US MMR Litigation – The Truth – And Was Dr Stephen Bustin A Reliable Witness?

….. this is the story of the illegal behaviour of the US Department of Justice in the Michelle Cedillo case.  And how the English and US Federal Courts acted to torpedo one severely injured little girl’s claim for much needed financial compensation – and with it over 5000 other US childrens’ cases.

Who & Why

This is about how the might of the US Government and others was brought to bear to  do all they could to destroy this brave child’s chance of recompense for severe injuries caused by vaccines. And Michelle’s crime? She is living evidence supporting what has been called the “discredited”  Wakefield hypothesis.

If her case was allowed to succeed it would have been the first demonstration that Wakefield was onto something and that children could suffer severe chronic ill-health as a result of an ever increasing childhood vaccination schedule.

Michelle has a substantial inflammation level (“SIL”) and medical evidence showed high levels of measles virus in her body.  So if the Wakefield hypothesis was to be discredited, it was crucial to destroy this little girl’s case by whatever means were available. Michelle had expert opinions supported by scientific literature.  The US Government and its 17 experts provided no evidence of an alternate cause of Michelle’s injuries.

Her appeal to the US Federal Court of Appeals was heard on 10th June 2010 and judgement of the US Appeal Court is pending.

Her case was turned into a test case for thousands of American children who have autism, inflammatory bowel disease and other medical problems caused by vaccines.

The following account is researched from US court documents filed in the case, English court documents [supposedly “public-domain” but no one is being told about them and what they contain], from published formal journals and other public sources.

What Did Wakefield Say

Dr Andrew Wakefield’s research implicated the MMR vaccine.  The research was of the known medical literature and of  clinical cases of children investigated after injury from receiving the measles mumps and rubella triple vaccine.  They were treated at the internationally renowned Royal Free Hospital, London, England.  Wakefield demonstrated that the MMR vaccination is a biologically plausible risk for inflammatory bowel disease, autism or other immune-mediated diseases.

The Wakefield hypothesis is based on sound known medical science.  Something not easy to “discredit”, [by legitimate means that is].  The known virological and immunological evidence shows that it is both biologically plausible and consistent with temporal trends.   It was and remains legitimate to hypothesize that the combination of three viruses that have been associated both independently and in combination with autism, may represent – through mechanisms that are not yet fully understood – a  compound risk for the disorder.

The hazards of viral infection to genetically susceptible individuals have been long known.  So the risks of giving very young children a vaccine containing three live viruses were predictable. These two World Health Organisation papers published nearly 40 years ago set this out: “Virus-associated immunopathology : animal models and implications for human disease”: 1. Effects of viruses on the immune system, immune-complex diseases, and antibody-mediated immunologic injury Bulletin of The World Health Organisation. 1972; 47(2): 257-264.  2. Cell-mediated immunity, autoimmune diseases, genetics, and implications for clinical research Bulletin of the World Health Organisation. 1972; 47(2): 265-274.

How to Kill Michelle’s Case

If Michelle’s case was to be harmed, it was essential to cast doubt on the evidence of the presence of measles virus in her body.  The evidence was from testing in the Unigenetics Laboratory in Dublin, Ireland by Professor John O’Leary.

The problem for the US Federal Court appears to have been that Michelle presented unrebuttable evidence that the O’Leary lab’s test results were reliable with respect to patients like Michelle with a SIL. A SIL lab result is also referred to as one “with high copy numbers”.

The only dispute about the reliability of the O’Leary lab’s test results was those for minimal inflammation levels (“MILs”) and not for those like Michelle with SIL’s. “MIL” results are ones where inaccuracy is inherent in the process because of the low copy numbers and the iterations involved in achieving them, against inevitable background contamination found in all such labs.

The critical evidence for Michelle included the testimony of Michelle’s experts, the evidence the US Government submitted by Dr. Oldstone, and a dramatic concession by a last minute US Government witness, Dr. Stephen Bustin. At the hearing  Dr. Bustin conceded that  other laboratory results from Dr. Cottor’s lab were consistent with the O’Leary lab’s results for samples with SILs.

The US Federal Court Special Master ignored this evidence at trial.

Then on the initial appeal the appeal judge, Judge Wheeler, appears to have blindly accepted the Special Master’s conclusion, finding “no basis” to disturb the conclusion that SILs are irrelevant. This was error.

DoJ’s Ambush – 2 Days Before Trial – Secretly Obtained Complex Reports

On June 7, 2007, at the last moment, just as young little Michelle Cedillo’s US legal counsel were in the very final stages of the long process of preparing for  the full trial, the US Government requested the US Federal Court’s permission to file Dr.  Stephen Bustin’s reports from the English MMR litigation. This was without prior warning at the last moment in a surprise move.

Although Dr. Bustin’s reports were unrelated to Michelle, they were generally critical of the techniques used by the O’Leary lab.

Just two days after the English Court hearing there was an emergency status conference in the US Federal Court on Friday, June 8, 2007.

This was just three days before Michelle’s full trial. Michelle’s US counsel angrily opposed the introduction of the English MMR litigation reports. First, she argued, the reports addressed the reliability of the O’Leary lab, the single-most critical issue in the case. Next, they were filed without notice on the eve of trial. To permit these reports into evidence at that time, counsel argued, would be grossly unfair to Michelle, as her counsel and experts had no time to review them, let alone prepare for cross-examination of Dr. Bustin. These reports, counsel argued, were obtained only through the vastly superior financial resources, and combined efforts, of the US Government and the manufacturers. Worse, counsel argued, they were “cherrypicked” from scores of expert reports filed in the British litigation. Michelle’s counsel requested a continuance. The US Court refused to continue the hearing, permitted the reports to be filed, allowed Dr. Bustin to testify then relied upon his testimony to dismiss her petition.

Getting Bustin’s Reports

The US Government’s lawyers revealed that these confidential reports were obtained [“unsealed”] only after an extraordinary, expensive, several-month covert effort.

The US Government had secretly applied to the English Court over several months for copies of Bustin’s reports without telling Michelle’s lawyers.  This was a legally “dirty” business and legally and procedurally improper.  The US Government should have disclosed what they were proposing to do from the outset.  But had they done so they would not have been able to launch the surprise attack they did.  This is the US Government and what they did in this case stinks.

