Tullio v. Secretary of Health and Human Services

In the United States Court of Federal Claims

No. 15-51V

Filed: June 18, 2020 1

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

DOUGLAS TULLIO, *

*

Petitioner, * Vaccine Act; Motion for Review;

* Preponderance of the Evidence;

v.

* Expert Opinions; Influenza Vaccine;

SECRETARY OF HEALTH AND * Rheumatoid Arthritis; Epidemiology;

HUMAN SERVICES, * Application of Althen Test.

*

Respondent. *

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

Jennifer Ann Gore Maglio, Maglio Christopher and Toale, P.A., Sarasota, FL, for

petitioner.

Dhairya D. Jani, Trial Attorney, Torts Branch, Civil Division, United States

Department of Justice, Washington, D.C., for respondent. With him were Heather L.

Pearlman, Assistant Director, Torts Branch, Civil Division, Catherine E. Reeves, Deputy

Director, Torts Branch, Civil Division, C. Salvatore D’Alessio, Acting Director, Torts

Branch, Civil Division, and Ethan P. Davis, Assistant Attorney General, Civil Division.

OPINION

HORN, J.

On January 20, 2015, petitioner Douglas Tullio filed a petition for compensation

with the National Vaccine Injury Compensation Program (Vaccine Program), under the

National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1–300aa-34 (2012)

(Vaccine Act), for an off-Table injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii) (2012).

Petitioner claimed that a September 29, 2012 fluzone high-dose influenza vaccination

caused him to develop “rheumatoid arthritis.” On December 19, 2019, Special Master

Christian J. Moran of the United States Court of Federal Claims denied petitioner’s claim

for an award of compensation, finding that petitioner had not shown, by a preponderance

of the evidence, that he is entitled to compensation under the Vaccine Act. See generally

Tullio v. Sec’y of Health & Human Servs., No. 15-51V, 2019 WL 7580149 (Spec. Mstr.

Fed. Cl. Dec. 19, 2019). On January 21, 2020, petitioner filed a motion for review in this

1Reissued for Publication: July 22, 2020. This Opinion was issued under seal on June

18, 2020. The parties did not propose redactions to the June 18, 2020 Opinion, thus, the

court issues the decision without redactions for public distribution.

court of the Special Master’s decision denying his claim pursuant to Rule 23 of the

Vaccine Rules of the United States Court of Federal Claims (2019) (Vaccine Rules).

FINDINGS OF FACT

The following summary of the relevant facts regarding petitioner’s medical history

are established in the record before the court, many of which are not in dispute. On

September 29, 2012, petitioner received a fluzone high-dose vaccination. According to

the record before the court, at the time he received the vaccination, petitioner was working

full-time with his wife, with whom he owned a business, and was sixty-nine years old. On

October 12, 2012, petitioner saw an internist, Dr. John Samples, for the first time, at which

time he complained that his legs “feel weaker.” Thirteen days later, on October 25, 2012,

petitioner once again visited Dr. Samples for an “[u]rgent overbooked visit,” because

petitioner complained of “diffuse body pain, worse since the last visit here 12 [sic] days

ago.” At that visit, petitioner had bloodwork done.

Throughout November and December of 2012, petitioner complained of pain and

weakness in his legs to multiple medical providers. A diagnosis of possible Guillain-Barré

syndrome (GBS) was considered, which led Dr. Mark Bouffard, a pain specialist, to refer

petitioner to a neurologist, Dr. Catherine Brignoni, on November 28, 2012. On December

4, 2012, petitioner visited Dr. Brignoni with the chief complaint of “[p]ossible GBS, diffuse

weakness and paresthesia after a flu vaccine.” Dr. Brignoni conducted a neurological

exam on petitioner, and based on the results, Dr. Brignoni began to treat petitioner for

GBS. While Dr. Brignoni was treating petitioner for GBS, she stated “[h]e should not

receive the flu vaccine any more [sic].” According to petitioner’s medical records, the

treatments to improve his pain from GBS “helped his bilateral shoulder pains and leg/thigh

pains” initially, but “the weakness has not changed.” This led petitioner to seek a second

opinion from Dr. Perry Shieh at the University of California, Los Angeles, neurology

department on January 18, 2013. Dr. Shieh recommended that petitioner see a

rheumatologist.

Petitioner initially saw a rheumatologist, Dr. Sheri Hsu on January 30, 2013. At the

first visit with Dr. Hsu, petitioner was not suffering from joint swelling, but was suffering

from joint pain. At the January 30, 2013 visit, Dr. Hsu made a note in petitioner’s medical

records, “I am concerned about a pain syndrome associated with his flu vaccine.” In

February 2013, petitioner did complain of joint swelling. While treating petitioner, Dr. Hsu

provided several different theories to explain petitioner’s pain, including all of the following

potential and distinct diagnoses: “seronegative RA [rheumatoid arthritis],” “Reactive

arthritis,” “Arthralgia,” “DDD [degenerative disc disease] lumbar spine,” and “Atrial

fibrillation.” (brackets added). By June 6, 2013, Dr. Hsu had diagnosed petitioner with

“seronegative RA [rheumatoid arthritis].”2 (capitalization in original) (brackets added).

2One of petitioner’s experts Dr. Paul J. Utz testified at the hearing before Special Master

Moran, regarding the distinction between two types of rheumatoid arthritis, seropositive

and seronegative: “It is not a clean distinction. There is overlap between the two of them.”

Dr. Utz further testified that seronegative rheumatoid arthritis, “is more heterogenous in

2

According to the most recent medical records dated December 11, 2018 from Dr. Hsu, as

well as petitioner’s testimony at the March 6 through 8, 2019 hearing, petitioner was still

suffering from rheumatoid arthritis.

On January 20, 2015, petitioner filed a petition within the statutory time period for

filing a petition for compensation with the Vaccine Program pursuant to the Vaccine Act.

In his petition, Mr. Tullio alleged, in relevant part:

6. To the current date, Petitioner continues to suffer from his

vaccine-induced injury.

7. Petitioner’s injuries are causally related to an adverse reaction

to a vaccination or vaccinations listed in 42 U.S.C. § 300aa-14.

8. Petitioner’s vaccine related injuries have lasted more than six

months. See, e.g., P Ex. 10 at 2-3.

Petitioner also stated in his petition that “his condition continued and subsequent

evaluation identified Petitioner’s condition as a rheumatological injury, most likely reactive

arthritis caused by his influenza vaccination. See, e.g., P Ex. 4 at 11-15; P Ex 17 at 18-

19.” 3

On January 21, 2015, petitioner’s case was assigned to Special Master Christian

J. Moran. On January 22, 2015, petitioner filed eighteen exhibits, which included 1,257

terms of presentation and joint involvement and things like that. They tend to have less

severe disease.” Dr. Utz testified that generally seronegative rheumatoid arthritis is

determined by “the CCP test, which is just one test, is negative.” Dr. Utz also testified,

“CCP stands for cyclic citrullinated peptide.” Dr. Mehrdad Matloubian, respondent’s

expert, testified, “[a]s we have understood more about pathogenesis of seropositive

rheumatoid arthritis, this anti-citrullinated peptide antibody, ACPA, or anti-CCP is used to

distinguish between people who are seropositive and seronegative RA [rheumatoid

arthritis].” (brackets added). Respondent’s expert Dr. Matloubian also testified, when

asked “[d]oes seronegative RA [rheumatoid arthritis] in particular present

heterogeneously?” responded: “It can.” (brackets added).

3 By the time of the March 6-8, 2019 hearing before Special Master Moran, both parties

agreed that petitioner’s diagnosis is seronegative rheumatoid arthritis, not reactive

arthritis. At the hearing before Special Master Moran, petitioner’s counsel asked

petitioner’s expert, Dr. Utz, the following question, “hindsight being 20/20, what do you

believe that Mr. Tullio had after his September 2012 vaccination?” Dr. Utz responded, “I

think this was all seronegative rheumatoid arthritis from the beginning.” Respondent

agreed in its February 19, 2019 pre-hearing submission, stating, “petitioner was ultimately

diagnosed with seronegative RA [rheumatoid arthritis] by Dr. Hsu based on objective

findings of synovitis on examination. Pet. Ex. 4 at 23. The parties’ experts all agree with

this diagnosis.” (brackets added).

3

pages of contemporaneous records from physicians’ offices and hospitals Mr. Tullio had

visited prior to filing his petition. On January 22, 2015, Special Master Moran issued an

Order which required petitioner to file a statement of completion once any “outstanding

medical records and affidavits” were filed. On April 7, 2015, petitioner filed his statement

of completion, after filing an affidavit by petitioner and additional medical records.

Throughout the proceedings before Special Master Moran, however, petitioner continued

to file updated medical records, with the last filing submitted to the court on March 7, 2019

during the hearing.

On June 17, 2015, respondent filed a Vaccine Rule 4c Report in which respondent

stated “[n]either RA [rheumatoid arthritis] nor reactive arthritis are presumptive injuries

following flu vaccine. Therefore, petitioner necessarily pursues a cause-in-fact claim.”

(brackets added). Respondent also contended in the Rule 4c Report, “[o]n the existing

record, petitioner has failed to provide preponderant evidence in support of the petition

for compensation.” Respondent further stated:

Without an expert opinion to support his claim, the sum total of petitioner’s

case is: that he received a flu vaccine on September 29, 2012; within three

weeks developed a rheumatologic condition (either reactive arthritis or RA

[rheumatoid arthritis]); and, no other cause for his condition has been

identified. However, as the Federal Circuit has cautioned, “neither a mere

showing of a proximate temporal relationship between vaccine and injury,

nor a simplistic elimination of other potential causes of the injury suffices,

without more, to meet the burden of showing actual causation.” Moberly[ ex

rel. Moberly v. Sec’y of Health & Human Servs.], 592 F.3d [1315,] 1323-24

[(Fed. Cir. 2010)]; citing Althen[ v. Sec’y of Health & Human Servs.], 418

F.3d [1274,] 1278 [(Fed. Cir. 2005)].

(brackets added).

During the proceedings before Special Master Moran, the parties in this case

called four experts, two for the petitioner and two for the respondent, who filed, in total,

ten expert reports. Petitioner’s experts were Dr. Paul J. Utz and Dr. Lawrence Steinman.

As of the most recent Curriculum Vitae filed on February 28, 2019, Dr. Utz is Board-

certified in rheumatology and completed a residency in immunology and rheumatology.

Dr. Utz also is the Director Emeritus of the Medical Scientist Training Program and

Associate Director for Education of the Institute for Immunity, Transplantation, and

Infection at Stanford University. In addition, Dr. Utz provides care at the Veterans Affairs

Palo Alto Health Care Hospital and Clinics. Dr. Utz introduced and relied on the Bingham

article and the Hennecke, Birnbaum, and Wooldridge papers. As of the most recent

Curriculum Vitae filed on February 28, 2019, Dr. Steinman is a Board-certified neurologist

and is a professor of neurology and neurological sciences at Stanford University. Dr.

Steinman offered Blast search testimony. Respondent’s experts were Dr. Mehrdad

Matloubian and Dr. Neal Halsey. As of the most recent Curriculum Vitae filed on February

28, 2019, Dr. Matloubian is a Board-certified rheumatologist who practices rheumatology.

Dr. Matloubian has a Ph.D. in virology. Dr. Matloubian is a Clinical Professor at University

4

of California San Francisco. Dr. Matloubian introduced and relied on the Westra,

Malmström, Svendsen, James, and Snir studies. As of his most recent Curriculum Vitae

filed on February 28, 2019, Dr. Halsey is Board-certified in pediatrics and pediatric

infectious diseases. Dr. Halsey is the Director Emeritus of the Institute for Vaccine Safety

at the Johns Hopkins Bloomberg School of Public Health. Dr. Halsey introduced and

relied on the Bardage and Ray studies. The various articles, studies, and papers

introduced by the experts are discussed more fully below.

On January 4, 2019, petitioner submitted his pre-hearing brief to Special Master

Moran. The Special Master, however, indicated in an order on January 22, 2019 that “Mr.

Tullio’s brief did not persuasively advocate his case, and he was instructed to file an

amended brief.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *4. On

January 28, 2019, according to Special Master Moran, the petitioner “filed an amended

and improved brief.” Id. Petitioner’s January 28, 2019 pre-hearing brief alleged that “[t]he

primary issue in controversy in this case is Althen[ v. Secretary of Health & Human

Services] prong I, whether or not the influenza vaccination can cause RA [rheumatoid

arthritis].” (brackets and emphasis added). Petitioner also stated he is “not required to

introduce evidence of epidemiologic studies” because “[s]uch an approach would be

inconsistent with allowing ‘the use of circumstantial evidence envisioned by the

preponderance standard and negates the system created by Congress.’” (quoting Althen

v. Sec’y of Health & Human Servs., 418 F.3d at 1280). Regarding expert’s opinions that

are not directly supported by literature, petitioner stated the expert’s opinion “can also

surpass the threshold requirement for reliability, provided that the expert explains his

process at arriving at that opinion by scientific methodology.” (citing Daubert v. Merrell

Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1319 (9th Cir.), cert. denied, 516 U.S. 869

(1995)). Petitioner alleged “[t]hrough expert testimony consistent with his medical course,

Petitioner provides preponderant evidence that he suffered RA [rheumatoid arthritis] as

the result of an aberrant, individual immune response to what should have been a

beneficial influenza vaccination in 2012.” (brackets added). Petitioner also noted thirteen

cases in which a Special Master of the United States Court of Federal Claims has granted

compensation for a petitioner who developed rheumatoid arthritis after an influenza

vaccination. 4

4 Petitioner’s statement in its January 28, 2019 pre-hearing brief is misleading. Although

the cases that petitioner cited granted compensation for petitioners who received

influenza vaccinations that the petitioners alleged led to rheumatoid arthritis, the

respective Special Masters did not find causation. The petitioners and respondents in

each of those cases stipulated that petitioners were entitled to compensation, but the

respondent denied the influenza vaccinations led to petitioners’ injuries. See Egan v.

