Skinner-Smith v. Secretary of Health and Human Services ( 2022 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: September 9, 2022
UNPUBLISHED
Special Master Horner
ALICIA SKINNER-SMITH,
Petitioner, Tetanus, Diphtheria, Acellular
v. Pertussis (“Tdap”) Vaccine;
Cause in Fact; Cellulitis;
SECRETARY OF HEALTH AND Chronic Fatigue Syndrome
HUMAN SERVICES, (“CFS”); Motion for
Reconsideration; Denial
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Terrence Kevin Mangan, Jr., U.S. Department of Justice, Washington, DC, for
respondent.
ORDER DENYING MOTION FOR RECONSIDERATION 1
On December 17, 2014, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that the tetanus,
diphtheria, acellular pertussis (“Tdap”) vaccine that petitioner received on February 6,
2012, caused her to suffer an abscess, pain, and related injuries that became chronic.
(ECF No. 1.) By the time of the hearing held in this case in May of 2021, petitioner had
clarified that the chronic injury she alleges is Chronic Fatigue Syndrome (“CFS”). (ECF
No. 132.) On August 15, 2022, I issued a ruling on entitlement, finding petitioner
entitled to compensation for her alleged injection site injury (determined to be cellulitis),
but not her alleged CFS. (ECF No. 160.) On September 6, 2022, petitioner timely filed
a motion for reconsideration of the ruling on entitlement. (ECF No. 162.) For the
reasons discussed below, petitioner’s motion is DENIED.
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Because this order contains a reasoned explanation for the special master’s action in this case, it will be
posted on the United States Court of Federal Claims’ website in accordance with the E-Government Act
of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
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I. Legal Standard
Under the Vaccine Rules, motions for reconsideration are governed by Vaccine
Rule 10(e). Either party may file such a motion within 21 days of the issuance of a
special master’s decision so long as judgment has not entered and no motion for review
has been filed. The special master may seek a response from the nonmoving party, but
is only required to do so if granting the motion and reaching a different result. Vaccine
Rule 10(e)(2) and (3)(A)(ii). Thus, because I am denying petitioner’s motion, no
response is necessary.
Special masters have the discretion to grant a motion for reconsideration if to do
so would be in the “interest of justice.” Vaccine Rule 10(e)(3). It has previously been
noted, however, that there is little guidance interpreting Vaccine Rule 10(e)(3) beyond
the conclusion that it is within the special master’s discretion to decide what constitutes
the “interest of justice” in a given case. See Krakow v. Sec’y of Health & Human Servs.,
No 03-632V, 2010 WL 5572074, at *3 (Fed. Cl. Spec. Mstr. Jan. 10, 2011) (granting
reconsideration of motion to dismiss case for failure to prosecute). Generally “[a] court
may grant such a motion when the movant shows ‘(1) that an intervening change in the
controlling law has occurred; (2) that previously unavailable evidence is now available;
or (3) that the motion is necessary to prevent manifest injustice.’” System Fuels, Inc. v.
United States, 79 Fed. Cl. 182, 184 (2007) (quoting Amber Resources Co. v. United
States, 78 Fed. Cl. 508, 514 (2007)). Granting such relief requires “a showing of
extraordinary circumstances.” Caldwell v. United States, 391 F.3d 1226, 1235 (Fed.
Cir. 2004) (citation omitted), cert. denied, 546 U.S. 826 (2005).
Special masters have previously concluded with regard to Vaccine Rule 10(e)
that “the ‘interest of justice’ standard is likely less onerous than ‘manifest injustice.’”
Krakow, 2010 WL 5572074, at *5. Nonetheless, “a motion for reconsideration should
not be used to gain a second opportunity to argue what was already decided.”
Chuisano v. Sec’y of Health & Human Servs., No. 07-452V, 2013 WL 6234660, at *20
(Fed. Cl. Spec. Mstr. Oct. 25, 2013) (citing Fillmore Equipment of Holland, Inc. v. United
States, 105 Fed. Cl. 1, 9 (2012)). A party seeking reconsideration “must support the
motion by a showing of extraordinary circumstances which justify relief.” Fru–Con
Constr. Corp. v. United States, 44 Fed. Cl. 298, 300 (1999). The motion for
reconsideration “must be based ‘upon manifest error of law, or mistake of fact, and is
not intended to give an unhappy litigant an additional chance to sway the court.’” Prati
v. United States, 82 Fed. Cl. 373, 376 (2008) (quoting Fru–Con Constr. Corp., 44 Fed.
Cl. at 300).
Additionally, petitioner files four new exhibits that purport to support petitioner’s
arguments on reconsideration. (ECF No. 163; Exs. 39-42.) As a threshold matter,
consideration of new evidence upon reconsideration is generally limited to evidence that
was not previously available. See, e.g., Cozart v. Sec’y of Health & Human Servs., No.
00-590V, 2015 WL 6746499, at *4 (Fed. Cl. Spec. Mstr. Oct. 15, 2015) (“The additional
evidence that petitioners presented is not new evidence; rather, it is an article that was
available to petitioners at the time this case went to hearing. The argument that
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petitioners did not deem this article relevant until the undersigned issued her decision is
not proper grounds for reconsideration of the undersigned's decision.”). Petitioner has
not established—nor even asserted—that any of this newly filed evidence was
previously unavailable. 2 Accordingly, none of these exhibits is properly presented as a
basis for reconsideration.
