A busy week in vaccine-injury news: the Cedillo appeal

4 Sep

The past week has had three somewhat major news events in the world of vaccine injury: the denial of the Cedillo appeal, the award of damages in the UK for an MMR case and the damages award in the Hannah Poling case. I thought I would write about them all, but the Cedillo appeal part is already long so I will leave the other subjects for another time.

The Cedillo Appeal

Kev blogged the denial as Cedillo appeal denied. I had blogged the hearing in June as Another appeal heard in the Autism Omnibus, then blogged the actual audio from the hearing as Audio of the Cedillo appeal part 1 and Audio of the Cedillo appeal part 2.

The arugument used in the Omnibus Autism Proceeding for MMR causing autism is basically the model that grew out of the work of Andrew Wakefield: that measles virus (MV) from vaccines persisted in the body, particularly in the digestive tract. Wakefield’s theory involved the MV infection causing intestinal permeability which allowed substances to “leak” out into the system (the “leaky gut” hypothesis). The Cedllio’s attorneys argued that the measles virus itself traveled to the brain, causing inflammation and autism.

This is not the first appeal for the Cedillo family, or for the test cases in the Omnibus. It is likely the last, however. The next step would be the U.S. Supreme Court. The Supreme Court would be unlikely to hear an appeal. The Supreme Court does not hear all the cases submitted, instead choosing to hear mostly cases which clarify points of law. The Cedillo appeal so far has not been about the laws for the most part but about the procedure of the case. One exception is the question of whether the correct standard was applied to reviewing the admissibility of the evidence. The Court used the Daubert standard, which the Cedillo’s attorneys argued was incorrect. This is not the first time the Court used Daubert, and it is not the first time the appeals court upheld it.

The other arguments made include whether the testimony and reports of Dr. Stephen Bustin should have been allowed. Dr. Bustin’s reports were obtained very shortly before the hearing and were based on closed documents from a U.K. proceeding on MMR and autism. The Cedillo’s attorneys argued that they were unable to prepare a counter argument to Dr. Bustin on short notice and that since they did not have access to the underlying data and documents. In a civil court, these arguments would have carried much weight. However, in the vaccine court, much flexibility is allowed. In this case, the Special Master allowed the evidence to be heard, and gave the Cedillo’s attorneys over a year to obtain the background data from the UK and mount a counter argument.

The Cedillo’s attorneys did not attempt to obtain the background data for the Bustin testimony in year that followed the hearing. Yes, it isn’t that they were unsuccessful, they didn’t try to obtain it. They stated that their consultants in the UK advised them that it was unlikely that they would be able to obtain the documents without the permission of the experts. However, Dr. Bustin gave his permission.

From the appeals court decision:

Petitioners considered making such a re-quest from the UK court, but never did so. They contend that British counsel informed them that it was unlikely that the UK court would permit disclosure of the expert reports without the consent of the experts, which peti-tioners stated that they could not obtain. But Dr. Bustin did consent to the release of his reports. Once his consent for the release of his reports had been obtained by the government, there is no reason why the data underlying his reports could not also have been requested

Dr. Bustin’s testimony focused on a critical part of the argument used to claim that MMR causes autism: the claimed presence of measles virus in the bodies of autistics like Miss Cedillo. Dr. Bustin is arguably the worlds top expert on PCR, the method used by the Unigenetics Laboratory to test tissue samples for measles virus. Dr. Bustin discussed at length multiple reasons why the Unigenetics Laboratory results were not reliable.

A few points to be made here.

(1) The Cedillo’s attorneys presented an expert (Dr. Kennedy) to claim that the Unigenetics laboratory was reliable. Dr. Kennedy also had worked on the UK litigation and Dr. Kennedy’s underlying data were also under seal in that litigation. In other words, the Cedillo’s attorney’s were asking that the Special Master apply one standard to the government’s witness (rejecting his report without the underlying data) while applying the exact opposite standard to their own witness (Dr. Kennedy, who also didn’t have the underlying data).

