excluding expert who provided testimony on voir dire inconsistent with his deposition testimony as unreliable
How later courts described this case
- excluding expert who provided testimony on voir dire inconsistent with his deposition testimony as unreliable
- noting that the expert witness’s lack of candor was one of five reasons that special master should have “at the very least . . . significantly discount[ed]” the opinion from that expert
- finding expert witness who perjured himself as to his qualifications should have been excluded
- “[p]lausibility . . . in many cases may be enough to satisfy Althen prong one” (emphasis in 27 original)
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
No. 05-626 V
(Filed May 6, 2015)1
* * * * * * * * * * * * * * *
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.
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.
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, 2014 WL 8098606 (Fed. Cl. Spec.
Mstr. Oct. 24, 2014) (Contreras V),2 which denied Jessie Contreras’s petition for
compensation under the National Childhood Vaccine Injury Act of 1986, 42
U.S.C. §§ 300aa-1 to -34 (2012) (the Vaccine Act).3 Under the standard of review
applicable here, the special master’s denial of petitioner’s entitlement to
compensation under the Vaccine Act survives review. For this reason, the court
denies petitioner’s motion for review filed November 21, 2014.
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., 116 Fed. Cl. 472 (2014) (Contreras IV); Contreras v. Sec’y of Health &
Human Servs., No. 05-626V, 2013 WL 6698382 (Fed. Cl. Spec. Mstr. Nov. 19,
2013) (Contreras III), vacated, 116 Fed. Cl. 472 (2014); Contreras v. Sec’y of
Health & Human Servs., 107 Fed. Cl. 280 (2012) (Contreras II); Contreras v.
Sec’y of Health & Human Servs., No. 05-626V, 2012 WL 1441315 (Fed. Cl. Spec.
Mstr. Apr. 5, 2012) (Contreras I), vacated, 107 Fed. Cl. 280. The alleged injury
occurred in 2003 when Jessie was thirteen, approximately twenty-four hours after
Jessie received inoculations containing the hepatitis B vaccine and the tetanus-
diptheria vaccine. Jessie is now almost twenty-five years of age. The court
reserves further discussion of the factual background of this case for the analysis
section of this opinion.
II. Procedural History
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 (Contreras V 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.
2
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
/ 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.
3
Contreras IV, 116 Fed. Cl. at 484 (formatting slightly altered and footnotes
omitted). The special master’s opinion in Contreras V is structured to respond to
these three questions on remand. See Opin. at 2, 13.
DISCUSSION
I. Standard of Review
This court has jurisdiction to review the decision of a special master in a
Vaccine 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., 539 F.3d 1347, 1350 (Fed.
Cir. 2008) (quoting 42 U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005)) (alteration in
original). This court uses three distinct standards of review in Vaccine Act cases,
depending upon which aspect of a special master’s judgment is under scrutiny:
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., 970 F.2d 863, 870 n.10 (Fed.
Cir. 1992).
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
4
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., 99 Fed. Cl. 47, 59 (2011).
Thus, a special master’s determination as to the reliability of expert witness
testimony is reviewed under the abuse of discretion, or manifestly erroneous,
standard. Terran, 195 F.3d at 1316 (citing Burns v. Sec’y of Dep’t of Health &
Human Servs., 3 F.3d 415, 416-17 (1993)); Jarvis, 99 Fed. Cl. at 59. The United
States Supreme Court has also stated that a fact-finder’s decision to admit or
exclude expert testimony is reviewed for abuse of discretion, and that this review
is deferential. Joiner, 522 U.S. at 143 (citing Koon v. United States, 518 U.S. 81,
98-99 (1996)).
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., 991 F.2d 1570, 1575 (Fed.
Cir. 1993) (quoting Hambsch v. Dep’t of Treasury, 796 F.2d 430, 436 (Fed. Cir.
1986)). The court has found no authority, however, which states that a credibility
determination is immune from review, particularly where, as here, extrinsic
5
evidence has subsequently been disclosed which shows a lack of candor on the
part of an expert witness. For this reason, the court reviews the special master’s
determinations regarding Dr. Sladky’s credibility and the reliability of Dr.
