Another Autism "Test Case" Appeal Dismissed · 2009-08-11 11:30

On August 6, 2009, Judge Thomas C. Wheeler of the United States Court of Federal Claims affirmed the Vaccine Injury Compensation Program’s February 12, 2009 dismissal of Cedillo v. U.S. Department of Health and Human Services (Case No. 98-916V), one of the three Omnibus Autism Proceeding test cases which sought to establish that vaccines can provoke the development of autism.

In his original ruling, Special Master George Hastings found that the petitioners had failed to demonstrate that either the MMR vaccine or thimerosal-containing vaccines can harm infant immune systems, cause gastrointestinal dysfunction, or cause autism; that they had failed to demonstate that a vaccine reaction had harmed their child’s immune system, caused her gastrointestinal problems, or caused her to become autistic; and that they had failed to demonstrate that an MMR vaccination caused her mental retardation or seizure disorder. Additionally, the Special Master deemed ureliable the testing the petitioners offered to show the presence of the measles virus in their own child and in other autistic children.

The ruling on appeal adds to the accumulation of comprehensive, reasoned judicial assessments of the scientific evidence offered in support of vaccine causation hypotheses and of the credibility of the “scientific experts” who promote those hypotheses in the courtroom and the clinic.

From the decision:

The Cedillos assert seven arguments in their motion for review to show that the Special Master’s decision is arbitrary, capricious, an abuse of discretion, and contrary to law:

(1) A panel of three Special Masters should not have heard the general causation evidence;

(2) The Special Masters should not have allowed the last-minute expert reports and testimony of Dr. Stephen Bustin;

(3) The Special Master improperly discounted the medical diagnoses and opinions of [the child’s] treating physicians;

(4) The Special Master improperly ignored concessions made by Respondent’s expert witnesses;

(5) The Special Master ignored important aspects of [the petitioners’] evidence;

(6) The Special Master abused his discretion by refusing to consider important post-hearing evidence; and

(7) The Special Master’s decision was contrary to law. (p. 9)

A hotly contested issue in this case is whether the measles virus detection tests performed by the Unigenetics Laboratory in Dublin, Ireland produced reliable results. Petitioners’ expert witnesses, Dr. Marcel Kinsbourne and Dr. Arthur Krigsman, acknowledged that their opinion on causation depended upon the existence of a reliable laboratory finding of persistent vaccine-strain measles in the body of the person tested. Thus, absent evidence of persistent vaccine-strain measles in [the child’s] body, Dr. Kinsbourne and Dr. Krigsman cannot show that the MMR vaccine caused [her] autism or her inflammatory bowel disease…

Weighing all of the evidence, the Special Master concluded that the Unigenetics testing for the detection of measles virus was not reliable. The Special Master emphasized that other researchers had been unable to replicate the Unigenetics findings. He found it significant that Unigenetics had failed to employ “sequencing” in its testing procedures. He was troubled by the many problems with Unigenetics’ procedures, facilities, and equipment. Among these were the failure to employ “blinding” procedures so that the laboratory technicians would not know whether the samples being tested were from the patient group of interest. These procedures are regarded as “critical” to prevent conscious or subconscious bias from affecting test results. The Special Master found the efforts of [petitioners’ experts] Dr. Hepner and Dr. Kennedy to defend the Unigenetics work largely ineffective. Their testimony was “too summary and nonspecific to answer the criticisms leveled by [respondent’s experts] Drs. Bustin and Rima, which were specific and detailed.” Moreover, even the Unigenetics’ test results failed to identify any vaccine-strain measles, which would have been critical to linking the MMR vaccine to autism or inflammatory bowel disease. Petitioners needed to show that the measles virus allegedly detected in [the child’s] tissue sample derived from the MMR vaccine, rather than the natural, “wild” form of measles virus, but they did not. On balance, the Special Master concluded that Respondent’s experts, Drs. Ward, Bustin, Rima, and MacDonald, had “vastly more experience and academic credentials” than Petitioners’ expert, Dr. Hepner, and that Dr. Bustin’s PCR experience and Dr. Rima’s measles virus experience far exceeded Dr. Kennedy’s.

