Case Information
*1 In the United States Court of Federal Claims
No. 05-626 V
(Filеd May 6, 2015) * * * * * * * * * * * * * * *
JESSIE CONTRERAS, *
* National Childhood Vaccine Petitioner , * Injury Act of 1986, 42 U.S.C.
* §§ 300aa-1 to -34 (2012); v. * Review of Credibility
* Determination; Deferential SECRETARY OF HEALTH AND * Review of the Fact Findings of HUMAN SERVICES, * the Special Master.
*
Respondent . *
* * * * * * * * * * * * * * *
Jeffrey S. Pop , Beverly Hills, CA, for petitioner. Kristina E. Grigorian , Beverly Hills, CA, of counsel.
Linda S. Renzi , United States Department of Justice, with whom were Joyce R. Branda , Acting Assistant Attorney General, Rupa Bhattacharyya , Director, Vincent J. Matanoski , Deputy Director, Voris E. Johnson, Jr. , Assistant Director, Washington, DC, for respondent.
________________________________ OPINION AND ORDER ________________________________ BUSH , Senior Judge .
*2
Now pending before the court is petitioner’s motion for review of the
special master’s decision upon a second remand from this court,
see Contreras v.
Sec’y of Health & Human Servs.
, No. 05-626V,
BACKGROUND
I. Factual History
Along with
Contreras V
, prior decisions in this case provide a factual
background for Jessie’s alleged vaccine injury of transverse myelitis (TM) and
Guillain-Barré Syndrome (GBS).
See, e.g.
,
Contreras v. Sec’y of Health & Human
Servs.
,
II. Procedural History
*3 In Contreras I , the special master denied petitioner entitlement to compensation under the Vaccine Act. In Contreras II , this court vacated that opinion and remanded the case to the special master for a revised causation analysis. In Contreras III , the special master issued a revised causation analysis which again denied petitioner entitlement to compensation. Before the special master issued his decision, however, on May 1, 2013 the Secretary filed a status report revealing previously undisclosed information regarding one of respondent’s experts, Dr. John T. Sladky, M.D. The general nature of the information concerned alcohol abuse and the suspension of Dr. Sladky’s license to practice medicine. Dr. Sladky carefully avoided revealing this negative information in documents he supplied to the court and in his testimony before the special master. [4]
In Contreras IV , in light of the recently-divulged information regarding Dr. Sladky, the court again remanded this case to the special master in order to obtain three clarifications of his fact findings as to Jessie’s entitlement to compensation under the Act. These clarifications required by the court were set forth in the “Instructions for Remand” section of Contreras IV :
(1) The special master must address Dr. Sladky’s credibility and reliability in light of the consistent pattern of misrepresentations by Dr. Sladky in his work as an expert for respondent, and provide an unambiguous estimation of Dr. Sladky’s credibility and reliability as an expert.
(2) The special master must compare Dr. Sladky’s credibility to the credibility of the experts for petitioner and the witnesses testifying for petitioner. These clarified credibility determinations should then be integrated into the special master’s decision in a manner that presents a clear ruling on entitlement for this court’s review.
(3) The special master must present an alternative ruling on causation which completely disregards all of Dr. Sladky’s opinions and testimony.
*4
Contreras IV
,
DISCUSSION
I. Standard of Review
This court has jurisdiction to review the decision of a special master in a
Vaсcine Act case. 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court
of Federal Claims reviews the decision of the special master to determine if it is
‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with
law[.]’”
de Bazan v. Sec’y of Health & Human Servs.
,
These standards vary in application as well as degree of deference. Each standard applies to a different aspect of the judgment. Fact findings are reviewed . . . under the arbitrary and capricious standard; legal questions under the “not in accordance with law” standard; and discretionary rulings under the abuse of discretion standard.
Munn v. Sec’y of Dep’t of Health & Human Servs.
,
The third standard of review, abuse of discretion, is applicable when the special master excludes evidence or otherwise limits the record upon which he relies. See id. As this court has stated, the third standard applies to the special master’s evidentiary rulings, including those regarding the qualifications of an expert:
Notably, such [discretionary] rulings include determinations regarding the qualification of expert *5 witnesses and the reliability of expert testimony.