Sec’y of Health & Human Servs., No. 15-976V; Zimmerman v. Sec’y of Health & Human

Servs., No. 14-323V; Walker v. Sec’y of Health & Human Servs., No. 14-921V; Ward v.

Sec’y of Health & Human Servs., No. 16-72V; Stolowski v. Sec’y of Health & Human

Servs., No. 12-635V; Miller v. Sec’y of Health & Human Servs., No. 13-837V; Hambleton

v. Sec’y of Health & Human Servs., No. 13-819V; Scales v. Sec’y of Health & Human

Servs., No. 13-501V; Habchy v. Sec’y of Health & Human Servs., No. 11-680V; Wallace

v. Sec’y of Health & Human Servs., No. 11-627V; DeMartini v. Sec’y of Health & Human

5

Respondent filed its final pre-hearing submission on February 19, 2019, in which

respondent contended, “[i]n evaluating the reliability of petitioner’s expert’s opinion, a

special master ‘may conclude that there is simply too great an analytical gap between the

data and the opinion proffered.’” (quoting Cedillo v. Sec’y of Health & Human Servs., 617

F.3d 1328, 1339 (Fed. Cir. 2010)). Respondent stated, “[g]eneric theories of causation

are patently insufficient to meet petitioner’s burden of proof.” (citing Broekelschen v. Sec’y

of Health & Human Servs., 618 F.3d 1339, 1350-51 (Fed. Cir. 2010)). Respondent argued

that the absence of an association between the flu vaccine and rheumatoid arthritis “is

striking, given the high incidence of influenza infection globally and the numerous articles

that have been published on both influenza and RA [rheumatoid arthritis].” (brackets

added). Regarding the comment by Dr. Hsu, petitioner’s treating rheumatologist, at Mr.

Tullio’s first visit that stated “I am concerned about a pain syndrome associated with his

[petitioner’s] flu vaccine,” the respondent noted “it does not appear from her [Dr. Hsu’s]

later medical records that once she diagnosed petitioner with seronegative RA

[rheumatoid arthritis], that she ever mentioned the flu vaccine as a cause of his condition.”

(brackets added). Finally, respondent stated “[t]here is no ‘appropriate’ timeframe within

which medical science would expect RA [rheumatoid arthritis] to occur following the

administration of the flu vaccine, because the flu vaccine does not cause RA [rheumatoid

arthritis].” (brackets added).

From March 6, 2019 until March 8, 2019, Special Master Moran held an entitlement

hearing in San Francisco, California to determine whether petitioner should receive

compensation under the Vaccine Act, at which petitioner and all four experts testified. On

December 19, 2019, after describing the relevant medical events in petitioner’s history

and reviewing the evidence in the record before him, including the expert opinions offered

by both petitioner and respondent, Special Master Moran issued his decision denying

petitioner’s claim of entitlement to compensation. The Special Master found petitioner had

failed to carry his burden of proving how the flu vaccine had caused his rheumatoid

arthritis.

With regard to the first prong of the Althen test, described more fully below, “a

medical theory causally connecting the vaccination and the injury,” Althen v. Secretary of

Health & Human Services, 418 F.3d at 1278, 5 Special Master Moran concluded that the

evidence presented by petitioner regarding molecular mimicry “fell short” of being

persuasive to establish petitioner’s case. See Tullio v. Sec’y of Health & Human Servs.,

2019 WL 7580149, at *22. The Special Master indicated that the epidemiological

evidence presented by respondent “weakens the reliability of opinions that the flu vaccine

Servs., No. 12-734V; Gifford v. Sec’y of Health & Human Servs., No. 10-325V; Merrill v.

Sec’y of Health & Human Servs., No. 7-278V.

5 The three prongs described in Althen v. Secretary of Health & Human Services, are: “(1)

a medical theory causally connecting the vaccination and the injury; (2) a logical

sequence of cause and effect showing that the vaccination was the reason for the injury;

and (3) a showing of a proximate temporal relationship between vaccination and injury.”

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278.

6

can cause rheumatoid arthritis.” Id. at *11. Special Master Moran also wrote “there is

ample legal justification for considering epidemiological studies in determining whether

the flu vaccine can cause rheumatoid arthritis.” Id. at *8. Special Master Moran disputed

the proposition urged by petitioner – that petitioner’s T cell repertoire was so rare that it

would not have been detected by epidemiology. Special Master Moran stated: “As Dr.

Halsey pointed out, epidemiological studies have identified that the risk of developing

Guillain-Barré syndrome after flu vaccination is increased by one case or two cases per

million doses of vaccination. This example refutes a commonly offered argument that

epidemiological studies cannot detect rare events.” Id.

Despite finding that “Mr. Tullio did not meet his burden of proof for Althen prong

one,” Special Master Moran reviewed “the remaining two Althen prongs . . . for

completeness.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27.

Special Master Moran reviewed petitioner’s claim under the second prong of the Althen

test, whether there exists a “logical sequence of cause and effect.” Althen v. Sec’y of

Health & Human Servs., 418 F.3d at 1278. Special Master Moran stated “[t]he lack of

support from treating doctors is consistent with the lack of information about the cause of

rheumatoid arthritis. As explained much earlier in section I.B of this decision, the cause

of rheumatoid arthritis is not known.” Tullio v. Sec’y of Health & Human Servs., 2019 WL

7580149, at *28. Special Master Moran stated, “given this information, it would be

surprising for a doctor to tell Mr. Tullio that the flu vaccination caused his rheumatoid

arthritis.” Id. The Special Master found “Mr. Tullio also has not established, by

preponderant evidence, a logical sequence of cause and effect.” Id. at *5.

In addition, Special Master Moran examined the case in the context of the third

prong of the Althen test, “a showing of a proximate temporal relationship between

vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278.

Based only on Dr. Utz’s testimony that molecular mimicry would take at least one week,

and Dr. Matloubian’s testimony that molecular mimicry would take between one and six

weeks, Special Master Moran made his finding that “the appropriate time period would be

one to six weeks.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27.

As a result, because the petitioner had reported experiencing calf pain approximately one

week after receiving the flu vaccination and had complained to Dr. Samples of “diffuse

body pain” on October 25, 2012, about one month after the vaccination, Special Master

Moran concluded that “[b]oth dates fit within the accepted temporal interval of one to six

weeks. Therefore, if Mr. Tullio had established prong one, he would have also established

prong three.” Id. As a result of his review of the record before him Special Master Moran

denied petitioner’s claim for compensation. Thereafter, petitioner filed the motion for

review currently under consideration on January 21, 2020. 6 The government responded

on February 19, 2020, and petitioner filed his reply on April 14, 2020. On April 28, 2020,

this court held a telephonic oral argument.

6 Mr. Tullio’s motion for review was filed within the statutory time period on Tuesday,

January 21, 2020 because Monday, January 20, 2020 was a federal holiday and this court

was closed.

7

DISCUSSION

When reviewing a Special Master’s decision, the assigned Judge of the United

States Court of Federal Claims shall:

(A) uphold the findings of fact and conclusions of law of the special master

and sustain the special master’s decision,

(B) set aside any findings of fact or conclusions 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 findings 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.

42 U.S.C. § 300aa-12(e)(2) (2018). The legislative history of the Vaccine Act states: “The

conferees have provided for a limited standard for appeal from the [special] master’s

decision and do not intend that this procedure be used frequently, but rather in those

cases in which a truly arbitrary decision has been made.” H.R. Rep. No. 101-386, at 517

(1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.

In Markovich v. Secretary of Health & Human Services, the United States Court of

Appeals for the Federal Circuit wrote, “[u]nder the Vaccine Act, the Court of Federal

Claims reviews the Chief Special Master’s decision to determine if it is ‘arbitrary,

capricious, an abuse of discretion, or otherwise not in accordance with the law.’ 42 U.S.C.

§ 300aa-12(e)(2)(B).” Markovich v. Sec’y of Health & Human Servs., 477 F.3d 1353,

1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007); see also K.G. v. Sec’y of Health

& Human Servs., 951 F.3d 1374, 1379 (Fed. Cir. 2020); Oliver v. Sec’y of Health & Human

Servs., 900 F.3d 1357, 1360 (Fed. Cir. 2018) (citing Milik v. Sec’y of Health & Human

Servs., 822 F.3d 1367, 1375-76 (Fed. Cir. 2016)); Deribeaux ex rel. Deribeaux v. Sec’y

of Health & Human Servs., 717 F.3d 1363, 1366 (Fed. Cir.), reh’g and reh’g en banc

denied (Fed. Cir. 2013) (The United States Court of Appeals for the Federal Circuit stated

that “we ‘perform[ ] the same task as the Court of Federal Claims and determine[ ] anew

whether the special master’s findings were arbitrary or capricious.’” (brackets in original)

(quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir.

2000))); W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1355 (Fed. Cir. 2013);

Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1363 (Fed. Cir. 2012);

de Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008);

Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1347 (Fed. Cir.) (“Under the

Vaccine Act, we review a decision of the special master under the same standard as the

Court of Federal Claims and determine if it is ‘arbitrary, capricious, an abuse of discretion,

or otherwise not in accordance with law.’” (quoting 42 U.S.C. § 300aa-12(e)(2)(B))), reh’g

and reh’g en banc denied (Fed. Cir. 2008); Althen v. Sec’y of Health & Human Servs.,

418 F.3d at 1277; Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. 445, 458 (2019);

Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 47 (2013); Taylor v. Sec’y of

8

Health & Human Servs., 108 Fed. Cl. 807, 817 (2013). The arbitrary and capricious

standard is “well understood to be the most deferential possible.” Munn v. Sec’y of Health

& Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992). The United States Court of Appeals

for the Federal Circuit has indicated that:

These standards vary in application as well as degree of deference. Each

standard applies to a different aspect of the judgment. Fact findings are

reviewed by us, as by the Claims Court judge, under the arbitrary and

capricious standard; legal questions under the “not in accordance with law”

standard . . . ; and discretionary rulings under the abuse of discretion

standard. The latter will rarely come into play except where the special

master excludes evidence.

Munn v. Sec’y of Health & Human Servs., 970 F.2d at 871 n.10; see also Carson ex rel.

Carson v. Sec’y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013);

Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366; W.C.

v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &

Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012); Porter v. Sec’y of Health & Human

Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen v. Sec’y of Health &

Human Servs., 618 F.3d at 1345) (explaining that the reviewing court “do[es] not reweigh

the factual evidence, assess whether the special master correctly evaluated the evidence,

or examine the probative value of the evidence or the credibility of the witnesses—these

are all matters within the purview of the fact finder”) reh’g and reh’g en banc denied (Fed.

Cir. 2012); Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 56. “[T]he special

masters have broad discretion to weigh evidence and make factual determinations.”

Dougherty v. Sec’y of Health & Human Servs., 141 Fed. Cl. 223, 229 (2018).

With regard to both fact-findings and fact-based conclusions, the key

decision maker in the first instance is the special master. The Claims Court

owes these findings and conclusions by the special master great

deference – no change may be made absent first a determination that the

special master was “arbitrary and capricious.”

Munn v. Sec’y of Health & Human Servs., 970 F.2d at 870; see also 42 U.S.C. § 300aa-

12(e)(2)(B).

Generally, “if the special master ‘has considered the relevant evidence of record,

drawn plausible inferences and articulated a rational basis for the decision, reversible

error will be extremely difficult to demonstrate.’” Hibbard v. Sec’y of Health & Human

Servs., 698 F.3d at 1363 (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d

1518, 1528 (Fed. Cir. 1991)); see also Porter v. Sec’y of Health & Human Servs., 663

F.3d at 1253-54; Lampe v. Sec’y of Health & Human Servs., 219 F.3d at 1360; Avila ex

rel. Avila v. Sec’y of Health & Human Servs., 90 Fed. Cl. 590, 594 (2009); Dixon v. Sec’y

of Health & Human Servs., 61 Fed. Cl. 1, 8 (2004) (“The court’s inquiry in this regard must

therefore focus on whether the Special Master examined the ‘relevant data’ and

articulated a ‘satisfactory explanation for its action including a rational connection

9

between the facts found and the choice made.’” (quoting Motor Vehicle Mfrs. Ass’n v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines,

Inc. v. United States, 371 U.S. 156, 168 (1962)))).

As noted by the United States Court of Appeals for the Federal Circuit:

Congress assigned to a group of specialists, the Special Masters within the

Court of Federal Claims, the unenviable job of sorting through these painful

cases and, based upon their accumulated expertise in the field, judging the

merits of the individual claims. The statute makes clear that, on review, the

Court of Federal Claims is not to second guess the Special Masters [sic]

fact-intensive conclusions; the standard of review is uniquely deferential for

what is essentially a judicial process. Our cases make clear that, on our

review . . . we remain equally deferential. That level of deference is

especially apt in a case in which the medical evidence of causation is in

dispute.

Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366-67

(modification in original) (quoting Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958,

961 (Fed. Cir. 1993)); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at 1363;

Locane v. Sec’y of Health & Human Servs., 685 F.3d 1375, 1380 (Fed. Cir. 2012). The

United States Court of Appeals for the Federal Circuit has explained that the reviewing

courts “‘do not sit to reweigh the evidence. [If] the special master's conclusion [is] based

on evidence in the record that [is] not wholly implausible, we are compelled to uphold that

finding as not being arbitrary and capricious.’” Deribeaux ex rel. Deribeaux v. Sec’y of

Health & Human Servs., 717 F.3d at 1367 (modification in original) (quoting Lampe v.