The Court performed a detailed review of the record and the Special Master’s analysis of the Unigenetics testing. The Court agrees with the Special Master that the evidence strongly favors Respondent’s position. Aside from the superior qualifications and experience of Respondent’s experts, the Court finds the results of the 2006 Afzal and D’Souza studies to be most compelling. The researchers in those studies sought to replicate the Uhlmann Study upon which Petitioners so heavily rely. Not only did the Afzal and D’Souza researchers fail to replicate the results of the Uhlmann Study, they came to a conclusion directly opposite to the Uhlmann Study, and they offered likely reasons to explain how the Uhlmann Study had gone astray. The Court also finds that the flaws in the Unigenetics Laboratory procedures were so pervasive that the test results simply cannot be trusted… The Special Master’s decision regarding the Uhlmann Study and the Unigenetics testing is reasonable in all respects, and could not in any sense be regarded as arbitrary, capricious, or an abuse of discretion. (pp. 13-14)

While it may be true that requiring Petitioners to persuade three special masters of their “general causation” theory would have violated the fundamental fairness provision of Vaccine Rule 8, Petitioners cite nothing in the Special Master’s decision or the record to indicate that they were held to an impermissible burden. To the contrary, while Special Masters Vowell and Campbell-Smith sat on the bench with him during the evidentiary hearing, Special Master Hastings explained that the role of the two additional Special Masters was not to decide Cedillo, but to hear the general causation evidence provided by expert witnesses so that they could apply the evidence to the other individual test cases assigned to them. Special Master Hastings noted, “[w]hile the ‘general causation’ evidence is common to the three cases, each of us has analyzed that common evidence independently of the other two; each has reached his or her own conclusion.”

A review of the record and the Special Master’s decision shows that Petitioners were not required to persuade Special Masters Vowell and Campbell-Smith of the merits of their case. The assignment of two additional Special Masters to hear the “general causation” evidence in the test cases, and to assist in deciding some 5,000 autism cases, is an eminently reasonable case management approach. When asked at the oral argument to identify any prejudice from having a three-member panel, Petitioners’ counsel responded, “I don’t know that there was any, Your Honor.” Petitioners have failed to establish that the presence of three special masters required them to convince anyone beyond Special Master Hastings to prevail in their case, and, therefore, their challenge to the procedures used at the hearing is unavailing.

At the July 7, 2009 oral argument, the Court asked Petitioners’ counsel how the Special Master’s handling of Dr. Bustin’s reports from the British proceedings prejudiced the Cedillos, if at all. Petitioners’ counsel could not identify any prejudice aside from short-term disruption, explaining that he thought Dr. Bustin was helpful to the Cedillos’ case, and admitting, “there was no ultimate prejudice” from Dr. Bustin… [T]he Court concludes that the Special Master’s admission of Dr. Bustin’s testimony and expert reports was reasonable, Petitioners suffered no prejudice therefrom, and the Special Master did not abuse his discretion in this regard. The Special Master further observed, and the Court agrees, that he would have decided the petition on the merits the same way even if he had disregarded Dr. Bustin’s testimony and expert reports. (pp. 17-20)

Upon careful review of the “concessions” cited by Petitioners, the Court finds that Respondent’s expert witnesses indeed agreed with some aspects of Petitioners’ theory of causation. However, in their motion for review, Petitioners simply have woven together as many areas of agreement as possible, and have blindly overlooked the compelling conclusions advanced by Respondent’s experts.

This is not a case where the Special Master declined to consider important evidence, or failed to admit relevant exhibits or testimony. To the contrary, the Special Master thoroughly considered every viewpoint of every expert witness, both Petitioners’ and Respondent’s, and concluded that the evidence was “overwhelmingly” in Respondent’s favor. This Court will not second guess a Special Master’s fact-intensive conclusions, especially when medical evidence of causation is in dispute. (pp. 22-23)

Petitioners incorrectly contend that the Special Master afforded the records of the treating physicians “absolutely no probative value.” The Special Master devoted a separate section of the decision to the records of the treating physicians. As the Court finds that the Special Master properly evaluated these records, it will not disturb the Special Master’s conclusions…

Petitioners challenge the Special Master’s assessment of Dr. Krigsman, their expert in gastroenterology. Petitioners allege that the Special Master “reserved special venom” for Dr. Krigsman and failed to evaluate his diagnosis of [the child], while crediting instead the testimony of Respondent’s expert, Dr. Hanauer. Contrary to Petitioners’ assertion, the Special Master analyzed Dr. Krigsman’s testimony in great detail, and found it unpersuasive. Dr. Krigsman testified that [the child] has inflammatory bowel disease, which the MMR vaccination caused. The Special Master rejected this view…