Piscopo v. Sec’y of Health & Human Servs. , 66 Fed. Cl. 49, 53 (2005); see [ Gen. Elec. Co. v. Joiner , 522 U.S. 136, 142-43 (1997)] (holding that “abuse of discretion is the proper standard of review of a [trial] court’s evidentiary rulings,” including determinations regarding the reliability of expert testimony under [ Daubert v. Merrell Dow Pharm., Inc. ,509 U.S. 579 (1993))]; [ Terran ex rel. Terran v. Sec’y of Health & Human Servs. ,195 F.3d 1302 , 1316 (Fed. Cir. 1999)] (reviewing for abuse of discretion the Special Master’s decision to reject as unreliable the testimony of the petitioner’s expert). Determinations subject to review for abuse of discretion must be sustained unless “manifestly erroneous.” Piscopo ,66 Fed. Cl. at 53 ; see Milmark Servs., Inc. v. United States ,731 F.2d 855 , 860 (Fed. Cir. 1984) (holding that decisions that lie within the trial court’s discretion are to be sustained unless “manifestly erroneous”).
Jarvis v. Sec’y of Dep’t of Health & Human Servs.
,
On the particular topic of a fact-finder’s determination as to the credibility
of a testifying witness, the United States Court of Appeals for the Federal Circuit
has often stated that such determinations are “‘virtually unreviewable.’”
E.g.
,
Bradley v. Sec’y of Dep’t of Health & Human Servs.
,
II. Analysis
As a threshold matter, the court examines the scope of the remand ordered
by
Contreras IV
, which appears to have created, or at least to have contributed to,
some confusion.
See
Pet’r’s Mot. at 1 n.1 (stating that the “procedural state of the
case is unclear”); Resp’t’s Resp. at 7 n.4 (arguing that some of petitioner’s
arguments are “beyond the scope of the Court’s remand”).
Contreras IV
clearly
indicated, however, that both the special master’s denial of entitlement and his
assessment of the credibility and reliability of medical opinions are within the
scope of the latest remand.
See Contreras IV
,
In light of the foregoing, the scope of the remand ordered by Contreras IV included, at least, the following three elements: (1) clarified credibility/reliability determinations for the medical opinions offered by the рarties’ experts and witnesses in this case; (2) the entitlement decision set forth in Contreras III (supplemented by the clarifications of the special master’s credibility/reliability determinations set forth in Contreras V ); and, (3) the alternative entitlement decision rendered in which excluded Dr. Sladky’s evidence. These *7 three aspects of Contreras III and Contreras V were set forth as the proper subject for petitioner’s motion for review and the Secretary’s response brief. These three topics also provide the general outline for the court’s opinion here.
A. The Special Master’s Reliance on Dr. Sladky’s Medical Opinions Was an Abuse of Discretion
1.
Credibility/Reliability in the Context of Later-Disclosed
Misrepresentations and Lack of Candor
The court acknowledges, as does the special master in , that
there is no binding precedent from the Federal Circuit as to the proper course of
action to be followed when an expert’s lack of candor and misrepresentations
regarding his credentials are discovered after a bench trial or hearing. Opin. at 20.
Nor is the court aware of any precedent from the Supreme Court that directly
addresses this specific question. The special master examined a number of cases
for guidance and appears particularly influenced by
Elcock v. Kmart Corp.
, 233
F.3d 734 (3d Cir. 2000). Opin. at 17-18. The court does not find
Elcock
particularly helpful because much of the instruction in that opinion is focused on
the trial court’s limited role in assisting a jury to find facts.
See
The Secretary cited to
United States v. Shaffer Equip. Co.
,
The basic fact scenario in Shaffer involved a key government employee who *8 directed environmental clean-up efforts at a polluted site, oversaw the creation of the administrative record of the clean-up efforts, and testified in support of the government’s claims seeking to recoup clean-up costs from the landowners. 11 F.3d at 453-55. This employee lied about his educational credentials on his government employment application, his resume, and in depositions or testimony in various lawsuits. Id. at 454-55. The trial court, finding that the government’s attorneys had violated their duty of candor to the court by not disclosing the credibility problem for this witness, dismissed the government’s claims in their entirety. Id. at 456.
On appeal, the United States Court of Appeals for the Fourth Circuit first discussed the fundamental requirement for truth in court proceedings:
Our adversary system for the resolution of disputes rests on the unshakable foundation that truth is the object of the system’s process which is designed for the purpose of dispensing justice. However, because no one has an exclusive insight into truth, thе process depends on the adversarial presentation of evidence, precedent and custom, and argument to reasoned conclusions – all directed with unwavering effort to what, in good faith, is believed to be true on matters material to the disposition. Even the slightest accommodation of deceit or a lack of candor in any material respect quickly erodes the validity of the process. As soon as the process falters in that respect, the people are then justified in abandoning support for the system in favor of one where honesty is preeminent.