This covert action came in for direct criticism from the US Federal Appeals Court during oral arguments in the appeal hearing in the US Court of Federal Appeals: Case No. 2010-5004  Cedillo v HHS 10 June 2010 .

The US Government’s surreptitious effort should have been condemned by the prior US Federal Court hearing Michelle’s case.  Instead they were rewarded with a favourable decision in January 2009.

Ironically, the committee of US lawyers representing the US child claimants [the “Petitioners’ Steering Committee”] in the Omnibus Autism Proceedings had asked US Federal Court Special Master Hastings three years earlier to subpoena Bustin I and II reports from Merck, the American MMR vaccine manufacturer defendant in the English High Court cases.  Special Master Hastings denied the request. Michelle had been given time to find her own British counsel to seek to unseal other documents but had been unsuccessful. This did not cure the prejudice. The playing field was not even.

The US Government had unlimited financial resources and the full assistance of attorneys with the Department of Justice who could counsel them to obtain extra territorial documents, the consent of the vaccine manufacturers, and the ability to hire British attorneys to unseal the Bustin reports.

And there was a snowball’s chance in hell of Michelle’s lawyers getting the documents. In a formally delivered judgement the English Judge  refused the US Government’s request on 6th June 2007. But the US Government got the release of Bustin’s second report [“Bustin II”] at the last minute and persuaded the English Judge to change his decision without an appeal.  This was  only made possible because the UK litigation MMR Defendant drug company Merck and its lawyers bent over backwards to help.  Would they have done that for Michelle’s lawyers had they been making the application instead.  Not a chance.

Just after the English Court had given a reasoned judgement refusing release a Merck English lawyer arrived in the English High Court after a crazy dash through London to provide documents it was claimed facilitated the release by the English Court.  What was odd about this was that there was no  witness or affidavit evidence to confirm the claims made in Court on 6th June 2007 by Merck’s lawyer to get the reports released.

The Mystery of Bustin’s Second Report

Was and is Bustin II reliable?  And how did the US Government come to know of its existence?

Bustin first produced a report in the English MMR vaccine injury litigation for Defendant MMR vaccine manufacturer Merck in 2000 [“Bustin I”].

Much later a request was made in April 2004 for Bustin to inspect Unigenetics – the O’Leary lab in Dublin Ireland.  The odd thing about this was that it was made when the UK inflammatory bowel disease/autism cases in the English MMR litigation were over – the UK Government having withdrawn funding to the cases to continue without a “single shot” being “fired”.

So what was the purpose of the April 2004 request?  Was it  forward planning by Merck to obtain evidence for other cases in the USA or other parts of the world?  Or was it for other purposes?  There was no likelihood of data obtained by an inspection of the O’Leary lab ever being used in the English MMR litigation.  So what was the point?

The UK children’s cases never saw the light of day.  There was no public examination of any of the cases or evidence. The UK childrens’ funding for the autism claims had their funding taken away in September 2003. This was confirmed on English High Court judicial review on 27th February 2004 by Judge Nigel Davis.   [Judge Davis is brother of Sir Crispin Davis a main board director of the Defendants in the case GlaxoSmithKline and the CEO of the owners of The Lancet journal which published and then withdrew the Wakefield/Royal Free 1998 paper suggesting the possibility of a link between autism and the MMR vaccine].

The English Court obliged Merck regardless and provided a letter of request to the Irish Court in Dublin for an order permitting Bustin to have access to the O’Leary lab to facilitate the production of Bustin II. It also seems Bustin was allowed access on behalf of Merck by the Irish Court without an expert also appointed to have access on behalf of the claimants.  There was no means of scrutiny of what he did or the report he wrote.

In May 2005 an application was made to the English Court for disclosure of other documents but not Bustin II.  This application was not for the purposes of the English MMR litigation  nor was this application made by the US Government or for the US Federal Court Omnibus Autism Proceedings.  It was for use in the US in the case of Jared Wright and others in May 2005.  So whilst the title of the application to the English court was that of the English MMR litigation case [Sayers et al] the application was not made for any purposes in that case at all.

Bustin II was also never formally filed or lodged with the English Court.  It was never available from the Court for public access or scrutiny.  So when the US Government came to the English Court at the last minute in June 2007, Bustin II and some other expert reports were not disclosable or useable in other proceedings without permission of the English Court.

How Did the US Department of Justice Learn About Bustin II

The US Department of Justice originally knew nothing of the content of Dr Stephen Bustin’s reports.  It seems The Sunday Times’ journalist Brian Deer was routinely colluding with and passing information and documents to the US Department of Justice. This is according to his own admission posted on a well-known web blog leftbrainrightbrain.co.uk and quoted by respected UK journalist and political commentator Melanie Phillips: “A Deer In The Headlights” The Spectator 16th February 2009.

Deer wrote:-

the US government sought my help in mounting its case in Cedillo ….. I assumed that they would have sophisticated contacts …… and could pretty much get what they wanted. However, on a number of occasions I would come home, find an email from the department of justice asking me for a document, and see that the next day it was being run in court. ……. I recall supplying a key document on the O’Leary lab business, which the DoJ didn’t seem to know about just weeks before the hearing. Hence the late surfacing of Bustin and Chadwick. It was me wot done that, and I’m glad.”

So before the US Government came to the English Court it seems someone had provided Sunday Times journalist Brian Deer with a copy of Bustin II prior to June 2007.   If that is the case and if Deer disclosed that document to the US Department of Justice, that was done without sanction from the English Court.  No ordinary member of the public would have known the document existed, nor what it contained nor could they have obtained a copy from any official source without application to the English Court. If what Deer disclosed was Bustin II then that seems to be something which could not be done lawfully.

Is this the reason the US Department of Justice embarked on this surreptitious course of action?  If they disclosed in the US Federal Court  even at this late stage that they were applying for Bustin II and were seeking to introduce it, presumably they would have to have said why.  If the reason was they already had Bustin II [seemingly illegally under English law but presumably not under US law] would they have been required by the US Federal Court to disclose the copy of Bustin II they already had and how they got it?  Would they also then in so doing have revealed the means by which they obtained it was not lawful under the law of another country? [Added 21 June 2010].

