Federal Claims Court Dismisses Third MMR-Autism Appeal · 2009-08-12 17:30

In a 59-page decision issued yesterday afternoon, August 11, Judge Margaret M. Sweeney of the United States Court of Federal Claims sustained the ruling of Special Master Denise K. Vowell dismissing the Vaccine Injury Compensation Program claim, Snyder v. U.S. Department of Health and Human Services (Case No. 01-162V) — the last of the three Omnibus Autism Proceeding test cases in which petitioners sought to establish that a combination of the MMR vaccine and thimerosal-containing vaccines, acting in concert, are capable of causing autism spectrum disorders.

Arguments raised in the Snyder appeal were virtually identical to those raised by the petitioners in Cedillo v. HHS and Hazlehurst v. HHS.

The decision includes an extensive discussion of the role of the special master in Vaccine Injury Compensation Program proceedings, elucidating the differences between VICP vaccine injury claims and conventional tort claims. Judge Sweeney herself served as a VICP special master from 2003-2005, and ruled on dozens of such cases.

From the decision:

[W]hen considering the provisions and legislative history of the Vaccine Act, the language of the Vaccine Rules, and the case law, one factor that has remained constant in the Vaccine Program is the necessary and important role of special masters in conducting proceedings and rendering decisions in Vaccine Act cases. The special masters have great leeway in how they conduct proceedings, including what evidence to consider and how to weigh that evidence, and their credibility determinations and fact-intensive conclusions are afforded great deference. However, this is not to suggest that the special masters are infallible and that their final decisions are sacrosanct. To be sure, the Court of Federal Claims on review, and the Federal Circuit on appeal, do not merely rubber stamp special master final decisions. Decisions from both courts demonstrate a willingness to reverse the decision of a special master when the special master has failed to adequately develop the record, failed to consider facts critical to the case, failed to give adequate consideration to a viable medical theory, or otherwise misapplied the law. Nevertheless, the law is settled that neither the Court of Federal Claims nor the Federal Circuit can substitute its judgment for that of the special master merely because it might have reached a different conclusion. Reversal is appropriate only when the special master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law. (pp. 16-17)

[P]etitioners’ contention that they were required to prove their case to all three special masters lacks merit. Although all three special masters heard and considered the general causation evidence, they issued separate decisions applying that evidence to their respective test case. The special masters were free to reach different conclusions based on the same evidence. That all three reached the same conclusion – rejecting petitioners’ theory of causation – does not mean that petitioners were required to satisfy all three special masters. There is nothing in the record suggesting that the special masters were bound to speak with one voice. Nor can petitioners point to evidence that Special Master Vowell rendered her decision in consultation with the other two special masters. Rather, petitioners generally contend that their review of the three special masters’ decisions caused them to conclude that they had to prove their individual case to all three special masters. The court finds no evidence in the record to support this purported heightened burden. Moreover, the decision of the special masters to conduct the general causation hearing together, rather than require three separate hearings concerning the general causation issue with the resultant duplication of the time and resources of the OSM, petitioners, and respondent, hardly suggests fundamental unfairness. To the contrary, it reflects a common-sense, cost-saving approach to complex litigation. Accordingly, the use of a panel of three special masters to hear the general causation evidence was not arbitrary, capricious, an abuse of discretion, or contrary to law. (pp. 19-21)

Petitioners complain that the filing of Dr. Bustin’s “highly technical” reports from the U.K. MMR litigation “on the eve of trial” and the submission of Dr. Bustin’s “impossibly technical power-point [sic] presentation at the hearing” were “grossly unfair” because counsel for the Cedillo petitioners had “no time to review the documents, let alone prepare for crossexamination.” However, petitioners could not have been surprised that respondent would need to address the laboratory results from Unigenetics – evidence that the petitioners, not respondent, put in play. As is clear from the record and as they acknowledge in their motion for review, the Unigenetics test results were “the single-most critical issue in the case.”