Shaffer
,
The appeals court did not agree with the trial court, however, that the extreme sanction of dismissal was the appropriate resolution with regard to the credibility and lack of candor problems in the government’s presentation of its case. Instead, the circuit court’s approach was to caution that a trial court was required to not only exercise its inherent power to dismiss with restraint, but that it could only exercise that power after considering several factors. These factors, which in the court’s view evince an obvious general applicability to situations in which candor to a court has been lacking, were set forth by the circuit court as follows:
(1) the degree of the wrongdoer’s culpability; (2) the extent of the client’s blameworthiness if the wrongful conduct is сommitted by its attorney, recognizing that we seldom dismiss claims against blameless clients; (3) the prejudice to the judicial process and the administration of justice; (4) the prejudice to the victim; (5) the availability of other sanctions to rectify the wrong by punishing culpable persons, compensating harmed persons, and deterring similar conduct in the future; and (6) the public interest.
Shaffer
,
The special master here does not appear to have considered either deterrence or the public interest in his credibility and reliability findings regarding Dr. Sladky, or in his decision to rely upon Dr. Sladky’s evidence in this case. Dr. Sladky’s evidence on every topic, save his credentials, has been accorded full and undiminished weight in Contreras III and . [5] According to the special *10 master’s opinion:
Dr. Sladky satisfies the minimal standard for credibility. Dr. Sladky also offered opinions based upon reliable methodologies. His opinions, therefore, remain in the record and, to the extent that Mr. Contreras has argued that his testimony should be stricken, Mr. Contreras’s request is denied.
Opin. at 31. In the court’s view, the special master’s reliance on Dr. Sladky’s testimony and opinions constitutes manifest error and an abuse of discretion.
In his latest opinion, the special master ably surveys cases which show the
range of measures that a judicial officer may take in response to the disclosure of
negative information reducing a witness’s credibility. Opin. at 16-26. It is
difficult to establish a bright-line rule for Vaccine Act proceedings from these
cases, for a number of reasons. Some of the cases discussed by the special master
address the admissibility of witness testimony, and give basic guidance as to when
a trial judge should permit a witness with credibility problems to testify in front of
a jury.
See, e.g.
,
In re Heparin Prods. Liab. Litig.
,
Even when a bench trial ruling regarding a witness’s below-average
credibility is presented in the cases cited by the special master, it is impossible to
discern a rule for solving the problem of an expert witness who consistently
misrepresents his credentials. In an unreported decision cited by the special
master, a United States District Court was adjudicating a damages dispute after
liability had already been decided when one of the damages experts
*11
misrepresented his recently-expired credential.
Pikas v. Williams Cos.
, No. 8-cv-
101-GKF-PJC,
The court finds more persuasive authority in
In re Unisys Sav. Plan Litig.
,
Even if a pattern of misrepresentation is seen by the fact-finder as less
consequential in its effect on an expert witness’s credibility and reliability, the
court cannot read persuasive caselaw as permitting a fact-finder to brush past the
credibility problem merely because the only documented misrepresentations in the
record were on the subject of the expert’s qualifications. In similar cases, a
rational approach is to diminish the weight of that expert’s testimony or to subject
that expert’s testimony to stricter scrutiny.
See, e.g.
,
Harkabi v. SanDisk Corp.
,
*12
In another Vaccine Act case, the chief special master thoroughly explored
the issue of Dr. Sladky’s credibility and reliability, as well as the pattern of
misrepresentations in his work for respondent in a number of cases, when she
discussed two expert “witnesses with ethical challenges.”
Raymo v. Sec’y of
Health & Human Servs.
, No. 11-654V,
Standing alone, the basis for Dr. Sladky’s disciplinary action might not affect the reliability of his expert opinions. However, his failure to disclose the disciplinary action to respondent, his authoring of expert opinions while he did not have an active medical license, and the failure to reflect his voluntary leave from medical practice due to a substance abuse problem on the [ curriculum vitae ] filed in this case all cast doubt about his credibility as a witness.
Id. at *15. The court notes that the chief special master, like the Third Circuit in Unisys , treated credibility and reliability as related and roughly equivalent concepts. See id. at *13-15 (employing the terms credibility and reliability interchangeably).
