# In th e United States Court of Federal Cl aims

No. 13-675V (F iled Under Seal: Aug

ust 9, 2017) ( Reissued for Publication: Aug u st 25, 2017) 1

************************************* B O DEPENA and NATAL I E DEPENA, * leg al representatives of a minor child, R.D., *

* Petitioners, * Vaccine Act; Motion for Review; MMR

* Vaccine; Severe Pneumonia; Althen;

v. * Causation-in-F act; Consideration of Medical

* L iterature; Ex pert Credibility SECRETARY OF HEAL TH AND * HUMAN SERVI CES, *

* Respondent. *

*************************************

Michael B aseluos, San Antonio, TX, for petitioners.

Heather L . Pearlman, United States Department of J ustice, W ashing ton, DC, for respondent.

OP INION AND ORDER

SWEENEY , J udg e

Petitioners B o and Natalie DePena seek compensation under the National Childhood Vaccine I njury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34 (2012), alleg ing that their son, R.D., 2 developed severe pneumonia as a result of a Measles-Mumps-Rubella (“MMR”) vaccination. I

n a F e b ruary

22, 2017 decision, the special master denied petitioners’ request for compensation. B efore the court is petitioners’ motion for review of the special master’s decision. F or the reasons set forth below, the court denies petitioners’ motion and sustains the decision of the special master.

1 Vaccine Rule 18(b), contained in Appendix B of the Rules of the United States Court of F ederal Claims (“RCF C”), affords each party fourteen day s in which to object to the disclosure of (1) trade secrets or commercial or financial information that is privileg ed or confidential or (2) medical information that would constitute “a clearly unwarranted invasion of privacy .” Neither party

objected to the public disclosure of any information contained in this opinion.

2 B ecause R.D. is a minor, the court will refer to him by his initials. See RCF C 5.2(a).I. BACK G ROUND

A. R.D.’s Medical History

R.D.’s medical history , which is undisputed by the parties, can be briefly summariz ed. 3 R.D. was born in 2003. He received his first MMR vaccination in Aug ust 2004. He also received three pneumococcal conjugate vaccinations–which protected ag ainst seven strains of Streptococcus pneumoniae (“pneumococcus”)–in November 2003, March 2004, and J une 2005.

On September 15, 2010, during an appointment with his pediatrician, R.D. received several vaccinations, including a second MMR vaccination. Two day s later, R.D.’s mother reported that R.D. had a bad reaction to the vaccinations, and there is photog raphic evidence of raised dots on R.D.’s thig h. Then, on September 25, 2010, petitioners took R.D. to the
emerg ency

room because he was ex

p eriencing

lower back pain; R.D. also had a two-day history of coug h and a hig her-than-normal temperature. The emerg ency room doctors diag n osed an acute viral sy

ndrome.

B e cause R.D.’s health did not improve, his mother took him to his pediatrician on September 28, 2010. R.D. had a hig h fever, his skin had a g r a y ish color, and he made g runting sounds when breathing . A chest x -ray revealed bilateral pneumonia. R.D. was admitted to the hospital. During the hospitaliz ation, R.D.’s phy sicians determined that pneumococcus was the cause of R.D.’s pneumonia. They further determined, after testing R.D.’s blood for the presence of antibodies ag ainst fourteen seroty pes (i.e., strains) of pneumococcus, that R.D. had protective levels of antibodies for only three seroty

pes. Due to the severity

of his pneumonia, R.D. remained hospitaliz ed for twenty

- one day s, and ultimately was discharg ed on October 18, 2010.

I n the y ears following

his discharg e from the hospital, R.D. was diagnosed with mild reactive airway disease and prescribed an inhaler, a CT scan revealed slig h t scarring

in R.D.’s chest, and a spirometry

test was normal. B y

2016, R.D.’s condition had improved. Moreover, even thoug h testing conducted in 2016 revealed that R.D. did not have protective levels of antibodies for thirteen seroty pes of pneumococcus, he had not suffered from any episodes of pneumonia since his 2010 hospitaliz ation.

B. Medical and Scientif ic Background

I n their motion for review, petitioners contend that the special master erred by rejecting their theory

that R.D.’s September 15, 2010 MMR vaccination caused R.D.’s severe pneumonia. However, neither they

nor respondent contests much of the medical and scientific backg round

3 The court derives this information from the special master’s decision. See generally DePena v. Sec’y of HHS, No. 13-675V, 2017 W L1075101, at *2-6 (F ed. Cl. Spec. Mstr. F eb. 22, 2017).

-2-information contained in the special master’s decision. B ecause this information provides

contex t for the arg

u ments set forth in petitioners’ motion for review, the court briefly recounts it.

1. Operation of

the Im m une System

As an initial matter, the special master provided a basic ex planation of the immune
sy stem:

A body ’ s responses to foreign invaders, often called antig ens or pathog ens, are controlled by

the immune sy stem. I mmunolog ists g enerally divide the immune sy stem into two branches: the innate immune sy stem and the adaptive immune sy stem.

I nnate I mmune Sy stem. The innate immune sy stem is relatively primitive. The innate immune sy stem g enerally recog niz es foreig n invaders. Components of the innate immune sy stem include cy tokines, natural killer cells, and complement.

. . . . Adaptive I mmune Sy stem. I n comparison to the innate immune sy stem, the adaptive immune sy stem is more advanced. The adaptive immune sy stem recog niz es specific antig ens. The adaptive immune sy stem contains two ty pes of cells: B cells and T cells. . . .

B cells. B cells make antibodies. Antibodies, in turn, can be classified into different ty

pes of immunog lobulin. Antibodies recog niz e poly saccharides (or
sug ars). Antibodies’ ability to respond to poly saccharides is one trait that disting uishes them from T cells.