Nonetheless, the principle of fundamental fairness that governs the admission of
evidence in this program (see Vaccine Rule 8(b)(1)) requires a special master to
carefully consider whether additional evidence should be admitted, even after the
evidentiary record has closed. Horner v. Sec’y of Health & Human Servs., 35 Fed. Cl.
23, 27 (1996) (explaining that “[i]n light of the critical importance of the record and the
possibility of authentication, the Court finds that fundamental fairness requires that the
special master determine whether the document is genuine and admit the document if
he confirms its authenticity . . . Although consideration of the vaccine record at this point
is inconvenient, it is not fundamentally unfair to the respondent.”)
The Court of Federal Claims has recognized four factors that should be
considered when determining whether it is appropriate to reopen the record on
entitlement to consider subsequently filed evidence. Vant Erve v. Sec’y of Health &
Human Servs., 39 Fed. Cl. 607 (1997), aff’d, 232 F.3d 914 (Fed. Cir. 2000). Those four
factors are: (1) the nature of the proffered new evidence; (2) the prejudice to the parties;
(3) the length of the delay; and (4) the reason for the delay. Id. at 612. Importantly,
however, the factors do not warrant equal weight, with the nature of the proffered
evidence being the “paramount test.” Id. The first prong examining the nature of the
evidence looks to “the extent to which the new evidence is both relevant and affective of
outcome.” Id. The second prong examining prejudice to the parties should focus on
“evaluating the practical consequences of reopening on the nonmoving party’s ability to
re-establish its case.” Id. at 614. The third and fourth prongs, the length and reason for
delay, are of lesser importance, but should be considered in connection with the other
factors by examining “whether the delay has prejudiced the nonmoving party and the
identity of the party that caused the delay.” Id.II. Discussion
Petitioner asserts that the testimony of her expert, Dr. Lapp, and the medical
opinion of her treating physician, Dr. Ferrier, both require clarification. (ECF No. 162, p.
10.) In that regard, petitioner files four new pieces of evidence (ECF No. 163; Exs. 39-
42.) Specifically, petitioner files the following: A letter by treating physician, Dr. Ferrier
2
The four pieces of evidence include three letters and one piece of medical literature. Although the three
letters themselves all likely post-date the ruling on entitlement (one letter by Dr. Chu is undated), the
record of this case makes clear that petitioner had access to each of these individuals during the
entitlement phase of the case. Specifically, two of the letters are by individuals who previously submitted
written opinions in the case. (Exs. 8, 16, 21-22.) The third letter is by the author of a study previously
cited by petitioner’s testifying expert, Dr. Lapp. During the hearing, Dr. Lapp, confirmed in his testimony
that he had previously spoken with the author of the letter regarding the specific question addressed in
her letter. (Tr. 72.) The newly submitted medical literature, a Report of the CFS/ME Working Group, was
published in 2002. (Ex. 41, p. 1.)
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(Ex. 39); A letter by Dr. Chu, author of a study discussed in the ruling at issue (Ex. 40);
A 2002 Report of the CFS/ME Working Group (Ex. 41); and a letter by petitioner’s
testifying expert, Dr. Lapp (Ex. 42). Petitioner’s motion does not otherwise offer any
specific discussion of the procedural history of this case or assert any particular
rationale as to why either reconsideration or reopening of entitlement is appropriate.
Petitioner has not discussed the legal standard for the relief she seeks or explicitly
asserted that any extraordinary circumstance exists. Instead, petitioner’s motion is
devoted to specific substantive arguments based on the prior ruling’s Althen analysis,
an implicit argument that the ruling at issue suffers a mistake of either fact or law.
In order to better inform the analyses with respect to reconsideration and
reopening of entitlement, section (a) of the below discussion examines the potential
evidentiary value of each of the four new pieces of evidence. Finding that these four
pieces of evidence are not likely to change the outcome, the discussion turns in section
(b) to the procedural history of this case and why the interest of justice does not favor
the relief petitioner seeks. Finally, section (c) explains why petitioner’s legal arguments
have not identified any mistake of fact or law that would otherwise warrant
reconsideration.
a. Even if considered, petitioner’s newly filed evidence would not be
likely to change the outcome
As a threshold matter, petitioner must establish that it is appropriate to reopen
entitlement to consider these exhibits as a matter of fundamental fairness. As
discussed above, the paramount consideration in that analysis is the degree to which
the exhibits are relevant and likely to affect the outcome. See Vant Erve, 39 Fed. Cl. at
612. For the reasons discussed below, each of the exhibits presented, though broadly
meeting the standard for relevancy, are of limited utility and would be very unlikely to
change the outcome.
i. Ex. 39 (Dr. Ferrier’s letter)
Petitioner asserts in her motion that the opinion of her treating physician, Dr.
Ferrier, requires clarification. (ECF No. 162, p. 10.) In addition to her medical records,
the ruling at issue also discusses a letter that Dr. Ferrier had provided (Ex. 8) purporting
to provide a supporting causal opinion. Petitioner now files a second letter by Dr.
Ferrier. (Ex. 39.) This new letter raises several points serving mainly to endorse Dr.
Lapp’s assessment of petitioner’s medical history. Significantly, however, all of these
points have the effect of confirming the accuracy of the ruling at issue. Accordingly, it is
highly unlikely to change the outcome of the case.
First, Dr. Ferrier confirms that she has reviewed Dr. Lapp’s November 2019
evaluation and “[t]he history recorded by Dr. Lapp is accurate. Mrs. Smith does have
the diagnoses of fibromyalgia and chronic fatigue syndrome as diagnosed by Dr. Lapp.”
