic studies have been too small to detect a subgroup of children who are hypersensitive to mercury. These theories were thoroughly debunked by the Special Masters.
In the case of Colin R. Dwyer, Special Master Denise K. Vowell concluded:
Page 3: In essence, petitioners propose effects from mercury in TCVs that do not resemble mercury’s known effects on the brain, either behaviorally or at the cellular level. To prevail, they must show that the exquisitely small amounts of mercury in TCVs [thimerosal-containing vaccines] that reach the brain can produce devastating effects that far larger amounts experienced prenatally or postnatally from other sources do not. In order to account for this dichotomy, they posit a group of children hypersensitive to mercury’s effects, but the only evidence that these children are unusually sensitive is the fact of their ASD itself. In an effort to render irrelevant the numerous epidemiological studies of ASD and TCVs that show no connection between the two, they contend that their children have a form of ASD involving regression that differs from all other forms biologically and behaviorally. World-class experts in the field testified that the distinctions they drew between forms of ASD were artificial, and that they had never heard of the “clearly regressive” form of autism about which petitioners’ epidemiologist testified. Finally, the causal mechanism petitioners proposed would produce, not ASD, but neuronal death, and eventually patient death as well. The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent. Therefore, I hold that petitioners have failed to establish their entitlement to compensation, and their petition is denied.
Page 309: Unfortunately, the Dwyers (and uncounted other parents of children with ASD) have relied upon practitioners and researchers who peddled hope, not opinions grounded in science and medicine. My heart goes out to parents like the Dwyers who struggle daily, emotionally and financially, to care for their children, but I must decide cases based on the law and not sentiment.
In the case of Jordan King, Special Master Hastings concluded:
Page 2: The petitioners in this case have advanced the theory that thimerosal-containing vaccines can substantially contribute to the causation of autism, and that such vaccines did contribute to the causation of Jordan King’s autism. However, as to each of those issues, I conclude that the evidence is overwhelmingly contrary to the petitioners’ contentions. The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning the key points. The numerous medical studies concerning the issue of whether thimerosal causes autism, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. . . . I further conclude that while Jordan King has tragically suffered from autism, the petitioners have also failed to demonstrate that his vaccinations played any role at all in causing that condition.
In the case of William P. Mead, Special Master Patricia E. Campbell-Smith concluded:
The decisions were not appealed and are now final.
Page 169: Petitioners have not shown that the inorganic mercury deposited in the brain—in the amount that could be received from a full complement of thimerosal-containing vaccines—can cause the effects that petitioners have alleged. Inorganic mercury is not the form of mercury understood to be most toxic in the doses involved in childhood vaccines, and a normal fish-eating diet by pregnant mothers produces a greater source of inorganic mercury for deposition in the brain than thimerosal-containing vaccines do. Moreover, the metabolic processes and complex compensatory systems in the body are sufficiently robust to address the cellular effects of inorganic mercury deposits in the brain. The mechanism of chronic cellular dysfunction that petitioners have hypothesized cannot be maintained without inducing progressive neurodegenerative disease that leads to death, and autism is not a progressive neurodegenerative disease.
The Unvarnished Truth
Public health officials and other knowledgeable observers hope these rulings will reassure parents that vaccination is safe. Arthur Allen, author of Vaccine: The Controversial Story of Medicine's Greatest Lifesaver, placed the situation in further perspective in an article titled In Your Eye, Jenny McCarthy.
Surveys of U.S. parental opinion conducted for the American Medical Association in 2006 and 2008 show growing concern about the safety of vaccines. A study done by APCO Insight found that about 18 percent of parents had changed their vaccination practices out of safety concerns—compared with 12 percent in 2006. There's hope that today's ruling will reverse that trend. It won't affect the true believers. The notion that a government-backed, pharmaceutical-company-enriching program damaged their children has become a crusade and hobby and hangout for thousands of people, including movie stars like Jenny McCarthy and Jim Carrey, as well as doctors, lawyers, businessmen, and even a few scientists. An industry of hucksters, personal-injury lawyers, and clueless alternative-medicine practitioners has fed off of the desperation of parents of autistic children. Many parents, frantic to alter their children's diagnosis, turn to untested drugs, foods, vitamins, and extracts that promise to halt, or even reverse, autism—promising claims that some parents cling to.
In order for the approximately 4,700 remaining cases to continue, the petitioners would have to demonstrate another causational theory, which they cannot do. In September 2010, the Special Masters announced that the petitioners were not planning to do so, so the Omnibus Autism Proceeding is likely to conclude after various administrative details are settled.
For Additional Information
- Index to hearing transcripts
- Snyder decision (2/12/09)
- U.S. Court of Federal claims denies Snyder appeal (8/11/09)
- Hazlehurst decision (2/12/09)
- U.S. Court of Federal Claims denies Hazlehurst appeal (7/24/09)
- U.S. Court of Appeals denies Hazlehurst appeal (5/13/2010)
- Cedillo decision (2/12/09)
- U.S. Court of Federal Claims denies Cedillo appeal (8/6/09)
- U.S. Court of Appeals denies Cedillo appeal (8/27/10)
- Dwyer decision (3/10/10
- King decision (3/10/10)
- Mead decision (3/10/10)
- Update, September 29, 2010
- Autism Omnibus Proceeding docket
- Index to expert reports
This article was revised on October 6, 2010.