T cells. The other part of the adaptive immune sy stem is T cells. T cells derive their name from the thy mus, where they

mature.

T cells are further classified. The basic division is into two g r oups, known
as cy totox ic T cells and helper T cells. Cy totox ic T cells, which are also known as CD8+ cells, kill cells that are infected by viruses. . . .

There are multiple ty

pes of helper T cells, also known as CD4+ cells. Th1 cells help cy

totox ic T cells kill cells infected with infectious ag ents, especially viruses. Th2 cells help B cells. Th17 cells help cells at the mucosal level respond to infections . . . . Another ty pe of helper T cell makes sure that the immune

-3-sy stem does not overrespond. These helper T cells are known as T reg ulatory cells.

DePena, 2017 W L 1075101, at *5-6 (footnotes and citations omitted).

2. The MMR Vaccine and the Measles Virus

The special master also provided information reg arding the MMR vaccine and the measles virus:

The MMR vaccine is an attenuated vaccine, that is, the vaccine contains a weakened form of the live measles virus. I n its wild (or natural) state, the measles virus is ex tremely

virulent. Measles causes the death of thousands of unvaccinated people each y ear.
The people who survive measles infection are more vulnerable to infection from other pathog ens for 1-4 weeks. Scientists have recently theoriz ed that the measles virus destroy s the memory aspect of the survivor’s immune sy stem. W ithout this memory

in their immune sy stem, survivors of the measles virus may be unable to fig ht off infection and may contract diseases.

I d. at *4. He further ex

plained “that the MMR vaccine can have the same consequence as the wild measles virus: a suppression of some parts of the adaptive immune sy stem.” I d.

3. P neum ococcus

F inally , the special master described pneumococcus and how the body can react to it:

Pneumococcus is a ty

pe of bacterium. There are more than 90 strains of pneumococcus and the numerous strains contribute to the difficulty in developing an effective vaccine. The outside capsule of pneumococcus is comprised of poly saccharides. Poly saccharides are carbohy drates, like sug a

rs. W hen faced with a poly saccharide invader, the body ’s adaptive immune sy stem responds by producing antibodies, which come from B cells, and the body does not produce T cells in response. Consequently , pneumococcus has been categ oriz ed as a ty pe I I T cell-independent antig en.
The body ’s encounter with pneumococcus is unusual in the sense that the first step is coloniz ation. Coloniz ation means that a strain of pneumococcus is living in a person’s nose and throat. This nasophary n g eal coloniz ation is

ex tremely common with estimates ex ceeding 25 percent. Coloniz ation, which is also known as carriag e, is especially frequent in the very

y oung and the very

old.

-4-During coloniz ation of the mucosal surfaces of the nose and throat, the

body ’s adaptive immune sy stem produces an antibody known as immunog lobulin A. On some occasions, and in some people, a coloniz ation resolves without a worsening of sy

mptoms.

However, pneumococcus can also mig rate from the nasophary

nx to other portions of the body . . . . [ R] elatively little is known about how this chang e occurs. W hen pneumococcus moves to the ears and sinuses, it causes otitis media and sinusitis. These ty

pes of infections are both relatively common and mild. I t is much more alarming

when pneumococcus infects the lung s, causing a condition called pneumococcal pneumoniae.

I n the United States in 2015, more than one million people suffered from pneumococcal pneumoniae.

I d. at *3 (citations omitted). He further noted that “the innate immune sy stem contributes to how the body responds when pneumococcus becomes infectious.” I d. at *5.

II. P ROCEDURAL HISTORY

Petitioners filed a petition for compensation under the Vaccine Act on September 12, 2013. Upon reviewing

R.D.’s medical records, respondent recommended that the special master deny petitioners compensation. Thereafter, the parties submitted ex pert reports. Petitioners ultimately

provided the special master with six submissions–five reports and a response to a leg al brief–from pediatric pulmonolog ist B oris M. L okshin, M.D., and respondent provided three reports from pediatric immunolog ist Neil D. Romberg , M.D. The special master convened an evidentiary

hearing
, 4 during which he heard the testimony of Dr. L o kshin and Dr. Romberg . The parties offered posthearing submissions, and the special master issued a decision on F ebruary 22, 2017.

I n his decision, the special master noted that there was no dispute that R.D. developed severe pneumonia caused by pneumococcus. Rather, the parties disputed whether R.D.’s September 15, 2010 MMR vaccination caused the pneumonia. Petitioners arg ued, based on the opinion of Dr. L okshin, that the MMR vaccination impaired R.D.’s immune sy stem’s ability to produce T cells, and that the lack of T cells rendered R.D.’s body unable to resist the pneumococcal infection. Respondent countered, based on the opinion of Dr. Romberg , that the MMR vaccination did not affect the parts of R.D.’s immune system responsible for responding to pneumococcal infections and, as a result, the MMR vaccination could not have led to R.D.’s severe pneumonia. I

n short, the parties disag r eed reg arding the role that T cells play in responding to a pneumococcal infection; petitioners contended that T cells play a role, while respondent contended that T cells are ex pendable.

4 The hearing

occurred over two day

s–F e bruary

11, 2016, and April 12, 2016.

-5-After identify ing the parties’ dispute, the special master analy z ed the viability

of petitioners’ theory of causation. F irst, he compared the qualifications of the parties’ ex perts. Dr. L okshin, the special master noted, was not board certified in immunolog y , did not have any training in T cells, and was not performing research. The special master qualified Dr. L okshin as

an ex pert in pediatric pulmonolog y and declared that Dr. L okshin “possesse[ d] the minimum qualifications to testify

about immunolog ic concepts because of his training and ex perience.” I d. at *8. However, the special master continued:

Dr. L o kshin’s lack of specializ ed training in immunolog y affected the quality of his testimony . W hen Dr. L okshin presented the articles on which he relied, he frequently

stated that he was not presenting his opinion, he was simply presenting a view someone else ex pressed. W hile it is hornbook law that a testify ing ex pert may

rely upon the work of another ex pert if the testify

ing ex p ert would normally

rely upon the second ex p ert’s work, Dr. L okshin often left the impression that he did not have the depth of experience in immunolog y necessary to evaluate and render an opinion on immunolog ic topics.