(Ex. 39, p. 1.) However, ruling at issue already addressed this at least in part. With
regard to fibromyalgia, the ruling indicated that “[t]he updated medical records petitioner
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filed after the hearing seem to suggest Dr. Ferrier added fibromyalgia to petitioner’s
problem list in December of 2019 based on Dr. Lapp’s assessment.” (ECF No. 160, p.
33.) The ruling concluded it was not ultimately necessary to resolve whether petitioner
suffered fibromyalgia, but concluded that Dr. Lapp was persuasive in opining that
petitioner suffered CFS, which is the operative diagnosis relative to petitioner’s causal
allegations. (Id. at 33-36.) Because the ruling at issue had already accepted Dr. Lapp’s
diagnostic assessment, Dr. Ferrier’s subsequent adoption of that additional diagnosis
based on Dr. Lapp’s say-so is of no moment.
Second, Dr. Ferrier indicates that petitioner “developed new symptoms of fatigue,
fevers and myalgias following her 2012 TdAP vaccination.” (Ex. 39, p. 1.) This is also
stated in Dr. Ferrier’s earlier letter to the court which is addressed and considered by
the ruling at issue. (ECF No. 160, pp. 24-25 (quoting Ex. 8).) In the prior letter, Dr.
Ferrier discusses these same symptoms and indicates that they can be attributed to her
vaccination. (Id.) Petitioner stresses that this constitutes Dr. Ferrier’s agreement with
Dr. Lapp that onset of CFS occurred within days of her vaccination. (ECF No. 162, pp.
6-7.) However, this does not contradict the ruling on entitlement. In addressing Althen
prongs two and three, the ruling explained that “[p]etitioner received a Tdap vaccination
on February 6, 2012, reported unusual symptoms beginning that same night, and
sought follow up care rather promptly. Thereafter, Dr. Lapp opines that she developed
classic signs of CFS within two weeks. However, upon closer examination of Dr. Lapp’s
opinion, there is no basis for finding significance in that temporality.” (ECF No. 160, p.
45 (internal citations omitted).) Even with the added clarification that Dr. Ferrier agrees
with the CFS diagnosis, Dr. Ferrier’s new letter addresses only the fact of the apparent
onset of symptoms and does not shed any new light on the issues discussed in the
ruling’s analysis of Althen prongs two and three. While Dr. Ferrier’s opinion as a
treating physician is entitled to weight, the analysis in the decision turned largely on
factors relating to the nature of CFS, which is better viewed as Dr. Lapp’s domain.
Third, Dr. Ferrier revisits her medical record of January 16, 2012. (Ex. 39, p. 1.)
Petitioner stresses that the letter confirms petitioner’s symptoms from that illness were
“common and transient” and resolved prior to the vaccination. (ECF No. 162, p. 7.)
Here, too, however, Dr. Ferrier’s new letter only confirms what was already clear in the
ruling at issue. Dr. Ferrier confirms that on January 16, 2012, petitioner reported “sore
throat, postnasal drip and bilateral ear pain that started 3 weeks prior to presentation.
On exam, she was noted to have pharyngeal erythema and pustules. Her symptoms
and exam at that time were indicative of infection. She was prescribed clindamycin and
Diflucan.” (Ex. 39, p. 1.) This merely restates the medical record and is identical to how
petitioner’s presentation is discussed in the ruling’s analysis. (ECF No. 160, p. 49.)
Contrary to what petitioner suggests in the instant motion, nothing in the ruling suggests
that these symptoms failed to resolve. In fact, the analysis at issue specifically quotes
Dr. Lapp’s explanation that his opinion was based in part on the fact that the symptoms
had resolved. (Id. at 49-50 (quoting Tr. 229-30).) The gravamen of the analysis is that
Dr. Lapp was unpersuasive in light of his own reliance materials in asserting that
infection always leads seamlessly into CFS. (Id.) Accordingly, Dr. Ferrier’s purported
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clarification of her January 16, 2012, record provides no clarification at all and is of little
utility.
ii. Ex. 40 (Dr. Chu’s letter)
Dr. Lapp’s opinion with respect to timing of onset was informed in significant part
by a study by Chu et al. The study is discussed at length in the ruling on entitlement.
Petitioner now files a letter by Dr. Chu in response to a footnote appended to that
discussion. In the ruling at issue, a footnote explains that:
The Chu paper includes a table that indicates that 10% of subjects identified
a medical injection as a factor associated with the onset of their CFS. (Chu
et al., supra, at Ex. 30, p. 4.) Importantly, however, nothing in the study
provides information regarding the time between such injections and onset
of CFS. Nor does the study otherwise provide any discussion sufficient to
assess the reasonableness of the subjective claim of association. During
the hearing, Dr. Lapp indicated that he spoke with Chu and purportedly
confirmed that the medical injections at issue mostly referred to vaccination.
(Tr. 72.) However, this is not confirmed by the paper itself, and in fact the
paper confirms that patients having had a flu vaccination within the
preceding four weeks were specifically screened out of the study
population. (Chu et al., supra, at Ex. 30, p. 2.)
(ECF No. 160, p. 48 n.30.)
In the newly filed letter, Dr. Chu states in full:
In our 2019 study, “Onset Patterns and Course of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome,” 13 out of 132 subjects
affected by ME/CFS responded that their illness began with an injection
they received at their doctor’s office. When questioned about what type of
injection, 9 out of the 13 (69%) replied that they were being vaccinated.
Four people did not specify/ remember the exact vaccination(s). Otherwise,
2 people reported Hepatitis B vaccinations; 1, Hepatitis B + tetanus; 1,
typhoid; and 1, tetanus vaccine.
