Another appeal heard in the Autism Omnibus

14 Jun

Part of the United States Court of Federal Claims includes the “vaccine court”, where claims against the government are heard regarding vaccine injuries. Probably the most well known activity of the vaccine court, especially to readers of LeftBrainRightBrain, is the “Omnibus Autism Proceeding“. The Omnibus comprises over 5,000 families claiming vaccine injury resulted in autism. Rather than hear all these cases individually, both sides agreed to first hear “test cases” where the stories of six children were heard to answer the question of whether vaccines induced autism in those children and to decide whether the general question of whether vaccines cause autism could be addressed. The first three test cases presented the argument that the MMR vaccine, either alone or with thimerosal from other vaccines, could cause autism. The next three cases presented the argument that thimerosal alone could cause autism.

The Omnibus is back in the news, in a small way, after another appeal for the Cedillo test case was heard last week. The attorneys and the bloggers are concentrating on whether the testimony and expert reports of Prof. Stephen Bustin should have been allowed. I’ll go into the detail about this argument below. It is worth saying at the outset that this argument is likely to accomplish nothing, whether they win or lose. The Special Master who decided the Cedillo case and the judge who heard the first appeal both stated, clearly, that the decision to deny the Cedillo claim would be the same without Prof. Bustin’s testimony and report.

That is worth repeating: win or lose on this point in the appeal, the Cedillo’s still do not have a compelling case that the MMR vaccine causes autism.

Before going any further, it is worth stopping and recognizing the human side of this proceeding. The “test cases” are six children whose families agreed to let their stories be heard and analyzed in public. They went into this with faith in their positions, but without the knowledge of the legal outcome. When the decisions were handed down against them (yes, they lost), they didn’t have the opportunity to change their arguments. They were committed. So, in two big ways, these are brave families. Agree or disagree with the science they depend upon, they had some guts to step forward as they did.

It is also worth noting that no one gets wealthy from successful claims in the Court. Settlements are typically around US$1 million. While this sounds like a lot, the purpose is to pay for the needs of the injured and to set up an annuity which will supplement the government support already in existence for the disabled. Most readers to this blog will have an idea to how far that support goes.

The Omnibus hearing and the appeals

The first of the test cases heard was that of Michelle Cedillo. Miss Cedillo is a severely handicapped girl with multiple disabilities. Her case was heard in June 2007. The decision, by Special Master Hastings, was handed down in February 2009. The Cedillo family appealed and the case was heard by a Judge in the U.S. Court of Federal Claims, Judge Wheeler, whose decision in August 2009 went against the Cedillo family. The Cedillo family appealed again, this time to the U.S. Court of Appeals for the Federal Circuit. Their appeal was heard on June 10 before judges Newman, Linn and Dyk.

The Court of Appeals for the Federal Circuit is probably the last appeal for the Cedillo family. Should this go against them, they have the right to appeal to U.S. Supreme Court. But the Supreme Court is not required to hear their case. In fact, the Supreme Court usually chooses cases which decide points of law. The arguments by the Cedillo family are more questions of procedure and, as such, I would expect the Supreme Court would refuse to hear any appeal. But, that is getting ahead of ourselves. Right now, we still haven’t heard the decision from the Appeals Court.

Public Responses to the Recent Appeal

What we have heard is some minor publicity about the hearing in the Appeals Court. The Age of Autism blog has Olmsted on Autism: Day in Court and one of the Examiner blogs has Oral arguments made in Cedillo Omnibus Autism Proceeding mercury and MMR vaccine test case appeal.

I haven’t heard the arguments made in court. I wish I had because in my experience there is a fairly large gap between what I’ve heard in past proceedings and how they are portrayed on the net. A fairly egregious example was in the portrayal of an expert witness for the Cedillos, Dr. Vera Byers. When she testified in 2007, someone was portraying her as coming across with the gravity of Dame Judi Dench (who plays “M” in the James Bond movies, amongst other roles). During the hearing, Dr. Byers was found to have seriously padded her resume, claiming she worked at the prestigious University of California San Fransisco when, in fact, she only used their libraries and attended their parties. She also accused the Department of Justice lawyer of “making faces” at her. I did not think of Dame Judi Dench when I heard her testimony.

Following the original hearings for the Cedillo case, many bloggers in the vaccines-cause-autism groups were optimistic. They felt that they had made a strong case and they would prevail, complete with imagery of “Dark Towers” being brought down by bolts of lightening. From my perspective, such cheer-leading seemed to border on cruel given the very weak case made to support the general question of MMR causing autism.

Given this background you would probably not be surprised that I look at the optimistic reports coming out of last week’s appeal with a somewhat skeptical eye. Which begs the question, “what was said” by these bloggers? From Mr. Olmsted’s piece, here are two quotes.

The first is from one of the attorneys working with the Cedillo family:

“I have a very positive feeling about the federal judges,” said Sylvia Chin-Caplan, who argued the appeal.

The second quote comes from an attorney who blogs for the Age of Autism blog and who, I believe, has a child who is a claimant in the Omnibus:

“I leave with the sense that the judges were very troubled that the government had not acted in good faith,” said Mary Holland. “Those judges were very troubled by what the government’s done – very troubled.”

The argument for the appeal: Prof. Bustin’s testimony

So, what are the judges supposedly “troubled” by? Well, this has to do with part of the appeals argument by the attorneys for the Cedillo family: the testimony of Prof. Stephen Bustin.

Professor Bustin is a world expert on a technique called polymerase chain reaction (PCR) which he describes as

Real-Time PCR is a variation of the polymerase chain reaction (PCR) that allows simultaneous (i.e. in real-time) amplification and detection of DNA templates. Because it is used to quantitate DNA, it is often abbreviated to qPCR, although that abbreviation is not universally accepted.

PCR played an important rule in the Omnibus. PCR was used in attempts to identify measles in tissue samples taken from autistic children’s bowels. One of the key papers for the families in the Omnibus was written by Uhlman et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. The Uhlman paper concluded “The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. ” One of the co-authors on that paper is Professor J J O’Leary, whose laboratory, Unigenetics, performed the tests on samples sent from the group headed by Andrew Wakefield in London. The same laboratory was used to test samples taken from Michelle Cedillo.