Following whatever it was journalist Deer disclosed to the US Government, the US Department of Justice [“DoJ”] representing the Defendant US  Department of Health and Human Services [“US DHHS”] in the US Omnibus Autism Proceedings made the application which was heard in the English High Court on 5th and 6th June 2007 for release of a copy of  Bustin II and some other expert reports.

US Government’s Request Denied By English Court And Suddenly Granted The Same Day

Early in 2007 the US Department of Justice instructed English law firm Nabarros to apply for Bustin II and other documents.  At the hearing in London on 5th June 2007 and to persuade the English High Court to release the UK MMR vaccine injury expert reports of the drug company defendants from Drs. Bustin, Rima, and Simmonds the US Government’s lawyers threatened the English Court that American vaccination rates would fall if Michelle’s claim was not defeated.  [Sayers v. Smithkline Beecham Plc, (2007) EWHC 1346 (QB), 2007 WL 2041770].

This was an odd argument to deploy before the judge concerned. English High Court judge, Judge Keith, was responsible for the case management of the UK MMR vaccine injury litigation cases. Why should the English lawyers have thought such an argument was worth putting to the judge responsible for the UK litigation corresponding to the US case of Michelle Cedillo and 5000 or so other injured US  child litigants. [Added 21 June 2010].

Judge Keith, in his 6th June 2007 judgement dated and issued the same day then agreed release of Bustin II  notwithstanding having stated in his judgement he was clear only a witness statement and summary had been included in the 2005 bundle:-

23. Different considerations apply to Professor Bustin’s second report.  Despite what I thought yesterday, that report was not filed with the court as part of the bundle filed with the court in May 2005 for the use at the hearing of Merck’s application under rule 31.22.  What was included in that bundle was a witness statement from Professor Bustin, summarising the effect of the report.  Since that report has not been filed with the court, it is not a document to which rule 5.4C(2) can apply.  That does not mean that the Secretary for Health can never get access to it.  Merck is prepared to make it available to the Secretary for Health, but in order to do so, Merck has to obtain the court’s permission to do so under rule 31.22.  No such application is currently before the court, but if one was, it is difficult to see how that application could be decided any differently from the Secretary for Health’s present application under rule 5.4C(2).

So the English Court judgement of 6th June 2007 granted consent only for the use of Bustin I and the reports of Professor Simmonds and Professor Rima and strictly only for use in the US Omnibus Autism Proceedings.  But immediately after giving that Judgement with the parties concerned in the application still in Court [other than the UK parents] Merck’s lawyer turned up with documents claiming to facilitate the release by the English Judge.  Michelle’s lawyers were of course not present. Only a handful of the legally unrepresented UK parents were present from the 1600 or so sets of UK parents involved – not having been served with any or proper notice of the US DHHS’ application. [Added 21 June 2010].

Whilst the parties were still in Court before Judge Keith the English solicitors acting for Merck had gone to look for what was claimed to be a duplicate of a hearing bundle used in the May 2005 Jared Wright application and brought it to the court.  This was to substantiate the claim Bustin II was in divider 2 of that bundle.  The bundle was handed to Judge Keith to examine.  No formal witness statement or affidavit was produced to verify the provenance of the bundle of documents concerned.

Clearly, it is unlikely Merck would have gone to this effort for Michelle’s or any other US Claimant child’s lawyers.  The end result of any attempt by the US Claimant children to have obtained Bustin II would have been a certainty of failure.

After getting this information but after already having delivered his judgement Judge Keith stated:-

I am sorry I rather led you up the garden path yesterday.  My recollection was wrong.

….  I will tell you where I got my latest information from.  That was the supplemental bundle that had been filed for the application at the beginning of last month.  That supplemental bundle included the relevant documents which had been included in the May 2005 bundle.  That included the witness statement of Professor Bustin in 2005, but not his November 2000 report.  I was assuming that that meant that the November 2004 report had not been included in the hearing bundle.  If it transpires that it was included in the hearing bundle, then no distinction can be or ought to be drawn between his second report and his first report and the reports of Professor Simmons and Mr Rema.  The question is how one resolves that now.

…. When the judgment has been transcribed, I will make amendments to it to reflect — no, I will only be re-writing history.  The transcript of our discussion post-judgment will reflect the alterations will have been made.

Relaxed Approach of The English Court to Keeping Documents

Unlike the USA where documents are formally filed, docketed and kept for public inspection and copying, the English Court does not apply that level of formality.  Including a document in a bundle produced for a hearing does not mean any copy is ever kept by the Court or that the document is available to anyone.  Document bundles are often handed back to the parties’ respective lawyers at the end of a hearing.  The Court normally does not keep hearing bundles.

Unless directly involved in the litigation ordinary members of the public are unlikely to know what is going on in any English Court case.  Even if they are to know and understand they would have to be closely involved, such as a lawyer managing the case on behalf of a client.

Who Is Dr Stephen Bustin

Stephen Bustin is a Professor at the Institute of Cell and Molecular Science (School of Medicine and Dentistry) at Queen Mary College, University of London.  His claimed areas of expertise are molecular oncology; genetics of colorectal cancer; role of dietary factors in aetiology of colorectal cancer; real-time PCR; real-time RT-PCR.

And Was Bustin II Reliable

It seems not according to the Michelle’s Lawyers in their appeal case.

In his reports, Dr. Bustin stated he had the opportunity to examine a small sampling of the O’Leary lab notebooks — notations totally unrelated to Michelle or any petitioner in the OAP. In this regard, this small sampling formed the basis for the opinions of three British “manufacturers’” experts used by the US Government to attack the O’Leary lab. In sum, the US Federal Court at Michelle’s original hearing allowed highly technical, last-minute evidence, totally unrelated to Michelle, and used it to assist the Special Master of the US Federal Court to dismiss her petition for compensation.

This was despite the fact that the O’Leary lab notebooks claimed to have been reviewed by these experts have never been unsealed in the British litigation and were unavailable for Michelle to inspect.  It in fact seems they were never made available in the UK MMR litigation, let alone filed with the English Court, access having been provided to Stephen Bustin by a Court in a different Country, Eire [Republic of Ireland].