(Ex. 40.)
Even accepting this additional information at face value, it does not meaningfully
change the understanding of the Chu study as discussed in the ruling at issue. Nor
does it even address the specific points presented in the footnote regarding the lack of
information regarding timing and the lack of sufficient information to assess the
reasonableness of the attribution. Notably, Dr. Chu’s letter indicates that the data
includes four instances, roughly half of the nine subjects reporting post-vaccination
CFS, where the vaccine at issue could not be identified because the subject could not
recall. This strongly suggests that the history of vaccination was not verified as part of
6
the study and underscores, rather than resolves, the concern expressed in the ruling on
entitlement that there are insufficient details available to assess the reasonableness of
the patient’s subjective attribution of CFS to the vaccine. Thus, this exhibit is highly
unlikely to change the outcome of the case.
iii. Ex. 41 (A Report of the CFS/ME Working Group)
Petitioner presents a 2002 Report of the CFS/ME Working Group for the
proposition that medical literature supports the “biological plausibility” of vaccine-caused
CFS. (ECF No. 162, pp. 2-5.) This is presented in support of a legal argument by
petitioner that she need only present a “biologically plausible” theory of causation
pursuant to Althen prong one. (Id.) However, even assuming the correctness of
petitioner’s legal argument, mere reference to the term “biologically plausible” would not
be the end of any analysis of this literature.
While petitioner is correct that this document characterizes a role for vaccinations
as triggers of CFS as “biologically plausible,” the actual statement stressed by petitioner
is far more equivocal and limited than petitioner lets on. (Ex. 41, p. 32.) First, this
statement is based on “a few” unspecified case reports. While case reports are not
wholly without evidentiary value, this document presents only reference to the fact of
this limited number of case reports. It contains none of the information that would be
necessary to assess the value of the specific reports. Second, and relatedly, the report
relies only on temporality being established by the case reports and further clouds that
reliance by noting that infection may also have played a role. Third, and relatedly, the
caution to avoid vaccinations is specifically limited to those suffering infections,
suggesting the real-world concern expressed by the working group does not extend to
vaccines alone. (Id.)
Nor is it clear that consideration of the document as a whole would support
petitioner’s claim on balance. The same report cautions in a discussion of onset and
course of the disease that “[f]actors relating to the development of CFS/ME have been
considered as including predisposing, triggering, and maintaining factors, which is
conceptually helpful, but is fraught with problems of interpretation and attribution at the
level of the individual.” (Id. at 48.) The report explains that both the etiology (cause)
and pathogenesis (disease process) of CFS remain uncertain. (Id. at 31.) The report
does not even commit to the contention that CFS constitutes a primary disease process.
(Id.)
In any event, the Althen prong one analysis contained in the ruling at issue
addresses issues beyond the availability of “a few” case reports. On the whole, while
the conclusion of the working group may be entitled to some weight, this exhibit would
provide only very minimal support to the causal opinion actually presented by Dr. Lapp.
Accordingly, is highly unlikely to change the outcome of the case in light of the ruling’s
actual analysis of Dr. Lapp’s medical theory.
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iv. Ex. 42 (Dr. Lapp’s letter)
Finally, petitioner seeks to submit a letter by Dr. Lapp. This letter amounts to a
supplemental expert report by Dr. Lapp, seeking to restate and revise his opinion now
that he has the benefit of the undersigned’s analysis. Dr. Lapp states that “I am
disappointed in the final opinion and feel that Mr. Horner does not fully understand the
ramifications of Chronic Fatigue Syndrome (CFS/ME), apparently misunderstood what I
was trying to explain, and misconstrued some of the evidence. As such, I would like to
re-state my opinion in different words.” (Ex. 42, p. 1.) Dr. Lapp provides a general
restatement of his opinion before turning to a list of “specific misunderstandings.”
However, none of what Dr. Lapp raises in his letter actually identifies any
misunderstanding:
• Dr. Lapp takes issue with Dr. He’s criticism of his diagram as “severely
outdated,” noting it was meant only as a simplification for descriptive
purposes. (Ex. 42, p. 2.) However, the ruling indicated that Dr. He’s
criticism was being set aside, explaining that “I assume for purposes of
this decision that Dr. Lapp’s diagram at Exhibit 33 reasonably depicts the
relevant immune response without actually deciding that issue.” (ECF No.
160, p. 40, n.24.)
• Dr. Lapp highlights the statement in the ruling that “[t]his underlying
immunology speaks to the chronicity of CFS but does not in itself reveal
what potential triggers may provoke CFS.” (Ex. 42, p. 2 (quoting ECF No.
160, p. 40).) However, Dr. Lapp continues “[t]he point is that any foreign
substance – be it a vaccine, a virus, a bacteria, a chrome joint implant, a
medication, etc. – can stimulate the immune system in this way. Some
elements are more immunogenic than others, obviously.” (Id.) Setting
aside the specifics of his list of stimuli, this purported rebuttal confirms the
correctness of the statement quoted from the ruling. Dr. Lapp here
underscores both that the immunology being discussed is not specific to
any particular trigger and that the various potential triggers are not uniform
in their immunogenicity.
• Dr. Lapp states that “I am not at all sure how to respond to Mr. Horner’s
criticism on Page 41 of the report that, ‘Four articles are key to Dr. Lapp’s
theory – Mu and Sewell (1993), Rook and Zumula (1997), Devnaur and
Kerr (2006), and Hardcastle, et al (2015). However, these articles fall
short of demonstrating what Dr. Lapp claims they support.’” (Ex. 42, p. 2
(quoting ECF No. 160, p. 41) (internal citations omitted).) Dr. Lapp
disputes these articles are “key” to his opinion, but confirms his reliance
on them. (Id.) Although Dr. Lapp stresses specific points from the
articles, he does not identify any error in the ruling’s discussion of the
papers.