. . . . . . . [ H ] e did not appear fluent in the lang uag e of immunolog y . This lack of fluency , ag ain, g ave the impression that Dr. L okshin had limited ex perience on which to base his opinions. This impression, in turn, diminished the overall value of Dr. L okshin’s testimony

.

I d. at *8-9 (footnote and citations omitted); see also id. at *13 (“Dr. L o kshin . . . seems ill-equipped to topple established immunolog ic ideas . . . . Dr. L okshin does not routinely treat patients with immunolog ic disorders, he does not teach classes of medical school students in immunolog y , he does not have any advanced certifications in immunolog y , and he does not currently author articles on immunolog y . I n short, when the topic is cutting -edg e immunolog y , Dr. L okshin has [ fewer] qualifications to present new ideas persuasively .”). I n contrast, the special master credited Dr. Romberg ’s education and experience in pediatric immunolog y , and remarked: “Overall, Dr. Romberg ’s knowledg e about immunolog y was impressive. His demeanor and the content of this testimony demonstrated that he understood how the human immune sy stem functions to a level of g reat detail. He took care to be precise in his wording

. ” I d. at *10. The special master concluded that “[ o ] n immunolog ic topics, Dr. Rombergwas, simply
, a much strong er witness than Dr. L okshin.” I d.

After evaluating

the ex perts’ credentials, the special master discussed three immunolog ical principles related to pneumococcal infections that, he asserted, were not in dispute: (1) “an effective response to pneumococcal infection requires both the innate immune
sy stem and antibodies from the adaptive immune sy stem,” id.; (2) “T cells do not respond directly to pneumococcal infection,” id.; and (3) individuals whose immune sy stems produce no

-6-B cells or produce defective B cells “do not develop pneumococcal infections” when they receive antibodies, reg ardless of whether T cells are also present, id. at *13.

The special master then evaluated the proposition at the heart of petitioners’ theory of causation–that a human’s response to pneumococcal infection involves T cells–and the medical literature that petitioners submitted in support of that proposition. Several of the submitted articles described mouse studies, and revealed that mice produce T cells in response to pneumococcal infections. Dr. L okshin arg ued that the results of these studies supported a conclusion that humans also produce T cells in response to pneumococcal infections. The special master noted, however, that Dr. L okshin did not ex plain the similarities between mice and humans that would support ex trapolating the results of the studies from mice to humans, and that Dr. Rombergtestified–and provided supporting evidence–that “with respect to the response to pneumococcal infections, mice differ from people.” I d. at *14. The special master concluded that “[ w] ithout some reliable showing that an ex trapolation from mice to people is appropriate, the studies based upon mice are not useful.” I d

. Petitioners also submitted articles that described studies in humans, as well as other related documents, in support of their proposition that T cells are involved in a human’s response to pneumococcal infection. This evidence reveals that researchers and at least one company are “attempting to develop a vaccine ag ainst pneumococcus that stimulates the production of T cells,” and “that the National I nstitutes of Health has funded research into a T cell based vaccine
ag ainst pneumococcus.” I d. However, the evidence also reveals that the company suspended development of the vaccine because it was not obtaining statistically sig nificant results; indeed, Dr. L okshin testified that “research into a T cell based vaccine is ‘just too early ’ and ‘not moving as fast’” as desired. I d. at *15. The special master noted:

The g oal of developing

a T cell based vaccine is certainly laudatory –a successful T cell based vaccine could protect ag ainst many

(may be all) strains of pneumococcus. The potential benefits, especially in the reg ions of the world with less access to medical care, could be immense. However, the worthiness of the pursuit does not automatically make any

of [ the human] studies a reliable basis for

an ex pert’s opinion.

I d. He therefore concluded that “[ t] he articles did not present a persuasive basis for toppling the
g enerally accepted principle in immunology that a human being ’s response to a pneumococcal infection does not involve T cells.” I d.

At the close of his decision–after noting that “Dr. Romberg ’s opinion was more persuasive than Dr. L okshin’s opinion” because of “Dr. Romberg ’s superior qualifications in immunolog y , the well accepted and well demonstrated idea that T cells cannot recog niz e poly saccharides, and the undeveloped effort to overturn immunolog ic dog ma,” id. at *16–the special master analy

z ed petitioners’ case under the test for causation set forth in Althen v. Secretary of HHS, 418 F .3d 1274 (F ed. Cir. 2005). I n Althen, the United States Court of

-7-Appeals for the F ederal Circuit (“F ederal Circuit”) articulated a three-part test, based on prior

precedent, ex

plaining what a petitioner must show to prove causation under the Vaccine Act:

[ Petitioner] ’s burden is to show by preponderant evidence that the vaccination broug ht about [ the] injury by providing : (1) a medical theory causally connecting the vaccination and the injury ; (2) a log ical sequence of cause and effect showing that the vaccination was the reason for the injury ; and (3) a showing of a
prox imate temporal relationship between vaccination and injury

.

