Audio of the Cedillo appeal part 2

16 Jun

We’ve recently discussed the first part of the audio from the Cedillo appeal (the part where Miss Cedillo’s attorney was speaking) in Audio of the Cedillo appeal part 1. Here I share notes on the second half of the audio: where the government’s attorney is speaking.

I should have done this before, but a little nomenclature:
The U.S. Government is represented by the Secretary of Health and Human Services. She doesn’t actually take part, but is represented by attorneys from the Department of Justice (DoJ). The government is referred to as the “Respondent” in these proceedings.

The Cedillo family is represented by their attorney, Ms. Chin-Caplan. Michelle Cedillo is the “petitioner”. Her case is one of the “test cases” heard in the portion of the hearings to determine if MMR causes autism. Her case served two purposes. First, to argue that in her specific situation vaccines resulted in some or all of her conditions. This is referred to as “specific causation”. Second, her case presented evidence on the general question of whether the MMR (alone or with Thimerosal) could cause autism. This is referred to as “general causation”.

Ms. Chin-Caplan is working as both the attorney for Ms. Cedillo and as a member of the “Petitioner’s Steering Committee” or PSC, which is the association of attorneys working with the 5,000 plus families who filed petitions claiming autism as a vaccine injury. Those 5000 plus cases are grouped in the Omnibus Autism Proceeding, or for short: OAP, or “Omnibus”.

Again, my observations are added in italics.

The DoJ attorney didn’t even finish her introduction before one of the judges jumped in to ask about the fact that in a regular civil court, the underlying documents would have to be produced or Prof. Bustin’s testimony would be excluded. The fact remains that in the vaccine court, that rule (rule 26) does not apply. As noted in the first half of the audio, the PSC attorneys could have asked for those rules to apply but they did not do so.

The judge goes on to say that it was the government’s responsibility under the federal rules to obtain the documents to support the testimony.

I will add here that I am somewhat unclear if these are the Federal rules for the vaccine court, or the Federal rules (e.g. Rule 26) for the civil court. It sounds to me like they are the rules for the civil court.

The DoJ attorney noted that they tried to get everything from the UK litigation. All the expert reports and information. However, the solicitors they were working with in the UK suggested that their petition was too broad and would be denied. So, on advice of those solicitors, the DoJ narrowed the request down to only the three expert reports.

It sounds to me as though the DoJ attorneys were possibly unaware that the evidence–in this case the actual lab notebooks from the Unigenetics laboratory–were not going to be produced in full with the expert report. Even if so, I don’t see this really as an excuse.

However, some of the pages which Prof. Bustin used in his testimony were reproduced. These include pages that showed that Unigenetics made corrections after the dates on the notebooks.

Another observation: the laboratory notebooks are not all of the information from which Stephen Bustin made his report and it is not all the information which he used to form his testimony in the Cedillo case. Not all of his testimony would be excluded without the full laboratory books, in my opinion. Prof. Bustin spent considerable time investigating Unigenetics

The DoJ attorney noted that they went to the UK to obtain the information only after they learned that the Unigenetics laboratory results constituted a key part of the petitioner’s case–four months before the case was heard. They had to “hussle” to get the information unsealed. The judge asked if the DoJ had a responsibility to inform the petitioners of their intent to obtain this information. The DoJ stated that she did not believe that was the case.

The full witness list for the government was not finalized and made public until shortly before the proceeding. One list of potential witnesses was made available to the petitioners in March 2007–four months before the hearing–but that list is not public. The final list for both sides was made public on June 12, 2007. To me, this may indicate that the DoJ attorneys were *not* required to give more lead time on their witnesses or strategy.

The petitioner’s attorneys were given a year after the hearing to request the lab notebooks from the UK. DoJ attorneys offered to join in the request and the Special Masters wrote a letter of support for the request. The petitioners never filed an application in an attempt to obtain the documentation.

The DoJ attorney stressed again that the Special Master stated that he didn’t need the testimony from Prof. Bustin or some of the other information to make his decision.

I keep thinking that in many ways the Special Master should have been present in this appeal. Both Ms. Chin-Caplan and the DoJ attorney spent a considerable amount of time discussing what the Special Master thought and did. I realize that is not how appeals work, but as the appeals judges keep saying, this is not supposed to be an adversarial procedure. The goal is to bring in all the information and weigh it

One of the judges made a short speech about how scientific opinion progresses and that new data, new techniques could emerge which might support the petitioners. The DoJ attorney noted that the Courts can not wait indefinitely for the science. The petitioners deserve to have cases settled.