The Special Master noted that Dr. Krigsman diagnosed [the child] with inflammatory bowel disease in July 2003, before he ever met or examined her. He also observed that Petitioners never offered any rebuttal testimony to Dr. Hanauer’s criticisms of Dr. Krigsman’s opinion. The Special Master offered three chief reasons why Dr. Krigsman’s opinion should be rejected. First, Dr. Krigsman relied upon the discredited Unigenetics testing in forming his opinion. Second, the Special Master determined that Dr. Krigsman had a “grossly mistaken understanding of the history of [her] gastrointestinal symptoms,” and that his testimony was inconsistent with [her] medical records. Third, he found Dr. Krigsman’s conclusion that [the child] suffered from chronic gastrointestinal inflammation to be “substantially outweighed by a combination of the medical records and the testimony of respondent’s experts, especially Dr. Hanauer.” The Court will not second-guess the Special Master’s analysis and credibility assessments of Dr. Hanauer or Dr. Krigsman.(pp. 21, 24-25)

The Special Master acknowledged the testimony of Petitioners’ expert, Dr. Marcel Kinsbourne, that persistent measles virus in the human brain might cause a different disorder besides SSPE or MIBE. The Special Master explained, however, that Dr. Kinsbourne “supplied no evidence for such a possibility, beyond his own unsubstantiated speculation.” …The evidence on neuroinflammation supports the Special Master’s conclusion that Respondent’s experts presented a far more compelling position, and were much better qualified, than Petitioners’ experts. The Special Master carefully examined every position advanced by the parties in his undeniably thorough decision. The Court rejects Petitioners’ assertion that the Special Master’s determination was arbitrary, capricious, or an abuse of discretion.

The Special Master provided a full and careful analysis of [the petitioners’] experts’ testimony and their qualifications, and concluded Petitioners failed to demonstrate that thimerosal damaged [the child’s] immune system. The Court sees no basis for disturbing the Special Master’s evaluation of these expert witnesses… Based upon all of the expert testimony, the Special Master found no evidence that the amount of ethyl mercury in thimerosal causes any immune dysfunction. The record supports this determination. Furthermore, the Special Master provided sufficient reasoning in his decision for his acceptance of Dr. Brent’s expert analysis instead of Dr. Aposhian’s. Upon careful review, the Court will not disturb these conclusions. (pp. 26-27)

Petitioners challenge the dismissal of their motion for reconsideration, contending that the Special Master abused his discretion by refusing to consider significant post-hearing evidence. Petitioners filed their motion for reconsideration with the Special Master on March 13, 2009, just three days before a motion for review would have been due in this Court… Petitioners offered no explanation for filing their motion outside of the 21-day time period. As the Special Master speculated, by filing on March 13, 2009, Petitioners seemingly positioned the motion for a prompt ruling from the Special Master without an opportunity for Respondent to answer… The Court finds that the Special Master acted well within his discretion in denying Petitioners’ motion for reconsideration. Petitioners did not timely file their motion under Vaccine Rule 10(e), and the Special Master properly determined that there was no reason “in the interest of justice” to consider the evidence proffered with the motion. (pp. 28-29)

Petitioners first argue that the Special Master improperly applied Daubert in evaluating the reliability of their expert testimony and other scientific evidence. In Daubert, the Supreme Court set forth four factors for determining the admissibility of scientific evidence at trial. These factors are (1) general acceptance in the scientific community, (2) whether the theory has been subjected to peer review and publication, (3) whether it can and has been tested, and (4) whether the known potential rate of error is acceptable. According to Petitioners, courts may only use the Daubert factors to assess expert witnesses’ methodology and not their ultimate conclusions. Therefore, the Special Master acted contrary to the law in applying Daubert to assess the reliability of Petitioners’ expert witnesses and other scientific evidence. Federal Circuit precedent clearly permits the Special Master to apply Daubert when evaluating the reliability of the parties’ evidence. In Terran v. Secretary of Health and Human Services, the Court of Federal Claims concluded that “Daubert is useful in providing a framework for evaluating the reliability of scientific evidence,” both under the Federal Rules of Evidence and in Vaccine Act cases. In affirming this decision, the Federal Circuit found reasonable the trial court’s application of Daubert to assess the reliability of an expert witness. Furthermore, the Supreme Court has clarified language in Daubert stating that the focus of a Daubert inquiry must be “‘solely on principles and methodology, not on the conclusions that they generate’” by acknowledging that “conclusions and methodology are not entirely distinct from one another… A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”