The presence of measles virus in the tissues is key to the theory argued in the Omnibus. This was made very clear when the expert reports were filed, in February of 2007. At that time, the Department of Justice attorneys sought information to rebut the “persistent measles in the gut” argument. One source they sought was information filed in the United Kingdom for the MMR litigation that was held there. In specific, they sought the report by Prof. Bustin, who had testified in that litigation. Those reports are sealed and require special permission to obtain. The DoJ attorneys received the first of those reports on May 31, 2007, 1 hour after receiving it, but only 12 days before the start of the Cedillo hearing. One week later, the DoJ filed two more reports by Prof. Bustin.

The attorney’s for the Cedillo family argued that they didn’t have time to assimilate such technical information and prepare a good response. Further, they argued that the reports were submitted after a deadline imposed by the Special Master. The Special Master allowed Prof. Bustin to testify and to submit his expert reports. The Special Master argued that the admissibility of the testimony and reports could be decided after the hearings.

This history and greater detail are summarized in the Wheeler decision denying the first Cedillo appeal.

Was Prof. Bustin’s Testimony Damning to the Case?

Professory Bustin is possibly the word’s number one expert on PCR. Not only that, he was given access to the Unigenetics laboratory and the notebooks they kept. He found that the Unigenetics laboratory was missing a key step in the process. PCR tests DNA. Measles is an RNA virus. So, there must be a step to turn the RNA into DNA or PCR won’t work.

At the time Unigenetics were testing samples for the Uhlmann paper and the sample from Michelle Cedillo, they weren’t using RNA–>DNA step. Whatever they were detecting, it wasn’t an RNA virus and, hence, it wasn’t measles.

Prof. Bustin also testified that at that time Unigenetics was not using “controls” correctly, making interpretation of their results problematic at best.

Prof. Bustin also testified that the laboratory notebooks had been altered after the fact.

Prof. Bustin also testified that Unigenetics found the same results from two different types of samples (fresh-frozen and formalyn fixed). That could only happen if they were detecting contaminants.

And the list of errors at Unigenetics goes on. (There is an extensive summary in the Hastings decision for the Cedillo case)

These are only parts of the testimony. But, yes, it is safe to say that Prof. Bustin’s testimony hurt the case the attorneys for the Cedillos were trying to make.

Would the case have been decided for the Cedillos had Prof. Bustin’s testimony been excluded?

As noted at the outset of this piece, Prof. Bustin’s testimony is not key to the decision to deny the claim of the Cedillo family. It also isn’t key to denying the question of general causation (does MMR, in general, cause autism).

Special Master Hastings has a section of his decision entitled, “Even if I were to disregard Dr. Bustin’s expert reports and hearing testimony, all my conclusions in this case would remain the same.” I quote that section in its entirety below:

Finally, even if I were to completely exclude and disregard all of Dr. Bustin’s reports and all of his hearing testimony, nevertheless all of my conclusions in this case would remain exactly the same.

First, the testimony and reports of Dr. Bustin were relevant chiefly in establishing my conclusion discussed at pp. 58-60 above, i.e., that there were severe problems with the facilities and procedures of the Unigenetics laboratory. But even concerning this narrow point, Dr. Bustin’s testimony was not the only evidence. Dr. Rima provided extensive, convincing evidence to the same effect, and Dr. MacDonald provided some corroboration as well. (See discussion at pp. 52-54, 58-59 above.) I would have reached the same conclusion, that there were severe problems with the Unigenetics facilities and procedures, based just on the evidence supplied by Dr. Rima and Dr. MacDonald, even without any information from Dr. Bustin.

Second, even if there had been no testimony from Dr. Bustin, Dr. Rima, Dr. MacDonald, or any other expert who participated in the British litigation, concerning the problems with the Unigenetics procedures and facilities, nevertheless I still would have concluded that the Unigenetics testing was not reliable. That is, as explained above (p. 77), the most important points in my rejection of the Unigenetics testing were (1) the fact that the laboratory failed to publish any sequencing data to confirm the validity of its testing, (2) the failure of other laboratories to replicate the Unigenetics testing, and (3) the demonstration by the D’Souza group that the Uhlmann primers were “nonspecific.” The testimony by Drs. Bustin, Rima, and MacDonald, about the many problems with the Unigenetics laboratory and procedures, was merely a secondary, additional reason to doubt the reliability of the Unigenetics testing. Accordingly, I would still have found the Unigenetics testing to be unreliable even if there had been no reports or testimony at all from Drs. Bustin, Rima, or MacDonald.

Accordingly, for all the reasons set forth above, I conclude (1) that there is no valid reason for me to disregard the evidence supplied by Dr. Bustin, and (2) that even if I did disregard that evidence, my conclusions concerning all of the issues in this case would remain the same.

Testimony of Nicholas Chadwick

One reason that the Special Master could be so decisive on the unreliability of the Unigenetics laboratory was the fact that other groups were unable to replicate those findings. One of those researchers was Nicholas Chadwick, a post doctoral researcher in Wakefield’s own group. Dr. Chadwick used PCR to test biopsy samples from autistic children–many of whom were a part of the now-retracted Lancet paper by Wakefield’s team–and found that they were negative for measles virus.

Dr. Chadwick’s Ph.D. thesis includes results from “Autistic enteropathy samples. Biopsies, PBMCs and Vero/PBMC cocultures were analysed from 22 patients with autistic enteropathy and 6 controls.”

He found

Results. Hybrid capture and RT-PCR could detect 104 molecules of a measles RNA transcript added to control tissue homogenates. The fidelity of NASBA, in terms of its nucleic acid error rates, was found to be comparable with that of RT-PCR. All samples were found to be positive for a housekeeping RNA species and internal modified positive control RNA. None of the samples tested positive for measles, mumps or rubella RNA, although viral RNA was successfully amplified in positive control samples.

Conclusion. The results do not support previous data implicating persistent measles virus infection with the aetiology of IBD or autistic enteropathy.

He studied gut biopsy samples, cerebral spinal fluid samples and blood samples.

This isn’t a separate group and different children. This is Mr. Wakefield’s own hospital, someone he was in contact with. It is likely that some of these children’s samples were also tested by Unigenetics and with false positive results.

Dr. Chadwick’s expert report and testimony are online.