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• Dr. Lapp states that the ruling “accepts the argument by Dr. He that
immunizations are localized and do not affect the immune system like an
infection, which can replicate and spread throughout the body. I am not
aware of any support for this notion, which is ridiculous considering the
plethora of reports of severe immune reactions following vaccinations.”
(Ex. 42, p. 3.) This assertion presents two issues. First, it
mischaracterizes Dr. He’s testimony. Dr. He did not testify that
vaccination has no systemic effect. He testified that vaccination and
infection have major differences and that vaccines do not include
“systemwide immunopathic replication.” (ECF No. 160, p. 44 (citing Tr.
285-86, 301-03).) Second, to the extent Dr. Lapp is interpreted as now
indicating that it is “ridiculous” to state that immunization is distinct from
infection because infection replicates throughout the body, this would
constitute a recanting of his own testimony, which is not necessarily
credible. 3
• Dr. Lapp also includes brief discussion of Althen prongs two and three;
however, these points merely restate aspects of the case that were
already thoroughly addressed by the ruling.
On the whole, Dr. Lapp’s letter merely expresses disappointment with the
outcome. He has not raised any point that is concerning for error or omission in the
ruling at issue. Nor has he provided any new information that would affect the
complained of analysis. Accordingly, Dr. Lapp’s letter is highly unlikely to affect the
outcome of this case.
It should also be noted that Dr. Lapp’s letter does nothing to tie together the
evidentiary value of the three other pieces of evidence. As discussed above, each
individual piece of evidence fails on its own to represent evidence that would affect the
outcome. It is also the case, however, that all four of these exhibits considered
collectively likewise fail to offer meaningful evidence that would be likely to change the
outcome. This is not a scenario in which the whole is greater than the sum of its parts.
b. The interest of justice does not favor the relief petitioner seeks
Petitioner’s request to reopen the record and reconsider entitlement rests on a
purported need to “clarify” the opinions of Drs. Ferrier and Lapp. (ECF No. 162, p. 10.)
However, the procedural history of this case disfavors this relief.
3
With regard to the point at issue, the ruling specifically noted Dr. Lapp’s testimony at page 211 of the
transcript. (ECF No. 160, p. 44.) Dr. Lapp was asked on cross-examination, “The Tdap vaccination is not
biologically equivalent to a live infectious agent, correct?” He answered, “That’s correct.” He was then
asked “Tdap cannot reproduce itself inside the human body, correct?” He answered, “As far as I know,
yes.” Subsequently asked to confirm that “[t]he immune system responds differently to a live infection
than it does to the Tdap vaccine,” Dr. Lapp opined “I can’t say that. I can’t say that one way or the other,
but I’m not sure you could say it’s different.”
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Special masters are tasked with “endeavoring to make the proceedings
expeditious, flexible, and less adversarial, while at the same time affording each party a
full and fair opportunity to present its case and creating a record sufficient to allow
review of the special master’s decision.” Vaccine Rule 3(b)(2). The special master
must receive and consider all relevant evidence “governed by principles of fundamental
fairness to both parties” (Vaccine Rule 8(b)(1), but is given the discretion to “determine
the format for taking evidence and hearing argument based on the specific
circumstances of each case and after consultation with the parties” (Vaccine Rule 8(a)).
All of these precepts have been followed in this case and petitioner has been
provided a full and fair opportunity to present her case. Petitioner has not asserted
otherwise. In fact, petitioner’s motion offers no specific argument addressing the
“interest of justice” standard at all. There are circumstances where fundamental
fairness dictates reopening of the evidentiary record. See Horner, 35 Fed. Cl. at 27.
However, the “paramount” test for reopening the record is an examination of the
evidence to be added to the record. Vant Erve, 39 Fed. Cl. at 612. Here, for the
reasons discussed in section (a) above, it is unlikely that the newly filed evidence would
change the outcome. Thus, petitioner’s burden with respect to the delay and prejudice
caused by her late filing “increases dramatically.” Id.As explained in the ruling at issue, this case has been litigated over an extended
period. (See ECF No. 160, pp. 3-6.) In that regard, Dr. Ferrier’s contemporaneous
medical records have been a part of the record of this case literally for years. Petitioner
also previously filed a letter by Dr. Ferrier supporting vaccine-causation November 14,
2016. (ECF No. 55; Ex. 8.) Subsequent to the hearing, petitioner was ordered to file
updated medical records and this included medical records from Dr. Ferrier. (ECF Nos.
143, 146; Exs. 37-38.) All of these materials were thoroughly addressed in the ruling at
issue. Furthermore, petitioner was previously put on notice regarding the assigned
special master’s concerns regarding the adequacy of Dr. Ferrier’s causal opinion letter
and provided an opportunity to file a more detailed report. (ECF No. 56.) After
petitioner failed to produce a further clarifying report the special master issued an order
to show cause why the case should not be dismissed (ECF No. 62) and petitioner filed a
response indicating that “[a]lthough further information from Dr. Ferrier may help clarify
some issues in this case, it is not necessary for this case to move forward” (ECF No. 63,
pp. 1-2). Petitioner did not subsequently file any further opinion from Dr. Ferrier prior to
the close of the entitlement phase of this case and, instead, filed reports by Dr. Lapp.
