Skinner-Smith v. Secretary of Health and Human Services

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UNPUBLISHED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

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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

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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

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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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