Should Prof. Bustin’s Testimony have been Allowed?

Prof. Bustin’s report was submitted very close to the start of the Cedillo hearing. In fact, it was past a deadline imposed by the Special Master. The attorneys for the Cedillos have argued that they were unable to prepare a response to such a technical report and that they didn’t have access to the lab notebooks which Prof. Bustin relied upon.

Let’s take this in stages.

First, yes the report was submitted past the deadline. So were reports submitted by the attorneys for the Cedillos. The vaccine court is supposed to be flexible in allowing evidence in.

How about the idea that the attorneys for the Cedillos were unable to prepare a case in time? First, page back and recall how all this got started. The Cedillo’s attorneys submitted expert reports which relied upon the results of the Unigenetics laboratory results. Not only that, but the expert who submitted that report, Dr. Ronald Kennedy. Kent Heckenlively, blogger for the Age of Autism, wrote in a post following Prof. Kennedy’s testimony, “Dr. Kennedy is familiar with the Unigenetics Lab of Dr. John O’Leary and Dr. Laura Shields at Trinity College in Dublin, Ireland where measles virus RNA was diagnosed in the cerebral spinal fluid of Colten Snyder.” (Colten Snyder was one of the other “Test Cases”)

So, the attorneys for the Cedillos not only had an expert on their team to discuss PCR, but their expert was familiar with the Unigenetics laboratory. Their report was filed four months before Stephen Bustin’s reports and, presumably, their team had access to information from well before that.

How about the idea that the attorneys for the Cedillos didn’t have access to the lab notebooks which Prof. Bustin reported upon? First, it is clear that Prof. Bustin’s analyses did not rely solely on the lab notebooks. Some of the problematic results were public (from the paper) and other information he obtained in his 1,500 hours spent analyzing the Uhlmann work. Yes, 1500 hours.

The whole argument begs the question: how are the Cedillo’s attorneys and their expert (Prof. Kennedy) so confident of the Uhlmann results if they haven’t seen the notebooks?

One of those attorney’s is quoted:

Chin-Caplan told Examiner.com, “Two reports that he submitted on behalf of the government were of such technical matter and so incomprehensible that at the very least a motion to continue the hearing should have been entertained and it wasn’t.”

I am again at a bit of a loss. Why were Ms. Chin-Caplan and her team unprepared to respond to Prof. Bustin’s reports? She and her team were the ones who were admitting PCR testing as evidence.

Ms. Chin-Caplan is also quoted:

“The fact that they went over there (to the U.K.) secretly four months before the hearing to try and get these documents without giving me notice that they were going to do this leads me to think that they wanted to examine those documents without me being present,” Chin-Caplan told Examiner.com. “And that violates the concept of fundamental due process as far as I’m concerned.”

The idea of obtaining information from the U.K. litigation was not a surprise to the Cedillo’s attorneys. They had attempted as early as 2004–three years before the hearing–to obtain reports from the U.K. The idea that the DoJ attorney’s “wanted to examine those documents wihout me being present” is totally at odds with the fact that the DoJ submitted the first report 1 hour after receiving it. One hour.

One might ask why Ms. Chin-Caplan didn’t call upon, say, Andrew Wakefield or others to write reports or to serve as an expert witness. Mr. Wakefield is on the list of potential experts. Mr. Wakefield is one of the authors of the Uhlmann paper. Of course, the answer is that Mr. Wakefield, father of the MMR causes autism hypothesis, is not a very credible witness.

Friend of the Court Brief

Much of the argument for the appeal is summarized in a “Friend of the Court” brief.

That brief concentrates much space to the reliability of the O’Leary lab results. It introduces new “data”

Michelle submitted further compelling evidence of the reliability of the O’Leary lab results in her motion for reconsideration. She submitted a new study on the recovery of measles RNA from the gut tissue of autistic children. The multi-center Hornig study,57 relying on laboratories at HHS’s own Centers for Disease Control, Columbia University and Dr. O’Leary’s laboratory at Trinity College were all concordant in finding measles RNA in one clinical subject and one control, again showing the O’Leary laboratory’s reliability.

The Hornig study was an attempt to recreate some of the Wakefield group’s studies. The study was much more careful than Wakefield’s team’s efforts. It was discussed on this blog at that time.

I am always amazed when people try to use the Hornig study to support the MMR-causes-autism hypothesis. The paper concluded:

This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure

As far as supporting the idea that the O’Leary laboratory was reliable, it is far from convincing. There is a vast difference between how a laboratory performs in, say, the late 1990’s and ten years later after facing much criticism and while under intense scrutiny for accuracy. In other words, it is very possible that the O’Leary laboratory’s methods were different for the Hornig study than used for the Wakefield/Uhlmann studies.

Summary

It seems unlikely to this observer that the Cedillos will win this appeal. They rely on discounting the testimony of Stephen Bustin. The arguments to throw out his testimony have not proven persuasive in a previous appeal. More importantly, the Court made it extremely clear that the decision would be the same whether or not Prof. Bustin’s testimony was allowed. The public statements being made about this appear to be coloring the facts somewhat to create an image of impropriety by the government. Also, those making public statements appear to ignore the fact that even without Prof. Bustin’s testimony, the case was not close.

At every step along the process of the Omnibus Proceedings, public statements have been heard suggesting the families had a strong case. In my opinion, this has been a disservice to those families. I worry that this is yet another instance of building up false hope for the families in the Omnibus.

56 Responses to “Another appeal heard in the Autism Omnibus”

  1. Marcia Depak June 14, 2010 at 23:51 #

    For a minority of cases: A new study finds a NON Inherited genetic source for a minority but growing percentage of children having been diagnosed with Autism. This likelihood is already explained in a recent book based on Systems Theory rather than statistical study. The book is called Xzenobia. (available USA Amazon) At the end it also predicts that autism incidence will rise slowly but exponentially as a result which is what we are seeing.

    The book is also elegant and positive thinking as well as practical. Written for regular fathers to encourage them to act early but totally brilliant and touches on a lot of subjects germane to learning disabilities which is not commonly found else ware.
    Worth a look-see even though not directed to this audience. You will get a new view and also a perspective of the medical profession from a layman you may not expect.

  2. KWombles June 14, 2010 at 23:55 #

    Thanks for the detailed look at this.