Sladky’s expert opinions for manifest error.
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, 116 Fed. Cl. at 484 (requiring
clarified credibility/reliability determinations and an integration of these
determinations into the special master’s entitlement decision, as well as an
alternative finding on entitlement which excludes Dr. Sladky’s evidence).
Because Contreras V does not restate the special master’s entitlement decision set
forth in Contreras III, but merely references that decision as the embodiment of
the special master’s entitlement decision, the parties were not prevented from
contesting the lengthy entitlement analysis which was provided by Contreras III.
See Contreras V, at 37 (“For the reasons explained in [this opinion], Dr. Sladky is
sufficiently credible and sufficiently reliable that his evidence should remain in the
record. Thus, the outcome of [Contreras III], a denial of compensation, does not
differ.”). Therefore, even though Contreras III was vacated by this court, the
analysis contained in that decision was incorporated into Contreras V by the
special master, and that entitlement decision remains within the scope of the
court’s remand.
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 parties’ 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 Contreras V which excluded Dr. Sladky’s evidence. These
6
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 Contreras V, 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 233 F.3d at 751
n.8 (warning that an aggressive approach to assessing the credibility of an expert
might “improperly impinge on the province of the ultimate fact-finder, to whom
issues concerning the general credibility of witnesses are ordinarily reserved”).
Where there is no jury, as here, the credibility/reliability question must be
approached differently.
The Secretary cited to United States v. Shaffer Equip. Co., 11 F.3d 450,
458-59 (4th Cir. 1993) when she revealed Dr. Sladky’s transgressions, Opin. at 10,
and the court finds this case to be more helpful. Although the special master noted
differences between the circumstances in Shaffer and the circumstances in this
case (in that case the government’s attorneys unethically delayed the revelation of
their deceitful witness problem), Shaffer offers almost exactly the same underlying
factual scenario as this case – an important witness is discovered to have
repeatedly misrepresented his credentials to his employer and various judicial
officers. A brief examination of Shaffer is instructive.
The basic fact scenario in Shaffer involved a key government employee who
7
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, the 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, 11 F.3d at 457. In the case before the Fourth Circuit, the government’s
key employee was “responsible for making” the administrative record of the clean-
up, and his “credentials, capability and credibility [we]re relevant to the
examination of the administrative record in this case.” Id. at 460. The appeals
court concluded that “[t]he fact that the government’s agent in charge of
monitoring expenses and selecting responses [to the presence of hazardous waste]
filed fraudulent documents with the federal government and perjured himself
repeatedly in connection with his federal employment is, we think, of primary
8
relevance to an examination of the integrity and reliability of the administrative
record.” Id. Thus, this employee’s credibility was material to the outcome of the
dispute before the trial court. Id. at 461.
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 committed 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, 11 F.3d at 462-63. The court notes, in particular, the Fourth Circuit’s
interest in the deterrence of similar conduct in the future, as well as its interest in
safeguarding public access to judicial proceedings untainted by deception.
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 Contreras V.5 According to the special
5
/ The special master was obliged by the remand to also provide an alternative finding on
(continued...)
9
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., 803 F. Supp. 2d 712, 752 (N.D.
Ohio 2011) (admitting some testimony and excluding other testimony by a
medical expert and indicating that the trial judge would “provide a cautionary
instruction informing the jury that Dr. Burch lied under oath in this proceeding
and others about some aspects of his credentials, and his opinions are therefore
subject to greater scrutiny”). Because a special master is the ultimate fact-finder
and does not instruct a jury, these evidentiary rulings in the context of jury trials
are not as relevant to the issue presented in this case.
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
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.
10
misrepresented his recently-expired credential. Pikas v. Williams Cos., No. 8-cv-
101-GKF-PJC, 2013 WL 622234, at *1 (N.D. Okla. Feb. 20, 2013). The district
court refused to strike the expert’s declarations, without much explanation, other
than to state that his opinions were “helpful to understanding the issues before the
court.” Id. at *2. As the special master noted here, not only did Dr. Sladky
repeatedly misrepresent that he was currently licensed in Pennsylvania (although
that license had expired almost ten years before the filing in this case of his
inaccurate curriculum vitae), he also repeatedly misled a number of special
masters as to his licensure in Georgia and his medical practice. Opin. at 24-26.