I d. at 1278. The special master concluded that petitioners had not established either of the first two prong s of the Althen test, ex plaining that petitioners had not reliably shown “that T cells have a substantive role in a human being ’s response to a pneumococcal infection.” 5 DePena, 2017 W L 1075101, at *16. Moreover, with respect to the second prong of the Althen test, the special master further noted that none of R.D.’s treating phy sicians posited that R.D.’s severe pneumonia was the result of his September 15, 2010 MMR vaccination; that R.D.’s case did not fit within the challeng e-rechalleng e paradig m (when an individual who reacts to the administration of a vaccine ex hibits a more severe reaction to a second administration of that vaccine); and that R.D.’s persistent low levels of antibodies protective against pneumococcal infection and concomitant failure to develop a second pneumococcal infection did not mean that R.D.’s September 15, 2010 MMR vaccination–which trig g ered a decrease in T cells–was the only event that could have caused R.D.’s severe pneumonia because “isolat[ ing ] the MMR vaccination and consequent decrease in T cells as the reason for [ R.D.’s] pneumococcal pneumonia seem[ ed] to overlook many other potentially

contributory

factors.” I d. at *18. He therefore denied petitioners’ request for compensation. Petitioners, alleg ing error, seek review of the special master’s decision, which respondent opposes. Upon reviewing the record that was before the special master and hearing the parties’ arg

uments, the court is prepared to rule.

III. DISCUSSION

The United States Court of F ederal Claims (“Court of F ederal Claims”) has jurisdiction to review the record of the proceeding s before a special master, and upon such review, may :
(A) uphold the finding s of fact and conclusions of law of the special master and sustain the special master’s decision,

(B ) set aside any

finding s of fact or conclusion of law of the special master found to be arbitrary , capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own finding s of fact and conclusions of law, or

(C) remand the petition to the special master for further action in accordance with the court’s direction.

5 Respondent conceded that the third prong of the Althen test had been satisfied.

-8-42 U.S.C. § 300aa-12(e)(2). The standards set forth in section 12(e)(2)(B ) “vary in application as well as deg ree of deference. . . . F act finding s are reviewed . . . under the arbitrary and capricious standard; leg al questions under the ‘not in accordance with law’ standard; and discretionary

ruling s under the abuse of discretion standard.” Munn v. Sec’y of HHS, 970 F .2d 863, 870 n.10 (F ed. Cir. 1992).

I n the instant case, petitioners enumerate, pursuant to Vaccine Rule 24, three objections to the special master’s decision. F irst, petitioners contend that the special master failed to seriously consider the medical literature supporting their theory

of causation. Second, petitioners assert that the special master improperly relied solely

on an assessment of ex pert credibility in rejecting their theory of causation, impermissibly raising their burden of proof. Third, petitioners aver that the special master erroneously determined that they

could not causally

link R.D.’s September 15, 2010 MMR vaccination to his severe pneumonia. I n short, petitioners believe that they have established a prima facie case of causation under the Vaccine Act.

A. P r oving Causation Under the Vaccine Act

Pursuant to 42 U.S.C. § 300aa-13(a)(1), the court shall award compensation if a petitioner proves, by a preponderance of evidence, all of the elements set forth in 42 U.S.C. § 300aa11(c)(1), 6 and if there is not a preponderance of evidence that the illness is due to factors unrelated to the administration of the vaccine. A petitioner can recover in one of two way s: either by proving an injury

listed on the Table or by

proving causation-in-fact. See 42 U.S.C. §§ 300aa-11(c)(1)(C), -13(a)(1). Under the first method of recovery , a petitioner must demonstrate that the injury was sustained within the time frame set forth in the Table. I d. § 300aa-11(c)(1)(C)(I

), -14(a). “I f petitioner can make such a showing , causation is presumed and petitioner is deemed to have made out a prima facie case of entitlement to compensation under the Act.” W hitecotton v. Sec’y of HHS, 81 F .3d 1099, 1102 (F ed. Cir. 1996).

To establish a prima facie case when proceeding on a causation-in-fact theory, as petitioners attempted to do in this case, a petitioner must “prove, by a preponderance of the evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor in bring ing about the injury .” Shy face v. Sec’y of HHS, 165 F .3d 1344, 1352 (F ed. Cir. 1999).

6 Subsection (c)(1) requires, among other thing s, that the following elements be satisfied: (1) that the vaccine in question is set forth in the Vaccine I njury Table (“Table”); (2) that the vaccine was received in the United States or in its trust territories; (3) that the injured person either sustained an injury as a result of the administration of a Table-desig nated vaccine for a period of more than six months after the administration of the vaccine, suffered illness, disability
, injury , or condition from the vaccine that resulted in inpatient hospitaliz ation and surg ical intervention, or died from the administration of the vaccine; and (4) that the petitioner has not previously

collected an award or settlement of a civil action for damag es arising from the alleg ed vaccine-related injury

or death. 42 U.S.C. § 300aa-11(c)(1).

-9-“[ T] o show that the vaccine was a substantial factor in bringing about the injury
, the petitioner

must show ‘a medical theory causally connectingthe vaccination and the injury .’” I d. at 1352-53 (quoting Grant v. Sec’y

of HHS, 956 F .2d 1144, 1148 (F ed. Cir. 1992) (per curiam)). I n other words, “[ t] here must be a ‘log ical sequence of cause and effect showing that the vaccination was the reason for the injury ,’” id. at 1353 (quoting Grant, 956 F .2d at 1148), and “[ t] his ‘log ical sequence of cause and effect’ must be supported by a sound and reliable medical or scientific

ex p lanation,” Knudsen v. Sec’y of HHS, 35 F .3d 543, 548 (F ed. Cir. 1994) (citingDaubert v. Merrell Dow Pharms., I

nc., 509 U.S. 579 (1993); J a y v. Sec’y of HHS, 998 F .2d 979, 984 (F ed. Cir. 1993)); accord Grant, 956 F .2d at 1148 (“A reputable medical or scientific ex planation must support this log ical sequence of cause and effect.”); see also 42 U.S.C. § 300aa-13(a)(1) (“The special master or court may not make such a finding

based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.”). However, medical or scientific certainty is not required. Knudsen, 35 F .3d at 548-49; B unting v. Sec’y of HHS, 931 F .2d 867, 873 (F e d. Cir. 1991).