    • Sullivan June 15, 2010 at 00:40 #

      KWombles,

      thanks. I realize this is very long. I made it even longer after the fact by adding the section on Nicholas Chadwick. While he did not give evidence about Unigenetics in particular, he shows clearly that the idea of persistent measles infection was not supported by PCR testing.

      I found this statement in the amicus brief interesting: “The Special Master abused his discretion to permit HHS to focus on Dr. Wakefield and to taint Michelle’s treating physicians and medical theory by mere association.”

      Yes, even they acknowledge that association with Andrew Wakefield is something that “taints” a person.

      The attorneys for the families (petitioners) tried a very strange tactic–they tried to argue the MMR causes autism idea and not mention Andrew Wakefield. They just present his ideas. Oh, and papers where he was an author, just not the first author, like the Uhlmann paper. When the DoJ/HHS respondents didn’t let them get away with this, they (the petitioner’s attorneys) called “foul”. Are we just supposed to all pretend that Andrew Wakefield’s name isn’t on the Uhlmann paper?

  3. FreeSpeaker June 15, 2010 at 00:46 #

    Another post which will become a classic in the archives of resources to refute the anti-vaxxers.

  4. Kwombles June 15, 2010 at 01:09 #

    Ah Sullivan,

    I seem to think if a post isn’t several thousand words long, I haven’t done my best. 🙂 Your length on this was necessary and appreciated.

  5. Broken Link June 15, 2010 at 01:26 #

    I’m very saddened by this whole thing. I think that it is a terrible shame that the Cedillos are being used in this manner. The lawyers MUST know that this is an argument doomed to failure (for the reasons you discuss) and yet they continue to encourage this family to act as the poster family for the autism-is-caused-by-vaccines argument. I can’t help, in my cynical way, assuming that the Cedillos were chosen for this role because they are so fragile, so clearly deserving of all our sympathy. It seems a last ditch effort to win sympathy and the case.

    MY sympathy is with the Cedillos, and not with the argument presented.

  6. FreeSpeaker June 15, 2010 at 01:34 #

    One point…you said no one gets rich…Neurodiversity weblog documented how the lawyers get a real nice payday. They have no incentive to give their clients a reality check and tell them that they do not have a claim.

  7. David N. Brown June 15, 2010 at 07:10 #

    Irony: While they complain that evidence that would vindicate them is somehow being covered up, they build a court appeal around trying to exclude evidence.

    I find parallels to two other “spins”: The claim that the UK MMR litigation was “only” stopped because of a ruling by Justice Eady, and Jim and Jenny’s press release promoting wakefield’s “14 monkeys” paper several days AFTER Wakefield was informed the paper was being removed from press. I deduce the following process:
    1. Make an argument that can’t withstand scrutiny.
    2. Move forward with said argument as far as you possibly can.
    3. Make optimistic predictions even in the face of repeated failures and foreseeable future ones.
    4. When even the most last-ditch, forlorn efforts fall through, say you only failed because of cover-ups, conflict of interest, etc.

  8. bensmyson June 15, 2010 at 14:01 #

    Although I appreciate such lengthy discussions on this, Im not convinced that this is a waste of time on the behalf of young Miss Cedillo. As a parent of a child diagnosed with autism I find it encouraging that so much effort is being put into this case. It seems to me that many issues are being addressed in the open and arguments and debates on specific points allow parents of other children believed to be vaccine injured to learn the objections the government has to the plantiff’s case.

    I can only imagine my son’s injury being the focus of such debate and how I would fight till my dying breath to seek justice, no matter where the decisions fell. If I am of the belief that my son was injured and nothing could convince me otherwise, why stop, why not push every single button that there is?

    I seriously do not believe this has anything to do with money, lawyers stand a better chance in whiplash and slip and fall lawsuits than they do with vaccines. Dont believe me, talk to some lawyers.

  9. Kwombles June 15, 2010 at 14:31 #

    Bensmyson,

    So you’ve filed then? Right? You’re absolutely certain of your claims, you’ve not gone past the three years, so you’ve filed?

    And the lawyers for the Cedillos get paid for their time, period. It’s a win-win for them. The longer it goes on, the more they make.

  10. BobD June 15, 2010 at 15:06 #

    ” The trial was a pig circus they never had a chance. “

  11. Broken Link June 15, 2010 at 15:57 #

    Bensmyson,

    Kwombles is right. The lawyers made out like bandits over this case. This is documented at

    http://www.neurodiversity.com/weblog/article/180

    “The Cedillo fee and cost request totals $2,180,885.29. $19,321.28 of that amount represents costs incurred by the Cedillo family for travel and housing during the lengthy hearing held in June 2007 in Washington D.C.,”

    and

    “The Cedillos’ attorneys have been awarded $1,452,806.11 for attorneys’ fees and costs, which is significantly less than they asked for but still a pretty decent payday.”

  12. bensmyson June 15, 2010 at 17:49 #

    K, yes we filed some time ago and Im not sure what certainty has to do with any parent of an injured child’s claim, this is about the child, not the parent, but yes we are certain of our claims, its pretty simple really.

    Broken, I know parents of a child who sued a school system on the behalf of their child in order to receive, or have the hope to receive additional services for their child that they believed their son was entitled to, the lawyers representing them charged over $80,000. A million and a half sounds high,
    but so does $80,000, I had a speeding ticket two years ago and it cost me $300 for an attorney to get me a reduced charge in order to save on insurance. Im not sure the point, how is that any different than what goes on in other cases, or holy cow, what about doctors and hospitals fees. It’s the nature of the beast I suppose.

    I havent seen too many awards for fees in excess of $50,000. In fact last year the average attorney fees awarded were $44,000 in winning cases, with the average award being half a million.

    BTW noticed that there were a total of 130 awards and 59 dismissals in 2009.

    http://www.hrsa.gov/vaccinecompensation/statistics_report.htm

  13. Anne June 15, 2010 at 19:35 #

    An audio recording of the oral argument in Cedillo is available on the website of the Court of Appeals for the Federal Circuit here:
    [audio src="http://oralarguments.cafc.uscourts.gov/mp3/2010-5004.mp3" /]

    From what I can tell, Age of Autism blogged only half of the oral argument. They left out the part where the court grilled the Cedillos’ attorney about why the petitioners didn’t make an effort to obtain the underlying Bustin documents if they thought they were so important – either by moving to have the Federal Rules of Evidence apply or by pursuing release of the documents from the UK proceeding where they had been placed under seal.