The chief special master in Raymo concluded that she must exclude Dr. Sladky’s opinions:
Although both Dr. Becker and Dr. Sladky are well qualified to opine, I cannot rely on their opinions. I administer an oath to witnesses that requires that they tell the whole truth. Neither Dr. Becker nor Dr. Sladky told the whole truth. Both demonstrated a lack of candor that, although not related directly to the substance of their causation opinions, reflect their willingness to, at the very least, shade the truth. In the case of Dr. Becker, he attempted to pass off another’s work as his own. In the case of Dr. Sladky, it appears that he so feared the loss of his position and income as a case reviewer for respondent that he withheld facts concerning his medical license suspension. I thus do not rely at all on their expert opinions in this case.
Having reviewed the most persuasive cases discussing, in a non-jury setting, the significance of: (1) truthfulness in judicial proceedings; (2) lack of candor to the court; (3) misrepresentations of an expert witness’s credentials; (4) the importance of deterrence of similar behavior; and, (5) the close connection between credibility and reliability, the court believes that in the circumstances of this case it was manifest error for the special master to fail to exclude Dr. Sladky’s evidence, or at the very least, to significantly discount the reliability and weight of Dr. Sladky’s opinions. Although a variety of meaningful responses to Dr. Sladky’s “ethical challenges” might have been appropriate, it was an abuse of discretion to completely ignore those ethical challenges in weighing the reliability of Dr. Sladky’s opinions. See Opin. at 27 n.17 (“The reliability of Dr. Sladky’s opinion does not take into account the lack of disclosures that diminish his credibility.”). In other words, the special master’s conclusions that “Dr. Sladky satisfies the minimal standard for credibility,” id. at 31, and that Dr. Sladky’s opinions on diagnosis, timing, and causation were reliable, id. at 29-31, constitute manifest error.
2. Credibility and Reliability Cannot Be Viewed as Distinct and Severable Concepts
The special master analyzed Dr. Sladky’s credibility and reliability separately, and treated these two terms as distinct aspects of an expert’s evidence. It appears that the special master believes that an expert witness can be judged to be not credible, but can at the same time be judged to be a source of reliable expert testimony. The court provides here a few excerpts from to illustrate the special master’s logical construct.
First, after a lengthy discussion of Dr. Sladky’s lack of candor with the Secretary and this court, the special master notes:
It is relatively easy to find that Dr. Sladky feared answering questions about why he lost his license and his fear motivated him to do what he could to avoid answering those questions. What Dr. Sladky did to protect himself was to remain silent. This was an error on Dr. Sladky’s part and this error appears to be intentional.
Opin. at 25 (discussing one “factor weighing against Dr. Sladky’s credibility”). Nonetheless, the special master balanced Dr. Sladky’s credibility “negatives” with what he apparently viewed as credibility “positives”:
Given that Dr. Sladky testified in Mr. Contreras’s case, it is appropriate to review the remainder of his testimony to look for places when he could be viewed . . . as shading the truth. . . . The remainder of Dr. Sladky’s testimony should be considered in evaluating his credibility because special masters should consider the entire record in making a decision.
Does Dr. Sladky’s substantive testimony demonstrate other examples of presenting something other than the truth, the whole truth, and nothing but the truth? Apart from the aspect of his testimony concerning his personal qualifications, Dr. Sladky appeared *15 accurate, honest, and forthcoming.
Id. at 26 (citations omitted). The court notes that this is an odd test for credibility, which apparently calculates whether the number of instances of known deceptions are outweighed by instances of what appear to be truthful and accurate statements. The special master cites as authority for this approach the dissent rejected in Unisys . Id.
After recounting elements in Dr. Sladky’s testimony which could be viewed as favoring petitioner’s cause, the special master stated that “[f]or his substantive opinions, Dr. Sladky appeared credible,” and that “[o]n the whole, Dr. Sladky’s candor on substantive matters offsets his lack of disclosures regarding personal matters.” Opin. at 27. The special master then concluded that “Dr. Sladky is sufficiently credible that his testimony should be evaluated for its reliability.” Id.
In the court’s view, the first half of the credibility/reliability analysis in
, which apparently gives Dr. Sladky a passing credibility score
because his misrepresentations as to his qualifications were outnumbered by
“forthcoming” statements interpreting medical science, is neither logical nor
grounded in persuasive authority. In
Shaffer
, for example, the government’s
attorneys, despite their ethical lapses, ceased to rely on their key witness once they
knew he had repeatedly lied about his credentials.