As noted above, the F ederal Circuit, in Althen, distilled this prior precedent into a threepart test, holding that to prove causation-in-fact, a petitioner must provide “(1) a medical theory causally connectingthe vaccination and the injury ; (2) a log ical sequence of cause and effect showing that the vaccination was the reason for the injury ; and (3) a showing of a prox imate temporal relationship between vaccination and injury .” 418 F .3d at 1278. All three prong s “must cumulatively

show that the vaccination was a ‘but-for’ cause of the harm, rather than just an insubstantial contributor in, or one among several possible causes of, the harm.” Pafford v. Sec’y of HHS, 451 F .3d 1352, 1355 (F ed. Cir. 2006).

The F ederal Circuit also ex plained in Althen that causation-in-fact can be established with circumstantial evidence–in other words, with medical records or medical opinion. 418 F .3d at 1279-80 (citing 42 U.S.C. § 300aa-13(a)(1)). A petitioner “need not produce medical literature or epidemiolog ical evidence to establish causation,” but “where such evidence is submitted, the special master can consider it in reaching an informed judg ment as to whether a particular vaccination likely caused a particular injury .” Andreu v. Sec’y of HHS, 569 F .3d 1367, 1379 (F ed. Cir. 2009); see also id. at 1380 (remarking that a special master may assess “the relevant scientific data” when determining whether a petitioner has offered a reputable and reliable ex planation supporting his theory of causation); Capiz z ano v. Sec’y of HHS, 440 F .3d 1317, 1325 (F ed. Cir. 2006) (“[ R] equiring either epidemiolog ic studies, rechalleng e , the presence of patholog ical markers or g enetic disposition, or g eneral acceptance in the scientific or medical communities to establish a log ical sequence of cause and effect is contrary to what we said in Althen[ , and] impermissibly raises a claimant’s burden under the Vaccine Act . . . .”). B ut see L aL onde v. Sec’y

of HHS, 746 F .3d 1334, 1341 (F e d. Cir. 2014) (“I n Vaccine Act cases, petitioners must proffer trustworthy testimony from ex perts who can find support for their theories in medical literature in order to show causation under the preponderance of the evidence standard. The level of specificity of such support may

vary from circumstance to circumstance.”).

- 10-Once a petitioner has established a prima facie case, the burden shifts to the respondent to

show, by a preponderance of the evidence, that the injury was caused by a factor unrelated to the vaccine. 42 U.S.C. § 300aa-13(a)(1)(B ); Shalala v. W hitecotton, 514 U.S. 268, 270-71 (1995); Deribeaux v. Sec’y o f

HHS, 717 F .3d 1363, 1367 (F ed. Cir. 2013). However, if a petitioner fails to establish a prima facie case, the burden does not shift. B radley v. Sec’y of HHS, 991 F .2d 1570, 1575 (F ed. Cir. 1993). Reg a rdless of whether the burden ever shifts to the respondent, the special master may

consider the evidence presented by the respondent in determining whether the petitioner has established a prima facie case. See Stone v. Sec’y of HHS, 676 F .3d 1373, 1379 (F ed. Cir. 2012) (“[ E] vidence of other possible sources of injury can be relevant not only

to the ‘factors unrelated’ defense, but also to whether a prima facie showing has been made that the vaccine was a substantial factor in causing the injury

in question.”); de B az an v. Sec’y of HHS, 539 F .3d 1347, 1352 (F ed. Cir. 2008) (“The g o vernment, like any defendant, is permitted to offer evidence to demonstrate the inadequacy of the petitioner’s evidence on a requisite element of the petitioner’s case-in-chief.”).

B. P etitioners Have Not Established That the Special Master Erred in Considering the

Medical Literature That They Subm itted

I n their motion for review, petitioners first challeng e the special master’s consideration of the submitted medical literature. I n particular, they

argue that a “cursory

review,” Mot. 9, of a sample of fifteen of the articles they submitted supports their theory that “the absence of [ the] protection provided by

antibodies” does not automatically result in the development of a pneumococcal infection and that “[ n] atural protection from pneumococcal infection in those without ready

to use specific antibodies is very much T cell dependent,” id. at 8. See also id. at 12 (“The articles cited by

Petitioners, even under the most cursory of reviews, reasonably

stand for the proposition that T cells play a substantial role in the modulation and prevention of invasive pneumococcal disease.”). B y failing to properly

consider this evidence, petitioners
arg ue, the special master “impermissibly raised [ their] burden under Althen prong one from a reputable medical theory

in which T cell suppression from MMR vaccine can substantially play a role in the development of [ invasive pneumococcal disease] to one of medical and scientific certainty .” I d . at 12. Respondent, in contrast, contends that the special master’s decision reflects that the special master reviewed all of the medical literature in the record, including the medical literature submitted by

petitioners, and properly determined that the medical literature did not support petitioners’ theory of causation.

Under the Vaccine Act, “a special master, reviewing the entire record of the case before him, must consider all relevant medical and scientific evidence contained in the record,” and “‘shall’ consider the entire record, which includes this relevant evidence, when assig n ing the weig ht g iven to particular evidence.” Moriarty v. Sec’y of HHS, 844 F .3d 1322, 1327-28 (F e d. Cir. 2016). Moreover, reviewing courts g enerally presume that a special master has considered all of the material in the record, reg ardless of whether it is mentioned in his or her decision. I d. at 1328; Haz lehurst v. Sec’y of HHS, 604 F .3d 1343, 1352 (F ed. Cir. 2010). In his decision, the special master referenced and discussed many of the articles submitted by the parties by

name.