    More importantly, the court questioned Sylvia Chin-Kaplan about how the petitioners could possibly have been prejudiced by admission of the Bustin evidence when the special master stated in his decision that the outcome would have been the same had the evidence not been admitted, and petitioner’s counsel actually agreed at the hearing on the petition for review in the Court of Federal Claims that there had been no prejudice. Even where there is error, a lower court’s decision won’t be reversed unless the error is prejudicial. Where there is no prejudice, the lower court’s decision will be affirmed.

    It’s worth noting that the Federal Circuit has already rejected the argument that the admission of the Bustin evidence was erroneous when it upheld the special master’s decision in the Hazlehurst case on May 13, 2010. The court also found no prejudice from the admission of the Bustin evidence. The analysis of the Bustin issue in the Hazlehurst decision was lengthy, and the arguments the petitioners made were clearly the same ones made in Cedello. The Federal Circuit’s opinion in Hazlehurst is here:
    http://www.cafc.uscourts.gov/opinions/09-5128.pdf

    In light of the Hazlehurst decision, it is extremely unlikely that the same court would accept the arguments in Cedillo that it rejected in Hazlehurst. It’s far more likely that the result in Cedillo will be the same – the special master’s decision will be affirmed.

    The third of the original OAP test cases, Snyder v. HHS, was not appealed to the Federal Circuit, and none of the test cases on Theory 2 (causation by thimerosal alone) was appealed. So I think the next step in these cases will be to see how they fare in state court or US District Court should the petitioners decide to pursue their cases there.

  14. Sullivan June 15, 2010 at 21:25 #

    KWombles,

    I am not sure if the attorneys for the petitioners get paid for the appeals–at least if the vaccine program pays for their efforts.

    I am sure that if/when they move to a civil court, the program will not be paying fees.

    However, much of the costs of prepping the case and discovery will have already been paid by the program. So, yes, the taxpayers will be in effect subsidizing that effort to some degree.

  15. Sullivan June 15, 2010 at 21:28 #

    Anne,

    thank you very much for that information. I am not surprised that the information out so far is somewhat one-sided.

    I don’t think that this does the families in the OAP a service. They need to know that this is a tough battle.

    I will watch. The appellate Court judges could very well rule against the Cedillos. If that happens, will the story change from “the judges were good guys” to “they are bought and paid for by big pharma”?

  16. FreeSpeaker June 15, 2010 at 22:50 #

    Broken link said: ““The Cedillos’ attorneys have been awarded $1,452,806.11 for attorneys’ fees and costs, which is significantly less than they asked for but still a pretty decent payday.”

    Just to put this in perspective, the attorney who began the Agent Orange lawsuit in the 1970’s, and was sque4ezed out along the way by a group of Park Avenue law firms, was awarded a fee of just over $1.1 million to cover his legal services and costs. His net profit was just under -$100K. That’s right. He lost money on the case. However, the Vets are loyal, and made him wealthy by having him as their lawyers for everything else. They understand loyalty.

  17. bensmyson June 15, 2010 at 22:54 #

    Sullivan – You said, ” the taxpayers will be in effect subsidizing that effort to some degree.”

    I believe you will find that the attorney fees, as well as all awards and costs come from the special fee placed on each vaccine sold, something like one dollar per vaccine that each recipient pays for when purchasing the vaccine. This money does not come from the General Revenue Fund.

    • Sullivan June 15, 2010 at 23:52 #

      bensmyson,

      first, I hope you don’t revert back to your admitted effort of commenting on blogs such as this as a method of disrupting conversations.

      Second, I consider the fee paid for each vaccine to be a tax. Lawyers might quibble with the distinction between “fee” and “tax”, but it is a reasonable description.

  18. Sullivan June 16, 2010 at 00:12 #

    In general I don’t have a problem with the lawyers for the petitioners

    The Omnibus took years. Sure, much of the delay was from the petitioner’s lawyers themselves. But there was a considerable amount of work involved. It will be interesting to see what the total bill comes to. I know HSS were requesting $7M from the HHS budget to cover the costs of the Omnibus–yes, taxpayer dollars.

    There are documented cases of very questionable billing by experts working for the Court.

    Frankly, the petitioners deserved much better than what they got from their experts. They were, on the whole, people with low levels of expertise. Given the importance of this, the PSC should have sought out a better quality “expert”.

  19. FreeSpeaker June 16, 2010 at 01:14 #

    Sullivan, I believe that the PSC got the best experts money could buy for their position. The problem is, anyone better would be testifying for the defense.

  20. sheldon101 June 16, 2010 at 06:34 #

    Anne points out that the argument in Cedillo before the Court of Appeal is pretty much the same as the argument in Hazlehurst.

    What really bothered me about Olmsted’s article at Age of Autism is that he didn’t explain why the appeal has essentially zero chances of winning.

    Because the job of a court hearing an appeal from a criminal case can overturn a decision if they decide the court made a mistake in interpreting the law. For example, they decide that the judge let in evidence that should have been excluded.

    But this compensation program allows in evidence that wouldn’t normally be part of a court hearing as the special master feels necessary.

    That means the court hearing an appeal can’t merely decide (as they can in a criminal case) that they disagree with the decision to include or exclude evidence. They have to decide the decision was really, really wrong and that is was fundamentally unfair.

    And whether you think the Bustin testimony should or shouldn’t have been allowed in— it isn’t a decision that is really, really wrong.

    For more details see:http://vaccineswork.blogspot.com/2010/06/appeals-wont-succeed-olmsted-isnt.html

    • Sullivan June 16, 2010 at 07:28 #

      Thanks shedlon101.

      I linked to your post. Least I could do since I took your conclusion! I’ll pull that out if you wish.

      I agree that Dan Olmsted and others are not doing a great service to the Omnibus families by painting this in such rosy terms. At best, this is a tough fight for Miss Cedillo’s attorney.

    • Sullivan June 16, 2010 at 07:28 #

      Thanks shedlon101.

