Autism Omnibus - Cedillo family loses

The Verdict

Ten years after first petitioning the United States Court of Federal Claims, aka the Vaccine Court, the Cedillo family have their answer.

After studying the extensive evidence in this case for many months, I am convinced that the reports and advice given to the Cedillos by Dr. 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. Nevertheless, I can understand why the Cedillos found such reports and advice to be believable under the circumstances. I conclude that the Cedillos filed this Program claim in good faith.

Thus, I feel deep sympathy and admiration for the Cedillo family. And I have no doubt that the families of countless other autistic children, families that cope every day with the tremendous challenges of caring for autistic children, are similarly deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of causation-in-­fact evidence, to a listed vaccination. In this case the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude that the petitioners in this case are not entitled to a Program award on Michelle’s behalf.

(Office of Special Masters 98-916V (henceforth Cedillo 2009) pages 173-174)

This is what I feared would happen back in June 2007 when the case finally came to court. I wrote a post entitled Autism Omnibus - a disaster for the parents which ended thus:

The family have my complete sympathy. I do not blame the parents for believing their lawyers’ arguments and accepting the claims of these so-called experts. But if those lawyers and their expert witnesses are laughed out of court what will happen to the Cedillo family and all the other families relying on their case? Do the anti vax campaigners have their own Anti-Vaccine Injury Compensation Fund to help the families left high and dry in the wake of their failed agenda?

I have just finished reading all 174 pages of the judgement by Special Master George L. Hastings Jnr. in the case of Michelle Cedillo and it is a damning judgement on the expert reports and testimony presented by the  Cedillos’ legal team. It also offers many useful insights into the background to the omnibus proceeedings and the conduct of all the parties concerned. Unless otherwise indicated all references are to Cedillo 2009.

The Cedillo family

Michelle Cedillo was born August 30th, 1994. She received her MMR vaccination on December 20th, 1995. Within a week she had a high fever that subsided and then returned, necessitating a visit to the doctors. Three months later her doctor noted that since this illness she was talking less.  In July 1997 she was diagnosed with severe autism and profound metal retardation. Michelle has also suffered from gastrointestinal symptoms including constipation, diarrhea and reflux, as well as arthritis, uveitis, pancreatitis and epilepsy.

Michelle’s family suspected vaccine damage and entered their claim in December 1998. The initial expert reports, filed in 2001, were for a table injury. Table injuries are recognized side effects of vaccines. If a parent can demonstrate that a table injury occurred within the specified timescale following vaccination they will usually be compensated. It is not necessary to prove that the vaccine actually caused the injury, only that it is plausible. In looking at the balance of probabilities this requirement has been described as 50 per cent plus a feather. The burden of proof is much less onerous than in a civil court.

Then, in January 2002 the family were persuaded to change their claim from one of table injury to one of causation-in-fact. To win a claim like this one has to demonstrate that an injury that is not included in the table of injuries was, nevertheless, vaccine induced. The burden of proof is greater than in a simple case of a table injury. But the standard of proof remains “50 per cent plus a feather.”

I do not know the basis for the Cedillos’ original table injury claim. According to the National Vaccine Injury Program Factsheet it could have been any of the following consequences of MMR:

Encephalopathy, Chronic Arthritis, Thrombocytopenic purpura,
Vaccine-strain measles viral infection in an immunodeficient receipt.

But not autism. I wonder if the Cedillo family know that the arthritis reaction to the Rubella component of the MMR was first established as a table injury by Special Master George L. Hastings, who presided over the Cedillo case, following an omnibus proceeding in 1993. The Petitioners Steering Committee certainly did because they cited it as a model for the Autism Omnibus. (Cedillo 2009, page 16)

Special Master George L. Hastings’ expresses a high opinion of the Cedillo family. It was reasonable for them to believe their daughter’s ill health was a result of vaccine damage. It was reasonable for them to seek legal advice and to be guided by the health care professionals provided to them. Unfortunately their legal/medical team seem bereft of reason. It is plausible that a table injury claim would have been successful. Instead her family were persuaded that Michelle was a poster child for the vaccines-cause-autism hypothesis and now they are left with nothing.

The Process

Michelle Cedillo’s claim was first lodged in December 1998.