Sec’y of Health & Human Servs., 219 F.3d at 1363); see also K.G. v. Sec’y of Health &

Human Servs., 951 F.3d at 1379 (“With respect to factual findings, however, we will

uphold the special master’s findings of fact unless they are clearly erroneous.” (citing

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278)); Hibbard v. Sec’y of Health

& Human Servs., 698 F.3d at 1363 (citing Cedillo v. Sec’y of Health & Human Servs., 617

F.3d at 1338).

The United States Court of Appeals for the Federal Circuit has explained that:

A petitioner can establish causation in one of two ways. Id. [Broekelschen

v. Sec’y of Health & Human Servs., 618 F.3d at 1341] If the petitioner shows

that he or she received a vaccination listed on the Vaccine Injury Table, 42

U.S.C. § 300aa–14, and suffered an injury listed on that table within a

statutorily prescribed time period, then the Act presumes the vaccination

caused the injury. Andreu[ ex rel. Andreu] v. Sec’y of Health & Human

Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009). Where, as here, the injury is

not on the Vaccine Injury Table, the petitioner may seek compensation by

proving causation-in-fact.

10

Milik v. Sec’y of Health & Human Servs., 822 F.3d at 1379 (citing Andreu ex rel. Andreu

v. Sec’y of Health & Human Servs., 569 F.3d at 1374); see also W.C. v. Sec’y of Health

& Human Servs., 704 F.3d at 1356; Broekelschen v. Sec’y of Health & Human Servs.,

618 F.3d at 1346; Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1356 (Fed.

Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2006), cert. denied, 551 U.S. 1102 (2007);

Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1147-48 (Fed. Cir. 1992); Faup

v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458; Dodd v. Sec’y of Health & Human

Servs., 114 Fed. Cl. at 50; Paluck v. Sec’y of Health & Human Servs., 104 Fed. Cl. 457,

467-68 (2012); Fesanco v. Sec’y of Health & Human Servs., 99 Fed. Cl. 28, 31 (2011).

For petitioner to establish a prima facie case in a vaccine case, decisions of the

Federal Circuit permit the use of circumstantial evidence, which the court described as

“envisioned by the preponderance standard” and by the vaccine system created by

Congress, in which “close calls regarding causation are resolved in favor of injured

claimants” without the need for medical certainty. See Althen v. Sec’y of Health & Human

Servs., 418 F.3d at 1280; see also Cloer v. Sec’y of Health & Human Servs., 654 F.3d

1322, 1332 n.4 (Fed. Cir. 2011), cert. denied, 566 U.S. 956 (2012); Andreu ex rel. Andreu

v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (“In Althen,

however, we expressly rejected the Stevens test, concluding that requiring ‘objective

confirmation’ in the medical literature prevents ‘the use of circumstantial evidence . . . and

negates the system created by Congress’ through the Vaccine Act.” (modification in

original)); La Londe v. Sec’y of Health & Human Servs., 110 Fed. Cl. 184, 198 (2013)

(“Causation-in-fact can be established with circumstantial evidence, i.e., medical records

or medical opinion.”), aff’d, 746 F.3d 1344 (Fed. Cir. 2014). The Althen court further noted

that “the purpose of the Vaccine Act’s preponderance standard is to allow the finding of

causation in a field bereft of complete and direct proof of how vaccines affect the human

body.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1280 (citing Knudsen ex

rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)); see

also W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1356.

When proving eligibility for compensation for a petitioner of an off-Table injury

under the Vaccine Act, such as the one filed by Mr. Tullio, petitioner may not rely on his

or her testimony alone. According to the Vaccine Act, “[t]he 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.” 42 U.S.C. § 300aa-13(a)(1). A petitioner who

meets his or her burden is entitled to recovery under the Vaccine Act, unless the

respondent proves by preponderant evidence that the injury was caused by factors

unrelated to the vaccine. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,

1379-80 (Fed. Cir. 2012); Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,

1151 (Fed. Cir. 2007); see also Rus v. Sec’y of Health & Human Servs., 129 Fed. Cl. 672,

680 (2016) (citing 42 U.S.C. § 300aa-13(a)(1)(B); Shalala v. Whitecotton, 514 U.S. 268,

270-71 (1995)). “But, regardless of whether the burden of proof 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.” Rus v. Sec’y of

Health & Human Servs., 129 Fed. Cl. at 680 (citing Stone v. Sec’y of Health & Human

Servs., 676 F.3d at 1379; de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1353).

11

Petitioner also must prove causation-in-fact in an off-Table injury. See Grant v.

Sec’y of Health & Human Servs., 956 F.2d at 1147-48. The United States Court of

Appeals for the Federal Circuit has held that causation-in-fact in the Vaccine Act context

is the same as the “legal cause” in the general torts context. See Shyface v. Sec’y of

Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Therefore, drawing from

the Restatement (Second) of Torts, the vaccine is a cause-in-fact when it is “‘a substantial

factor in bringing about the harm.’” de Bazan v. Sec’y of Health & Human Servs., 539

F.3d at 1351 (quoting the Restatement (Second) of Torts § 431(a) (1965)); see also Oliver

v. Sec’y of Health & Human Servs., 900 F.3d at 1361 (citing Moberly ex rel. Moberly v.

Sec’y of Health & Human Servs., 592 F.3d at 1321); Deribeaux ex rel. Deribeaux v. Sec’y

of Health & Human Servs., 717 F.3d at 1367 (“To prove causation, a petitioner must show

that the vaccine was ‘not only a but-for cause of the injury but also a substantial factor in

bringing about the injury.’” (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d

at 1352–53)). A “‘substantial factor’ standard requires a greater showing than ‘but for’

causation.” de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1351 (citing Shyface

v. Sec’y of Health & Human Servs., 165 F.3d at 1352). “However, the petitioner need not

show that the vaccine was the sole or predominant cause of her injury, just that it was a

substantial factor.” Id. (citing Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,

1150 (Fed. Cir. 2007)). A Judge of the United States Court of Federal Claims has

explained the relationship between “but-for” causation and “substantial factor” in

Deribeaux ex rel. Deribeaux v. Secretary of Health & Human Services:

The de Bazan [v. Sec’y of Health & Human Servs., 539 F.3d at 1351] court

defined but-for causation as requiring that “the harm be attributable to the

vaccine to some nonnegligible degree,” and noted that, although substantial

is somewhere beyond the low threshold of but-for causation, it does not

mean that a certain factor must be found to have definitively caused the

injury. Id. [de Bazan v. Sec’y of Health & Human Servs., 539 F.3d at 1351]

Accordingly, a factor deemed to be substantial is one that falls somewhere

between causing the injury to a non-negligible degree and being the “sole

or predominant cause.” Id.

This definition of substantial—somewhere between non-negligible and

predominant—is applicable to respondent's burden to prove a sole

substantial factor unrelated to the vaccine. Accordingly, a respondent's

burden is to prove that a certain factor is the only substantial factor—one

somewhere between non-negligible and predominant—that caused the

injury.

Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 105 Fed. Cl. 583, 595

(2012), aff’d, 717 F.3d 1363 (Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2013)

(emphasis in original).

In order to recover under the Vaccine Act, a petitioner “must show, by a

preponderance of the evidence, ‘that the injury or death at issue was caused by a

12

vaccine.’” Milik v. Sec’y of Health & Human Servs., 822 F.3d at 1379; (quoting

Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at 1341 (citing 42 U.S.C.

§§ 300aa–11(c)(1), –13(a)(1))); see also Oliver v. Sec’y of Health & Human Servs., 900

F.3d at 1361; W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1355-56 (“The Vaccine

Act created the National Vaccine Injury Compensation Program, which allows certain

petitioners to be compensated upon showing, among other things, that a person

‘sustained, or had significantly aggravated’ a vaccine-related ‘illness, disability, injury, or

condition.’” (quoting 42 U.S.C. § 300aa–11(c)(1)(C))); see also Boatmon v. Sec’y of

Health & Human Servs., 941 F.3d 1351, 1355, 1359 (Fed. Cir. 2019); Oliver v. Sec’y of

Health & Human Servs., 900 F.3d at 1360; La Londe v. Sec’y of Health & Human Servs.,

746 F.3d 1334, 1339 (Fed. Cir. 2014); Lombardi v. Sec’y of Health & Human Servs., 656

F.3d 1343, 1350 (Fed. Cir. 2011) (“A petitioner seeking compensation under the Vaccine

Act must prove by a preponderance of the evidence that the injury or death at issue was

caused by a vaccine.”); Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458;

see also Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. 353, 358 (2012), aff’d,

503 F. App’x 952 (Fed. Cir. 2013); Jarvis v. Sec’y of Health & Human Servs., 99 Fed. Cl.

47, 54 (2011). “Nonetheless, the petitioner must do more than demonstrate a ‘plausible’

or ‘possible’ causal link between the vaccination and the injury; he must prove his case

by a preponderance of the evidence.” W.C. v. Sec’y of Health & Human Servs., 704 F.3d

at 1356 (quoting Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d at

1322); Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; Hines v. Sec’y of

Health & Human Servs., 940 F.2d at 1525.

While scientific certainty is not required, the Special Master “is entitled to require

some indicia of reliability to support the assertion of the expert witness.” Moberly ex rel.

Moberly v. Sec’y of Health & Human Servs., 592 F.3d at 1324; see also Hazlehurst v.

Sec’y of Health & Human Servs., 88 Fed. Cl. 473, 439 (2009), aff’d, 604 F.3d 1343 (Fed.

Cir. 2010) (quoting Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d

at 1379). The United States Supreme Court has explained that:

Claimants who show that a listed injury first manifested itself at the

appropriate time are prima facie entitled to compensation. No showing of

causation is necessary; the Secretary bears the burden of disproving

causation. A claimant may also recover for unlisted side effects, and for

listed side effects that occur at times other than those specified in the Table,

but for those the claimant must prove causation.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-29 (2011) (footnotes omitted); see also

Kennedy v. Sec’y of Health & Human Servs., 99 Fed. Cl. 535, 539 (2011), aff’d, 485 F.

App’x 435 (Fed. Cir. 2012).

The Federal Circuit in Althen v. Secretary of Health & Human Services defined a

three-prong test by which a petitioner can meet his or her burden to establish causation

in an off-Table injury case:

13

To meet the preponderance standard, [petitioner] must “show a medical

theory causally connecting the vaccination and the injury.” Grant v. Sec’y of

Health & Humans Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (citations

omitted). A persuasive medical theory is demonstrated by “proof of a logical

sequence of cause and effect showing that the vaccination was the reason

for the injury[,]” the logical sequence being supported by “reputable medical

or scientific explanation[,]” i.e., “evidence in the form of scientific studies or

expert medical testimony[.]” Grant [v. Sec’y of Health & Human Servs.], 956

F.2d at 1148. [Petitioner] may recover if she shows “that the vaccine was

not only a but-for cause of the injury but also a substantial factor in bringing

about the injury.” Shyface[ v. Sec’y of Health & Human Servs.], 165 F.3d at

1352-53. Although probative, neither a mere showing of a proximate

temporal relationship between vaccination and injury, nor a simplistic

elimination of other potential causes of the injury suffices, without more, to

meet the burden of showing actual causation. See Grant[ v. Sec’y of Health

& Human Servs.], 956 F.2d at 1149. Concisely stated, [petitioner’s] burden

is to show by preponderant evidence that the vaccination brought about

[the] injury by providing: (1) a medical theory causally connecting the

vaccination and the injury; (2) a logical sequence of cause and effect

showing that the vaccination was the reason for the injury; and (3) a

showing of a proximate temporal relationship between vaccination and

injury.

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278 (first three sets of brackets

in original); see also Boatmon v. Sec’y of Health & Human Servs., 941 F.3d at 1354-55;

Oliver v. Sec’y of Health & Human Servs., 900 F.3d at 1361; Deribeaux ex rel. Deribeaux

v. Sec’y of Health & Human Servs., 717 F.3d at 1367; Porter v. Sec’y of Health & Human

Servs., 663 F.3d at 1249; Moberly ex rel. Moberly v. Sec’y of Health & Human Servs.,

592 F.3d at 1322; Pafford v. Sec’y of Health & Human Servs., 451 F.3d at 1355;

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1324 (Fed. Cir. 2006);

Faup v. Sec’y of Health & Human Servs., 147 Fed. Cl. at 458; C.K. v. Sec’y of Health &

Human Servs., 113 Fed. Cl. 757, 766 (2013).

With regard to the first Althen prong, “a medical theory causally connecting the

vaccination and the injury,” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278,

the Federal Circuit in Althen analyzed the preponderance of evidence requirement as

allowing medical opinion as proof, even without scientific studies in medical literature that

provide “objective confirmation” of medical plausibility. See id. at 1278, 1279-80; see also

Shapiro v. Sec’y of Health & Human Servs., 105 Fed. Cl. at 358. In rejecting a requirement

that a claimant under the Vaccine Act prove confirmation of medical plausibility from the

medical community and medical literature, the Althen court turned to the analysis

undertaken in Knudsen ex rel. Knudsen v. Secretary of Health & Human Services, 35

F.3d at 549. See Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1279-80. In

Knudsen ex rel. Knudsen v. Secretary of Health & Human Services, the United States

Court of Appeals for the Federal Circuit wrote, “to require identification and proof of

specific biological mechanisms would be inconsistent with the purpose and nature of the

14

vaccine compensation program. The Vaccine Act does not contemplate full blown tort

litigation in the Court of Federal Claims.” Knudsen ex rel. Knudsen v. Sec’y of Health &

Human Servs., 35 F.3d at 549. The Federal Circuit in Knudsen stated further:

The Court of Federal Claims is therefore not to be seen as a vehicle for

ascertaining precisely how and why DTP [diphtheria-tetanus-pertussis

vaccine] and other vaccines sometimes destroy the health and lives of

certain children while safely immunizing most others. This research is for

scientists, engineers, and doctors working in hospitals, laboratories,

medical institutes, pharmaceutical companies, and government agencies.