      I linked to your post. Least I could do since I took your conclusion! I’ll pull that out if you wish.

      I agree that Dan Olmsted and others are not doing a great service to the Omnibus families by painting this in such rosy terms. At best, this is a tough fight for Miss Cedillo’s attorney.

  21. TLPG June 16, 2010 at 13:58 #

    For those of you who are interested, I am using the three original appeals and the Hazelhurst final appeal in my defamation action against a certain blogger who I won’t name here – in order to show the court here that vaccines do NOT cause Autism. I’ve included Blackwell v Wyeth as well. The Cedillo appeal, if the decision is issued in time before the next hearing here (and it’s upheld as the others have been) will also be included.

  22. FreeSpeaker June 16, 2010 at 14:13 #

    TLPG, where can we find a place where you name that blogger and discuss the suit? You can visit me a http://www.age-of-ignorance.blogspot.com and let me know.

  23. Julian Frost June 16, 2010 at 18:28 #

    Sullivan,

    The appellate Court judges could very well rule against the Cedillos.

    Not could. Almost certainly will.
    What puzzles me is that the Cedillos have the worst case. Experts for the government viewed video footage of Michelle before she received the MMR jab and testified that she was showing signs of autistic behaviour. Even if Bustin’s testimony is overturned (not likely) the Cedillos would still have to face that obstacle. Why are they appealing?

    • Sullivan June 16, 2010 at 18:52 #

      Julian Frost,

      I think that if the appellate judges work from the existing law, they will probably rule against the appeal. If, however, they feel strongly enough that the rules in place are unfair, do they have the ability to rule on that?

      In specific, if they believe the rule whereby testimony can be submitted without the underlying supporting evidence is unfair, could they use this case to make that change?

      It would seem a bad idea to me. The rule exists so that the petitioners can submit testimony and evidence that may not be fully supported by documentary evidence. Take, for example, the case of Michelle Cedillo. Her team submitted lab results from the O’Leary lab. There was nothing to substantiate that those results were of high quality. Her team did not obtain and submit the background data to support those lab results. Those results should be allowed in and considered–as they were.

      Changing the rules of evidence in the vaccine court would seriously harm future petitioners.

  24. Brian Deer June 16, 2010 at 19:24 #

    Sullivan,

    I think you spotted the weakness in the DHHS presentation: Ms R forgot to point out just what it was the petitioners had put forward as their evidence from O’Leary.

    In short, a note, which I don’t have in front of me right now, which was pretty much written on the back of a Subway menu stating: “Michelle Cedillo had vaccine strain measles virus in her. Definitely. Signed, Fat Irish Professor”.

    My feeling is that the appeal judges were just rooting around for something to sound indignant over. There’s no way that a report has to be supported by all the data, or all the scientific papers would fall away as well. The volume of data would become overwhelming.

    In any case, as I heard it, the petitioners submitted that there was no prejudice by Hastings. I’d say that ends it for them, being a submission and all.

    PS, I too was in court when the videos were played. Michelle’s mother, Theresa Cedillo, was there, laughing and snorting through the hearing, arms spread along the back of her seat like she owned the courtroom. She was having a great old time, I can tell you.

    And, of course, there was not a word of comeback over the videos. Hell, Michelle was autistic before her vaccination. So what? MMR did this to her. Definitely. Signed…

  25. Broken Link June 16, 2010 at 20:34 #

    Mr. Deer,

    Theresa Cedillo still seems to believe that Michelle was not autistic prior to the MMR vaccine, as she explains in this post to EoH:

    http://groups.yahoo.com/group/EOHarm/message/97839

    Personally, I think that the Cedillo case is the one chosen for exhaustive appeals because the petitioner’s lawyers believe that she is the case most likely to elicit sympathy.

    • Sullivan June 16, 2010 at 21:39 #

      Broken Link,

      I would tend to disagree. I think that the fact that the Cedillo family had the lab results pointing to persistent measles infection (flawed they may be) was likely the key. This was *the* main case to prove general causation and that piece of data was key to their hypothesis.

      Part of the reason why they are fighting so hard, in my opinion, is that the O’Leary laboratory results have very little chance of being admissible in civil court. The only way they can get those data in would be to unseal the records. I tend to believe that would not help their argument. Without the evidence of persistent measles infection, the MMR theory is very difficult to prove.

  26. Anne June 17, 2010 at 01:47 #

    “In specific, if they believe the rule whereby testimony can be submitted without the underlying supporting evidence is unfair, could they use this case to make that change?”

    This case doesn’t involve any rule specifically prohibiting or allowing the submission of testimony without the underlying supporting evidence. At the oral argument, the appellate judges were asking about two things – (1) the exclusion of evidence as a discovery sanction, and (2) whether the admission of the evidence violated the rule requiring “fundamental fairness” in the taking of evidence.

    I’ve listened more carefully to the oral argument, and I see that I was wrong when I said the appellate judge was referring to the Federal Rules of Evidence. He was referring to discovery rules – Rule 26 and Rule 37 of the Rules of the US Court of Federal Claims, which are identical to Rules 26 and 37 of the Federal Rules of Civil Procedure.

    Rule 26 requires that a party make certain disclosures. Those disclosures include the identity of expert witnesses, along with the expert’s written report containing “(i) a complete statement of all opinions the witness will express and the basis and reasons for them; (ii) the data or other information considered by the witness in forming them; … .”

    If a party fails to make this disclosure, then under Rule 37, the adverse party can move the court for an order compelling the disclosure, and if the court’s order isn’t followed, the court can impose sanctions, including a sanction “prohibiting the disobedient party from supporting or opposing designated claims or defenses, or from introducing designated matters in evidence.” Thus, if a party who identifies an expert witness fails to disclose the data or other information that the witness relied on to form his opinion, and a motion to compel such disclosure is made and granted, and then the party disobeys the order compelling disclosure … then the court could order that the expert testimony not be introduced at trial.

    In Vaccine Act cases, however, the discovery rules don’t apply unless a party moves to have them apply and the motion is granted. Rule 7 of the Vaccine Rules of the US Court of Federal Claims provides that there is no right to discovery in vaccine cases, but that “informal and
    cooperative exchange of information is the ordinary and preferred practice.” However, if a party believes that this informal discovery is insufficient, “the party may move the special master,
    either orally during a status conference or by filing a motion, to employ any of the discovery procedures set forth in RCFC 26–37.”