To demonstrate the complexity of this material, Dr. Bustin asked Special Master Hastings at Michelle’s original hearing whether he understood the testimony. Special Master Hastings said “no.” In the end, Dr. Bustin, unwittingly, helped Michelle. He attacked another British expert, Dr. Finbar Cotter, whose report the US Government had neglected to obtain. Dr. Bustin was forced to concede that Dr. Cotter’s lab had replicated the O’Leary lab’s results of samples with substantial inflammation levels (“SILs”).   For good reason, the US Government also “neglected” to obtain the key reports filed by Dr. O’Leary himself or by his molecular biologist, Dr. Shields.

The US Federal Court’s Special Master’s reliance on these materials is even more troubling in light of the ample evidence of the  O’Leary lab’s reliability at the original hearing and in Michelle’s motion for reconsideration and in the absence of any dispute with respect to Michelle [because her biopsy revealed a substantial inflammation level (“SIL”)].

However, in the appeal decision the Appellate Court stated to the contrary that:-

In particular, petitioners describe Dr. Bustin’s and Dr. Rima’s testimony regarding the reliability of the Unigenetics work as equivocal, or as only applying to some of the Unigenetics results, but not all. However, as both the Special Master and the court noted, Dr. Bustin and Dr. Rima clearly testified that their criticisms were not simply limited to certain of Unigenetics’ results and that they found all of the Unigenetics work to be unreliable. Petitioners also urge that a letter written by a Dr. Michael Oldstone, which was filed in Snyder, supports the reliability of the Unigenetics work. To the contrary — Dr. Oldstone’s letter is clear in stating that he could not reliably replicate the Unigenetics results and that the 20 percent error rate he encountered completely undermined his confidence in the testing. It was on this basis that he declined further work with the laboratory. We find that the Special Master considered all of the evidence in context and did not err in concluding that the Unigenetics testing was unreliable. ” [Text added 5 October 2010]

Judge Wheeler had blindly accepted the Special Master’s conclusion that SILs were irrelevant.

To “remedy” this error, at the subsequent hearing of a completely different child’s US Court case [Snyder], the US Government presented the testimony (and reports) of another British manufacturers’ expert, Dr. Bertus Rima.

Although Michelle’s counsel was not present at Snyder, unaware that he would testify against Michelle, and not permitted to cross-examine him, Dr. Rima attempted to rebut this powerful aspect of Michelle’s evidence. Her SIL, he said, was too high. It was implausible, he swore, and could only have resulted from contamination in the O’Leary lab.  Despite the unfairness of this surprise testimony in Snyder, Special Master Hastings relied upon it when he dismissed Michelle’s petition.   Worse, he rejected her petition for reconsideration even when she pointed out to him that Dr. Rima’s opinion was based upon a gross mathematical miscalculation.  For him to do so was error. For Judge Wheeler to have permitted him to do so was error.

Dr Bertus Rima’s Error of Basic Math

Dr. Kennedy demonstrated that, in Snyder, Dr. Rima had made a division error when he testified that Colton Snyder’s copy numbers (i.e. inflammation levels) of 3400 were unbelievably high. When Dr. Rima divided 34,000 by 100, he mistakenly arrived at 3400, when the correct number should have been 340.   When Dr. Kennedy used Dr. Rima’s formula to calculate Michelle’s copy numbers (i.e. inflammation levels), he found the levels to be “very plausible.”   Affirming the Special Master’s decision, Judge Wheeler implied that Michelle waived this argument by failing to bring it to the Special Master’s attention sooner.   This was unfair and unjust.

It was only when Michelle realized the importance that her special master would give this evidence, presented by a different expert, in a case by a different petitioner, heard by a different special master, that she felt the need to respond. In these circumstances  key evidence has been ignored and deference is unwarranted. In any event, Dr. Kennedy’s affidavit remains a part of the record. Special Master Hastings commented upon all of the new evidence submitted by Michelle except Dr. Kennedy’s affidavit! Judge Wheeler’s failure to address this gross omission on the initial appeal was clear error.

What Else Was Done Wrongfully In Michelle’s Case

The US Federal Court Special Master discounted the opinions of Michelle’s treating physicians.

Michelle’s medical records demonstrate that several of her treating physicians associated her illness with her MMR vaccine. These physicians include: (1) Dr. Daniel Crawford, her pediatrician; (2) Dr. William Masland, a neurologist; (3) Dr. Lisa Shigio, an audiologist; (4) Karlsson Roth, a developmental psychologist; (5) Dr. Sudhir Gupta, an immunologist; (6) Dr. Ira Lott, a pediatric neurologist; and (7) Dr. B.J. Freeman, a neuropsychologist.

The special master afforded these records absolutely no probative value. In this regard, Michelle concedes, these doctors did not conclude that her MMR vaccine had caused her autism. However, they should have been afforded significant probative weight that the vaccine likely harmed her. Capizzano, 440 F.3d at 1326. In these circumstances, the special master abused his discretion by affording no weight to the statements of treating physicians in Michelle’s medical records. Judge Wheeler’s blind acceptance of this finding was error.

The special master rejected the opinions of Michelle’s experts who testified that her measles vaccine substantially contributed to her IBD, brain damage, and autism. Instead, he accepted all of the opinions of the US Government’s seventeen (17) experts. Michelle did object to the gross unfairness of permitting the highly prejudicial, last minute, technical materials submitted by Dr. Bustin. However, in the end, the US Government’s expert evidence was largely supportive of Michelle’s (7) Dr. B.J. Freeman, a neuropsychologist. The special master, however, afforded these records absolutely no probative value. In this regard, Michelle concedes, these doctors did not conclude that her MMR vaccine had caused her autism. However, they should have been afforded significant probative weight that the vaccine likely harmed her. Capizzano, 440 F.3d at 1326. In these circumstances, the special master abused his discretion by affording no weight to the statements of treating physicians in Michelle’s medical records. Judge Wheeler’s blind acceptance of this finding was error.

The Special Master ignored concessions of the US Government’s expert witnesses.