Here, the Special Master concluded that “another important aspect of the causation-in-fact law under the [Vaccine] Program concerns the factors that a special master should consider in evaluating the reliability of expert testimony and other scientific evidence relating to causation issues.” He then referenced the Daubert factors “that federal trial courts should utilize in evaluating proposed expert testimony concerning scientific issues.” In applying Daubert, the Special Master simply found that the evidence did not support the conclusions proffered by Petitioners’ experts. The Special Master had the discretion under Terran to apply Daubert when assessing the conclusions of the parties’ expert witnesses, and, therefore, he did not act contrary to law. (pp. 29-30)

The Special Master determined that Petitioners failed to offer a reliable medical theory as to how the MMR vaccine can cause autism or inflammatory bowel disease, and that any such theories were highly speculative… The Special Master’s conclusion that Petitioners failed to demonstrate any relationship between the MMR vaccine and [the child’s] autism is eminently reasonable. He determined that they offered “virtually no evidence” to support their claim… The Special Master provided substantial evidentiary support for his conclusion that Petitioners failed to show, by a preponderance of the evidence, a scientific temporal relationship between the MMR vaccine and [the child’s] autism or gastrointestinal problems. There is no evidence to support Petitioners’ claim that the Special Master elevated the burden of proof set forth in Althen.

Petitioners allege that the Special Master disregarded precedent in which the Court granted relief to petitioners, particularly where the MMR vaccine caused injury, based on evidence allegedly similar to or less compelling than the evidence presented here. Petitioners point to a list of cases in which medical records, affidavits, expert testimony, and scientific articles, all based on circumstantial evidence alone, established that vaccines have caused certain injuries… The Special Master explicitly rejected Petitioners’ argument for faulty logic, noting that Petitioners failed to mention the thousands of other cases in which special masters have denied relief for failure to prove by a preponderance of the evidence that a vaccine caused an injury. Furthermore, he concluded that [the child’s] case bears no resemblance to those cited by Petitioners… The Court finds no legal error in the Special Master’s determination that these cases are factually distinct from the case at hand. Unlike the medical issues raised in other Vaccine Act cases, autism is not an area “‘bereft of complete proof.’” As the Special Master explained in his decision, scientists have performed numerous, reputable epidemiological studies worldwide that have attempted, and failed, to detect an association between childhood vaccinations and autism. Furthermore, Petitioners have again mischaracterized the law under Althen. While a special master must resolve “close calls” in favor of a petitioner, Special Master Hastings concluded that this “is not a close case;” rather, “[t]he overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories.” Petitioners still have the burden of proving their claims by a preponderance of the evidence, and the Special Master reasonably concluded that they failed to do so. Accordingly, Petitioners’ argument that the Special Master’s decision was not in accordance with the law is without merit. (pp. 32-33)

The issue before our Court is not to determine the causes of autism. The Court can only hope that medical professionals succeed in identifying the causes and developing a cure for this tragic disease. Rather, the Court’s task is to weigh the Special Master’s February 12, 2009 decision under the applicable review standards of the Vaccine Act, and determine whether it should affirm or modify the decision to any extent. After performing this review, the Court is satisfied that the Special Master’s decision is rational and reasonable in all respects, and is in accordance with law. For the reasons addressed above, the Special Master’s decision is AFFIRMED. (p. 33)

As with the Hazlehurst “test case” dismissal issued on July 24, any appeal of this latest ruling in Cedillo v. HHS must be filed in the U.S. Court of Appeals for the Federal Circuit.

Comments


  1. “This is not a case where the Special Master declined to consider important evidence, or failed to admit relevant exhibits or testimony. To the contrary, the Special Master thoroughly considered every viewpoint of every expert witness, both Petitioners’ and Respondent’s, and concluded that the evidence was “overwhelmingly” in Respondent’s favor.”