(2) Michelle Cedillo was one of three “test cases” used to test the question of “general causation”. The other two children used as test cases did not have evidence of persistent measles virus in their bodies.

There is only one paper with reliable data showing the presence of measles virus in the tissues of an autistic child. This paper came out after the Cedillo hearing. The paper: Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. In that study they found measles virus in one autistic child, and in one non-autistic “control”. The Cedillo’s attorney’s argued that this was “significant new evidence” that showed the reliability of the Unigenetics laboratory.

I found it very odd that a paper titled “Lack of association between Mealses Virus Vaccine and Autism with Enteropathy” would be used as evidence for an association between measles virus vaccine and autism. But the argument is that this paper validates the Unigenetics laboratory as being able to produce reliable results. The argument is not valid, and the court did not agree with it. The work done by Unigenetics on Miss Cedillo was performed in 2002. The research on the paper was performed much later, after significant criticism was already levied against Unigenetics. Quite simply put, it is possible that Unigenetics “cleaned up its act” by the time of the recent paper.

(3) It was noted that the arguments about Dr. Bustin’s testimony were essentially moot, as the Special Master would have come to the same decision without his testimony.

(4) It was also noted that the appeals court had already decided on Dr. Bustin’s testimony in an appeal mounted by the attorneys for the Hazelhurst family (another of the Omnibus test cases).

The Cedillo’s attorneys further argued that it was unfair that evidence was brought in from the other “test case” hearings (Hazelhurst and Snyder). The appeals ruling noted that the Cedillo hearing was not a stand-alone proceeding. As a test case in an Omnibus Proceeding, evidence from all the test cases would be used to answer the question of general causation. I was surprised at the time of the appeal that the Cedillo’s attorneys were arguing that they were not actively monitoring the other test case hearings. What, in the end, is the point of an Omnibus Proceeding or a “petitioners steering committee” of the petitioners are not acting in some way as a group?

The Cedillo’s attorneys argued that the Special Master did not give enough weight to Miss Cedillo’s doctor, Dr. Krigsman, who stated that her condition was caused by MMR. The fact is that the Special Master rejected Dr. Krigsman’s argument with good cause:

He [the special master] also concluded that Dr. Krigsman’s opinion should be rejected because 1) he relied on the discredited Unigenetics testing in forming his opinion, 2) he misunderstood Michelle’s medical history and his testimony was inconsistent with her medical records, and 3) his conclusion that Michelle suffered from chronic gastrointestinal inflammation was substantially out-weighed by Michelle’s medical records and the testimony of the government’s experts.

The Cedillo’s attorneys argued that sufficient weight was not given to Miss Cedillo’s other physicians whom, they assert, associated her condition with the MMR vaccine:

Petitioners cited nine notations in Michelle’s records from eight individuals, including four physicians who treated Michelle and four non-physicians who exam-ined Michelle, in which the treating physicians mentioned her vaccinations, as support for the proposition that these individuals concluded that her autism was caused by her MMR vaccine.

The appeals court disagreed:

The Special Master did not err in failing to afford sig-nificant weight to the opinions of Michelle’s treating physicians. As the Special Master observed in his deci-sion, in seven of the nine notations, the physician was simply indicating an awareness of a temporal, not causal, relationship between the fever Michelle experienced after her MMR vaccine and the emergence of her autistic symptoms sometime thereafter. Initial Decision, slip op. at 100. In one of the other notations, the physician sim-ply noted that an exemption for Michelle from vaccination requirements could be arranged. In the other notation, the physician speculated that Michelle’s fevers might have caused her neurological abnormalities. However, he expressly stated that it would be “difficult to say” whether this was “a post-immunization phenomenon, or a separate occurrence.” Id. at 100. Thus, “none of the treating physicians concluded that the MMR vaccine caused Michelle’s autism.” Final Decision, 89 Fed. Cl. at 176. The Special Master

In the end, the appeals court decision takes on the arguments by the Cedillo’s attorneys point by point and refutes them. The closest the Cedillo’s attorneys got to making a point stick was in the case of Dr. Bustin’s testimony, which the appeals court stated:

We agree with petitioners that the government’s fail-ure to produce or even to request the documentation underlying Dr. Bustin’s reports is troubling, but we think that in the circumstances of this case, that failure does not justify reversal.