In the Vaccine Program a petitioner is required to prove a preponderance of evidence and not a scientific treatise proving to the scientific standard of beyond doubt what caused the injury and exactly by what biological mechanism.  This is in fact no different from standard pharmacology and the assessment of adverse drug reactions.  It is possible to prove to with high certainty that a drug has caused an adverse reaction without carrying out scientific experiments or proving the exact causal mechanism.  So the standard of proof in this special US Federal Court is little or no different to that applied by drug regulators and in standard pharmacology.

The US Government experts conceded important aspects of Michelle’s case.

The special master, however, relied solely upon the number of the US Government’s experts, their obvious qualifications, and their conclusions to find against Michelle.  However, in so doing, the special master chose to ignore the many concessions of the US Government’s experts that supported Michelle’s case.

Oddly the special master found the US Government’s experts’ conclusions reliable, but their concessions unreliable. This was legally in error.

For Judge Wheeler on the initial appeal to have permitted this grossly selective consideration of the record was also error.

Dr. Jeffrey Brent’s Concessions

Immune dysfunction must be present to permit a measles infection to persist. That fact was not in dispute. Michelle presented evidence that, in her case, mercury containing vaccines [“TCVs”] likely caused the initial damage to her immune system which allowed measles to persist in her gut long after it should have been eliminated from her body.

The special master rejected this. He found no evidence that TCVs can harm the immune system. However, to do so, the special master was required to ignore all evidence that contradicted this conclusion. This included that provided by the US Government’s expert toxicologist.

Dr. Brent conceded

• a large body of literature exists concerning the adverse effects of mercury on the immune system;
• the effect of organic mercury (contained in TCVs) on the immune system is five times more potent than inorganic mercury;
• “mercury containing compounds are immunomodulatory” and toxic at very low exposure levels to T-cells;
• exposures to low concentrations of heavy metals, including mercury, causes “silent” clinical symptoms which upon long term follow-up reveals “clear evidence of tissue or organ dysfunction”;
• low doses of mercury can have an inhibitory effect on human T-cells.

It was error for the special master to ignore these concessions and the supporting literature. The special master dismissed the Goth study for being an invitro study that studied Thimerosal, not ethyl mercury (again, Thimerosal is approximately 50% ethyl mercury).  He criticized the Agrawal study. While an in vivo study, this study was deficient since it too studied Thimerosal.  He ignored the entire body of literature that Dr. Brent conceded showed ethyl mercury has a detrimental effect on all elements of the immune system.

It was error for the special master to ignore the vast body of evidence regarding the effects of mercury on the immune system, and then declare that Michelle had failed to prove that mercury exposure can lead to a dysfunctional immune system. In any event, it is not necessary for Michelle to prove that TCVs damaged her immune system. It is only necessary for her to show that a dysfunctional immune system, for any reason, allowed the vaccine-strain measles virus to harm her.

Dr. Stephen Hanauer’s Concessions

Michelle alleges that the persisting vaccine-strain measles virus from her MMR caused her to suffer IBD. The special master, however, determined that she does not suffer IBD. Dr. Hanauer, however, the US Government’s expert gastroenterologist, provided significant support for Michelle’s argument. While denying that Michelle has IBD, he reluctantly conceded that she has significant bowel symptoms.

He also agreed she has aphthous ulcers, which can evolve into IBD, specifically Crohn’s disease, and that the ulcers are often the first sign of Crohn’s disease. He agreed that Michelle has elevated OmpC and that OmpC is elevated in 60% of Crohn’s patients. He agreed that diarrhea frequently occurs after measles vaccine. He agreed that Michelle’s lower abdominal symptoms persisted after her measles vaccine. He agreed that both genes and environmental triggers cause IBD, a chronic condition.

He conceded that a virus can trigger a chronic inflammatory response.

He conceded that Michelle suffers from arthritis and eye problems, both of which, he agreed, are associated with IBD.  He conceded that Michelle’s present gastroenterologist, Dr. Ziring, treats Michelle with Humira, a medication used for IBD.

In light of these concessions, as well as the opinions of Michelle’s present treating gastroenterologist that she has IBD, the special master’s finding was in error and unlawful.

Dr. Diane Griffin’s Concessions

Dr. Griffin, an immunologist and virologist, conceded:

• measles is one of the most infectious of all viral diseases;
• a “target organ” of the measles virus is the gastrointestinal tract;
• the attenuated measles vaccine can cause progressive, fatal respiratory disease or neurological disease in immunocompromised individuals;
• measles virus affects many components of the immune system;
• measles virus causes immunosuppression for months after the period of viremia;
• measles virus skews T cells, and that when Th1 and Th2 are not in balance the body’s ability to clear viruses will be impaired;
• the measles vaccine, like the wild virus, causes lymphopenia;
• “you can definitely identify changes [in antibodies] that are occurring as part of the induction of the immune response to the vaccine”;
• Michelle’s first fever after the MMR vaccine was related to the MMR vaccine;
• measles can cause neurologic disease;
• the risk of viral persistence increases in an immunosuppressed person;
• viruses can persist in the human body;
• in her own study, she found the presence of a virus’ RNA indicated that “viral protein may continue to be made, providing the impetus for the continued presence of [virus]-specific B cells in the brain.”

Dr. Griffin agreed that the PCR technique used by the O’Leary lab is commonly used to detect viral RNA.

She agreed she has used the PCR technique and detected measles RNA in the blood of immunodeficient children long after exposure to the virus. Indeed, she wrote:

we believe the presence of measles virus RNA represents continued measles virus replication, not simply the persistence of measles virus RNA after cessation of viral replication. This is supported by detection of measles virus RNA from multiple clinical sites.

Dr. Griffin agreed that a measles vaccine should not be given to an immunosuppressed child and agreed that if Michelle had evidence of a persisting, replicating measles virus, it would be “an important observation” and “should definitely be followed up” by a physician.

Dr. Brian Ward’s Concessions

Dr. Ward agreed that

• wild measles virus causes a skewing towards a Th2 response, which happens to occur during the period of maximum viremia (1-2 weeks after exposure or immunization);
• this skewing of the Th2 response causes immunosuppression and allows the development of opportunistic infections;
• measles vaccine can cause a skewing towards a Th2 response, like wild type measles can;
• measles virus can persist;
• “‘[t]he type of diseases that persisting viruses cause are often novel and unexpected’”;
• “‘[t]he result is a disturbance in the host’s biologic equilibrium. That’s one important direct effect of persistent virus replication is to disorder the normal homeostasis of the host and thereby cause disease without destroying the infected cell.’”