- 11-See DePena, 2017 W L 1075101 passim. He also specifically declared that he had reviewed all of the submitted medical literature. See id. at *1 (“The undersig ned has reviewed all [ of petitioners’] articles. . . . The undersig ned has reviewed all [ of respondent’s] articles as well.”), *9 (“[ T] he undersig ned has reviewed all the articles . . . .”). Thus, petitioners do not attempt to rebut the presumption that the special master considered all of the submitted medical literature. Rather, their arg

ument is focused on the weight that the special master assigned to the articles that they submitted.

Special masters “have very wide discretion” in determining what evidence to consider and “the weight to be assig ned that evidence.” W h itecotton, 81 F .3d at 1108; accord Koehn v. Sec’y of HHS, 773 F .3d 1239, 1244 (F ed. Cir. 2014) (remarking “that it is within the Special Master’s discretion to weig h the relevant evidence”). Consequently , the court accords deference to the special master’s factual finding s and fact-based conclusions, Hodg es v. Sec’y of HHS, 9 F .3d 958, 961 (F ed. Cir. 1993), and may not reweig h the evidence, id. (holding that “on review, the Court of F ederal Claims is not to second gu ess the Special Master[ ’] s fact-intensive conclusions”); Hines v. Sec’y of HHS, 940 F .2d 1518, 1527 (F ed. Cir. 1991) (“[ A] rg uments as to the weig hing of evidence . . . do not demonstrate reversible error.”); see also L ampe v. Sec’y

of HHS, 209 F .3d 1357, 1363 (F ed. Cir. 2000) (“[ W ]e do not sit to reweig h the evidence.”); Munn, 970 F .2d at 871 (“[ I ] t is not then the role of this court to reweig h the factual evidence, or to assess whether the special master correctly evaluated the evidence.”). I ndeed, “reversible error is ‘ex tremely

difficult to demonstrate’ if the special master ‘has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision.’” L ampe, 219 F .3d at 1360 (quoting Hines, 940 F .2d at 1528); accord Hibbard v. Sec’y of HHS, 698 F .3d 1355, 1363 (F ed. Cir. 2012).

According

to petitioners, had the special master properly evaluated the medical literature they submitted, he would have concluded that their theory of causation was supported by the
necessary “‘indicia of reliability ,’” Mot. 12 (quoting Moberly v. Sec’y of HHS, 592 F .3d 1315, 1324 (F ed. Cir. 2010)), and that they had satisfied the first prong of the Althen test. Petitioners’ contention is problematic for two reasons. F irst, as reflected in his decision, the special master considered the articles submitted by petitioners, but concluded that those articles were outweig hed by

other evidence in the record. See, e.g ., DePena, 2017 W L1075101, at *12 (“Despite the additional articles providing some evidence to the contrary , Dr. L okshin conceded that T cells do not respond directly to pneumococcal infection.”), *13-14 (noting that Dr. L okshin “cited several articles that reported on ex periments using mice” but did not make “a reliable showingthat an ex trapolation from mice to people is appropriate”), *14 (“Dr. L okshin relied upon human studies to show that a person’s response to a pneumococcal infection involves T cells. . . . The undersigned reviewed this material multiple times and has considered the testimony from both Dr. L o kshin and Dr. Rombergabout those articles. The articles did not present a persuasive basis for toppling the g enerally

accepted principle in immunology that a human being ’s response to a pneumococcal infection does not involve T cells.”). I n other words, the special master considered the relevant evidence, drew plausible inferences, and articulated a rational basis for his conclusion. Second, petitioners’ contention that the special master

- 12-improperly considered the evidence in the record amounts to a request that this court reevaluate that evidence. However, the court is not empowered to undertake such a task unless it first concludes that the special master’s fact-based conclusions were arbitrary and capricious–and it has not so concluded. I

n sum, petitioners have not established that the special master failed to properly consider the articles they submitted.

C . P etitioners Have Not Established That the Special Master Solely Relied on an Assessm ent of Expert Credibility

I n their second objection to the special master’s decision, petitioners contend that the special master relied solely on his assessment of the credibility of the testimony of the parties’

ex p erts in rejecting their theory of causation, and as a result disreg arded the evidence in the record, impermissibly

raising their burden of proof. Specifically , petitioners contend that the special master (1) “refus[ ed] to apply the results of mouse studies to human studies,” Mot. 13; (2) “essentially

disreg ard[ ed] any evidence that T cells respond to pneumococcus,” id. at 15; (3) ig nored a “weakness” with Dr. Romberg ’s proposition that R.D.’s severe pneumonia was likely caused by

a lack of protective antibodies, id. at 16; (4) “ig nored [ the] contradictions” in Dr. Romberg ’s testimony

reg arding the role and importance of Th1 and Th17 cells, id. at 17; and (5) improperly

relied on evidence–a six ty -five-y e ar-old case study of one individual and testimony from Dr. Romberg

–reg arding the development of pneumococcal infections in individuals with dy sfunctional immune sy stems when “Dr. L o k shin effectively countered” that evidence, id. at 18. Respondent, on the other hand, asserts that there was no leg al error in either the special master’s credibility assessments or the special master’s conclusion, based on the evidence in the record, that a human’s response to a pneumococcal infection is not dependent on T cells.