    The petitioners in the OAP were given the fairest hearing imaginable. If they bring their case as a tort claim in another court, much of their evidence will probably never even reach the jury.

    Thanks for blogging about this. It’s been a really interesting look at the workings of the vaccine court, a place I’ve never been and probably will never go. The Special Masters’ handling of these cases has been impressive to me.

    — Anne    2009-08-11 15:23    #

  2. Not sure how any of this, the case or the reporting on the case helps the very real struggles of autistic people throughout a lifespan. Inclusion, opportunity, education and support services are a much better focus in my opinion than vaccine reporting. Not a single adult or child will be helped by the thousands of well researched words evidenced here. How beautiful a thing it would be if this energy were devoted to shutting down JRC, expanding opportunities in education for autistic people and preventing institutional abuse and neglect. Such a waste. Sorry to be Danny Downer.

    — K    2009-08-11 17:34    #

  3. K, if you think my reporting on autism-vaccine litigation is a waste of time, why do you waste your own time reading it and responding to it? There are plenty of other things you could be doing. I welcome you to check out my index of articles by date and subject. You will find many posts devoted to the sort of advocacy you feel is superior to what you have found on this page.

    — Kathleen Seidel    2009-08-11 18:17    #

  4. I agree with Anne that the test cases got the fairest hearing possible. They were allowed to argue from evidence no other court would let in. They had years to prepare.

    I sincerely doubt they can win in civil court unless they get some new evidence.

    — Sullivan    2009-08-11 18:55    #

  5. K, it’s interesting to me because I’m interested in law stuff, and also from the perspective of how autistic kids are treated medically. In a couple of these cases, the special masters seemed horrified by the medical treatment the kids received from practitioners with hairball ideas.

    Re the JRC, there’s an interesing case pending in the US District Court for the Northern District of New York, Alleyne v. NYSED, where a group of parents of JRC inmates are suing the NY State Education Department for enacting regulations that allegedly violate their kids’ “civil right” to be shocked.

    All these cases are interesting because of the issue of how you evaluate the best interest of kids who are developmentally disabled.

    — Anne    2009-08-11 23:02    #

  6. “K, if you think my reporting on autism-vaccine litigation is a waste of time, why do you waste your own time reading it and responding to it?”

    Good question. Its just a suggestion. However, this ground has been covered ad nauseum through the decades and nothing has changed and it won’t change because your dealing with grief. Some folks respond to grief appropriately and some do not.

    The link you gave to the Rick Astley video, was that meant to be light-hearted? I didn’t find it very funny nor appropriate considering we are talking about helping folks with real lifespan issues.

    The index you referenced contained very few links on improving inclusion, opportunity, services and education. About 95% of it had to do with biomedical and or vaccines.

    Anyone can concentrate on the area they choose I suppose. I think your a talented researcher, I just wish that talent was used to shut down or put the spotlight on the systemic abuses taking place right now as I type with children and adults being electrocuted and very few people are advocating for them. They could really use the help.

    — K    2009-08-12 09:54    #

  7. K, the Rick Astley video was an appropriate response to any concern troll.

    Kathleen is within her right to investigate what she wants. If you want a blog to investigate your concerns, then go and get your own blog.

    In the meantime send over your support to Kristina Chew’s new blog, http://www.kristinachew.com/Site/vox/vox.html and Mike Stanton’s blog, http://actionforautism.co.uk/ and the multi-author blog, http://leftbrainrightbrain.co.uk/

    — Chris    2009-08-12 13:20    #

  8. So what happens next, since the petitioner parents have vowed never to give up? Will they all go home and file 5000 individual cases in their local federal district courts?

    — DT35    2009-08-12 14:42    #

  9. They’ll probably appeal to the Federal Circuit. And once those appeals are dismissed (the most likely scenario), some of the more imaginative attorneys may try to appeal to the Supreme Court — though it’s not likely they would be granted certiorari, since there are no constitutional questions involved.

    What'll happen after that is anybody's guess. Here are a couple of mine. One, I guess that there aren't too many parents of spectrum kids who have the means to pay an attorney $300/hour to pursue a civil suit. And two, I guess that there aren't too many attorneys who would be foolish enough to take on contingency a medical causation case in which all of the evidence and arguments have already been so thoroughly evaluated and deemed both scientifically and legally inadequate.

    — Kathleen Seidel    2009-08-15 11:15    #