Dr. Ward when confronted with Dr. Oldstone’s statement that an important direct effect of persistent virus replication might be a “‘virally caused neurotransmitter defect of neurons altering cognitive learning and yielding behavioral disorders.’” said he is not an autism expert, but agreed that it would “describe some of the children with ASD.”

Dr. Robert Fujinami’s Concessions

Dr. Fujinami failed to appear at the hearing, but provided significant evidence for example, that measles virus can persist in human cells, injure tissues, and cause a potentially damaging autoimmune response.

The US Government’s Experts’ Concessions On the O’Leary Lab

Dr. Bustin’s testimony supported the reliability of the O’Leary lab for Michelle’s test result. At the hearing, he attempted to show that another laboratory (Dr. Finbar Cotter) in London was unable to replicate the O’Leary lab’s results (i.e. detecting measles RNA in samples) using the O’Leary techniques. However, as Dr. Bustin’s power point presentation showed, Dr. Cotter’s lab was able to replicate the O’Leary results using the O’Leary techniques for test results with SILs.

Although this critical fact was discounted by the special master and Judge Wheeler, it remains in the record that Dr. Bustin agreed that his dispute was only with the O’Leary lab’s MILs and he did not deny that Michelle had SILs.

In the US Snyder case the US Government  introduced a letter from Dr. Michael Oldstone. 88 Fed.Cl. at 731. In his letter, Dr. Oldstone revealed “[i]n the early 2000s” he reviewed the O’Leary lab’s protocols for detecting measles virus with PCR, and found them “to be sound.”  In addition, Dr. Oldstone stated, Dr. O’Leary’s test results agreed with his own in 80% of the samples he sent to the O’Leary lab.  Dr. Oldstone also indicated that there was concordance between the two laboratories with respect to SILs.  Thus, there was concordance among three separate laboratories for test results for patients with SILs. The only disputes concerned the results with MILs.

The special master used Dr. Rima’s testimony in Snyder against Michelle to reject this argument. In Snyder, Dr. Rima testified that the O’Leary lab’s SILs for Colten Snyder were “[t]oo high to be believed.”   Unable to cross-examine Dr. Rima in Snyder, Michelle filed the affidavit of Dr. Ronald Kennedy, who explains that Dr. Rima’s opinions in Snyder with respect to SILs were based upon a gross mathematical computation error.  Dr. Kennedy then uses Dr. Rima’s properly corrected formula to calculate Michelle’s SIL, and concludes that her SIL, like that of Colten Snyder, was “very plausible.”

Michelle also relied on portions of the testimony of the US Government’s expert Dr. Rima, who conceded that the O’Leary lab used allelic discrimination to attempt to distinguish between vaccine-strain and wild measles viruses. Snyder, 2009 WL 332044 at 125.

Dr. Rima also agreed:

• if measles virus RNA is present, the virus may be replicating;
• the Uhlmann paper indicated that the O’Leary lab had detected measles protein using immunohistochemistry;
• the US Government’s expert Dr. Griffin, in her 2001 paper, using PCR technology, found positive measles RNA in samples of immunosuppressed children taken 60-90 days after exposure to the measles virus.

The special master’s refusal to consider this evidence was error.

The Special Master ignored evidence of allelic discrimination

The process of “allelic discrimination” is the method used by scientists to determine whether a virus in question is of wild origin or of vaccine-strain origin.

The special master determined that Michelle had failed to prove that Michelle’s measles virus RNA, if detected at all, was vaccine-strain measles virus.  However, in making this finding, the special master ignored the absence of evidence that Michelle was ever exposed to a wild measles virus. He also discounted Michelle’s direct evidence that the O’Leary lab had used allelic discrimination and that the RNA recovered was vaccine-strain measles virus.

Michelle’s medical records indicate that she has never been exposed to wild measles.

In addition, the O’Leary lab’s method used to distinguish between wild type and vaccine strain measles, an accepted methodology, was not challenged by any of the US Government’s experts.

The special master’s refusal to consider this evidence was error.

The Special Master refused to consider evidence concerning persistent measles virus and replication

Dr. Griffin, the US Government’s expert virologist, discounted the results of Michelle’s gut biopsy that the presence of a significant amount of measles virus RNA in her gut tissue. She indicated that the presence of measles virus RNA was not indicative of disease because protein was required for the virus to replicate.

During cross-examination, however, she acknowledged that she had not reviewed the Uhlmann article that formed the basis for Michelle’s contentions that the O’Leary laboratory engaged in good and accepted practices.

Dr. Griffin was thus unaware that the O’Leary laboratory had found protein via the process of immunohistochemistry and that the Uhlmann article reflected that finding.

In any event, once again, Dr. Griffin, herself, had found replication of measles virus, in the absence of protein, in one of her publications.  In this article, Dr. Griffin was able to recover measles RNA from the blood, urine and trachea of HIV positive patients 30 – 60 days post-immunization. In her article, she declared that recovery of measles RNA from multiple sites from different patients was indicative that measles virus was persistent and replicating. The special master, however, ignored this evidence.

Thus, the special master ignored multiple sources of information that supported Michelle’s medical theory that the measles RNA found in her gut tissue was not inert, but multiplying in her gut tissue and causing harm to her gut and her brain. The special master’s refusal to consider this evidence was error.

The Special Master rejected the opinions of Dr. Krigsman

The special Master accepted the testimony of the US Government’s expert, Dr. Hanauer, who has never seen Michelle, that she does not have IBD. In so doing, he rejected the testimony of Michelle’s treating gastroenterologist, Dr. Arthur Krigsman. Indeed, special master reserved special venom for Dr. Krigsman, a board-certified gastroenterologist, accusing him of “gross medical misjudgment.”