The special masters are not “diagnosing” vaccine-related injuries. The sole

issues for the special master are, based on the record evidence as a whole

and the totality of the case, whether it has been shown by a preponderance

of the evidence that a vaccine caused the [petitioner’s] injury or that the

[petitioner’s] injury is a table injury, and whether it has not been shown by a

preponderance of the evidence that a factor unrelated to the vaccine caused

the child's injury. See 42 U.S.C. § 300aa-13(a)(1), (b)(1).

Id. (brackets added).

The Federal Circuit also has indicated that:

Although a finding of causation “must be supported by a sound and reliable

medical or scientific explanation,” causation “can be found in vaccine

cases . . . without detailed medical and scientific exposition on the biological

mechanisms.” Knudsen v. Sec’y of the Dep’t of Health & Human Servs., 35

F.3d 543, 548-49 (Fed. Cir. 1994). It is not necessary for a petitioner to point

to conclusive evidence in the medical literature linking a vaccine to the

petitioner's injury, as long as the petitioner can show by a preponderance

of the evidence that there is a causal relationship between the vaccine and

the injury, whatever the details of the mechanism may be.

Simanski v. Sec’y of Health & Human Servs., 671 F.3d 1368, 1384 (Fed. Cir. 2012)

(omission in original).

Regarding the use of epidemiological evidence in a case in which causation is at

issue, the United States Court of Appeals for the Federal Circuit has found that a Special

Master may consider epidemiological evidence in determining causation. See Andreu ex

rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1379 (“Although Althen[ v.

Secretary of Health & Human Services,] and Capizzano[ v. Secretary of Health & Human

Services] make clear that a claimant need not produce medical literature or

epidemiological evidence to establish causation under the Vaccine Act, where such

evidence is submitted, the special master can consider it in reaching an informed

judgment as to whether a particular vaccination likely caused a particular injury.” (brackets

added)); see also Grant v. Sec’y of Health & Human Servs., 956 F.2d at 1149 (“These

15

epidemiological studies are probative medical evidence relevant to causation.”); Althen v.

Sec’y of Health & Human Servs., 418 F.3d at 1280.

The second prong of the Althen test requires the petitioner to demonstrate “a

logical sequence of cause and effect, showing that the vaccination was the reason for the

injury” by a preponderance of the evidence. See Althen v. Sec’y of Health & Human

Servs., 418 F.3d at 1278; see also Pafford v. Sec’y of Health & Human Servs., 451 F.3d

at 1355. In order to prevail, the petitioner must show “that the vaccine was not only a but-

for cause of the injury but also a substantial factor in bringing about the injury.” Althen v.

Sec’y of Health & Human Servs., 418 F.3d at 1278 (quoting Shyface v. Sec’y of Health &

Human Servs., 165 F.3d at 1352). In Capizzano v. Secretary of Health & Human Services,

the Federal Circuit stated, “‘[a] logical sequence of cause and effect’ means what it

sounds like – the claimant’s theory of cause and effect must be logical. Congress required

that, to recover under the Vaccine Act, a claimant must prove by a preponderance of the

evidence that the vaccine caused his or her injury.” Capizzano v. Sec’y of Health & Human

Servs., 440 F.3d at 1326 (quoting 42 U.S.C. §§ 300aa-11(c)(1)-13(a)(1) (2006)); see also

Cozart v. Sec’y of Health & Human Servs., 126 Fed. Cl. 488, 498 (2016). The Federal

Circuit has found that treating physicians’ opinions can help satisfy the second prong of

the Althen test:

Such testimony is “quite probative” since “treating physicians are likely to

be in the best position to determine whether a logical sequence of cause

and effect show[s] that the vaccination was the reason for the injury.” Id.

[Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326] (citations

and internal quotation marks omitted); see also Althen[ v. Sec’y of Health &

Human Servs.], 418 F.3d at 1279–80 (noting that the Vaccine Act provides

for the use of “medical opinion as proof” of causation); Zatuchni v. Sec’y of

Health & Human Servs., 69 Fed. Cl. 612, 623 (Fed. Cl. 2006) (relying

heavily on the testimony of treating physicians in concluding that Vaccine

Act causation had been established).

Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1375 (first set of

brackets in original); see also Paluck v. Sec’y of Health & Human Servs., 786 F.3d at

1385 (finding “the special master erred in disregarding contemporaneous statements from

K.P.’s [petitioners’ minor child] treating physicians regarding the cause of his

neurodegeneration” and “[a]s we explained in Andreu, ‘treating physicians are likely to be

in the best position to determine whether a logical sequence of cause and effect show[s]

that the vaccination was the reason for the injury.’ [Andreu ex rel. Andreu v. Sec’y of

Health & Human Servs.,] 569 F.3d at 1375” (brackets added)).

The third prong of the Althen test requires the petitioner to demonstrate, by a

preponderance of evidence, “a proximate temporal relationship between vaccination and

injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278. The United States

Court of Appeals for the Federal Circuit emphasized the importance of a temporal

relationship in Pafford v. Secretary of Health & Human Services, when the court noted

that “without some evidence of temporal linkage, the vaccination might receive blame for

16

events that occur weeks, months, or years outside of the time in which scientific or

epidemiological evidence would expect an onset of harm.” Pafford v. Sec’y of Health &

Human Servs., 451 F.3d at 1358. Requiring evidence of strong temporal linkage is

consistent with the third requirement articulated in Althen because “[e]vidence

demonstrating petitioner’s injury occurred within a medically acceptable time frame

bolsters a link between the injury alleged and the vaccination at issue under the ‘but-for’

prong of the causation analysis.” Pafford v. Sec’y of Health & Human Servs., 451 F.3d at

1358 (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326). The Pafford

court further explained,

[i]f, for example, symptoms normally first occur ten days after inoculation

but petitioner's symptoms first occur several weeks after inoculation, then it

is doubtful the vaccination is to blame. In contrast, if symptoms normally

first occur ten days after inoculation and petitioner's symptoms do, in fact,

occur within this period, then the likelihood increases that the vaccination is

at least a factor. Strong temporal evidence is even more important in cases

involving contemporaneous events other than the vaccination, because the

presence of multiple potential causative agents makes it difficult to attribute

"but-for" causation to the vaccination. After all, credible medical expertise

may postulate that any of the other contemporaneous events may have

been the sole cause of the injury.

Id. A petitioner must offer “preponderant proof that the onset of symptoms occurred within

a timeframe which, given the medical understanding of the disorder’s etiology, it is

medically acceptable to infer causation.” de Bazan v. Sec’y of Health & Human Servs.,

539 F.3d at 1352. Determining what constitutes a medically appropriate timeframe, thus,

is linked to the petitioner’s theory of how the vaccine can cause petitioner’s injury. See

id.; see also K.T. v. Sec’y of Health & Human Servs., 132 Fed. Cl. 175, 186 (2017);

Shapiro v. Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011).

According to the court in Capizzano v. Secretary of Health & Human Services,

evidence used to satisfy one of the Althen prongs may overlap with and be used to satisfy

another prong. See Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326 (“We

see no reason why evidence used to satisfy one of the Althen [v. Secretary of Health &

Human Services, 418 F.3d at 1278] prongs cannot overlap to satisfy another prong.”

(brackets added)). If a petitioner satisfies the Althen test, the petitioner prevails, “unless

the [government] shows, also by a preponderance of the evidence, that the injury was in

fact caused by factors unrelated to the vaccine.” Knudsen ex rel. Knudsen v. Sec’y of

Health & Human Servs., 35 F.3d at 547 (brackets in original; quotation omitted).

The Special Master has discretion to determine the relative weight of evidence

presented, including contemporaneous medical records and oral testimony. See Burns v.

Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (finding that the Special

Master had thoroughly considered evidence in record, had discretion not to hold an

additional evidentiary hearing); Hibbard v. Sec’y of Health & Human Servs., 698 F.3d at

1368 (finding it was not arbitrary or capricious for the Special Master to weigh diagnoses

17

of different treating physicians against one another, including when their opinions

conflict).

“Clearly it is not then the role of this court to reweigh the factual evidence,

or to assess whether the special master correctly evaluated the evidence.

And of course we do not examine the probative value of the evidence or the

credibility of the witnesses. These are all matters within the purview of the

fact finder.”

Dodd v. Sec’y of Health & Human Servs., 114 Fed. Cl. at 56 (quoting Munn v. Sec’y of

Health & Human Servs., 970 F.2d at 870 n.10); see also Rich v. Sec’y of Health & Human

Servs., 129 Fed. Cl. 642, 655 (2016); Paluck v. Sec’y of Health & Human Servs., 104

Fed. Cl. at 467 (“So long as those findings are ‘based on evidence in the record that [is]

not wholly implausible,’ they will be accepted by the court.” (quoting Lampe v. Sec’y of

Health & Human Servs., 219 F.3d at 1363 (alteration in original))). “Determinations

subject to review for abuse of discretion must be sustained unless ‘manifestly erroneous.’”

Heddens v. Sec’y of Health & Human Servs., 143 Fed. Cl. 193 (2019) (quoting Piscopo

v. Sec’y of Health & Human Servs., 66 Fed. Cl. 49, 53 (2005) (citations omitted)).

Additionally, a Special Master is “not required to discuss every piece of evidence

or testimony in [his or] her decision.” Snyder ex rel. Snyder v. Sec’y of Health & Human

Servs., 88 Fed. Cl. 706, 728 (2009) (brackets added); see also Paluck v. Sec’y of Health

& Human Servs., 104 Fed. Cl. at 467 (“[W]hile the special master need not address every

snippet of evidence adduced in the case, see id. [Doe v. Sec’y of Health & Human Servs.,

601 F.3d 1349, 1355 (Fed. Cir. 2010)], he [or she] cannot dismiss so much contrary

evidence that it appears that he ‘simply failed to consider genuinely the evidentiary record

before him.’” (brackets added) (quoting Campbell v. Sec’y of Health & Human Servs., 97

Fed. Cl. 650, 668 (2011))).

With regard to the Special Master’s weighing of evidence when testimony conflicts

with contemporaneous medical records, a Special Master generally should afford

contemporaneous medical records greater weight than conflicting testimony offered after

the fact. See Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991) (citing

United States v. United States Gypsum Co., 333 U.S. 364, 396 (1947) (“It has generally

been held that oral testimony which is in conflict with contemporaneous documents is

entitled to little evidentiary weight.”)), aff’d, 968 F.2d 1226 (Fed. Cir.) reh’g denied, (Fed.

Cir. 1992). This is because medical records, created contemporaneously with the events

they describe are presumed to be accurate and complete. See Cucuras v. Sec’y of Health

& Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

As discussed above, petitioner must prove by a preponderance of the evidence

that his rheumatoid arthritis was caused by the influenza vaccination he received. See 42

U.S.C. § 300aa-11(c)(1)(C)(ii)(I). If the Special Master’s decision was not arbitrary,

capricious, or not in accordance with the law, the reviewing court shall uphold that

decision. See 42 U.S.C. § 300aa-12(e)(2). Special Master Moran spent significant

amounts of time in his decision devoted to the details of the scientific and medical

18

evidence, although often without offering definitions of the scientific and medical terms he

used in his decision. Also, given that the petitioner has the burden of proof, the Special

Master’s decision oddly starts his discussion of the experts’ opinions by first reviewing the

respondent’s experts, and then goes on to review the petitioner’s experts. Nonetheless

he did carefully try to review the record before him, including petitioner’s medical history,

the expert reports, and information provided to him at the hearing over which he presided.

As indicated above, petitioner submitted his medical records and offered two

experts, Dr. Paul J. Utz and Dr. Lawrence Steinman to support petitioner’s theory of

molecular mimicry and his theory of causation. At the oral argument before this court,

petitioner’s counsel indicated: “Dr. Steinman looked at the BLAST searches, Dr. Utz

looked at the articles on both, the HA collagen and how the T cells bond, but also on how

the tetramers, which are a portion that have the specific peptide complexes, how those

create these bonds.” (capitalization in original). Dr. Utz’s original expert report, submitted

on February 29, 2016, discussed petitioner’s theory of molecular mimicry, including

“[w]hen an immune response to a nonself antigen such as components of an influenza

vaccine cross reacts with self molecules, the process is termed ‘molecular mimicry.’” Dr.

Utz stated in his February 29, 2016 original expert report that the medical theory of

causation proffered by petitioner is that “the vaccine triggered activation of B and/or T

lymphocytes through molecular mimicry, formation of immune complexes, cross-priming,

or a combination of these.” Dr. Utz also stated in his February 29, 2016 original expert

report that “[m]any arthritides including systemic lupus erythematosus (SLE), rheumatoid

arthritis (RA), Lyme arthritis, serum sickness, and parvovirus infection are postulated to

be (SLE [systemic lupus erythematosus], RA [rheumatoid arthritis]) or known to be (the

remaining illnesses), caused by exposure to an infectious antigen or foreign antigen.”

(capitalization in original) (brackets added). Dr. Utz cited the Clifton O. Bingham III and

Malini Moni article (the Bingham article) in his November 7, 2016 first supplemental expert

report and stated “the Bingham article does not link influenza vaccination and RA

[rheumatoid arthritis]; however, it clearly shows that another expert considers molecular

mimicry to be a possible trigger in RA [rheumatoid arthritis], in contrast to the position

taken by Dr[.] Matloubian.” (brackets added). The Bingham article, titled, “Periodontal

disease and rheumatoid arthritis: the evidence accumulates for complex pathobiologic

interactions,” published in May 2013, examined “the associations between periodontal

disease and rheumatoid arthritis.” In the article, molecular mimicry is not mentioned by

name. The authors state that when other researchers “immunized” animals “using Pg-

enolase and human a-enolase” that “the study demonstrated that a Pg protein could

induce arthritis and propagate an immune response against citrullinated peptides.”