After this case was remanded for further proceedings in December of 2018,
petitioner was permitted a year and a half to develop her expert’s opinion prior to the
scheduling of an entitlement hearing. (ECF No. 106-121.) After petitioner filed an initial
report from Dr. Lapp (ECF No. 113; Ex. 16), petitioner was allowed additional time to
schedule an in-person evaluation with her expert. She was then permitted to file a
second report by Dr. Lapp and then filed a third report by Dr. Lapp responding to
respondent’s experts’ reports. (ECF Nos. 115, 121; Exs. 21-22.) Further still, the
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undersigned permitted petitioner to file additional medical literature just prior to the
hearing, out of time and over respondent’s objection. (ECF No. 140.) During the
hearing, Dr. Lapp cited still further unfiled literature during the hearing and used an
unfiled demonstrative. Petitioner was permitted to file those materials into evidence as
well. (ECF No. 143.) During the hearing, the court was actively engaged to ensure the
clarity of Dr. Lapp’s testimony. (Tr. 182-83, 189, 192, 194-95, 214, 223-24.)
Additionally, Dr. Lapp sat for a court examination (Tr. 229-42) and petitioner presented
rebuttal testimony by Dr. Lapp after respondent had presented his case (Tr. 306-09).
Thus, petitioner has clearly been provided a full and fair opportunity to develop
and present her proffered opinion evidence from both Dr. Ferrier and Dr. Lapp. In fact,
it is difficult to see how petitioner could have been accommodated further. Moreover,
though she disagrees with the outcome of the ruling on entitlement, petitioner does not
suggest that any aspect of the complained of analysis was beyond the scope of what
was litigated by the parties. And, in fact, as discussed above, Dr. Lapp fails to articulate
any error or omission in the ruling. His supplemental report represents nothing more
than the hope for a second bite at the apple whereas motions for reconsideration are
“not intended to give an unhappy litigant an additional chance to sway the court.” Prati,
82 Fed. Cl. at 376 (2008) (quoting Fru–Con Constr. Corp., 44 Fed. Cl. at 300). To the
extent petitioner merely disagrees with the outcome, her rights and interests are instead
protected via the procedures for a Motion for Review. Vaccine Rules 23-28.
Considering the substance of petitioner’s new submissions and the procedural history
above, petitioner has not demonstrated that reconsideration or reopening of entitlement
is necessary to prevent any type of injustice, manifest or otherwise.
Nor is it the case that the relief petitioner seeks would be without negative
consequences if it were granted. In keeping with fundamental fairness to both parties
(Vaccine Rule 8(b)(1)), accepting petitioner’s proposed new evidence would require
providing respondent an opportunity to respond. This would result in delay in itself – a
delay clearly caused by the petitioner – and could also open the door to a proliferation
of proposed new evidence from both parties. Additionally, because Dr. Lapp’s
supplemental report purports to restate to his own testimony and appears in part to
recant certain testimony, respondent would have a clear interest in seeking further cross
examination to explore what would be a credibility issue. Thus, the possible need for a
further entitlement hearing to prevent prejudice to respondent cannot necessarily be
excluded. Prolonged delay and/or prejudice to respondent are not an inevitably in this
case; however, judicial economy disfavors the relief petitioner seeks given that
entitlement was resolved fairly in the first instance. In that regard, this program’s
crushing caseload should not be discounted. Given the thousands of petitions pending,
this program’s resources could be focused on more pressing needs.
This order does not accept the premise that either Dr. Ferrier’s or Dr. Lapp’s
opinions were in need of clarification, or that the ruling at issue has misunderstood
either. However, the procedural history of this specific case also counsels that
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petitioner has been given ample opportunity to remedy any shortcomings in the causal
opinions offered in this case. As the Court of Federal Claims indicated in Sword v.
United States: “What trial attorney worth his or her salt would not try a case a bit
differently once counsel knew what the fact-finder found important within the body of
evidence? But fairness does not require that we accede to this all-to-human desire.” 44
Fed. Cl. 183, 191 (1999).
Accordingly, reconsideration is not in the interest of justice and petitioner’s
motion should not be granted pursuant to Vaccine Rule 10(e). Nor is a reopening of the
record necessary to maintain fundamental fairness in the receipt of evidence in this
case.
c. Petitioner’s legal arguments are not persuasive
Finally, regardless of all of the above, if the ruling at issue includes a material
error of fact or law, reconsideration could be warranted. In that regard the bulk of
petitioner’s motion is dedicated to legal analysis under the three Althen prongs for
determining causation-in-fact. However, to the extent the motion for reconsideration
implicitly relies upon the assertion of a mistake of fact or law, it is also the case that
petitioner’s substantive legal arguments are unavailing.
i. Althen prong one
Petitioner argues with respect to Althen prong one that “[t]he Althen Court was
clear that Prong One was satisfied by a plausible medical theory causally connecting a
vaccine to an injury. Althen has never been overruled.” (ECF No. 162, p. 3.) Petitioner
notes that the ruling at issue accepted that CFS “may involve an aberrant chronic
immune response and that CFS symptoms may be cytokine-related.” (Id. (quoting ECF
No. 160, p. 43).) Petitioner contends that medical literature shows that immunizations in
rare circumstances can cause cytokine dysregulation. In support of this argument,
petitioner files a new exhibit – “A Report of the CFS/ME Working Group” (Ex. 41) –
which she quotes as indicating that
A few case reports have suggested that CFS/ME has occurred after
immunisations, though intercurrent events, including infection, might have
played a part in the disease process. It is biologically plausible that some
processes seen after infections could also occur after immunisations, but
this has yet to be confirmed by a good quality cohort study in the case of
CFS/ME.