The court does not view Pikas as persuasive authority – it presents neither a
thorough analysis nor an analogous fact-pattern.
The court finds more persuasive authority in In re Unisys Sav. Plan Litig.,
173 F.3d 145 (3d Cir. 1999), a precedential decision also cited by the special
master. The United States Court of Appeals for the Third Circuit affirmed the trial
court’s decision to exclude expert testimony because “[w]e would be hard pressed
to require a District Court judge sitting in a non-jury case who credibly and with
reason found that he could not believe a witness to nevertheless hear the witness’s
direct examination, cross-examination, and rebuttal examination in an extended
trial when he knew that he would only reject it as unbelievable.” Id. at 157. The
trial judge could not believe the expert because his credibility and reliability had
been diminished for a number of reasons, including the provision of conflicting
testimony regarding his credentials. Id. at 156-57. It is important to note that the
Third Circuit in Unisys appears to have found rough equivalence among the terms
“credibility,” “reliability,” “believability” and “weight to be accorded expert
testimony,” because such terms are used interchangeably in its analysis. Id. at
156-58. The court finds this analytical construct persuasive, and concludes that an
expert witness who is not credible does not, as a general rule, provide reliable
expert testimony.
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.,
11
891 F. Supp. 2d 527, 539 (S.D.N.Y. 2012) (noting that an expert, Dr. Johnson, had
twice exaggerated her credentials in that litigation and stating that “this Court
discounts Dr. Johnson’s opinions and views them skeptically”); Roberts v. Sec’y of
Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *9 (Fed. Cl. Spec.
Mstr. Aug. 29, 2013) (finding the opinions of Dr. Sladky to be less reliable and of
less weight than those of the petitioners’ experts due, in part, to his lack of candor
regarding his licensure problems). The court sees no sign that the special master
in this case discounted the substantive testimony and opinions provided by Dr.
Sladky, despite being confronted with far more information regarding Dr. Sladky’s
pattern of misrepresentations as to his credentials than had been presented to the
special master in Roberts.
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, 2014 WL 1092274, at *14 (Fed. Cl. Spec.
Mstr. Feb. 24, 2014). The chief special master carefully examined the importance
of truthfulness as a factor in credibility and reliability:
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:
12
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.
2014 WL 1092274, at *16. The court notes that the chief special master in Raymo
based her decision to exclude Dr. Sladky’s opinions on her knowledge of a limited
number of misrepresentations by Dr. Sladky, whereas the special master in this
case has now reviewed a more complete record yet he continues to rely on Dr.
Sladky’s opinions.
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.
13
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 Contreras V 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
14
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
Contreras V, 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. 11 F.3d at 455. They clearly
had no expectation that the fact-finder would credit his testimony after his untruths
had been revealed. The court sees no logical reason why a pattern of
misrepresentation and lack of candor should be seen as a minor factor in the
determination of the credibility of a witness which can be overshadowed by
testimony which contains no apparent falsehoods.
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., 489 F. Supp. 2d 587, 591-94 (E.D. La. 2007) (granting a new
trial because a testifying cardiologist with an expired board certification had
asserted that he was “board certified,” and commenting that the expert’s
“misrepresentation call[s] into question the Court’s acceptance of him as an expert
witness, [and] also sheds an unfavorable light upon his propensity for
truthfulness”). In a non-jury setting, where the judge or other judicial officer is the
ultimate finder of fact, such misrepresentations are a dominant factor in credibility
15
determinations, not a minor one. See, e.g., Bonar v. Dean Witter Reynolds, Inc.,
835 F.2d 1378, 1383-86 (11th Cir. 1988) (finding that where the testifying expert
for the prevailing party had perjured himself as to his qualifications, a lower court
had abused its discretion when it refused to vacate the portion of an arbitration
award which relied upon that expert’s testimony); In re WRT Energy Corp., 282
B.R. 343, 371 (Bkrtcy. W.D. La. 2001) (“The court cannot trust the word of an
expert witness who would brazenly lie about her credentials and then further lie
when caught. If she would lie about her academic credentials, there is no reason
to believe that she would not provide erroneous and/or misleading valuation
testimony if she believed it would benefit her client. The court, therefore, will not
ascribe any weight to the evidence supplied by [this expert].”). In cases which do
not involve juries, the court has found no authority for the proposition that a
judicial officer should establish his or her credibility determination by balancing
known lies or deceptions against representations which appear to be forthright.