Taken as a whole, petitioners’ arg ument is that the special master’s determinations
reg arding the credibility

of the parties’ experts tainted his consideration of the evidence in the record, causing him to improperly reject evidence supporting their theory

of causation and accept evidence that did not support their theory of causation. The F ederal Circuit remarked in Andreu that “[ w] hile considerable deference must be accorded to the credibility d e terminations of special masters, this does not mean that a special master can cloak the application of an erroneous leg al standard in the guise of a credibility determination, and thereby shield it from appellate review.” 569 F .3d at 1379 (citation omitted). The F ederal Circuit ex panded on these remarks in subsequent decisions:

[ T] his court has unambig uously ex plained that special masters are ex pected to consider the credibility

of ex pert witnesses in evaluating petitions for compensation under the Vaccine Act. . . . I n Moberly , we reiterated that a special master may

not cloak the application of an erroneous leg al standard in the g uise of a credibility

determination to shield it from appellate review. W e went on to clarify that this does not mean that “a special master, as the finder of fact in a Vaccine Act case, is prohibited from making credibility

determinations reg arding

- 13-ex p ert testimony .” W e indicated that “[ a] ssessments as to the reliability of ex pert

testimony often turn on credibility

determinations” and “[ f] inders of fact are entitled–indeed, ex pected–to make determinations as to the reliability of the evidence presented to them and, if appropriate, as to the credibility of the persons presenting that evidence.” Our discussion of the issue in B roekelschen is equally clear. 7 I n that case, we recog niz ed that “[ e ] x pert medical testimony is often very important in Vaccine Act cases based on off-Table injuries requiring proof of actual causation.” W e ag ain ex plained that “the special master’s decision often times is based on the credibility of the ex perts and the relative persuasiveness of their competing theories” and such credibility finding s “‘are virtually unchalleng eable on appeal.’” F inally , in Doe, 8 we upheld a special master’s factual finding s as not arbitrary and capricious “particularly in lig ht of the credibility

finding s made as to the parties’ respective ex perts.” W e found no basis for disturbing the special master’s credibility finding s as to those ex perts, and
ag ain emphasiz ed that “the special master’s unique position to see the witnesses and hear their testimony

” makes “such credibility assessments . . . ‘virtually unreviewable on appeal.’”

Porter v. Sec’y

of HHS, 663 F .3d 1242, 1250-51 (F ed. Cir. 2011) (footnotes added) (citations omitted).

As an initial matter, the special master was entitled to assess the credentials of the parties’

ex p erts as a means of assisting his evaluation of the ex p erts’ reports and testimony . I d. He was also entitled to g aug e the credibility of the ex p erts throug h a review of their reports and testimony . I d. Apply ing the deferential standard of review that is required in such circumstances, the court finds no error in the special master’s determination that Dr. L okshin was a less credible expert witness than Dr. Romberg on immunolog ical topics. The special master thoroug hly

reviewed the ex

perts’ educational and professional backg rounds, and properly assessed the ex perts’ understanding of both the relevant immunolog ical concepts and the relevant medical literature. I

n short, there is nothing arbitrary or capricious in the special master’s credibility

determinations.

Petitioners complain that by concluding that Dr. L okshin was less suited than Dr. Romberg to render opinions on the immunolog ical issues implicated in this case, the special master erroneously

disreg a rded both the evidence that Dr. L okshin relied upon in advancing petitioners’ theory of causation and the flaws in Dr. Romberg ’ s opinion and evidence. However, as repeatedly

recog n iz ed by

the F ederal Circuit, special masters are entitled to use their credibility

assessments to inform their conclusions reg arding whether a petitioner has offered a reputable and reliable ex

planation supporting his or her theory of causation. I d. I n this case, the

7 B roekelschen v. Sec’y of HHS, 618 F .3d 1339 (F ed. Cir. 2010).

8 Doe 11 v. Sec’y

of HHS, 601 F .3d 1349 (F ed. Cir. 2010).

- 14-special master did not use his credibility determinations as an ex cuse not to evaluate the evidence in the record. Rather, he evaluated the evidence keeping in mind the ex perts’ credentials and understanding of the pertinent immunolog ical topics, and thoroug hly ex plained his reasons for crediting or discounting the evidence. The five purported errors hig hlig h ted by

petitioners do not demonstrate otherwise.

F irst, with respect to the mouse studies relied upon by petitioners, the special master discussed the studies, the ex perts’ testimony reg arding the studies, Dr. L okshin’s failure to

ex p lain how humans and mice are similar, and the evidence sug g esting that the results of mouse studies cannot be applied to humans before concluding that “[ w] ithout some reliable showing that an ex trapolation from mice to people is appropriate, the studies based upon mice are not useful.” DePena, 2017 W L 1075101, at *14. Second, with respect to whether T cells can respond to pneumococcus, the special master discussed the relevant medical literature and the

ex p erts’ testimony
, and ex p lained that Dr. L okshin conceded that “pneumococcus is a T cell independent antig en” and that “T cells do not respond directly to pneumococcal infection.” I d. at *12. Third, with respect to petitioners’ sug g estion that Dr. Rombergerroneously posited that R.D.’s severe pneumonia was likely caused by

a lack of protective antibodies, the special master–referring

to two of Dr. Romberg ’s reports and his hearing testimony

–ex plained that petitioners had misconstrued Dr. Romberg ’s opinion: “Dr. Romberglisted parts of the innate immune sy stem, such as complement, as contributing to the protection ag ainst pneumococcal infection.” I d. at *18; accord id. at *5 (noting Dr. L okshin’s ag reement with Dr. Romberg ’s opinion that “the innate immune sy stem contributes to how the body responds when pneumococcus becomes infectious”), *10 (quoting Dr. Romberg ’s first report for the proposition that parts of the innate immune sy stem contribute to “‘human immunity ’” to pneumococcus). F ourth, with respect to Dr. Romberg ’s testimony reg arding the role and importance of Th1 and Th17 cells, the special master reviewed the articles submitted by petitioners on this topic and petitioners’ interpretation of those articles in their posthearing brief, but found the articles unpersuasive in lig ht of Dr. L okshin’s concession that “T cells do not respond directly to pneumococcal infection.” I d. at *12. F inally , with respect to evidence presented by Dr. Romberg reg arding the development of pneumococcal infections in individuals with dy sfunctional immune sy stems, the special master discussed the relevant medical literature and the ex perts’ testimony , and concluded that such evidence “strong ly support[ e d] the argu ment that T cells are expendable in the body ’s response to pneumococcal infection.” Id. at *10.