In persuasive caselaw, courts typically consider an expert’s
misrepresentations as to his qualifications to be serious transgressions.
See, e.g.
,
In re Vioxx Prods.
,
The court turns now to the special master’s assessment of the reliability of the evidence provided by Dr. Sladky. As stated supra , the special master excluded Dr. Sladky’s lack of candor and misrepresentations from the inquiry into the reliability of Dr. Sladky’s evidence. Opin. at 27 n.17. Instead of clarifying the impact of Dr. Sladky’s credibility problems upon the reliability of his evidence, as this court attempted to request in its remand, the special master performed a Daubert analysis of Dr. Sladky’s opinions provided in this case. Id. at 27. The special master acknowledged that there is some imprecision in the use of the terms credibility and reliability in Vaccine Act cases and elsewhere. Id. at 20 n.13 (citations omitted).
To the extent that the remand instructions in
Contreras IV
may have
contributed to the special master’s decision to divorce credibility from reliability,
the court regrets any ambiguity in that opinion. The court utilized both terms,
credibility and reliability, in its remand instructions because each of these terms is
present in precedential cases discussing the credibility of expert witnesses in the
Vaccine Program.
See, e.g.
,
Porter v. Sec’y of Health & Human Servs.
, 663 F.3d
1242, 1250 (Fed. Cir. 2011) (holding that “this court has unambiguously explained
that special masters are expected to consider the credibility of expert witnesses in
*17
evaluating petitions for compensation under the Vaccine Act”);
Broekelschen v.
Sec’y of Health & Human Servs.
,
A distinction should be drawn between the content of Dr. Sladky’s opinions, which may match the special master’s view of the case, and the credibility of Dr. Sladky as an expert who provided two expert reports and testimony in this case. In essence, the question of credibility focuses on whether Dr. Sladky was a reliable source of expert opinion in this case, not whether his opinions, as buttressed by othеr expert opinion and evidence, were persuasive on particular issues.
Id. at 484 n.12.
In , the special master concluded that Dr. Sladky’s diminished
credibility was not relevant to the determination of the reliability of Dr. Sladky’s
testimony and opinions. In
Contreras III
, he came to the opposite conclusion:
“The failure to disclose this important information [regarding Dr. Sladky’s
alcoholism and licensure problems] bears on [Dr. Sladky’s] credibility and
reliability as an expert witness.”
The court cannot wholly separate credibility from reliability in this case. As
noted
supra
, courts generally find a strong connection between an expert’s
credibility and the reliability of that expert’s opinions; further, these
determinations are not unrelated to the question of how much weight should be
accorded to a particular expert’s opinion, or whether such an opinion is ultimately
found to be persuasive.
E.g.
,
Porter
,
3. The Special Master’s Credibility and Reliability Determinations Cannot Stand The abuse of discretion standard applicable here is highly deferential, as noted supra . In the particular circumstances of this case, however, the court finds that the special master failed to integrate a rational credibility determination into his ruling on entitlement in Contreras III . It would have been rational to have excluded Dr. Sladky’s evidence, as did the chief special master in Raymo . It could have been rational to have considered Dr. Sladky’s evidence while assigning that evidence diminished weight and greater scrutiny. The special master in this case chose neither of these rational courses of action. Based on this court’s review of relevant authority, and particularly in light of the need for deterrence of similar behavior from experts guiding speciаl masters in Vaccine Act cases, the court finds that the special master’s credibility and reliability determinations in constitute manifest error and an abuse of discretion.
B. The Special Master’s Denial of Entitlement to Compensation in Contreras III , Tainted by Unqualified Reliance on Dr. Sladky’s Testimony and Opinions, Cannot Be Sustained *19 1. Dr. Sladky’s Testimony and Opinions Were Sufficiently Important to the Result in Contreras III to Invalidate That Ruling
If Dr. Sladky had been merely a peripheral witness in this litigation, the special master’s unqualified (and inappropriate) reliance on Dr. Sladky’s testimony and opinions for his entitlement ruling in Contreras III might have been harmless error. But as the special master clearly shows in Contreras V , Dr. Sladky’s testimony and opinions were considered for rulings on Jessie’s diagnosis, Opin. at 39, 41; the timing of onset, id. at 44-47; the theory of causation, id. at 53- 56; and, albeit minimally, any logical sequence of cause and effect connecting Jessie’s vaccinations to his alleged vaccine injury, id. at 57. Because Contreras III and the special master’s findings on entitlement therein, as clarified by , rely on Dr. Sladky’s testimony and opinions as if he had no credibility problems at all, the court finds that the entitlement ruling in Contreras III is tainted by the special master’s manifest error and cannot be sustained.