(ECF No. 162, p. 4 (quoting Ex. 41, p. 32).)
Petitioner also argues by citation to a previously filed article by Devanur et al.
(Ex. 17) that various vaccines, including the tetanus vaccine at issue in this case, are
implicated as triggers of CFS. (ECF No. 162, p. 4 (quoting Ex. 17, p. 7).) Petitioner
12
further cites Dr. Lapp’s discussions with Lily Chu, author of a previously filed article (Ex.
30), as confirmation that the study implicates the Tdap vaccine. (ECF No. 162, pp. 4-5.)
Petitioner newly files with this motion an undated letter by Dr. Chu to that effect. (Ex.
40.) Thus, petitioner argues that she has presented preponderant evidence of a
biologically plausible theory linking the Tdap vaccine to CFS. (ECF No. 162, p. 5.)
It is not necessary to parse petitioner’s specific understanding of the Althen
decision. While the Althen Court stressed that a petitioner may prove causation
circumstantially, the Federal Circuit has also repeatedly held that cause-in-fact claims
must be supported by “sound and reliable” medical or scientific explanation. Knudsen v.
Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994); Boatmon v. Sec’y
of Health & Human Servs., 941 F.3d 1351,1360-61 (Fed. Cir. 2019); Kirby v. Sec’y of
Health & Human Servs., 997 F.3d 1378, 1384-85 (Fed. Cir. 2021). Petitioner is correct
that Althen has not been overruled, but nor has it been contradicted. Kottenstette v.
Sec’y of Health & Human Servs., 861 Fed. App’x 433, 441 (noting of the Knudsen
holding regarding “specific biological mechanisms” that “Boatmon did not, and indeed,
could not, overrule these previous articulations of the standard for causation”); but see
Simanski v. Sec’y of Health and Human Servs., 671 F.3d 1368, 1384 (Fed. Cir. 2012)
(specifically explaining that while petitioner need not identify a specific biologic
mechanism, causation must also be supported by “sound and reliable medical or
scientific explanation”). As the Federal Circuit explained in Knudsen, “[c]ausation in fact
under the Vaccine Act is thus based on the circumstances of the particular case, having
no hard and fast per se scientific or medical rules.” 35 F.3d at 548.
Here, citing the above-discussed caselaw, the ruling at issue explained that
petitioner’s burden was to present a theory that was legally probable rather than
scientifically certain and that is supported by sound and reliable explanation. (ECF No.
160, p. 39.) The ruling stressed that petitioner need not present either literature or a
specific mechanism. (Id.) Applying that standard, the ruling addressed in detail why Dr.
Lapp’s explanation was unpersuasive, both because he oversold the value of the
literature he himself had relied upon and because his own testimony was not persuasive
with regard to a key point. The fact that petitioner has belatedly filed an article that uses
the term “biologically plausible” would not be dispositive in itself. Nor does it suggest
that the ruling applied an incorrect burden of proof or otherwise misconstrued the
evidence. Petitioner’s further arguments relating to cytokine dysregulation and aberrant
immune response are answered by the analysis already contained in the ruling at issue.
ii. Althen prong two
Quoting Andreu v. Secretary of Health and Human Services, petitioner stresses
that “treating physicians are likely to be in the best position to determine whether a
logical sequence of cause and effect shows that the vaccination was the reason for the
injury.” (ECF No. 162, p. 5 (quoting 569 F.3d 1367, 1375 (Fed. Cir. 2009).) Petitioner
charges that “[t]he Ruling takes issue with the fact that none of Mrs. Skinner-Smith’s
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treating doctors diagnosed her with CFS close to the time of the vaccination.” (Id. at 5-
6.) Petitioner argues that it is irrelevant whether the treating physicians could identify
petitioner’s condition as CFS if they attributed her symptoms to her vaccine. (Id. at 6.)
Importantly, however, the Vaccine Act requires special masters to consider
treating physician opinions based on the record as a whole rather than blindly accept
the views of the treating physicians in isolation. Section 13(b)(1) provides that “[a]ny
such diagnosis, conclusion, judgment, test result, report, or summary shall not be
binding on the special master or court.” Petitioner’s motion for reconsideration is silent
as to how the treating physician opinions support Dr. Lapp’s opinion. Contrary to what
petitioner argues in her motion for reconsideration, the opinions of the treating
physicians have been considered in the ruling at issue. However, they are not
consistent with Dr. Lapp’s opinion. The ruling at issue explained:
Petitioner was never diagnosed with CFS by any of her treating physicians
prior to consulting Dr. Lapp. Accordingly, while the treating physicians felt
a vaccine reaction was possible, they did not offer any contemporaneous
opinion that petitioner suffered vaccine-caused CFS. Instead, petitioner’s
claim is based entirely on Dr. Lapp’s hindsight. Taking petitioner’s
symptoms and the close temporal relationship to vaccination, the treating
physicians were willing to opine that petitioner was suffering an adverse
vaccine reaction in the form of a likely serum sickness. (Ex. 1, p. 706; Ex.