Ultimately , by

flag g ing these purported errors, petitioners are requesting that this court reevaluate the evidence and draw conclusions that are different from the conclusions reached by the special master. B ut so long as a special master “has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for” his conclusions, Hines, 940 F .2d at 1528, the court must not reevaluate the evidence, id. at 1527; Lampe, 209 F .3d at 1363; Hodg es, 9 F .3d at 961; Munn, 970 F .2d at 871. Here, as reflected in his decision, the special master considered the relevant evidence, drew plausible inferences, and articulated a rational basis for his conclusions. Therefore, petitioners have not established leg a l error under their second objection.

- 15-D. P etitioners Have Not Established That the Special Master Erroneously Concluded That They F ailed to Satisf

y the Second P rong of

the Althen Test

Petitioners’ third and final contention is that the special master erroneously determined, under the second prong

of the Althen test, that they could not causally

link R.D.’s September 15, 2010 MMR vaccination to his severe pneumonia. Specifically , they argue that the special master (1) improperly

considered the lack of treating phy sician opinion supporting a causal link; (2) impermissibly

implied that the failure of this case to fit within the challeng e-rechalleng e paradig m, a possibility

raised and ultimately

rejected by

Dr. L okshin, weig hed ag ainst finding a causal link; (3) failed to recog niz e a flaw in Dr. Romberg ’s proposition that R.D.’s severe pneumonia was likely

caused by

a lack of protective antibodies; and (4) improperly offered alternative ex planations for R.D.’s development of severe pneumonia. 9 I n response, respondent observes that petitioners’ failure to establish that the MMR vaccine can cause severe pneumonia under the first prong

of the Althen test means that petitioners cannot demonstrate that R.D.’s September 15, 2010 MMR vaccination did cause R.D.’s severe pneumonia under the Althen test’s second prong . Respondent further contends that even if petitioners had satisfied the first
prong of the Althen test, the special master did not err in concluding that petitioners had not satisfied the Althen test’s second prong . Respondent is correct on both points.

F irst, to prove causation-in-fact, a petitioner must satisfy all three prong s of the Althen test; a failure to satisfy

one prongis fatal to the case. See Pafford, 451 F .3d at 1355; Althen, 418 F .3d at 1278. B ecause petitioners failed to establish that the special master erred in rejecting their theory

of causation, the special master’s conclusion reg a rding the Althen test’s second
prong is of no moment.

Second, even if petitioners had demonstrated that the MMR vaccine can cause severe pneumonia, their objections to the special master’s analy sis of the second prong

of the Althen test lack merit. The Althen test’s second prong requires a petitioner to show “that the vaccine was the ‘but for’ cause of the harm,” Pafford, 451 F .3d at 1356, or, in other words, “‘that the vaccine actually

caused the alleg ed sy

mptoms in [ the] particular case,’” id. (quoting the decision of the special master as recited by the trial court). To show that the vaccine did cause the injury
, a petitioner may , but is not required to, offer evidence of “rechalleng e, the presence of patholog ical markers or g enetic disposition, or g eneral acceptance in the scientific or medical communities,” or evidence in the form of epidemiolog ical studies. Capiz zano, 440 F .3d at 1325. Moreover, the “medical records and medical opinion testimony ” of treating

phy sicians can be

9 Petitioners also take issue with the special master’s “claim[ that] the innate sy stem, including complement, contributes to protection ag a inst [ invasive pneumococcal disease] ,” Mot. 19, inferring

that the special master concluded that a flaw in R.D.’s innate immune sy stem could have led to his development of severe pneumonia. Petitioners’ inference is unwarranted. The special master merely

stated that R.D.’s “innate immune sy stem could have protected [ R.D.] from further pneumococcal infection” in the y ears following

his severe pneumonia. DePena, 2017 W L 1075101, at *18 (emphasis added).

- 16-“probative” because “treating phy sicians are likely

to be in the best position to determine whether a log ical sequence of cause and effect show[ s] that the vaccination was the reason for the injury .’” I d. at 1326 (quoting Althen, 418 F

. 3d at 1278); accord L ombardi v. Sec’y of HHS, 656 F .3d 1343, 1353 (F ed. Cir. 2011); Moberly , 592 F .3d at 1325; Andreu, 569 F .3d at 1375-76. B a sed on this precedent, the special master did not err in discussing whether a treating

phy sician had opined on the cause of R.D.’s severe pneumonia or whether R.D.’s case fit within the challeng e-rechalleng e paradig m. F urther, as noted above, with respect to petitioners’ contention that Dr. Romberg ’s theory of causation was flawed, the special master observed that petitioners had misconstrued Dr. Romberg ’s opinion, and the court finds no error in that observation. F inally , the special master did not err in discussing a lternative ex planations for R.D.’s development of severe pneumonia. Evidence of alternative causes can be used to demonstrate that a petitioner has not established a prima facie case of causation-in-fact, see Stone, 676 F .3d at 1379; de B az an, 539 F

. 3d at 1352, and the special master supported his conclusions with evidence from the record. I n sum, the special master did not err in concluding that petitioners did not satisfy

the second prong

of the Althen test.

IV. CONCLUSION

As reflected in his decision, the special master thoroug hly reviewed the record before him, fairly

considering and weig hing the evidence presented by the parties. Thus, for the reasons stated above, the court DENIES petitioners’ motion for review and SUSTAINS the decision of the special master. The clerk is directed to enter judg ment according ly

.

IT IS SO ORDERED.

s/ Marg aret M. Sweeney MARGARET M. SW EENEY J udg e

- 17-