2.
Less Significant Errors in
Contreras III
and
Contreras V
a.
Diagnosis Not Required in Jessie’s Case
The special master’s causation analysis in
Contreras I
bеgan with his
diagnosis of Jessie’s alleged vaccine injury; the special master found preponderant
evidence of a sole diagnosis of TM, not TM and GBS.
Contreras I
, 2012 WL
1441315, at *8. In
Contreras II
, this court opined that diagnosis by a special
master of an alleged vaccine injury is not appropriate except in limited
circumstances, none of which applied in this case.
Contreras II
,
The court restates here its concern regarding the special master’s threshold inquiry into the diagnosis of Jessie’s alleged vaccine injury. In a typical Vaccine Act case adding this threshold inquiry does not serve a useful purpose and may actually cause significant harm:
If . . . the petitioner’s array of symptoms is diagnosed, perhaps wrongly, by the special master, as an initial step in the causation-in-fact analysis, that petitioner’s case could be drastically compromised. The testimony mustered by the petitioner might focus on a causation mechanism that could persuasively link a vaccine to petitioner’s proffered diagnosis, but that same testimony might be unpersuasive as to causation of the diagnosis assigned by the special master. The special master’s fact findings as to the diagnosis of the petitioner’s illness, under an overbroad reading of Broekelschen , would be virtually unassailable upon review. The petitioner, in essence, would be forced to prove causation-in-fact of an illness diagnosed by the special master based on his reading of the evidence.
Contreras II
,
In Hibbard , the Federal Circuit broached the diagnosis topic by first summarizing thrеe cases where a special master correctly conducted a threshold diagnosis inquiry as a supplement to the causation inquiry set forth in Althen :
In previous cases, this court has sanctioned an approach
similar to the one taken in this case, in which a special
master has addressed the nature of the injury suffered
*21
before addressing the question whether there is a viable
medical theory by which a vaccine can cause the injury
claimed by the petitioner.
See Locane
,
In each of those cases, there was a dispute as to the nature of the petitioner’s injury, and in each case the special master’s findings on the nature of the injury that the petitioner incurred were sufficient to resolve the case because the special master found that the injury the petitioner incurred was not one that could have been vaccine-induced according to the petitioner’s medical theory.
Hibbard
,
Here, however, as this court stated in Contreras II , there was no significant dispute as to the type of illness Jessie suffered, and a diagnosis of TM versus TM plus GBS was not considered by the parties, or even by the special master, to be crucial to the resolution of this case. Yet the special master apparently believes that even in these circumstances it was appropriate for the special master to diagnose Jessie’s alleged vaccine injury before conducting the causation analysis required by Althen . The court disagrees, and turns to Hibbard for further guidance.
In
Hibbard
, the causation analysis was distinguishable from the analysis
required in this case. Although the parties agreed that Ms. Hibbard’s chronic
nerve condition was dysautonomia, they disagreed as to whether an intermediate
injury, autonomic neuropathy, linked the vaccine to her chronic condition.
Hibbard
,
The issue that the special master addressed in this case is whether Ms. Hibbard suffers from autonomic neuropathy. As [her expert’s] report and testimony made clear, that was a necessary component of her theory of vaccine-induced injury. Therefore, even assuming the medical plausibility of Ms. Hibbard’s theory of causation – that the vaccine triggered an immune response that damaged her autonomic nerves – her failure to show that she had autonomic neuropathy would be fatal to her case.
Hibbard
,
For the reasons stated in Contreras II , and in light of the Federal Circuit’s decision in Hibbard , the court continues to believe that, except in unusual circumstances, a threshold inquiry by the special master into the diagnosis of the alleged vaccine injury is not appropriate. Most cases can be decided through the Althen framework, by establishing through a preponderance of the evidence:
(1) a medical theory causаlly connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.
Althen
,
*23 b. Althen Prong One Burden Was Inappropriately Heightened
Althen
prong one examines whether a petitioner has established “a medical
theory causally connecting the vaccination and the injury.”