First, this is precisely why the evidence standards in the vaccine court are low. The idea is to give the petitioners the chance to win cases before the evidence is in. This is what happened in the DTP cases in the early phases of the vaccine court. Many cases were decided–for the petitioners, mind you–which later evidence showed were not supported. Second, this is not the purview of the appellate court. They shouldn’t be deciding on the merits of the evidence but on procedural questions. Third, as time progresses, the MMR causation theory has only become more implausible. The Hornig study, for example, came out after the Cedillo trial and was a clear rebuke of the early papers by Wakefield’s team

At one point, the DoJ attorney suggested that the underlying data would have buttressed Prof. Bustin’s testimony and she wishes she did have it. One judge, quite rightly in my opinion, corrected her with “how do we know that?” The Judge asserts that Prof. Bustin relied upon the documents to determine that Unigenetics was “a bad laboratory”

I would disagree at this point. The lab notebooks were *part* of the data Prof. Bustin used to form his opinion. But, they were not *all*

Ms. Chin-Caplan claims that she would have joined the DoJ in their attempt to obtain the documents had she known they were attempting that. One judge pointed out that she was given a year after the hearing to obtain the documents and failed to even make the attempt.

I don’t see how Ms. Chin-Caplan aiding the DoJ in their attempt would have changed what she is claiming it would have changed. She demonstrated that she was unable to obtain the documents on her own, so her expertise would not have been helpful. What this would have done is signaled to her 4 months in advance that the DoJ planned to challenge the quality of the Unigenetics laboratory. Frankly, that should have come as no surprise. There was much criticism of the Unigentics laboratory and the resutls in the public arena. The petitioners were aware of the UK litigation as they had also attempted to get data from that proceeding–and some of the petitioner’s experts had worked on the UK litigation.

Ms. Chin-Caplan argues that the one year she was given to obtain the documents was not enough because it was “an impossible task”. One of the judges points out that she has no way of knowing it was impossible since she didn’t try.

Ms Chin-Caplan stated that she didn’t want to waste the taxpayer’s money on an attempt to get the documentation since she wasn’t sure it could be obtained. She argues that it would be difficult because it involved possibly two foreign jurisdictions.

This is a very weak argument. First, the question of whether she was sure or not really doesn’t apply. The only thing that would apply is if she was sure are request would be denied. Second, the idea that she was saving the taxpayer’s money doesn’t really work. The costs of the appeals far outweigh the savings involved. Third, the DoJ had already shown that it could obtain documents from the UK litigation in a matter of four months. The DoJ offered to assist the petitioners, but they apparently did not avail themselves of that opportunity.

Another observation: the petitioners relied upon the Unigenetics laboratory. This is a laboratory which refused to be allow standard inspections to be come an accredited laboratory. It strikes this observer that it was the responsibility of the petitioners to obtain the laboratory notebooks. Without them, the DoJ was unable to effectively cross examine their witness who was claiming that Unigenetics was a good laboratory. That expert, Dr. Kennedy, took part in the UK Litigation, so he too was relying at least in part on data which was not entered into evidence.

The Judge asked Ms. Chin-Caplan if she could have made her case if Dr. Bustin’s testimony were excluded. Ms. Chin-Caplan claimed that she could

this is counter to what the special master who heard the case and wrote the decision *clearly* wrote in that decision

I think it is safe to say that *neither* the DoJ *nor* the petitioner’s attorney came away without some very tough scrutiny by the judges.

More on this appeal can be found in a piece on the VaccinesWork blog, Appeals Won’t Succeed – Olmsted Isn’t Honest

Even though I give away the ending of his excellent post, I quote it here:

The Court of Appeal panel in Hazlehurst faced roughly the same arguments as the Cedillo panel. The Court of Appeal reviews the trial court decision ‘de novo’, or brand new. If they don’t like the trial court decision, they replace it with theirs. However, the appeals court and the trial court can’t merely replace their judgment for the Special Master. All quotes below are from the Court of Appeals decision in Hazlehurst.

By statute, the Court of Federal Claims may set aside the special master’s decision “only if the special master’s fact findings are arbitrary and capricious, its legal conclusions are not in accordance with law, or its discretionary rulings are an abuse of discretion.”

Appeals courts are very limited in what they can do when they disagree with the facts decided by a trial court (in a criminal matter) or the medical facts (before the Special Master). But normally the Court of Appeal can substitute its views on admissible evidence for that of the trial court (criminal court) or the Special Masters. That isn’t the case here, because following the statute that governs the Vaccine Court, Rule 8 states:

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.” Vaccine R. 8(b)(1) (2009).

Even if the Court of Appeals thinks that the Special Master was wrong when letting in Dr. Bustin’s testimony after giving the plaintiffs a year to apply to the British for access to the reports, that isn’t enough for them to substitute their opinion for that of the Special Master.
So there is near zero chance that the appeal would succeed. Dan Olmsted should have said so and explained why.

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