    This is what the appeals judge was asking Ms. Chin-Kaplan about – why the Cedillos didn’t make a motion under Vaccine Rule 7 to use the discovery rules to obtain the underlying data and information for the Bustin opinion. There was a procedure available by which they could have tried to force HHS to disclose this information and, if HHS was ordered to do so and disobeyed the order, then the Cedillos could have sought an evidentiary sanction for it prohibiting HHS from introducing the Bustin report and testimony. The Cedillos’ attorneys didn’t do any of these things.

    Separate from discovery issue, though, is the issue of fairness in the taking of evidence. Vaccine Rule 8 provides that “In receiving evidence, the special master will not be bound by common law or statutory rules of evidence but must consider all relevant and reliable evidence governed by principles of fundamental fairness to both parties.” The argument in both Cedillo and Hazlehurst was that it violated principles of fundamental fairness to admit Bustin’s reports and testimony when the underlying data was not available.

    The issue of fairness has to depend on the circumstances. In this case, where the underlying data was under seal and not under the control of HHS, and where the petitioners were given more than a year within which to obtain evidence to counter Bustin, the special master made the call that it was fair to admit the evidence. The appellate court in Hazlehurst found that it was fair to admit the evidence under the circumstances, and in fact, fairness dictated that the evidence be admitted because of the petitioners’ use of Unigenetics data:

    “The special master’s decision to admit and consider Dr. Bustin’s testimony and reports was in full accord with the principle of fundamental fairness. Although not obligated to do so, the petitioners chose to introduce the Unigenetics data and thus placed its validity squarely in issue. Fairness dictated that the government be given an opportunity to refute that critical evidence …. .”

    I don’t think the Cedillo case holds out the prospect that the appellate court will change any rules. It’s simply applying existing rules to this set of facts. The case actually doesn’t raise any important legal issues in my opinion.

    TMI, I know.

    • Sullivan June 17, 2010 at 02:25 #

      Anne,

      thanks for that.

      I have three long winded posts on the appeal. I am not going to claim your comment is TMI.

      Interesting that “fairness” is exactly what allows the Bustin testimony considering that the lawyers for the Cedillos are arguing the opposite.

      Again I am bothered that the one-sided story given out on AoA and other places is worse than nothing. It doesn’t help anyone to be given partial and misleading information. Dan Olmsted is not doing his former profession (journalism) proud.

  27. Dawn June 17, 2010 at 13:16 #

    Just went to the link on Yahoo that Broken Link attached. Interesting, the way Ms. Cedillo presents her side. But one thing that struck me with her story…if she was video taping the baby, wouldn’t her voice be heard calling to the baby to get the baby’s attention? Either she wasn’t calling to the baby at the points the doctors were referring to, or the video had no sound, which seems weird to me.

    Her other point, about the baby not smiling, and she gave pictures of Michelle “smiling… at 1 month old”… she obviously doesn’t know about normal child development. There is no way that Michelle was intentionally smiling at her father and grandmother at 1 month of age. I am sure that Fombonne and Wiznitzer were referring to SOCIAL smiling, which does not occur until 3-4 months in most babies and which appears to have been delayed in Michelle to 5-6 months. Social smiling is different visually to an observer than the early, relaxation smiles of a very young infant (compare the relaxed “smile” of someone sleeping to the same person awake and smiling at someone they love).

    While I feel for them, caring for Michelle can’t be easy, their refusal to understand the truth is frustrating to read.

  28. Brian Deer June 17, 2010 at 14:16 #

    Sadly, the family did this huge song and dance about Michelle and Sesame Street, then fought the government in an effort to stop the videos being shown in court, lost, and then produced no rebuttal after we all sat there and watched this poor little girl fixated on Sesame Street and taking not a blind bit of notice of her carers. With the date stamps on the frame showing it to have been before her MMR.

  29. Broken Link June 17, 2010 at 20:38 #

    The other interesting thing is that Theresa Cedillo seems to believe that the videotape evidence was the part of the proceeding that was most wrong or unfair. But, the videotapes and the conclusions of Fombonne were never brought up in the appeals.

    So, either her lawyers are not explaining things very well to her, or she just prefers to cling to her belief that Michelle was SO not autistic before the MMR.

  30. TLPG June 17, 2010 at 23:59 #

    She also hasn’t been held to a count for not taking Michelle to hospital when her body temp shot up to 104F at the time that it did. I doubt you could count on the fingers of both hands the number of things Theresa done wrong here and she’s too proud to admit it. A rather common practice amongst parents who refuse to accept that vaccines have nothing to do with their child’s Autism.

    Michelle’s social smiling was delayed? That’s pretty strong evidence to Autistic Spectrum in my non-professional but educated opinion.

  31. David N. Brown June 18, 2010 at 05:35 #

    “It doesn’t help anyone to be given partial and misleading information. ”
    I expect AoA is used to being able to censor anything that goes against what the story they want to tell. But that won’t work here. If they report on the court case in such a way as to raise expectations of success, there’s no way to conceal or distract from a defeat. The only thing they can do is spin it as more machinations of a “conspiracy”. I believe the ultimate effect will be to drive their readers in one of two directions: to become disillusioned with and stop listening to AoA, or to become more paranoid and closed off for the wider world. The only way this can end is with the extinction of Age of Autism as an influential voice in the autism or any other community- altogether to be desired!

    • Sullivan June 18, 2010 at 17:13 #

      David N. Brown,

      AoA is not truly influential beyond their readership. They are voicing their opinions. But, in the end, what have they accomplished really? The only accomplishment I can point to was possibly contributing to the removal of Story Landis from the IACC. They misquoted her to put her in an even worse light–and no one in their readership even noticed. They have failed to get the “Autism Advisory Board” into existence and they have failed to increase representation on the IACC. They have misled their readership about the shift in causation research, failing to note the increased funding for environmental and gene-environment projects. They have alienated many in the autism communities, the research community and the disability communities. Heck, they couldn’t even help Mr. Wakefield keep his job at the clinic he founded.

      A friend of mine puts it like this: “They are their own worst enemies”.