Thus, the court finds the first half of the special master’s credibility/reliability
analysis to constitute manifest error and an abuse of discretion, because it runs
counter to reason and persuasive authority.
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
16
evaluating petitions for compensation under the Vaccine Act”); Broekelschen v.
Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (noting
that a special master weighs both “the credibility of the experts and the relative
persuasiveness of their competing theories”) (citation omitted); Moberly ex rel.
Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1325-26 (Fed. Cir.
2010) (“Assessments as to the reliability of expert testimony often turn on
credibility determinations . . . .”) (citations omitted); Andreu ex rel. Andreu v.
Sec’y of Dep’t of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009)
(distinguishing credibility, as a measurement of candor, from the assessment of the
weight of scientific evidence). In light of the varying precedential formulations of
the credibility inquiry, the court included both credibility and reliability in its
instructions for remand so that no aspect of Dr. Sladky’s diminished credibility
would be overlooked by the special master. See Contreras IV, 116 Fed. Cl. at 484
(stating that “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”). The court also attempted to
explain the purpose of its request for a clarified credibility determination:
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 other expert opinion and evidence, were
persuasive on particular issues.
Id. at 484 n.12.
In Contreras V, 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.” 2013 WL 6698382, at *5 (citations omitted).
17
Perhaps this is merely a question of imprecision as to the meaning of the term
“reliability.” In the court’s view, once Dr. Sladky’s misrepresentations and lack of
candor came to light, the question necessarily became one of credibility and
reliability as these terms refer to trustworthiness, not as to the scientific legitimacy
of his opinions that might be tested through Daubert or other means.
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, 663 F.3d at 1250-51; Broekelschen, 618 F.3d
at 1347; Moberly, 592 F.3d at 1325-26; Unisys, 173 F.3d at 156-58; Harkabi, 891
F. Supp. 2d at 539; Raymo, 2014 WL 1092274, at *16; Roberts, 2013 WL
5314698, at *9. The court finds nothing in the special master’s assessment of Dr.
Sladky’s “reliability,” under Daubert, to redeem the special master’s determination
that Dr. Sladky “satisfies the minimal standard for credibility.” Opin. at 31.
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 special masters in Vaccine Act cases, the court
finds that the special master’s credibility and reliability determinations in
Contreras V 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
18
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
Contreras V, 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 began 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, 107 Fed. Cl. at
293-95 (citing Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1381
n.3 (Fed. Cir. 2012); Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343,
1351 (Fed. Cir. 2011); Broekelschen, 618 F.3d at 1346). In Contreras III, the
special master again began his causation analysis with a diagnosis of Jessie’s
alleged vaccine injury, although he asserted that his “finding that Mr. Contreras
did not suffer GBS appears to be in accord with this [court’s] instruction [in
Contreras II] because Dr. Lake (not the undersigned) diagnosed Mr. Contreras’s
illness.” Contreras III, 2013 WL 6698382, at *25 n.24. Although Dr. Lake never
testified and never submitted a report in this case, the special master relied on Dr.
Lake’s notes in Jessie’s medical records, among other sources of information, to
19
diagnose Jessie with TM, not TM and GBS.
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, 107 Fed. Cl. at 295. Once Contreras II issued, however, the
precedential landscape changed somewhat, and a threshold inquiry into diagnosis
was approved in another decision by the Federal Circuit. See Hibbard v. Sec’y of
Health & Human Servs., 698 F.3d 1355 (Fed. Cir. 2012). The court sees no
authorization in Hibbard for the type of causation analysis conducted here,
however.