During the first two years after the filing of the petition, petitioners’ counsel were primarily engaged in the tasks of (1) assembling and filing the voluminous medical records pertaining to Michelle’s illness, and (2) searching for one or more expert witnesses who could opine that Michelle’s illness was vaccine-caused. On October 31, 2000, the petitioners filed the expert report of Dr. Cindy Schneider, and on May 8, 2001, they filed the expert report of Dr. Marcel Kinsbourne, both reports contending that Michelle suffered a “Table Injury.” Respondent then filed an opposing expert report, of Dr. Max Wiznitzer, on July 11, 2001. (Cedillo 2009, page 17)

Then, in 2002 the table injury petition was altered to one of causation-in-fact and the Cedillo case joined the Omnibus Autism Proceedings (OAP). The OAP were meant to speed up the process as first hundreds and then thousands of parents lodged their petitions claiming that vaccine caused their child’s autism. Under the arrangements agreed by all parties the Petitioner Steering Committee (PSC) would gather the evidence for a general causation theory which would be presented at a hearing in 2004.

So why did it take until 2007 for the first test case to be heard and 2009 before a judgement was reached? One might be forgiven for thinking that the respondent for the government, the Dept of Health and Human Services (HHS), had been dragging its heels.

In fact it was the PSC that constantly returned to the court seeking more delays. They did not have a viable case in 2002. But they did believe that the government and the drug companies were conspiring to hide the evidence. By the end of 2006 they had requested and received 214,000 pages of documents from government files.

A lot of the science that they were to rely on in court did not exist in 2002. To take an example, the evidence for thiomersal damaging the immune system relied upon research by Goth et al (2006) and (Agrawal et al (2007). The evidence for a “mercury reflux disorder” or the theory that some children were poor excretors of mercury depended inter alia on research by Holmes et al.(2003), Bradstreet et al. (2003) and Adams and Romdalvik (2007).

Regarding their central idea, that vaccine strain measles could enter the brain and cause autism, Special Master Hastings expressed surprise that the PSC offered so little evidence. Two of their expert witnesses, Hepner and Krigsman, were involved in a study of measles virus persisting in the gut of autistic children but it has yet to be published.

So many of the delays are down to the PSC seeking to buy time while they looked for evidence that might bolster their claim. Finally they proposed a change to the OAP. Instead of a general causation hearing they wanted to present three general causation theories:  thiomersal/MMR together, thiomersal acting along, MMR acting alone and they wanted to introduce a test case - Michelle Cedillo. This is in contrast to the process Special Master Hastings describes in relation to the aforementioned Rubella/arthritis hearing over which he presided.

For example, I myself presided over an “omnibus proceeding” concerning the “general causation” issue of whether the rubella vaccine can cause chronic arthropathy. I met with counsel representing petitioners whose cases involved that “general causation” issue, and respondent’s counsel. Those counsel developed evidence concerning the general causation issue, filed expert reports and medical literature, and then presented oral testimony from the experts at an evidentiary hearing. Based upon that evidence, I filed a published opinion concluding that the rubella vaccine can cause chronic arthropathy under certain circumstances, if a case meets certain criteria. In re Ahern, No. 90- 1435V, 1993 WL 179430 (Fed. Cl. Spec. Mstr. Jan. 11, 1993). Based on that opinion, most of the pending or later-filed cases involving that general causation issue then resolved without the need for an individual, case-specific trial. For example, in 70 such cases the parties reached a settlement affording compensation to the petitioner, based upon the similarity of those petitioners’ situations to the criteria outlined in the Ahern opinion. In 52 other cases, the petitioner either voluntarily dismissed the petition or abandoned prosecution, apparently in light of the fact that the petitioner’s case did not fit within the stated criteria. In only 31 cases was I required to make a formal ruling concerning whether the petitioner was entitled to an award, and even those cases involved either no trial or a limited trial, because the “general causation” evidence from the omnibus proceeding was available for application to those individual cases. (Ten of those 31 cases were resolved in favor of a petitioner,(Cedillo 2009, page 16)

I suspect that the PSC, realizing the weakness of their position and running out of reasons to delay even further, wanted a test case around Michelle Cedillo because they hoped that her obvious physical ill health would persuade the special master that she deserved an award for her injuries and the merits of her case would ease the passage of the general causation hypothesis.