      They will always be there. They will always be strident. But, “influential”?

  32. bensmyson June 18, 2010 at 13:43 #

    David- “The only way this can end is with the extinction of Age of Autism as an influential voice in the autism or any other community- altogether to be desired!”

    Exactly how to you propose doing that? And once you’ve accomplished that who becomes your next target?

    What’s wrong with giving someone their day in court or speaking their mind? Im pretty sure come July 4th we will be celebrating the right to do those very things.

  33. David N. Brown June 18, 2010 at 20:10 #

    bensmyson,
    Age of Autism has proven many times over that they have no respect for any speech but their own, and none whatsoever for facts. But, I am not discussing any outside action. Even if they are not obliterated when a victim of their libels finally sues them,their policies are such that they will predictably have fewer and fewer readers, and even less influence.

    Sullivan,
    I expect that Olmsted et al will continue to promote an “anti-vax” message by any means available. But I believe the survival of AoA is open to considerable doubt. It also bears keeping in mind that they ARE part of several broader communities: biomed, anti-vax, alt health, etc. It is my strong impression (based particularly on “hits” for AoA posts on other sites) that they are losing circulation and influence even in those circles.

  34. bensmyson June 18, 2010 at 22:03 #

    David – Ive found AoA to be informative and it touches a good number of people, lifting spirits and dishing out a handful of hope to those of us who seek answers but of course Im just another one of those koolaide drinkers and we are all alike right? But Im sure you feel the same way about Glenn Beck or whoever’s show. That’s the way life is, its what makes it exciting to have someone to argue with.

    And this claim of liable, dont know how many people have had success with that in the blogosphere. And then there is the matter of proving harm and damages. Particularly since there is no way of proving who is saying what about whom.

  35. David N. Andrews M. Ed., C. P. S. E. June 19, 2010 at 22:55 #

    As Sullivan has mentioned elsewhere on this blog:

    bensmyson has posted to AoA that his goal in commenting on forums such as this is as a troll. Keep that in mind.”

  36. bensmyson June 20, 2010 at 00:30 #

    David – please post the link, Sullivan knows better, I doubt he said that. Thanks.

    • Sullivan June 21, 2010 at 02:39 #

      bensmyson,

      it isn’t an exact quote of what you wrote, but it is what you said.

      You were banned from this blog for abusive posting. You comment on AoA only confirmed it.

      “In my sense of adventure I will tickle these people from time to time. I have to admit Im impressed with their ability to piece together threads that as a group they spin into a quilt that they all crawl underneath, sort of like bedbugs, irritating little creatures with dungeon and dragons or Star Trek style monikers. “

      I have no problem with people who disagree with me. I don’t see the value in abusive posters whose goal is to “tickle” people for their own “sense of adventure”.

  37. David N. Brown June 21, 2010 at 08:13 #

    “but of course Im just another one of those koolaide drinkers and we are all alike right? ”
    Entirely insulting. I would not even treat fictional villains as interchangable.

    “And this claim of liable, dont know how many people have had success with that in the blogosphere. And then there is the matter of proving harm and damages.”
    AoA is CERTAINLY guilty of libel. This is especially true in light of their systematic censorship of critical comments, which if allowed to appear in a timely way might satisfy as a “correction” for legal purposes. The only possible explanation for their continued existence is that they generally libel people and organizations too powerful to be seriously threatened by anything they have to say.

  38. bensmyson June 21, 2010 at 11:06 #

    Sullivan I believe “tickle” may be a southern term, as in, “I know it tickles him to watch his boy dance in the rain.” “tickled her funny bone” “that boy tickles me with his silly hat that he wears”

    In my sense of adventure (exploring outside my familiar realm) I make those regulars at left brain/ right brain laugh (at my opinions)

    I am no troll.

    I am curious why so many of you save posts. This isnt the first time one of you have pulled things out of your neather regions and called me on an old quote. Makes me think this site is more about poking AoA than chatting about autism.

    • Sullivan June 22, 2010 at 01:18 #

      For what it is worth–I held back bensmyson’s latest post thinking it was time he again joined the small band of people who have lost their right to post here.

      But, his explanation is, in my opinion, worth reading. I leave it to you to decide if it is at all convincing. I have my own opinion, which I am sure most of you can guess.

  39. TLPG June 21, 2010 at 12:40 #

    Bensmyson, calling AoA “informative”, “lifting spirits” and “dishing out a handful of hope” is like calling the National Enquirer a reputable publication that is above reproach. Yeah right! AoA is nothing more than what the NE is – a filthy lying dirtsheet with no basis in information or hope, except the false hope that a cure is coming. It’s not.

    And what you admitted to doing here (as Sullivan so effectively exposed) is the perfect definition of a troll.

    Would someone let me know if the decision is handed down in the next month? I don’t know how long it took for the Hazelhurst decision to be made.

  40. Sullivan June 21, 2010 at 16:48 #

    TLPG,

    I read somewhere that the judges have 60 days to decide the appeal. When I hear about it I will blog it.

  41. David N. Brown June 22, 2010 at 05:54 #

    Something I seriously believe: AoA’s “vaccine concerns” are equivalent to the fear of Balkan peasants that their dead were coming back as “kudlaks” to harm the living. In both cases, the one thing of which there is compelling evidence is a psychological or spiritual force of oppression. The difference is that the peasants were reasonably aware that they were, on some level, dealing with the non-physical.

    In my judgment, AoA is a toxic influence. Based on my experiences, I would say that even engaging them for purposes of “debate” is potentially unbalancing.

  42. Theresa Cedillo April 23, 2011 at 04:01 #

    For Dawn – although this response is very late after the Jne 2010 posting of your comment. I have dated photographs of Michelle smiling at her father and grandmother. Her age in those photos is one month old. The USCFC would not allow this evidence into the record.

  43. Chris April 23, 2011 at 08:09 #

    And video evidence was allowed. Okay. R..I..G..H..T

  44. Dawn April 23, 2011 at 11:32 #

    Not to continue a necromancing thread but…Ms Cedillo. I did not deny that Michelle might have been smiling at that age. What I said was that SOCIAL SMILING (which is a totally different entity and requires facial memory that babies do not have at one month) was not found at the age it would normally appear.

Trackbacks/Pingbacks

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