In Hibbard, the Federal Circuit broached the diagnosis topic by first
summarizing three 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
20
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, 685 F.3d 1375;
Lombardi v. Sec’y of Health & Human Servs., 656 F.3d
1343 (Fed. Cir. 2011); Broekelschen v. Sec’y of Health &
Human Servs., 618 F.3d 1339 (Fed. Cir. 2010).
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, 698 F.3d at 1365. Thus, Hibbard teaches that in some cases where a
significant dispute as to diagnosis has been presented by the parties, and where a
specific diagnosis is sufficient to resolve the case, a special master may diagnose
the alleged vaccine injury.
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, 698 F.3d at 1358. In such a circumstance, where the damage caused by
autonomic neuropathy was posited to have caused the chronic condition of
dysautonomia, the special master rightly inquired as to whether Ms. Hibbard had
ever experienced autonomic neuropathy. Her entire medical theory depended on
21
that crucial intermediate step:
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, 698 F.3d at 1365. Here, in contrast, the theory advanced by Jessie’s
experts did not rely on a crucial, intermediate injury in whose absence Jessie’s
petition would necessarily have been dismissed.
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 causally 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, 418 F.3d at 1278. The Althen framework, often referred to as the three
Althen prongs, allows the typical petitioner to attempt to prove his or her own
prima facie case, and does not require that the petitioner defend against the
diagnostic fact-finding of a special master. The court does not believe that a
threshold inquiry into the specific diagnosis of Jessie’s alleged vaccine injury was
appropriate in this case.6
6
/ By itself, this error is harmless, because the special master has made it clear that his
(continued...)
22
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.” 418 F.3d at 1278. The
special master did not make any findings of fact regarding Althen prong one in
Contreras I, but was required to do so by Contreras II. In Contreras III, the
special master found that petitioner’s evidence did not establish, by a
preponderance of the evidence, the reliability of the causation mechanism posited
by petitioner’s experts. See Contreras III, 2013 WL 6698382, at *39 (“Mr.
Contreras has not provided preponderant evidence that demonstrates the reliability
of the proposition that the hepatitis B vaccine can cause transverse myelitis (or
GBS) via molecular mimicry with respect to the Daubert factors.”). In Contreras
V, the special master again concluded that petitioner “failed to show the
persuasiveness of [his expert’s] theory as measured against the Daubert factors.”
Opin. at 56.
In Contreras V, 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,
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, 2013 WL 6698382, at
*25 (stating that “the medically-acceptable time-frame for the onset of transverse myelitis after
vaccination would remain an issue even if Mr. Contreras were found to suffer from GBS in
addition to transverse myelitis”); see also Contreras I, 2012 WL 1441315, at *8 (“It is important
to emphasize that the same result would be reached if Mr. Contreras suffered from both
transverse myelitis and Guillain-Barré syndrome. The outcome of Mr. Contreras’s case depends
on the interval between his vaccinations and the onset of his disease, not on the specific
disease.”).
23
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, 592 F.3d at 1322).
Plausibility, however, in many cases may be enough to satisfy Althen prong
one. See, e.g., Hibbard, 698 F.3d at 1365 (stating that under Althen prong one
“Ms. Hibbard had to show . . . the medical plausibility of her theory of
causation”); [M.S.B.] ex rel. Bast v. Sec’y of Health & Human Servs., 117 Fed. Cl.
104, 119 (2014) (stating that the burden for Althen prong one is for the petitioner
to “put forth a biologically plausible theory explaining how the vaccines could
have caused the sustained injury”); Hirmiz v. Sec’y of Health & Human Services,
No. 06-371V, 2014 WL 4638375, at *15 (Fed. Cl. Spec. Mstr.) (describing the
burden under Althen prong one as “petitioners’ burden of demonstrating a
plausible medical theory”), aff’d, 119 Fed. Cl. 209 (2014). Althen prong one
merely demands a threshold level of scientific reliability for an expert’s proposed
biological mechanism which can cause a vaccine injury.