In , the special master expounded upon his ruling on
Althen
prong one, noting, in particular, that the petitioner’s expert Dr. Steinman relied
upon a causation theory founded on the mechanism of “molecular mimicry,” a
theory which has some credence in the scientific community. Opin. at 56 (noting
that Dr. Steinman’s theory is a “plausible construct”);
see also Contreras III
, 2013
WL 6698382, at *34 (“Molecular mimicry appears in articles published in highly
regarded medical journals and Dr. Steinman has written some of these articles.”).
The special master also mentioned that petitioner might have buttressed the
persuasiveness of his expert’s theory with evidence of testability and peer review,
*24
but that such evidence was lacking in this case. Opin. at 53. In the end, the
special master ruled that “plausibility does not satisfy Mr. Contreras’s burden” on
Althen
prong one.
Id.
at 56 (citing
Moberly
,
Plausibility, however, in many cases
may
be enough to satisfy
Althen
prong
one.
See, e.g.
,
Hibbard
,
Any reliance on
Moberly
by the special master to reject plausible biological
mechanisms, Opin. at 56 (citing
Moberly
,
Moberly does indicate that plausibility, in general, is insufficient for a petitioner to establish overall causation-in-fact in Vaccine Act cases. See 592 F.3d at 1322 (distinguishing a lower plausibility standard from the preponderant standard for evidence of causation-in-fact). But that guidanсe refers to petitioner’s overall burden to prove causation under the Vaccine Act, not petitioner’s specific burden under Althen prong one. See id. (citing 42 U.S.C. § 300aa-13(a)(1)(A)). The court has found no evidence that a plausible medical theory is per se inadequate to satisfy Althen prong one.
A recent decision of the Federal Circuit, which again focused on the overall causation-in-fact burden for petitioners under the Vaccine Act, also discusses plausibility:
[I]n the past we have made clear that simply identifying a “plausible” theory of causation is insufficient for a petitioner to meet her burden of proof. Moberly , 592 F.3d at 1322. Instead, the statutory standard of preponderance of the evidence requires a petitioner to demonstrate that the vaccine more likely than not caused the condition alleged. See id. (“[P]roof of a ‘plausible’ or ‘possible’ causal link . . . is not the statutory standard.”); see also 42 U.S.C. § 300aa-13(a)(1).
LaLonde v. Sec’y of Health & Human Servs.
,
The inquiry for
Althen
prong one has often been described as the question of
whether a particular vaccine “can” cause a particular type of injury.
See, e.g.
,
Hibbard
,
The court has reviewed the expert reports and hearing transcripts in this
case. Dr. Steinman’s molecular mimicry theory appears to be far more reliable and
viable than the theories criticized and rejected in
LaLonde
and
Moberly
.
See, e.g.
,
*26
Barone v. Sec’y of Health & Human Servs.
, No. 11-707V,
C. Although the Special Master Abused His Discretion When
Relying on Dr. Sladky’s Testimony and Opinions, His Alternate
Ruling on
Althen
Prong Three Which Ignores Dr. Sladky’s
Testimony and Opinions Survives Review
The special master has consistently ruled, in
Contreras I
,
Contreras III
, and
Contreras V
, that twenty-four hours is too short a time-frame for Jessie’s
vaccinations to have caused TM, or a combination of TM and GBS. For this
reason, the special master denied Jessie entitlement to compensation under the
Vaccine Act because the preponderance of the evidence as to
Althen
prong three
did not weigh in his favor.
See Althen
,
In , as required by Contreras IV , the special master removed all evidence provided by Dr. Sladky and reweighed the remaining evidence which related to Althen prong three. The expert opinions on this issue differed, and the scientific studies in the extensive record contained somewhat ambiguous evidence *27 as to a medically-acceptable time-frame for the onset of TM, or of TM and GBS. The court finds, nonetheless, that the special master rationally weighed this evidence and rationally relied upon respondent’s other expert, Dr. Whitton.
Dr. Whitton opined that twenty-four hours was too short a time for either TM or GBS to develop after vaccination, even if molecular mimicry had been triggered by Jessie’s vaccinations. Dr. Whitton’s opinion was buttressed by his persuasive analysis of numerous scientific articles. The special master carefully considered the views of opposing experts and the totality of the evidence, and concluded that
Dr. Sladky’s evidence added little to the [ Althen prong three] analysis. Thus, eliminating the (meager) contributions from Dr. Sladky does not change the undersigned’s view that the evidence is not close. The evidence preponderates in favor of finding that the minimal amount of time needed for molecular mimicry exceeds one day and is likely to be around five days.