The fact of the matter is, the petitioners in general, and the Cedillo’s in specific, did not have a good case for MMR causing autism. The mechanism they proposed was not sound, the data they had was poor and incomplete and the experts speaking for the government were excellent and refuted the petitioner’s arguments. The Omnibus cases were, as the Special Masters noted, not close.

4 Responses to “A busy week in vaccine-injury news: the Cedillo appeal”

  1. Science Mom September 4, 2010 at 03:44 #

    I found it very odd that a paper titled “Lack of association between Mealses Virus Vaccine and Autism with Enteropathy” would be used as evidence for an association between measles virus vaccine and autism. But the argument is that this paper validates the Unigenetics laboratory as being able to produce reliable results. The argument is not valid, and the court did not agree with it.

    I, too cannot fathom the mental gymnastics that it takes to make this rationalisation. Furthermore, Unigenetics Ltd was a for-profit, private lab in Coombe Women’s Hospital, Dublin. The Hornig et al. study took place at O’Leary’s academic laboratory Trinity College Dublin. As far as I know, Unigenetics was out of business by the time that the Hornig et al. study even took place.

  2. Sullivan September 5, 2010 at 03:05 #

    Science Mom,

    the Hornig paper represented Dr. O’Leary’s lab as the same one that tested Wakefield’s samples–

    “Ileal and cecal tissues from 25 children with autism and GI disturbances and 13 children with GI disturbances alone (controls) were evaluated by real-time reverse transcription (RT)-PCR for presence of MV RNA in three laboratories blinded to diagnosis, including one wherein the original findings suggesting a link between MV and ASD were reported.”

    There was a conference call with reporters before the Hornig paper was published. David Kirby pushed the idea that this paper exhonerated the O’Leary lab in that call (about minute 47)

    He comes back at minute 55. Same question, same answer.

    As an aside–Kirby tends to lecture in his questions. For example, he misinterprets “regression” as “regression into autism”.

    I believe the response in both cases was Ian Lipkin, but he suggested there could be problems with sample contamination before they got to Dr. O’Leary’s laboratory. I think Dr. Lipkin was being generous.

    Let’s consider the timeline–

    O’Leary tests Wakefield’s samples

    Bustin looks into O’Leary’s lab and points out all the flaws which make the results unreliable.

    O’Leary works with the Hornig/Lipkin team on a followup study

    Let’s do an analogy.

    Let’s say I failed freshman chemistry.

    That summer, an extremely well respected chemistry professor looks over my notes, tests and homework and points out how my study methods were faulty.

    I take freshman chemistry again and I get an A.

    Does the A mean that the Fail I got was wrong? No. It just says I had the capability to do well and I failed to fulfill the promise.

    The fact that O’Leary’s lab performed well for the Hornig test doesn’t say that his original work wasn’t fatally flawed.

    All this begs the question: did Michelle Cedillo’s attorney’s attempt to get Dr. O’Leary to present evidence or an expert report?

  3. Science Mom September 5, 2010 at 15:54 #

    the Hornig paper represented Dr. O’Leary’s lab as the same one that tested Wakefield’s samples—

    I missed that statement, but strange given that his affiliation on that publication is Trinity College Dublin and has a different physical location than Coombe.

    In any event, your analogy is spot on and it defies logic to make the rationalisation they are with the measles results.


  1. Tweets that mention Autism Blog - A busy week in vaccine-injury news: the Cedillo appeal « Left Brain/Right Brain -- Topsy.com - September 4, 2010

    […] This post was mentioned on Twitter by Kev, Brandon Blietz. Brandon Blietz said: http://bit.ly/15gSni Autism Blog – A busy week in vaccine-injury news: the Cedillo …: The arugument used in the … http://bit.ly/dnYSHf […]

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