Any reliance on Moberly by the special master to reject plausible biological
mechanisms, Opin. at 56 (citing Moberly, 592 F.3d at 1322), is misplaced. The
discussion of plausibility in Moberly does not focus on Althen prong one
specifically, and has no relevance to the question of whether a plausible medical
theory satisfies Althen prong one. Instead, the Federal Circuit in Moberly simply
required “some indicia of reliability” regarding the medical theory advanced by
petitioners for the purposes of satisfying Althen prong one. 592 F.3d at 1324.
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 guidance 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:
24
[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., 746 F.3d 1334, 1339 (Fed. Cir.
2014). But this same decision also references Hibbard and the burden on
petitioners to prove the “medical plausibility” of their proposed biological
mechanism so as to satisfy Althen prong one. Id. at 1340 (citing Hibbard, 698
F.3d at 1365). Thus, while plausibility is not enough to show that a particular
vaccine caused a particular injury, this is a separate question from the inquiry
required by Althen prong one. See, e.g., Veryzer v. Sec’y of Health & Human
Servs., 100 Fed. Cl. 344, 352 (2011) (explaining that plausibility goes to Althen
prong one, because “plausibility is confined properly to general causation – the
biological or medical theory put forward – [not] Althen’s second prong . . .
examining specific or legal causation”), aff’d, 475 F. App’x 765 (Fed. Cir. 2012).
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, 698 F.3d at 1365 (describing the inquiry for Althen prong one as “the
separate (and frequently more difficult) question whether there is a medical theory,
supported by ‘reputable medical or scientific explanation,’ by which a vaccine can
cause the kind of injury that the petitioner claims to have suffered” (citing Althen,
418 F.3d at 1278)). In other words, the petitioner must present a “viable” medical
theory. Id. The special master did not apply this precedential standard in his
Althen prong one analysis, because he required more than a plausible medical
theory. Perhaps this error was based on a misreading of the discussion of
plausibility in Moberly and LaLonde.
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.,
25
Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at
*8 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (listing cases accepting molecular
mimicry as a reliable medical theory for vaccine injuries). Respondent’s most
persuasive expert in this case testified that molecular mimicry has been the subject
of study for a number of years, and that there is some evidence that molecular
mimicry is linked to auto-immune diseases, a category of diseases which includes
TM and GBS. Hearing Transcript at 419, 426. Because the special master’s
analysis of Althen prong one imposed a higher burden on petitioner than is
appropriate under Federal Circuit precedent, and because the record evidence
regarding Dr. Steinman’s proposed biological mechanism appears to present a
sufficiently reliable scientific theory, the special master’s ruling on Althen prong
one in this case was in error.7
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, 418 F.3d at 1278 (requiring that a
petitioner establish a “proximate temporal relationship between vaccination and
injury”). As this court noted in Contreras II, petitioner was required to show that
the onset of Jessie’s alleged vaccine injury occurred within a “medically-
acceptable time-frame.” 107 Fed. Cl. at 302-03.
In Contreras V, 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
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, 698 F.3d at 1364-65.
26
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, 195 F.3d at 1316. Under this standard, the court has examined the
alternative Althen prong three analysis in Contreras V, which references and relies
heavily on Contreras III, for any manifest error in the consideration of the
evidence presented by the parties. There is no sign that the special master
erroneously excluded petitioner’s scientific evidence as unreliable.
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
27
of the special master’s weighing of the evidence is highly deferential. See, e.g.,
Munn, 970 F.2d at 870 (“This is a standard [of review] well understood to be the
most deferential possible.”) (citations omitted). As long as the special master’s
findings of fact and conclusions regarding the preponderance of the evidence
going to Althen prong three are reasonable, this court must sustain the special
master’s entitlement decision. See, e.g., Broekelschen, 618 F.3d at 1348
(“‘[R]eversible error is “extremely difficult to demonstrate” if the special master
“has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.”’” (quoting Hines v. Sec’y of Health &
Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991))) (alteration in original).
Under this highly deferential standard of review, the special master’s alternative
Althen prong three analysis, which is rational, survives review.
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, 663 F.3d at 1254 (citations
omitted). Thus, the court must defer to the fact-finding role of the special master
and cannot reconsider the expert opinions and other evidence cited by petitioner.
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
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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
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