It was not to be. Special Master Hastings was quite clear that the primary purpose of the hearing was to adjudicate the evidence for general causation.  Only then would he apply the evidence to the particulars of the Cedillo case. By opting for a test case the PSC undertook first to prove that MMR could cause autism and then, and only then, could they argue that in this particular case MMR did cause autism. The office of the special masters (OSM) agreed to the test case procedure but asked for three test cases for each causation theory. You have to read the docket for the OAP to appreciate just how hard this was for the PSC. They really struggled to find enough parents who would come forward as test cases.

You would think that after five years of activity and around 5000 families signed up for the OAP they would have no problem identifying test cases. But they kept missing deadlines. As late as April 2007 they still had not found a second test case for the thiomersal/MMR theory even though the first test case was due to start in June. When they did find a family like the Polings who were willing to step up to the mark for the thiomersal causation theory, it turned out that their case was so atypical that they were able to settle with HHS without going to court. Then the family chosen to replace them dropped out as well.

In following this for so long I got an impression of the PSC as something that talked a good fight but backed down every time it was challenged. Then it finally had to take its case to court and it very soon became apparent that the PSC had no case at all.

The year long delay between the hearings and the judgement tempted some to speculate that it was a very close decision. The Poling decision was erroneously regarded as de facto recognition by HHS that vaccines cause autism.  But Special Master Hastings offers a more realistic reason.

Finally, I note that much time has passed since the conclusion of the evidentiary hearing in this case in June of 2007. However, two major factors should be recognized.

First, the completion of the three-week evidentiary hearing in this Cedillo case in June of 2007 did not mark the end of the presentations by the parties relevant to this case. Additional “general causation” expert testimony, much of it relevant to this Cedillo case, was presented during the evidentiary hearings in the Hazlehurst and Snyder cases in the fall of 2007, with the Snyder hearing not concluding until November 9, 2007. Then, the parties’ process of briefing this Cedillo case extended into May of 2008. Finally, even at that point the petitioners in this case were still keeping alive their option to submit additional “general causation” evidence that they hoped to obtain from a British litigation file. It was not until July of 2008 that the Petitioners’ Steering Committee in the OAP concluded that they would not attempt to obtain further evidence from that British litigation. (See discussion at p. 83 below.) Thus, it was only at that time that I could, as I did on July 30, 2008, file an Order declaring that the evidentiary record in this case was closed.
Second, it should be recognized that the evidentiary record, based upon which I have decided this case, is massive. This record dwarfs, by far, any evidentiary record in any prior Program case. A few statistics may give a flavor of the amount of material involved. The record contains about 7,700 pages of Michelle Cedillo’s medical records alone. The parties filed a total of 23 expert reports in this Cedillo case alone, and a total of 50 expert reports including the Hazlehurst and Snyder cases. During the evidentiary hearings, 16 expert witnesses testified in Cedillo, four in Hazlehurst, and eight in Snyder. The hearing transcripts totaled 2,917 pages in Cedillo, 1,049 pages in Snyder, and 570 pages in Hazlehurst. The parties filed six post-hearing briefs in this Cedillo case alone, totaling 462 pages.

In addition, the amount of medical literature filed into the records of the three cases was staggering. In the Cedillo case alone, the parties filed a total of 658 medical journal articles, medical textbook excerpts, or other items of medical literature. Many more such documents were filed into the Hazlehurst and Snyder cases, so that a total of 939 different items of medical literature were filed into the three case files (even after excluding from the count those documents that were filed in more than one case). Some of those items were extremely lengthy. (E.g., Ex. JJ, 163 pages; Ex. L, Att. 1, 617 pages; Ex. BB, Att. 94, 306 pages.) I have not attempted to calculate the total number of pages of those 939 documents, but clearly the total runs well into the tens of thousands of pages. And most of those documents are densely packed with difficult, technical information, so that studying even a medical journal article that is only a few pages long can require a lengthy time period.
Further, the complexity of the material involved here is daunting as well. The medical records, expert testimony, and medical literature involve many different subspecialties of biology and medicine, including neurology, gastroenterology, virology, immunology, molecular biology, toxicology, genetics, and epidemiology.

In sum, the massive nature of the evidentiary record, along with the complexity and variety of the scientific issues involved, necessitated the lengthy time period spent in preparing this Decision. (Cedillo 2009, pages 18-19)

To my mind the situation prior to the decision was this.