In fact, the special master’s attack is grossly unfounded.  The special master relied heavily upon the disciplinary action instituted by Lenox Hill against Dr. Krigsman for attacking his credibility. What he failed to relate was that the hospital, in violation of its own medical staff by-laws, attempted to curtail Dr. Krigsman’s privileges, without due process, to prevent him from conducting further colonoscopies of autistic children. The hospital paid damages, and the parties went their separate ways. The “Texas matter,” as the special master noted, involved an administrative error, and the “Florida proceeding” involved a failure to fulfill a special continuing education requirement of the Florida Board. None of these proceedings concerned the competence of Dr. Krigsman as a physician or gastroenterologist.

In response, Michelle points out, at the time of her hearing, Dr. Krigsman had evaluated the gastrointestinal tracts of a thousand autistic children.

He testified:

• about his initial skepticism that autistic children had significantly more bowel symptoms than nonautistics;
• that he conducted a history and physical of the initial eight (8) autistic patients referred to him, and when appropriate, ordered non-invasive testing; when testing revealed no abnormalities, he declined to treat them further;
• only when shown an article by the author of a medical school textbook did Dr. Krigsman reconsider his original thinking.

He offered to conduct additional evaluations of the original patients and all parents agreed. See generally. The special master failed to acknowledge that most parents will not allow a physician to conduct invasive procedures on their child unless the symptoms are chronic and unremitting, cause physical and emotional distress to their child, and the child has been non-responsive to traditional treatment. All eight of Dr. Krigsman’s original patients ultimately underwent  colonoscopies.

In all eight patients, he saw similar findings as were described in the article.

The special master also ignored the fact that Theresa Cedillo, Michelle’s mother, only sought Dr. Krigsman’s help after Michelle’s treating gastroenterologist refused to transfer her to the hospital where he practiced, despite the fact that she was dehydrated and had lost approximately 20 pounds.  He ignored the fact that Dr.  Krigsman obtained a proper history, conducted a proper physical exam, ordered appropriate testing and only after doing so arrived at a diagnosis.

He ignored Dr. Krigsman’s testimony that the diagnosis of Michelle’s IBD was based on all the evidence available to him, evidence that included Michelle’s history, her physical examination, results of diagnostic testing that included positive serological marker for IBD (+ Omp-C), elevated inflammatory markers (C-reactive protein (“CRP”)) and the presence of aphthous ulcers (pre-Crohn’s lesion). Further, the special master ignored the fact that Michelle had both uveitis and arthritis, commonly associated disorders of IBD. The special master especially ignored the fact that Michelle had responded to treatment with Remicade, an anti-inflammatory agent used for the treatment of IBD. Even worse, he ignored the findings of Michelle’s current treating gastroenterologist, Dr. David Ziring, who had no doubt that Michelle had inflammatory bowel disease  and who ordered Humira for it, specifically noting on the prescription that it was for “Crohn’s Disease.” The records of Dr. Ziring, Michelle’s current treating gastroenterologist, were not available at the time of hearing and were filed in support of a motion for reconsideration, which was denied by the special master.

The special master also ignored evidence of the consensus statement formulated by a renowned body of specialists in autism and pediatric gastroenterology convened by Autism Speaks on the “appropriate diagnostic evaluation and treatment of GI symptoms in children with ASD [autistic spectrum disorder].”

He ignored the fact that Dr. Krigsman was an invited participant, and that the evaluation that was subsequently deemed proper and appropriate, mirrored the evaluation he had provided for Michelle.  Instead, the special master credited the testimony of Dr. Hanauer, the government’s paid witness, an adult  gastroenterologist who does not evaluate pediatric patients, who has never looked at the gastrointestinal tract of an autistic child, and who has never examined Michelle.

Dr. Hanauer’s conclusion that Michelle does not have IBD is based on only one fact — that inflammation was not found in Michelle’s pathology slides.  He asserted that IBD could not be diagnosed in its absence.  What both Dr. Hanauer and the special master refused to acknowledge was that the successful treatment noted in Michelle after she began Remicade, was likely responsible for the lack of inflammation noted on the pathology slides. While the special master can be excused for this oversight, Dr. Hanauer does not enjoy that deference.

The special master’s refusal to consider this evidence was error.

The Special Master refused to consider evidence of neuroinflammation

Tthe US Government’s experts did not deny “that inflammation may be present in the brains of autistic persons, and may possibly play a causal role in autism.”  The special master conceded as much.  He asserts, however, that Michelle failed to establish that measles caused her to suffer persistent neuroinflammation. Once again, the special master ignored relevant evidence to arrive at this conclusion.

First, it is undisputed that persistent wild measles infection has resulted in two recognized brain disorders, subacute sclerosing panencephalitis (“SSPE”) and measles inclusion body encephalitis (“MIBE”), and that both disorders involve neuroinflammation. It also is undisputed that both disorders have a prolonged latency period after exposure before the onset of symptoms. The special master failed to acknowledge, however, that vaccine-strain measles, was recovered from the brain of one child with MIBE. Clearly, then, if wild type measles can cause a latent inflammation of the brain, it is reasonable to believe that the attenuated measles vaccine, which is simply a weakened version of the live measles virus, can also cause a latent infection of the brain.

In addition, as the special master was well aware, if encephalitis occurs in a child 5-15 days after measles immunization, it constitutes a Table injury and it is presumed that the vaccine is the cause of the encephalitis. § 14. Encephalitis is an inflammation of the brain. Thus, it is difficult to fathom why the special master ruled that it is unproven that measles vaccine can cause neuroinflammation.  Michelle was unable to present direct evidence of neuroinflammation. No autopsy can be performed as she is still alive.

Michelle’s “Motion for Reconsideration” included several chapters from a text edited by Dr. Andrew Zimmerman, one of respondent’s expert pediatric neurologists, who the US Government declined to call at hearing. They support Michelle’s theory that autism is caused by neuroinflammation. The special master ignored them.

He also ignored the findings of Dr. Oldstone who has spent his career studying persistent viral infections. For him to have ignored this evidence was error.

The Special Master ignored evidence concerning Michelle’s immune dysfunction

The special master discounted the testimony of Dr. Vera Byers.