(emphasis in original). Regarding this statement in the Bingham article, Dr. Utz stated

“the authors clearly describe the ability of a bacterial protein to break tolerance and to

cause arthritis in an animal model, acting as a molecular mimic.”

In his November 7, 2016 first supplemental expert report, Dr. Utz also cited to the

Jens Hennecke and Don C. Wiley paper (the Hennecke paper), titled, “Structure of a

Complex of the Human α/β T Cell Receptor (TCR) HA1.7, Influenza Hemagglutinin

Peptide, and Major Histocompatibility Complex Class II Molecule, HLA-DR4 (DRA*0101

and DRB1*0401): Insight into TCR Cross-Restriction and Alloreactivity,” published

19

February 25, 2002. (capitalization in original). Dr. Utz stated “the authors demonstrate

that a cross-reactive peptide (ie, [sic] a molecular mimic) derived from the hemagglutinin

molecule from influenza was able to bind the DR4 MHC molecule.” (capitalization in

original). The authors of the Hennecke paper described the findings of the study as: “This

structural study of TCR cross-reactivity emphasizes how MHC sequence differences can

affect TCR binding indirectly by moving peptide atoms.” (capitalization in original). Dr. Utz

stated, regarding the findings of this study, “this paper only demonstrates that DR4 can

bind an influenza or collagen peptide; it does not demonstrate that T cell receptors (TCRs)

on human T cells can recognize collagen or influenza peptides.” (capitalization in original).

Dr. Utz, in his September 4, 2018 third supplemental expert report also introduced the

Michael E. Birnbaum, Juan L. Mendoza, Dhruv K. Sethi, Shen Dong, Jacob Glanville,

Jessica Dobbins, Engin Özkan, Mark M. Davis, Kai W. Wucherpfennig, and K.

Christopher Garcia paper (the Birnbaum paper) as support for molecular mimicry and

stated “autoimmune T cells have the ability to be activated by immunogens encountered

in the environment, which may serve as the triggers for the initiation of autoimmunity.”

The Birnbaum paper, titled, “Deconstructing the peptide-MHC specificity of T cell

recognition,” published on May 22, 2014, examined “[d]econstructing the peptide-MHC

specificity of T cell recognition.” (capitalization in original). The Birnbaum paper stated:

While the naturally occurring peptides in this study were found as a proof of

principle for our methodology, they further support the hypothesis that

autoimmune T cells have the ability to be activated by immunogens

encountered in the environment, which may serve as the triggers for the

initiation of autoimmunity.

Dr. Utz in his September 4, 2018 third supplemental expert report also introduced the

Linda Wooldridge, Julia Ekeruche-Makinde, Hugo A. van den Berg, Anna Skowera, John

J. Miles, Mai Ping Tan, Garry Dolton, Mathew Clement, Sian Llewellyn-Lacey, David A.

Price, Mark Peakman, and Andrew K. Sewell paper (the Wooldridge paper), titled, “A

Single Autoimmune T Cell Receptor Recognizes More Than a Million Different Peptides,”

published November 18, 2011. (capitalization in original). The Wooldridge paper

researchers stated, “[a] single autoimmune T cell receptor recognizes more than a million

different peptides.”

In his June 8, 2017 second supplemental expert report, Dr. Utz also stated that the

evidence he provided should be sufficient to support molecular mimicry, but that he

cannot prove that molecular mimicry can occur without “culturing these autoreactive,

stimulated, expanded T cells and transferring them into an asymptomatic healthy human

subject to attempt to induce RA [rheumatoid arthritis] in fulfillment of Koch’s postulates,[7]

an experiment that would be completely unethical.” (emphasis in original) (brackets and

footnote added). Dr. Utz also admitted in his September 4, 2018 third supplemental expert

report, “I have not proven that the molecular mimic influenza peptides directly influence

the same T cells that are activated by collagen peptides.” (emphasis in original). Dr. Utz,

7 Dr. Utz does not define “Koch’s postulates” in his expert report.

20

nonetheless, stated in his September 4, 2018 third supplemental expert report, “[i]n many

cases, I have successfully argued for molecular mimicry just by” “show[ing] sequence

homology between a vaccine component and a self molecule,” without citing to those

other cases.

In his November 7, 2016 first supplemental expert report, Dr. Utz indicated that

because rheumatoid arthritis is so heterogenous in its pathology it is difficult to determine

a cause. Dr. Utz then listed environmental factors that “the vast majority of

rheumatologists and immunologists would agree” contribute to rheumatoid arthritis. Dr.

Utz acknowledged environmental factors that contribute to rheumatoid arthritis in his

November 7, 2016 first supplemental expert report, such as use of “tobacco,” “age, sex,

family history, and gingivitis, among others.” Dr. Utz also stated in his February 29, 2016

original expert report, “my search identified no epidemiological link between RA

[rheumatoid arthritis] and influenza vaccination.” (brackets added). Dr. Utz, however,

stated in his February 29, 2016 original expert report that “many studies and textbooks

postulate that RA [rheumatoid arthritis] can be caused by viruses themselves, or by other

inflammatory triggers” without citing to the studies or textbooks to which he was referring.

(brackets added). Dr. Utz also stated in his February 29, 2016 original expert report that

petitioner’s T cell repertoire, which is the type of cell that would mistake a foreign antigen

for a self antigen to cause molecular mimicry, is so rare that “epidemiologic studies will

not have the power to capture rare, patient-specific events such as occurred in Mr[.]

Tullio’s case.” 8

8 The court notes that Dr. Utz had been the retained expert in Parker v. Secretary of

Health & Human Services, No. 14-979V, 2019 WL 3425297 (Fed. Cl. Spec. Mstr. June

24, 2019). Because Dr. Utz was a retained expert in Parker v. Secretary of Health &

Human Services, petitioner had requested access to the hearing transcripts in the Parker

case, which was denied by the Special Master during the course of the proceedings

before him. In the motion for review to this court, petitioner also requested access to the

hearing transcripts in Forrest v. Secretary of Health & Human Services, No. 14-1046V,

2019 WL 925495 (Fed. Cl. Spec. Mstr. Jan. 28, 2019), in which Dr. Steinman was an

expert witness. To explain the issues petitioner raises, petitioner states in his motion for

review, “[i]t is erroneous and harmful to Petitioner to permit a credibility determination of

his expert based on extra-judicial information inaccessible to Petitioner.” Petitioner also

states: “This situation underscores the problems inherent in the Special Master’s pre-

hearing order denying Petitioner’s request for the transcript of a related proceeding.” It is

not apparent that the position taken by Dr. Steinman in Forrest v. Secretary of Health &

Human Services or by Dr. Utz in Parker v. Secretary of Health & Human Services would

have undermined the opinions as expressed in the instant case. The court believes that

the unavailability of the two hearing transcripts to petitioner would not have altered the

consideration given to the opinions offered by those two petitioner’s experts, impacted

concerns about Dr. Steinman’s credibility expressed by the Special Master in his decision,

or go to the credibility of Dr. Utz. This court, therefore, considers review by the petitioner

of the transcripts in Parker and Forrest not necessary nor of assistance to this court in its

review of the Special Master’s decision, and the Special Master did not err when he

denied petitioner’s request for the Parker transcript. Moreover, as discussed below, Mr.

21

With respect to the “evidence regarding experiments on the hemagglutinin in flu

virus and collagen,” Special Master Moran found that the papers Dr. Utz relied upon to

assert the molecular mimicry theory to be “relatively unimportant” because the studies

“basically report on how an antigen-presenting cell interacts with hemagglutinin and with

collagen,” and not “whether T cells bind to the hemagglutinin and/or collagen as

presented through the antigen-presenting cell.” See Tullio v. Sec’y of Health & Human

Servs., 2019 WL 7580149, at *14, *16. Special Master Moran found that, without the

theory that hemagglutinin and collagen are molecular mimics having been tested, a “gap

of knowledge and evidence exist[s].” See id. at *24. During the course of the case before

the Special Master, respondent offered expert testimony to refute petitioner’s offers of

proof and to refute petitioner’s evidence. The respondent’s expert Dr. Matloubian agreed

with petitioner’s expert Dr. Utz in that the presentation of rheumatoid arthritis can be

heterogenous, however, Dr. Matloubian asserted in his June 10, 2016 original expert

report, “[f]or molecular mimicry to be relevant to an autoimmune disease and the vaccine

in question, the natural infection itself, i.e. with influenza virus in this case, should also

lead to development of that disease in some people.” (emphasis in original).

In his decision, Special Master Moran also relied on and discussed a number of

previously decided vaccine cases to bolster his conclusion to deny compensation to

petitioner, including W.C. v. Secretary of Health & Human Services and Caves v.

Secretary of Health & Human Services, as part of his analysis of petitioner’s theory of

molecular mimicry. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d 1352 (Fed.

Cir. 2013); Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. 119, 135 (2011), aff’d,

463 F. App’x 932 (Fed. Cir. 2012). In W.C. v. Secretary of Health & Human Services,

petitioner alleged that his influenza vaccination caused aggravation to his multiple

sclerosis (MS) through the process of molecular mimicry. The United States Court of

Appeals for the Federal Circuit in W.C. v. Secretary of Health & Human Services

described the evidence presented by a petitioner:

The special master found that “[m]olecular mimicry is a well-regarded theory

in some contexts,” Special Masters Decision, 2011 WL 4537877, at *11, but

correctly required additional evidence showing that molecular mimicry can

cause the influenza vaccine to significantly aggravate multiple sclerosis,

see Broekelschen [v. Secretary of Health & Human Services], 618 F.3d at

1345 (holding “a petitioner must provide a reputable medical or scientific

explanation that pertains specifically to the petitioner's case”).

In support of his theory that molecular mimicry between the influenza virus

and myelin caused Petitioner's multiple sclerosis, Dr. Tornatore relied

primarily on an article by Wucherpfennig and Strominger at Harvard

University's Department of Molecular and Cellular Biology. Kai

Tullio failed to offer sufficient evidence to meet his burden of proving that his rheumatoid

arthritis was caused by the influenza vaccination petitioner received. See Tullio v. Sec’y

of Health & Human Servs., 2019 WL 7580149, at *28.

22

Wucherpfennig & Jack L. Strominger, Molecular Mimicry in T Cell–Mediated

Autoimmunity: Viral Peptides Activate Human T Cell Clones Specific for

Myelin Basic Protein, 80 Cell 695 (1995). The Wucherpfennig article

showed that human myelin basic protein-specific T-cell clones derived from

the blood of multiple sclerosis patients were “cross-reactive” with one

peptide from a wild influenza Type A strain. Id. at 697. Dr. Tornatore testified

that this evidence, demonstrating that influenza proteins can stimulate

T-cells specific to myelin basic protein, makes it “beyond plausible” that the

influenza vaccine could stimulate the immune response that led Petitioner

to develop multiple sclerosis. J.A. 170.

W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1360. In W.C. v. Secretary of Health

& Human Services, the Federal Circuit outlined the reasons, which were also identified

by the Special Master, as to why the petitioner’s theory of molecular mimicry was

insufficient to prove petitioner’s case, finding, “Petitioner provided no evidence that the

portions of the influenza virus shown by Wucherpfennig [referred to in the quote

immediately above] to mimic myelin basic protein were present in the influenza vaccine

Petitioner received,” and “Petitioner also did not provide evidence that any peptide from

the influenza vaccine he received was cross-reactive with myelin basic protein-specific T-

cells.” Id. at 1360-61 (brackets added). The Federal Circuit in W.C. v. Secretary of Health

& Human Services also found that two studies which examined patients with MS relied

upon by the Special Master showed that MS was not exacerbated by the influenza

vaccination to be more persuasive than petitioner’s expert’s theory and affirmed the denial

of compensation by the Special Master. See id. at 1361.

The second case regarding molecular mimicry that Special Master Moran

discussed was Caves v. Secretary of Health & Human Services, a case also decided by

Special Master Moran, and which was then affirmed by Judge Bush of the United States

Court of Federal Claims. Subsequently, the United States Court of Appeals for the

Federal Circuit affirmed the Court of Federal Claims’ decision. See generally Caves v.

Sec’y of Health & Human Servs., 463 F. App’x 932 (Fed. Cir. 2012). In the Court of

Federal Claims decision, the Judge found:

The theory of molecular mimicry does not apply specifically to petitioner’s

case; on the contrary, that general theory could be used to demonstrate an

association between virtually any combination of antigens and autoimmune

injuries. Without any empirical evidence that the theory actually applies to

the influenza vaccine and TM [transverse myelitis], the first prong of Althen

would be rendered meaningless.

Caves v. Sec’y of Health & Human Servs., 100 Fed. Cl. at 135.