• A speculative claim for vaccine damage as a cause of autism was entered with the court.
• Petitioners were given lots of time in order to substantiate their claims.
• Petitioners were allowed to determine the format of the hearings.
• Petitioners were given every assistance by the court in order to assemble their evidence.
• Petitioners were given every assistance in discoverng potentially damning material held by the government.
• The initial test case was presided over by a special master who had previously ruled in favour of general causation for a vaccine injury in an omnibus hearing concerning the rubella vaccine. He subsequently decided in favour of the majority of cases in that omnibus proceeding.
• The Special Master examined every possible reason for finding in favour of the PSC.

And still they lost. The hypothesis was found wanting.

The Hypothesis

Michelle Cedillo became the first of three test cases for the hypothesis that the mercury in a vaccine preservative called thiomersal [thimerosal in the USA] weakened the immune system in susceptible children and subsequently enabled live measles virus from the MMR vaccine to persist in the body, particularly in the gut where it caused gastrointestinal dysfunction, and in the brain, where it caused autism. Although Special Master Hastings dealt at length with the argument that thiomersal weakened the immune system he was also clear that this was essentially a sideshow.

I find the first part of the petitioners’ theory of this case–i.e., their contention that thimerosal-containing vaccines damaged Michelle’s immune system, thereby making it possible for the vaccine-strain measles virus to persist within Michelle’s body–to be essentially unnecessary to the rest of their causation argument. That is, if petitioners were able to persuade me that the vaccine-strain measles virus did likely persist in Michelle’s body and cause damage to either (or both) her brain or gut, I would compensate such damage. It would not matter why the measles vaccine-strain virus was able to persist; whether that persistence was the result of thimerosal-containing vaccines or for some other reason would be irrelevant. (Cedillo 2009, page 21)

The PSC have announced that they will no longer be presenting a third set of cases to test the hypothesis that MMR alone causes autism as they feel that the evidence presented in the three test cases for the thiomersal/MMR hypothesis made the case sufficiently for MMR alone as a cause of autism. In effect they are agreeing with Special Master Hastings that the evidence on thiomersal that they presented in the Cedillo case was unnecessary and irrelevant. This did not stop Special Master Hastings from carefully considering the evidence for thiomersal harming the immune system before rejecting it in its entirety. All the arguments are set out in Cedillo 2009, pages 22 - 40.

The single biggest problem with attempting to connect thiomersal with MMR is this. If Michelle Cedillo had a compromised immune system as a result of vaccine damage in the first months of life why did it not show itself at the time? She did not have adverse reactions to her early vaccinations. In fact tests show that her immune system responded appropriately to the vaccines, creating antibodies and strengthening her immune system. Her medical records show no signs of an abnormal immune system in the first year of life. When the petitioner’s expert witness, Dr Byers, attempted to use test results that showed abnormalities the respondent’s witness, Dr McCusker pointed to a fundamental error. Dr Byers was comparing Michelle’s results to values for adults. If you compared them to age adjusted values for children the results were normal. Even using adult values Michelle only deviated slightly.

Dr. Gupta himself, after doing the 1997 testing in question, described Michelle as having “almost normal immune functions.” (Cedillo 2009 page 38)

Confusion

rather than Conclusion seems to sum up proceedings thus far. At three years old, after receiving all her vaccines and being diagnosed with autism, Michelle Cedillo had a normal immune system. She had other health problems and a year later her parents entered a petition for a table injury with the vaccine court. Three years later in 2001 an expert report was entered in support of the petition by Dr Marcel Kinsbourne.

Then, somehow by 2002, Michelle’s parents had been persuaded that she did have an abnormal immune system. Moreover she had had it for most of her life as a result of receiving thiomersal containing vaccines. Her dysfunctioning immune system had allowed the measles component of her MMR jab to persist in her body and enter her brain, causing her autism. The table injury was replaced by a causation-in-fact claim. And when it finally came to court in 2007 it seems that Dr Marcel Kinsbourne had been similarly persuaded because he was the main witness for the contention that MMR had caused Michelle’s autism.

The most bizarre revelation in the record so far (Cedillo 2009 page 42) is that the Cedillos decided to alter their claim two weeks before their doctor took a biopsy from Michelle and two months before they got the results back confirming (erroneously as it turned out) that measles virus had persisted in Michelle’s gut. Someone was very persuasive indeed.

But, in the absence of hard evidence, they could not persuade the special masters. In my next post on the Omnibus I will look more closely at the standard of evidence in support of the MMR hypothesis and  role of Dr Krigsman

February 22nd, 2009 Posted by Mike | MMR, autism Omnibus, science, vaccines | 18 comments