Opin. at 51-52. Because Jessie’s alleged vaccine injury did not occur within a medically-acceptable time-frame, the special master denied entitlement in this case.
The special master’s alternative fact-finding as to
Althen
prong three which
excluded Dr. Sladky’s evidence contains no error of law or abuse of discretion.
The special master applied the appropriate standard for establishing a proximate
temporal relationship between a vaccine and a vaccine injury. Opin. at 51-52. As
for the special master’s evidentiary rulings, the court notes that special masters
have broad discretion in determining the reliability of scientific evidence.
E.g.
,
Terran
,
Nor, in the court’s view, is the special master’s alternative ruling on
Althen
prong three arbitrary or capricious. It is important to note that the court’s review
*28
of the special master’s weighing of the evidence is highly deferential.
See, e.g.
,
Munn
,
The court turns to petitioner’s arguments in this regard. Petitioner first
invites the court to reweigh the record evidence as to the timing issue. Pet’r’s
Mot. at 23-24. This reviewing court “does not reweigh the factual evidence or
assess whether the special master correctly evaluated the evidence, nor does it
examine the probative value of the evidence.”
Porter
,
Second, petitioner attacks Dr. Whitton, whose opinion was persuasive on the timing issue. None of these criticisms of Dr. Whitton’s expertise, opinions or credibility renders the special master’s reliance on Dr. Whitton’s opinions arbitrary or capricious. Although Dr. Whitton may not have been the ideal expert in every respect, the court finds that the special master’s reliance on Dr. Whitton’s opinions was rational. In addition, although petitioner attempts to portray Dr. Whitton as applying an inappropriate “scientific certainty” standard when rendering his opinions, Pet’r’s Mot. at 24-25, it is clear that the special master applied the correct preponderance standard to the parties’ evidence which related to Althen prong three. Under the highly deferential standard of review that applies here, the court finds nothing arbitrary or capricious in the special master’s alternative ruling on Althen prong three.
CONCLUSION
For the above-stated reasons, the court sustains the entitlement decision of *29 the special master which did not rely on the evidence of Dr. Sladky. Accordingly, it is hereby ORDERED that
(1) Petitioner’s Motion for Review, filed November 21, 2014, is DENIED ;
(2) The decision of the special master, filed October 24, 2014, is SUSTAINED ;
(3) The Clerk’s Office is directed to ENTER final judgment in accordance with the special master’s decision of October 24, 2014; and
(4) The parties shall separately FILE any proposed redactions to this opinion, with the text to be redacted clearly marked out or otherwise indicated in brackets, on or before May 1, 2015 .
/s/Lynn J. Bush LYNN J. BUSH Senior Judge
Notes
[1] / Pursuant to Rule 18(b) of Appendix B of the Rules of the United States Court of Federal Claims, this Opinion and Order was initially filed under seal on April 17, 2015. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions of the information contained therein on or before May 1, 2015. No proposed redactions were submitted to the court.
[2] / The court cites not to the Westlaw version of the special master’s opinion on remand, but follows the practice of the parties and cites to the opinion version ( or Opin.) available on this court’s website.
[3] / Hereinafter the court will refer to Mr. Contreras as “petitioner” or “Jessie,” because he was thirteen years old at the time of his alleged vaccine injury.
[4] / A full recitation of Dr. Sladky’s misleading misrepresentations and lack of candor, in this Vaccine Act case and in others, is provided in Contreras IV and Contreras V .
[5] / The special master was obliged by the remand to also provide an alternative finding on (cоntinued...)
[5] (...continued) entitlement which excluded Dr. Sladky’s evidence. For this alternative finding, the special master’s assessment of Dr. Sladky’s credibility and reliability was irrelevant.
[6] / By itself, this error is harmless, because the special master has made it clear that his (continued...)
[6] (...continued)
findings as to the timing prong of
Althen
apply whether Jessie experienced TM, or TM and GBS.
See Contreras V
, at 43 (noting that the opinion of respondent’s expert regarding the timing issue,
which was ultimately the most persuasive evidence considered by the special master, would not
change if Jessie had TM and GBS, as opposed to TM only);
Contreras III
,
[7] / This, too, is harmless error, because petitioner needed to prevail on all three
Althen
prongs to establish entitlement to compensation, and a special master may focus on just one
Althen
prong to deny entitlement.
See, e.g., Hibbard
,