A case not relied upon or cited by the Special Master, but relevant to the instant

case, is a decision discussing molecular mimicry issued by United States Court of

Appeals for the Federal Circuit. See generally Broekelschen v. Sec’y of Health & Human

Servs., 618 F.3d 1339. The evidence the petitioner in Broekelschen v. Secretary of Health

23

& Human Services offered to “connect[ ] the molecular mimicry theory to the flu vaccine”

was “a literature review based on two papers from the early 1950s, which in turn

considered vaccine cases between 1929 and 1952.” Id. at 1350. The Federal Circuit in

Broekelschen v. Secretary of Health & Human Services affirmed the Special Master’s

decision that petitioner “had not provided a ‘reliable medical or scientific explanation’

sufficient to prove by a preponderance of the evidence a medical theory linking the flu

vaccine to anterior spinal artery syndrome.” Id. at 1351 (quoting Knudsen ex rel. Knudsen

v. Sec’y of Health & Human Servs., 35 F.3d at 548). Although Mr. Tullio provided more

evidence than a literature review of two 1950s studies, Mr. Tullio failed to “provide

evidence that any peptide from the influenza vaccine he received was cross-reactive with”

the specific T cells. See W.C. v. Sec’y of Health & Human Servs., 704 F.3d at 1360–61;

see also Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d at 1351. When

arriving at his decision, Special Master Moran was justified in focusing on petitioner’s

expert Dr. Utz and respondent’s expert Dr. Matloubian, who shared concerns that the

cause of rheumatoid arthritis is unknown. The Special Master rationally could conclude

that that the influenza vaccination petitioner received was not the cause of Mr. Tullio’s

rheumatoid arthritis. As Dr. Utz testified at the hearing before Special Master Moran: “It is

currently not known what causes rheumatoid arthritis.” In response to the question from

respondent’s counsel at the hearing before Special Master Moran: “Does the medical

community know what causes rheumatoid arthritis?” Dr. Matloubian testified: “No.” As

discussed further below, based on a review of the record before the court, the Special

Master was justified to require more evidence than what was in the record to support

petitioner’s allegations that petitioner’s influenza vaccination caused the petitioner’s

rheumatoid arthritis. The Special Master’s conclusion was not arbitrary or capricious

based on his in-depth examination of the record before him. The Special Master also

stated:

The mechanistic evidence tends to align with the epidemiologic evidence,

which did not detect an increased incidence of rheumatoid arthritis following

flu vaccination. Thus, exclusively for the reasons set forth . . . Mr. Tullio has

failed to carry his burden of presenting a reliable and persuasive theory that

the flu vaccine can cause rheumatoid arthritis.

Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *22 (internal references

omitted). Special Master Moran, therefore, concluded that petitioner had not satisfied his

burden to prove by a preponderance of evidence that petitioner had presented a “logical

sequence of cause and effect,” and his conclusions were not arbitrary or capricious. See

Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278; see also Tullio v. Sec’y of

Health & Human Servs., 2019 WL 7580149, at *5.

At the oral argument before this court, petitioner’s counsel, however, stated that,

in addition to relying on the studies regarding hemagglutinin and collagen introduced by

Dr. Utz, petitioner also tried to rely on “how the tetramers, which are a portion that have

the specific peptide complexes, how those create these bonds.” Respondent’s expert Dr.

Matloubian had introduced the information regarding tetramers in his November 16, 2018

second supplemental expert report, in part in response to petitioner’s expert Dr. Utz

24

indicating that testing his theory of molecular mimicry only would be possible through

unethical means. 9 Dr. Matloubian also stated in his November 16, 2018 second

supplemental expert report, “[u]sing current immunological tools and techniques, such as

widely available tetramers, the question of whether the same T cell receptor can

recognize both collagen and HA peptides bound to the same HLA can be readily

addressed.” Dr. Matloubian described tetramers by stating, “these tools allow

identification of T cells that recognize a specific MHC-peptide complex (i.e., T cells that

are specific for HLA-DR4 containing the HA peptide or HLA-DR4 containing the collagen

II peptide).” (capitalization in original). Petitioner did not address the theory of tetramers

until petitioner’s expert Dr. Utz testified at the March 6-8, 2019 hearing before Special

Master Moran, in response to a question from petitioner’s counsel, “[h]ow would you go

about observing molecular mimicry in one of your patients in a clinical setting?”

Petitioner’s expert Dr. Utz replied:

In a clinical setting, to observe molecular mimicry or study it would be an

enormous challenge. So one of the things would be to identify collagen

antibodies. That would be one thing that would be supportive. Those assays

are not available in clinical labs to my knowledge. I have never ordered one.

They are only available in a research lab.

The second would be to create tetramers which Dr. Matloubian has

provided three [sic] exhibits on tetramers. Tetramers are MHC molecules

that are loaded in this case with DR4, loaded with collagen, or with HA.

The four studies on tetramers introduced by Dr. Matloubian in his first and second

supplemental reports were the Svendsen, Snir, James, and Malmström studies. Special

Master Moran evaluated the four studies regarding tetramer experiments introduced by

respondent. Special Master Moran found that the petitioner’s contention that tetramer

experiments can “explain how the flu vaccine can cause rheumatoid arthritis” “lacks

persuasive value because Dr. Utz extends the studies beyond what the authors of those

studies reported.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *18.

The Special Master evaluated the Pia Svendsen, Claus B. Andersen, Nick Willcox,

Anthony J. Coyle, Rikard Holmdahl, Thomas Kamradt, and Lars Fugger study (the

Svendsen study), titled, “Tracking of Proinflammatory Collagen-Specific T Cells in Early

and Late Collagen-Induced Arthritis in Humanized Mice” accepted for publication on

9 According to the Benaroya Institute, a source cited by Dr. Matloubian in his November

16, 2018 second supplemental expert report, tetramers are “are a multivalent synthetic

mimic of the peptide binding proteins found on the surface of antigen presenting cells.”

Scientists & Laboratories: Tetramer Core Laboratory, Benaroya Research Institute,

https://www.benaroyaresearch.org/what-is-bri/scientists-and-laboratories/core-

labs/tetramer -core-laboratory (last visited on June 18, 2020). Dr. Utz testified at the

hearing as to his definition of tetramers: “Tetramers are MHC molecules that are loaded

in this case with DR4, loaded with collagen, or with HA. Four of them tether together and

they have fluorophores on them so they glow. You can use those to look at antigen-

specific T cells.” (capitalization in original).

25

August 10, 2004, which was introduced by Dr. Matloubian in his November 16, 2018

second supplemental expert report. The Special Master described three experiments

which took place to try to determine whether B or T cells “initiated the disease,” when

“struggling to understand the pathology of rheumatoid arthritis.” See id. In order to test

the theory, the researchers had used petri dishes and mice. One experiment referenced

in the Svendsen study involved mice being immunized with collagen, hemagglutinin with

an adjuvant, as well as an adjuvant, and saline. Blood was drawn from mice lymph nodes

thirteen days after immunization of collagen, hemagglutinin with an adjuvant, as well as

an adjuvant, and saline, and “researchers determined the frequency of the targeted T

cells, expressed as a percentage of T cells” that responded. See id. The frequency of the

T cells from the hemagglutinin-immunized mice that were stained with hemagglutinin

tetramer was 0.86 percent and with a collagen tetramer was 0.08 percent. Dr. Utz testified

that 0.08 demonstrates cross-reactivity between hemagglutinin and collagen. The Omri

Snir, Mary Rieck, John A. Gebe, Betty B. Yue, Crystal A. Rawlings, Gerald Nepom,

Vivianne Malmström, and Jane H. Buckner study (the Snir study), titled, “Identification

and Functional Characterization of T Cells Reactive to Citrullinated Vimentin in HLA–

DRB1*0401–Positive Humanized Mice and Rheumatoid Arthritis Patients,” which was

published in October 2011, was introduced by Dr. Matloubian in his November 16, 2018

second supplemental expert report. (capitalization in original). In the Snir study the

“hemagglutinin antigen tetramer was used as a negative control.” In addition in the Eddie

A. James, Mary Rieck, Jennifer Pieper, John A. Gebe, Betty B. Yue, Megan Tatum,

Melissa Peda, Charlotta Sandin, Lars Klareskog, Vivianne Malmström, and Jane H.

Buckner study (the James study), titled, “Citrulline-Specific Th1 Cells Are Increased in

Rheumatoid Arthritis and Their Frequency Is Influenced by Disease Duration and

Therapy,” published in July 2014, also introduced by Dr. Matloubian in his November 16,

2018 second supplemental expert report, the peptide control was again hemagglutinin.

(capitalization in original). In the Vivianne Malmström, Anca I. Catrina and Lars Klareskog

study (the Malmström study), titled, “The immunopathogenesis of seropositive

rheumatoid arthritis: from triggering to targeting,” published December 5, 2016, likewise

was introduced by Dr. Matloubian in his February 23, 2017 first supplemental expert

report. In the Malmström study, hemagglutinin from the influenza vaccination is described

as “an unrelated antigen” to the research regarding seropositive rheumatoid arthritis,

similar to how hemagglutinin was a control in the James study. When Special Master

Moran asked petitioner’s expert Dr. Utz at the hearing before him about the statement

that hemagglutinin is an unrelated antigen to seropositive rheumatoid arthritis, Dr. Utz

responded that “they are using these tetramers as a control. They are not studying

mimicry. They are not studying people like Mr. Tullio. So they are using this as a control

for a totally different purpose.”

At the oral argument before this court, petitioner’s counsel argued that, in addition

to the expert reports provided by Dr. Utz and the tetramer experiments introduced by

respondent, petitioner also relies on petitioner’s expert Dr. Lawrence Steinman’s “BLAST

searches.”10 (capitalization in original). Petitioner’s expert Dr. Steinman, in his November

10At the hearing before Special Master Moran, Dr. Steinman described the Blast searches

as a computer program “aligning vast domains of these proteins and assigning weights

26

7, 2016 original expert report, discussed the similarities between hemagglutinin, the

protein in the influenza vaccination, and that the “major proteins considered to be the

major targets of the response in RA [rheumatoid arthritis] are collagen, fibrinogen,

enolase and vimentin (8).” (brackets added). Dr. Steinman conducted what he called Blast

searches to determine “any relevant molecular mimics between” the proteins and the

components of the influenza vaccination the petitioner received by searching a National

Institute of Health database of amino acids. The enolase and hemagglutinin peptide

sequence homology 11 was deemed “relevant” by Dr. Steinman because the “peptides of

enolase and the hemagglutinin from the 2012 vaccine have 5 of 12 or 4 of 11 identities

with 2 close matches within 12 amino acids, making it 7 of 12 positives.” The protein

vimentin also was deemed by Dr. Steinman to have relevant molecular mimics because

there were “4 of 12 identical, 5 of 12 positive, and 5 of 13 identical and 6 of 13 positive”

in the sequence homology Blast search. Regarding fibrinogen, Dr. Steinman stated there

was “a 4 of 7 identity and a 5 of 7 positivity” with hemagglutinin, which meant “this was

sufficient to induce clinical autoimmune disease.” Finally, in his November 7, 2016 original

expert report regarding collagen, Dr. Steinman stated, “[t]here were many molecular

mimics but these two above are stunning, including a 6 of 11 with four consecutive

IDENTICAL amino acids between collagen and the Hemagglutinin from Influenza Virus

A/Victoria/361/2011.” (capitalization in original). Dr. Steinman stated that “[s]trikingly,

there are extensive molecular mimics between the contents of the 2012 influenza vaccine

received by Petitioner and the critical antigens that are associated with rheumatoid

arthritis.” (emphasis in original omitted).

Regarding Dr. Steinman’s Blast searches, offered in support of petitioner’s case,

respondent’s expert Dr. Matloubian, in his June 10, 2016 original expert report, stated the

presence of linear sequence homology does not necessarily translate to

immunogenicity. Proteins consist of linear sequence of amino acids but fold

into complex three-dimensional structures. Therefore, the same sequence

of amino acids may be on the surface of one protein, and thus easily

accessible to antibodies, while in another protein the same sequence could

be buried inside the molecule and hidden from those antibodies.

Disputing petitioner’s theory of sequence homology, Dr. Matloubian also stated in his

February 23, 2017 first supplemental expert report:

and actually lining them up.” Regarding the Blast searches, which petitioner’s counsel

called the “Steinman study” at the oral argument, this court asked the petitioner’s counsel:

“You cannot tell me that Dr. Steinman’s experimentation had anything to do with either

high dose Fluzone influenza vaccine or rheumatoid arthritis. Is that correct?” Petitioner’s

counsel responded: “Yes, ma’am.”

11 Dr. Steinman, who performed the Blast searches, stated that sequence homology, in

his view, has an “operational definition that a sequence of 12 or fewer amino acids that

are identical at 4 positions.”

27

Even though the same peptide sequence of 7-12 amino acids can occur in

two different proteins, its proper processing could be affected by the

surrounding amino acid sequences resulting in differences in the ability of

MHC molecules to present them to T cells. Because of these caveats, in

science, the standards of proof for molecular mimicry are quite high and

sequence homology itself is not sufficient evidence.

Moreover, Dr. Matloubian stated in his February 23, 2017 first supplemental expert report

that researchers generally focused much more heavily on studying the structure of

proteins, rather than on the sequence of proteins, because most algorithms regarding

sequence “have low accuracy for predicting MHC class II restricted epitopes,

underscoring the principle that just finding sequence homology in several proteins does

not imply antigenicity, let alone molecular mimicry.” (emphasis in original). In his

November 16, 2018 second supplemental expert report, Dr. Matloubian stated: “Just

because two peptides (small pieces of protein) may share similar sequences and even

bind to the same major histocompatibility complex (MHC/HLA) does not necessarily mean

that the same T cell can see them as similar (i.e. does not mean that they have the same

‘immunologic epitope’).” (capitalization in original) (emphasis omitted). In addition, Dr.

Matloubian stated in his November 16, 2018 second supplemental expert report that in

order for molecular mimicry to occur “at the T cell level, the same T cell must recognize

both the influenza peptide and the RA [rheumatoid arthritis] peptide associated with

MHC/HLA.” (capitalization in original) (emphasis omitted) (brackets added).