…[I]t is clear to the court that petitioners have no basis to complain about the special master admitting Dr. Bustin’s expert reports into the record. It was not until February 2007 – when petitioners filed their expert reports – that respondent could have been aware that the test results from Unigenetics were crucial to petitioners’ theory of causation. Indeed, respondent did not actually become aware of the importance of the test results until March 2007 after he retained expert witnesses to review, analyze, and respond to petitioners’ expert reports. There is no question that respondent was not dilatory in obtaining as much information relevant to petitioners’ theory of causation as possible prior to the Cedillo hearing in June 2007. It would have been grossly unfair to respondent had he been hampered in his ability to counter petitioners’ theory of causation as a result of petitioners’ failure to fully explain their theory of causation until four months before hearing, especially in light of his due diligence. It is worth remembering that in Vaccine Program proceedings, petitioners have the burden of going forward, and only after petitioners have made a prima facie case does the burden of persuasion shift to respondent. Thus, without the formal discovery that is available in other civil litigation, it is not surprising that respondent in this case could not anticipate the precise nature of petitioners’ theory of causation and supporting testimony.

Moreover, as previously described, the special master afforded petitioners ample opportunity to respond to the contents of Dr. Bustin’s reports once the Cedillo hearing had concluded. She, along with the two other special masters, repeatedly queried petitioners about their efforts to obtain additional information from the U.K. MMR litigation, encouraged petitioners to obtain the information, and offered to join in petitioners’ application for the release of the information from the court in the United Kingdom. There were almost five months between the Cedillo and Snyder hearings, eight months between the Snyder hearing and the close of the evidentiary record, and six months between the close of the evidentiary record and the special master’s issuance of a decision. Thus, petitioners had approximately nineteen months within which to obtain whatever information they believed necessary to respond to Dr. Bustin’s expert reports and testimony. Given this extraordinary amount of time to secure any additional information, petitioners’ claim of prejudice fails. The special master’s conclusion to this effect was not arbitrary, capricious, or an abuse of discretion. (pp. 22, 24-25)

Immediately problematic is that petitioners do not explain how the special master’s alleged failure to consider certain evidence would have altered her decision. They allege that the special master disregarded evidence, but fail to explain the evidence’s materiality to their case. This failure, in itself, nullifies petitioners’ criticism. Yet, even presuming that petitioners’ contention is that this evidence would have tipped the scales in their favor such that they would have been able to demonstrate causation by a preponderance of evidence, their contention is flawed in two respects. First, the special master’s decision reflects that she carefully considered the entire voluminous record in this case. Second, petitioners fail to demonstrate that the special master improperly weighed the evidence in the record. (pp. 25-26)

It is of no import that the special master may not have attributed [certain] assertions to Dr. Griffin or indicated that Dr. Griffin concurred with them – it is clear that she did, in fact, consider the statements, or the underlying ideas represented by the statements… [I]t is of no import that the special master may not have attributed [certain] assertions to Dr. [Brian] Ward or indicated that Dr. Ward concurred with them – it is clear that she did not ignore the statements, or the underlying ideas represented by the statements… Had [Dr. Robert Fujinami’s] article been as valuable to petitioners’ case as they claim, surely they would have sought to subpoena Dr. Fujinami’s testimony or retain his services… It does not matter that the special master may not have attributed the assertions to Dr. [Bertus] Rima or indicated that Dr. Rima concurred with them – it is clear that she considered the statements, or the underlying ideas represented by the statements. Altogether, there is no indication that the special master ignored the evidence cited by petitioners regarding the reliability of the test results from Unigenetics when rendering her decision.(pp. 29, 31, 32, 37, 38)

Petitioners did not advance a theory of “mercury induced immune dysfunction” in [this] case. Therefore, the special master had no obligation to make such a finding. Similarly, because the special master was not obligated to consider an argument that was not advanced by petitioners, she could not have ignored evidence related to that argument…

[F]ar from disregarding the statements and various subject matter cited by petitioners, the special master both considered them and assigned them the weight that she felt appropriate. Although they never expressly discuss the materiality of these statements, it is apparent that petitioners’ grievance is that the special master did not find petitioners’ expert testimony persuasive. However, the weight afforded such evidence is within the sound discretion of the special master. Because the special master did not abuse her discretion, the court will not disturb those findings. (pp. 40-41)

Although the special master had complete control over the discovery process in this case, such control does not extend to compelling a court in a foreign jurisdiction to unseal documents. Petitioners acknowledged this fact at oral argument before the undersigned. Accordingly, the special master did not improperly shift the burden to petitioners to obtain the documents from the U.K. MMR litigation – there was no burden to shift because the special master could not have obtained the evidence sought by petitioners in the first instance. (p. 46)