3, pp. 1-3.) Dr. Lapp, however, has opined that petitioner never suffered
any serum sickness reaction. Instead, he opines that the symptoms the
treating physicians identified as serum sickness were actually symptoms of
the CFS itself. (Tr. 230.) Moreover, even if petitioner did suffer a temporary
serum sickness that explains her initial symptoms, Dr. Lapp further opined
that “I have never known serum sickness to lead to chronic fatigue
syndrome.” (Tr. 231.) Additionally, to the extent he opined that petitioner
suffered a vaccine-caused cellulitis, he also opined that the cellulitis would
not have caused petitioner’s CFS. (Tr. 212.) Thus, Dr. Lapp rejects either
cellulitis or serum sickness as part of the relevant causal chain, thereby
dismissing any causal connection between petitioner’s CFS and any illness
documented in the medical record that may have in turn been causally
connected to the vaccination.
(ECF No. 160, p. 46.)
By and large the treating physicians opined that petitioner’s symptoms were
caused by her vaccine based upon their own diagnosis of a serum sickness. (Dr.
Ferrier being the notable exception who originally provided no diagnosis to support her
opinion as explained in the ruling at pages 29-30.) However, Dr. Lapp opined on
petitioner’s behalf that their diagnosis was incorrect and based his causal opinion on the
presence of a different condition, CFS. Moreover, the ruling concluded that there is not
preponderant evidence that petitioner suffered a serum sickness based in significant
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part on the strength of Dr. Lapp’s testimony. (See ECF No. 160, pp. 29-30.)
Accordingly, petitioner directly and fatally undercut the actual causal assessment of
most of the treating physicians. Conversely, as the ruling noted, the treating physicians
did not diagnose CFS. This fact was not fatal to petitioner’s claim insofar as the ruling
credited petitioner as suffering CFS based on Dr. Lapp’s opinion; however, petitioner
cannot reasonably interpret the treating physicians’ statements as recognition that her
vaccine caused a condition they did not know she had.
iii. Althen prong three
With regard to Althen prong three, petitioner stresses Dr. Lapp’s experience in
treating patients with CFS and contends that the ruling discounts that experience. (ECF
No. 162, p. 7.) Petitioner argues that the literature confirms that a significant number of
CFS sufferers experience a quick onset. (Id. at 8.) Petitioner stresses “[t]he pertinent
question is what is possible.” (Id.) Petitioner also takes issue with discussion in the
ruling of a sore throat approximately three weeks before the vaccination. 4 (Id. at 8-9.)
Petitioner argues that
to suggest that a past sore throat might be causative violates 42 USCA
§ 300aa-13. In general, compensation cannot be made if an injury is due
to factors unrelated to vaccination. Critically, “the term ‘factors unrelated to
the administration of the vaccine’ – (A) does not include any idiopathic,
unexplained, unknown, hypothetical, or uncommentable cause, factor,
injury, illness, or condition.
(ECF No. 162, p. 9.) Petitioner argues that she is not obligated to eliminate alternative
independent potential causes. (Id. (quoting Walther v. Sec’y of Health & Human Servs.,
485 F.3d 1146, 1152 (Fed. Cir. 2007).)
Petitioner’s argument misconstrues the ruling. Petitioner’s reliance on Dr. Lapp’s
prior clinical experience in preference to the Chu paper is misplaced. As the ruling
explains, “[d]uring the hearing Dr. Lapp confirmed that he felt the Chu study supported
his theory vis-à-vis timing.” (ECF No. 162, p. 48 (citing Tr. 238-39).) Additionally,
petitioner’s focus on Chu et al. as evidencing “quick onset” is misleading. As explained
in the decision, the Chu study focuses largely on “abrupt” versus “gradual” onset of
CFS. Especially with respect to injections, the study lacked information regarding the
time interval between injections and onset of CFS. (Id. at 48-51, n.30.)
4
In her motion, petitioner repeatedly refers to her preceding illness as merely a “sore throat” and
characterizes it as idiopathic. (ECF No. 162, pp. 8-9.) This mischaracterizes the record. While petitioner
did have a sore throat, the record confirms for reasons discussed throughout the ruling that petitioner’s
illness was not limited to a sore throat. In fact, even in petitioner’s newly submitted letter by Dr. Ferrier
she confirms that petitioner’s “symptoms and exam at that time were indicative of infection.” (Ex. 39, p.
1.)
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Additionally, the ruling did not require petitioner to disprove a causal connection
to her prior infection. Nor did the ruling find that the infection and vaccination may have
acted in conjunction to cause petitioner’s CFS as petitioner asserts. The ruling
explained that “[b]oth the Evans and Chu articles explain that the so called ‘succumbing’
to CFS is not the same as onset, which may in fact occur nascently much earlier. In
that regard, the actual onset of petitioner’s CFS is not clear.” (ECF No. 160, p. 50.)
The ruling further explained that
Even if there is the appearance of a temporal relationship here, Dr. Lapp
has little basis for selecting petitioner’s vaccination as the starting point of
a logical sequence of cause and effect to suggest, pursuant to Althen prong
two, that her vaccination caused her CFS. Nor has he persuasively
addressed pursuant to Althen prong three what would constitute an
appropriate temporal relationship between onset of CFS and an antecedent
trigger. The Evans and Chu papers, coupled with Dr. Lapp’s own testimony,
suggest that the medical community’s understanding of the onset of CFS
lacks the degree of understanding or precision Dr. Lapp would need to
pinpoint the actual onset of her condition and/or distinguish petitioner’s
vaccination as the initiating cause of her CFS.
(Id. at 51.)
III. Conclusion
For all the reasons discussed above, petitioner’s motion for reconsideration of
the August 15, 202 Ruling on Entitlement (at ECF No. 160) is DENIED. Petitioner’s
status report as ordered by the Damages Order at ECF No. 161 remains due by
September 14, 2022.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
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