Regarding Dr. Steinman’s Blast searches, Special Master Moran wrote that

because all proteins “are built from the same 20 amino acids, it is inevitable that some

sequences of amino acids will repeat.” Tullio v. Sec’y of Health & Human Servs., 2019

WL 7580149, at *15. In this respect, Special Master Moran indicated that “the finding of

sequence homology does not necessarily mean the similarity has significance to the

immune system.” Id. Special Master Moran also noted that “scientists have identified the

portions of the flu virus that are peptides and created a database of them. Dr. Matloubian

queried the database to see whether the epitopes that Dr. Steinman had identified

appeared in the database. Dr. Matloubian disclosed that he did not find any positive hits.”

Id. After his review of the record before him, Special Master Moran found the Blast

research to be unpersuasive because of Dr. Steinman’s “lack of meaningful response”

when compared to respondent’s expert, Dr. Matloubian’s, conclusion, who searched the

influenza virus peptide database, as opposed to a more general database. See id.

After reviewing the record before him, Special Master Moran stated petitioner’s

expert Dr. Steinman “misses its mark” when Dr. Steinman “added a critique that those

studies[12] were not relevant to Mr. Tullio’s situation because none of those studies

12Although not clear in the Special Master’s decision, based on the hearing transcript,

Dr. Steinman seemed to be referring to the Ray and Bardage studies discussed below.

The Bengtsson study, also discussed below, could also have been included because

petitioner argues that petitioner also would not have qualified for that vaccination. The

28

involved the exact vaccine that he received.” Id. at *11 (footnote added). Dr. Steinman

testified at the hearing before Special Master Moran: “And again, I state in my report,

referring to Dr. Matloubian’s Exhibit CC [the Ray study] where he talks about vaccines

from the 1997 to 1999 season, that that epidemiology is totally irrelevant because those

vaccines didn’t have the 2009 A/California, the 2011 A/Victoria, the 2010 B/Wisconsin

because it was only 1999.” (brackets added). Dr. Steinman also testified: “Generally

speaking, there’s a whole problem with lumping all influenza vaccines into one boat

because, as I said this morning, they’re seasonal. The CDC [Center for Disease Control]

nominates well ahead of time the virus strains. The virus strains differ from year to year.

And we know, for instance, that one year a virus strain that was used with an adjuvant,

not here, but it led to an outbreak of narcolepsy.” (brackets added). Regarding this

argument offered by petitioner, Special Master Moran stated:

Dr. Matloubian tested the degree of difference among various iterations of

flu vaccines. Using the same methodology Dr. Steinman used to determine

the degree of homology between a component of the flu vaccine and a

component of joint tissue . . . Dr. Matloubian found that the flu vaccines

retain at least 90 percent homology across the years.[13] When asked about

this approach, Dr. Steinman did not contest Dr. Matloubian’s findings.

Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *11 (internal citations

omitted) (footnote added). The Special Master also concluded that “Dr. Steinman’s

challenge to the usefulness of epidemiologic studies not involving the 2015 [sic] flu

vaccine that Mr. Tullio received is not persuasive. Instead, the epidemiologic studies are

persuasive. As such, the epidemiological evidence weakens the reliability of opinions that

the flu vaccine can cause rheumatoid arthritis.” Id.

In Moberly ex rel. Moberly v. Secretary of Health & Human Services, the United

States Court of Appeals for the Federal Circuit found, “[a]s a general matter,

epidemiological studies are designed to reveal statistical trends only for a carefully

constructed test group. Such studies provide no evidence pertinent to persons not within

the parameters of the test group.” Moberly ex rel. Moberly v. Sec’y of Health & Human

Servs., 592 F.3d at 1324 (finding that because petitioner could not have belonged to a

test group that the study could not apply to petitioner). In Lampe v. Secretary of Health &

hearing transcript, however, cited by the Special Master cited only petitioner’s references

to the Ray and Bardage studies.

13 In this statement, Special Master Moran appears to be referring to a database

introduced and examined by respondent’s expert Dr. Matloubian. According to the Special

Master’s decision, “scientists have identified the portions of the flu virus that are peptides

and created a database of them. Dr. Matloubian queried the database to see whether the

epitopes that Dr. Steinman had identified appeared in the database. Dr. Matloubian

disclosed that he did not find any positive hits.” Tullio v. Sec’y of Health & Human Servs.,

2019 WL 7580149, at *15.

29

Human Services, the United States Court of Appeals for the Federal Circuit also found

that because petitioner did not fit into the study’s “paradigm” that the study could not “shed

light on the issue of causation in her case.” Lampe v. Sec’y of Health & Human Servs.,

219 F.3d at 1366. 14

In his decision, Special Master Moran criticized petitioner’s expert Dr. Steinman

for “suggesting that his methods in forming an opinion in a legal proceeding are less

stringent than if he were submitting his theory for peer review.” Tullio v. Sec’y of Health &

Human Servs., 2019 WL 7580149, at *24. Regarding Dr. Steinman, Special Master Moran

noted, “if he were trying to publish a paper in a peer-reviewed journal, he would do more,

such as model his theory in mice.” Id. Special Master Moran further wrote:

Dr. Steinman stated that his work is sufficient for a court but not for the

broader community. Tr. 354 (“And that’s about the best I could do and that’s

the foundation of a theory for this Court. I’m not applying for a prize. I’m just

saying that this is where an experiment led me [to that says could a vaccine

that has the components of Mr. Tullio’s that are shared with those antigens

that are imputed to be involved in the pathogenesis of rheumatoid arthritis,

could they have done it?]”).

Id. (brackets added). Special Master expressed concern that “Dr. Steinman seemed to

indicate that he expressed opinions, as an expert, more readily than he would outside a

legal proceeding” and that “[o]ther special masters have expressed similar concerns.” Id.

at *26 (citing D.G. v. Sec’y of Health & Human Servs., No. 11-577V, 2019 WL 2511769,

at *182 (Fed. Cl. Spec. Mstr. May 24, 2019); Chinea v. Sec’y of Health & Human Servs.,

No. 15-095V, 2019 WL 1873322, at *19 (Fed. Cl. Spec. Mstr. Mar. 15, 2019), aff’d, 144

Fed. Cl. 378, 386-87 (2019)). Special Master Moran wrote in his decision that Dr.

Steinman’s approach on behalf of the petitioner was inconsistent with the United States

14 The court notes that in an unpublished decision, McCollum v. Secretary of Health &

Human Services, the United States Court of Appeals for the Federal Circuit upheld a

Special Master’s determination that the studies regarding the adjuvanted H1N1

Pandemrix vaccination and narcolepsy were not persuasive to petitioner’s case because

petitioner in that case received the unadjuvanted influenza vaccination. See McCollum v.

Sec’y of Health & Human Servs., 760 F. App’x 1003, 1008-09 (Fed. Cir. 2019). In another

unpublished decision cited by petitioner, D’Toile v. Secretary of Health & Human

Services, the United States Court of Appeals for the Federal Circuit found appropriate the

lack of deference given to a study involving Pandemrix when the petitioner received a

different influenza vaccination than Pandemrix. See D’Tiole v. Sec’y of Health & Human

Servs., 726 F. App’x 809, 811 (Fed. Cir. 2018). Thereafter, in a decision issued by another

Judge of the United States Court of Federal Claims, Dougherty v. Secretary of Health &

Human Services, the Judge cited D’Tiole and found that the Special Master had

reasonably found insufficient evidence existed to support that the petitioner’s narcolepsy

was caused by the influenza vaccination because the vaccination was sufficiently different

from Pandemrix. See Dougherty v. Sec’y of Health & Human Servs., 141 Fed. Cl. at 229-

30.

30

Supreme Court’s decision in Kumho Tires Co., Ltd. v. Carmichael, 526 U.S. 137 (1999),

because testimony in the courtroom should employ “‘the same level of intellectual rigor

that characterizes the practice of an expert in the relevant field.’” Tullio v. Sec’y of Health

& Human Servs., 2019 WL 7580149, at *26 (quoting Kumho Tires Co., Ltd. v. Carmichael,

526 U.S. at 152). In a somewhat contradictory statement, Special Master Moran also

wrote in his decision, “[h]owever, Dr. Steinman’s approach might be consistent with a

view that distinguishes scientists from participants in the civil litigation.” Id. (citing Andreu

ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1380).

Another of the petitioner’s arguments before this court is that the Special Master

erred because “[t]he weight placed on the epidemiological evidence herein influenced the

Decision’s entire causation analysis.” Petitioner argues that “the Special Master should

have rejected the epidemiology herein as not dispositive and of little persuasive value, as

opposed to finding it ‘powerful.’” (quoting Tullio v. Sec’y of Health & Human Servs., 2019

WL 7580149, at *11, *27). Although at the oral argument before this court, petitioner’s

counsel indicated that, in part, “Petitioners [sic] weren’t [sic] relying on epidemiological

studies in support of their [sic] position. Only Respondent was relying on them to counter

the Petitioner’s position,” petitioner also referred to some of the respondent’s evidence to

support his case, as described above regarding tetramers. Petitioner points to four studies

that the Special Master allegedly relied on too heavily: the Ray, Bengtsson, Bardage, and

Westra studies, each of which was introduced by the respondent. The Paula Ray, Steven

Black, Henry Shinefield, Aileen Dillon, Diane Carpenter, Edwin Lewis, Pat Ross, Robert

T. Chen, Nicola P. Klein, Roger Baxter study (the Ray study), titled, “Risk of rheumatoid

arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among

persons 15-59 years of age,” published on July 16, 2011, introduced by Dr. Halsey in his

February 23, 2017 original expert report, examined influenza, hepatitis B, and tetanus

vaccinations from 1997 until 1999 in individuals from the ages of 15-59. To rebut Dr.

Steinman’s contention that the studies on influenza vaccinations from other years are

inapplicable, specifically the years covered in the Ray study, Dr. Matloubian stated in his

February 23, 2017 first supplemental expert report:

Two out of the four sequences are identical between the 1998-1999 strain

and the 2012-2013 one (Figure 3). The other two, only differ by one amino

acid between the two strains, resulting in 12 out of 13 in one case and 10

out of 11 in the other case of identical amino acids. This type of similarity is

what Dr. Steinman would term ‘stunning’ and is more remarkable than any

he has described in his report. (Ex. 40 at 20).

Petitioner claims in his motion for review that the Ray study raised by respondent should

not be dispositive, because “the high-dose influenza vaccine received by Petitioner was

not available during those years.” Petitioner also argues that petitioner would not have

qualified for the Ray study because “Petitioner was too old.”

The Camilla Bengtsson, Meliha C. Kepetanovic, and Henrik Källberg, et al. study

(the Bengtsson study), titled, “Common vaccinations among adults do not increase the

risk of developing rheumatoid arthritis: results from the Swedish EIRA study,” published

31

on July 5, 2010, also introduced by respondent, although not through an expert, was

conducted from 1996-2006, and the class of people studied were from the ages of 18-70

living in Sweden. Additionally, the Bengtsson study noted that “[s]pecific vaccinations

studied were flu, tetanus, diphtheria, tickborne encephalitis, hepatitis (A, B, C), polio and

pneumococcus.” The Bengtsson study stated, “it is unlikely that vaccinations in general

should be considered as a major risk factor for RA [rheumatoid arthritis].” (brackets

added). Petitioner claims in his motion for review he would not have qualified for the

respondent-introduced Bengtsson study because “Respondent offered no evidence that

the influenza vaccination given in Sweden in 1998 was similar to the high-dose vaccine

given to Petitioner in 2012.”

The Carola Bardage, Ingemar Persson, Åke Örtqvist, Ulf Bergman, Jonas F

Ludvigsson, and Fredrik Granath study (the Bardage study), titled, “Neurological and

autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a

monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden,”

published in 2011, introduced by Dr. Halsey in his February 23, 2017 expert report, was

conducted with individuals who lived in Stockholm county, Sweden from January 1, 1998,

through at least October 1, 2009. These individuals received the H1N1 influenza

vaccination Pandemrix, and the researchers found that the risk for rheumatoid arthritis for

those who received the vaccination remained “unchanged.” Petitioner also argues that

the respondent-introduced Bardage study should not be heavily relied upon because,

“epidemiological and other evidence involving the Pandemrix vaccine have been

consistently rejected by special masters in decisions approved by this Court and the

Federal Circuit.”

The Johanna Westra, Christien Rondaan, Sander van Assen and Marc Bijl study

(the Westra study), titled, “Vaccination of patients with autoimmune inflammatory

rheumatic diseases,” published in March 2015, introduced by Dr. Matloubian in his June

10, 2016 original expert report stated:

In most of the latest studies of the efficacy of influenza vaccination in

patients with RA [rheumatoid arthritis], safety is considered and yet no

significant influence of vaccination on disease activity has been reported.

Also, in pre-post studies after influenza vaccination, patients with RA

[rheumatoid arthritis] did not experience increased disease activity.

(internal references omitted) (brackets added). According to the Westra study

researchers, corticosteroids, methotrexate, TNF inhibitor, and anti-IL-6-receptor antibody

have “no significant influence on influenza vaccination,” while the methotrexate plus TNF

inhibitor, anti-CD20 antibody, and abatacept “can cause a reduced immune response to

vaccination.” (capitalization in original). Using the Westra study as support in his February

23, 2017 first supplemental expert report, Dr. Matloubian stated that “even though it [the

influenza vaccination] elicits an immune response, the influenza vaccine does not

exacerbate the disease.” (brackets added). Dr. Matloubian, in his February 23, 2017 first

supplemental expert report described the results of the Westra study: “although these RA

[rheumatoid arthritis] patients were on immunosuppressive therapy, they still made an

32

immune response to the influenza vaccine, but did not have an exacerbation of their RA

[rheumatoid arthritis].” (brackets added). Petitioner notes, however, that he “would not

have been included in” the respondent-introduced Westra study because “he was not

already suffering RA [rheumatoid arthritis] and receiving serious immune-modifying

medications at the time of vaccination.”15 (brackets added).