Dr. Byers testified that Michelle “has an unusually low CD8 count, and as a result she has an elevated CD4:CD8 ratio. An elevated CD4:CD8 ratio is compatible with autoimmune disease.”  In addition, Dr. Byers stated, Michelle had an elevated CD 20. In this regard, she testified, the significance of an elevated CD 20 is that, “you’ve got abnormally elevated B cell precursors, and it could go along with the abnormally elevated IgG2 and IgG4. . . .The fact that she has abnormally elevated IgG2 and IgG4. . .is consistent with TH1/TH2 skewing.”

At the hearing, referring to the laboratory findings of one of Michelle’s treating physicians, Dr.  Gupta, the US Government’s expert Dr. Ward, once again,  acknowledged that TH2 skewing causes immunosuppression.  In a letter to Michelle’s parents, Theresa and Michael Cedillo, Dr. Gupta wrote, “the immunology testing. . .shows that Michelle has almost normal immune functions.”  In the same letter, Dr. Gupta advised Michelle’s parents that she qualified for “a medical exception to the vaccination requirements of the school system.”

Incomprehensibly, the special master accepted the testimony of the US Government’s expert, Dr. McCusker, who constructing her own chart from different sources, then concluded that Michelle’s immune system was normal. The  record clearly indicates that Michelle’s immune system was damaged. Dr. Zimmerman’s text, significantly, includes a chapter by Dr. Paul Ashwood, who discusses immune abnormalities in autistic children.   Michelle suffered from several of the abnormalities listed by Dr. Ashwood and Michelle relies upon Dr. Ashwood to support her theory that she suffers from immune dysfunction. Further, the special master ignored evidence submitted by the US Government’s expert, Dr. Fujinami that some autistics, as does Michelle, suffer from a Th2 skewing of the adaptive immune system, that affects a person’s ability to eliminate viruses from the body.

The Special Master refused to consider significant post-hearing evidence

This was an aspect the US Court of Federal Appeals stated it found troubling in the recent 10th June oral appeal hearing.

Michelle asked the special master to reconsider his decision of February 12, 2009 dismissing her petition. On March 16, 2009, the special master denied Michelle’s Motion for Reconsideration as both untimely filed and without “a good reason” for reconsideration.

The Motion for Reconsideration was filed in light of new evidence not available at the time of the hearing in June of 2007. This evidence, Michelle stated, is based upon the research of leading scientists in the field of autism, including the US  Government’s expert pediatric neurologist, Dr. Andrew Zimmerman. In sharp contrast to critical findings by the special master, this evidence demonstrates that:

• Postnatal environmental triggers may impact the immune system during the development of the brain, disrupt the normal development of the brain, and cause autism.
• Regressive autism is not purely genetic and may be caused by postnatal environmental factors.
• Scientists now accept the concept of gastrointestinal inflammation in autistic children.
• There is a strong relationship between the immune system, gastrointestinal disorders, and autism.
• Michelle has inflammatory bowel disease.
• The O’Leary lab’s primers are reliable in detecting measles RNA
• Dr. Bertus Rima’s testimony in Snyder, a critical factor in the special master’s rejection of Michelle’s O’Leary lab result, was based upon a gross mathematical error.

In light of the significance of the evidence and the impact of the decision upon thousands of autistic children the Special Master’s failure to reconsider was an abuse of his discretion. Once again, the special master did not strike this evidence and it remains part of the record in this case.

The Special Master’s Decision Was Unlawful

Has Michelle satisfied the burden of proof?

She has a medical theory. Her evidence is overwhelming that the MMR vaccine is capable of causing a wide variety of brain injuries, including autism. Next, there was a logical sequence of cause and effect between her MMR vaccine and her injury. She was healthy, received a MMR vaccine, and as her several treating  physicians attest, she was never again the same. There is no question that her symptoms first occurred within an appropriate time after her MMR vaccine. This fact is supported by Michelle’s medical records and by the US Government’s expert Dr. Griffin. It is even supported by the Vaccine Injury Table that lists “5-15” days after the MMR vaccine as the appropriate time frame for the onset of symptoms of brain damage.

Having presented such a case the burden of proof shifts and the government must prove that the “‘injury. . . described in the petition is due to factors unrelated to the. . .vaccine.’ 42 U.S.C. § 300aa-13(a)(1)(B).” Knudsen by Knudsen v. Sec’y of HHS, 35 F.3d 545, 547 (Fed. Cir. 1994).

She offered expert opinions supported by scientific literature. the US Government offered no evidence of an alternate cause of Michelle’s injuries.

Michelle clearly had a plausible medical theory supported by substantial circumstantial evidence as to how the MMR caused her gut and brain injuries. The records of several treating physicians support a “logical sequence” between the MMR and her injuries, an appropriate temporal relationship, and the absence of an alternative cause.

When Michelle became the first autism “test case,” however, everything changed:

• Due process was suspended.
  
• Now, she had to convince not one, but three special masters.
  
• Phalanxes of experts were pitted against her, not just Dr. Wiznitzer.
  
• The Federal Court Special Master allowed the US Government to present surprise evidence from England on the eve of trial, use a host of experts provided by the pharmaceutical industry, and even present expert testimony against her in another trial.
  
• The US Court refused to accept any aspect of her evidence, even the major concessions made by the US Government’s experts.
  
• The special master, and Judge Wheeler, even refused to accept the fact that Dr. Rima’s critical testimony was based on a mathematical error.
  

Michelle fully appreciates the emotions surrounding her case. She also appreciates the importance of vaccines. However, Michelle submits, she must not be penalized for choosing this unpopular route. She is entitled to compensation based on the evidence in accordance with the statute.

At this time, approximately 5,000 autistic children in the OAP claim vaccines harmed them. There is a $3.1 billion fund available to compensate appropriate cases. An adverse finding in her case, Michelle submits, will drive many of these autistic children into the civil arena. This Court cannot permit this to happen. Certainly, this is not what congress intended.

It is essential that the Vaccine Program, rather than crippling civil litigation, resolve Michelle’s case as well as those of all autistic children in OAP. Persons fairly compensated in the Vaccine Program will not sue manufacturers. How can these persons be kept in the Vaccine Program? The answer is simple. An evidentiary standard that promotes congressional intent must be employed. The Vaccine Act, as interpreted by Althen and Capizzano, provides such a standard.

Fundamental fairness, not hysteria, must prevail.

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