Petitioners filed their motion [for reconsideration] on Friday, March 13, 2009, at 6:02 p.m. Almost all of the “new” evidence submitted with the motion was published before [the special master] rendered her decision. The deadline for filing such a motion, pursuant to Vaccine Rule 10(c), was March 5, 2009. And, pursuant to Vaccine Rule 23, the thirty-day filing deadline for any motion for review fell on Monday, March 16, 2009… The court finds no abuse of discretion here. The special master held that petitioners failed to comply with the requirements of the Vaccine Rules, and even had they so complied, the evidence was insufficient to result in the granting of their motion. Both of these reasons for the special master’s denial of petitioners’ motion were well within her discretion to make. (pp. 46-47)

Petitioners first make the blanket accusation that the special master “improperly applied Daubert to the experts’ conclusions,” rather than to the methods employed by the experts. They do not expand on this allegation to show how error was committed or provide any citation to the portions of the decision containing the alleged misapplication. Thus, petitioners place the burden on the court to divine precisely how the special master’s application of Daubert might have been improper. (pp. 50-51)

The court finds no error in the special master’s application of the framework suggested by Daubert. Federal Circuit precedent explicitly permits a special master to evaluate scientific evidence using the Daubert factors. Here, the special master considered all of the relevant evidence submitted by both parties, using the Daubert factors only to determine the reliability of that evidence and, hence, the weight it should be assigned. Indeed, by allowing all relevant evidence to be admitted into the record, regardless of its reliability, the special master was actually being quite generous to petitioners. As the special master noted throughout her decision, petitioners’ expert witnesses compared unfavorably to respondent’s expert witnesses in many respects: their credentials, their demeanor, how forthcoming they were at hearing, and the quality of their testimony. Accordingly, to the extent that petitioners are complaining that the special master’s use of the Daubert factors resulted in a failure to consider their evidence, they are mistaken. Rather, the special master evaluated all of the evidence presented by both parties and determined that the science behind petitioners’ theory was lacking. Contrary to petitioners’ contention that the investigation into the link between the MMR vaccine, along with all thimerosal-containing vaccines, and autism spectrum disorders “is ‘bereft’ of science,” the record demonstrates that there is an abundance of science in this area – just not science that supports
petitioners’ position. The special master’s application of Daubert was in accordance with the law. (pp. 53-54)

When determining fundamental fairness to the parties, there is no direct correlation between the sheer volume of evidence offered and amount of evidence that must be admitted and ultimately credited at hearing. Merely because a party offers a huge volume of evidence does not mean that the special master is duty bound to accept any of that material as persuasive. (p. 50, fn. 63)

The court finds no error in the special master’s findings. The special master’s conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitioners’ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. Next, the special master’s conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record. As noted above, petitioners’ theory of causation depended upon, among other things, [the child’s] immune system being damaged by the MMR vaccine (but not thimerosal-containing vaccines), the persistence of the measles virus in [the child’s] body, [the child’s] development of inflammatory bowel disease, and the presence of the measles virus in [the child’s] brain. The special master found that petitioners had demonstrated none of these necessary elements by a preponderance of the evidence. Further, the special master’s conclusion that the onset of [his] symptoms did not occur within a biologically acceptable time period following the MMR vaccination is supported by the record. She found that based on the medical records, the onset of [the child’s] symptoms did not occur at the time suggested by petitioners. Given that petitioners had not established any of the prongs of the test set forth in Althen, the special master correctly concluded that the burden of proving an alternative cause never shifted to respondent.

Petitioners’ complaints with the special master’s decision amount to nothing more than dissatisfaction with the weight she assigned to the evidence… The special master exercised her discretion appropriately here and her decision was not contrary to law. (p. 56)

The court has addressed all of petitioners’ numbered objections, finding them to be without merit. However, petitioners lodge other complaints about the special master’s conduct that despite their lack of merit, cannot be ignored. Specifically, petitioners advance the remarkable complaint that “the special master abandoned her obligation to impartially weigh the evidence. . . . [I]nstead, the special master inappropriately assumed the respondent’s role as protector of the integrity of vaccines.” Petitioners later elaborate:

During the past decade, the publicity afforded the issue of whether vaccines can cause autism has been intense. . . . [D]ue to this publicity, . . . the special master feared that a finding in [petitioners’] favor would drive down immunization rates. For this reason, to protect the integrity of vaccines, [the child’s] case, a so-called “test” case, was treated far differently than other vaccine program petitioners. First, after thousands of other autistic children had filed claims, and after years of intense public controversy over the vaccine/autism connection, the respondent was permitted to present the opinions of seventeen experts to defeat [the petitioner’s] claim. In so doing, the special master treated [the petitioners] far differently than other petitioners. In addition, disregarding the Federal Circuit’s recent decisions in Althen and Capizzano, the special master instead invoked Daubert and found virtually all of [petitioners’] evidence unreliable. For her to do so . . . was fundamentally unfair. [Petitioners were] entitled to equal treatment.

To reinforce their attack on the special master, petitioners reiterate their allegations of bias, charging:

[T]he special master ignored [petitioners’] considerable, albeit circumstantial, evidence that a persisting vaccine-strain measles virus caused [his inflammatory bowel disease] and autism… [S]he did so because of the intense national publicity this case has received… [S]he did so to assure the American public that vaccines are safe. She did so because she views her role as a protector of the integrity of our nation’s vaccines. This, however, is the role of the respondent, not a special master.

…[T]he special master, to protect vaccine integrity in a very public case, chose to impose upon [petitioners] an unattainable standard of proof. To protect the vaccine’s integrity she rejected all of petitioner’s credible evidence and simply accepted the conclusions of the respondent’s seventeen experts, denying [petitioners] the fundamental fairness required by the Vaccine Rules, ignored Congress’[s] intent in establishing the Vaccine Program, and rejected the Federal Circuit’s interpretation of that intent.

Finally, at oral argument, petitioners attempted to justify their charge of bias by arguing that it was fundamentally unfair for the special master to admit the purportedly unreliable evidence from Dr. Bustin and Dr. Rima and, thereafter, “allow[] the credibility of those witnesses to substitute for the reliability of those witnesses on key issues…”

Petitioners’ charge – that the special master feared a public backlash against vaccines if she ruled in their favor – is preposterous. There is not a shred of evidence to support petitioners’ claim; it rests solely on petitioners’ speculation. Merely because the special master found that petitioners did not carry their burden of proof does not diminish her integrity or render her decision unsupported. Claims of error by a losing party against a decision maker are hardly unusual, but should be grounded in reality. There is an enormous chasm between disagreement with a judicial officer’s findings of fact and conclusions of law and the accusation that the judicial officer is, in essence, intellectually dishonest. An allegation of bias raises ethical concerns, not errors in judgment (i.e., legal or factual errors). Although petitioners appeared to understand this distinction at oral argument, they maintained that the special master was biased against them by unfairly “shift[ing] the burden of discovery” and “weighing… the evidence…” However, alleged errors of this nature are grounded on purportedly mistaken evidentiary rulings, factual findings, and legal conclusions, not bias. And, the court has already held that it identified no legal or factual error in the special master’s decision.

Indeed, it is abundantly clear from her decision that the special master took great care in considering all of the evidence in the record–whether presented by petitioners or respondent – and applying the appropriate legal standards in evaluating that evidence. As the Court of Federal Claims stated in Ultimo:

This sort of personal attack on the [special master] is highly inappropriate, contentious, and unpersuasive. . . . Petitioner . . . accuses the [special master] of subverting the intent of Congress in establishing the Program. The court will not condone such frivolous, unsubstantiated accusations. Accordingly, the court finds that petitioner’s… objection is completely without merit. Petitioner is forewarned that any repetition of such groundless accusations may cause the court to entertain sanctions against petitioner and petitioner’s counsel pursuant to RCFC 11. 28 Fed. Cl. at 153. (pp. 56-59)

As the special master’s decision makes clear, [the child], and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitioners’ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitioners’ motion for review. (p. 59)

Comments


  1. So that’s it for the first theory of causation. I think it’s likely that the petitioners will appeal these cases to the Federal Circuit.

    Next up should be the special masters’ decisions in King, Mead and Dwyer – the cases based on the theory that thimerosal-containing vaccines alone cause autism.

    There hasn’t been a rush to the door among the 5,000 autism claimants in the compensation program yet, though one recently sought a dismissal based on the outcome of the first test cases. I think most of them will sit tight until the appeals run their course.

    — Anne    2009-08-13 21:06    #