As noted above, the Special Master examined in detail the epidemiological studies

presented and wrote that the respondent’s epidemiological studies were “persuasive” and

“powerful.” See Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *11, *27.

Special Master Moran concluded his discussion of the first prong of the Althen test by

stating “the powerful epidemiologic evidence does not support this [petitioner’s]

hypothesis.” Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *27 (brackets

added); see also Althen v. Sec’y of Health & Human Servs., 418 F.3d at 1278. The Special

Master also stated, “[n]evertheless, it remains the case that, as Vaccine Program

precedent indicates, epidemiology is not dispositive.” Tullio v. Sec’y of Health & Human

Servs., 2019 WL 7580149, at *11. Special Master Moran also provided a cautionary note

to his findings by stating, “[r]egardless, this case does not turn on why experts presented

the opinions they presented. Instead, the case resolves on the (lack of) persuasiveness

of the theory that the flu vaccine can cause rheumatoid arthritis via molecular mimicry.”

See id. at *27. Although the Special Master in his decision appears to give more credence

to the respondent’s experts than to petitioner’s experts, he did carefully review all the

evidence before him in reaching his ultimate conclusion denying compensation and was

not arbitrary or capricious in doing so.

As also discussed above, the United States Court of Appeals for the Federal Circuit

has addressed the weight that epidemiological evidence should play in a Special Master’s

decision, for example, in Grant v. Secretary of Health & Human Services. See Grant v.

Sec’y of Health & Human Servs., 956 F.2d at 1145-49. In Grant v. Secretary of Health &

Human Services, the petitioner received the Quadrigen vaccination as an infant, to protect

petitioner from diphtheria, pertussis, tetanus, and polio, which petitioner alleged caused

his encephalopathies. See id. at 1145-46. The respondent in Grant introduced

epidemiological evidence which demonstrated that children who had received the

diphtheria, pertussis, and tetanus (DPT) vaccination, which is different than the

Quadrigen vaccination, experienced the same amount of infantile spasms as those who

did not receive the DPT vaccination. See id. at 1148-49. The Federal Circuit in Grant v.

Secretary of Health & Human Services approved the Special Master’s reliance on the

scientific evidence presented by the petitioner regarding the Quadrigen over the

respondent’s presentation of DPT epidemiology because “the epidemiological studies

cited by the Secretary in this appeal related to a general DPT vaccine, not the Quadrigen

vaccine,” and the epidemiology was “not dispositive of the actual causation question in

this case.” See id. at 1149. In Heddens v. Secretary of Health & Human Services, a

decision issued by a Judge of the United States Court of Federal Claims, a petitioner

15 In his decision, Special Master Moran did not indicate that the patients in the Westra

study were all taking immune-modifying medications.

33

alleged that a human papillomavirus (HPV) vaccination caused her MS. See Heddens v.

Sec’y of Health & Human Servs., 143 Fed. Cl. at 195. In her motion for review, the

petitioner in Heddens v. Secretary of Health & Human Services argued that the Special

Master’s reliance on epidemiology which did not examine HPV and MS was appropriate.

See id. at 197-98. The Judge in Heddens v. Secretary of Health & Human Services found

that, because the Special Master “considered the epidemiological evidence presented by

respondent, but did not treat that evidence as weighing heavily against petitioner,” that

the Special Master did not abuse his discretion. See id. at 198. The Judge also stated

that because there was no indication that the Special Master “regarded the

epidemiological evidence with what petitioner calls ‘fervor,’” that the weight given to

epidemiological evidence did not heighten petitioner’s burden. See id. at 199.

Petitioner also appeals the Special Master’s finding that petitioner did not satisfy

the second prong of the Althen test, that there was a “logical sequence of cause and

effect” from the vaccine to petitioner’s injury. See Althen v. Sec’y of Health & Human

Servs., 418 F.3d at 1278. Petitioner argues in his motion for review, “[a]lthough it briefly

discussed Althen prong two, the decision failed to set forth whether this prong was

satisfied, likely as a result of its conclusion on prong one,” and petitioner, therefore,

requests “that any remand include an instruction to evaluate Petitioner’s evidence on

Althen prong two in accordance with Capizzano[ v. Secretary of Health & Human

Services, 440 F.3d at 1326].” (brackets added). Respondent argues, however, that the

Special Master made a proper finding that petitioner had not established a logical

sequence of cause and effect because the Special Master found that Dr. Hsu did not

associate petitioner’s rheumatoid arthritis with the flu vaccine in the petitioner’s medical

records once petitioner had received the rheumatoid arthritis diagnosis. Respondent also

argues that “the Special Master provided a sound reason, based on a contextual analysis

of the record as a whole, to conclude that no treating physician persuasively opined that

the flu vaccination caused petitioner’s RA [rheumatoid arthritis].” (brackets added).

Petitioner’s reply to respondent in this court concedes that Special Master Moran had

come to the conclusion that petitioner had not satisfied the second prong of Althen.

Petitioner, therefore changed his argument in this court to argue that “requiring multiple

treator attributions in order to reach an acceptable level of persuasiveness is not in

keeping with case law.” (citing Paluck v. Sec’y of Health & Human Servs., 786 F.3d at

1385-86). As stated above, the United States Court of Appeals for the Federal Circuit has

found that treating physician statements are considered “quite probative” because

“treating physicians are likely to be in the best position to determine whether a logical

sequence of cause and effect show[s] that the vaccination was the reason for the injury.”

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326 (internal quotation marks

omitted); see also Andreu ex rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at

1375.

In Capizzano v. Secretary of Health & Human Services, the United States Court of

Appeals for the Federal Circuit found “[a]s far as the second prong is concerned, in our

view, the chief special master erred in not considering the opinions of the treating

physicians who concluded that the vaccine was the cause of Ms. Capizzano’s injury.”

Capizzano v. Sec’y of Health & Human Servs., 440 F.3d at 1326. Regarding petitioner’s

34

physicians, Special Master Moran noted petitioner’s visits to Dr. Samples, Dr. Bouffard,

Dr. Brignoni, and Dr. Shieh, before addressing the consultations with petitioner’s

rheumatologist, Dr. Hsu, including Dr. Hsu’s statement, that “I am concerned about a pain

syndrome associated with his flu vaccine.” Tullio v. Sec’y of Health & Human Servs., 2019

WL 7580149, at *28. The Special Master stated that “after Dr. Hsu diagnosed Mr. Tullio

with rheumatoid arthritis, she did not associate his disease with his flu vaccination.” Id.

As discussed above, the petitioner’s treating doctors were unable to diagnose petitioner’s

disease for months. Petitioner came to Dr. Hsu initially with an incorrect diagnosis of

Guillain-Barré syndrome, which has been recognized by the Secretary of Health and

Human Services to be associated with the influenza vaccination. See Vaccine Injury

Table, 42 C.F.R. § 100.3(a) (2019) (associating “Seasonal Influenza vaccines” with

“Guillain-Barré Syndrome” “3-42 days” after vaccine administration). After diagnosing

petitioner with rheumatoid arthritis, however, Dr. Hsu did not mention the influenza

vaccination in the medical records of when she saw petitioner. Therefore, Special Master

Moran did not discount the treating physician’s statement, but Special Master Moran took

the entire record into consideration when he found that the second prong of the Althen

test, “logical sequence of cause and effect,” was not satisfied because “no treating doctor

has persuasively opined that the flu vaccination caused Mr. Tullio’s rheumatoid arthritis.”

Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *28; see also Althen v.

Sec’y of Health & Human Servs., 418 F.3d at 1278.

Special Master Moran also stated that “[t]he lack of support from treating doctors

is consistent with the lack of information about the cause of rheumatoid arthritis” because

“the cause of rheumatoid arthritis is not known.” Tullio v. Sec’y of Health & Human Servs.,

2019 WL 7580149, at *28. According to Special Master Moran, “when epidemiologic

studies have explored a potential association, they have not found an increased incidence

of rheumatoid arthritis in people who received the flu vaccine.” Id. Also according to

Special Master Moran, “given this information, it would be surprising for a doctor to tell

Mr. Tullio that the flu vaccination caused his rheumatoid arthritis. See Tr. 219 (Dr. Utz

stating that he has never told any of his rheumatoid arthritis patients that flu vaccination

caused their rheumatoid arthritis).” Id.

The final, and most unusual, section in Special Master Moran’s decision is the

“Testability” section. See id. at *22-*26. Special Master Moran stated, “Dr. Utz and Dr.

Steinman have presented a hypothesis—hemagglutinin and collagen are molecular

mimics—that is testable, but has not been tested directly.” Id. at *24. Special Master

Moran also stated, “[i]f Dr. Steinman or Dr. Utz had conducted experiments about

molecular mimicry, the results could have assisted Mr. Tullio in meeting his burden of

proof.” Id. at *25. Special Master Moran goes so far as to state:

The Vaccine Program would seem to allow for time to seek approval from

an overseeing institution, to carry out the experiment, and to submit an

article for peer review because the pace of litigation has dramatically

slowed. Mr. Tullio’s case came to hearing approximately four years after it

was filed and this time was relatively quick. Moreover, the presence of

35

approximately $4 billion in the Vaccine Injury Compensation Trust Fund

suggests that money is available to pay for experiments.

Id. at *25 n.23. Then, at the end of the section regarding testability, Special Master Moran

presented a caveat that applied to the entire section:

As discussed in sections A and B, the epidemiology and the mechanistic

evidence do not support a finding that the hypothesis of molecular mimicry

between flu vaccine and hemagglutinin is sound and reliable. Therefore, the

lack of testing does not affect the outcome of the case—if this section on

testability were excised from the decision, the undersigned still would have

found that Mr. Tullio did not establish prong 1 [of the Althen test].

Tullio v. Sec’y of Health & Human Servs., 2019 WL 7580149, at *26 (brackets added).

This court notes that at the oral argument before this court, the petitioner explicitly

rejected the Special Master’s suggestion that petitioners in the Vaccine Program should

perform experiments to assist in providing proof for his or her case. In particular, the

petitioner’s attorney stated at the oral argument that the idea of testing “is not really a

practical approach,” because “it raises a lot of concerns for Petitioner, because as in this

case, first of all, I mean, who is going to do this research?” Further, petitioner argued at

the oral argument, that requiring testing “would not resolve their cases quickly” and “it

could be prohibitive, and if they [petitioners] were at a risk of losing the funds they put into

research, then it would, you know, be a reasonable basis type of analysis where they

would not be reimbursed their costs, then you have the -- it would be highly troubling.”

(brackets added). In addition, petitioner states in his motion for review that testing is

“impractical,” asking:

Would petitioners be expected to delay already crucially needed

compensation while their experts engage in testing? Would petitioners be

required to bear the cost of such testing unless and until it is reimbursed

through the granting of a motion for fees and costs? Would petitioners run

the risk of not being compensated for the costs of testing if their claims prove

unsuccessful and are challenged as not having a reasonable basis? What

is the practicality of finding expert researchers willing to sideline present

research and academic focus to run the experiments proposed in the

Decision?

Respondent stated in its response to petitioner’s motion for review in this court, regarding

the Special Master’s testability comments that “his discussion as to testability of

petitioner’s causation theory was clearly dicta.” Moreover, as noted above, the United

States Court of Appeals for the Federal Circuit in Knudsen ex rel. Knudsen v. Secretary

of Health & Human Services outlined the role of the United States Court of Federal Claims

in deciding cases in the Vaccine Injury Compensation Program:

36

The Court of Federal Claims is therefore not to be seen as a vehicle for

ascertaining precisely how and why DTP and other vaccines sometimes

destroy the health and lives of certain children while safely immunizing most

others. This research is for scientists, engineers, and doctors working in

hospitals, laboratories, medical institutes, pharmaceutical companies, and

government agencies. The special masters are not “diagnosing” vaccine-

related injuries. The sole issues for the special master are, based on the

record evidence as a whole and the totality of the case, whether it has been

shown by a preponderance of the evidence that a vaccine caused the

[petitioner’s] injury or that the [petitioner’s] injury is a table injury, and

whether it has not been shown by a preponderance of the evidence that a

factor unrelated to the vaccine caused the child’s injury. See 42 U.S.C.

§ 300aa-13(a)(1), (b)(1).

Knudsen ex rel. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d at 549 (brackets

added); see also Broekelschen v. Health & Human Servs., 618 F.3d at 1345; Andreu ex

rel. Andreu v. Sec’y of Health & Human Servs., 569 F.3d at 1382.

In sum, after reviewing the evidence in the record before him, Special Master

Moran found that the petitioner had failed to meet his burden of proving “a medical theory

causally connecting the vaccination and the injury” with “some indicia of reliability to

support the assertion of the expert witness.” Althen v. Sec’y of Health & Human Servs.,

418 F.3d at 1278; Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d

at 1324.

CONCLUSION

Upon review of the record before this court, including the medical records, the

expert reports, the testimony taken at the hearing before Special Master Moran, and

Special Master Moran’s decision, this court finds that Special Master Moran’s decision,

which concluded that the petitioner had failed to prove, by a preponderance of the

evidence, a medical theory of causation connecting the influenza vaccination to the

petitioner’s allegation that the vaccination caused his rheumatoid arthritis, was not

arbitrary or capricious. The Special Master’s ruling on entitlement denying compensation

to petitioner is AFFIRMED. The Clerk of the Court is instructed to enter JUDGMENT

consistent with this Opinion.

IT IS SO ORDERED.

s/Marian Blank Horn

MARIAN BLANK HORN

Judge

37